Tuesday, August 05, 2008

Panel Urges End to Prostate Screening at Age 75

In a move that could lead to significant changes in medical care for older men, a national task force on Monday recommended that doctors stop screening men ages 75 and older for prostate cancer because the search for the disease in this group was causing more harm than good.

The guidelines, issued by the U.S. Preventive Services Task Force, represent an abrupt policy change by an influential panel that had withheld any advice regarding screening for prostate cancer, citing a lack of reliable evidence. Though the task force still has not taken a stand on the value of screening in younger men, the shift is certain to reignite the debate about the appropriateness of prostate cancer screening at any age.

Screening is typically performed with a blood test measuring prostate-specific antigen, or PSA, levels. Widespread PSA testing has led to high rates of detection. Last year, more than 218,000 men learned they had the disease.

Yet various studies suggest the disease is “overdiagnosed” — that is, detected at a point when the disease most likely would not affect life expectancy — in 29 percent to 44 percent of cases. Prostate cancer often progresses very slowly, and a large number of these cancers discovered through screening will probably never cause symptoms during the patient’s lifetime, particularly for men in their 70s and 80s. At the same time, aggressive treatment of prostate cancer can greatly reduce a patient’s quality of life, resulting in complications like impotency and incontinence.

Past task force guidelines noted there was no benefit to prostate cancer screening in men with less than 10 years left to live. Since it can be difficult to assess life expectancy, it was an informal recommendation that had limited impact on screening practices. The new guidelines take a more definitive stand, however, stating that the age of 75 is clearly the point at which screening is no longer appropriate.

The task force was created by Congress and first convened in 1984 to analyze current medical research and to make recommendations about preventive care for healthy people. Its guidelines are viewed as highly credible and are often relied on by physicians in making decisions about patient care.

“When you look at screening, you have a chance the screening will help you live longer or better, and you have the chance that screening detection and treatment will harm you,” said Dr. Ned Calonge, chairman of the task force and chief medical officer for the Colorado Department of Public Health and Environment. “At age 75, the chances are great that you’ll have negative impacts from the screening.”

It is estimated that one out of every three men 75 and older is now screened for prostate cancer, although some studies suggest the number is even higher. The Journal of the American Medical Association reported in 2006 that in a group of nearly 600,000 older men treated by the Veterans Administration, 56 percent of those ages 75 to 79 had been screened for prostate cancer. Given the large numbers of men over 75 who are being screened, even a small decline in testing may greatly reduce the number of prostate cancer cases detected.

Dr. Calonge said it was important that the guidelines not be viewed as “giving up” on older men. While the new rules should discourage routine testing of older patients, the recommendations will not prevent a man from seeking screening if he desires it, Dr. Calonge said. The new guidelines are not expected to alter Medicare’s current reimbursement for annual PSA screening of older men.

“There will be some men who would say, ‘Let’s do it anyway,’ and other men who say, ‘If we don’t need to do it, let’s not do it,’ ” Dr. Calonge said.

The guidelines focus on the screening of healthy older men without symptoms and will not affect treatment of men who go to the doctor with symptoms of prostate cancer, like frequent or painful urination or blood in the urine or the semen.

Studies of the value of prostate cancer screening for younger men have produced mixed results, but a major clinical trial under way in Europe will try to determine whether there is any value, in terms of longer life expectancy, to screening this group for prostate cancer. Those results may be published as early as next year.

While the verdict is still out on younger men, the data for older men are more conclusive, experts say. The American Cancer Society and the American Urological Association both say annual PSA screening should be offered to average-risk men 50 and older, but only if they have a greater than 10-year life expectancy.

Recently, Swedish researchers collected 10 years of data on men whose cancer was diagnosed after the age of 65 and found no difference in survival among those who were treated for the disease and those whose cancers were monitored but treated only if the cancer progressed. The finding suggests that for most men, stopping screening at 75 is a safe option.

“If someone has made it to the age of 75 and they don’t have an elevated PSA, the likelihood of them developing clinically significant prostate cancer in the last 10 to 15 years of their life is pretty low,” said Dr. Peter C. Albertsen, professor of urology at the University of Connecticut Health Center. “The downside risk begins to outweigh the upside at the age of 75.”

Some studies suggest that as many as half of men 75 and older have clinically insignificant prostate cancer that is unlikely to affect their health but may be found through a biopsy. If the disease is detected as a result of screening, the men may be actively treated with radiation or hormone therapies, or may endure the stress of “watchful waiting” to see if the disease progresses.

Treatments for prostate cancer can cause significant harm, rendering men incontinent or impotent, or leaving them with other urethral, bowel or bladder problems. Hormone treatments can cause weight gain, hot flashes, loss of muscle tone and osteoporosis.

“I’m very pleased the prevention task force has said, at least for the old guys, ‘Leave them alone because our evidence suggests it doesn’t help,’ ” said Dr. Derek Raghavan, director of the Cleveland Clinic Taussig Cancer Institute. “Taking an 80-year-old and telling him he has cancer and telling him he needs radiotherapy or surgery uses up medical resources and puts him at risk. It’s a step toward rational thinking.

Sunday, July 06, 2008

Costly Cancer Drug Offers Hope, but Also a Dilemma

It took only an instant for 58-year-old Gailanne Reeh to go from the picture of health to death’s door. By chance, her doctor noticed a lump under her arm during a routine exam. It turned out to be advanced breast cancer.

Soon she was having tests to reveal the extent of the cancer and hearing the grim results.

The surgeon, she recalled, “looked at me and said: ‘This is not a conversation I like to have. But I can’t do anything for you. You can’t be cured. You can’t be treated. All we can do is manage your cancer.’ ” On scans to detect tumors, the doctor told Ms. Reeh, “you light up like a Christmas tree.”

And so, like many others in that situation, Ms. Reeh, the vivacious owner of a staffing agency in Boston, was given bevacizumab, also known as Avastin, a drug that signifies both the hopes and dilemmas of modern medicine.

Looked at one way, Avastin, made by Genentech, is a wonder drug. Approved for patients with advanced lung, colon or breast cancer, it cuts off tumors’ blood supply, an idea that has tantalized science for decades. And despite its price, which can reach $100,000 a year, Avastin has become one of the most popular cancer drugs in the world, with sales last year of about $3.5 billion, $2.3 billion of that in the United States.

But there is another side to Avastin. Studies show the drug prolongs life by only a few months, if that. And some newer studies suggest the drug might be less effective against cancer than the Food and Drug Administration had understood when the agency approved its uses.

While many patients and their doctors say the drug can improve the quality of life — like a sense of well-being and an ability to carry out daily tasks without exhaustion or pain — such effects can be hard to document. Meanwhile, many patients with cancers other than those of the colon, lung or breast are taking the drug, even in cases where there is no compelling evidence that it can help.

Avastin also has serious, if infrequent, side effects, some of which can be lethal. And because it is almost always used with standard chemotherapy — it did not work as well when researchers tried it alone — patients on Avastin do not escape chemotherapy’s side effects.

“I still use Avastin routinely, but it’s sobering,” Dr. Leonard Saltz, a colon cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, said of the new data. “It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.”

If Avastin were inexpensive or if it cured cancer or even held it at bay, as the drug Gleevec does for blood cancer, few might care. But like a half-dozen or so new biotechnology drugs with a similar combination — alluring promise, high price and only arguable benefits — Avastin raises troubling questions:

What does it mean to say an expensive drug works? Is slowing the growth of tumors enough if life is not significantly prolonged or improved? How much evidence must there be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation?

For a patient like Ms. Reeh, fighting for her life, the cost is not the main concern. If her insurer did not pay, she said, she would go into debt, find a way to raise the money.

But some in the pharmaceutical industry worry that such prices will raise concerns about whether the drugs are worth it, leading to a backlash like price controls or restrictions on use.

Roy Vagelos, a former chief executive of Merck who is considered an elder statesman of the industry, said in a recent speech that he was troubled by a drug, which he would not name but which was a clear reference to Avastin, that costs $50,000 a year and adds four months of life. “There is a shocking disparity between value and price,” he said, “and it’s not sustainable.”

Some patient advocates are also troubled by very expensive treatments like Avastin coming into routine use on what they see as little more than a hope and an expensive prayer.

“It’s absolutely critical that we start having a public discussion,” said Barbara Brenner, executive director of Breast Cancer Action, an advocacy group. “I think of Avastin as a model that is showing us where the problem is.”

The Rising Cost

The problem is largely one of cost.

Cancer drugs constitute the second biggest category of drugs in the United States behind cholesterol-lowering medicines, and accounted for $17.8 billion of total prescription drug sales of $286.5 billion in 2007, according to IMS Health, a health care information company. Spending on drugs for cancer grew 14 percent last year, faster than for all but three other diseases.

About 100,000 Americans take Avastin, according to Genentech’s data. The drug is being formally tested in as many as 450 clinical trials for about 30 types of cancer. And Genentech, its partner Roche and the National Cancer Institute are now starting studies that will include more than 26,000 people with lung, colon or breast cancer at earlier stages of the disease than were studied initially. If Avastin is approved for those earlier-stage patient groups, it could have a major impact in delaying the return of their cancer, but hundreds of thousands of additional people could end up taking it, possibly for years.

And that, insurers and patient advocates say, could impose a considerable financial burden.

The drug’s price, as charged by Genentech, can be $4,000 to more than $9,000 a month, depending on a patient’s weight and the type of cancer. Avastin’s cost to patients and insurers can be much higher, though, because doctors and hospitals buy the drug and then sell it to patients or their insurers, often marking up the price. So the $2.3 billion that Genentech recorded in sales of Avastin represents only part of what Americans spent on the drug last year.

And while doctors typically want the best for their patients, there also are other factors that may push them to prescribe Avastin.

“Think about where the interests are aligned,” said Dr. Deborah Schrag, a colon cancer specialist at the Dana-Farber Cancer Institute in Boston. “Patients who seek out cancer care are often quite willing to try all kinds of things. Doctors want to help them and may be financially incentivized. And it is often quite hard for insurance companies to intervene.”

Medicare requires that the doctor or hospital buying Avastin be paid an amount equal to Genentech’s average selling price plus a markup of 5 to 6 percent. Of that amount, Medicare pays 80 percent and the patient pays 20 percent. Doctors and hospitals typically do not make much money on Avastin for Medicare patients, and can even lose money if they buy the drug at a price that is higher than average. But patients can end up paying thousands of dollars a month. Some have supplemental insurance to take care of it; others do not.

But private insurers sometimes pay several times as much as Medicare pays for Avastin. Doctors and hospitals have at times charged as much as $35,000 a month for the drug, said Dr. Peter Dumich, who reviews claims for cancer patients for AWAC, a company that helps employers contain health care costs. The insurers have little choice, Dr. Dumich says, when their contracts say they must pay a portion, like 80 percent of the charge, whatever the charge actually is. “Providers have them over a barrel,” he said.

And, like Medicare, private insurers may in turn require patients to pay a percentage of what can be hefty bills.

That has happened to Jim Lemieux, a colon cancer patient at Dana-Farber. His private insurance requires that he pay 25 percent of the cost of his treatment, which includes Avastin. His insurer, he said, is charged $6,000 a month for the drug, making his share $1,500.

Mr. Lemieux, who was a sales manager at a car dealership, says he cannot bear to look at his medical bills. They include bills for hospitalizations and surgery and co-payments for standard chemotherapy, as well as Avastin.

To try to make ends meet, he and his wife just sold their house and are moving into their son’s basement. Even so, he says, he expects he will have to file for bankruptcy.

“You figure you’ve got insurance,” Mr. Lemieux said. “I paid 30 years and never got sick. I should have just paid the money to myself.”

But he is not planning to give up Avastin.

“I’m trying to stay alive,” Mr. Lemieux said. “I decided I’m not going to die from Stage 4 colon cancer.”

A Promising Dream

When Napoleone Ferrara was hired by Genentech in 1988, he was assigned to work on a drug to ease labor during childbirth. But he could not get cow pituitary glands out of his mind.

Dr. Ferrara had noticed in his previous academic job that when he mixed extracts from the glands with cells from blood vessels, the vessel cells started to grow rapidly. Something made by those glands, he reasoned, could spur vessel growth. He found that substance in 1989 and called it vascular endothelial growth factor, or VEGF (pronounced VEJ-eff). He even isolated its gene. And that led to a new idea for a cancer drug.

It drew from a hypothesis for a sort of universal cancer treatment, advanced by the late Dr. Judah Folkman of Harvard. Dr. Folkman had argued, starting in 1971, that tumors must grow their own blood vessels to bring them nourishment and oxygen. If you could choke off those vessels, Dr. Folkman said, you could halt cancers.

Dr. Ferrara and his colleagues realized that if they could block VEGF, cancer cells might not be able to grow blood vessels. So Genentech developed a monoclonal antibody, a type of protein, that would bind to VEGF and disable it. In 1997, the company began testing its antibody, which became Avastin, in cancer patients.

There were some setbacks. Avastin failed in its first big clinical trial, against very advanced breast cancer. Genentech’s stock dropped 10 percent in one day, and some analysts questioned whether the company’s investment would ever pay off.

Meanwhile, the company was well into a trial of Avastin for colorectal cancer. Patients got chemotherapy plus either Avastin or a placebo. The Avastin patients lived more than four months longer, a median of 20.3 months, compared with 15.6 months for the other group. “We were excited,” Dr. Schrag said. “Four months is big.”

In February 2004, 15 years after Dr. Ferrara’s initial discovery, the Food and Drug Administration approved Avastin for patients with advanced colon cancer. A blockbuster was born.

But now there is a question mark over that evidence. That first exciting result compared Avastin with a type of chemotherapy that has since been widely replaced by a more effective regimen.

In a later, larger study comparing Avastin with current chemotherapy, Avastin slowed the growth of tumors but did not extend life by an amount considered statistically significant.

Dr. Schrag said she would continue to give the drug to her colon cancer patients. But when she talks to patients about Avastin now, she said, she will add a few more caveats.

She believes that some patients are helped — that they may feel better and, she hopes, may even, in some cases, live longer. She says a few of her Avastin patients lived several years and some are still alive. Of course, she acknowledges, there is no proof that Avastin was responsible, but it is stories like those that give her, and patients, hope.

“All patients want to be the tail end of the survival curve,” Dr. Schrag said.

When Avastin was approved for colon cancer, Genentech decided to charge $2,200 for an average dose, taken every two weeks. That was a reflection of the research and development it had put into the drug as well as continuing research, said Walter Moore, the company’s director of government relations.

Genentech, which has never before revealed what it spent to develop Avastin, now says that it and its partner Roche have spent more than $2.25 billion starting with Dr. Ferrara’s original work. The figure includes research, clinical trials and filing for regulatory approval and is well beyond what was spent by the federal government, which conducted important clinical trials of Avastin. Through May 2006, the government had spent $44.6 million on Avastin trials and related laboratory work, according to figures obtained from the National Cancer Institute by Consumer Watchdog, an advocacy group.

While it is impossible to compare directly the company’s investment to the costs of developing other cancer drugs, the amount Genentech says it spent is “on the high side” of the industry average, said Henry Grabowski, a professor of economics at Duke University who has analyzed drug development costs.

Genentech says it and Roche — which owns a majority of Genentech and markets Avastin outside the United States — will spend an additional $1 billion testing Avastin as a treatment for early-stage cancers.

The price also reflected Genentech’s perceived value of the drug compared with other cancer treatments. The price was half that of Erbitux, a colon cancer drug from ImClone Systems and Bristol-Myers Squibb that was approved the same month as Avastin and had not been shown to prolong life.

But Avastin is typically used for a longer time and by more patients than Erbitux. And the Avastin dose for lung and breast cancer is twice that for colon cancer, doubling the price.

Eric Schmidt, an analyst at Cowen and Company, said pharmaceutical companies typically based drug prices on what the market could bear.

“It’s high because Genentech can price it high,” he said, noting that Avastin’s price was in line with that of some other cancer drugs. Despite the company’s research and development costs, Mr. Schmidt said, Genentech is one of the most profitable of pharmaceutical and biotechnology companies.

Other countries have different views about whether Avastin is worth its price. An institute that advises the British government on which drugs to pay for recommended against it, saying that the drug was not cost effective based on its cost per year of life extended.

In the United States, Genentech argues that it puts patients first, with free drugs for those who have no way to pay for them and donations to charities that can help with payments. It also capped the price for a year’s supply of Avastin at $55,000 (not counting markups by doctors and hospitals) for patients with incomes of less than $100,000 a year.

But progress against cancer has a price, the company says.

“The quest is to eliminate the disease,” Arthur D. Levinson, Genentech’s chief executive, said at an annual investor meeting. “And, yes, there is going to be a cost to that.”

Of Dubious Benefit

After colon cancer, the next target was lung cancer.

Dr. Bruce Johnson of Dana-Farber knew the difficulties well. He had been at the National Cancer Institute, where he reviewed 25 years’ worth of clinical trials, 30 studies that started with high hopes and ended with little progress. He used to give talks quoting a World War I general: “Ground gain minimal. Casualties huge. Conclusion — press on.”

Avastin, in that context, looked like something of a triumph. Patients who took it along with standard chemotherapy survived for a median of 12.3 months, compared with 10.3 months for those getting only chemotherapy. The results were announced in 2005. “Finally,” Dr. Johnson said, “something worked.”

But as with colon cancer, a newer study adding Avastin to a different chemotherapy regimen has raised questions about its effectiveness against lung cancer. The study’s Avastin patients lived no longer than those who got the chemotherapy plus placebo. Although the drug did slow the median time until progression of tumors, the difference was less than a month.

The third approval for Avastin, for advanced breast cancer, came in February of this year. The clinical trial found it significantly slowed the progression of cancer but did not significantly extend life. The F.D.A. went against its own panel of outside experts, who had voted 5 to 4 against approval.

The agency’s action has not sat well. Senator Charles E. Grassley, Republican of Iowa, asked the Government Accountability Office to look into the F.D.A.’s approval of Avastin and some other drugs that “appear to have little to no effect in protecting lives and increasing health.”

Dr. Lee Newcomer, an oncologist and executive at the insurer United HealthCare, said patients were not well served, and neither were insurers, nor the public, which ultimately foots the bill. If a drug just stops tumor progression, without the woman’s living longer or feeling better, without her noticing anything different, Dr. Newcomer said, “you’re treating an X-ray.”

Patient advocacy groups were split.

“Even when these drugs ‘work,’ what kind of impact are you talking about?” said Fran Visco, president of the National Breast Cancer Coalition, which opposed approval. “But we market them and give them to everybody.”

Yet other doctors and advocates for patients say that when tumors grow, patients can notice new or worsening symptoms. And they certainly experience greater anxiety.

Dr. Kathy Albain, a breast cancer specialist at Loyola University Medical Center in Maywood, Ill., polled colleagues and patients and found overwhelming support for approving drugs based on delaying tumor progression. It would be ideal to show that a drug also prolongs life, but that may not be realistic, she said. The reason is that when a woman’s cancer progresses, doctors change the drugs they use, hoping to slow the cancer. That dilutes any impact of the first drug — in this case Avastin.

Kay Wissmann, director for government relations at the Breast Cancer Network of Strength, a patient advocacy group, said women should have a choice to use Avastin.

“We’ve got some good evidence about this particular drug,” she said, “so maybe we should let the people with metastatic disease have the option of using it.”

Unapproved Uses

Then there are patients who cannot wait for evidence that a drug works for their cancer.

One patient’s husband had no medical training. But he determined through his own literature search that his wife’s form of brain cancer produced a lot of VEGF, the very substance Avastin neutralized. So the couple wanted to try Avastin, even though it had never been tested for brain cancer. It was 2004, when the only Avastin approval was for colon cancer.

They asked the woman’s doctor, Dr. Virginia Stark-Vance, to give them the drug.

Dr. Stark-Vance, a solo practitioner in Dallas and Fort Worth, was reluctant, worried that Avastin could cause bleeding in the brain. That had happened in one of the earliest clinical trials, when a 29-year-old woman whose liver cancer had spread to her brain collapsed from a hemorrhage while riding her bicycle.

Finally, Dr. Stark-Vance agreed on the condition that the woman be hospitalized to receive Avastin, in case there was a brain hemorrhage. Had there been one, Dr. Stark-Vance “could have lost her license,” said Dr. Henry Friedman, a brain cancer specialist at Duke.

Like many others taking Avastin, this woman plunged into the unknown, without the assurance of a clinical trial studying whether the drug worked for her type of cancer.

Doctors are free to prescribe Avastin, or any other drug on the market, for unapproved uses, at their discretion. As much as 75 percent of cancer drug use is of this “off label” variety, according to an estimate by the National Comprehensive Cancer Network, a group of big cancer centers. And some doctors say that with patients dying, they simply cannot wait for airtight evidence.

“Of course we want everything to be evidence-based,” said Dr. Yashar Hirshaut, an oncologist in Manhattan. “I also like the American flag and apple pie.”

But, he explained, “You say, ‘This person is dying right here and I need something that will help, and there’s a logical construct that I can see how it will help.’ ”

One of his patients, Alice Lichter, has had gastric cancer since 2006. Dr. Hirshaut is throwing the whole arsenal at it, giving her gemcitabine, a drug used for pancreatic cancer, plus virtually every drug approved for colon cancer: Avastin, Erbitux, Eloxatin, irinotecan, 5-FU and leucovorin. Most are not approved for gastric cancer.

Once every two to four weeks, Ms. Lichter, 72, flies from her home in Miami and checks into Lenox Hill Hospital in Manhattan, where she undergoes four days of intravenous infusions.

“I call Lenox Hill my second home,” she said.

‘You Name It, It Got Tried’

Ms. Lichter, whose cancer appears to have receded, said she never questioned Dr. Hirshaut’s judgment. And she has no idea how much her drugs cost because Medicare is paying for them and her supplemental insurance covers her co-payment. Insurers say they are often forced by state laws to pay for cancer drugs not approved by the Food and Drug Administration, and Medicare must pay if the drug’s use is listed in a compendium, a reference compiled by cancer specialists, whose standards are looser than the F.D.A.’s.

Such requirements are one reason about 12 percent of United HealthCare’s Avastin patients have cancers other than colon, breast and lung. “Brain, stomach, pancreas, primary cancers of the liver, bladder, small bowel, larynx, prostate — you name it, it got tried,” Dr. Newcomer said.

But the anecdotes and evidence from small trials that may seem to justify off-label use sometimes turn out to be misleading. That happened with pancreatic cancer. After patients and doctors decided Avastin had to be helping, cancer researchers themselves conducted a large study. So did Roche. Avastin, both studies concluded, did not prolong life for people with cancer of the pancreas.

For brain cancer, doctors are encouraged, although they do not really know for sure whether Avastin helps. The brain tumor in Dr. Stark-Vance’s patient shrank so much after two infusions of Avastin that the radiologist who performed the brain scans called Dr. Stark-Vance in wonderment.

Dr. Stark-Vance began treating more patients. Some insurers paid for the drug. Others, including Medicare and Medicaid, did not. But Dr. Stark-Vance said Genentech agreed to provide the drug free for her patients who could not otherwise pay.

As word spread, Dr. Friedman at Duke and Genentech organized studies of a type generally considered less than definitive. There was no control group that took another drug or got a placebo. Everyone got Avastin. Otherwise, no one would enroll in the study, doctors argued.

Then the investigators compared the results with what they thought would have happened without Avastin. The patients lived a median of about nine months, about three months longer than the researchers estimate would have been expected.

But such comparisons have led scientists seriously astray in the past because the people being treated with a new drug often are very different from previous patients who did not take it and because overall medical care steadily improves. Nonetheless, Genentech has said it planned to apply this year to the F.D.A. for approval for Avastin to treat glioblastoma, the deadliest form of brain cancer.

Dr. Stark-Vance said her initial Avastin brain cancer patient broke her hip and had to be taken off the drug because it interfered with wound healing. She eventually died.

But by now, even without an F.D.A. approval, “the whole country” is using Avastin for glioblastoma, Dr. Friedman said.

Better Than Nothing?

Gailanne Reeh remembers what life was like within a few months of those initial scans, when her cancer began causing terrible symptoms.

Her abdomen grew so full of fluid that it was hard to bend to tie her shoes. Bowel movements were difficult, and even lying down was uncomfortable with that huge mass in her abdomen.

She says she was chilled by what she recalls her doctor saying: “There was so much growing so fast in my abdomen and so much in my bowel, it was not a matter of maybe I would get a bowel obstruction. It was when I would get a bowel obstruction,” Ms. Reeh said. “And when I got it, there would be nothing anyone could do. I would die.”

To try to stave off such a horrible outcome, her oncologist, Dr. Eric Winer of Dana-Farber, offered to enroll her in a clinical trial comparing Avastin with another new biotech drug. Ms. Reeh was assigned to the group that got Avastin in combination with the chemotherapy drug paclitaxel, also known as Taxol.

The study closed after six months, but Ms. Reeh continued with her drug regimen, and her insurer is paying. After six months of treatment the fluid in her abdomen was down to just a trace, her tumors were stable or smaller and she felt like her former self again.

“I’m really, really excited,” she said.

Was it the Avastin?

Dr. Winer said he did not know, since Taxol can also shrink tumors. It is impossible to draw conclusions from individual patients, he said. Still, he said, “I think it is quite likely that the combination of Taxol and Avastin improved her odds of having a better quality of life.”

Dr. Winer says that when he is not sitting in front of a patient, he thinks about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit — even if only a little — from Avastin along with chemotherapy, he has to think about his patient’s needs.

“I can’t say, ‘Let’s not use Avastin; it’s a very expensive drug and I am worried about the cost to society,’ ” Dr. Winer said.

And so, Dr. Winer said, the answer you get when you ask whether drugs like Avastin are worth it very much depends on whom you ask.

“A person who hasn’t been affected by cancer will say, ‘Gee, why should we pay for an expensive treatment that doesn’t extend life when we have other needs?’ ” Dr. Winer said.

A person like Ms. Reeh will have a different response. She does not want to give up Avastin.

Last month, she reluctantly stopped taking her drugs for a while because Taxol was injuring the nerves in her feet. But later this month she hopes to resume taking both drugs, or at least Avastin.

Ms. Reeh says she knows her cancer may very well kill her eventually. But what is it worth to feel better again?

“It’s really about living and not waiting to die,” she said.

And what if 5 percent of Avastin patients live a lot longer than they would have without the drug?

“I might be in that 5 percent,” she said.

The New York Times -- Health

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Sunday, June 29, 2008

Weighing the Costs of a CT Scan’s Look Inside the Heart

A group of cardiologists recently had a proposition for Dr. Andrew Rosenblatt, who runs a busy heart clinic in San Francisco: Would he join them in buying a CT scanner, a $1 million machine that produces detailed images of the heart?

The scanner would give Dr. Rosenblatt a new way to look inside patients’ arteries, enable his clinic to market itself as having the latest medical technology and provide extra revenue.

Although tempted, Dr. Rosenblatt was reluctant. CT scans, which are typically billed at $500 to $1,500, have never been proved in large medical studies to be better than older or cheaper tests. And they expose patients to large doses of radiation, equivalent to at least several hundred X-rays, creating a small but real cancer risk.

Dr. Rosenblatt worried that he and other doctors in his clinic would feel pressure to give scans to people who might not need them in order to pay for the equipment, which uses a series of X-rays to produce a composite picture of a beating heart.

“If you have ownership of the machine,” he later recalled, “you’re going to want to utilize the machine.” He said no to the offer.

And yet, more than 1,000 other cardiologists and hospitals have installed CT scanners like the one Dr. Rosenblatt turned down. Many are promoting heart scans to patients with radio, Internet and newspaper ads. Time magazine and Oprah Winfrey have also extolled the scans, which were given to more than 150,000 people in this country last year at a cost exceeding $100 million. Their use is expected to soar through the next decade. But there is scant evidence that the scans benefit most patients.

Increasing use of the scans, formally known as CT angiograms, is part of a much larger trend in American medicine. A faith in innovation, often driven by financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques. Patient advocacy groups and some doctors are clamoring for such evidence. But the story of the CT angiogram is a sobering reminder of the forces that overwhelm such efforts, making it very difficult to rein in a new technology long enough to determine whether its benefits are worth its costs.

Some medical experts say the American devotion to the newest, most expensive technology is an important reason that the United States spends much more on health care than other industrialized nations — more than $2.2 trillion in 2007, an estimated $7,500 a person, about twice the average in other countries — without providing better care.

No one knows exactly how much money is spent on unnecessary care. But a Rand Corporation study estimated that one-third or more of the care that patients in this country receive could be of little value. If that is so, hundreds of billions of dollars each year are being wasted on superfluous treatments.

At a time when Americans are being forced to pay a growing share of their medical bills and when access to medical care has become a major political issue for states, Congress and the presidential candidates, health care experts say it will be far harder to hold down premiums and expand insurance coverage unless money is spent more wisely.

The problem is not that newer treatments never work. It is that once they become available, they are often used indiscriminately, in the absence of studies to determine which patients they will benefit.

Some new treatments, like the cancer drug Gleevec and implantable heart defibrillators, undoubtedly save lives, contributing to the United States’ reputation for medical breakthroughs. But others — like artificial spinal disks, which can cost tens of thousands of dollars to implant but have not been shown to reduce back pain in many patients, and Vytorin, a new cholesterol drug that costs 20 times as much as older medicines but has not been proved superior — have been criticized for not justifying their costs.

And sometimes, the new technologies prove harmful. Physicians were stunned, for example, when clinical trials showed last year that expensive anemia medicines might actually hasten death in kidney and cancer patients. Such drugs are used more widely in the United States than elsewhere.

“We have too many situations where we thought we knew what the answer was and it didn’t turn out like everyone thought,” said Dr. Mark Hlatky, a cardiologist and professor of health research and policy at Stanford University.

A Tool of Dubious Value

The problem of inadequate study is especially serious for medical devices and imaging equipment like scanners, which typically are not as strictly regulated as prescription drugs. Under Food and Drug Administration regulations, the makers of CT scanners — CT is short for computed tomography — do not have to conduct studies to prove that their products benefit patients, as drug makers do. The manufacturers must certify only that the scanners are safe and provide accurate images.

Once the F.D.A. approves a test or device, Medicare rarely demands evidence that it benefits patients before agreeing to pay for it. But last year, Medicare officials raised questions about the benefits of CT heart scans and said it would demand more studies before paying for them. But after heavy lobbying by cardiologists, Medicare backed down. Private insurers, while initially reluctant to pay for the tests, are also covering them.

Physicians in this country have a free hand in deciding when to use new technology like CT angiography. Some are conservative. But others, especially doctors in private practice who own their scanners, use the tests aggressively.

Douglas Ring, a 63-year-old Los Angeles real estate developer, said he received a CT heart scan in October 2005, on the advice of Dr. Ronald P. Karlsberg, a Beverly Hills cardiologist. “Ron has been my physician for 15 or 20 years, and he got this new toy in his office, and he said I should try it,” Mr. Ring said. He took the test despite having no symptoms of heart disease, like shortness of breath and chest pain. He was already taking cholesterol medicine, and a different test had shown no problems with his heart.

The CT heart scan by Dr. Karlsberg found a moderate buildup of plaque in one of Mr. Ring’s coronary arteries. The doctor increased Mr. Ring’s cholesterol medicines and encouraged him to diet and exercise.

Dr. Karlsberg said he considered the information from Mr. Ring’s CT scan extremely valuable. “Here’s a case of near-serious coronary disease that required medical management,” said Dr. Karlsberg, a partner at the Cardiovascular Medical Group of Southern California, which conducted about 1,400 CT heart scans last year.

Many other cardiologists, though, say patients like Mr. Ring do not benefit from CT scans. And by the time they are 50, most people will have plaque visible on a CT scan, so the findings of Mr. Ring’s scan were not surprising.

Arteries narrowed by plaque are not necessarily a threat, said Dr. Eric Topol, a practicing cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. The danger arises when bits of plaque break and produce a clot that blocks blood to the heart. But CT angiograms cannot tell whether a particular blockage is likely to rupture or, except in extreme cases, is keeping the heart from receiving enough blood.

If doctors do choose to treat blockages, they can insert stents — small metal scaffolds that prop open arteries. But while stents have been proved to reduce chest pain, they have not been shown to prolong patients’ lives or help them avoid heart attacks. Patients with the most severe blockages can receive bypass surgery, which when necessary can be a lifesaving procedure.

And so patients who do not have chest pain, like Mr. Ring, should not receive CT heart scans, said Dr. Rita Redberg, a cardiologist and researcher at the University of California, San Francisco, who is a leading critic of the scans.

“No data suggests that there’s any reason for anyone asymptomatic to have a test,” she said. “There certainly is this idea that having a test can help you prevent a heart attack, and I don’t know where it came from.”

Further, each scan creates an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1 in 5,000, said Dr. David J. Brenner, director of the Center for Radiological Research at Columbia University. Younger patients and women are at higher risk.

Dr. Karlsberg and other cardiologists who support widespread use of CT heart scans argue that they can reduce the need for other tests — like conventional angiograms, which can find plaque but require a catheter to be threaded through the arteries. Conventional angiograms are more expensive than CT scans and carry their own risks.

If a CT heart scan finds plaque that a doctor intends to treat with a stent, a conventional angiogram will still be necessary to determine where and how to implant the stent. So a CT scan does not always eliminate the need for a conventional angiogram.

The most valuable use of a CT angiogram may be when a patient comes to an emergency room complaining of chest pains but has few other symptoms of a heart attack. The test can quickly rule out heart trouble. But such patients represent a minority of those receiving CT heart scans.

Dr. Karlsberg also pointed to the case of a seemingly healthy 68-year-old patient whom he scanned in his office in 2006. To the shock of both doctor and patient, the scan revealed a 95 percent blockage of the patient’s main coronary artery. The patient had immediate bypass surgery to relieve the blockage, an operation that may have saved his life, Dr. Karlsberg said. The man, who cited privacy concerns in asking that his name not be used, confirmed the doctor’s account.

Cardiologists who oppose wide use of the scans agree that they can sometimes find dangerous blockages that require immediate surgery in asymptomatic patients. But they said such cases are extremely rare — not common enough to justify using the scans routinely, given their cost and radiation risks.

For too many people, the scans are simply inappropriate, said Dr. Howard C. Herrmann, director of interventional cardiology at the University of Pennsylvania. “I find many patients have CT angiograms who shouldn’t be getting CT angiograms.”

As more than 13,000 heart doctors gathered in Chicago in late March for the annual American College of Cardiology conference, the biggest and best-located booths belonged to General Electric, Philips Electronics, Siemens and Toshiba, the leading makers of the machines used for CT angiograms.

Cardiologists hired by the companies offered short briefings on ways to reduce radiation doses, while sales representatives in business suits quietly talked up the benefits of the scans and the clarity of the images. The sales atmosphere was low key, more art gallery than “Glengarry Glen Ross.”

A hard sell is unnecessary because the manufacturers are finding a receptive audience. Many cardiologists have been eager for a new tool that lets them see inside the heart with unprecedented clarity — while also providing a new source of revenue.

Use of CT scans accelerated after 2004, when manufacturers introduced a new generation called 64-slice scanners, which are fast enough to capture images of a beating heart. The scanners fire X-rays in a series of rotations around the torso, generating thousands of narrow vertical images. Sophisticated software then combines data from the X-rays into a single image.

The Financial Incentives

Already, more than 1,000 hospitals and an estimated 100 private cardiology practices own or lease the $1 million CT scanners, which can be used for the angiograms and for other imaging procedures. Once they have made that investment, doctors and hospitals have every incentive to use the machines as often as feasible. To pay off a scanner, doctors need to conduct about 3,000 tests, industry consultants say.

Fees from imaging have become a significant part of cardiologists’ income — accounting for half or more of the $400,000 or so that cardiologists typically make in this country, said Jean M. Mitchell, an economist at Georgetown University who studies the way financial incentives influence doctors.

Besides generating profits themselves, the scans enable cardiologists to find blockages in patients who have no symptoms of heart problems. Doctors can then place stents in patients who would not otherwise have received them, generating additional revenue of $7,500 to $20,000 per patient.

While clinical trials have not shown that stents benefit patients with no symptoms of heart disease, they are still routinely inserted in such patients when tests find significant blockages. Cardiologists joke that the phenomenon is “ocular stenosis” — blockages that can be seen are stented.

“You find a lot of asymptomatic disease,” said John O. Goodman, a business consultant to cardiologists. “It will put more patients in the cath lab” — medical shorthand for a cardiac catheterization laboratory, where conventional angiograms and stenting procedures take place.

Ms. Mitchell said cardiologists simply practice medicine the way the health system rewards them to. Given the opportunity to recommend a test for which they will make money, the doctors will.

“This is not greed,” she said. “This is normal economic behavior.”

Doctors who perform a lot of CT heart scans tend to be evangelists for the technology. Dr. John A. Osborne, a cardiologist in solo practice in Grapevine, Tex., just outside Dallas, argues that CT angiograms catch heart disease at its earliest stages. His Web site, sothcardiology.com, states the proposition in stark terms: “Half of Americans have died of heart attacks and strokes. Which one are you?”

Supported by a staff of about 20 people, Dr. Osborne estimates that he does 15 CT angiograms a day. Arterial plaque is “cancer of the coronaries,” he tells patients. “Do you have it or not?”

Before their plaque creates symptoms, Dr. Osborne asserts, patients should be aggressively treated, urged to diet and exercise and given cholesterol-lowering and other drugs.

Scans ‘Sell Themselves’

Like many cardiologists who perform CT scans, Dr. Osborne relies on primary-care doctors to send him candidates. He frequently gives lectures to primary-care doctors on the technology’s benefits. When doctors see the images, he said, “they become true believers.”

Two years ago, Dr. Osborne persuaded a family practice doctor, Dr. Michael Dotti, to have his own CT angiogram at no cost. Dr. Dotti was amazed at the scan’s ability to spot early signs of disease. “It’s nice to know I have clear arteries at 51,” he said. “The scans sort of sell themselves.”

The technology has been covered in the news media, including a September 2005 Time magazine cover on CT angiograms, “How New Heart-Scanning Technology Could Save Your Life.” The following month, Oprah Winfrey devoted a segment of her television program to women’s heart disease and recommended that her viewers consider taking the test. Representatives for Time and Ms. Winfrey declined to comment on their coverage of the technology.

Even cardiologists who think the CT scans are overused say they may one day prove valuable. If manufacturers can produce scanners that can determine which plaques are stable and which are likely to rupture, the machines could revolutionize the treatment of heart disease. Patients found to be at low risk might be able to avoid taking medicine entirely, while others would be given intensive treatment.

But for now, doctors cannot use the images that way. Finding out whether the heart is actually short of blood and at high risk for an attack requires tests other than a CT scan — most likely, a nuclear stress test, which uses radioactive dye to track blood flow through the coronary arteries.

The CT angiogram is “a great technology searching for a great application,” said Dr. Charanjit S. Rihal, the director of the cardiac catheterization laboratory at the Mayo Clinic in Rochester, Minn., who sees little diagnostic value in the current generation of heart scanners.

CareCore National, a Bluffton, S.C., company that reviews treatment and test requests for health insurers, has found that when doctors request a CT angiogram for a patient, they also frequently ask for a nuclear stress test.

“We’re seeing layering of tests on top of each other,” said Dr. Russell Amico, a CareCore executive. His company denies as many as 70 percent of the CT scans requested, a much higher rate of rejection than for other kinds of tests his company reviews.

Impatient Patients

Sometimes, it is not the doctor but the patient who is eager for the scan. On a recent Wednesday morning on the Upper East Side of Manhattan, Dr. Harvey Hecht at Lenox Hill Hospital watched from a lead-shielded control room as a 59-year-old patient, Robert Franks, underwent a CT angiogram.

Mr. Franks has a family history of cardiac disease, and his father and two uncles died of heart attacks. But Mr. Franks, director of corporate security for Time Inc., is in excellent shape. He works out daily and takes two cholesterol-lowering medicines. The drugs have reduced his LDL, or bad, cholesterol to 60, a remarkably low level.

Nonetheless, in February, Mr. Franks took a test called a calcium score, which measures the amount of calcified plaque in the arteries. The test, a less extensive form of scanning, revealed a moderate buildup of calcium in his arteries, a potential sign of heart disease.

So he decided to have a nuclear stress test. When that test showed no problem, the cardiologist who conducted it said he did not need more testing.

But Mr. Franks was still not satisfied. “I’m someone who wants to know,” he said.

After doing research on the Internet, he found Dr. Hecht, who recommended a CT angiogram. Dr. Hecht acknowledged that Mr. Franks probably did not have severe heart disease. But he said the scan would be valuable anyway because it might reassure him. And his insurance would cover the cost.

A CT scanner is 8 feet high by 8 feet wide and 2 feet deep, with a doughnut-shaped hole at its center. Wearing a hospital gown, Mr. Franks lay on a table attached to the machine and was injected with a drug to lower his heart rate, along with a contrast dye to improve the quality of the images from the test. (Mr. Franks later compared the warmth he felt after the injection of the dye to “the first sip of a well-blended martini.”)

In the control room, Salvatore Fevola, the manager of the CT scanning equipment at Lenox Hill, instructed Mr. Franks, who was raising his hands over his head, to hold his breath as the table moved through the machine.

Twelve seconds later, the test was complete, and the machine’s software began to assemble information from thousands of images into a single coherent picture of Mr. Franks’s heart.

A few minutes later, Dr. Hecht studied the results. As he had expected, the angiogram revealed that Mr. Franks’s arteries were healthy. In some places, plaque had blocked 25 percent of their blood flow, but in general, cardiologists do not consider blockages clinically relevant until they reduce blood flow at least 70 percent.

After Mr. Franks finished dressing, he joined Dr. Hecht, who went over the results, explaining that his heart appeared healthy and that he would not need a stent. Still, Dr. Hecht recommended that Mr. Franks have another CT angiogram next year to check that the plaque was not thickening. Mr. Franks agreed, pronounced himself satisfied and left.

For Mr. Franks, the test was quick and painless. But it subjected him to a significant dose of radiation.

Based on a reporter’s notes about the duration of the scan and the power output reported by the scanner, Dr. Brenner of the Center for Radiological Research estimated that Mr. Franks had received 21 millisieverts of radiation — even more than a typical test, equal to about 1,050 conventional chest X-rays.

Given the radiation risks, Dr. Ralph Brindis, another cardiologist, said Dr. Hecht had erred. Because Mr. Franks had already taken a nuclear stress test with normal results, he did not need a CT angiogram, said Dr. Brindis, vice president of the American College of Cardiology. And particularly because the scan’s results were benign, he said, Dr. Hecht should not have recommended a follow-up test.

“The biggest problem we have with radiation is that the doses are cumulative and additive,” Dr. Brindis said. “So the concept of doing serial CT testing on asymptomatic patients, I think, is abhorrent. I cannot justify that.”

Dr. Hecht said he sharply disagreed with Dr. Brindis. The scan was appropriate for Mr. Franks, despite his normal results from the nuclear stress test, because of Mr. Franks’s other risk factors for heart disease, including his higher-than-average calcium score, Dr. Hecht said. And he said he recommended a follow-up scan next year so he could see how quickly the plaque in Mr. Franks’s arteries was thickening.

Otherwise, “how do we know that our therapy is effective?” Dr. Hecht said. He acknowledged that many cardiologists do not favor repeat scans but said long-term radiation risks were a relatively minor issue for patients 60 and older.

Cardiologists like Dr. Brindis hurt their patients by being overly conservative and setting unrealistic standards for the use of new technology, Dr. Hecht said.

“It’s incumbent on the community to dispense with the need for evidence-based medicine,” he said. “Thousands of people are dying unnecessarily.”

Medicare’s Scrutiny

The Centers for Medicare and Medicaid Services had decided to push back.

The agency, which this year will spend more than $800 billion on health care, rarely questions the need to pay for new treatments. But last June, Medicare said it was considering paying for CT heart scans only on the condition that studies be done to show they had value for patients.

Concerned about the overall proliferation of imaging tests, Medicare said it might require a large-scale study to determine the scans’ value.

The plan met with fierce resistance, particularly from a relatively new organization of specialists, the Society of Cardiovascular Computed Tomography. The society has 4,700 physician members and one purpose — to promote CT angiograms.

“For the CT society, this was life or death,” said Dr. Daniel S. Berman, the group’s president-elect. “This decision could essentially put them out of business.”

Galvanized, at a meeting in November in Chicago, the CT specialists vowed to overturn any possible Medicare proposal.

“We didn’t need to be talking about registries and the research,” Dr. Berman said. “We needed to be questioning the wisdom of the Medicare decision itself.”

The next month, Medicare issued the draft of its proposal, saying that it would pay for the scans only if a large-scale study were conducted. The CT society, along with other prominent medical groups whose members performed scans, set to work lobbying the agency and members of Congress.

One group marshaled the evidence the doctors would take to Medicare, arguing that the agency had ignored some studies, including those of the new 64-slice CT scans. Another group visited Congressional offices. Defenders of the technology argued that Medicare had agreed to pay for other tests, like mammograms, without requiring proof that they improved patient care. Breakthrough technologies, they said, need time to prove themselves.

Medicare “set the bar so high, no new technology would be able to survive,” said Dr. Michael Poon, a New York cardiologist who is the CT society’s current president.

Cardiologists met with Representative Carolyn McCarthy, a New York Democrat. In March, she and other members of Congress wrote to Medicare, urging it to reconsider its plan. Eventually, a dozen or so senators and 79 representatives lined up to support the society’s efforts.

And Medicare gave way.

“There are a lot of technologies, services and treatments that have not been unequivocally shown to improve health outcomes in a definitive manner,” Dr. Barry Straube, Medicare’s chief medical officer, explained when announcing that the agency would keep covering the tests.

In other words, the lack of evidence that the CT scans provide measurable medical benefit would not stop Medicare from paying for them.

Heavy lobbying makes it virtually impossible for the agency to insist on more evidence before agreeing to pay for a new technology, said Dr. James Adamson, chief medical officer for Arkansas Blue Cross and Blue Shield. “Medicare,” he said, “does not make a lot of really hard decisions.”

In a subsequent interview, Marcel Salive, a Medicare official, said the agency still hoped for large-scale studies to demonstrate the value of CT scans.

The technology’s proponents say they understand the need to prove its value. “It’s incumbent on us to do more work,” said Gene Saragnese, vice president for molecular imaging and CT at General Electric.

Doctors are also discussing the creation of registries to track patients who have had CT angiograms. But now that Medicare has backed down, skeptics say it is unlikely that anyone will conduct a major clinical trial to determine if patients who receive CT heart scans have better medical outcomes than those who do not.

“It’s clearly going to be much more difficult, given the Medicare decision,” said Dr. Sean Tunis, a former Medicare official who directs the Center for Medical Technology Policy, a nonprofit group.

Industry consultants say that now that Medicare has agreed to pay for the tests, resistance among commercial insurers is likely to disappear. “I believe the holdouts will be paying within 12 months,” said Michelle Boston, the chief executive of Partners Imaging, a Dallas company that works with doctors to offer CT scans.

And so CT angiograms seem destined to continue, in ever greater numbers. “Once the train leaves the station, once the technology gets on the marketplace, we don’t get the evidence,” said Dr. Redberg, the University of California, San Francisco, cardiologist. “We’re spending a lot of money on technology of unclear benefit and risk.”

Tuesday, June 17, 2008

Eyes Bloodshot, Doctors Vent Their Discontent

By SANDEEP JAUHAR, M.D.

“I love being a doctor but I hate practicing medicine,”
a friend, Saeed Siddiqui, told me recently. We were sitting in his
office amid his many framed medical certificates and a poster of an
illuminated lighthouse that read: “Success doesn’t come to
you. You go to it.”



A doctor in his late 30s, he
has been in practice for six years, mostly as a solo practitioner. But
he told me he recently had decided to go into partnership with another
cardiologist; his days, he said, will be “totally busy.”

“Your days aren’t busy enough already?” I asked.

The
waiting room was packed. He had a full schedule of appointments, and
after he was done with his office patients, he was going to round at
two
hospitals.

He smiled wanly. “Just look at my eyes.”

They were bloodshot.

“This whole week I haven’t slept more than about six hours a night.”

I asked when his work usually got done.

“It is never done,” he replied, shaking his head. “See this pile?”

He pointed to five large manila packages on a shelf above his desk. “These are reports I still have to finish.”

As
a physician, I could empathize. I too often feel overwhelmed with
paperwork. But my friend’s discontent seemed to run much deeper
than that. Unfortunately, he is not alone. I have been hearing
physician colleagues voice a level of dissatisfaction with medical
practice that is alarming.

In a survey last year of nearly 2,400 physicians conducted by a physician recruiting firm, locumtenens.com,
3 percent said they were not frustrated by nonclinical aspects of
medicine. The level of frustration has increased with nearly every
survey.

“It will take real structural change in the work
environment for physician satisfaction to improve,” Dr. Mark
Linzer, an internist at the University of Wisconsin
who has done extensive research on physician unhappiness, told me.
“Fortunately, the data show that physicians are willing to put up
with a lot before giving up.”

Not long ago, fed up with
what he perceived as a loss of professional autonomy, Dr. Bhupinder
Singh, 42, a general internist in New York, sold his practice and went
to work part time at a hospital in Queens.

“I’d
write a prescription,” he told me, “and then insurance
companies would put restrictions on almost every medication. I’d
get a call: ‘Drug not covered. Write a different prescription or
get preauthorization.’ If I ordered an M.R.I., I’d have to explain to a clerk why I wanted to do the test. I felt handcuffed. It was a big, big headache.”

When he decided to work in a hospital, he figured that there would be more freedom to practice his specialty.

“But managed care is like a magnet attached to you,” he said.

He
continues to be frustrated by payment denials. “Thirty percent of
my hospital admissions are being denied. There’s a 45-day limit
on the appeal. You don’t bill in time, you lose everything.
You’re discussing this with a managed-care rep on the phone and
you think: ‘You’re sitting there, I’m sitting here.
How do you know anything about this patient?’ ”

Recently,
he confessed, he has been thinking about quitting medicine altogether
and opening a convenience store. “Ninety percent of doctors I
know are fed up with medicine,” he said.

And it is not just managed care. Stories of patients armed with medical knowledge gleaned from the Internet demanding antibiotics
for viral illnesses or M.R.I. scans for routine symptoms are rife in
doctors’ lounges. Malpractice worries also remain at the
forefront of many physicians’ minds, compounded by increasing
liability premiums that have forced many into early retirement.

In
surveys, increasing numbers of doctors attest to diminishing enthusiasm
for medicine and say they would discourage a friend or family member
from going into the profession.

The dissatisfaction would
probably not have reached such a fever pitch if reimbursement had kept
pace with doctors’ expectations. But it has not.

Doctors
are working harder and faster to maintain income, even as staff
salaries and costs of living continue to increase. Some have resorted
to selling herbs and vitamins
retail out of their offices to make up for decreasing revenue. Others
are limiting their practices just to patients who can pay out of pocket.

There
are serious consequences to this discontent, the most worrisome of
which is that it is difficult for doctors who are so unhappy to provide
good care.

Another is a looming shortage of doctors, especially
in primary care, which has the lowest reimbursement of all the medical
specialties and probably has the most dissatisfied practitioners.

Last
year, residency programs in family practice took only 1,096 graduating
medical students, the fewest in the last two decades. The number
increased just slightly this year. Students who do choose internal
medicine increasingly are forgoing primary care for subspecialty
practices like cardiology and gastroenterology.

“For me
it’s an endless amount of work that I can never get through to do
it properly,” said Dr. Jeffrey Freilich, 38, a primary-care
physician on Long Island. “I’m a bit compulsive. As an
internist, I have to worry about working up so many conditions — anemia, thyroid problems and so forth. There is no time to do it all in a day.

“On top of all that, there are all the colonoscopies and mammograms
you have to arrange, and all the time on the phone getting
preauthorizations. Then you have to track the patient down. And none of
it is reimbursed.”

Many primary-care physicians have
stopped seeing their patients when they are hospitalized, relying
instead on hospitalists devoted to inpatient care. Internists have told
me that it is prohibitively inefficient to drive to a hospital, find
parking, walk to the wards, examine a patient, check laboratory tests
and vital signs, talk to a nurse and write orders and a note —
for just a handful of cases. They cannot afford to leave their offices
long enough to do it.

The upshot is that the doctor who knows a
patient best is often uninvolved in her care when she is hospitalized.
This contributes to the poor coordination and wanton consultation that
is so common in hospitals today.

“Years ago you had one or
two doctors,” a hospitalized patient told me recently. “Now
you’ve got so many people coming in it’s hard to know
who’s who.”

A 10.6 percent cut in Medicare
payments to physicians is scheduled to take effect on July 1. Further
cuts are planned in coming years. Many doctors have told lawmakers that
if the cuts go through, they will stop seeing Medicare patients. But
reimbursement cuts are only a small part of doctors’ woes today.

“I
was naïve,” Saeed Siddiqui said. “When I was a
resident I thought it was enough to take good care of patients. But the
real world is totally different.”

Dr.
Sandeep Jauhar, a cardiologist on Long Island, is the author of a new
memoir, “Intern: A Doctor’s Initiation.”

Wednesday, June 11, 2008

Showing the Patient the Door, Permanently



Published: June 10, 2008
New York Times







Lauren Nassef














It wasn’t the boy I had a problem with. It was his mother.

We had met a few months earlier, when I gave her 14-year-old son a diagnosis of mild asthma.
I didn’t mind her tough questions, but her tone of voice put me
on edge. She seemed suspicious, almost angry. Still, in the end I
decided she was just a smart, assertive parent, and I let it go.


This time, she was more confrontational. She complained she had been
“forced” to bring in her son for a physical because his
school needed a doctor’s clearance before he could play sports.
What kind of racket did we doctors have with schools? Why did she have
to bring in her son when she knew he was healthy? I was taking her
money for doing this?

I bit my tongue and tried to tell her why
I thought they belonged here. Yes, he was probably very healthy. But an
annual checkup could help him learn to take charge of his own health as
he grew up, and it would give me a chance to encourage healthy choices
and to get a good sense his emotional health during these challenging
years. Finally, I pointed out, he was due for a tetanus booster.

She
was unimpressed. “I don’t believe in preventive
care,” she said. “I’ll treat him for tetanus if he
needs it.”

The rest of the visit went more smoothly,
mainly because Mom left the room so I could examine her son. But before
they left, she again accused me of taking her money, saying I
hadn’t done anything different from their previous visits. Before
I could reply, her son politely confirmed that this visit had been more
comprehensive.

I have had my share of difficult patients and
parents. But putting up with this lady had taken more time than it was
worth, and it interfered with my taking care of her son. I wasn’t
sure I wanted to do it again.

I considered my options. I could
be stoic, do my job and keep the boy in my practice. I could call his
mother and ask her to keep her opinions to herself so I could focus on
her son, though my instincts told me that this wouldn’t stop her.
Finally, I could decline to see her son, and therefore her, ever again.
In other words, fire my patient.

The physician-patient compact
basically states that a doctor will care for a patient in exchange for
compensation and that the patient will heed the doctor’s advice.
Patients who disagree with their physicians, or just dislike them, are
free to go elsewhere.

By the same token, this mutual contract
gives a doctor the right to dismiss a patient. The most obvious reasons
are failing to pay or missing multiple appointments. Refusing to adhere
to treatments can lead to dismissal. So can being abusive to the
medical staff.

Of course, we need to exercise this option
sensibly. Doctors cannot fire a patient in dire straits like severe
pain, bleeding or a life-threatening situation. And of course, we
cannot refuse to see patients because of their race, age, sexual
orientation and so on.

But could I fire a patient because I
didn’t like his mother? Colleagues who had studied the ethics and
legal issues told me that the answer wasn’t clear-cut. Obviously,
I couldn’t just abandon them. Yet like a lot of legal jargon, the
word “abandonment” is open to interpretation. I decided it
meant that as long as I wasn’t leaving anyone out to dry with a
serious, immediate medical problem, that I gave a patient reasonable
notice and provided options about where to continue getting care, I was
within my rights.

I thought about our conversation on the tetanus
booster, when the mother said she didn’t believe in preventive
care. I’m a pediatrician — prevention is in my DNA. If I
accepted her view, I’d be compromising my conscience and my
professional ethics. I couldn’t do that.

I wrote a letter
addressed to my patient’s mother and sent by certified mail. I
kept it brief: “Sometimes, a patient or family and doctor
aren’t compatible. ... Therefore, I will be dismissing you from
my practice.” I went on to advise them how they could get a new
pediatrician and told them that until they found a new doctor, I would
continue to care for her child’s mild asthma.

Two weeks
later, I received notice that they had gotten it. The child had signed
for it, which made me feel bad because I didn’t have anything
against him. Checking his chart, I saw that his mother had chosen a new
pediatrician, a colleague of mine. They hadn’t seen him yet.

I
considered telling my colleague about my experience. Perhaps warning
him so he could remember to take extra care would help get them off to
a better start. On the other hand, perhaps I would unfairly bias him
against this child and his mother.

I decided to keep quiet. After all, it could have just been me.

Rahul K. Parikh is a physician in Walnut Creek, Calif. He writes about medicine for Salon.



Readers' Comments

"Any good relationship is symmetrical. You should be free to fire your doctor and vice versa, no questions asked."
Carl R, London, UK

Wednesday, June 04, 2008

Prostate Cancer Screening: Why It's Not for Every Man

Screening for prostate cancer in men age 50 and older is common in clinical practice today, but it's not based on adequate evidence that it improves health outcomes. That's why the US Preventive Services Task Force, the leading independent panel of experts in prevention, has found insufficient evidence to recommend for or against routine screening for prostate cancer.

The benefits of screening for early prostate cancer are unknown. There are substantial harms associated with detection and treatment of prostate cancer, and the research fails to show a reduction in prostate cancer death and a net improvement in a patient's well-being.[1]

Patients deserve to know when there's insufficient evidence that a preventive screening will do more good than harm. Do not screen for prostate cancer without first discussing with patients the potential -- but uncertain -- benefits and possible harms. We need to inform patients about the gaps in the evidence. Then we need to help them assess their personal risks and other individual considerations and preferences that might influence their decisions.[2]

Be prepared to answer questions. Patients are likely to want to know what the potential harms of screening, detection, and treatment of prostate cancer might be. These potential harms include fairly frequent false-positive results from PSA screening tests that might lead to unnecessary anxiety and unnecessary biopsies. All treatments for prostate cancer carry risks of harm.[3]

Remember this is your patient's decision, too. And helping patients make decisions that are appropriate for them as individuals is one way to provide high-quality care, in the absence of definitive evidence.[4]

This is an opinion of Michael LeFevre, MD, MSPH of the US Preventive Services Task Force.

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Sunday, May 18, 2008

Doctors Start to Say ‘I’m Sorry’ Long Before ‘See You in Court’

CHICAGO — In 40 years as a highly regarded cancer surgeon, Dr. Tapas K. Das Gupta had never made a mistake like this.

As with any doctor, there had been occasional errors in diagnosis or judgment. But never, he said, had he opened up a patient and removed the wrong sliver of tissue, in this case a segment of the eighth rib instead of the ninth.

Once an X-ray provided proof in black and white, Dr. Das Gupta, the 74-year-old chairman of surgical oncology at the University of Illinois Medical Center at Chicago, did something that normally would make hospital lawyers cringe: he acknowledged his mistake to his patient’s face, and told her he was deeply sorry.

“After all these years, I cannot give you any excuse whatsoever,” Dr. Das Gupta, now 76, said he told the woman and her husband. “It is just one of those things that occurred. I have to some extent harmed you.”

For decades, malpractice lawyers and insurers have counseled doctors and hospitals to “deny and defend.” Many still warn clients that any admission of fault, or even expression of regret, is likely to invite litigation and imperil careers.

But with providers choking on malpractice costs and consumers demanding action against medical errors, a handful of prominent academic medical centers, like Johns Hopkins and Stanford, are trying a disarming approach.

By promptly disclosing medical errors and offering earnest apologies and fair compensation, they hope to restore integrity to dealings with patients, make it easier to learn from mistakes and dilute anger that often fuels lawsuits.

Malpractice lawyers say that what often transforms a reasonable patient into an indignant plaintiff is less an error than its concealment, and the victim’s concern that it will happen again.

Despite some projections that disclosure would prompt a flood of lawsuits, hospitals are reporting decreases in their caseloads and savings in legal costs. Malpractice premiums have declined in some instances, though market forces may be partly responsible.

At the University of Michigan Health System, one of the first to experiment with full disclosure, existing claims and lawsuits dropped to 83 in August 2007 from 262 in August 2001, said Richard C. Boothman, the medical center’s chief risk officer.

“Improving patient safety and patient communication is more likely to cure the malpractice crisis than defensiveness and denial,” Mr. Boothman said.

Mr. Boothman emphasized that he could not know whether the decline was due to disclosure or safer medicine, or both. But the hospital’s legal defense costs and the money it must set aside to pay claims have each been cut by two-thirds, he said. The time taken to dispose of cases has been halved.

The number of malpractice filings against the University of Illinois has dropped by half since it started its program just over two years ago, said Dr. Timothy B. McDonald, the hospital’s chief safety and risk officer. In the 37 cases where the hospital acknowledged a preventable error and apologized, only one patient has filed suit. Only six settlements have exceeded the hospital’s medical and related expenses.

In Dr. Das Gupta’s case in 2006, the patient retained a lawyer but decided not to sue, and, after a brief negotiation, accepted $74,000 from the hospital, said her lawyer, David J. Pritchard.

“She told me that the doctor was completely candid, completely honest, and so frank that she and her husband — usually the husband wants to pound the guy — that all the anger was gone,” Mr. Pritchard said. “His apology helped get the case settled for a lower amount of money.”

The patient, a young nurse, declined to be interviewed.

Mr. Pritchard said his client netted about $40,000 after paying medical bills and legal expenses. He said she had the rib removed at another hospital and learned it was not cancerous. “You have no idea what a relief that was,” Dr. Das Gupta said.

Some advocates argue that the new disclosure policies may reduce legal claims but bring a greater measure of equity by offering reasonable compensation to every injured patient.

Recent studies have found that one of every 100 hospital patients suffers negligent treatment, and that as many as 98,000 die each year as a result. But studies also show that as few as 30 percent of medical errors are disclosed to patients.

Only a small fraction of injured patients — perhaps 2 percent — press legal claims.

“There is no reason the patient should have to pay the economic consequences for our mistakes,” said Dr. Lucian L. Leape, an authority on patient safety at Harvard, which recently adopted disclosure principles at its hospitals. “But we’re pushing uphill on this. Most doctors don’t really believe that if they’re open and honest with patients they won’t be sued.”

The Joint Commission, which accredits hospitals, and groups like the American Medical Association and the American Hospital Association have adopted standards encouraging disclosure. Guidelines vary, however, and can be vague. While many hospitals have written policies to satisfy accreditation requirements, only a few are pursuing them aggressively, industry officials said.

“We’re still learning the most effective way to have these most difficult conversations,” said Nancy E. Foster, the hospital association’s vice president for quality and patient safety. “It’s a time of high stress for the patient and for the physician. It’s also a time where information is imperfect.”

The policies seem to work best at hospitals that are self-insured and that employ most or all of their staffs, limiting the number of parties at the table. Such is the case at the Veterans Health Administration, which pioneered the practice in the late 1980s at its hospital in Lexington, Ky., and now requires the disclosure of all adverse events, even those that are not obvious.

To give doctors comfort, 34 states have enacted laws making apologies for medical errors inadmissible in court, said Doug Wojcieszak, founder of The Sorry Works! Coalition, a group that advocates for disclosure. Four states have gone further and protected admissions of culpability. Seven require that patients be notified of serious unanticipated outcomes.

Before they became presidential rivals, Senators Hillary Rodham Clinton and Barack Obama, both Democrats, co-sponsored federal legislation in 2005 that would have made apologies inadmissible. The measure died in a committee under Republican control. Mrs. Clinton included the measure in her campaign platform but did not reintroduce it when the Democrats took power in 2007. Her Senate spokesman, Philippe Reines, declined to explain beyond saying that “there are many ways to pursue a proposal.”

The Bush administration plans a major crackdown on medical errors in October, when it starts rejecting Medicare claims for the added expense of treating preventable complications. But David M. Studdert, an authority on patient safety in the United States who teaches at the University of Melbourne in Australia, said the focus on disclosure reflected a lack of progress in reducing medical errors.

“If we can’t prevent these things, then at least we have to be forthright with people when they occur,” Mr. Studdert said.

For the hospitals at the forefront of the disclosure movement, the transition from inerrancy to transparency has meant a profound, if halting, shift in culture.

At the University of Illinois, doctors, nurses and medical students now undergo training in how to respond when things go wrong. A tip line has helped drive a 30 percent increase in staff reporting of irregularities.

Quality improvement committees openly examine cases that once would have vanished into sealed courthouse files. Errors become teaching opportunities rather than badges of shame.

“I think this is the key to patient safety in the country,” Dr. McDonald said. “If you do this with a transparent point of view, you’re more likely to figure out what’s wrong and put processes in place to improve it.”

For instance, he said, a sponge left inside an patient led the hospital to start X-raying patients during and after surgery. Eight objects have been found, one of them an electrode that dislodged from a baby’s scalp during a Caesarian section in 2006.

The mother, Maria Del Rosario Valdez, said she was not happy that a second operation was required to retrieve the wire but recognized the error had been accidental. She rejected her sister’s advice to call a lawyer, saying that she did not want the bother and that her injuries were not that severe.

Ms. Valdez said she was gratified that the hospital quickly acknowledged its mistake, corrected it without charge and later improved procedures for keeping track of electrodes. “They took the time to explain it and to tell me they were sorry,” she said. “I felt good that they were taking care of what they had done.”

There also has been an attitudinal shift among plaintiff’s lawyers who recognize that injured clients benefit when they are compensated quickly, even if for less. That is particularly true now that most states have placed limits on non-economic damages.

In Michigan, trial lawyers have come to understand that Mr. Boothman will offer prompt and fair compensation for real negligence but will give no quarter in defending doctors when the hospital believes that the care was appropriate.

“The filing of a lawsuit at the University of Michigan is now the last option, whereas with other hospitals it tends to be the first and only option,” said Norman D. Tucker, a trial lawyer in Southfield, Mich. “We might give cases a second look before filing because if it’s not going to settle quickly, tighten up your cinch. It’s probably going to be a long ride.”


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Tuesday, April 29, 2008

Heart warning for women taking osteoporosis treatment

A drug for the bone-thinning disease osteoporosis taken by thousands of women in Britain nearly doubles the risk of a common heart condition, scientists warned yesterday.

A study of more than 700 women found those who had taken the drug, Fosamax, were 86% more likely to develop an irregular heartbeat. Although atrial fibrillation is rarely life-threatening, it can cause palpitations, fatigue and fainting and, in some cases, congestive heart failure. It can also raise the risk of blood clots and stroke.

More than 420,000 prescriptions for the drug, also known as alendronate, were dispensed in England in 2006, according to the latest figures from the NHS. The vast majority were for women who developed the bone-wasting disease as a side-effect of the menopause.

Dr Susan Heckbert, at the University of Washington in Seattle, studied medical records of more than 700 women who had developed atrial fibrillation and compared them with a control group of more than 900 healthy women. "Having ever used alendronate was associated with an 86% higher risk of newly detected atrial fibrillation compared with never having used the drug," she said.

The finding contradicts a much larger Danish study which appeared in the British Medical Journal in March. In that research doctors studied more than 13,000 women with atrial fibrillation and found no evidence of increased risk among users of the drug.

In Britain 3m people have, or are at risk of developing, osteoporosis. As the disease progresses it makes bones more brittle and likely to fracture. According to the National Osteoporosis Society, half of all women and one in five men over the age of 50 will break a bone, mostly because of osteoporosis.

Heckbert, whose study is published in the Archives of Internal Medicine, said alendronate's ability to slow osteoporosis and reduce the risk of bone fractures outweighed the dangers of atrial fibrillation for women most at risk of fractures.

Guidelines issued by the National Institute for Health and Clinical Excellence, which are under review, recommend Fosamax only for patients aged 75 and over, unless they have had a bone scan revealing the severity of their osteoporosis.

Sarah Leyland, of the National Osteoporosis Society, said: "Fosamax is highly effective at reducing someone's risk of experiencing a fracture due to osteoporosis. The results of this study are interesting but should be considered in context with other recent research, which has not shown the same increase in atrial fibrillation.

"There are a range of treatments available to people with osteoporosis and at risk of breaking bones. We would urge anyone who is concerned about possible side-effects to speak to their GP about the most appropriate treatment for them."


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Thursday, April 24, 2008

Discount on Professional Fees and Fee Splitting

Recently, negotiations between doctors represented by the Joint Inter-hospital Healthcare Committee (JIHC) and ING Insurance Bhd hit an impasse. ING, a major health insurance provider in Malaysia, had demanded discounts on professional fees from doctors, and it was in the process of compiling a list of preferred healthcare providers (doctors who agreed to give them discounts), and a blacklist of those who do not agree with their terms. (See Docs and ING in Stalemate over proposal in The Star, Thursday, April 3, 2008).


This impasse finally resolved when ING retreated from its previously entrenched postition, a turn-about prompted by the Director General of Health's statement that "discount for professional fees is not allowed because it would be infringing on the regulations and the code." The DG went on to elucidate that if "fee splitting" is carried out for professional fees, the practitioner is subject to disciplinary punishment under the Medical Act." (See Only six MCOs have signed up...)

Subsequently, in an open letter to The Star, April 3, TAN SRI DR MOHD ISMAIL MERICAN, Director General of Health, Malaysia, further clarified the stand of the Ministry of Health on this issue of discount on practitioners' professional fees. He reiterated his opinion that such discounts constituted fee-splitting, which is prohibited under the Code of Professional Conduct (CPC) for Practitioners of the Malaysian Medical Council. Fee-splitting is a serious offence and can bring about strict disciplinary action under the CPC.

So now, dear readers, the situation is clear: all patients are entitled to seek any treatment with any doctor or health care provider of his choice. It does not matter whether a patient has a health insurance policy, or is under a scheme provided by a third-party Medical Care Organisation (MCO) or a corporation that pays for its worker with health care expenses, the patient has freedom of choice to seek the treatment that best suits his or her needs.

See what MD thinks .... coming feature.


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Wednesday, April 23, 2008

For Your Good Health

Having nightmares with health care solutions? It is important to start looking into that health insurance policy -- and the sooner it is done, the better. Health care is getting more and more expensive, and no one can predict when an accident can happen or an illness can strike.

The Star Newspaper has recently published a number of articles and interviews that help to shed some light on the questions that many will need to ask when pondering their health care needs and provisions.

  • Managing Healthcare: Investing in a medical insurance plan may be a wise move to prepare for medical emergencies, but before you commit to any health plan, choose your policy wisely.
  • For your good health: It is still good if you get yourself medical insurance, but you need to get one that provides adequate coverage, and it cannot deny you of your choice of doctors or hospitals,” says Dr Steven Chow, president of the Federation of Private Medical
    Practitioners Association of Malaysia.
  • Complaining: If you face any discrepancy or dissatisfaction from your insurance
    company or takaful operator, there are different avenues where you can
    complain....
  • Medical & Health Insurance Information: Things I should know....



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Looking to insure your health

With the increasing cost of medical treatment and hospitalisation, private health insurance plays an increasingly important role in today's healthcare conundrum. Government hospitals continue to contribute an important segment of Malaysia's health care, but with growing affluence and heightened public expectations, a significant proportion of Malaysia's population turn increasingly towards private healthcare providers. But with its perceived advantages over the public hospitals, comes the high cost of private treatment -- which as pointed out by Dr. Milton Lum, clearly and early on in his article, is not a subsidised service; it is a profit-oriented business, and therefore, all costs will eventually have to be borne by the consumer, the hapless patient.

Heightened expectations of patients and subsequently increased demand for the use of high-end equipment and state-of-the-art medical technology all contribute towards an acceleration in the cost of treatment. The majority of patients will not be able to afford such high costs on their own. Having an adequate medical insurance policy is important.

Dr. Milton Lum writes an excellent article about the types of medical insurance coverage, and tells us what to watch out for when buying an medical or health insurance policy...

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What are little boys made of? Scientists pinpoint bananas

What are little boys made of? Scientists pinpoint bananas

* Ian Sample, science correspondent
* The Guardian,
* Wednesday April 23 2008



This article appeared in the Guardian on Wednesday April 23 2008 on p1 of the Top stories section. It was last updated at 02:24 on April 23 2008.

Women are more likely to give birth to boys if they have a high-calorie diet in the run-up to becoming pregnant, according to a team of scientists. The finding is the first clear evidence that a mother's eating habits around the time of conception can influence the sex of her baby.

The discovery points to a natural way for women to boost, if only slightly, their chances of having a boy or a girl, depending on whether they consume large amounts of foods such as bananas and cereals, or have a more restricted diet.

Scientists at Oxford and Exeter universities asked 740 women, who had become pregnant for the first time, about their eating patterns in the year before they conceived. They then divided the women into high, medium and low calorie groups.

They found that 56% of women in the high calorie group gave birth to boys, compared with 45% in the lower calorie group. None of the women was obese or aware of the gender of her baby throughout her pregnancy.

"For the first time, we've shown there is a clear association between a mother's diet and the gender of her infant," said Fiona Mathews, a specialist in mammalian biology at Exeter University, who led the research.

"The mother seems to be able to influence the survival of either the sperm or the fertilised egg in its very early stages, probably before it has even implanted in the womb."

When the researchers looked more closely at the women's diets, they found that certain nutrients were key to the effect, she said.

"We were able to confirm the old wives' tale that eating bananas and so having a high potassium intake was associated with having a boy, as was a high sodium intake. But the old tale about drinking a lot of milk to have a girl doesn't seem to hold up. In fact, more calcium meant they were again more likely to have a boy.

"It does not seem to matter whether you get most of your energy from carbs or fat, it's about the total amount of calories consumed," she said.

The study, which appears today in the Proceedings of the Royal Society B, showed that 59% of women who ate breakfast cereal every day had boys, compared with only 43% of women who rarely or never ate cereal.

Nutritional data was collected for three time periods: usual intake before conception (preconception); intake at around 16 weeks' gestation (early pregnancy) and usual intake between 16 and 28 weeks' gestation (later pregnancy).

While it might be possible for a woman to boost the effect by substantially changing her diet, scientists warned that consuming high levels of salt or dramatically altering levels of other nutrients could be harmful.

"If you're looking for a boy, then eating breakfast cereal every day and within safe limits, having a reasonable intake of sodium, potassium and calcium, plus a good intake of protein looks like a sensible option. It's the converse of that if you're hoping for a girl, but again, only within safe limits," Mathews said.

The finding makes evolutionary sense and mirrors a similar effect seen in other animals. Females are more likely to be born when food is scarce, since they are more likely to produce at least some babies. Males are more of a gamble though, with some having lots of offspring and others having none.

"If times are good, it can make a lot of sense to invest in boys because you might produce a strapping great warrior, who could go on to produce far more grandchildren than a daughter would," said Mathews.

Professor Stuart West, of Edinburgh University, said women should be extremely cautious about using diet to influence the sex of their offspring.

He pointed out that similar studies in animals showed huge variations in the effect and warned that changing diet could have other health implications for mothers and children.

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Monday, April 21, 2008

Enslaved by Ketamine

Monday April 21, 2008
The Guardian


Enslaved by K


A whole new realm of the imagination opened up when David Eggins took his first line of ketamine. In the real world, however, he was lucky to get out alive ...



I first took ketamine in 2002, between my second and third years at university. I was mourning the end of a long-term relationship with a massive bender. It was a weekday afternoon and I was necking ecstasy and playing pool when a mate asked me if I'd ever tried "K".

We didn't even finish the game. We went back to my flat and it was love at first snort.

One of the problems with K is trying to explain what a "K-hole" is like. Nothing can prepare you for the chaos. All you can say is that it is really weird, but until you have taken it, even the most drug-fried mind can't comprehend what "weird" can mean. Most people hate it; it's just too much. Many are sick because of a sort of mental travel sickness. But I didn't throw up: I adored it.

The K-hole has been described as an endless dimension to explore, and that's exactly what it is. Space, time and language either have no meaning or become ridiculously distorted. It can seem as if you are travelling through time or seeing into the future, as if you are living multiple lives or not living at all. And you feel something coming, something huge with you at the centre, because there is a massive messiah complex in there as well.

I have been at one with the cosmos, communicated with the universal forces that are our true gods, and been told that death should be embraced as the next level of everything. All complete bollocks, of course, but I never got that from a wrap of coke.

For a little while I had my ketamine use under control and found it therapeutic.

K - which was originally developed as an anaesthetic and is still used to treat animals and occasionally humans - did wonders for my ego. I lost my sense of shame and fear of death, I felt liberated. I got an unexpected first at uni, I was writing book reviews for a national magazine, and I had a new, beautiful girlfriend. I hung out with fellow K-heads, or "wrong 'uns", as we were known to other druggies, whose company I loved. I felt part of something and life was good, but all the time I was using more and more K.

It is the tolerance that gets you. When you start, a gram might see you through three or four nights out. Before long it will be enough for only a few hours and, sooner or later, you start using it at home. I started selling it to pay for my habit.

Today, ketamine is a class-C drug, on a level with cannabis, but until a few years ago it was regulated only by the Medicines Act, and although it was still illegal to deal in it, the police took less of an interest. I used to buy it in liquid form and then cook it in a pan or microwave to create powder. The liquid came from India, often disguised as rose water. Someone would have it posted to their house and I would buy a litre from them for £300. That litre would turn into 50 grams, which I sold for £15 or £20 a gram. It never felt like a risk, at least as far as the police were concerned. But I couldn't have that much K around me without doing it, all the time.

If I wasn't at work - I had become a chef after leaving university - I was taking K.

I would take a gram during the break in my split shift. I would get home and sniff three grams in front of the television, and then take another three to bed with me. I had a line before work, not knowing if I had slept. And I was starting to get ill. I have always liked drink and drugs but, other than tobacco, I had never been truly addicted to anything before. I never used heroin or crack, and could tell when any substance was becoming a problem. I usually just got bored of something and moved on - but not this time. K may not be physically addictive, but it is compulsively psychologically addictive.

I stopped dealing when my girlfriend asked me to, hoping that this would help, but I was too far gone. I still did as much, but I started to hide it from her.

After about two years of using ketamine, I was spending more and more time in the toilet, and urinating was beginning to hurt.

I developed a stoop because my penis was always burning. One day, on a train, I had my first cramp attack; I thought my lung had collapsed. I went to a doctor, who told me to stop taking K or I would die, but then an older user told me not to worry, it was "just K cramps". He said that they wouldn't kill me, but I might wish that they would. Apparently they could last for days.

I still didn't stop. The cramps got worse, the blood and mucus began to appear frequently in my urine and I had to pee every 20 minutes. I lied more than I told the truth, particularly to my girlfriend, and I hated myself. I couldn't stand to be around myself and wanted to cause myself harm. K worked on both fronts.

I stopped going out because my friends didn't want to see me like that, I quit my job because I was in too much pain to work, and I lost the review gig because I could no longer read a book. I fell further into debt.

By the time I realised that ketamine was ruining my life, I no longer cared. I didn't want to die as such; I just didn't mind if I did. My girlfriend couldn't save me. She begged me to leave the west country town where I was living, surrounded by other K-heads, and move back to Devon, where I had grown up.

I told her I would, but I was lying. I didn't want to give up. I was positive I was going to die whether I did or not.

One evening, about a year ago, when I was supposed to be watching a friend's band play at our local, I found myself naked, writhing on my kitchen floor, racked with abdominal cramps and self-loathing, and praying.

Praying to a God I don't believe in to show Himself, to intervene, to give me something to believe in other than ketamine, and the certainty that my life was over. He didn't, but when the pain subsided, the relief was almost like a drug in itself.

In the end change was forced on me. A local street gang had tried to break into my flat on several occasions. They held a knife to my flatmate's throat as he left for work. We managed to fight them off, but I could hardly walk by then and weighed nine stone. It was the street or home. I called my mum.

Once back home, I could barely sleep and suffered from night terrors and sleep paralysis. I started to smoke cannabis, scored black-market codeine and Valium. And I kept begging my K dealers to send me some. I offered them silly money, but they still said no, because they truly were worried about me. Later, when I did find another source of K, I used the bare minimum to get me through the craving.

So here I am, living on my mum's settee. I've got my health back but lost everything else, including my girlfriend. She had lost all trust, and in the end she realised she would be glad to see the back of me.

Do I think that ketamine should be higher than its class-C listing? No, but people should know what they are dealing with. By the time I did, it was too late. There is so much media coverage of illegal drugs, yet K is rarely mentioned, although it is everywhere and spreading fast. Most people who try it won't develop any major problems, but a minority of users get very sick. A friend of mine lost so much control over his bladder that he had to have a catheter fitted when he was 21, and there are going to be a lot more cases like this. He didn't know it was addictive either.

The one bright spot in all this is that the human body has amazing powers of recovery. If there is any addict of any substance reading this who thinks that they have destroyed their body beyond hope, you might be surprised what happens if you give it a break. Within a month of moving home, I got a job as a builder. I even pee like a normal person. Do I drink too much and smoke too much pot now? Yep. Do I still crave K when I'm down or depressed? Sometimes. Do I ever give in to those temptations? Never. Am I still a liar? Of course not, darlin', I promise.

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Sunday, April 13, 2008

GPs warned over failure to diagnose cancers

Patients are dying of cancer because GPs are failing to identify their symptoms, the government's top cancer expert has warned. Professor Mike Richards said botched diagnoses were now 'a significant concern'.

In an interview with The Observer, Richards, national cancer director at the Department of Health, warned about the consequences of these mistakes. 'Ultimately it can mean that the cancer has progressed to a stage where it can't be cured,' he said. Failed diagnoses also meant that, when cancers were eventually spotted, particularly aggressive treatments, such as chemotherapy or surgery, had to be used. 'That could be a mastectomy rather than perhaps a breast conserving operation,' he said.

The government's recent Cancer Reform Strategy identified late diagnosis as a major reason why the UK has poorer survival rates than some other countries in Europe. Although the cancer death rate is falling, it killed 153,491 Britons in 2005.

'There are 250,000 new patients with cancer every year,' said Richards. 'It's probably only a small proportion who experience a missed or delayed diagnosis. It's a small minority of patients overall. But it's not a negligible figure. We want to reduce this to the smallest possible number.'

Cancer in children and breast cancer were especially hard to diagnose, he said. 'There will be a significant number of women with breast cancer where this may happen, especially where cancer is uncommon, for example women under 50 and even under 40. This can happen among that group. It can happen with any cancer.'

There are no official annual statistics on the scale of the problem. But an unpublished joint study by the Health Department and the National Patient Safety Agency, which investigated records involving missed or late diagnoses of cancer patients from January 2004 to November 2006, showed:

· More than 1,900 patients - 55 a month - suffered a missed or late diagnosis, though officials admitted the problem was probably much greater;

· Patients waited for periods between a day and 23 months to have their condition confirmed because of diagnostic errors, often at their GP's surgery;

· Breast, bowel and lung cancer were the likeliest to involve a botched diagnoses;

· Blunders in hospitals added to delays in cancers being identified. These include X-rays, biopsies or blood tests misfiled or misread.

'This is an important issue because in some cases things are going wrong,' said Ben Thomas of the Patient Safety Agency. 'Nobody wants this to happen. Nobody wants to miss a diagnosis or have a late diagnosis. But it does happen. This could happen to anyone. Unfortunately people suffer and people die. We think that practitioner delay, where someone turns up at the GP with symptoms but there's a delay in the GP referring the patient to a specialist, is fairly common.'

Richards said some GPs felt they could not refer patients for tests as often as they would like in case hospitals became overloaded. 'Many patients are referred the first time they go to their GP. But some will go three, four, or even more times,' he said.

Richards's comments come as cancer charities warn that some GPs are wrongly telling sufferers they have other, less serious conditions, such as irritable bowel syndrome, haemorrhoids or gastroenteritis, and send them away with tablets. Similarly some patients in their twenties, thirties and forties are being misadvised by their GP that they are too young to have breast or bowel cancer, which mainly affects the over-50s, despite early signs of the disease.

Cancer experts agree it can be hard for GPs to identify correctly the signs of the disease, partly because the symptoms of certain cancers are also those associated with many other illnesses. A typical GP with a list of 1,800 patients will only see eight or nine new cancer patients every year, and there are about 200 different types of cancer.

'Cancer is difficult to identify and GPs sometimes get it wrong,' said Dr Steve Field, a Birmingham GP and the chairman of the Royal College of General Practitioners. Many of the signs of cancer, such as tiredness, weight loss and rectal bleeding, are also associated with many other conditions, making diagnosis difficult, Field said.

GPs sometimes did not glean enough information about a patient's health from their case history or physical examination to indicate if it is cancer, and some feel they need to see a patient several times before forming a judgment on what was wrong with them, he said.

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Thursday, August 23, 2007

Intravesical Therapies May Reduce Bladder Cancer Survival

NEW YORK (Reuters Health) Aug 10 - The increasing use of intravesical therapies for stage T1 bladder cancer has coincided with decreasing survival after cystectomy, according to New York-based researchers.

This treatment approach has allowed conservative bladder-sparing strategies in patients with high-grade disease, lead investigator Dr. Erica H. Lambert and colleagues at Columbia University Medical Center point out. However, "the excessive use of intravesical therapy could theoretically worsen survival for those understaged patients whose surgery is delayed by these more conservative measures."

To examine this possibility, the researchers evaluated 44 patients with T1 high-grade transitional cell carcinoma who underwent radical cystectomy between 1990 and 1998 and 80 patients who underwent the procedure between 1998 and 2005. The findings are published in the July issue of BJU International.

The mean number of intravesical therapy courses per patient was 0.53 before 1998, which rose to 1.2 per patient afterwards.

Before 1998, the researchers note, 74% of the patients proceeded directly to cystectomy without having undergone intravesical therapy, compared with 43% of patients in the following years.

These proportions were reflected by the 69.7% disease-free survival at 5 years seen in patients who had radical cystectomy before 1998, and the 39.6% rate in patients who underwent the procedure after that year.

The researchers note that "in very few other cancers has disease-free survival reduced over time."

"We postulate that the decrease in survival might be related to a delay in definitive treatment."

BJU Int 2007;100:33-38.

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Prostate Cancer Survival Better Among Most Groups of Asian Men

August 13, 2007 — The majority of Asian men residing in the United States have better prostate cancer survival rates as compared with white males. In the first comprehensive ethnic analysis of Asian American men with prostate cancer, the study found that patients from all Asian subgroups except for South Asians had a better prognosis than white men.Another notable finding of the study, which appears online August 13 in Cancer, found that Asian prostate cancer patients enjoyed a more favorable survival, despite poorer prognostic profiles

"We had expected that Asians and whites would have more similar survival and that Asian subgroups would be more similar to each other," said lead investigator Anthony S. Robbins, MD, PhD, from the California Cancer Registry, in Sacramento. "One of the most surprising findings was how different the Asian subgroups were from each other, ranging from the Japanese, with only about an 8% risk for death from prostate cancer, all the way to South Asians, at about a 16% risk for prostate cancer death."

Data from previous studies conducted in the United States have consistently showed that Asian men have one of the lowest incidences of prostate cancer, compared with other racial/ethnic groups. However, available data on survival among Asian American prostate cancer patients are scant. The researchers also point out that it is not advisable to group all Asians together into 1 category, as it may conceal differences in both incidence and survival among the numerous subgroups.

Using the California Cancer Registry to identify prostate cancer cases, Dr. Robbins and colleagues compared prognostic factors and survival rates of 116,916 men — 108,076 whites and 8840 Asians. The Asian patients were representative of the six largest Asian ethnicities residing in California — Chinese, Filipino, Japanese, Korean, South Asian, and Vietnamese. All patients in the cohort had been diagnosed with incident prostate cancer from 1995 through 2004 and were followed through 2004.

Each of the 6 Asian subgroups had risk factors that put them at a survival disadvantage, as compared with white patients. The researchers noted that patients in every Asian subgroup had unfavorable distributions of summary stage, histologic grade, and primary treatment. Except for South Asians, all of the subgroups had unfavorable distributions for 5 of the 6 prognostic factors. South Asian men showed unfavorable distributions for 3 of the 6 prognostic factors.

Every Asian subgroup had a higher proportion of men with distant or unknown stage, as compared with whites. South Asian men tended to be diagnosed at a younger age than white males, while the other groups were diagnosed at an older age. The South Asian men had a higher socioeconomic status as compared with white patients, while the other subgroups had a lower status.

Paradoxical Findings

However, despite the presence of poor prognostic factors, survival rates were equal to or better than those for whites, with the exception of South Asians. The 10-year risk for prostate cancer–related death was lower for all groups except for South Asians, with Japanese men showing the lowest risk. Japanese men had an unadjusted risk for death that was 34% lower than that of white patients, while South Asians had a risk that was 40% higher than whites.

The heterogeneity of South Asians relative to the other subgroups might partially explain the disparate results, note the researchers. These include the linguistic and religious variations within this large subgroup, which contribute to differences in lifestyle factors that can affect cancer incidence and survival.

"Other reasons for poorer survival in South Asian men might be a higher incidence of comorbidities like heart disease and diabetes," Dr. Robbins told Medscape. "If this were true, interventions to reduce cardiovascular disease, such as smoking cessation, dietary changes, and weight control, might also have a payoff for other diseases like cancer."

The researchers point out that their findings were paradoxical, as 5 of the 6 subgroups demonstrated better unadjusted survival than whites, even though they had risk-factor profiles that put them at a survival disadvantage. They speculate that this may be due to factors that were not addressed in the study, such as endogenous hormone levels, dietary factors, and body composition.

"In my mind, the leading hypothesis to explain why nearly all Asian subgroups had better survival is the concept of better general health in all of the groups except South Asians," said Dr. Robbins. "Thus, when they get cancer, they may be better able to fight it. Other factors like less overweight or obesity may also make treatment more effective."

A take-home message from this study is that nearly all Asian subgroups have better survival from prostate cancer, he added. "In other words, except for South Asian men, being Asian is a favorable prognostic factor. Usually when patients have good or bad prognostic factors, doctors share this information with patients so it can inform them about their expectations about survival and it can be factored into treatment decisions."

Cancer. Published online August 13, 200

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Wednesday, August 22, 2007

Medicare Says It Won’t Cover ‘Preventable’ Hospital Errors

Americans seem to like psychotherapy. Whether it’s for the mundane conflicts of everyday life or life-threatening illnesses like major depression, psychotherapy is widely viewed as a healthy, if not harmless, pursuit.

Yet unlike most other medical treatments, psychotherapy can take considerable time. An infection can be cured in days, but remission of severe depression or anxiety disorder usually takes weeks or months, and a personality disorder typically requires years of intensive psychotherapy.

So if the outcome may be months or years away, how can a person tell whether his psychotherapy is any good?

It’s harder than you’d think. For one thing, people commonly equate feeling better with getting good treatment. But since psychiatric disorders fluctuate spontaneously with time, like most illnesses, many patients would get better even if they got no treatment at all. A patient getting bad psychotherapy might flourish, while another patient getting exemplary treatment might suffer terribly.

Judging from one of the largest surveys of psychotherapy to date, most Americans who try psychotherapy think it is beneficial. In its 1994 annual questionnaire, Consumer Reports asked readers about their experience in psychotherapy. Of 7,000 subscribers who responded to the mental health questions, 4,100 saw mental health professionals. Most reported feeling better with therapy, regardless of whether they were treated by a psychologist, a psychiatrist or a social worker. And those in long-term therapy reported more improvement than those in short-term therapy.

Of course, not all therapy is helpful, and some of it can be downright harmful. Many patients have problems with relationships in the first place; they can find it difficult to extricate themselves from bad or ineffective therapy.

I recall a successful writer whom I saw in consultation. At 44, he had been in psychotherapy for several years and felt that while he had gained much self-understanding, his chronically depressed mood had not changed.

After seeing his depressed partner respond vividly to an antidepressant, he wondered if he too might benefit from a similar drug, but his therapist was opposed.

“He told me that I would be forestalling symptoms with medication that would return years later when I stopped medication,” the writer said. He persisted and got a second opinion.

“Be very wary of any therapist who discourages a consultation,” said a colleague of mine, Dr. Robert Michels, university professor of psychiatry at Weill Cornell Medical College. “If a patient is uncomfortable at the start of treatment, he should leave. But if a patient dislikes his therapy later on, he should discuss it with his therapist, and, if they can’t agree, then it’s time for a consultation. A competent therapist should welcome it.”

It is hardly surprising that many patients are reluctant to seek a second opinion; they may fear rejection by their therapist, or hurting the therapist’s feelings. And therapists, having egos like everyone else, may resist an independent consultation because they see it as a sign of their own failure, not to mention the obvious financial incentive to hold on to a patient.

It’s not just patients who have a hard time knowing if their treatments are helping them; sometimes the therapists themselves can’t tell.

In a study published last month in the journal Psychotherapy Research, Michael J. Lambert and Cory Harmon, psychologists at Brigham Young University, gave psychotherapy patients a questionnaire about how they were feeling and functioning. They randomly gave feedback from the questionnaires to half the patients’ therapists; the other half received strengthened feedback, which included patient self-assessment plus specific information about how the patients viewed their therapists and their social supports. These two groups were compared with a control group of patients whose therapists received no feedback.

The researchers found that giving feedback to therapists clearly improved treatment outcome: When therapists received no feedback, 21 percent of their patients deteriorated. With therapists who received regular feedback, 13 percent of patients deteriorated; with strengthened feedback, 7 percent of patients deteriorated.

The clear implication is that therapists are not always the best judge of how their patients are doing, perhaps because they are blinded by their own optimism and determination to succeed.

Some therapists might even view worsening during treatment as a sign of progress — a misguided “no pain, no gain” view of psychotherapy.

It’s probably easier to say what is bad psychotherapy than what is good, but there are qualities that all good therapies share. You should feel that you are understood as an individual, and that your therapist is compassionate and nonjudgmental. Good therapists should be able to explain the nature of your problem, and which of several treatments might help you.

Ask yourself not just whether you are getting better, but whether you are getting optimal treatment. Information about psychiatric disorders and recommended treatment can be found at several of reputable Web sites, including those of the American Psychiatric Association at www.psych.org, and the National Institute of Mental Health at www.nimh.nih.gov.

The psychiatric association’s treatment guidelines describe what is considered state-of-the-art treatment for various disorders and the empirical basis for the recommendations; see them at www.psych.org/psych_pract.

While it will not guarantee good therapy, seeing an accredited mental health professional provides some assurance of skill and competence.

Feeling better is important, of course, but it is possible to feel good and be stalled, where little significant change is taking place. If you are in therapy, don’t just rely on your own feelings to judge the treatment; speak to good friends and family members and see what they think about how you’re doing.

In the end, psychotherapy is a very personal business. If you need brain surgery, it doesn’t really matter if you like your surgeon as long as he’s skilled and competent. But in therapy, skill and competence are necessary but not enough; personal fit, more than almost anything, can make the therapy — or break it.

Richard A. Friedman is a professor of psychiatry at Weill Cornell Medical College.


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Sunday, August 05, 2007

Your Friends of Friends

IN a way it all seems so obvious. Your friend found a lump in her breast, so you have that long-delayed mammogram. One by one your friends stop smoking, so you stop, too. Of course people are affected by their friends’ habits and their health

But what seems obvious in the abstract can lead to surprising findings. A recent study found that obesity can spread from friend to friend much like a virus. When one person gains weight, close friends tend to gain weight, too.

The study, published recently in The New England Journal of Medicine, involved a detailed analysis of a large social network of 12,067 people who had been closely followed for 32 years, from 1971 to 2003.

Now, scientists believe that social networks not only can spread diseases, like the common cold, but also may influence many types of behavior — negative and positive — which then affect an individual’s health, as well as a community’s.

“In the past few years we have been seeing a network revolution,” says Albert-Laszlo Barabasi, a physics professor at the University of Notre Dame. “People sensed that networks were out there, but they never had large enough data sets to start understanding them in a quantitative fashion.”

For example, he said, sociologists would go into a classroom and ask students to list their friends. That, he said, can be useful, but social networks are huge, and they evolve over time. They involve you, your family, your friends, your friends’ friends and your friends’ friends’ friends.

The researchers who found the obesity effect stumbled upon the data they needed in the Framingham Heart Study. It has gone on for decades and followed most of the population of Framingham, Mass. As part of the study, participants named friends who could help locate them if researchers lost contact. That link was just what was needed to construct a social network and watch it evolve over decades — a web of friends and friends of friends along with family members.

The striking feature of networks, notes Dr. Nicholas Christakis of Harvard Medical School, is that they amplify whatever effect they are propagating. One person catches a cold and spreads it to 10 friends, each of whom spreads it to 10 more friends.

But obesity? Dr. Christakis and his colleague James H. Fowler, a political scientist at the University of California, San Diego, say they do not know how it happened, but the dynamic was clear — when one person became obese, that person’s friends were more likely to become obese and so were their friends and their friends’ friends.

Obesity was just the start, the researchers say. They have already begun asking about other health-related issues. Smoking, for example — have smokers become more isolated over time?

After all, networks evolve, and if smoking becomes unacceptable, smokers might be expected to cluster in their own little orbits, cut off from the mainstream. That, Dr. Fowler said, is exactly what happened. The Framingham data from the 1970s show smokers embedded in social networks just like everyone else. But by the 1990s, smokers began to be shunted to the side, their links to nonsmokers breaking.

Dr. Fowler and Dr. Christakis are now looking at depression, asking whether it spreads from friend to friend. There are hints from another study that it might.

The network in that case was derived from the federal National Longitudinal Study of Adolescent Health, a study of tens of thousands of teenagers that asks them to name their friends and follows them for years. It turned out, says Peter Bearman, a social scientist at Columbia University, that certain friendships increased the likelihood of suicide or suicidal thoughts in teenage girls.

The risky friendships are what Dr. Bearman calls a contradictory network — a teenage girl has two friends who dislike each other. “It tells you about the importance of social relationships for girls’ health and self-esteem,” Dr. Bearman says. “If you are in an unstable triad, it makes it much more difficult to fit in.”

Now Dr. Bearman and his colleagues are studying autism. The number of autistic children has increased rapidly in recent years, but it is not clear how much resulted from increased diagnosis and how much from an increase in the actual disease.

Dr. Bearman is studying how diagnoses of autism spread. When a child is diagnosed, friends of that child’s parents may wonder whether their child has autism as well, and have their child evaluated. Demand for autism evaluations would increase, and doctors and schools would become more sensitive to the disorder and more likely to suspect it. Schools would then provide services for the autistic children in the community, attracting families from other areas where autism was less common and where schools were not as prepared to help.

“There is an enormously important dynamic that draws people into a diagnostic maelstrom,” Dr. Bearman says. “Autism is real, but the epidemic very likely has a very important social network component.”

The challenge in medicine now is to map out complex dynamic networks, Dr. Barabasi said, and he does not just mean networks of people. The proteins and enzymes in a cell also form a closely connected network, Dr. Barabasi says. And when you tweak one protein, the whole web is affected. “That is why drugs have side effects,” Dr. Barabasi said.

And, he adds, “we will not have cures for obesity or cancer until we understand those networks.”

But he’s an optimist, believing that these cellular networks will be mapped sooner or later. “Right now, this is a work in progress,” Dr. Barabasi says, “but I believe we will get there in 10 years.”



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Sunday, July 15, 2007

Private IVF clinics are 'exploiting women'


Private IVF clinics are 'exploiting women' | UK News | The Observer
Britain's leading foetal medicine expert has condemned the IVF industry, saying some private clinics are exploiting women desperate to get pregnant by offering them unproven and expensive treatments.

Speaking publicly for the first time, Professor Charles Rodeck, founder and head of the unit for foetal medicine at University College Hospital London, has expressed particular concern over some of the drugs and tests being offered to infertile couples.

'The commercial world of IVF provision is a very competitive one, so some clinics try to keep a step ahead by offering more interventions than their competitors, even if they know those procedures might not work,' he said.


Rodeck transformed the use of foetal medicine in Britain by initiating the use of ultrasound for foetal therapy and diagnosis of malformations in the late Seventies. He went on to set up the first foetal medicine unit in the early Eighties, as well as setting up clinics specialising in the care of young women.

'Even though I have no evidence that the mothers or babies are being harmed by the extra hormones and steroids they are increasingly being given by these clinics, you can't be sure what happens to a baby when you put unnecessary and unproven medicines into its mother's body,' he said.

His work has left him open to attacks from the anti-abortion lobby but he is defiant. 'The truth is that not all human life is totally sacrosanct,' he said. 'Nature has a mechanism called "miscarriage" which eliminates many of its early errors but it is not always totally efficient and so some of these errors survive. What we are trying to do simply use technology to assist Nature.'

Rodeck also criticised some private clinics for giving poor information to couples. 'Offering these interventions becomes exploitation when clinics do not spell out the pros, cons and limitations of these interventions because couples so desperately want to get pregnant, that they will pay for virtually any treatment if they think it will increase their chances,' he said.

There are 85 licensed fertility clinics in the UK, in an industry worth up to £500m a year. According to latest figures from the Human Fertilisation and Embryology Authority, in 2004 more than 30,000 patients underwent more than 40,000 treatment cycles, each costing up to £8,000.

Rodeck says he agrees with the concerns voiced earlier this year by Lord Winston, professor of fertility studies at Imperial College London, that the IVF industry has been corrupted by money. He pointed to a growing range of expensive clinical practices offered to couples at private clinics, despite there being very limited evidence that such interventions work.

Rodeck is also highly critical of the lack of care women receive from the NHS. Women struggling to conceive and maintain a pregnancy frequently feel a fear and anxiety in labour that increases the likelihood of an emergency caesarean section having to take place, he said.

'Being pregnant and giving birth with the NHS can often be an impersonal and isolating experience,' he said. 'The process has become an anonymous production line. Many women hardly ever see the consultant they are registered with. Instead, they see a whole array of different doctors and midwives.'

The Healthcare Commission for England called his comments a 'useful contribution to a debate we are already having among ourselves as a matter of priority. The quality of maternity services is one of our biggest priorities.'

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Sunday, July 08, 2007

Catwalk ban for under-16 models

It is about time that those knuckleheads in the fashion industry wake up. There is little doubt that ordinary folks, bombarded daily with images of ultra-thin glamorous models in magazines and television, are influenced by these images; in other words, people are told what to accept as a fashionable body-type.

While this initial step of righting the ills that plague the fashion industry is laudable, it still falls far short of the real action that should be taken.


Catwalk ban for under-16 models | UK News | The Observer
Girls under the age of 16 will be banned from catwalks and photoshoots under new fashion industry rules drawn up to defuse the controversy over ultra-thin models.

The new age limit will mean that teenagers hoping to follow in the footsteps of Kate Moss, Lily Cole and Naomi Campbell, who all began modelling at 14 or 15, will no longer be used to sell clothes.

However, fashion bosses have decided not to ban 'size zero' models, who have sparked accusations that those, particularly the young, who seek to emulate them end up with eating disorders.

Article continues
The new guidelines will come as part of the independent report into the 'size zero' crisis. The inquiry, under Labour peer Baroness Kingsmill, follows the death last year of two South American models working on the international circuit, one from anorexia and the other from malnutrition.

Kingsmill's Model Health Inquiry will release an interim report on Wednesday which also recommends better health and nutritional advice for models, improving ways in which they can complain about their working conditions and education for models' agents about eating disorders. The British Fashion Council, the industry's trade body which commissioned the inquiry, has indicated that it will accept and implement the recommendations.

Industry representatives welcomed the moves. Gavin Myall, managing director of top London agency ICM Models, said: 'I have been quite vocal on the fact that we would like it to be 16 or above. We do have models below that age but very few, and whenever they are on jobs they are accompanied by parents and do not do shows.'

Myall also agreed with the inquiry's refusal to propose a ban on 'size zero' models, who are the equivalent of a UK size four. 'I do not think putting a limit on size is the answer. Saying someone cannot work because they are not a certain size is not right, but no reputable London agency looks after size zero models.'

Susan Ringwood, chief executive of the eating disorders campaign group Beat, added: 'Banning size zero models isn't the whole answer. The taller, younger and skinnier that someone is at the same time, that is a risk to health. But you can also be very slender and very healthy. You can't tell if someone is unhealthy just by looking at them.'

But the industry needed to use more models whose size is closer to that of British women - whose average size is 16 - said Ringwood. 'The fashion industry needs to widen its definition of beauty and embrace a more diverse aesthetic in the way that Dove and John Lewis have by using more normal-sized women, which is healthy.'

She endorsed any ban on under-16 models 'because using young girls to sell women's clothes is distasteful'.

'Using the slender bodies of 14- and 15-year-old girls, who don't have adult curves and shapes, means clothes hang beautifully on them but that's unhealthy because it creates a chasm between the way we are in our bodies and the aspiration that that sets up. It makes people think they are buying the youth of the model as well as the clothes themselves,' said Ringwood.

The Model Health Inquiry's members include fashion designers Betty Jackson and Giles Deacon, supermodel Erin O'Connor, Storm Models boss Sarah Doukas and consultant psychiatrist Dr Adrienne Key. They have spent the past six weeks holding discussions with models, designers, magazine editors, photographers and models' agent about the problem and remedial action.

Models have demanded the industry introduces a standard contract of employment to prevent exploitation by unscrupulous agents through, for example, excessive working hours.

Hilary Riva, the BFC's chief executive would only say: 'The British Fashion Council commissioned the independent Model Health Inquiry to look into the health issues of models on London's catwalks and looks forward to receiving the interim report on Wednesday.'

The facts about thin

· 'Size zero' models became the subject of international debate when organisers of Madrid Fashion Week banned models with a body mass index below 18 last year.

· The deaths of models Luisel Ramos and Ana Carolina Reston from South America have been attributed to the size-zero trend.

· Although Milan and Madrid prohibited size zero models from their catwalks, London did not adopt the same policy last year.

· The European Union's move is expected to halt the trend of girls trying to copy size zero fashion models. Traditional dress sizes may be replaced with bust and waist measurements


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New health fears over big surge in autism

New study from Cambridge University is bound to stoke further controversy surrounding the link between vaccines, particularly the MMR triple vaccine, and childhood autism. Researchers from the Autism Research Centre in Cambridge found the incidence of autism to be much higher than previously thought (one in 58 as opposed to one in 100).

When this link was first proposed in 1998 by Dr. Andrew Wakefield -- who, together with several two former colleagues from Royal Free Hospital in London, is facing General Medical Council disciplinary action related to his work -- a huge controversy had erupted. Many parents defaulted MMR vaccinations for their children, electing instead to have vaccinations in private with three separate injections.

This latest finding is bound to fuel the controversy much further.


New health fears over big surge in autism | UK News | The Observer
The number of children in Britain with autism is far higher than previously thought, according to dramatic new evidence by the country's leading experts in the field.

A study, as yet unpublished, shows that as many as one in 58 children may have some form of the condition, a lifelong disability that leads to many sufferers becoming isolated because they have trouble making friends and often display obsessional behaviour.

Seven academics at Cambridge University, six of them from its renowned Autism Research Centre, undertook the research by studying children at local primary schools. Two of the academics, leaders in their field, privately believe that the surprisingly high figure may be linked to the use of the controversial MMR vaccine. That view is rejected by the rest of the team, including its leader, the renowned autism expert, Professor Simon Baron-Cohen.

The team found that one in 58 children has either autism or a related autistic spectrum disorder. Nationwide, that could be as many as 210,000 children under 16. The research is significant because that figure is well above the existing estimate of one in 100, which specialist bodies such as the National Autistic Society have until now accepted as correct. It is also significantly more than the previous highest estimate of one in 86, which was reported in research published last year in the Lancet.

Some experts who previously explained the rise in autism as the result of better diagnosis and a broader definition of the condition now believe the upward trend revealed by studies such as this indicates that there has been a real rise in the numbers of children who are affected by it. Although the new research is purely statistical and does not examine possible explanations for the rise, two of the authors believe that the MMR jab, which babies receive at 12 to 15 months, might be partly to blame. Dr Fiona Scott and Dr Carol Stott both say it could be a factor in small numbers of children.

Professor Baron-Cohen, director of the centre and the country's foremost authority on the condition, said he did not believe there was any link between the three-in-one vaccination and autism. Genetics, better recognition of the condition, environmental factors such as chemicals and children's exposure to hormones in the womb, especially testosterone, were more likely to be the cause, he commented. 'As for MMR, at this point one can conclude that evidence does not support the idea that the MMR causes autism.'

Baron-Cohen and his team studied the incidence of autism and autistic spectrum disorders among some 12,000 children at primary school in Cambridgeshire between 2001 and 2004. He was so concerned by the one in 58 figure that last year he proposed informing public health officials in the county.

Controversy over the MMR jab erupted in 1998 after Dr Andrew Wakefield, a gastroenterologist at the Royal Free Hospital in north London, said he no longer believed it was safe and might cause autism and inflammatory bowel disease in children. Many parents panicked and MMR take-up fell dramatically. More families opted to have their child immunised privately through three separate injections to avoid the possibility of their immune system being overloaded by the MMR jab, thus leaving them at greater risk of infections.

The medical and scientific establishment denied Wakefield's claim, described research he had co-authored as 'bad science', and sought to reassure the public, with limited success. Wakefield and two former Royal Free colleagues are due to appear before the General Medical Council next week to answer charges relating to the 1998 research. The trio could be struck off.

The doctors' disciplinary body claims that Wakefield acted 'dishonestly and 'irresponsibly' in dealings with the Lancet, was 'misleading' in the way he sought research funding from the Legal Aid Board, and 'acted unethically and abused his position of trust as a medical practitioner' by taking blood from children after offering them money.

A book to be published this month by Dr Richard Halvorsen, a London GP who provides single vaccines privately to babies of parents concerned about MMR, will fuel the controversy. It will present new evidence of children allegedly being damaged by vaccinations and linking increased autism to MMR.

But Dr David Salisbury, national director for vaccines and immunisation at the Department of Health, said last night: 'The evidence is absolutely clear. No published study has ever shown a link between autism and the MMR vaccine. It is absolute nonsense to suggest otherwise.'


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Thursday, June 14, 2007

F.D.A. Panel Rejects Drug for Obesity



F.D.A. Panel Rejects Drug for Obesity - New York Times



A drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide.



Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the Food and Drug Administration will approve its sale in the United States without additional safety data.



The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.



The panel’s vote was a blow to Sanofi-Aventis, the French company that makes the drug, which is sold in many countries under the brand name Acomplia. As the advisory committee finished voting, the company’s stock, which trades in this country as American depositary receipts, closed at $43.07, down $1.31 or 2.95 percent. It fell another $1.02 in after-hours trading.



Sanofi had expressed hope that the drug would be a $3 billion seller, with much of that market in the United States, a country with a growing obesity problem.



In a statement issued after the panel’s vote, the company said it would continue to work with the F.D.A. to address the panel’s concerns, which included worries about a high dropout rate in clinical studies of the drug, evidence of a doubling of psychiatric events and questions about whether the drug induced seizures.



Dr. Jules Hirsch, an advisory committee member who is a research physician at Rockefeller University, summed up the sentiments of the other panelists. “I couldn’t in any way suggest that it be approved at the present time for use.”



The drug, which the company had planned to call Zimulti in the United States, works on the brain’s endocannabinoid system. The system was discovered through research into marijuana, which works on brain receptors to give users the “munchies.”



By suppressing those receptors, Zimulti curbs hunger. Clinical studies revealed that patients taking it lost about 5 percent of their weight.



But the same brain system also modulates depression, phobias, anxiety and post-traumatic stress disorder. Testimony before the panel yesterday in Silver Spring, Md., suggested that tampering with the endocannabinoid system also increased such psychiatric symptoms, including suicidal thoughts.



“The potential market for this drug and the continued uncertainty about its risks, both known and unknown, lead to our concern about the use of this drug in the general population,” an F.D.A. staff medical reviewer, Dr. Amy G. Egan, told the panel.



The committee’s vote that there was not enough safety data to approve the drug came after Dr. Egan’s presentation, which indicated that the drug doubled a patient’s risk of problems like anxiety, depression, aggression and psychosis.



The committee also heard about data showing an increase in suicidal thinking among users of the drug, including four patients who did commit suicide while taking it: three during clinical studies and one in Europe after the drug was approved last year.



In a presentation to the panel, representatives of Sanofi recommended a special screening of prospective patients to measure their risk for psychiatric symptoms.



The company also argued that the drug should be evaluated in light of a growing need for drugs to treat obesity, citing benefits in glucose, HDL cholesterol, tryglycerides and inflammatory markers in patients taking the drug.



Currently only two drugs are approved to assist patients with weight loss. One of them, Meridia, by Abbott Laboratories, has been linked to high blood pressure. The other, Xenical by Roche, causes diarrhea and gas.



Yesterday’s vote came on the same day that Xenical became available without a doctor’s prescription under the brand name Alli. The drug is being marketed by GlaxoSmithKline, which purchased over-the-counter rights to the drug from Roche and won F.D.A. approval this year to sell the product directly to consumers.



Dr. Hirsch of Rockefeller University said Zimulti’s effects on weight were similar to those of other drugs already marketed — a 5 percent loss followed by a regain of weight.



“The problem I see with this whole thing is that the number of people who are going to lose weight is very small,” Dr. Hirsch said. “You’re telling a 220-pound woman that she has a one in four chance of getting down to 200 pounds if she sticks with the program. That’s not going to make anyone very happy.”



Sanofi-Aventis had first petitioned the F.D.A. in 2005 to approve the drug, counting on it to help replace the sales lost through the patent expiration this year of its sleep medication Ambien as well as the anticipated 2011 patent expiration of another big seller, Plavix, an anticlotting agent.



In a statement yesterday after the panel’s vote, the company said it would work with the F.D.A. to address concerns about the drug.

Thursday, May 10, 2007

Cancer Protection



Cancer Protection - New York Times
Gardasil vaccine protects against cervical cancer caused by a sexually transmitted wart virus for at least three years and also prevents lesions that can grow into vaginal and vulvar cancer, two studies said. A third study found that the virus might cause a significant number of throat cancers. Gardasil protects against the four strains of the human papillomavirus, or HPV, that cause 70 percent of cases of cervical cancer. The cost of the vaccine, manufactured by Merck, is $360 for six months. That may be too high in poorer countries where HPV is the biggest threat, some experts have said.


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Wednesday, May 09, 2007

Doctors Reap Millions for Anemia Drugs



Doctors Reap Millions for Anemia Drugs - New York Times

Yesterday, the Food and Drug Administration added to concerns about the drugs, releasing a report that suggested that their use might need to be curtailed in cancer patients. The report, prepared by F.D.A. staff scientists, said no evidence indicated that the medicines either improved quality of life in patients or extended their survival, while several studies suggested that the drugs can shorten patients’ lives when used at high doses. Yesterday’s report followed the F.D.A.’s decision in March to strengthen warnings on the drugs’ labels.



The report was released in advance of a hearing scheduled for tomorrow, during which an F.D.A. advisory panel will consider whether the drugs are overused.



The medicines — Aranesp and Epogen, from Amgen; and Procrit, from Johnson & Johnson — are among the world’s top-selling drugs, with combined sales of $10 billion last year. In this country, they represent the single biggest drug expense for Medicare and are given to about a million patients each year to treat anemia caused by kidney disease or cancer chemotherapy.

Friday, May 04, 2007

Epilepsy Drug Can Increase Risk for Newborns, Study Says



Epilepsy Drug Can Increase Risk for Newborns, Study Says - New York Times

Doctors reported yesterday that expectant mothers with epilepsy who took a commonly prescribed drug to control seizures were at increased risk of having a child with mental deficits.



Toddlers who had been exposed in the womb to the drug Depakote, from Abbott Laboratories, scored seven to eight points lower on I.Q. tests at age 2 than those whose mothers had been taking other epilepsy drugs while pregnant, the study found. They were twice as likely to score in the range associated with mental retardation, according to the authors, who presented the findings at the annual meeting of the American Academy of Neurology in Boston.




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Tuesday, May 01, 2007

Heart Scans: Finding More Than You May Need to Know



Heart Disease - Scanning - Prevention - Heart Scans: Finding More Than You May Need to Know - New York Times



Nearly everyone agrees on the basics. Adults should know their cholesterol, blood-sugar and blood-pressure levels and should keep them within national guidelines. It is often reasonable to try dieting and exercising, but if that fails, most people should take prescription drugs.



If everyone took those steps, that alone could make the heart attack rate plummet, says Dr. Daniel Levy, the director of the Framingham Heart Study, a federal study of the population of Framingham, Mass. Dr. Levy said the study indicated that nearly every heart attack from age 50 to age 95 could have been prevented if people had their blood pressure, blood sugar and cholesterol under control at age 50 and did not smoke. Yet, he noted, only 5 percent of the nation’s 50-year-olds do this.



But the testing question gets murky after that. Some, like the United States Preventive Services Task Force, a federally sponsored panel of experts in primary care and prevention, says that most people should take only basic tests. “The message we are trying to get across is that more testing is not always beneficial,” said the panel’s chairman, Dr. Ned Calonge.



The concern is that seemingly innocuous tests will give false-positive results, which lead to more tests and even treatments, when there was nothing wrong to begin with.



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Scientists Look to Vaccines in the War on E. Coli

Shousun C. Szu, a scientist at the National Institutes of Health, says the best way to prevent people from being poisoned by deadly E. coli would be to vaccinate all infants against the bacteria.

Graeme McRae, a Canadian biotechnology executive, says it would be more practical to inoculate cows instead.

Vaccines for people and for cattle are just two approaches under development to prevent or treat food poisoning by the strain E. coli O157:H7.



E. Coli - Bacteria - Vaccines - New York Times

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Saturday, April 28, 2007

Merck Receives Non Approvable Letter from FDA for ARCOXIA(R) (etoricoxib)





Merck Receives Non Approvable Letter from FDA for ARCOXIA(R) (etoricoxib) - MarketWatch

WHITEHOUSE STATION, N.J., Apr 27, 2007 (BUSINESS WIRE) -- Merck & Co., Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a non-approvable letter in response to the Company's New Drug Application (NDA) for ARCOXIA(R) (etoricoxib) for the symptomatic treatment of osteoarthritis (OA). ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the NDA was submitted in December 2003 for a 60 mg once-daily dose along with review of a separate related NDA for a 30 mg once-daily dose submitted in April 2004. In the non-approvable letter, the FDA indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of ARCOXIA in order to gain approval.






FT.com / Companies / Drugs & healthcare - FDA rejects Merck’s Vioxx successor

US regulators on Friday refused to approve Arcoxia, Merck’s successor drug to withdrawn painkiller Vioxx, as drug safety concerns continue to tighten regulation for drugmakers.



The Food and Drug Administration’s refusal also underlines the fact that the controversy over the class of drugs known as cox-2 inhibitors - developed as safer painkillers with less stomach irritation than older medicines - continues after Merck withdrew Vioxx in September 2004 due to increased heart risks.



The wake of that withdrawal increased scrutiny on the FDA drug safety regime for all drugs and drew a cloud over cox-2 drugs in particular. The Arcoxia decision bodes poorly for Swiss drugmaker Novartis’s similar drug Prexige, still pending approval.



In addition, the FDA denial comes despite Arcoxia’s approval in 63 countries, raising questions about how regulatory agencies abroad could react to the drug’s rejection in the US.



Merck said it had no plans to change its support and marketing strategy of Arcoxia in markets including Europe and Asia, where five years of user experience backs its utility and safety.



But Merck failed in its expensive, nearly four-year attempt to get US approval. It declined to comment on whether it would continue to study the drug for approval.


F.D.A. Turns Down Merck Arthritis Drug - New York Times

The Food and Drug Administration has rejected Merck & Company’s bid to win approval for a successor to Vioxx, the arthritis medication that Merck withdrew from the market more than two years ago, the company said yesterday. The decision had been widely expected ever since a panel of F.D.A. advisers voted two weeks ago by 20 to 1 against approval of the drug, Arcoxia, because of concerns that it could cause as many as 30,000 heart attacks a year if widely used.

Texas Legislators Block Shots for Girls Against Cancer Virus



Texas Legislators Block Shots for Girls Against Cancer Virus - New York Times

HOUSTON, April 25 — A revolt by lawmakers has blocked Gov. Rick Perry’s effort to make Texas the first state to require sixth-grade girls to be vaccinated against a sexually transmitted virus that causes cervical cancer.




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Friday, April 27, 2007

Scientists Identify 7 New Diabetes Genes





Scientists Identify 7 New Diabetes Genes - New York Times

Researchers said yesterday that they had identified seven new genes connected to the most common form of diabetes — the latest result of an intensifying race between university researchers and private companies to find genes linked to a range of diseases.



Yesterday’s reports bring the number of well-attested genes involved in adult-onset, or Type 2 diabetes up to 10, from the 3 known previously. The new genes do not immediately suggest any new therapy, but may point to a new biological basis for the disease, from which effective treatments could emerge in time.





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Scientists Identify 7 New Diabetes Genes





Scientists Identify 7 New Diabetes Genes - New York Times

Researchers said yesterday that they had identified seven new genes connected to the most common form of diabetes — the latest result of an intensifying race between university researchers and private companies to find genes linked to a range of diseases.



Yesterday’s reports bring the number of well-attested genes involved in adult-onset, or Type 2 diabetes up to 10, from the 3 known previously. The new genes do not immediately suggest any new therapy, but may point to a new biological basis for the disease, from which effective treatments could emerge in time.





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Thursday, April 26, 2007

Circumcision May Reduce Penile Sensitivity



Circumcision May Reduce Penile Sensitivity

NEW YORK (Reuters Health) Apr 13 - Findings from a new study suggest that circumcised penises are less sensitive than their uncircumcised counterparts.



The study, which is reported in the April issue of BJU International, was conducted by a research team headed by Dr. Morris Sorrells and Dr. Mark D. Reiss, both affiliates of Doctors Opposing Circumcision, a group opposed to non-therapeutic neonatal circumcision.




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Sunday, April 22, 2007

HRT Linked to Ovarian Cancer Deaths in Britain



HRT Linked to Ovarian Cancer Deaths in Britain - CME Teaching Brief® - MedPage Today

OXFORD, England, April 19 -- Use of hormone replacement therapy for at least five years added up to 1,300 additional ovarian cancers over 14 years in Britain and 1,000 extra deaths, researchers here reported.


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Saturday, April 21, 2007

Pill That Eliminates the Period Gets Mixed Reviews



Pill That Eliminates the Period Gets Mixed Reviews - New York Times



For many women, a birth control pill that eliminates monthly menstruation might seem a welcome milestone.



But others view their periods as fundamental symbols of fertility and health, researchers have found. Rather than loathing their periods, women evidently carry on complex love-hate relationships with them.



This ambivalence is one reason that a decision expected next month by the Food and Drug Administration has engendered controversy. The agency is expected to approve the first contraceptive pill that is designed to eliminate periods as long as a woman takes it. Doctors say they know of no extra risk to the new regimen, but some women are uneasy about the idea.

Doctors Try New Surgery for Gallbladder Removal





Doctors Try New Surgery for Gallbladder Removal - New York Times

Doctors in New York have removed a woman’s gallbladder with instruments passed through her vagina, a technique they hope will cause less pain and scarring than the usual operation, and allow a quicker recovery. The technique can eliminate the need to cut through abdominal muscles, a major source of pain after surgery.



The operation was experimental, part of a study that is being done to find out whether people will fare better if abdominal surgery is performed through natural openings in the body rather than cuts in the belly. The surgery still requires cutting, through the wall of the vagina, stomach or colon, but doctors say it should hurt less because those tissues are far less sensitive than the abdominal muscles.

Thursday, April 19, 2007

HRT linked to 1,000 deaths from cancer





HRT linked to 1,000 deaths from cancer | Special reports | Guardian Unlimited

Hormone replacement therapy may have caused the deaths of more than 1,000 women in the UK from ovarian cancer since 1991, scientists reveal today.



But today's authoritative study by Professor Valerie Beral and colleagues from Oxford University reveals that those who take HRT for five years or more are risking death from a particularly lethal form of cancer. The research, published online by the Lancet medical journal today, will not be the last straw for HRT, but it may well reduce the numbers willing to take the risk of hormone treatment.



It is the first firm calculation of deaths related to HRT, but Prof Beral and her colleagues have already shown that women who take the therapy are at increased risk of breast cancer and womb cancer. The risks of breast cancer are the highest, accounting for a probable 20,000 cases over a decade.



In a commentary in the Lancet, Dr Steven Narod of the Women's College Research Institute at the University of Toronto said that use of HRT had declined dramatically in the UK and elsewhere since concerns were initially raised and it was thought this had led to a decline in breast cancer rates in the USA.



"With these new data on ovarian cancer, we expect the use of HRT to fall further. We hope that the number of women dying of ovarian cancer will decline as well," he said.

Sharp Drop in Rates of Breast Cancer Holds





Sharp Drop in Rates of Breast Cancer Holds - New York Times

Breast cancer rates fell sharply in 2003, and the lower rate remained in 2004, researchers are reporting today.



The finding, they say, fits with a hypothesis they advanced last December when they had data only from 2003. At that time, national data showed that breast cancer rates fell by nearly 15 percent in the 18 months from July 2002 through December 2003.



The most likely reason for the fall in rates, the investigators, led by Donald A. Berry of M. D. Anderson Cancer Center in Houston, said, was that large numbers of women stopped taking hormone therapy for menopause. And that therapy, a combination of estrogen and progestins, can increase the incidence of breast cancer.



Now, with the 2004 data, the researchers say the effect is less likely to be an anomaly. If rates had gone up again, they explain, it would have meant that their hypothesis was incorrect.

Tuesday, April 17, 2007

How (and How Not) to Battle Flu: A Tale of 23 Cities



Spanish Flu Epidemic: How (and How Not) to Battle Flu: A Tale of 23 Cities - New York Times

Scientists are still studying the 1918 pandemic, the deadliest of the 20th century, looking for lessons for future outbreaks — including the possibility that H5N1, the avian influenza virus, could mutate into a form spread easily from human to human. This month, researchers published two new studies in The Proceedings of the National Academy of Sciences comparing public-health responses in cities like St. Louis and Philadelphia.



Using mathematical models, they reported that such large differences in death rates could be explained by the ways the cities carried out prevention measures, especially in their timing. Cities that instituted quarantine, school closings, bans on public gatherings and other such procedures early in the epidemic had peak death rates 30 percent to 50 percent lower than those that did not.

Sunday, April 08, 2007

China alters organ transplant laws



China alters organ transplant laws - CNN.com

BEIJING, China (AP) -- China published new rules governing human organ transplants in its latest effort to clean up a business critics say has little regard for medical ethics.

But the regulations were packed with shortcomings, a human rights group said Saturday, including a failure to address what it called the "crucial issue" of the procurement of organs from executed prisoners.

The rules issued Friday by China's State Council, or Cabinet, include a ban on the sale of human organs for profit and on donations by people under 18, according to the text of the regulations published by the Communist Party newspaper People's Daily.

The regulations, which take effect May 1, are also meant to standardize transplant procedures at the limited number of hospitals licensed to perform them.

Little information about China's lucrative transplant business is publicly available. Human rights groups have said many organs -- including those transplanted into wealthy foreigners -- come from executed prisoners who may not have given their permission.

Human Rights Watch urged Beijing for full transparency on the removal of body organs from executed prisoners.

"The regulations show that China is responding to great international concern over organ trade in the country," said Nicholas Bequelin, a Hong Kong-based researcher for Human Rights Watch, in a telephone interview.

"But the regulations are no substitute for an open and transparent system. It leaves vague areas under secrecy, such as the crucial issue of the provenance of the organs, which we know are through judicial executions," Bequelin said.

F.D.A. Orders End to Production of a Form of Anti-Nausea Drug



F.D.A. Orders End to Production of a Form of Anti-Nausea Drug - New York Times

The Food and Drug Administration yesterday ordered drug companies to stop making and selling anti-nausea suppositories containing the active ingredient trimethobenzamide, a drug that the agency said did not work when used in that form.

Trimethobenzamide in other forms, including pills and injectables, does have F.D.A. approval for use against nausea and vomiting, the agency said.

Other drugs: Since last June, the FDA has removed its previous approvals of products containing quinine for leg cramps, ergotamine tartrate for migraines and carbinoxamine for children’s allergies and colds. Although the agency estimates that less than 2 percent of prescription drugs sold now are unapproved, it believes there are “several hundred” unapproved active ingredients in prescription drugs.



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Saturday, April 07, 2007

Statins Linked to Lower Incidence of Sepsis in Patients With Chronic Kidney Disease



Statins Linked to Lower Incidence of Sepsis in Patients With CKD


April 4, 2007 — Statins help reduce the incidence of sepsis in patients receiving dialysis for chronic kidney disease, according to the results of a prospective, observational cohort study reported in the April 4 issue of JAMA.

"Patients with chronic kidney disease are at high risk for sepsis and sepsis-related mortality," write Rajesh Gupta, MD, from Northwestern University in Chicago, Illinois, and colleagues. "Experimental evidence in animals has indicated that statins may prevent sepsis and modulate the severity of sepsis. Two smaller observational studies in humans have shown lower rates of sepsis-related mortality among patients being treated with statins and a reduction in the incidence and severity of sepsis among patients treated with statins."

JAMA. 2007;297:1455-1464.