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 na├»ve,” 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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