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OHSU doctor takes on Big Pharma, medical establishment


TRIBUNE PHOTO: JONATHAN HOUSE - 'We want a system that puts the interest of the patients and people first. If the price is we have to go to the public and say, 'Here is what is going on,' then maybe that's what it takes.'--Dr. Vinay Prasad, OHSU oncologist and co-author, 'Ending Medical Reversals.'If he were playing it safe, Dr. Vinay Prasad might be among the last to turn into a medical provocateur.

Prasad works at Oregon Health & Science University’s Knight Cancer Institute as a cancer physician, and OHSU has gone all-in trying to make it a flagship department.

The institute is run by oncologist Dr. Brian Druker, whose discovery of Gleevec as a cure for chronic myeloid leukemia has helped put OHSU’s cancer institute on the national map.

Yet Prasad has become increasingly outspoken about how medicine, and especially the cancer industry has become dominated by forces that do not have patients’ best interests at heart. Prasad even criticizes Gleevec. Not the drug’s effectiveness, but its cost.

“Novartis, the maker of Gleevec, has raised the price of the drug from an already-high $30,000 in 2001 to $76,000 today, despite the fact that it costs less than $200 to manufacture a year’s supply,” Prasad wrote last year in a Huffington Post article.

To be sure, Druker also has criticized the cost of Gleevec. And Prasad points out that at least Gleevec saves lives. In the Huffington Post article, he wrote, “Most cancer drugs are not close to being great — they have only a tiny positive impact on longevity and often cause many side effects.”

That’s not exactly the kind of statement to put a cancer doctor in the good graces of the companies that pay a lot of the freight.

Prasad says that the interests of the drug companies cannot be his first priority.

“We want a system that puts the interest of the patients and people first,” he says. “If the price is we have to go to the public and say, ‘Here is what is going on,’ then maybe that’s what it takes.”

Prasad’s outspokenness and willingness to criticize industrywide assumptions place him in the ranks of a small but influential group of physicians and researchers who are either having an impact on the way medicine is practiced in the United States, or tilting at windmills. That depends on whom you ask.

Prasad’s voice is starting to get noticed on a national stage, says Diana Zuckerman, president of the Washington, D.C.-based National Center for Health Research. When Prasad published a study last year showing new cancer drugs were no more effective than cheaper drugs already on the market, Zuckerman had the work distributed to members of Congress, the White House and science reporters around the country.

“To me, that’s huge news,” Zuckerman says of Prasad’s findings. “Why wasn’t that in every media outlet in the country? Why wasn’t it on every TV news program?”

Zuckerman says she knows why: “It’s not funded by the (pharmaceutical) industry.”

She calls Prasad an iconoclast, and says the work he and others perform detailing conflicts of interest is more important than ever, because there is more money involved today and more lives affected when bad drugs are put into the marketplace.

“It’s one thing when there’s only one cancer drug and it’s not very good, but maybe it’s better than nothing,” Zuckerman says. “But it’s another thing when there are 10 different cancer drugs for the same type of cancer and eight of them have exaggerated their effectiveness in the research, and the two that are perhaps the best are the oldest generic drugs that nobody is advertising or promoting because they don’t cost much.”

Prasad’s latest joust with the medical establishment took place four weeks ago, when he authored a study in The Journal of the American Medical Association Internal Medicine, once again peeking behind the curtain of drug-approval policies. His research revealed that a third of the speakers supposedly representing cancer patients at industry conferences about new drugs were being paid by the drug companies, and that nine out of 10 already supported the drugs’ approval.

That study was part of a pattern. Last year Prasad co-authored a review of clinical trials for new drugs that showed the trials were flawed in their basic design, because they were not intended to measure whether patients survived better or longer.

In 2013 Prasad wrote an editorial in JAMA Internal Medicine excoriating widespread use of a cardiac device — the inferior vena cava filter — when there was virtually no evidence that the device worked and plenty of evidence that it was harming patients.

In 2012 Prasad was the lead author on an Archives of Internal Medicine article claiming too many patients with chest pain who hadn’t actually suffered heart attacks were being treated for them.

Highlighting oops moments

Prasad’s new book, “Ending Medical Reversal: Improving Outcomes, Saving Lives,” co-authored with Dr. Adam Cifu, takes on the “oops” moments of medicine — drugs or therapies that are used on patients until new science reveals they are ineffective or dangerous. An example is Vioxx, an effective and popular arthritis drug — until it was found to cause heart attacks and recalled.

U.S. medicine is experiencing “a near epidemic of medical reversals,” Prasad says. He claims to have found 146 examples of medical reversals in 2013 alone.

Prasad says that pharmaceutical companies are becoming more adept at getting physicians to accept drugs that are no better than current, less-expensive versions. They’re also pushing through therapies without adequate clinical testing and sufficient after-release followup to make sure they are really working as intended, he says.

Critics’ impact questioned

The attention focused on drug companies by Prasad and others hasn’t substantially changed things yet, says Dr. Adriane Fugh-Berman, who teaches at Georgetown University Medical Center in Washington, D.C., and is director of PharmedOut, a university project that shows how drug companies use marketing to get doctors to use their products.

“Many physicians think it’s a whole lot of fuss over nothing,” Fugh-Berman says. “Very few physicians are activists, and many of them don’t even vote.”

The problem, she says, lies with drug companies and physicians, not complacent or uneducated consumers. She cites a recent study that showed even medical school residents who have been educated about the best drugs choose inferior drugs if they have free samples on hand.

“In general, consumers are more savvy about these issues than physicians are,” Fugh-Berman says.

Dr. Erick Turner, an OHSU psychiatrist who has criticized drug companies for, among other things, failing to publish data from studies that fail to support their products, disagrees.

“I think it’s most definitely having an impact,” Turner says of physicians speaking out. Big Pharma, he says, is paying attention.

More clinical trials are now required to be registered with federal agencies, and results from those trials more often are made public, though Turner notes that usually it is just summary data, not the patient data that researchers might use to draw different conclusions.

“This is all stuff that didn’t exist even a couple of years ago,” Turner says.

PHOTO COURTESTY: ZDENKO ZIZKOVIC - Surgeons perform too many unnecessary operations on patients with degenerative menisci tears, according to OHSU physician Vinay Prasad.

New era for promoting medical advances

Twenty-five years ago, the possibility that pharmaceutical companies could market new drugs directly to the public was considered irresponsible — drug companies dealt with physicians. That changed in 1999, when the federal Food and Drug Administration relaxed rules that previously had required drug companies to list all product risks in advertising.

Similarly, physicians who wanted to effect change dealt with other physicians, or hospitals and medical associations.

Today, pharmaceutical companies with new drugs take out full-page ads and buy 60-second commercials that require ridiculously lengthy side-effect warnings, but only on major risks. Similarly, a number of physicians, Prasad included, are not content with speaking out only to the medical establishment by publishing in medical journals.

Last year, Prasad wrote an op-ed piece for The New York Times decrying high-profile science awards for high-profile scientists because they “diminish the way that great medical advances build on one another.” Like the drug companies, he’s going after the hearts and minds of the public.

Prasad has published articles exposing conflicts of interest among physicians working to get approval for drugs. He has questioned the widespread use of statins for healthy people with high cholesterol.

He also published a study revealing the exaggeration and hyperbole scientists use to gain attention for their clinical studies — words like “breakthrough” and “cure.”

In Prasad’s view, he has no choice. Consider the issue of stents for coronary angina. The use of stents for those not suffering heart attacks grew in the early 2000s, to an annual cost of about $14 billion a year. Yet in 2007, a new study “resoundingly found (stents) not to improve survival,” according to Prasad. Cardiologists, he says, are aware of that study. And they still overuse stents. Prasad is convinced that habit is as much a factor as undue influence from drug companies.

“When you do something for a person and you believe you are helping them and you’re rewarded for doing that, psychologically it’s very hard for those of us who have done it to let go,” he says.

So why write for The New York Times and other newspapers? “My experience tells me that more doctors read those papers than the journal articles,” he says.

Prasad has taken on surgeons for unnecessary operations designed to repair degenerative menisci tears. He’s also written against current estrogen-replacement therapy protocols and overuse of mammograms.

Many of the treatments Prasad assails turn out to have unintended consequences. Ironically, it is just such an impact that has him worried about his own advocacy work, something he calls “the third harm.”

If people lose trust in the medical system, he says, science suffers. He’s aware that fewer than 10 percent of adult cancer patients enroll in clinical trials designed to reveal the best therapies. Still, third harm or not, he says he has to speak out.

Zuckerman agrees.

“It’s hugely important that they’re doing this,” she says. “If they weren’t, nobody would have any idea of what’s going on.”


Find out more

For more on Prasad’s writings:

www.vinayakkprasad.com/books/

bit.ly/216b0Zr


Prasad takes ‘do no harm’ oath to heart

Dr. Vinay Prasad never planned on becoming a public advocate. He was headed for a career in private practice until his third year of medical school, when he began to see “warning signs” that best practices often were being ignored. During his internship in a hospital cardiac intensive-care unit, a woman patient he was treating suffered a complication from a stent, which motivated him to review the clinical trials that had been conducted for stents. He learned that his patient was unlikely to have benefited at all from the device.

“She experienced harm without possibility of benefit,” Prasad wrote about the experience. “What about our oath to ‘do no harm?’ ”

That’s what got him looking at all the drugs and procedures that were being widely used despite evidence that they weren’t the most effective.

In its review of the book Prasad co-authored, “Medical Reversals,” The New York Times called it “a subtly subversive book in need of a considerably snappier title.” Prasad says he’s comfortable being called subversive.

“We’re not calling for anarchy,” he says. “We’re calling for a shift to evidence.”