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Clinical trials

Review of scientific journals shows steadily increasing conflict of interest in funding of drug trials

Tuesday, August 15, 2006 by: Jessica Fraser
Tags: clinical trials, drug companies, medical journals


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When scientific research appears in a peer-reviewed journal, readers are supposed to be able to trust that the research is honest, unbiased and accurate -- especially when it concerns prescription drug safety. Thus, when journalists at mainstream news publications in turn relay that scientific research to the general public, the public should be able to trust that information.

Unfortunately, in light of a recent review of major scientific journals, the information contained in many drug safety studies seems to be more corporate-spun PR than genuine science, especially when it concerns psychiatric drugs. According to new findings by a team of researchers from Beth Israel Medical Center in New York, between 1992 and 2002, the number of psychiatric drug studies paid for by pharmaceutical companies more than doubled -- from 25 percent in 1992 to 57 percent in 2002.

Psychiatrist Igor Galynker and a team of researchers reviewed clinical research from four major psychiatric journals -- Archives of General Psychiatry, American Journal of Psychiatry, Journal of Clinical Psychiatry and Journal of Clinical Psychopharmacology -- and discovered that eight out of 10 studies paid for by the pharmaceutical company making the drug in question showed favorable results. That's an unbelievable 80 percent success rate. Conversely, when studies were paid for by pharmaceutical companies competing with the firm making the drug in question, only three in 10 studies showed positive results. The studies conducted with no support from the pharmaceutical industry showed favorable results five out of 10 times.

The issue at hand is bias, and sadly, it's not a new phenomenon. It is also not limited to psychiatric drug studies. According to a June 2006 Agence France-Presse (AFP) article, private drug companies finance 75 percent of the studies published in the New England Journal of Medicine, the Journal of the American Medical Association and The Lancet in Britain. Do the math. That's a lot of potential bias.

"Anytime you leave the conduct, the analysis and writing up of a study in the hands of those likely to profit for it, you run the risk of bias and distortion," said Peter Lurie, deputy director of the Health Research Group at Public Citizen -- an organization for protecting consumers. Lurie also said that in addition to Big Pharma firms sponsoring drug studies, they also finance much of the drug approval work done by the Food and Drug Administration (FDA). "There is a fundamental conflict of interest in considering a drug for approval when you know the sponsor is paying your salary," Lurie said.

Dr. John Abramson, a clinical instructor at Harvard Medical School and author of the critical 2004 book, "Overdosed America: The Broken Promise of American Medicine," said in an op-ed piece he wrote in January 2006 for the Los Angeles Times: "Before 1980, most medical studies were publicly funded, and most academic researchers scorned industry support. Now, however, the vast majority of clinical trials are commercially funded, and with the financial stakes so high, there is mounting evidence of individual scientists and corporations manipulating their findings."

Abramson cited the now-well-known case of Vioxx to illustrate his argument, pointing out that U.S. doctors prescribed $7 billion of Vioxx prescriptions after Merck and the FDA knew that Vioxx caused significantly more heart attacks, strokes and blood clots than naproxen -- sold over the counter as Aleve -- regardless of whether or not patients had a history of heart disease. Why?

"Because the New England Journal article that ostensibly reported the results of Merck's study didn't even mention either the cardiovascular or the overall dangers of Vioxx," Abramson wrote. "Instead, it reported only selective data on heart attacks and strokes, allowing Merck to claim that Vioxx wasn't a risk to people without a history of these problems ... Doctors were left with the impression that Vioxx was safer than naproxen when exactly the opposite was true."

Abramson also said in his Los Angeles Times op-ed article that commercial bias in research studies has led him to the conclusion that "...most of the evidence in what doctors believe to be 'evidence-based medicine' is more infomercial than dispassionate science."

Why peer review is broken

One might wonder how prominent, peer-reviewed medical journals could be fooled into printing such biased studies. After all, the very idea behind peer reviewing is to weed out inaccurate work by having experts approve scientists' work prior to publication. According to Abramson, a vocal critic of commercial bias in medical reporting, the problem largely stems from the fact that, "At present, journal editors and peer reviewers typically are not allowed unrestricted access to the data from commercially sponsored research." Not even the drug companies' own researchers, who generally write the articles that appear in medical journals, are allowed complete access to all of the funding company's data.

And to compound the problem further, most medical journalists aren't trained in the scientific or statistical fields necessary to sift through the corporate propaganda rampant in today's medical studies. In a critical 2003 "Watchdog" article that appeared in Harvard University's Nieman Reports, Abramson called for a much-needed middle ground between today's standard of scientific reporting -- "simply passing on sensationalized, commercially-generated versions of 'breakthroughs' in medical science" -- and shouldering long, drawn-out investigative reports to unravel corporate-spun data.

Abramson also delved into medical reporters' difficulties in properly reporting the results of scientific studies. He offered this advice to aid medical journalists: "When financial ties exist between researchers and the medical industry, the results of a study are 3.6 times more likely to be pro-industry. Be suspicious ... With many millions, even billions of dollars at stake, the drug and device industries hire the best and the brightest researchers, writers, business people, and public relations firms to spin research findings to their advantage."

And therein lies the rub. Research findings can be spun any number of ways to suit any number of corporate aims. The statistics are telling: Eighty percent of studies paid for by the drug firm making the tested drug come out positive, but only 30 percent of the studies paid for by drug companies testing a competitor's drug come out positive.

What do these statistics tell the consumer? An obvious argument is that drug companies shouldn't be funding their own studies, given the suspiciously high success rate in such cases. However, what the public should take away from the results of the Beth Israel study is that no scientific study funded by any drug company can be trusted to be accurate. "Most clinical research is fundamentally commercial activity -- albeit cloaked in the guise of public service -- designed to maximize corporate profits," Abramson wrote in his Watchdog article.

What, then, can the public do to protect itself from such fraudulent, often dangerous pseudo-science? The answer offered by Sidney Wolfe of Public Citizen is to completely remove pharmaceutical company funding from the picture. Wolfe says the government should be footing the bill for drug research because public programs pay so much for the medications that come from that research.

However, since Big Pharma's pockets are far deeper than Uncle Sam's, it seems unlikely that the government will step in anytime soon. In the meantime, medical journalists -- including the editors of scientific journals -- must probe deeper into the possible biases of drug research, and must verify all data received from drug companies prior to publication, which is considered verification by readers of those journals. However, as Abramson says, "Whether this is an achievable goal -- within the customary practices of journalism today -- is another story."

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