Thursday, 15 July 2010

Avandia: A Case Study in Big Pharma-FDA Collusion

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AvandiaPharmaceutical manufacturer SmithKline Beecham, now GlaxoSmithKline, found in a 1999 study that its diabetes medicine, Avandia, posed serious heart attack risks — then buried the study for the next 11 years, according to the New York Times, which recently obtained documents related to the study and the cover-up.

The reason for the cover-up was simple: Had the risks of the drug become public, it could have cost the company “$600 million from 2002 to 2004 alone,” according to one of the documents obtained by the Times. Thus, reports the paper, “the company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.”

The heart risks were discovered in the course of a trial to determine whether Avandia was safer for the heart than a competing medicine, Actos. The study found that Avandia was actually riskier than Actos. The company got similar results from a later study comparing Avandia to glyburide, described by the Times as “a cheaper and older diabetes medicine.” Both studies should “not see the light of day,” Dr. Martin I. Freed, a GlaxoSmithKline executive, wrote in emails in 2001.

The company did more than just try to keep the Avandia trial data secret. Said the Times: “An F.D.A. reviewer who closely examined a landmark Avandia clinical trial called ‘Record,’ found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.”

“Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had not provided the results of its study because they ‘did not contribute any significant new information,’” according to the Times. Furthermore, said the newspaper, “The company said that Avandia was safe and that Dr. Freed no longer worked for GlaxoSmithKline.”

One may wonder where the FDA, charged with ensuring that pharmaceuticals are both safe and effective, has been for the last 11 years. The answer seems to be that some FDA employees have been to some degree complicit in the cover-up.

Dr. John Jenkins, director of the FDA’s office of new drugs, wants Avandia to remain on the market and therefore “briefed the company extensively on the agency’s internal debate,” writes the Times. The report continues:

“It is clear the office of new drugs is trying to find minimal language that will satisfy the office of drug safety,” a top company official wrote in an e-mail message after he spoke with Dr. Jenkins, according to a sealed deposition obtained by The Times.

In the deposition, Dr. Rosemary Johann-Liang, a former supervisor in the drug safety office who left the F.D.A. after she was disciplined for recommending that Avandia’s heart warnings be strengthened, said of Dr. Jenkins’ conversations with GlaxoSmithKline, “This should not happen, and the fact that these kind of things happen, I mean, I think people have to make a determination about the leadership at the F.D.A.”

The cozy relationship between big pharmaceutical companies and the FDA is not new. In a 2007 article in the Freeman, Larry Van Heerden wrote:

Beginning with the Prescription Drug User Fee Act of 1992, Congress required drug companies to pay up to half a million dollars to the FDA with each new drug application. The money was used to hire more reviewers to get drugs on the market more quickly. By 2003 over half the FDA’s drug reviewers were paid with industry money and approval time for drugs had gone from over two years to less than six months. In fiscal 2006 industry money paid to the FDA was estimated to hit $382 million.

Meanwhile, the culture at the FDA had become industry friendly, which included a reluctance to challenge company claims about drug safety and effectiveness. The number of drug approvals became part of FDA employees’ performance evaluations. FDA reviewers were pressured to approve drugs or soften the language in their reviews or on drug labels. It became common for researchers with ties to the drug industry to serve on FDA advisory panels. In 2005, in the wake of a series of drug-safety scandals and criticism from Congress, the FDA changed course again, issuing a flood of drug-safety warnings and slowing approval times for new drugs, prompting charges that the FDA was over-reacting.

The existence of the FDA creates a false sense of security among consumers, who think that FDA approval automatically guarantees that a drug is 100 percent safe. In addition, its existence causes drug companies to be less careful about what they bring to market — to “lose the moral sense of their actions as they act out their role of company and shareholder advocate,” as Van Heerden put it — knowing they can use the FDA as cover for their actions.

“Another factor that helps explain (though not excuse) such industry behavior is the ‘all or nothing’ system that FDA gatekeeping perpetuates,” continued Van Heerden. “Companies spend huge sums of money to shepherd a drug through FDA approval. The withdrawal of a single approved drug may affect a company’s finances to the point of endangering its survival.”

Indeed, as the Times report noted, “Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products.” Had the drug’s risks become known, it could have seriously harmed, if not destroyed, the company.

Van Heerden advocated abolishing the FDA, saying, “In a system without such gatekeeping, where drugs were available along with all the information on risks and benefits, the market would sort the wheat from the chaff, dramatically lowering the financial stake in any single drug and reducing the temptation for drug companies to engage in fraud and deception.”

Instead, given the existence of the FDA, “a panel of experts,” reported the Times, is meeting “to decide whether Avandia should still be sold,” with “some officials arguing that the drug is useful despite its risks and others insisting that it must be withdrawn.”

Shouldn’t it be up to each individual consumer to decide whether the benefits of a drug outweigh its risks for his particular situation? How can a handful of “experts” possibly know what is best for 300 million Americans, all of whom have different health histories and levels of risk tolerance?

A genuinely free market in pharmaceuticals, where consumers chose to be educated about drugs rather than depending on the government to act as a gatekeeper of what drugs they were allowed to purchase, would likely have brought the cardiovascular risks of Avandia to light long ago. In fact, it was a Cleveland Clinic researcher, not an FDA bureaucrat, who first made the Avandia risks known back in 2007, using data that GlaxoSmithKline was forced to reveal as the result of a lawsuit. Three years later the FDA is finally getting around to ruling on the issue.

FDA or no FDA, wrote Van Heerden, “there is no alternative to becoming an informed consumer of pharmaceutical drugs. Ignorance is not an option.” Getting rid of the FDA would only encourage more Americans to become informed consumers instead of helpless sheep to be shorn by the medical-industrial complex.

Photo: AP Images

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