Ritt Goldstein

STOCKHOLM, Dec 30 2004 (IPS) — While the U.S. Food and Drug Administration (FDA) is supposed to safeguard the nation’s medical products, drawing upon the substantive expertise of its drug scientists in vigilant dedication to the public’s health, that is not the case today.

Documentation, interviews and recent drug debacles depict a brutally different reality, with the Vioxx scandal alone estimated to have resulted in 30,000-55,000 U.S. deaths.

“You have an agency in denial – the FDA still maintains it made no mistake in the approval or regulation of Vioxx,” says the agency’s associate safety director, Dr David J Graham.

Vioxx was voluntary withdrawn by its manufacturer, Merck and Co, on Sep. 30, 2004 due to substantively increased risk of heart attack and stroke. Since then, questions have been raised regarding similar problems in other pain medications like Celebrex and Aleve.

Graham, who provided the figures on the Vioxx deaths, also told IPS that – despite the recent linkage between some antidepressants and suicide – the FDA is in the process of “misleading the public in their (antidepressant) labelling … taking care of business rather than patient safety.”

Graham, whose November testimony before the U.S. Senate Finance Committee rocked the FDA’s leadership, warned that while the agency’s proposed new label for the class of antidepressants known as SSRIs cites a “suicidality” rate of one-two percent, a senior FDA official acknowledged in September that number was based upon drug trials that “failed to capture most of the reactions of suicidality.”

A 20-year FDA veteran, Graham then noted that an alternative trial found “the actual rate was somewhere around seven or eight percent,” an incredibly substantive difference from the proposed FDA numbers.

Investigation reveals that dangers of drugs are being deliberately downplayed, and the public misled.

Notably, a March 2003 report by the U.S. Department of Health and Human Services Inspector General (DHHS-IG), Janet Rehnquist, found that just 12 percent of FDA scientists were completely confident that “labelling decisions adequately address key safety concerns.”

In his most recent congressional testimony on Nov. 18, Graham named five drugs as candidates for market withdrawal: Accutane, an acne treatment; Bextra, the pain medication; Crestor, which lowers cholesterol; Meridia, a weight reduction drug; and Serevent, an asthma medication.

All of the preceding drugs’ manufacturers were reported declaring their medications safe, paralleling similar pronouncements made by Merck and Company prior to its withdrawal of Vioxx.

At the same time, the Senate Finance Committee chairman, Iowa republican Charles Grassley, expressed his belief the FDA was “too cosy” with the drug industry.

Graham urged Congress to pursue legislation separating the FDA offices that address drug safety from the drug review and approval structure, arguing that creating an independent body to review drug problems would avoid the need to seek action on problem medications from the very individuals who had approved them, which is now what happens.

Both the FDA and the National Institutes of Health (NIH) have come under increasingly strong criticism for alleged distortion of research, their “cosy” relationship with the drug industry said to be at the root of the problem.

‘The National Institutes of Health: Public Servant or Private Marketer?’ headlined the Dec. 22 ‘Los Angeles Times’, which revealed that while physicians have relied on the NIH to draft medical standards, the agency’s researchers accepted “substantive fees and stock from drug companies … an unabashed mingling of science and commerce.”

The NIH creates treatment guidelines for use by physicians, but documentation reveals that many of those working at the institutes to create the guidelines were quietly on the pay of the drug companies whose products they were suggesting.

“It’s more than manipulation – they (the FDA and NIH) put their seal of approval on things that they knew were false, were wrong … they’ve betrayed the trust. Instead of servants of the public, they became truly agents and promoters of the Industry,” said Vera Hassner Sharav, a renowned drug industry critic whose years of work as head of the Alliance for Human Research Protection (AHRP) broke much of the ground for today’s revelations.

“Now we’re seeing the pattern, we’re seeing that it isn’t one drug, not one company, but rather the entire enterprise,” added Hassner Sharav in an interview.

What continually resurfaces is federal agencies’ effective abdication of their watchdog role, interrupted only by scientists of integrity who have gone beyond their agency structures in attempting to alert the public to growing dangers.

Economic and political goals appear to have replaced the need to safeguard the safety of the U.S. public and agencies’ scientific integrity, say observers.

“Over the last couple of years, we … began to hear reports out of a number of the federal agencies that ‘something was going on’, that research and analysis by government scientists was being systematically censored or ignored … or misrepresented in some way,” said Kathleen Rest, executive director of the Union of Concerned Scientists (UCS).

In an interview Rest described what she saw as a “pattern,” one of “politicising or manipulating scientific advisory boards.” The UCS – whose membership encompasses much of the cream of America’s scientists, including a number of Nobel laureates – also found “evidence and cases of agencies manipulating or suppressing scientific analysis.”

The March 2003 FDA report by the DHHS-IG, whose public release presented only information portraying the agency in a favourable light, was obtained in full under the Freedom of Information Act by the UCS and another non-governmental organisation (NGO), Public Employees for Environmental Responsibility (PEER).

While the release of only the report’s positive conclusions further highlights the official spin being broadly put on research findings, all of those interviewed spoke of the devastating potential of disseminating misleading scientific data. Graham described the yearly death toll from Adverse Drug Reactions (ADRs) across the full spectrum of available medication as “massive.”

Both the ‘Journal of the American Medical Association’ and Britain’s ‘Lancet’ have described ADRs as the fourth leading cause of death in the United States. But despite such severe human costs, the full version of the DHHS-IG report revealed that about one-fifth of FDA scientists had “been pressured to approve or recommend approval” for a medication “despite reservations about the safety, efficacy or quality of the drug.”

According to Graham, “the agency (FDA) has never given a high priority to safety.” Instead he saw its main pursuit as the “review and approval of drugs,” adding that the vast majority of agency resources were expended in this effort. Accordingly, those who work in review and approval areas have the most influence upon FDA policy, he added.

Confirming reports of the pressures applied to government experts who dare to speak out, Graham warned, “intimidation of scientists who threaten the status quo at FDA is routine.”

He described how, after he sought the withdrawal of an arthritis drug called Arava, his superior addressed his concerns that the medication induced liver failure.

“The division director spent the first 10 minutes of that meeting screaming at me. Basically, standing up, jugular veins bulging in his neck, eyes sort of bugging out of his head, screaming … basically trying to intimidate me so that I’d change my conclusion.”

Arava is still on the market today.

Citing another instance, Graham recalled his 1999 attempt to have the diabetes drug Rezulin withdrawn for also inducing liver failure. He noted that while Britain withdrew the drug in 1997, the FDA delayed Rezulin’s market recall until 2000, citing a policy of “risk management,” though Graham noted that his findings already indicated the futility of such an approach.

Those marketing Rezulin “were making roughly two million dollars a day” on the medication, Graham added, so the extra market time provided a financial bonus to the medication’s makers.

The scientist also described how he was given a poor performance evaluation after providing accurate congressional testimony on drug safety shortcomings. His supervisor at the time informed him “my job was to please him,” describing that as a “direct quote.”

When asked if this meant his job was “not to safeguard the public,” Graham replied, “right, my job was to please him.”

Complicating efforts to maintain scientific integrity, Graham noted that existing federal protections for whistleblower have been gutted, and that a current whistleblower protection bill is being blocked in Congress.

Despite obvious concern over the potential ramifications for his future, Graham emphasised his belief that “my job is to look after drug safety for the American people.”