We highlighted the failure of the FDA to alert physicians and patients to the dangers of Avandia, a diabetes drug marketed by GlaxoSmithKline. We ascribed the sorry state to which the FDA has sunk to the system whereby the drug industry funds a major portion of the new drug examination process. This allows them to gain faster examination and approval of their drugs. Just as important, the insidious influence of money “buys” them the loyalty of the agency’s management.

Today, the New York Times published an article titled, “Potentially Incompatible Goals at FDA.” Here are some choice quotes, with my comments in italics.

  • “A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of FDA drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.”
  • “The latest to suffer this fate is Dr. Rosemary Johann – Liang, 42, who recommended more than a year ago that the diabetes drug Avandia carry the agency’s strongest possible safety warning for its effects on the heart.”
  • “Dr. Avigan (her boss) took over the supervision of the safety review of Avandia and Actos and told Dr. Johann-Liang that she could no longer approve strong safety recommendations without his say-so, she said. Over the next year, she was increasingly excluded from crucial safety reviews and meetings, which contributed to her decision to leave the agency on Friday, she said. In an interview, Dr. Avigan said that he did not intend to punish Dr. Johann-Liang. “My view was simply that when there were conversations going on about important safety issues that were likely to garner a lot of attention, that I needed to be in the loop,” he said.” C’mon, how long have you been in management? Is this the only way, or even the preferred way, to stay in the loop? This is either managerial incompetence or an insult to our intelligence.
  • “At least four other FDA safety reviewers in recent years have been punished or discouraged after uncovering similar drug dangers, according to Congressional investigations. Among them:In 2003, Dr. Andrew Mosholder discovered that antidepressants led some children to become suicidal. When his findings were leaked to a reporter, the agency began a criminal investigation. Dr. Mosholder was prevented from speaking to an advisory committee about his analysis, and the agency hired Columbia University researchers to reanalyze the data; they concluded a year later that Dr. Mosholder had been right.In 2006, Dr. David Ross became increasingly concerned about reports of serious illness and death from patients taking the antibiotic Ketek. Dr. Ross met with top agency officials and pleaded with them to take action. Nothing happened, he said. A month later, Dr. Ross complained privately to Congressional investigators. After articles about Ketek’s safety problems appeared in The Wall Street Journal and The New York Times, the agency and Ketek’s maker, Sanofi-Aventis, agreed to take actions.”
  • “After the articles were published, Dr. von Eschenbach held a meeting with Dr. Ross, Dr. Johann-Liang, and other safety officials in which he urged them to keep their disagreements ‘inside the locker room’, Drs. Ross and Johann-Liang said. Those who discussed issues with outsiders would be ‘traded from the team’, Dr. Eschenbach said, according to Drs. Ross and Johann-Liang…” Andrew, you are soiling your reputation as a brilliant oncologist and scientific leader with this kind of talk.
  • “In interviews, safety reviewers said problems at the agency could be traced back to a deal struck in 1992.In the 1980s, the FDA took nearly three years to approve most drugs. The AIDS crisis demonstrated that such long delays could condemn to death patients who might have been helped by recent scientific breakthroughs. FDA managers said they did not have enough people to assess reviews more quickly.So in 1992, Congress helped the FDA and the drug industry reach a deal. Companies agreed to pay millions of dollars in fees, and the FDA guaranteed that drug reviews would be completed within a year or as little as six months for a life-saving medicine.

    At the time, it seemed a good solution. But the deal’s fine print soon came to haunt the agency. Drug makers refused to let their money pay for the routine monitoring of drugs’ safety once they were on the market. As the agency began to depend more and more on industry fees, those parts of the agency slowly withered.

    Perhaps even more important, the culture at the FDA shifted toward valuing speed over safety. The 1992 deal required annual reports to Congress listing review times, but no such reports were demanded of the agency’s assessments of the safety of drugs already on the market.

    Managers are now largely judged on how quickly their employees make a decision on new drug applications, safety officials say. Questions about the safety of already-marketed drugs are increasingly seen as sand in the gears, they say.”

  • “‘If managers were held accountable on safety issues, they’d pay more attention to them,’ said Dr. Victoria Hampshire, who was disciplined and investigated criminally in part because of her work to uncover the dangers of a heartworm medicine that killed at least 500 dogs.”

So there you have it. The disheartening fact is that the FDA is not an isolated case. The assault on science, fueled by corporate special interests, is widespread throughout the Federal government. How did Jim Cramer put it?

“Of the corporation, by the corporation, for the corporation.”

Dov Michaeli, MD, PhD
Dov Michaeli, MD, PhD loves to write about the brain and human behavior as well as translate complicated basic science concepts into entertainment for the rest of us. He was a professor at the University of California San Francisco before leaving to enter the world of biotech. He served as the Chief Medical Officer of biotech companies, including Aphton Corporation. He also founded and served as the CEO of Madah Medica, an early stage biotech company developing products to improve post-surgical pain control. He is now retired and enjoys working out, following the stock market, travelling the world, and, of course, writing for TDWI.