THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING
Book Review

The unhealthy ties that bind FDA to drug firms

Email|Print|Single Page| Text size + By Chuck Leddy
July 5, 2008

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial
By Alison Bass
Algonquin Books of Chapel Hill,260 pp., $24.95

In her new book Alison Bass obeys the most important rule of investigative journalism: She follows the money wherever it leads. In "Side Effects," her examination of mammoth pharmaceutical companies and their pursuit of profits at any cost, she exposes the dark web of researchers, doctors, and regulators feeding at the Big Pharma trough and undermining public health in the process. The term for what Bass discovers is "systematic funding bias." As she makes abundantly clear, medical professionals taking money from Big Pharma tend to give Big Pharma what it wants.

The Food and Drug Administration is supposed to be looking out for public health and consumer safety by objectively reviewing drug trials submitted by pharmaceutical companies seeking approval for new drugs. But who pays the FDA for this important watchdog function? Big Pharma does. As Bass, a onetime Globe reporter, writes, "The industry's allocation of $232 million in user fees represented 53 percent of the agency's entire drug review budget" in 2004. Does this funding system, which continues to this day, create the potential for the FDA to become indebted to the very industry it's supposedly regulating?

If Bass's investigation into the antidepressant Paxil, a multibillion-dollar cash cow for GlaxoSmithKline, is any indication, the FDA's public-watchdog function seems to need more teeth. She shows that Glaxo's research studies found that Paxil "failed to demonstrate any separation" between itself and a placebo (a sugar pill) in adolescents. Moreover, she contends Glaxo and its researchers either ignored or suppressed evidence that the pediatric use of Paxil could lead to thoughts of suicide. Glaxo "made no reference to the negative results" from these trials, instead recommending Paxil for pediatric use. Bass illustrates how Glaxo paid huge amounts of money to conduct these research trials, and how medical researchers in the pay of Glaxo worked to give the firm the positive study results it wanted.

Bass looks at a Paxil study conducted by a medical researcher whose employee, Donna Howard, came to believe that he "was playing fast and loose with the protocols for the Paxil study" and was suppressing evidence of suicidal thinking in patients by "not accurately coding these adverse events." Eventually she contacted the author. Bass finds that the researcher was receiving hundreds of thousands of dollars annually from Big Pharma.

With evidence of Paxil's problems mounting, the FDA belatedly required that a warning label be placed on the drug. Meanwhile, it took the New York attorney general's office to compel Glaxo to publicly disclose Paxil's link to suicidal thoughts. Bass provides a dramatic account of this lawsuit, following state attorney Rose Firestein as she digs up evidence of Glaxo's deceptive conduct. Firestein pursues a consumer-fraud case against Glaxo, arguing that "the negative study results on Paxil were material to a doctor's judgment in treating patients, and they had been concealed."

Glaxo eventually made a cash settlement and disclosed the negative studies. More important, notes Bass, the case "shone a spotlight into the black hole of drug research" and triggered "a growing outcry about the enormous influence the pharmaceutical industry wields over the practice of medicine." As Bass demonstrates, the free market is a powerful, creative force, but some things should never be put up for sale. Public health is one of them, and with the help of investigative journalism like "Side Effects," maybe "Money talks" will give way to the needs of public health. Stranger things have happened.

Chuck Leddy is a freelance writer who lives in Dorchester.

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