The unhealthy ties that bind FDA to drug firms

[Guest guest]

The unhealthy ties that bind FDA to drug firms 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 GlaxoKline, 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 , 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.

http://www.boston.com/ae/books/articles/2008/07/05/the_unhealthy_ties_that_bind_\

fda_to_drug_firms/

Chuck Leddy is a freelance writer who lives in Dorchester.