Disclosure of Clinical Trial Results by Prescription Drug Companies

Consumers Union (the publishers of Consumer Reports magazine) sent out the following to people on its Minnesota e-mailing list regarding a bill introduced in the Minnesota Legislature that would require drug companies to release ALL the results of their clinical drug trials to the public, not just the ones that make their latest drug look good.  If you want to send a letter on this to Governor Pawlenty click here (this will bring you to a secure website used by Consumer Reports to allow people to easily communicate with public officials).


CONSUMERS UNION SUPPORTS SF 3342 (Hottinger):

Disclosure of Clinical Trial Results by Prescription Drug Companies

 Consumers Union is the nonprofit publisher of Consumer Reports magazine and Consumer Reports Online, with approximately 5 million subscribers nationwide.  Consumers Union’s “Prescription for Change” Campaign (www.prescriptionforchange.org) works on prescription drug reform at the state and national levels.

We strongly support SF 3342 which will give patients and medical professionals alike key information to help them weigh the benefits and risks of medicines, and not have to rely on one-sided information often promoted in prescription drug ads.  We, along with many other groups, support public access to clinical trial results, and this legislation would make that a reality.

Clinical trials are the tests that involve giving a drug to human subjects.  Drug companies now sponsor more clinical trials than the federal government, but tend to publicize only the positive findings in medical journals. There is no legal requirement that they make these trial results publicly available.  Drug companies have vowed to make clinical trials more transparent.  In fact, in fall of 2004 the drug industry launched a web site that was supposed to give the public access to trial results.  But the prescription drug industry has been slow to live up to that promise.  

Drug ads are everywhere – on TV, in print, on the radio.  They have something in common – they advertise prescription drugs in a way that is designed to sell them – extolling benefits and downplaying negative side effects.  An ad for Viagra was cited by the FDA because it failed to disclose the drug’s major side effects and implied that it was better than similar medications.[1]  An ad for Paxil was flagged because it promoted the use of the drug for a wide range of ordinary kinds of anxiety, while minimizing serious risks associated with the drug.[2]   Pfizer conducted two clinical trials from 1999-2001 to test Zoloft on depressed children. Zoloft did not perform well and the FDA did not approve Zoloft for treating depression in children. Yet Pfizer did not disclose the results from these tests.  The FDA also did not disclose its conclusion deeming the studies “proprietary.”[3] 

In June 2004, the New York State Attorney General filed suit against GlaxoSmithKline alleging fraudulent marketing. GSK had studied the effects of Paxil in adolescents and learned that children and adolescents taking Paxil were “twice as likely to show behaviors that may be associated with suicide than children on sugar pills.”  At the same time GSK’s detailers were telling doctors and health care professionals that Paxil worked well in children. Since the studies were unpublished, there was no way for health care providers to learn the truth.  The FDA knew, but again, it did not act because the data it had from GSK was considered proprietary.[4]

The problems are not just limited to antidepressants.  In 2004, Vioxx was withdrawn from the market based on a study showing that Vioxx increased heart attack risk. It appears that Merck was aware of the cardiovascular risk as early as 2000.[5]  While Merck has posted some previously unpublished clinical trial data Merck did not publish results from a significant Vioxx trial from 2000 indicating these risks because PhRMA voluntary guidelines only call for posting data completed after October 2002.[6] Since 1999, when it was approved, until it was withdrawn in 2004, Vioxx had been taken more than 80 million people worldwide.  In the US, it is estimated that between 88,000 and 140,000 more cases of “serious coronary heart disease” have resulted from the use of Vioxx.[7]

We have heard from consumers whose families have experienced devastating problems with drug side effects that neither they nor their doctors were aware existed.  A mother in Rhode Island contacted us about her daughter.  In the fall of 2002 her nine year old began acting differently and lost weight.  She was prescribed Paxil by a doctor their family trusted.  She almost immediately began experiencing self-abusive behavior and feelings of suicide.  She was hospitalized then transferred to a day hospital program for three months, while her Paxil dosage was increased.  Within a six month period she was prescribed up to 30 mgs. of Paxil and up to 12.5 mgs. of Zyprexa though she weighed a mere 70 lbs.

This mother told us, “Our world changed overnight from one of a happy, healthy family to a living hell for all of us.  My daughter had been an incredibly sweet child, extremely bright and creative, well-liked by other children and teachers.  Please keep in mind that she was only nine years old and had just started fourth grade.  We had no idea what was happening to her as we had to physically restrain her most nights to keep her from harming herself and us at times.  She exhibited suicidal behavior but was young enough for us to protect her from her own thoughts.”

It turns out, her daughter suffered from chronic Lyme disease which caused her initial problems but were undetected for more than a year and a half.  She is now getting the proper treatment for Lyme disease.  But the trauma of watching their young daughter go through this has been overwhelming for them, and for the girl’s sister.  This mother is now an activist, testifying twice before the FDA on antidepressants and suicidality in children.  Their family was horrified to learn that clinical studies from companies like GlaxoSmithKline, the makers of Paxil, had known about these side-effects and had hidden them from the public for years.

With examples like this, it is no wonder that the public is losing confidence in drug companies.  A Wall Street Journal/Harris Interactive Poll found that 60 percent of US adults are not very confident or not at all confident that drug companies will publish information they have about side effects of their drugs as soon as they have that information.[8] 

A Kaiser Family Foundation survey found that consumer sentiments about drug companies have been in decline since 1997 when almost eight in ten (79%) people said drug companies generally do a “good job” serving consumers. In 2004, for first time, more people said drug companies generally do a “bad job” (48%) than a “good job” (44%) of serving consumers.  And the survey found 70 percent of people say drug companies put profits ahead of people, while about a quarter say that drug companies are most concerned with developing new drugs that save lives and improve quality of life and that profits come second.[9]

There is widespread support in the healthcare community for public access to clinical trial results.  The AMA testified that clinical trial results should be made publicly available.[10]  More recently, the American Pharmacists Association adopted a resolution calling for “access by healthcare professionals and the public to all clinical trial data derived from scientifically valid studies.”[11]

SF 3342 is based on law enacted last year in the state of Maine.  It would substantially improve the information that health care professionals and patients have so they can make better informed decisions about the drugs they take, weighing the benefits with the risks of prescription drugs. This is a strong piece of consumer legislation that will benefit the people of Minnesota.

Thank you for your consideration of our views. 

Contact:

Earl Lui

Senior Attorney, Consumers Union, West Coast Office

1535 Mission Street

San Francisco, CA 94103

415-431-6747 (p) 415-431-0906 (f)

elui@consumer.org

www.consumersunion.org


[1] November 10, 2004 letter to Robert B. Clark, Vice President, US Regulatory, Pfizer Inc., from Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration.

[2] June 9, 2004 letter to P. Kaia Agarwal, M.Sc., Senior Director, Regulatory Affairs, GlaxoSmithKline, from Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration

[3] Prakash, Snigdha. “Lawmakers grill drug companies and find many are not disclosing enough information on anti-depressants.” NPR’s Morning Edition. September 10, 2004.

[4] Prakash, Snigdha. “Drug giant GlaxoSmithKline being sued by New York for suppressing studies showing their drug may not be effective in children and might increase their risk of suicide.” National Public Radio, June 11, 2004.

[5] Horton, Richard. ‘Vioxx, the implosion of Merck, and aftershocks at the FDA.” The Lancet. November 5, 2004.

[6] Rowland, Christopher. January 9, 2005.

[7] Maxwell, Simon and David J. Webb. “COX-2 selective inhibitors – important lessons learned.” The Lancet, January 25, 2004.

[8] The Wall Street Journal Online/Harris Interactive Health –Care Poll, January 18, 2005.

[9] Kaiser Health Poll Report Survey [February, 2005].  Available at www.kff.org.

[10] “AMA provides outline for developing national clinical trials registry,” American Medical Association News Release, September 9, 2004.

[11] 2005 Action of the APhA House of Delegates, Orlando, Florida, April 2-5, 2005.