Consumersunion.org

STATE-BASED MANDATES REQUIRING REGISTRY AND REPORTING OF CLINICAL TRIALS AND RESULTS

Overview:

Currently, drug companies conduct clinical trials but may not release the final results to
physicians and the public if the results do not reflect favorably on their product. The widely-
reported problems of Vioxx and antidepressants in children are just two of several examples of
this problem. Physicians and consumers deserve full and complete information about
prescription drugs.

The Problem:
Drug companies now sponsor more clinical trials than the government but are free to publicize
only the positive findings in medical journals.onths after the drug industry vowed to
make its clinical trials more transparent, and three months after launching a common website to
give the public "unprecedented access" to studies both good and bad, drug companies have
posted unpublished trial results on the site for just five drugs.”
Non-Steroidal Anti-Inflammatory Drugs (NSAIDS): In 2004, Vioxx was withdrawn from the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.hile 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unpublished clinical trial data Merck did not publish results from a significant Vioxx trial from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.
Since 1999, when it was approved, until it was withdrawn in 2004, Vioxx had been taken more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.
Antidepressants: 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
1 Deardorf, Julie. “Medication should be cheaper, sure—but it also should work.” Chicago Tribune. September 5, 2004. 2 Rowland, Christopher. “Drug firms lagging on openness despite vow, few studies publicized.” Boston Globe. January 9, 2005. 3 Horton, Richard. ‘Vioxx, the implosion of Merck, and aftershocks at the FDA.” The Lancet. November 5, 2004. 4 Rowland, Christopher. January 9, 2005. 5 Maxwell, Simon and David J. Webb. “COX-2 selective inhibitors – important lessons learned.” The Lancet, January 25, 2004. 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.”
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.
Diabetes medication: In early trials of Rezulin, Parke-Davis learned of “important liver
damage” but did not disclose that information to FDA prior to approval. Subsequent to approval,
Parke-Davis provided FDA with more details about those prior trials, but since it had already
been approved, the information was not widely distributed. Rezulin stayed on the market and
despite continued reports of post-marketing adverse effects, Rezulin continued to be sold in the
US until 2000.
After just three years on the market in the US, Rezulin was withdrawn from sale in the US in
March 2000. The UK withdrew the drug in December 1997, after being on the market for just
three months. Unfortunately, it was withdrawn too late in the US for the more than 66
individuals who died as a result of acute liver failure.
The solution:

States can and should require that the results from clinical trials be available to the public,
physicians, and researchers. States spend billions of dollars every year to provide prescription
drugs for their residents – and have a responsibility to be sure those drugs are safe and that the
state is spending its money wisely. The state of Maine recently adopted a requirement that drug
companies post information from their clinical trials, and other states should follow suit.
We propose state legislation, based on the Maine model. The bill would require that drug
companies provide information about their clinical trials and make it available on a publicly
accessible web site, like the federal government'Such a bill would be a big step forward in making clinical trial results available to physicians and
consumers.
6 Prakash, Snigdha. “Lawmakers grill drug companies and find many are not disclosing enough information on anti-depressants.” NPR’s Morning Edition. September 10, 2004. 7 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. 8 Avorn, Jerry, MD. Excerpt of “Chapter 4: Too Sweet To Be True.” Powerful Medicines. 2004. 9 Avorn, Jerry, MD. 2004.

Source: http://consumersunion.org/pdf/905_fact_registry.pdf