Drug Manufacturers May Still Be Withholding Information, NY Times Reports
WASHINGTON, DC -- June 10, 2005 -- Many drug manufacturers are still not disclosing data from important clinical studies, the New York Times concludes in a recent article (NY Times, May 31, 2005). This is despite promises made last year that clinical trial information would be provided in both clinicaltrials.gov, a web site sponsored by the National Institutes of Health (NIH), and in clinicalstudyresults.org, a web site created by an industry lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA).
"There are a lot of public statements from drug companies saying that they support the registration of clinical trials or the dissemination of trial results, but the devil is in the details," said Dr. Deborah Zarin, director of the NIH-sponsored web site. She went on to charge that companies such as Merck, Pfizer and GlaxoSmithKline have met the letter but not the spirit of the law. She pointed to what Merck described as a "one-year study of an investigational drug in obese patients" as an example of a vague description that does not even identify a drug.
We did a brief check of the NIH site, and confirmed this pattern for Merck. The company referred to clinical trials of "investigational drugs" to treat bronchitis, for nausea and vomiting during chemotherapy, for neutropenia and fever, for anogenital warts, for type 2 diabetes, for insomnia in adults and the elderly, and for HIV. The list goes on and on, but the actual drugs are not identified. A search of the industry PhRMA database provided only seven studies of drugs manufactured by Merck. Although Merck listed the citations for the studies, it did not include abstracts or full text. Under "company study," Merck consistently wrote "no document provided."
The NY Times points out that clinical registries are designed to prevent companies from conducting several trials of a drug, but only reporting on those with favorable results. Leaving out drug names confuses the research process. "If you're a systematic reviewer trying to understand all the results for a particular drug, you might never know," Dr. Zarin commented. "You don't know whether you're seeing the one positive result and not the four negative results--you don't have context."
A History of Deception by Drug Makers
Unfortunately, some drug companies have a history of deception. Last year, Merck and Pfizer downplayed the risks from their arthritis drugs known as COX-2 inhibitors, and delayed release of important studies. Celebrex® (celecoxib) and Bextra® (valdecoxib), both manufactured by Pfizer, may increase the risk of heart attacks and strokes. Bextra® has the additional problem of causing severe, sometimes fatal, skin allergies in some patients. Merck's drug, Vioxx® (rofecoxib), also causes heart problems, and was the first of the three drugs to be withdrawn from the market last September. Bextra® was withdrawn in April of this year, while Celebrex® remains on pharmacy shelves. See Merck Faces Increased Credibility Problems Over Arthritis Drug, Vioxx®, Vioxx® Side Effects Were Apparent, and Arthritis Drug Bextra® Withdrawn from the Market.
In August, GlaxoSmithKline agreed to a $2.5 million settlement concerning use of its antidepressant, Paxil® (paroxetine). New York Attorney General Eliot Spitzer had charged the company with concealing data that showed Paxil® was ineffective in treating children and teenagers, and could led to suicidal thoughts and actions. The complaint claimed that Glaxo ignored four damaging studies concerning young Paxil® users, and only published one study, which gave Paxil® mixed results.
Misleading Drug Studies
Besides suppressing clinical studies, some drug companies may be submitting biased articles or marketing pieces to medical journals, according to news sources (USA Today, May 30, 2005). Martha Gerrity, co-editor of the Journal of General Internal Medicine, reports that out of 70 to 80 manuscripts received by her publication each month, about two to four present glowing reports of a drug's benefits, while excessively criticizing competitors.
The pharmaceutical company AstraZenaca asked Dr. Adriane Fugh-Berman, a professor of physiology, to write a paper about herbs and the blood thinner warfarin, according to USA Today. The company than sent her a completed, biased draft for her sign off on. She refused to put her name on the article, and spoke about the situation to the medical journal.
Catherine DeAngelis, editor of the Journal of the American Medical Association, says that the practice of ghostwriting medical articles has been going on for a long time. She calls it "manipulation by for-profits to alter what's in the medical literature so companies can sell their products."
The World Association of Medical Editors has issued a policy entitled "Ghost Writing Initiated by Commercial Companies ." "The scientific record is distorted if the primary purpose of an article is to persuade readers in favor of a special interest, rather than to inform and educate, and this purpose is concealed," the article says "....Ghost authorship exists when someone has made substantial contributions to writing a manuscript and this role is not mentioned in the manuscript itself. [We] consider ghost authorship dishonest and unacceptable." The article points out that both "submitting authors" and drug companies bear the responsibility to not mislead the public.
The FDA's Role in Regulating New Drugs
The reports on misleading medical journal articles and the suppression of clinical trial data come at a time when many question the role of the Food and Drug Administration (FDA). The agency has been roundly criticized for lax enforcement against drug companies and for failing to issue timely, adequate warnings about Celebrex®, Bextra®, Vioxx®, Paxil®, and other medicines.
This week, a committee of the Institute of Medicine met to consider ways to improve the FDA's oversight of new and approved medical drugs. "The keystone of the current system is the prescriber, and that person is the one who decides if the benefits of a drug outweigh the risks for that patient," FDA Deputy Commissioner, Dr. Janet Woodcock, said at the hearing. She admitted that "this system has obviously broken down." "...The bottom line is that a lot of drug safety problems are actually preventable," she continued, because "most adverse [drug] events are from known side effects."
The Institute of Medicine's committee is expected to issue a report about the FDA next year. However, Senator Charles E. Grassley (R-IA) is concerned that 11 of 15 voting members of the committee are also employed by the FDA and may not be able to provide unbiased opinions.
Sen. Grassley has repeatedly called for the creation of a new federal center for drug safety that would be independent of the FDA. He believes that the FDA does not work hard enough at monitoring drug safety and effectiveness. This view has been echoed by consumer groups and many medical experts. For more details, see FDA Is Not Doing Enough to Protect Public.
Injuries from Medications
At Brayton Purcell, we are committed to helping people who have been injured by unsafe medicines. For more information about medical drug injuries and your legal options, please feel free to contact us. We have been handling medically-related consumer cases for over 20 years, and work hard to defend the legal rights of our clients.