The testing process as presented by the FDA was designed with the safety and protection of the population intended. However, this “scientific method” is fraught with human errors and interests, and the FDA, along with the pharmaceutical corporations and the AMA, should not have a monopoly in determining what is a scientific methodology for testing medicines or healing therapies–in the interest of the public’s health as we’ll see. Several faults in the FDA’s testing process have serious impact on our health and severely constrain our understanding of how to take care of ourselves and our options in therapies.
The methodology of the FDA and the pharma corporations does not determine long-term safety of a drug before it is licensed. The consequences of several years’ use of a drug are only known after the drug has been prescribed to millions of patients over several years. In effect, then, the general population serves as the test population. Now if the FDA required, say, over 10 years of testing, we’d rarely see new pharmaceutical medicines. However, the severe side effects of drugs plus 100,000 deaths per year from their use, argue for limiting the use of drugs to traumatic interventions.
Why Pharmaceutical Drugs Can Be Risky
A recent study published by the AMA, in effect, confirms this. The Journal of the American Medical Association (JAMA) reported May 1, 2002, a review of a quarter-century of unexpected and harmful side effects of prescription drugs and concluded that newly approved drugs are riskier than older ones. Doctors, the authors advised, should avoid prescribing new drugs when equally effective and long-used medications are available.
Several studies released this year on Hormone Replacement Therapy (HRT) have had dramatic impact on women’s health during menopausal years. A government-funded study of 16,000 healthy women taking estrogen and progestrin was stopped three years early when those on the hormonal treatment had (26%) higher incidence of breast cancer, (29%) higher incidence of heart attacks, (41%) more strokes and twice as many blot clots in the lungs and leg veins as those taking the placebo. About 14 million women in the U.S. have been taking pharmaceutical HRT. 1 In conclusion, the patients using prescription drugs are the long-term experiment.
The prescribed dosage and duration for taking drugs are also problematic. The pre-determined, one-dose-fits-all, 10-day-order does not allow for all the variables in the population, much less the individual. Clinical trials to obtain the FDA approval are conducted with either healthy, relatively young samples (and very small numbers of subjects) or the trials are on individuals with the illness, each of whom have their own health-impacting characteristics, such as age, duration of illness, other health complications, other drugs they’re taking. Age and gender–and certainly the individual’s body–respond to the drugs uniquely!
In 1989 the US Department of Health and Human Services estimated 243,000 elderly Americans are hospitalized each year for adverse reactions to pharmaceuticals, while another 163,000 older adults experience “serious mental impairment caused or aggravated by drugs.” 2 Drug testing on primarily young adults ignores the potential effects on elderly individuals, who are the largest population taking pharma drugs.
How Bad Drugs Affect Women
As a group, women are the most complicated vis-á-vis using pharmaceutical drugs. Women’s metabolism varies throughout the monthly cycle, and so how we metabolize drugs varies–for each one of us, each day. Since 1993, the FDA has required the industry to separately test women patients’ metabolic response in drug tests. (In effect, they’re capturing the data for that woman on that day of her cycle.) However, the results are not reported to the consumer on the package or anywhere else readily available to either women or their MDs. Eight out of the 10 drugs pulled from the market in recent years had proven to be more dangerous for women than men, according to a report from the General Accounting Office this year (2002). They included such commonly prescribed medications as antihistamines and decongestants–some now sold over-the-counter have caused strokes in women.3
Another very serious fault in this medical establishment domain is that physicians prescribe drugs for uses for which they were never tested. A 1978 study of the 100 most common drug uses in the country revealed 31 were for purposes not then approved by the FDA, and 18 of those did not become approved subsequently. In 13 cases the drugs were used for a secondary effect–not the effect for which it had been given FDA approval 4 One recent disaster resulting from the practice of prescribing drugs for uses they were never tested is Phen-Fen. Now statins (drugs to lower cholesterol) have been found to have unexpected, positive side-effects, and statins are being touted as a good cure-all for many ailments–without proper testing.
Industry Influences on Medical Publishing
Pharma testing results have historically been influenced by the pharma companies sponsoring the research, and the result is medical literature–professional reports that keeps the MDs informed of developments in the field, that is skewed. Pharma companies have blocked publication of unfavorable findings or delayed it for years. The severity of this problem resulted in 12 of the world’s most prominent medical journals jointly deciding in September 2001 to reject outright any scientific studies that are submitted without assurance from the author(s) that the sponsor (drug company or other organization) gave researchers complete access to the data and freedom to report the findings. 5
As the cost of developing new drugs has grown–$802 million for a new product according to a Tufts University study in December 2001 6 — companies have tightened their control over all aspects of research they sponsor. The five general medical journals with the largest circulation in the world will routinely require authors to disclose details of their own and the sponsor’s role in the study. The responsible author will have to sign a statement that s/he accepts full responsibility for the conduct of the trial, had access to the data, and made the decision to publish.
The results of clinical trials are also inflated and distorted by publishing results in several journals despite publishers’ rules forbidding submission of clinical results being published elsewhere. When meta-analysis is done of the literature, as it often is, the publication of one clinical trial of a drug in several journals skews the data. 7
If the record shows the imprint of the pharma industry in publishing the drug research results, the noose is about to tighten as the drug companies line up to pay user-fees to the FDA to enable the government office to respond more quickly to their new drug applications. A bill to expand the program of the businesses being regulated footing the bill for their regulation was put on the fast track by tacking in onto the bioterrorism bill. 8 The bill was crafted in private meetings between the FDA and industry; this occurred with negligible public discussion, before the General Accounting Office (a rare government office independent of the White House and Congress) completed a review of the current FDA user-fee program, and without debates or votes in either chamber of Congress. With this new level of industry financing, 55 percent of FDA’s staff of about 1,530 will be reviewing drug applications.
See also Impact of the Scientific Method and Research and Regulation
Footnotes:
1. Washington Post, Hormone Treatment is Called Harmful, July 10, 2002, A1
2. Michael Castleman, The Healing Herbs, Emmaus, PA: Rodale Press, 1991
3. Glamour, The Threat in Your Medicine Cabinet, April 2002, p. 144)
4. Lawrence C. Horowitz, MD, Taking Charge of Your Medical Fate, (New York: Random House, 1988
5. Washington Post, Medical Journals Set New Publication Rules, Sept. 10, 2001, p.A6
6. Washington Post, Price Tag for a New Drug: $802 Million, Dec. 1,2001 p. A10
7. D. Rennie, Fair Conduct and Fair Reporting of Clinical Trials, JAMA 282 (1999)
8. Washington Post, Bill to Boost Industry Fees that Fund FDA, May 23, 2002, A1
