Arthur M. Evangelista
Late last year we heard the terrifying news that several antidepressant drugs prescribed for adolescents were unsafe, and have led to suicide in some children.
Late last year we heard the terrifying news that several antidepressant drugs prescribed for adolescents were unsafe, and have led to suicide in some children. We also learned that these hazards were well known to the drugs’ manufacturers but had been deliberately concealed from the public.
It was the British regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHPRA) that reviewed all of the data from the company-controlled clinical trials of the antidepressants (selective serotonin reuptake inhibitors or SSRIs). They found that in some of the trials the risk of suicidal thoughts and suicide attempts was two times greater among Paxil (paroxetine) users, mostly teens, than those given a placebo, and in several trials a placebo had been significantly more effective than the drug in relieving depression.
The Canadian Medical Association Journal (February 2004) obtained a confidential internal document from the drug giant GlaxoSmithKline (GSK) that advised staff of GSK “to withhold clinical trial findings in 1998 that indicated that the antidepressant paroxetine (Paxil) had no beneficial effect in treating adolescents.”
The British regulatory agency has now banned the use of all antidepressants except fluoxetine (Prozac) for the treatment of major depressive disorder in children under 18. Since then Health Canada has issued a warning that “Paxil should not be prescribed as new therapy for patients under 18” and is investigating other SSRIs, and the US Food and Drug Administration has more or less followed suit.
For the estimated three million Canadian and eleven million American kids on antidepressants, this is an obvious case of too little, too late.
Profit Before Public Safety
Research data, public records, and regulatory evidence indicate that false drug claims and unethical or fraudulent pharmaceutical clinical and marketing practices such as these create serious health threats for individuals (and their families) who use prescription or conventional over-the-counter (OTC) drugs or health products.
Deceptions in testing, clinical trials, product safety, and marketing may also occur in concert with corrupted or negligent regulatory processes. According to commentary about the antidepressant scandal by Dr. Jane Garland, Clinical Head, Mood and Anxiety Disorders Clinic, British Columbia’s Children’s Hospital, “Pharmaceutical companies seeking regulatory approval are obliged to make the results of all clinical trials they sponsor available to regulatory agencies. However, there is no requirement for these results to be published or even made available to investigators.”
Many health advocates have drawn the same conclusion as Dr. Garland, who said, “Data must be subject to analysis by independent experts who are alert to conflicts of interest that may distort the interpretation of data.”
A review of financial statements indicates that the global drug industry pocketed more than $471 billion US in 1999. Canadian 1999 drug sales were almost $9 billion, and profits are growing. Drug companies are thus highly motivated, and well able to pay, to make sure experts are not independent. In fact, the companies exert enormous political pressure through lobbying, which may occur in concert with corrupt or negligent regulatory processes such as having the experts who test the drugs or advise the regulatory agencies on the company payroll, a sure way to “grease the wheels” of the regulatory process that is supposed to protect by the public by determining if a drug is safe and effective.
More Faulty Drugs
Another classic example of falsification of test data and deceptive marketing practices occurred in 1995 with the appetite-suppressing drug, Fen-Phen (fenfluarmine). Basically, Fen-Phen affects serotonin levels in the brain, providing a slight elevation of mood. Marketed as a diet drug for weight loss, it was not very effective: only three per cent of the individuals taking Fen-Phen experienced any weight loss.
What the drug was “effective” at, as reported in the August 8, 1997 issue of The New England Journal of Medicine by Dr. Heidi Connelly of the Mayo Clinic, was causing users to begin experiencing pulmonary hypertension and heart-value damage. This resulted in approximately 123 reported American deaths, and heart valve damage severe enough to require valve-replacement surgery in some users.
Another product we have seen in many recent TV commercials is Celebrex, an anti-arthritic drug. Promoted by its maker, Monsanto (Pharmacia), Celebrex was hyped as causing fewer gastrointestinal problems and complications and therefore having a “proven” safety advantage over its older competition, diclofenac and ibuprofen.
A subsequent investigation by the FDA into Celebrex marketing claims and test data revealed adverse reactions of gastrointestinal and stomach ulcers, the very reactions the company had claimed the drug protected against. These reactions raised an additional concern about less obvious adverse effects from decreased blood flow to the heart. In consumer information about Celebrex, the FDA now lists “stomach ulcers that bleed” as a “special warning,” and explains that fluid retention can be “a serious problem” if you have high blood pressure or heart failure.
What makes false drug claims so sinister, and what sets this kind of deception apart from most other types of manufacturing or marketing fraud, is that false drug claims can kill. False drug claims deceive doctors, medical associations, regulators and, too frequently, entire populations. The end result is a despicable and dangerous public health program where people are dying or becoming seriously ill from the harmful effects of pharmaceuticals, as well as paying money for drugs that simply do not work.
What can you do? Personal health and safety is each individual’s responsibility - a responsibility to be informed, and to understand the “bigger picture” of business and medicine. To learn more, visit the International Coalition for Drug Awareness at drugawareness.org or the Alliance for Human Research Protection at ahrp.org.