The Science of Deceit
by Burton Goldberg
The mainstream media regularly reports on the "dangers" of "unproven" herbal remedies and supplements. But what is the reported number of people who have died from using herbs and supplements? According to the FDA, between 1993 and 1998, federal, state and local agencies reported a total of 184 deaths, most of which were associated with weight loss formulas. Compare that to the reported number of people who die in hospitals because of the side effects of properly prescribed pharmaceutical drugs: more than 100,000, every year. You can add to that the number of patients killed in hospitals because of "medical errors": another 100,000 or so. Those statistics are from the Journal of the American Medical Association (JAMA). This means that the ordained guardians of our health kill as many people every week as died in the September 11 terrorist attacks.
And that number only includes people who died in hospitals. A 1998 JAMA article estimated that more than 2 million people require hospitalization every year because of the adverse side effects of drugs. Moreover, it is widely conceded that the number of adverse reactions and fatalities attributable to prescription drugs is actually many times the number reported.
Statistics aside, let's put a face on what I'm talking about. Paul Domb is the son of a dear friend of mine. Two years ago, Paul was a 41-year-old endurance athlete who had run thousands of road races, hundreds of triathlons and other world-class endurance events. Paul had regularly trained twice a day for 20 years to stay in competitive shape, so it was hard for him to understand why he should begin to experience anxiety and panic attacks. He went to a psychologist who, after a few sessions, recommended that Paul take the antidepressant drug Paxil. Paul was reluctant, but his anxiety was affecting his work in corporate real estate, so he started taking a daily dose of 20 mg.
About three weeks later, Paul was set to begin an early morning swim when he felt his heart suddenly speed up. For the first time in his life, he felt faint and lost consciousness. He fell backward, crashing onto a metal pool chair. He revived after several seconds, and felt ready to continue his workout, but his training partner convinced him to take it easy and go home. Paul related the incident to his wife, who insisted he go to the hospital for an examination.
At the hospital, he underwent an extensive battery of tests. They took Paul's medical history, asking what medications he was on, and took brain scans, electrocardiograms and various other tests. Paul's electrocardiogram – measuring his heartbeat rhythms – showed an unusual pattern. A cardiologist specializing in heart rhythms was called in. He told Paul that he needed to put a catheter up Paul's groin to stimulate the heart in an effort to reproduce the earlier arrhythmia. Paul refused, but the physician told him that a previous patient with the same symptoms who refused the test died soon after. Scared into it, Paul took the test. Afterward, the doctor came back with the bad news: Paul had a rare disorder called Brugada Syndrome. Without having a pacemaker/defibrillator inserted, he was told, his heart could suddenly stop and he could drop dead at any moment.
There was worse news: The disease was genetic and the possibility existed that Paul's 5-year-old daughter had the same condition and could die at any time.
Paul had the pacemaker inserted. Unfortunately, his doctors did not take into account that he was a competitive athlete, and they set the parameters of the pacemaker wrong. Whenever Paul went to sleep, his heart rate dropped below "standard," and the device would rapidly pace his heart. Paul was unable to get more than two hours of sleep at a time. Although the doctors eventually reset his pacemaker, that was just the beginning of what became almost six months of physical and emotional hell. He was nauseated, but vomiting brought no relief. He frequently had convulsions. Electric shocks would shoot through his body 30 or 40 times a day, sometimes violent enough to cause him to fall. He started having recurring thoughts of suicide or violence toward others. And through it all he was tortured by the fear that his daughter was going to die because of the genes he had passed on to her. Paul traveled the country, seeking an answer, but no doctor could help him. So Paul buried himself in research, trying to find a solution to his problems. And then one day he happened to catch the TV news show 20/20. On it were people describing exactly the same symptoms as he had, only they didn't have Brugada Syndrome, they were suffering side effects of trying to withdraw from Paxil.
Paul could hardly believe it. His doctor had told him to stop taking Paxil before his heart surgery. Paul started studying Paxil, and what he found shocked and enraged him. He discovered an astounding pattern of apparently deliberate deception by SmithKline Beecham (now called GlaxoSmithKline), the manufacturer of Paxil, withholding information on the dangers of this drug from the FDA and the medical community. In June 2001, GlaxoSmithKline lost a lawsuit when a Wyoming jury awarded $6.4 million to the family of a man who killed three relatives and himself after taking the antidepressant. The verdict was based on the company's failure to sufficiently warn doctors and patients that the effects of the drug could include violence. It has since come to light that 20% of patients worldwide who were prescribed Paxil for depression stopped taking it because of suffering adverse effects. And effects of withdrawal include intense insomnia; vertigo; electric shocks; profuse night sweats; nausea; extreme confusion; intense fear of losing sanity; and thoughts of suicide and homicide. A class action filed in San Diego, representing thousands of victims of Paxil is pending.
Paul then went to an expert: Pedro Brugada, the physician son of Dr. Ramon Brugada, for whom the condition is named. Brugada the younger looked at all of Paul's records and told him that he didn't have Brugada Syndrome. Other experts concurred. Paul was told that the hospital's original procedure to reproduce arrhythmia "would've brought a horse down." His "abnormal" heart rhythms come from having the benign "athletic heart syndrome," a sign of a super heart. The original fainting was probably due to taking Paxil; the later problems were likely due to withdrawal from it.
Even with this confirmation, Paul had to go to more than 20 doctors before he found one who would remove the pacemaker. Paul is recovering from his ordeal; he is able to walk a mile now, although previously he could run 50. Despite off-the-record confirmations of incompetence and negligence in Paul's misdiagnosis and treatment, not one physician would sign a letter to that effect, or agree to testify on his behalf. Now, multiply Paul's story by thousands – by millions – every year, and you can understand my anger over sensationalistic headlines about the "dangers" of taking herbs like St. John's wort.
Here are some truths about the "scientific" testing of pharmaceutical drugs that you probably are not aware of.
Did you know that the research information contained in the Physicians' Desk Reference – the pharmaceutical bible used by M.D.s – is supplied by the drug manufacturers themselves? Did you know that the FDA approves drugs not by actually doing the testing, but simply by reviewing studies submitted by the drug manufacturers? Did you know that a drug manufacturer needs to submit only two studies showing satisfactory results to get a drug approved by the FDA – even if there are even more studies showing the drug causes adverse reactions in an unacceptably high number of cases? Did you know that most of the articles discussing the efficacy of drugs that are published in medical journals are studies paid for by the drug manufacturer? And that often, as the New York Times reported last summer, the academic scientists listed as lead authors are often just "window dressing, to lend credibility to papers that are really the work of drug companies. The academic scientists' main role in such studies is to recruit patients and administer experimental treatments. The scientists or their universities are paid for this work."
And did you know that a study conducted by USA Today found that more than half of the experts hired to advise the government on the safety and effectiveness of medicine had a direct financial interest in the drug or topic they were asked to evaluate? An analysis of financial conflicts of interest at 159 FDA advisory committee meetings from January 1, 1998, through June 30, 2000, found that at 92% of the meetings, at least one member had a financial conflict of interest, while at 55% of meetings, half or more of the FDA advisers had conflicts of interest. These conflicts included helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug.
You may not know that a significant portion of your tax dollars earmarked for healthcare goes to research on patentable drugs that make billions of dollars for drug companies. The government should fund research into nontoxic, nonpatentable remedies at a much higher level than it is presently doing. This situation again points out the need for political action, for campaign reform. For 2001, the budget for the National Institutes of Health was $20 billion. This amount could be doubled by 2003. Approximately 83% of this is spent on research performed outside the NIH. This is serious money, and most of it goes to developing patentable drugs.
A recent article in the New York Times revealed that the pharmaceutical industry spent $177 million on lobbying in 1999 and 2000: That's $50 million more than their nearest rival, the insurance industry. They employ more lobbyists (625) than there are members of Congress – and more than half of the lobbyists are former members of Congress, congressional staff members or government employees.
This shows how important it is to get involved politically, and work for campaign-finance reform. It's also time for individual physicians to take responsibility for their actions, and stop being pawns in the economic games played by the drug and health insurance industries. Physicians will change only if their patients demand it. Reform will only come from market forces, which means you: how you spend your money on healthcare, and on charitable and political donations. Get informed, take responsibility for your own health, and choose your doctors and medicines wisely.