For many Americans, doctors are the last earthly gods–politicians and clergy having long since lost their glow. We want to believe that our brilliant “medicine men” will save us from our self-destructive habits and so we dutifully go to our annual check-ups and make appointments at the first sign of any symptom (especially if we have health insurance). We listen childlike to the doctor’s sage pronouncements, and we feel sanctified when, finally, He reaches for His pen and scribbles some indecipherable wisdom on His R. pad. And we vow to swallow the treasured “magic pills” according to His every command…
While we cling to this reassuring ritual, it is becoming harder and harder to remain blind to the signs that these “magic pills” are more like double-edged swords. Rarely a week goes by when we don’t read about some celebrated “wonder” drug or miracle medical device – from diet pills and pain relievers to anti-psychotics and synthetic implants – suddenly discovered to have dire or deadly side effects.
The New York Times recently reported on a major study detailed in the April 1998 Journal of the American Medical Association (JAMA) which attributed an average of over 100,000 deaths a year in American hospitals to adverse drug effects making drugs reactions the fourth leading cause of death in the United States, behind heart disease, cancer and lung disease. The researchers emphasized that these deaths were not due to negligent use, but rather drugs prescribed and administered according to accepted protocols.
“We want to increase awareness that drugs have a toxic component,” said Dr. Bruce Pomeranz, an author of the study and a professor of neuroscience at the University of Toronto. “It’s not rare.”
However, Dr. Pomeranz said that these numbers are surprising because drugs are rarely recognized as the official cause of death. Even when the drug is known to be the cause, the death certificate generally lists the effect, e.g., a stomach hemorrhage or liver failure, as the cause of death, without mentioning the drug that brought it on. Sometimes, of course, the drug is not recognized as the cause as patients and doctors believe their bad reactions are a result of the underlying disease being treated and not the medication.
In addition to the deaths, the JAMA study reported that patients in hospitals experience about 2.2 million non-fatal adverse drug reactions a year. While Dr. Michael A. Friedman, lead deputy commissioner of the Food and Drug Administration (FDA), the federal agency responsible for overseeing approval of all prescription and over the-counter drugs, declined to comment on the unexpectedly high numbers in this study, he remarked, “…we recognize that every medication has some side effects,” and noted that adverse reactions were particularly common in antibiotics, heart medications, blood thinners and chemotherapy agents for cancer.
These findings are corroborated by Thomas J. Moore, a medical writer and senior fellow in health policy at George ,Washington University Medical Center, in his recent book Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet (Simon & Schuster, 271 pp., $25.00). Moore states the figures somewhat more graphically: “…the number of Americans killed by pharmaceuticals is quadruple the number of people who are murdered and double the number who die in car crashes.” He says that one million Americans per year are “severely injured” by medications and 2 million are harmed by drugs in the course of a hospital stay.
Where is the magic that we want so fervently to believe in? The reality is that drugs are largely blockers of natural bodily processes: e.g., antibiotics, anti-histamines, anti-inflammatories, calcium blockers, protease inhibitors, etc. Used routinely for inflammatory or chronic conditions, drugs may temporarily mask the uncomfortable symptoms of healing, but they also add stress to the body by increasing the toxic load violation of the most basic tenet of the art of medicine, “First, do no harm.” In acute situations drugs can buy time for patients, even save lives–at least giving the patient an opportunity to build back enough strength to proceed with a more natural approach. But drugs contain no intrinsic healing properties. They alleviate symptoms without correcting the underlying cause of a problem. By interfering with the body’s signals, it is not surprising that medications can cause adverse reactions in other parts of the body, especially when used over long periods of time. After all, the body is an integrated whole: we have just one circulation system, one nerve network, etc. What occurs in one part has consequences for the total system.
Thus, we pay a price for the “quick fix” in the form of mild to severe side effects – a fact that the medical community does not negate. The nature of these effects depends on a variety of factors, many of which are difficult to predict given the unique condition of each patient – drug history, sensitivities, constitution, etc. The question, therefore, becomes one of degree: when is the benefit worth the price?
A case in point: two new drugs, Gluocophage and Rezulin, products of two different pharmaceutical companies, were widely hailed as the first new “wonder7 treatments in 20 years for a.dult-onset diabetes, a disease that can often be controlled by diet and exercise but for which drugs are usually prescribed. However, after a year or so on the market, data began to emerge implicating the drugs in dozens of deaths – possible liver damage in the case of Rezulin, and, in the case of Glucophage, lactic acidosis, a buildup of acid in the blood that signals organ failure. Moreover, there appeared to be no way to predict who would be at risk to develop these severe reactions. In the United Kingdom Rezulin was removed from the market and Gluocophage is being intensely scrutinized. However, the drugs remain on the U.S. market, though the FDA has strengthened labels and oversight.
The potential benefits of Glucophage and Rezulin have been claimed to be enormous. About 15 million people in the U.S. have Type II or adult onset diabetes, a leading cause of death in the U.S. These drugs became blockbusters after approval trials showed them to be more effective than previous drugs in helping the body use its insulin stores. Are the 60 or so deaths and numerous other adverse reactions thus far reported worth the apparent benefit to millions?
Another case in point: The New York Times recently reported on problems with non-prescription drugs used in routine low-risk out-patient surgery. Specifically, a 4-year old boy died after a standard procedure to remove his adenoids and insert tiny tubes in his eardrums to drain fluid. The subsequent investigation revealed that the most probable cause of death was an adverse reaction to an over-the-counter drug, phenylephrine, sold commercially as Neo-Synephrine for nasal congestion relief. Many doctors, it seems, use phenylephrine to stop local bleeding, even though FDA has not approved such use – doctors are legally free to use a marketed drug for any purpose that they believe justified. The drug stops bleeding by causing constriction of the blood vessels, but this increases blood pressure. In the case of the 4-year old, after administering the phenylephrine, the doctor gave the boy a beta blocker drug to lower blood pressure which, for this patient, proved a fatal interaction.
An expert panel looking into this death uncovered at least 11 similar cases. Dr. Jacqueline E. Jones, director of pediatric otolaryngology at New York Hospital who headed the investigation, said that her panel came to a striking realization that at times doctors are “cavalier about the drugs they give patients in the operating room and assume that nothing bad will happen with non-prescription drugs.”
And what of the recent hoopla over Tamoxifen? This is the estrogen-inhibiting drug long-approved for treatment of breast cancer, but now claimed to dramatically increase the chances of preventing the disease in high risk women. Results of a large study of 13,388 women revealed that the drug also carries the risk of serious side effects including uterine cancer, blood clots in the lungs and major veins. Critics of the study also suggest longer trials might have revealed that the drug only delays the onset of the disease. Over 178,000 women in the U.S. will be diagnosed with breast cancer this year and 43,500 will die of the disease. How great a percentage of adverse effects should be tolerated for the apparent benefits? In this case the dark sides of the drug are well documented and patients will likely be better informed about possible adverse consequences than in the previous two cases. Still the nagging question remains, how much risk is worth the alleged benefit?
FDA is our consumer “watchdog” agency charged with oversight of all pharmaceuticals. To attain approval, drugs must go through extensive trials, determining the nature of risk vs. benefit. If approved, doctors are asked to voluntarily report any side effects their patients may experience in the course of treatment and pharmaceutical manufacturers are expected to document any evidence of previously unnoted adverse reactions so that the drugs can be periodically reevaluated.
That’s the way is supposed to work, but there are vast holes in this oversight system! FDA, ever focused on the “revolving door,” seems more concerned with not upsetting industry interests than with protecting the public. Rather than demand more accountability from the pharmaceutical companies or budgetary increases from Congress, the agency too often pleads impotence due to lack of sufficient funds. They claim this leads to reliance on industry studies which are often of too-short duration or flawed. FDA laments the voluntary reporting of side effects by doctors which sounds nice in theory, but is rarely adhered to in practice. As one study in Rhode Island found, while doctors’ files show 26,000 adverse reactions to drugs, only 11 of these were reported to FDA! According to Thomas Moore, only about 1% of serious adverse reactions are ever reported. Doctors claim they are just too busy or patients don’t report or don’t return for follow-ups. The pharmaceutical companies, allocating the bulk of their resources to promotion once a drug is approved for the market and not wishing to increase public worries about drug dangers, are not a reliable monitor of adverse effects either. And even if reports do come in, FDA, with an oversight staff of only 54, can always cry that it simply does not have the resources to effectively follow up on the 3,200 drugs now on the U.S. market.
In those cases where FDA has acknowledged problems and issues warnings, doctors don’t necessarily pay heed. When Halcion, a popular sleeping pill, was found to induce aggressive behavior and psychosis in some patients, FDA requested that the drug be prescribed for no longer than 7 to 10 days. However, a 1996 FDA report found that 85% of prescriptions were for longer periods. But FDA was powerless to do anything because once a drug is approved, doctors are free to use it as they see fit.
Besides FDA’s lack of intestinal fortitude, there is plenty of fault to go around: doctors who do not inform patients about side effects or who prescribe drugs largely because patients ask for them; pharmacists who don’t notice harmful drug combinations or do not provide labeling information; and patients who don’t ask about drugs they are taking or take them inappropriately.
Many may take solace in the fact that serious side effects occur only in a small percentage of patients taking any particular drug. A New York Times editorial (4/18/98), following the story on the JAMA drug study, appeared to seek to calm popular hysteria by stating: “There is no epidemic of drug accidents. Two million adverse reactions represent less than 1 percent of the more than 200 million drug treatments administered to hospital patients each year.”
“Epidemic” may not be the appropriate word, but when a popular drug is taken by millions, a 1-2% risk of injury can affect tens of thousands of people. For instance, Prozac, a product of Eli Lily & Company, a truly blockbuster drug swallowed by millions of people in this country and around the world, was, according to Moore, “associated with more hospitalizations, deaths, or other serious adverse reactions reported to the FDA than any other drug in America.”
As long as the populace seeks salvation in pharmaceutical drugs, doctors will prescribe pills for every ill, and patients will experience an increasing panoply of adverse reactions. Much suffering could be avoided by strengthening FDA’s latent “watchdog” instincts. Of course, that would involve the agency’s risking industry ire to make a strong case for increased funds to a Congress inclined more toward cutting taxes and regulations and accommodating powerful commercial lobbies. Tightened FDA surveillance could enable drugs to be revaluated at least every 5 years and with stepped up muscle the agency could enforce mandatory – instead of voluntary – reporting of adverse effects by doctors and companies. Thomas Moore suggests that pharmaceutical companies should be required to do long-term studies of some drugs, using money from a tax on companies that profit from the huge market for drugs. He recommends further a standard rating system for drug toxicity and better consumer education on issues such as how to interpret labels, what questions to ask to insure informed decisions, etc. Consumers need to know, for instance, at what point a drug is in its history – the longer on the market, the greater likelihood that warnings accurately convey risks. Consumers also should be aware that when doctors prescribe drugs prophylactically, they are often acting defensively. The drug may have been totally unnecessary, but, as Joseph J. Neuschatz, M.D. wrote in a letter to the Editor of The New York Times: “A physician sued for bacterial comp4ations is doomed if the answer to the question, ‘Doctor, did you use antibiotics on this patient?’ is no.”
To those of us who favor a more natural approach to dealing with our health problems, pharmaceutical drugs are the choice of absolute last resort. The body is an incredible survival machine! Why block up the natural healing processes by loading ourselves down with synthetic toxic material? Attention to a balanced lifestyle, hopefully, reduces the occurrence of desperate situations where powerful “magic pills” may be necessary. But when such situations do occur, ifs always best to go in with eyes open wide, to be skeptical of cavalier claims, to question interactions with other medications, to avoid long-term dependence, etc.
As the saying goes, if we don’t know where we’re going, we’re likely to end up somewhere else.