Prescription Drugs that kill

medical report in 1998 approximated that adverse reactions to prescription substances are killing about 106,000 Americans each year -- roughly three times as many as are killed by automobiles. This makes prescription drugs the fourth leading killer in the nation, following heart disease, cancer, and stroke. The study included only substances that were given properly and under normal circumstances, excluding drugs that were administered in error or taken in attempted suicides. (When errors of administration are included, the fatal toll may be as high as 140,000 per year. Such errors include prescribing the wrong substance or the wrong dosage; giving medications to the wrong individual; giving medications to the right person but in the wrong amounts or the wrong frequencies, and so forth.)
According to the 1998 report, which analyzed the information from 39 separate studies conducted over the last 32 years in the country’s hospitals, 3.2 out of every 1000 (or 3200 per million) hospital patients die from adverse reactions to prescription drugs. Of the 106,000 people killed annually by prescription drugs in the nation, 41% (43,000) were admitted to the hospital because of an adverse drug reaction; the other 59% (63,000 people) were hospitalized for some other cause but developed a fatal reaction to prescription substances they received while hospitalized. In the country, in 1994, there were 33,125,492 hospital admissions.
The sale of prescription drugs has more than doubled in the country during the last 8 years. In 1990, American citizens spent $37.7 billion on prescriptions; in 1997, national spending on prescriptions reached 78.9 billion. Prescription substances are the fastest-growing portion of health-care costs, having increased at the rate of 17% per year for the past few years.
Urging doctors to prescribe particular drugs -- particularly new drugs -- is a huge business. According to the NEW YORK TIMES, the sales force of the widest 40 drug companies has "boomed" in recent years. In 1994, there were 35,000 full-time "detail individuals" employed by drug companies to visit physicians and describe pharmaceutical products; by 1998, the amount had grown to 56,000 -- one sales person for every 11 physicians. These companies spent $5.3 billion in the first 11 months of 1998 sending their "detail people" into physicians' offices and hospitals, plus another $1 billion putting on "marketing events" for doctors.
Not all detrimental reactions to new drugs can be anticipated or avoided under the current system, according to medical experts. "It is simply impossible to identify all the adverse effects of substances before they are marketed," declare three physicians writing in the NEW ENGLAND JOURNAL OF MEDICINE. Indeed, "Overall, 51% of approved drugs have important side effects not detected prior to approval."

Side effects from new substances cannot be predicted for 2 main reasons:  individuals vary widely in their reactions to chemical substances; and drugs are tested rare side effects may not appear in such a small group but may become painfully obvious when millions of individual start taking the drug. Even a few years ago, drugs reached a mass audience slowly, providing time for adverse side effects to show up in relatively small amounts of people. But today drugs are marketed straight to consumers via TV, so a huge market for a new product can be created immediately and side effects can appear in large numbers of individuals. The sexual potency drug, Viagra, provides an example of this phenomenon. Within a few months of its introduction, several million individuals began taking Viagra, and many important side effects, including fatalities, suddenly appeared.
Despite the widespread knowledge that 50% of all new drugs will cause important side effects in some individuals, neither the government nor the drug companies systematically collect information on adverse reactions to new substances. "Even when it is acknowledged that a new drug will be given to many patients for several years, rarely are systematic post-marketing studies carried out."
In the country, there is no established procedure for monitoring substance safety. If doctors became aware that a new drug has killed or maimed one of their patients, or caused an adverse reaction, they may report it but they also may not. As reports filter into the U.S. Food and Drug Administration (FDA) in hit-or-miss fashion, FDA can revoke the authorization for a drug, and sometimes does, but almost never fast. In December, 1997, the popular no sedating antihistamine Terfenadine was taken out from the market because a safer alternative existed without terfenadine's danger of a potentially deadly heart arrhythmia (irregular heart beat). Nonetheless, by that time, Terfenadine had been on the market 12 years. Last September, the FDA took the diet drugs fenfluramine and dexfenluramine off the market because of heart valve damage to 31% of those who took the substances in combination with another diet pill, phentermine (a combination known as fen/- phen) Fenfluramine could also damage heart valves when consume alone. By the time fenfluramine was prohibited, it had been on the market for 24 years.
In drug safety, there is only one agency. The Food and Drug Administration (FDA) authorizes pharmaceuticals and it also has responsibility for investigating injuries and fatalities caused by those pharmaceuticals. As we have seen, FDA has a very limited ability to conduct surveillance studies so, in fact, they rely on the drug companies to provide information on deaths and illnesses caused by their own products.
As mentioned above, the diet drug dexfenfluramine was taken off the market in 1997 because, combined with phentermine (the fen/- phen diet-pill combination), it harmed heart valves. When the FDA found out that dexfenfluramine was hazardous, the agency had no good data on the total amount of individuals harmed. At the time, the director of FDA's Office of Epidemiology and Biostatistics affirmed, defensively, "We've done what is needed to determine there is a problem. Other data is up to American Home Products [which marketed dexfenfluramine] to discover." Obviously, American Home Products had little incentive to investigate the number of issues caused by its product.
The three physicians comment, "Given the litigious climate surrounding concerns of drug safety, information from investigations conducted by parties with vested interests is unlikely to be impartial and is seldom publicly available to improve future decision making."
The three doctors mention an independent drug safety board -- analogous to the National Transportation Safety Board -- is necessary to study fatalities and illnesses from drugs. They point out that FDA officials spend up to a year of their lives evaluating a substance before approving it for marketing "and it is unlikely that those who recommended a drug for approval could later conduct an impartial evaluation of possible harm due to that drug."

 

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