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| From the January 16 2001 PRnewswire is a story that reveals some startling numbers. According to a survey conducted for the American Society of Health-System Pharmacists (ASHP), 51% of American adults take two or more medications per day, which include over-the-counter drugs. The study also showed that 46% take at least one prescription medication daily and 28% take multiple prescription drugs per day. These figures show that an alarming rate of the adult population in the United States uses drugs of some kind. As expected the elderly have the highest rate of medication usage with 79% of those over 65 reported to be taking at least one medication daily. Americans who are over 65 and take medications take an average of 4 medications per day per person. One of the concerns expressed by the ASHP president, Mick L. Hunt, M.S., was that medications could have bad interactions when mixed. Hunt said, “We want all patients to be aware of the potential for drug interactions that occur when mixing all of these remedies, especially when taking multiple medications each day.” |
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deaths finally pulled off market |
| Several recent stories reported that the Bayer Corp. has voluntarily removed a popular cholesterol drug, Baycol, off the market after it has been linked to as many as 40 deaths. One such article appearing on the August 8, 2001 MSNBC website said that the drug was taken by 700,000 Americans, and was pulled off the market because of muscle destruction linked to at least 40 deaths around the world. According to a similar story in the August 9, 2001 New York Times Health section, the United States Food and Drug Administration "agrees with and supports this decision," the agency said. It said pharmacists would be instructed to return the drug to Bayer for refunds. The F.D.A. approved Baycol for use in the United States in 1997. It should be noted that no where in the reports does it say that the FDA has removed its approval for Baycol. Baycol was in a class of drugs called "Statins". "All statins have been linked to muscle cell damage in rare cases, but the problem is much more common with Baycol than with other such drugs," said Dr. John Jenkins, the director of the office of drug evaluation at the F.D.A. The Times article states, "From the beginning, medical experts said, statins were known to cause the muscle problem, rhabdomyolysis, which can lead to kidney failure and other problems. But it occurred very rarely and was almost never fatal." With Baycol, however, reports of serious rhabdomyolysis were about 10 times as frequent as with the other statins, Dr. Jenkins said. Lawsuits have begun to appear following the drug being removed from the market. According to the website DrKoop.com, a Tallahassee, Florida woman has sued Bayer Corp., claiming its recently recalled cholesterol drug, Baycol, caused her to suffer muscle degeneration and chronic fatigue. Separately the Chicago-based law firm of Kenneth B. Moll & Associates said it plans to file a class action lawsuit against Bayer in Cook County, Illinois, on behalf of all patients who were prescribed Baycol. The law firm, which estimates that about 6 million people worldwide have taken the drug, said the suit will seek among other things the establishment of a medical monitoring fund "to enable people that have taken Baycol to monitor the existence of dangerous side effects." |
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| The debate over Direct-to-Consumer Drug Ads, known as "DTCs" has heated up on several fronts as some in the medical profession and government see it as an expensive threat to consumer health, while others see it as the next step in consumer education. In the July 2, 2001 issue of the AMA News, was a report from the recent AMA annual meeting where the debate raged on and the opinions varied. Recently, an effort by many doctors to press the AMA to petition the Food and Drug Administration and the Federal Trade Commission to ban DTC advertising failed. Angelo Agro, MD, a New Jersey delegate from Voorhees who proposed a policy to ban DTC ads said. "We recognize that a ban is just not going to happen for all sorts of reasons. What we really want is some oversight with some real teeth." Another dissenting voice came from Dr. Fryhofer who stated, "Not only do we have to explain to our patients the nature of the medical problems that they have, but we also have to discuss why they don't need the drug that was advertised and what is the best option." Dr. Agro summed up his opinion by saying, "The public is not being given the whole truth. By its very nature advertising is biased, and it's compressed. We are not against information being brought to the patient, but we have a problem when it's biased, limited and brought about by multimillion-dollar organizations that have a profit motive only." Even state legislature are starting to get into the debate. According to a report in Reuters Health Jun 27, 2001, "A handful of states have introduced bills this year to force pharmaceutical manufacturers to disclose what they spend on advertising and promoting their products to consumers." State legislatures are not only concerned about the health implications, they are also concerned about the bottom line. Legislation targeting direct-to-consumer (DTC) advertising is part of a growing strategy that states are using to contain double-digit growth in drug spending. According to the National Governors Association and National Association of State Budget Officers, prescription medication now represents the third largest expenditure in state Medicaid budgets. Drug costs under Medicaid are growing about 18% annually nearly double the rate of growth in overall state Medicaid spending, they report. This trend is reflected on a national basis where some of the largest increases in prescription drug utilizations have been shown over the last 5 years. Currently drug companies spend approximately $2.5 billion per year on DTC ads. |
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| A jury in Wyoming found the British based drug company GlaxoSmithKline 80% responsible for a family murder-suicide committed by a patient taking a drug produced by the company. The drug was was an anti depressant marketed as Praxil in the United States and Seroxat in Britain. According to the report published in the June 16, 2001 issue of the British Medical Journal, a 60 year old Wyoming man who was suffering from episodic depression but who was not showing any signs of homicidal or suicidal tendencies was prescribed the drug. Several years earlier he was given Prozac, but was taken off the drug because he became agitated. In February of 1998 he was put on Praxil for mild depression. Within several weeks he then went on his murderous rampage. In the trial several experts were brought in to testify including Dr. David Healy, director of psychological medicine in Bangor, North Wales. Dr Healy testified that both his own research and the research of the drug maker GlaxoSmithKline both showed that a full 25% of healthy volunteers who were given this type of drug became "extremely agitated". Dr Healy also testified that in his own studies of volunteers who were not depressed who were given these drugs that only 33% felt better while on the drug, while 33% felt worse, and 33% felt no change. However, two previously non-suicidal and non-depressed volunteers became suicidal and depressed while on the drug. The jury in the Wyoming case awarded the surviving family $6.4 million and found that the drug company was 80% responsible for the deaths. This court decision is the first time that a drug company has been held responsible for suicidal and homicidal actions of patients who were using it's product. Representatives of GlaxoSmithKline said that they were surprised by the verdict and continue to state the drug is safe. |
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