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| The prescription drugs many people take may be based on inaccurate and faulty studies. This concept was based on a new study published in the August issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP). Researchers at Johns Hopkins University (JHU) and the University of California found that 30 percent of volunteer patients in a clinical drug research trial reported that they did not take their medication despite reporting to the clinical researchers that they did. This trend raises serious questions about the accuracy of study conclusions from drug studies. This deceptive practice called "dumping", is where individuals remove or discharge all the medication from the dispensing canister so when it was weighed at the next patient visit, it would suggest that the patient had been taking medication as instructed. Most drug usage recommendations are based on clinical trials. These types of trials have been previously regarded as one of the most reliable forms of research, and many practice guidelines for drug use are often based on trial results. The researchers noted that conclusions drawn from the results of clinical trials are based on the assumption that the prescribed study medication has been taken according to the study protocol. If a fairly high percentage of testers in these studies are "dumping" the medications, the results from these studies are invalid and the medications, even though they may already be approved, could potentially be ineffective and dangerous. |
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financial conflict of interest |
| In two recent articles on September 25, 2000 by both Reuters News and USA Today came reports that that 54 percent of the experts the FDA asks for advice on which medicines should be approved for sale had a direct financial interest in the drugs or topics they were evaluating.These financial conflicts or interest typically include stock ownership, consulting fees or research grants. Federal law prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998. Although the FDA does reveal when financial conflicts exist, since 1992 it has kept the details of any conflict secret so it is not possible to determine the amount of money or the drug company involved. The USA Today article stated, "These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice." USA TODAY conducted an analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30. The following are listed in the article as their findings:
Larry Sasich of the advocacy group, "Public Citizen", concluded by saying, "The industry has more influence on the process than people realize." |
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drug ads are deceptive |
| The US Food and Drug Administration regularly sends out citation letters to many drug companies for overstating the effects of their drugs in advertising. Tom Abrams, the chief watchdog at the Food and Drug Administration for deceptive advertising, says some ads stretch the truth with overstated claims of effectiveness and understated descriptions of side effects. This report was aired on January 3, 2001 by ABC News. According to the report, every year, the FDA sends about 100 letters to drug companies demanding changes in television commercials, magazine ads and other promotional materials. Many companies are repeat offenders and continue to use deceptive advertising. Some examples include the allergy drug Claritin. According to the FDA the makers of this drug are repeat offenders. Since 1997, the manufacturers have been told 10 times to change their advertisements. Additionally, makers of two other allergy drugs, Flonase and Flovent have been cited 12 times for commercials the FDA claimed were misleading. Dr. Sharon Levine of RX Alliance says, “This is intentionally misleading, the drug companies are trying to suggest they can deliver more than they do.” Amazingly, the ABC story noted that the FDA has never taken a company to court. They noted that most offenders simply change their advertisements and come up with another sales approach. |
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| Corporate Crime in the Pharmaceutical Industry is a book by Dr John Braithwaite where he describes many examples of corporate crime in the pharmaceutical industry. Dr Braithwaite's revealing study is based on extensive international research and includes interviews with 131 senior executives of pharmaceutical companies in the United States, the United Kingdom, Australia, Mexico and Guatemala. "Data fabrication is so widespread", says Dr Braithwaite, "that it is called 'making' in the Japanese pharmaceutical industry, 'graphiting' or 'dry labelling' in the United States." He further states: "Pharmaceutical companies face great temptations to mislead health authorities about the safety of their products. It is a make or break industry - many companies get virtually all their profits from just two or three therapeutic winners. Most of the data that the Australian Drug Evaluation Committee relies upon in deciding questions of safety and efficacy is data from other countries, particularly the US. Inquiries into scientific fraud in the US have shown there is a substantial problem of fraud in safety testing of drugs in the US, just as has been documented in Japan." In his book Dr. Braithwaite reports that between 1977 and 1980 the United States Food and Drug Administration discovered 62 doctors who had submitted manipulated or downright falsified clinical data. A separate study conducted by the FDA has revealed that one in five doctors investigated, who carry out field research of new drugs, had invented the data they sent to the drug companies, and pocketed the fees. |
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