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. Volume IX Number 14. . . . March 14, 2003
Drug Deals is a powerful documentary about the approval and withdrawal of prescription drugs. It cites a number of specific cases with doctors, journalists, parents, and drug approval agencies giving opinions and facts regarding this important topic. A major problem illustrated in the video is the lack of a separate watchdog organization similar to the Aviation Board which is separate from the airline industry and the airplane producers.
The video begins with the sirens of an ambulance. A 15-year-old girl is rushed to the hospital with cardiac arrest. Her father, Terence Young, talks about his daughter's bulima and her prescription for Propulsid, a brand name for Cisapride, taken for bloating after meals. The video continues with a shot of a cemetery and a child's head stone. Mr. Young states that a paramedic said, "They prescribe this stuff like water."
There are shots of articles both in Canadian and American newspapers about cases in which patients have died with suspected drug interactions or causes. Drugs, such as Thalidomide in the 1960's, were prescribed for morning sickness in pregnant women who did not realize the devastating consequences the drug would have on their unborn children. People believe that the drug industry is reliable, and yet the drug industry has a financial need to market drugs faster. With AIDS and other health conditions, drug companies have changed from a review time of 1100-1200 days in 1990 to 350 days in 2001. Health Canada is under increasing pressure from the industry to speed up the approval time. In 1992 in the United States, user fees were introduced for drugs used in serious diseases. Half of the profit went to regulators of the drug. The video supports the idea that this is a major conflict of interest.
The FDA and the drug industry have often been adversarial in the past, but, in the speeding up of the approval system, the industry becomes the client Another example given is the drug Rezulin prescribed for Type 2 Diabetes. The fast track for approval was one year instead of three, and now there are 300 deaths suspected to be connected to its use. The video also comments on the difficulty of tracking deaths in drug interaction cases. Often the death is identified as an overdose or unrelated cause. Mr. Willman, a reporter from Los Angeles was investigating Rezulin and is interviewed for the documentary. He had discovered that one of the scientists had reservations about the clinical tests with Rezulin, but, although the manufacturer had ordered larger trials which would take three months to analyze, the company didn't want to wait and the FDA agreed. The drug was found to have a lethal toxicity.
In 1993, Cisapride was approved although there was some evidence to support prolonged QT interval in the heart. The FDA had cases on file but failed to consult its own experts. The ramifications were not well understood. In 1992, Health Canada had identified similar problems. One of the scientists interviewed said that there was "gold standard" evidence to show that the drug caused the problems. The FDA said that the benefits to thousands of people could not be delayed because of ten cardiac deaths. They further said that there was no evidence that Cisapride caused the deaths but only that it was possible that Cisapride was the cause. Mr. Young states that this drug is routinely prescribed for non-life threatening illnesses, and his daughter's death was predictable and preventable.
In the court case results which are shown to end the video, Janssen, the Drug Company, and Health Canada communicated their information about the drug to each other prior to a report aired on the television show Market Place, four months before Vanessa's death. Terence Young says that, if he had seen the program, his daughter would still be alive.
Another concern that is mentioned is drug and food interaction. Scientists discovered that Cisapride interacts negatively with grapefruit. It takes the company five years to issue the warning to doctors. Another problem is in the "Dear Doctor" letters which are sent out by the drug companies. Many doctors fail to read the information completely or to take action on the information and rely on drug representatives for their information. Doctors also prescribe the drug "off label." In this way, drugs approved for adult use are given to infants with sometimes disastrous results. With Cisapride, four letters were sent over a five year period, but doctors were still prescribing the drug for babies that were spitting up. Because of industry regulation, the FDA cannot go public with warnings. Dr. Billy Bourke said that Cisapride was not effective for use in babies, and that effective is different than safe. If it is not effective it should not be used.
The video shows examples of the high pressure and marketing techniques that the drug companies use to promote the drugs such as dinners, shows, and free samples. The publication information shows a bias to positive results.
The National Film Board combines pictures, interviews, case studies, lawyers, etc. to produce a powerful video. They not only identify what they see as the problem but offer some solutions. France has people trained to monitor new drugs and look for problems rather than wait for problems to perhaps be diagnosed. The video ends with the conclusion of the Vanessa Young case wherein the jury had a number of recommendations which the lawyer for the drug company said would be considered. Janssen declined to comment over the three months of the taping of the video.
The video is interesting and easy to watch for the general public with a non-medical background. There are a good variety of locations and presentations so that the flow of information is coherent and "watchable." Although there is a pre-determined bias, the material is presented in a fair way which brings out a variety of sides to each issue. The purpose is not on blaming but on finding a safe solution for society. Language and content is very appropriate to the audience. This video is suitable for high school students and would be a good addition to courses such as Law, Ethics, and Social Sciences or any course dealing with controversial issues. It would also be useful for adults interested in the subject and the general public's concern about problems of prescription drugs.
Deborah Mervold is a teacher-librarian and a Grade 12 English teacher at W.P. Sandin Composite High School, a grade 5 to12 school in Shellbrook, SK.
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Copyright © the Manitoba Library Association. Reproduction for personal use is permitted only if this copyright notice is maintained. Any other reproduction is prohibited without permission.