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Flawed Prescription Drug Studies

Flawed Studies Allow Dangerous Prescription Drugs to be approved for Public Consumption

Last year almost 12,000 Canadians died from adverse drug reactions caused by prescription drugs. This terrifying statistic, almost 30 deaths a day, was published in the Canadian Adverse Events Study.

If the testing of prescription drugs was done honestly and fairly in the studies preceding their approval and if these drugs were carefully monitored after their release into the public, maybe a great number of these deaths could have been prevented.

The approval of a drug from concept until final approval for use in the public domain usually takes about ten years. Starting with laboratory testing, animal testing and finally human studies, the dose and effectiveness of the drug is determined. However the human testing is so flawed that even the manufactures themselves may have no idea how dangerous their drugs could be.

Human drug studies are carefully crafted company-sponsored clinical trials studied under the best of conditions. They are also very selective. In other words, as long as the test drug lowers the cholesterol, the researchers do not look very hard at what other organs in the body are affected. To be more specific, the study is only about the amount of cholesterol lowered and not whether the drug actually prevents heart disease.

This type of testing would not be so bad if the drugs were actually tested on the people who should receive them; but they are not. If a pharmaceutical company is testing a drug to see if it reduces blood pressure, rather than test this drug on people over 50 years of age who have elevated blood pressure, they test the drug on healthy 25 year olds. When they do this, they can still measure the effectiveness of the drug but they are very unlikely to see any side-effects or adverse reactions when they give the drug to young healthy people. These test subjects are carefully monitored, given the exact dose and only take the drug for a short period of time.

In the real world this never happens. The people who take the prescribed drug will most likely be taking other medications as well. They will be older and most likely have medical conditions that did not exist in the young test subjects. They will be taking the drug for a prolonged period of time and all of these circumstances raise the distinct possibility of unforeseen interactions, side-effects and even deaths. Yet once the drug is out there it has already been approved and very unlikely to be disapproved and removed from the market.

PHARMACOVIGILANCE

This is a great sounding word that reminds me of those long German words that require a whole sentence for translation. In fact it is the” science of collecting, monitoring,researching,assessing and evaluating information on the adverse effects of medicines after they are marketed, in order to obtain new information about the hazards associated with medicines and to prevent harm to patients.”

This definition is from a new report commissioned by the Health Council of Canada entitled Keeping an Eye on Prescription Drugs, Keeping Canadians Safe. It was prepared by York University researchers Mary Wiktorowicz and Joel Lexchin and it notes that pharmacovigilance, although very seldom practiced, is essential to a safe and effective delivery of health care in our drug-saturated culture. The problem is, the horses have already escaped from the barn and now we want to lock the door.

Canadians spend approximately 25 billion dollars each year on prescription drugs and all of these drugs are only tested on carefully selected groups of people and very rarely on the people for whom the drugs were intended. Rather than fix this process, the study put out by York University suggests that Health Canada spend more money tracking drugs after their release. At the present time it has a staff of 827 and a budget of $74.6 million for drug approvals. On the other hand it has a staff of 213 and a measly $23.6 million for monitoring the safety of drugs.

Since we do not have a national system of surveillance, only a voluntary reporting system, the number of drug interactions is grossly underreported.

In 2008 there were only 16,272 reports of adverse drug reactions entered in the Canada Vigilance Registry. Only one in five doctors ever reports an adverse drug reaction and the incidence is even less among pharmacists who should know better. Studies show that voluntary reporting systems capture from 1 to 10 percent of all adverse reactions. The incident report seems extremely low when you consider that 453 million prescriptions were filled in Canada in 2008.

Most of you may not be aware that Health Canada does not have any legislative authority to remove dangerous drugs from the market. They cannot order post-market studies, cannot demand label changes and it does not have the power to monitor patient registries. They depend on the pharmaceutical manufacturers to withdraw dangerous drugs. Merck voluntarily removed Vioxx from the market because of the bad publicity, not because they had to.

A few years ago there was a lot of controversy about Bill C-51 and how it affected the Health Food Industry. Although this legislation was dropped when Parliament was prorogued, Bill C-51 gave Health Canada all of the above powers which would have enabled it to track and remove dangerous drugs even before the manufacturer voluntarily withdrew them.

Just recently new studies have shown that the antipsychotic drugs Zyprexa and Risperdal could cause very dangerous adverse reactions in seniors. The drug companies sent out mild “Dear Doctor” letters advising the physician of these effects while sending their sales reps to push even harder. The result; even more prescriptions written even after the so-called “warnings”.

So even though we have taken away the teeth from Health Canada, the researchers at York University want to give them more money to track prescription drugs after they are approved. To me this is another waste of taxpayer’s dollars. We should be thinking of how to stop the pharmaceutical companies from bringing out dangerous drugs in the first place and you can do it.

The next time your physician wants to prescribe a new drug for you, ask your doctor if that drug was tested on people your age and with your physical conditions. It is all there in the small print presented to him by the drug rep in shiny embossed lettering. If your doctor was like most physicians, she simply accepted the samples and read the first two or three lines of the brochure. Insist that you do not want to take drugs that have not been adequately tested on people like you. This may not have any impact on the whole order of things and the unscrupulous marketing methods of the pharmaceutical companies, but at least you may avoid becoming one of those adverse reaction statistics or even deaths.

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