An Easy Way to Report Adverse Drug Reactions

An Easy Way to Report Adverse Drug Reactions

All of us see an endless stream of television ads showing happy, attractive people who no longer have the aches, pains or allergies which were ruining their lives before they took a wonderful pill manufactured by a drug company. It is interesting that only the United States and New Zealand force their citizens to see this advertising of prescription drugs directed at patients. The European Union is being extensively lobbied by the drug companies but has not removed its ban on television ads for drugs. Why do drug companies spend billions of dollars on these ads? They work. Since most people spend much more time watching television than they ever spend with their doctor, consumers are strongly influenced by these ads. Doctors are reporting more and more patients are demanding that they prescribe the drugs that they saw on television.

Patient Testimonial

One Novus patient related to us how television drug ads affected her. She went to her doctor and asked to be prescribed a drug that she saw advertised on television. The ad showed people who were happy and no longer bothered by the condition exhibited by the patient. She said that yes, she sort of heard the side effects listed at the end of the commercial but assumed that her doctor, who she had been seeing for years, would not allow her to take something that would be harmful. She recounts taking the drug and experiencing headaches, one of the side effects listed on the drug label and stated at the end of the commercial. When she called the doctor, he didn't take her off the drug but simply prescribed another drug to treat the headaches. Unfortunately, this new drug created dizziness and rather than be alarmed, the doctor prescribed another drug for dizziness. By the time the patient arrived at Novus, she was hooked on five drugs and had no life. After she got off the drugs and was feeling better for the first time in years, she was very upset. She wanted to report the side effects of these drugs to the FDA, but this is not an easy process and she eventually just dropped the idea.


Under existing law, reporting harmful side effects is left to hospitals and doctors and the drug companies. This is clearly not working well. According to the Consumers Union, in 2005 only 465,000 reports of adverse drug reactions were collected by the FDA, even though adverse drug reactions account for nearly 700,000 emergency room visits each year. Based on pharmacy records and other data, it has been estimated that millions of people suffer such serious side effects that they stop taking a drug. However, this information is rarely reported and is thus not being made available to the FDA, the medical community, and the public. Since the clinical trials required by the FDA to obtain drug approval normally involve no more than 3,000 carefully selected people, the actual tests of a drug don't really take place until the drug is used by the general public, and the true side effects often come to light only after the drug has been on the market for some time. Doesn't it seem logical that the side effects of a drug should be reported by the public so that dangerous drugs can be more quickly withdrawn before they harm even more people?

The Food and Drug Administration Revitalization Act passed in September of 2007 took a step toward this reporting, but it doesn't go far enough. The new law requires that all drug print ads include information on how to report side effects and other adverse drug reactions. However, the decision to make the drug companies include the same information in their television ads was not ordered-thanks to intensive drug company lobbying. Instead, the law instructed the FDA to conduct a study by March of 2008 to determine if such information about how to report side effects with a toll-free number and on the internet should also be included in television ads.

This is disturbing because FDA officials have admitted it does not really see the public as its clients. Instead, the drug companies' payments to the FDA for drug approvals are making up a larger and larger portion of the FDA's budget and are who the FDA is really serving. It may seem cynical to you, but companies that pay in excess of $1 billion in settlements to consumers harmed by their drugs and still keep those same drugs on the market are not likely to be in favor of anything that allows the millions of adverse reactions and side effects to their new drugs to become public information. I'm sure the drug companies are confident that the FDA will decide that the information about reporting side effects and adverse drug reactions of the drugs advertised does not need to be included in the television ads. If the FDA were to receive millions of complaints about a drug, then it would be forced to take immediate action, not delay for years and allow the drug companies to make billions more in profits before the drugs are finally withdrawn.


Since it is predictable that the FDA will attempt to avoid making the reporting of adverse drug reactions easier, the Consumers Union, publisher of Consumer Reports, has been circulating a petition that demands the FDA require the television ads to include a toll-free number and web address so the public can easily report adverse events. With easier reporting of dangerous side effects of the drugs, many lives will be saved and untold misery will be avoided. I have signed and certainly encourage you to sign the petition.

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