Despite research showing that the drug Avandia causes an increased risk of heart disease in patients with diabetes, the FDA yesterday voted to allow the drug to remain on the market. So how is this protecting the public? Isn’t part of the job of the FDA to protect us from drugs that can harm us? Apparently not. BTW a scientist from the FDA supposedly was taken off the case when he or she found information that suggested that the drug was not safe. Read the article here.
Is this an FDA problem or an issue that goes much deeper. My opinion is the latter. It is a system that no longer holds the pharmaceutical companies accountable in a real world manner. The FDA is shorthanded, under-budgeted and faced with billion dollar lobbyists pressuring them to “fast-track” their next blockbuster drug. This is a huge problem and will likely not get fixed any time soon. People I’ve talked to with an inside knowledge of the FDA tell me that there is a growing frustration level at the agency because they feel like they are being lied to and deceived by some of the pharmaceutical companies when it comes to adverse event reports and followup efficacy research.
What is needed is independent research into drug on the market. My proposal is to create a government agency under the FDA which would give out grants to universities to study the effects of drugs on patients, kind of a Phase IV research program. The research would be funded by the pharmaceutical industry in a pooled manner. You sell 1 billion dollars worth of a drug, you put in 3% into the pool. All the companies are mandated to put the money in depending on the sales figures for their drugs in the U.S. In the case of Avandia, since they sell 3 billion dollars a year of the drug, Glaxo would be forced to fork over 90 million to the project.
From this, we could have a top notch monitoring system to oversee the safety of the drugs being marketed to physicians. The other overhaul would be to severely curtail advertising of drugs to the consumer. The crap from the industry that they are just educating the public is just that, crap. The education, and I mean education not bribery, should be focused strictly on the physicians, with strict guidelines. No trips to the Bahamas to hear a sales pitch, just local lectures and information passed on in a professional manner. One other issue, no more marketing to physicians about off label uses of drugs. The sales rep should be banned from touting a drug for treatment of a disease that has not been approved by the FDA. This is dangerous and unscientific and needs to be prosecuted if found.
This issue is not going away anytime soon as long as the pharmaceutical industry is not run just for profit. Time for a change.
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