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I think there are three possible root causes for dangerous drugs reaching the market without adequate testing and warning. First, I think that the patent period is too short. Second, I think that drug companies are competing with each other based on the side effects listed on their competitors label. Finally, I think that the "fast track" process has been abused.

In this blog entry, I attempt to explain why each of these contribute to the public unknowingly and perhaps unnecessarily being exposed drug side effects without adequate testing and without adequate warning.

Patent law: A short patent period limits the number of years that a drug company has to charge a premium price for a drug. While the drug is under patent, the company has the exclusive right to manufacturer and sell the medication. Once that patent period runs out, other manufacturers can take the molecule and manufacture a "bio-identical" product which they then sell at a price well below the price of the "name brand" drug. The patent period begins to run the day that the drug is invented – when it is filed with the patent office. Thus, during the 5 or so years of clinical trials (if that many years are used… and I might add, it used to take 10-12 years to clinically test a drug), the clock is ticking and potential profits are slipping away. Thus, companies want to minimize the time it takes to get a drug to market so that they can increase the number of years of premium pricing. Thus, the abuse of the fast track process, which is discussed as my third point. If the patent period were longer, we might see more time taken to test drugs before rushing them to market in order to preserve the number of days of highly profitable sales.

Competition: The drug companies compete with each other. They create "me too" solutions to problems. Thus, when side effects are identified, we often see class wide problems because multiple manufacturers have come out with drugs that do the same thing (only slightly differently). For example, with pain killers, we saw a number of Cox II inhibitors… Vioxx, Celebrex, Bextra. It was company after company coming out with a drug that was just like another companies "blockbuster." Thus, there was incentive for manufacturers train their sales reps to play down the side effects of their drug, while playing up the side effects of the competitors. Thus, there was incentive to keep the warnings to a minimum, since those warnings would be used by competitors’ sales reps as amunition when trying to sell their drug over another company’s. If as a class they would all warn, no one would be at a disadvantage, but competition being what it is, no one wants to be the first to issue such a warning for fear of losing market share.

Fast Track Abuse: The fast track process was pushed through Congress as a means of getting life saving treatments to patients without their having to wait for a more detailed clinical trial process. As a result of this change, approval periods were reduced from 10-12 years to about 5 years. In the process, the number of patients studied taking a drug and the length of those studies were shortened. When people ask me, what drugs should I take, I usually answer, "Wait until it is generic. At least then the missing years of clinical trials have been filled in." But the public is generally not aware of the shortened approval process and thinks that drugs all have gone through as much testing as they did in the past. How do drugs get fast tracked? All a manufacturer is required to show is a "unique benefit." That is not necessarily a "life-saving" benefit. Thus, nearly every drug has some "unique benefit." For example, Vioxx was approved because it was not as harsh on the stomach as Naproxin. Since Naproxin was already approved, and Vioxx was less likely to cause an ulcer, it got fast track approval. We all know how that story ended, with 10,000’s of cardiovascular events (heart attacks, strokes) in users of Vioxx, and the eventual withdrawal of the drug from the market? If fast tracking were reserved for truly life saving drugs, we would see a longer testing period for most drugs.

One might ask, why didn’t Merck simply warn of the risk? The answer might be that they did not have enough data from which to make that determination. But I think that the records produced in that litigation show that they knew long before the public was made aware. I think that the incentive for not warning was that Celebrex was safer in terms of a heart attack risk. So had Merck warned, I think it would have armed the Celebrex reps with amunition with which to have their drug prescribed by doctors instead of Vioxx.

What do you think are the root causes of dangerous drugs reaching the market? And what changes could we make to the way we approve drugs to address the problems I have mentioned above. Let me know if you agree, disagree and why, and perhaps together we can identify some positive steps to be taken to protect patient safety, while still allowing life savings drugs to reach the market with adequate warnings.

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