FDA - We Are Your Clients Not The Drug Companies

FDA - We Are Your Clients Not The Drug Companies


Jack Benny was a beloved comedian and is credited by many for creating the funniest moment in radio. Jack Benny’s character on his radio show was very miserly and would never spend a dime unless forced. Benny was walking home one night because he was too cheap to take a cab and was accosted by a man who pointed a gun at him and said, “Your money or your life?” There was a long pause and then the thief said, “Come on, I am serious, your money or your life?” There was another pause and Benny answered impatiently, “I’m thinking about it.” I relate this story because this is similar to a question that is asked in the corporate headquarters of most of the major drug companies when they are considering a new drug.

Their question is, “Their money or their lives?” The answer—the money. Drug companies continue to prove to us that they don’t care about the harm their products do to people who use their drugs, but only about the profits the drugs make. Do they want to kill people? No, that is bad for business and eventually will cost them money in paying off lawsuits or, if they kill or harm too many, they may even have to withdraw the drug from the market. Ideally for these despicable people, if their drug does cause deaths they want it to take a long time so that they can make as much profit as possible before it is discovered.

On the other hand, one of their biggest fears is to spend an enormous amount of money testing a new drug and finding out that their new product actually cures a disease. For them, they would prefer that their drugs simply help alleviate the symptoms and must be taken for the rest of someone's life. This way their profits will increase. Of course, treating symptoms is not treating the real source of the problem and they know that the underlying physiological condition will just worsen, but that is really not their problem—making money is their problem.

They also know that because their drugs are not really curing anything, they will likely cause side effects that Radio Medicine doctors will treat by prescribing more prescription drugs. This will result in more profits. It all makes sense to these jerks. So you see if they confront the question, “Their money or their lives?” the answer is simple for these amoral people—“their money.”

DEFINITION OF SAFE Most American's believe that the primary purpose of the FDA is to ensure that drugs are safe. Most of us think “safe” means that something is not harmful. If someone tells us that it is safe to drink the water, we assume that means that we won’t have any ill effects from drinking the water. Here is the way safe is defined in the Merriam Webster On-Line dictionary:

1. free from harm or risk

2. secure from threat of danger, harm, or loss

However, we know of drugs that have killed people or created many very serious health problems. These drugs are definitely not “safe.” The mystery is resolved when we understand the FDA definition of “safe.”Janet Woodcock, M.D., is the director of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER), the part of the FDA that is responsible for assuring us that drugs are “safe.” According to Dr. Woodcock, "safe" means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. "Safe does not mean harmless." (Why Drugs Get Pulled off the Market, by Michelle Meadows; FDA Consumer, Vol.36, January-February 2002) If the drug companies can convince the FDA that a drug can create more good than harm, it is considered safe and the FDA will approve it—even if there is a good chance that many will be harmed.


Readers of this newsletter know that the FDA requires drugs to go through clinical trials where the drug is evaluated. In the final clinical trial, people are selected who have the disease or problem for which the drug is designed to treat. Commonly, part of these people are given the new drug and another group are given a placebo (sugar pill). Neither group is supposed to know if they are taking the drug or the placebo. The FDA will normally approve a drug if it can be shown a clinical trial where the drug was even a little better than the placebo. Our readers know that the drug companies also will keep conducting clinical trials until they finally get a clinical trial where there seems to be some improvement compared to someone just being given a placebo. This is particularly true for many of the psychotropic drugs. As researchers are discovering, a number of clinical trials were required before one could be found that showed these dangerous and largely ineffective drugs were more effective than a placebo. In fact, when researchers look at all the clinical trials, they find that the evidence is that these drugs are not more effective than a placebo.

“Me Too” Drugs


In the United States, a drug company can obtain a patent on a new drug that runs 20 years from the date it was “invented.” Since it may take six to eight years to get FDA approval, this means that the drug company's monopoly on the drug generally runs from 12 to 14 years. During this time, no one else can market the exact same drug and compete with the drug company. Because it is more important that the drug company make money than if the drugs can be available to people, the prices of these new drugs are set as high as possible. Once the patent has expired, then other companies can make a copy of the drug and sell it under a different name. This is called a generic drug—a copy of a drug that formerly had patent protection. Generic drugs are obviously much less expensive because many companies can make them. Drug companies are always looking to get a new drug that they can patent and promote.


Doing research to develop new drugs that might be an improvement over existing drugs or, heaven forbid, might actually cure a disease, is the most risky type of research. Again, because profits are the sole purpose of the drug companies, they often try to develop drugs that are similar to other drugs on the market. This is generally much less risky because they can learn from the patents of the other drugs and make their drug just enough different to qualify for a patent. These are called “me too” drugs--drugs that are designed to treat illnesses for which there are already drugs on the market. Once approved by the FDA, the drug company marketing machine will promote their new drug as the “latest and greatest.” They try to convince the public and the medical community that failing to prescribe their new drug is actually not doing the best thing for the patient.

There is almost always no evidence how the new drug compares to existing drugs or, horrors, to those awful and much cheaper generic drugs. REAL REFORM An interesting proposal was discussed in an article in the August 12, 2009 edition of the New England Journal of Medicine titled, “New, but Not Improved? Incorporating Comparative-Effectiveness Information into FDA Labeling”, written by Randall S. Stafford, M.D., Ph.D., Todd H. Wagner, Ph.D., and Philip W. Lavori, Ph.D. The authors discuss what they consider a major failing of the FDA—not requiring a company wanting to release a new drug or medical device to show the new product’s comparative effectiveness when compared to existing products already on the market. The authors state, “If the FDA label were required to indicate what is and is not known about a product’s superiority to other treatments, then clinicians, patients, and payers would be less willing to pay more for a new treatment without proof that it improved health outcomes.

In addition, manufacturers would have an incentive to conduct much-needed active-comparator superiority trials.” (Active-comparator trials are where a drug is compared to another drug or drugs used for the same purpose.) While the FDA does require evidence that some drugs or treatments, like for cancer and AIDS, must show that they are superior to existing products, most new products are only required to show that they are superior to placebo.

The authors point out that, “Yet placebo-controlled trials that are not supplemented by active-comparator trials leave clinicians, patients, and payers in the dark, providing no guidance on a new product’s advantages or disadvantages relative to existing products.” Doing active-comparator testing against the other drugs that are used for the same treatment is more risky for the drug company. If they are forced to show that there is real evidence to support their marketing hype, this could be a problem. You see, in many cases the “me-too” drugs have not proven more effective than drugs already on the market—many of them generic drugs.

The authors believe that, “In the absence of comparative data, drug and device labels should include a statement indicating that there is no evidence of the product’s superiority to other products. For example, the label or advertising text for a new calcium-channel blocker might state, 'Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class.'” The article concludes, “A few products will be breakthroughs that improve health outcomes; most will offer little, if any, advantage over existing treatments. At the time of FDA approval, it is rarely clear whether a new drug or device falls into the first category or the second. With the expanded labeling requirement we propose, stakeholders would have explicit information about proven comparative benefits or the lack thereof — and drug and device manufacturers would have an incentive to design more informative clinical trials.”


One of the problems at the FDA is the fact that there is no real prohibition against an FDA official who is regulating a drug company working for that drug company a few months later. This creates enormous clout for the drug companies. The message is clear—treat me right and maybe I will offer you a lucrative job. Don’t treat me or other drug companies right and you won’t get that lucrative job. There are FDA employees who tell the drug companies to “stuff it” and see that their job is really protecting the public, but it is still a great temptation for anyone. If President Obama and Congress are really interested in protecting our health, they should:

  • Ensure that the FDA really sees the people and not the drug companies as their clients.
  • Ensure that there is a required period, like five years, before a person can leave the FDA and go to work for a company that they were regulating.
  • Ensure that the drug companies are not allowed to obtain approval of these expensive “me-too” drugs unless they show that they are demonstrably more effective than existing drugs or much less expensive generics.
  • Understand that the only thing that these drug companies really care about is to get more profits—regardless of the cost to the health of the people.
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