There was a time when Americans could feel protected by the Federal Drug Administration (FDA). It was a time when only 3-4% of all new drugs were first released in the United States. Eighteen-years later an estimated two-thirds of all new drugs are first being approved in the U.S. What is important to understand is that the FDA and pharmaceutical companies are aware that adverse reactions to a new drug will not become fully evident until after the drug is approved for sale by the FDA.

What makes a bad situation worse is the way the FDA now fast-tracks drugs. They would like the public to think that the reason for fast-tracking is because of public demand to make ‘cures’ available quickly. One has to question this rationalization with the revolving door between the FDA and pharmaceutical companies. It is not unusual for someone working for the FDA to approve drug XYZ and once approved this person soon goes to work for the same pharmaceutical company that manufactures the same XYZ drug. Even those physicians who sit on panels to approve new drugs often receive benefits, in one form or another, from the pharmaceutical company they are suppose to be overseeing.

Dr. Strand, takes us along a journey that explains how drugs are approved today and contrasts today’s policy with procedures before the radical FDA policy changes of 1990. Some questions you might want answered the next time your physician prescribes a medication is if they accept any gifts or money as a speaker from the pharmaceutical company that manufactures the drug. Sure, he or she may appear offended, but in all fairness you are entitled to know if there is a possibility the decision to prescribe that drug is being influenced in any way.

Another question to ask the physician, and one you can follow-up on your own, is how long the drug has been on the market. If it is only a few years, you might want to read Dr. Strand’s, Death by Prescription, before accepting a new drug as the best course of treatment. Otherwise, you may be a Guinea pig instead of just a patient.

When Rost brought an illegal practice to his employer’s attention he thought he was doing a good thing. Little did he suspect that his efforts to help his employer avoid running afoul of Federal law was placing his career in something akin to a Chinese finger trap.

The problem began when as vice president of marketing for Pharmacia he was responsible for both U.S. and global marketing of a human growth hormone named Genotropin. What he first suspected, then later established, was that Pharmacia’s sales reps were in the practice of encouraging physicians to write ‘off-label’ prescriptions for Genotropin to be used for life-longevity. In the U.S., as well as in most of the world, it is a Federal offense for a pharmaceutical company to encourage physicians to write prescriptions for purposes other than the use for which they are approved. In the U.S. it is the Federal Drug Administration (FDA) which approves a drugs use.

What Rost uncovered were incentive programs to encourage the sales of Genotopin for life-longevity purposes. In addition, he also discovered that some countries used practices that made the sales of the drug appear higher than they should have been—also a Federal violation. The result was that the annual sales of Genotopin fraudulently exceeded $600 million annually.

When Pfizer purchased Pharmacia they had no idea that the sales for Genotopin were inflated and the actual sales were less than what the accounting books showed. Rost knew that Pfizer overpaid for Pharmacia. He knew that the illegal practices that he had uncovered were partly to blame for the inflated sales figures. Rost wanted Pfizer to know what he knew so they would be able to correct the situation and head off any Federal action that could be brought against them.

The harder he tried to convey to Pfizer the illegal practices that he had uncovered the tighter the metaphorical Chinese finger trap tightened around his career. Clearly, it appeared that Pfizer was not eager to act immediately on what Rost was telling them. They especially did not want their investors to hear anything that sounded like fraud or possible Federal violations.

You would think that Pfizer might appreciate knowing about fraud and Federal violations. Instead, what resulted is that Pfizer distanced themselves as far from Rost as possible. They could not fire him though. When there is an allegation that results in an investigation the company is required to retain the whistle blower. That did not keep Pfizer from doing everything possible to keep tabs Rost’s activities. His phone calls were screened, his phone was tapped, and his emails watched.

What you do not discover until the end of the book is that Rost risked a $600,000 a year job to bring the illegal practices to light. At first he was more interested in protecting his employer from Federal action, but when Pfizer took an offensive position forcing Rost to go outside the company for protection, he had no choice but to retain a lawyer and to make his allegations public.

Probably the most disturbing chapter in the book is chapter 19, How Corrupt Is the Drug Industry? The chapter deals with the exorbitant fines paid by the pharmaceuticals in just the past few years. For example, Pfizer was fined $430 million for encouraging off-label prescriptions of Neurontin. Considering Pfizer has sales that exceeded $2 billion dollars for Neurontin the fine makes little sense from a strict profit-and-loss position. The list of pharmaceutical companies that have paid exorbitant fines is too extensive to even begin to list here, but a quick Internet search results in a massive list of drug companies.

After reading Selling Sickness, by Ray Mounihan and Alan Cassels, I had to wonder if one of my 6th grade classmates went into marketing for the pharmaceutical industry.

What we did in the 6th grade as a practical joke on one of our classmates is basically what the drug companies are doing to us, as a population, in order to sell more drugs. For example, the National Institutes of Health’s guidelines for cholesterol in the 1990′s warranted treatment for 13 million Americans. By revising the guidelines in 2001, the number of Americans who warranted treatment jumped to 36 million. In 2004 the guidelines were readjusted yet again with the result of 40 million Americans needing to be treated for cholesterol.

In less than 5-years, the number of Americans in need of treatment for cholesterol jumped from 13 million to 40 million. That is a lot of new prescriptions that had to be written for medication to control cholesterol levels. If you are thinking that the pharmaceutical companies stand to make a huge profit, you would be right,—and therein is the motive for the guideline revisions.

Taking the profit motive out of the picture for a moment, what can be the harm? So what if someone takes medication for better health? What can be the harm? In short—side effects. There are some people who need the medication because of excessively high cholesterol; that cannot be argued. What can be argued is whether an otherwise healthy person needs medication to treat something for ‘better health’ when the side effects of the medication will do more harm than good.

Maounihan and Cassels paint a disturbing picture of how guidelines are revised to create a larger customer pool for their pharmaceuticals. How the FDA has turned from a consumer watch dog to an arthritic hound.

The authors also expose the pharmaceutical companies’ tactic of hiring celebrities to go on talk shows to bring attention to a particular health problem like ADD. What the public never learns is that the celebrity is well paid by the pharmaceutical company to bring this ‘awareness’ to the public’s attention. When challenged, the pharmaceutical companies can disclaim that the celebrity was hired to sell their drug(s). After all, the celebrity is there only to bring public attention to the ‘disease’. This raises another issue that the authors discuss in some detail; how many viewers are going to self diagnose and request the drug from their physician?

After reading the book, you may find yourself challenging your doctor’s diagnosis, because by the standards of only a decade ago you would be considered a ‘healthy specimen’.

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