Automation & Control / QRM Process

Therapeutic Dose: When the Truth Is Found to Be Lies [1]

Expecting the drug industry to police itself is unrealistic; granting FDA more power and funding to supervise clinical trials may be the answer

By Emil W. Ciurczak, Contributing Editor

There is a tendency to think that the pharmaceutical world is populated with a different breed of human. After all, we make a product that alleviates human suffering, saves lives, or at least takes away symptoms.

However, it is still just a product. People in the pharmaceutical industry demonstrate all the frailties seen in any other group of people: they have big dreams, can be greedy, they fight, they can be jealous and make mistakes in judgment.

Consider the recent, disturbing news about Merck’s and Schering-Plough’s Zetia (ezetimbe, often prescribed with Zocor) and Vytorin, a ready-made mixture of Zetia and Zocor.

A Merck- and Schering-Plough-funded study of Zetia completed in 2006 showed that the compound provided no medical benefit to users (millions of users, thanks to the power of television). In fact, when Zetia was added to Zocor (a statin), its use caused human arteries to clog twice as fast as they would have with Zocor alone.

This study was completed in April 2006! But the companies continued to advertise on TV and radio (and in doctors’ offices). The report was only released this year because of pressure from physicians.

We all recognize the name Merck, especially if, like me, you suffer from arthritis. Does the name Vioxx also ring a bell? And, who can forget the “safer” substitute for Vioxx: Celebrex? Both were linked to heart problems after extensive, time-consuming studies.

There seems to be a rash of drugs being linked to more problems than they solve. So, what is the truth about these “new and improved” [2] products? “Truth! You want the truth? You can’t handle the truth.” [3] The truth is quite complex, but for the sake of argument, let’s say that companies want to make money.

One of the arguments for the application of PAT/QbD is that these initiatives can speed up product development and lower costs of production so that the short time of a product’s patent protection is more fruitful. At present, the profit realized by a proprietary drug is maximized by rapid approval and heavy marketing, much as is done with a new car model. But, as my wife says, “I never buy a first or second model-year automobile.” She likes to wait a few years and see if there are any problems or recalls.

There are many, many pressures on FDA to release a new drug to market fast: patient support groups, doctors, and now PhRMA, the lobby for the proprietary drug manufacturers. In addition, the FDA has been tasked with policing the world for proper production practices of products bound for U.S. soil.

In a recent internal report, FDA was deemed to be understaffed and under-funded to a critical degree. Each year, a growing number of generic drug manufacturers and foreign drug makers must all come under FDA scrutiny.

FDA, while doing a yeoman’s job, cannot see every scrap of data (especially when it is kept in a safe in the fourth sub-basement of a company) on every new drug. Again, my partner-in-life had an interesting suggestion: Why not let FDA (with funding from pharmaceutical companies) conduct the clinical trials? Do I already hear the wailing and gnashing of teeth? What’s wrong with letting the companies police themselves?

Well, do we ask motorists to turn themselves in when speeding? Do we ask taxpayers to be on the honor system and dismiss the IRS? What makes us believe that there is no wrongdoing or dishonesty in the pharmaceutical industry, peopled as it is (like every industry) with flawed individuals?

Recently, a number of executives were fined heavily for lying about the risk of Oxycontin. An executive at Schering-Plough was reported to have dumped millions of dollars of company stock just prior to the release of the long-delayed Vytorin report. Never forget the old Barr decision. Many of the “insurmountable opportunities” in drug-patient interactions stem directly from the honor system used in clinical trials. If a lab tech were to throw away a result and retest until something passed, there would be a major 483 issued. How different is cherry picking which clinical result a company chooses to show to FDA?

I guess my wife is right, as usual. How about giving the money and power to the FDA to oversee clinical trials? Couldn’t hurt that much, could it? Maybe waiting for a drug to go generic and seeing what problems were encountered is a better way to prescribe drugs. Then, at least, we would have several years of data with which to judge a drug’s safety as well as its efficacy.

References
  1. “Somebody to Love,” Jefferson Airplane, 1967
  2. Actually, if something is new, it never existed and, therefore, cannot have been improved; “improved” implies changing an existing product.
  3. Jack Nicholson, “A Few Good Men.”

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