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Birth of a drug monopoly

Updated on January 9, 2017

It starts with a rash of television advertisements describing a health problem no one ever heard of, such as fibromyalgia, hepatitis C, restless leg syndrome, shingles, and the latest, PBA (pseudobulbar affect, a condition that causes episodes of uncontrolled crying or laughing which is inappropriate or disproportionate in intensity). Viewers start their usual self-diagnosis and determine that they are suffering from the phenomenon.

After three or four months, the ads direct viewers to an Internet site which explains the condition, its symptoms, its causes, and the history of attempts to treat it. Three or four months later, ads start appearing that there is in fact a drug to treat the condition, and all those self-diagnosed sufferers skedaddle to their physicians not only with a believable list of symptoms, but a ready-made cure to be prescribed. Doctors, flooded with medical information on a daily basis, might do a cursory attempt at research, then prescribe the drug. Physician Assistants, whose better-than-nurse training and pay makes their sole profession the prescribing of drugs, do not even do the research.

This is an example of creating demand so that supplies can be sold. Pharmaceutical companies cannot always come up with a newer or better treatment for cancer, arthritis or heart disease. So they also tackle lesser known problems. The research, clinical trials and submission to the FDA incur tremendous costs. The reward is a ten year patent on the drug. But that won’t pay off until the drug is heard about and used. Hence the campaign to create the demand. If the patients listened carefully to the FCC-required listing of side effects and warnings, of course, this plan could backfire. But most prospective patients are closer to Munchausen than Mr. Spock.

When the patent is ready to expire, the pharmaceutical company comes up with a new method of drug delivery. If the drug originally came out as a tablet/pill, the new method could be a time-released capsule, a patch, or injection. Research, trials and submission go much faster than the original, and the company gets a new ten year patent. This can go on, changing the delivery method, for decades. By the time the company runs out of patents, the drug has finally made a profit.

Is this legitimate? Yes. The patent is the government’s method of encouraging pharmaceutical research, by guaranteeing a return on investment. Is it ethical? Well … let’s say it is practical. Without the patents and the ad campaigns, pharmaceutical companies could not afford the research at all.

Any medical student or nursing student will admit that on learning the symptoms of a disease, there is a human tendency to suspect one is suffering from that disease. And the ordinary person in the street is often relieved to discover a reason for some odd little symptom he or she has noticed in the past. Even doctors, hoping to have their patients feel 100%, will become curious.

A good example is hepatitis C. A check with the CDC site suggests that anyone who is a “baby boomer” should be tested. Since this is the largest purchasing group in America, such testing would bring in a good amount of income, especially if tests are positive. Hep C has a dormant form which doesn’t display symptoms for decades, so this older population is most at risk. Hep C is not recognized in standard blood tests, so anyone who was an intravenous drug user or who had a transfusion before 1992 (at which point blood supplies started testing for Hep C) is at risk. This narrows down the number of prospective patients but is not included in the advertising.

By optigan13 - Based on File:Sources of Infection for Persons with Hepatitis C (CDC) US.png which was created from CDC figures (http://www.cdc.gov/ncidod/diseases/hepatitis/c/plan/HCV_infection.htm).
By optigan13 - Based on File:Sources of Infection for Persons with Hepatitis C (CDC) US.png which was created from CDC figures (http://www.cdc.gov/ncidod/diseases/hepatitis/c/plan/HCV_infection.htm).

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