Vol. 29 September 15, 2010 Big Pharma and $$$

“Doc, you say I’m too heavy?

You want me to exercise more and go on a diet?

Hey, I’m an American. Give me a pill!”

This is my short form of the more nuanced statement by Daniel Callahan noting that one secret of pharmaceutical companies’ success is to designate life’s problems as diseases and then aggressively market a treatment (usually a pill) for them. Obesity, ADHD, acne, aging, and “low” testosterone are just some of the examples. (1) One study counted up the number of people designated as “sick”, and therefore could benefit from a particular drug, in all the drug ads and arrived at the fantastic total of 1.5 billion sick people in the U.S, or five times our population. (2) A growing volume of “neuroenhancer” drugs to fight memory loss of dementia (Aricept) or improve your academic performance (Ritalin, Concerta, Adderall, Provigil) is an another example of life’s problems being given disease status. In 2007 more than 1.6 million people in U.S. used prescription stimulants (Ritalin, Adderall, Provigil) for “non-medical” purposes. On some college campuses 25% of students reported using them.  One rationale is that “cognitive enhancement through drugs is just like improving vision by wearing glasses.” (3)

Only the U.S. and New Zealand permit direct-to-consumer advertising by drug companies. In 2009 drug companies spent $4.8 Billion on direct consumer advertising alone. (4) Drug companies spend more on all forms of marketing than they do on research and development of new drugs. (Some say it is 50-50). The FDA has 57 employees to monitor over 75,000 drug advertisements per year, and that does NOT include  the internet with its Facebook banners, widgets, and now Twitter. Online ads are increasingly aimed at teenagers with musical themes and flashy, MTV-like editing; methods that drug companies refer to as “informational tactics”. The FDA did succeed in shutting down “Tupperware parties” for women during which certain IUD’s were promoted as a surer route to “carefree happiness”. Direct-to-consumer advertising works because 1) companies say they are “informing” the patient, 2) no doctor wishes to take time to discuss one of several effective drug options if the patient has already asked for one of them, and 3) “patient-centered care” has become the new Holy Grail of medical care quality.

FDA regulations require that a new drug has to be compared only to a placebo (no drug) in order to be approved. No proof of superiority over existing drugs is required. This has spawned many “me too” drugs which may differ in small biochemical and clinical ways from an existing drug whose patent protection is about to expire. Nexium, the purple pill antacid, is the classic example of this as it differs only slightly in chemical orientation (“racemic” is the chemical term)  from Prilosec that was about to have its patent protection expire. The health care reform law under its section of Comparative Effectiveness Research (CER) will require new drugs to show some advantage over existing ones through direct comparison studies.

In 2004 $73 million was spent by the pharmaceutical industry lobbying at the federal level. Another $49 million was spent on the state level and about $5 million was spent just lobbying a single agency, the FDA. In just the first quarter of 2009 $66 million was spent on lobbying at the federal level. (5) The drug company organization, PhRMA (Pharmaceutical Research an Manufacturers of America), has successfully blocked the importation of drugs from Canada and Medicare’s ability to negotiate drug prices with manufacturers; a sizable cost savings to many state’s Medicaid programs.

If there is any doubt that big money is involved, just take a look at Genzyme. In one week the same newspaper reported that Genzyme was laying off 1,000 workers (10% of its total) to cut costs in order “to stay competitive” AND another drug company, Sanofi-Aventis SA, had offered to buy Genzyme for $18 Billion. Much of Genzymes fortunes have been made on two drugs for two different rare diseases, Fabry and Gaucher diseases. What the prospective buyer sees are three new drugs that Genzyme has “in the pipeline” for other two other uncommon diseases. They may bring in new revenue of $1 Billion per year.(6)  Such drugs for rare diseases are called “orphan drugs” and have their own “special economics.

Next Post: “Fake Pharma and an orphan drug gone wild, Botox.”

References:
1.Taming the Beloved Beast, How Medical Technology Costs are Destroying Our Health Care System, Daniel Callahan,, 2009
2. Critical Condition: How Health Care in America Became Big Business – and Bad Medicine, Bartlett and Steele, 2004
3. Brain Gain: The Underworld of Neuroenhancers, Margaret Talbot, New Yorker Magazine, April 27, 2009
4. Outgunned FDA, Rueters, September 2010
5. Center for Responsive Politics, http://www.opensecrets.org
6. Boston Globe Sept. 11 and 13, 2010

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