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Spring 2006

   Generation Rx
    How Prescription Drugs Are Altering American Lives, Minds and Bodies
    By Greg Critser
    Houghton Mifflin Company, New York, 2005: 308 pp. (with notes and index)

   This topical book details the modern, often sordid, history of the pharmaceutical industry (big pharma).
   A lot of insider stuff is chronicled and the battles with the FDA and Congress, generic drug companies,
   physicians and consumer advocate groups are all described in some detail. Landmarks such as the
   Kefauver hearings of the 1960s, the Hatch-Waxman act, conflicts with a variety of FDA commissioners,
   direct to consumer advertising (DTC), off-label prescribing right up to the recent Medicare part D drug
   plan are included.

   Many of the drugs cited are common household names: Seldane, the first major drug promoted directly
   via DTC and later recalled; the marketing campaigns for Paxil and Zoloft in an attempt to compete with
   Prozac; the invention of a new name for heartburn (GERD) to promote Zantac and assist Glaxo's war on
   Tagamet; the marketing of Wellbutrin as a smoking deterrent when doctors were not prescribing it much
   for depression, the Lotronex story, initially approved for irritable bowel syndrome and later recalled for
   severe gastrointestinal side effects, only to be re-released with major use restrictions. The story of the
   advertising for these and other drugs offers an inside and often fascinating view of how the drug
   companies have allowed marketing to dictate science.

   One of the best features of this account are the personal glimpses of the pharmaceutical company
   CEOs and other executives. For example, Jan Leschly, former Danish tennis star who morphed into
   executive spots at Squibb and later SmithKline Beecham, only to be phased out by a takeover despite
   some brilliant career moves. Or Tony Wild, who turned Parke Davis around with insightful marketing
   strategy for Neurontin and later Lipitor and the birth control pill Loestrin. His targeting of the doctors
   most likely to prescribe his drugs and more importantly to convince others to do so practically defines
   the art of data mining. Or Bill Steere at Phizer who purchased Parke Davis, revolutionized marketing,
   and turned his company into the largest pharmaceutical house in the world. Thus Lipitor became the
   bestselling statin drug not by preventing heart attacks but largely by stressing cholesterol numbers in
   its ads; and Viagra by inventing erectile dysfunction, a "new" disease that used to be called impotence,
   hawked by TV ads featuring athletes and Bob Dole; or Rezulin for diabetes type 2, emphasizing the
   reduction in the need for multiple insulin injections, outweighing possible liver toxicity.

   Drug approval by the FDA was generally speeded up despite calls for caution by some medical and
   consumer groups. Mostly this was a result of the new laws allowing the drug companies to pay a fee
   to the agency for rapid review and by the "expedited review" for new drugs that were intended for
   conditions without current drugs already on the market. Of course politics always plays it's role as in
   the current Plan B "morning after pill" to over-the-counter status controversy. Still, disease activist
   groupsfor AIDS and breast and prostate cancer and the anti-smoking campaign have speeded up the
   new drug process by lobbying Congress and laws allowing companies to utilize research and drug
   development by government scientists (NIH, CDC, etc.). The latter may alleviate the relative lack of
   new drugs emerging from the companies' own R&D divisions over the past few years.

   The book is fairly short, easy to read and unsparing in its views; yet this is no diatribe. The author,
   a California based journalist and medical writer, devotes a chapter to reviewing some of pharma's
   newer marketing techniques. Many of these are based on data mining doctor and pharmacy records
   and utilizing this data to target certain physicians and patient groups for intense advertising of a drug's
   merits. Similar techniques are used to recruit volunteers to participate in new drug clinical trials, usually
   speeding up the process of getting a new drug to market. Pre-approval branding of a new drug also
   allows advertising before it reaches the market and begins earning money for the company.         

   Mr. Critser divides up Generation Rx into three groups: children (and some adults) with ADD (ADHD)
   with their Ritalin and other amphetamine-like drugs; middle-agers and their remedies for chronic
   diseases such as medicines for high cholesterol, hypertension, osteoporosis and diabetes; and the
   elderly with drugs to keep them youthful such as Viagra, Botox or hormone therapy (HCG, estrogen or
   anabolic steroids). Each group is subject to a sophisticated marketing campaign by the drug companies,
   letting the folk know about disorders and drugs they never knew about.

   The author devotes a section of the book to drug toxicity and the eternal battle of the consumer
   groups and the scientific community with the FDA. He points out that genetic-influenced drug
   metabolism is critical to safety and individuals vary considerably in their ability to metabolize
   pharmaceuticals. But genetic screening, even when possible, is impractical and expensive, a least
   for now. The story of David Graham, the FDA drug safety officer who battled his FDA superiors over
   Rezulin for diabetes and Arava for arthritis, has been made public through Congressional hearings well
   covered by the media. Unfortunately, even the most effective and useful prescription drugs may
   assault the liver, heart, lungs or kidneys of some individuals. Figuring the cost/benefit ratio requires
   long hours of studying post-marketing safety data by a staff that is undermanned and under funded.
   Often the data are ambiguous or incomplete and the conclusions are vilified by pharmaceutical
   executives if their product is questioned.

   Still, Critser may be a bit overzealous in his critique of prescription drugs. They are largely responsible
   for the increased average lifespan of the past 30 years and the rejuvenation of the elderly such that 75
   or 80 is now what 65 used to be. True, there are many unfortunate side effects and some drugs should
   never have been allowed on the market, but overall, the picture is brighter than the author believes. One
   must be realistic, diet and exercise or refraining from smoking or alcohol or psychotherapy or any forms
   of healthy lifestyle choices will never outweigh the ease and convenience of popping a pill. Yes, there
   are numerous changes that could improve things such as better regulation of the drug firms by the FDA
   and larger and more complete clinical trials not funded by the industry and improved post-marketing
   safety analysis of drugs that do make it to drugstore shelves. Like so much else in our capitalistic society,
   there may always be a tension between the marketplace and the desire for the safest possible effective
   drugs.
                            
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