Dr. Clif Cleaveland, Commentary

Behind the headlines of some “miracle drugs” lurks a disturbing story of marketing excesses on the part of America’s pharmaceutical industry.

This story is detailed by Melody Petersen, a former reporter for the New York Times, in her newly released book, “Our Daily Meds” (Farrar, Straus, Giroux 2008). Anyone who takes, prescribes, or regulates drugs should read this important book.

In the first half of the 20th century, American drug makers scored a succession of triumphs through research and manufacture of such drugs as Streptomycin, one of the first agents effective against tuberculosis, and vaccines such as those engineered to prevent polio. The nation revered its discoverers of new weapons against disease.

While drug research and development became increasingly expensive, manufacturers could reap huge profits from individual drugs. Drug makers were granted patents that protected their discoveries and profits for years.

Concerned by rising profits and promotional practices of the drug companies, U.S. Sen. Estes Kefauver, of Tennessee, convened a series of hearings in the early 1960s to investigate the drug industry. After the hearings began, a pharmaceutical disaster unfolded.

Thalidomide, a drug marketed as a sedative, was identified as the cause of severe deformities in newborns whose mothers had taken the drug. In response to this tragedy, Congress unanimously passed in October 1962 the Kefauver-Harris bill which gave the Food and Drug

Administration authority to regulate promotional practices, but not the

profits, of the drug industry.

Subsequent decades have seen the steady erosion of these restrictions as competition has intensified among drug makers. As costs for developing new medications have risen, companies have increasingly devoted their energies to the manufacture of “me-too” drugs, compounds that are chemically quite similar to drugs already on the market.

Intense marketing becomes necessary if the new agents are to succeed in the marketplace. Companies have sought to expand the clinical uses of established drugs. Marketing practices have increasingly moved into ethically shaky territory.

* New drugs are almost always compared against placebos rather than against similar drugs already in the marketplace.

* Clinical trials are increasingly run by marketing firms who recruit and board subjects in private, research facilities.

* Papers supporting new drugs are often written by marketing firms who recruit scientists to submit the work as their own.

* Negative studies have until recently been suppressed.

* Writers of scientific papers and supporting editorials receive pay from drug companies in the form of consultancies and lecturing fees.

* Physicians, whose prescribing habits determine the success of new drugs, are won over by dinners, gifts, all-expense-paid trips to resorts for seminars on a new drug, and speaking fees.

* Promotion of “off-label” use of medications has generated large profits for drug companies.

* Direct-to-consumer advertising of drugs never mentions costs or alternative therapy and glosses over side effects.

n Because medical journals depend heavily upon income from drug

advertisements, they dare not criticize these practices. Physician

organizations are likewise dependent upon grants from drug companies and revenues from their displays for support of scientific meetings. This limits dialog about promotional practices.

* The U.S. Supreme Court is scheduled to rule in its next term on the doctrine of “pre-emption” as it applies to lawsuits against drug makers. Under this principle, a manufacturer would not be liable for injuries resulting from use of a drug once that drug had been approved by the FDA. In its current under-funded and under-manned status, the FDA lacks the resources to determine if medications are safe over time. Vioxx, Rezulin, and Propulsid are recent examples of once popular prescription drugs that have been withdrawn because of adverse reactions that became apparent only after years of use.

Ms. Petersen’s book raises disturbing questions about the integrity and the validity of research that backs drug claims. In effect, seriously flawed research could block lawsuits filed by persons injured by medications.

Consideration of the doctrine of pre-emption should be postponed until research and clinical trials of prescription drugs can be pursued independently, with integrity, and with the close oversight of a fully functioning FDA.

Contact Clif Cleaveland at cleaveland1000@comcast.net.