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Part 2: “MY SPIRIT IS BROKEN” Will the New Statin Guidelines Do More Harm Than Good?

The selling of a disease



Part 1: A $29-billion-dollar-a-year industry Part 2: The selling of a disease Part 3: The statinization of society When he was nearing the end of his career, Henry Gadsden, then-CEO of pharmaceutical giant Merck, gave an interview to Fortune magazine in which he said that he regretted that he couldn’t sell drugs to healthy people. He said his dream was to be able to peddle his company’s wares to everybody, like chewing gum giant Wrigley’s.
Mr. Gadsden’s dream soon began to come true. A few years earlier, Japanese biochemist Doctor Akira Endo surmised that a compound that could inhibit the production of cholesterol could be used to treat or prevent Cardiovascular Disease, CVD, then as now the number-one killer in the developed world. He also reasoned that since cholesterol was such an essential, life-sustaining substance, natural selection would favor microorganisms that could produce a poison to prevent its synthesis, enabling them to kill off competing microbes. He was right. The first statin, mevastatin, proved too toxic for human use, but senior officials at Merck got wind of Dr. Endo’s discovery, and the race was on. Lovastatin, isolated by Merck scientists from Aspergillus mold, was the first statin approved by the FDA for use in humans. It was first marketed to the public in 1987 under the trade name Mevacor, and soon was joined by another Merck product, simvastatin, sold as Zocor. Initially sales were lackluster, but two alterations to FDA regulations changed all that. The first was the decision by the FDA to allow drugs to be approved on the basis of so-called surrogate outcomes, of changes that are of no direct benefit to the patient (such as a reduction in cholesterol levels) but which are assumed to correlate with some kind of clinical benefit (such as a reduction in the rate of heart attack or death). The second was the decision by the FDA to permit direct-to-consumer advertising of prescription drugs, something almost no other nation in the developed world allows. The switch to surrogate outcomes as clinical endpoints had its roots in the AIDS crisis of the 1980’s. Young gay men were dying in droves. The average life expectancy for patients newly diagnosed with AIDS was two years or less – and under a year for those with AIDS-related pneumonia. No effective treatment existed for this disease. The FDA responded by rushing the antiretroviral drug AZT through the approval process in record time, but it wasn’t enough. Young gay men continued to die. On October 11, 1988, the AIDS Coalition to Unleash Power, or ACT-UP, staged a demonstration outside the FDA headquarters. Over 50 activists were arrested. Just one week later, the FDA promised to reduce the time required to the agency to approve new medicines. FDA Commissioner Frank Young declared “[F]or treatments for AIDS and AIDS-related complications and opportunistic infections, for example, as well as for other life-threatening conditions, we want to reduce that time to the bare minimum.”

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FDA enacted a variety of proposals to streamline the approval process

The commissioner was as good as his word. Over the next several years the FDA enacted a variety of proposals to streamline the approval process. Of particular interest were the “Accelerated Approval Regulations” announced by the FDA on 11 December 1992 which allowed the greenlighting of new drugs “when approval can be reliably based on evidence from adequate and well-controlled studies of the drug’s effect on a surrogate endpoint that reasonably suggests clinical benefit.” This was a sea change, one that went virtually unnoticed at the time. Doctors had gone from treating patients to treating number on a sheet of paper. Benjamin Goldacre, psychiatrist and author of Bad Pharma, writes, “At that time, HIV and AIDS had suddenly appeared out of nowhere, and young, previously healthy gay men were falling ill and dying in terrifying numbers, with no treatment available. We don’t care, they explained, if the drugs that are currently being researched for effectiveness might kill us: we want them because we’re dying anyway. “This legislation was intended for use on lifesaving drugs, in situations where there was no currently available medical treatment. Unfortunately, now that they have been in place for more than a decade, we can see that this is not how they have been used.”

FDA lifted key restrictions on direct-to-consumer advertising of prescription drugs

The other change came in 1997, when the FDA lifted key restrictions on direct-to-consumer advertising of prescription drugs. The FDA had already decided to allow direct-to-consumer advertising back in the 1980’s, with the stipulation that all the side effects on the warning label be included – a requirement which in practice limited such advertising to newspaper and magazine ads. This requirement was removed, and a sop was thrown to public safety by requiring advertisements to mention the most important side effects, which as anyone who ever watches television knows, the announcer often reads through at breakneck speed while viewers are distracted by images of figure skaters, or kindly old grandfathers taking their grandsons fishing. One memorable ad by Pfizer depicted a rower effortlessly gliding across a pristine lake, while Doctor Robert Jarvik, identified as “the inventor of the artificial heart,” declaimed in voice-over, “Ask your doctor if Lipitor is right for you.” For the record, Robert Jarvik does indeed hold a doctorate in medicine, but he is not a cardiologist, has never been licensed to practice medicine, and did not invent the artificial heart. Plus, according to longtime collaborator Doctor O.H. Frazier of the Texas Heart Institute, “He can’t row.” The part of the rower in the commercial was played by a body double. In countries which did not allow such advertising, drug companies could make an end run around the rules by selling the “disease” of high cholesterol, without mentioning their wares by name. An advertisement in French magazines and newspapers depicted a corpse in a morgue with a tag on its toe, along with the notice “Un simple dosage de son cholésterol aurait pu lui eviter ça.” (“A simple cholesterol test could help you avoid that.”) The ad was sponsored by Pfizer.

Drugmakers also sponsored “patients advocacy groups” to push their message

Drugmakers also sponsored “patients advocacy groups” to push their message. During the 2004 Academy Awards, the American public was introduced to one such group calling itself the “Boomer Coalition” by means of a 30-second commercial message titled “Falling Stars.” With Steppenwolf’s “Magic Carpet Ride” inexplicably blasting in the background, viewers were treated to images of James Coburn, John Ritter, and Mama Cass, while an announcer intoned “One by one, we’ve lost them to CVD, America’s number one killer. CVD is preventable. Let’s fight CVD. Join the Boomer Coalition!” The message was produced by the Dutch advertising agency Strawberry Frog, with funding provided by Pfizer. Other commercial messages, while never mentioning any Pfizer product by name, exhorted “CVD is our generation’s disease! Let’s fight it!” and urged viewers to “know your [cholesterol] numbers.” All this turned into a bonanza for the drug companies. Mevacor and Zocor became billion-dollar blockbusters, but both were soon eclipsed by Lipitor, which went on to become the highest-grossing drug of all time, with cumulative sales of over a hundred billion dollars. How is all that working out for the rest of us? List of Sources 1. Robertson, W. 1976. Merck strains to keep the pots aboiling. Fortune March 1 1976 pp. 134-139, 168, 170. 2. Endo, A. et al. 1976. ML-336A, ML-236B, and ML-236-C, new inhibitors of cholesterolgenesis produced by Pennicilium citrum. Journal of Antibiotics 29:1346-1348. 3. Endo, A. 2004. The origin of statins. Atherosclerosis Supplements 5:125-130. 4. Hoyert, D.L. 2012. 75 Years of Mortality in the United States, 1935–2010. NCHS Data Brief 88 March 2012 . Retrieved 26 December 2013. 5. Shah, S. 2006. The Body Hunters: Testing New Drugs on the World’s Poorest Patients. New Press. 6. Simons, J. 2003. The $10-billion pill hold the fries please: Lipitor, the cholesterol-lowering drug, has become the bestselling pharmaceutical in history. Here’s how Pfizer did it. Fortune January 20 2003 [url=http://money.cnn.com/magazines/fortune/fortune_archive/2003/01/20/335643/]http://money.cnn.com/magazines/fortune/fortune_archive/2003/01/20/335643/[/url]. Retrieved 29 March 2014. 7. Johnson, L.A. 2011. Against odds, Lipitor became world’s top seller. Associated Press December 28 2011. Retrieved 29 March 2014. 8. Cimons, M. 1987. US approves sale of AZT to AIDS patients. Los Angeles Times March 21 1987. 9. O’Reilly, B. 1990. The inside story of the AIDS drug. Fortune November 5 1990. Retrieved 29 March 2014. 10. Salholz, E. and P. McKillop 1988. Acting up to fight AIDS. Newsweek June 6 1988 p. 42. 11. Okie, S. 1988. AIDS coalition targets FDA for demonstration. Washington Post October 11 1988. 12. Young, F. 1988. Making drugs available for life-threatening diseases. Press release October 11 1988. . Retrieved 29 March 2014. 13. Clark, M. and M. Hager 1988. The drug-approval dilemma. Newsweek November 14 1988 p. 63. 14. FDA 1992. New drug, antibiotic, and biological drug product regulations; accelerated approval – FDA. Final rule. Federal Register 57:58942-58960. 15. Goldacre, B. 2013. Bad Pharma: How Medicine is Broken and How We Can Fix It. Fourth Estate. 16. Quick, J.D. et al. 2003. Ensuring ethical drug promotion: whose responsibility? Lancet 362:747. 17. White, E. 2004. Behind the Boomer Coalition: a heart message from Pfizer. Wall Street Journal March 24 2004. 18. Saul, S. 2008. Drug ads raise questions for heart pioneer. New York Times February 7 2008. 19. Saul, S. 2008. Pfizer to end Lipitor ads by Jarvik. New York Times February 26 2008.


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Patrick D Hahn -- Bio and Archives

Patrick D Hahn is the author of Prescription for Sorrow: Antidepressants, Suicide, and Violence (Samizdat Health Writer’s Cooperative) and Madness and Genetic Determinism: Is Mental Illness in Our Genes? (Palgrave MacMillan). Dr. Hahn is an Affiliate Professor of Biology at Loyola University Maryland.



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