Have a Heart

Have you heard the flak that began early this year over the now infamous ad for the cholesterol drug Lipitor? In the world of marketing nothing beats celebrity.

In the view of Pfizer, apparently, nothing beats a celebrity doctor to convince folks that the science behind a medicine is sound. Thus began the 2-year ad campaign in 2006 in which the famous inventor Dr. Robert Jarvik touts what became the world’s best selling medication, Lipitor, with billions in sales. Except that, even though Robert Jarvik got his M.D. and created the artificial heart, he is not licensed to practice medicine. (He tells his side of the story here.)

File this under: “I’m not a practicing physician, I just play one on TV”? If only.

Following Pfizer, we now have more pharmaceutical shenanigans.

Just a couple of weeks after the House of Representatives began to investigate Jarvikgate, a study named “Enhance” was released disclosing that the popular heart drug Vytorin was not all it was cracked up to be. Vytorin had been marketed as being more effective at preventing cardiovascular disease than statins – drugs which block bad LDL cholesterol absorption and thus artery clogs – because it contains a statin, Merck’s Zocor, plus a drug that supposedly prevents the accumulation of plaque on artery walls, Schering-Plough’s Zetia.

The Enhance study found, however, that Vytorin is no more effective than generic statins that cost 1/3 the price. The added benefit of Zetia is no benefit at all, just a higher price tag.

Which has led Congress to question why the drug’s marketers, Merck and Schering-Plough, blocked the release of the study for nearly 2 years and at one point considered retro-actively changing its supposed goal. It took investigative action, by Congress, to make both of these findings public.

Shortly thereafter, a key advocacy organization for heart health was implicated:

• The American Heart Association, whose mission is to reduce heart disease and stroke, issued a statement in support of Vytorin despite the Enhance study’s findings.

! The statement failed to note that the AHA receives nearly $2 million a year from Merck/Shering-Plough Pharmaceuticals.

The medical community was initially split over the study’s findings.

• The American College of Cardiology, an organization of doctors whose mission is to advocate for quality cardiovascular care and to influence health care policy, issued a statement in support of Vytorin in January after the preliminary release of the study results.
• After further analysis – and a letter from the House of Representatives requesting information on the organization’s funding from drug companies – the ACC announced March 31 at their annual meeting that doctors should stop prescribing Vytorin and go back to statins. (Which hasn’t shaken the largest U.S. insurer, United Health Group, from their confidence in the drug.)

Which begs the question of why the drug was ever approved in the first place.

Stay tuned to What If for an analysis of the FDA.

And stay tuned for Crestor, a big Vytorin competitor made by AstraZeneca, to soon hit the market. The company ended their study of the drug early after citing clear success – perhaps in order to swoop in on Vytorin’s declining market share?