Taxpayer Money Squandered for Cholesterol Drug Vytorin
"The American Heart Association is cautioning patients if they stop taking Vytorin abruptly, Schering-Plough and Merck's stock price will fall."
That's how a cartoon showing a news anchor would read after revelations that the American Heart Association -- which receives nearly $2 million a year from Vytorin makers Merck and Schering-Plough -- and the American College of Cardiology told patients to stay on the drug despite a recent damning study.
Cholesterol drug Vytorin was hyped as treating "cholesterol from two sources: food and family" but found to work no better than lower priced Zocor in the Enhance clinical study whose results were released in January.
Merck and Schering-Plough have pulled Vytorin ads, prescriptions are down 22 percent and federal and state law makers are asking What-did-they-know-and-when-did-they-know-it? questions of the pharma giants.
Rep. John D. Dingell (D-MI), Chairman of the House Energy and Commerce Committee, which requisitioned the study results, and Rep. Bart Stupak (D-MI), Chairman of the Oversight and Investigations Subcommittee, now want to know if an outside panel Merck and Schering-Plough convened which changed the "end points" or purpose of the study to finesse the bad results is guilty of manipulating data and whether the Enhance study had a data safety monitoring board.
Dingell and Stupak also want to know more about the Merck and Schering-Plough-funded, $350,000 "cholesterol page" on the American Heart Association Web site.
Months before the HRT-implicating Women's Health Initiative (WHI), the American Heart Association ran an article paid for by Wyeth-Ayerst Research in its journal Circulation that said hormone therapy had "no significant effect on the risk for stroke among postmenopausal women with coronary disease."
They've also requested the amount of Medicare and Medicaid dollars spent on Vytorin since April 2006, arousing memories of the overpriced and over-prescribed to the elderly drug, Vioxx.
The state of New York, for example, spent $21 million for Medicaid prescriptions for Vytorin in the last two years -- it costs $3 a pill compared with 3 cents a pill for Zocor -- prompting New York Attorney General Andrew Cuomo to also launch an investigation.
"Drug companies are on notice that concealing critical information about life-saving prescription drugs, profiting at the expense of patients' health, and wasting taxpayer dollars, is simply unacceptable," said Cuomo.
Cuomo also has questions about why Carrie Smith Cox, a Schering-Plough executive vice president, sold 900,000 company shares for $28 million on April 20, according to an SEC filing.
The U.S. Food and Drug Administration is also reviewing the Enhance study -- who remembers when FDA was the first not last responder? -- though it's not advising doctors to stop prescribing the drug because of the clinical belly flop.
Similarly, many doctors the Arkansas Democrat-Gazette interviewed said they were keeping patients on Vytorin despite being "inundated" with calls from patients asking if they should continue. The data are not all in yet, they say.
But on the industry site, cafepharma.com, an anonymous drug salesman met a different reception from a doctor he calls on.
"Got my ass chewed about if I knew... when was I going to give him the head's up ... he looks like an ass in front of his patients," posts the drug rep days after the Enhance study results hit.
"I just nodded and said that I got the information just about the same time he did and that I'm heartsick over it. LDL lowering more than Zocor!! I got thrown out."
One patient in Little Rock came out and asked his doctor the question that must be on many Vytorin takers' minds. "[I]f they say that 'It's not doing any good,' then why take it ?" Ronald Hesselschwerdt, 74, told the Arkansas Democrat-Gazette.
We don't know if the doctor answered, Ã¢â‚¬Å“The stock price will fall if you don't.Ã¢â‚¬Â