Prescriptions for cholesterol drug Vytorin were down 22 percent in the weeks following the release in January of the Enhance clinical study that found it worked no better than lower priced Zocor. Merck and Schering-Plough even pulled the ads.
But now prescriptions are "stabilizing" said Kenneth Frazier, president of global human health at Merck, to investors at a Merrill Lynch conference. "Merck and Schering-Plough are actively engaged in helping physicians and patients more fully understand what Enhance actually means and what it doesn't mean."
Did anyone think Merck and Schering-Plough would kiss Vytorin's $5.2 billion a year profits, combined with Zetia, goodbye just because it's overpriced, doesn't work and bilks tax payers through pharma-infiltrated Medicare drug programs?
Lucky for pharma the American Heart Association and American College of Cardiology sang on cue and told patients to stay on the drug despite Enhance.
But federal and state law makers were not so easily bought off.
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.
The Heart Association has been caught in bed with pharma before. Months before the HRT-implicating Women's Health Initiative (WHI), its journal Circulation ran an article paid for by Wyeth-Ayerst Research asserting hormone therapy had "no significant effect on the risk for stroke among postmenopausal women with coronary disease." Hello?
Dingell and Stupak have also requested the amount of Medicare and Medicaid dollars spent on Vytorin since April 2006, arousing memories of the overpriced and over prescribed Vioxx and ongoing use of controversial drugs Zyprexa and Seroquel in nursing homes.
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 has agreed to review 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 one of the drug reps whose job is "helping physicians and patients more fully understand what Enhance actually means" 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 anonymously.
