Healthy Skepticism Library item: 13413

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Publication type: news

Pettypiece S.
Schering's Hassan Says Pharmacia Rescue Readied Him
Bloomberg News 2008 Apr 2
http://www.bloomberg.com/apps/news?pid=20601202&sid=apjIiFvlDaWI&refer=healthcare

Full text:

Schering-Plough Corp. Chief Executive Officer Fred Hassan said he’ll continue to promote the cholesterol pill Vytorin, even after a panel of cardiologists said the drug shouldn’t be used as an initial treatment.

In his career as a pharmaceutical executive, the 62-year-old Hassan rebuilt a crippled Pharmacia Corp. and sold it to Pfizer Inc. for $58 billion, engineered the $37 billion takeover of Monsanto Co., and made Schering profitable after losses in 2003 and 2004. Persuading doctors to use a pill that may not be any better than an older drug costing 80 percent less isn’t as difficult as rebuilding a company, Hassan said.

``If you look around for a CEO that has had more experience dealing with these type of issues you won’t find one,’‘ Hassan said in a telephone interview yesterday. ``I’ve been in numerous companies, and in every one, I was challenged with difficult projects. That is why I did well with my career.’‘

In January, Schering and Merck & Co., its marketing partner, reported partial results from a study called Enhance that suggested Vytorin, which combines Schering’s Zetia and Merck’s Zocor, works no better than Zocor alone in reducing plaque in neck arteries. Since then, Schering has lost $21 billion in market value as prescriptions for the drugs fell 18 percent.

Full study results released at the American College of Cardiology meeting in Chicago cemented the finding last weekend. A panel of research physicians afterward determined that doctors shouldn’t use Vytorin until they have tried other cholesterol drugs, led by the generic version of Zocor or Pfizer’s Lipitor.

Shares Plunged

The panel’s statement drove down Schering’s stock 29 percent in three days. One analyst, Jim Kelly with Goldman, Sachs & Co., suggested the panel’s statement may erode Vytorin and Zetia sales, which totaled more than $5 billion last year, by 24 percent this year and 20 percent in 2009.

Fitch Ratings, a New York-based credit assessment firm, today put Schering’s approximately $11.98 billion of outstanding debt on negative watch for a possible downgrade, citing ``potential sales erosion of Vytorin and Zetia.’‘

Schering-Plough fell 89 cents, or 6 percent, to $13.86 at 4 p.m. in New York Stock Exchange composite trading. Merck fell $1.22, or 3.2 percent, to $37.10.

Hassan is undeterred, saying the panel’s deliberations were unfair.

The ``scientific process was hijacked’‘ because there were no opposing viewpoints on the panel and questions weren’t taken from the audience, he said. Also, Hassan said one of the panelists, Harlan Krumholz, a cardiologist at Yale University in New Haven, Connecticut, once served as a consultant to lawyers suing Merck.

`A Consensus’

Krumholz, in a telephone interview, confirmed he had been a consultant in a case involving Merck’s painkiller Vioxx. ``This isn’t the first time it was disclosed,’‘ Krumholz said. ``It’s a different drug. I understand their strategy is to try to isolate me as a zealot, but this was a consensus.’‘

The other three physicians who worked on the panel ``all have impeccable reputations,’‘ he said. ``I have an impeccable reputation.’‘

``There might have been a different opinion if four different people were on the panel,’‘ said Jack Lewin, chief executive officer of the American College of Cardiology, in an interview. Those that were on the panel ``weighed the pros and cons about Vytorin before the meeting and presented a consensus view after much debate before hand.’‘

`Legitimate Criticism’

Lewin said Hassan ``probably had a legitimate criticism’‘ about the lack of microphones in the audience because there would have been some dissenting voices. Overall, Lewin said he agreed with the panel’s position.

``There are still people who are going to use Vytorin, but I don’t think many people are going to use Vytorin as a first line drug, which some of the marketing might imply,’‘ Lewin said. ``Until more evidence is available, it makes sense for this drug to be reserved for patients who have intolerance to statins.’‘

Hassan began his career in 1970 as a drug salesman, and was director of marketing for five years for Sandoz Pharmaceuticals, a predecessor to Novartis AG.

He will start his effort for Vytorin by marketing to doctors and patients. Hassan said it may include an expanded print campaign that targets consumers, and the company said it may also involve the resumption of television advertisements.

`Very Determined’

``We are very determined, very resolute, and very confident that we can get through this,’‘ Hassan said.

There are many patients who can’t lower their levels of artery-clogging LDL cholesterol enough without using higher doses of other drugs and may benefit from use of Vytorin, he said. Also, the study was small and targeted a unique patient population that may not be representative.

Some physicians interviewed yesterday said the promotion won’t work.

``By the time definitive trials of Vytorin are done in 2012, the drug will be dead,’‘ said Fayez Shamoon, director of cardiology at Seton Hall University in Newark, New Jersey.

``I don’t feel I have the right to put my patient on Vytorin’‘ because if something goes wrong or the patient has a complication, ``he’s going to come after the physician,’‘ said Shamoon, who currently takes the drug and plans to stop. ``We are really under pressure not to use the drug again.’‘

Other doctors say they agree with Hassan that Vytorin may continue to work for some patients.

Mike Valentine, a cardiologist in private practice in Lynchburg, Virginia, said the Enhance trial didn’t answer many questions about the majority of his patients who have already had a heart attack. The trial examined people with a family history of heart problems who didn’t necessarily have cardiac disease themselves.

`Jury Out’

``The jury is still out on many sets of patients,’‘ Valentine said. ``I don’t think the book is closed on Vytorin.’‘

Valentine said he will still give Vytorin to patients who can’t take other cholesterol-lowering drugs because of side effects or insufficient efficacy. ``After a heart attack, Vytorin is still the best option for a lot of my patients,’‘ he said.

Steven Kurtzman, a cardiologist in Gaithersburg, Maryland, said he is unsure what to do with Vytorin. ``The message I got was relax, just wait until more trials are done,’‘ he said. `Don’t let your patients panic.’‘

``This is a challenge, it is a setback that we are on course to overcome,’‘ Hassan said, while meeting in Miami with 300 of the company’s managers. ``We are probably the best story among our peers, if you look at our patent portfolio and the size of our phase-three pipeline. You can compare that with even companies that spend double the amount on research and development that we do.’‘