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On March 30, 2008, doctors urged a return to older, tried-and-true treatments for high cholesterol after hearing full results of a failed trial of Vytorin. Millions of Americans have been prescribed and current take the drug or one of its components, Zetia. However doctors were astonished to learn that Vytorin failed to improve heart disease even though it worked as intended to reduce three key risk factors.

“People need to turn back to statins,” said Yale University cardiologist Dr. Harlan Krumholz, referring to Lipitor, Crestor and other widely used brands. “We know that statins are good drugs. We know that they reduce risks.”

The study was closely watched because Zetia and Vytorin have racked up $5 billion in sales despite limited proof of benefit. Two Congressional panels launched probes into why it took drug makers nearly two years after the study’s completion to release results.

Results were presented at an American College of Cardiology conference in Chicago Sunday and published on the Internet by the New England Journal of Medicine.

Doctors have long focused on lowering LDL or bad cholesterol as a way to prevent heart disease. Statins like Merck & Co.’s Zocor, which recently came out in generic form, do this, as do niacin, fibrates and other medicines.

Vytorin, which came out in 2004, combines Zocor with Schering-Plough Corp.’s Zetia, which went on sale in 2002 and attacks cholesterol in a different way.

The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder.

The results show the drug had no result. In no subgroup, in no segment, was there any added benefit” for reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.

That happened even though Vytorin dramatically lowered LDL, fats in the blood called triglycerides and a measure of artery inflammation CRP.

Some doctors noted that hormone pills for menopausal women and torcetrapib, a promising cholesterol drug Pfizer Inc. recently abandoned, also lowered cholesterol but were found in big studies to raise heart risks, not lower them.

Another ominous sign was the decision on March 28, 2008 by other researchers to expand enrollment in a more pivotal study of Vytorin to 18,000 people because early results suggest it will be harder than anticipated to see if it is any better than Zocor alone.

“It will be 2012 ten years after the drug was introduced before we know the answer,” said Dr. Steven Nissen, a Cleveland Clinic cardiologist who has no role in the studies and has criticized the drug makers over the one reported.

Dr. Robert Spiegel, chief medical officer for Schering-Plough, said the study was done “with the highest integrity” and that doctors can believe the results “because of the time we took to make sure the data are right.”

“We were disappointed that it was not a very balanced panel discussion” by the heart doctors who urged their peers to focus on more established treatments.

However, Kastelein said the data were far more consistent than anticipated and ample to show that the drug simply did not work.

“A lot of us thought that there would be some glimmer of benefit,” said Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association.

Many doctors have prescribed Vytorin without trying older, proven medications first, as guidelines advise. The key message from the study is “don’t do that,” Blumenthal said.

No one should ever stop any heart drug without talking with their doctors, heart specialists stressed.

However, doctors “should be thinking twice,” said Duke University cardiologist Dr. Robert Califf. He takes the drug himself because he cannot tolerate the high dose of statins he otherwise would need.

Dr. James Stein, director of preventive cardiology at the University of Wisconsin-Madison, said many doctors prescribe Zetia and Vytorin because they seem to be safe ways to get cholesterol down quickly, without annoying side effects like flushing that some other medicines carry.

Stein, who has consulted for Schering-Plough, said that after six years on the market, it would have been good to see better results on a drug so many doctors believed would help, “but the reason we do research is so we don’t have to rely on our ‘beliefs’ we can rely on data.”

The New England Journal also published a report showing that Vytorin and Zetia’s use soared in the United States amid a $200 million advertising blitz. In Canada, where marketing drugs directly to consumers is not allowed, sales were four times lower.

Merck is based in Whitehouse Station, N.J.; Schering-Plough, in Kenilworth, New Jersey

In addition to the two Congressional committee probes, New York State Attorney General Andrew Cuomo subpoenaed the companies in a similar probe in January. “While these corporations profited, Americans were left in the dark,” Cuomo said in a written statement. “The millions who take this drug, taxpayers who subsidize its use through the Medicaid and Medicare programs, and Merck and Schering-Plough’s investors deserve to know why it took so long for the results to be made public. This new information underscores our concerns and advances our investigation, which we will pursue aggressively.

Fourteen physicians and three surgery centers tied to the hepatitis C outbreak in Nevada have had their contracts suspended by three of Nevada’s largest health insurances providers.

Representatives of Anthem Blue Cross Blue Shield, Sierra Health Services and Cigna HealthCare said on March 27, 2008 that the contracts were suspended or terminated after they received information from the Southern Nevada Health District about six hepatitis C cases linked to one of the surgery centers affiliated with the Gastroenterology Center of Southern Nevada.

The Endoscopy Center of Southern Nevada is believed to have spread the potentially deadly blood-borne virus by reusing syringes and vials of medication.

Some doctors worry that taking 14 gastroenterologists out of the mix exacerbates a shortage of these physicians.

Assemblyman and doctor Joe Hardy estimated that the 14 doctors who worked within the Gastroenterology Center group represent more than one-third the gastroenterologists in southern Nevada.

He said the large practice served a majority of patients who had gastrointestinal problems.

“Without the 14 physicians, it’s going to be a real difficult time for patients in Las Vegas,” Dr. John Gray, a Reno gastroenterologist, told the Las Vegas Review-Journal.

Gray said his practice was contacted by a Sierra Health executive this week about providing medical services in Las Vegas.

According to the American Medical Association, Nevada has 2.5 gastroenterologists per 100,000 residents, well below the country’s ratio of four gastroenterologists per 100,000.

Sierra Health insures roughly 650,000 Nevadans between its Health Plan of Nevada, Senior Dimensions and Sierra Health and Life plans. Anthem Blue Cross Blue Shield insures 317,000 Nevadans. Cigna HealthCare insures approximately 100,000.

Leigh Woodward, a spokeswoman for Cigna HealthCare Arizona-Nevada, said the company issued termination letters to the Gastroenterology Center of Nevada group on March 3.

She said Cigna members have access to ambulatory surgery centers and roughly 30 gastroenterologists within 25 miles of the terminated endoscopy centers.

“We are aware that some gastroenterologists (not affected by the terminations) in Las Vegas are not accepting any new patients and that there is a capacity issue,” she said.

Though the majority of the physicians have privileges at most Southern Nevada hospitals, it is unclear if they are still practicing medicine. None have lost their medical licenses.

Dr. Dipak Desai, majority owner of the Endoscopy Center of Southern Nevada, has voluntarily agreed to quit practicing medicine. The other physicians within his group have been asked by Tony Clark, executive director of the state Board of Medical Examiners, to do the same. They have not agreed to do so.

On March 27, 2008, James Cayne, Chairman of Bear Stearns Cos Inc (BSC) sold $61.3 million of his shares of the company. As a result, the bank’s shareholders are unlikely to get a higher price for their shares.

JPMorgan agreed earlier this week to increase its original bid for Bear Stearns, which had faced a run on the bank and was close to collapse. Some investors were clearly hoping JPMorgan Chase would increase its bid again, or that Bear Stearns would find another buyer, because Bear Stearns shares closed on Thursday at $11.23 on the New York Stock Exchange, about 20% above the current value of JPMorgan’s offer.

If getting a higher price were likely, Cayne would be unlikely to sell his shares.

Bear’s share price fell about 5% in after market trading to $10.68. The share sale took place on March 25 but was disclosed in a document after the market closed on March 27, 2008.

The 5.66 million shares Cayne sold would have been worth about $1 billion last year, when Bear’s share price peaked at over $170.

JPMorgan Chase’s sale is expected to close by mid-June, assuming a majority of shareholders approve it.

The banks helped ensure the deal would be approved earlier this week when JPMorgan agreed to buy 95 million newly issued Bear Stearns shares, equal to a 39.5% stake in the company.

Bear’s board members agreed to use their shares to vote in favor of the deal. It is not clear who bought Cayne’s shares.

Cayne in January stepped down as chief executive after nearly 15 years at the helm of what was once the fifth-largest investment bank in the United States.

Bear Stearns experienced a run on the bank earlier this month as clients withdrew funds and the investment bank lost access to a form of secured financing known as repo funding.

Bear Stearns, once the fifth-largest U.S. investment bank, earned most of its profit from U.S. bonds, and had a large mortgage-backed securities business, which made some investors concerned about its stability.