Study Questions Treatment Used in Heart Disease

The study could change the way doctors treat millions of patients with heart disease. Common wisdom has been that such patients should take a statin drug like Lipitor or Zocor to lower bad cholesterol and, in many cases, the vitamin niacin to raise their good cholesterol. But in the trial, niacin provided no benefit over simple statin therapy.

The results are part of a string of studies that suggest that what doctors thought they knew about cholesterol may be wrong. Studies that track patients over time have for decades shown that patients with higher levels of high-density lipoproteins (H.D.L., or good cholesterol) tend to live longer and have fewer heart problems than those with lower levels of this cholesterol.

Not surprisingly, doctors thought that if they could raise H.D.L. levels, their patients would benefit. So far, that assumption is not panning out. Nobody knows why.

In 2006, Pfizer halted development of a drug that raised good cholesterol levels after studies showed that the medicine increased the risks of death. And on Thursday, government scientists announced that Niaspan, an extended release form of niacin, not only did not provide any protection against heart attacks when taken with Zocor in patients with heart disease but also slightly increased their risk of stroke.

“We were stunned, to say the least,” said Dr. William E. Boden, a professor of medicine and preventive medicine at the University at Buffalo who was a trial investigator.

What is remarkable about the study is that niacin seemed to be working. Patients taking the medicine along with Zocor had higher levels of H.D.L. and lower levels of triglycerides, a fat in the blood. Despite these seeming improvements, the patients fared no better and may have done slightly worse than those taking Zocor alone. That is why the entire theory behind trying to increase H.D.L. levels in patients with heart disease may need rethinking.

The study results may be greeted as a mixed blessing by some patients. A drug many had hoped would help is now thought to be at best useless. But for many people, niacin is hard to take because it can cause flushing and headaches. Doctors have for years wheedled patients into tolerating these side effects in hopes that the medicine would save their lives. Now, they will not have to.

Dr. William M. Schreiber, a Louisville, Ky., internist, said he had stopped prescribing niacin because so many patients told him they could not abide its effects. “I’m delighted to hear that statins alone are just as good as statins and niacin,” he said.

The study is bad news for the maker of Niaspan, Abbott Laboratories, for the drug industry as a whole and even for the Food and Drug Administration. Abbott last year had $927 million in Niaspan sales, and the company spent $32 million on the study (the government spent $21 million) in the hope that it would increase sales. Instead, the results are bound to lower use of the drug.

In a statement, Dr. Eugene Sun, a vice president at Abbott, said, “Based on its long history of clinical evidence, Niaspan remains an important agent for patients with” blood lipid problems.

The study gives no comfort to other drug makers, many of which have been trying to come up with new drugs to raise levels of good cholesterol or otherwise lower heart attack risks. Statins and other drugs have proven so effective in treating heart disease that improvements are proving very tough to find.

The study is also bad news for the F.D.A., which heavily relies on laboratory results to decide whether to approve drugs.

“This study shows that approving drugs and allowing them to stay on the market on the basis of how they affect lipids and other biomarkers is not good policy,” said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “It’s time to have a new regulatory approach.”

In the trial, 3,414 participants with heart and vascular disease were given either Zocor and a placebo or Zocor and Niaspan and followed for 32 months. The trial ended 18 months early because it was found that there was almost no chance taking Niaspan would prove beneficial. Zocor and other medications did a good job of keeping patients’ bad cholesterol levels relatively low.

Researchers said patients should not stop taking Niaspan without talking to their doctors first.

“We have great evidence that lowering L.D.L. is beneficial,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. “We lack good evidence that changing H.D.L. or triglycerides does much.”

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Signs That Bin Laden Weighed Seeking Pakistani Protection

The documents, which officials said included messages between Bin Laden and his top operations chief over the past year, provide the first suggestion that Bin Laden considered Pakistan’s government amenable to a bargain that would ensure the safety of top Qaeda leaders.

The officials emphasized that they had found no evidence that such a proposal, which one American official said was in the “discussion phase,” was ever raised with Pakistani military or intelligence operatives. 

But the fact that Bin Laden even considered a truce with Pakistan suggests that he thought the idea might have had some support inside the country’s national security establishment. At the same time, Pakistan could argue that the discussions provided evidence that there was no deal already in place allowing Bin Laden to hide in the sprawling compound in Abbottabad, a middle-class town 75 miles by road from the Pakistani capital.

The Central Intelligence Agency is poring over a huge electronic database that Navy Seal commandos seized during the raid that killed Bin Laden this month. The new details about the information came as American officials said that Pakistan had granted permission for the C.I.A. to send a forensics team to search Bin Laden’s compound.

Many American officials are skeptical that Bin Laden could have hidden for so long inside Pakistan without at least the tacit approval of some Pakistani officials.

Top American officials said they had yet to see any evidence of official approval from the electronic files. But new information is being discovered about Al Qaeda’s structure, particularly about a tier of operatives Bin Laden corresponded with who were in charge of the network’s daily operations.

In particular, the documents highlight the central role played by Atiya Abdul Rahman, the operations chief with whom American officials said Bin Laden discussed a possible truce with Pakistan. Mr. Rahman is a Libyan operative who came into the job after a drone strike in 2010 killed his boss, Sheik Saeed al-Masri.

The job of Qaeda operations head is particularly perilous, as C.I.A. drone strikes in Pakistan have killed a number of people holding that position over the past year. American officials and terrorism experts said the position was dangerous because the operations chief had to communicate with Qaeda operatives outside Pakistan, communications that are often intercepted by American eavesdropping.

Last year, American officials said, Mr. Rahman notified Bin Laden of a request by the leader of Al Qaeda’s affiliate in Yemen to install Anwar al-Awlaki, the radical American-born cleric, as the leader of the group in Yemen. That group, known as Al Qaeda in the Arabian Peninsula, apparently thought Mr. Awlaki’s knowledge of the United States and his status as an Internet celebrity might help the group’s operations and fund-raising efforts.

But, according to American officials, Bin Laden decided that the group’s leadership should remain unchanged.

Pakistan’s decision to allow a C.I.A. forensic team to search the compound, first reported on Thursday by The Washington Post, comes after weeks of private talks between uneasy allies.

It may be more important for symbolic than substantive reasons, as the Obama administration does not appear optimistic that the team would uncover secret tunnels or buried clues that could yield fresh information about Qaeda operations.

Still, American and Pakistani officials are, at least publicly, trying to play down tensions in a deeply fractured relationship. In another move aimed at thawing relations, Pakistan last week returned to the Americans the severed tail of a Black Hawk helicopter that crashed at the Abbottabad compound on the night of the raid.

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