Pfizer Shuts Down Cholesterol Drug Development
The world's largest drugmaker has shut down development of its star cholesterol drug because of an unexpected number of deaths and cardiovascular problems in patients who used it.
Pfizer Inc. announced that an independent board monitoring a study for torcetrapib, a drug that raises levels of good cholesterol, HDL, recommended Saturday that the trial end because of "an imbalance of mortality and cardiovascular events," the Associated Press reported.
Pfizer said it has asked that all clinical investigators conducting trials warn patients to stop taking the drug immediately.
According to Pfizer spokesman Paul Fitzhenry, in a trial of 15,000 patients, 82 of those taking the combination of torcetrapib and Lipitor had died, compared to 51 deaths among those taking only Lipitor alone. Pfizer said that the study didn't raise any questions about Lipitor's safety.
There had been concerns about torcetrapib, which was designed to be taken with a statin like Lipitor, because a recent study showed it triggered a slight increase in blood pressure.
But only two days ago, Pfizer had announced its intention to file an application with the Food and Drug Administration for approval of torcetrapib by the second half of next year.
The company had expected to sell torcetrapib in combination with Lipitor, which lowers bad cholesterol and is the company's -- and the world's -- best-selling drug.
Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's news release that the findings were a surprise "in light of prior study results," the AP reported.
"We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, director of the Heart Research Institute in Australia.
Fewer Older Americans Struggle With Disabilities: Study
The number of older Americans with a chronic disability has dropped dramatically in the last 20 years, and the rate of decline has accelerated as well.
That's the encouraging news from a new federal study that found the prevalence of chronic disability among people 65 and older fell from 26.5 percent in 1982 to 19 percent in 2004-05. The findings suggest that the health of older Americans continues to improve at a critical time in the aging of the population, the researchers said.
"This continuing decline in disability among older people is one of the most encouraging and important trends in the aging of the American population," said Dr. Richard J. Hodes, director of the National Institute on Aging (NIA).
"The challenge now is to see how this trend can be maintained and accelerated, especially in the face of increasing obesity," added Richard Suzman, director of the NIA's Behavioral and Social Research Program. "Doing so over the next several decades will significantly lessen the societal impact of the aging of the baby-boom generation."
According to the study, from 1982 to 2004/2005:
Chronic disability rates decreased among those over 65 with both severe and less severe impairments, with the greatest improvements seen among the most severely impaired.
The proportion of people without disabilities increased the most in the oldest age group, rising by 32.6 percent among those 85 and older.
The percentage of Medicare enrollees 65 and older who lived in long-term care institutions such as nursing homes dropped from 7.5 percent to 4 percent.
If the downward trends continue, they could bode well for the Medicare program's fiscal health, suggested the study, a joint effort between the NIA and Duke University. It was published in this week's Proceedings of the National Academy of Sciences.
Experimental Ultrasound May Detect Breast Cancer
An experimental ultrasound technique may allow doctors to determine if a woman has breast cancer without having to perform a biopsy, suggest the findings of a study reported this week at a meeting of the Radiological Society of North America.
The technique, called elastography, measures how easily breast lumps compress and bounce back. The study of 80 women found that elastography was nearly 100 percent accurate in distinguishing between malignant and benign breast lumps, the Associated Press reported.
Elastography correctly identified 105 of 106 benign lumps and 17 of 17 cancerous lumps.
If the same kind of results are achieved in a larger study, the technique could spare many women the discomfort, stress, and cost of having a breast biopsy, experts said.
"There's a lot of anxiety, a lot of stress, a lot of fear involved," with a biopsy, Susan Brown, manager of health education at the Susan G. Komen Breast Cancer Foundation, told the AP. "And there's the cost of leaving work to make a second appointment. If this can be done instead of a biopsy, there would be a real cost reduction."
Concerns Raised About Clotting Drug Used on U.S. Troops
The U.S. Defense Department should look into the use of the blood clotting drug Factor VII on wounded troops in Iraq, two U.S. Senators say.
Sen. Barbara Mikulski (D-Md.) and Senate Minority Whip Richard Durbin (D-Ill.) called for the investigation after reports that the drug may have caused life-threatening clots, the Associated Press reported.
In a letter to Dr. William Winkenwerder Jr., Assistant Secretary of Defense for Health Affairs, Mikulski said the Pentagon should track all patients who receive Factor VII on the battlefield in order to assess whether they are at increased risk for blood clots and other complications. As of Thursday morning, she had not received a reply.
In related news, a group of experts that specialize in hematology and blood clotting says there are "rightful concerns" about the use of the drug on the battlefield, the AP reported.
The seven scientists and doctors made the comment in an editorial they wrote for an upcoming issue of the journal Applied and Clinical Thrombosis/Hemostasis.
"Our soldiers are already in great danger and the availability of a lifesaving drug such as [Factor VII] is welcome," they wrote. "It is, however, equally important to recognize and investigate the reported adverse reactions with its use to avoid additional risk to these Army personnel."
Factor VII was originally designed to treat patients with rare forms of hemophilia. The U.S. military says the drug gives front-line doctors a way to control potentially fatal bleeding in wounded troops, the AP said.