Health Highlights: June 22, 2010

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Consumer Protection Key Feature of Health Reform Enforcement

Consumer safeguards are expected to be a major focus when the U.S. government reveals details about how it will enforce the new health reform law.

On Tuesday, Obama administration officials were meeting with insurance company CEOs and state insurance commissioners, the White House said. It's believed the president will attend at least part of the meeting, the Associated Press reported.

The president was then expected to announce rules for putting in place consumer protections enacted by the health reform law.

The main provisions of the consumer safeguards include federal money to help 32 million uninsured people get health insurance. But that won't happen until 2014, and White House officials are concerned that rising premiums could force people to abandon their policies before the law is fully implemented, the AP reported.

A Kaiser Family Foundation survey released Monday found that the 14 million Americans who buy health coverage directly from insurers face average premium increases of 20 percent this year.

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Most U.S.-Approved Drugs Tested in Other Countries: Report

Eighty percent of drugs approved in 2008 for sale in the United States had clinical trials in other countries and 78 percent of all participants in clinical trials were enrolled at sites in other countries, says a report by the inspector general of the U.S. Department of Health and Human Services.

The document, scheduled for release Tuesday, also found that 10 drugs approved in 2008 were tested entirely abroad and didn't include a single test patient in the United States, The New York Times reported.

Most of the foreign clinical trial sites and participants were in Western Europe, where rules about research ethics are generally as strong as in the United States, according to Inspector General Daniel R. Levinson.

However, he also found that Central and South America had the highest number of participants per site and accounted for 26 percent of all patients enrolled in foreign trial sites, The Times reported.

The document "highlights a very frightening and appalling situation," said Rep. Rosa DeLauro (D--Conn.). "By pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the (drug) industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health."

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Pfizer Pulls Leukemia Drug Off Market

Pfizer Inc. has agreed to stop selling its leukemia drug Mylotarg because post-market research has shown it does not slow the disease it is supposed to treat.

The drug was first given the U.S. Food and Drug Administration's blessing in 2000 under the agency's accelerated approval program. It was to be used in people with acute myeloid leukemia (AML), a bone marrow cancer, who were over 60.

But the FDA said in a statement Monday that a follow-up study that began in 2004 showed no difference in survival time when gemtuzumab (Mylotarg) was paired with chemotherapy; more patients actually died on the combination treatment than on chemotherapy alone.

"Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer," Dr. Richard Pazdur, director of the Office of Oncology Drug Products at the FDA's Center for Drug Evaluation and Research, said in a statement. "However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML."

The FDA also said that Mylotarg was associated with a serious, and sometimes fatal, liver condition called veno-occlusive disease when it was first approved, and rates of this side effect have increased since 2000.

Mylotarg will not be available to new patients, but those who are currently getting the drug may complete their therapy following consultation with their health care professional, according to the FDA.

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Private Health Insurance Premiums Rise Sharply: Survey

Americans renewing private health insurance policies earlier this year faced average premium increases of 20 percent, according to a Kaiser Family Foundation survey released Monday.

Some respondents said they switched to less expensive plans that offered less coverage, while others negotiated a premium lower than what was originally requested by their insurer, said the nonprofit health research group, The New York Times reported.

As a result, the actual average increase of private health insurance plan premiums was 13 percent.

The survey, conducted in March and early April, shows that price increases for private health insurance far outpace those for large employers buying coverage for workers, said Drew Altman, president and chief executive officer of the Kaiser Family Foundation, the Times reported.

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Coffee 'Aphrodisiac' Product Poses Danger: FDA

An instant coffee product being sold as an sexual aphrodisiac contains a chemical that could interact with some prescription drugs and significantly lower blood pressure, warns the U.S. Food and Drug Administration.

The product, called Magic Powder Coffee, is sold online by several independent distributors, the Associated Press reported.

"Because this product is an instant coffee labeled as an 'all natural dietary supplement,' consumers may assume it is harmless and poses no health risk. In fact, Magic Powder Coffee can cause serious harm," Deborah M. Autor, director of FDA's Center for Drug Evaluation and Research, Office of Compliance, said in an agency news release.

A sudden drop in blood pressure can lead to dizziness or lightheadedness. So far, the FDA hasn't heard of any adverse incidents associated with Magic Powder Coffee, the AP reported.

Posted: June 2010


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