U.S. Public Health Agency Leaders Being Replaced
The leaders of a number of U.S. government public health agencies are expected to resign or be shown the door as President-elect Obama's team takes control of the White House.
Each of the current public health agency chiefs has severe critics on Capitol Hill and in the public health community, and there have been repeated charges that the Bush administration has let politics play a major role in science policy, The New York Times reported.
On Tuesday, Food and Drug Administration commissioner Dr. Andrew C. von Eschenbach said he would resign on Inauguration Day, Jan. 20. Dr. Elias Zerhouni has already left his position as director of the National Institutes of Health, and it's widely expected that Centers for Disease Control and Prevention director Dr. Julie Gerberding will be replaced by the new administration.
In addition, National Cancer Institute director Dr. John E. Niederhuber is expected to surrender his post, but may remain at the institute, The Times reported.
One leading candidate for the new FDA chief is Dr. Joshua Sharfstein, a pediatrician and health commissioner of Baltimore. Last year, he petitioned the FDA to ban some pediatric over-the-counter cough and cold medicines.
Another short-listed candidate for FDA leader is Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic. He's been a fierce critic of the safety of several big-selling medications.
There's wide agreement among drug companies, drug-safety advocates, and powerful members of Congress that the FDA needs a major overhaul.
"The FDA has increasingly lost its emphasis on public health, and all of us have been harmed as a result," Diana Zuckerman, president of the National Research Center for Women and Families, told the Times.
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Illinois Company Faces Lawsuit Over Preemie Heart Drug
Illinois-based Ovation Pharmaceuticals illegally maintained a monopoly on the only two medicines approved to treat a potentially life-threatening heart defect in premature infants, the U.S. Federal Trade Commission alleges in a civil lawsuit filed Tuesday.
The FTC said that after buying the rights to the two medicines (NeoProfen and Indocin) a few years ago, the company boosted the drugs' prices by nearly 1,300 percent. The lawsuit seeks to prevent Ovation from maintaining simultaneous interest in the two drugs and also seeks forfeiture of all unlawfully obtained profits, the Associated Press reported.
Ovation set the price for both medications at about $500. Before it was acquired by Ovation, Indocin cost $36. Each year, the two drugs are used to treat an estimated 30,000 babies with the heart defect called patent ductus arteriousus. The only other option to drug treatment is surgery, which costs far more than the drugs and carries a risk of serious complications.
"As a result, hospitals have little choice but to pay Ovation's price," the FTC said in the lawsuit. "The artificially high prices that hospitals are forced to pay ultimately raise costs for families, tax-supported programs such as Medicaid, and other public and private insurers."
Ovation disputed the FTC's allegations, the AP reported.
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Gene Mutation Effects Should Be Listed on Cancer Drug Labels: Lilly, Amgen
Instructions on the cancer drugs Erbitux and Vectibix should include information on a gene mutation that affects whether the medicines will work, drug makers Eli Lilly & Co. and Amgen Inc. told U.S. regulators Tuesday.
Recent research showed that a mutation in the KRAS gene renders the drugs ineffective in colon cancer patients. Overall, the drugs reduced by 30 percent the risk of a patient's colon cancer worsening. However, more detailed analyses showed that patients with KRAS mutations fared much worse than those with a normal KRAS gene, Bloomberg news reported.
An FDA advisory panel met Tuesday to discuss data on the KRAS gene mutation. The advisers said new types of analyses may be required to better screen people for gene mutations, and they also suggested larger clinical trials may be necessary to determine other biochemical influences on drug performance.
"Two companies have come to us to try to create a situation where they sell less products. This is the first time I've seen this at the FDA," said advisory panel member Derek Raghavan, director of the Taussig Cancer Institute at the Cleveland Clinic, Bloomberg reported.
The FDA is currently working to identify genes that interact with medications. The agency already requires patients to undergo genetic testing before they're prescribed certain drugs.
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Actor Peter Falk Has Alzheimer's, Daughter Says
Actor Peter Falk, best known as the disheveled TV detective Columbo, whose "Just one more thing" became a household phrase, has developed Alzheimer's disease and no longer recognizes people, according to papers filed in Los Angeles Superior Court, the Associated Press reported.
The papers were filed by the 81-year-old Falk's daughter, Catherine Falk, requesting a conservatorship of his assets. A hearing has been scheduled for late January, the AP said.
People magazine's online edition quoted Catherine Falk's petition as saying that her father "requires full-time custodial care for his health and safety," and that she was worried he could "easily be deceived into transferring away property."
Falk, who has won five Emmys and a Golden Globe award, also has been an Academy Award nominee twice. He lives in Beverly Hills with his wife, actress Shera Danese.
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Cleveland Clinic Announces First U.S. Face Transplant
The United States' first almost total face transplant was done a few weeks ago at the Cleveland Clinic, it was announced Tuesday.
About 80 percent of a woman's face was replaced with that of a dead female donor. The procedure was performed by reconstructive surgeon Dr. Maria Siemionow, the Associated Press reported.
The Cleveland Clinic did not release the name or age of the transplant recipient, and has scheduled a news conference for Wednesday.
The world's first face transplant was conducted three years ago on a French woman who'd been mauled by her dog, the AP reported. Since then, two other face transplants have been performed: on a Chinese farmer attacked by a bear, and on a European man disfigured by a genetic condition.
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