CDC Failed to Screen Vaccine Panel Experts

A report by the inspector general of the Department of Health and Human Services said that medical experts were not properly screened for financial conflicts when they were hired in 2007 by U.S. Centers for Disease Control and Prevention to provide advice about safety of flu and cervical cancer vaccines.

Daniel Levinson found that 64% of the experts had potential conflicts that were never identified or resolved. In some cases, experts who were largely barred from advising on the vaccines did so anyway. The CDC failed to ensure that experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions. Levinson said the CDC must do a better job of screening experts who serve on its advisory panels.

Since the period covered in this review, the CDC has strengthened the financial disclosures and conflict-of-interest process by instituting improved business processes and realigning responsibilities and oversight.

Source: Health Day News, December 19, 2009

 


No Proof of Vytorin Cancer Link

Federal drug regulators say an extensive data review of the cholesterol drug Vytorin turned up no evidence that the drug causes cancer.

There were concerns raised by a patient study last year and the FDA examined all of the data from that study and reviewed available information from two ongoing large studies. But whether Vytorin, which is made by Merck & Co., is linked to a higher risk of cancer or death from cancer cannot definitively be ruled out.

Vytorin combines two types of cholesterol pills, Zetia and Zocor.

Source: Associated Press, December 28, 2009

 


Flu Vaccine for Seniors Approved

The U.S. FDA has approved Fluzone High-Dose, a seasonal flu vaccine for people 65 and older.

Seniors are at highest risk for complications of seasonal flu, including hospitalization and death. The Fluzone High-Dose vaccine was given accelerated approval as a product designed to prevent serious or life-threatening disease. It is designed to prevent infection with influenza subtypes A and B.

As part of the approval, manufacturer Sanofi’s Pasteur is required to “conduct further studies to verify that the vaccine will decrease seasonal influenza after vaccination.”

People who are sensitive to egg products or who have had life-threatening reactions to prior flu shots should not be vaccinated with Fluzone High-Dose.

Source: Health Day News, December 24, 2009

 


FDA Approved Spiriva Inhaler

The U.S. FDA has expanded approval for the Spiriva Handihaler to include reducing symptoms during flares of chronic obstructive pulmonary disease (COPD), makers Boehringer Ingelheim Pharmaceuticals and Pfizer said.

The Spiriva Handihaler, first FDA-approved in 2004, is already sanctioned as a once-daily maintenance treatment for COPD-related problems, including cough, wheezing, or difficulty breathing.

COPD is a broad term for respiratory disorders that include chronic bronchitis and emphysema. COPD leads to the deaths of an estimated 120,000 Americans annually.

Source: Associated Press, December 27, 2009

 



 
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Ex-CDC Chief to Run Merck’s Vaccines Business

The former head of the U.S. Centers for Disease Control and Prevention will soon head Merck & Co.’s $5 billion vaccines business.

Julie Gerberding, CDC director from 2002 until earlier this year, will take over as president of Merck’s vaccines operations, overseeing sales of its existing vaccines, development of vaccines currently in the works and continuation of plans to expand vaccinations in developing countries.

She assumes her new position on January 25, replacing Margaret McGlynn, Merck’s recently retired head of vaccines. Richard Clark, Merck chairman and chief executive, described Gerberding as a “preeminent authority in public health, infectious disease and vaccines.”

Source: Business Wire, December 28, 2009


FDA Opens Mexico City Office

A Mexico City office opened by the U.S. FDA is the agency’s 10th international post in a program meant to improve the safety of food and medical products imported into the United States.

FDA staff at the Mexico City post will work with counterparts in the Mexican government on a number of initiatives, including harmonization of regulations and guidance standards, collaboration on the use of the latest laboratory techniques and joint training on food-borne illness and food oversight. In addition, FDA experts will educate Mexican industries that ship food and medical products north of the border about U.S. safety and product quality expectations.

Dr. Margaret Hamburg, FDA Commissioner, stated, “The opening of this office represents an important step as we re-design our product safety strategy. We, like our partners in the Mexican Government, realize that prevention is the key. Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens.”

The FDA’s other posts include China, India, Europe, Chile and Costa Rica.

Source: CNN.com, December 22, 2009


FDA Panel Backs Crestor

The U.S. FDA should approve expanded use of the cholesterol-lowering drug Crestor to reduce the risk of heart attack, stroke and death in people with healthy cholesterol levels.

The FDA advisory panel decided that Crestor’s benefits outweigh its risks in patients with normal cholesterol and no history of heart disease.

Source: Health Day News, December 21, 2009


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