Recent human tissue scandals have prompted the U.S. Food and Drug Administration to form a task force on human cell and tissue safety that will assess the effectiveness of regulations that took effect in 2005.
The task force's mandate will include a review of recent reports that some companies are not adhering to federal requirements for tissue recovery. For example, a now-defunct New Jersey company was accused of harvesting body parts without consent.
The Human Tissue Task Force (HTTF) will be led by senior FDA officials from the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs.
"The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products," Dr. Jesse Goodman, CBER director, said in a prepared statement.
Within the next three months, the task force will develop an action plan and, where necessary, propose changes to current policies. It will also identify the resources needed to support the plan and how to quickly implement it.
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Nicotine Levels Increase in U.S. Cigarettes
Nicotine levels in U.S. cigarettes have increased about 10 percent since 1998, making it easier for people to get addicted and harder for smokers to quit, according to a Massachusetts Department of Health report released Tuesday.
Of the 179 cigarette brands tested in 2004 for the report, 93 percent were in the highest range for nicotine, compared to 84 percent of 116 brands tested in 1998, the Associated Press reported.
The three brands most popular with young people -- Camel, Marlboro and Newport -- contained much more nicotine in 2004 than they did years ago. The study also found that nicotine levels in Kool, a popular menthol cigarette, increased 20 percent from 1998 to 2004.
There's not much point in turning to "light" cigarette brands to reduce nicotine intake, the report said. It found no significant difference in total nicotine content between "full flavor," "medium," "light" or "ultra-light" cigarettes, the AP reported.
The results indicate that health-care providers trying to help people quit smoking need to adjust the strength of nicotine-replacement therapies, said Sally Fogerty, associate commissioner with the Massachusetts Department of Public Health.
The state is one of three that require cigarette makers to submit information about nicotine levels in their products. Massachusetts is the only state with nicotine data going back to 1998.
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Chinese Company Plans to Mass Produce Bird Flu Vaccine
A Chinese vaccine maker says it plans to mass produce a vaccine to protect humans against the H5N1 bird flu virus and that it could be producing 20 million vaccines a year within the next few years, according to Chinese state media.
Initial tests of the vaccine, developed by Sinovac Biotech Ltd. and government researchers, indicated it was safe. Company officials said this week that the tests found that 120 people who received the vaccine had no serious adverse reactions.
"These results indicate that we should expand our production capabilities to prepare for mass production of the vaccine against a possible bird flu pandemic," a Sinovac official told the Xinhua news agency.
However, the vaccine must undergo two more clinical trial phases before it can be approved for widespread use.
A number of vaccines to protect against H5N1 are under development worldwide but they could prove useless if the virus mutates and causes a pandemic, said the World Health Organization's top official in China.
It's difficult to predict virus mutations and it could take months to create a new vaccine to counter a mutation in H5N1, the official said.
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FDA Proposes Ban on OTC Sales of Skin Lighteners
The U.S. Food and Drug Administration wants to ban over-the-counter sales of skin-lightening products because they may cause cancer.
The proposed ban was announced Tuesday and there will be a four-month comment period for doctors and others to express their views. Dermatologists and other skin experts are expected to strongly oppose such a ban, the Los Angeles Times reported.
The FDA said the skin-lightening creams contain hydroquinone, a drug that showed "some evidence" of possibly causing cancer in rodents.
"We're acting for safety reasons. There is a potential for hydroquinone to be a carcinogen in humans. We are looking for additional information," Susan Johnson, associate director of the FDA's Office of Nonprescription Products, told the Times.
The agency also cited studies that found an association between creams with hydroquinone and a condition called ochronosis, which can cause darkening and thickening of the skin, dome-shaped yellowish bumps, and grayish-brown spots.
In the United States, about 65 companies sell more than 200 skin-lightening products that contain hydroquinone, the FDA said. About two-thirds of the products are available without a prescription.
Hydroquinone has been banned in Japan, the European Union and Australia, the newspaper said.
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U.S. Said to Spend Millions for Questionable Cancer Data
U.S. cancer specialists last year received about $275 million from the federal government and Medicare beneficiaries as part of a Bush administration research project that many experts say won't produce any useful information, the Associated Press reported.
The Centers for Medicare and Medicaid Services paid participating chemotherapy doctors $130 each time they submitted information about a Medicare patient's pain, fatigue and nausea. Patients were charged $26 each time their doctors billed Medicare for submitting the information.
During the year-long project, the median amount paid to each doctor was $23,000. However, some physicians received much more money. The top 10 billers received more than $270,000 each, including a Florida oncologist who was paid $625,803 and a Kansas doctor who received $507,563, the AP reported.
The goal of the project was to collect data to improve cancer patient care.
In a report to be released Wednesday, the inspector general for the U.S. Health and Human Services Department cast doubt on the integrity of the data submitted by the doctors and questioned whether the government money had been well-spent.
"We identified numerous anomalies and gaps in the data and collection methods," the report said. It also noted that a commission that advises Congress on Medicare issues found that many oncologists felt the project wouldn't produce any useful research findings and would not help improve patient care, the AP reported.
Taxpayers and Medicare patients were "bilked," because they paid for services that the oncologists were already supposed to provide, said Sen. Charles Grassley (R-Iowa), chairman of the Senate Finance Committee. |
