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Fri, 13 Oct 2006 16:41:14 EDT

10.13.06, 12:00 AM ET

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

The U.S. Food and Drug Administration must investigate a whistle blower's charges that a company seeking approval to sell silicone breast implants withheld safety data from federal regulators, the advocacy group Public Citizen says.

Mentor Corp. of Santa Barbara, Calif., is one of two companies seeking FDA approval to sell silicone breast implants in the United States. A former Mentor scientist alleges that the company concealed, misrepresented, or withheld data about durability and leakage in its implants, the Associated Press reported.

"Unless the FDA opens a criminal investigation into Mentor's failure to submit the studies, it will only encourage Mentor and other device manufacturers to selectively send the agency only those studies that put their products in the most favorable light," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

A statement released by Mentor said, to the company's knowledge, all questions about the its silicone implants were answered to the satisfaction of the FDA, the AP reported.

Silicone breast implants first went on sale in the United States in 1962, but concerns about cancer and leakage problems led to their removal from the market in 1992. In July 2005, the FDA told Mentor and another company that it would allow them to start selling silicone breast implants if the companies met certain unspecified conditions. Neither company has yet received final marketing approval from the FDA.

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Important information was missing from a company research file given to United Kingdom regulators prior to the start of a drug study that left six men seriously ill, says a report by drug research experts from the Netherlands who investigated the incident.

The missing data may have alerted U.K. officials about the potential harm that the experimental drug TGN1412 could cause study volunteers, BBC News reported.

The man who suffered the worst effects from the drug had his fingers and toes amputated and his health outlook is uncertain.

The Dutch report noted that scientists from the German drug company TeGenero said that the site in the body where TGN1412 binds was identical in humans and monkeys. No detailed data on such a comparison was included in the research file given to U.K. regulators, the report said.

The Dutch investigators did their own research on the binding site and concluded that, in fact, there are clear differences between humans and monkeys, BBC News reported.

The investigators said the file also lacked information about how TGN1412 affects certain human immune cells compared to monkey immune cells.

Drug developers must provide all essential information for regulators to properly evaluate which human drug trials should be approved, the report said.

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Nearly three in five (58 percent) U.S. travelers age 30 and over say getting a cold while traveling is as annoying as sitting next to crying child while traveling, says a national survey released Thursday.

The online survey included 1,366 adults, age 30 and over, who took at least one leisure, business, or combined leisure/business trip by plane in the previous year. The survey also found:

• 79 percent said getting a cold while traveling is annoying or very annoying.
• 37 percent said getting a cold has negatively affected their travel experiences.
• 49 percent said they feel dissatisfied with their vacation if they catch a cold.
• 51 percent said they can't perform at their best while traveling if they have a cold.

The survey was conducted by Harris Interactive on behalf of a company that makes a cold remedy.

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Women who've worked on farms are almost three times more likely to develop breast cancer than women who've never worked in agriculture, says a Canadian study published Thursday in the journal Annals of the New York Academy of Sciences.

The 2 1/2-year study included 564 breast cancer patients, 154 of whom had worked on farms, and all were treated at the Windsor Regional Cancer Center in Ontario, the Toronto Star reported.

The breast cancer patients were compared to a group of women who did not have any kind of cancer. And after the researchers accounted for a number of known breast cancer factors -- including age, smoking, genetics, hormone replacement therapies, and number of children -- the association between agriculture and breast cancer became evident.

Exposure to pesticides and other substances commonly found on farms may explain the link, the study said.

"We also found that if she went on to work in healthcare or in auto (manufacturing) her breast cancer risk continued, and in the case of the auto industry, it actually slightly increased," study author James Brophy, an occupational and environmental health scientist, told the Star.

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Just 30 minutes a day of riding on the New York City subway can cause permanent hearing loss, says a Columbia University study just published in the Journal of Urban Health.

The findings were immediately criticized by the New York City Transit Authority, which called the study "fundamentally flawed due to inadequate research," United Press International reported.

The Columbia researchers found that regular subway noise averaged about 94 decibels to 95 decibels, but reached 106 decibels at some of the subway platforms. By comparison, a lawn mower produces about 107 decibels.

According to U.S. Environmental Protection Agency (EPA) and World Health Organization guidelines, people should not be subjected to levels of 106 decibels for more than 30 seconds, UPI reported.

"By itself, riding (the subway) long enough could definitely put your hearing at risk," said study lead author Robyn Gershon, a professor at Columbia's Mailman School of Public Health. "Once the damage starts, it passes a threshold and keeps adding and keeps adding, and pushes you over the edge."

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Hispanics in four cities -- New York, Chicago, Miami and San Diego -- will be the focus of the largest long-term government study of health and disease in that group of Americans.

The 6 1/2-year, $61-million study will include about 16,000 people (4,000 per city) who will undergo a series of physical examinations and interviews to help researchers identify the prevalence and risk factors for a wide number of diseases, disorders, and conditions. The study volunteers will range in age from 18 to 74 years.

The Hispanic Community Health Study, funded by the U.S. National Institutes of Health (NIH), will also examine the role of cultural adaptation and disparities in the prevalence and development of disease among Hispanic Americans.