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WASHINGTON (AP) -- The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
In a warning letter posted online Monday, FDA regulators say that the Silicon Valley company has not shown that its tests are safe or effective despite "more than 14 face-to-face and teleconference meetings" and "hundreds of email exchanges." The agency orders 23andMe to stop marketing its test immediately, warning that erroneous results could cause customers to seek unnecessary or ineffective medical care.
23andMe's saliva-based test kit, launched more than 5 years ago, claims to tell customers if they are at risk for more than 250 diseases and health conditions. The FDA says only medical tests that have been cleared by the government are permitted to make such claims.
The letter follows years of back-and-forth between the government and 23andMe, the most visible company among a new field of startups selling personal genetic information. The spread of consumer-marketed DNA tests has troubled doctors and health officials who worry that the products are built on flimsy science.
For years, 23andMe resisted government regulation, arguing that it simply provides consumers with information, not a medical service. But last year the company changed course, submitting several of the disease-specific tests included in its test kit.
A spokeswoman for the Mountain View, Calif.-based company said 23andMe recognizes it has been late responding to FDA questions about the application.
"Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns," said Kendra Cassillo in a statement.
The FDA letter suggests that regulators have gone to great lengths to try and work with the company, citing months of meetings and dozens of letters between the two parties.
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated" its technology, states the letter.
The FDA warning, dated Nov. 22, takes issue with a number of claims the company makes for its test kit, particularly calling it a "first step in prevention" against diseases like diabetes, heart disease and breast cancer. Regulators worry that false results from the test could cause patients to receive inadequate or inappropriate medical care. For instance, 23andMe says its test can identify women who carry the BRCA gene mutation that significantly increases the risk of breast and ovarian cancer. But a false result could lead women to undergo unnecessary screening, chemotherapy and surgery.
The FDA gives the company 15 days to respond in writing to the letter's concerns. Warning letters are not legally binding, but the government can take companies to court if they are ignored.
23andMe was co-founded by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. Both Google and Brin have invested millions in the privately held company over the years.
Company executives previously said that they first contacted the FDA in 2007, before launching their product. The agency did not take an interest in the technology until 2010, when it issued letters to several testing companies, warning that their products must be approved as safe and effective.
The FDA already regulates a variety of genetic tests administered by health care providers. The FDA's concern with 23andMe appears to center on its marketing approach, which sidesteps doctors and health professionals.
Consumers order the company's $99 product online. Once the kit arrives by mail they are instructed to spit into a small tube, providing a saliva sample which is sent back to the company for analysis. 23andMe says the customer's DNA is analyzed to determine their likelihood of developing various diseases and responding to various drugs. The test also claims to provide information about ancestral background, though this information is not regulated by the FDA.
PARIS (AP) -- A French contraceptive maker said Tuesday its morning-after pill doesn't work when taken by women who weigh more than 80 kilograms (176 pounds) and plans to change its labels to warn patients.
The decision to change its labels by HRA Pharma is based on a previous study of levonorgestrel, one of the active ingredients in its Norlevo emergency contraceptive, said Frederique Welgryn, HRA Pharma's head of women's health.
Some doctors said heavy women shouldn't assume emergency contraception won't work for them and that they should talk to a health professional or consider alternatives like a copper IUD, a birth control device that can be fitted on the uterus.
Norlevo is not sold in the U.S. but another drug with the same active ingredient is widely available.
Welgryn said a dose of HRA's drug contains 1.5 mg of levonorgestrel, identical to that found in Plan B One-Step, manufactured by Teva Pharmaceuticals in the U.S. Denise Bradley, a spokeswoman for the company, declined to comment.
The Food and Drug Administration is currently reviewing the issue and will determine "what, if any, labeling changes to approved emergency contraceptives are warranted," according to spokeswoman Erica Jefferson in an email.
Welgryn said that while the results of the study conducted by the University of Edinburgh in 2011 were "quite surprising," the last few years have seen much discussion about contraceptives' efficacy in overweight or obese patients.
HRA Pharma Chief Executive Erin Gainer estimated that millions of women across Europe use emergency contraceptives identical to Norlevo. Gainer declined to give sales figures for Norlevo alone.
Anna Glasier, a lead researcher in the 2011 study, said that their research wasn't designed to look specifically at the effect of weight on emergency contraception. She said their study only included about 1,700 women.
"It is not my place to comment as to whether the company's decision to change advice is premature," she said in an email.
She also noted another previous analysis that found there was no solid evidence to show that hormonal contraceptives were less effective in overweight women, but the quality of the studies was low.
The morning-after pill contains a higher dose of the hormone in regular birth control pills. Taking it within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent, but it works best within the first 24 hours. If a woman is already pregnant, the pill, which prevents ovulation or fertilization of an egg, has no effect.
HRA began the process of consulting with French regulators about changing the pill's labeling in 2012 and it has taken until now for Europe's drug regulators to approve the change, Welgryn said.
The new warning also says that the drug's efficacy is reduced in women who weigh more than 75 kilograms (165 pounds), and it is ineffective in women who weigh more than 80 kilograms.
Dr. Diana Mansour, a spokeswoman for Britain's Faculty of Sexual and Reproductive Healthcare, said in overweight and obese women the drug probably gets absorbed into their fat more quickly and doesn't have enough time to work in their bodies.
"It has less of a chance to delay ovulation and there are lower levels (in the blood) of the drug to have an effect," she said. Mansour said there wasn't enough information to know if simply giving obese women a higher dose of the drug would solve the problem.
In the U.K., doctors haven't been given any advice to stop giving overweight or obese women Levonnelle, which contains the same active ingredient as Norlevo.
Lynn Hearton, clinical lead for the FPA sexual health charity, said any overweight or obese women concerned about emergency contraception should speak to a medical professional.
"It is particularly important we don't put some women off taking emergency contraception because they think it won't work anyway," she said.
She said women should consider using an IUD, which can be inserted in the womb up to five days after unprotected sex.
HRA markets Norlevo in about 50 countries worldwide. It began marketing the pill in France in 1999.
It will begin printing the warning on packaging in the first half of 2014.
Cheng reported from London. Associated Press writer Matthew Perrone in Washington contributed to this report.
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Keeping citizens safe and their property secure are the top priorities for the St. Louis County Police, so the department has announced that it's annual Holiday Enforcement/Crime Prevention Program in underway.
The County Police Department will have both uniformed and undercover officers working in and around shopping centers.
The Metro Air Support Unit will also continue patrolling commercial parking lots and shopping centers. Officers of the St. Louis County Police Department’s Highway Safety Unit will be working additional patrols throughout the holidays, emphasizing DWI enforcement.
Chief Tim Fitch stated, "We want everyone to enjoy a safe and happy holiday season. In addition to each precinct implementing specific strategies for their area, officers from our Division of Special Operations, such as the Highway Safety Unit, will also be highly visible. Remember, keep your eyes and ears open and immediately call the police if you see suspicious activity. Prevention is the key, and if we all pitch in and work together, I know we can be successful."