Posts Tagged ‘ FDA ’

FDA Recommends HPV Test, Not Pap, for Cervical Cancer Screening

Monday, March 17th, 2014

The Pap smear test, which women have had annually for decades as a way of screening for cervical cancer, may soon become passe, as a Food and Drug Administration panel has recommended a different test, also performed by vaginal swab, as the first line of defense against the disease.  The new test looks for the DNA of the human papillomavirus, or HPV, which is the cause of more than 99% of all cervical cancers, while Pap tests look for abnormal squamous cells that could indicate cervical cancer.  More from CNN.com:

Up until now, the Pap was the first test women had to detect the illness, with the HPV test as a second analysis. But if the FDA follows the advisory committee’s recommendations, that would change.

The committee, which voted unanimously to make the switch, would only allow the Roche cobas test to be used alone as the primary evaluation for women 25 years and older. Although there are other HPV tests available, the Roche test detects two strains of the virus that are found in 70% of all cervical cancers.

“Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer,” said Dr. Thomas Wright Jr., an expert in gynecology and pathology at Columbia University Medical Center.

“I am pleased that the FDA panel recognized the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”

This does not mean the Pap test will go away. It will really be up to the physician and the patient on how best to handle testing. But according to women’s health experts, in most cases, patients who don’t have HPV are less likely to need a Pap, which is why the advisory committee felt it best to recommend the Roche test be administered as the first form of detection.

“I think anytime guidelines are changed, it becomes confusing for both patients and physicians. And we’re going to have to do more research on what’s best,” said Dr. Angela Marshall, director of Comprehensive Women’s Health of Maryland. “But the fact that the FDA is looking to make these changes says we’ve made great strides in detecting and treating cervical cancer.”

Image: Speculum, via Shutterstock

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Raw Milk Won’t Help Lactose Intolerance, Study Shows

Thursday, March 13th, 2014

Despite FDA warnings against drinking unpasteurized, “raw” milk, some parents continue to choose it for their families, citing a number of health claims including that it is a gentler alternative for lactose intolerant people.  A new study published in the Annals of Family Medicine has found, however, that no such link with lactose intolerance exists. More from Time.com:

Only a small population of people drink unpasteurized milk, also known as “raw” milk, but its increasing popularity has some medical groups concerned. Some raw milk advocates argue that it’s healthier for us since raw milk contains no antibiotics or hormones, while others say it’s better for people with lactose allergies. For its part, the FDA advises against drinking raw milk, which can contain bacteria from fecal matter and sometimes be fatal, and has long stated that it doesn’t help with lactose intolerance.

But a new study published in the Annals of Family Medicine is definitively poking holes in the allergy theory, by reporting that lactose-intolerant people have the same symptoms from raw and pasteurized milk.

Advocates for raw milk claim that it contains good bacteria that can help with lactose absorption. “When I heard that claim it didn’t make sense to me because, regardless of the bacteria, raw milk and pasteurized milk have the same amount of lactose in them,” said study author Christopher Gardner, a professor of medicine at the Stanford Prevention Research Center in a statement. “But I liked the idea of taking this on since it seemed like a relatively straightforward and answerable question because the symptoms of lactose-intolerance are immediate.”

The study was small, with only 16 lactose-intolerant participants. All 16 tried three different types of milk–raw, pasteurized, and soy–over multiple eight-day periods.

For eight days, the participants were randomly assigned to one of the three milks, and they drank an increasing amount of that milk as the study period went on. They then reported their allergy symptoms, which were usually gas, diarrhea, and cramping, and rated them on a scale of 0 to 10. Their breaths were also measured for hydrogen, which can indicate undigested lactose in the colon and intolerance.

After the first eight days of drinking one type of milk, the participants took a week off where they drank no milk, and then started up again with another eight days of a different type of milk. To mask which type of milk participants were drinking, researchers randomized the order and added sugar-free vanilla syrup. Soy, which doesn’t contain lactose, acted as the control.

Researchers found no differences in the hydrogen breath tests between consuming pasteurized or unpasteurized milk. Participants also rated their symptom severity the same, regardless of the type of milk they drank.

Image: Milk, via Shutterstock

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7-Year-Old Denied Experimental Medication by Drug Company

Wednesday, March 12th, 2014

A 7-year-old Memphis boy who is suffering from heart and kidney failure has been denied an experimental drug that could very well help improve his condition.  The drug company, in denying the drug to Josh Hardy, says its efforts to get the drug to market–with full FDA approval–will be severely impeded if the medication is given to patients at this stage.  More from CNN:

Here’s the way it works: According to the Food and Drug Administration, if someone has a serious or immediately life-threatening disease and has tried and failed other available treatments, they can ask a drug company for an experimental drug, one that they’re still studying and has not yet been approved by the FDA.

Companies often say yes: The FDA approved 974 compassionate use arrangements in fiscal year 2013.

But pharmaceutical companies often say no, as they did to Josh Hardy.

“Our son will die without this drug,” said Todd Hardy, Josh’s father. “We’re begging them to give it to us.”

So now, like many families, the Hardys have turned to the media, Facebook, and change.org to pressure the drug company to change its mind.

Countless members of “Josh’s army” have responded with angry tweets to @chimerix, telling them to “open their hearts,” asking the executives how they can sleep at night.

“Everyone is watching,” one tweeter warned the company. Others have tweeted out the e-mail addresses of the company’s board members. Chimerix executives say they’ve received physical threats.

Moch, the company president, has read these tweets and said he is heartbroken, but the issue is complex and unsuitable for a 144-long character debate.

At its very simplest, this is it: Chimerix is going full speed ahead to get the drug on the market hopefully by the end of 2016, and if they spend time and money on compassionate use cases, it would greatly hinder their effort to get the drug, brincidofovir, on the market and available to everyone.

The company would have to dish out $50,000 per compassionate-use patient, since insurance doesn’t usually pay for experimental drugs, Moch said. And perhaps even more important than the money, it would divert manpower in this 50-person company, since they’d have to handle the requests and then get the patient’s records and follow up with them, as required by the FDA.

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FDA Announces New Infant Formula Safety Rules

Monday, February 10th, 2014

The Food and Drug Administration has announced new guidelines meant to make sure infant formula is both safe and nutritious.  The new guidelines are based on two years’ worth of research, during which time Gerber voluntarily recalled some formula because of a strange odor, and some brands of organic formula were found to contain high levels of inorganic arsenic.  More on the FDA’s new rules from The Associated Press:

Most formula makers already abide by the practices, but the FDA now will have rules on the books that ensure formula manufacturers test their products for salmonella and other pathogens before distribution. The rules also require formula companies to prove to the FDA that they are including specific nutrients — proteins, carbohydrates, fats, vitamins and minerals — in their products.

It is already law that formula must include those nutrients, which help babies stay healthy. But the new rules will help the FDA keep tabs on companies to make sure they are following the law. The rule would require manufacturers to provide data to the FDA proving that their formulas support normal physical growth and that ingredients are of sufficient quality.

“The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being,” Michael Taylor, the FDA’s deputy commissioner for foods, said.

The rules also are aimed at new companies that come into the market. In recent years, grocery store aisles have become even more crowded with new kinds of formula, some capitalizing on natural or organic food trends.

The agency said breastfeeding is strongly recommended for newborns but that 25 percent of infants start out using formula. By three months, two-thirds of infants rely on formula for all or part of their nutrition.

The FDA doesn’t approve formulas before they are marketed but formula manufacturers must register with the agency. The FDA also conducts annual inspections of facilities that manufacture infant formula — far more often than the agency does inspections of other food facilities.

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How to Prepare a Bottle of Formula
How to Prepare a Bottle of Formula
How to Prepare a Bottle of Formula

Image: Infant formula, via Shutterstock

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Whooping Cough Vaccine Less Effective Than Hoped; Researchers May Know Why

Tuesday, November 26th, 2013

The vaccine against pertussis, which is commonly known as whooping cough, has been perplexing researchers who are observing that it’s less effective than anticipated at halting the spread of the disease.  2012 was the worst whooping cough outbreak in 50 years, and the continued presence of the disease is troubling, especially as many families choose not to have their children vaccinated–or to get Tdap booster shots themselves.

A new study by the Food and Drug Administration may be onto the reason why even in communities with high vaccination rates, whooping cough can appear and spread.  More from NBC News:

The research suggests that while the vaccine may keep people from getting sick, it doesn’t prevent them from spreading whooping cough — also known as pertussis — to others.

“It could explain the increase in pertussis that we’re seeing in the U.S.,” said one of the researchers, Tod Merkel of the Food and Drug Administration.

Whooping cough is a highly contagious disease that can strike people of any age but is most dangerous to children. It was once common, causing hundreds of thousands of illnesses annually and thousands of deaths. But after a vaccine was introduced in the 1940s, cases dropped to fewer than 5,000 a year.

The vaccine was replaced in the 1990s because of side effects that included pain and swelling from the shot and fever. The newer vaccine is part of routine childhood vaccinations as well as adult booster shots.

But cases have rebounded. Last year was the nation’s worst year for whooping cough in six decades — U.S. health officials received reports of more than 48,000 cases, including 18 deaths.

This year hasn’t been half as bad — about 20,000 reported illnesses, including six deaths so far. Whooping cough ebbs and flows in cycles, so experts aren’t surprised to see cases recede. But 20,000 can still be seen as a lot when a widely used vaccine is supposed to protect the public.

Image: Child coughing, via Shutterstock

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