Stomach pump- new FDA approved weight loss device. #isthisforreal

No, this is NOT an onion article… the FDA has just approved a weight loss device called Aspire Assist which is essentially a stomach pump that can directly remove food from your stomach after it has been consumed. Glad we’re doing something to battle the obesity problem in this country, however, what happened to good old fashioned diet and exercise?

The Food and Drug Administration approved a weight loss device on Tuesday that pumps food out of a person’s stomach after they eat a meal.

While some have criticized the device as “assisted bulimia,” the FDA stressed in a statement, that the AspireAssist device is not meant for anyone with an eating disorder, and should only be used by adults 22-and-older who are obese and have failed to lose weight through non-surgical methods.

To place the device, a surgeon makes a tiny incision and endoscopically puts a tube in the patient’s stomach, which is attached to a “disk-shaped port that lies outside the body,” according to the statement.  To drain the contents of the stomach, a person should wait twenty or thirty minutes after they eat, and then attach an external connector to the port and open the valve.

According to the statement, 30 percent of the calories consumed during a meal can be removed by the device, which takes five-to-ten minutes to drain the food from the stomach into the toilet. Continue reading

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FDA finally lifts ban on blood donations by gay men

‘Tis the season to give? The FDA announced yesterday that they are finally lifting the ban on blood donations by gay men. There are still several restrictions however. From NPR:

The Food and Drug Administration is relaxing a 32-year-old ban on blood donations from gay and bisexual men.

The FDA announced Monday that it was replacing a lifetime prohibition with a new policy that will allow gay and bisexual men to donate blood, but only if they have not had sexual contact with another man for at least one year.

“Relying on sound scientific evidence, we’ve taken great care to ensure the revised policy continues to protect our blood supply,” said Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research.

In 1983, the FDA banned gay and bisexual men from ever being eligible to donate blood to protect people receiving blood transfusions from the possibility of getting infected with the human immunodeficiency virus, which causes AIDS.

But gay-rights advocates and many medical groups have been urging the FDA to lift the ban for years. They argue the policy is discriminatory because it singles out gay and bisexual men and that it is unnecessary because blood donors can be screened for HIV.

Others, however, have urged the FDA to keep the ban, saying that infected people can slip through the screening process. Blood tests remain negative for about nine days after a person has been infected with HIV.

After weighing the arguments, Marks announced the FDA is finalizing a policy change it proposed last year. The new policy brings the U.S. in line with other countries, including Australia, New Zealand and Britain, Marks says. Research in Australia indicates the policy would not jeopardize the safety of the blood supply.

But this has not satisfied many advocates.

“It perpetuates the stigma that HIV is a gay disease,” says Kelsey Louie, who heads Gay Men’s Health Crisis, an advocacy group.

Gay or bisexual men in monogamous relationships may be at much lower risk as donors than, say, promiscuous heterosexuals, Louie said.

But others are praising the new policy as a reasonable compromise.

“The gay community and many people view blood donation as a civil right. And I don’t think it is,” says Dr. Kenrad Nelson, a professor of epidemiology at Johns Hopkins Bloomberg School of Public Health who advised the FDA about the policy.

Nelson points out he can’t donate blood for a year after he returns from countries where he might have gotten infected with malaria.

The FDA says it will monitor the new policy to see whether the restrictions could eventually be relaxed more.

FDA commisionner Margaret Hamburg schools us on measles and the measles vaccine!! #science

hamburgMargaret A. Hamburg, M.D., the Commissioner of Food and Drugs at the FDA, has written a terrific piece in response to the recent measles outbreak. Check it out here at the FDA blog. Hamburg emphasizes the importance of high vaccination rates, the safety of the vaccines, and the effectiveness of the vaccine!

In recent weeks we’ve seen an alarming outbreak of measles; a highly contagious and serious virus, especially in babies and young children who have not been vaccinated. This outbreak is particularly disturbing because measles was effectively eliminated from the United States in 2000 thanks to nearly universal vaccination, the single best way to prevent the spread of this disease.

Vaccination works with the body’s natural defenses to help it safely develop immunity to the measles. When more people are vaccinated, there are fewer opportunities for the disease to spread. A community generally needs more than ninety per cent of its members to be immunized against the virus in order to protect those who can’t be.

Before the first measles vaccine was approved in 1963, hundreds died from the disease each year. Others developed pneumonia, lifelong brain damage or deafness.

Let’s not return to these grim statistics. There is no shortage of measles vaccine. It should be used by everyone who has not been vaccinated to prevent measles and the potentially tragic consequences of the disease.

Sen. Elizabeth Warren supports science based policy for FDA blood donation!

Senator Elizabeth Warren continues to be an amazing advocate for SCIENCE and SCIENCE-based policy. The FDA recently renewed the ban on blood donation by many Americans (specifically by members of the LGBT community), Senator Warren tweeted her frustration. More info on the blood donation ban here, and responses from other Senators here (both via Towleroad Blog).

[tweet https://twitter.com/SenWarren/status/547548361503428608] [tweet https://twitter.com/SenWarren/status/547548317622620160]

Senator Warren has previously voiced her support for science and research here.

#Ebola Update: FDA approves 3-hour Ebola test from Roche, Ebola case count surpasses 20,000!

The FDA has approved a Roche test for Ebola that detects the virus in 3 hours (LightMix Ebola Zaire rRT-PCR). More info here.

New case counts from the World Health Organization indicate there have been more than 20,000 Ebola cases in the current West African outbreak.

More than 20,000 people have been diagnosed with Ebola virus and more than 7,800 have died of it, according to the latest data from the World Health Organization. It’s a new milestone in the ever-worsening Ebola epidemic in Sierra Leone, Liberia and Guinea, and it shows Sierra Leone has more cases than any other country.

Science Quotable: Mary Woolley #Research!America

Complex global disease threats exemplify the importance of both the public and private sectors in protecting our health.  Why, then, are we not fully funding the NIH, CDC and FDA to ensure the  robust public health infrastructure needed to respond to population-wide threats, to pursue vaccine development and other prevention strategies, and to develop new treatment options for Ebola and a host of other threats?  Why have we not truly empowered industry and public-private partnerships with a regulatory and tax environment worthy of the 21st century? – Mary Woolley – President of Research!America

Mystery Ebola serum + racism + humor = complicated mess #Ebola #science #research

You may have heard about the ‘mystery’ vials that were given to 2 Americans that contracted the Ebola virus. These vials contained an anti-ebola serum called zMapp, an antibody treatment for Ebola that is untested in humans. It has been quite successful in limited primate studies, but is still quite far from being ready for routine human use. One reason for this, is that the serum is made up of 3 monoclonal MOUSE antibodies. Most antibody treatments used in humans are humanized, meaning they are modified to look like they are part of our bodies so that our immune systems don’t recognize them as foreign. When you put a protein or antibody from mouse, or other animal, into humans, our immune systems attack and remove it. Therefore, putting mouse antibodies against Ebola virus into humans will mean that the antibodies can have an impact on the virus for only a short period before our immune system gets rid of them. This makes future treatment with the serum basically useless.

Many people have questioned why this serum was used on 2 Americans when it has not been used on the more than 800 people in Africa who have died during this Ebola outbreak. Even The Onion has taken up this issue in a sarcastic article:

ebolaonion

“While all measures are being taken to contain the spread of the contagion, an effective, safe, and reliable Ebola inoculation unfortunately remains roughly 50 to 60 white people away, if not more,” said Tulane University pathologist Gregory Wensmann, adding that while progress has been made over the course of the last two or three white people, a potential Ebola vaccination is still many more white people off.

While the humor in the article rings true, there are many reasons that we are not sending this untested serum all over Africa. I’ll mention a few of the poignant reasons here, while hoping we can also figure out a way to get this treatment or some treatment out fast.

First, it is extremely experimental. As mentioned above, it has never been given to humans.

Second, one factor contributing to the current Ebola outbreak is a mistrust of western medicine and medical workers in affected communities. Using an untested treatment would almost certainly make this situation worse.

Third, although it may seem racist (as pointed out by the Onion article) to only use the serum on Americans, the medical community has sort of a rough history of testing experimental treatments on specific communities, ethnicities, races, countries etc. The last thing the medical research community needs is to look like it is experimenting with an untested treatment on a vulnerable population that has no other options.

There is also the distinct possibility that there is not a real supply of the serum, since it is so early in development. Hopefully the serum will prove effective in the cases of the Americans and can be fast-tracked or somehow used compassionately in Africa as well, but there are many reasons this may not happen in the immediate future.

More info on zMapp here.

Also be sure to check out the many CauseScience posts about Ebola virus and the current outbreak!