Science Policy For All

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Science Policy Around the Web – June 9, 2015

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By: Cheryl Jacobs Smith, Ph.D.

Drug Policy

FDA Backs Experimental ‘Female Viagra’

Amidst previous accusations that the Food and Drug Administration (FDA) maintains a gender bias when it comes to treating sexual dysfunction, there may finally be a drug on the market intended to treat female sexual dysfunction. Flibanserin (proposed trade name: Addyi), produced by Sprout Pharmaceuticals, has been recommended for approval by the FDA. The recommendation is lauded as a victory by advocates for a female version of the blockbuster male sexual dysfunction drug, Viagra. Finally, there is a product on the market tailored to specific biological sexual dysfunction in women—but the FDA warns that it should be considered cautiously.

For years the FDA has struggled to approve female sexual dysfunction drugs in part due to lackluster effectiveness and safety issues. In a report released by the FDA from the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee, individuals on the committee show interest in getting flibanserin approved; however, they are hesitant due to the interactions flibanserin has with alcohol consumption. The agencies assert that although the observed treatment benefits are significantly beneficial when compared to those individuals who took a placebo, the safety concerns outweigh the risks. Those risks include that co-consumption of flibanserin and alcohol can lead to heavy sedation, and that there are cardiovascular issues, such as syncope and hypotension, that can lead to low blood pressure and fainting. “We really know almost nothing about the actual clinical effects of using this product together with alcohol,” said Dr. Tobias Gerhard of Rutgers University. “We have some indication that there is clearly a concern from very small studies.”

Despite FDA’s caution concerning flibanserin’s drug interactions, there is still a desire to take flibanserin even to achieve the drug’s expected modest results. “I want to want my husband, it is that simple,” said Amanda Parrish, a mother of four from Nashville Tenn. “For us, flibanserin is a relationship-saving and life-changing drug.” (Matthew Perrone, Huffington Post)

Precision Medicine

NIH researchers sequence healthy volunteers’ DNA and find they aren’t so healthy after all

The National Institutes of Health (NIH) conducted a study a few years ago where they sequenced the genome of 1,000 healthy volunteers. The volunteers appeared to be free of disease as assessed by blood tests, echocardiograms, and self-reported systems. The sequencing result of these 1,000 healthy volunteers shocked the NIH team.

Many of the presumably healthy volunteers’ DNA contained mutations that made them more susceptible to certain conditions such as cancer and kidney disease. Interestingly, these some of individuals, or their family members with the same genetic background, were living with the disease mutation but did not have any clinical indication or outward sign of the disease. All of the participants in the study were adults, ranging from 45 to 65 years of age. The researchers who designed the study assert that this age range is prime to observe many signs of genetic disease, so it was interesting to observe volunteers whose diseases had not manifested despite their genetic susceptibility.

NIH researchers did contact participants about their genetic findings concerning disease and one volunteer shared the information with his sister. The sister sequenced herself and found that she shared the disease mutation that predisposed her to breast and ovarian cancer. She decided to undergo preventative surgery for ovarian cancer and during the procedure the doctors found a tumor.

Such findings are important to understand in light of DNA testing and in the wake of the 21st Century Cures Initiative that aims to put personalized medicine in the forefront of patient care. (Ariana Eunjung Char, Washington Post).

Global Science and Development

Nigeria’s new leadership raises hopes for science

On May 29, 2015, Muhammadu Buhari assumed office as the President of Nigeria. Although Nigeria is one of Africa’s most populous country with the largest economy, it publishes much fewer times than other African countries relative to the size of its economy.

Oye Ibidapo-Obe, vice-chancellor of the Federal University Ndufu-Alike Ikwo in Ebonyi State and former president of the Nigerian Academy of Science explains that Nigeria has suffered from leadership that has paid only lip service to the contribution of science to national development. The administration failed because they were not proactive in implementing a national science and innovation policy it introduced in 2012. Changes for the future of science in Nigeria could include implementing the 2012 policy and putting in place a NSF-like body to review grants and give funding. Mr. Ibidapo-Obe says, “I would like to see a country that is aware of the value of science. Our leaders know and profess that science can provide solutions to our contemporary challenges — poverty, education, good health provision, human security, clean and adequate energy, proper public infrastructure, food, climate-change adaptation, democracy and good governance. But they have not shown sufficient courage to invest massively in science and technology.” (Jackie Opara, Nature)

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Written by sciencepolicyforall

June 9, 2015 at 9:00 am

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