Daily Bulletin


The Conversation

  • Written by The Conversation

Following on from my previous post about the misleadingly dubbed “pink Viagra”, the drug flibanserin, to treat low sexual desire in women, news was received today confirming approval of the drug by the Food and Drug Administration. The approval follows the recommendation of an advisory committee convened to assess the safety and efficacy of the drug. After a day of hearings on 4 June the advisory committee agreed to recommend approval but did so reluctantly, and with a number of concerns about the management of the potential risks.

Three members of the scientific advisory committee subsequently published a viewpoint article in the Journal of the American Medical Association. They explained that in the highly politically charged environment surrounding flibanserin it is difficult for the FDA to balance a number of issues:

Firstly, the Even the Score consumer advocacy campaign mobilised a groundswell of support, campaigning on the platform of gender equality in medicine.

Secondly, there were concerns about the validity of the outcome measure used in new evidence provided to the committee following two previously unsuccessful attempts to gain FDA approval. The usefulness of the outcome measure (retrospective recall of sexual satisfaction over a month), however, was not the focus of the committee discussions.

Thirdly, there was considerable speculation about the way the drug would be likely to be used in clinical practice, and the committee noted significant concerns about the risks associated with potential off-label use of the drug.

The scientific advisory committee clearly recommended approval reluctantly, and the authors of the JAMA article note that:

“The FDA regulates drug approval and marketing, not the practice of medicine. The Committee’s discussions about flibanserin and off-label use highlight the challenge that the FDA encounters when considering a product that may help a subpopulation of patients, but also has a risk-benefit profile that may make it unacceptable for broader use.”

Today’s FDA decision to approve flibanserin ends weeks of speculation but is not unexpected. The question now is how women, their partners, their doctors, and society in general will embrace this new option.

Disclosure

Jayne Lucke is the Director of the Australian Research Centre in Sex, Health and Society at La Trobe University. She receives funding from the Australian Research Council and the National Health and Medical Research Council. She has served as a Director of Family Planning Queensland and been Chief Investigator on an ARC Linkage Grant that involves cash and in-kind support from Family Planning New South Wales and Bayer Australia. The Australian Research Centre in Sex, Health and Society receives funding from diverse sources listed in the annual report available from the website: http://www.latrobe.edu.au/arcshs

Authors: The Conversation

Read more http://theconversation.com/the-drug-flibanserin-is-approved-for-the-treatment-of-low-sexual-desire-in-women-46335

Writers Wanted

Queensland's LNP wants a curfew for kids, but evidence suggests this won't reduce crime

arrow_forward

We can no longer ignore the threats facing the Pacific — we need to support more migration to Australia

arrow_forward

The Conversation
INTERWEBS DIGITAL AGENCY

Politics

Prime Minister Interview with Kieran Gilbert, Sky News

KIERAN GILBERT: Kieran Gilbert here with you and the Prime Minister joins me. Prime Minister, thanks so much for your time.  PRIME MINISTER: G'day Kieran.  GILBERT: An assumption a vaccine is ...

Daily Bulletin - avatar Daily Bulletin

Did BLM Really Change the US Police Work?

The Black Lives Matter (BLM) movement has proven that the power of the state rests in the hands of the people it governs. Following the death of 46-year-old black American George Floyd in a case of ...

a Guest Writer - avatar a Guest Writer

Scott Morrison: the right man at the right time

Australia is not at war with another nation or ideology in August 2020 but the nation is in conflict. There are serious threats from China and there are many challenges flowing from the pandemic tha...

Greg Rogers - avatar Greg Rogers

Business News

What Few People Know About Painters

What do you look for when renting a house? Most potential tenants look for the general appearance of a house. If the house is poorly decorated, they are likely to turn you off. A painter Adelaide ...

News Co - avatar News Co

Important Instagram marketing tips

Instagram marketing is one of the most important approaches for digital advertisers. If you want to promote products online, then Instagram along with Facebook is the perfect option. After Faceboo...

News Co - avatar News Co

Top 3 Accident Law Firms of Riverside County, CA

Do you live in Riverside County and faced an accident and now looking for a trusted Law firm to present your case? If yes, then you have come to the right place. The purpose of the article is to...

News Co - avatar News Co



News Co Media Group

Content & Technology Connecting Global Audiences

More Information - Less Opinion