Would you take a pill to prevent AIDS? Those at risk should consider it, says Massachusetts.

The Globe reports today on the push to make Capturean AIDS prevention drug available. After
many years of struggling to come up with a vaccine, this was a true breakthrough. (We don’t use that word lightly on this page.) But instead of a shot that stays with you for year, here you have to take a pill.

Critics questioned the wisdom of giving powerful drugs to healthy people, and worried that access to a preventive drug would encourage promiscuity or lead to a spike in other sexually transmitted diseases by reducing condom use.

But as study after study — some conducted in Boston — found the drug safe and effective, public health officials came to embrace PrEP, concluding the benefits exceed the hazards. The US Centers for Disease Control and Prevention estimates that some 1.2 million people at risk of HIV infection should at least consider PrEP.

 

 

 

 

 

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The New Yorker:#Boston researchers are hunting for a #Zika vaccine — trco201

The August 22 edition of The New Yorker includes a story by Siddhartha Mukhergee on Dan Barouch, director, Center for Virology and Vaccine Research at BIDMC. He’s on the hunt for a Zika vaccine and his work on HIV is informing the effort. From the article, which is not behind the NYer pay wall:

Capture

 

Should the FDA approve Vertex’s new cystic fibrosis drug?

The scene at the FDA hearing was familiar. All the  advisory committees have seen it play out again and again. Yesterday, it was the Pulmonary-Allergy Drug committee: The pharma doc with the convincing statement. The weeping patients. The drug likely to cost a couple thousand a month offering a slim  benefit over an existing drugs. But it works, and it’s safe.

From the Globe:VertexLogoSOP

“I think this is a much-needed advance for patients with cystic fibrosis,” said committee member Dr. Michelle S. Harkins, associate professor of medicine at the University of New Mexico Albuquerque, one of the majority voting to recommend approval.

The lone dissenter in the 12-1 vote recommending approval of the drug, Dr. Yanling Yu, the president and cofounder of Washington Advocates for Patient Safety in Seattle, said she was not convinced the data generated by the Vertex testing supported the approval of Orkambi.

“I really understand the patients critically need a new drug, but sometimes a new drug does not provide [the needed effectiveness],” she said.

From The New York Times story:

An issue for the advisory committee was that Orkambi had what the F.D.A. said was only modest effectiveness, improving lung function by only about 3 percentage points relative to placebo.

Some family members or advocates, some of them crying, pleaded with the committee to endorse the drug.

Some patients who took the drug in clinical trials said it had made a huge difference in their lives, reducing their coughing, allowing them to exercise better, helping them gain weight or reducing how often they ended up in the hospital…

Michael Yee of RBC Capital Markets, for instance, expects the price will be $225,000 to $250,000 a year.

The vote is advisory. The FDA staff will make the final call.

More here:

The financial stakes for Vertex.

FDA briefing for meeting.

Vertex briefing for the meeting

@CommonHealth: Wikipedia and “energy” therapist clash over definition of “respectable scientific journals”

ss We link to a CommonHealth guest post by a Spaulding Rehab doc Eric Leskowitz. He promotes new age approach to pain known as “energy medicine “ and says he’s  been dismissed by Wikipedia as a “quack” despite his peer-reviewed work and Harvard cred

Hard to disagree with the first part of Wikipedia’s response to a petition supporting Leskowitz…

 If you can get your work published in respectable scientific journals – that is to say, if you can produce evidence through replicable scientific experiments, then Wikipedia will cover it appropriately..

.…except to say: What’s defines a “respectable”  journal.  True, not all peer review is equal, but who makes that call?

Wikipedia errs on the safe side and sets a high evidence bar. Still, Wikipedia’s ‘s citation of  Quackwatch — a virulently  anti-alt medicine web site — seems shaky. That site casts its net widely, ragging on everything from faith healers to acupuncture and massage therapy.

And the rest of Wikipedia’s response seemed kind of harsh…

What we won’t do is pretend that the work of lunatic charlatans is the equivalent of “true scientific discourse”. It isn’t.

At the same time, Leskowitz doesn’t do himself any favors by citing Dr. Mehmet Oz’s endorsement.  Dr. Oz has been known to promote less than substantiated therapies.

Energy Psychology has even gotten some fairly mainstream attention, from television’s Dr. Oz to The Huffington Post.

 

 

Supported by evidence? Mobile health screening gets scrutinized

My latest for HealthLeaders Media looks at Public Citizen charges that a health screening program overstates the promise of its services. Public Citizen takes issue with company claims that cardiac screening saves lives. After issuing am initial statement criticizing Public Citizen as proponent of “government-run health care”, HealthFair now says it wants to work with regulators to ensure the accuracy of its advertising.

The debate over screening for heart disease and other conditions is playing out in a consumer group’s campaign to get hospitals to cut ties with the mobile screening company HealthFair Health Screening.

Last week, Public Citizen expanded its campaign by asking the Federal Trade Commission to investigate whether HealthFair’s promotional materials amount to deceptive advertising.A handful of hospitals have discontinued their relationships with Florida-based HealthFair after Public Citizen’s Health Research Group (HRG) accused the company of “fear-mongering.” In June, Public Citizen contacted HealthFair’s hospital clients and The Joint Commission to complain that company overstates the health benefits of its screening programs.      

Science writers meet in Cambridge MA to discuss the shabby treatment of female sci scribes

On deadline today, but will be keeping an eye on this.  You can too.  

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The world of science writers has a dual problem that we have confronted recently, involving issues of sexual equality and of sexual harassment. As an initial step toward grappling with these problems, the National Association of Science Writers held a session at its 2013 meeting in Gainesville, the XX Science Question, featuring six panelists and a standing-room-only audience intent on airing these concerns. What was originally planned as a session on women and representation among science writers instead grew into a plenary in which the community brought forward a number of issues. But time was necessarily limited, precluding getting into any single concern in any depth.

Now, the members of that panel have expanded what began at the plenary in Gainesville and are coordinating a conference to address these issues, with generous funding from the National Association of Science Writers. The conference will take place at MIT on June 13-15, 2014, to bring together stakeholders in the community for training, discussion, and finding consensus on solutions. While the team listed below is serving to organize and coordinate, the important contributions at this conference will come from attendees, some invited and others registered through open registration, all with the goal of having as much representation as possible across community stakeholders.

The Boston Globe’s science blog is worth digging for

ss2aCarolyn Y. Johnson’s “Science in Mind”  blog in the  Globe, which is buried in the print version of the paper and difficult to find online. (Hover over  “News” and it’s in the menu to the right.)

Science reporting is hard. Writers have to find a spot between jargon spewing and oversimplification. The “why should I care?” bar can be difficult to scale, especially for important but incremental developments. The tendency is to hype it up, follow the crowd or regurgitate journal findings because they are vetted – so they must be important.

They aren’t always, so we need sharp blogging like Johnson’s. She does a bit of reporting on journal articles herself. But, she puts the research in context. At a time when even papers like The Washington Post are printing press releases as stories, blogging like this is even more valuable.  (For more on the need for good science reporting, see Sense about Science.)

Johnson’s latest post deals with the tendency of some to judge the value of science by the silly title or obscure topic of research articles. Here, she alerts to some pushback from a UMass researcher Patricia Brennan who studies reproduction in ducks.

Can’t resist the – Ha ha, duck dick –  pun? Unless you’re handing out Ig Nobels, grow up and read on:

Her work became the butt of political jokes when a $385,000 grant from the National Science Foundation to study duck penises attracted the attention of a conservative news website. Brennan found herself in the somewhat unusual situation of defending the scientific validity of her work to the masses, and saw a need for greater engagement with the public…

 In an interview, Brennan said that examining sexual conflict between male and female ducks provides a fascinating insight into evolutionary biology and sexual competition. That information is interesting in its own right, but she also notes that duck penises, which have an external sperm channel, may ultimately lead to new molecular insights that could be deployed in medicine. Or they might not. But unless scientists learn, no one will ever know.

Brennan points to research into avian genitalia that may already have a medical impact. Colleagues are examining why chickens do not have penises and ducks do, which may provide clues to better understand hypospadias, a birth defect in which boys’ penises are malformed.

Other posts of note:

STEM CELLS Already, scientists in laboratories across the world have begun dipping mature cells in acid, hoping to

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 see whether this simple intervention really can trigger a transformation into stem cells, as reported by a team of Boston and Japanese researchers in January.

At the Harvard Stem Cell Institute, a number of scientists have embarked on the experiment, which they’re informally calling “stem cell ceviche,” comparing it to the Latin American method of cooking seafood in lime and lemon juice.

 RESEARCH DATA:  For the past year, physicians, researchers, and ethicists have vigorously debated whether unexpected findings detected in people’s genomes should be reported back to patients or research subjects. In a provocative essay published Thursday, researchers from Harvard Medical School and King’s College London argue that an even more fundamental right has been totally absent from the conversation: research participants’ access to the raw data they provide.