Larry Hosken. Technical writer. Puzzlehunt enthusiast.
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Why a lot of important research is not being done

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The following originally appeared on The Upshot (copyright 2017, The New York Times Company).

We have a dispiriting shortage of high-quality health research for many reasons, including the fact that it’s expensive, difficult and time-intensive. But one reason is more insidious: Sometimes groups seek to intimidate and threaten scientists, scaring them off promising work.

By the time I wrote about the health effects of lead almost two years ago, few were questioning the science on this issue. But that has not always been the case. In the 1980s, various interests tried to suppress the work of Dr. Herbert Needleman and his colleagues on the effects of lead exposure. Not happy with Dr. Needleman’s findings, the lead industry got both the federal Office for Scientific Integrity and the University of Pittsburgh to conduct intrusive investigations into his work and character. He was eventually vindicated — and his discoveries would go on to improve the lives of children all over the country — but it was a terrible experience for him.

I often complain about a lack of solid evidence on guns’ relationship to public health. There’s a reason for that deficiency. In the 1990s, when health services researchers produced work on the dangers posed by firearms, those who disagreed with the results tried to have the National Center for Injury Prevention and Control shut down. They failed, but getting such work funded became nearly impossible after that.

I have also discussed the too-slowly changing approach to back pain. There’s a reason for that, too. When research was published, also in the early 1990s, arguing that the proper treatment of back pain was nonsurgical, some with a financial interest in surgical intervention tried to have the Agency for Health Care Policy and Research (now known as A.H.R.Q.) defunded. They failed, too, but left researchers skittish about focusing on this topic.

The area I complain about most, though, concerns nutrition, including supplements. That domain allows us to focus on another type of intimidation: lawsuits.

In 2013, scientists at the Food and Drug Administration published a study in The Journal of Pharmaceutical and Biomedical Analysis showing that nine brands of dietary supplements sold in the United States contained a synthetic analogue of amphetamine. The authors noted that the efficacy and safety of this stimulant, β-methylphenylethylamine (BMPEA), had never been studied in humans.

A year later, Canadian health authorities recalled supplements containing the stimulant, noting the potential for “serious cardiovascular complications.” The F.D.A., inexplicably, remained silent. The agency did not warn the public, recall products or warn manufacturers.

Dr. Pieter Cohen, an associate professor of Medicine at Harvard Medical School, replicated aspects of the 2013 study and came to the same conclusion as the F.D.A. experts: The stimulant was available in multiple brands of supplements, and a comprehensive review of the biomedical and chemistry literature found not a single scientific study of the stimulant’s efficacy or safety in humans. These results were published in Drug Testing and Analysis in 2015 and widely disseminated by national and international media outlets. Two weeks after that, the F.D.A. alerted consumers that the stimulant was potentially dangerous and warned manufacturers to remove it from their products.

One of the companies that received an F.D.A. warning letter, in turn, sued Dr. Cohen for $200 million in damages for libel, alleging that statements in the peer review article, and subsequent interviews with the media, were false. The company asserted, without supporting scientific evidence, that while the article said the stimulant was not “natural,” it had extracted it from a Mexican shrub. Company officials also claimed they had evidence of the stimulant’s efficacy and safety in humans. The lawsuit, initially filed in Georgia, was dismissed because of lack of jurisdiction there, then refiled in federal court in Massachusetts.

During the lawsuit’s discovery phase, the supplement company demanded and received access to emails related to the study, including those with co-authors, journal editors, the F.D.A., outside experts and the news media. The company also demanded and received all revisions of the manuscript, as well as peer reviewers’ comments and the authors’ responses. Despite the absence of evidence of wrongdoing, the judge allowed the case to go to trial.

Dr. Cohen got entangled in what legal scholars call a strategic lawsuit against public participation, or Slapp. Anti-Slapp laws are intended to prevent people from using courts, and even the threat of a lawsuit, to intimidate people who are exercising their First Amendment rights. But in Dr. Cohen’s case, the court refused to give full weight to Massachusetts’ anti-Slapp statute on the ground that dismissing the case would undermine the supplement company’s constitutional right to a jury trial.

Although the jury eventually found for the defense, the experience was extremely unsettling. “Preparation for the trial included a six-hour deposition, a mock trial and a review of more than 4,000 pages of studies, emails, correspondences, drafts and depositions,” Dr. Cohen told me. “The trial itself lasted seven days, and put my family through the wringer.” He was fortunate to have the full support of his university in defending his work.

Dr. Cohen and I, along with Nicholas Bagley, a law professor at the University of Michigan, recently wrote in JAMA Internal Medicine about the damage such suits inflict on scientific inquiry. We pointed out that the peer-review process already provides a way to question a study’s conclusions before publication, and that less formal peer review continues afterward in the form of letters to the editor and editorials.

If errors or mistakes are believed to be fraud, mechanisms for review exist in university systems. Only if evidence of fraud surfaces does it make sense for courts to be brought into play.

“Courts aren’t equipped to referee scientific disputes,” Mr. Bagley said. “And they have an obligation to prevent unscrupulous plaintiffs from abusing the machinery of justice to stifle science.”

Lawsuits like these are too common in health research. Mr. Bagley did a fairly comprehensive search of the reported opinions over the past 40 years. He found two cases in the 1980s and two in the 1990s. Since 2000, however, there have been 10. These numbers greatly understate the number of filed cases, however, since the vast majority are settled.

The manufacturer of a hip protector sued a researcher in 2008 over a study published in JAMA that showed the device didn’t prevent fractures. The C.E.O. of a pharmaceutical company sued a researcher who led his data monitoring committee when the researcher published a 2011 article in Annals of Internal Medicine disputing the way the C.E.O. had described a study’s results.

Lawsuits like these aren’t necessarily bound by ideology or partisan politics. Mark Z. Jacobson, an energy systems engineer at Stanford University, is suing the National Academy of Sciences and the authors of a recent paper published in the academy’s journal, PNAS. The paper criticized Mr. Jacobson’s analyses that the United States could fully power itself with wind, water and solar energy. Many, including some identified as environmentalists, have criticized the lawsuit.

For his part, Dr. Cohen remains undeterred. Last month he published a new paper finding that experimental stimulants continue to be placed in sports and weight-loss supplements. That’s what research is supposed to do: give us more data, so that we can make better decisions about our health.

@aaronecarroll

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lahosken
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AMAZON MOBILE SITE 2091

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AMAZON MOBILE SITE 2091

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Robin Sloan: "Sourdough" | Talks at Google

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From: Talks at Google
Duration: 36:07

Lois Clary is a software engineer at General Dexterity, a San Francisco robotics company with world-changing ambitions. She codes all day and collapses at night, her human contact limited to the two brothers who run the neighborhood hole-in-the-wall from which she orders dinner every evening. Then, disaster! Visa issues. The brothers close up shop, and fast. But they have one last delivery for Lois: their culture, the sourdough starter used to bake their bread. She must keep it alive, they tell her―feed it daily, play it music, and learn to bake with it.

Lois is no baker, but she could use a roommate, even if it is a needy colony of microorganisms. Soon, not only is she eating her own homemade bread, she’s providing loaves daily to the General Dexterity cafeteria. The company chef urges her to take her product to the farmer’s market, and a whole new world opens up.

When Lois comes before the jury that decides who sells what at Bay Area markets, she encounters a close-knit club with no appetite for new members. But then, an alternative emerges: a secret market that aims to fuse food and technology. But who are these people, exactly?

Leavened by the same infectious intelligence that made Robin Sloan’s Mr. Penumbra’s 24-Hour Bookstore such a sensation, while taking on even more satisfying challenges, Sourdough marks the triumphant return of a unique and beloved young writer.

Get the book here: https://goo.gl/MRBaPC

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6 days ago
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FTC Halts the Deceptive Practices of Academic Journal Publishers

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Operation made false claims and hid publishing fees, agency alleges

A federal court has granted a preliminary injunction requested by the Federal Trade Commission, temporarily halting the deceptive practices of academic journal publishers charged by the agency with making false claims about their journals and academic conferences, and hiding their publishing fees, which were up to several thousand dollars.

The preliminary injunction against OMICS Group Inc., iMedPub LLC, Conference Series LLC, and their CEO, director, and owner, Srinubabu Gedela stems from a complaint the FTC filed last year that names Gedela and his three companies as defendants.

The defendants operate several websites, including OMICSonline.org, iMedPub.com, and Conferenceseries.com.  They advertise hundreds of online academic journals and international conferences for scientists and medical professionals. 

According to the complaint, the defendants deceptively claim that their journals provide authors with rigorous peer review and have editorial boards made up of prominent academics when in fact, many articles are published with little to no peer review and many individuals represented to be editors have not agreed to be affiliated with the journals.

The FTC’s complaint alleges that the defendants do not tell authors submitting papers for publication that, after their online journals accept an article, the defendants charge the authors significant publishing fees and often do not allow authors to withdraw their articles from submission, making their research ineligible for publication in other journals.

The FTC also alleges that, to promote their scientific conferences, the defendants deceptively use the names of prominent researchers as conference presenters, when in fact many of those researchers had not agreed to participate in the events.

The FTC’s complaint charges the defendants with multiple violations of the FTC Act’s prohibition on deceptive acts or practices.

The preliminary injunction entered by a federal district court in the District of Nevada prohibits the defendants from making misrepresentations regarding their academic journals and conferences, including that specific persons are editors of their journals or have agreed to participate in their conferences.  It also prohibits the defendants from falsely representing that their journals engage in peer review, that their journals are included in any academic journal indexing service, or any measurement of the extent to which their journals are cited.  It also requires that the defendants clearly and conspicuously disclose all costs associated with submitting or publishing articles in their journals.

NOTE: The Commission files a complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law.

The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.

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lahosken
19 days ago
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Sugar Industry Suppressed Evidence of Health Risks of Sucrose

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The sugar industry buried scientific research almost 50 years ago that pointed to negative health effects of sugar, ceasing funding the research when it reflected negatively on the industry's interests.
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lahosken
20 days ago
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Worth the Weight

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In the midst of a long New York Times article about the serial theft of offensive cyberweapons from the National Security Agency, there’s a brief but interesting image. “Much of [a core N.S.A. group’s] work is labeled E.C.I., for ‘exceptionally controlled information,’ material so sensitive it was initially stored only in safes,” the article explains. “When the cumulative weight of the safes threatened the integrity of N.S.A.’s engineering building a few years ago, one agency veteran said, the rules were changed to allow locked file cabinets.”

It’s like some undiscovered Italo Calvino short story: an agency physically deformed by the gravitational implications of its secrets, its buildings now bulbous and misshapen as the literal weight of its mission continues to grow.

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lahosken
25 days ago
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