Author Jon Entine, associated with George Mason U.’s STATS project and a visiting fellow at AEI, wrote a highly critical piece at Forbes.com about Mike Adams, whose extremely controversial views on science, medicine, vaccines, GMOs and other topics get wide circulation through the site Natural News, much shared on the internet. Adams’s resulting legal threats led Forbes to pull down the Entine piece (the publication of which Adams deemed “cyber-bullying” and “electronic harassment”), and Keith Kloor at DiscoverBlogs prints choice excerpts from what is said to be Adams’s electronic correspondence with Entine. More: Sharon Hill, Doubtful News.
- Environmental advocates and their fans in the press come off badly in Chevron/Ecuador litigation scandal [Coyote, earlier]
- Drought disaster unfolds in California’s Central Valley, where project water is allocated by fiat, not bid for in market [Allysia Finley, WSJ; San Jose Mercury-News]
- Other large democracies resist the idea of packing environmental terms into trade treaties, and maybe they’re right [Simon Lester, Cato]
- “A Tough Day in Court for the EPA’s Greenhouse Gas Regulations” [Andrew Grossman]
- R.I.P. leading environmental law professor Joseph Sax [NYT, I discussed his work in Schools for Misrule]
- Lawyers have hijacked Endangered Species Act [Congressional Working Group report via Washington Examiner editorial]
- When science begins bringing extinct animals back to life, watch for unintended legal consequences [Tyler Cowen]
Yes, that article decrying academic freedom is just as bad as you’ve heard.
“A self-described astrobiologist is asking a federal judge to compel NASA to take a closer look at a mysterious Martian object.” [Eric Mack, CNet] Too late, though? “Scientists have solved the mystery of the ‘jelly doughnut’ rock on Mars that appeared to come out of nowhere. NASA said Friday that a wheel of the rover Opportunity broke it off a larger rock and then kicked it into the field of view.” [Associated Press]
French researcher Gilles-Eric Seralini is not taking particularly gracefully the withdrawal of “a controversial and much-criticized study suggesting genetically modified corn caused tumors in rats” [Reuters]:
“Were FCT [Reed Elsevier’s journal Food and Chemical Toxicology] to persist in its decision to retract our study, CRIIGEN would attack with lawyers, including in the United States, to require financial compensation for the huge damage to our group,” he said in a statement.
CRIIGEN is short for the group with which Seralini has worked, the Committee for Research and Independent Information on Genetic Engineering.
There are so many reasons to resist the FDA on this action — really, as many reasons as there are individual 23andme users. Some of us want to seek out distant relatives and clues about national origins, or satisfy curiosity about patterns of disease in our family lines. For adoptive families, home genome testing can be hugely valuable in cases where one knows little about the medical history of an adoptee’s birthfamily. It’s our body, and our right to inform ourselves about it — or so we thought.
Some are blaming the company for rolling out the popular service in the absence of a clear regulatory go-ahead, and, in recent months, ignoring repeated signals of the FDA’s wish that it submit to comprehensive regulation that would greatly drive up the cost of its service. But other commentators have suggested that the firm has some pretty decent legal arguments that its service is not subject to regulation as a diagnostic test or “medical device” (genetic predispositions are not diagnoses). As an information-based service, it might even enjoy protection under the First Amendment. Admittedly, the company waved a red flag in front of regulators when it launched a marketing campaign that stressed the possible health benefits of knowing one’s genetic predispositions. But as Timothy Lee argues at the Washington Post:
Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions. But most dangerous medical decisions can’t be made unilaterally; they generally require the assistance of licensed medical professionals who will do their own assessment of the situation before performing procedures that could harm patients.
The FDA very likely has decent legal grounds to forbear from a crackdown should it choose to. But the key takeaway sentence from Matthew Herper’s piece in Forbes criticizing the company is: “This is not the way to deal with a powerful government regulator.” Disrespectful, anti-authority attitudes from someone an agency intends to regulate? Ask former Buckyballs CEO Craig Zucker where that gets you.
What can users, potential users, and well-wishers do?
* “First, download your 23andMe raw results now if you have them,” warns Razib Khan at Gene Expression.
* If you like signing Change.org petitions, there’s one here asking the FDA to back off.
* In a separate piece for Slate, Khan suggests where the situation might head before long: services like this can move offshore. All the relevant information consumers want from them can be delivered via the web. In the mean time a highly innovative and valuable enterprise will have been pushed out of the U.S. to some freer part of the globe, but maybe we need to get used to that happening.
And then? It may take a while before our government works up the nerve to ban mailing a saliva sample to a foreign address. Based on existing trends, I’d guess the more likely intervention, circa 2018 or so, would be for the Treasury to direct credit card companies not to process payments from U.S. residents to genome kit providers. Would we have the spirit to resist then? And if then, why not now? More: Alex Tabarrok, Slate Star Codex (by analogy, “banning people from weighing themselves without a prescription is neither clinically nor ethically sound,” although weight awareness sometimes leads patients into unwise health decisions), Nita Farahany, Brad Warbiany, earlier 2011. Alex Tabarrok’s post is especially worth reading, an excerpt:
…Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. …
…the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases….
The FDA also has the relationship between testing and clinical validity ass-backward. The FDA wants to say no to testing until clinical validity is established but we are never going to discover clinical validity until we have mass testing.
- Stop and bleed: Tennessee rolls out “no refusal” blood-draw DUI driver checkpoints, which already go on in Texas [WTVF, Reddit, Tom Hunter/Liberal America, Charles “Brad” Frye (Texas practice)]
- Issues raised by growing practice of placing government “monitors” inside businesses to police compliance [Veronica Root, Prawfs]
- “Faulty Justice: Italian Earthquake Scientist Speaks Out against His Conviction” [Scientific American]
- California: suit could probe patterns of harassment against Orange County officials who’ve resisted police union demands [Krayewski, earlier]
- Illinois “[makes] it a felony to flick cigarette butts onto streets for the third time” [Gideon’s Trumpet]
- Before making laws intended to benefit sex workers, take time to listen to them [Popehat via Maggie McNeill]
- Report: state of Florida investigating Zimmerman prosecutor Angela Corey over sacking of alleged whistleblower [Washington Times, earlier] “A Visitor’s Guide to Florida’s Most Notorious Law Enforcement Agencies” [Mike Riggs, Atlantic Cities]
- New Obama “pay-for-performance” scheme for higher ed would drastically increase federal power over university sector [D.C. Examiner editorial] Don’t expect new moves to curb the escalating cost of college [Neal McCluskey, Cato]
- Funniest IRB (institutional review board) anecdote in a while [via Tyler Cowen, earlier]
- Will colleges start awarding admissions preferences to applicants who say they’re gay? [John Rosenberg, Discriminations]
- “8 Cringeworthy Allegations From The New Lawsuit Against Donald Trump” [Business Insider]
- Judge rules student can proceed with suit against Morgan State over attack by brain-eating cannibal, because what could be more reasonably foreseeable than that? [Baltimore Sun, Daily Caller]
- Dartmouth, USC: Office of Civil Rights, following “blueprint,” suggests colleges’ procedures not extreme enough in campus sex cases [KC Johnson/Minding the Campus, earlier]
- NCAA concussion suit seeks class action status [ESPN]
- “Bryon Farmer of the Blackfeet Tribe Jailed For Talking About Corruption In Tribal Government” [Ken at Popehat] “Popehat Signal: Vengeful AIDS Denialist Sues Critic In Texas” [same]
- Persons with federal government contracts can’t give to federal candidates or parties. Too broad? [Ilya Shapiro and Trevor Burrus, Cato]
- “Together at last! ‘Some US conservatives laud Russia’s anti-gay bill.'” [@jon_rauch on Associated Press re: “propaganda” measure]
- More on Second Circuit decision ruling scientific conclusions akin to protected opinion for defamation purposes [Digital Media Law Project, earlier]
- San Antonio bars appointment to its city boards and commissions of anyone who has ever said anything demonstrating bias “against any person, group or organization on the basis of race” or various other protected categories [Eugene Volokh]
- Cincinnati Bengals cheerleader wins defamation suit holding gossip site operator liable for user comments [Sporting News] Michigan: “Ionia newspaper editor files defamation suit against critics” [MLive, Popehat with a critical view, update at Popehat following dismissal]
- “Hate speech” at issue: “Twitter releases users’ identities to French authorities after tough legal battles.” [JOLT]
Commentary has un-paywalled my July article on the feds’ “blueprint” for how colleges and universities must deal with charges of sexual misconduct. I explain why despite a retreat to a seemingly less extreme interpretation of the law, the dangers remain that the Department of Education and Department of Justice will arm-twist academic institutions into stacked disciplinary methods and new curbs on speech. Read it here (and also consider subscribing to Commentary, gates aside). Earlier here, here, etc.
Two points worth noting: first, while the Obama administration has pushed the new plan hard, the wider trend of gradually stepped-up federal supervision over university life has been going on for decades under Republican and Democratic administrations alike. There is not much resistance: university officials and organized professors themselves are relatively half-hearted about sticking up for their own institutional autonomy. Indeed, the federal prescriptions represent in some ways a consolidation of power by already-powerful elements within the academy, as opposed to a perceived hostile takeover from the outside. In the same July issue of Commentary, Philip Hamburger has an excellent article outlining how university researchers have for decades now tamely submitted to federally prescribed controls — overseen by so-called IRBs, or institutional review boards — over such relatively innocuous forms of “human-subjects research” as interviewing politicians and observing passersby in public places. In 2007, David Hyman wrote for Cato’s Regulation magazine on “The Pathologies of Institutional Review Boards.”