As any fan of The Daily Show knows, satire is often the only defense.1. …I can’t pin HPANTHRAPOX on anyone, though. That one is all mine.
As any fan of The Daily Show knows, satire is often the only defense.1. …I can’t pin HPANTHRAPOX on anyone, though. That one is all mine.
It’s not exactly been what one would call a banner month for the National Institutes of Health or the Centers for Disease Control and Prevention. In the last week and change, it’s been revealed that oops, the CDC completely screwed up how it handles anthrax and possibly exposed 86-odd people to anthrax and they accidentally shipped out H9N2 that had been contaminated with H5N1. Then, this morning, a study from the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service–a study that the CDC has known about since July 10–revealed such charming details as anthrax being stored in refrigerators in an unrestricted hallway with the key to one sitting in its lock.2 (I hope you weren’t planning on sleeping ever again.) And of course, in case any of that isn’t close enough to a Richard Preston novel, there was the whole “forgetting those vials of smallpox in cold storage” thing with NIH and the Food and Drug Administration.
As a result of all this Three Stooges-esque mishandling of select agents and scary things, the House Energy and Commerce Oversight and Investigations Subcommittee is convening Wednesday to ask Dr. Thomas Friedan, director of the CDC, and friends (like Joseph Henderson, deputy director of the CDC’s Office of Security and Emergency Preparedness; Jere Dick, associate deputy administrator of APHIS; and Nancy Kingsbury, a managing director of the Government Accountability Office) to come explain exactly how Larry, Moe, and Curly ended up wreaking havoc at the Center.
So naturally, Sunday night was the perfect time to dismiss the remaining inaugural members of the National Science Advisory Board for Biosecurity.
Now, apparently the NSABB hadn’t met in two years, and according to Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Twin Cities, his last contact with the NIH regarding the NSABB was in the Spring of 2013.2 Which, if you’ve been following dual-use research of concern or gain of function research news, is concerning, to say the least.
But possibly even worse is how utterly tone deaf and cheerful this “your services are no longer required, you’re dismissed” email is. Apparently Mary Groesch is, in addition to being the Executive Director of the NSABB, the Queen of Perky. Don’t believe me? Lucky for you, I just so happen to have acquired a copy of the dismissal letter.
Dear Members of the NSABB,
Greetings! I hope that all is well with each of you. My purpose in writing to you, the last of the original NSABB members, is several fold. First, I wanted to tell you that a new slate of NSABB members has been approved as your replacements, and thus your service on the board is ending. Since you have all been so gracious as to extend your service for several years beyond your initial term, this may come as welcome news!
Yes, I’m sure it’s welcome news that, after a week of Really Bad Revelations from the CDC, NIH, and FDA, their expertise will no longer be needed. The expertise they bring as inaugural members of the NSABB. The expertise they bring being the people who had to figure out how to deal with the Fouchier and Kawaoka H5N1 publishing crisis. I can’t imagine how any of that might be necessary or needed now.
But hey, don’t worry. The inaugural members of the NSABB that were dismissed have been invited to join the next NSABB meeting in the fall, where they can watch, as ad hoc members, as the new committee largely goes “nyah nyah” and ignores their recommendations. Of course, that’s just my interpretation of the email, but “I welcome you to attend in an ad hoc capacity the next meeting of the NSABB, where we will recognize your service on the Board,” “We will also recognize your service and introduce the new members to the Board,” and “We also would welcome your attendance at this meeting in a non-voting, ad hoc capacity both to contribute to our discussions and to say farewell” doesn’t exactly inspire confidence, faith, or trust in the now-gutted NSABB. In fact, I’m really only surprised that “YOU CANNOT VOTE AND YOU HAVE NO SAY” wasn’t included in bolded, underlined text.
What in the bloody hell is the NIH thinking? I’d ask if they have no policy or communications advisers on staff, except that I see at least one science policy analyst on the email CC list, so clearly this was signed off by at least one person who should know better.
When the theoretically premier laboratory in the world is as badly compromised by ineptitude as the CDC has stunningly demonstrated that they are, you don’t turn around and dismiss your experts. You hang on to those experts, grateful that they’re still around, and you say help. You say help really loudly. And then you sit down, shut up, and listen.
You don’t fire the people who’ve been around so long that they can say “I told you so.”
Unless, of course, that’s the point.
And frankly, at the moment, given who was released and their expertise, it’s hard to see how this is anything other than an effort to stack the deck towards people who will be sympathetic to the NIH and CDC, rather than be the critical, independent review board with teeth, a la the National Transportation Safety Board, that biosecurity research needs.
Which is not to say that all is lost, or that there are not people much more impressive and with much bigger sticks who are not willing to sit down and shut up and let the NIH run amok without oversight. While I wish the House committee all the best this Wednesday, my faith more strongly lies with the Cambridge Working Group,3 who ever-so-coincidentally met today in Cambridge,4 and their Consensus Statement on the Creation of Potential Pandemic Pathogens (see below for full text).
The following NSABB members were informed they were no longer needed Sunday evening:
• Arturo Casadevall, MD, PhD – Chair, Department of Microbiology & Immunology, Albert Einstein College of Medicine
• David R. Franz, DVM, PhD, Colonel, USA (Retired) – Former Commander, United States Army Medical Research Institute for Infectious Diseases
• John A. Gordon, General, USAF (Retired) – Former Deputy Director, CIA
• Michael J. Imperiale, PhD – Professor and Associate Chair, Department of Microbiology and Immunology, University of Michigan School of Medicine
• Paul Keim, PhD – Regents’ Professor and Cowden Chair in Microbiology, Department of Biological Sciences, Northern Arizona University
• Stanley M. Lemon, MD – Professor of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine
• John R. Lumpkin, MD, MPH – Senior Vice President and Director, Targeted Teams, Robert Wood Johnson Foundation
• Stuart B. Levy, MD – Director, Center for Adaptation Genetics and Drug Resistance, Tufts University
• Michael Osterholm, MD, PhD – Director of CIDRAP, University of Minnesota
• David Relman, MD – Department of Medicine, Division of Infectious Diseases,
and Department of Microbiology & Immunology, Stanford University
• James A. Roth, DVM, PhD – Director, Center for Food Security and Public Health, Iowa State University
Maybe it’s just me, but that’s a list of guys5 and expertise I’d feel better having on the NSABB than off.
Especially right now.
Definitely right now.
The below text has been reprinted with permission. Please share. Please do not credit Kelly Hills for this work. She just happened to get a copy and the permission to post it.6
July 14, 2014
Cambridge Working Group Consensus Statement on the Creation of Potential Pandemic Pathogens (PPPs)
Recent incidents involving smallpox, anthrax and bird flu in some of the top US laboratories remind us of the fallibility of even the most secure laboratories, reinforcing the urgent need for a thorough reassessment of biosafety. Such incidents have been accelerating and have been occurring on average over twice a week with regulated pathogens in academic and government labs across the country. An accidental infection with any pathogen is concerning. But accident risks with newly created “potential pandemic pathogens” raises grave new concerns. Laboratory creation of highly transmissible, novel strains of dangerous viruses, especially but not limited to influenza, poses substantially increased risks. An accidental infection in such a setting could trigger outbreaks that would be difficult or impossible to control. Historically, new strains of influenza, once they establish transmission in the human population, have infected a quarter or more of the world’s population within two years.
For any experiment, the expected net benefits should outweigh the risks. Experiments involving the creation of potential pandemic pathogens should be curtailed until there has been a quantitative, objective and credible assessment of the risks, potential benefits, and opportunities for risk mitigation, as well as comparison against safer experimental approaches. A modern version of the Asilomar process, which engaged scientists in proposing rules to manage research on recombinant DNA, could be a starting point to identify the best approaches to achieve the global public health goals of defeating pandemic disease and assuring the highest level of safety. Whenever possible, safer approaches should be pursued in preference to any approach that risks an accidental pandemic.
Amir Attaran, University of Ottawa
Barry Bloom, Harvard School of Public Health
Arturo Casadevall, Albert Einstein College of Medicine
Richard Ebright, Rutgers University
Nicholas G. Evans, University of Pennsylvania
David Fisman, University of Toronto Dalla Lana School of Public Health
Alison Galvani, Yale School of Public Health
Peter Hale, Foundation for Vaccine Research
Edward Hammond, Third World Network
Michael Imperiale, University of Michigan
Thomas Inglesby, UPMC Center for Health Security
Marc Lipsitch, Harvard School of Public Health
Michael Osterholm, University of Minnesota/CIDRAP
David Relman, Stanford University
Richard Roberts, New England Biolabs
Marcel Salathé, Pennsylvania State University
Silja Vöneky, University of Freiburg Institute of Public Law, Deutscher Ethikrat
Affiliations are for purposes of identification only and do not imply any institutional endorsement
As expected, the last case ruled on before the Supreme Court of the United States adjourned until October was the Hobby Lobby/Conestoga case. For those unaware, this case is based on the Affordable Care Act’s contraception mandate, classifying contraceptives as preventive healthcare required under all insurance plans without a co-pay. Hobby Lobby and Conestoga Wood both objected to this, saying that covering some forms of birth control, like the IUD/IUS or Plan B, violated their religious beliefs by requiring them to fund abortive medications.
Unfortunately, SCOTUS ruled for Hobby Lobby/Conestoga, agreeing that the contraception mandate of the Affordable Care Act violates the Religious Freedom Restoration Act.
Now, before we get into the particulars,
This is a limited ruling that does not affect publicly-held corporations, or privately or closely-held corporations that do not also have sincere religious beliefs.
So what did happen? SCOTUS ruled that closely-held corporations owned by people with sincere religious beliefs do not have to provide contraception coverage that violates those sincerely-held religious beliefs.
It’s important to note that this is a very, very narrow ruling. In the majority rule, Justice Alito noted that this particular ruling would not give companies room to discriminate; for example, a closely-held corporation owned by folks whose religion finds gay people an abomination would not be allowed to freely discriminate against gay folks. This ruling does not overturn federal protections for suspect or quasi-suspect classes.
…your eyes just glazed over, didn’t they? At the end of this post, you’ll find a treatise on legal vocabulary that might help the above make sense. For now, let me put it into English for you: highly religious families that own large businesses that employ lots of people but don’t share that stock love around are allowed to deny female employees certain types of contraception based on scientifically incorrect notions of what an abortion is, but that’s all they’re allowed to do.
In line with the Citizen’s United ruling that says corporations (are people too) have free speech, this ruling says that a small, small group of companies in the United States are protected under the RFRA, because they have a religion.
In the run-up to this decision, I’ve quipped (repeatedly) that I’ve never seen a corporation in a church before. SCOTUS would reply: when that company is held by five or fewer related family members with shared sincere religious beliefs, if you’ve gone to church with that family, you’ve seen that corporation in church.
In other words, there is no firewall between the religious beliefs of a family and the company that the family runs. (This also would apply to a small group of people who share a sincere religious belief but are not related.)
The reason for this is that the ACA mandate fails the Sherbert Test. Justice Kennedy said that he believed that the option for religiously-affiliated organizations, such as Catholic hospitals, to opt-out of contraception coverage meant that the government could not prove that requiring Hobby Lobby and Conestoga Wood (or other closely-held corporations with sincere religious beliefs) to include contraception coverage in the health policies they contribute to was the least restrictive or burdensome option. In the case of the religiously-affiliated non-profit organizations, women are able to receive contraceptive coverage through separate health policies provided by the federal government at no charge; Justice Kennedy clearly feels that this will be extended to women who work at closely-held corporations with sincere religious beliefs against some contraceptives.
Of course, as SCOTUSblog noted, there are a couple of issues here. The bigger one is whether or not the Department of Health and Human Services has the authority to extend the non-profit contraception exemption to closely-held corporations; I expect we’ll see the Obama Administration clarify this quickly (and most people seem to think that HHS has the authority to do this, including SCOTUS).
The smaller issue is an interesting one. There are some non-profit groups that have argued that even signing a certificate that says they object to providing contraception coverage for their female employees is a violation of the RFRA. Today’s Hobby Lobby/Conestoga ruling seems to imply that SCOTUS does not find the process of certifying beliefs an undue burden under RFRA, which could effectively shut down some 20-odd cases around the country.
So in sum, closely-held corporations can express religion and are protected under RFRA as long as it’s a sincerely-held religious belief, but the expression of their religious beliefs does not go so far as to allow discrimination; women employed by these companies should still be able to receive free contraceptive coverage from HHS, like women who work for religious non-profits do; and signing a piece of paper to indicate that your company’s sincerely held religious beliefs is probably not going to be viewed as an undue burden by SCOTUS.
It’s an interesting ruling, and one that I suspect isn’t going to make too many people happy, even while people will incorrectly make absurd statements on what the ruling means.
My personal take is a bit more esoteric: I actually think this Supreme Court is laying the groundwork for a robust federalized healthcare for everyone; clearly, they have established that it is appropriate for the government to offer and require insurance. This shifts another bit of the burden away from companies and towards the federal government, and I suspect that these tiny shifts are what it’s going to take to end up in a system of basic healthcare services provided by the government, with the option for additional insurance offered by companies as hiring incentives or purchased on the market for those interested. The question then becomes: is this intentional by Justice Alito and the other conservatives judges, or is this just happy coincidence as they strive to protect the rights of corporations to be people?
Let’s talk about vocabulary, everyone’s favourite subject! In specific, let’s get some definitions for SCOTUS vocabulary and legal language out and down on paper, so that we’re all on the same page.
A closely-held corporation is a private company owned, directly or indirectly, by a small group of people; the majority of the shares are held by five or fewer people.
Religious Freedom Restoration Act
The RFRA is a 1993 law, signed by Bill Clinton, that prevents laws that substantially burden a person’s free exercise of religion. RFRA applies to the federal government, not state governments. As ACA is also a federal mandate, it is subject to scrutiny under RFRA. The law reinstates the Sherbert Test to see if an individual’s right to free expression of religion has been violated by the government, and mandates that any challenge involving the Free Exercise Clause of the First Amendment be subject to strict scrutiny.
This is the test used to determine whether or not the government has violated free expression of religion. For an individual, (and remember, corporations are people, too!), the court must determine:
If these two elements can be established, the government must then prove that it:
This is the most stringent standard of judicial review available, and is generally invoked in situations that either involve suspect classifications or constitutional challenges.
Suspect and Quasi-Suspect Classification
A suspect classification is any group of people that meet criteria suggesting they have been or will be the subject of discrimination. This criteria includes a history of discrimination, hostility, prejudice, and stigma against the group in question, which can be based on stereotypes; immutable or highly visible traits; little to no political power; their distinguishing features do not render the group unable to meaningfully contribute to society.
The Supreme Court recognizes race, national origin, religion and alienage (not being citizen of the United States) as suspect classes. Gender, parentage (legitimacy), and sexual orientation are recognized as quasi-suspect classes.
Sincere religious beliefs
First, let’s be clear: a religious belief does not necessarily mean a belief in God(s). In Welsh v. United State, SCOTUS ruled that “the definition of “religion” is not dependent on a belief in a “Supreme Being.” A person’s beliefs may be deemed “religious beliefs” if those beliefs occupy in the life of that individual a place parallel to that of God in traditional religions.”
In Brown v. Pena, SCOTUS cited three things to determine whether or not a belief is a religious belief:
Unique moral preferences thus are not also religious beliefs. (So, for example, being a vegan without also being a member of a religious order whose institutional and accepted religious texts required a vegan diet, would not be a religious belief.)
And finally, how do you determine if said religious belief is sincere? There are multiple cases that discuss what a sincere belief is
I’ve debated whether or not to post this since seeing Robert Whitaker’s lecture slides and heard about the results of his talk to NAMI from friends who were there, but ultimately decided that since this is an actual personal issue for many people, due to your own health or those of people you love, it’s worth making sure the information is available as far and wide as possible. Consent to medication needs to be informed, blah blah bioethics stuff.
Before the TLDR, the gist is this: evidence suggests that the best treatment for schizophrenia is not continual medication, and that
a significant percentage of those with schizophrenia who did not receive antipsychotics or took them for a very limited time had better long- term outcomes than those who took them on an ongoing basis.
And perhaps even more importantly, there’s significant evidence that the long-term use of antipsychotics creates a vulnerability to future psychotic episodes.
It’s important to note that Whitaker isn’t saying antipsychotics shouldn’t be taken, or aren’t needed by all people who are on them. But he’s gone over something like 60 years of data, a lot of which is from longitudinal studies spanning 20-30 years, and it looks like fully 50 – 75% of patients could make a complete functional recovery sans long-term antipsychotic use:
Medication compliant patients throughout 20 years: 17% had one period of recovery.
Those off antipsychotics by year two who then remained off throughout next 18 years: 87% had two or more sustained periods of recovery.
The data was so compelling by 1992 that Finland switched to a selective-use of antipsychotics that year… and now has the best long-term outcomes of anywhere in the world. Fully 79% of people – not just schizophrenics, but anyone who might be given a neuroleptic for psychiatric issues – are asymptomatic at five years, with 80% either in school or the workforce.
A lot of the issue appears to be what is known as “oppositional tolerance.” Anyone with chronic pain recognizes the concept if not the phrase: it’s what requires a gradual dose increase in medication to continually receive the same pain management. Essentially, the brain compensates for blocked dopamine or serotonin receptors in two ways. In the case of dopamine, postsynaptic neurons increase their receptors for dopamine as presynaptic neurons increase their firing rate. The opposite happens for serotonin: as the presynaptic neurons decrease their firing rate, the postsynaptic neurons decrease the density of receptors. In each case, the brain is trying to compensate for the effects of the drug being released into the system. Depending on the kind of drug being taken, we change the structure of the brain making it even more (or less) sensitive.
And, in fact, it’s the very recognition of concept that makes me wonder if Whitaker’s results can be extrapolated beyond neuroleptic use for management of mental health related illnesses and into chronic pain management; perhaps it’s better to treat acute instances of pain (“flares”) and then gradually decrease dosing until the patient is off medication than to continually dose the body with drugs “just in case.”
Anyhow, the very accessible and easy-to-read slides for Whitaker’s NAMI presentation can be found at this link, which includes detailed citations for those who’d like to read the journal literature. There’s also a good mother-of-patient perspective from Kathy Brandt at Mad In America. And if you really feel like having a sad today, you can read Carl Elliott’s comprehensive coverage of the death of Dan Markingson in the Seroquel studies, which should be required reading for anyone contemplating participation of themselves or a loved one in a drug study, or exposure to contemporary antipsychotics.
One of the first things I saw when I got off the plane in Philadelphia Sunday night, after a trans-Pacific flight, was this statement from Rep. Jodie Laubenberg:
In the emergency room they have what’s called rape kits where a woman can get cleaned out. The woman had five months to make that decision, at this point we are looking at a baby that is very far along in its development.
This is Laubenberg’s justification for why Texas SB5, which seeks to limit abortion services even further in Texas, including banning abortion after 20 weeks (and currently being filibustered by the amazing Wendy Davis), does not have an exception for rape or incest victims.
I’ve seen a lot of statements that Laubenberg is clearly confused, and a lot of very pointed comments about her lack of knowledge on a subject she seeks to legislate – all of which are true. But what I haven’t seen is the very simple differentiation between a rape kit and an abortion. So here, let me make a tiny contribution to the growing body of evidence that Rep. Laubenberg is in no way qualified to sponsor bills on or otherwise discuss rape kits, abortions, or women’s health issues.