Archive for the 'Public Health' category

Ebola and ZMapp...A scientist explains

Aug 07 2014 Published by under Conduct of Science, Public Health

Erica Ollman Saphire (lab website, PubMed, RePORTER) was interviewed on KPBS in San Diego about the use of highly experimental antibody therapy for the US health workers infected with Ebola virus.

It's a pretty interesting viewpoint on basic science, translation to humans and what we do when an emergency situation like an infectious disease outbreak happens. I have been struck in past days about the huge international discussion this ZMapp treatment has been sparking. As you might expect, we have dark thoughts being expressed along the lines of "Why does this apparently miraculous treatment emerge all of a sudden when Americans are infected but it hasn't been given to suffering Africans, hmmmm?". There are all kinds of ethical issues to think about.

The television version linked below is 5 minutes but be sure to click on the link to the "midday edition" which is a longer voice interview. It gives a much fuller discussion.

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Additional Reading:

CDC: Questions and Answers on experimental treatments and vaccines for Ebola

Experimental Ebola drug based on research from Canada’s national lab

Ebola experimental drug, ZMapp sparks ethical controversy

UPDATE:
David Kroll on ZMapp

David Kroll on two other Ebola therapies

26 responses so far

Insinuations, misdirections, straw arguments and obsfucation in drug abuse journalism

Jul 18 2014 Published by under Drug Abuse Science, Public Health

Maia Szalavitz has penned a new article on addiction that has been circulated, credulously and uncritically, on social media by people who should know better. So, once more, into the breech, Dear Reader.

The article in question is Most of Us Still Don't Get It: Addiction is a Learning Disorder is posted at substance.com.

We can start with the sub-header:

Addiction is not about our brains being "hijacked" by drugs or experiences—it's about learned patterns of behavior. Our inability to understand this leads to no end of absurdities.

From whence comes learning if not from experiences? And what is the ingestion of a psychoactive drug if not an experience? She is making no sense here. The second sentence is pure straw-man, particularly when you read the entire piece and see that her target is science, scientists and the informed public rather than the disengaged naive reader.

Academic scientists focused on drug abuse have talked about the learning aspect, of habits and of the lasting consequences of drug experiences since forever. This is not in the least little bit unknown or novel.
Continue Reading »

13 responses so far

Medical marijuana "researcher" fired by U of A

Jul 02 2014 Published by under Cannabis, Public Health, Science Politics

From the LA Times:

The University of Arizona has abruptly fired a prominent marijuana researcher who only months ago received rare approval from federal drug officials to study the effects of pot on patients suffering from post traumatic stress disorder.

The firing of Suzanne A. Sisley, a clinical assistant professor of psychiatry, puts her research in jeopardy and has sparked indignation from medical marijuana advocates.

I bet. Interestingly I see no evidence on PubMed that this Sisley person has any expertise in conducting research at all. I'm not saying I need exhaustive credentials but I'd like to see a published study or two.

Cue the usual raving about how this is all a vast right wing conspiracy to keep down miraculous medication...

Sisley charges she was fired after her research – and her personal political crusading – created unwanted attention for the university from legislative Republicans who control its purse strings.

“This is a clear political retaliation for the advocacy and education I have been providing the public and lawmakers,” Sisley said. “I pulled all my evaluations and this is not about my job performance.”

Well, this IS Arizona we're talking about. I'm going to want to see more* but I guess I am going to have to score myself as sympathetic to the notion that this was a political squelching.
Still, the University is denying the charge...

University officials declined to explain why Sisley’s contract was not renewed, but objected to her characterization.

“The university has received no political pressure to terminate any employee,” said Chris Sigurdson, a university spokesman. He said the university embraces research of medical marijuana, noting that it supported a legislative measure in 2013 permitting such studies to be done on state campuses.

Ok, "embraces", eh? We'll see if that turns out to be true.

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h/t: clbs

*if this holds true to form the University will be compelled to make a case for how she wasn't competent at the "clinical assistant professor" category of association with U of A.

4 responses so far

23andMe resumes sales: Ancestry only!

Apr 30 2014 Published by under Ethics, Medicine and Law, Public Health

Well this is interesting. After being spanked by the FDA for selling their services without proper review and approval of their medical test (as the FDA interpreted it), the 23andme company is back.

I received an email spam suggesting I purchase one of their kits as a Mother's Day present.

Intrigued, I see this in an alert banner across the linked page.

23andMe provides ancestry-related genetic reports and uninterpreted raw genetic data. We no longer offer our health-related genetic reports. If you are a current customer please go to the health page for more information.

When you go to purchase a new kit you are obliged to check a box indicating you've read an additional warning.

I understand I am purchasing ancestry reports and uninterpreted raw genetic data from 23andMe for $99. I understand I will not receive any reports about my health in the immediate future, and there is no timeline as to which health reports might be available or when they might be available.

Ok. Got it.

So what about existing customers who purchased their kit in the old, pre-ban era? Guess I'd better visit that "health page".

Current 23andMe customers who received health-related results prior to November 22, 2013 will continue to have access to that information. However, no new health-related updates will be provided to your account.

Customers who purchased kits before November 22, 2013 will still receive
health-related results.

Customers who purchase or have purchased 23andMe’s Personal Genome Service (PGS) on or after November 22, 2013, (date of compliance letter issued by the FDA) will receive their ancestry information and uninterpreted raw genetic data. At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.

Customers who purchased kits on or after November 22, 2013 through December 5, 2013 are eligible for a refund. 23andMe has notified all eligible customers by email with refund instructions. If you are eligible and have not received an email, please click here.

Ok, so they are not turning off the results already provided to the older customers. If you fell into the cease-and-desist gap, you don't get your info (boo FDA) but you can get a refund.

In the mean time, 23andme is an ancestry / genealogy company.

I suppose that is it until they pass regulatory approval for their health and trait information?

20 responses so far

A chance to support research on Parkinson's Disease

Apr 23 2014 Published by under CrowdFund, LinkLove, Neuroscience, Public Health

The scientist known as @parklifensci (Parklife blog) on the Internet will be walking in the Parkinson's Unity Walk. The donation page says:

Why I'm walking:
Every walker and donor makes a difference by taking the Walk one step closer to finding the cause and cure for Parkinson’s. By joining together with thousands of others, we'll be empowering those who are living with the disease, and honoring those who lived with Parkinson’s.

Who I’m walking for:
Over 1 million people in the United States have Parkinson’s. 60,000 people are newly diagnosed every year – one person, every nine minutes. Walking and raising funds and awareness for research is my chance to help.

Why I'm supporting the Parkinson’s Unity Walk:
100% of donations go to research. The Parkinson’s Unity Walk is the largest grassroots event in the U.S., raising funds and awareness for research.

Ways to support my fundraising efforts:
There's strength in numbers so please join me. Donate, register to walk, and fundraise.

I encourage you to donate if you can or join the walk if you are nearby.

No responses yet

Guest Post: The brightest and the most insightful people in the country?

Mar 08 2014 Published by under Academics, Careerism, NIH, NIH Careerism, Public Health

bluebirdhappinessThis is a guest appearance of the bluebird of Twitter happiness known as My T Chondria. I am almost positive the bird does some sort of science at some sort of US institution of scientific research. The bird is normally exhausted by typing messages 140 characters at a time so I was skeptical but....well, see for yourself.


MDs and PhDs are considered to be some of the brightest and the most insightful people in the country. Indeed, look no further than the nearest MD or PhD and ask them; they will attest at great length to their exceptional smarts and individual importance in maintaining the sun orbiting the Earth. Yet for all the combined education there remains a fundamental lack of appreciation of how intertwined the fate of these two professions are - ranking right up there on the irony scale with Pakistan threatening to nuke India (they are geographic neighbors, so that’s ironic, you see).

For anyone who has ever worked at a major academic medical center, we are told ad nausea how important we are in understanding human health. Yet we do so almost exclusively in parallel universes. Asked what its like to try to work with an MD, a PhD will often tell you MDs are ‘erratic, ill informed and totally lacking in any understanding of what goes into doing real research’. Conversely, asked what PhDs do, MDs will likely reply ‘they like to present very complex diagrams, write grants and develop models of disease and pathology that have little to do with any case I’ve ever seen.

I get to surf between these groups; my primary appointment in a clinical department affords me a perspective that is unique in that I am able to pass as either an MD or a PhD on any given day. I spend the majority of my time running a research lab but I can scream “House! Put down the scalpel you jackass! All you have to do is order a chest x-ray and look for pulmonary infiltrates to know it’s not sarcoidosis!” with the best of interns.

Figure 1. “It’s a fan!” “It's a spear!” The hilarity of people in white coats looking at their own little microcosm of an elephant and being unable to appreciate it is actually a bloated endangered species that could kill them all. And by bloated endangered species, I mean academic medicine*.  *Author note: Am I going to have to explain all my jokes?

Figure 1. “It’s a fan!” “It's a spear!” The hilarity of people in white coats looking at their own little microcosm of an elephant and being unable to appreciate it is actually a bloated endangered species that could kill them all. And by bloated endangered species, I mean academic medicine*.
*Author note: Am I going to have to explain all my jokes?

In drifting between these lands, I noticed the rifts earlier between ‘researchers and doctors’ which seemed vaguely amusing not so much now as first but as the business of academic medical is getting the shitte kicked out of it and PhDs think it has little to do with them.

In previous faculty meetings, I would watch tenure track PhDs glaze over as our beloved leader discussed the ‘blah, blah’ of clinical revenue streams.

Conversely, the MDs would eagerly reengage a new level of Candy Crush Saga as our chair commiserated with PhDs about pay lines and sequestration. (So clueless were the MDs about the recent plight of scientists that the esteemed journal JAMA even had to run an article in their online edition earlier in the year explaining sequestration to the primarily MD audience.)

At our most recent faculty meeting, there seemed to be a moment of real illumination between both groups that everyone in the medical center was screwed and better start making more widgets faster. Our Fearless Leader informed faculty that our hospital budget shortfall was progressing more quickly than we had anticipated even three months ago and vacations were canceled for faculty, more clinical hours were going to need to be booked and the bergermeister was coming to take all our toys (only two of these three have happened so far).

Figure 2. Predoctoral kitten downed by lack of understand of the health care industry on academic medicine.

Figure 2. Predoctoral kitten downed by lack of understand of the health care industry on academic medicine.

Later that day, I took to on Twitter to vent and look for pictures of kittens doing cute things (see Fig 2 as evidence of my hard work). Many of my Twitter followers are porn bots, but at least 2 or 3 are PhD-types and aghast that my medical center was being so aggressive. There were many sad emoji’s sent my way and a flutter of ‘how could they’ and ‘oh, your poor little university’ that made me wonder what planet everyone is on and if donuts were as delicious there as they were here (see Storify by @mrhansaker here).

EVERY medical center in the US is getting carpet bombed into financial oblivion by the economy, Medicare reimbursements and Obamacare. And yes, I assured my Tweeps, the amount of our gross national product that goes to health care is stoopidly high. But, a startling number of my PhD buddies were taken aback by the idea that those pesky ‘high health are cost’ they glaze over in faculty meeting or when listening to NPR is also covering their academic PhD arses.

So, for my PhD pals, whom I shall refer to as ‘People who are doctors only when they book hotel rooms’ (I’m kidding, I’m a kidder!), I wanted to run this down a bit further. If you have a medical center as part of your university, you have been riding clinician’s financial coat tails for a long friggin time. The indirect rate charged to granting organizations in no way covers operating costs for research. That takes an endowment or an additional revenue stream. Endowments usually come from long dead old rich doods. These endowments don't just sit in Scrooge McDucks cave. They get invested in things like the stock market. And the stock market got the shitte kicked out of not too long ago. Billions in endowment money were lost in the economic collapse - most Universities took 25-50% hits on their Scrooge McDuck funds. So, if you’re a PhD, you can take endowments out of the equation as what’s been filling in those pesky financial gaps between costs and expenses. No worries, you’re at a medical center so you have a revenue stream- your clinical enterprise. Sick people. America is ALWAYS good for some damn unhealthy and foolish folks who will make the worst choices possible and rack up a small fortune in insured and uninsured care.

Thank God for stoopid and unhealthy people, amirite?? This is even better because our Commander-in-Chief got an electoral mandate to insure everyone’s (ish) stoopid arse. More money for medical centers has got to be a win, yes? Not so much. Show me a medical center meeting its financial goals, hell even one that isn’t heading for a hundreds of millions of dollars of deficit for 2014, and I will show you a for profit medical center (read here: “not academic, so no jobs for you PhDs”).

The proverbial sky has been falling for research scientists for some time now as well documented by my kind host Drug Monkey and others with inferior blogs and better shoes. And indeed, MDs have been hounded into appreciating the genius that is the bench scientist. So valued are the basic researchers that they are sought after to heap more prestige on the medical center and an even better training environment which increases numbers of trainees, blah, blah.
Unlike clinicians, scientists have known the economic sky was falling for some time and have been zealously advocating the importance of science research bracing for impact. To the outside world, that looks a lot like holding your collective sphincters together as tightly as humanly possible and waiting for things to improve. Well-done people. Actually, you sort of sucked at advocating for yourselves as evidenced by the two of you who actually sent @nparmalee letters to hand deliver to your Congress Critters a few weeks ago, but I will need another bottle of wine for that.

The first warning to those PhD types in the 35+-age bracket would have been when Scamp-in-Chief Bill Clinton never quite delivered on his ‘peace dividend’. The one where all those pesky defense dollars would go to building a bigger, better, smarter American work force with futures in STEM (Dumber Bombs! Smarter People!). We would turn in our tanks and churn out better-educated versions of ourselves with outstanding oral hygiene to lead us forth into the new millennium free of disease and with cats with laser vision. Not only did we forget to provide sustainable growth mechanisms for STEM, we also neglected to maintain world peace and not screw the interns. Bill, you lovable rascal, at least you didn’t shoot anyone in the face. Just in the foot. Or both feet.

Metaphorically.

In the parallel world of MDs, who kindly request you simply refer to them as ‘real doctors’ for the rest of this diatribe, the pesky business of health care in academia has always been a house of cards. About 7% of MDs practice in the rare air that is academic medicine. This affords prestige, time for clinical research, collegiality, security and none of the business hassles of private practice, but about half the salary. Which, to be honest, is still a metric shitte ton of money especially if you do a bit of consulting. But now, there’s no research time, Medicaid is squeezing out every reimbursable dime and you are keeping the same hours as your hapless residents.

My take home from today friends is that the party seems to be winding down. Rather than recognizing that our fates are intertwined, MDs and PhDs frantically see more patients and write more grants and wonder when the sun will shine on us once again and society will appreciate our true worth. I have yet to see any evidence that for all the brain power and letters after peoples names, PhDs are even aware of that medicine money is research money. So you go put your blinders on and find that spear, and I’ll put mine on and grab this rope and no one will call it an elephant.

34 responses so far

FDA shuts down 23andMe

Nov 25 2013 Published by under Public Health

Wow!

The Food and Drug Administration has ordered DNA testing company 23andMe to stop marketing its over-the-counter genetic test, saying it’s being sold illegally to diagnose diseases, and with no proof it actually works.

I did not see this coming at all. Guess I was too focused on thinking about informed consent issues.

40 responses so far

Repost: Musty Must-Read: "Mrs. Winslow's Soothing Syrup"

I originally posted this Jan 09, 2008 on the old blog and reposted it 12/12/2008 with small improvements over the prior version. It has been one of my more popular posts when it comes to Google hits. You might want to check out a personal recipe for opiate based cough remedy as well.


The US Food and Drug Administration (FDA) began sending warning letters to sellers of so called "bio-identical hormone replacement therapy" today according to an AP report. Apparently the claims for alleviating menopausal symptoms are

not supported by medical evidence and are considered false and misleading.

Needless to say, these "compounded" products are being sold without FDA approval. It's all a conspiracy man! Dang FDA is a tool of BigPharma trying to keep cheap and effective remedies from the public. Noted tool of TheMan(BigPharmaDivision) Abel Pharmboy has a recent post in which he touches on "cosmeceutical" marketing of drugs and the FDA's authority to regulate cosmetics under

their regulatory authority is in part ordered by the Federal Food, Drug, and Cosmetic Act of 1938 (and subsequent legislation).

soothingsyrup.jpg
source
This reminds me of the glory days of the quack remedy / patent medicine era and today, from the mouldering archives, we take up a Case Report published by A. B. Hirsch, M.D. ["Mrs. Winslow's Soothing Syrup. American Medical Journal, 1884, 12(11):504-506] which is available from Google Books here. A footnote indicates that this Abstract was read before the Philadelphia County Medical Society on Sept 17, 1884. Ahh, Mrs. Winslow's . Used for over 60 years by mothers for their teething children.

Continue Reading »

One response so far

The Obama Administration's 2013 National Drug Control Strategy

Apr 24 2013 Published by under General Politics, Public Health

The ONDCP has been twittering up a storm about the release of the latest National Drug Control Strategy document [ PDF ].

The website touts five bullet points:

  • Prevent drug use before it ever begins through education
  • Expand access to treatment for Americans struggling with addiction
  • Reform our criminal justice system
  • Support Americans in recovery

Whether you think the Obama ONDCP has changed quickly enough for your liking or not, there has clearly been a change in the rhetoric compared with past...all the way back to the Reagan ONDCP. Rhetoric such as this....

While law enforcement will always play a vital role in protecting our communities from drug-related crime and violence, we simply cannot incarcerate our way out of the drug problem. Put simply, an enforcement-centric “war on drugs” approach to drug policy is counterproductive, inefficient, and costly. At the other extreme, drug legalization also runs counter to a public health and safety approach to drug policy. The more Americans use drugs, the higher the health, safety, productivity, and criminal justice costs we all have to bear.

...differs very clearly from the prior ONDCP approaches. Even McCaffrey, as conversant as he was with the science*, still leaned heavily toward the punitive side.

Naturally, I am best pleased that they have a section entitled "The Science":

Throughout much of the last century, scientists studying drug abuse labored in the shadows of powerful myths and misconceptions about the nature of addiction. When science began to study addictive behavior in the 1930s, people addicted to drugs were thought to be morally flawed and lacking in willpower. Those views shaped society's responses to drug abuse, treating it as a moral failing rather than a health problem, which led to an emphasis on punitive rather than preventative and therapeutic responses.

And I would say that we still labor under a great deal of resistance, even though the hard edges may have morphed. We hear people trying to parse "only psychological" addiction from "physiological" addiction...what is this if not more of the "moral failing" argument? We also have attempts to define some substances (and non-substance reinforcers) as being out of consideration for genuine addiction.....again, a similar discounting of the science related to addiction. If you grasp the fact that addictions are disruptions of reward pathways, and that there are a limited set of final-common-mechanisms for reward in the brain then it is no surprise that anything which trips the reward triggers has the potential to cause disruption.

Today, thanks to significant advances in neuroscience, our Nation's responses to drug abuse have begun to change. Groundbreaking discoveries about the brain have revolutionized our understanding of drug addiction, enabling us to respond more effectively to the problem.

Science demonstrates that addiction is a disease of the brain—a disease that can be prevented and treated, and from which people can recover.

Well yes...buuuuuut. Our ability to prevent and treat still has a long way to go. And this, I recognize fully, contributes to public misunderstanding. After all, if it is a disease, surely we must have very specific and mechanistically coherent treatments, right? We don't, for the most part, and so skepticism over the assertion of "a disease of the brain" will continue.

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*He was the first Drug Czar I heard address a scientific audience. He was impressive. They guy that came after him during the Bush administration was...not.

3 responses so far

Pondering the Pitbulldenialista

Fascinating.

The dog botherers always insist the dog attacks are due to "bad owners". And that presumptively "good owners" will never have a dog that attacks or kills anyone.

We'll leave aside their denialism about their own doggy's noninjurious but threatening behavior and the inherent circularity of their argument for now.

The interesting point is what it takes to be a "good" owner. You have to train and "socialize" the dog. Control it. Keep it in the right circumstances. Train toddlers how to "approach it properly". Leash it. Lock the gate. Etc. never let down your vigilance for one little second.

What is all of this but a frank admission that these alleged domesticated animals are INHERENTLY dangerous to other citizens? If they weren't, the only problem would be "bad owners" who actively train the dog to aggress.

51 responses so far

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