Tuesday, August 23, 2011

"Pfizer drug studies fudged, report says" - Pfizer misleads us about Neurontin. NEJM.

 
I am not really great at blogging. I just figured out how to review older posts. I saw this headline was a "draft," so to go ahead and get it posted, I had to look the story back up.
 
Very sad.

Monday, August 22, 2011

Prof Boards Fail to Protect Patients Allan Aven

We healthcare professionals are a bit safer from the long arm of the law than other citizens. If a client believes we have performed wrongly in our job duties, the issue can go to a professional license board, rather than being a matter of criminal or civil court.

Ideally, this works well. It would be a challenge for criminal law -- judges with warrants, law officers with probable cause, prosecutors, juries -- to determine whether various situations met the criteria of a clear crime or not. It would be a challenge for civil courts to make judgments abt what is in bounds or out of bounds for practice - say, billing, or malpractive, or "dual relationships."

So, the state licensing board can set standards for getting licensed, and for monitoring ongoing stuff such as license renewal. They also can  -- and usually are -- a substitute system for grievances. A board generally has a committee to hold hearings in response to filed reports of misbehavior. The board is usually composed of volunteer professionals in the same profession. So, the board members should be able to judge whether some behavior is fine or not, and what a fitting punishment might be.

The board has punishments limited to its domain: revoking license, requiring specific profesional education, and other license-related things. The board will not give prison time, or a civil dollar amount settlement.

This system has its strengths, and its criticisms. One criticism is that the boards give "hand-slaps," in a colleague-buddy way. Kind of like the "code of blue."

Arizona has a recent news story where this profesionnal review system failed big time.

Allan Aven, a 70-year-old physician, apparently worked a depressed female married client into a sexual relationship, kept her in line by making her feel bad about herself, then dumped her.
http://www.azcentral.com/news/articles/2011/08/21/20110821arizona-doctors-license-revoked0822.html

Has his license been revoked? No. It has been suspended. Maybe he will learn his lesson.

Let's see. I have this data base that helps me explore disciplinary records of physicians. I am sure the Az Board used this to decide Doc Aven's punishment. My data source is called "Google."

http://articles.chicagotribune.com/2010-11-13/news/ct-met-doctor-sex-with-patients-20101113_1_sexual-relationship-doctors-sexual-problems

This guy had gotten in trouble for the same thing in Illinois a year ago, and the woman had gotten suicidal.

The Illinois story reports he had done this before, back in 2001, and the woman had gotten suicidal, and did end up killing herself.

Now, based on the 2001 suicide, and regular training, certainly this doc, of any docs, would recognize the problems with this type of relationship with this type of vulnerable client. Well, a newspaper reporter asked him:

"When a Tribune reporter asked whether having sex with the patient was wrong, he said: 'We were both in unpleasant marriages. Does that give you a right to have sex? People do it all the time. Clinton did it. Kennedy did it. I guess I'm in good company.' "

Hardly a comparison. This doc used his knowledge of the person's problems, and advice-giving credibility, and unique one-to-one office visit-nature of med practice to work on these women.

A Tucson discussion board has some comments...
http://boardreader.com/thread/Review_Aven_Allan_B_MD_Allan_B_Aven_MD_T_5n0rz__T9G71B099QCSHPCPF.html

The guy is trouble. But the sad thing is that this manipulator was known to medical boards. And may have / should have been known to the Arizona board when they threw the book at him - a flimsy paperback book of license suspencion. A more fitting response might be to pull his license, and phrase the judgment (available online - skeletal/skimpy) to include language that would make a civil suit very obvious.

Wednesday, July 13, 2011

Do diff OCD sx differ genetically? Let's ask normal ppl.

Do diff OCD sx differ genetically? Let's ask normal ppl.

http://archpsyc.ama-assn.org/cgi/content/abstract/68/6/637


A Multivariate Twin Study of Obsessive-Compulsive Symptom Dimensions.
Alessandra C. Iervolino, PhD; Fruhling V. Rijsdijk, PhD; Lynn Cherkas, DPhil; Miquel A. Fullana, PhD; David Mataix-Cols, PhD. Arch Gen Psychiatry. 2011;68(6):637-644. doi:10.1001/archgenpsychiatry.2011.54

This study was recently published. It is a good example to support my idea that we generally should be wary of "findings" published in psychiatry. Apparently, anything goes.

It also is a good example of the leading way to critique any study: evaluate the degree that the hypothesis, what the study is supposed to be about, with what was actually analyzed - how were the different constructs measured, what was the study sample, etc.

I will note a little abt this study just to show how commonplace it is for "findings" to pop up in the literature, and be accepted as knowledge, when the actual evidence is nothing like the supposed finding or knowledge.

Here is the trick: recognize that for every scientific idea, there is the general, global statement being investigated, and then there is the technical specification of that. Kind of like the difference between what a new "law" is supposed to be, and what the legalese sounds like. The health care reform bill says a few things, such as "there will be these state 'exchanges," and "kids can be on their parents' health ins until the age of 25." Now, does it take 1,000 pages to say those things? No. But the law has to be technically specified with all of that stuff about "the party of the first party" and "the party of the second party."

So: Big Picture, and Devilish Details.
We often have these questions about some psychological issue. We go get articles, and try to figure out what evidence there is. Since the technical aspects can be difficult to understand, there is the opportunity for the authors to fudge, or embellish, or interpret beyond the data.
We should always have our skeptical-lens glasses on. We should always ev aluate the degree that the devilish details line up with the big picture - the goal.

Here is an example: these researchers claimed to investigate whether the genetics differ between people with different types of OCD. We know some ppl with OCD do washing, and some do checking. Are there genetic differences?

That is my rephrasing. We can look at theirs (it is not necessarily the case that authors actually tell you the big picture - here, they are not too clear).
From  the abstract, which should hit the essentials clearly and succinctly:
"Context: Obsessive-compulsive disorder (OCD) is clinically heterogeneous, but it is unclear whether this phenotypic heterogeneity reflects distinct, or partially distinct, etiologic mechanisms."
"Objective: To clarify the structure of the genetic and environmental risk factors for the major symptom dimensions of OCD."
(Did you notice the drift? No. Neither did I.)
"Results: A common pathway model did not fit the data well, indicating that no single latent factor can explain the heterogeneity of OCD."
(Of what? Of "OCD.)
"Conclusions: Obsessive-compulsive disorder is unlikely to be an etiologically homogeneous condition."

OK: look back at my paraphrase - very close to their "conclusion:" "OCD is unlikely to be homogenous."
(did you see that drift? Is "unlikely" in there because they found support for the competing hypothesis, and they are just refraining from strong wording so as to be more speculative, as early science should be? Or, are they saying "unlikely," because their study actually has no dirent relevance to this "conclusion"? -If it has no relevance, then why conduct the study and why publish it?
Serioulsy. This is a problem. We are failing to advance our knowledge of psych problems because we are goofing around with non-issues and worthless studies. This gets us nowhere.
How does this stuff get funded and published? We have to look elsewhere, like sociology and anthropology.

OK, MedsVsTherapy, what is your beef?
Here it is: genetic connections were studied between categories of obsessive characteristics and compulsive characterostics in - get this - totally normal ppl.
As far as we can tell, there was NO ONE with OCD in the data set. No one.
How do you study the genetics of OCD when your data set has no one with OCD?

You can't.

Look back: Big Picture, Devilish Details. The big picture is abt OCD types, and the devilish details are abt normal ppl.

Those of us who do not have OCD still recognize OCD traits in ourselves.
If you gave 4,000 of us a questionnaire that asked us how much we like to hoard things, or put things in order, or be scrupulous about washing for fear of germs, some of would score higher on each of these characteristics, and some of us woould score lower.

Then, you could look at our genetic similarities and differences. Do non-clinical OC traits vary by gen similarities and differences? Yes, no, or maybe.
This is what the study did. They looked at many pairs of twins. Not ppl with OCD. Why? Because they were there.

Do they make this clear? Not really. They drift from talking about abnormal to analyzing normal with little fanfare - they move from a Big Picture abt one thing to Devilish Details abt another thing without making it clear.

Now, go back to those statements I quoted earlier, and see how they drift. Now, you see the drift.
Why not study this in lab rats, and never make it obvious that rats were used?
Now - is this legit? Depends.

It is possible that the genetic variance in non-OCD ppl matches onto OCD ppl? Are the genes in a non-OCD person who scores high on "non-clinical hoarding" also having their influence upon the OCD hoarder? Possibly. But that is way mor efar-fetched than this study assumes. This study has little problem tying the two together tightly.

Consider this: just as we non-OCD ppl vary on washing compulsiveness, within a normal range, and we vary, within a normal range, on hoarding proclivity, we vary on height, and on forehead size.
If the taller among us share genes, does that mean that gigantism is caused by those genes?
Probably not. Gigantism is probably an injection of some other factor that makes that person uniquely different. A phenomenon beyond our normal height range.

If there is shared genes among those of us with bigger foreheads, does that mean elephantitis, like the Elephant Man, is a problem of those genes? No. The Elephant Man had something distincly differnt going on beyond what is going on for those of us with larger foreheads.

Ther is something distinctly different about someone who has OCD. Those of us with OCD have gone beyond the normal range of  obsessive thoughts or compulsive behaviors. This may or may not relate to normal OCD characteristics. what we do know is that those of us without OCD do not have whatever it takes to make one have OCD - whether our genes are one way or another.

The authors could clue us in regarding how extreme some high scoring people were in this study.
But they commit a major fundamental flaw - with the assistance of the journal's editorial board: the devil is in the details - nowhere so they report the actual scores on the OCD "trait" scale: means and deviations. Nowhere do they tell us whether a score of some level or greater is in the "pretty-darn-high, possibly OCD" level. Nowhere. So, we readers cannot get a grasp of the degree that higher scorers might simply be a bit more OC than the next guy, or whether high scorers are really alarmingly OC.

Not in the noted "online supplemental" info, either.

So, there you have it. If OCD is merely a matter of being a high scorer, as prompted by a strong genetic effect that is also seen at non-clinical levels, then OCD types are genetically different. But if OCD is a matter of some qualitative difference - maybe an additional genetic or environmental issue - then this study is 1. irrelevant and 2. misleading to valuable OCD research. This is at the heart of the matter in this whole study, but is not directly addressed.

They propose to study one thing, but actually study another. With this type of strategy, the field of psychiatry can mislead us abt all kinds of stuff. Now, ppl will be going around saying, "Iervolino found that the subtypes of OCD, including hoarding, are genetically distinct." THe present study speaks nothing to this.

I can't really blame the authors - hey, I need to get published, too. I will publish any half-baked, off-track study that Arch Gen Psych is willing to publish. The journal, however - they should know better.

Tuesday, July 12, 2011

Who Ya Gonna Call, Kramer: Robinson?

OK, the guy who wrote "Listening to Prozac" has made a career off of discussing the use of antidepressants.
He's working at again in the New York Times.
http://www.nytimes.com/2011/07/10/opinion/sunday/10antidepressants.html?_r=1&hpw

Peter Kramer, "In Defense of Antidepressants."
He notes how sad it is that antidepressants are finally getting raked over the coals in the public sphere, a justice paralleled to the Casey Anthony case, where, sure, we know she is guilty, but the types of evidence used just don't add up to a legal conviction.

Kramer's friends, the psychiatrists, use all kinds of tricks to avoid conviction in the courts of the FDA and the Psych journals. Out here in the real world, we know what is up.

1. We don't get better when we take antidepressants. Kramer knows this. He makes a case for having the pills boost response time in talk therapy. They are so lousy that there is now a huge industry devoted to what pill you should ADD when your pill for depression does not work.
2. We here in the real world have learned, no thanks to the pill pushers, that these pills cause problems. Suicidaility in some, such as Phoebe Prince and many others profiled at the SSRI Stories website http://www.ssristories.com/
Otherwise, they cause bad with drawal problems - any drug that has that much influence on your brain will be accomodated by your brain, and so withdrawal will upset the balance of neurotransmitters. Stories of terrible withdrawal experiences are legion on the web, and, as Kramer notes, these pills are prescribed so broadly, that us everyday people know better than to buy this line anymore.
I mentioned Kramer's friends. He mentions one of the top five psychiatrists who have been caught with their hand in the cookie jar: sponsored heavily by the money of Big Pharma, and publishing lousy stories.

Robert Robinson.
Kramer says, "Surprised that my friend had not been offered a highly effective treatment, I phoned Robert G. Robinson at the University of Iowa’s department of psychiatry, a leading researcher in this field."

Robinson is now notorious as patient zero in the failure-to-disclose controversy that took JAMA from the magazine racks in the medical library an onto the grocery store check-out line. After Robinson published in JAMA a sales-brochure touting antidepressants - certain antidepressants - as treatment for post-stroke depression, it was revealed that Robinson had been on the payroll of that drug's manufacturer, Forest, but not disclosed as he ought to have, per JAMA policy, as well as plain ethics.
http://www.ncbi.nlm.nih.gov/pubmed/18505948

"Harris G. Top psychiatrist didn't report drug makers' pay. New York Times. October 3, 2008."

(I think Robinson claimed that it was an ovesight, or he did not understand the form, or something like that - oh, here is the lame response...NEVER connects escitalopram with Forest-)
http://jama.ama-assn.org/content/301/10/1023.2.full?ijkey=c6427e8f9fbc3589821c37b780a59f18792ad7e5&keytype2=tf_ipsecsha
The JAMA editor, DeAngelis, got involved with at least TWO editorials devoted to the firestorm. At first, she tried to tell everyone to shut up.
http://jama.ama-assn.org/content/302/2/198.long

http://www.furiousseasons.com/archives/2009/03/jama_editor_in_chief_upset_at_researcher_for_pushing_conflict_disclosure_at_journal_1.html

AND JAMA collaborated with a handful of other leading journals to commit to new, improved disclosure standards AS A RESULT OF Robinson's unethical behavior.
http://www.ncbi.nlm.nih.gov/pubmed/19826011
http://www.ncbi.nlm.nih.gov/pubmed/20595375
All of this launched by Kramer's buddy, Robinson.
I hope Robinson shared some of that pharma cash with Kramer.
So, Robinson is like the last guy to call if you want to get the low-down on antidepressants for post-stroke.
On top of all of that, I revealed in a blog post back then a handful of SIGNIFICANT shenanigans that were involved in that "PostStroke Depression" study. I am not widely read. Along with my blog post, I tried to spoon-feed this story to a few other places, but no one picked up the as-yet unrecognized garbage science in that study, and treid to hold Robinson, or JAMA, to task for it.

http://www.medsvstherapy.com/2008/07/license-please-or-what-happened-to.html

What I exposed then, in brief, was 1. that Robinson had pitted an under-patent drug against talk therapy to prevent post-stroke depression, but that the talk therapy did not use licensed counselors, so it was an illegitimate comparison intervention - but still fared pretty well, not-far second place! 2. there was yet ANOTHER drug -nortriptyline - NOT under patent - in the trial, but that was 100% UNreported 3. There was yet another drug - citalopram - in the trial - but not reported, but just going off patent, AND the trialed drug, escitalopram, just getting FDA approval!

This monkey business was conducted by Robinson, the guy who Kramer just called for medical advice regarding antidepressants.

Monday, July 11, 2011

Phoebe Prince: Media Loves Bullying, Forgets SSRI Warning Label

Here in America, we are still clueless.There it is on the warning label: Antidepressants can cause suicidality in teens.
So, a teen commits suicide. This event is widely covered by the media. As a bullying issue, not as an antidepressant-related suicide.
The fact that this teen was taking a pill that has, on the warning label, suicidaility as a side effect, is never mentioned.
Phoebe Prince. Go look for yourself.
http://news.bostonherald.com/news/regional/view/20110630ag_martha_coakley_schools_should_report_bullying_data/srvc=home&position=recent
http://www.dailymail.co.uk/news/article-2012694/Teen-charged-connection-Phoebe-Prince-suicide-breaks-silence.html

http://www1.whdh.com/news/articles/local/12004784059216/phoebe-prince-bully-speaks-to-today-show/

http://www.gjsentinel.com/news/articles/grand-junction-man-fights-back-against-bullies1

This dude thinks he gets the point:
http://articles.boston.com/2011-06-12/news/29650387_1_phoebe-prince-south-hadley-high-school-yearbook-photo

He doesn't.

Hypothetically, you could google "Phoebe Prince" and "SSRI"  -- would that be too hard? Do we really expect this level of knowledge and professionalism to be present in the Tara Parker-Popes of the world?
Well, let's see where this super-advanced sophisticated NASA technology info search gets us:

I repeat: this is really technical: google the girl's name, and SSRI.

http://health.groups.yahoo.com/group/SSRI-Crusaders/message/36885

http://www.life360.com/blog/truth-about-phoebe-prince/

http://thestir.cafemom.com/teen/106984/the_truth_behind_phoebe_princes


And plenty more.
Adolescence is not easy. You will get bullied. But why add a drug that is noted to increase suicidality?
OK, that is one issue. The bigger issue is: why have no journialists or commentors in the major media picked up on this?
All they have to do is use google.
I know I have education and training far beyond Tara Parker-Pope. But seriously: can't you use google?

Wednesday, April 27, 2011

No Excuse for Absence.

Hi. I have no great excuse for not blogging the entire year until now.
There has been plenty to blog about.  And plenty of need for this type of contrarian blogging. There is a growing anti-med and conservative-med sentiment in society, but the prominent discussion does not seem to assuage demand in the least. Someone has to make a few good points, or come up with a jingle, or a viral video, and get things rolling.

Well, for 2011 thus far, it obviously has not been me.
I have been busy. Personal and professional life have been active.

I will try to blog more.

I really don't have an audience, but I believe it will pop up one day. And I need to have something for them to read. Something that really illuminates where we are as a society with the ideas of mental illnes and pill-based treatments - all the illusions we are sustaining right now, rather than face the hard work that pays off.

So, I will try.

Anonymous Pushing Birth Control

Anonymous Pushing Birth Control

Who is anonymous, pushing birth control? And why are they staying anonymous?
As researchers, we are slaves of patronage: we rely on the largess of the wealthy to allow us to carry out our craft. If you talk to us, or let us pontificate, you will hear the theme that society should allow us to pursue our scientific interests, with no regard for cost, and no responsability for finding, identifying, justifying, or accounting for the money in any way. Sorry. That is just how we are - or at least the way we have constructed the fable of research. However, like Handel eagerly accepting the commission to compose music at a king's request - and eager to pretty much become British, too, we are eager to accept the call to conduct research if only we can find the patronage.
So, I can understand accepting Pharma money. If, one day, my agenda and Pharma's agenda cross, I just might. In my clinical resaerch world, however, I don't have an agenda to pursue that would add to their sales, and my agenda is basically contrary - I believ we should prioritize non-pharmaceutical interventions wherever there is equivalency, or where psychotherapeutic interventions are better.
Nothing wrong with getting funding, thoughm now and again. So, hey, money comes along from Pharma, and what can you say? What if it is Anonymous money?
Looking through research, I stumbled upon politically charged clinical issues studied with anonymous money. Think about this: Pharma's name is already on research worming its way into policy. And they are allowed to bank-roll FDA, for Goodness sake. Why be anonymous?
So, I looked into this. Why? One, because I am pretty much always suspicious of Pharma. If they have a magic pill, they will run with it. If they don't, they will act like it, and run with it. Once you see their tentacles, be suspicious.
Politics: if you can get your med to be delivered as a matter of government policy, you win. Big time. Scientists at least have half a chance to recognize skull-duggery, and act the right way, despite the influence of money. But when it comes to politics, there are no such checks in place.
The full frontal assault to get Gardasil mandated as policy for all teen-age girls was one clear example.
So, this "anonymous" story makes me wonder.
http://www.choiceproject.wustl.edu/
Put "contraceptive choice project" and "anonymous foundation" into your favorite search engine, and you get a lot. Including the Choice Project.
If you were a suspicious person, you would figure out some guesses pretty quickly. Either a Pharma company is eager to get their birth control to be widely pushed through goverment-dependent systems, such as Planned Parenthood, or an advocacy group who stands to make a lot of money, like Planned Parenthood, has developed a foundation and is getting Pharma to carry out their research. Or something like this.
Where does this suspicion come from? The over-billing stories. One of the Pharma-related stories is that Planned Parenthood, due to their benevolence, gets a discount on prescription medication, and then bills the government full price. This has the potential to be amazingly profitable. Amazingly. I was party to a knowledgeable-insider discussion recently about the dollar value on patented medications. A couple speakers were familiar with the donated-medication programs provided by Pharma. While a drug might have a price tag of $10/pill, the "marginal cost" of each pill may be less than a penny. so, a politically savvy arrangement might have an organization like Planned Parenthood buying a month of birth control pills, let's say a $25 value, for only $5. Pharma can afford it. It won't spoil competition for the ways they sell the Ortho-N for $25. Everyone gets to make some politicla contributions and feel like they have made the world a better place. The only chump is the taxpayer, where the bill for thousands is spread out across tens of thousands.
So, if you can develop the next birth control pill, or ring, or patch, or injection, everybody wins.
Unless you get caught.
But how much trouble can that get you? Elected officials already take all kinds of money from Pharma. No surprise there. If PP gets caught, they just isolate the specific clinic for accounting irregularities, and find the fall guy.
So, the sweet spot is to develop yet another birth control drug that will be viable on the lucrative free market, but that you can also channel through Planned Parenthood. Or, maybe not develop another. Looking over the "Choice Project," it appears that it is a study of current medications. Why study current contraceptive medications?
Why the heavy funding for current contraceptive medications?
Anonymously?
If you google "contraceptive" and "anonymous foundation," you will see that this funding is not limited to St. Louis' "Choice Project." And, it did not start yesterday.