Monday, June 9, 2008

Big Troubles at Mass General

The blogosphere is buzzing with the Sunday New York Times article by Gardiner Harris and Benedict Carey in which we learn that three child psychiatrists at MGH did not report most of the payments they received from drug companies on conflict of interest disclosures.

I have been reading the pertinent documents in the Congressional Record
in order to figure out whether these three psychiatrists, all of whom I know from my training days at MGH, behaved very badly or just a little badly. All three are highly intelligent and committed researchers. During my residency days, I received a few lectures from Dr. Wilens, and he is a good, solid person. I didn’t have as much contact with Dr. Biederman or Dr. Spencer.

The issue at hand is a little complicated, but here’s my understanding. Whenever a researcher is awarded money from the NIH (National Institutes of Health) to conduct research, the employing institution (in this case, Harvard) must obtain detailed conflict of interest disclosures from these researchers. After all, this is public money, and the NIH wants to make sure that our hard-earned tax dollars are being spent responsibly. There are two big rules that are relevant to this controversy. Rule One is that researchers cannot accept more than $20,000 in payments from a drug company whose drug they are funded by NIH to research. Rule Two is that they must disclose any payments of $10,000 or more that they have received from any drug company.

The most serious of Senator Grassley’s allegations (Grassley being the ranking member of the Senate Finance Committee) is that all three doctors broke Rule One. They all conducted NIH-funded studies of Eli Lilly’s Strattera (atomoxetine) for ADHD during years that they also received payments from Lilly—payments that exceeded the maximal payments permitted. If this is true, it represents a pretty significant breach in the integrity of the NIH funding process.

The other allegation is that the doctors chose to reveal only a fraction of all the money they actually received from drug companies. When Grassley and his aides looked over each doctor’s yearly disclosures, it appeared that they received no more than a combined few hundred thousand dollars over a seven year period. However, when the doctors were asked to look back over their financial records for the Senate Finance Committee, they suddenly discovered quite a few overlooked checks, to the tune of $1.6 million each for both Biederman and Wilens, and $1 million for Spencer.

I am inclined to give them the benefit of the doubt on this issue. I don’t think they hid these payments out of greed, sneakiness, or the thrill of getting away with something. They probably simply didn’t believe these earnings were relevant to the NIH funding they received. If you look at the charts detailing each doctor’s income in the Congressional Record, you can get a sense of why this might have occurred. Many of the large payments were not from drug companies directly but from third party medical education companies, with vague and uninformative names such as “Phase 5,” “MedLearning,” “Strategic Implications,” and “Primedia.”

For example, in 2005, Dr. Wilens received only $9500 directly from Eli Lilly, but $70,000 from “Promedix,” and $37,750 from “Advanced Health Media.”
A little googling reveals that Promedix is a division of Advanced Health Media, which in turn is a company that does “speaker program management.” So Wilens received a total of $107,750 for speaking programs, but the disclosure does not allow us to track things any more specifically. Who was he speaking for? Was this CME or promotional? How did this relate to his NIH funded research?

I’m willing to bet that most of this money came from Shire, because I have seen Wilens, Biederman, and Spencer headlining many Shire-supported CME programs on ADHD. (See here for some background).

So the psychology of non-disclosure may have gone something like this: “I’m doing NIH-funded research on an Eli Lilly drug, so I’d better be scrupulous about disclosing payments from Lilly. But the marketing work I’m doing for Shire is not relevant to my NIH research, and it’s indirect CME money anyway, so I won’t disclose that.”

A little sleazy? Maybe. Malevolent? I don’t think so.

The big lesson here is that Congress must pass the Physician Payment Sunshine Act, because we will never be able to grasp the extent of the complex financial relationships between companies and thought leaders without this legislation.

51 comments:

Anonymous said...

This is absolutely unethical behavior. Giving them a pass on this puts you on the wrong side of this issue. You are telling me these guys are well-organized and smart enough to run big NIH research projects but 'accidentally' fail to disclose these monies?

If there were real ethical standards in psychiatry, they would be fired, no one would believe their research, and practitioners would be really angry at these guys, not making excuses for them.

Your stand on this issue is very telling.

therapyfirst said...

This comment is hypocritical of me to be forwarding, as I was planning to not return here, but when I came on to get your email address and saw today's posting, which was my intent to contact you, I just had to forward this to the comments section and not your personal email.

"..benefit of the doubt"!?!?!?!?!?!

you have to be kidding me! What does constitute an egregious infraction by a colleague that demands consequences? Taking obscene amounts of money does not have an impact on the results of the "research" such funds pay for!?

What has happened here at this site? I am so disappointed in the way things are minimized or rationalized these days. Bet that laypeople reading this have to wonder which side of the fence you reside.

Well, you know the story, so I don't have to bring it to your attention.

Anonymous said...

Danny, I'm a little confused. Are these lectures these docs are giving funded indirectly by the relevant drug companies (e.g., through "unrestricted educational grants")? Or is that unclear at this point?

Marilyn Mann

Daniel Carlat, M.D. said...

Hey, c'mon guys. What happened to innocent until proven guilty. People have had it in for Biederman and company for a long time and are all too eager to jump on the bashing bandwagon. I agree that they behaved unethically (as I said, the question is whether they behaved "very badly or just a little badly.") But I would like to let them explain their side before condemning them out of hand.

Regarding Marilyn's question, it's not clear where all the money came from. Probably it came from both direct drug company payments for research and speaking, and indirect payments from medical education companies for CME events.

Gina Pera said...

Thank you, Dr. Carlat, for your reasonable commentary.

It's just amazing to me that few people see the story behind the story here--the clear footprints of a certain religious cult composed of people with mental disorders who don't want to be "controlled" with medication.

They have been very effective in cozying up to conservative politicians of Grassley's ilk, and the NYTimes simply took the bait and provided a mouthpiece for his grandstanding.

This anti-psychiatry cult targeted Swedish psychiatrist Chris Gillberg--with terrifying results-- and they've been aiming to do the same with Biederman et al for a long time. Anyone who doesn't know this simply isn't paying attention.

Moreover, the public has no idea about the hoops that scientists have to jump through to get grants and then conduct studies. And with a top guy like Biederman, the public also has no idea how many desperate parents constantly contact him for help.

The public doesn't want to believe that toddlers can come at a parent with a steak knife or try to jump out of a moving car--and it is not due to parental abuse or neglect. It has to do with the BRAIN. But that is too scary a concept for a largely science-phobic, religiously obsessed population.

And, "anonymous," you obviously aren't familiar with research scientists. These folks can indeed be brilliant at the research and successful in getting the grants. But many of them can't even keep track of filing personal expense reports--much to their financial loss. Scientists are not bean-counters. They are chasing the stimulation of discovery.

Anonymous said...

Dr Carlat,

I agree that we need to respect "innocent until proven guilty", and if it turns out to be CME confusion (since they make grants, and don't pay directly, and there may be multiple sponsors), then I don't have a problem with it.

However, if it turns out they were giving promotional talks, then they should be tarred and feathered for not reporting it. Regardless of who actually payed them (management company, etc.), they would know that they were speaking on behalf of a specific pharma company and who the payment was coming from.

Daniel Carlat, M.D. said...

Gina, I appreciate your comment but I have to say that I am extremely skeptical about this oft-repeated conspiracy theory that scientologists have overrun the media and government etc... I'm open to any real evidence you can provide me of this.

Anonymous said...

So, I am a physician earning OVER A MILLION DOLLARS from sponsored speaking engagements and consulting and I don't disclose this?!? You yourself, Dr Carlat, have renounced such industry pimping, and I doubt you ever made that much. How is it moral, ethical, or legal not to disclose the details of this to your academic institution? I am an academic psychiatrist, earning $125,000/yr. The amount those three were paid is unbelievable, and it's outrageous that they didn't disclose it properly. I don't care whose name was on the check.

I agree that there is a lot of anti-psychiatry bias in the media, maybe based in scientology, but quite frankly, these days, I'm not sure the media is wrong...

Gina Pera said...

Daniel,

Sure, it's not purely this cult's efforts. It takes an ignorant populace and cynical politicians to help their propaganda take root. Add dyed-in-the-woolly-headed psychoanalytic throwbacks, and it's a perfect storm of obfuscation.

Check out this well-heeled hit job on Chris Gillberg in Sweden. It's common knowledge in the ADHD field that the pattern has been the same with their attempts on Biederman. Maybe you just need to get a little closer to the ground to understand it. Cognitive dissonance among reasonable people can be very strong in this area. ( Just like the cognitive dissonance around the first few years of the Bush presidency...no one could believe he was as ADDled as he acted. But he was! And now look at what his untreated disorder has cost us.)

The terminology plastered all over the internet is always a variation on a few themes, for example. "Teachers are making children take drugs so they won't have to teach them," etc.

And too many otherwise intelligent people are taking the bait--which sounds so reasonable--instead of doing real-life research and critical thinking.

As for your appeal to Congress, well, good luck. The pathology among politicians could fill a warehouse of DSMs. :-)

Supremacy Claus said...

Dan: This is rare. Your position is proper.

The biggest damage done by Dr. Biederman is to promote the overdiagnosis of bipolar disorder in children with ADHD. They then get placed on dangerous mood stabilizers when they need safer amphetamines.

However, I know that lawyer gotcha is not acceptable as a way to resolve a scientific controversy.

I can review the records of everyone on earth. I can find lawyer gotcha, and the violation of a rule, a malum prohibitum (infraction of a esoteric, hidden rule in the 50,000 page book of federal regulations passed each year), and not a malum in se (an inherently evil act).

Lawyer gotcha is a form of bad faith, and should be crushed. Lawyer gotcha is a malum in se. This bully, Grassley, offends and frightens me as a patient. By attacking clinical research, he deters the entire enterprise. I want to rummage around in his records. I can find a malum prohibitum in a few minutes.

If you were a child psychiatry resident, and someone said, go into research. How would answer after this article?

I would like to see enemies lists started. The enemies of clinical care get shunned and boycotted by all productive sectors.

Gina Pera said...

"Lawyer gotcha is a form of bad faith, and should be crushed. Lawyer gotcha is a malum in se. This bully, Grassley, offends and frightens me as a patient. By attacking clinical research, he deters the entire enterprise. I want to rummage around in his records. I can find a malum prohibitum in a few minutes."

What's stopping you??? :-)

How about starting with Grassley's donations from agribusiness, including the fertilizers that cause crops to grow so fast they lack the key nutrients critical to a developing fetus? A national epidemic straight from the federally subsidized heartland.

The fish oil that's now being recommended for bi-polar patients (thought to be low in Omega-3s)...guess what? Our livestock used to provide us with Omega-3s, until we started feeding them grain. And, again, thank you, Iowa!

Good point about the gotcha--common in journalism, too.

Doctor F said...

Just sent the following letter to Harvard Medical School. Made me feel a bit better. Maybe if they get swamped with mail and calls they won’t languish in their decisions.

“I am a psychiatrist who trained at NYU. There I was taught that honesty was integral to the practice of good medicine. I’m sure that’s what you teach at your institution as well.
Please do not just discipline but fire Biederman et al. as quickly and publicly as possible. Their moronic greed is going to have hideous ramifications in medicine for some time but the quicker that we all publicly denounce what they did and begin to take steps to correct our imperfect system, the sooner we will begin to earn our patient’s trust back.
That is of course, unless we just want to go back to a laying of the hands and stop prescribing drugs altogether.”

P.S. I also think that their licenses should come under review for revocation for unethical conduct. The real shame is that is that their research has really helped lots of kids and now it's going to be even more repudiated and damaged in the pubic eye and harder to treat these children effectively.

Anonymous said...

gina pera says (disingenuously) that scientists are NOT bean counters. they absolutely are! that is what clinical research is about - counting beans.

the mgh physicians also have plenty of administrative help so the unaccounted for millions didn't just go absent-mindedly missing..

dr.carlat - i am disgusted and disappointed with you. your shameful stance on this makes one wonder what your own agenda might be in all this

Gina Pera said...

Interestingly enough, Grassley's second-biggest donor is Blue Cross/Blue Shield. I can't imagine it appreciates paying for the costly medications that these physicians promote.

Grassley's top donor: the "public affairs" firm DCI group, hired by Burma's military junta to do PR.

Its CEO, Doug Goodyear, also played a role in RJ Reynold's efforts to manufacture a grassroots campaign against tougher tobacco laws. (Hmm, grassroots campaign against medication for children.)

A third top donor is FPL, which seems poised to benefit greatly from ethanol.

I don't think links come through, but here it is:

http://www.opensecrets.org/politicians/summary.php?CID=N00001758

Anonymous said...

I think you come down harder on a primary care doc taking a sticky pad.

Stephany said...

Regardless of any opinion of Biederman and company; we are talking about millions of dollars here, lack of ethics, and downright lack of moral standards, ok, --so give them the benefit of the doubt--nothing happens by accident.
The amount of money involved here is over the top.

I have a feeling Pandora's box has just been opened and the fall out will be worse than this.

Stephany said...

I agree with the letter Dr F. wrote, and as a consumer and mother, thank you for writing it.

Daniel Carlat, M.D. said...

Uh oh, Supremacy Claus is supporting my position. The stars must be misaligned.

Look, maybe I came across as a little soft on these guys. Just realize a couple of things. First, MGH is my alma mater so I don't like appearing too nasty in print about them. They did a great job in teaching me how to be a psychiatrist!

Second, now I'm on these APA committees in charge of fixing the system and I'd prefer to work with the "bad guys" rather than hurling missiles.

Am I being coopted? I don't think so. I sincerely hope not.

Anonymous said...

Innocent until proven guilty wasn't your motto, Dr. Carlat, when you lashed out on physicians for accepting pens and free lunches. Now you are defending $1.6questionable research leading to pediatric bipolar epidemic.

If this isn't hypocricy, what is?

Doctor F said...

You're welcome Stephanie. I think a lot of doctors are just scared because what happened suddenly affects a lot of research that we depend on for the off label prescribing of drugs.

I know in psychiatry if I have to wait for the the FDA to approve an already available drug for a particular indication, usually I’m doing my patients a tremendous disservice. The reason for this is that as a specialist, usually the patient I'm treating has already failed treatment with, let's say, the standard indicated antidepressant that was prescribed by their internist and they are going to need augmentation strategies and combinations of medications that are not approved for that indication by the FDA but are documented to be therapeutic in the scientific literature.

The fact that Biederman somehow "wasn't aware of" on the average of $225,000 a year of income for seven years simply isn't believable. I simply think he felt he was above the rules. They all did, and they really hurt the field of psychiatry, which I, for one, am very angry at them for.

therapyfirst said...

my mistake for coming back to read what others had to say after this AM.

Allegiance to your alma mater? Come on, sir, that is not acceptable as a physician, and I think you know that. Your allegiance is to patients first, and to not take a stand for an institution, even though I do agree facts need to be put out there before a quilty verdict is issued, is what I thought this blog was about.

I warned you to consort with this committee could compromise your position, and that last comment validates my concerns. I may be one opinion in a sea of millions, but I have seen good people get corrupted with the best of intent at first, and I see you stuck in that current. This revelation has serious repercussions if truth is not maintained; stalling and deflecting are the defenses of the guilty. Sorry, but I've seen that first hand in professional disputes.

Better to say nothing than to give support to someone who has not been forthright from the beginning.

After all, you might get what you wished for. You've done good things here, don't mess it up!!!

Supremacy Claus said...

Dan: Here is lawyer gotcha, and why it is bad faith and evil.

The rich hated Bill Clinton for raising their taxes. They should have tried to impeach him for this sincere reason. Instead, they did so for a lie on a deposition, on the definition of the word, sex. The lawyers put him through the wringer for a year, including the loss of his lawyer license.

He likely spent a 1000 hours of President time on impeachment. It failed.

What happened during those years of lawyer gotcha? The preparation for 9/11. That's right, lawyer gotcha is a proximate cause of 9/11 because Clinton fought impeachment instead of Al Qaeda. That will never get into the 9/11 Report, mostly written by self-dealing lawyers.

In this case, things are worse. Research will get deterred, not just by the low pay, but by the hassles. We lost 3000 to Al Qaeda. We can lose 3,000,000 to inadequate research effort.

No one is free of malum prohibitum, no one on earth. I do not know Gina. However, it took her a minute to find Grassley's agenda, as anti-medication intimidation of anyone generating costs for his donor, insurance companies. The maxim in legal remedies is, those who seek equity should come with clean hands. Grassley's hand are ultra-filthy. His filthy hands qualify for EPA superfund toxic field remediation.

I hope that Biederman takes a strong stance, and counterattacks the lawyer weasels. He will not, at the request of MGH, which has $hundreds of millions in grants. All of those are subject to extra careful review for compliance with 10's of 1000's of federal regulations in the Federal Registry.

That is the game. Once he leaves academia, his income will dwarf all his earnings in the past.

I thought Biederman an ass. However, this is not the way to end his legitimacy. It should be done with scientific data. And the lawyers should buzz off or face the same treatment themselves.

Always attack the personal future of the government jack booted thug, even the one wearing a suit. They are vicious land pirates, and members of a criminal cult enterprise, running all of government, the lawyer profession.

The supercilious doctors here are their running dogs, and a disgrace to the medical profession. They should carefully review their lawyer gotcha exposure before getting too uppity about Biederman.

Sara said...

You've shed some interesting light on this story with regard to the payments these doctors received. I still think it is a reflection of just how corrupt things have become. Whether it was directly for promoting drugs or giving CME lectures that promoted them indirectly does it really matter? How can you be objective about anything if you are getting hundreds of thousands of dollars from drug manufacturers? In this situation it is pretty unlikely you are going to explore any other paradigms to help troubled kids. No one is really looking scientifically at the long term harm these drugs are causing or their addictive problems. It's just outrageous that little kids are being put on such potent drugs with no understanding of how they affect development -- physical and mental -- and what it means to be taking this stuff for life. Maybe these doctors are not deliberately malicious but at this point they have been completely hijacked by a paradigm that works in their favor and the favor of the drug industry but it doesn't appear to be working at all in favor of patients.

Radagast said...

Well, as I posted on the Pharmalot thread that discusses this matter, what the funds were for is largely irrelevant, I think. The fact that they were not disclosed goes to the very heart of integrity.

In the UK financial services industry, we have an Approved Persons regime, wherein one completes a lengthy form if one wishes to receive the badge of honour that is approval to carry out a Controlled Function. One must pass the "Fit and Proper Test" (ie, one must be honest, competent and financially sound).

Now, a traffic offence (and consequent fixed fee penalty + points on one's driving licence), means precisely bugger all - provided one discloses it, because driving offences have no impact on one's ability to carry out a Controlled Function. But a failure to disclose a minor offence... Well, now, that's a different matter. Bang! goes honest and integrity, for a start.

Matt

Anonymous said...

The point is Dr. Carlat, every single Psychiatrist along with the APA should be sending letters just as Doctorf has done.

Gina blames the scientologists for this mess Psychiatry is in. Guess what Gina? It's not the Scientologists at fault here. The "critical psychiatry movement" is growing each and everyday because Psychiatry has allowed this kind of behavior to run rampant within their profession. People are pissed off because of shitty treatment based on shitty research and until Psychiatry as a profession takes a hard long look at what has been aloud to pass as scientific research and demand change your problems have only just begun.

We are not all Scientologist who are pissed off. We are people who have been harmed by the Bierderman's and Sackiem's of the Psychiatry world with disgusting research ethics. We are people harmed by their collegues who try to justify this behavior because they know them to be honarable guys.

Radagast said...

anonymous said said:
"...The "critical psychiatry movement" is growing each and everyday because Psychiatry has allowed this kind of behavior to run rampant within their profession..."

Yes, but what is Psychiatry, as a profession, actually professing? In 100 years they've taught themselves nothing about the way that the human mind works. There are still people who seem to imagine that certain parts of the brain have control over certain functions and that the "intelligence" and persona we possess at the age of 18 are more or less what we die with.

If people accept the suggestion that people in authority know what they're talking about (and we're taught this from the cradle, or more to the point, we're strongly discouraged from questioning authority), then it's really very easy to have them accept that they're mentally ill, on the say-so of authority - purely by dint of some behavioural characteristic, or other. And, by God, if you want somebody to be mentally ill badly enough, then they'll be mentally ill for you, and they'll carry on being mentally ill for you, even though they don't understand why they're still being punished, when they're doing what you asked of them.

What if mental illness was a myth, dreamt up by people who don't like the way others behave (in the same way that certain adherents to certain religions don't like the way that people of other religions behave)? What if, in the diseased mind of some psychiatrist, the only explanation for a child's outburst of anger can only be explained by mental illness, of some sort or other, at which point it's only a question of putting the child in the appropriate box, with the appropriate label affixed? Has it never occurred to anybody to try to establish what has provoked a person to become angry, sad, elated, etc, in a seemingly uncontrolled manner? There'll be a logic there, because there always is.

Matt

Gina Pera said...

"Gina blames the scientologists for this mess Psychiatry is in. Guess what Gina? It's not the Scientologists at fault here..... People are pissed off because of shitty treatment based on shitty research and until Psychiatry as a profession takes a hard long look at what has been aloud to pass as scientific research and demand change your problems have only just begun."

Guess what, Anonymous. I said the anti-psychiatry cult is ONE factor. And I'll be the first to agree: Psychiatry has brought this on itself, but it is precisely because too many psychiatrists have DISREGARDED research.

For eight years, as a volunteer (no money involved!) I've listened to bone-chilling stories of psychiatric incompetence, specifically in the area of ADHD and its comorbidities-- with and without medication. I don't know which are worse.

But I'd say, docs' failure to follow evidence-based protocols strongly fuels public positive response to scare-mongering headlines. They tried medication, and it wigged out them or their loved one.

(And Supremacy Claus, you make some great points, but I don't understand your wanting to give children with bi-polar amphetamines!!! yikes! That's what we're trying to get AWAY from.)

Yes,pharma does some dastardly things. But my God, without pharma, so many people I know personally--hundreds--would still be languishing. You just can’t imagine the joy experienced when people find the ADHD medication that fits their biochemistry.

People in the healing profession should celebrate, not disparage and shoot down, these breakthroughs. They should educate the public, not pander to their fears.

We can "follow the money" down all kinds of other anti-medication spider holes, too--not just Grassley's campaign donors:

 The "anger-management" specialists who want to maintain their court-system contracts (when medically treating the "perps’" impulse disorders would create much lower recidivism rates)
 The therapists who’d rather entertain their own psyches and fill their pocketbooks with years of treating a patient’s lingering "core therapeutic issues" (when, if they are ADHD symptoms, they disappear when the right medication is in place)
 and all the various scams that have sprung up as "alternatives" to ADHD medication and shamelessly exploit the public's fears.

Consider the massive fraud committed just this week by the Dore Method in Australia, heavily promoted by psychiatrist Ned Hallowell in this country for ADHD despite NOT A SHRED of evidence. Ah, but these bogus therapies bring in a lot of dough ($5,000 for a series of exercises)--much more than docs can make prescribing meds with managed-care's measly reimbursements. Seems like a pretty canny business decision, doesn't it?

Follow the money indeed. The researchers and pharma get the money--and everyone who doesn't get the money (or, worse, has to pay it, like the insurance companies) joins the attack.

Gina Pera said...

Anonymous wrote: gina pera says (disingenuously) that scientists are NOT bean counters. they absolutely are! that is what clinical research is about - counting beans.

----
You obviously have no idea how scientists' brains work, Anonymous (why are you so afraid to use a name?). Or, indeed, how human brains work.

The neural pathways fire up when there is INTEREST. STIMULATION.

And if you for one minute think that brilliant scientists, however batty or maniacal they might be in other ways, like to hyperfocus on financial spreadsheets, you are woefully mistaken.

That doesn't mean they don't like money. But money can be an abstraction.

Supremacy Claus said...

The officious, know nothing intermeddlers here are missing something. Facts.

We do not know the facts. 1) Harvard needs to investigate further; 2) the payments may have been too low for the time spent and the work done, a kind of personal sacrifice; 3) a deal in academia is that one get paid a low wage, for less work, and that outside consulting is allowed. So the law profs can take a case, and do. This arrangement benefits the students by having a prof more familiar with recent outside world activity.

This attack by Grassley changes the deal without notice, after it has gone on for decades. Let's say, Harvard prohibits these activities entirely to avoid bad publicity. It prohibits ownership of stock relevant to research activity. It requires full disclosure of all finances of all faculty on its website. It requires the disclosure of the acceptance of a sandwich from industry on its web site. It bans all sponsored activity. It bans outside consulting. It bans participation in journals for pay, since the money comes from industry advertising. The sole source of permissible revenue is the central government (the hidden agenda of the enemies of clinical care).

What is the effect on research? On recruitment of researchers and research patients?

Sara said...

To say that this brouhaha is all the result of Scientology propaganda is naive and gives that movement far more credit than it deserves. The problems within psychiatry and, to a lesser extent throughout medicine, are so profound and corrupt that it is not surprising a whole movement, completely separate from Scientology, has sprung up and is finally making some headway. The interests of psychiatry and the pharmaceutical industry have created a perfect storm of collusion and chicanery, so perfect, in fact, the players don't even realize what's going on. The evidence that most of these drugs are neurotoxic is accumulating, but there is little incentive to study this in depth, certainly not by their manufacturers nor their prescribers. In the meantime the victims pile up -- patients who may have reaped some short term "benefit" only to find out down the line that it came at enormous cost to their physical and mental well being, that is, if they are not so addicted and dependent, that they don't even realize that it's the drug affecting them not their "treatment resistant disorder." It is my experience that, in the long run, psychiatric medications make people worse, not better, and limit the possibility of healing.

therapyfirst said...

Some phrases are timeless, and the one I will repeat until I am done on this planet is simple and well known: deeds, not words, are what define us. The last anonymous comments at 6:13P are true; if we as physicians who maintain the code of ethics and morality that serve the patients as best able give these cretins a free pass by rationalizing and intellectualizing their behaviors and agendas, we are as much guilty as the poor judgments these failed doctors have provided.

The question this most recent revelation raises for me is, do we rise up and say enough, or do we just submit to these "people" (as I cannot call them what I know them to be and hope this submission will be printed) and allow the continual deterioration of psychiatry to proceed?

You know, Dr Carlat, Dr Reid from Texas wrote a great column back in 1998 in the Journal of Practical Psychiatry that addressed reporting impaired colleagues. He said (I have to paraphrase as I am too tired to drag it out of my files in my basement) that if you know someone is impaired and do not perform your duty and report it, you are as culpable as the one who is actively putting others at risk. That is one serious expectation to uphold. And yet so many of my peers either don't get it or don't care to get it. This apathy or ignorance is unacceptable. But, in the end I guess we are more representative of the society we serve than we want to admit to practicing.

These guys at Mass G will get a pass. And when the truth comes to bear, we are as much the scoundrels as are they. That is sad to type out, but it is the truth I see.

America, what a country!

Anonymous said...

" a little sleazy " Bwahahahahaha. it is ridiculous that you would give your teachers at MGH a free pass for their unethical behavior and assail us hardworking clinicians in the trenches for taking some pens and an occasional free lunch. Call it for what it is or you've lost your moral authority.

DocJohn said...

I don't know... It feels like a softball from someone who typically has had few good words to say about anyone who takes CME money coming directly from pharma CE fronts. It feels like that, because it's your alma mater, you're being light on them and your tone would be different if this wasn't Mass. General or people you trained under.

Are we supposed to believe these guys don't know drug-company funded CME? Of course they know. And I'd suggest they knew what they were doing when they failed to disclose these payments, because they knew that it would look badly for their reputations. Which it did.

If you truly believe this was more of a misunderstanding on the part of these otherwise smart researchers, we would expect to find similar problems with this particular kind of disclosure across the board, in multiple research fields, at multiple universities, no?

Ana said...

Attention Deficit Disorder Association (ADDA)

An Update On Medications Used In The Treatment Of Attention Deficit Disorder
by John Ratey, M.D.

Excerpt:
"Contrary to popular wisdom and media perception, they are among the safest drugs. For instance, the only longitudinal studies to date on adolescents show that rather than being a stepping stone to addiction, the one robust finding is that those ADHD adolescents who took Ritalin were less likely to have a substance abuse problem at the end of their teens and early twenties. For the adult population this is also true. Most of the patients who are treated with stimulants do very well and have little need to escalate the dose once the proper level has been established."
About the author:
John Ratey, M.D., is an assistant professor of psychiatry at Harvard Medical School. He practices psychiatry in the Boston area.
http://www.add.org/articles/updatemed.html

Can we rely on the data that is on this site?

And

Ana said...

In Brazil the "Attention Deficit Brazilian Association" is supported by Janssen-Cilag and Novartis.
There are Brazilian psychiatrist that are working with Dr. Biederman and his colleagues.
I believe that with the lack of good pharmacovigilance in countries like Brazil and the total support of media this people will continue to make profits.
These drugs are global.

Anonymous said...

The real issue is this:

Do you really believe that researchers who are made into millionaires through their links with drug companies will produce unbiased scientific research?

This contradicts everything we know about human behavior...

therapyfirst said...

To be consistent, the source to my comment last night regarding reporting impaired colleagues was from a September 1999 article by William Reid, MD & MPH entitled "Impaired Colleagues" from Journal of Practical Psychiatry & Behavioral Health, now called J of Psychiatric Practice (there is no direct link as you have to subscribe to the Journal to access archives, I checked).

The point to this reference, and I will quote directly:

This may sound heavy-handed (and hard to define), but it is important to remember that licensed clinical practice is a privilege, not a right. States regulate it and are generally entitled, within boundaries, to dictate your duty in both practice and reporting. IF YOU FAIL TO REPORT UNSAFE OR INCOMPETENT COLLEAGUES OR THOSE WHO ARE ACTING ILLEGALLY, YOU CAN HURT BOTH PATIENTS AND YOUR PROFESSION AND BECOME VULNEARABLE TO LIABILITY AND LICENSURE SANCTIONS YOURSELF.

This was an article I cited when I filed a complaint against both a hospital and a colleague about 9 years ago. To this day it resonates in me when I come across inappropriate, incompetent, and what I deem ruthless behaviors to further a selfish interest, especially when putting patients at risk.

So, does this current matter apply? I do not know exactly, but there are tones that resonate now that echo past feelings.

Try to find it and read it yourself. William Reid may be a source to Google and get it from him.

Iowa Doc said...

First of all, in defense of my fellow Iowan, I have to say (his flaws notwithstanding) that he is an ally in the movement to establish appropriate boundaries between the medical profession and Pharma. I have been to his office before, and did not notice any paintings with ancient aliens on walls, nor did I have to submit to auditing.

Speaking of Scientology...the only reason that any of their silly and irrational views ever gain any traction is that sometimes there is a grain of truth to them...perhaps more than a grain. When psychiatrists get in bed with Pharma, it only strengthens Scientology's case. They would not be able to influence members of Congress to any extent unless their position had some validity. I personally believe that many people in our society are indeed overmedicated and that this is direct result of marketing directed at prescribers and patients.

I find it curious and amusing that we insist on double-blinded studies as a gold standard in research, yet some investigators will claim that their financial entanglements have no impact whatsoever on their conduct as researchers. Either their own narcisissm won't allow them to admit that they can be influenced, or the subconscious isn't really as powerful as we have been led to believe.

Lastly, now that Dan is on record as having agreed with Supremecy Clause, does this mean that he is no longer a tool of the "Left Wing"?

Anonymous said...

Actually, I think no one should be surprised at the stand you are taking. You, yourself, have spent money promoting drugs and contributing to the problems we have with evidence-based psychiatry.

You have never returned the money, instead deciding that your counter-detailing services are worth a substantial sum of money.

So, since you have profited from the drug companies yourself, of course you take this stand.

Here are some of the biggest names in Psychiatry:

Gorman
Nemeroff
Kessler
Biederman

Got Ethics?

Got ghost-writing?
Got millions of dollars?

Gina Pera said...

Iowa doc wrote:
I find it curious and amusing that we insist on double-blinded studies as a gold standard in research, yet some investigators will claim that their financial entanglements have no impact whatsoever on their conduct as researchers.
--------
Do you seriously believe these docs are working in isolation? Do you completely dismiss the peer-review process? Not to mention the real-life effect on patients?

Biederman et al would not be in business had they not earned the respect of their peers. Moreover, communities affected by these disorders have a way of separating the wheat from the chaff. They are the true litmus test. So, give the real world some credit.

Anonymous said...

@gina pera
I wonder what your agenda is here.
You seem to have trotted out every argument and excuse that you can trump up.

First it's the Scientologists, then the absent-minded Researcher theory followed within minutes by lawyer-gotcha and Grassley's political affiliations. Now it's peer review - to spread the blame and absolve the perpetrators!!

Got any more in your bag-of-tricks there?

I am both a physician and a mother. Let's keep the focus where it belongs - not on the evil-doer scientologists/lawyers/peer reviewers but on the well-being of children who are entrusted to our care.

As for you supremacyclause : your choice of pen-name displays a certain freudian slippage there. I hope to god you are a lawyer and not a physician: and assuming I am right about that we don't give a tinker's what you personally think of Biederman.

Iowa Doc said...

I respect Dr. Carlat's willingness to give his former colleagues a pass; this demonstrates a capacity for mental flexibility. It proves that he is no "Johnny-One-Note", and that he approaches this issue with fairness. However, is it possible that his former association with these doctors is influencing him in ways that he isn't consciously aware of?

I raise this question because it is central to this whole overarching issue: To what extent can a physician's judgment be affected by subconscious factors, learned attitudes, and conditioning? I suspect that Pharma has known for quite some time that we can be manipulated much more easily than we would care to admit; what is it going to take for the medical community to come to grips with this?

Stephany said...

Dr.Carlat has the best opportunity to step up to the plate and start cleaning house. Someone needs to take a stand, and if paying back (counter-detailing)and not having drug reps bring lunch anymore is as far as he will take this--I feel it is a great loss of a chance to really push things forward.

Dr.F-I appreciate your letter as I stated earlier, and high lighted it in a post I wrote on my blog.

Though for some reason my blog is not showing up being linked in the list below.

I do wonder though, Dr.F. about the off-label use of medication you discussed. Isn't it true, that with regard to children it's been this way all of this time? re: psych meds? only until recently have Risperdal and Abilify for example been approved, yet my daughter was given those drugs as far back as 1999 with severe adverse effects.

It causes me concern there is such a heavy reliance on off-label use, but that's just my opinion.

I hope Dr.Carlat is sitting back with words he cannot freely express here, with regard to this issue, due to his APA connection, but in my opinion, he is in perfect positioning to really make a difference we can all applaud him for later!

Dr.F- here is a link to my post The Carlat Blog: Troubles at Mass General:Biederman's million dollar mistake: greed.

Thank you all for a fascinating discussion as usual!

Supremacy Claus said...

One notes personal remarks from the left wing ideologues. Personal remarks show frustration in the debate.

Nicolas Martin said...

Dr. Carlat said: "Hey, c'mon guys. What happened to innocent until proven guilty."

Considering that psychiatrists routinely assist in stripping people who have committed no crimes of their legal rights, and imposing involuntary treatments on them, this response is risible.

Anonymous said...

Obviously none of you were ever a patient or have personally known Dr. Biederman. If you had you would know what an honest and great man he is. The article in the New York times is full of holes and is extremely one sided. It does not even give Dr Biederman a chance to explain himself. When you are at the top of your field everyone is gunning for you to put you down. The funding for all drugs is sponsored by big pharma and to assume that because they pay for the research is a huge jump. The gross generalizations and exaggeration's of funding is ridiculous. I challenge any of you to truly look through the documents and find a gross conflict of interest by dr biderman. If you want to read a newspaper and believe everything you read you neew a better education.

Stephany said...

Biederman refuses to do public interviews, which could get in the way of "explaining himself".

It's also not just him being called to the carpet--it's 3 ppl with over 3 million dollars that has questionable and ethical responsiblity and accountability, and the public deserves to know the truth. No matter WHO got the cash.

Also, the article, is not just a "I don't agree with or like Biederman" it's an article about money laundering! too bad for Biederman et al they are the ricipients of that cash! I'd love to know what they want to say to the public, and in my opinion should have addressed this publicly by now.

Gina Pera said...

Do we have another Anonymous?

Re: this post from THIS Anonymous, if there were more like this--posts that reflected reality--I wouldn't have gotten so "tightly wound."

Anonymous said...
Obviously none of you were ever a patient or have personally known Dr. Biederman. If you had you would know what an honest and great man he is. The article in the New York times is full of holes and is extremely one sided. It does not even give Dr Biederman a chance to explain himself. When you are at the top of your field everyone is gunning for you to put you down. The funding for all drugs is sponsored by big pharma and to assume that because they pay for the research is a huge jump. The gross generalizations and exaggeration's of funding is ridiculous. I challenge any of you to truly look through the documents and find a gross conflict of interest by dr biderman. If you want to read a newspaper and believe everything you read you neew a better education.

IntegrityInScience said...

"Anonymous said...
@gina pera
I wonder what your agenda is here.
You seem to have trotted out every argument and excuse that you can trump up."

Gina Pera 'leads California's first CHADD support group for partners' of people who have been diagnosed as having ADHD http://www.chaddnorcal.org/ADHD_Partner/partners.htm

CHADD works hard on behalf of the industry to promote ADHD and associated drugs. Dr William Pelham, who was himself a leading ADHD researcher, exposed in 2004 how CHADD failed to disclose major conflicts of interest with pharmaceutical companies that deal with ADHD products.

More exposure of misconduct surrounding very influential key opinion leaders in the same area of disorders and pharmaceutical products must be a threat. As Daniel Carlat said in his report above:

"...I’m willing to bet that most of this money came from Shire, because I have seen Wilens, Biederman, and Spencer headlining many Shire-supported CME programs on ADHD..."

On that report, I'm very disappointed to see Daniel Carlat choose to be an apologist for misconduct in science.

Tables of undisclosed money relating to Biederman, Wilens and Spencer are at the end of this document:
http://frwebgate5.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=378806285228+0+0+0&WAISaction=retrieve

Anonymous said...

The reality is, we're all in some conflict. If we have drug stocks, we want them to rise, but if we get sick we want quality drugs cheaply as possible. The same for energy stocks and gas prices. That said, I saw the amount paid for CME talks was much greater than the consulting. How should we as a profession deal with this?

MedInformaticsMD said...

Harvards's not the only Ivy having problems related to grants.

See this document.