Abbott’s Admissions of Criminality: Do They Accomplish Anything?

Thanks for this explicit argument, Jim. You are raising the points that reflect the state of ineptitude within the APA. The guidelines for the safe practice of prescribing psychotropic drugs should be forthcoming from the professional organization that exists to legitimize the practice of psychiatry in America. Long overdue …

Starting with “The Agreed Statement of Facts” as an example of required reading before prescribing Depakote, there is an opportunity to focus on the crux of the matter that is somehow ignored when the cases of “illegal off-label marketing” by pharmaceutical companies are reported. The dissemination of false and potentially harmful information to psychiatrists is the crux of the matter. An education campaign should be launched by the APA, along with requirements for retaining prescribing rights implicit in the successful completion of these education courses. REQUIRED CME’s for retention of the license to practice psychiatry, is what I am talking about. A professional organization concerned about safe practice, or rather, protection of trusting patients, would definitely take these measures at this time.

Incorporating the factual information that dispels the widespread acceptance of what is proven to be “illegal off-label marketing” should be immediately included in the examination for “Board Certification” of psychiatrists.

I believe that in the absence of a reasonable response from the APA regarding the evidence provided in the civil and criminal cases against pharmaceutical companies, there is reasonable cause for concern that there is no organized group of academic medicine based psychiatrists, or even any practicing psychiatrists to challenge the deaf and blind leaders of the APA, who are simply ignoring what the public is becoming more aware of. Those sitting comfortably in their seats of authority, either in academic medical centers or behind their desks, are either criticizing their opponents (us), or silently condoning the lack of response to their opponents (protecting each other). Some psychiatrists in this category, blog on MIA. I hope they reflect on their role in failing to challenge the APA, and academic based psychiatrists- DIRECTLY, as they get cheers from the MIA audience who has zero influence with either of the sources of this scourge.

From my vantage point I notice that there is precious little concern over the unsafe practices of prescribing psych drugs for children in the medicaid system or the elderly on medicare. This, unfortunately, illuminates the darker aspects of our society’s failure to protect children and the elderly from abuse, while claiming to be resolving the behavior problems in this ‘cast aside’ population. The humanism required to address the actual behavioral ‘problems’ is lacking. This is very hard to address without becoming a target. The self proclaimed martyrs in the positions within the social service agencies that can effect things like drug prescribing policies, are more likely to contend that they are employing the best approach to dealing with an impossible set of circumstances. They whine. They get hostile when criticized. They unit for the expressed purpose of removal of anyone who is making them feel badly about their shortcomings and weaknesses of character. I totally support activism within these social service agencies. It is just a very slow process riddled with numerous obstacles so long as the ‘prescribers’ continue to be criminals at large with no fear of punishment!

In discussion with my renegade colleagues, we come down to these questions:

1) How long can a psychiatrist’s ignorance of the factual information on these drugs be excused?

2) Who is responsible within psychiatry to establish the factual, scientific basis for the practice? The authors of the Board Certification exams? (Medical Board of Examiners); The reviewers who certify that a psychiatrist has met the requirements to retain his/her license? The APA? Harvard Medical School Department of Psychiatry?

3) What is a reasonable amount of time to lapse between irrefutable, established evidence of the harmful effects of of acting on the “fraudulent claims made to secure profits” by drug companies and responsible accountability by the leading psychiatrists in America?

4) When does ‘ignorance’ become ‘malicious intent’? or collusion become established between the APA and the headline making, cited for illegal off-label marketing for the sake of their own financial gain, drug companies?

5) IF the APA will not take action to regain the public trust in their medical practice as a ‘first, do no harm’ , patient -centered practice., should we hope that the legal profession will step up to the plate and prosecute the protective guardians of psychiatry as criminals?

I am deeply disappointed and thoroughly disgusted with the unabated corruption in academic psychiatry, the APA and NIMH. I think there has been adequate time for more than sufficient evidence of life endangering harm to evoke strong action from all three. The lack of action reflects an undeniable breach of the public trust, and because it is clear that financial gain is the only common denominator supporting a shared motive, I say …

“Book ’em, Jim!”

The sooner the better…

Why would the government want to stop it? This is yet another hidden tax. The government allows illegal reimbursements by medicaid which is paid for by U.S. tax dollars and then the government sues the drug companies to take a percentage of that money.

In regards to:

“consultant then told Abbott that while the study “does not support combination use (as defined strictly the combination being superior to each [neuroleptic] alone), we could still argue for [the study’s] applicability to add on” therapy. ”

I’d translate it to this, and this is from experience reading grant applications:

“Depakote’s not good for combination use. I’ll admit that. But we can bookmark this study. It has value, even though all it proves is that Depakote’s not good for combination use. The study has value in considering what to add on to an antipsychotic regimen by excluding Depakote. That’s what this study is still good for.”

If you don’t read it that way, I’d be interested in your read.

Now the *motive*. The motive is political in intent. It’s one writer’s last attempt to wring some positive light out of the reader’s confusion onto the star product by masking “rule out” with “applicable to add on therapy”. It’s deceptive.

Regards,

D.Goncz
Peer Specialist (Community Health Worker)
Replikon Research
Alexandria, VA

As someone from Australia it is amazing to watch what we want to happen here, being debated overseas. The problem here is that we are not allowed to know what drug companies spend money on and the maximum they can be fined is a mere $50,000 per drug. Our $ values are about equal with the US $!! Just trying to allow the community to even have the right to know how drug companies pay doctors and community organisations would be a start for us, but I wonder, when we will still have off label prescribing.

Like many countries we have a public health system and so all of our medications are subsidised by the government. Technically we are supposed to have two levels of checks for medications. In order for them to be allowed into Australia, they must first be approved by the Theraputic Goods Administration – our FDA. They approve them for age groups and conditions. Then if they reach a higher level of approval and there is proof the medication will be of benefit to the community they can be approved for use on the PBS (Pharmacueitcal Benefits Scheme). This is usually a really good thing and for most conditions it works great. You can usually take medications involved in medical trials, but you must be part of that trial or you must pay the full cost of the medication, and paying the full cost, means you know they are not approved for use. Except we have a loophole. ANY psychotropic medications are available under the PBS for anyone at all. We have infants under 12 months taking antidepressents and thousands of toddlers on antipsychotics. Almost every coroner in the country has demanded that nursing homes not be allowed to prescribe antipsychotics to those with dementia. The government has defended the right of these drugs to be used off label in that way and are denying families the right to make those decisions themselves.

While I want and we need for truth of what drug companies are doing here, and we need bigger fines I can also see from this that that alone will not be enough. We must stop the off labeling prescribing that is happening through the public health system and at taxpayer expenses. Although I do at times wonder how much it would change. The amount of people now taking and paying millions of dollars for off label prescriptions if huge, and private health insurance is now footing the bill for it, so most people assume if they are willing to pay it must be OK.

The fact remains though that throughout the world psychiatry is working hand in hand with drug companies and fines, even big ones make no difference at all to what they are doing. While it is questionable as to what most of these drugs do for conditions that are on label, to pay for someone to take them off label is even more pathetic.

I do however wonder if psychiatry will simply solve the problem of no government funding of off label prescribing by simply changing the diagnoses they give people, since they manage to give them out at the whim of a hat anyway. I and many others in Australia have already had that happen. I for over 10 years had a psychiatrist ring up and tell the authorities that I had schizophrenia, she said it was necessary as while the research proved that these drugs worked for PTSD they did not understand the research and would not fund them. It is so so so common here, and I can imagine the same would happen in the US. It is not as though they have any proof that we do or do not have said condition. When they fail to be allowed to prescribe it off label, simply change the diagnosis, it works wonders for drug companies and psychiatrists, just not for the individuals concerned.

Great post Jim.

Consciously! What seems perfectly obvious, is an economic motivation to outrageous dysfunction in the management of human affairs? Surely its all about the money, “we think.”

“The $500 million paid by Abbott as a fine for its criminal activity in promoting Depakote for use in the elderly and for schizophrenia was a small price to pay — just a cost of doing business.

Does anyone expect that the use of Depakote on the elderly, and people diagnosed with schizophrenia will plummet? I don’t. Why haven’t the past revelations of drug company fraudulent marketing causing tremendous harm to millions of patients without benefiting them resulted in any meaningful change in prescribing practices?

The big fines paid by the drug companies are not effective, yet the government is ignoring the simple solution of enforcing Medicaid and Medicare’s restrictions to drugs that are prescribed for medically accepted indications. It is hard to take seriously the government’s stated commitment to rooting out fraud when this massive fraud is consciously allowed to continue. I know it is consciously allowing the fraud to continue because the government has been antagonistic to our whistleblower cases raising this point.”

Yet is the real motivation far more “unconscious” than we care to admit to, and are we all guilty of collusion when it comes to the denial of our emotive-motivations? “We have permission to up their medication dosage, to make them easier to manage,” a psych nurse once told me on our blind date.

IMO Its the management of comfort & ease that “unconsciously” motivates human behaviors, like our uncanny ability to “turn a blind eye?” IMO Society operates on an emotional-dynamic far more than it does in any rational or objective way. Fear & shame motive our reactive urges more than objective rationality, in the rank and status structure of society. Hence highlighting the facts of obvious dysfunction in “the system,” always meets a predictable sweep-it-under-the-carpet response, with appeals for justice meeting the most common form of ignorance, ignore-it?

We all love to pretend that we are fully conscious human beings who “know” what we are doing? Yet judging by the state of affairs that Jim reports on, are we perhaps still waiting for the fully conscious generation to emerge, or in that other term for God, “evolve?”

Is there an unconscious cost to doing business? An emotional dynamic, as much involved in normal human motivations, as the so-called pathology of mental-illnesses? Please consider;

“Challenge to and Regulation of Homeostasis (comfort & ease)
(“The cost of doing business”)

•During the first 6-months of life the measurement of vagal regulation during feeding provides an early marker of the developmental status of the neural platform for social behavior.
•During the first year of life, cortical pathways develop that regulate the striated muscles of the face and head and the vagus continue to myelinate to form an integrated social engagement system – the same circuits involved in feeding (ingestion) and state regulation.
•As the infant matures, social context displaces feeding as the most important regulator of behavioral state.” http://ccf.nd.edu/assets/32275/porges.pdf

“social context displaces feeding as the most important regulator of behavioral state.” Consciously, my comment reply would appear to be way off-topic in regard to Jim’s post, yet consider my previous comments about how we unconsciously project “the system” onto the world “out there?” Does the above mention of the term “feeding” resonate with the emotional nature of the way human beings actually react to each other? As some cynical philosophers
note, “the cost of doing civilization, is human misery.”

“Massive harm is not enough to cause government action. Massive fraud when the government is drowning in red ink is not enough either. What is it going to take?”

More honest self-realization, and far less intellectual pretense, perhaps?

Warm regards,

David Bates.