Monday, August 18, 2008

Guidelines in Whose Interest? - the Withdrawal of the Children's Medication Algorithm Project (CMAP) Guidelines

In 2006, we posted about striking allegations that guidelines used in the state of Texas and elsewhere for management of adult psychiatric patients, the Texas Medication Algorithm Project, (TMAP) were influenced by payments by pharmaceutical companies to the state, and to the people developing the guidelines.

Now the Dallas Morning News has reported that a parallel set of guidelines for the management of pediatric psychiatric patients has been put on hold amid more allegations that these too have been so influenced.

A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list.

The Children's Medication Algorithm Project, or CMAP, was supposed to determine which psychiatric drugs were most effective for children and in what order they should be tried at state-funded mental health centers. In April, high-ranking state health officials gave researchers the go-ahead to roll out the guidelines.

A month later, the officials delayed the protocol, after Texas Attorney General Greg Abbott's office objected to it.

At most, the suspension indicates that state investigators fear fraud has occurred. At the least, it reflects nationwide unease with potential conflicts of interest between leading medical researchers and the pharmaceutical firms that fund much of their work.

Publicly, officials say it's because the state is suing a pharmaceutical company alleged to have used false advertising and improper influence to get its drugs on Texas' now-mandatory adult protocol, the Texas Medication Algorithm Project.

Privately, individuals with knowledge of the case – who spoke only on condition of anonymity because of the pending litigation – say the attorney general's investigation of possible fraud in the adult protocol has spread to the children's version.

At least four of CMAP's key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms, according to their own published papers and financial disclosure forms filed with the university. Drugs made by some of these manufacturers appear in the children's drug protocol.

The doctors say there's no room for improper influence when their reputations are at stake. If the drugs weren't effective, they wouldn't endorse them – and the research they conducted to craft CMAP wouldn't have been published in prestigious medical journals.

Dr. Graham Emslie, a UT-Southwestern psychiatry expert, said he never once witnessed improper influence from drug companies while he helped conduct CMAP research.

The news article listed four CMAP researchers and their financial relationships with pharmaceutical companies.

DR. M. LYNN CRISMON: The CMAP project director who heads UT-Austin's College of Pharmacy has received research funding or consulting dollars from at least 10 different drug companies, according to his published studies, including Eli Lilly, Janssen, and Pfizer. He said he could not comment on CMAP or the lawsuit.

DR. GRAHAM EMSLIE: The UT-Southwestern Department of Psychiatry researcher has consulted for several different drug companies, including GlaxoSmithKline and Pfizer. He has received research grants from at least three drug companies, including Eli Lilly and Forest Laboratories. University financial disclosure forms, where these drug companies are listed, report income in broad ranges. They indicate he may have made up to $125,000 from drug companies since 2004. He said the CMAP protocol was about evidence-based medicine, 'not the [drug] the most recent representative told me about.'

DR. STEVEN PLISZKA: The UT Health Science Center in San Antonio scientist has received research funding from Cephalon and AstraZeneca and has served as a consultant and speaker for McNeil and Shire. University financial disclosure forms, where these drug companies are listed, indicate he has made at least $130,000 in drug company speakers fees and consulting contracts since 2002. Dr. Pliszka said he didn't know CMAP had been delayed until a reporter asked about it. 'For any physician, the bottom line is, does their patient get better,' he said.

DR. CARROLL HUGHES: The UT-Southwestern's Department of Psychiatry doctor has received research funding from GlaxoSmithKline. University financial disclosure forms also indicate he was once an ad-hoc consultant for BioBehavioral Diagnostics, which designs equipment to test for behavioral disorders, and was awarded shares of company stock. He declined to comment.

Here we go again. I would note that the article included examples of the now familiar protests by a academic physicians with substantial financial relationships with pharmaceutical or device companies that such relationships have no effect on their judgments or decisions. But the psychological evidence suggests that the influence of conflicts of interest may not act at the conscious level. Furthermore, as Joe Collier observed [Collier J. The price of independence. Br Med J 2006; 332: 1447-9], "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."

Furthermore, there is increasing evidence, (see this recent post, for example), that pharmaceutical and device companies cultivate "key opinion leaders" primarily to help them with marketing their products, and that they may be selected for their willingness to endorse these products as much as for their experience or intellectual prowess. It is the KOLs who generally get the consulting fees and speakers' honoraria. (Some academics may actually be consulted for specific technical or clinical expertise. But note that in this article, as is often the case, the consultants and paid speakers did not explain what they were paid to do, other than to market the payers' products.)

As I just said, --- there is a growing and ever more pervasive web of financial ties among academic medicine and commercial firms that make drugs and devices and provide various health care services. The resulting conflicts of interest suggest patients, physicians and policy-makers should be ever more skeptical about seemingly authoritative medical research, and medical education, practice guidelines, and health care policy based on this research.To make better decisions for individual patients, and better policies for populations, people, patients, physicians and policy-makers at least need clearer and more detailed information about all conflicts that may affect the evidence and opinions that influence their decisions. But might it not be simpler and ultimately better for people, patients, physicians and policy-makers to eliminate some of these conflicts so that we can begin to believe that researchers and academics are paid only to take care of patients, and create and disseminate new knowledge?

See also this post on PharmaLot.


Anonymous said...

Reviewing PBS's The Medicated Child is worth the effort and addresses some of these issues.

From a business stand point this makes perfect sense. The low hanging fruit of the drug industry has been plucked. It will be hard to duplicate the success of statins. An easy target becomes children. Measurement becomes very subjective, and once started, medication will be a life long reality for these children. What better way to ensure long term sales and have a natural opening to future products?

Parents want only the best for their children. Schools want only a disciplined classroom. A pediatrician friend is frustrated by the demands of teachers and school administrators to medicate children. A couple, both pharmacist, agree we would be shocked at the number of school personnel on mood altering medications. I will leave the concept of transference and self-justification to a medical professional.

MedInformaticsMD recently posted a list of pharma executives. These are all business people and this only represents an expansion of their marketing efforts. The issue then becomes: Do we want an entire generation depended on some type of medication?

My short answer is no.

Steve Lucas

Anonymous said...

'For any physician, the bottom line is, does their patient get better,'
--DR. STEVEN PLISZKA (from the Dallas Morning News article posted).

Is that really the bottom line for Dr. Pliszka??

I ask: What about for "any" physician...who ALSO is under professional and legal obligations to a business (pharmaceutical company)?

Does that physician, with many masters, make decisions with one of them in mind? Both? One with greater priority than the other? In the latter two scenarios is the complication of the physician having to sort out loyalties GOOD for the patient? Doesn't that immediately complicate decision making?

As a patient, I want a physician making decisions based on my condition not on her last drug lunch, her most recent paid lecture, or relationships to "nice" want-to-be-your-friend drug reps.

As a patient, I want a physician NOT a businessman.

A physician should be rooted in science--veritas! Not avaritia!