Thursday, March 5, 2009

Psychiatry's Leadership is Getting Real

I believe it is important to give credit where credit is due. The current issue of the American Journal of Psychiatry features a commentary entitled "Conflict of Interest--An Issue for Every Psychiatrist." The article is authored by all 23 editors and editorial board members of the journal, with additional contributions from three others. This is a who's who of psychiatry, including Jerry Rosenbaum, the psychiatry chairman at Mass General, Robert Freedman, the Editor-in-Chief of the journal, Nancy Andreason, winner of the National Medal of Science, and many others.

Furious Seasons criticizes the piece for being too vague and offering no specific solutions, but I see it differently. The authors do a good job of laying out the major issues related to conflicts of interest in psychiatry, and in fact they do have some specific recommendations:

"More acceptable alternatives—-industry support of education through unrestricted gifts to APA, universities, or other public institutions and journal advertising that resembles sponsorships on public television rather than network prime time commercials—-will likely result in less financial support than we currently receive for our professional activities, because this financial support would no longer be assumed by the companies as part of their marketing strategy. The subsidy that each of us has been receiving is part of what has fueled the excesses that are currently under investigation. Accordingly, in the future it may cost more to attend meetings, to earn CME credits, and to receive journals."

It seems to me they are recommending that industry money be disconnected from specific educational programs, and instead should be donated to medical societies and universities into pools of money that can be used to fund any education, even programs that don't serve the specific promotional aims of the funders. If instituted, this would represent a huge change in business as usual.

Perhaps they are vague in not naming names--but when they reference "congressional hearings and articles in the New York Times or Boston Globe" it's pretty obvious who they are talking about. Look, this is a guild, folks, and you don't smear members of your own guild (unless you are as reckless as I am!). I think it is remarkable that these 26 authors were able to agree on a document that is pretty critical of industry's coziness with psychiatry--especially since many of them are direct beneficiaries of industry's largesse.

On another note, while the Furious Seasons post quoted me accurately in the opening paragraph, it was pulled from a different context--namely a December 1 posting in which I was responding to recent revelations on serious conflicts of interest regarding Dr. Biederman and Dr. Goodwin. The comment was meant to point out that if psychiatry were a patient, it would need ICU treatment to pull it out of its ethical crisis. The fact that the leaders in the field could have written this AJP commentary shows that the patient is looking much healthier.

19 comments:

James M. La Rossa Jr. said...

I concur: The American Journal article is noteworthy based on both its signatories and its directness. And while the FS blog's criticism of the commentary as having offered no specific solutions is overly dismissive, some of the recommendations are unrealistic and without teeth, which gives FS some major points. In essence, there is little currency in making recommendations about "acceptable" industry support unless an acceptable case can be made to industry. Otherwise, by definition, a "solution" cannot be arrived at.

To make an appeal for "industry support of education through unrestricted gifts to APA, universities, or other public institutions," is fine and dandy. But it is not a plausible solution unless there is a way that industry can benefit without compromising the principles which the American Journal and its editors exemplify. Why not consider RESTRICTED grants for CME sponsorship? If the APA is controlling content, why not give the Pfizer's of the world the opportunity to show good will through sponsoring CME via the APA and allow the company to make a targeted grant? There would be no direct marketing tie-in for Pfizer (thus no conflict of interest), but at least they could be good citizens by "underwriting" physician CME. Isn't it worth giving industry a credit line if it results in independent, free CME? Are psychiatrists reticent to even hint at targeted grants for the purpose of underwriting CME because the APA makes a lot of money on CME programming at the annual convocation?

Likewise for the American Journal's suggestion that medical publication "advertising should resemble sponsorship on public television rather than network prime time commercials." Public television is transmitted on public airwaves by not-for-profit corporations. Journals, by and large, are owned by private for-profit companies, or medical societies -- and are immensely profitable (mainly from ad revenue) to those societies. Also, medical journals share the same First Amendment rights over content as the public press, so you cannot dictate advertising to them. That is based on custom and ethics. Thirdly, the FDA, by law, is solely charged with regulating industry advertising. Since the 1990s, the FDA has consistently broadened the rules governing industry advertising, so there is little chance that it will reverse itself now and chance the ire of a hostile media and the legal battles that would ensue. Again, this is not plausible.

As a final comment, it IS plausible that if industry cannot advertise its products in the professional media, nor sponsor CME for professionals, it will take those billions of dollars straight to the market-driven public. Whether that is beneficial to psychiatry or not, I leave to smarter people than this writer. Good wishes to all.

ps -- To Cara (via Stephany) and Gina regarding Of Seroquel, Sex, and Secret Documents, thank you for all the interesting comments of late. Cheers, j.

therapyfirst said...

I know this will come across as a bit rude or dismissive, but I feel it has to be asked: do you have a bit of terminal optimism or blind faith in our colleagues to do the right thing in the end? I have to hypothesize that as an outward figure in the press/internet and being a product of an alleged prestigous program in Massachusetts, you might be at least a bit fearful or reticient to call these alleged renewed knights of honor what their true agenda is: looking for cover so they can connive enough people to think they really give a damn. I'm just curious, how many on that list are over the age of 60? You think they are going to compromise their livelihood and good ol boy cronies for ethics and morals? Think again, please.

It is deeds, not words that define one, and their deeds are not worth defining in any positive light. It is too late to redeem oneself when you sell out the ones you took an oath to basically serve and protect. And I know YOU know that, but what is this post about!?

Sincerely, therapyfirst

James M. La Rossa Jr. said...

Yes, TF, that last post was rude. Your criticism is based on what? DC is Ivy League educated? The authors are over 60? What misdeeds do you refer? Courtesies must be made. Otherwise the debate is degraded. I write with all due respect. Why so dismissive? It is unlike you.

Steven Reidbord MD said...

I agree Dan. It's a positive step to see such a statement, endorsed by so many notables, in AJP. Yes, talk is cheap, but it's also a start.

It's also important to anticipate likely consequences, such as the industry shifting marketing dollars to consumer ads. Rather than leading to fatalism or inaction, forethought may allow us to more intelligently limit conflicts of interest. Maybe we'll join most of the western world and limit pharma ads for the public too.

Nancy Frugé said...

Re: Commentary, American Journal of Psychiatry (AJP), 166:3, March 2009

The other day I read about Clara Cannucciari, an innovative woman who learned to cook during the Depression. Ms. Cannucciari teaches others how to make nutritional, delicious, economical meals. Check out her Web site: http://www.greatdepressioncooking.com/Depression_Cooking/Welcome.html

Ms. Cannucciari inspired me to use a cooking analogy in my response to the AJP commentary, because she gives us, in addition to food recipes, a recipe for living graciously during good times and bad times.

Here are excerpts from the AJP commentary and my responses:

1. “Guidelines for the type of pharmaceutical industry support that we each accept for our professional activities, including CME, and how our receipt of this support is shared with our patients when we prescribe drugs need to be more precisely defined by APA and our other professional organizations.”

The guidelines sought by the authors have been in the recipe file for years. The problem is that some cooks chose not to read and/or follow the recipe, leaving a messy kitchen and a bad taste in one’s mouth. The answer is simple: Observe the cooks to ensure they create only acceptable variations of the master recipe. If the meals are not fit for consumption, toss them in the garbage can and restrict or ban the cooks’ kitchen privileges.

2. “APA ethical guidelines currently take into account the considerable expense of CME
and journal publication and therefore allow pharmaceutical company support for these
activities...It is timely to reexamine and revise these practices.”

Last week I received in the mail my newsletter on best practices in food preparation. The paper on which the newsletter is printed is not the expensive glossy paper, but plain white paper, which in no way affects the readability or attractiveness of the publication. The newsletter does not contain any food industry advertisements; just honest, reliable information arranged in columns and set off by thin, pretty blue borders. This demonstrates that inexpensive things can be just as good as, or better than, expensive things.

The timeline for examining and revising APA ethical practice guidelines must be ongoing; rather than piecemeal, after ethical practice guidelines come to the attention of criminal investigators.

3. “The subsidy that each of us [psychiatrists] has been receiving is part of what has fueled the excesses that are currently under investigation. Accordingly, in the future it may cost more to attend meetings, to earn CME credits, and to receive journals.”

Contrary to popular belief one is not required to eat everything that is placed on one’s plate. The newsletter I described in paragraph 2 was created with good quality, yet inexpensive, materials. Consequently, the publication is affordable—even for those of us who earn less than psychiatrists. As well, subscribers have opportunities to earn professional continuing education credit.

In closing, I would like to share my favorite psychiatrist’s recipe for success:

“Six essential qualities that are the key to success: Sincerity, personal integrity, humility, courtesy, wisdom, charity.” –William Menninger, M.D.

Clara Cannucciari, through her teaching, graciously demonstrates these qualities for all of us.

therapyfirst said...

When people are evil, they count on those who are responsible and ethical to stay within the boundaries of being cordial and respectful, because evil people will try to use this restraint against those who are trying to be fair. When will responsible and ethical people wake up and call the crap that is going on in this field for what it is, instead of still trying to explain and rationalize it? I am tired of reading people be nice to whores and cowards, and frankly, I have to wonder what is the agenda of posts like this that try to bargain with this evil. And it is evil, and I really do not care to get into a debate with anyone who wants to waste mine or other readers' time trying to make sense of senseless things. I stand by what I wrote, Dr Carlat was nice enough to print it, which I appreciate his candor in allowing an opposing view, and I took responsibility in saying up front it can be construed as being rude or dismissive. Go back to what I said in last year's post when he announced he was on this committee at the APA investigating the role. By accepting the position, he compromised his role here.

The post now seems to validate it for me. If I am wrong, then deeds will speak louder than my words. Others want to take a risk and chime in agreeing or refuting me?

James M. La Rossa Jr. said...

Tf, it is never simple to broadcast one's thoughts and opinions to the public. Whether smooth or full of warts, it's all there for everyone to see. As I've told many a horrified young editor when they see their first error in black and white, "publishing is not for the faint of heart." (This would include blogging in the presentday media.) And while I often fall short in the graciousness department as compared to the wise sentiments expressed by Dr. Fruge, you have to admit that it can't be easy to provide the content for a blog like this one. We can't expect DC to hit a home run every time. Singles advance the bases too.

Your last sentence -- asking other readers to chime in or refute you -- is exactly why I chance being a pedantic bore here: I think you'll find when you whitewash a debate with accusations of evilness, that this is a brush that paints over any civil debate. It would be difficult for anyone other than, say, your former nemesis, Supremacy Claus, to chance airtime after such a whitewashing. (Perhaps people like DC and I, who are father's of relatively young children, are too willing to compromise because that's the only way we're going to survive the terrorism of youth.)

BTW, I do not disagree with you: the Commentary falls short. A hard line may be the better tact. But, selfishly, I'd rather have your help in furthering the debate, not stopping it. Respectfully, j.

Cara T. Hoepner, MS, RN, CNS, PMHNP said...

Dr. Carlat, James, et al -

I found the the tone of AJP piece, with its naïve, idealistic, unrealistic and ill-informed suggestions, to be reactionary in a way that feels as though it means to cover for some collective embarrassment or other, or perhaps to serve as a talisman to ward against comeuppance for past transgressions of some of the signatories... In other words, the editors doth protest too much. Pardon my lack of intelligent contribution to the discussion here, but I found the piece just basically irksome.

I was reminded of an experience I had recently in which I received 23 hrs industry-sponsored CME (for nurses, CEU) at Stephen Stahl's wonderful annual congress, which this last yr was held in Colorado Springs. In exchange for their extremely generous backing of Dr. Stahl's educational programs, the sponsors all had booths in the hall where we took our meals. I paid around $450 to attend the congress; without drug company sponsorship it would have set me back fully $2K. I'd not have been able to attend. What's more, Dr. Stahl takes an audience poll at each of his events to guage the participants' approval of industry participation, and the number of people who express disapproval is pretty small.

Best - Cara

Nancy Frugé said...

James, thank you for your kind words. And for the record, I am a nurse, not a doctor. :-)

therapyfirst said...

A few comments to note:

James, you begin to sound like supremacy claus, just to be a devil's advocate, and I don't get it in the end. Pick a position and stick with it unless evidence you respect makes you think the contrary. You seem in the beginning to echo the sentiments of this blog author, and then waver with the commentary. ???

Re Dr/Ms Hoepner, why do conferences pick expensive places to hold seminars? To distract and encourage the opinions of the speakers, more so if not? So, if you as a speaker want to get an audience to sell a credible/responsible position, hold it where as many people can afford it and not give a potential sense you have an ulterior motive by being funded by pharma or other less than saviory agenda. Just my opinion, but physicians should expect to pay $8-10 for written CMEs and about $15-20 for seminar credits, to hear the opinion first hand. So, if you need 25-30 credits a year, and you make an effort to earn a reasonable living, it should not be outrageous to expect to pay about 300-400 dollars a year for this. I now subscribe to a yearly CME course that is not pharma supported and it costs me $200 a year for a three year committment at 40 credits a year. A good deal, I note it up front. But, I am willing to pay for unbiased credit. Shouldn't responsible and invested clinicians feel the same way? Shouldn't that be most of us?

Finally, at the Friday posting, there is yet another comment by SC that is just demeaning and rude and makes no effort to apologize for it coming across that way. I do not understand why this person is allowed to comment here after this and a recent past posting that was so inciteful. I like this site because it seems to stay on message for the most part and involves a professional group overall. I hope the blog author balances fairness with reasonableness and really considers banning when someone crosses the line so blatantly.

I hope my opinions are seen as at least worthwhile to read.

If you are on the east coast today and aren't outside if the weather is warm, GET OUT!

Cara T. Hoepner, MS, RN, CNS, PMHNP said...

Hi, TF -

Thanks for the cogent observation...

Regarding holding Stahl's conference in CS—indeed, some of the sponsors' money went to lowering room rates from around $500 --> $200 at this lush 'destination'. And the food... ohhh... Most of the money goes twd technology and speaker training, however There are lots of each... they even have trainers on site and coach before and after sessions!

Anyhow, even with reduced rates, self and others stayed at a Marriott down the street. And, with the 10 hr/d conference schedule, there wasn't time enough to even enjoy the grounds let alone the surrounding area. So I, too, thought the whole business a bit of an extravagant waste— however:

When they held an electronic poll (using keypads during session) re having the shindig at CS again, there was an overwhelming 'yes' from attendees and so it's CS again next yr!

Finally, if you think the E Coast is looking good this wkend, you should all visit San Francisco... lush green on Twin Peaks, the Painted Ladies (our colorful Victorians)beaming in the warm, clear light... I love my town!

And Nancy—nice to see a fellow nurse up here... and your post was a pleasure to read

James M. La Rossa Jr. said...

I hope I am permitted one more (last) off-topic posting.

TF, I pray I do not sound at all like Supremacy Claus since he was just banned from the site. Why do you make that comment? Because I respectfully agree with some points and disagree with others? That doesn't sound like the SC I know. Glad we're all back on track. That will help keep the debate flowing -- my only point.

...appreciate Nancy Fruge's comments (and thoughtful writing) and Cara's significant contributions, though you don't need to address me, Cara, only Dr. Carlat. I am just a reader here. But thank you.

I surmise from TF that you're having a wonderful day on the East Coast. As most of my loved ones are still in the NYC vicinity, I am always glad to hear that. In the South Bay of Los Angeles, where I live, the Pacific is gleaming, there is a slight breeze, and the surf's up. Happy days, j

ps--while SC's banning is understandable, it does bring up a need for more contributions from readers who are versed in the medical-legal arena, since so much of "real world" debate hinges on legal permissibility.

James M. La Rossa Jr. said...

FYI -- Speaking of the possibility of increased cost of CME due to potential industry restrictions...

While a lot of negative things have been said about Medscape/WebMD, the internet giant does have a small group of independent publishers who provide content that is devoid of any industry tie-ins whatsoever. The only way I know how to access the area is through Psychopharmacology Bulletin's articles at http://cme.medscape.com/index/list_3091_0. Same-day CME diplomas are provided free of charge.

Nancy Frugé said...

Cara, I enjoyed reading your comments as well. I live in the Dallas/Fort Worth area. We are enjoying fair weather today, however tomorrow's forecast is for isolated thunderstorms.

James, I use the Medscape Nurses Web site. And, by the way, I like your new laid-back look.

Anonymous said...

James, why should physicians receive industry funded/supported CME? It rarely happens for lawyers with CLE.

If a judge was weighing in on case between the insurance and energy industries, would he be allowed to get Exxon-Mobil funded CLE?

If he was found to be giving AIG promotional talks, do you think that he would have to recuse himself from the trial?

John McManamy said...

Put me with the skeptics. Here are some excerpts from my blog post on the topic:

The commentary acknowledged reality, namely that if journals didn't publish industry-supported clinical trials, there would be little in the way of new meds research to report. As a bulwark against the industry pushing its own PR disguised as research, the commentary pointed to the AJP's rigorous editorial review standards.

Hold on a second ...

In Feb 2006, the AJP published an Eli Lilly-supported study that found:

"Compared to placebo, olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients ..."

In other words, according to the study, patients on Zyprexa stayed well much longer than patients taking a sugar pill.

The study also revealed that only 21 percent of the Zyprexa patients actually completed the long-term (48-week) phase of the study. These were patients who had responded well to the med during the initial phase of the study.

To phrase this another way, eight in ten patients stopped taking their Zyprexa. Transposing this result to life in the real world, a doctor might think twice before prescribing Zyprexa over the long term. After all, even the best med in the world is useless if patients refuse to take it. Or, based on this information, a doctor might spend extra time informing the patient of the value of staying on the med.

Surely, such an important finding would be highlighted toward the beginning of the article. Surely, it would appear in the article abstract (which is the part most doctors actually read).

Well, no. The finding was buried deep in the study.

Are these the high editorial standards this month's AJP commentary was referring to? If so, heaven help us all.

http://knowledgeisnecessity.blogspot.com/2009/03/conflict-of-interest-considerable-room.html

James M. La Rossa Jr. said...

Anonymous brings up a valid comparison: The common practice of industry-funded CME in medicine vs. the lack of funded CLE in the legal field. Why the difference?

CLE is a relatively new industry, is not regulated by an ACCME-equivalent, and is not recognized by most practitioners as important (except in very specialized areas such as tax law, perhaps). In other words, it is optional -- so your analogy about the conflict of interest in a judge receiving free CLE credits from an oil company would NEVER happen.

CME is -- and has been for decades -- an ABSOLUTE REQUIREMENT for EVERY physician in the United States. Furthermore, the FDA, which regulates industry "gifts" to physicians, uses the ACCME guidelines as a litmus test for whether sponsored material is kosher or not, which is why industry relies so heavily on CME sponsorship -- to pass muster with the FDA. As I have written many times in the past, the FDA has, unwittingly, caused this alliance between industry and CME. Industry did NOT create this monster. The FDA sanctioned it and the APA and other universities have made CME huge profit-centers. Meanwhile the ACCME -- by and large -- has looked the other way,

After all the blood, sweat, and tears wasted on trying to tease-out the appearance of collusion in CME, lawyers are fortunate not to have made the same mistake. Should CLE become a requirement, my guess is that it will become the billion dollar business that CME has become. Westlaw, Lexis/Nexus and the other giant legal book/info companies will have a field day. But I wouldn't bet on it. Not after watching the suffering the medical field has endured.

As to John McManamy's re-telling of a Feb. 2006 AJP Eli Lilly-supported study, it is true that publisher's, including this one, have made the same mistakes. Yet I believe that medical literature is best served by independent publications, which are not regulated by the FDA nor the ACCME, and whose fortunes will rise or fall on what matters: the opinions of front-line practitioners.

therapyfirst said...

I went back to the March 31 2008 post that noted Dr C being on this committee to examine the role of pharma at the APA, and correct me if I am wrong, but did I miss the committee summary that was due in Oct of 2008 the post noted was due?

If this is the "summary" this committee was to conclude, lame is the only word applicable. I thank Mr McManamy for his contribution here through his own blog writings, which I recently read today. For any and all interested readers, peruse back to the March 31 posting and read what I wrote, which I think is still applicable almost one year later. People do not change unless they have found the motivation and drive, and this group called the APA is not there yet, if ever will be.

You have the right motives and agenda for change, Dr Carlat, but you are standing in front of a wave that will wash you aside until a bulk head of sizeable proportion can slam it back in place. That bulk head is civil and criminal liability, and I sure hope some people experience it sooner than later.

New year, same old s---!

Doug Bremner said...

I felt the editorial was fairly lame as well. It is like they want to have their cake and eat it too.

Nancy-- I was born at Menninger clinic. LOL!