NAMI exposed: the drug money behind this supposedly grassroots group

Earlier this week, Senator Charles Grassley announced a probe into the nation's largest advocacy group for people with mental illness, the National Alliance for Mental Illness, asking the nonprofit group to disclose the funding it has received in recent years from the drug industry. The fact that NAMI is heavily dependent on drug company money is old news, but Grassley's investigation, first reported in Bloomberg News, may shed a welcome spotlight on an lobbying organization that masquerades as grassroots.

In Side Effects, I reveal that drug company contributions have always been a substantial portion of NAMI's revenues. I also tell the story of how Jim McNulty, president of NAMI from 2002 to 2004, failed to disclose the fact that he was being paid thousands of dollars from drug makers for promoting their products to NAMI members and others at various speaking engagements. In a particularly intriguing twist, McNulty laundered this drug company money through a state chapter of NAMI.

This is how the scheme worked, according to McNulty himself and others in the know. He would be paid thousands of dollars to speak about the benefits of various antidepressants -- McNulty himself suffered from depression -- and rather than pay him directly, companies such as Eli Lilly, the maker of Prozac, Pfizer, the maker of Zoloft, and GlaxoSmithKline, which made Paxil, would give his speaking fees to the Rhode Island chapter of NAMI, which would then cut McNulty a check. When I asked McNulty why he was paid this way, he said, "Paperwork. It was simpler that way."

McNulty, of course, never disclosed these conflicts to his constituents or to the NIH (which appointed him to sit on influential advisory boards that rendered opinions about the safety and efficacy of the drugs he was being paid to promote).

NAMI continues to receive hefty contributions from the drug industry but it no longer reveals the specific donors in its annual report, published online. So Grassley's team has asked the organization to disclose the specifics of its funding so that people with mental illness and their families can see for themselves how conflicted this advocacy group is. At FDA hearings over the years held to examine the safety and effectiveness of antidepressants like Prozac and Paxil, NAMI was always quick to come to the defense of these drugs. And NAMI opposed the black box warnings the FDA required drug makers to put on the labels of antidepressants in 2004 about their increased risk of suicidal thoughts and behaviors. Now that Grassley's team is looking into NAMI's books, perhaps the group's members -- people with mental illness and their families -- will cast a more skeptical eye on its credibility.

Brown psychiatry chief Martin Keller to step down in June...

Martin Keller is finally stepping down as the long time chief of psychiatry at Brown University. Brown University officials made the announcement in a Dear Colleagues letter dated today from Edward J. Wing, Brown's new Dean of Medicine and Biological Sciences.

Keller is the latest psychiatry kingpin to fall. In recent months, Emory University forced its psychiatry chief Charles Nemeroff to step down and Stanford is looking for a new head to replace Alan Schatzberg after reports that these two prominent psychiatrists, like Keller, failed to disclose years of lucrative financial payments from the pharmaceutical industry.

While Brown officials insist that the decision to step down was Keller's, my understanding from several sources is that the university has been under pressure to take action against him for months.

As I have reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he has received over the years from companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents.

Yet as it turns out, the data in this trial do not corroborate the company's claims that Paxil was more effective than a placebo or sugar pill in treating depression in adolescents. The 2001 study also under-estimated the rate of suicidal thoughts and behaviors among participants taking Paxil in the study (in a 2006 paper, GlaxoSmithKline acknowledged that those taking the drug were five times more likely to be suicidal than those taking the placebo). GlaxoSmithKline is now under investigation by federal Department of Justice officials, and Keller himself has been deposed by attorneys in Boston's U.S. attorney's office, according to sources.

I also understand that the NIH recently refused to renew a long-term research grant submitted by Keller, in large part because of the allegations about Keller's scientific misconduct and his failure to disclose his conflicts of interest. Although Brown officials refused to confirm the NIH action, if you search the federal database for NIH grants (CRISP), you can see that Keller currently has three long-term research grants with National Institute of Mental Health; one of those grants, for a study comparing psychotherapy to drugs in treating depression, runs out this June. Another grant, for a long-term collaborative study of depression, ends in January.

Until recently, Keller was a major rainmaker for Brown, bringing in millions in research funding from the NIH and pharmaceutical companies to the university's medical school. Indeed, in a 2006 deposition, Keller said his department of psychiatry received $50 million in research funding, a significant hunk of change. Some have speculated that is why Brown has been reluctant to move against him. But now that NIH is no longer renewing Keller's research grants, one might speculate that his usefulness to Brown has diminished.

All of this may explain why come June, Martin Keller will join Nemeroff and Schatzberg on the growing roster of once-powerful psychiatry chiefs who have toppled from grace.

A new approach to treating mental illness?

When people exhibit signs of psychosis – they hear voices, they think someone is out to get them – more often than not, they are referred to psychiatrists who immediately put them on powerful drugs like Haldol, Depakote, Abilify or Seroquel. These drugs sometimes tamp down the voices and other psychotic symptoms (and sometimes they don’t). Such medications also make many people feel like zombies and carry a plethora of severe side effects such as excessive weight gain and an increased risk of diabetes and heart problems. Too often, their benefits are short-lived, and many people experiencing psychosis end up in a vicious cycle of hospitalization and isolation – unable to hold down a productive job and stigmatized by the world at large.

In her new book, Agnes’s Jacket, Gail Hornstein, a professor of psychology at Mount Holyoke College, offers an intriguing alternative to dealing with psychosis: support groups that allow people to discuss and deal with the voices they are hearing without medication, in a caring and empathetic environment. She explores this “psychiatric survivor movement” in great depth in her book, chronicling the Hearing Voices network and other support groups that have made this movement possible. She presents vivid examples of people who were previously labeled psychotic and slapped on drugs, but who, with the help of support groups, have learned how to live with and control the voices they hear inside their heads. Some of these people have gone on to live rich, productive lives without the need for medication or hospitalization. As Hornstein writes in her book, “Sharing experiences in peer support groups has led them to a whole different way of understanding their distress…Psychiatric survivor groups teach patients that emotional difficulties, no matter how severe, can coped with."

Hornstein makes a persuasive case for the power of peer support and the importance of understanding psychotic symptoms in the context of the trauma that many people with such symptoms have experienced in their lives. And she rightly points out that psychiatrists -- under the sway of the pharmaceutical industry and managed care – have been much too quick to put their patients on powerful drugs instead of exploring other therapeutic alternatives first.

Just one quibble. In her book, Hornstein seems to sweep all American psychiatrists into the same boat, ignoring those who remain committed to psychotherapy (despite inadequate reimbursement from insurers) and to developing the kind of positive, trusting relationships that put patients on the road to recovery.

Last year, for example, I had the opportunity to attend a meeting of the International Society for the Psychological Treatments of the Schizophrenias and other Psychoses (ISPS), where I heard a previously psychotic patient talk about how his relationship with his psychiatrist enabled him to recover from years of mental illness. As a young man, Mark had been labeled schizophrenic because he heard voices all the time. He was repeatedly hospitalized, put on Haldol and Clozaril, powerful anti-psychotics that made it difficult for him to function. For years, Mark couldn’t hold down a job or live on his own.

Over the past 10 years, however, Mark has been in therapy with the same psychiatrist, and they have developed such a strong relationship, one based on mutual respect and trust, that Mark is no longer psychotic. He now has a job, lives by himself and, judging by what he had to say at the ISPS meeting, is a thoughtful, articulate man. He credits the relationship he has developed with this particular psychiatrist for his recovery, noting: “When you feel good about the people you’re working with, you generally want to stay healthy.”

And that, of course, is precisely what makes the support groups that Hornstein extols so effective as well. Regardless of what experiences people are sharing and who they share it with, they are much more likely to recover from mental illness when they are surrounded by understanding, empathy and respect. And that’s not something you can get from a pill.

Negative findings about ADHD drugs downplayed by researchers on drug companies' payroll

Thanks to unsealed documents from legal proceedings, we now know that many drug makers routinely hid negative findings about antidepressants and anti-psychotics (ranging from Paxil to Seroquel) from doctors and consumers. Now comes evidence that the researchers who conducted a long-term study on the effectiveness of drugs for attention-deficit disorder (ADHD) also sought to play down results showing that these drugs are not particularly effective over the long haul.

According to an article in The Washington Post today, researchers involved in a large federally funded study knew by 2007 that drugs like Concerta and Adderall are not effective in treating ADHD over the long term (i.e., the children in the drug group did no better than a control group who received no medication). This negative data came from a study that followed up on a well-publicized 1999 report showing that these drugs were initially effective in treating ADHD. The 2007 followup study also showed that children who took these drugs for 36 months were about an inch shorter and six pounds lighter than those who did not.

While the 2007 data were duly reported in a medical journal, a news release from the National Institute of Mental Health (NIMH) presented the study in a far more favorable light than it deserved, playing down the negative findings about the drugs' lack of long-term efficacy as well as their disconcerting side effects, according to The Washington Post article by Shankar Vedantam.

In reading Mr. Vedantum's excellent story, I couldn't help but wonder whether any of the researchers in this study, some of whom continue to minimize the drugs' negative effects, were getting paid on the side by the companies who sell them. Sure enough, a quick glance at the latest published results of the federal study in the Journal of the American Academy of Child and Adolescent Psychiatry show that seven of the principal researchers disclosed myriad conflicts of interest. For example, Peter Jensen, the former Columbia University researcher who so fervently defends the drugs in The Post article reports receiving consulting and speaking fees from Shire (which makes Adderall), Janssen (which makes Concerta) and a host of other drug companies.

Indeed, the list of conflicts disclosed by these researchers takes up a sizable chunk of fine print at the end of the article. If you're a subscriber to JAACAP, you can see for yourself at MTA at 8 Years: Prospective Follow-up of Children Treated for Combined-Type ADHD in a Multisite Study. Hat tip to Peggi Johnson for alerting me to The Washington Post article.

On a completely different note, I was asked to write a piece for the spring issue of the Nieman Reports about whether the blogosphere will be able to reproduce the watchdog role that newspapers have so honorably fulfilled over the last 100 years (now that many of them can no longer afford to perform that function). Here is my answer: Blogs, Watchdog Reporting and Scientific Malfeasance.

Is psychiatry more corrupt than other medical specialties?

At a talk I gave Wednesday at George Washington University, someone in the audience asked why there seemed to be an inordinate number of psychiatrists on the take to the drug industry. Was it something about the specialty of psychiatry itself or the individuals involved? I have often pondered the same, especially since this is not simply an anecdotal observation. In 2007, The New York Times examined the payments made to all doctors in Minnesota in the years since that state passed one of the first laws in the nation requiring the public disclosure of payments from the pharmaceutical industry. Based on that investigation, Times reporters concluded that as a specialty, psychiatry topped the list in lucrative drug company payments.

So what's going on? A couple of things, I think. First off, there's a reason why drugs like Paxil, Zoloft, Prozac and Lexapro are top sellers: it's easier to expand the criteria for who might benefit from these drugs. After all, almost everyone has experienced depressive or anxious symptoms at one time or the other, so if the makers of these drugs can reach psychiatrists and persuade them to prescribe pills for such universal symptoms, we're talking real profits here. And what better way to influence psychiatrists' prescribing behavior than to put their most prominent colleagues -- the key opinion leaders (KOLs) -- on your payroll?

Secondly, as someone who came to the talk astutely noted, psychiatrists have been squeezed by managed care into the role of pill prescribers. Unlike other medical specialties, doctors in psychiatry don't get adequately reimbursed for treating the whole patient -- by doing psychotherapy, for instance -- so all they can do these days is prescribe drugs. In a sense, psychiatrists are gatekeepers for the pharmaceutical industry, much like surgeons (who put in stents and other devices) are gatekeepers for the medical device industry.

Because of these trends, partnering with the drug industry has become a pervasive part of the psychiatric culture in recent years. It has become, for example, common practice for drug companies to bankroll symposia at the specialty's top medical conferences, at which psychiatrists on their payroll extoll the benefits of their products (without disclosing their conflicts of interest). As I reported in a previous blog, Nada Stotland, the current president of the American Psychiatric Association (APA), initially took umbrage when Sen. Charles Grassley questioned the organization's incestuous ties with the drug industry. In a memo to APA members, Stotland wrote: "Long traditions and established practices are not only being questioned, but also criticized across the board." As I said then, it almost sounded like Stotland's problem was with the criticism of these longstanding practices, not the practices themselves.

And that is why I was gratified to see in the Carlat Psychiatry blog, that the APA has officially decided to phase out all industry-funded symposia that take place at their annual meetings.

That's a good first step to reform. But there is still a long way to go, as evidenced by the news reported today in The New York Times that court documents appear to indicate that Dr. Joseph Biederman promised a drug company (Johnson & Johnson) positive results about its drug Risperdal from studies that had not been undertaken. Biederman, as has already been reported, not only earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 (the bulk of which he failed to report), but also received funding from J&J for a research center at Massachusetts General Hospital, which he headed.

Like Martin Keller, the psychiatrist I expose in my book, Biederman is one more example of how science can be skewed and public interest harmed when doctors are the beneficiaries of industry largesse. Psychiatry may be particularly vulnerable to such corporate blandishments, but I would argue that it's time for all medical specialties to take a good look at the way they do business and start healing.

Massachusetts fraud case exposes deep flaws in our system of medical research and publication

The news that a Massachusetts anesthesiologist fabricated data in at least 21 studies (and probably more) is disturbing on several counts. First, it raises serious questions about the credibility of the peer review process at all the supposedly respectable journals this doctor published in. Second, it sets in sharp relief what happens when journals do not require researchers to disclose their conflicts of interest, i.e., their financial ties to the drug or medical device companies who stand to benefit from their work. And third, it makes you wonder: where were the institutional review boards at Baystate Medical Center and Tufts Medical School when Dr. Scott S. Reuben (who was affiliated with both institutions) was faking all this research?

In sum, the case of Dr. Reuben, who has been apparently been faking research data for more than a decade, highlights the serious shortcomings in our current system of conducting and disseminating medical research. It also spotlights why the much-heralded disclosure regulations recently promulgated by the state of Massachusetts are not as effective and far-reaching as state officials would have us believe.

The facts first. Baystate Medical Center in Springfield discovered Reuben's extensive fraud last spring after a routine audit of research summaries revealed that Reuben had failed to obtain approval of the hospital's institutional review board for two of his newer studies. As Anesthesiology News was the first to report,"What ensued was the unraveling of what medical ethicists are calling one of the largest instances of research fraud ever reported, a massive scandal that has led to the withdrawal of as many as 21 journal articles."

Many of the studies that were found to have been fabricated are positive findings about painkillers like Vioxx, Celebrex, Bextra and Oxycontin, two of which have since been withdrawn from market because of their untenable side effects (an increased risk of heart failure). Also tainted is a study purportedly showing the value of Effexor, an antidepressant, in reducing pain among patients who underwent a mastectomy because of breast cancer. Now, Reuben may or may not have been getting money from Wyeth, the maker of Effexor, but we do know that, according to The Boston Globe, he was a long-time member of Pfizer's speaker bureau. That means he was getting speaking fees from the drug company that makes Celebrex and Bextra at the very same time he was reporting positive findings about the drugs. Yet none of these conflicts of interest were disclosed in the journal articles he published about these controversial painkillers.

That, to me, is an egregious oversight. It's all well and good if the leading medical journals like the New England Journal of Medicine and JAMA require conflict of interest disclosures from their researchers. But most doctors publish their work in less rigorous journals, among them Dr. Reuben, who published the bulk of his phony research in such second-tier journals as Anesthesia and Analgesia and the Journal of Pain and Symptom Management. The fact that Reuben's results did not raise red flags at these journals says as much about the inadequacy of their peer-review process as it does about their shoddy disclosure policies around conflicts of interest.

The Reuben case is just one more pressing reason why we need a federal Physician Payment Sunshine Act that requires drug and medical device companies to routinely disclose such conflicts of interest to the American public. If Reuben's conflicts of interest had been more transparent, there's a possibility that someone in the field of pain medicine might have questioned sooner why all of his studies seemed to find positive benefits to the drugs he was studying. (Obviously, this kind of scrutiny was not going to come from Pfizer and other drug companies who were only too happy to reward Reuben for his glowing results).

The Reuben case also illustrates the weaknesses in Massachusetts' new regulations banning free gifts to doctors and requiring the disclosure of payments (over $50) to health-care professionals involved in sales and marketing of drugs or medical devices. There is a big loophole in these regulations: they exempt the disclosure of payments to doctors "in conjunction with genuine research and clinical trials," according to the rules posted on the state's Department of Public Health website. What this means is that Reuben (or any researcher) could have been paid a consulting fee to help drug companies plan and disseminate the results of his research to other doctors (at conferences and in journals) and these payments might not have to be disclosed. In an interview, Tom Lyons, a spokesman for the Mass Department of Public Health, said he thinks that consulting payments after a clinical trial is finished would have to be disclosed, but payments while the trial was ongoing would not have to be. "This kind of thing will have to be decided on a case by case basis as questions come up," he said.

One other thing: in the interview with Anesthesiology News, Baystate officers insisted that no patients were harmed by Reuben's fraud. That's a ridiculous assertion. Based on research done by Reuben and others, many patients were given drugs like Vioxx, Celebrex and Bextra, all of which have serious side effects, and they may well have been harmed as a result. If I were a patient who had a heart attack after taking one of these nonsteroidal anti-inflammatory painkillers, I might want to re-examine the culpability of all of the players in this horrendous case of scientific fraud.

Sales Tactics in the Drug Industry: Plus Ca Change

Not a week goes by without news of the growing concern -- among consumer advocates, medical students and Congressional watchdogs -- about the financial conflicts of interest that bind doctors to the pharmaceutical industry and may bias their judgment about new drugs. Several drug companies, hoping to forestall federal legislation, have announced their intention of disclosing these conflicts of interest -- which take the form of lucrative personal payments to prominent doctors and researchers (key opinion leaders or KOLs in the industry vernacular) who are in a position to influence other doctors.

But within the industry itself, status quo reigns.

One need only glance at the flyer for an upcoming conference targeting the industry's army of salesmen and women. Dubbed "the premier event in pharma sales," the May sales force effectiveness summit in Princeton, New Jersey, features several seminars on how sales agents can improve their access to physicians and "connect directly" with them, in order to promote new products. Five "key opinion leader physicians" will be on hand to lead one seminar (highlighted in bright yellow) and instruct attendees on what works the best with their busy medical colleagues. (I'm sure these KOLs are being paid handsomely to attend; I'm equally sure that KOLs who are currently under Congressional investigation such as Charles Nemeroff, Martin Keller and Alan Schatzberg will probably not be in attendance, but I could be wrong).

Attendees can also learn how to maximize the use of software to sort through doctors' prescribing practices to determine which doctors to hit on and how best to capitalize on all this lovely data for sales. In the conference organizers' own words: "Enhance your [sales] reps' interpretation of patient-level data to ensure increased success with physicians." Why do I have the feeling that patient privacy is not going to be high on the agenda here?

In sum, the two-day conference boasts a virtual smorgasbord of tips for getting close to doctors in order to maximize drug sales. The price of entry may be a bit steep -- fees range from $1,795 to $2,895 depending on whether you buy a platinum, gold or just a silver pass -- but don't worry: if you're a hard-hitting pharmaceutical sales rep, your company will no doubt pick up the tab.

Hat tip to Marilyn Mann for spotting this brochure and sending it my way.