Shining the light on drug company shell games

First the good news: The Physician Payment Sunshine Act is now law, signed by President Obama as part of the health care bill overhaul. Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website. This is an important first step toward making transparent the pervasive financial ties between doctors who are studying or promoting specific drugs and medical devices and the companies that manufacture these products.

There is one significant loophole in the law: according to the final provisions, payments related to clinical trials or product development agreements for new products are allowed a publication delay of four years or until product approval, whichever comes first. So if a particular doctor is researching a drug that has not yet been approved for a specific condition, we will have to wait four years to find out whether he or she is on the drug company's payroll. But at least the disclosure will eventually see the light of day, and patients who are prescribed the drug in question can seek a second opinion from a doctor who is not on the drug firm's payroll and whose medical judgment can be trusted.

The Physician Payment Sunshine Act, however, only goes so far. While it covers doctors and teaching hospitals, it does not extend to all the advocacy groups and professional organizations that have substantial influence on over how particular illnesses are treated. For example, as I reported, the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness, received millions of dollars in funding from drug companies for years -- a payola that no doubt spurred this group's embrace of potent psychoactive drugs over alternative methods of treating mental illness.

And now, in the current Psychiatric Times, two Massachusetts researchers tear the veil off efforts by the American Psychiatric Association (APA) to hide industry funding of its two philanthropic arms -- the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE). As Lisa Cosgrove and Harold Burszstajn report: "While the APA recently announced it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding" of APF and APIRE.

Why does this matter? Because the APA is not only a powerful lobbying force in Washington and the premier trade group for America's psychiatrists but it also publishes the DSM, the diagnostic bible of psychiatry, that largely determines how psychiatrists treat mental illness. As I've blogged about before, the proposed DSM-V further broadens the categories of various disorders, which will have the net effect of creating profitable new markets for drug companies.

Hence, Cosgrove, a clinical psychologist at the University of Massachusetts, and Bursztajn, a psychiatrist at Beth Israel Hospital and Harvard Medical School, decided that the public has a right to know about any hidden financial ties between the APA and the pharmaceutical industry. So they investigated and found that the boards of both APF and APIRE were stuffed with high-level executives from companies that make drugs recommended by the APA and with psychiatrists who have financial ties to these drug companies. They discovered, for example, that nine of 16 board members of APIRE had industry ties.

Yet neither organization requires disclosure of financial conflicts of interest. Nor is there much information as to how much money Big Pharma is giving these organizations. In their Psychiatric Times piece, Cosgrove and Bursztajn ask the valid question:

Has industry removed the transparent and visible shell of professional education programs and replaced it with the more opaque shells of foundations such as APF and APIRE?

The authors go onto recommend that individuals serving on APF and APIRE's boards post disclosure statements and that the total amount of industry funding given to these organizations be posted. They also suggest that the boards of both groups be reorganized to more genuinely reflect a patient-centered focus. They conclude:

Steps need to be taken to lift the cloak of silence that surrounds the issue of indirect or covert ties exerting undue industry influence.

I couldn't have said it better.

Why tort reform isn't on the table: hard lessons about special interest money in Washington

Every semester, I do an in-class competition to show my students the power of the Web in digging up data for stories. I separate them into groups and ask them to find the answers to specific questions about current sociopolitical trends. Two questions I always ask are: one, what are the top industries in terms of campaign contributions to Congress and two, which are the top industry spenders on lobbying Congressional and federal officials. (These are two very different ways of influencing policy decisions).

The answers this year were instructive, particularly in the light of the ongoing battle to pass a health care bill.

Not surprisingly, the pharmaceutical/health products industry topped the list of industries spending millions of dollars to sway the opinion of Congressional and executive policy makers, according to Center for Responsive Politics, a nonpartisan, nonprofit research organization that tracks money in U.S. politics. This industry, which includes Big Pharma, biotech and the medical device industry, spent $263 million in 2009, far ahead of the second (business associations), third (oil and gas) and the fourth highest (insurance companies) spenders on the list. This ranking comes as no surprise, since the pharma/health industry has dominated the list of big spenders on lobbying for more than a decade, which goes a long way toward explaining why Big Pharma almost always gets its way in Congress and with the FDA as well.

What may come as more of a surprise is the industry that of late has topped the list of big spenders on Congressional campaign contributions: lawyers and law firms. In the 2009-2010 election cycle, lawyers gave Congress $27 million and the top recipient of their largesse was none other than Harry Reid, the Majority Leader for Democrats in the Senate. In the 2008-2009 election cycle, Barack Obama was the top recipient of their money, and in 2007, it was Hillary Clinton, then considered the front runner as the Democratic presidential candidate, again according to the Center for Responsive Politics, which culls its data from government records.

Such over-the-top spending explains why tort reform has been consistently excluded from each version of the health care bill, despite the fact that it's a favorite cause of Congressional Republicans. There's an ongoing debate over just how much money tort reform, or putting caps on the amount of money plaintiffs and their attorneys can reap from malpractice lawsuits, would actually save. For example, it's debatable whether tort reform would generate much savings in malpractice insurance, but there's no question that if doctors were less afraid of getting sued for big bucks, they might order fewer tests and procedures for patients and that could generate considerable savings, particularly if it was linked with real changes in the way doctors are reimbursed for care (i.e. being paid by salary rather than fee for service).

But what I haven't understood until now is why the Democrats haven't been using tort reform as a bargaining chip to bring some moderate Republicans into the fold on the health care bill.

Now that I (and my students) see how much big money lawyers have been throwing at Congress and our current President, I understand why tort reform is not on the table. And that's a damn shame. If capping monetary damages in medical malpractice suits were part of health care reform, some Republicans might just break rank and vote for it.

Instead, we see special interests once again calling the shots. No wonder the American public is, as Neal Gabler says in The Boston Globe today, so enervated and apathetic.

Financial conflicts and other problems with the proposed DSM-V

I have hesitated to weigh in on the debate raging over the proposed changes to the DSM-V (psychiatry's diagnostic bible), in large part because others more literate in psychiatric minutiae have already done so. To wit: Dr. Allen Frances in the Psychiatric Times, Dr. Edward Shorter in the The Wall Street Journal, and Dr. Daniel Carlat on his blog.

All three of these experts agree that the DSM-V (which, like previous DSMs, was created by psychiatrists appointed by the American Psychiatric Association) is dangerously broadening the categories of various disorders, which will have the net effect of creating profitable new markets for drug companies. As Frances, the chair of the previous DSM-IV task force, puts it:

DSM5 would create tens of millions of newly misidentified false positive “patients,” thus greatly exacerbating the problems caused already by an overly inclusive DSM4. There would be massive over-treatment with medications that are unnecessary, expensive, and often quite harmful. DSM5 appears to be promoting what we have most feared--the inclusion of many normal variants [like grief] under the rubric of mental illness, with the result that the core concept of "mental disorder" is greatly undermined.

However, the pundits seem to disagree when it comes to one particular change: subsuming Asperger's and other similar disorders under the broadened category of autistic spectrum disorders. While Shorter and Carlat think it's a good idea, Frances argues that this consolidation presents serious problems -- see again his Psychiatric Times essay. At a dinner party last night, I heard similar concerns from several mental health professionals, including allegations that the change may have been pushed for less than noble reasons -- i.e. financial gain.

But before I get to the possible conflict of interest here, let me enumerate their larger concerns:

1. There seems to be no scientific basis for subsuming Asperger's syndrome under the tent of autistic spectrum disorders.
2. Many children and adolescents with Asperger's benefit from a specially constructed type of environment (with special supports at school to bolster the social skills they lack). If these children are subsumed under the autism tent, there may be less emphasis on constructing such supportive environments and they may be more likely to be prescribed powerful anti-psychotic drugs like Abilify and Risperdal that are now approved for use with autism. Forget the fact that these drugs have significant side effects. If this happens, many Asperger's patients will not get the specialized attention they need.
3. There may be a temptation to diagnose children with mild autism as having Asperger's, thus undercutting the reality that while some people with Asperger's are highly functioning individuals, many others are severely disabled. As a result, people with severe Asperger's may also not receive the intensive care they need.

Now to the potential conflict of interest with the proposed change. As it turns out, one of the members of the DSM-V task force is Catherine Lord, a professor at the University of Michigan, who gets big royalties from a diagnostic test she helped develop (known as ADOS) that is used to diagnose autistic spectrum disorders in children. As it turns out, the subcategories for the ADOS test fit very neatly into the new criteria proposed for the autistic spectrum disorders in the DSM-V.

Now, according to an APA disclosure report I found online, Lord has agreed not to accept more than $10,000 from "industry sources" each year from the time the DSM-V is approved until its publication (the report says that will be in 2012, but recently the APA agreed to delayed publication of a new DSM until 2013).

What I want to know is: does this agreement include all the royalties Lord currently receives from the ADOS diagnostic test and the expensive bucket of toys that come with it? And if so, what happens after the DSM-V is published when all those royalties start flooding back in?

More importantly, should Lord have been allowed to sit on the DSM-TV task force in the first place and influence major policy changes in psychiatric diagnoses that will affect millions of vulnerable children? I think not.