Monday, June 30, 2008

Heat Building on Schatzberg

When the story originally broke on Dr. Alan Schatzberg's holdings in Corcept Therapeutics and on whether he had properly informed Stanford of this conflict of interest, I assumed the controversy would take on the usual inverted U-shaped curve that these things often do. You know, a lot shocked reactions, some interviews with experts, an official response from the university, and a gradual subsiding of all the commotion into quiescence.

But it doesn't seem to be working out that way, largely because an influential English Professor, Margaret Soltan, has taken up the issue, and has been expressing her outrage in some of the most eloquent writing I've seen on anything, anywhere (she is, after all, an English professor).

Soltan teaches at George Washington University and writes the fascinating blog University Diaries, which is a kind of expose of contemporary university life. She is such a prominent woman of letters that she was featured on PBS's Lehrer
News Hour to discuss Dorris Lessing after she won the Nobel Prize in Literature in 2007.

Soltan posted this long article on the affair last Friday, and this short entry today. Friday's posting is notable for Soltan's interesting perspective from the standpoint of a long-time observer of university politics throughout the U.S.; accordingly, she is no stranger to techniques for outflanking regulations:

"So Schatzberg complies with Stanford’s rules when he tells them, as he did, that his holdings in such a company are indeed over that amount [$100,000]. He didn’t need to specify that he stands to earn six million dollars more than that amount. From a drug company he founded."

Soltan realizes that universities can set up conflict of interest policies until the cows come home, but at the end of the day, they have to trust the ethics of their employees:

"For the reality is that universities can set all the conflict of interest standards they like, but a university is not a policing agency. It will always tend to respect, trust, and support its professors in their research, and it will seldom have the investigative capacity to find financial or research wrongdoing, or the judicial capacity to punish it in a serious way. If universities can no longer trust their professors to do honest science and to remain intellectually and morally independent of drug companies, the universities have a couple of choices open to them:

1.] They can hire a permanent team of financial investigators of the sort Grassley has on his staff, and this team can regularly investigate faculty who receive grants and who have financial interests in various companies. Professors would be called in for questioning, their tax documents might be scrutinized, their business associates interviewed. In short, the university can make itself over into a policing agency.

2.] The university can relax and accept the fact that because ” drug makers have displaced the U.S. National Institutes of Health as the primary source of research financing,” some of its professors in the sciences are not professors at all, but contract employees of drug companies. Leave research integrity to the National Institutes of Health; our campus is about enhancing the profits of drug companies and enriching our researchers."

Her post today was short, but to the point. She links to this article by Bernard Carroll, calling it "expert and eloquent testimony against a professor at Stanford University who seems, like Harvard’s Joseph Biederman, to have allowed greed, arrogance, and deception to guide his clinical work. Our function relative to these men, our job as ordinary American citizens, is to:
1. subsidize their already commercially subsidized work with our tax dollars;
2. buy and take the insufficiently or inappropriately tested medications they’re selling; and
3. swallow the stories their universities are telling about their integrity."

Perhaps the most interesting part of Soltan's original article is in the comments section, where Ian Hsu, from Stanford's Public Affairs Office, tries to explain what the heck Stanford was thinking all of these years. Understanding his explanations (in three separate comments) may require that you consult this translation of Bureaucratic Speak.

Thursday, June 26, 2008

The Six Million Dollar Man: Witch Hunt? Or Call to Action?

Senator Grassley has called both Alan Schatzberg and Stanford University onto the carpet about inadequate disclosures of Dr. Schatzberg's interests in a pharmaceutical company which he cofounded, Corcept Therapeutics. Grassley's investigation is ongoing, and I assume we can expect to see many other academics taking their own places in the Senate hot seat over the next few months. I assume Grassley is starting with the most dramatic examples of conflict of interest, and unfortunately for my specialty, the first of the all-stars have been psychiatrists.

I won't go into all the details of Dr. Schatzberg's financials, since I have covered them in a prior post
here, and they have been covered in more detail at Health Care Renewal here, and at Pharmalot here, where you can also find a comment form Bernard Carroll documenting Dr. Schatzberg's past failed attempts to cash in on his stock holdings.

In this formal
statement, Stanford has defended Dr. Schatzberg and the university's conflict of interests policies. Regarding Dr. Schatzberg, I have no problem with him owning $6 million worth of shares in a company trying to bring a new antidepressant to the market. While he may have inappropriately tried to hide this disclosure in the past (judge for yourself by reading this account), he has made no secret of his net worth over the past few years.

However, I do find it incredible that Stanford finds it acceptable for him to serve as the chairman of an academic department. As chairman of psychiatry, Dr. Schatzberg is involved with many decisions having to with hiring staff and funding research. While I have no doubt that he is an ethical person, the fact that he owns $6 million in stocks can never be far from his mind. If it were me, I'd be thinking about it when I woke up in the morning, during my coffee breaks, my meals, and while I was brushing my teeth at night. We're talking $6 million here, people.

Here are some problematic possible scenarios. A young professor in his department is up for promotion. But he is researching a medication in direct competition with mifepristone. Dr. Schatzberg has to make a decision, knowing that this could have an eventual impact on his ability to retire with $6 million.

Another scenario. A psychiatry resident has written a wonderful review paper on antidepressants which has been submitted for a departmental award. In it, the resident has concluded that mifepristone is not a promising agent. Schatzberg has to decide who will get the award.

Equally amazing to me is the American Psychiatric Association has no policy forbidding this level of conflict of interest in candidates for APA president. Shatzberg won the most recent election, and will be installed as APA president next May. What will happen if and when Dr. Schatzberg is asked to make decisions regarding the appropriate relationships between the pharmaceutical industry and the organization?

Tuesday, June 24, 2008

Key Opinion Leaders as Drug Reps

I just noticed this interesting post over on Health Care Renewal reviewing this article in the British Medical Journal. The article interviews a former U.S. drug rep, Kimberly Eliot, who recounts how key opinion leaders are groomed to be salespeople for the pharmaceutical industry:

"Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations," she said. "If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back."
It is another nail in the coffin of the notion that drug companies pay doctors to provide medical education. It's all about marketing.

Saturday, June 21, 2008

Using ACCME's New Rules for Bias and Profit

In bmartin’s pro-industry-CME blog Pathophilia, there is an interesting post about the newly proposed ACCME rules intended to stamp out commercial bias while still allowing commercial support. Bmartin parses out the wording of ACCME’s proposal in order to try to divine the organization’s actual intentions, and finds much to ridicule.

You can detect a heavy dose of financial anxiety in this post. It’s an attempt to read the tea leaves in ACCME’s new policy, in the hopes that it will not actually mean any significant changes in the current system. But bmartin ends on a decidedly pessimistic note, predicting that the regulations will lead to less industry funding, and ultimately, to the disappearance of ACCME itself.

While I wish I could agree with bmartin, unfortunately I see this as very good news for industry support. Anybody who owns a CME company and has undergone accreditation and reaccreditation (as I have) knows that there is really nothing new in this “new” guidance. Any company will be able to demonstrate compliance with each of these and yet still produce promotional and biased CME. Let’s take each of these elements point by point and apply it to a recent promotional CME article produced by Medscape (see here for more details, and see Bernard Carroll's excellent investigative journalism on Medscape here and here).

1. Needs assessment will have to be identified by neutral organizations. Not a problem! You want to keep the flow of money coming from Janssen to help it promote Invega? Many non-industry funded organizations will report that practitioners have a need to learn more about the appropriate use of antipsychotics. Bingo—you’ve just done your needs assessment.

2. Practice gaps will have to be identified by neutral organizations. Same non-issue as number one. Any reasonable organization will identify adequate treatment of schizophrenia as a “practice gap.” For example, the AHRQ produced this document
which can be cited to support the need for education about how to use atypical antipsychotics. Medscape will argue that focusing an article on treating a schizophrenic patient with liver disease (which just happens to be the specialty of Invega, its sponsor’s medication) fills an identified “practice gap,” and ACCME won’t argue with them.

3. The curriculum must be specified by a bona fide organization. This is a hard one…let me see…okay, how about psychiatry’s specialty board, the American Board of Psychiatry and Neurology, Inc., which publishes these “core competencies” in psychiatry.
Go to the “Somatic treatment” section and you’ll find the following recommended curriculum for psychiatrists:

“Somatic treatments, including:
a) Pharmacotherapy, including the antidepressants, antipsychotics, anxiolytics, mood-stabilizers, hypnotics, and stimulants, including their:
i) Pharmacological actions
ii) Clinical indications
iii) Side effects
iv) Drug interactions including over-the- counter, herbal, and alternative medications
v) Toxicities
vi) Appropriate prescribing practices including age, gender, and ethnocultural variations
vii) Cost-effectiveness”

I think this is broad enough to support any CME activity, no matter how blatantly promotional, as long as it relates to some aspect of pharmacotherapy.

4. It must be verified as “free of commercial bias.”

This is a redundancy, since this is already a centerpiece of ACCME Standards for Commercial Support. The organization will never have the resources to monitor the thousands of industry-supported CME activities hatched yearly.

So don’t fret, bmartin—in fact, I would argue that this is a cause for great joy. ACCME is handing you the perfect mechanism for a commercial CME whitewash. Use some of that industry money to celebrate.

Thursday, June 19, 2008

ACCME Gets Serious with "New Paradigm"

Given AMA's recent decision to slow down on CME reform, these new guidelines proposed by ACCME are more than welcome. The ACCME is focusing on the epicenter of commercial bias, which is the choice of topics to be covered in CME programs. As I have detailed in my last two posts, the cutting edge technique for ensuring that CME contains promotional content is to choose topics that are in line with the sponsor's commercial interests. The resulting course may be a scientifically accurate portrayal of a carefully pruned topic, showing no obvious "bias" within that topic area. But it is promotional nonetheless, just as drug company advertisements are promotional even though the FDA oversees them to ensure scientific accuracy.

The new guidelines will not allow MECCs to choose the topics; instead, they will chosen in consultation with relatively unbiased government agencies and medical societies. The one aspect of the "new paradigm" that is a head scratcher is the stipulation that CME be "free of bias." That's been a requirement for years, but has never been enforced. It appears that the organization has beefed up enforcement efforts--the say they have put 10% of providers on probation for breaches of their Standards of Commercial Support, up from 1% in the past.

We'll all have to stay tuned.

Wednesday, June 18, 2008

Dinosaurs Roam the Earth Once More

The AMA House of Delegates had a chance to make history, but they flinched. Faced with their own ethics council’s recommendation to declare industry funded CME unethical, they had three choices: approve, reject, or delay. They chose to delay, referring the proposal back to committee.

While MECC websites crowed victory, in fact, this is not really their victory at all. The proposal will return. It will be tweaked to become less objectionable to some, and will be resubmitted in November or next June.

Yes, the medical dinosaurs are prowling the earth once more, and that crashing sound through the jungle is heard nowhere louder than in the editorial offices of Medscape, where George Lundberg, their editor in chief, released one of the more bizarre performances in recent memory. In this videotorial, Lundberg declares that CME is “under siege.” Consumer warning: if you watch this, be prepared to cringe.

Like a cornered animal, Lundberg widly lashes out at all progressive forces in medicine, including, in no logical order: Jerome Kassirer, the American Association of Medical Colleges, Jordan Cohen
, the American Medical Students Association, the AMA’s Ethics Council, the Josiah Macy Foundation, Senator Charles Grassley, and even JAMA, the journal which Dr. Lundberg once edited. All of these individuals and institutions are part of the vast conspiracy to destroy continuing medical education. What irked me, though (aside from his failure to mention me in his Rogue’s Gallery) were his parting comments: “What does all this mean for Medscape and eMedicine, the largest single source of CE for health professionals? We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”

Good? Clean? Transparent? Are we still talking about Medscape, the discredited purveyor of drug company ads, disguised as CME?

In a prior post, I deconstructed this offering funded by Janssen in which good, clean, and transparent Medscape editors scoured the ends of the earth for the single case study that might make Invega look good—and then created a CME article out of it.

Lundberg’s preposterous opinion piece prompted me to dig a little more deeply into their CME, and it gets worse. Let’s go down the list of their industry-supported CME (there are a few token non-industry funded articles sprinkled in here too). We’ll start with New Data in the Recognition and Management of Bipolar Disorder, an article funded by Lilly, which mentions their Symbyax (a combination of Prozac and Zyprexa) over and over again. When Lilly funds a CME, the editors know exactly what they are paid to do: discuss Zyprexa in a way that downplays its infamous metabolic dangers. True to form, here is the only discussion of weight issues in this article:

“Dr. Thase: Well, the good news on both OFC [Symbyax] and quetiapine is that they do not cause switching, do not induce cycling, and the primary metabolic consequence is weight gain, which is very reliably, accurately measured sequentially and you see it coming. No one will gain 5 kg without first gaining 2 kg, and particularly when they're warned ahead of time. So I would say 1 thing for the interest of primary care prescriber would be to gain some comfort with at least these 2 members of the atypical antipsychotic class, engage the patient in collaborative care and follow-up, watch weight gain closely.
The diabetes risk independent of weight gain is rare. It does happen, but you will need to treat well more 100 patients before you actually see someone who develops new-onset diabetes out of the blue, so it is a real consequence, but a rare one and the dyslipidemia is almost entirely weight dependent. So if there is no weight gain, there will be no dyslipidemia.”

This is the gentlest discussion of Zyprexa’s side effects that I’ve ever seen. The activity is ostensibly a discussion between luminaries in psychiatry, and I’m sure that’s how it began. But the editors can cut and paste interviews to achieve a variety of results--I should know, because I do this every month for my own CME newsletter. When I edit my interviews, I do so for clarity and conciseness—but when Medscape edits, they do so to push the sponsor’s product.

Lundberg: “We are good. We are clean. We are transparent.”

Next up: “The Evolving Management Paradigms for Pediatric ADHD.” There isn’t even an effort to provide the illusion of balance in this CME article. It quite simply a parade of praise for Shire products. After the introduction, ten of the first ten slides on treatment are advertisements for Shire products, in this order: Vyvanse (two slides), Focalin (two), Daytrana (three), and Guanfacine XR (three). How will Medscape defend the integrity of this article to ACCME? They will say that the article’s focus is on new ADHD treatments, and it just so happens that Shire has produced them all. It’s a beautifully-honed method of turning CME into promotion while skirting regulations. “It’s not biased—we just chose a topic that inevitably makes our sponsor’s products shine.”

If you keep going down the list, you’ll see the same pattern. Each CME article is biased in favor of the sponsor’s product.

Note to Dr. Lundberg and Medscape: what you are doing is not clean, not good, and most definitely not transparent.

Friday, June 13, 2008

Medscape's CME Corruption

As debate over the American Medical Association's upcoming vote on industry funding of CME builds up to a fever pitch (see here and here), the popular physician website Medscape is being unmasked as nothing more than a CME industry voicebox. Of even more concern for the company, some of its CME offerings have become blatantly corrupted by their sponsors' marketing goals.

I cover their corrupt CME below. First, note that Medscape has conducted this poll asking doctors if they would support the AMA proposal to ban industry funding of CME. The results are being used as ammunition by industry stakeholders. But this is a sham poll. Here is how Medscape introduces their survey:

"At its June 14-18 annual meeting, the AMA will consider its ethical council’s call for a ban on industry support of CME for physicians, medical schools, teaching hospitals, and societies. Critics say the ban would reduce the availability and quality of CME and increase its cost. Do you favor or oppose such a ban on industry support of CME?"

This would be analoguous to the Gallop organization introducing a poll by saying, "John McCain is running against Barack Obama in the upcoming presidential election. Critics of Obama say that he will increase our taxes, damage our economy, and will pull our troops out of Iraq, leading to civil war and instability in the Middle East. Do you favor or oppose Barack Obama?"

And here are the unsurprising results of Medscape's "poll":

In favor of banning industry funding:
19% (464)

80% (1907)

Medscape is a medical education communication company entirely dependent on drug company advertising and CME funding for its existence. Many doctors have noticed recently that the company has dropped even the pretense of objectivity. Yesterday, I received a letter from Medscape in my office; inside was a brochure from Forest Laboratories advertising Lexapro, and nothing else. It was creepy, like Invasion of the Body Snatchers.

If you want to judge for yourself whether Medscape is capable of producing unbiased CME, go to their main CME page. You'll find dozens of CME articles, almost all of which are sponsored by different companies.

Here's one that can serve as a poster child for all that is wrong with industry-funded CME. Entitled "Managing Schizophrenia in a Patient With Alcohol Abuse and Hepatic Impairment", it is sponsored by Janssen, maker of Invega, a "new" antipsychotic which is simply the active metabolite of their now off-patent drug, Risperidone. As I've written here in The Carlat Psychiatry Report, Invega is simply a patent extender, with no real benefit other than the fact that it is not metabolized in the liver, and therefore is easier to dose in patients with hepatic impairment. In the grand tradition of promotional CME, Janssen commissioned Medscape to come up with a case-based program focussing on the single clinical situation in which Invega has an advantage.

For Janssen, the key promotional message is found in a section where readers are prompted to check off which treatment option would be most appropriate for the hepatically impaired patient who is profiled. Here is how it is worded:

"Selecting Treatment in a Dual Diagnosis Patient

How would you treat this patient now?

Don't make any changes to his current medication regimen

Switch him from olanzapine to clozapine

Switch him from olanzapine to quetiapine

Switch him from olanzapine to paliperidone"

The right answer, of course, is to switch him to paliperidone, Janssen's product! Here is the CME-arketing copy that follows this question, just in case you haven't yet been convinced to start prescribing Invega:

"A retrospective chart review of psychiatric inpatients found patients receiving either clozapine or olanzapine had a higher likelihood of having at least one condition associated with metabolic symptom.[8] Further, both agents have been associated with weight gain.[10] The adverse effects associated with use of olanzapine indicates the need to change this patient's medication regimen to one with fewer metabolic and hepatic side effects. Some of the newer typical treatments and delivery routes are associated with fewer adverse metabolic effects while affording a means of achieving improved adherence -- particularly among patients with metabolic disturbances.[28]
Research suggests quetiapine is less strongly associated with adverse metabolic effects and weight gain than olanzapine[10]; nevertheless, the potential adverse effects profile of quetiapine makes it a less-than-ideal option. Aripiprazole and ziprasidone are reasonable choices for patients who have experienced weight gain and metabolic adverse effects, but both drugs are metabolized in the liver.
In contrast to the majority of available antipsychotic agents, paliperidone is not metabolized by the liver, minimizing the risk of hepatic adverse effects and other hepatic drug-drug or drug-disease interactions.[21] Clinical trials have shown paliperidone extended-release tablets to be safe and effective in improving the symptoms of schizophrenia, including personal and social functioning.[21] The patented OROS technology allows for once-daily dosing and minimizes the variations in peak-to-trough plasma levels, thereby reducing the occurrence of adverse effects. Clinical trials have demonstrated the high efficacy and tolerability of paliperidone ER in patients with acute schizophrenia, with a rapid onset of action, as well as in maintenance treatment.[21,29] Early studies indicate few metabolic side effects, including only small increases in body weight. These advantages facilitate its use for this patient."

Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No. But is this blatantly promotional of the sponsor's product? Of course. If Medscape had followed ACCME's Standards for Commercial Support, they would have had an independent expert read the article to determine three things: 1. Is the article sponsored by a company that produces a product relevant to the topic? (The answer is yes.) 2. If so, does the article appear to be commercially biased in favor of that product? (Yes). 3. How do you propose to alter the content of this article to eliminate this bias?
Medscape may have done numbers 1 and 2, but they forgot about number 3, the management of commercial bias, which is the most important thing about the ACCME standards.

I intend to lodge a formal complaint regarding this activity with ACCME, and I will also forward this information to various members of the AMA as they are deliberating in Chicago this weekend.

Corruption is a bad thing. It's time to root it out of Medscape, and the rest of medicine.

Thursday, June 12, 2008

Listen To NPR's Show on the Drug Industry

I recommend that you listen to this morning's NPR program, "On Point," with Tom Ashbrook, which featured an interview with Melody Peterson, author of the devastating new book, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. I was brought on toward the end of the program to participate in the discussion.

Melody Peterson is a former reporter for the New York Times, and she spent the last 4 years researching the pharmaceutical industry. Many of the revelations in the book will be quite familiar to those reading this blog, but her research is so extensive that it is worth reading. You can read an excerpt of the book here. And you can listen to the show here.

Tuesday, June 10, 2008

Where’s the Money? Harvard, MGH, and Money Laundering’s Perfect Storm

It will take us some time to figure out what went wrong at MGH’s Department of Child Psychiatry, but we already have enough data to make some reasonable conjectures.

It’s clear that Dr. Biederman, Wilens, and Spencer did not disclose the majority of their drug company payments to Harvard University. Their motivations were unclear. In yesterday’s posting, I proposed a kind and gentle possibility—namely, that they made honest mistakes, and really believed that most of the payments were not relevant to their NIH grants. Most of those who commented yesterday did not find this explanation exactly…shall we say…convincing. They may well be right.

As I have read more about this scandal, I think the more likely explanation is that these doctors felt embarrassed about accepting so much drug company money. On some level, they likely made conscious decisions to hide these payments. If true, this is a serious ethical breach, and all three of them may be in bigger trouble professionally than I originally thought.

As I’ve gone through the list of payments posted publically in the Congressional Record (click here and then type “Biederman” in the search box), it’s clear that the majority of money received by these doctors did not come directly from drug companies, but indirectly from various third party companies. And this is likely the key to the mystery of why the doctors assumed they could ethically hide these payments.

As I described last year in this New York Times op-ed, much of the continuing medical education (CME) industry in the United States is a legalized money laundering operation. Rather than paying doctors directly to give accredited CME courses (which is illegal), drug companies pay third party companies to create the courses. The checks are actually written by the education company, but the ultimate source is clearly the sponsoring pharmaceutical company. The drug industry has gravitated to this form of marketing because they realize that doctors are more likely to believe information in CME courses than information from drug reps.

The Harvard scandal represents the perfect storm of this money laundering operation. It appears that the vast majority of the money eventually reported by the Harvard Trio, a combined $4.2 million over 7 years, was drug company money that was laundered and processed to seem like it wasn't drug company money. And this, I suspect, is why it was so easy for the doctors to rationalize not disclosing it.

The most glaring example comes from Dr. Wilens disclosures. Senator Grassley posted slightly more than a third of Wilens’ payments ($612,303 out of a total of $1.6 million). Only $69,915 of this (11%) came directly from drug companies. Most of the money ($542,388) came from various third pary companies, many, possibly all of which, are CME companies.

Here’s the breakdown of Wilens’ indirect drug company payments:

1. TVG (p
harmaceutical marketing company): $42,000

2. J.B. Ashtin (m
edical communication company): $14,500

3. Phase 5
(marketing research and strategy company): $194,250

4. Medlearning (m
edical education communication company): $70,000

(Here is an example of a CME newsletter Wilens wrote for Medlearning)

5. Promedix/Advanced Health Media (s
peaker program management): $163,750

6. Primedia (former administrator of MGH Psychiatry Academy CME programs
): $32,000

7. Veritas Institute for Medical Education (m
edical education communication company): $25,388

None of this "soft" money was reported in Wilens' forms.

As a sad post-script, the Physician Payments Sunshine Act, a financial transparency bill which is likely to be passed by Congress, would allow essentially all such soft money to go unreported, because of a CME exemption tacked on to appease the pharmaceutical industry. It's likely that companies are already making plans to funnel even more of their promotional money through these opaque third party companies.

And so it goes....

Monday, June 9, 2008

Big Troubles at Mass General

The blogosphere is buzzing with the Sunday New York Times article by Gardiner Harris and Benedict Carey in which we learn that three child psychiatrists at MGH did not report most of the payments they received from drug companies on conflict of interest disclosures.

I have been reading the pertinent documents in the Congressional Record
in order to figure out whether these three psychiatrists, all of whom I know from my training days at MGH, behaved very badly or just a little badly. All three are highly intelligent and committed researchers. During my residency days, I received a few lectures from Dr. Wilens, and he is a good, solid person. I didn’t have as much contact with Dr. Biederman or Dr. Spencer.

The issue at hand is a little complicated, but here’s my understanding. Whenever a researcher is awarded money from the NIH (National Institutes of Health) to conduct research, the employing institution (in this case, Harvard) must obtain detailed conflict of interest disclosures from these researchers. After all, this is public money, and the NIH wants to make sure that our hard-earned tax dollars are being spent responsibly. There are two big rules that are relevant to this controversy. Rule One is that researchers cannot accept more than $20,000 in payments from a drug company whose drug they are funded by NIH to research. Rule Two is that they must disclose any payments of $10,000 or more that they have received from any drug company.

The most serious of Senator Grassley’s allegations (Grassley being the ranking member of the Senate Finance Committee) is that all three doctors broke Rule One. They all conducted NIH-funded studies of Eli Lilly’s Strattera (atomoxetine) for ADHD during years that they also received payments from Lilly—payments that exceeded the maximal payments permitted. If this is true, it represents a pretty significant breach in the integrity of the NIH funding process.

The other allegation is that the doctors chose to reveal only a fraction of all the money they actually received from drug companies. When Grassley and his aides looked over each doctor’s yearly disclosures, it appeared that they received no more than a combined few hundred thousand dollars over a seven year period. However, when the doctors were asked to look back over their financial records for the Senate Finance Committee, they suddenly discovered quite a few overlooked checks, to the tune of $1.6 million each for both Biederman and Wilens, and $1 million for Spencer.

I am inclined to give them the benefit of the doubt on this issue. I don’t think they hid these payments out of greed, sneakiness, or the thrill of getting away with something. They probably simply didn’t believe these earnings were relevant to the NIH funding they received. If you look at the charts detailing each doctor’s income in the Congressional Record, you can get a sense of why this might have occurred. Many of the large payments were not from drug companies directly but from third party medical education companies, with vague and uninformative names such as “Phase 5,” “MedLearning,” “Strategic Implications,” and “Primedia.”

For example, in 2005, Dr. Wilens received only $9500 directly from Eli Lilly, but $70,000 from “Promedix,” and $37,750 from “Advanced Health Media.”
A little googling reveals that Promedix is a division of Advanced Health Media, which in turn is a company that does “speaker program management.” So Wilens received a total of $107,750 for speaking programs, but the disclosure does not allow us to track things any more specifically. Who was he speaking for? Was this CME or promotional? How did this relate to his NIH funded research?

I’m willing to bet that most of this money came from Shire, because I have seen Wilens, Biederman, and Spencer headlining many Shire-supported CME programs on ADHD. (See here for some background).

So the psychology of non-disclosure may have gone something like this: “I’m doing NIH-funded research on an Eli Lilly drug, so I’d better be scrupulous about disclosing payments from Lilly. But the marketing work I’m doing for Shire is not relevant to my NIH research, and it’s indirect CME money anyway, so I won’t disclose that.”

A little sleazy? Maybe. Malevolent? I don’t think so.

The big lesson here is that Congress must pass the Physician Payment Sunshine Act, because we will never be able to grasp the extent of the complex financial relationships between companies and thought leaders without this legislation.

Tuesday, June 3, 2008

Unintended Silliness: Free Lunches get a New Cheerleader

The law banning pharmaceutical gifts to doctors continues to pick up steam, having already been passed by the Massachusetts State Senate, and now being considered in the House Ways and Means Committee. You can get a quick education on the issue by watching this NECN debate between myself and Harvard's Tom Stossel.

I recently learned about an unintended putative victim of this bill: companies that specialize in catering all those free lunches. Kevin Abt, CEO of Restaurants to You, has written this letter to his state representative complaining that not only will his business suffer, but that caterers state-wide will lose $40 million if the bill is passed.

The letter, along with 22 entertaining comments, is posted on the political blog Blue Mass Group, which bills itself as "reality based commentary on politics and policy in Massachusetts and around the nation."

Please go to this great site and read. Here are snippets from some of my favorite responses to Mr. Abt-the-caterer's concerns:

1. "Just because a drug rep isn't paying doesn't mean the doctors won't be eating lunch. This isn't going to be $40 million just disappearing from our economy. It's going to be shifted around some. I bet non-catering deli counters in the vicinity of hospitals will be thrilled to have the gift ban passed. I don't mean to be insensitive to the plight of Mr. Abt and other caterers who have made a business out of catering lunches between doctors and drug reps, but businesses are forced to adjust and adapt all the time for any number of reasons."

2. "So, let's not ban lunch-n-learns. In fact, there's no request to do so. Let's just let the doctors buy their own lunch. After all, at only $8-$20, it wouldn't be a burden on the doctor. Doctors gotta eat. So, it's not about, it's about who pays for This bill wouldn't allow the drug companies to buy the food for the doctors."

3. "By his logic doctors will just go hungry if they don't get free lunches from PhRMA companies. The doctors I know, including my wife, are getting their lunches from the small local restaurants he is claiming will lose money. Of course, the last thing this guy wants is for health care workers to walk to their local restaurants instead of eating catered lunches. More and more hospitals are banning such practices in any case, so whining about it to the legislature is probably not going to do all that much good in the long run."

I might add that Mr. Abt's pulled-out-of-the-air estimate of $40 million cuts both ways. From his point of view, it is $40 million lost from the pockets of a niche food business. But from the consumer's point of view it reminds us of the enormous scale of the pharmaceutical marketing endeavor. The drug industry was once considered an important engine of research and development. But the dirty little secret is that pharmaceutical companies spend more on promotion than on research--much more. The latest analysis, published in PLOS Medicine, estimates that in 2004, drug companies spent $31.5 billion on R & D, dwarfed by the $57.5 billion they spent on marketing and promotion.

I suggest the Mr. Abt begin marketing his tasty offerings directly to physicians--I doubt he'll go out of business.