Monday, September 29, 2008
Medtronic manufactures, among other things, various spinal devices, and spared no expense in bribing neurosurgeons to use its products in spinal surgery cases. The suit alleges that neurosurgeons such as Jeffrey Wang, now director of the Universityof California at Los Angeles's Comprehensive Spine Center, were taken to Memphis’s Platinum Plus strip club, which was eventually shut down because it ran a whore-house. Dr. Wang denies such trips.
Another surgeon named in the suit is Hallett Mathews. According to a former Medtronic attorney, Dr. Mathews was paid $450,000 a year under a sham“consulting agreement.” Apparently, Dr. Mathews brought so much money into the company by using its spinal devices that he was given a Medtronic credit card. Bribery is much easier when you cut out the middle man.
Then there were the Alaskan “think tank” trips. Here’s how these are alleged to have worked. First, Memphis neurosurgeon Maurice Smith was given a pre-paid 10 year “consulting” contract. His job duties had little to do with helping patients, however. Instead, he specialized in planning annual all-expenses-paid trips to Alaska. The doctors were supposed to present case studies during the trips but evidently they were too busy enjoying themselves to bother with such niceties. According the Journal:
Ms. Kelley [the former Medtronic attorney] alleges Medtronic sent physicians on lavish trips under the guise of medical conferences, but where little work was done. Her complaint claims that on a five-day, all-expenses-paid trip to Alaska in 2001, which was billed as a "think tank," doctors were supposed to present case studies. But, according to the complaint, little discussion of the case studies took place. One doctor scheduled to give a talk stood before the group, "said he was sorry, but he had not prepared anything," and "drinking then commenced in place of discussion," Ms. Kelley said in the suit. Medtronic picked up the cost of fishing guides and clothing for the doctors, the suit said. It said "women were also provided for the doctors," but didn't elaborate.
Evidently, spinal surgeons were partial to New Orleans, and Medtronic was happy to let the good times roll during Mardi Gras:
At a Medtronic-sponsored "discussion group" in New Orleans, according to the complaint, the company paid $20,000 to $25,000 to get a group of doctors on a Mardi Gras parade float and another $15,000 to supply doctors with Mardi Gras beads.
In this embarrassing statement responding to the article, Medtronic begins by scolding the Wall Street Journal for reporting the allegations, which were supposed to have remained hidden from the public in a “sealed” lawsuit. Then, they refuse to admit any wrongdoing, saying only that “allegations of inappropriate business practices described in the article are said to have occurred years ago.” Then, they assure us that “the company has put more rigorous systems and processes in place to assure alignment with these standards, identify any break from standards, and address behavior that is in violation.” But if they had done nothing wrong, why did they have to beef up their internal reviews? They don’t get around to answering this question in their statement.
Wednesday, September 24, 2008
This is the latest in a series of Eli Lilly firsts in transparency. They were the first company to disclose their educational grants, and the first to endorse the Physicians Payments Sunshine Act. This is all good stuff.
So why do I say Eli Lilly is "ethically confused"? Because they still shamelessly participate in marketing deception. They hid risks of Zyprexa from doctors long after they knew about them, and still deny that this was wrong. They continue to fund a malpractice insurance company, PRMS, to provide sham risk management education to psychiatrists in an effort to prevent them from switching patients to less toxic antipsychotics. In this particularly ugly marketing tactic, they are paying attorneys to do their "education," payments which would remain hidden even under their new disclosure policy.
So, to borrow a phrase from Merrill Goozner's Integrity in Science Project, Lilly deserves both cheers and jeers for their efforts to reform themselves.
Monday, September 22, 2008
While the finding may sound bland, such are the stakes in the epic drama accompanying the dying breaths of industry-funded CME that the Cervero and He non-conclusion is being used by MECCs (and by some misguided medical societies) as ammunition in their fight for the money. For example, you'll find the Cervero paper featured in letters to ACCME from both NAAMECC and AAFP (American Academy of Family Practice).
But Cervero’s sleepy conclusion is actually fraught with its own drama. Because if you were to read the original articles upon which this conclusion is based, you’ll find that this conclusion is wrong—and not just a little wrong. It is so far off the mark that one wonders if they made some sort of MS Word error, and accidentally pasted in the conclusion from an entirely different paper.
I don’t know much about the authors, but they appear to be well regarded academics in the world of continuing education. I assume they take no money from drug companies or their surrogates, although I haven’t done any serious investigating. I’ll give ACCME the benefit of the doubt here, imagining that it would be highly embarrassing if these authors had some undisclosed conflicts of interest.
Here’s what I assume has happened here. Cervero and He realized very quickly that this is no ordinary literature review. Not to be overly dramatic, but this is a $1.2 billion paper, the project of their lives.
If they had concluded what they should have concluded—namely, that the evidence is overwhelming that industry funding biases CME—they would have been responsible for the immediate disappearance of commercial CME.
Who can blame them for having treated each paper they reviewed as though it were ticking with radioactivity. Don’t get overly involved. Keep your distance. Be very, very cautious.
In this post, I’ll begin the slow and excruciating process of deconstructing the Cervero and He review. No fancy footwork here. I’ll simply plod through each the 10 studies they reviewed so that readers can make up their own minds.
First, the authors searched Medline and other databases for articles relating to commercial funding of CME. They identified 2000 potential articles, but rejected most of them because they were either not directly related to CME or did not discuss original data, which is fair enough. They ended up with 10 papers.
They begin their review with the famous paper by Wazana published in JAMA in 2000 entitled: “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" Wazana reviewed 29 studies of industry/physician interaction (two of which focused exclusively on accredited CME), and concluded that in most cases these interactions led doctors to favor the sponsor's drug, even when it posed no advantages. Wazana concluded that: “The present extent of physician-industry interactions appears to affect prescribing and professional behavior and should be further addressed at the level of policy and education.”
Wazana provides a tsunami of evidence that commercial bias affects how doctors make clinical decisions, both in CME and other settings. But Cervero and He see this rather differently: “An important point is that none of the 29 studies used patient outcome measures, and therefore there is no evidence about the positive or negative impact of the prescribing practice changes.”
But wait a minute! ACCME didn’t ask the authors to assess whether industry funding harms patients, they asked them to “analyze the research literature about the relationship between commercial support and bias in CME.” Which is exactly how they start, by reviewing Wazana. But once it is clear that Wazana demonstrates bias, Cervero and He revise their mission by raising the bar. Now they are saying, essentially: “Okay, we’ll concede your point that commercial CME is biased, but that’s not the real issue. The crucial issue is whether the bias harms patients, and none of your 29 articles have shown that.”
How unfair is that? It reminds me of a technique often used in industry-funded CME articles: when the data begins to imply a positive conclusion for your competitor, you shift the emphasis to a different outcome variable.
But okay, let’s play along here a bit, because this is a favorite argument of industry CME defenders: "It’s one thing to demonstrate bias, but unless you can show that this leads directly to doctors making bad decisions that harm patients, you have no argument."
Why is this absurd? Because if lack of demonstrated patient harm constituted ACCME’s criteria for accreditation, every drug advertisement in every medical journal would potentially qualify as a CME activity. Drug ads are biased—nobody would argue this point. But they do provide accurate information. And they have never been shown to lead to patient harm. So why not accredit drug ads?
Accredited medical education is “accredited” precisely because it is held to a higher standard than drug promotion. That standard is lack of bias, and not lack of patient harm.
Of course nobody has shown that drug ads or CME events have actually harmed a patient. Why? Because it’s an impossible study to do.
Here’s what would be required. Enroll 1,000 physicians into a study in which half of them are randomized to industry-sponsored CME and half to independent CME. Their patients, of course, would have to be enrolled as well, because the outcome of interest is patient harm.
Imagine that a researcher presents you with papers to sign, and gives you the following disclosure: “This is a study to see if patients whose doctors are educated by drug companies will have more or less heart attacks than patients whose doctors pay for their own education. Your doctor will be randomly assigned to either drug company sponsored education or independent education. Neither you nor your doctor will know which group you are assigned to. You will receive free care for the duration of the study.”
Not only would this be an impossible study to recruit for, but no institutional review board (IRB) on the face of the earth would approve it. Why? Because they would rightly maintain that the goal of this study—to decide whether industry should continue to fund medical education—is not worth the potential danger to patients.
Next post: Cervero’s take on the Bowman and Pearle study…or, “so what if a CME course made Diltiazem number one…what’s wrong with that?”
Thursday, September 18, 2008
Apparently you are the only pure one left on the planet. You have no biases or opinions that color your judgment or clinical practice. And of course your opinion about the negative pharmaceutical industry's impact on research -- none of which can be demonstrated through the traditional scientific methods but only appeals to emotion -- are right and everyone else is wrong. But that's not bias. Apart from the fact that the Sourcewatch material is three years old and outdated (which means you didn't even bother to check the facts since our 990 is readily available) you don't even have the intellectual or moral courage to engage on the merits of the issue CME or more generally the relationship between industry and academia. Rather, you resort to the oldest rhetorical trick in the book: attacking the character or motives of a person who has stated an idea, rather than the idea itself. That's the sign of a bully and a coward. If you had any integrity or guts at all you would show up at our session (the very thought of it must give be keeping you up nights!!) engage in reasoned discussion. But I doubt you will.
In this response, Mr. Goldberg demonstrates exactly why his organization and his blog have become notorious for perfecting the art of personal-attack-as-policy-discussion. Those who want to find example after example of Mr. Goldberg's and Mr. Pitt's inimitable rhetorical style should read this expose recently published in opednews.com.
Some of their pit bull (sans lipstick) pronouncements:
--"Sidney Wolfe, Public Citizen’s General Secretary of Junk Science..."
--"Not the real FDA - a Grahamatization" (referring the David Graham, the FDA analyst who revealed the extent of the Vioxx health risks)
--"That's the sign of a bully and a coward," describing me. We've descended to that level of name-calling now?
If Mr. Goldberg would like to engage in the merits of the CME discussion, he merely has to read dozens of my prior postings, in which I comment ad nauseum on the innumerable developments, debates, and policy pronouncements in the world of CME. If he would like concrete examples of commercially biased CME, I have provided them in spades.
Unlike the speakers at his conference, I don't have Fortune 500 companies standing in line ready to pony up for a trip to Washington D.C. at a moment's notice. If CMPI really wanted to engage in an "evidence-based" discussion, they would have invited speakers with alternative points of view, but they didn't, and because of that, the conference is a charade and is merely an opportunity for networking among those who profit mightily from industry-sponsored CME.
Wednesday, September 17, 2008
That reactionary unthink tank, Center for Medicine in the Public Interest (CMPI), is sponsoring what they are calling an "Evidence-Based Evaluation" of industry support of continuing medical eduation. You can view their invitation here.
For those who have not yet learned about CMPI, go to Sourcewatch for as much information about them as you can stomach. Essentially, they are a front group for the pharmaceutical industry, the CME industry, and whatever other stakeholding company is willing to fund them according to this menu of donating options. For example, $10,000 buys you a "corporate sponsorship" and up to four meals with "CMPI research scholars," $25,000 nets you a seat in the "Chairman's Circle" and an invitation to a "summit," and big spenders can go whole hog with a $100,000 membership in the "President's Club," and a "personal briefing."
Joining with this den of integrity will be none other than George Lundberg, M.D., editor-in-chief of Medscape. Dr. Lundberg embarrassed Medscape and the entire medical community recently with this video editorial in which he responded to the CME concerns of the nation's top medical organizations by saying: "We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”
Other participants, all of whom will examine the issue from a balanced and "evidence-based" perspective, are:
--Roger Meyer, MD, listed on the brochure as "Clinical Professor of Psychiatry at Georgetown University and Adjunct Professor of Psychiatry at the University of Pennsylvania." Unfortunately, there just wasn't room to disclose the fact that he is actually the CEO of a company called Best Practice, which helps companies market their drugs via CME and provides a roster of "key opinion leaders" for hire.
I've only scratched the surface here, folks. There are many more speakers scheduled, all of whom are similarly dispassionate observers of the CME scene, and are equally scrupulous in their disclosures.
If you do go, I have a word of advice. Be careful around the speakers. Dinosaurs bite.
Monday, September 15, 2008
When Claire, a pixie-faced 6-year-old in a school uniform, heard her older brother, James, enter the family’s Manhattan apartment, she shut her bedroom door and began barricading it so swiftly and methodically that at first I didn’t understand what she was doing. She slid a basket of toys in front of the closed door, then added a wagon and a stroller laden with dolls. She hugged a small stuffed Pegasus to her chest. “Pega always protects me,” she said softly. “Pega, guard the door.”
Claire, of course, is not the patient. Her brother James, age 10, is. And one of the underappreciated ravages of pediatric bipolar is the effect these children have on their younger siblings, who learn to do what they can to protect themselves from unpredictable rages.
Egan is a journalist and a novelist who spent several months following different families with children who have received the bipolar diagnosis. While acknowledging that the diagnosis is over-used, she makes it abundantly clear that these children are not normal, and tend to be “wildly, explosively angry.” For example, 7 year old Joe’s mother describes a tantrum at Walmart, when she refused to buy him a video game, that “resulted in her having to sit on Joe in an aisle until store employees could help her wrestle him into the car… A recent rampage at school concluded with a 20-minute physical fight with a police officer….”
In describing some of the children’s evaluations at the University of Pittsburgh bipolar clinic, we are reminded how difficult it is to tease out ADHD from bipolar disorder, since three of the seven criteria for mania are also criteria for ADHD: distractibility, activity increase and talkativeness. Egan interviews Gabrielle Carlson, the director of child and adolescent psychiatry at the Stony Brook University School of Medicine, who uses the apt phrase “diagnostically homeless,” to describe these extremely troubled kids who don’t quite fit known categories. She believes that that it’s crucial to come up with a clear diagnosis, although it’s not clear to me that she makes a strong case. Regardless of the diagnosis, out of control kids end up getting the same meds to protect themselves and others around them.
The article is long but keeps your interest. You’ll get a family’s eye view of what it’s like to live with these children, and you’ll understand why these kids end up rotating through a laundry list of medications.
In her concluding comments, Egan focuses too much on the kindling theory of bipolar disorder, a worn-out hypothesis which I put in the category of wishful thinking. Yes, it would be nice if bipolar disorder turned out to be a kind of epilepsy of psychiatry, preventable with early anticonvulsant meds. But the evidence is indirect and inconsistent, which even the father of the kindling theory, Robert Post, acknowledges.
I can’t blame her—it’s best to end an article on a hopeful note. Unfortunately, the science is still in its infancy, and we have to muddle through, guessing as we go, hoping that we’ll fall into an answer someday.
Friday, September 12, 2008
But it gets even worse for the reputation of cardiologists. In another recent issue of the Journal of the American College of Cardiology, the president of the ACC, W. Douglas Weaver, wrote a clone of Dr. Demaria's editorial called "Disclosures, Transparency, and Firewalls Protect Integrity." But guess who forgot to disclose his own conflicts of interest? Poor form, Mr. President.
By the way, cardiologists pull in an average of $270,000/year. But according to Dr. Demaria, they are still too poor to pay for their own education: "In addition, it is not clear how or if the financial support for CME provided by industry could be replaced. Without these funds, important opportunities to increase knowledge might be unavailable to busy clinicians, thereby denying their patients the benefits of this learning."
A bake sale for cardiologists, anyone?
Wednesday, September 10, 2008
“Persons paid to create, or present, promotional materials on behalf of commercial interests cannot control the content of accredited continuing medical education on that same content.”
ACCME had been hearing about situations in which medical writers were paid to write promotional material for drug companies, and then were hired by MECCs to write CME for the same companies. In addition, often physicians are on speakers bureaus and advisory boards and are then also allowed to deliver CME content funded by the same companies. Obviously, this defeats the purpose of the firewall between CME and marketing. A firewall is essentially worthless if writers are allowed to shuttle back and forth between marketing and CME.
With this new policy, ACCME is saying to doctors: “If you want to be on speakers bureaus and advisory boards of drug companies, that’s fine. But you can’t double dip. You can’t then also get paid by the CME companies that are taking grants from those same companies.”
Of course this is a necessary policy, and many readers will find it amazing that this loophole even exists.
The ACCME has its heart in the right place, but is in an impossible situation. Its mission is to make sure continuing medical education leads to improvements in patient care that reflect the best medical science. But once the drug industry discovered ways to produce CME via the strategy of funding third party companies to do their bidding, ACCME became involved in a futile struggle against the inexorable logic of the market. When a system is structured to allow huge financial incentives to create biased education, the education will, in fact, become biased.
Nonetheless, over the past 15 years or so, ACCME has been gamely trying to swim against this current and has instituted progressively stricter versions of its Standards for Commercial Support. First, they required disclosure of industry ties. But this didn’t change the bias, and may have simply whitewashed the process. After this requirement, industry funding of CME skyrocketed.
Then, seeing that simply disclosing conflicts of interest did nothing to stem the tide of industry bias, they required that companies institute systems for identifying and neutralizing that bias. But the only thing that got neutralized was this new Standard. Companies gamed the system by using their drug company grants to hire “independent reviewers” who didn’t have ties to industry. These reviewers’ job description was to sign a form stating that every industry-funded CME activity crossing their desk was “fair balanced.” The bias continued, and industry funding grew some more.
Next, ACCME told MECCs that they could no longer get any advice from drug companies about topics or speakers to use. This didn’t affect anything, because MECCs don’t need to hear from sponsoring companies to figure out what topics they are interested in funding, or which speakers can be counted on to say good things about their products. There’s this new thing out called “Google” that allows MECCs to learn all this information on their own.
The latest proposal—no more double-dipping—is simply ACCME’s latest efforts to slap some duct tape over the porous firewall between MECCs and industry. Who could possibly argue against this? The MECCs are, and, once again, are making themselves look very bad in the process.
Among the various specious arguments I’ve heard against this policy, the most astonishing is the censorship argument. By forbidding doctors on company speakers bureaus from writing accredited CME, so the argument goes, ACCME is “censoring” them. At Policy and Medicine, for example, Tom Sullivan, president of the MECC Rockpointe, says that “banning certain authors from writing books and giving talks doesn't seem to accord with freedom of speech, but that is exactly what the ACCME is proposing.”
Come on folks. Let’s get real. ACCME is not preventing anybody from saying or writing anything they want, anywhere, at any time. They are simply withholding a lucrative seal of approval from speech that does not meet their requirements. When Good Housekeeping Magazine withholds its seal of approval from a shoddy product, they are not preventing the company from making it. The shoddy product can still be sold; the company just can’t use the seal to market the product.
Similarly, ACCME is saying that medical communication produced by people who take marketing money from drug companies no longer meets its standards for high quality CME, and it will no longer accredit such communication. MECCs are still free to provide it, print it, circulate it in conferences, but it won’t be accredited information. How is this “censorship?”
The real issue is whether the new rule will have any effect on commercial bias in CME. I’m skeptical, if only because MECCs have shown themselves so adept at coming up with regulation work-arounds in the past. They will presumably have to groom a new generation of writers and speakers who have not taken money directly from industry. That’s not hard to do. All it takes is a lot of money and a little patience.
Clearly, the only real solution is to end commercial support for CME, and ACCME is actually requesting comments on this very proposal. Who knows? Maybe they are finally tired of participating in this perennial dance of making rules that can’t stick. Only Murray Kopelow knows for sure!
Monday, September 8, 2008
But a steady drumbeat of research is showing that free samples are ultimately more expensive, and may even be unhealthy. The current issue of the Southern Medical Journal reports that free samples actually cost patients more in the long run, because they encourage doctors to prescribe more expensive drugs. Researchers tracked the prescriptions written by 70 doctors in a large internal medicine practice. During the first 9 months of the study, doctors had access to free samples, but halfway through the study period, the medical offices moved to a different building, resulting in the sample closet being closed for 9 months. This provided an ideal accidental experiment for seeing whether samples lead doctors to prescribe more expensive brand name drugs. In fact, during the first 9 months, only 12% of prescriptions were for generic drugs. But during the 9 month sample-free period, prescriptions for cheaper and therapeutically equivalent generics nearly tripled to 30%.
Those who argue that the doctors prescribing brand name drugs were providing more modern and therefore better care would do well to read this study from 2002, which showed that uninsured patients who were given free samples of blood pressure medications had higher blood pressures than patients who did not receive free samples, implying that use of free samples leads to suboptimal treatment.
In fact, the popular notion that samples are given primarily to uninsured patients is untrue, according to an article published recently in the American Journal of Public Health. Researchers analyzed data from a nationally representative sample of 32,681 US residents, and found that the poorest third of respondents were less likely to receive free samples than were those with incomes at 400% of the federal poverty level or higher.
The data are clear. Free samples are simply another marketing tool for drug companies. I guess it's time for me to empty out my sample closet!
Wednesday, September 3, 2008
Relman concludes with the following eloquent call for an end to industry involvement in accredited medical education:
"It is time for the leadership of the medical profession to make clear to an increasingly skeptical public that physicians, and not the pharmaceutical industry, are in charge of the education of physicians. There is an evident and very important distinction between accredited professional education and the information about new drug products the pharmaceutical industry distributes to physicians for marketing purposes. The responsibility for medical education should be entirely in the hands of the medical profession and funding should not compromise, or even call into question, the integrity and independence of what is taught or of the physicians who teach. Marketing drugs, on the other hand, is industry's job. Industry likes to call this education but it is not. It is marketing.
Some firms may want to assist the medical profession with educational programs in areas not directly related to drugs. However well-intentioned, that would be unwise. The public relies on the medical profession to evaluate the products that industry wants to sell, so the profession should not be beholden to industry for any reason. To be trusted, medicine must be free of all such dependency; it should be accountable only to the society it serves and to its own professional standards.
Industry and the medical teaching institutions should each recognize their separate and distinct responsibilities, and should not encroach on the other's sphere. Properly regulated cooperation between the 2 in research sometimes furthers the public interest by advancing medical progress, but the medical academy and its salaried staff do not belong in pharmaceutical marketing any more than the pharmaceutical industry belongs in medical education. More respect for this distinction by both the academy and industry would lead to healthier and more honest relationships between the 2, and there would be fewer embarrassing ethical missteps and boundary violations, which have been undermining public trust and lowering the reputation of both the pharmaceutical industry and the medical profession."
Tuesday, September 2, 2008
For some rather evil fun, check out Mail Order Academics.
Then, learn all about that new epidemic, Motivational Deficit Syndrome.
After your laughs, get down to some serious debate about industry sponsorship of medical education in this issue of British Medical Journal.
Finally, sober up completely by realizing how utterly deceptive were the pharmacetical industry's arguments against the Massachusetts gift ban and disclosure law. In today's Boston Globe, we read that three more life science companies have announced major expansions in the state. This puts the lie to the claims by industry during its lobbying campaign that the bill would have a "chilling effect" on the life sciences industry in the state. Particularly unsavory was GlaxoSmithKline's blackmailing letter. Other states are considering similar legislation, and legislators there can rest assured that drug companies are able to do business without resorting to bribing physicians with mugs and hiding the details of their payments to hired guns.