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Thursday, August 6, 2009

ACRE Meeting: Welcome to Anger Village

Yesterday, I attended the charter meeting of ACRE (Association of Clinical Researchers and Educators) in Boston. The title of the conference was “Optimizing Value to Patient Care of Industry-Physician Collaboration,” and the schedule called for 23 speakers over a 6 hour period, all in a hot amphitheater crowded with pharmaceutical reps, doctors, reporters, and miscellaneous others.

Obviously, I arrived with a skeptic’s attitude. After all, I had already parodied the organization with this mock blog renaming ACRE “Academics Craving Reimbursement for Everything.” I was not alone in my difficulty taking the organization seriously. On the pharma gossip website, there was an even more vicious parody, in which the organization is renamed Forum for University Corporate Kickbacks in Education as Determined by University Professors, yielding a more colorful acronym which you can work out on your own.

Why is ACRE so very ripe for satire? Because it consists of rich doctors complaining that they want more money from drug companies, and such an organization lacks any inherent credibility, and seems, frankly, absurd. On the other hand, I like and respect the “two Toms” (Tom Stossel and Tom Sullivan) who formed the organization and I realize that there are some purer motives than greed operating here. That’s why I attended the meeting.

The whole experience felt very much like an anthropological expedition. I took Boston’s Green Line to Harvard’s Brigham and Women’s Hospital (where Dr. Stossel is an esteemed faculty member), a building so massive that the main hallway is called the “Pike.” I was directed by the information clerk to walk down the Pike and take “exit 6” to reach the Bornstein Amphitheater. I arrived 10 minutes late and encountered a small auditorium with steep rows of seats so crowded with pharmaceutical executives and physicians that people were sitting on the steps. I squeezed into a seat in the middle of a row that had been overlooked by the masses, and began my experience of the cultural village that is ACRE.

For the most part, what unreeled over the next 6 hours was an endless succession of smart, accomplished, and furious men (actually, there were three women—two of whom were patients).

Harvard’s dean, Jeffrey Flier, introduced the conference, but his comments must have been exceedingly short, because by 10:10 AM, Dr. Stossel was speaking. As I said, I’ve always liked Tom Stossel, even though we disagree about the value of industry’s use of physicians as marketers and educators. He’s always entertaining and creative. He’s the guy who hatched the evocative term “pharmascolds” to describe people like Senator Grassley and me and plenty others, and in this talk he called the current regulatory environment a “conflict of interest police state.” Though some paint Stossel as an extremist, he is not, and in fact made clear at the outset that the goal of ACRE is not to repeal the recent gift ban and disclosure law passed by the Massachusetts legislature. Rather, he wants ACRE to act as a forum for preventing further restrictions on industry-academic interactions which he feels would be detrimental to medical research and treatment. His heart is in the right place.

Unfortunately, after Stossel’s introductory remarks, the program devolved into a collective middle finger pointed at everybody viewed as the “enemy,” which included government, elite academics (yes, even though the conference was held at Harvard), bloggers, The New York Times, all medical journals, most lawyers, and then I began to lose count.

A major agenda of the speakers was to expunge the term “conflict of interest” from the English language. Dr. Lance Stell, professor of philosophy, said that since there is no “canonical” criteria to distinguish “undue COI” from regular COI, it would be better to just get rid of the term altogether. Other speakers, taking hints from the George W. Bush playbook (eg., it’s “climate change,” not “global warming”), introduced a series of substitutions for conflict of interest, such as “congruence of interests,” “overlapping interests,” “confluence of interests,” or, my favorite, simply “interests.”

It may seem comical, but something more serious than word-play was happening here. The defining problem with inappropriate industry influence in medicine, is, indeed conflicts of interest. When doctors are paid by drug companies to give talks, they are accepting two conflicting and competing incentives: first, deliver the carefully crafted marketing message provided by the drug company, or second, tell the entire truth, which may well include bad things about the drug. Except in rare cases, this ends up not being a convergence, an overlap, or a confluence—it is a conflict.

But industry “interests” were celebrated at this meeting. Culture shock really set in when
Dr. Michael Weber, a New York cardiologist with an Australian accent, described his industry ties by saying “I’m proud to say that my list of disclosures is longer than anyone else’s.” Everybody laughed. This was funny. This was clever. Subverting the “politically correct” value system of pharmascolds was a crowd-pleaser in ACRE Village.

Actually, Weber was wrong. University of Texas oncologist Avi Markowitz had him beat in the disclosure department. Markowitz also one-upped his colleagues in the sarcastic fury category. Sarcasm, anger, bitterness, and pride of massive industry involvement are popular emotions among ACRE-nauts. After dismissing the arguments of his critics as “inferential dribble,” Markowitz summarized the opposing side’s argument thusly: “Obviously, if you work with industry you’re evil.” One of his slides encapsulated the baseline attitude of most ACRE-nauts: “#1 Lie in Life: Hi! I’m from the government and I’m here to help you.”

But the eeriest presentation came from one J. Michael Gonzalez-Campoy, an endocrinologist who was flown out on the ACRE-jet from Minnesota. His job was to convince everybody that Minnesota’s 1993 physician payment disclosure law (the first in the nation) was an awful mistake. His tactic, theoretically, was a good one. “The law has been terrible for patients,” he declared, speaking in the ominous tones of a doctor notifying you of grim laboratory results.

“Oh boy,” I thought, pen poised, “finally, some data on the effects of transparency laws on patient outcomes.” But alas, Dr. Gonzalez-Campoy’s evidence base amounted to a single patient, a 73 year old man with severe diabetes. “Do you know what drug he was on?” He asked incredulously. “The cheapest drug money will buy—Glyburide….When I asked my patient why he was on that drug, I was appalled by his answer. He told me that his PCP said it is the most cost-effective drug.” It got worse: the patient had apparently been reading newspaper articles saying bad things about the newer diabetes drugs, like Avandia. The kicker was when he told Dr. Gonzalez-Campoy that “I’ve read that doctors are getting brain-washed by drug companies to prescribe these drugs.” Don’t you see what the Minnesota disclosure law has wrought? Patients getting prescribed generic medications. Patients reading the newspaper. Patients questioning the morals of their physicians.

“Please learn from our mistakes,” Dr. Gonzalez-Campoy, now impassioned, concluded. “Massachusetts should have asked us before they passed their law. They didn’t.”

Thank the Lord!

Tom Sullivan, who put together the event, sounded entertainingly like one of his blog postings—outraged, sarcastic, but with enough actual policy information to keep my attention. Boy, is Sullivan ever pissed at Senator Herb Kohl , who has just announced a senate hearing on industry funding of CME to be held next Wednesday. “Senator Kohl woke up one day last week,” he riffed, “and decided that his staff hadn’t done anything for a while, so he told them to get a hearing together.” I can see why Sullivan is threatened—industry-funded CME is his company Rockpointe’s bread and butter.

There are various awards to be given. Dr. Carey Kimmelstiel, an interventional cardiologist and a professor at my own medical school, Tufts, gets the award for whiny entitlement. His talk was about the value of industry-supported promotional talks. Among the benefits: You learn a lot when you give them, you can network with your colleagues, and your colleagues learn a lot from you. That’s true, but has nothing to do with industry support. It’s possible to give the same talks to colleagues and reap the same benefits without getting a drug company check. It’s actually part of the job of being a medical school professor. But this was merely the irrelevant portion of his talk. The whiny entitled part came when he showed us an email from Doug Drachman, a Mass General cardiologist who has been organizing quarterly meetings of Boston interventional cardiologists to talk about interesting cases. His email broke the bad news that because of the Massachusetts law banning industry from taking doctors out to fancy dinners, these meetings are being postponed. Dr. Kimmelstiel was outraged. Look at the unintended consequences of the gift ban law—now cardiologists can no longer meet with another. That’s rich. Interventional cardiologists are some of the highest salaried professionals in the world, and yet they refuse to pay for their own dinners four times a year? That’s why I call the organization Academics Craving Reimbursement for Everything.

Oddly, the best and most convincing presentation was also the shortest. Dr. Jeffrey Garber, chief of endocrinology at Harvard Vanguard, profiled the American Association of Clinical Endocrinologists, of which he is the president. He outlined all the good things the organization is doing to educate primary care doctors and the public about diabetes and thyroid disease, all of it funded by industry. His point was that without industry money his organization couldn’t do all these great things. Probably true, though there are other ways for doctors to learn this information, like grand rounds, journals, and meetings that they might have to pay for themselves.

Henry Black, the President of the American Society of Hypertension, basically made the same case as Garber, arguing that his entire organization would cease to exist without drug company money. Unfortunately, Dr. Black got the day’s award for the most mangled slide. In a tirade against a recent JAMA paper recommending that medical societies cease industry ties, he started insulting the individual authors, saying, essentially, that most of them are washed up has-beens. Unfortunately, he had Dr. James Scully listed as the “president of the Josiah Macy Foundation,” rather than his actual job, which is the executive director of the APA. I didn’t point it out, because he was just working up steam and was beginning to froth at the mouth.

It was the quintessential ACRE moment: fury, self-righteousness, and getting everything a little bit wrong.

Live Blogging the Senate Hearing on Industry-Funded CME

2:15-- Senator Al Franken: Proud that his state of Minnesota was the first to pass a disclosure law in 1993. However, transparency is not enough, because between 2002-2004 many millions were paid to physicians for marketing activities.

2:25-- Lew Morris, General Counsel, U.S. Department of Health and Human Services, Office of the Inspector General: We need more effective safeguards. The current environment allows drug companies to choose topics related to their products. We suggest independent CME grant organizations. They would serve as firewalls between donors and the education. It's not clear that companies will go along with this.

2:30-- Dr. Steven Nissen, Chair, Cleveland Clinic Department of Cardiovascular Medicine:
CME has become an insidious vehicle for the promotion of medical products. This is undermining the independence of medical societies. Current ACCME oversight is ineffective. Few if any communication companies have lost their accreditation for biased CME. He has written letters of complaint about some activities to ACCME but he received no response.

2:35-- Dr. Eric Campbell, Associate Professor and Director of Research, Institute of Health Policy, Massachusetts General Hospital, Harvard Medical School:
The members of the Institute of Medicine Committee generally agreed that CME has become far too reliant on industry funding. The current system of funding is unacceptable. More transparency is necessary.

2:40-- Jack Rusley, Chair, Culture of Medicine Action Committee, American Medical Student Association; Student, Brown University Alpert School of Medicine:
AMSA has been a leader in the movement to clean up conflicts of interest. Students are able to be passionate advocates for patient care, since they are not already tangled up in payments from industry. He talked about the Harvard Medical student's rally to improve its COI policy. Harvard had received an "F" on AMSA scorecard in past but due to recent changes now earns a "B".

3:00-- Dr. Thomas Stossel, Director, Translational Medicine Division and Senior Physician, Hematology Division, Brigham & Women’s Hospital; Leadership, Association of Clinical Researchers and Educators (ACRE):
Medicine is much better now than when he started training. Death rates from cancer and heart disease are lower. We have a great system of innovation and education. There has been a lot of moral bullying, but not a lot of evidence. Do patients benefit from physician industry collaboration? Definitely.

3:05-- Dr. James Scully, Medical Director and CEO, American Psychiatric Association (APA):
We do need to support continuing innovation in medicine. But patients need to be able to rely on the objectivity of their physicians. The APA has decided to phase out all industry-supported medical education symposia. We are the first medical society to do this. This will cost us a million and a half dollars this year. But we feel it is well worth the cost.

3:10-- Dr. Murray Kopelow, President, Accreditation Council for Continuing Medical Education:
ACCME is the firewall between promotion and education. 15% of providers receive 80% of commercial support. He recounted many proposals to limit promotional influence, but said that none of them have been implemented yet. We are improving our surveillance of CME activities. We are increasing our staff.

Did Drug Company Gifts Kill the Gift Ban?

In April, the Massachusetts State Senate passed a total ban on all drug company gifts to physicians (see my post here). Spearheaded by Senate President Therese Murray and supported by many others, the ban appeared certain to be approved in some form by the House, and Massachusetts could have bragged about taking the hardest line of any state against this form of legalized bribery.

But in what must go down as one of the greatest ironies in political history, the legislators visited BIO 2008, a massive Biotech conference in San Diego and one of the last of the great dug company swagfests--and now even Senator Murray wonders whether gifts might be necessary for good medicine. According the the State News Service, covered here in the Policy and Medicine Blog, Senator Murray said researchers in San Diego told her the ban would prevent productive interactions between doctors and researchers who are trying to treat the same diseases. “It’s something that we didn’t discuss when we did it, because we were looking purely at gifts to doctors,” Murray said in a telephone interview with the News Service. “But the fact is that some of these companies do bring researchers and doctors together to go over the latest research.”

Wow. Something happened at the convention to hoodwink our finest legislators into believing that doctors can't learn about research without being given free lunches. I didn't attend BIO 2008, but my colleague Harry Tracy did. Dr. Tracy is the writer and publisher of NeuroInvestment, quite possibly the best single source of cutting edge information for those investing in the pharmaceutical industry. Here is his review of BIO 2008, reprinted with his permission from his latest newsletter:

“At the BIO International Convention, 24,000 attendees had the opportunity to watch companies who were limited to fifteen minute sound bites, and much of the fun was to be had in the Exhibits area, where various companies, countries, and municipalities handed out tapas, wine, single-malt scotch, novelty pens, and miniature stuffed koalas, while holding raffles for everything from laptops to trips to London. Indeed, the local paper of record, the San Diego Union-Tribune, devoted a high-profile article to the bounty of "swag" available to attendees. Apparently they overlooked the gift available at the State of New Hampshire booth, which was a plastic band-aid dispenser. While we will treasure ours forever, this stretches the definition of "swag" beyond recognition. But these silly 'Freebies' are just a minor symptom of a larger problem with public relations and perception. San Diego, as it does for other large conventions, literally walled off for an afternoon and evening a five block section of the Gaslamp District, for a BIO-only party. There were three soundstages and seemingly acres of free food laid out for the occasionally semi-intoxicated revelers. Of course, those without a BIO badge were not allowed in, the party was only for "VIP's." As much as NI enjoys VIP treatment, there was something unsettling about seeing the excluded public peering over the barriers at the party-goers. At a time when the pharma industry is widely perceived as concerned with profit rather than with patient care, at a time that the industry is under siege by the Charles Grassley's of the world who believe that the industry deserves to be taken down a notch, this seems unwise. It is probably naive to think that the industry will police its excesses, but if it does not, its losses in the court of public opinion will continue to mount, and few in the audience will protest when the guillotines are brought out.”

I don't mean to imply that Senator Murray, or any other legislators, accepted any of these freebies in San Diego. But there's no question that they allowed their opinions to be influenced in a carnival of swag. Meanwhile, BIO 2008 has announced that Massachusetts Deval Patrick is their "Governor of the Year" on the strength of his support for a $1 billion Life Sciences initiative. I assume they will honor the Massachusetts Legislature with a similar award, depending on the outcome of the vote on S 2660.

Ghostwriting for Premarin: Steroids on Steroids

Today's New York Times reveals the not particularly astonishing fact that Wyeth Pharmaceuticals engaged a medical writing company to produce 26 articles pushing Premarin as Hormone Replacement Therapy (HRT) in women from 1998-2005. The articles were outlined and written by writers employed by Design Write, and then were sent to top academics in the Ob/Gyn field, who reviewed them, rubber stamped them with occasionally minor edits, and submitted them to journals under their names. In no case was Wyeth's involvement in funding the articles disclosed.



We've heard this sordid tale before. Last year, an article in JAMA revealed that Merck commissioned ghostwriters to produce dozens of articles pushing Vioxx (see the NY Times coverage here--you'd need a subscription to JAMA to read the original paper by Joseph Ross); Eli Lilly paid ghostwriters to push Zyprexa; and Pfizer-funded ghostwriters generated the majority of articles about Zoloft in the late 1990s, according to the British Journal of Psychiatry.

What to make of all this? The best analysis I've heard yet was provided by Dr. Joseph Ross of Mt. Sinai Hospital in New York, who was quoted in today's paper:

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

In this case, since Premarin is a steroid, Wyeth put its own steroids on steroids. As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company's version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it's a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It's essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.

As the New York Times article says, some journals now require that all authors detail precisely who wrote what and who was paid by whom before considering manuscripts. It is time for all journals to institute this policy. In addition, several academic medical centers now forbid their faculty from engaging in ghostwriting, a trend that will continue.
As I've said before, it would be nice if those who are caught with their hands in the cookie jar would have the courage to apologize. But nobody involved in this latest scandal is willing to so. Design Write, the company that did Wyeth's dirty work, said that:

[the company ] “has not, and will not, participate in the publication of any material in which it does not have complete confidence in the scientific validity of the content, based upon the best available data.”

Dr. Gloria Bachmann, a professor of Ob/Gyn who rubber stamped an article pushing Premarin for hot flashes and other symptoms, said:

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”

And Wyeth's spokesman said that "the articles on hormone therapy were scientifically sound and subjected to rigorous review by outside experts on behalf of the medical journals that published them."

Actually, the proper collective response from all of these participants should have been: "We sincerely apologize for having deceived the medical community by engaging in ghostwriting without disclosure. We have contributed to the erosion of the public's trust in medicine, and we regret it."

How You Can Help the Louisville Free Public Library Recover from Disaster

I don’t usually blog about libraries here, but the Louisville Free Public Library needs our help – Louisville, KY received about 6″ of rain in 3 hours this week, creating a flash flood situation that filled their Main Library with sewage-contaminated water. Early estimates are that damages are in the $1 million range for the main branch, with approximately 10,000 items (books, audiobooks, and the like) lost. The servers flooded; the bookmobiles flooded; the processing room where the new materials live flooded; 40 new computers for a branch library are gone, as are countless other items. In a time when libraries all over the country are cutting staff, salaries, hours, and purchases because of the economy, I imagine that recovery at LFPL is going to be a long and painful process.

To understand the extent of the damage, you really need to see the photos. The one to the left (click to embiggen for full effect) made me tear up a little yesterday. Here you can see one library staffer’s office – that’s the doorknob just above the water line. This one shocked even the non-librarian spouse. This one, from this morning, reminds us that even when the water starts to subside, there is a whole lot of damage to deal with and materials that are simply unsalvageable.

In the face of all of this bad news for LFPL, the good news is that there are ways for us to help.