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Archive for the ‘Academic Medical Centers’ Category

In the headlines: the Sunshine treatment, payments to academics

Wednesday, November 4th, 2009

Two stories in the New York Times today look at the payments made to physicians by the pharmaceutical and medical device industry, and what provisions in the health care reform bills might do to illuminate those ties.  The Times notes AdvaMed’s support for the Senate bill.

Using Eli Lilly’s court-ordered faculty registry, the Times focuses on an adjunct professor of psychiatry at Stanford University, Dr. Manoj Waikar, who participates in advisory roles and speakers’ bureaus of four major drug companies. At fifty-one speaking events and nearly $75,000, Dr. Waikar was one of Lilly’s top five earners in the first quarter of this year.

Some universities, including Stanford, prohibit such arrangements because of their marketing-based aims (physicians use drug company-proffered slides), but such limits often extend  only to full-time faculty, leaving adjuncts such as Dr. Waikar to serve multiple industry interests.

The WSJ Healthblog goes to a new Health Affairs article for a little perspective on the situation:

“Sometimes it seems like everybody has financial ties to the drug or device industry,” writes the Healthblog’s Jacob Goldstein. “As it turns out, it’s only a little more than half of everybody,” pointing to a new survey in Health Affairs that found 53 percent of life sciences academic research faculty had relationships with industry. The survey found that clinical researchers were significantly more likely to receive industry funding than non-clinical researchers.

So what’s a top school? The survey, conducted in 2007, was mailed to more than 3000 researchers at the 50 U.S. universities that receive the most funding from the National Institutes of Health, a common metric used to measure research status.

–Kate Petersen, PostScript blogger

Disclosure of research payments: One step forward, two steps back?

Tuesday, February 10th, 2009

Pfizer announced today that it will begin to disclose payments made to physicians in a public online database beginning in the first half of 2010. Not only does this signal another Big (+ Wyeth = Bigger!) Pharma player hopping on the voluntary disclosure train, it would be the first company to post such information including payments to PIs of clinical trials.

Even though Pfizer is proposing a higher reporting threshold of $500, which would miss out on a healthy portion of payments like meals, the move takes more wind out of the already drooping sail of an argument the industry is hammering Massachusetts regulators with: that disclosure of clinical trial payments is Fatal to Business (especially, to hear them tell it, the Massachusetts Convention Industry).

It’s worth remembering Eli Lilly already discloses consulting and advisory payments on its website, and had pledged to widen that disclosure to match the Physician Payments Sunshine Act by 2011 (go here to read about other company promises) – so it could be said that Pfizer’s announcement is a case of the Great One-Up. But coming now – as Massachusetts Dept. of Public Health continues to come under industry fire for drafting regs that would require companies to do as Pfizer is doing – the move is significant.

As Newton’s First Law of News requires, the wires also brought this not-so-great report out of Minnesota indicating that the ethics chair and outgoing dean of the University of Minnesota Medical School, Dr. Deborah Powell, has significantly weakened recommendations by her own conflict of interest reform committee, which handed in a bold and comprehensive draft COI policy earlier this academic year.

According to the Minnesota Daily, which received a copy of the unreleased draft, “key elements of the task force’s recommendations, believed by some to be among the most needed changes, are notably absent from Powell’s draft, among them a recommendation to sever financial ties between industry and continuing medical education programs.”

Among those nips and tucks Dean Powell made to the committee’s recommendations? Yep, research:  “The task force recommended that faculty fully disclose the source of research funding as well, particularly those with clinical trials funded by industry,” but such disclosure didn’t make it into the new draft, either.

“They gutted it,” Center for Bioethics professor Carl Elliott told the Daily. Another Minnesota faculty member, Gary Schwitzer, a health journalist who has been a strong voice in calling for the separation of pharma money and faculty, told the paper he had not seen the latest draft at all, and American Medical Student Association Scorecard Director Gabriel Silverman said that the draft changes would take his read on the policies from strong to “borderline.”

Dean Powell, whose leadership of the task force was already marred by reports that the co-chair she named, Dr. Leo Furcht, was sanctioned for violating the university’s old conflict of interest policies, will step down as medical school dean but continue to chair the ethics reform committee, according to the Daily.

“In the light of day”

Thursday, January 22nd, 2009

“And those of us who manage the public’s dollars will be held to account — to spend wisely, reform bad habits, and do our business in the light of day —”

That call to transparency President Barack Obama issued in his inaugural address Tuesday seems to be answered, at least in part, by the reintroduction of the Physician Payments Sunshine Act today. The bill, co-sponsored by Sens. Charles Grassley (R-IA) and Herb Kohl (D-WI) would require prescription drug, medical device, biotech companies and their subsidiaries to disclose all payments that add up to more than $100 into a national and publicly accessible online database. It would capture not only small gifts, meals and conference payments, but the big-ticket consulting, advisory payments and honoraria that have landed some physicians in the hot seat and the headlines lately.

It’s a strong bill, and we are excited to see gathering support for it from editorial boards and industry bloggers alike.

This two-part series in the Milwaukee Journal-Sentinel last week is a great case study in why a Sunshine law is important – it highlights some of the problems with the current patchwork system of self-reporting at some medical centers, which Robert Steinbrook eloquently lays out in this week’s New England Journal of Medicine.

“At present,” Steinbrook writes, “physicians and researchers often report industry payments confidentially to their medical school or medical center. Such reporting, however, may be voluntary and may not be subject to verification. There are wide variations in the level of detail, reporting procedures, and stringency of institutional policies and oversight. The information may be actively reviewed or merely collected.” He looks at the move of a few medical centers to make that information public online, and the prospect of the federal bill.

In FDA news, In Vivo blog wonders whether it’s Dr. Joshua Sharfstein for commissioner as the new administration looks closer to tapping someone to lead the FDA.

And Dr. Steve Nissen, one of those on the short list, is one of six scientists who penned public letters to the new President in Nature journal.

“Secrecy is antithetical to both science and good government, but much of what the FDA knows about drugs, it never publicly discloses,” Nissen writes, and says that secrecy is one of the reasons many consider the FDA “a failed agency”. “The Obama administration has the opportunity to reinvigorate the FDA, but only through major restructuring and policy changes that are designed to protect the agency from undue influence, and to promote transparency,” Nissen wrote.

The Bureau of National Affairs Health Care Daily Report (subscription required) has the roundest of all round-ups on what Congress plans to do on pharmaceuticals this session (including outtakes from our conference keynote speaker Rep. Henry Waxman.) Drug safety, marketing, off-label usage, biogenerics and reimportation: it’s all here.

The growing proportion of pharmaceutical ingredients made at uninspected overseas plants, particularly China, concerns those that think about U.S. drug supply and stockpiling efforts, according to the New York Times.

And we’ll close with another beginning: Eye on the FDA has a good post about FDA Acting Commissioner Frank Torti’s version of an inaugural address, which you can read or listen to here.

Acknowledging the ‘acting’ part of his title makes the job even tougher, Torti addresses consumers, Congress, academics, and industry, to which he offers this pledge: “We promise you that our deliberations will be completed with respect, diligence and speed, but always remembering the old, but wise admonition of Hippocrates, to first do no harm.”

RxP Weekly Reader

Monday, November 10th, 2008

MedPac approves disclosure recs

Last week, the Medicare Payment Advisory Commission approved recommendations that would require pharmaceutical and medical device companies to disclose payments to clinicians, academic medical centers, continuing medical education programs, and other health care entities in a public database.

We discussed the recommendations and their potential influence on the next Congress last week here.

Medical school mashup

Conflicts of interest in academic-industry relations were the hot topic at the annual meeting of Association of American Medical Colleges last week, said Stanford School of Medicine Dean Phillip Pizzo in his Dean’s newsletter last week.

Speaking of academic-industry relations, Emory University has announced that it has formed an ethics panel to look into its management of researcher conflicts of interest. The move comes after a Senate Finance Committee investigation into the extra-curricular and undisclosed industry payments of Dr. Charles Nemeroff led to his stepping down as chair of Emory’s psychiatry department last month.

Check out RxP director Rob Restuccia’s op-ed on why greater transparency like the kind the Finance Committee is seeking is essential for good medicine, and find out more about the new Emory ethics panel here.

Hunting caps

Based on the GlaxoSmithKline’s recent comment that it will be capping industry payments at $150,000 per doctor per year in line with the industry’s current standards, Ed Silverman at Pharmalot went on an epistolary hunt to see exactly what those industry norms were. Many of the responses he received from companies suggested they were looking at current practices, and referenced compliance with the revised PhRMA code which, incidentally, is silent on caps on payments to doctors.

Papers weigh in on pre-emption

And thought it seems forever ago, it was just last week: Before there was Election Hubbub, there were opening arguments in the Supreme Court’s hearing of Wyeth v. Levine, the preemption case that will determine whether consumers can file suits over FDA-approved drugs in state courts. Here are opposing editorials from the Boston Globe and Wall Street Journal – we’re sure they won’t be the last – and the Kaiser Daily Health Policy Report provides a good soup-to-nuts.

Subcommittee refutes FDA safety finding

In a follow-up to a story we touched on last month, Integrity in Science Watch reported that the FDA subcommittee assigned to look at the FDA’s prior ruling on bisphenol-A “blasted the agency for declaring the plasticizer safe, saying the agency used unacceptable criteria for selecting studies to inform its deliberations.” Some groups had been concerned with a possible conflict of the subcommittee chair, who received a large undisclosed gift for his University of Michigan research lab from a Michigan-based plastic maker.

Despite the subcommittee report, the FDA issued a statement saying it stands behind its position that BPA is still safe for water bottles everywhere.

RxP Weekly Reader

Friday, October 17th, 2008

This week, House Energy and Commerce Committee Chair John Dingell (D-Mich) and Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.) sent a letter to the FDA asking about just how and why the agency chose non-profit EthicAd to partner on the creation of the “Be Smart About Prescription Drugs” website, launched last month to help consumers navigate drug ads.

In September, we had some questions of our own about EthicAd’s mysterious funding sources and close ties to Shaw Science Partners, a pharmaceutical marketing company with a long list of Big Pharma clients.  We broke news of Shaw Science Partners and EthicAd’s office- and phone-sharing arrangement here on Postscript, and look forward to hearing of the agency’s reply. 

And the latest joint probe of the Senate Finance Committee and the Special Committee on Aging, Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) are looking into industry payments received by Columbia University cardiologist and stent entrepreneur Martin Leon and other Columbia researchers at the Cardiovascular Research Foundation.  The probe seems to center around the CRF’s industry–sponsored device conference, Transcatheter Cardiovascular Therapeutics, and Leon’s ties to the sponsoring companies.

Here’s more at Bloomberg.

But it’s only the latest investigation, and if history’s any guide, won’t be the last. With the troubling discovery of piles of undisclosed industry payments an Emory University psychiatrist took from a company whose drug he was testing on the government’s dime, and new revelations about the wag-the-dog marketing tactics used to push Neurontin, editors of the New York Times and Atlanta Journal-Constitution write this week that all this coziness between drug companies and doctors “underscores the need for Congress to pass a bipartisan bill, sponsored by Senators Chuck Grassley and Herb Kohl, that would require drug companies and other medical manufacturers to publicly disclose payments to physicians that exceed $500 a year.” (10/11, New York Times).

The Journal-Constitution went further in its recommendation, saying passage of the disclosure bill – also known as the Physician Payments Sunshine Act – is a “bare minimum,” and that the “culture that has infected drug company sponsorship of academic medicine needs a thorough cleansing,” including a “temporary reduction in the amount of money going into research and continuing physician education.”(10/12, Atlanta Journal-Constitution)

And another editorial in the Arizona Republic this week takes a puzzling non-stand on the PPSA: First they were against, then they were for it? In the end, we’re not really sure. Just like the writers don’t seem very sure whether or not doctors are influenced by pharmaceutical marketing. The verdict?  “Probably not.” Sure, we’d heard the West is a place of fewer words, but this is taking it too far.

The first two editorials were no doubt spurred by the controversy around Dr. Nemeroff’s busy speaking schedule. News came this week that he’s about to get a little less busy – the National Institutes of Health have hit pause on the 5-year, $9.3 depression grant that Nemeroff was heading up at Emory. The AJC says despite his freed up schedule, Nemeroff is still turning down interviews.

And over at A Healthy Blog, RxP’s Kathy Melley looks ahead at what we’ve all been waiting for. Our 401Ks back? Ok, the other thing we’ve been waiting for – the decision from the U.S. Court of Appeals on prescription data-mining bellwether case, Ayotte v. IMS Health.

“The court ruling could have the effect of ratcheting up or down state legislative activity on data mining,” Melley writes, but that “regardless of where the court comes down, there’s a good chance the U.S. Supreme Court may be the final arbiter on this issue.”

Medical students and local physicians will rally at the Harvard Medical School campus today, urging their adminstrators to create better conflict-of-interest policies around pharmaceutical marketing.  According to a press release from the American Medical Student Association, which is capping its National PharmFree Week at the Longwood medical campus in Boston, “Students are asking for involvement in the policy drafting process, increased transparency, mandatory lecturer disclosure and a reasonable timeline for drafting and implementation.”

Check out the AMSA scorecard rating medical school COI policies here.

Reading between the headlines

Tuesday, October 14th, 2008

A conversation with Michael Hochman, MD

A study this month in the Journal of the American Medical Association found the mainstream news media isn’t passing muster when it comes to sussing out industry bias in pharmaceutical research. Investigators looked at more than 300 articles in the mainstream print media about major medical studies and found that 42% of the articles neglected to indicate when the research being reported was funded by pharmaceutical company, and that two-thirds of news articles refer to medications by their brand names, rather than the generic ones, the majority of the time.

We talked with lead author Dr. Michael Hochman, an internal medicine resident at Cambridge Health Alliance, who says that both the fourth estate and the medical community need to be asking more questions about why and how industry funds the research of its own drugs, and what that could mean for our health.

RxP: Why did you do this study?

MH: From numerous recent studies, we know that company funded research is more likely to generate positive results than non-company funded research. We also know that company funded research frequently uses “soft endpoints,” such as improvement in cholesterol levels rather than more meaningful endpoints like all-cause mortality. Because of the important impact company funding can have on the reliability of research results, readers of the lay media need to be aware when a study has been company-funded so that they can interpret the results appropriately. We found that the news media do not always do a great job of this.

Based on our findings, here’s what I think needs to be done:

1. News organizations must adopt and enforce formal, written policies stating that all articles about medical research must indicate how the research was funded and must refer to medications predominately by their generic names.

2. Doctors need to be aware of the biases inherent in company funded research, and view the results in that light.

3. We need to consider alternative funding sources for clinical research, such as the National Institutes of Health, that do not have direct financial interests in the results.

RxP: You say journalists should use a drug’s generic name instead of the widely-used brand-names owned by the companies that sponsor the studies. If journalists did use generic names more often, would it change a doctor’s choice of drug?

MH: I think it could. Patients often come to their doctor requesting specific medications that they see in advertisements or read about in news articles, and if they read about generic medications in news articles then I think they will be more likely to ask their doctors about generic medications, and doctors will be more likely to prescribe generic drugs.

RxP: You’ve said: “We in the medical community realize that research funded by pharmaceutical companies can’t always be trusted…” Has the press played a role in telling that story?

MH: Yes, but not as well as they could. We have had several prominent recent examples in which company funded proved to be biased. The most widely known is the rofecoxib (Vioxx) scandal in which company researchers were not forthcoming about the adverse cardiovascular effects of the drug. Company researchers were also not particularly forthcoming about cardiovascular side effects associated with rosiglitazone (Avandia).

I think these are all very important news stories, and the news media has covered them, but they haven’t driven home the point.

RxP: How could the press done better by the public around Vioxx?

MH: I think they did a good job of identifying the problem, but they didn’t do a good enough job of emphasizing that the same problems that led to the rofecoxib scandal are probably at work in many other company funded studies. It’s probably a much more widespread problem than this one isolated case. The media didn’t ask us to reexamine the fundamental way we do research in this country, or question that maybe having Merck research its own drug isn’t the best way to get meaningful results.

RxP: Do you think physicians have fully acknowledged the influence of their relationships with industry?

MH: Unfortunately, no. If we had, we would be actively seeking alternative funding sources for medical research – the National Institutes of Health, for example. To be quite frank, I am much more skeptical of company funded research than I am of other research, and I try to rely on non-company funded research as much as possible when making decisions about my patients. I think some of my colleagues feel similarly, but not the majority.

RxP: How will the current economic crisis affect our ability to consider seriously restructuring research funding through the NIH?

MH: At one level, sure, bailing out Wall Street means the government will have less money to support the NIH, but keep in mind, we’ve seen a pretty significant cutback in NIH research funding in the eight years prior. That said, I think this economic fallout has made all Americans more skeptical of corporate practices, and perhaps that skepticism will spill over to the pharmaceutical industry.

RxP: You point out in a Boston Globe op-ed that journalists get promotional press releases from the industry and interact with pharmaceutical representatives at medical conventions. But we expect and need journalists to hear from all stakeholders for any story. Where’s the evidence that coverage has somehow been biased?

MH: A number of previous studies have shown that medical coverage by the news media overstates medication benefits and underplays their side effects. There are a number of reasons why this may be the case. I think the main reason is that journalists want to write interesting stories that will keep readers engaged.

However, pharmaceutical promotions may also play a role. I can’t site specific evidence that the news media are influenced by company promotions, except to say that if the advertising didn’t work, the companies wouldn’t do it.

RxP: But do you find petitions by drug companies to the press corps more harmful to health care than gifts from detailers to physicians or the interactions clinicians have with pharma reps at conventions and CME courses?

MH: All are problems. I believe that we doctors should not accept any gifts from pharmaceutical representatives of any value. Medical decision making should be based on evidence, not advertising. And we have strong research that shows physicians who accept gifts are more susceptible to advertising.

RxP: So you seem to say there’s an absence of skepticism around company-funded trials the larger medical community, not just in the news. If that’s the case, are you asking the press to go first?

MH: I wish I could place all the blame on the media, but medical journals and doctors – who have bought into our current system – probably deserve the lion’s share of the blame. It is the medical community – not journalists – that has allowed a system to develop in which companies fund the vast majority of clinical research. However, I think both the medical community and the news media can play an important role in counteracting corporate influences in medicine.

We in medicine have a long way to go on this – we have the power to keep reps out of our hospitals and out of our clinical decision-making, and many medical schools and some hospitals have begun to ban gifts to doctors, but a lot more work needs to be done.

In terms of the news media, they sometimes get carried away in reporting exciting new medical developments before they’re ready for prime time. But patients’ lives are at stake, and we really need to be more vigilant in weeding out the junk, and determining how good these treatments really are, and what the risks are.

RxP: Do you think physicians should be required to disclose their own financial relationships with industry to patients?

MH: I think patients absolutely should be aware of any company funding that their doctors have received, however the best way to transmit this information is unclear. Perhaps physicians should be required to disclose financial relationships on publicly available websites.

RxP: Reporting on the source of funding doesn’t really tell patients or doctors whether a study is biased or well-designed. Are there more substantive changes you’d like to see in how journalists report medical studies?

MH: Again, this is challenging, because in order to really understand medical research, you need a medical background and some training in epidemiology, and you can’t expect this of most journalists — and perhaps not even of all doctors. I think the responsibility for fleshing out the details of studies and exposing their shortcomings must come from non-biased medical journal reviewers who carefully go through the study methods. The FDA must also do a better job of critically analyzing medical research when making decisions about drug approvals.

The Association of Healthcare Journalists has published an excellent set of guidelines about the appropriate way to cover medical research, and I think journalists should focus on abiding by these principles (http://www.healthjournalism.org/secondarypage-details.php?id=56).

Also, the Health News Review (http://www.healthnewsreview.org/) evaluates the quality and fairness of medical stories in the popular press, and I think the standards by which they grade articles are very appropriate and should be followed by journalists.

Thanks to co-authors: Steven Hochman, Pomona College; Dr. David Bor, Chief of Medicine, Cambridge Health Alliance, associate professor of medicine, Harvard Medical School; Dr. Danny McCormick, Cambridge Health Alliance, assistant professor of medicine, Harvard Medical School.

Oh Dear Me

Tuesday, October 7th, 2008

When is writing a memo fun? When the sender is you, the recipient is you, and its purpose is to authorize payment - to you.  We’re pretty sure Dr. Charles Nemeroff enjoyed getting that memo (from himself) authorizing $3000 to be paid (to himself) for writing a medical journal supplement, as much as we would enjoy a similar return-address windfall.

But what about that journal supplement itself? These ‘special sections’ in medical journals – often sponsored and usually focused around a related topic, like a disease group or drug class – tend to be less editorially rigorous, amounting to nothing more than glossy chances for companies to buy extra ad space.  In this Journal of the American Medical Association study, blinded reviewers found that the quality of the medical articles – in study design, sample size, and analysis — was inferior in the supplements to those published in the parent journals. And other scholars and clinicians have wondered openly whether they are worth the paper they’re printed on – much less $3000.

Yet, that self-payment was just one of the more trifling findings of the Senate Finance Committee into the large undeclared industry payments to Dr. Charles Nemeroff, former head (and by former, we mean Friday) of the Emory University Department of Psychiatry and principal investigator on an NIH grant to study a GlaxoSmithKline drug there. And by industry payments, we mean GlaxoSmithKline.

While the Committee has been hot on the trail of 30 academic psychiatrists and their disclosure sheets that don’t match up to company records, the case around Dr. Nemeroff – depicted in this letter from Committee Chair Sen. Charles Grassley to Emory and obtained by Pharmalot — is singular in the repeating and bald-faced quality to Nemeroff’s bucking of the NIH rules, which require universities to ‘manage’ conflicts caused by investigators’ significant conflicts of interest (defined as $10,000 per year).

For instance, in August 2004, Nemeroff wrote to Emory’s conflict-of-interest committee to say he was in compliance with the $10,000 limit — and in that month alone Nemeroff took in excess of that yearly maximum in speaking gigs and “non-product” phone calls alone.

After Emory’s COI committee raised questions about his failure to follow approval protocol of his consulting agreements and discrepancies on his disclosure sheets, Nemeroff wrote another memo, this one not as fun, about his future compliance, which read: “I will follow the management plans for my conflicts of interest”… and “I shall limit my consulting to GSK to under $10,000/year and I have informed GSK of this policy.”

Grassley’s letter goes on:

Barely a week after this promise, on July 12, 2004, GSK paid Dr. Nemeroff $3,500 in fees and $505.40 in expenses for a talk he gave regarding Paxil at the Larkspur Restaurant and Grill in Las Vegas, Nevada. The following day, Dr. Nemeroff gave two more talks in exchange for $7,000 from GSK ($3,500 per talk).

Maybe the maxim, What happens in Vegas, stays in Vegas, just hasn’t made it to the Beltway yet.

RxP Weekly Reader: Bastille Edition

Thursday, July 17th, 2008

Boston Globe coverage of the progress of the Massachusetts health cost containment and quality bill, which was debated in the House yesterday, runneth over –

The gist

The letters

Lisa Kaplan Howe, Health Care for All

Brian Hurley, American Medical Student Association

The outcome

Now the omnibus bill (56 sections!) goes to conference, where the Sen. President’s version including a complete gift ban, disclosure and academic detailing should keep things interesting.

Singing the PhRMA Code Blues

This week, the head of a Kaiser Permanente’s physician network, the largest of its kind in the U.S., spoke out against the revised PhRMA code in the pages of the San Francisco Chronicle, calling it “nothing more than window dressing,” and “a weak, transparent move by an industry that is pretending to take strong action.”

Dr. Pearl, CEO and executive director of The Permanente Medical Group, a 6000-physician network that serves 3.3 million patients in northern California and abides its own pharmfree code, said that instead of relying on the profit-driven drug industry to police itself, physicians must collectively take responsibility for limiting the influence of pharmaceutical marketing on the medicine they practice, writing that “we cannot abdicate our responsibility as professionals – whose duty is to put patients’ interest first – by relying on the industry that benefits from those inducements to self-regulate.”

Rx realignment

Times of London columnist Carl Mortished says that in a convergence unseen in ElectionLand in recent years, both presumptive U.S. presidential candidates have angled to take on big Pharma: Obama has talked about allowing Medicare to negotiate drug prices, and both he and McCain have been seen stumping drug reimportation, which has had banana-peel traction under the current administration.

Though the Times online headline, “Barack Obama and John McCain go to war with Big Pharma” probably overstates things a bit, the article takes a good look at how U.S. politics may feed and shape bigger Western pharma trends.

Legislative affairs

As part of his continuing inquiry into medical conflicts of interest and financial ties to the pharmaceutical industry, Sen. Chuck Grassley (R-IA) has asked the American Psychiatric Association to submit to him its financial statements, citing concern that the degree of support the specialty society receives from commercial interests is causing field-wide bias.

Here’s coverage in the New York Times, and an opinion piece in the Boston Globe by former New England Journal of Medicine editor Dr. Arnold S. Relman discussing the proper source of incentives in academic research.

And in the San Francisco Chronicle, Dr. Lawrence Diller, a UCSF-affiliated pediatrician writes:

“The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children’s mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.”

Maple Leaf Rag

The Canadians have found us! Proof in the pages of this month’s Canadian Medical Association Journal.  Thanks, Canada. We’ll watch hockey this year, promise.

And these last two are from the Wall Street Journal Healthblog. The first told us more than we knew about PhRMA chief Billy Tauzin and his history on the Hill, and the second – well, though the Healthblog wasn’t first to pick it up, we liked the desk-cowering image: Turns out injury-by-spacecraft has its own diagnostic code.

Lends a whole new meaning to Universal health care.

RxP Weekly Reader: 57 varieties edition

Thursday, May 22nd, 2008

Reading the fine print

Glad we read the Boston Globe this week, where we stumbled across this great opinion piece by internal medicine resident Dr. Michael Hochman, who says that recent revelations about pharmaceutical companies ability to bury unfavorable studies (or just write better ones themselves) have got him and his colleagues at the Cambridge Health Alliance thinking twice about the sizeable chunk of industry-funded research in the medical literature.

“One of the more experienced doctors I work with, for example, told me that he no longer views industry-funded research as an unbiased source of information but rather treats these studies like advertisements for pharmaceutical products,” Hochman writes.

Though he says he’s encouraged by recent changes to limit marketing influence on good medicine, such as the Journal of the American Medical Association’s pledge to exorcise itself of ghostwriters, and Boston University School of Medicine’s recent introduction of strong policies that ban industry gifts and payments, he will “rely less heavily on studies funded by pharmaceutical companies when making decisions about my patients. And when I do read industry-funded studies, I will use the skeptical mindset I developed during my medical training not only to evaluate the study methods but also to consider the motives of the researchers involved.”

After the Wire, Under the Arch: med school policies in perspective

The Baltimore Sun ran this comprehensive article on the AAMC recommendations and the state of pharmaceutical conflict-of-interest work at the state, federal, and academic medical center level.  According to the Sun, “The Johns Hopkins University and the University of Maryland allow doctors and researchers to accept gifts that have “educational value” and to earn money for company-sponsored speeches. Officials at both schools say the policies are under discussion and might be tightened in response to the new AAMC guidelines.”

Here’s another good omnibus article in the St. Louis Post-Dispatch on the state of industry influence on academic medicine – and the effect of the AMSA Pharmfree Scorecard last year.

According to the Post-Dispatch, after the scorecard came out “Washington University adopted a policy to ban representatives from interacting with students without faculty supervision. Among other rules, representatives are barred from bringing food on campus.”

A second year medical school put it this way: “By the time I’m done, I’ll have paid a couple hundred thousand dollars for my medical education,” she told the Post-Dispatch.  “I think I’ll be well-qualified enough to educate myself.”

And the accompanying editorial says that it’s no coincidence that “Americans spent $216 billion on prescription drugs in 2006, an increase of nearly 80 percent over the $121 billion spent in 2000.

“The simple truth is that when drug and medical device makers offer a free lunch, the rest of us pay the bill.”

American College of Physicians mag looks at COI policies

Here’s a great look at what AMCs are doing about industry influence from a professional perspective.  The ACP Hospitalist talks with RxP and a whole starting line-up worth of adminstrators who have taken their organizations pharm free, including BUSM’s Dr. David Coleman, University of Pittsburgh Medical Center associate dean Dr. Barbara Barnes, and SMDC Health System’s Dr. Kenneth Irons, who took the out-of-sight-out-of-mind approach offshore, orchestrating the shipment of all his clinics’ pharma gizmos to Cameroon earlier this year.

In Heinz sight

And for anyone who doubts that pharmaceuticals have gotten away from the science in favor of lifestyle marketing campaigns run by brand-savvy MBAs, we bring you this nugget, courtesy of the WSJ Health Blog.

RxP Weekly Reader

Thursday, May 15th, 2008

So long, samples

The Carolinas HealthCare System is nearly halfway through its first year of zero free drug samples, reports the Charlotte Observer.  Dr. William Sugg, the medical director of the 600-member CHS physician network, told the Observer that though some of the physicians are “violently opposed” to the new rule, the system made the change out of concerns over both safety and the marketing influence. 

“If it wasn’t influencing prescribing habits, why would they be doing it?” Sugg said of sample hand-outs.

The Trees for the forest: Stanford paper praises policies

And it’s a pat on the back for Stanford Medical School, which the Stanford Daily editors say “has beaten the AAMC to the punch” with its 2006 conflict of interest policy.  Well, that’s one way of looking at it – it’s possible, though,  that movement toward strong conflict of interest policies by early adopters like Stanford helped create momentum that influenced the AAMC task force findings.  

According to the editorial, a working group at Stanford is now looking at industry involvment in continuing medical education.

Tech-ethics in AAMC guidelines

Though there was a flurry of coverage on the new AAMC guidelines, which prescribe a ban on all industry gifts, this week Modern Healthcare zeroed in on a different part of the recommendations that discussed healthcare IT – electronic medical records and e-detailing, for example. From the Reader’s reading of things, seems like the recommendation in question amounts to: technology is medical education is important – let’s talk about it more.

State savvy

The USA Today opinion blog says that the states with gift bans and disclosure laws have the right idea when it comes to pharmaceutical generosity toward MDs.  “While each of the state programs has its flaws,” the editors write, “the forced transparency is a sensible first step toward curbing abuses.”

Speaking of transparency…

The Physician Payments Sunshine Act has undergone some changes in the Senate as members prepare to attach it to this year’s Medicare bill.  Eli Lilly has come out in support of the amended version, in which the reporting threshold was raised from $25 to $500, the start date moved back from 2008 to 2011, and which would, if passed, preempt existing state disclosure laws beginning in January 2010. 

Read coverage in the Indianapolis Star and The Hill for more.

And for the weirdest idiom tweak of the week, this DigitalJournal.com article on the co-opting of news by drug marketers takes the grain of cake:

“When health care experts appear on 24/7 news stations to promote the latest gastric bypass surgery, viewers should take their announcements with a large bear-hug of salt.”