This week, I talked by email with physician and researcher Dr. Joseph Ross about the importance of using unique identifiers in pharma disclosure data, and other ways to take the guess work out of the Physician Payments Sunshine database.

PS: Last week, a commentary in JAMA (Carpenter/Joffe) suggested that unique investigator identifiers should be used in the Physician Payments Sunshine database to make the data most usable, accurate, and suitable for cross-reference with other databases.

You’ve spent a lot of time with data collected under similar disclosure laws in Minnesota and Vermont. From your point of view as a researcher, what aspects of an identifier are important or helpful to looking at these data?

JR: From our experience examining the data in Minnesota and Vermont, I can only say that some unique identifier is necessary. Neither the Minnesota or Vermont data that we used included a unique identifier, just the name of a physician, clinician, or hospital/clinic that accepted the payment from the pharmaceutical company.

We found that trying to determine exactly who accepted which payment was virtually impossible, because one could not be sure whether a “Dan Smith” in Minneapolis was the same or a different “Dan Smith” in St. Paul, for example. Without a unique identifier, doing research to examine which physicians or clinicians are accepting payments can only be done in the aggregate, not at the individual level.

However, what is most interesting about Carpenter and Joffe’s proposal is not the unique identifier in itself, but the development of an identifier that could be used across databases, linking payment disclosure data, to grant applicants, to manuscript submissions and publications, to service on NIH or FDA committees. I could imagine this identifier being an expanded use of the NPI (national provider identifier), or another number, but it would certainly make identifying potential conflicts of interest far simpler.

PS: One of the reasons these authors suggest a unique identifier is to capture payments made to non-physician investigators. Did you deal with this issue in your work with the Minnesota and Vermont data?

JR: Yes, examining the data in Minnesota and Vermont, there were a substantial number of payments made to non-physicians, although these clinicians were not necessarily investigators. I agree that if the PPSA is broadened to include payments made to non-physicians, an alternative identifier to the NPI might be necessary. NPIs are required by all health care providers, including non-physicians who bill insurance companies or write prescriptions. But some non-physicians who receive payments from industry may not fall into this category.

However, to me, the real issue is a shortcoming of the PPSA, which requires companies to include physicians’ NPIs in their annual submissions, but prevents these numbers from being made publicly available.

PS: Why is that a problem?

JR: This is a problem because, as it stands, the payment disclosure data cannot be confidently attributed to an individual without using the NPI as a unique identifier. Our prior experience suggests that individual physicians will appear in the disclosure data multiple times, potentially with different spellings of their names, different practice addresses and so forth. It becomes a bit of guess work to determine if a payment to Daniel Smith from Lilly in September should be combined with the payment to Dan Smith from Lilly in April.

PS: In your 2007 JAMA article, you wrote about difficulty you had obtaining the Vermont/Minnesota data, and the poor quality of the information once you received it. Out of this experience, what should some of the priorities be in developing Sunshine systems and payment categories to produce a meaningful public disclosure scheme?

JR: Well, we’re still more than two years away from seeing how the PPSA plays out in practice. The legislation was fairly specific in terms of what information is to be collected.

Of all the categories pre-specified, the “nature” of the payment is most subject to interpretation.

My hope is that they interpret it as specifically as possible, so that, for instance, its disclosed when a payment is for a) speaking at a ACCME accredited educational event, b) speaking at a non-ACCME accredited educational event, c) attending a ACCME accredited educational event, or d) attending a non-ACCME accredited educational event. If the “nature” of a payment is disclosed vaguely, all four of those activities could be listed under the umbrella of “education.”

Otherwise, I agree with the Carpenter/Joffe commentary: Something needs to be done to ensure that a unique identifier is required for disclosure by companies and made available to the public. Without this, these payments may be misattributed, particularly within larger markets, limiting the effectiveness of this law within those communities.

Joseph S. Ross, MD, MHS, is an Assistant Professor in the Section of General Internal Medicine at the Yale University School of Medicine in New Haven, CT. He holds a medical degree from the Albert Einstein College of Medicine, Bronx, NY, and completed his post-graduate training in primary care internal medicine at Montefiore Medical Center in Bronx. As a fellow in the Robert Wood Johnson Clinical Scholars program at Yale University, Dr. Ross earned a Master’s degree in health sciences research. Using health services research methods, Dr. Ross’s research focuses on examining factors which affect the use or delivery of recommended ambulatory care services for older adults and other vulnerable populations, evaluating the impact of state and federal policies on the delivery of appropriate and higher quality care, and issues related to conflicts of interest, medical professionalism, and drug safety.

Interviewed by Kate Petersen, PostScript blogger

Despite a heightened awareness of the need for transparency of financial relationships in clinical medicine and research, a new review of meta-analyses in JAMA found that among a sample of high-impact publications, very few of the reviews acknowledged industry-backing of the source trials.

According to the review, only two of 29 of the meta-analyses selected from recent editions of influential journals identified industry-backed trials as such, even though nearly two-thirds of the trials with declared funding sources were sponsored by drug companies.

A considerable body of research suggests that industry-backed trials tend to portray the drug more positively, favor the drug over placebo, and downplay side effects more often than in non-industry trials (see the JAMA bibliography). This 2006 BMJ article found industry support tended to lower the rigor of meta-analyses.  It seems, then, a matter of some import to have an understanding of trials’ funding sources, both in their original publication and when they are aggregated in reviews.

Of course, blame for this dearth of financial disclosure doesn’t rest solely with the reviewers of the trials – the lack of standard documentation of industry funding and relationships in trials published in major medical journals is a complex and compound problem. For instance, among the Randomized Control Trials (RCT) included in the 29 meta-analyses, only a quarter included financial disclosures for authors, and only two-thirds listed sources of trial backing. In such a landscape, then, it’s tricky–if not impossible–for a meta-analysis to accurately or completely describe the shape and scope of the funding behind the findings.

The researchers call for a standard policy:

The results of the present study highlight a major gap in the reporting of COIs and suggest that, without a formal reporting policy, COIs from RCTs are unlikely to be reported when results are synthesized in meta-analyses. The PRISMA statement should be updated to require authors of meta-analyses to report funding sources of included RCTs or report that funding sources were not disclosed.

There’s much agreement that transparency of potential COIs is important in clinical care and prescriber settings. But progress toward transparency in the clinic may be diluted, if not undermined, without a more unanimous foundation of disclosure in the medical literature, which serves to set the therapeutic standards and practice guidelines used there.

–Kate Petersen, PostScript blogger

A new survey of physicians published in the JAMA Archives of Surgery this week suggests that across specialties, the majority of physicians still hold a positive attitude about gifts and meals from pharmaceutical and medical device companies.

Confirming what previous studies on marketing influence have found, cognitive dissonance was at work here: the majority of the 590 respondents (52.2 percent), who worked at Mount Sinai School of Medicine and its affiliated hospitals, believed that receiving industry gifts and meals influenced other physicians’ prescribing, but just about one-third believed that they themselves were influenced by gifts and meals. Earlier studies quantifying physician attitudes have suggested an even greater differential.

And though the majority of respondents thought that industry funding of medical education was acceptable, more than two-thirds of them perceived bias in such sponsored lectures.

The researchers hypothesized that surgeons, whose journals had published little of the literature to date on gifts’ prescribing influence, would have more favorable views of industry gifts and involvement in medical education. The results bore this out, with surgeons significantly more amenable to certain types of gifts, and industry funding of medical school programs (82.8 percent compared to 71.1 percent overall). Recent news stories in Bloomberg and the New York Times have revealed the unique coziness between some high-profile surgeons and makers of implants and devices that failed their patients.

In an interesting aside, the specialty most likely to say that its institution should prohibit residents, students and attendings from interacting with pharma and device reps were psychiatrists, who have been the focus of a series of headlining Congressional investigations in recent years and have consequently done a lot of work to clean their house.

So where is education and awareness in all this? In many cases, the more familiar a physician was with her institution’s guidelines, the less likely she was to rate gifts and meals as appropriate or very appropriate, and the less likely she was to say that samples improve patient care.

But just over half of the respondents surveyed said they were familiar with their institution’s guidelines–guidelines, we note, that received an “A” on the American Medical Student Association 2009 Scorecard. One question then is: How are the many institutions that have strengthened or developed new policies communicating them to their clinicians – or are they?

The authors suggest that despite such policy changes, the medical practice environment still fosters a “hidden curriculum” that approves of industry gifts, meals and relationships–a curriculum that has left physicians behind the public and regulatory movement toward trimming marketing’s influence on medicine.

Despite this sea change in public and governmental attitudes during the last several years, the physicians we surveyed retain generally positive attitudes toward many industry gifts, and more than two-thirds still find gifts and lunches from industry acceptable. In fact, our findings are remarkably similar to results of other studies of physician attitudes toward industry from as early as 2001….

The positive attitudes of physicians we surveyed are likely to reflect the continuing acceptability of industry interactions and gifts within the culture of medicine despite changing guidelines. Physicians in practice continue to speak frequently with industry representatives, and academic physicians enjoy food and other industry gifts when they attend continuing medical educational events and national specialty meetings. Although other groups have found that education about the effect of industry contact may have a modest effect on physician attitudes, physician attitudes are not likely to align with those of the public until the culture of medicine rejects industry marketing interactions more fully.

–Kate Petersen, PostScript blogger

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.

In a week where spending your taxpayer dollars on bad investments suddenly sounds like a ‘rescue plan,’ read this: the FDA spent a chunk of their not-so-spare change  (OK, so $300,000 is a lot less than $700 B) to hire a PR firm to “create and foster a lasting positive public image of the agency for the American public,” the Washington Post revealed this week. Instead of issuing the request for bids required for federal government work, a former public affairs executive for a medical-device firm now working for the FDA orchestrated a no-bid contact through Alaska Newspapers, Inc, which isn’t subject to government bidding requirements because of its special status. 

So are we more enraged at the fact the agency went the good ol’ boys route and circumvented the rules process to find the best and lowest-cost bidder, or that even as the chronically under-funded agency was asking Congress for more dollars to shore up its crumbling safety and oversight divisions, it was working this hard and shelling out this much to shine up the story in tomorrow’s social studies books? Right now, we’d say it’s a coin toss.

Putting ADHD drug ads in timeout

The FDA has warned five drugmakers about false or misleading advertisements of five ADHD drugs, according to the Bureau of National Affairs Health Care Daily Report. “The FDA sent letters to Eli Lilly and Co., Mallinckrodt Inc., Novartis Pharmaceuticals, Johnson & Johnson, and Shire Development.” One of them was a video testimonial by Extreme Celebrity Home-giver Ty Pennington for Shire’s Adderall XR, an unapproved ad the FDA says overstates efficacy but which company officials claim was never supposed to leave the Shire website, where the side effects, dosage and indications were plain for all to see.

The pre-emption question

As the Supreme Court’s November date with pre-emption case Wyeth v. Levine nears, this Boston Globe editorial argues the evidence has shown that the FDA approval process requires “insufficient proof” of drugs’ safety “and then does not recognize their harmful effects quickly enough.” The Globe continues: “the Supreme Court has no business depriving patients of their recourse to courts.”

Pharmalot’s Ed Silverman has made his site the one-stop shop for all things pre-emption. Check out his syllabus here.

Media matters

And in this week’s Journal of the American Medical Association, researchers from Harvard Medical School and Cambridge Health Alliance look at news reports on industry-funded pharmaceutical studies in the mainstream media and found that about 40% of 300 major news stories failed to mention the source of the study’s funding. 

Of course, reporters aren’t alone – recently, major medical journals have been discovered to have missing disclosure statements from industry-funded authors, and Congressional queries have found giant gaps in payment disclosures by university researchers. When it comes to disclosure, these researchers seem to be asking that the fourth estate go first.

UMN ponders new stronger COI policy

Minnesota Public Radio revealed leaked recommendations by a University of Minnesota medical school task force on new conflict of interest policies. The recommendations called for health care providers to disclose to patients any interest they have in companies whose products they prescribe them, developing a conflict of interest website, a complete phaseout of industry funding for continuing medical education, and a requirement that all physician-industry relationships be disclosed (currently, only payments above $10,000 are required to be reported). The University received a D on the American Medical Student Association scorecard for its current policies earlier this year. Here’s the AP follow-up.

Cephalon settlement calls for disclosure

As part of $444 million in settlements of whistleblower lawsuits related to illegal off-label marketing, Cephalon is the first drugmaker to enter into a corporate integrity agreement that will require it to disclose prominently payments to physicians and amounts on its website; the move comes a week after Eli Lilly and Merck announced they will voluntary disclose such payments beginning next year; two years ago, five medical device makers began to disclose such payments under a similar settlement agreement to Cephalon’s.

Find out more at Marketwatch and Wall Street Journal Healthblog.

We heard the Early Reader gets the Bookworm, but whether that’s fact or fable, the Reader gets an early start this week with news that Stanford University School of Medicine will be decoupling pharmaceutical industry funding from its continuing medical education programs, effective Monday. The move comes in the wake of Congressional inquiries into a Stanford psychiatrist’s financial interests and research post earlier this year, as well as growing calls for limits on industry involvement with doctors’ continuing education.

According to the San Jose Mercury-News, the new policy mandates that “companies will no longer be able to designate that their contributions be used for specific types of medical training, to limit the companies’ ability to tailor those sessions around their products.”  These restrictions make Stanford’s CME policy among the strongest in the nation.

“It’s a good plan, and it’s a big deal that a place like Stanford has adopted it,” Dr. Murray Kopelow told the New York Times.  Kopelow heads the Accreditation Council for Continuing Medical Education. “When this is all over, medical education will not be the same as what it’s been.”

All-you-ever-wanted-to-know at:

Wall Street Journal Health Blog

San Francisco Chronicle

Chronicle of Higher Education

Speaking of CME, this historical look at industry involvement in continuing medical education in last week’s Journal of the American Medical Association demonstrates just what a ‘therapeutic jungle’ it is out there. According to authors Scott Podolsky and Jeremy Greene, concerns about industry involvement in medical education are much the same now as they were 50 years ago, though they argue the stakes are higher now.

“Technological and regulatory solutions intended to defend professional control over knowledge circulation—such as CME—have instead provided novel sites of intersection between pharmaceutical marketing and physician education,” they write.

Label liability?

And now to Washington, where this week the FDA finalized a rule that will make it tougher to update a drug label to reflect warnings and side effects.

According to the BNA Health Care Daily Report:

“The final rule published in the Aug. 22 Federal Register (73 Fed. Reg. 49603) allows manufacturers to submit a supplemental application to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the product.

‘Expressly requiring that a CBE supplement reflect newly acquired information and be based on sufficient evidence of a causal association will help to ensure that scientifically accurate information appears in the approved labeling for such products,’ the FDA said.

Critics are saying that the rule adds up to immunity for drug makers, who would no longer have to warn consumers about drug risks or new side effects without proof of causation and newly acquired information. The American Association for Justice, which holds the new rule protects drug manufacturers, told the BNA the FDA’s decision “leaves the drug and device companies too much discretion in determining when to include safety hazards on warning labels.”

Baby steps

In other FDA news, the agency signaled it would be revising rules on over-the-counter cough and cold medications for children, according to the Washington Post. Last fall, an advisory panel convened to look at the safety and efficacy of the drugs, which have been linked to children’s deaths and have not been put to effectiveness tests.

Now, a year on, the agency has scheduled a meeting on Oct. 2 to consider questions about whether the products should be proven effective or safe to remain on the market, and if so, how. Baby steps? Maybe. But experts say this is how it gets done.

“This is how the agency can take these products off the market,” Baltimore Commissioner Joshua Sharfstein told the Post.  “I think this signals the agency is going to apply a modern standard of safety and efficacy to these products, and that is a standard these products cannot pass.”

Sharfstein organized the citizens’ petition filed in March 2007 requesting that the FDA review the safety of these drugs.

And the midyear update from the National Conference of State Legislatures says that prescription drugs continue to be a hot topic in state houses everywhere; 540 pharmaceutical-related bills have been filed this year, to date.

If you don’t already know about it, these topical legislative reports on the NCSL website are a dynamite resource: You can read description of all prescription drug bills filed so far this year by state, topic, or status of bill.  Find clusters of states where similar legislation has been introduced, or just see things that make you go ‘Hmm.’  Like how earlier this year Florida House members passed H.9065, a non-binding resolution honoring PhRMA on the anniversary of its program…honoring pharma.

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.

A whole lot of bloggers have taken on last week’s ghostwriting study in JAMA. Here are a few of our faves:

National Physician’s Alliance, the RxP partner group of physicians to which JAMA author Joseph Ross belongs, has this analysis of the latest chapter in the Vioxx saga.

Here’s NPA member Howard Brody’s take at the Hooked blog.

And in other blogs:

Daniel Carlat at the Carlat Psychiatry Blog compares the Pentagon’s use of thought-leaders (in this exhaustive New York Times investigative report) with Pharma’s strategy to push its message through ‘hired gun’ physicians.

Researcher and watchdog Aubrey Blumsohn has built a Scientific Misconduct Wiki to pair with his Scientific Misconduct blog.  Blumsohn writes:

Hopefully this will form the seed of a peer reviewed online journal devoted to Scientific Integrity. For the moment, it will serve as a non-collaborative repository for reports and academic analysis of the integrity scandal involving Procter and Gamble and the drug Actonel (including the serious implications of the failed but rather sad attempts at coverup and delay by ‘regulators.’”

And here’s a real time example of a university enforcing its policy of financial disclosure for physicians.  Pharmagossip and Pharmalot posted on a story in The Cincinnati Enquirer that the University of Cincinnati has a closer eye on psychiatry professor Melissa Delbello these days after big discrepancies in the size of her paycheck from AstraZeneca came to light.  The letter from Sen. Grassley probably helped things along, but it’s good to see an academic medical center acting on its conflict of interest policies.

Using court documents from lawsuits over Merck’s Vioxx, a study in this week’s Journal of the American Medical Association found that Merck often wrote first drafts or commissioned for-profit ghostwriters to write academic articles on the pain drug, then paid academic thought leaders for claiming primary authorship. Half the time, those doctors did not disclose that payment in publication, and often the corporate ghostwriter was not listed among authors at all. 

In a companion editorial, JAMA editor-in-chief and RxP advisory board member Catherine D’Angelis M.D. decries the practice, writing, “it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors.”  The lead author of the paper, Dr. Joseph Ross of Mount Sinai School of Medicine in New York, is a member of the National Physicians Alliance, a partner of the Prescription Project.

Read more in the Washington Post, the Boston Globe, and the New York Times.

Yesterday, the Wall Street Journal Health Blog talked with JAMA editor-in-chief Cathy D’Angelis about this editorial, which breathed a big sigh of peer-review relief at a judge’s decision to stop Pfizer from getting its hands on some confidential journal documents.

In continuing court cases over adverse cardiac events skipped over in ads for its pain drugs Celebrex and Bextra, Pfizer subpoenaed from JAMA and sister publication Annals of Internal Medicine all documents relating to the drugs – including the internal comments, correspondence, and profiles of peer reviewers, among the most guarded of guarded documents in academia. Earlier this month, a district court judge ruled denied the motion to compel subpoena, effectively shutting the door on Pfizer’s attempt to get into the proverbial back room of medical journal peer review.

This is good news to D’Angelis. One of the reasons the peer-review process works, she said, is that reviewers trust the anonymity and confidentiality of the process, and handing over such revealing into the internal workings of the process would not only give a pharmaceutical giant a super-inside look at how scientific papers are vetted and published at two major medical journals, but would harm participation in the process itself.

“You’re asking people to put their reputation on the line, to spend their time, their expertise and their effort for nothing,” D’Angelis told the Healthblog. “Why should they do it if they fear there’s going to be some retribution?”