It’s a week of catch up at PostScript – here’s a little link-love before the weekend hits:

A great opinion column appeared in yesterday’s Eugene Register-Guard. The author Gail Hacker M.D., medical director at Lane Community College Health Clinic, does an eloquent job of explaining why drug samples aren’t a solution for her and her underserved patients – and why she feels it’s incumbent on her fellow physicians to turn back pharma’s advances, not the other way around. She writes:

Physicians can afford office supplies and food. Physicians can read journals to get unbiased updates on medications. And if physicians choose to get medical information from a representative of a pharmaceutical company, they can certainly do so without being fed.

Former drug rep talks to docs to Beantown

As we posted earlier this week, former Eli Lilly rep Shahram Ahari was in town talking to medical students and trainees at Boston University, Harvard, Tufts, and Mass General Hospital.  Joe Shortsleeve of WBZ-TV reported on one of his talks and legislation in Massachusetts that would ban gifts to doctors. Watch here.

Congressional clips

Cleveland Plain-Dealer columnist Diane Suchetka takes a look at the proposed federal academic detailing initiative in Congress right now, and talks about the bill with RxP member Allan Coukell, who testified about the practice before the Senate this month.

Coukell also spoke with Pharma Executive about the Physician Payments Sunshine Act, which has been introduced in both houses of Congress.

Business Journal features chief of UMass

John O’Brien, president and CEO of UMass Memorial Medical Center in Worcester, penned this column in the Worcester Business Journal about the process his medical center used to build new, top-tier confict-of-interest policies.

Aussies, AMSA, and Academe

Pharmalot’s been busy, as usual. Here are some recent posts that caught our eye:

Australian Rx is spending big bucks on doctors, too 

AMSA’s how-to on holding pharm-free meetings and conferences

Two MIT researchers’ big idea for restructuring the drug pipeline

Lit review: a false positive?

UC Davis Professor of Medicine Michael Wilkes has this caveat emptor in the Sacramento Bee for those trying to make sense of recent study that found antidepressants little better than placebos in most cases.  Wilkes reads the PLoS Medicine paper as both a case study and cautionary tale about how much we – patients, doctors, even journal editors -  can trust ‘the literature’ in a scientific culture where pharmaceutical companies own the studies and the data they produce.

“Even the process of getting research published in a major medical journal is subject to bias,” Wilkes writes.  “For example, in one recent report, 8 percent of research with a negative result was published in medical journals, compared with 97 percent of research with a positive result.”

This education brought to you by Merck: OK with IOM?

This article from Medical Marketing & Media says the Institute on Medicine is halfway through its slate of meetings on commercial funding of CME, and reports that attitudes on the committee against industry CME may be thawing, but warns that “conflict hawks” like the Josiah Macy Foundation and the Association of American Medical Colleges could still change the status quo.

Shahram Ahari, a former Eli Lilly sales rep, is in Boston this week talking to medical students at Tufts, Harvard, and Mass General Hospital about how reps make the sale to physicians — and how the future docs can resist the pitch.   He speaks here to Jim Braude of NECN about the rules of engagement for pharma’s sales force.

Ahari, now at the University of California-San Francisco School of Pharmacy, has testified recently before Congress on the Physician Payments Sunshine Act and federal academic detailing initiative.

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?”

Dan Greenberg, author of Science for Sale: The Perils, Delusions and Rewards of Campus Capitalism and blogger at the Chronicle of Higher Education posted a list of information he thinks “should be posted in a public database and maybe even on the front page of the campus newspaper.”  Among them – board memberships, consulting gigs of faculty and administrators, research contracts, and institutional financial holdings that may conflict with the work or decisions of the non-profit institution of learning.  While scientific research is Mr. Greenberg’s bailiwick, this is a whole-cloth call for transparency across universities, from which he says there is clearly “a great deal to be gained” in the public interest. (And maybe now Harvard will call him back).

Forget the front page of campus papers — national headline-maker The New York Times has been spending some serious inches in the last week on the less-than-transparent aspects of dealings between doctors and drug and device companies.

“New Focus of Inquiry into Bribes: Doctors,” March 22, 2008

“Countering the Drug Salesmen,” March 20, 2008

“Our Daily Meds,” Book Review, March 17, 2008

And that’s just last week.  With newsrooms digging this stuff up at a faster and faster rate, and legislation on disclosure of payments to doctors now out in both houses of Congress, it seems that universities who get on the transparency train in the ways Greenberg recommends now are much less likely to be left on the tracks if and when further federal action comes down the line.

Last week, we pointed to a story about a settlement Fidelity Investments made with the SEC after word emerged about some pretty opulent VIP handouts from brokers to some Fidelity traders whose business they were courting, including Superbowl tickets, booze cruises, and more – an estimated $1.6 million in gifts between 2002 and 2004.

Now, Roy Poses at Health Care Renewal has brought our attention to some creative non-profit spending by the University of Texas Southwestern Medical Center, courtesy of an investigative reporting team at the local CBS affiliate in Dallas.

Apparently, President Kern Wildenthal and Vice President Cyndi of the (non-profit) Medical Center racked up $125,000 in credit card charges for fine wine (haven’t they heard of Charles Shaw?); but that’s not all. According to the report:

CBS 11 uncovered more than $500,000 in expenses charged over the past two years to credit cards issued to Wildenthal and Cynthia Bassel, UTSW’s Executive Vice President for External Relations. Financial records obtained under the Public Information Act indicate that most of the expenses were paid for with money that was donated to the medical institution.

And $40,000 of a life savings memorial fund given to the Medical Center for ‘professional development’ ended up going toward, well, edibles, including a really top-grade sirloin.

Wait, there’s more. CBS also found:

Both Wildenthal and Bassel have charged thousands of dollars to the credit cards for memberships in social and civic organizations. CBS 11′s review found that donors’ money from the Southwestern Medical Foundation was used to pay for Wildenthal’s 2007 membership dues in the Dallas Symphony ($3500); Dallas Museum of Art ($5000); Nasher Sculpture Garden ($5000); British North American Committee ($6000); Dallas Women’s Club ($850); and the SMU Town and Gown Club ($140).

While this indiscriminate – or very discriminate – spending (depending on how you look at it) may not have altered Wildenthal’s and Bassel’s decisions about a drug being petitioned for formulary, or the type of statin a patient should start on – the kind of conflicts we usually focus on here at PostScript – they are still conflicts of interest, writ large, as Poses points out by returning several times throughout the post to the mission statement of the Medical Center which, it takes little imagination to guess, focuses on the health of patients and the community.

In the same way that consulting retainers bigger than salaries, box seats, and paid educational trips to the tropics for doctors change the subject from good, evidence-based medicine, even subtly, so to do these expenditures at the very top at UTSMC distract from the center’s mission to deliver quality patient care, and set a troubling tone that spending at Southwestern is all about “To your health,” but no good for it.

PostScript goes to the Hill this week, where the Senate Aging Committee held a hearing on academic detailing, the practice of providing doctors with unbiased, evidence-based drug information to counteract pharmaceutical sales pitches.  The hearing was held in anticipation of legislation from Sens. Herb Kohl (D-W) and Richard Durbin (D-IL) to build a federal academic detailing program.

According to the BNA Health Care Daily Report, “The Kohl-Durbin proposed academic detailing legislation would provide grant money to public entities…for hiring academic detailers who would provide educational materials at doctors’ offices and conferences.”

Among those who testified were Dr. Jerry Avorn, a Harvard Medical School professor and lead of the Independent Drug Information Service in Pennsylvania; Sharam Ahari, a former drug-rep who now educates about insider tactics of sales reps; and Allan Coukell, policy director of the Prescription Project.

The BNA also reported that a Senate committee aide called the bill a cost-saver and anticipated strong bi-partisan support.  Read the Prescription Project report on the cost-effectiveness of academic detailing here.

More coverage in the Wall Street Journal Health Blog, ABC News, and Medical News Today.

Good day, Sunshine

And yesterday on the other side of the Hill, Reps. Peter DeFazio (D-OR) and and Pete Stark (D-CA) announced a companion bill to the Senate’s Physician Payments Sunshine Act.  Both bills would require drug and medical device companies to disclose payments to physicians twice yearly in a centralized and public online database.

The Prescription Project is a member of the National Coalition on Medicine and Marketing, which supports both bills. Read DeFazio and Stark’s news release here.

Data-mining bill falls in Evergreen State

The Washington state legislature came close to passing a data-mining bill that would have prevented the commercial use of prescriber data in that state, but fell a few votes short at the close of session.  To find out more on what happened, check out Kate Petersen’s interview with state Rep. Jamie Pedersen at the NLARx website.

Firms settle in drug-pricing case

And news of a third settlement in a 2002 drug-pricing class action lawsuit came this week.  Plaintiffs were awarded $125 million in the case, which alleged that drugmakers artificial inflated the Average Wholesale Price, used by many public and private payors to set drug prices.  Read all about it at the PAL blog.

In case you thought Canadians were less conflicted:

A University of Toronto publication reports that Dr. Claire Bombardier has just been named to a new rheumatology research chair in the Faculty of Medicine.

Who is Bombardier? She was the lead author of VIGOR. That’s the famous Vioxx study in the New England Journal of Medicine — the one in which the authors removed information describing the number of heart attacks in the Vioxx group two days before publication.  There were 17 heart attacks among Vioxx patients and 4 among patients taking the control drug (old, inexpensive generic naproxen). Merck, the study sponsor, continues to defend itself in court.

But, hey, there’s no need to worry any more about ties between Dr. Bombardier and Merck. Her new position is funded by a $1.5 million grant — from Pfizer.
Reference: U Toronto Medicine (March 2008)

Gift ban part of Sen. Murray’s health care bill

On Wednesday, the Massachusetts Joint Health Care Financing committee will hear Senate President Therese Murray’s health care cost and quality.

The Prescription Project, a member of the Massachusetts Prescription Reform Coalition, supports the bill, which includes a total ban on gifts from pharmaceutical and medical device makers to physicians and their families, and provides for an academic detailing program to be established through the state’s public health department.

And it was a newsbuster.

The Boston Globe 1 and 2

Wall Street Journal HealthBlog

WBUR

Boston Herald 1 and 2

Boston Business Journal

Worcester Telegram

Sentinel and Enterprise

Pharmalot

Oregon family physicians go pharm-free

The Oregon Academy of Family Physicians (OAFP) has gone pharm-free, reports the Eugene Register-Guard.  Other Oregon medical centers and private payers are thinking about conflict-of-interest in medical practice, too.

The OAFP, the largest professional medical society in Oregon, announced it will no longer accept industry support for its organizational or educational programming.

This article does a good job of reviewing the literature, the progress, and the industry perspective. RxP director Rob Restuccia talks about how drug samples can serve as another type of inducement for physicians.

For some docs, off-label ads are way off-base

The New Jersey Star-Ledger takes a close look at the guidance on off-label marketing that the FDA proposed two weeks ago.

“It’s easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials,” JAMA editor and RxP advisory board member Catherine DeAngelis told the Star-Ledger.

Americans: Love the pills, hate the bill

Big survey out of Kaiser, USA Today, and the Harvard School of Public Health last week on the way Americans are feeling about prescription drugs. Superquick summary: The drugs? Love them. The prices and the companies? Not so much.

Wonder how those responses change with the news today that we are getting the stuff for free in our water…

Man bites dog

A Massachusetts-based medical device company has sued a doctor for writing a scholarly article that found its artificial hip inferior to another brand of artificial hip, The Boston Globe reported last week.

Beyond the ultra-iffy grounds for the suit, this sets an appalling precedent for an industry whose companies retain armies of lawyers and have marketing budgets comparable to the GDPs of small nations.

But it’s also an interesting switch-up from industry’s more common game of paying physician-researchers as consultants in hopes that their products get more favorable play in research, or of medical ghostwriting, where doctors put their names to scientific articles that really come from the same place press releases do.

Germ theory => conflict of interest

Anyone who studied history of science (don’t be shy) may appreciate this analogy as much Howard Brody and PostScript did.

In a television interview Brody found, Healthy Skepticism’s Peter Mansfield compared germ theory father Ignaz Semmelweis’ controversial claim in the 1840s that doctors were giving their patients childbed fever by not washing their hands to modern doctors’ incredulity that accepting gifts from companies could harm their patients.

Of course, Mansfield says it better, so read on.

Yesterday, The Boston Globe reported that Fidelity Investments will pay $8 million to settle charges that traders improperly accepted gifts from brokers seeking their business.  The SEC investigation revealed that traders for the Boston-based company received an estimated $1.6 million in gifts (including sports tickets and some very strange bacchanalia involving dwarves) between 2002 and 2004. Some of the 13 traders involved are still under investigation by the SEC, and Fidelity has admitted no wrongdoing in the settlement.

The Globe excerpts several email from brokers who were gifting, including this one to a Fidelity trader in March 2003: “Your prompt response will be rewarded w/ Celtic playoff seats. Thanks for caring.”  According to The Globe, “the SEC said Fidelity traders failed to seek the best stock trades on behalf of its mutual fund customers because their choice of brokers was influenced by gifts.”

Different verse, same refrain.  Gifts influences behavior, whether you’re prescribing Zocor or selling shares of Merck.  And in both cases, the costs of those compromised decisions fall to a party that, well, wasn’t invited to the party…or the Celtics game…or the golf trip.  While the guardians of our health and our finances jockey for favor and market share, it seems we patients and investors are left to pick up the tab, and swallow the pill.

And speaking of gifts…

 A relevant editorial appeared in the Hartford Courant today about the dim prospects for two bills that address the gifts-for-prescribing regulatory waltz industry has been doing around federal anti-kickback rules.  Last year’s bill, which never got voted on, would have required pharmaceutical companies to disclose all gifts to docs and other health care providers or face a hefty fine. This year’s, also DOA, would ban quid pro quos (which the federal anti-kickback statute already does), gifts for physicians personal use, pharma-physician consulting deals without specific deliverables, but would allow small business-use gifts (like post-its) and samples to continue. 

Both bills were proposed by Connecticut AG Richard Blumenthal and supported by the Connecticut Center for Patient Safety.

The Wall Street Journal health blog puts the Courant editorial in the context of several other state and federal bills being considered to rein in the gifting of doctors – including Massachusetts, where Senate President Therese Murray introduced a health care bill this week that would, if passed, become the first complete ban on industry gifts to physicians in the country.

PostScript spends a lot of time talking about industry payments to physicians – often bribes by another name.  So when we ran across this article in the Economist Budapest diary about bribes to doctors – from patients – we were intrigued.  (Inside the link, scroll down a bit to the Thursday post).

In Hungary, it seems it’s customary for obstetricians to receive a halapenz, or “gratitude money,” after making deliveries. That’s why it’s “easy to spot the gynecologists and obstetricians’ vehicles in the hospital car parks—they are usually the row of shiny new Audis, BMWs and Mercedes,” writes the Economist.  The medical tipping is a vestige of the Soviet rule (when doctors pay was slashed) and is done, to some extent, in all specialties, with an estimated 20 percent of Hungarian physicians pocketing such handouts from patients.

The article is full of interesting nuggets about the Hungarian health care system (including the shutdown of a disclosure website that outed doctors accepting halapenz and published their going rates).   For instance, Hungarians go to the doctor 12.6 times per year, to the British’s 5.1 and Americans’ 3.8 – so the Hungarian government has created a 300 forint surcharge for each visit – despite the fact the health care system is managed and paid for by the state. And Hungarians have 9.7 children per thousand citizens, compared to 14 children per 1000 in the United States.

The correspondent writes:

 Perhaps Hungarians might have more children if it did not cost so much. Doctors often charge around 7,000 forint for each monthly examination. Birth costs around 80,000 forint—more than the monthly minimum wage—for the doctor, and perhaps another 10,000 forint for the midwife. This even though the patients and their employers have already paid their social insurance and the medical staff are state employees, working in state hospitals.

Of course, the lower birthrate may have nothing to do with the price of Hungarian prenatal care. And the correspondent seems to imply that 14 births per 1000 is a just-right sort of number, without addressing the personal/private/government breakdown of birthing costs in the U.S. (According to the Healthcare Cost and Utilization Project, the average hospital cost for a U.S. birth in 2003 was $8,300, or 1,426,272 forint today – not including regular prenatal checkups or complications.)

Still, it’s a fascinating glimpse into the strange personal spending required in a post-Soviet socialized health care system.