It was a big week for the AMSA Scorecard, which popped up in the New York Times story about Harvard Medical School’s extensive ties to industry and what some medical students and faculty are doing to bring them to light. The story topped the most-read column on the nytimes.com site for a few days and sent Sen. Charles Grassley back to his writing desk, where PostScript imagines he writes all his letters to wayward drug companies and non-disclosing academics. This time he wrote to Pfizer, asking for the details of payments to 149 Harvard medical school faculty revealed in the article, and for any information the company has on the amateur photos of a medical student rally at Harvard in November snapped by one of its employees.

Time magazine had this look at AMSA’s campaign to get prescription drug money out of medical education. “The school might have turned a whole new shade of crimson when its flunking grade from AMSA was made public last summer,” Time wrote of Harvard’s now very public F on the Scorecard.

AdvaMed, the medical device industry’s trade association has introduced new guidelines for direct-to-consumer advertisements. The guidelines, which are voluntary, suggest that device ads should be consumer-friendly, and can feature celebrities, but while they may be friendly,  they won’t protect consumers, RxP’s Marcia Hams told Reuters.

Federal prosecutors will begin to single out and prosecute doctors who accept kickbacks for prescribing, according to this New York Times story. In the past, prosecutors have taken on the companies rather than the doctors, because they believed juries would not convict respected clinicians, a strategy that they say is about to change.

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services told the Times. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”

And in the wake of the Wyeth v Levine decision at the Supreme Court this week, Congressional leaders are preparing to introduce a law that would overrule the Court’s Riegel v. Medtronic decision, which established that consumers injured by a medical device could not seek recourse in state courts because federal law pre-empts it.

“Any impact of the Wyeth decision for device companies would depend on whether Congress does respond by overriding the device decision by the Supreme Court last year,” wrote the Times. “That ruling said the 1976 law giving the F.D.A. authority over medical devices had also provided a legal shield to devices that undergo the agency’s highest level of review.”

In the heartland, a bill that would limit gifts to doctors, require physician payments to be disclosed and creates an academic detailing program has passed the full Health Committee in the Iowa legislature.

Read more about the original bill in the Des Moines Register.

This in-depth story in the Milwaukee Journal-Sentinel looks at the new conflict-of-interest rules drafted by a task force at the University of Wisconsin. If approved, the rules would prohibit physicians from doing ‘dinner talks’ for drug companies and require faculty to disclose specific amounts of payments from drug and device companies, to within $1000. The current policies received a strong B grade on the AMSA Scorecard in 2008.

“When the spotlight of impropriety is shone on an institution, they either create a set of policies or they establish an office,” COI expert Eric Campbell told the Journal-Sentinel, noting that enforcement of any final policies is just as critical as the policies themselves.

A goof by the IRS has revealed some previously undisclosed donations to a charity Sen. Orrin Hatch started and for which he is still a booster. Payments by five pharmaceutical companies and PhRMA to the Utah Families Foundation far exceed what the companies could donate to Sen. Hatch’s re-election campaign.

“The donations, $172,500 in all, came at the same time that the Pharmaceutical Research and Manufacturers of America (PhRMA) was paying one of Mr. Hatch’s sons, Scott, to be its lobbyist in Congress,” wrote the Washington Times, which obtained the documents.

And just when we thought everyone had stopped asking, the Associated Press went and did it again: Is the FDA a broken agency?

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Rep. John Dingell, (D-MI) told the paper. “They are running around like a lot of headless chickens.”

Amidst all the merrymaking of the past weeks, here’s what PostScript was reading…

FDA: a fixer-upper?

Obama and the FDA – will he fix it, and when? Those are the questions Tribune reporter Noam Levey asks about the troubled agency and where its reforms may fall on the growing list of the President-Elect’s priorities.

And Merrill Goozner at Gooznews talks about the consumer voice in discussions about the next FDA commissioner. Goozner says Obama’s FDA transition team has worked to bring all voices to the table, and is confident the consumer perspective has been heard.  We liked his credo of sorts at the end:

“Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner,” Goozner writes.  “That’s not faster cures. That’s smarter cures, even as the new commissioner insists that they still meet the agency’s statutory hurdles for safety and efficacy.”

Northern Disclosure

And in the snowy Midwest this week, there were two very different stories swirling around conflicts of interest at two major academic medical centers.

The University of Wisconsin-Madison announced it will post signs at its health clinics indicating that doctors may take drug company money for research and consulting beginning in January. Earlier this year, the UW School of Medicine and Public Health revised its conflict of interest policies, tightening restrictions on industry-sponsored meals and establishing a strong samples program that would provide pharmacy vouchers to clinic patients, eliminating the freebies-bias toward newer and often more expensive drugs.

The Wisconsin State Journal reports that despite this move toward greater transparency with patients, who will be able to ask for details about their doctor’s industry relationships, the University will not be publishing physicians’ corporate receipts in a public way anytime soon.

“It would take a lot of time and effort to have an updated database,” the dean of the medical school, Dr. Robert Golden, told the Journal. “We believe it will be only a handful of patients requesting this.”

Meanwhile, the Minnesota Star-Tribune revealed that the head of the committee charged with developing a new set of conflict of interest policies for the University of Minnesota Medical School, Dr. Leon Furcht, was censured in 2004 by the Dean that appointed him for diverting $500,000 in industry research dollars to his own stem cell company.  Furcht, who just emerged from a three-year sanction period that banned him from involvement with any commercially-backed research, is now co-chair of the committee convened to write the University’s policies regulating faculty and student interaction with industry.

This Star-Tribune editorial praises the COI policy process at the med school but says the choice of Furcht to head the committee undermines the credibility of any policies it will produce.

Diagnose This

And the Los Angeles Times looks at the kerfuffle developing around the nondisclosure agreement the American Psychiatric Association had the writers of the DSM-V sign. The Diagnostic and Statistical Manual of Mental Disorders, which was last updated in 2000, has major influence on and implications for psychiatric diagnoses and treatment, insurance reimbursement, and social concepts of what it means to be well or disordered.

One of the new authors, Dr. Robert Spitzer of Columbia, has broken rank and has openly opposed the mandated secrecy as something neither his profession nor the field of medicine can afford. Reading about “chronic complaint disorder” from published working papers of an earlier DSM committee, we understand why they might not want to let the diagnostic dogs out just yet.

An excellent piece on the DSM in the New York Times, as well.

Angell Reviews Rx Books of 2008

Along literary lines, former New England Journal of Medicine editor Dr. Marcia Angell writes in the New York Review of Books about three books on Big Pharma’s influence on medicine: Our Daily Meds, Side Effects, and Shyness: How Normal Behavior Became a Sickness.  Without the space limitations of other publications that tackle this complex web of problems around industry involvement with medical decision-making, Angell is free here to connect the dots: from the systemic bias of company-sponsored clinical trials, to the cultural secrecy and acceptance of corporate support by academic researchers who write treatment guidelines, prescribe, and advise the FDA, to the growth of off-label prescribing and industry’s subtle and multi-front campaign to promote it – Angell brings these texts together with her own experience as editor in what makes for an eloquent problem statement about the state of industry influence on academic medicine.

“The mission of medical schools and teaching hospitals—and what justifies their tax-exempt status—is to educate the next generation of physicians, carry out scientifically important research, and care for the sickest members of society,” Angell writes. “It is not to enter into lucrative commercial alliances with the pharmaceutical industry. As reprehensible as many industry practices are, I believe the behavior of much of the medical profession is even more culpable.”

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.

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.

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.

Data-mania!

Eighteen states considered restrictions on commercial use of prescriber data this year, according to this Associated Press story.  But a pending decision in the 1st Circuit Court of Appeals (IMS v. Ayotte) about the legality of the first-in-nation New Hampshire data mining ban has largely frozen the issue, which is earning attention at the federal level, as well.  In the spring, Sen. Herb Kohl (D-WI)  made some inquiries into the American Medical Association’s sale of its prescriber profiles for hefty sums each year.

“We have no privacy issues here,” IMS vice president Randy Frankel told the AP, but many physicians and their advocates (RxP among them) say it goes beyond politesse, and that pharma reps who know covertly doctors’ prescribing patterns are invading the doctor-patient relationship by often pitching the most expensive, least-proven drugs.

Read the RxP fact sheet on data mining here.

Speaking of places where there are privacy issues, this Des Moines Register says that no one has been prosecuted for violating the federal patient privacy law known as HIPAA, the Health Insurance Portability and Accountability Act, even though “38,000 Americans, including 267 in Iowa, have complained of HIPAA violations to the federal Office for Civil Rights” since enforcement began in 2003.  According to the Register, “[m]ore than half of those complaints nationally have been disposed of with no investigation. Until last year, no one nationally ever was prosecuted for violating HIPAA.”

And then there were two

Though we saw numbers like this earlier this year, now there are Just Two, so here’s a pre-convention update: Going by campaign contributions, Pharma is hedging for Obama, and in a big way. According to a Center for Responsive Politics study, first reported by Bloomberg, presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) has received three times as much pharma moula as presumptive Republican nominee John McCain (Ariz.).

Check it out at The Scientist Blog.

Vioxx papers reveal marketing roots

In a paper published in the Annals of Internal Medicine this week, researchers found evidence in the Vioxx documents that the ADVANTAGE trial was drummed up entirely by the Merck marketing department.

According to the paper:

The trial emerged from the marketing division with a marketing objective; Merck’s marketing division collected, analyzed, and disseminated both the scientific and the marketing data; and Merck did not reveal the marketing purposes of the trial to participants, physician-investigators, and institutional review board members.

For those of us who read Melody Petersen’s book, Our Daily Meds, such news isn’t as surprising as it ought to be, but all the same, we’re glad to see this truth vs. advertising getting into the medical literature.

Now you CMAP, now you don’t

The Dallas Morning News reports that the Children’s Medication Algorithm Project, a preferred drug program for psychiatric medications in Texas, has been halted as part of an ongoing investigation by that state’s Attorney General.  TMAP, the adult precursor, triggered a suit alleging undue pharmaceutical company influence on the selection of the drugs.

According to News, “[a]t least four of CMAP’s key developers – all affiliated with the University of Texas system, and all of them published child psychiatry experts – have received research funding from drug companies, or have been consultants and speakers for several different pharmaceutical firms.”

“In our country, there’s been a switch from taking care of people to focusing on big corporate money,” Rep. Juan Escobar told the News.  According to the News, Rep. Escobar proposed unsuccessful legislation in Texas last year that “would have banned researchers or government employees funded by the pharmaceutical industry from designing state psychiatric drug protocols.”

Hat tip to Pharmalot.

Deja – vu all over again

Harry and Louise are back, and they’re having some second thoughts about healthcare. Check out the story in the Detroit Free-Press here.

Gooznews says ‘Well-I-Never’ to results from a survey by marketing researchers at PeopleMetrics that talked docs about sales rep interactions around atypical antipsychotics, grouping them into ‘Fully Engaged,’ ‘Engaged,’ ‘On the Fence,’ ‘Disengaged’ (all terms for prescribing potential, we presume). The survey concluded that “emotional components such as friendship with the reps are the strongest indicators of Fully Engaged physicians,” and will be “the most impactful drivers of physicians’ prescribing behaviors.”

Reading this made us think of another industry opinion survey, released last month by the Pharmaceutical Researchers and Manufacturers of America, that showed relationships with sales reps have relatively light impact on final prescribing decisions.  (That survey coincided with the trade industry’s introduction of new guidelines, which prevent those non-influential reps from giving doctors non-influential gifts or lavish meals.)

TIME  has a great story on prescriber education that focuses on South Carolina’s program SCORxE, or South Carolina Offering Prescribing Excellence, “which trains its pharmacist-reps to visit doctors’ offices armed with unbiased studies.”   TIME says that as Congress considers a new bill, the Independent Drug Education and Outreach Act of 2008, SCORxE is receiving unexpected support and enthusiasm from government leaders looking for ways to improve evidence-based prescribing in their state. 

The Boston Globe looked at biotech and medical device companies’ reactions now that Gov. Deval Patrick signed the cost and quality bill with pharmaceutical marketing restrictions. According to the Globe, companies that threatened in advertisements and op-eds last week to leave Massachusetts or halt clinical trials there now have no plans to move operations.  In addition, “Patrick said he is confident the state health department could develop regulations consistent with both the law and the state’s commitment to strengthen the life sciences sector, a statement that reassured some executives.”

And Bernard Carroll at Health Care Renewal digs deeper into the conflict storm around Alan Schatzberg, the Stanford psychiatrist who was the focus of a recent conflict of interest by Sen. Chuck Grassley (R-IA).  Carroll discusses the ways in which Schatzberg’s position as principal investigator in NIH-funded trials for the drug mifepristone, a depression treatment created by Schatzberg’s own company, Corcept Therapeutics, muddied reports on the drug’s efficacy. 

The Reader can’t do Carroll’s dot-connecting justice, but we encourage you to read for yourself.

The American Psychiatric Association, where Schatzberg is slated to take the reins next year, is taking a look at its own ties.  The American Medical News checks in with the APA Ad Hoc Workgroup on Adapting to Changes in Pharmaceutical Revenue, which was appointed to review its reliance on and ties to industry last Spring and will report in October.

According to the AMN, “Pharmaceutical revenue accounted for 28%, or $14 million, of the 38,000-member APA’s 2007 budget.”

The Health Care Blog has a discussion of the UK’s National Institute for Clinical Excellence, as presented at a recent HealthTech lunch in California. Interesting discussion as the Congress considers a comparative effectiveness institute, introduced by Senators Max Baucus (R-MT) and Kent Conrad (D – ND) before the summer recess.

And to make sure folks on the Hill hear from the folks not at the rallies and fundraisers, our friends at Prescription for Change/ Consumers Union got in ‘the RV’ (we wish it had a name ending in –mobile, but can’t find one on the site) and are driving across the U.S, talking to people struggling to afford health care and those going without.  We can’t help wondering if the Cover America crew has ever been stuck behind PhRMA’s ‘Help is Here Express’ or McCain’s ‘Straight Talk Express’ at the tolls.

Now that we think about it, maybe it’s better the RV remains unnamed.

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.

PhRMA announces changes to marketing code

The main trade association of the drug industry, Pharmaceutical Researchers and Manufacturers of America, announced today it is revising its voluntary code ‘Interactions with Healthcare Professionals’ to ban small gifts such as pens, mugs, stethoscopes, and impose bigger suggested limits on support for travel, Continuing Medical Education, and consultants. [For you seeing-is-believing types, check the revised code out here.]

According to the New York Times, the new code “provides no definite limits on the millions of dollars spent on speaking and consulting arrangements that drug makers have forged with tens of thousands of doctors. Nor does it ban the routine provision of office breakfasts and lunches, or the occasional invitation to educational dinners at fancy restaurants.”

Though the industry’s Code till now has been unenforceable and vague, the announcement of the change, a day after the UK drugmakers association adopted new provisions, may change the game for state lawmakers considering a ban on gifts to physicians. Such a ban is currently under review by Massachusetts state lawmakers, and is already on the books in Minnesota.

“A voluntary restriction on the small gifts used by pharmaceutical companies to curry favor with doctors is a step in the right direction, ” said Rob Restuccia in a Prescription Project statement on the Code revisions, and added that the change “is an important complement to efforts by state and federal policymakers to limit industry marketing.”

And it’s time to get your own pens, docs, says the droller Wall Street Journal Health Blog.

Salesforce in the Green Mountain state grows

Pharmalot’s Ed Silverman sums up the latest numbers from Vermont’s pharma payment disclosure law: “A total of 84 drugmakers spent more than $3 million dollars in Vermont in fiscal 2007 to influence sales, a 33 percent increase over the previous year and a 42 percent jump from two years ago, according to a report issued by the state’s attorney general.”  Four out of the five of the top marketed drugs in the Green Mountain State are used to treat ADHD or depression, according to the report.

Acronym Soup

This Inside Higher Ed article looks at the path toward greater federal regulation of conflicts of interest among academic researchers, some pending legislation on the Hill that might change the laws around financial disclosure of those funded by NIH grants, and some of the milestones (and Senators) that got us here.

From the glad-someone-caught-it dept.

Howard Brody over at the Hooked blog spotted this exchange between former NEJM editor Marcia Angell and the Manhattan Institute’s Benjamin Zycher in the pages of the Wall Street Journal. When Mr. Zycher opinioned in the Journal that Big Pharma is an indispensable piece of the research machine, Dr. Angell cries foul on industry credit-taking for what she writes is often publicly-funded university research that gets licensed (and profits) later.

It’s a slugfest, and Brody is the best sort of bystander, polite but not deferent, someone who knows a ball from a strike before the umpire moves, and doesn’t spill nachos on your feet in the fourth.

AMSA applause

And a few RxP allies at the American Medical Student Association got a tip of the hat and a little cash to boot for their notable work in AMSA’s PharmFree program, in the form of The Medical Letter-AMSA PharmFree Scholarships. Congratulations Jonas, Gabe, and Lekshmi.

Keep on keepin’ on – the Lipitor bump

And in a predictable industry find, the good folks who bring you Lipitor found in a study published in the July issue of Current Medical Research and Opinion – surprise! – patients are more likely to stay on Lipitor than its competitor class of  (cheaper) simvastatins. The text: good news for patients and doctors, because medicine adherence is key to managing disease. The subtext: good news for Lipitor, because once you’re on it, you stay on it, even though recent studies dispute its artery-clearing powers against a placebo.

We’re waiting for someone to do an adherence study comparing a drug and nothing-at-all. PostScript bets it’s easier for folks to remember to take the pill you don’t have to.

This, of course, is only a hypothesis.