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.

With headlines about Sen. Chuck Grassley’s investigations into industry payments to psychiatrists rolling in as predictably as, well, payday, PostScript thought it would be good to get a little perspective from someone in the field.

So we talked last week with Dr. Joseph Sokal, an associate professor of psychiatry at the University of Arkansas – Little Rock, and chair of the ethics committee at the National Physicians Alliance. 

Here’s what he had to say about the industry’s footprint on the field and what Grassley’s inquiry means for his work.

PS – Do you think your field has special need for pharmaceutical collaboration or, conversely, a special susceptibility to pharma influence?

JS – To date the data indicates that psychiatrists often lead other specialists in taking money from the pharmaceutical industry.

There are a number of forces at play here. One is psychiatry’s movement towards a more biological, brain-based model of psychiatric illness and a correspondent emphasis on pharmaceuticals to correct underlying, “chemical imbalances.” This has naturally led to closer relations with the pharmaceutical industry who play a critical role in developing the treatments that most in the field rely on.

Pharma also heavily funds research that helps advance many an academic career. It is too much to say that philosophy only follows funding in this case, but it is naïve to think that philosophy has not been effected by this funding source. Psychiatry is one of the most poorly paid specialties in medicine, making money from the pharma industry that much more attractive. 

Add to that the emergence of relatively safe antidepressants in a culture very interested in happiness but not necessarily so interested in reflection, and a healthy pharmaceutical industry that has championed those diagnoses that lead to greater profit, and you have the environmental conditions for a perfect storm.

Clearly, psychiatry needs to clean its house. With that said, it is clear that this is a major problem for medicine as a whole, and focusing exclusively on psychiatry would be significant mistake.

PS – So you’ve already talked a bit about the changes you’ve seen in the field over the last thirty years—do you see that the awareness is changing also?

JS – I do think that there is an increasing awareness that this is a meaningful problem that must be addressed.

PS – Does Grassley’s inquiry into the financial statements of the American Psychiatric Association (and his earlier inquiries into Dr. Biederman and Dr. Schatzberg) have impact on your work, and if so, on what level?

JS – Yes. When the major professional organization for my field is being critically evaluated it affects the public’s view, which ultimately affects the work I do with patients.

PS – As a member of the University of Arkansas medical faculty, have you seen your institution take steps on these issues?

JS – UAMS does have guidelines for interacting with Pharma reps. The NPA ethics committee is also working on guidelines to address several aspects of medicine/pharma relations.

PS – Do you have the sense that these will be stronger than many med schools?

JS – Yes. At the NPA, we are fundamentally committed to strengthening the public’s trust in the integrity of medicine. This means actively addressing and sanctioning behaviors that undermine physicians’ fiduciary relationship with patients or give the impression of doing so. Because of this, we intend to set the highest possible standard. It is worth noting that the NPA does not get any of its funding from the pharmaceutical industry.

Yesterday, Massachusetts Gov. Patrick signed the omnibus health cost containment bill, enacting some of the strongest pharmaceutical marketing restrictions in the country. (Press release here) The law requires drug and medical device companies to disclose payments to health care providers over $50, establishes a prescriber education program, and gives the Department of Public Health power to establish regulations at least as strong as those in the Pharmaceutical Researchers and Manufacturers of America voluntary Code, which prohibits small gifts, travel payments, and extravagant restaurant meals to doctors.

S.2863, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care, also expands state medical school rolls to train more primary care physicians, encourages the use of electronic medical records, and establishes a hearing process for insurance companies that choose to raise premiums.

The governor weathered a heavy week of lobbying from the industry, including a full page ad in the Boston Globe threatening to leave the state if he signed the bill into law. (See our blog here.)

“I have a lot of respect for the governor, and I am proud that he did not bend to the pressure,” state Sen. Mark C.W. Montigny (D-New Bedford) told the Standard-Times. “I have never seen lobbying this intense. They have been swarming the Statehouse for weeks.”

Health Care For All, our coalition cousins in the Massachusetts Prescription Reform Coalition, cheered the signing on A Healthy Blog, reminding us that the bill is a victory not just for better pharmaceutical marketing practices in the state, but because it makes way for better health care for all. 

The passage of important checks on excessive industry marketing “shouldn’t lead us to ignore the many other provisions in the bill, from an e-health program that preserves consumer confidence to significant primary care enhancements to a directive to find a way to fundamentally restructure the payment system to promote health, rather than high-cost treatments. The statute truly is Health Reform II, and will undoubtedly be followed by further refinements in the future.”

Coverage abounds:

Boston Globe

Associated Press

Wall Street Journal Health Blog

For an industry that regularly tops the charts on profit margins, we weren’t surprised to see the full page ad in the Boston Globe today, signed by the Biotechnology Industry Association, Massachusetts Biotechnology Council, Associated Industries of Massachusetts, Massachusetts High Technology Council, Cambridge Chamber of Commerce, and the Pharmaceutical Researchers of Manufacturers of America itself.  To be honest, we were sort of surprised that they didn’t underwrite an entire special edition of the Globe.

Framed as an epic decision for Massachusetts Gov. Patrick, who must soon take action on the health care cost and quality bill passed by the Massachusetts legislature last week, the full-page humdinger pulls out all the stops. There’s size, of course. Flattery: (“Governors everywhere…have always been extremely envious of the Massachusetts’ Life Sciences sector”).  Matters of Life and Death: “The hope for so many patients, suffering so much, will be diminished.”).  And then, our personal favorite, the good ol’ Pat on the Back: “Is our industry successful, absolutely!”

But it’s hard for us to see why an industry so successful is fearfully baring its teeth at a bill that merely codifies its own code of conduct, which already bans sales reps from giving doctors small gifts and travel. If the industry is as proud as it says about making “products that save thousands of lives every day,” then it shouldn’t be so worried about having to stop treating doctors to dinner. The merits of those products should speak for themselves.

The ad signatories go on to warn of the doom to befall the Bay State if Gov. Patrick signs this bill, which they say will force clinical trials being done in the Commonwealth “elsewhere tomorrow.” “The chilling effect that this will have on the life sciences industry in Massachusetts could not be more obvious,” the ad intones. A less than gracious threat to a state that just committed $1 billion to the life sciences enterprise.

Now, we don’t know much about writing newspaper ads – but we think that when you address the Governor, you should assume he’s read the bill. And for anyone who has read the bill, the claims about clinical trials in this full-page epistle are plainly false – lawmakers explicitly designed it so it would not hinder or interfere with biopharmaceutical research: ( S. 2863 Chapter 111N, Section 2) “The marketing code of conduct adopted by the department shall allow:… 4) compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial.” Furthermore, patients will still be able to receive free drugs during clinical trials, since samples continue to be allowed under the bill.   

“The legislation that awaits Governor Patrick’s decision will significantly curtail, if not end all together, the availability of these last hope clinical trials,” the ad says, because the law would require companies to disclose “the products and areas of research” in which they are involved.

This law wouldn’t do that at all.  And much information about clinical trials is already public record – by law, drug companies seeking FDA approval are required to register those data about all clinical trials on clinicaltrials.gov.  The only way the new law would affect clinical trials is to disclose the amounts paid to investigators.  And if the industry is as proud as it claims to be for creating life-saving products, then viable payments for legitimate services should be no problem – and are certainly no trade secret. 

“These are your family members, friends, neighbors,” the ad goes on. Precisely. This act, as part of the larger cost and quality bill, would serve those very people by making sure their doctors have the unbiased information on the safest, most effective drugs, and by letting them see whether their doctors take money and gifts from the companies who make the drugs they’re prescribed. 

Governor, this bill means good medicine for your family members, friends, and neighbors, and we urge you to sign it.