Last week, Maine’s governor signed LD719 into law, repealing a series of pharma transparency laws including one that required drug companies to report certain marketing costs, including meals and gifts to physicians. I talked with Maine representative and director of the National Legislative Association on Prescription Drug Prices Sharon Treat (D-Hallowell) to find out what this repeal means for her state, the wider transparency landscape, and what we might expect next.

PS: There’s been a lot of action on the state front again at the end of this budget season. Massachusetts protected its gifts ban from some aggressive repeal threats, and now Maine has repealed its disclosure law. Maine’s move doesn’t seem to reflect a bigger consensus. What do you see happening at the state level?

ST: The new Republican governor and majority in the Maine Legislature have together now repealed not only the state’s gift disclosure law, but nearly every progressive prescription drug policy we have, including our pharmacy benefit manager (PBM) law, and pricing transparency.  This is not surprising as there are very close ties between the pharmaceutical industry and the Republican party in Maine. None of these laws were easy to pass in the legislature even when Democrats had the majority, because the drug industry is very powerful when it comes to influencing politicians.

I don’t think the repeals reflect a change in what the public thinks.  In fact, I doubt if most Maine people have any idea what’s been repealed.  This session a lot of attention was focused on proposed repeals of many of our environmental laws, and in that case the public uproar stopped the rollbacks from going forward.  In the case of the pharmaceutical laws, there aren’t strong consumer advocacy groups in the state that have taken up these issues, partly because so many other social policies are on the chopping block at the same time.

PS: There’s a lot of talk about state Medicaid budgets these days. Why is disclosure an important piece of the cost equation, to your mind?

ST: Maine’s gift and advertising disclosure law was enacted originally because legislators wanted to know how much was being spent by the pharmaceutical companies on promotional activities, since the industry claimed that drug prices had to be high in order to support their R & D activities.

The information gathered showed that advertising and promotion outspent R & D.  It helped make the public case for reducing high drug prices.  Then, as the data was collected, more public attention was paid to conflicts of interest and the role of gifts and payments in driving prescribing of the highest priced branded drugs.  It helped open peoples’ eyes to larger issues of safety and appropriateness of prescribing.

Maine also had a law, also just repealed,  that directly collects drug price data from the pharmaceutical companies and requires a person with authority to certify the truth of this data. This independently collected information was a direct help to the state in negotiating very favorable rebates and limiting pricing fraud under the Medicaid “best price” requirement (nationally major drug pricing fraud cases are common).  Maine gets a return on average of about 50 percent of its Medicaid drug spend back in rebates, and having this check on drug company pricing reports has helped avoid fraud and keep our Medicaid prescription drug budget in line, with minimal increases over the years.

PS: Your colleague, physician Linda Sanborn, also supported the Maine transparency law, and state physician groups have supported similar bills and laws elsewhere. Have you heard from Maine physicians on the repeal, and next steps?

ST: Dr. Sanborn spoke eloquently in the floor debate about the need to have public disclosure of the clinical trials data- another law that was repealed.

Fortunately, federal laws will eventually pick up the slack on both the clinical trials database and reporting on gifts and payments, but the Legislature’s majority did not support even linking our state website to the federal databases.  All of the Democrats on the Health and Human Resources Committee strongly supported these laws and spoke to the issues.

The physician groups were most active trying to prevent the repeal of the academic detailing program, which they are now very involved with implementing.  Although the funding was reduced, this program did stay alive in part because of their advocacy.

In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor.  If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.

I was actually shocked that so many legislators who ran for office on platforms of preventing fraud and abuse passed two laws that repealed effective anti-fraud laws– the PBM law repeal and the pricing disclosure law. These repeals will hike the costs of the Medicaid program (as confirmed by the Legislature’s fiscal office in the fiscal note on the legislation).

PS: Transparency of industry marketing relationships with prescribers isn’t going away. Taking the long view, what can we expect next?

ST: I think we will see a more active media in Maine looking into the federal doctor payment databases and the financial links between big pharma and Maine politicians.  I expect that there will be more awareness going forward about these conflicts of interest.  My hope is that this awareness will once again lead to taking action with public support and a more receptive legislature and governor.

–Interviewed by Kate Petersen, PostScript blogger

Α new study in the Archives of Internal Medicine suggests that academic detailing may improve physicians’ adherence to clinical guidelines, findings that boost AHRQ’s recent announcement to back 9000 academic detailing visits over the next three years.

Using the not-so-memorably-named ALLHAT/JNC7 Dissemination Project, researchers looked at office-based academic detailing visits to more than 18,000 physicians in 41 states between 2004-2007 and correlated data from a national pharmacy database. The ALLHAT clinical trial, published in 2002, found that the use of thiazide-type diuretic, an antihypertensive, lowered risk of heart attack. Prescribing of thiazide-type diuretic during 2004-2007 in counties that received academic detailing visits rose 8.7 percent, but only 3.9 percent in those without academic detailing programs.

This study was conducted using county level data, so causal associations between educational interactions and prescribing at the individual physician level could not be established. Still, this paper supplements a body of evidence suggesting that academic detailing visits can improve physicians’ awareness of and reliance on evidence-based clinical guidelines.

Academic detailing sends physicians, pharmacists, nurses and other clinical professionals into practice settings to give unbiased, balanced, evidenced-based information to prescribers on the safety and efficacy of certain drugs. I wrote about academic detailing as one piece of the evidence-based prescribing policy puzzle here.

–Kate Petersen, PostScript blogger

We read with interest Merrill Goozner’s blog, “Putting Academic Detailing in Perspective.” See, the Agency for Healthcare Research and Quality recently distributed $30 million of stimulus funds to 9000 locations around the country to get doctors unbiased patient-centered outcome research through academic detailing, also sometimes called prescriber education. (Community Catalyst and the Pew Prescription Project have supported federal and state academic detailing efforts–more here and here.)  Goozner seems to suggest that, while nice,  such grants cannot hope to match “the combined might of the marketing arms of Big Pharma, Big Bio and Big Device.” With a little guess-timation, he says the number of academic detailers that such grants could deploy is a drop in the bucket compared to pharma sales reps: “Do the math,” Goozner writes. “50,000 for the drug industry; 300 for the truth squad. Henry V had better odds at Agincourt.”

Well, sort of. Yes, in numbers, the (shrinking) army of company detailers far outstrips the number of academic detailers currently in the field, or that would be deployed as part of AHRQ grants. But there are other questions of public policy and public health at work here, and it’s worth looking at what those are.

Academic detailing, to refresh, sends trained clinicians such as pharmacists and nurses into the field to talk to doctors. Versed in the body of research on a condition or drug class, the academic detailers talk with doctors about what the science shows to be the safest, most effective treatment out there. They are employed by a nonprofit or a public agency—and therefore not working on a sales commission or motivated by profit to promote one product over another.

Though some doctors may be looking for perks or samples, many say they talk to drug reps because they can’t always find the information they need elsewhere. But it’s more useful for a busy doctor to meet with one academic detailer who knows about all therapies for a given condition and how they’ve faired in trials, than to meet with several commercial detailers, who rarely have clinical backgrounds and are interested, in every case, in talking up one product: theirs.

And there’s the big difference: sales reps are there to sell drugs. Academic detailers are there to talk about what drugs and therapies are out there, and what the science shows works best.

Goozner’s shrug of a post also ignores the bigger picture: Academic detailing isn’t happening in a vacuum. The deployment of prescriber education at local, state and regional levels in the last five years—and now at the federal level—is part of a growing awareness that pharmaceutical marketing has the potential to interfere with safe prescribing and patient care—and a broader effort to make sure it doesn’t.  Medical schools, trade organizations, and a range of medical specialty societies have adopted policies to clarify the relationship between pharmaceutical companies and their members and faculty. Companies have begun to disclose their payments to doctors, and the Physician Payment Sunshine Act passed, establishing a new national transparency standard.

Goozner (and PhRMA President Ken Johnson, in recent comments), seem to suggest that academic detailing is a purely counter-industry tactic, designed to take on—or take down—Big Pharma.  But it isn’t, and to suggest so obscures academic detailing’s real, and very common, mission: to improve clinical care.

There are thousands of investments made daily at local and system-wide levels to improve patient care, and this is one of them. Academic detailing is, at bottom, an effort to improve patient outcomes through rational, evidence-based prescribing. Just as one hospital’s efforts to reduce its infection rates should not be dismissed for not reversing the national trend of hospital-acquired infections, so attempts to get the best science into the hands of doctors who want it should not be dismissed as insignificant or trifling. Good medicine matters, at every level.

UPDATE: I originally wrote 9000 groups will receive the dissemination grants. I have corrected it to read: 9000 locations.

–Kate Petersen, PostScript blogger

‘Marketplace’ (American Public Media) takes a look at what some states are doing to combat pharmaceutical sales reps influence on prescribing, and help get doctors the best evidence–without the sales pitch.

‘Marketplace’ followed “academic detailers” employed by the state of Pennsylvania as they visit with physicians. Tom Snedden, the director of the program, which employs 11 academic detailers–often nurses or pharmacists–said the program was small but effective in improving quality and reducing unnecessary costs.

“The industry’s trying to sell a product. What we’re trying to sell is clinically-appropriate prescribing,” he said. “Since the program began in 2005, the doctors who have met with academic detailers have prescribed fewer brand name drugs and fewer drugs overall.”

Other states have taken their cue from Pennsylvania since it implemented it’s academic detailing program 5 years ago. Three New England states are sharing best practices and resources in a regional academic detailing initiative. Legislation has passed in four states and D.C., while three additional programs were implemented by state Medicaid agencies.

This session in Wisconsin, Rep. Chuck Benedict has introduced an academic detailing bill, which is backed by the broad group of supporters, led by the Coalition of Wisconsin Aging Groups. The bill will be heard in a joint public hearing on prescription drug reform in March.

And in Minnesota, academic detailing legislation is being considered as part of a prescription reform package. The bill (Sen. Sheran) backed by the newly-formed Minnesota Prescription Coalition, has cleared two key committees in the Senate and is now before the Finance Committee; a House counterpart (Rep. Liebling) is due to be heard by the House Health Policy Committee in early March. (More information at the coalition website)

Because of the success of such programs at the state level, development of a federal prescriber education program is underway.

Wisconsin Sen. Herb Kohl, Chair of the Congressional Special Committee on Aging, sponsored the federal Independent Drug Education and Outreach Act of 2009.

And the Obama administration and Agency for Healthcare Research and Quality have demonstrated support for this approach, too, including academic detailing as an example of an intervention to promote the adaptation and dissemination of comparative effectiveness research products in a request for proposals the Agency posted in September, 2009—a new round of AHRQ grants was announced last week as well.

Listen to the full Marketplace story, or learn more about prescriber education at Prescription Access and Quality and the Pew Prescription Project.

–Kate Petersen, PostScript blogger

A bill, introduced today in both House and Senate, would have the federal government go head-to-head with the pharmaceutical industry’s 100-thousand-or-so sales reps.

The Independent Drug Education and Outreach Act of 2008 provides grants for the creation of unbiased educational materials for doctors. And another set of grants funds pharmacists and nurses to take that good information to the doctors in their offices.

Office calls work. That’s why they are the preferred sales tactic of industry. So it makes sense that governments and others who actually foot the cost of prescription drugs should adopt the same tactic, albeit with the goal of encouraging the use of the best, safest, most cost-effective drugs.

This idea, sometimes called “academic detailing” has been around for at least 20 years. Programs are well established in other countries and in several states. Australia and Pennsylvania have model programs. Kaiser Permanente has its own long-established initiative. The evidence shows that such programs not only improve patient outcomes, they also produce net savings – by one estimate two dollars is saved for every dollar invested. See our related Senate testimony here.

But it is also important to note that these programs are not mainly about cost savings; they are about providing good information. Sometimes that even means encouraging more use of pharmaceuticals. And doctors who have a chance to participate generally appreciate having a source of information they can trust.

IDEA is being sponsored in the Senate by Sen. Herb Kohl (D-WI), Sen. Edward Kennedy (D-MA), Sen. Richard Durbin (D-IL) and Sen. Robert Casey (D-PA), and in the House by Rep. Henry Waxman (D-CA) and Rep. Frank Pallone (D-NJ). Both the Prescription Project and the National Coalition for Appropriate Prescribing support passage of this bill.

The IDEA Act allows for public payors and non-profits – those free of pharmaceutical industry funding – to apply for grants. That means a new potential source of funding for state programs, such as the one Massachusetts is likely to pass today [tune in tomorrow for more on that]. The Congressional Budget Office should score this bill. The House and Senate should pass it quickly. We have neither time nor money to waste.

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.

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.

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.

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.