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.

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.

We’re late out of the gate on this one, but the numbers still bear mentioning – a report from the Center for Public Integrity out last month showed that the pharmaceutical industry’s been getting its money’s worth on K Street. Good news for the industry, because those expenditures totaled $168 million in 2007, up 32 percent in a year.  Bad news for those concerned that pharma’s influence on the Hill and on its own regulation is already too big.

In the win column for the industry in 2007: the reauthorization of the Prescription Drug User Fee Act, and a blocked bill that would have permitted drug reimportation.

The eye-opening stat for PostScript? “More than $6.8 million of the $14.4 million the pharmaceutical and health product industry gave in contributions went to members of three committees that regulate the industry: the House Committee on Energy and Commerce, House Committee on Ways and Means, and Senate Committee on Health, Education, and Labor.”

And while some may still hold out hopes of Karl Rove’s ‘permanent majority’, this report made it clear that pharma isn’t among them – support for candidates by party has swung widely since the Dems’ 2006 takeover, and for the first time in history, Democratic candidates received more funding from the industry than Republicans did. 

A couple of weeks ago, GlaxoSmithKline Chief Chris Viehbacher tried out the bully pulpit on Massachusetts lawmakers considering a gift ban for physicians.  Too early to tell, but it may have done more harm than good.  So now pharma companies are trying a different tactic – have the caterers plead their case for them.

The caterers who make all those physician lunches certainly have a horse in this race – Kevin Abt, Founder of RestaurantstoYou.com, a corporate catering service in Stoughton, Mass., estimates that pharmaceutical reps drop $40 million on food in for docs in the state every year. Hardly chump change.  And because of this, he’s asking Massachusetts representatives to strike meals from the list of gifts that would be banned under proposed bill S.B. 2660.

We know that pharma has long found ways to get what it wants by talking through others – physicians, say, or advisors for the FDA. But a tip to the letter-writers of the world: if you don’t want to look like you were put up to something, don’t parrot information you probably couldn’t get doing your job. 

The petitioner from RestaurantstoYou moves quickly from entreating to indignant: “How could we think “the most educated people in the world, Doctors, could be manipulated by the offer of a ham sandwich and chips from a pharmaceutical or medical device company sales agent?  Instead, the opposite is true. Doctors routinely ask these reps to go do more research for them, at no cost to the doctor, so that they can have additional information for their individual analysis that they will use to make decisions regarding their patients.”

Abt knows this because he says to better understand his clients, he has watched from the back of the room in admiration as the reps performed their lunch and learns. Fine.

But if you are the one making the sandwiches, do you really want to sound like you are reading off the same talking points as the state policy director for the PhRMA trade association? PostScript has been to enough hearings to know those talking points when we hear them. Sales reps with no background in science are providing valuable information about drugs that physicians can’t get anywhere else? And pasta salad.

Yep. 

No doubt: $40 M is a lot of money to spend on food every year – but if that number tells Massachusetts lawmakers anything, it’s the sheer scale of investment these companies have made in wooing physicians, evidence that it’s probably time for the marketing machine is to be reined in.

If nothing else, it’s intriguing to see pharma moving the mouths of both Ivy League physicians who are recruited to speakers bureaus where they use marketers’ slides to pitch their drugs for them, and those of the blue collar catering drivers from Stoughton: “The food we deliver is wholesome and delicious, but it is not flashy or expensive.”  We have to hand it to them: The chemical pushers have become deft chameleon puppeteers.

But in another sense, pharma has found authentic common ground with the simple ham sandwich makers of the world – they’ve got mouths to feed, starting with the shareholders.

Medpin, or medicine for people in need, began in 1999 as a project of the Public Health Institute. During its eight-year tenure, Medpin worked with a broad group of California clinics, pharmacy schools, and health care foundations to get people appropriate medications in safety net settings. PostScript recently talked with Kathryn Saenz Duke, director of Medpin until it closed under funding challenges late last year. In the aftermath of the California showdown over health reform, PostScript asked Saenz Duke about what the defeat of universal coverage means for Californians who can’t afford their prescription drugs.

PS: What was your background before Medpin?  How did you get interested in prescription drug access issues? 

KSD: As a senior staffer on the California State Select Committee on AIDS in the 1980s, our committee worked with a broad spectrum of patients, advocates, and political groups to create new laws and policies, sometimes finding common ground and unexpected allies.  After the Senate, I joined a University of California research team looking at managed care’s impact on safety net providers. 

From there, I moved to the California Medical Association, where I met many doctors who felt caught between rapidly increasing direct-to-consumer drug advertising, formularies, and their relationship with patients.  All those experiences brought me in 1999 to the project that became Medicine for People in Need (Medpin).

PS: Is there a short version of what Medpin was, and what happened to it? 

KSD: Medpin’s first project was based on a cy pres litigation settlement in which all parties agreed to have an independent nonprofit organization distribute more than $170 million worth of diverse brand name drugs from 25 companies at no charge to recipients. 

We worked with 150 California public hospitals and community clinics caring for uninsured people, designed and operated a new, award-winning drug order and distribution system, and helped safety net providers fill 2,600,000 one-month medication supplies for indigent patients who might otherwise not have received those medications. 

Those were real achievements.  But we were also committed to bringing longer term benefits to safety net clinics.  We introduced many to the federal 340B discount program, promoted greater awareness and use of generic drugs, and helped the clinics better use drug companies’ patient assistance programs.  We sponsored California’s law allowing expanded use of 340B with community pharmacies, and created new working relationships among California’s large county indigent care systems, nonprofit community clinics, and faculty from California’s seven pharmacy schools.

PS: Will the needs Medpin met be met by something/someone else, or is that still unclear?

KSD: When the decision was made to close Medpin due to funding challenges, we were pleased to look back at how much of our past work has ongoing impact, and to know that many of the other nonprofits we have partnered with continue their work. 

But important work remains, and many of our former partners are facing their own funding difficulties.  

PS: Is the pharmaceutical industry doing its part to help patients in need? 

KSD: Medpin has always encouraged safety net providers to avoid confusing patient assistance programs with drug samples, which are part of drug companies’ marketing efforts.  It’s interesting that Medicare Part D’s infusion of federal funds into prescription drug spending has brought greater scrutiny to the design of patient assistance programs and their impact on that federal spending. 

This new legal attention is especially important for safety net providers, who feel pressure to accept much-needed financial help for many of their low-income patients, including from drug companies through patient assistance programs (and for some clinics, through drug samples).  There is tension between using this short term help vs. moving toward evidence-based prescribing that may favor lower cost, generic drugs that aren’t “free,” but can offer better overall value.  

PS: Is the government doing its part to help patients in need? Where’s the slack? 

KSD: Two existing federal programs immediately come to mind as needing more government attention and support:  Part D Low Income Subsidies, and “340B.”  (The 340B program helps uninsured and Medicaid patients by requiring significant purchase discounts for their safety net providers).

With this being such an exciting election year, maybe there’s a chance that policy leaders can engage people to think broadly about what government should be doing to help all of us improve our health, and particularly those in most need. 

PS: How did Medpin relate to pharmaceutical companies?

KSD: When I started with Medpin, I assumed we would eventually come together with PhRMA to identify and pursue some common interests, while agreeing to disagree on other matters. 

But I soon realized that PhRMA didn’t need or want to work with us. It’s more comfortable for them to purchase communications, outreach, or other assistance than to develop a relationship with an independent nonprofit like Medpin. 

Someone once commented to me that “Drug companies don’t understand and therefore don’t trust a nonprofit organization.”  At first I scoffed at this, but later came to see it as an insight into our experience with them.

We did interact with a few individual drug companies.  For instance, we gave several awards each year of the cy pres project to companies judged to have been most constructive in providing good products for uninsured patients. 

After that project ended, a few drug companies—most notably Merck and AstraZeneca—responded to our invitation for dialogue about continuing some portion of the work we had done together.  But these conversations did not progress, partly because Medpin decided to proceed only if a larger number of companies agreed to move ahead, and that never happened.

PS: Did Medpin work with patient advocacy groups? Considering that they are powerful consumer voices, but that some take funding from PhRMA members, what do you think their net effect has been on the conversation around prescribing and access?

KSD: Medpin’s focus has been on helping vulnerable patients by working with health care professionals in “safety net” settings.  We have promoted evidence-based prescribing through drug monographs, guidelines, and other materials we’ve developed with two pharmacy schools and our statewide group of safety net pharmacists and physicians. 

As for groups taking PhRMA funding, I believe that leaders from a number of “disease groups” are trying to think carefully about whether and how it’s possible to accept drug company funding while staying independent of pressure–however subtle or self-generated–to avoid ruffling their funders’ feathers.  Do I think there could be more self-examination on this issue?  Absolutely, yes.

PS: What does the defeat of California Health Reform mean for patients who can’t afford their prescription drugs and the community health clinics that serve them? 

KSD: Watching California’s recent health care reform efforts has been déjà vu for those of us who followed this state’s earlier drama over drug pricing.  We had several years of high-profile legislative efforts to address drug costs in California, followed by a confusing and expensive ($80 million) campaign in 2005 involving two drug discount program ballot initiatives. 

After voters failed to approve either measure, our Governor and legislative leaders enacted the bipartisan California Discount Prescription Drug Program in early 2006, which blended elements from both initiatives.  But that law failed to include any funding, and we’re waiting to see if anything comes from all the money and political negotiating invested these past years. 

Uninsured people will continue to need care and help on their drug costs from safety net providers.  There is some good news these days because a number of medications that used to be high priced are now available generically at much lower cost.  The bad news is that effective pharmaceutical care must be set within larger medical care and health promotion activities, and our state and national leaders are still trying to patch together financing and delivery system for those activities. 

Right now California’s public officials face a $16 billion budget deficit, so I don’t expect health reform here anytime soon.  

A final thought: Just as pharmaceutical care should be only one part of effective medical care, so should medical spending and attention be put into a larger framework of topics not typically considered medical or health-related. 

Recent writing by Michael Pollan, Steve Schroeder, Dick Jackson, and other thoughtful observers should move us all to pay more attention to our food, the built environment of our communities, tobacco use, and other factors whose combined power to help or hurt our health status is greater than the impact of medical care. 

How ironic it would be if we in the U.S. achieve access to appropriate medication at affordable prices for everyone, but see growing numbers of people eating fast food, smoking cigarettes, and living in communities designed more for cars than humans. I think sometimes we need to step back and at least acknowledge this bigger picture of “health.”