Our Fellow coalitioneers over at Health Care for All have a good post on the Massachusetts pharma gift ban as we await word on whether House lawmakers will include the section in its recommended version of the health care cost containment bill being finalized now. Check it out here.
This week, Pfizer announced that it will stop funding physician continuing medical education through medical education and communication companies (MECCs), effective immediately. According to the company’s press release, the move is meant to curb conflicts of interest engendered by industry funded CME. The drug giant says it will continue to provide CME through academic medical centers and professional medical societies.
For more, check out:
Kaiser Daily Health Policy Report
The Denver Post reports this week that a new set of conflict of interest guidelines being proposed at the University of Colorado would curb industry influence on faculty and students there in a major way, but that it’s raised the hair on the backs of some faculty members.
Richard Krugman, dean of the CU School of Medicine, said the guidelines will bolster the medical professionalism the public deserves.
“I chafe at lots of federal and state regulation,” Dr. Krugman told the Post, “but the reality is, we have to have guidelines and policies and regulations.”
And though this story comes out every year (see last year’s version), the economic downturn, and the astro-price of fuel and food make this Pharmalot story about gianormous FDA bonuses seem especially egregious this year.
On Wednesday, The Boston Globe looked closely at how Sen. Ted Kennedy is convening health care leaders from Massachusetts in discussions that may yield the blueprints for a universal health care plan. Among those in attendance were Community Catalyst Director Rob Restuccia and former director of Health Care For All, John McDonough, who is now chairing Sen. Kennedy’s health initiative.
We hope prescription reform is one of the pieces of the health care cost puzzle that gets talked about as national health care plans are shaped, and so do the writers of this opinion piece in the Syracuse Post-Standard, who include AARP New York director Lois Aronstein and the Center for Medical Consumer’s Art Levin.
At it Aggie-an: The University of California - Davis student newspaper, The California Aggie, picked up the story about the medical schools’ top mark on the AMSA Scorecard.
Here are two mega-articles in the Philadelphia Inquirer that center around a lawsuit filed after a hip replacement patient wasn’t told about her doctor’s financial ties to the maker of the implant.
(For the CliffsNotes version, check out the Wall Street Journal Healthblog entry.)
The Chronicle of Higher Education says Sen. Chuck Grassley’s conflict of interest disclosure hunt – which has so far trawled up undisclosed millions taken by three Harvard psychiatrists and the incoming president of the American Psychiatric Association at Stanford – is far from over.
Two belated pick ups from the blogosphere that are worth a read:
University of Maryland professor and blogger Steven Salzberg’s post on the ubiquity of Pfizer-funded trials for its own smoking-cessation drug Chantix in the literature is exhaustive and damning. PostScript felt a twinge of fellow-feeling for Salzberg, whose search for authorship affiliations and disclosures was steered by the capricious winds of e-journal privileges, just like our searches are.
And a blog tip to Mike Barr at Shillfactor, a site devoted to illuminating financial conflict in the world of AIDS research and treatment. Check out his blog and encyclopedic list of people with conflicts running the show.
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.
The fourth national Integrity in Science conference is coming up on July 11th in Washington D.C.
At “Rejuvenating Public Sector Science,” join lead thinkers, policymakers, and regulators as they discuss priorities for the national agenda and ways to curb industry influence in areas such as prescription drugs, energy policy, and climate change.
To check out the details or to register, visit the Integrity in Science conference website:
http://www.cspinet.org/integrity/conflictedscience_conf.html
Stanford psychiatrist makes Grassley’s list
Continuing his I-Spy search for undisclosed financial ties among academic physicians, Sen. Chuck Grassley (R-IA) added Dr. Alan Schatzberg, head of psychiatry at Stanford School of Medicine to the Congressional Record this week after learning of Dr. Schatzberg’s $6 million investment in a company whose drug is in a clinical trial—run by Dr. Schatzberg. The drug is RU-486, manufactured by Corcept Therapeutics and is being studied for depression indications. According to the San Jose Mercury News, “Grassley and other critics do not charge Schatzberg with violating university policy. Stanford requires that professors report investments of “more than $100,000″ - and Schatzberg disclosed that he did.” He just didn’t tell the school how much more.
Sen. Grassley, who found big disclosure omissions among three psychiatrists at Harvard University earlier this month, is concerned that current disclosure policies don’t do enough to illuminate and eliminate the potential conflicts of interest created by investments such as Schatzberg’s. Schatzberg is the incoming president of the American Psychiatric Association.
For more:
Wall Street Journal Health Blog
Gift bananza
A group of prominent Massachusetts physicians, including a former editor of the New England Journal of Medicine and the chief medical officers of UMass Memorial and Boston Medical Center, have written to state lawmakers in support of the proposed cost control and quality bill, S2660, which would, among other things, ban gifts from pharmaceutical and medical device companies to physicians. Check out the news and letters here.
The Tchotchke Wars
In a primo set-up for a Jon Stewart monologue, those same Massachusetts legislators also heard from the state’s trinketmakers this week– the New England Promotional Products Association – who sent their representatives mugs to demonstrate…how mugs don’t influence behavior.
“Is it possible a mug, a pen, or a sticky-note pad could influence your vote? We doubt it….” Begins the note…Tucked inside this mug…For your desk…Don’t mention it.
We here at the Weekly Reader love ready-to-serve irony. The icing? The favors were shipped from Pennsylvania, where mugs still do influence behavior.
From the left coast comes a tchotchke story on a grander scale: San Diego was home to this year’s Biotechnology Industry Organization convention, and this San Diego Union-Tribune article is devoted almost entirely to cataloging the loot being passed out there, plus a little French accent mockery that would offend even Pepe Le Pew.
http://www.signonsandiego.com/news/business/biotech/20080619-9999-lz1n19bio.html
Other California news: Health information privacy advocates and enemies of junkmail everywhere breathed a sigh of relief last week when the Assembly Health Committee dropped a Senate-passed bill that would have allowed pharmacies to give out customers’ prescription information for reminder mail.
Blue skies, sad eyes?
And this guest editorial in the Boston Globe casts some healthy skepticism in the direction of a recent Pfizer-sponsored depression screening of Cape Codders, which the Globe reported on earlier this month. This sort of aggressive industry-backed screening and disease-prevalence report is often used by pharmaceutical companies to prime the pump for ‘blockbuster drugs,” a tactic that Melody Petersen discusses in her book Our Daily Meds. If you haven’t already, check out the PostScript interview with her here.
For us, the most shocking thing in Melody Petersen’s book Our Daily Meds was her description of a special voicemail system Parke-Davis (a division of Warner Lambert) set up for Neurontin, the epilepsy drug the company illegally marketed for just about anything above the neck in the late 1990s. Petersen, a former pharmaceutical reporter for the New York Times, recounted how executives encouraged Neurontin marketers to communicate only through the voicemail network, rather than through more traceable means, like emails. Many know the ending: former sales rep David Franklin still had enough to blow the whistle, and the company paid $430 million on federal charges of off-label marketing.
It’s just one of the many disturbing stories in Our Daily Meds, which tells how in recent decades, the marketing arm of the U.S. pharmaceutical industry has morphed into something of a hydra, mythic in scale and impervious to data that show fewer and fewer new drugs are making us better, and some are even making us sick.
Petersen, whose book has received great reviews and raised eyebrows about industry practices (www.ourdailymedsthebook.com), spoke with PostScript about why she wrote it, and how she believes proposed legislation may alter this story’s next chapter.
P.S: Was there one thing you learned or story you reported on that made you decide you should write this book?
M.P: There wasn’t one thing. Instead, I decided to write my book as I learned how extensive the industry’s promotional efforts were. For some stories, I couldn’t find a medical expert who was not on the industry’s payroll. I learned that some of the articles I was reading in medical journals had been ghostwritten by Madison Avenue ad agencies hired by the drug companies. I listened to an executive give a speech on how he and his company had created a disease.
It’s really the scope of the industry’s marketing operations that is frightening. That is what I wanted the public to understand.
P.S: In your chapter ‘Midwestern Medicine Show,’ you introduce the idea of tech transfer as one way industry got closer to academia in recent decades. Your book makes clear that there were many external factors that have led to the coziness between industry and academic medicine today, but in your mind is there one that stands out?
M.P: For decades, we counted on academic researchers to help protect us from dangerous medicines and fraudulent science. There was once a clear division between academia and industry.
But in 1980, two things changed. First, the federal law known as Bayh-Dole Act was passed. It allowed academics working on federal grants to patent and profit from their discoveries. Then, that same year, the Supreme Court allowed the first patent to be placed on a living organism. This opened the door to the patenting of genes, cell lines, tissues and organs. It was then that universities began to see their laboratories as profit centers and their professors at entrepreneurs. Most of our brightest academic minds became consultants to industry.
Today, there are very few medical researchers left who are independent from industry. There are few scientists willing to raise questions about the enormous amount of questionable practices that are going on in medical science today. It’s a tragedy that has had stunning consequences on society.
P.S: The recent probe by Sen. Grassley – your hometown senator – of the industry payments to 3 Harvard child psychiatrists illuminated some problems in the honor-system disclosure system many academic medical centers rely on. And you also discussed the management plans that often come with them. How do you see disclosure – is it part of the solutions to industry’s influence on physicians, or not?
M.P: Public disclosure of the dollar amount of consulting and other fees each academic receives from the drug industry will help. But it won’t solve the problem. I think that academics working on federal grants should be banned from accepting any industrial money. We desperately need more scientists who put the lives of patients before the interests of industry.
P.S: Speaking of Sen. Grassley, do you see him as Sen. Kefauver’s heir to pharmaceutical inquiry? And do you think it will take another tragedy like Thalidomide, or Vioxx to cement something like the Sunshine act, or do you think the Congress is more receptive to legislation than it was during the Kefauver hearings?
M.P: The public should thank Senator Grassley for all he has been able to uncover in his investigations of the drug industry. In recent years, no one else in Congress has done more to try to stop the industry’s egregious promotional practices than he has.
I think the Sunshine act – the legislation to disclose industry payments – will pass. Some drug companies have already agreed to a watered-down version of the bill. In Washington, proposed legislation has an unfortunate way of being weakened until it does little of what we thought it would do.
P.S: What does the thalidomide tragedy in the late 1950s and the drug’s reappearance on the market as ‘Thalomid’ for multiple myeloma today say for the importance of institutional memory? Whose job was it not to forget, the FDA? The media? The public?
M.P: In the 1950s, pharmaceutical companies caused a tragedy for tens of thousands of families by aggressively selling thalidomide to pregnant women even though there was no science that said this was safe. But now, if careful scientific studies show that thalidomide can help patients with multiple myeloma and those patients are informed of all the risks, I think it is wonderful that it is available to those patients.
This gets to a bottomline point in my book: It’s not the medicines that are the problem. Medicines can help you if you get the right one at the right time. The problem is the aggressive marketing of medicines. The industry’s relentless promotion is leading doctors to prescribe medicines in ways that go beyond what is safe.
P.S: Even though their costs are rising exponentially, pharmaceuticals are still a relatively small slice of the health care cost pie. Where do you think pharmaceutical marketing falls in the bigger health care conversation going on in the U.S. today?
M.P: The only reason that prescription drugs are relatively small part of health costs is that we pay our physicians and our hospitals so much money. Doctors make astonishing salaries in the U.S. compared to what they might make in other countries.
But even then, prescription drugs are eating up a larger slice of total health costs every year because of the drug industry’s non-stop promotion and steep price increases. In 1980, we spent $12 billion on prescription drugs. In 2005, we spent more than $250 billion.
And the same marketing techniques used to boost sales of medicines are now being used to sell medical devices, diagnostic tests, hospital procedures and physician services. American medicine today is driven by marketing.
The consequences of this go beyond the overwhelming financial cost. The aggressive promotion has made the system dangerous. Every year, there are thousands of needless deaths because of overtreatment.
P.S: With NEJM reporting that nearly 94 percent of physicians have some relationship with a drug company, and regulatory entrenchments like PDUFA, do you think there is political will to turn this around, and if so, from what corner will it come?
M.P: It needs to come from patients. Americans need to start a revolution. People need to stand up and say they’ve had enough. They need to demand that the nation’s medical system put patients before profit.
P.S: Our Daily Meds is a book that provides an I-can’t-believe on nearly every page. And to write it means you’ve seen a lot, and talked to a lot of people. Was there one discovery you made that most shocked you?
M.P: I’ve learned so many frightening things. It’s impossible to rank them. And that’s why I decided to write my book. A series of newspaper articles can’t describe the incredible power the pharmaceutical industry now has in American medicine. It has come to the point where the drug companies decide how patients will be treated and doctors just follow along.
A bill that would allow pharmacies to distribute customers’ information and provide reminder mail about their prescriptions has made it through the California Senate and is waiting for review by the Assembly. Senate bill 1096, the Confidential of Medical Information Act (CMIA), would allow pharmacies and third-party health information groups to contact patients by mail to remind them to fill prescriptions, a move advocates of patient and prescriber confidentiality worry would open the door for pharmaceutical companies to market in even more direct and personal ways than they do now.
PostScript talked about the bill’s potential reach with New Hampshire Rep. Cindy Rosenwald. Rosenwald, who chairs the Health, Human Services and Elderly Affairs committee, is the sponsor of New Hampshire’s embattled Prescription Data Privacy Act, which is currently under appeal in the U.S. 1st Circuit Court of Appeals.
P.S: What would the passage of CA S.B. 1096 mean for patients?
C.R: I think everybody has something to gain, except the patient. The pharmacies have something to gain, by selling the patient’s info. Second, they have something to gain if that patient fills the Rx. I believe the pharmaceutical industry [has something to gain], because now they know the end end user of their products.
But many people feel that’s another form of marketing. Because it’s in the pharmacy’s interest to have that patient fill that Rx again. There are many reasons someone might not refill their prescription, not the least of which they can’t afford them. You may have filled a prescription for one medication, but it didn’t work or you didn’t tolerate it. But if you get a letter from the pharmacy, it’s not hard to see a patient getting confused and filling the wrong prescription, or both.
P.S: Your recent presentation at the National Legislative Association to Reduce Drug Prices (NLARX) in Charleston, West Virginia outlined ways the pharmaceutical industry is getting around HIPAA – is this a case of the pharmaceutical or pharmacy industry getting around a stronger state law?
C.R: HIPAA’s definition of marketing is too narrow. If the communication is related to the individual’s treatment, HIPAA says it’s not marketing. To me, that’s marketing.
States are not allowed to loosen HIPAA. What the California bill would allow, if passed, is to break through that law, because pharma may be able to sign a business associate agreement with pharmacies.
The business associate is obligated to follow the same laws as the HIPAA–covered entity, but the covered entity is only liable if they knew or had reason to know of violations. There is a huge, huge gaping loophole.
I did hear an example of that happening in New Hampshire. A woman was taking an expensive hypertensive. She stopped filling her prescription because her doctor had given her free samples, and three weeks later she got three letters. One was from her insurer, one was from her pharmacy, and the third letter was from the drug company – which really upset her.
Why is it a drug company’s responsibility to have a patient adhering to a particular medication? It’s the responsibility of the doctor, the patient, and maybe the insurance company. I don’t even think it’s the pharmacy’s responsibility.
So I don’t see this as a healthcare issue, I see it as a marketing issue.
P.S: Are there characteristics of its passage that suggest this is unique to California and might not happen the same way in say, New Hampshire?
C.R: It looks like the California Senate wanted to allow this. I’m not sure our data mining ban [New Hampshire’s Prescription Data Privacy Act] would prevent that kind of activity here, if they came to us. But New Hampshire is fiercely protective of individual privacy.
I know that [the CMIA] failed narrowly in the California Senate the first time. And then they brought it back, with an opt out, and then it passed. Between 1 and 3 percent of consumers will opt out. And then, I believe there’s absolutely no control over what they will do with the information.
P.S: What does this mean for the data-mining legislation, both in California and more widely?
C.R: I know California looked at a data-mining ban, but most of those bans focused only on prescriber identity. The part of the [New Hampshire] law that’s in litigation is only related to prescribers. So the patient protections are still in force in New Hampshire.
I think if the bill becomes law, that’s not good for patients. There’s no reason to believe the pharmaceutical companies have the patients best interest at heart.
Making the rounds
The Reader starts with the most continental news in the world of pharmaceutical conflict of interest this week: the AMSA PharmFree Scorecard, released with RxP last week, made sea-to-sea headlines and/or waves. Here’s a handful of stories about schools who made the grade, and some that didn’t.
Pittsburgh Post-Gazette (and editorial)
ADHDing machine
A report that three prominent Harvard child psychiatrists failed to report large sums of drug company pay under institutional disclosure policy yanked the problem of disclosure squarely into the spotlight. Dr. Joseph Biederman, along with colleagues Dr. Timothy Wilens and Dr. Thomas Spencer, amended their disclosure reports after a Congressional probe by Sen. Chuck Grassley (R-IA) found that each had significantly underreported pharmaceutical payments, from which each made more than $1 million between 2000 and 2007. According to news reports, the amended disclosures still don’t match pharmaceutical company records, which indicate each of the doctors received more.
“Although many of his studies are small and often financed by drug makers,” the New York Times writes of Biederman, “his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. “
Back to the disclosure problem: Harvard, like many academic medical centers, had a disclosure policy in place, which relies on the honor system for faculty to report their own industry earnings. A system that didn’t work right this time, and which makes the case, as these Boston Globe and New York Times editorials do, for the Physician Payments Sunshine Act. The Sunshine Act, which is still under construction after a series of compromises with pharmaceutical companies reshaped the bill in May, would eliminate the problem of faulty and voluntary self-reporting by relying on mandatory company reporting –it was the company data, after all, that turned Grassley on to the discrepancies in the first place.
The long view
And since it’s always good to see something from a distance, we made the small hop across the pond (well, virtually) and to take a gander at the British Medical Journal’s account of the bill.
Grades are up at the AMSA PharmFree Scorecard, which assessed the conflict of interest policies of all 150 medical schools in the U.S. To develop the scorecard, the American Medical Student Association teamed up with RxP, which has been working to help schools strengthen their policies on limiting pharmaceutical marketing on campus.
Like your micro-econ class, it was pretty hard to get an A – only 7 schools did, along with 14 Bs, also a tough get, since the grades were tabulated on 11 areas of industry influence as diverse as gifts, purchasing and formulary, site access for industry vendors, and continuing medical education.
60 schools (40%) received a grade of F. This includes 15 that either submitted policies graded as F or indicated they had no relevant policies, as well as 16 schools that declined to submit policies and 29 that did not respond to repeated attempts at follow-up.
But unlike those pesky online grades posted after your professor was already well on his way to Provence with the kids, the AMSA interactive website allows you to sort by state, city, and strength of individual domain, plus read excerpts of actual policies that took interesting approaches and read model language for schools looking to raise their scores with some extra credit.
Plus, check out the pie chart and brush up on your geography with a spiffy map of the U.S.
And yes, all you primary junkies, Puerto Rico’s on there.
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.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of The Pew Charitable Trusts.
