After years of debate, the Massachusetts legislature yesterday weakened portions of a controversial law that bans drug and device makers from providing gifts to doctors. Lawmakers voted to allow doctors to receive free meals and they also repealed a disclosure rule that requires all financial arrangements between drug and device makers with prescribers to be posted on a website maintained by the state Department of Public Health.
The changes were included in the fiscal budget that must be approved by Massachusetts Governor Deval Patrick within 10 days, which sources say he is expected to approve. Currently, drug and device makers can only pay for meals offered in conjunction with an educational presentation - otherwise known as continuing medical education - if the meeting occurred in a hospital or office setting.
What will the rollback allow? Doctors can receive “modest meals and refreshments” in connection with non-CME educational presentations about the “benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information.” And these must occur in a venue and manner “conducive to informational communication,” according to the bill, although that is not the same thing as accredited continuing medical education.
However, there are reporting requirements. Drug and device makers must file quarterly reports detailing all educational presentations, which must include the location of the presentation; a description of any pharmaceutical products, medical devices or other products discussed at the presentation; and the total amount spent on the presentation and an estimate of the amount spent per participant on any meals, refreshments or other items of economic value provided (see sections 108 through 114 of the proposed budget).
The 2008 law, which you can read here, was seen as a way to limit undue industry influence over medical practice. Similar concerns sparked a US Senate investigation into financial relationships between drugmakers and physicians, and ultimately led to the Sunshine provision in the Affordable Care Act that, next year, requires payments for consulting and grants, among other things.
"The trust at the heart of the patient-doctor relationship is in danger," according to a web site run by the American Medical Student Association, which mounted a campaign against changing the Massachusetts law. "What is clear is that patients disapprove of 'free lunches' and 'wining and dining' for doctors, and they worry about the objectivity of medical decisions."
But the ban has upset some doctors (read here), and pitted various consumer and patient groups against restauranteurs and the pharmaceutical and device industries ever since. Those in favor of repeal argue the ban has stifled business seeking to expand in Massachusetts and robbed the state of revenue, such as a pair of medical industry conventions that were to have been held in the state.
“The gift ban has been devastating to restaurants and thousands of middle-class employees,” according to a statement on the Massachusetts Restaurant Association web site (read here). However, state tax receipts on meals increased last year and the same trend continued through the first five months of this year, according to the state Blue Book (see here and here).
State coffers aside, some eateries maintain the ban has had real consequences. The Chocolate Truffle, for instance, is not selling as many chocolate shoes, a popular corporate gift, since the ban took effect. “We have closed a store in Lynnfield, we have drastically cut the number of employees we have,” Erin Calvo-Bacci told a Boston television station last week (look here). “If that gift ban was gone then we could increase our production.”
Four years ago, the move to enact the ban prompted industry threats to curtail investments and meetings in the state. Four years ago, Sanofi ceo Chris Viehbacher, who then headed the GlaxoSmithKline North American pharma biz, sent harsh letters to Massachusetts lawmakers (read here) and several trade groups similarly issued warnings that clinical trial work may be curtailed (see this). Just the same, the Biotech Industry Organization just concluded its annual gathering this month... in Boston.
One proposal contained in the budget that heartened the American Medical Student Association is the creation of an academic detailing program, which would receive $500,000 in funding. This would provide an evidenced-based outreach and education program on the therapeutic and cost-effective use meds to physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs.
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Confusing I know, last name first name, first name last name.
Yes, thanks. You're right. It is confusing and hopefully is not a sign of dyslexia, because I probably made the same flub before. Anyway, I appreciate the note.
ed
It's all about dollars and cents, you know that as well as I do.
If there is a significant and novel product it will be covered : ie MS drugs, RA drugs , Onc drugs etc. When these "branded" products have 10 equivalent generics....please wake up!!
I don't know how these reps run around all day peddling this foolishness. I guess people will do anything for money. Not only that, doc and healthcare professionals don't need these clowns in and out of offices all day. Send the samples in the mail and save on the 100k salaries, bonuses and benefits.
Original, thanks for the offer ... but I'm in a relationship
also, drug reps don't want to do lunches and be treated like caterers - it's the doctors that demand them. "you want to see me, you feed my entire staff and I will give you thirty seconds to talk......"
John Abramson's book is called _Overdosed America_ (not "in" America).
Disclaimer: I have no financial relationship with John Abramson, but he is an old friend.
Personally (friendship bias factored in), I think it's the best of the bunch as a first read. I would also add the followiing as top notch:
John Braithwaite, _Corporate Crime in the Pharmaceutical Industry_. An older book which can be downloaded *free* on line. Maybe the most throughtful of them all from a policy perspective. It is not a "potboiler." But very readable.
Philip Hilts, _Protecting America's Health: the FDA, Business, and One Hundred Years of Regulation_. Also very accessible and a full history of the FDA by former science writer for the NYT and WP.
Both of these books put all the more recent headlines--e.g., Vioxx, Prozac, et. al.--into historical perspective. The result is generally not encouraging in terms of "progress."
There are many more. Indeed, "pharmanoia" (not sayin...) has become it's own industry. So you have to be selective.
Obviously, lots more on a more academic level--by Daniel Carpenter, Howard Brody, and others. Worth pushing oneself.
Oops, I did it again......
Everything is clearer in hindsight...........after a couple of years out, I couldn't carry water for most of these companies today!
This would be very helpful.
This would be very helpful.
Joker-if I may ask, and without naming names, did you see significant differences between different companies you've known on the kind of issues that concern a lot of people here? If so, do you have a sense of what made the difference--leadership? tradition? role of science? etc.
JiM, sorry to dominate the blog. I'm actually looking for a good Dominatrix myself.
I can't imagine there isn't more such writing that is accessible. I think Dan Carpenter's work is one example. Likewise, a collection I use edited by Santoro(Rutgers) and Gorrie (J&J), _Ethics and the Pharmaceutical Industry_, Cambridge UP, which I think most folks would consider pretty well balanced.
Most PhD dissertations are pretty far from "accessible," but maybe there are some dissertators who can write. To complete the circle, a penchant for being dominated may be intrinsic to writing a dissertation in the first place.
http://library.dialog.com/bluesheets/html/bl0035.html#AB
JiM, I sense a dark theme, here, for after all being a grad student is akin to a dominant/submissive relationship. Certainly pain is central to the experience, and may require half a lifetime to get over.
Where's the beef?
@oii - you might want to join Opus Dei (recently one of their own was put in charge of PR for the Vatican). Just let them know about the fetishes you have and you might get an invite to be the spiritual leader of - how did you put it? - ah, yes "my industry".
What's wrong with pharma? It's an animal husbandry business model. Except cows don't have to pay a fine to the IRS for being alive - at least not yet.
We're spinning off topic, but, yeah, that was my point. Which is why I don't treat my own grad students that way and have had the opportunity to give keynotes about some of the jerks who were on my own committee--not because of their behavior, but because they turned out to be dead wrong on the facts.
I do that for me, but I do it mainly for current grad students who may be bullied into blinding themselves to the obvious and betraying their own convictions.
dz, although cows don't have to pay a fine yet, once the government dictates the quantity of beef we will be able to consume the bovines will indeed pay a fine, perhaps indirectly.
Me thinketh not...
Everyone has a right to their own opinion, but facts are just that. I'm puzzled as to how Dr. Healy managed to be so adamant about an issue of fact when he apparently had never looked up the data. Or if he did, he was for some reason unwilling to share it.
Extreme viewpoints sell books. But policymaking requires familiarizing oneself with the facts, and interpreting them objectively.
http://www.huffingtonpost.com/2012/06/29/air-sex-world-championships-howard-stern_n_1637636.html?utm_hp_ref=new-york&ir=New%20York
When someone is "dead wrong" about the facts, someone ends up dead. Guess the Roche excuse works for everyone, every time - "...just need to train them to send in the reports....".
Having grown up in a family of surgeons I suspect that Healy might have been one in a prior life. He certainly fits the smug arrogant personality of a surgeon, someone who is "often wrong, but never in doubt".
http://www.youtube.com/watch?v=4FNoIDgNE6o
If you look up Angell's scathing indictment of the pharma industry's honesty on Amazon you'll find a remarkable accident of history. It turns out that Peter Roth, a self described "senior executive in the pharmaceutical industry who should be opposed to this book" found it "truthful and compelling". What is even more rmarkable is that Mr Roth somehow happened to get his hands on an early release of the book, which enabled him to write his objective and unbiased review in advance of the books general release, thus ensuring a prominent placing of his comments as the first customer review of the book at the worlds largest online bookstore.
Where it not for the obvious moral outrage these two express about dishonest marketing practices, one might almost suspect them of collusion to place a false and misleading independent review.
All the Justice Money Can Buy: Corporate Greed on Trial, by Snigdha Prakash. 2011.
Dispensing with the Truth: the Victims, the Drug Companies, and the Dramatic Story Behind the Battle over Fen-Phen, by Alicia Mundy. 2001.
Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, by Howard Brody, MD, PhD. 2007.
On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health, by Jerome P. Kassirer, MD. 2005.
Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by Melody Petersen. 2008.
Poison Pills: the Untold Story of the Vioxx Drug Scandal, by Tom Nesi. 2008.
Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial, by Alison Bass. 2008.
White Coat, Black Hat: Adventures on the Dark Side of Medicine, by Carl Elliott, MD, PhD. 2010.
ZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZZ....
In the example above, Mr. Rost and Dr. Angell appear to have perpetrated a deliberate act of marketing fraud on potential customers of Dr. Angell's book. On this forum, I've engaged "independent" commentators regarding the rigor and validity of articles criticizing the safety of certain drugs, only to later find that the independent commenter was a co-author of the study praising it under the cover of a psuedonym. Dr. Healey rails about "skyrocketing drug withdrawals", apparently without ever having looked up the data.
Some may see white hats and black hats. I see two industries with competing financial interests.
My hero, Benjamin Zycher.
http://zychereconomics.com/news.php?id=24
On the other hand, as my clinical supervisors taught us back in those wonderful grad school days, "paranoids are always right." That is to say, even if they cannot put things in proportion or perspetive, there almost always _is_ realistic ground for fear and even high (and sometimes hyper) vigilance.
So we will find a lot that is factually and otherwise wrong in some number of the books noted (I am a not-fan of Angell's, for example, mostly because of its relative lack of depth). And we will find a lot that is accurate and critically important in others (I've already expressed my particular admiration for Abramson, Brody, and Braithwaite. Mundy's book on fen-phen also important, in my view, and it has continues to amaze me how long she was the primary pharma reporter for the WS Journal--not a job for kooks.
So, in memory of Rodney King, it is the gross overgeneralizing--treating either all industry or all critics "as a class"--that we should guard against. We should welcome hard, including outraged, debate if it is informed by reason, knowledge, and principles to the degree we have 'em.
There's also a great book on the long history of thalidomide, Dark Remedy, by Yul Brynner's son, whose name I'm forgetting.
et cetera. et cetera.
People die every year from drug overdoses, inappropriate Rxs, side effects of drugs (both disclosed and undisclosed), unnecessary and/or incompetently performed surgeries, other medical error (disclosed and undisclosed), poor infection control, etc. Good to have an open and honest discussion on how to reduce all of these. But in the process, lets not lose track of the lives saved by the drugs that perform as advertised, and by the surgeries that were correctly performed.
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