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Fear Mongering in the Bay State ?
Massachusetts is facing some heat on their new regulations aimed at restricting financial relationships between Doctors and Pharma.
No doubt medical conventions generate lots of revenue for the local cities hosting them, hotels, restaurants and other related services benefit from them.
It seems the spirit of the new regulations are not so well understood, and this is causing a few medical conventions to pull out of Boston. Either that, or there is some unnecessary fear mongering going on...Here are the draft guidelines
Having worked many years in the Pharma industry, I can tell you one thing that I thought was pretty silly - those pens and other free gadgets given out at the booth. I always thought, how is it that Doctors make it through all their high level education, yet we need to supply them with pens, prescription pads, sometimes even stethoscopes, clocks - the list goes on and on...These little gifts are basic things that Doctors should have in order to do their job. Additionally, it is wasteful stuff, harms the environment (which cause more illness), and spends years rotting in some landfill somewhere. Why do we think the motto of the Doctors we are trying to sell to is "Will work for graft?" Isn't it some sort of mockery of their intelligence? We should have someone do garbage detail at one of those conventions. You would be amazed to see how much of that stuff is thrown away right at the convention center or dumped and left later in the vacated hotel room.
Why is this so important? Because the Obama team is looking at the Massachusetts regulations and their Health Care reform as a model for a National Program.
Here's the convention piece from today's Boston Globe. Come back and join the discussion over here:
First TAKE OUR POLL at the LEFT of the page, then add your comments!
1.) These regulations are aimed at reducing costs incurred by Pharma that can and should be reduced, which would hopefully have a positive effect on the cost of deliverables to the consumers. Doesn't it make sense that this is a good starting point in helping health care be accessible by all?
2.) After reading the draft guidelines, do we really think that taking away graft is going to stop Doctors from doing the work they spent many hard years in school to finally earn the right to do? Will they really stop coming to conventions and thereby earning important CME credits?
3.) It seems to me that the guidelines do not deter company scientists from doing their work, yet that seems to be the "battle cry" from the other team. Are the Pharma industry claims justified?
Sunday, January 25, 2009
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The fuss isn’t about mugs and pencils. It’s a rebellion against change.
ReplyDeleteWhat is the real reason some groups are threatening to pull out of Boston? It doesn’t bode well for the American Academy of Allergy, Asthma and Immunology; the American Society of Gene Therapy and the Heart Rhythm Society to change their plans when rules of ethics are being employed. Who will benefit from the "fear-mongering?" Certainly not the public's health.
The establishment of “a code of conduct for pharmaceutical company employees” has become necessary. Sometimes, if not done voluntarily, ethics and morals need to be legislated.
I confess I did not read all the guidelines, just the overview in the Globe.
ReplyDeleteAs I follow it, the key issue is CME and the claim, by docs and pharma involved, that presenters representing industry will be barred. Am I misunderstanding the _claim_? And is that, indeed, the core of the regs?
As for trinkets, I think it is probably a minority of docs (and the rest of us) who are _not_ drawn to "free stuff" - regardless. The claim that pens, mugs, etc. "aren't the issue" or "aren't important" is true, but I think it misses the psychological reality. Most of us _are_ drawn to these things, and especially those in "entitled" professions. To the recipient, all these goodies are a confirmation of just how important they are - kinda like being oe of the "popular" kids in class. People like being wooed - even if it's with plastic toys.
Former
ReplyDeleteWhy is the criticism of this proposed rule coming from Professional Medical Associations and not the pharmaceutical industry?
JimK
http://www.massbio.org/writable/files/Policy/draft_regulations_121008.pdf
The Pharma industry has indicated that the restrictions could potentially cause problems for the industry.
ReplyDeleteHowever, these medical associations will move their convention if the Pharma industry feels they can no longer support them. However, the guidelines do not prevent from buying kiosk space. It is restricting activities that are not entirely CME.
Dianne, you are right on the money. Medical professional organizations depend on drug and device company support. Rebel organizations will need to adjust to the new regulations, which are designed to protect the public’s health.
ReplyDeletehttp://www.youtube.com/watch?v=kJO1jFi3Hvo
Jim, thanks for posting the regulations.
Justice, industry may provide FDA-regulated promotional activities, but not certified CME activities. Here are some of the differences between promotional activities and CME activities:
PROMOTIONAL ACTIVITIES
Presenters are paid by the company to provide information about the company’s products.
Companies write the presentations, which focus on how a specific product is used for a certain medical condition.
Presenters may not discuss off-label use of the company’s product.
CME ACTIVITIES
Presenters discuss evidence-based information which aims to improve outcomes for individuals with medical conditions.
Presenters must disclose conflicts of interest, and any conflicts must be resolved beforehand.
CME providers write the lesson plans. Company sponsors do not provide feedback.
Off-label use of products may be discussed if identified as such and evidence-based.
Justice, is medical education the core issue? No, there is more here. To be continued...
I am sure Massachusetts’ legislation was intended to protect the public more than to punish the industry. I believe most doctors are good and honest and would not compromise their integrity for any gratuity, small or large. But, we know some companies offer, and some people are influenced by "gifts". Sometimes it is seemingly innocent, and sometimes it is overtly dishonest.
ReplyDeleteI do not want to have to question my doctor’s motives for prescribing a medication who’s name is stenciled on every pen, pad, and coffee cup in his office. I do question a group who protests so loudly over something they consider so innocent.
I'm somewhat amused by the hue and cry over Massachusetts new regulation since, from what I can tell, it is almost identically in line with the new PhRMA and AdvaMed Codes. Oh wait - there is one (1) significant difference - Mass will fine transgressors. But I would like to know what they see that causes such consternation. Industry may have a point when they worry about others knowing who they pay to do research, but why do doctors care that industry now really does have to abide by the rules? Is it simply entitlement? and as Joe Public mentioned - Do they think we don't notice how they deride the idea that a pen can influence them and then cry like babies because they can't have them anymore?
ReplyDeleteThe only ones I feel sympathy for in all of this are the non-profits. I have a friend who is a social worker at an AIDS service organization on a shoestring budget that's going to get tighter having to pay for office supplies.
But really, can anyone else see how this is significantly different from the voluntary industry codes? Reporting is a nuisance, but we have to in California. Registration is a pain, but Nevada requires it. DC is stricter than anyone, but they don't seem to care. Why Mass?
Harpy, The main difference between the Massachusetts regulations and voluntary industry codes is that the regulations mandate good behavior. Dianne explains in her post that, "Sometimes, if not done voluntarily, ethics and morals need to be legislated."
ReplyDeleteRight, Nancy, which is why this is so funny. Industry comes up with new standards ahead of legislation to show that they've changed their ways and the bad old stuff is in the past (really, we mean it). One state puts a couple of teeth in a regulation (really quite minor) that mimics the voluntary industry codes and requires adherence to ACCME (gasp!), and suddenly everybody's pulling out of Massachusetts! So basically they're saying "we didn't know you expected us to follow our codes!" My cat plays innocent better.
ReplyDeleteJohn Fauber and Susanne Rust, reporters for the Wisconsin Journal Sentinel, really did their homework on this one. Here is Fauber’s most recent investigative report in a series on conflicts of interest in medicine:
ReplyDeletehttp://www.jsonline.com/features/health/38283649.html
Harpy, is this an example of "the bad old stuff" you mentioned above?
The Journal piece is good because it points out where the issue gets sticky. I was thinking more along the lines of the extras that used to come with conventions. It's the curtailing of the freebie stuff that's really getting under their skins. But try to explain law to sales people. All they can think about is one-upping the other guy.
ReplyDeleteSpeaking and consulting are harder to control. Industry really does need doctors. Especially medical device. Pharma's research is done by chemists, device is done by doctors. I don't deny there has been a lot of abuse of this relationship, but finding a solution is going to be difficult. Have you seen Sen. Grassley's reintroduction of the Physician Payment Sunshine Act? Some of the changes will have industry kicking themselves that it wasn't passed last year.
Harpy
ReplyDeleteI only briefly perused the PPSA and it appears that the maximum penalty is 150K; for a large Pharmaceutical Company that does not seem like much of a deterrent.
JimK
Harpy, thanks for posting the Sunshine Act of 2009. I also looked at the 2008 bill. The penalty for each occurrence of failure to report was increased in 2009. I would like to hear your views on the changes that were made to the bill.
ReplyDeleteJames, I believe the deterrents will be in the details of the act. More later...
I guess this shows that pharma was bluffing when they came up with their own internal guidelines since they are obviously doing some arm twisting of the Asthma medical society. Maybe make them die while clutching their Singulair inhalers? I say People's Republic of Massachusetts don't give! Allons-y!
ReplyDeleteThey've added to the types of payments that need to be reported, stipulated aggregate reporting from the prior year, changed some of the reporting exclusions, and added a lot more data reporting. Jim, I can't remember how they define the cap - if it's per report or total, but the cap for bill 2029 was $50,000. $150,000 may not be much, but it's triple what it was.
ReplyDeleteAt first blush it seemed to be a huge burden for companies, but now it may be something of a relief - IF it preempts state legislation. Many companies, either voluntarily or due to CIAs, are already making plans to disclose payments. Like it or not, they're all going to have to do it in the future. I don't see things changing before then.
I came across an NYT article from last Friday that describes a little of what life is like under a CIA. It also mentions the disclosure rules.
John Fauber and Susanne Rust are back with a report on the new UW conflict of interest rules. Click on the UW link.
ReplyDeleteJerome Kassirer, an expert on conflicts of interest in medicine, gave the new plan a thumbs-up, but said that it lacked rules on CME.
Dr. Kassirer has written about the disclosure issue, here:
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2100135
Thanks, UW. Very interesting report. Of course, Kassirer is also known for his more general survey of such issues in his _On the Take_.
ReplyDeleteThanks for this. Go Badgers.