Academic Detailing Bill Is Introduced In Congress

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sales-rep2In an effort to dilute the impact of sales reps, several Senators and Congressmen today are introducing a bill that would create funding for a program to send trained pharmacists, nurses, and other health care professionals into a doctor’s office with independent data about benefits, risks, costs, and comparative effectiveness of prescription drugs, including generics.

The Independent Drug Education and Outreach Act of 2008 would make it possible to fund grants or contracts through the HHS Agency for Health Care Research and Quality to develop educational materials and to send trained medical professionals to a doc’s office to discuss “unbiased information on appropriate prescribing,” according to a summary of the bill. (Here is the Senate version.)

Applicants may not receive financial support from any manufacturer of the drugs being reviewed, and the AHRQ will review and approve the accuracy and effectiveness of the materials on a bi-yearly basis. Regulations are also supposed to be in place to ensure the accuracy and timeliness of the info distributed, to prevent conflicts of interest, and to promote the effectiveness of the program.

The sponsors cite a program in Pennsylvania found that drug expenditures for a single class of drugs were reduced by roughly $120 per doctor per month, and among the heaviest prescribers, the reduction was $378 per doctor per month. They also point to a study in the New England Journal of Medicine projected that for every dollar spent on academic detailing, two dollars can be saved in drug costs.

The sponsors are all Democrats and in the Senate include Wisconsin’s Herb Kohl, who heads the Special Senate Committee on Aging; Dick Durbin from Illinois; Ted Kennedy from Massachusetts, and Bob Casey from Pennsyvlania. In the House, the sponsors are California’s Henry Waxman and New Jersey’s Frank Pallone.

They maintain that a federal academic detailing program would likely pay for itself and create additional cost savings for the federal government, private insurers, and patients.

“We need a program like this to counter the pharmaceutical industry’s marketing free-for-all,” Robert Restuccia, executive director of the Prescription Project, says in a statement. “Academic detailing programs already exist in other countries and in several states, and they’ve been shown to improve care and generate savings.”

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  1. Bring it on! I can’t imagine these detailers being more shifty than industry detailers.

  2. This program has been tried in Pennsylvania and has had little or no impact despite what Prescription Project says. This would be another colossal waste of taxpayer dollars.

  3. Atlex,
    Interesting that your comment is 180 degrees from what is said in the story about PAs program.

    I know for a fact when high prescribers of costly name brand meds are counter detailed toward equally effective generic choices, the docs rx costs drop.

    With ACEIs, HMGs, B-blockers, Ca-blockers, PPIs, H2 blockers, etc now all with generic choices, it is hard for me to believe that nationwide counter detailing in those classes (which are huge)would not save money.

  4. Senators Kohl believes this government-funded scheme “would pay for itself by lowering drug costs to federal programs.”

    Perhaps, but at what cost to patient care? And what about the fact that “unbiased” and “objective” are in the eyes of the beholder?

    Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.

    But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer” in the nation. So the more drugs these government-funded workers classify as “wasteful,” the more money the government saves. Such a conflict is hardly” unbiased.”

    Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads” will deliver the findings their “funders” wants to see — that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well — Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.

    That’s what “government” care really delivers

  5. The Medicare prescription drug benefit has goosed pharma industry profits to the tune of $3.7 billion, said a report from Rep. Henry Waxman’s Committee on Oversight and Government Reform.

    It doesn’t look like government care was delivering that at all!

  6. Mr. Pitts,
    Valid points. Which statement do you find most interesting?

    1.) I’m from the government and I’m here to help you.

    2.) I’m from big pharma and I’m here to help you.

    I struggle with both. But there are many best in class generics available today.

  7. Doc,

    Managed care companies covering both commercial and Medicare beneficiaries have done all of the heavy lifting in this arena. They have general generic prescribing incentives; specific incentives tied to high use classes (statins, PPIs, etc.); PAs; and step edits. From within pharma, robust comparisons show that the geographies with so-called academic detailing are not impacted at any greater level. Anecdotally, pharma reps, who would be the first to complain if academic detailing was impacting them, tell me that managed care’s impact is significantly greater.

    Atlex

    PS to Hack; that’s the same tired comment you made previously and there’s plenty of evidence that Waxman’s report for single dimension, only looking at places where the costs were higher, but not looking at the significant cost offsets.

  8. Another waste of our well earned money that ends up in taxes.

  9. Atlex,
    I disagree with some of your views. Sure managed care has a sig impact on rx decicions, however from personal experience, when a managed care company employees counter detailing PharmDs, their influence has even more impact.

    The article sites a PA study and NEJM article that would argue otherwise from your assertions. My experience within pharma for 30+ years is that they have few if any ‘robust’ comparisons on this topic.

  10. I take great pride with my career as a Pharmaceutical Rep because of my education, ethics, company commitment to saving lives & helping patients and honesty. All my colleagues in the industry also provide the same passion and commitment to physicians, medical community and most importantly patients.

    Please congressmen and representatives STOP wasting my taxes fighting with Pharmaceutical Reps as these are NOT the real issues we are facing in the United States. Again another liberal wasting time, money and our taxes!

  11. Dear Professional Pharma Rep, Were you the rep that killed my son by hiding the lethal side effects of Lilly’s Zyprexa? Heavily scripted to answer the concerns of doctors watching their patients balloon up, did you have several ready, evasive answers handy? Did you consider that you were acting in the interest of public heath?

    I don’t know how anyone in good conscience could do the job you do, even though the pay and perks are good. There is more to life, such as ethics, morality, and having to live with yourself.

  12. Doc,

    The PA study was not at all robust. It only showed a decrease in cost, but did not have a comparator group. It also occured at a time when seniors in the program began getting the Part D benefit. And, notice that the NEJM “projects” a savings but it actually hasn’t demonstrated a savings–big difference. And, by the way, you don’t think that the State had a COI of interest in its study, do you?

    Atlex

  13. PPR-

    You’re obviously completely joking. If you’re acurately describing yourself, about 90% of your colleagues are not like you and are just in it for the money. As a profession, they long ago checked their morals, ethics and integrity at the door!

  14. The state’s “COI” is almost always invoked when traditional marketing is threatened. It’s a kind of post-modern relativism one wouldn’t expect from conservatives. Since everyone has “interests,” all truth is relative. Choose your poison.

    The reality is that there have been excellent public programs and formularies which specifically _prohibit_ their managers from considering cost in their recommendations.

    As hundreds of False Claims Act suits suggest, Uncle Sam has been scammed many times. Perhaps Uncle Sam is tired of it.

    Peter - I would _genuinely_ be interested to hear your response to my query on the Zyprexa thread.

  15. I have to wonder if Mr. Pitts is being honest or is this merely disinformation.

    Kennedy and Waxman were the sponsors of the Food and Drug Administration Amendments Act of 2007. If you look at this act closely virtually everything in it is to the benefit of the drug companies. To an unknowledgable reader this may not seem so. However if you know what’s actually going on with Pharma, FDA, and the Critical Path initiative this will provide a perfect opportunity to detail physicians about new drugs and new genetic tests for drug side effects that will be picked up in the monitoring program.

    This is simply a tactic.

    The strategy is:

    Cover up side effects during drug development.

    Put everything on the market no matter how dangerous.

    Monitor for the side effects that you expect to find. (Remember the whole body CAT scans and ECGs for children taking ADHD drugs).

    Develop a genetic tests for predisposing factors no matter how insignificant.

    When you find the problem, use the new risk communications from FDAAA 2007 etc. to publicize it.

    Use the sections on drug-devices and forced labeling changes from FDAAA 2007.

    Market a another drug that treats the side effect and use the CAT scans and new cardiac contrast agents to monitor how the treatments work.

    Use your government counterdetailing force to educate about genetic testing, monitoring, and treatments, with a veneer of respectability.

    Don’t forget to get preemption past the supreme court so you can’t be held accountable.

  16. Hey Ed, what’s with your source? You claim the bill will provide savings and provide a link to a Philadelphia Inquirer story that contains no mention of savings. Why?

    Prescription Project and Community Catalyst have been claiming there are savings in Pennsylvania, but have been unable to actually demonstrate it (no peer reviewed articles opening themselves up to actual scientific rigor and were unable to answer these same questions at town hall in Philadelphia back in April). The closest they can ever get are “accounting projections” (which never seem to materialize). They are long on rhetoric and short on caughing up actual facts (which can be verified independently).

    The Independent Drug Information Service (the group that administers the Pennsylvania program) mentions the potential for cost savings on its website, but is careful to not make any claims of actual savings to the State of Pennsylvania (much less actually going one step further and proving those savings). [Incidentally you quote Restuccia from his press release saying other countries have achieved savings through academic detailing, yet on the IDIS website, they use the same claim, but only say other countries have tried academic detailing...no mention of savings.]

    Jerry Avorn, the father of academic detailing (and some might say the brains behind groups like Community Catalyst and the Prescription Project), has admitted under oath in Federal Court that academic detailing is a utopian ideal that is unlikely to ever succeed and is unlikely to ever generate any real savings to the government and is unlikely to ever drive down drug prices. So why do it?

    The answer: Herb Kohl can show his brilliance once again! If you give people the impression you are actually doing something, it’s just as good as actually doing something. Get the ignorant masses to focus on academic detailing and Kohl and the elite club in Washington don’t actually have to tackle the major issues facing healthcare.

  17. Atlex,
    You conitnue to evade the fact that many of the most expensive, large drug categories have excellent generics avaiable that work relatively side effcet free in most patients. There is no need to use costly name brand drugs in most patients in many cases. Does the state have a COI? Of course it does - WE ARE THE STATE.

    The real question is, does pharma have a COI? Or do they only have the patients best interest at heart? After 30 + years and counting in pharma, I can tell you what I hear from upper, middle and lower management routinely - its all about the profit. Why? Because every manager’s and exces pay, bonus and promotion is based on sales success NOT patient welfare. Perhaps to you a subtle difference, but when worked out in practice, not so subtle.

    I find it amusing and sad that you would ascribe more genuine trust, ethics and truth to pharma!

  18. Hi Pharm-Aid,

    With all due respect, I think you’re confusing me with Herb Kohl and the Prescription Project. I reported the claim made by the senators that the program, as they see it, would save money. And I cited the savings they purport would occur.

    I didn’t personally make any claim about savings or somehow suggest that I support - or disavow - the program. I didn’t offer any opinion of my own in this post. Sometimes, I do that, but not this time. And I linked to the Inky piece simply because it explained the concept, to some degree. I apologize that it didn’t offer any of the numbers you sought.

    I hope this helps,
    ed

  19. Ah, I see the dreaded “liberal” word has been tossed into the debate. Quite disingenuous, I might add, given that pharma enjoys tremendous monopoly power through patents (and games pharma companies play with patents), a regulatory system essentially captured by the industry it regulates (called the “capture” theory in economics), and protected free commercial speech, etc.

    Counter-detailing is peer-to-peer communication, not market and sales. Deal with it; it’s been around for decades and will continue to grow, legislation or not.

  20. Ed, gotcha. I re-read it. I guess since you linked in the middle of that sentence, it made it seem as though it was supporting a claim from you.

  21. Really well put, Bob. Despite suggestions that things are getting more above-board in the marketing world - which I would genuinely like to believe - counter-detailing is a rational response to situation we are in.

    I know lots of reps who are straight-shooters, as do you. Some of my best students, as I said on another thread. They will not be threatened by the fact that docs are also getting info from additional sources, as (one hopes!) they already are. The fact that the two are seen to be opposed to each other (granting the implications of the word “counter) is also a bizarre part of this discussion.

    For them, it’s not “counter.” It’s why they got into their job in the first place. And when they get disillusioned, as some have, they become counter-detailers themselves.

    Truth is served either way.

  22. This bill is about more than a competition of government sales reps vs pharma industry sales reps. it’s about identifying problem areas with pharmaceuticals and improving quality.

    Medicare Data would be first used to identify potetnial areas of RX inappropriate use, inappropriate doses, drug interaactions, duplicative use etc. Once problem areas are identified, healthcare professionals can target specific quality of care issues…and yes they can also suggest lower costing options if outcomes would not suffer.

    It’s no different than what private insurers such as Aetna and United do when trying to ensure appropriate pharmaceutical use in their populations. Why can’t the government as the biggest insurer invest in these programs that actually can improve quality of care, prevent hosptializations and reduce overall medical costs. Remember…28% of all hospitalizations are caused by pharmaceuticals being prescribed or taken incorrectly, not taken at all (noncompliance) or adverse reactions.

    I’m not a big government program supporter, but don’t throw out the baby with the bath water because this program actually has merits if run correctly.

  23. Academic detailing isn’t about improving patient care. It’s simply about controlling costs. We can discuss the merits of academic detailing, but let’s just be honest about the motivations.

  24. Pharm Aid - I am still hoping you will respond to my posts on the “independent expert” thread. I will probably wait for a long time.

    I believe you are simply wrong about academic detailing, and, indeed, dishonest. Oregon’s and Washington’s medicaid formulary, which is an EBM approach along the lines of academic detailing, is legally forbidden to consider costs in making recommendations.

    Industry folk love to say “it’s about cost.” More false and misleading information.

  25. Doc,

    I have never argued against the fact that many categories have good generics. My point is that PA has never shown in an audited or peer reviewed manner that its program actually saves money. It “projects” that it will save money, it maintains that it saves money and even touts an ROI. The COI goes beyond the money. The folks who run the program have a vested political interest in demonstrating that it works. Political capital is far more important to government bureaucrats than money.

    Atlex

  26. Having been in and out of the industry for far too long, I would note these discussions remind me of the debates around formularies, prior authorization programs, drug utilization protocols and value propositions. All of the evidence, pro and con, doesn’t affect public policy–the programs are part of the context of drug production selection for better or worse. Some of the evidence also reminds me of the age-old question: does research drive policy or does policy drive research. I have come to the decision it is the latter.

    One notion does need to be debunked: very few drug products or programs “save” money. People tend to think cost-effectiveness is all about reducing expenditures and it is not. CEA is concerned with relative efficiencies in resource utilization.

    Consider an isolated example: Alzheimer’s Disease is a growing medical and budget problem. Any cost-effective innovation with superior treatment outcomes is going to result in an explosion in drug spending, pubic and private, for that product. Even if reduction in long-term, institutional services results, the overall impact is likely to be an increase in overall spending. My point is that financial and economics assessments are very limited in influencing decisions. The UK’s NICE program is an exception but I don’t see it transferring to the US environment. I realize I have strayed off-topic, but I was in the moment.

  27. Those of you who favor this legislation are opening up a pandora’s box.

    Do you want your tax dollars going to this sort of activity? Do you really believe that the congressman is truthful when he says the program will pay for itself? When has there ever been a government program that paid for itself? You might save a few dollars on your medicines but the net result is you will be more poor because more taxes will be taken out of your paycheck.

    Moreover, since you want the government to counteract the activities of pharma reps, then do you want the government to counteract sales activities of Starbucks? The oil industry? the medical industry? the movie industry? the financial industry? the insurance industry? Do you want the government to go to your clients and/or customers and persuade them to not buy what you sell or use what services you provide?

    If you were honest with yourself you would say “no”. So why is it okay for the government to go in and “undo” what the pharmaceutical industry is trying to do but it is not okay for the government to do the same in all other industries?

  28. Justice, you are confusing issues. Medicaid formularies are forbidden for considering costs in making recommendcations. Academic detailing, while receiving government funding, is NOT subject to the same rules. I can tell you that IDIS is all about costs. That’s fine, let’s just be honest about it.

    Jerry Avorn, father of academic detailing and the brains behind all of this, talks almost exclusively about academic detailings ability to drive down costs. Come to think of it, I’ve never heard him speak about academic detailing and quality.

  29. Pharm Aid,

    While Medicaid formularies are forbidden from considering costs, Medicaid PDLs are not. Many state Medicaid programs absolutely use cost as a major, if not the major, criterion in determining access to the PDL. Without PDL access, in most product categories, market share of a product drops precipitously.

    Other than that I agree with your viewpoint.

    Atlex

  30. PA - Jerry Avorn certainly talks about costs; I don’t think I suggested otherwise. He does, indeed, talk about a lot of other things as well. Sorry you’ve missed it.

  31. Below a link to Jerry A’s testimony about academic detailing in the Senate Committee on Aging. This is a context in which one would expect him to emphasize cost-saving above all.

    In fact, quality of care and cost issues are about equally represented.

    http://aging.senate.gov/events/hr190ja.pdf

  32. p.s. Looking back up the thread, I agree with PA that I consolidated the Medicaid and acad detailing issues. In my “irrational exuberance” against the inevitable “it’s all about costs,” I was irrationally exuberant in saying it isn’t.

    It is, indeed, partly about costs. And partly not.

  33. If pharmacists can be replaced with auto-dispensing robots then drug reps can too. Let’s face it, we are heading for socialized medicine in this country, espcecially after Obama gets in the White House. But reality is that the retiring baby boomers need Big Pharma, not the government, to keep them alive and improving their quality of life).

    Without Big Pharma, pharmacists would be faced with two weapons in their arsenal– leaches and bloodletting. Who develops next generation medicines- Congress? NIH? Universities? Ha! It’s being paid for and developed by US Big Pharma, at the tune of approx $800 million per compound (and that’s not any guarantee that it will be brought to market). When is the last time a Canadian drug manufacturer developed any life saving or life enhancing pharmaceutical (outside of another generic for Claritin)?

    Get ready for leaches and bloodletting, because Congress and the Democrats are going to kill the Golden Goose that laid the golden pill (credit to columnist William Safire).

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