Tuesday, October 11, 2011

Without Free Gifts from Pharma to Docs, Would Research be Useless?

In a recent blog post (here), PhRMA said "Without Promotion Research will be Useless." To support its case, PhRMA cited "an interesting opinion editorial" in the latest edition of the Annals of Emergency Medicine – the medical journal of the American College of Emergency Physicians (ACEP). In the op-ed, entitled "Limiting Gifts, Harming Patients," Emory University economist Paul Rubin, Ph.D. expressed concern that ACEP policy regarding Gifts to Emergency Physicians from Industry "could have the unfortunate effect of limiting the exchange of critical information between medicine makers and physicians about the benefits and risks of new medicines, how to use them properly and how best to diagnose the right candidates for particular treatments."

Basically, Rubin and PhRMA are saying that gifts to physicians are an integral part of promoting new discoveries to physicians and without these gifts and promotion, medical research would be "useless."

I haven't read the op-ed piece because it cost about $32 to download the pdf file for 24 hours! Highway robbery is all I have to say about that! I did, however, request a complimentary copy, but haven't received any response yet. No matter. The op-ed piece obviously is attacking ACEP policy on the subject of free gifts to emergency physicians. You can find that policy here.

What's so onerous about the ACEP policy that an op-ed piece would attack it as "harmful to patients" and PhRMA would claim it renders research useless?  I looked at the policy to learn first hand why it's research Agamemnon.

First, the ACEP policy does NOT make ALL gifts to physicians from pharma unacceptable by their members. Here are gifts ACEP says are perfectly acceptable:

Emergency physicians may accept educational gifts that are not of substantial value ($100 or less). Examples include:
  • Occasional modest meals in an office, clinic, or hospital setting that accompany an educational presentation 
  • Evidence-based clinical care guidelines or pocket handbooks 
  • Anatomical models designed for patient education 
  • Informational materials to facilitate patient understanding of a disease or treatment
This sounds familiar. The PhRMA Code on Interactions with Healthcare Professionals says essentially the same thing. Code #11 states "It is appropriate for companies, where permitted by law, to offer items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is therefore appropriate..."

The ACEP policy, however, cites examples of gifts that should NOT be accepted. These include:
  • Meals provided for physicians or their family members, staff, or guests (other than modest meals accompanying educational presentations, as noted above)
  • Personal or recreational items, such as tickets to theatrical or sporting events
  • Direct subsidy of any expenses (such as registration, travel, lodging, meals) incurred in attending CME events or other educational or professional meetings (All industry support for such activities should be provided directly to the activity provider to offset program costs or to a general fund for continuing education programs.)
  • Cash or cash equivalents such as gift certificates or vouchers
  • Gifts offered in exchange for prescribing or using a product
  • Medical equipment, such as stethoscopes or otoscopes
  • Payment for token consultant or advisory arrangements
  • Medical products for the personal use of the physician, the physician's staff, or family members
Again, PhRMA takes a similar stance. Code #3 states: "To ensure the appropriate focus on education and informational exchange and to avoid the appearance of impropriety, companies should not provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company."

It seems tio me that Dr. Rubin could just as well criticized the PhRMA Code, which limits gifts to physicians, as being "harmful to patients." So, I am confused why PhRMA would cite Rubin's op-ed piece in defense of promotion being necessary for research success.

Of course, the drug industry is free to promote drugs to emergency and other physicians. There's nothing in the ACEP policy that limits access to physicians for promotional purposes. In fact, the policy states:
"The College also recognizes that emergency physicians should be free to interact with industry representatives if they choose, and that physicians may receive useful information about particular products from industry representatives. Emergency physicians may receive compensation at fair market value from pharmaceutical and biomedical device companies for legitimate professional services rendered, including participation in research and service as faculty in continuing education programs."
What PhRMA and Dr. Rubin should have focused on is the role of "promotion" in general and not the free gifts to physicians straw man. Rubin, for example, says that "Research and promotion are merely 2 sides of the same coin," which is a more rational point of view that deserves a bit more analysis.

What PhRMA and Rubin are claiming is that pharmaceutical companies need to have the freedom to promote new medicines to physicians (and "maybe" consumers too, says Rubin) in order for research to have a successful commercial outcome. I can agree with that. But are gifts to physicians really necessary to achieve that outcome? I don't think so.

There are many other ways for pharmaceutical companies to reach physicians with promotional messages, including social media (eg, Twitter posts). If a gift is required to get the message out about research, then pharma is in deep doo doo.

What's needed is NOT promotion. What's needed is true two-way communication. Without that kind of communication, research truly is useless.

The Pharma Marketing News article "Physician Participation in Peer-to-Peer Social Media Sites," which will be published on October 12, 2011 (free to subscribers; available here to everyone else for $4.95) speaks about what physicians want from pharma: users of online physician peer-to-peer communities want open and transparent participation by pharma and non-promotional information: “Give us the data, let us make up our minds, don’t try to spin me, I’ve got a rep who does that,” is a typical physician comment. “Make dialogue two-way, respect us, and focus on scientific exchange,” is another. Physicians are looking for negative findings also!

Some other information physicians want from pharma companies include:
  • Drug pipeline information. 
  • New information about product—not interested in being detailed, however. 
  • Focus on topics like re-imbursement, patient education materials, etc.
So there's a lot more to "promotion" than detailing physicians after gaining access made possible by free gifts!

P.S. I finally did get a copy of Dr. Rubin's Op-Ed piece from ACEP. Thanks very much. The Annals of Emergency Medicine will publish a "rebuttal" to Dr. Rubin in the next few weeks. Meanwhile, here's my rebuttal:
After reading just the first three paragraphs of Dr. Rubin's op-ed, I am bowled over by his cherry picking of "the best evidence" (eg, 3 citations of the same author). Dr. Rubin also said that "the best evidence" indicates that ACEP's policies are "likely to lead to worse outcomes for patients." He did not cite any references to "the best evidence." 
Dr. Rubin's naivete regarding the FDA approval process is breathtaking. According to Dr. Rubin,  the FDA drug approval is "restrictive"; ergo "this means that we would expect that newer drugs would be better than older drugs. Because this is so [my emphasis], actions that lead to increased sales of newer drugs [eg, free gifts for physicians] would be expected to improve patient health." Whaaa? Dr. Rubin offered no proof -- eg, clinical outcomes -- that this is so. That did not stop him, however, from criticizing studies that find fault with pharma advertising because they too offered no real proof; ie, "clinical outcomes."
It doesn't take a PhD in economics to rebut Dr, Rubin's shoddy analysis. Even so, I can't wait to see the rebuttal to be published in the Annals of Emergency Medicine!


  1. A few points in response to the comments on my piece in Annals of Emergency Medicine. (My piece is called an op-ed but it was actually an invited editorial because my research was cited in an article announcing the new ACEP policies.)
    1. The “best evidence” I cite is Columbia Professor Frank Lichtenberg’s work in the benefits of new drugs. This may be criticized (although I have not seen any critiques in the literature) but it is based on analysis of patient outcomes. The two articles I cite critical of pharmaceutical promotion explicitly do not cite any patient related outcomes. I have not seen any systematic research showing that old drugs are better than new drugs. Also, the research with which I am familiar shows that the FDA is overly restrictive. I have not seen any rebuttal evidence indicating that the FDA is too lax. While some harmful drugs may be approved, the issue is the net benefit for patients, and the evidence I am familiar with shows that net patients are harmed by delays of useful drugs which more than outweigh any harm from harmful drugs that are approved. This evidence may exist, but PharmaGuy does not cite it.
    2. I agree that many forms of communication are useful. One of them is probably gifts. If we stop or restrict gifts, then other methods will substitute, but in the judgment of pharma’s marketing professionals these other methods will be somewhat less effective. The issue is not “either-or” issue, and I am not claiming that gifts are “required.” It is “more or less.” Stopping preferred methods does not mean that no information is conveyed; it just means that less information is conveyed or more must be spent on providing information.

    Paul H. Rubin, Samuel Candler Dobbs Professor of Economics, Emory University

  2. I have not claimed that FDA approves harmful drugs, so I am not obliged to cite evidence for that. I merely criticize your claim that every new drug FDA approves is better than older versions of drugs that treat the same condition. FDA does not require that the drugs it approves are better than competing, older drugs. All that is necessary for drug approval is that the new drug do no harm and is better than placebo (ie, nothing).

  3. Last point: I do not claim that every new drug is better, only that on average new drugs are better. It would be quite surprising otherwise. A drug company is not going to spend the huge amount needed to get a drug approved if it does not think the drug is in some way (e.g., reduced side effects) better than existing drugs. A company needs something to promote to get physicians to change prescribing behavior. Mistakes may be made, but on average we would expect new drugs to be better, and this is what the evidence shows.

  4. You still have not defined what you mean by "better." That could be anything. For example, a pharma company is seeking new approval for an already approved drug because it has added one additional score to the pill so it can be divided three ways instead of just two ways. Or a new approval can be based on a once-per-day dosage rather than 2 times per day. Etc. The real test of "better" is if the new drug is proved to improve health outcomes in the real world (not just clinical trials). That's not something the FDA looks at, although it may make assumptions based on clinical trial evidence.

    So you need to better back up your statement that "on average new drugs are better." I question your "best evidence" when you cite 3 papers by the same author - Lichtenberg. That's cherry-picking the data to prove your point. When you say this is the "best evidence," should I just take your word for it? If you had cited multiple studies by several different, independent authors, then your claim would be more credible in my eyes.

  5. Lichtenberg uses several measures, all related to patient outcomes. (for example, survival probability, perceived health status, activity limitations.) I agree -- more data would be better, but I am not aware of any. However, I am not aware of ANY data saying old drugs are better, and would be amazed if there were any. Just because the FDA does not require evidence does not mean that Pharma companies do not consider it. It is hard to sell worse products. No one requires that new computers be better than old ones. If you are depending on drugs getting worse over time you are betting on a weak horse.

  6. Again, I am not saying that old drugs are better than new ones. I only question your best evidence that new drugs are better than old ones. Not only that, but how much better are they when everything is considered, including side effects, increased copays, etc. that lead to non-compliance? If you don't take the drug -- because you can't afford it -- it is definitely NOT better. Also, some drugs may be "better" for certain patients than for others -- an argument the drug industry often makes to justify "me too" drugs -- new drugs that are virtually identical to competing drugs (not necessarily older drugs).

    Based on our conversation, I would say that "better" is difficult to define and quantify. This may be the real reason why pharma gives gifts to doctors who, all else being equal, would prescribe competitor's drugs. In other words, gifts to physicians may not help physicians in general get the latest drug information, but will help switch physicians from one new (expensive) brand drug to another new (expensive) brand drug. Old vs new is a moot point in that scenario.


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