Guest Blog: Real Influence, Pharma or Insurers?

With the recent proposal to repeal the so-called Massachusetts “gift ban” (referred to from this point as the “interaction ban”), I asked myself who stands to gain the most from such bans? Is it the consumers or patients?  Is it the physicians or their practices? Is it the federal or state governments?  Nope. Sadly, it is the insurers who gain the most, at the expense of patients. 

The argument for interaction bans is that generics will save money over name-brand medicines, which are being “unnecessarily” or “irrationally” prescribed (as defined by whom?). What is forgotten is who wields the most influence over the decision to prescribe a medication. The public is convinced that it is the physician, and, actually, that would make sense.   More recently savvy public relations campaigns and advocacy efforts have convinced legislators (and the public, so the advocates claim) that it is the Pharma rep that controls prescribing. In reality, it is the insurance companies.

Insurance company actuaries decide which drugs are on the formulary (what they will cover) and which one is a preferred name-brand medicine (cheaper co-pay), based on benefit-to-the-bottom-line calculations.  Ironically, some generics are not even on a formulary list and are NOT preferred over name brands. Consequently, these decisions, which are based on the whim of the insurer, dictate whether a patient has access to a medicine, not their physician, and definitely not the Pharma rep.

Does an intelligent Congressman or Senator really believe that a patient will blindly order a name brand drug when generics are available?  What would they do in that situation?  Why would they think the general public will be so eager to simply accept a costly name-brand medicine when money could be saved? Are Congress members so far removed from reality?  Some of my patients have to decide to forgo either food or medications.  I hope Congress members realize they lacked the proper infomation about the situation and correct their version of reality!

For example, it is already extremely challenging to get a name-brand medicine when it is medically necessary.  Many states have laws that mandate generic interchange (substitution when the active ingredient is the same); physicians must fill out prior authorizations, which are labor-intensive and represent uncompensated work; and pharmacies are pushing cheaper alternatives due to higher profit margins for them.

Among all these competing forces, where is the logic, or evidence, that a patient can walk into a physician’s office and end up with an unnecessary and expensive bottle of pills solely because of a Pharma rep?  Only in the minds of idealistic social science researchers who claim that a pen with a name brand label will overcome all these obstacles. Sadly, the true issue at hand is that many physicians will or cannot perform the extra work to obtain a name brand drug when it is safer or works better than a generic because of the extra time or staff involved with the myriad paper-work, which is a real cost-driver of health care.

So the next time you hear of the egregious cases of Pharma exerting their control by ‘wining and dining’ physicians, take a moment to consider who really stands to gain by the proposed solutions and whether patients have even entered into the equation.

Edison Wong, MD

Physiatrist, Massachusetts 

Lack of Context Leads to Conflict of Interest Charges at Patients Expense

The AdvaMed and PhRMA codes are widely acknowledged, if soto voce, as penance by many of the largest members of these trade organizations for being habitual offenders. Look up fines paid by Lilly, Pfizer, Merck, Medtronic, and on down the list. The codes were "retrospectively pre-emptive" and designed to mitigate huge OIG and DoJ judgments. This has now been spun by journalists as higher industry self-awareness. Little wonder the New York Times is failing.

Enthusiasm by physicians for relationships with industry tend to follow along lines of co-dependence and mutual benefit. Interventionalists and surgeons are inclined to work quite closely with device companies and orthopedic surgeons and cardiologists are probably the prototype. Psychiatrists and internists often have close ties to pharma. They write a lot of prescriptions, not because they got a free slice of pizza as a resident but because it's the best care they can offer to many of their patients. Imagine being a psychiatrist today without an SSRI or sedative option (psychoanalysis is on the decline for those who have been out of town lately), or an internist without antibiotics, beta blockers, statins or pain medications. Pretty much leaves bedside manner as the therapy of choice.

Pediatricians, dermatologists, pathologists, physicians in social medicine (Angell, Brody) and herbalists (of Albuquerque fame) tend to rely less heavily on and derive less value from technology, so are generally more critical of these translational relationships. If you look at the "inclusive" COI policy committees at many schools, you will see a population disproportionate to specialty percentages (check Pizzo's committee at Stanford on their website, for example). I believe this qualifies as bias, but not in the patient-sparing, pain-relieving sense.

The US government, through the department of agriculture, subsidizes many American farmers. Some farmers use their subsidies to buy a new tractor.
I'm not a farmer so I don't qualify for a new tractor. For this, I may be resentful and inclined to disparage both the farmer and USDA. This is kind of how it works for Marcia Angell and David Rothmann, only in this case, the subsidy is often a piece of pizza or a donut.

Is There a Role for Industry Sponsored Education?

Yes of course there is.  And here is a critique of a recently published commentary against commercial support of education from Jerry Avorn, MD (self proclaimed father of Academic Detailing) who’s goal is to use government funds to promote generic drugs to physicians and who's JAMA paper from 1983 is regularly referenced by politicians as current science.


His recent commentary, co-authored with his colleague Niteesh K Choudhry, "Is there a role for industry-sponsored education in cardiology?" was published in Circulation (volume 121, pages 2228-2234, 2010). The first paragraph uncritically invokes the authority of “behavioral economics” to build the frame that “unconscious biases and emotional factors” dominate educational messaging.


The second  paragraph concedes that industry makes “important” contributions to products that reduce morbidity and mortality (but doesn’t say how important). A book by the first author (Avorn) is then referenced to make the claim, “there is growing concern that educational activities should not be supported or influenced by companies whose profitability and very existence depend on the sales volume of the products they make.” Other than the book reference, no information quantifies the magnitude or source of “the concern.”


The third paragraph returns to behavioral economics to celebrate the policy of certain medical journals that preclude authorship of articles and editorials by individuals with ties to makers of products in order to avoid “unconscious bias.” It calls for extending the same policy to eliminating commercial support of education in cardiology. As a result, individuals with “minimal commercial interest in the topic being presented” transfer medical knowledge “most efficiently and with the least distortion.”


The next section of the paper outlines the types current levels of industry support of CME. It is particularly critical of salespeople, referred to as “detailers,” who “may have limited scientific training and are paid on a commission basis, depending on how much of their company’s products are prescribed by the clinicians they target.”


This section also alludes to large legal settlements paid by companies because of off-label marketing allegations. It does not mention the fact that these settlements are responsive to debarment threats (i.e., loss of government business including Medicaid and Medicare) or that indicted individuals who did not settle have won acquittal.

The article then states: “These developments demonstrate that the lure of multi-billion dollar sales from blockbuster drugs and devices can distort the accuracy of information provided by manufacturers to physicians, even when no laws are broken.” Is this emotion-laden conclusion not an example of “biases and emotional factors” influencing “educational messaging?”


In this section of the paper, the authors rehearse high-profile examples in which marketing allegedly contributed harm. In their reference to relative rather than absolute risk (Vioxx “doubled the risk of myocardial infarction and stroke”) to describe the harm and their invocation of one-sided accounts (including news media articles) of controversial but unresolved allegations, they again exhibit the “biases and emotional factors” they purport to want to eliminate.


The paper then summarizes “opinions from the leaders of medicine,” including policy recommendations by the AAMC, The Macy Foundation, the IOM, individual academic health centers and a widely cited article published in JAMA. It does not mention any dissent to these opinions, such as written objections raised by industry participants in the AAMC deliberations. It erroneously refers to “heated rebuttals” to the JAMA article, but, in fact, the reference cited is not a “rebuttal,” rather a call for eliminating industry support of CME. Is this “efficient” knowledge transfer “without distortion?”


The ensuing section of the paper explores the question of who should fund CME following elimination of commercial support. It prominently presents a glowing advertisement for the first author’s commerce-free “academic detailing” program based on “rigorous review of evidence.” Does behavioral economics not apply to this celebration of the author’s academic status and livelihood? Would the adoption of more academic detailing not be equivalent to paying commissions to a commercial sales representative? Neither author is a cardiologist; do concerns about “limited scientific training” not apply?


The paper ends with authoritative declarations that the march to suppress conflict of interest is akin to the introduction of statistics and human subjects protection to clinical trials. It ends on the note that we must eliminate bias, because it “can so easily be introduced unintentionally.” Continuing with their one-side account, the authors fail to cite four studies published in the past year documenting almost no perception of bias by participants in commercially sponsored CME activities. 


Having concluded that bias “is difficult to detect and prevent,” the paper sets as a standard the need to prove the nonexistence of nothing. It certainly isn’t hard to detect bias in this paper!

ACCME Changes office location to Salem, MA

Whom to censor next?  Former employees, relatives/spouses of employees, applicants/candidates for industry jobs, known associates, industry sympathizers, recipients of Lilly or RWJ foundation grants, mutual fund shareholders, employees of non-medically related companies, medical corporation volunteers, physician employees of for-profit hospitals, physicians with industry patients?  ACCME has not been specific about this and appears to have overlooked some potentially biased faculty whose presentations/contributions might lead to increased and irresponsible consumption of drugs, devices, soap, computers and other precious resources.

Recant or be dunked.  Welcome to Salem.  I never thought agar and mice knew the difference.

war horse was left standing as a burrito

In browsing the WSJ Heath Blog today, I found the following exchange when talking about the new APA COI proposal.  It seems that "war horse" was left standing like a burrito.   (This post is abridged for brevity).