Gates Foundation and Peter Pan

The COI jihadist went as far as insinuating that the Gates foundation needed extra scrutiny as it was working with industry in finding better treatments for malariaand the like. This was based on a PLoS paper suggesting extra scrutiny. When will these people stop? There should be only respect for the foundation! The root of all of their evil doing is an irrational belief that economic principles don't matter and can be circumvented. Just like Peter Pan circumvents gravity!

JAMA should take lessons in avoiding bullying

There is no doubt that the last paper in JAMA by Rothman and Chimonas (two sociologists and not physicians) represents the latest of a series of initimidation and bullying attempts at separating physicians from industry partners. It remains a puzzle why not more physicians are outraged by a McCarthysm article like this, and why JAMA allows for this to be publsihed. The problem is now greater given this is more than opinion, it is a thinly veiled threat! Read and get angry!

JAMA. 2010;304(20):2294-2295. doi: 10.1001/jama.2010.1714




- Posted using BlogPress

Conflct of interest and literature spin and JAMA

A recent article by Boutron and Altman in JAMA (2010, 303:2058) addressed the issue of spin in the medical literature. They stated a positive association between industry funding and a positive outcome of a publication. This is highly relevant since previous studies have shown a correlation, but no one has shown wrong doing. In fact its has been logically argued that given the massive investment of money needed for development that the private sector has to be more careful in designing trials that will allow purported benefits of new drugs or devices to be uncovered. This being imponderable the discussion can go on forever and become a chest beating exercise. However something very interesting has happened...

In the article by Boutron, they lacked a formal statistical analysis supporting their statement, and a letter to the editor by Allison and Cope (2010, 304:965) requested an analysis of "spin" and source of funding (primary methodology of their study was spin determination). They report that spin was not associated with source of funding (p value 0.6). I could spin this the Pharmascold way and say there may be a trend or spin it my way and say it not significant. We are better off just looking at the data and conclude there is no evidence that funding changes the RPMs (i.e. SPIN)!!

Conflicts of interest: Finally a formula that solves it!

It is now difficult to know what to do with the information provided in the disclosure section of journal articles.  I am puzzled as to how are we supposed to train residents and fellows into how to incorporate this information into the decision making process.  After all, we want the readers to formulate impressions about disclosures so that they attain objectivity about content.  And objectivity is about measurement.  So how is one supposed to do so?  Until now no one knew for sure.

As background I would suggest we needed a simplified statistical system for an audience who is known on occasions to struggle with stats.  For example many very smart colleagues still struggle with the significance of the p value.  Less than 0.05 Biblical!  Anything else discard immediately...  Let alone understanding a Bonferroni correction.

So to try to solve this problem I tackled a recent paper in the NEJM where C1 inhibitor deficiency is successfully treated by a new intervention (one of 3 papers in the same issue).  (Zuraw et al N Engl J Med 2010; 363:513-522August 5, 2010).  By the way congratulations to the authors on such important study.  (This comment is about the irony of disclosures not the value of their paper, which is truly outstanding).  The methods did not tell me how to account for the disclosures (Top figure).  So if you look at the results section there were 1006 words.  The disclosure text was almost as long (798 words).  There must be a way!  After many hours I took it upon myself to calculate the significance of disclosures and suggest the following formula for correction.

For the sake of providing due credit I thought about the "CANDAB correction" which is an acronym with the first letter of some of the most intense pharmascolds. (HINT:  Solving this is much simpler than my formula).  So here it is finally! Do this for every author.  X stands for the age of the author, y is the net compensation received in the last 12 months and n is the number of times they have participated in CME or consulting.  You add it all and move the p value as many decimal points as the result shows to know the truth. 

 Late breaking news: I heard JAMA will include automatic computation in their website.

Insel gets cold feet...

Trying to “back-pedal” on his support to Dr. Nemeroff, Dr. Insel, Head of The National Institute of Mental Health in Bethesda, has gone to extremes but without considering carefully the facts. A 2010 Research America poll shows that 88% of respondents favor physicians’ collaboration with industry! Yet he goes on to say that “… public’s disapproval of the physician-industry relationship is precisely why disclosure laws are so important.” (cited from Nature Biotechnology 28: 661, 2010) 

  What is the evidence for such disapproval?

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).

Big Pharma Paranoia

Advised by corporate counsel, Big Pharma is living in a state of maximal paranoia.  It goes like this ... they have immense legal and compliance teams that have simply formalized risk aversion.  Consequently, they are sustaining and adding to a toxic environment of mistrust.


Here is just one small example.  A recent request for information about Zometa yielded a reply from a mail box that has the standard "no-reply" mechanism.  This is to avoid having to establish any contact that may result in a conversation that may lead to "off label" discussions.  They still provide the service (answering my request) and much more safely in a manner that avoids untoward risks.  Sadly, it is a very impersonal approach that leaves much to be desired.  And all of this because physicians and pharma have not be willing to stand up to bureaucrats and pharmascolds!

WHO and Conflict of Interest; Chan versus Godlee

Without base, or substance, the WHO has come under fire for not having disclosed financial ties of some of its advisers regarding the influenza pandemic of last year.  It turns out the BMJ published an accusatory article, and accompanying editorial.  These accusations will persist in the blogosphere, despite very forceful and rightful fight back by Dr Chan (WHO director) and colleagues.  It seems that the BMJ editors are only is interested in self promotion of an agenda that has no basis.  If no influence is found (which will not be) then the WHO should press on with a request for a retraction, or at the very least an apology.

It is worth noting that criticisms for those who work with industry come  from people like Dr. F Godlee, who has no track record in having worked ever with industry. A quick Pub Med search reveals that most of her publications are commentaries while on editorial boards, and little in the way of original research.  One can easily conclude that her agitation and suspicion arises from a fundamental lack of understanding of the process of research involving industry.

Guest Post: Response to "Comparing Health Care Systems" (Minnesota Medicine)

Minnesota Medicine published a piece in their current issue entitled “Comparing Health Care Systems” (April 2010) that begged a response so guest blogger, Dr. Henry Kahn, kindly agreed to share insights he gained from extensive experience with the Canadian healthcare system:

Articles such as this appear in academic journals all the time. There is always a comparison of financing and health care outcomes among western countries that suggests the American health care system is wasteful and inferior. However, there is a significant disconnect between what these articles report and what is observed by people who live in these countries. The frustrations and disappointments experienced by health care providers and patients in Canada, for example, are never captured by these academic presentations.

I am a third-generation Canadian who trained as a urologist in New York City between 1960 and 1964. I practiced in Winnipeg for 38 years, was an associate professor at the University of Manitoba, head of urology at a major teaching hospital for 23 years, and head of surgery at a 132-bed community hospital for 30 years. After that, I was an urologist with the Mayo Health System in Owatonna, Minnesota, for more than seven years. I’m now retired.

The following is a short list of problems I encountered in Winnipeg:

• At any given time, elderly clients who were waiting for nursing home placement occupied about 30 percent of the beds in urban hospitals, thus making those beds unavailable for acute care
• In any given year, all elective services would be suspended for an aggregate of about three months because of holidays and summer closure. Hospitals close for at least six weeks during the summer and for one week around holidays such as Christmas, New Year’s, Easter, Thanksgiving, Queen Victoria’s birthday, and Memorial Day.
•  In the operating theaters, there could be no overtime because personnel who worked more than 15 minutes overtime had to be paid for at least four hours at two-and-half-times the normal rates. Thus, procedures that could result in overtime were routinely rescheduled.
• Procedures that require implants such as cataract surgery and hip and knee replacement were strictly rationed.
• Entire sections of the hospital were routinely closed when the facility’s annual budget was exceeded.
• Medical staff were not replaced when they retired.
• Outdated equipment was not replaced. For years, cancer patients were treated with radiotherapy machines that were not equipped with computers to accurately direct the beam.
• There was a shortage of primary care physicians in Winnipeg, so finding a family doctor could take two years. More than 50 percent of the doctors in rural Manitoba are recruited from Africa and Asia, according to the Manitoba College of Physicians and Surgeons. This is the result of a policy adopted by the federal government in 1975, which reduced medical school enrollment across Canada by 30 percent. The decision was based on the recommendation of an eminent health care economist at the University of British Columbia who thought that health care costs would be reduced if there were fewer providers.
• There was a dire shortage of diagnostic equipment such as imaging machines.

In Canada, there is a waiting list for everything but care for dire emergencies. For an imaging test, the waiting period is three to four months. The waiting list for the surgical treatment of urgent cancer cases is at least three months. Unfortunately, these waiting periods are not concurrent. It usually takes six months or more to get from the point of presentation to treatment. Not surprising, there are plenty of horror stories.

In 1995, during a severe influenza epidemic, there were 70 patients on gurneys in the corridor of a 132-bed hospital. At the time, 60 beds were closed because of budget concerns, and all elective procedures and admissions were ceased for more than two weeks. As chief of surgery, I had a patient with a perforated duodenal ulcer who had languished for more than 10 hours on a gurney in the corridor without diagnosis or treatment. I gave a public television interview, which was broadcast live on the evening news; the very next day the 60 beds were opened. Many of my cancer patients had their surgeries cancelled because their surgery might require staff to work overtime. These patients underwent extensive preparation for major surgery, only to be sent back to the ward.

My family, too, has experienced the long waits and inefficiencies. In 2002, my sister fell off a bicycle and sustained a comminuted wrist fracture. She waited on a gurney in a hospital corridor for three days before she could have an open reduction and fixation. In 2005, my sister, who lived in a rural area, was diagnosed with an acute lymphoma. She waited for three weeks to see an oncologist. By then, her cancer was too advanced and could not be treated. In 2008, my brother developed an ugly lesion in his mouth. He was slated for a biopsy as soon as possible. It took nearly five months for him to have the biopsy. A poorly differentiated cancer was diagnosed, but it was too late for anything other than palliative radiotherapy. A cousin felt something snap in his shoulder while playing tennis. It took more than six months to schedule a magnetic resonance study. It took another month for him to see a shoulder specialist. By that time, the tendon had deteriorated and surgery was not possible. He will never play tennis again. A relative with bowel symptoms is currently scheduled for a colonoscopy. The date has been set four months from now.

The Canadian news media regularly report the most dramatic cases. In 2003, the Winnipeg Free Press reported the story of a 58-year-old woman who died after waiting two years for heart surgery. Recently, media across Canada have followed the story of Brian Sinclair, whose primary care doctor sent him to the emergency department of the largest hospital in Winnipeg with an obstructed indwelling catheter. He was there for 34 hours and never examined. He had been dead for hours before he was noticed. Last month, CBC News reported on the sharp increase in the number of cancellations of heart surgeries and cardiac-related tests in Manitoba over the last three years, including 43 cancellations in December 2009 alone.

The problem in Canada is that health care institutions are given a fixed amount of money at the beginning of the year. The cost of all services then drains it. Instead of viewing the patient as a source of income, the institution sees the patient as an expense. There is no incentive to offer more expeditious care. A responsible and successful hospital administrator has to find ways to downsize, and this can only be done by rationing and curtailing care.

The sixty-four-thousand-dollar question I have is this: Why is it that the academics who deride the free enterprise system in the United States fail to capture the misery that socialized medicine brings with it?

Henry P. Krahn, M.D.

Retired urologist

Owatonna

The New Y-2-K

A friend of mine (Joe Mikhael, Mayo Clinic in Arizona) just came up with a great analogy about the COI saga.  He said that after having talked to me, he realizes the COI will be like the Y-2-K.  Everyone thought doomsday was coming, stacked up on supplies and expected the worst.  With 4 studies now showing that CME sponsored by industry is not biased any more than academic medical centers sponsored one, and with the realization that guidelines are not affected by financial relationships, I agree with him.  The COI saga is very similar to the Y-2-K!

Biscotti for the international docs

Yesterday we reported on the display of absurdity and non-sense the regulations regarding gifts have created for docs.  Today we post pictures of some of the signs that that are placed in the display booths at the ASCO meeting.  In one you can clearly see the text with the current regulations and limitations,  In the other you see the heavily fortified entrance to an "International Lounge."  Whose fault is it?  Physicians who are not outraged.  Government bureaucrats.  The "Pharmascolds."  And lets not forget, the always scared, pharma attorneys and compliance officers.  Oh, well I'll go back to a hot dog stand for some calories with my MA, MN and VT colleagues.

No free latte, unless you are not from the US!

A new MSNBC poll looks at the absurdity of the current regulations regarding interactions between physicians and industry.  The vast majority of poll responders agree, and  thankfully so, that the regulations have gone to far.  At medical meetings there are now booths for international attendees only.  Once you swipe your card you can go inside and get a coffee and a biscotti.  To keep this under veils they have posted guards at the entrance of these international lounges.  The general public seems to finally have gotten it and at least 80% of poll votes go for the regulations having gone too far.

AMA CEJA 2010: ACRE Recommends Rejecting CEJA Report

In response to the American Medical Association Council on Judicial and Ethical Affair's (CEJA) fourth attempt to hinder physician and institution relationships with industry, the Association of Clinical Researchers and Educators (ACRE) recommended (HERE) that CEJA Report 1-A-10 and its recommendations be rejected by the AMA House of Delegates.

CEJA’s report, entitled “Financial Relationships with Industry in Continuing Medical Education,” improperly asks individual physicians and institutions of medicine to not accept industry funding to support professional educational activities.  As a result, ACRE has called for the rejection of 1-A-10 for many reasons including:

• CME is already highly regulated to prevent undue influence from industry.

• Reducing resources in CME will result in less education of physicians.

• With the adoption of Health Care Reform and the subsequent addition of 30 million new patients to the healthcare system, additional financial resources will be needed to educate a greater number of physicians and other healthcare providers not less.

• The CEJA report ignores 3 recently published studies, involving very large study populations, which are directly relevant to the Report's subject matter but "contra" to the report's recommendations. By an overwhelming margin, doctors who actually attend commercially sponsored CME do not perceive bias.

• Passage of the Physician Payment Sunshine Provisions in Health Care Reform eliminates the need for more detailed disclosure as recommended in the CEJA report.

By ignoring ACRE’s previous response (HERE) to their third report (HERE) and ignoring recent evidence that industry support does not produce bias in CME, the most recent CEJA report is contrary to evidence-based professional ethics.  In fact, the report is a virtual replica of the previous report that was rejected on three separate occasions by the House of Delegates.  The most recent version contains the same 57 references and includes the same disclaimer that “to date, there is no empirical evidence to support or refute the hypothesis that CME activities are biased.” 

CEJA further acknowledges that presently, it “has not been clearly demonstrated to what extent the amount of a financial interest may influence perception and judgment” Instead, CEJA declares that “clear evidence is lacking” and acknowledges that most policies on “conflict of interest” at least tacitly assume that the greater the financial interest, the more problematic that interest is, but without any evidence.

What evidence does exist about commercial support of CME?

This past year, three studies produced substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF). So what did CEJA do with these data?  Nothing.

Ultimately, ACRE’s response reflects the organization's understanding, which is founded on experience and data, that there is value to physicians, medicine, medical education, and patients from the working relationship between physicians and industry. There is no conflict in advancing science, and there is no conflict in providing the education that is required to do so.

By working together with industry colleagues, physicians can explain to the public that the contributions of corporations to medicine are, on balance, more beneficial than harmful and that both medicine and the industries that provide it with its technologies are worthy of public support. Cooperation, instead of antagonism, can help industry develop and market therapies with the highest integrity, by keeping physicians current on the best available evidence and by providing excellent patient care.

Bias Towards Medical Progress

Efforts to avoid the appearance of bias for its own sake are futile and ill-advised. This caused some headaches for the religious court that condemned Galileo for proposing that the earth revolves around the sun. Science vs. empiricism vs. pragmatism. Still a problem today.

Bias is compatible with truth and fact. My bias for disc brakes and airbags is evidence-based. Preference for specific commercial products may also be biased, objective and evidence-based.

Manufacture and promotion of products that do not yield beneficial medical outcomes, superior to the current standard of care, is the single greatest cause of corporate extinction. Think of Chrysler. They managed to collapse without paying a single fine for off-label promotion. This is economic and independent of liability. Products that do not perform or do not reduce risk do not sell.

The recent fiduciary concern by many of America's doctors for high medical costs and the self-appointed obligation to recommend generics over costlier ethical drugs is romantic but hardly reassuring. Death and "conservative management" are always the low-cost option. Generics play a valuable economic role in the life cycle of technology and the cost-effective delivery of care but to suggest that cheap drugs developed in 1960 are generally preferable to today's patented products is a menace to public health.

The biggest problem with the reports regarding industry influence on medical education is that they miss the whole point of industry-sponsored medical education: company's have an incentive and bias for medical progress. Journals are incentivized by subscriptions and advertising revenue, AMCs by research grants, tuition and billing CMS for clinical care; and professional medical societies (PMS) by tuition and fees for knowledge and advocacy.  None of these entities have an explicit progress incentive.  

Novel technology, by definition, works from an implicit evidence disadvantage. Journals and PMS guidelines are legend for dismissing the scanty data on breakthroughs, especially since few of their members have either incentive or motive to champion accompanying changes in practice. One of the authors derides industry reps for often lacking scientific training. Science only proves or disproves a hypothesis, nothing more or less. Promoting change through the continuum of accumulating evidence (often 30 years and longer) depends on more than just clinical science, to the chagrin of some. Incentives to change practice are almost always small when compared to the status quo incentive, even when outcomes are superior. In hindsight, most skeptics claim to have been early adopters and it's not impossible to remember history that way 20 years after the fact.

Right or wrong, industry drives change and progress does not occur without change

Caught in the act! (Good Job Jenny)

Thought we should share this story ... Institutions have been concerned for a long time about the interactions of docs and drug reps.  After all they must be dangerous individuals (tongue in cheek) since so much credentialing is necessary for them to access hospitals and clinics.  TB testing, criminal background checking, drug testing and the like.  So we were surprised to find out that a Facebook friend, who works as a representative for a pharmaceutical company, posted a campaign to raise money for a someone diagnosed with cancer.  "It must be an aberration!"  (the critics would say).  The reality is that the current anti industry environment has created an environment for representatives of the pharmaceutical industry that is outright disrespectful and discriminatory.  She did not have to do what she is doing, but she did.  Keep up the good work Jenny!!

Names have been masked for privacy

NIH Proposes New Conflict of Interest Regulations

The original NIH regulations went into effect in 1995. At that time we were fairly early into the avalanche of allegations that financial “conflicts of interest” promoted research corruption and were just emerging from a spate of high-profile scientific misconduct incidents. Therefore, one might cut the NIH some slack for some of the disingenuous aspects of its policy.


First, I put “COI” in quotes, because it is a meaningless framing bias that ignores the fact that interests are only perfectly aligned in anthills and that the pejorative use of “conflicts” emphasizes potential risks over potential benefits (otherwise there would be no need to disclose, manage or eliminate them). If you accept the frame, it puts you in the impossible position of disproving a negative (“I am not a crook”). It gets worse when you stretch the rules to cover “appearance” of conflict, because appearance is reality in politics, not science and because it is totally subjective. “Appearance” is invoked frequently in the proposal (I assume it was in the original as well).


What is striking and focuses the discussion is the title of the document: “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors.” The assumption is that COI detracts from “objectivity in research.”


There was no evidence in 1995 that this assumption is true, and no evidence has emerged in the intervening 15 years. In fact the totality of evidence of “corruption” due to FCOI has shifted almost totally to marketing, not research – and that evidence is vanishingly weak.


I am unaware of a single case of research misconduct that involved industry-related FCOI. The approach to research misconduct has been to maintain a narrow definition of misconduct, investigate allegations thoroughly, and punish the convicted. We do not “manage” (and we can’t eliminate) misconduct. It is therefore bizarre that we have allowed a prophylactic regime to permeate biomedical research – instead of ticketing speeders, we ban fast cars.


The ramping up of regulation in the absence of substantive evidence that we need it is, of course, the fallout from demagoguery exercised by certain politicians abetted by COI critics and the media – and by the failure of rank and file researchers to resist.


The proposed regulations represent a stimulus plan for COI bureaucracy and the “COI experts” who encourage it. The emphasis on appearance empowers the type II error


At a time when the NIH budget is flat and the investment pipeline is seized up due to the recession, why would we divert energy and scarce resources into the minute compilation of who is being paid how much and speculate on what constitutes a “significant” COI – even a FUTURE COI -- “that COULD effect the design, conduct or reporting of research?”


Prior to 1995, commercial influence permeated biomedicine exponentially, and only good things happened. Investigators were free to mingle with industry, and research superstars deservedly made a lot of money. Medical research is not immune to opportunity costs and the emerging compliance culture will hurt progress – and patients.