On September 9, 2011, I was asked to be a guest editorialist for the Tennessean’s article on the relationship of the pharmaceutical industry and physicians. I respectfully declined. My response, if published, would have been as follows:

Generally speaking, this issue is already settled for many; any financial relationship of the pharmaceutical industry to individual physicians is merely influence peddling to doctors bought by "drug companies".  Although probably not appreciated, these critics are basing their conclusions on simplistic beliefs and assumptions:  (1) the root of all evil is money, (2) all exchanges of money from one party to another have nefarious consequences, and (3) human nature in general is easily persuaded by money into unethical actions. Certainly, there are many examples in history to support these stereotypic beliefs. In a capitalistic society, money is the currency of exchange of services. Consequently, are all relationships tainted which involve the exchange of money? If true, the implications are extensive. For example, are all of our politicians merely puppets of those that finance their campaigns?

In my case, I am paid for legitimate services of educating my healthcare colleagues. My participation in lectureship programs is driven by a genuine interest in learning and teaching. The content of and discussions in these programs are scripted by the Federal Drug Administration (FDA). The information that I offer regarding disease state management and correct usage of medications is consistent with the science sanctioned by the FDA.  The effects of these educational programs in which I participate are much needed. Although the pharmaceutical industry is criticized for “pushing” drugs for profit, there is an increasing need for such drugs to help individuals prevent or control diseases. What harm is causing society for promoting FDA sanctioned medications for treating diseases? In this society when personal accountability for one’s health is not encouraged effectively, pharmaceutical agents are in many situations substitutes for healthy lifestyle. Currently, the proportion of individuals that meet national treatment standards for diabetes, hypertension, and hyperlipidemia is abjectly low The national record in controlling these main diseases of modern life is abysmal and can be directly tied to lack of education of the health care providers in implementing theses guidelines. Only one out of twenty individuals with type 2 diabetes has their sugar, lipid, and blood pressure under control; only one out of five individuals with coronary artery disease has their lipid goals met; and only two out five individuals with hypertension have their blood pressure controlled.

Even if my statements were viewed as earnest, critics would see my comments as simply rationalizations for my continued receipt of money. Even if they acknowledged my sincerity, they would conclude that my financial relationship with industry had poisoned my reasoning.  They would argue that I was just spinning the truth to justify my position with industry. Even given the current strict regulatory environment governing education promotional programs, they would argue that such programs which I am associated are carefully staged to appear educational but really are vehicles to deceive or present misinformation for the purposes of promoting the sell of medications. With such attitudes, any response by me could never be compelling. Since the exchange of money is viewed as influencing and altering my objectivity, the critics would conclude simply that being a financial recipient of an agency taints me. In other words, it is mere receipt of money that is assumed as compromising my ethical standards and objectivity.

What do such viewpoints tell us about the critic’s own belief systems? Arguably, people criticize those things in others for which they see potentially offensive issues in themselves; in this case, the recognition of their own susceptibility to influence is the driving force behind their arguments. They assume that under similar circumstances, the financial ties to an agency could potentially influence their own actions. Inherent in their thinking is that man’s nature is flawed. They dismiss the notion that most individuals could morally hold up to the influence of money.

So what determines the nature of these relations? Although a presumption of influence legitimately should be presumed in ever transaction, what determines in the end whether the nature of a relationship is ethical or not is the moral strength and character of the parties- not the exchange of money!  Consequently, how can any one judge such a relationship without knowing the heart of the persons involved? As Dan Millman stated, “Money is neither my god nor my devil. It is a form of energy that tends to make us more of who we are already, whether it’s greedy or loving.”

Response to the Nashville Scene's Mr. Hargove's Posted Crticism December 8, 2010

In response to Mr. Hargove comment:

I'm also going to call Dr. Roseman out on his insistence that randomized clinical trials are the only way to judge Avandia (which was clearly contradicted in Glaxo internal memos). Given his education, Dr. Roseman should know that these kinds of clinical trials aren't designed to assess risk. They're designed to assess benefit. You'd have to have an impossibly massive trial to gauge risk. When he misleadingly points to the "insignificant risk," he fails to note that when that risk is spread out over the 23 million diabetes patients in the country, you have some serious numbers. The intent of the article isn't to villainize Dr. Roseman, but to question the close relationship he and others have with the industry. It's worth discussing why he would so steadfastly defend the drug of a company that pays him well when all indications point to its very real danger.

In this response, I will deal with the second of your criticisms, which I have copied above. First of all, please show in my writings or presentations that I asserted that the only way to examine the safety of a drug is through randomized clinical trials alone? Secondly, please show me what GSK internal memos to which you are referring that “clearly” contradict my alleged comment that “randomized clinical trials are the only way to judge Avandia”.

My so-called defense of Avandia, a “drug of a company that pays [me] well” is based upon solid science. As an academically minded physician, I feel that the scientific issues of safety of Avandia are far from settled. Contrary to you insinuation, Mr. Hargrove, my opinions cannot be bought. From a personal standpoint, I have not recognized any direct cardiovascular harm to my patients during my twelve years of experience of prescribing Avandia.

If your article is not meant to villainize me, why is it that you continue to take out of context my statements about the Avandia safety issue and to insinuate that my opinions are biased as a result of the patronage of the pharmaceutical industry? I have fully disclosed my position. I have made available to you my writings on this issue, which you have failed to include in your report: http://www.cardiologywellness.net/CWC/Writings.html, I have never stated that a signal about cardiovascular safety around Avandia dose not exists. Just to reiterate, the scientific evidence for affirming cardiovascular risk to Avandia is incomplete and conflicting. The observational studies, in their totality, have suggested that Avandia use may be linked to a small risk (which I called “insignificant”, not in statistical terms but in terms of absolute risk). (For the readers, the nature of observational studies is described at: http://en.wikipedia.org/wiki/Observational_study.) However, the experimental or randomized clinical studies (for definition: http://en.wikipedia.org/wiki/Randomized_controlled_trial) did not support this conclusion and in the case of two studies, VADT and BARI-2D, which was not funded by the pharmaceutical industry but by the United States government, actually suggested a benefit!

Not acknowledged in your article or your blog, my views comport with that of the American College of Cardiology, the American Heart Association, and even the FDA. Let’s take a look at the facts. In the FDA (Food and Drug Administration) ruling on Avandia, Dr. Woodcock, director of the Center for Drug Evaluation and Research (CDER), stated, “the cardiovascular safety profile of rosiglitazone is still an open question because there are conflicting data on the existence and magnitude of the risk.”[i] This conclusion is similar to the FDA’s position in 2007, “In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”[ii] Recently, in a 2010 update, the American College of Cardiology and the American Heart Association jointly reviewed the safety issue of thiazolidinediones and issued a statement, which concluded similarly, “In summary, an association between rosiglitazone [Avandia] and IHD [ischemic heart disease] outcomes has not yet been firmly established.”[iii] Contrary to your implied depiction of me in this article, I am not alone in my viewpoints. I believe that my viewpoint is credible and defensible, regardless of the appearance of bias related to my GSK association.

Now, lets return to your point about the nature of evidence in determining causation. Your attempt to discredit my viewpoints by quoting an unnamed source is obvious. “Given his education, Dr. Roseman should know that these kinds of clinical trials aren't designed to assess risk. They're designed to assess benefit.” Your statement is a simple distillation and dilution of a difficult issue in science, which in all due respect, you are not qualified to comment. Again I would refer to my writing on this subject included at http://www.cardiologywellness.net/CWC/Writings.html. I have enclosed an addendum, which is a part of my commentaries, which offers a complete response to this issue. Again, your attempts at pseudo-scientific reporting are showing. None other than the FDA’s own Dr. Woodcock disagreed with your insinuation that the randomized clinical trials to which I referred was in somehow inadequate in answering the question of cardiovascular safety of Avandia. In her previously mentioned statement, she exclaimed, “The most reliable evidence about clinical outcomes comes from well-conducted, randomized trials.”

Contrary to your comment, the results of the observation studies were conflicting, despite your suggesting their superiority over randomized clinical trials, For example, the three observational studies on the elderly, including one authored by the FDA’s analyst, Dr. David Graham (http://jama.ama-assn.org/content/304/4/411.abstract), did not show any significant difference in heart attacks among the users of Avandia. The studies did suggest an increase in total mortality, which the preponderance of the observation studies have not.

These observations formed the basis of the FDA’s restricted, not banned, use of Avandia. By the way, if the FDA was so convinced in Dr. Fugh-Berman and your point of view, don’t you think that the FDA would have removed the drug from the US formulary? They did not; they restricted it use until the RECORD safety trial can be reanalyzed.

Again, Mr. Hargove, your one-sided reporting is apparent. These issues, on which you are attempting to report, are complex and warrant more thorough and thoughtful reporting than your sensational snippets that you throw out to your readership in an attempt to push your particular agenda about a news issue. Again, your bias against the pharmaceutical industry has now been fully disclosed. Why don’t you report at least in passing some positive aspects of your subject matter? It would give some balance and credibility to your reporting.

I believe the problem here, a fundamental one in your so-called investigative reporting, is that you get a hold of a “hook” of a story, in this case my defense of Avandia for a company that employs my lecturing services, and create controversy around this news issue, in this case the influence of the pharmaceutical industry. As a passing note, even if we accept your premise that pharmaceutical industry is “pushing” its drugs, what is the harm? The only damages appear that physicians are either overtly or subtlety converted to using the company’s branded drugs, which have been certified as being both efficacious and safe by the FDA. So what is the rub, that the pharmaceutical industry is attempting to make a profit from their innovations and discoveries?

Your purpose seems not to analyze objectively a newsworthy story but to create a buzz in the news media for the purposes of drawing attention to your article. Despite my statements and published views on the issue, you continue to misrepresent my perspective on Avandia. Your presenting my alleged irremovable faith in Avandia, despite “all indications point[ing] to its real danger”, makes for a good headline about the influence of money by the pharmaceutical industry. But, it is not the valid story! Your continued manipulation of the true kernel of the story reveals you for who you are, a polemicist and not an objective reporter. Certainly, your depiction of me is demeaning, and your purposeful effect, contrary to your protestation, is to “villainize” me for the purpose of news sensationalism.

---

[i]                   http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf [assessed on December 5, 2010]

[ii]                   
FDA adds boxed warning for heart-related risk to antidiabetes drug Avandia "press release#. Silver Spring, Md: Food and Drug Administration; November 14, 2007. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm.

[iii]                   
Kaul S, et al., Thiazolidinedione Drugs and Cardiovascular Risks: A Science Advisory From the American Heart Association and American College of Cardiology Foundation. Circulation. 2010;121:1868-1877. Copy available at: http://circ.ahajournals.org/cgi/reprint/CIR.0b013e3181d34114

Formal Response to the ProPublica's Report on the Pharmaceutical Industry and Physician Relationships

As one of the stigmatized physicians in the October 18, 2010 ProPublica article “Docs on Pharma Payroll Have Blemished Records, Limited Credentials”, I feel compelled to respond.

On the face of it, the article seems reasonable. The initial part of the report depicts a few individuals that are singled out as poster children for the article’s main theme. The inherent message is clear that Big Pharma, in their aggressive marketing efforts as “pill pushers”, selects any physicians, even with inadequate credentials, to carry the company’s marketing banner to their colleagues in a disguised format of education. Big Pharma’s failure is the result of greed! By inference, with the exception of a few obligatory academics, the lecture bureau of Big Pharma generally consists of disreputable physicians with inadequate pedagogical skills but good marketing skills. The implication is that Big Pharma is indiscriminant in who they choose as a speaker, as long as that physician tolls the line and supports Big Pharma interests. What is clearly projected is an avaricious, socially uncaring, and civically irresponsible industry that seeks to make exorbitant profits at any cost to satisfy their shareholders and pay exorbitant management fees. Nice beginning of supporting the stereotypic condemnation of the industry, or any industry for that matter!

Then the article describes how the industry “makes their own experts”. I am one of those so-called “experts”. Thanks for presenting a fair balanced story, Charlie. Let's look at the reporter’s portrayal of me. "Roseman is not a researcher with published peer-reviewed studies to his name. Nor is he on the staff of a top academic medical center." Although not stated but implied is that I am poorly trained and educated, in order to fit with the message of the report. As discussed with the reporter, I have significant academic and clinical standing and am a well-respected cardiologist. My education was discussed with the reporter: BA, University of Pennsylvania (the reporter’s alma mater); MD, University of Tennessee; MPH, Yale University; Clinical Training at Yale and Brown University affiliated hospitals and Massachusetts General Hospital in Boston. I was one of the first in the country to take the National Lipid Boards, an inspiring subspecialty board under the Board of Internal Medicine. I am a specialist with the American Society of Hypertension. I have fellowship standing with at least three major societies, including the American Colleges of Internal Medicine and Cardiovascular Diseases. I am well regarded as a thought leader in my field of preventive cardiology, at least regionally. I have been offered academic positions, but I chose to remain in clinical practice. I have published, although minimally; a second paper on lipid treatment has been submitted and is awaiting approval. My lack of publication does not mean that I am not knowledgeable or that I am a poor teacher. In fact, a significant publication dossier does not guarantee anything about one’s capacity as an educator. Finally, my practice is one of a limited sites in the United States engaged in two international cardiovascular outcome trials related to contemporary diabetic medications. For further details, please refer to my website: www.cardiologywellnss.net.

Even after having discussed my position on rosiglitazone (Avandia) with the reporter, the article portrayed me as having full confidence in Avandia, despite all of the controversy around and the mounting evidence against the drug. The article insinuated that my alleged continued and unrelenting support of the agent followed from a bias that was a direct result of my association with GSK, the pharmaceutical company that manufactures and markets Avandia. The reporter failed to use any of my three authored position papers on the decision by the FDA in clarifying my opinions, which I sent to the reporter and now listed on my blog: http://cardiologist-on-call.blogspot.com/. The reporter chose to avoid or sidestep the nuances around the controversy and decided instead to take snippets of our discussion to insinuate that I was a bought mega horn for the product. In particular, the reporter chose to omit the information that I made available to him, which conveyed that the safety issue about rosiglitazone (Avandia) remains controversial. Furthermore, absent in the report was the recent statement by the FDA's own Woodcock, Director of the Center for Drug Evaluation and Research, comports with my own views about the uncertainty of harm: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. The issue of Avandia causing heart attacks is not settled, and currently the safety study RECORD is being re-evaluated. The absolute risk of Avandia causing heart attacks appears low, as I asserted! 

This experience with ProPublica “investigative reporting” has left me with a concern about “news’ in general. In an attempt to bring an issue to surface, it appears that any distraction from the main theme is minimized, even if the facts don’t totally match the desired effect. For example, ProPublica’s characterization of me was unfair; the reporter failed to include my background, despite knowing it. He misrepresented that I had no publication to my name, which I do (article included: www.amcp.org/data/jmcp/august_suppl.pdf). My training in the area of diabetes, contrary to what was reported, was not the primary result of corporate paid scholarship but countless hours of my own researching the medical literature and attending numerous conferences and conventions. My library includes hundreds of articles which I have collected about the drug class (thiazolidinediones or TZDs) to which Avandia is a member.

Because of these misrepresentations and omissions, I am left to believe that the reporter was merely using me as an example to demonstrate the extensive bias that he was attributing to industry connected physicians. The reporter cast my views on Avandia as being unreasonable given the alleged overwhelming evidence against the drug. Now I am aware why journalists get such a bad reputation! In situations like this, it appears that their main aim is to get out a controversial story and characterize situations to make a good story line. Based upon this involvement with the ProPublica reporter, I believe that the reporter failed his own ethics tests: http://www.spj.org/ethicscode.asp.

Since I was assumed by the reporter to be bias, I asked the reporter Charlie (Ornstein) when he first contacted me to produce evidence that he was not bias. I submitted him a series of questions, which he refused to answer. The “Objectivity Check-list” as I called it, is listed on my blog: http://cardiologist-on-call.blogspot.com/. Clearly, based upon the tenor of the article, the report had a pre-conceived agenda.

The other segments of this reporting effort “Dollars for Docs” have a larger message- yet again, another large corporation buying influence. But when you start looking at the substance of the article, the report falls short in demonstrating the harm from relationships between industry and physicians, or for that matter, large institutions. The inferences of the article were obvious, but actual damages not identified or fully clarified. The implication underlying this article is that money buys influence, but does it? Are the activities of the pharmaceutical industry causing harm? 

The receiving of appropriate payment for services rendered can be assumed as being corrupting, but not necessarily indicate corruption. Just because someone receives compensation from a company does not necessarily indicate bias or prejudice. Were the views of the reporter colored, influenced, affected, tainted, or altered by his employer, ProPublica? Certainly, there is presumption of bias when one is an agent of an institution or corporation. What dictates the nature of that agency relationship is the integrity of the individual, not the source of his income! Judge me for what I say and do; don't prejudge me simply because I am associated with a company. Using financial ties offers a beginning point to determine a person's bias but that metric is deficient in providing a conclusive and complete analysis of the individual's character. Should everyone be judged solely by one’s relationship to his employer?

As it relates to the education programs to which I am a part, I would certainly challenge the ProPublica reporting staff to research and write about the benefits of these educational programs, which are criticized without an opposing viewpoint. The article insinuates that these programs are part of insidious marketing scheme by the pharmaceutical companies to sell drugs for profit sake only. Of course, we do live in a capitalistic society that favors and rewards innovation. However, contrary to a widget company, the pharmaceutical industry’s ultimate aim is to make medications to help people. Certainly there are examples are overly zealous and avaricious businessmen that overstepped the boundaries of ethical practice in promoting their products. But generally, the pharmaceutical industry is in the service of providing safe and efficacious treatments. Even if greed was the main motivation, the current climate is highly punitive of companies that abuse their mandated role in providing effective and novel medications within the regulatory boundaries set forth by Congress and the FDA. Educating the medical personnel on the appropriate use of these medications is an important step to ensure that the health care provider has the most relevant and up-to-date information to make informed decisions about the treatment options for his/her patients.

After considering the content of these series of articles, I am left with an impression that this is adolescent journalism, well-written but not meeting the standards of true investigative reporting which requires fair coverage of all sides of an issue.

As such, I believe that the ProPublica journal should be renamed “PrePubica”!

Open Letter to Reporter of ProPublica

Dear Charlie Ornstein:

Thanks for presenting a fair balanced story. Let's look at my portrayal of me, as an example. "Roseman is not a researcher with published peer-reviewed studies to his name. Nor is he on the staff of a top academic medical center." If you had done further research about me, you would realize that you have misrepresented my credentials. As discussed, I have significant standing both academically and clinically. My education was discussed with you: BA, University of Pennsylvania (your alma mater), MD, University of Tennessee; MPH, Yale University; Clinical Training at Yale and Brown University. I was one of the first in the country to be selected to take the National Lipid Boards, an inspiring subspecialty board under the Board of Internal Medicine. I am a specialist with the American Society of Hypertension. I have fellowship standing with at least three major societies, including the American College of Internal Medicine and Cardiovascular Diseases. I am well regarded as a thought leader in my field of preventive cardiology, at least regionally, if not nationally. I have been offered academic positions, but I chose to remain in clinical practice. I have published, although minimally. A second paper on lipid treatment has been submitted and is awaiting approval. My lack of publication does not mean that I carry no authority nor provide credible knowledge. Furthermore, it does not indicate anything about my capacity as an educator.

In discussing my position on rosiglitazone (Avandia), you reported that after all of the controversy around Avandia that I still have confidence in the agent. The article insinuated that my confidence in the agent followed from a bias as a direct result of my association with GSK, the pharmaceutical company that manufactures and markets Avandia. You failed to use any of my three position papers on the decision by the FDA in clarifying this statement. Furthermore, you failed to mention that FDA's own Woodcock recent statement about the uncertainty of harm imposed by rosiglitazone:  http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. The issue of Avandia causing heart attacks is not settled. The absolute risk of Avandia causing heart attacks is low, as I reported! 

Your characterization of me was unfair. You failed to include my background, despite our having discussed it. You misrepresented that I had no publication to my name, which I do (article included). Now I am aware why journalists are so aptly painted. Your main aim is to get out a controversial story; you characterize situations to make a good story line. Based upon this involvement with you, you failed your own ethics tests: http://www.spj.org/ethicscode.asp.

My issue with you is not from a position of anger but disappointment. During the initial conversation with me, you portrayed yourself as being open-minded and unbiased, but the perspective of the story for which you were gathering information had already been formulated.  You failed to print much of which I shared with you that defended my participation as well as that of many other well-qualified physicians in lecture bureaus of the pharmaceutical companies. In other words, you and your fellow journalists print information that suits the purpose of your story line and diminish or suppress information that doesn't fit. As in this case, your headlines "Docs on Pharma Payroll Have Blemished Records, Limited Credentials", dramatize a situation that represents only a minority of the physicians involved in the educational efforts of the pharmaceutical industry. 

The purpose of the lecture bureau is to educate individual physicians about disease states and treatments. For many of the practicing physicians and health care providers in the country, especially primary care providers, their educational update on new products and on new concepts about disease mechanisms and pathophysiology stem from efforts by the pharmaceutical industry. The FDA has certainly curtailed the potential of misrepresenting the claim of a medication. A presentation has to be fair balanced, avoiding erroneous claims or unscientific information. The presentations must not contain overly exuberant statements about the use of the medication and must stay within the context of the prescribing guidelines as set forth by the FDA. Furthermore, unfair comparisons with other competing medications cannot be presented. Finally, a full disclosure of side-effects of a medication must be included. A world without these promotional programs would certainly limit access of these physicians to some of the latest scientific information that can have potentially important consequences to their patients. Finally, although I have confidence in the medications, which I represent, I regularly discuss the option of other medications, some even in the same treatment class, when appropriate in discussing clinical problems. 

The stigmatization of the pharmaceutical industry implicit in your report fails to take into account the extreme challenges of bringing a new drug, many life affirming and disease modifying, to market. Usually the intellectual assets or patents of these new drugs are only protected for 10-14 years. Because of the stringent requirements of bringing a drug to market, the average cost approaches $1 billion dollars. Of course, there is significant pressure to make the medical system aware of these newer treatments. Education, from peer-to-peer, is one method by which health care providers are familiarized with these agents. What is wrong with promotion of new drugs, many of which supplant less efficacious and legacy medications?

By the way, certain drugs that were approved for one condition have proven after entering the market place to have significant benefits for another disease. A good example is carvedilol (Coreg), which revolutionized the medical treatment of heart failure, although its first indication was hypertension.  It was only through the revenue from the product that research was able to expose this drug's superior benefit in treating heart failure.

I would certainly challenge you and your colleagues to research and write about the benefits of these educational programs. You insinuate that these programs are part of insidious marketing scheme by the pharmaceutical companies to sell drugs for profit sake only. Of course, we do live in a capitalistic society that favors and rewards innovation. However, contrary to a widget company, the pharmaceutical industry’s ultimate aim is to make medications to help people. Certainly there are examples are overly zealous and avaricious businessmen that overstepped the promotion of their products. But generally, the pharmaceutical industry is in the service of providing safe and efficacious treatments. Even if greed was the main motivation, the current climate is highly punitive of companies that abuse their mandated role in providing effective and novel medications within the regulatory boundaries set forth by Congress and the FDA. Educating the medical personnel on the appropriate use of these medications is an important step to ensure that the health care provider has the most relevant and up-to-date information to make informed decisions about the treatment options for his/her patients.

Best regards,

Hal Roseman, MD. MPH, FACC, FACP

Supportive Documentation for my Defense of Avandia (rosiglitazone)

Enclosed is my link to several papers and presentations that I have authored on the subject of rosiglitazone (Avandia):


http://www.cardiologywellness.net/CWC/Writings.html 

My Response to Dr. Fugh-Berman, Scene blog December 5, 2010

In response to Dr. Adrianne Fugh-Berman, who worte:

Actually, Hargrove's article is both fair and accurate, in stark contrast to Dr. Roseman's unwarranted attack on a journalist. Regarding the cardiovascular effects of Avandia, a small absolute increase in risk in people with diabetes - not a rare disease - translates to a large number of drug-induced heart attacks and deaths, especially when diabetics already have a higher risk of cardiovascular disease. Sure, Avandia lowers blood sugar, and if it were the only drug that did so, its use just might be justified. But the goal of diabetes treatment is to prevent long-term complications , including cardiovascular disease, kidney disease, and blindness. Why should someone with a disease that increases cardiovascular risk take a drug that increases cardiovascular risk when many other safer drugs are available?

As it relates to Dr. Fugh-Berman, she obviously did not read my blog carefully. The summary of my view on the Avandia controversy follows:

As it relates to his reporting of my defense of Avandia (rosiglitazone), I just wish the reporter would get his facts straight. It should be emphasized that the scientific information surrounding this contentious issue is complex and confusing. A definitive consensus about the safety of Avandia has yet to be established; the recent actions of the FDA to severely limit the distribution of Avandia were taken as a prudent measure given this uncertainty. My statements, which have been taken out of context in this and the ProPublica articles, have been consistent. The scientific evidence for affirming a cardiovascular risk to Avandia is incomplete and conflicting. In fact, in the FDA statement explaining its ruling on Avandia, Dr. Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) stated that “the cardiovascular safety profile of rosiglitazone is still an open question because there are conflicting data on the existence and magnitude of the risk.” If interested, please refer to Dr. Woodcock's complete statement that has been published on FDA’s website: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. Finally, my opinions comport with that of the American College of Cardiology and American Heart Association: http://circ.ahajournals.org/cgi/reprint/CIR.0b013e3181d34114. Contrary to the representation of me in this article, I believe that my viewpoint is credible and defensible, regardless of the appearance of bias related to my GSK association.

I have always made it clear that a signal suggesting cardiovascular risk associated with Avandia is present in some, but not all, of the observational studies. However, the more exacting six randomized clinical trials whose treatment protocols included Avandia, which represent a higher level of evidence, failed to show a risk!  In fact, two trials, the BARI-2D and VADT, suggested a benefit. (By the way, contrary to his report, three of the these six trials were not sponsored by industry, but by the United States government!)  Although the reporter refers to my July 14, 2010 presentation to the joint FDA advisory board: (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM224749.pdf),he failed to acknowledge that my main point at the meeting was to demonstrate the lack of conclusive evidence to take Avandia off the market. (By the way, contrary to the insinuation of the reporter, I was not compensated by GSK in any way for going to the meeting or provided with any support to make my presentation.) Guess what, the FDA agreed with me! Admittedly, the restriction of Avandia use is prudent, until the uncertainty of its safety profile can be reassessed following re-analysis of the singly dedicated safety trial RECORD trial. As it relates to reporter’s comments that RECORD trial was “viscerated”, he should check the record. None other than Dr. Unger, FDA Deputy Chief, came to aid of the trial, reporting that his division within the FDA still had confidence in the results, especially the mortality end-point. 

I am offering a more complete analysis of this article on my blog. Please read it carefully for a better explanation of my perspective and my "flawed reasoning": http://cardiologist-on-call.blogspot.com/2010/12/my-formal-response-to-nashville-scene.html. Hopefully, you will pay particular attention to my comments of the two experts mentioned in the article who allege harm from the industry-physician relationship of which I have been identified and stigmatized by this article.

As I have stated, no industry is spared from legitimate charges of excesses and malfeasance. In a similar vein, no one person can be shielded from the charge of prejudice and bias emanating from relationships with an employer, institution, company, or other agency. The true test of the individual, emanating from his moral constitution, comes from recognizing the potential of bias, being circumspect about it, and taking steps to ensure that the influence is limited and one’s judgment is unimpaired by it.

So, let’s take the example of Dr. Fugh-Berman, one of the experts used to support the main point of subtle corruption of individual physicians participating with industry.  In her defense of the reporter, she claimed that my attacks were “unwarranted”, despite that I take offense to his false characterization of my views.

So, Dr. Fugh-Berman, please explain why you chose not to expose your potential biases in your interview for this article. As a side, your expose of ghost-writing was admirable. However, your active promotion of natural herbal remedies and dietary supplements, which I do not professionally oppose and actually support within reason, seem to present as a major conflict of interest, which was not exposed in the article. Is it not possible that either directly or indirectly you benefit from creating uncertainty around allopathic pharmaceutical agents by criticizing the industry? You have written a book on the promotion of such products. Your website also lists you as a paid plaintiff expert against the pharmaceutical industry. Did the advertising of your perspective in this article increase your recognition that may contribute in the future to more lucrative consulting assignments for plaintiff lawyers?

You are right, Dr. Fugh-Berman, there are subtle influences that can creep into any type of relationship. When one lives in a glass house, one should not throw stones.

I do not pretend to be free of criticism or fault. However, I can claim that I am conscious and attempt to live life in a moral and ethical way. As it relates to my practice, I do strive to offer the best for my patients, which for me, has been facilitated through my contact with industry. Certainly, there are other channels of information of which I avail myself. In the end, the question of influence is one that begins in the heart. That is why I became a cardiologist. Contrary to the comments and the insinuations of this article, life is not always about money. As Dan Millman stated, “Money is neither my god nor my devil. It is a form of energy that tends to make us more of who we are already, whether it’s greedy or loving.”

My Formal Response to the Nashville Scene December 2, 2010 journal article about Pharmaceutical Industry and Physician Ties

I am Hal Roseman, one of the physicians mentioned in the December 2, 2010 Nashville Scene article titled “Should you be worried if your doctor is on Big Pharma's payroll?-Pharm League”: http://www.nashvillescene.com/nashville/should-you-be-worried-if-your-doctor-is-on-big-pharmas-payroll/Content?oid=2052989. Having been misrepresented by the Scene’s report, I feel obligated to offer a written response. On the face of it, the Scene article, and the ProPublica article from which the Scene article is copied, seems reasonable. Pictured is a physician cheering on their Big Pharma benefactor. The message is clear- yet again, another large corporation buying influence. But when you start looking at the substance of the article, the report falls short in fully demonstrating that the relationship between industry with physicians, or for that matter, with large institutions (such as Vanderbilt Medical Center, which receives an estimated $250 million dollars in grants) causes harm. The inferences of the article were obvious, but actual damages not identified or fully clarified. The implication underlying this article is that money buys influence, but does it? Are the activities of the pharmaceutical industry causing harm? 

The article fails to demonstrate damages, other than possibly increased sales of newer drugs. It should be emphasized that these drugs have been rigorously evaluated and found to be safe and efficacious by the FDA. Given the advantages of these agents over more legacy treatments, their wider utilization may be beneficial to society. In the case of the educational programs that are part of the promotional efforts of marketing, I know of no studies that have demonstrated adverse effects from the educational programs provided by Big Pharma. In fact, I suspect, because of fair balance requirements built-in to the lecture format, the healthcare providers attending such conferences are better knowledgeable about and avoid inappropriate usage of medications. I believe that those practitioners that know new medications and their appropriate usage are better equipped to handle the nuances of clinical problems posed by individual patients.

Although the reporter asserts that the relationship of physicians lecturing for industry as being corrupting, he offers no concrete proof, just innuendos.

To begin with, today’s highly regulated environment, with presentations being limited to approved slides, makes it unlikely that the intended usage of a drug be distorted by a lecturer. Certainly, the confining and proscribed nature of these presentations, with the content being carefully monitored to maintain fair balance and consistency with the designated FDA approved package information, minimizes the likelihood that a drug would be misrepresented.

The reporter references the University of Minnesota bioethicist Dr. Carl Elliott, who carries impressive credentials (M.D. and Ph.D. in philosophy). In the article, Dr. Elliott is ascribed with asserting that pharmaceutical companies use the lecture program to drum up new business. Citing a conversation with a single unnamed “drug rep”, Dr. Elliott claims, “if a speaker didn’t write a bunch of prescriptions, he wouldn’t speak.” Based upon twelve years of being involved with the pharmaceutical industry, this certainly has not been my personal experience. The decision for the pharmaceutical company to place an individual on their speaker's bureau is not based upon their prescribing behavior! It may be that a physician’s prescribing habits brought them initially to the attention of a pharmaceutical company, because their adoption of a product suggests that their perspectives may be aligned with that of the company. However, it is still their credibility, their professional standing in their community, and their ability to teach that ultimately leads to an invitation. In my case, I do not get any benefits financially for prescribing a product. I am not rated by the industry as to my prescription contribution to their bottom line. I have never been threatened with losing my place on a lecture bureau if I didn’t prescribe more drugs. If pharmaceutical companies dependent upon my low prescribing volume, the company would go backrupt! It is probably true that individuals that speak for a pharmaceutical company favor the use of that company's drug. For me, my endorsement of a drug is the result of the familiarity and knowledge acquired with usage of the drug in my clinical practice supplemented by the lecture preparedness process. Healthcare providers prefer treatments, including medications, about which they are most knowledgeable and familiar- human nature at work! 

By the way, Dr. Elliott in a published 2001 article lamented that none other than the American Society of Bioethics and Humanity was considering accepting money from institutions with potential conflicts with their society. As he stated, “we all get our money from somewhere-universities, grants, hospitals, managed care organizations. Few of us are so unsophisticated that we would allow our money to corrupt our moral judgment.” Dr. Elliott indicates that the gifting act carries subtle messages of influences. However, later in the article he cites several prominent bioethical departments being funded by private corporations. I surmise that despite the appearance of conflict, even the bioethical community has been able to maintain objectivity despite their funding sources.

Then the reporter cites Dr. Adriane Fugh-Berman, a Georgetown University School of Medicine professor and director of PharmedOut, a research and education project examining industry-physician interactions. According to her website, interestingly she is a promoter of alternative medicine, including herbal and natural remedies, and is a “paid expert witness on behalf of plaintiffs in litigation regarding pharmaceutical marketing practices.” Her potential conflicts are obvious, none of which were reported in the article.

But, lets examine her comments, because the appearance of bias does not necessarily confirm its presence.  Dr. Fugh-Berman stated that pharmaceutical companies disguise their training of physician lecture recruits as marketing indoctrination. What is interesting about this accounting is the internal contradictions that are apparent in the article. On the one hand, the reporter clearly sees us physicians as “sophisticates”, but on other hand, we are somehow unable to recognize a marketing message implicit in pharmaceutical lecture training.

In a recently published May/June 2010 Boston Review article, Dr. Fugh-Berman, indicates that the development of a marketing campaign begins 7-10 years before the expected release of an agent, beginning with disease awareness campaign stressing the under-diagnosis of a condition, a novel understanding of a disease, or serious consequences of delayed treatment. (By the way, that is certainly not my understanding. No pharmaceutical company, given the failure rate of a drug coming to market, would engage resources so early in the drug life cycle.) “A classic way to expand the market for a drug is to invent a disease state or exaggerate the importance or prevalence of an existing condition.” This characterization of the birth of a drug misses one major fact, that the process to market is heavily orchestrated, requiring years of basic science and clinical research, and governed by a highly suspicious FDA. If a new disease is discovered, it is the FDA that defines its significance. In fact, the process that Dr. Fugh-Berman is describing is what is better known as the advancement of science. It is the process that leads to greater understanding of the human body and the identification of new and potential pharmaceutical targets for the treatment of significant conditions in the body. Given the stiff barrier to market, with an estimated $800 million - $1 billion dollars in development costs, a pharmaceutical company would be financially suicidal to attempt to bring an agent with minimal benefits to market.

If the reporter had spent more time investigating his experts, his “investigative reporting” would have been more credible!

To begin my review of the article, it should be emphasized that when the reporter first approached me, I requested evidence that the reporter was knowledgeable of the subject matter and that he would approach the subject in a fair-balanced manner. Since it was obvious that he assumed that I was bias, that I should exact some evidence of his lack of bias. What is good for the gander is good for the goose! He failed to respond to my lengthy questionnaire. When I asked for proof from the reporter of his unbiased perspective, he offered this response in writing: "It’s not that I’m avoiding your questions; I’m simply not interested in the hardships the industry faces when attempting to bring a drug to market. They made $300 billion last year. In 2004 they spent more than 24 percent of their budgets on marketing and only 13 percent on R & D. They seem to be doing fine to me. And if the way the spend money is any indication, they seem more interested in marketing than they are in developing new drugs and bringing them to market." The reporter was obviously prejudiced against the pharmaceutical industry before he even wrote the story, which may explain his single sided approach expressed in the article.

As far as my credentials, I completed my undergraduate education from the University of Pennsylvania, my medical degree from the University of Tennessee, my masters in public health specializing in epidemiology of cardiovascular diseases from Yale University. My clinical training included stints at Yale University affiliated programs for my internal medical training, at Brown University for my cardiology fellowship training, and at Harvard Medical School affiliate Massachusetts General Hospital for my post-cardiology fellowship. Since my formal training, I have been certified by written examination in the area of hypertension (Specialist of the American Society of Hypertension) and lipidology (Fellow of the National Lipid Association). It is true that I have not published significantly, but publication by itself is not a definitive measure of one’s expertise. In fact, many of the community’s finest treating physicians in this area have never published an article! Furthermore, I engage in clinical research projects; my practice is one of a limited investigative sites involved in international large trials examining the effects of newer diabetic agents on cardiovascular disease. Over the years, my speaker engagements have included many non-promotional continuous medical education programs at several regional academic medical centers.

As it relates to his reporting of my defense of Avandia (rosiglitazone), I just wish the reporter would get his facts straight. It should be emphasized that the scientific information surrounding this contentious issue is complex and confusing. A definitive consensus about the safety of Avandia has yet to be established; the recent actions of the FDA to severely limit the distribution of Avandia were taken as a prudent measure given this uncertainty. My statements, which have been taken out of context in this and the ProPublica articles, have been consistent. The scientific evidence for affirming a cardiovascular risk to Avandia is incomplete and conflicting. In fact, in the FDA statement explaining its  ruling on Avandia, Dr. Woodcock, the director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) stated that “the cardiovascular safety profile of rosiglitazone is still an open question because there are conflicting data on the existence and magnitude of the risk.” If interested, please refer to Dr. Woodcock's complete statement that has been published on FDA’s website: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM226959.pdf. Finally, my opinions comport with that of the American College of Cardiology and American Heart Association: http://circ.ahajournals.org/cgi/reprint/CIR.0b013e3181d34114. Contrary to the representation of me in this article, I believe that my viewpoint is credible and defensible, regardless of the appearance of bias related to my GSK association.

I have always made it clear that a signal suggesting cardiovascular risk associated with Avandia is present in some, but not all, of the observational studies. However, the more exacting six randomized clinical trials whose treatment protocols included Avandia, which represent a higher level of evidence, failed to show a risk!  In fact, two trials, the BARI-2D and VADT, suggested a benefit. (By the way, contrary to his report, three of the these six trials were not sponsored by industry, but by the United States government!)  Although the reporter refers to my July 14, 2010 presentation to the joint FDA advisory board: (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM224749.pdf), he failed to acknowledge that my main point at the meeting was to demonstrate the lack of conclusive evidence to take Avandia off the market. (By the way, contrary to the insinuation of the reporter, I was not compensated by GSK in any way for going to the meeting or provided with any support to make my presentation.) Guess what, the FDA agreed with me! Admittedly, the restriction of Avandia use is prudent, until the uncertainty of its safety profile can be reassessed following re-analysis of the singly dedicated safety trial RECORD trial. As it relates to reporter’s comments that RECORD trial was “viscerated”, he should check the record. None other than Dr. Unger, FDA Deputy Chief, came to aid of the trial, reporting that his division within the FDA still had confidence in the results, especially the mortality end-point. 

Additionally, my statement about the small absolute risk of Avandia holds; the actual event rates were small! For example, in the referred Nissen study, the absolute risk difference was 0.1% rate of myocardial infarction but took on impressive numbers when translated into a percentage of relative risk.  

As mentioned in the article, GSK did present a meta-analysis in 2005 (not in 2006 as reported) that suggested, but did not prove, a cardiovascular risk associated with Avandia. The increased risk did not reach statistical significance, which meant that a relationship was not definitively found. This information was made known to the FDA who requested additional studies. [A more thorough review of the events surrounding this subject can be found in GSK’s White Paper Response to Senate Finance Committee]. The referenced 2007 Nissen meta-analysis, which has since been disputed and discredited, was not confirmed by the FDA’s own study using similar information. In fact, like the GSK study, the FDA did not determine a statistical significance. As a precaution, the FDA in 2007 issued a warning based upon this data of short-term trials (median duration of six months); however, the FDA warning also emphasized that the three longer clinical trials did not demonstrate a risk. All in all, the 2007 FDA warning indicated that the risk was far from conclusive. Although this point should have been emphasized, the reporter failed to mention this important distinction. By overlooking this difference, the reporter inferred that a risk had been confirmed. His own need for a consistent good by-line took preeminence over carefully researching and presenting the factual evidence of the issue! 

Contrary to the reporter’s claims, the FDA did not attribute 100,000 deaths to the use of Avandia; this assertion, based upon questionable statistical manipulation, was made by only one of their FDA statisticians, Dr. David Graham, whose analysis was not accepted by the FDA higher brass. As to the assumed bias of industry directed trials, which the reporter quotes, the ACCORD, BARI-2D, and VADT trials were government sponsored and did not indicate a risk from the use of Avandia.

I would also like to address several general issues. Let's begin with the assumed issue of prejudice that is ascribed to lecturers for the pharmaceutical industry. Just because someone receives compensation from a company does not necessarily indicate bias or prejudice. Were the views of the reporter colored, influenced, affected, tainted, or altered by his employer, The Scene? Certainly, there is presumption of bias when one is an agent of an institution or corporation. What dictates the nature of that agency relationship is the integrity of the individual, not the source of his income! Judge me for what I say and do; don't prejudge me simply because I am associated with a company. Using financial ties offers a beginning point to determine a person's bias but that metric is deficient in providing a conclusive and complete analysis of the individual's character. Should everyone be judged solely by one’s relationship to his employer?

The article, as the title suggests, infers that clinical physicians who work with industry are so biased in their prescribing approach that they have a disregard for  for the welfare of their patients. In my own practice, my patients are quite aware of my involvement with industry; they seem quite satisfied with my knowledge. I explain the benefits and risks of all agents and reference major studies, guidelines, and national scientific statements to justify the use of an agent, not infrequently choosing a competitive agent to the one I represent in my lectures.

As it relates to recruitment into industry’s lecture bureau, I believe that doctors are selected for such positions because of their capacity to represent professionally disease states relevant to a medication and the proper pharmaceutical usage of the drug featured in the lecture. It should be noted that there are strict guidelines of what can be said and presented at these meetings. A lecturer is required to adhere to rigid FDA guidelines, which require that information is consistent with the approved indications of the drug and not deviate from the approved package insert of the product. Discussions about off-label usage are strictly prohibited. By the way, there are many lectures that are not directed at all to marketing of a specific drug; these lectures, known as "disease state awareness", are presented to disseminate newer concepts about a disease. By the way, in such lectures, direct mentioning of products is discouraged.

In my own case, I became a lecturer because I wanted to be in a situation to influence health care practice and to channel my interests in education. I believe that I was selected because of my educational and scientific background and my capacities of distilling knowledge. Certainly, I could have entered an academic professional tract and was offered an academic position with the University of Tennessee. However, I remained in private practice to pursue my life-long love of treating individual patients, with the hope that I could make a difference in their lives. Lectureship through these pharmaceutical activities offered me yet another avenue to give back what I have learned.

By the way, my relationship with the pharmaceutical industry has had many professional benefits. I am a more fully informed physician as result of my attendance of the many conferences and symposia sponsored by industry. I have access to the latest research, which is only possible through industry’s largesse. I am exposed to latest insights of disease pathophysiology and new potential targets for pharmaceutical intervention.

I have become a better practicing physician as a result of my relationship with industry. In order to be fully prepared for my lectures on preventive cardiology, I read extensively in both the clinical and basic science literature. I have access to medical research, sometimes before its publication. I have personal relationships with many of the key academic physicians who are nationally recognized in lipidology, hypertension, coronary artery disease, and diabetes. As a result of the challenges of being a lecturer, I am knowledgeable of the latest scientific guidelines that form the basis of care in modern medicine. These experiences have translated in more discriminating administration of medications and choices of technology in treating my own patients.

As it relates to the conduct of the pharmaceutical industry, I am not here to defend it. As in any industry, there have been excesses and improper actions of marketing that have led to very well publicized charges and fines. There is not any industry, including journalistic publishing, which is free from similar charges. However, I do find it objectionable that the reporter’s view of the pharmaceutical industry was not fair-balanced. Even as a passing comment, he failed to mention the positive attributes of the industry and its contribution to the health of the nation and the world. The reporter failed to indicate that longevity in this country has increased by an average of 7 years since 1960, of which an estimated 40% of that change can be attributed to medications.  He failed to report that pharmaceutical industry spends more on research and development as a percentage of sales than many other research-intensive companies (e.g., computer software, electrical and electronics, automotive, and telecommunications). He failed to report that the “exorbitant” profits made by the pharmaceutical industry are similar to other companies in a variety of industries (e.g. Microsoft). He failed to report that it costs nearly a $1 billion dollars to get a new drug approved for the US market and the investment costs require expedient market adoption because of the short patent life of 10-15 years for the agent. Marketing is a necessary part of that process.

As it relates to the issues of profits earned by the pharmaceutical industry, the reporter failed to take into account that the pharmaceutical industry is part of our capitalistic system. Is the reporter insinuating that profits made by an industry are unjust; in the case of the pharmaceutical industry, these profits are the engine that drives innovation and scientific research for the world. Most of the pharmaceutical companies offer answers to the charges that the marketing budgets are excessive and their R&D efforts are low relative to their profits. The website of two large pharmaceutical companies, GSK and Lilly, offers responses:  http://us.gsk.com/html/healthcare/healthcare-common-questions.html and: http://www.lilly.com/research/value/. None of this was mentioned when the reporter was actively discrediting the industry. Not fair-balanced reporting, just grand-standing!

I offer these insights to make a point: there are many sides to the same coin. Journalism needs to be fair-balanced and credible. Unfortunately, although the reporter brings up several valid concerns and raises important issues, the report fails to offer any new information or insights, merely inferences, implied accusations, and in some cases misanalysis. Sensationalism, rather than even-handed reporting, appeared to have won out in the writing of this article. When I asked the reporter whether there was an editorial board governing his actions, he indicated no to the question. Given the article’s mishandling of some of the issues, maybe the Scene should institute one.