Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths

We recently discussed a simultaneous retreat from aggressive regulation and enforcement applied to big health care corporations by US government agencies.  Now a story published by Bloomberg (currently available without a subscription here on PharmaGossip) showed that the push for less disclosure of relationships with industry that generated conflicts of interest for academic medicine came not from industry, but from ... academic medicine:

The lobby for Harvard University and other research institutions drove the Obama administration to weaken draft rules for scientists to disclose potential conflicts of interest, according to U.S. records and watchdog groups.

In particular,

Universities objected to draft rules in a letter to NIH and in meetings with officials at the White House Office of Management and Budget, approver of the final version, said Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities that represents 61 research universities.

Also,

The letter was co-signed with the Association of American Medical Colleges, American Council on Education and Association of Public and Land-Grant Universities.

The one example of the universities' reasoning to justify their objections to greater disclosure of conflicts of interest was striking.

Wolinetz’s organization wrote in the letter that 'there is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity.'

Recall that the disclosure to which they objected would be by federally funded researchers, and of financial relationships with organizations that had vested interests related to the particular research projects. The Institute of Medicine's landmark report, "Conflict of Interest in Medical Research, Education and Practice,"  stated:

Disclosure of financial relationships with industry is an essential, though limited, first step in identifying and responding to conflicts of interest.

One could also argue, as did Senator Grassley, (see here) that disclosure is owed to the tax-payers who support the research.

On the other hand, I do not think anyone would argue that disclosure and the ill-defined "management" proposed by the NIH would be sufficient to guarantee "objectivity and integrity" of the research.

In fact, the IOM report called for going far beyond disclosure.  Specifically, it called for banning most conflicts affecting most clinical research:

researchers should not conduct research involving human participants if they have a financial interest in the outcome of the research

This goes far beyond what the original NIH revision of its conflict of interest rules mandated. However, I am sure that banning such relationships was the last thing that the AAU and AAMC wanted.

So the academic institutions' argument seems to be a variant on the false dilemma logical fallacy. If the only alternative to doing nothing about conflicts of interest is disclosure, and if disclosure is really a poor solution to the problem, than perhaps doing nothing makes sense. However, if disclosure is just a necessary first step, as the IOM asserted, then it is a first step that should be taken in preparation for other steps to come.

Note that the academic institutions' argument also seems to be a version of what has been called the Nirvana fallacy, or the perfect is the enemy of the good fallacy. That is, if what one can do does not result in Nirvana, then one should do nothing.

Finally, in this case the academic medical institutions' argument seemed too extreme even for their pharmaceutical industry supporters. As the Bloomberg article reported,

Researchers have been lax making financial disclosures and there’s been an absence of oversight, said Peter Pitts, president of the Center for Medicine in the Public Interest, a nonprofit research institute in New York. 'When you don’t properly disclose, you give the impression that you’re trying to hide something.'

Institutes should instead disclose all financial interests without trying to judge whether they are conflicts, Pitts said.

As we have discussed previously, Peter Pitts' main occupation has been as a leader in public relations for the pharmaceutical industry. He is currently a senior partner, director, global regulatory & health policy for Porter Novelli. Even though we have previously criticized Pitts for deploying logical fallacies in support of industry positions, in this case the academic medical institutions' argument was too much for him to support.

So we have come this far. Universities are ostensibly about finding and disseminating the truth. Yet universities' academic medical subsidiaries now deploy illogic to avoid revealing particular truths that they find uncomfortable, and which might raise questions about relationships with industry that are increasingly lucrative. Universities seem now willing to jettison their mission to make more money.

True health care reform would require academic medicine to put its mission ahead of its revenues.

Logical Fallacies and the Discussion of Health Care Policy: Examples Courtesy of DrugWonks.com

On the DrugWonks blog, blogger Robert Goldberg seemed terribly perturbed about Health Care Renewal, and me in particular. In the last week, he devoted two posts to disagreeing, to use a polite term, with me and this blog, and threw in parenthetical comments about me and this blog in two other posts. It is not exactly clear what I wrote that set him off. He never linked to particular posts, or quoted anything I actually wrote. My best inference is what most recently raised his ire was this post about conflicts of interest related to two public pronouncements by influential health care not-for-profit organizations urging patients and physicians not to abandon Zetia and Vytorin.

His posts are entitled "Beware of All Innovations, Especially New Ones," "Sanctimony About Vytorin's 'Secret' Panel,", "Everyone has a right to their own opinion as long as they agree with me," "Why the Media and Pharma Blogsphere Fails to Get Personal."

We have previously posted about op-eds in the mainstream media written by Robert Goldberg, and his boss, Peter Pitts, which have also featured logical fallacies (here, here, here, and most recently here.) Goldberg also once used DrugWonks as a platform to try to discredit Health Care Renewal, again making use of logical fallacies (see post here).

We have noted before that Goldberg works for the Center for Medicine in the Public Interest, whose president, Peter Pitts, is Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. Furthermore, in a post on Drugwonks, Goldberg acknowledged "CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people." In the op-eds noted above, neither Pitts nor Goldberg acknowledged their relationships to the pharmaceutical industry, giving us reason to label their writings in the media stealth health policy advocacy.

Goldberg's latest set of writing are notable mainly for their creative use of multiple logical fallacies. So to try to make some lemonade out of the lemons he has provided, let me respond to some of his points sorted by the kind of fallacies they represent, with discussion of the definition of these fallacies and how they were deployed. All definitions used here were from the Nizkor Project.


A Squadron of Straw-Men

The straw-man argument seems to be a favorite of Goldberg's. One working definition of the straw-man fallacy is: "The Straw Man fallacy is committed when a person simply ignores a person's actual position and substitutes a distorted, exaggerated or misrepresented version of that position." Here are some examples, in the order they appeared in his posts.

• "the Poses postulates" - In "Beware of All Innovations...," Goldberg invented a set of exaggerated postulates purportedly for the use of pharma-skeptics. They begin with "don't trust Pharam research or the researchers they pay," and go downhill from there to "don't use any drugs...." Obviously, the first could conceivably be an exaggeration of some things I have written, and the last is plain ridiculous. Also obviously, I never proposed anything remotely like these. So this is a quintessential straw-man fallacy. Goldberg has simply made up words and then attributed them to me.
• "this also should apply to Zocor," - In "Sanctimony About Vytorin's...," a post which starts by criticizing me as "insufferable," Goldberg seemed to imply that I suggested "people should stop taking SSRIs, Avandia, and Vytorin." He then added "now I guess this should also apply to Zocor." I have criticized the suppression and/or manipulation of clinical research about SSRIs, Avanda, and Vytorin, and noted that it is not clear that the benefits of the latter two drugs outweigh their harms. I have never had reason to directly discuss Zocor (simvastatin, by Merck), a commonly used statin lipid-lowering drug. I certainly never suggested that it not be used.
• "anyone who consults for drug companies is a prostitute and endangers the public health," - Also in "Sanctimony," Goldberg suggests I expressed this extreme sentiment. I surely have written about concern that medical academics who also have financial ties to commercial health care firms are hard pressed not to be influenced by such ties. But I never used the p-word in this context.
• "And he presumes that the only source of bias that affects the public health adversely - mostly without empirical evidence - is financial inducements from drug companies," - In "Everyone has a right...," Goldberg directly misrepresented my position as above. If he bothered to read Health Care Renewal, he would find that I (and our other bloggers) have been equal opportunity offenders, skewering deceptive marketing, conflicts of interests, and other such practices involving all sorts of health care organizations, not just pharmaceutical companies.
• "By his standards, Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one...," - This appeared in "Everyone has a right...." To be concrete, I don't think I have ever mentioned any of these luminaries in Health Care Renewal. More importantly, all these scientists were best known for basic research, and they all did their major work before the rise of pharma as a major sponsor of clinical research. All I have written about conflict of interest, research manipulation, and research suppression has been about clinical research, that is, research on intact human beings. I have been most concerned with influence by the manufacturers of particular products on human research that tests the products they make. The issue has never been commercial funding of basic science. So Goldberg's assertion in this case was certainly the biggest collection of straw so far.
• "So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind eye towards other sources of conflict." - Again, in "Everyone has a right," Goldberg demonstrates that he is not a faithful HCR reader. As noted above, we have criticized all sorts of conflicts of interest, involving not just pharma, but device, biotechnology, managed care, hospital suppliers, etc, etc. More straw piled on the camel.
• "And who said the conclusion of ENHANCE was to lower cholesterol at all costs? Roy Poses?" - This was in "Why the Media...." Of course, I didn't say that. Enough straw-men to break any camel's back.

Accusations of Guilt by Association

A working definition, "Guilt by Association is a fallacy in which a person rejects a claim simply because it is pointed out that people she dislikes accept the claim."

• "There is no doubt Poses is part of the 'I hate Pharma' crowd...." - Goldberg wrote this in "Everyone has a right...," This has elements of a straw-man too, since, as noted above, I have written quite a lot about health care organizations outside of pharma. Clearly, though, Goldberg has lumped me into an amorphous group whose existence is as plausible as Hillary Clinton's "vast right wing conspiracy."
• "the failure of the I hate pharma crowd in the media and blogsphere...." - This was in "Why the media...." See comments above. I guess Goldberg doesn't think I'm in with the in-crowd.

Down the Slippery Slope

A working definition, "The Slippery Slope is a fallacy in which a person asserts that some event must inevitably follow from another without any argument for the inevitability of the event in question. In most cases, there are a series of steps or gradations between one event and the one in question and no reason is given as to why the intervening steps or gradations will simply be bypassed. " Goldberg tended to employ slippery slopes in conjunction with straw-men.

• "the Poses Postulates" - Again, as noted above, these were certainly not my postulates. The postulates themselves were a fairly classic slippery slope, starting with exaggeration, "don't trust Pharma," proceeding through this dubious reasoning, "Don't trust the drugs they produce or market since the FDA is nothing but a tool of pharma," and ending with the ridiculous, "don't use any drugs...."
• From "any financial ties is a conflict," through "people should stop taking SSRIs, Avandia, Vytorin. Now I guess that should also apply to Zocor." Again, this was noted above as a case of a straw-man fallacy. Goldberg constructed his straw-man so as to slide down a slippery slope.

Fishing for Red Herrings

Working definition: "A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue. The basic idea is to 'win' an argument by leading attention away from the argument and to another topic."

• "Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to 'natural' cholesterol lowering products that they sell, etc." - Goldberg wrote this in "Everyone has a right...." Obviously, whether or not such web-sites exist, whether or not they are abusive, and whether or not I have noticed or commented on them has no bearing on whatever I wrote about ezetimibe, clinical research on it, etc that so offended Goldberg. (Goldberg actually never clearly referred in any of these posts to anything specific that I wrote, so what so offended him was never clear.)
• Goldberg wrote two paragraphs about alleged conflicts of interest affecting the Prescription project, then "Should Poses be suspicious about the choice of drugs made by the Prescription Project based on their source of funding? Not a peep." - This again was in "Everyone has a right...." Again, this is irrelevant to the ezetimibe controversy. I have tangentially referred to the Prescription Project on this blog, but not in a way that is relevant to anything else Goldberg was talking about.

For Latin Lovers, Ad Hominem Tu Quoque

This may not be the most well-known fallacy, but its working definition is: "This fallacy is committed when it is concluded that a person's claim is false because 1) it is inconsistent with something else a person has said or 2) what a person says is inconsistent with her actions. "

• After making the straw-man argument that I would have labelled a host of Nobel Prize winning basic scientists as untrustworthy, "while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses [sic] just got one Merck grant back in 1997-1999 (which he never declared in his blog.)" - This appeared in "Everyone has a right...." The argument seems to be that anyone who ever had a relationship with a pharmaceutical company of any type can never criticize anything to do with such relationships. (In a funny way, Goldberg thus seemed to be making an argument for how conflicts of interest do influence what people say and do.) I freely admit I was the Principal Investigator of a grant sponsored by Merck, and paid to the hospital which employed me. Why that singular relationship ten years ago should discredit my current arguments about conflicts of interest, arguments which Goldberg never directly addressed, is, to be charitable, not obvious.

Joe Collier wrote succinctly in the British Medical Journal, [Collier J. The price of independence. Br Med J 2006; 332: 1447-9.] "In my experience, people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." Goldberg's latest writing seem to demonstrate this well.

The writings of Goldberg and Pitts probably inadvertently have provided a great set of teaching cases about how logical fallacies can be used in persuasive writing to put forward dubious, and conflicted postulates. A working knowledge of logical fallacies should help readers separate the wheat from the chaff in the cacophonous clamour about the current crisis in health care. Some useful web-sites for those interested in logical fallacies are the Nizkor Project: Fallacies, LogicalFallacies.info, and the Fallacy Files. (I'm sure there are others.)

ADDENDUM (28 January, 2008) - Goldberg has also taken issue with Dr Howard Brody (of the Hooked: Ethics, Medicine and Pharma blog) and Dr Daniel Carlat (of the Carlat Psychiatry Blog), and then with Dr Aubrey Blumsohn (of the Scientific Misconduct Blog). See if you can spot the logical fallacies in Goldberg's pieces. Then see Dr Brody's reply here.

A Skeptical Look at a Dire Warning: Is Medicare "Willing to Let Seniors Suffer and Die Sooner from Cancer?"

Yesterday's Providence Journal included an op-ed by Robert Goldberg, entitled "Fewer Drugs, Fewer Seniors," featuring this dire warning:

Now, to save money, America’s Medicare program is willing to let seniors suffer and die sooner from cancer....

How in the world could Medicare do that?

As a first step, the Center for Medicare and Medicaid Services (CMS), which runs Medicare, decided to restrict reimbursements for erythropoiesis stimulating agents (ESAs) — drugs that prevent the fatigue from chemotherapy-induced anemia.

In this case, CMS came up with a new standard for paying for new drugs called the Precautionary Principle. This principle, developed by environmental extremists in Europe nearly 20 years ago, states that anything unknown is unsafe and should not be used. CMS asserts that it does not know enough about the safe use of ESAs beyond achieving a specific hemoglobin level. So it won’t pay for anything above that point. No exceptions. If seniors feel fatigued or confused they can pass the hat like Chantelle Hill.

And why in the world would they do that?

The CMS decision has nothing to do with safety and everything to do with cost.

But before hitting the panic button, consider how the author of the op-ed, Robert Goldberg, identified as "Vice President of the Center for Medicine in the Public Interest," tried to support his contention.

First, he ignored the most relevant evidence while criticizing less relevant studies.

CMS says that ESAs cause cancer and heart problems beyond hitting a hemoglobin target of 10 g/dL. But that claim is based largely on two studies that examined the experimental use of extremely high dosages of ESAs in patients without cancer.

Goldberg ignored six studies that used different doses of different erythropoetin products (or ESAs, to use his terminology) to achieve different target hemoglobin levels in patients with various kinds of cancer. Four were published, and all six were summarized last June in the New England Journal of Medicine [Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer. N Engl J Med 2007; 356:2445-2448. Link here.] Five of the studies showed shorter average survival in patients given erythropoetins. One showed increased progression of disease and a statistically insignificant trend towards decreased survival. This set of studies raise the concern that erythropoetins, rather than preventing early death, may hasten early death.

Next, Goldberg turned to the US Food and Drug Administration (FDA) for support.

The Food and Drug Administration, its European counterpart the European Medicines Agency, and physician groups such as the American Society of Clinical Oncologists recognized the value of these studies in guiding clinical decisions but not restricting them.

It is very rare for the FDA to restrict use of a drug already on the market. Actually, the FDA has emphatically warned about the possibility that erythropoetins may hasten death, rather than increase survival. The FDA considered the six studies summarized in the Khuri article above, and issued the following official "black box" warning for these drugs (for example, see label for Epogen below).

WARNINGS: Erythropoiesis-Stimulating Agents

Use the lowest dose of EPOGEN® that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion (see DOSAGE AND ADMINISTRATION).

EPOGEN® and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL (see WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events).

Cancer Patients: Use of ESAs
• shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;
• shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL;
• increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population.

Finally, Goldberg asserted,

Seniors who are stronger and don’t have to spend time shuttling to the hospital are better equipped to endure newer and more powerful combinations of cancer drugs in the elderly. Indeed, a recent study conducted by Columbia University’s Frank Lichtenberg found that an aggressive chemotherapy regimen for seniors extends life expectancy by 8 to 12 months.

Lichtenberg's study seems so irrelevant that I wonder if it was raised as a deliberate distraction. Goldberg's original warning was about restrictions on payments for erythropoetins, not about chemotherapy. That Lichtenberg's study is not yet published, and that Lichtenberg is an economist at the Columbia Business School, just add to the irrelevance.

So to summarize, Robert Goldberg's dire warning that Medicare is out to make sure, as implied by the title of his article, there are "Fewer Drugs, Fewer Seniors," seemed to be based on a mixture of half-truths and irrelevancies. So why did he make this warning?

I don't know, but what the Pro Jo article did not reveal is some relevant background information about the ties of Goldberg's organization to pharmaceutical companies. We have noted before that Goldberg works for the Center for Medicine in the Public Interest, whose president is Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. This suggests at least an indirect conflict of interest, favoring the interests of the pharmaceutical industry, that should have been revealed in this op-ed article. Furthermore, in a post on CMPI's DrugWonks.com blog, Goldberg acknowledged "CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people."

We have previously posted about other stealth health policy advocacy coming from CMPI (here and here.)

If CMPI really accepts money from pharmaceutical and biotechnology companies "proudly," its officers should not be afraid to make this and any other financial ties they may have to these companies clear when they write op-eds in major newspapers. That might at least alert readers who are not trained in evidence-based medicine to be a bit skeptical about the apparently scientific, but actually mostly irrelevant references with which they adorn their writing, and to wonder how much relevant evidence they did not bother to include.

That health care in the US is now in a crisis is now a cliche. Finding our way out of this crisis requires logical discussion based on evidence, not half-truths and irrelevancies promulgated by people with hidden financial ties.