Pharma

Attribute Substitution and Public Health

R. Horton2 Comments

Partly in response to a series of posts in the New England Journal of Medicine dealing with conflicts of interest in medical research, Austin Frakt wrote a piece for the New York Times titled, “A New Way to Think About Conflicts of Interest in Medicine.”  In the end, he claims that too many critics dismiss a study simply because it received industry funding, and he says this is a kind of attribute substitution (this is a fallacy whereby something may be rejected because it is associated with something negative, rather than on its own merits).

This is a bit of red herring, because attribute substitution is not always such a bad thing. If I am negotiating to buy a new car, it may be that everything checks out regarding the engine, interior, paint, brakes, and so on, but I may reject the car simply because I happen to know it is stolen. The fact that it is stolen doesn’t make it a bad car, but it does make it spectroscopeone I would not want to buy. In the same way, the fact that a study is industry funded does not prove it is a bad study, but it is possible for a reasonable person to object to it simply on the grounds that its funding encourages unethical behavior.

Also in his essay, Frakt mentions that research is often tainted by many things that are not industry funding: things like personal relationships, religious bias, and overweening personal ambition. On the other hand, industry-funded research often yields excellent, well-controlled studies with beneficial results.

All this is true, of course, and there may be critics out there who believe that no industry-funded research should be published, but I think that is an unusual view. What is more common is to call for disclosure of financial ties to industry. With such disclosure, readers can evaluate the data with an understanding of the possible bias of researchers. More importantly, in my opinion, is that disclosure helps us see whether anyone from outside of industry is working on the same problem.

Disclosure does nothing to eliminate bias. If I know that someone is working for Pharma Co. X, I know she is trying to develop profitable products for her employer. The best path to a high profit is probably through rigorously controlled research. The bias of the researcher is to develop a profitable product, and disclosure will not change that bias; it isn’t a conflict of interest as profit is really the only interest driving the research.

The problem is that most research is now funded by industry (in 2012, industry funded about 59 percent of medical research in the US).  When researchers are hired to create marketable products they are, indeed, motivated to show bias both in how they conduct their research and in what kind of research they begin in the first place. Unethical practices can happen both within and without industry, but we are better to have a variety of ways to fund research, and we are better to have transparency about how research is funded and how it is conducted. We need to know how research participants were recruited. We need to know what data was and was not used. On the issue of transparency, I agree completely with Frakt: “To the extent research design and methods are not up to snuff, that’s the red flag — the door through which conflicts of interest enter and exert undue influence. More rigorous, transparent and reliable research from both industry and nonindustry sources would reduce the need to lean so heavily on mental shortcuts like attribute substitution in judging scientific merit.”

Finally, we need to know whether research was aimed at reducing human suffering or merely at generating profits. On a good day, these two goals are perfectly aligned. On a normal day, reducing human suffering is at odds with creating products. I’ve mentioned before philosopher Thomas Pogge’s efforts to create incentives for companies to develop drugs for conditions that may not be profitable, and I think it is worth mentioning his Health Impact Fund once again. Pogge’s solution is one that works fairly well with market-based thinking. Love it or hate it, it is a good effort. Other solutions are possible, though. Governments could pool resources to simply set up labs and hire scientists to develop cures for diseases that affect global health. Capitalist investors might also want to develop cures in order to capitalize on improved human resources as John Rockefeller did about a hundred years ago.

Yes, I realize government funding and charitable institutes still exist (Rockefeller’s legacy continues), but research for profit (and only for profit) threatens our ability to continue advances in public health. We need greater transparency (of financial ties and data transparency) in research, greater protection for research subjects, more variety in funding sources, and more checks to replicate and confirm findings. It may be expensive, but mistakes are expensive, too.

All Research Is Biased – Might As Well Get Paid For It

R. Horton1 Comment

Capitalist Epistemology: Is Money Truth?

On November 28, 2014, the BMJ (formerly the British Medical Journal) posted an announcement that it would no longer publish papers from authors with financial ties to industry with the aim of eliminating harmful bias from published articles. I’ve since talked to some researchers who quickly pointed out that everyone has biases, so eliminating financial conflicts of interest will not result in objective research free from fraud or manipulation, and I agree with them on that point. [Note, a response from Fiona Godlee clarifies this policy: “The policy applies only to editorials and clinical education articles designed to guide patient care and does not extend to other types of article published in The BMJ.” updated 1/14/15.]

As far as I know, Gregor Mendel had no financial conflicts of interest, but his data proved Pharmaceutical-cartonhis theory of genetics perfectly—too perfectly, almost everyone agrees, to be true (see a brief discussion here). Paradoxically, Mendel seems to have cleaned up his data in order to help promote his theory, which happened to be true, so he used untruth to promulgate truth. Other researchers have let their biases affect them more nefariously, letting sexism and racism cloud their ability to form accurate or even coherent theories of health, intelligence, or moral agency.

But the goal of science has always been for an objective pursuit of truth free from emotional bias. Philosopher Alison M. Jaggar made a compelling argument that no scientific inquiry is value free or separate from emotion. She argues, on the contrary, that emotion is a necessary part of any pursuit of knowledge. “Disinterested inquiry,” she says, “Is an impossible dream.” (See “Love and Knowledge: Emotion in Feminist Epistemology.”) A scientific researcher with no bias and no values is both impossible and undesirable, I agree, but it is one thing to have a socially constructed bias and another to have a financially constructed bias. Being paid to have a bias raises a whole new set of problems.

I don’t mean to suggest that pharmaceutical or biotechnology companies should be prohibited from hiring scientific researchers or even that those researchers should be prohibited from publishing in scientific journals. They should, of course, have adequate oversight to detect and prevent fraud, but I’m sure many great products in medicine and elsewhere have resulted from an unbridled pursuit of profit.

The problem is that we don’t have enough independent researchers to ensure a robust search for solutions to human problems that may not lead to profit. Further, we don’t have enough independent researchers to prevent harm from flawed conclusions that may, in fact, generate a profit in spite of their flaws at great risk to public health.

We need publicly funded research centers or anonymously funded research centers where researchers can pursue knowledge that may or may not be convenient for corporations. These researchers would be freer to publish negative results of “promising” treatments. They would be freer to pursue treatments that may be effective but less profitable. As anyone familiar with this problem is aware, it is far more profitable to market maintenance treatments than treatments that will actually cure any given medical condition. Imagine if public funding were also used to manufacture inexpensive and effective cures rather than expensive and less effective treatments.

Of course, this is not the direction the United States (or the world, really) is heading. Rather, we have now entered the age of “venture philanthropy.” (Read Llewellyn Hinkes-Jones’ piece in the New York Times. ) Venture philanthropy enables foundations to use tax-exempt donations to invest in for-profit companies. Rather than using public funds to ensure research free from financial conflicts, venture philanthropy uses public funds to develop and market new products. As Hinkes-Jones puts it, “If the intent is to cure rare diseases, then we should be increasing the budget for the National Institutes of Health and other research initiatives. Instead of gala balls and donor drives, higher taxes on the same rich benefactors could be used to fund the research that isn’t already being supported.”

When the BMJ announced it would no longer publish pieces by authors with industry ties, one chilling line from the article leapt out at me: “In some fields—for example, obesity medicine, genetics, and rheumatology—we may find it difficult to recruit authors free of relevant financial links with industry. It might even prove impossible.” Somehow, we must find the will to make it possible for researchers to make a living and publish their findings without joining the payroll of for-profit corporations. I do not believe all researchers are motivated only by the opportunity to accumulate wealth. Jonas Salk passed the opportunity to amass great wealth with the polio vaccine. Others deserve the chance to do the same.