transparency

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.

Doctor, how much will this cost?

R. Horton2 Comments

When I was young, newly married, and in graduate school, I needed to have some wisdom teeth extracted. I went to a dentist near my home, and he took x-rays and explained what all needed to be done for the extraction. I had little money at the time and I asked, necessarily, how much it would all cost. He gave an exasperated sigh and told me we’d talk about that later. We wouldn’t, because I asked for my x-rays and left without scheduling the extraction.

Through family, I managed to find a dentist who was willing to do the extraction for a set Stethoscopeprice with the caveat that one always runs the risk of unexpected and unavoidable complications running up the costs. In the latter event, this dentist, knowing my family, agreed to work on a reasonable repayment plan. The extraction went well, I was able to pay for it, and we all went on about our business.

The remarkable part of this story is that I never again had a frank discussion with any healthcare provider regarding the cost of treatment, though I have often been shocked by the prices of tests, prescriptions, and other services.

Ideally, I think when doctors (or other providers) tell patients about a treatment’s risks, side effects, and benefits they should also talk about the treatment’s cost and whether there are cheaper alternatives. Sometimes, a cheaper alternative is just as efficacious as the expensive choice the doctor is prescribing. In this way, discussions of cost can be woven seamlessly into the informed consent process.

Of course, adding a discussion of price to the informed consent process will add another burden for doctors, who are already feeling pressured for time. In a column in the New York Times, cardiologist Sandeep Jauhar points out that reduced payments to doctors have forced doctors to take on more patients to maintain their income. As a result, doctors spend even less time talking to patients and feel even more rushed to move on to the next patient. Adding a discussion of cost to informed consent will only create more pressure for the doctor to hurry through each patient encounter.

Further, it is difficult for doctors to inform patients of something they don’t know themselves, and doctors are frequently unaware of the cost of medications and other services they prescribe or order. A 2007 paper by G. Michael Allan, Joel Lexchin, and Natasha Wiebe found that “Physicians’ awareness of the cost of therapeutics is poor. With only 31% of estimates within 20% or 25% of the true drug cost and the median estimate 243% away from the true cost, many of the estimates appear to be wild guesses.” If physicians knew the cost of their prescriptions, they might prescribe differently in many cases, so it would be a huge step forward if both physicians and patients could be better informed about healthcare prices.

Physician Peter Ubel wrote a blog post about his experience with getting a prescription from his own doctor that was $200, much more than he had anticipated. When Ubel spoke with his doctor, the prescribing physician admitted he had no idea the prescription would cost so much. Ubel asks whether we should expect doctors to research costs before prescribing. It may be too much of a burden to ask doctors to do more research, but this may be a case where the move to electronic health records (EHRs) may benefit patients directly.

If an EHR retains patient insurance information, then it should be able to calculate the cost of any treatment stored in database and automatically display it to the doctor when the prescription is entered. With a really expansive system, it might even show the cost of alternative treatments. The doctor could then easily present the patient with each treatment and its cost.

I have serious reservations about the growth of EHRs and massive databases of personal information that is not easily controlled or limited; however, if we have EHRs anyway, we might as well use them to save money for patients. In the meantime, I think we will all do well to bring up the issue of cost with healthcare providers at every available opportunity. By doing so, we will make our providers aware that cost is an important consideration in prescribing, and we may also slowly work our way toward much greater transparency.

 

Sunshine disinfects nothing

R. Horton5 Comments

I seem to remember Jon Stewart once playing a clip of a politician declaring that sunshine is the best disinfectant. After the clip, Stewart warned viewers that using sunshine as a disinfectant could lead to a nasty infection. In response to the Sunshine (Open Payments) Act, bioethicist Mark Wilson sounds a similar alarm in a recent paper.

For years, many people, including myself, have argued that industry payments to physicians should be disclosed to the public, so that we will all be aware of possible financial conflicts of interest (FCOI). My hope was that disclosing conflicts of interest might help actually reduce corruption or even simple bias in medical practice, but Wilson points to our experience of Wall Street before and after the 2008 financial collapse to show that knowledge of conflicts of interest does not prevent them. Rather, disclosure only shifts the burden for reducing FCOI to patients, who are least empowered to eliminate them. Rather than fixing the problem, Wilson claims the Sunshine Act only “mythologizes transparency.”

Wilson pointed me to a paper (“Tripartite Conflicts of Interest and High Stakes Patent Extensions in the DSM-5”) in Psychotherapy and Psychosomatics that illustrates the problem. If you want the details, you can read the paper yourself, but I will skip right to the conclusion, which I admit is how I read most papers anyway:

[I]t is critical that the APA recognize that transparency alone is an insufficient response for mitigating implicit bias in diagnostic and treatment decision-making. Specifically, and in keeping with the Institute of Medicine’s most recent standards, we recommend that DSM panel members be free of FCOI.

Telling people about FCOI does not reduce bias and corruption; it only offers an opportunity for people to be aware that bias and corruption exist. I think it is valuable that the Sunshine Act is making people aware of FCOI. In response, though, I hope we will take steps to reduce FCOI. Unfortunately, the burden is indeed shifted to voters and consumers. The most disturbing and obviously true statement Wilson makes in his paper is this: “Until politicians end their own commercial COIs, the Sunshine Act will likely remain the governance order of the day.”

We can’t hope the experts will solve this problem. We must demand that FCOI are eliminated.