Will industry-funded research kill you?

Last week, I wrote a blog about the effects of financial conflicts of interest (FCOI) on treatment decisions of doctors and whether disclosure alone will have any effect on eliminating bias and corruption. As a result, I received some comments and information on FCOI in published research.

Before I say more, I would like to clarify that someone who is conducting research funded by industry is not technically, in my studied opinion, involved in a FCOI, because such a person has the single interest of generating products that will result in profit for industry. It is possible that research undertaken with the aim of commercial success will benefit humanity, but if profit is not possible, humanity be damned. (I am making an assumption, which may be naive, that most of us think medical research should be aimed at making life better for humanity.)

To help combat the problem of bias in research, John Henry Noble suggests prison time for those found guilty of scientific fraud. In my opinion, he makes two strong claims: 1. “The false claims of the perpetrators rise to the status of crime against society, insofar as they endanger public health by sullying and misdirecting the physician’s ‘standard of care.’” 2. “The due process of law is likely to uncover and judge the evidence of guilt or innocence more reliably and fairly than will the institutions of science and the professions that historically have resisted taking decisive action against the perpetrators.”

I agree that jail time is appropriate for egregious cases of scientific fraud, but I’m not sure it eliminates the problem of industry-driven research. Another person told me industry-funded research should be published for two reasons: 1. Some people are biased without the benefit of industry funding. 2. Some industry-funded research proves to be quite beneficial. Perhaps surprisingly, I agree with both of these statements as well–as far as they go. Certainly, many people carry any number of biases that do not result from corporate funding, and the history of scientific fraud is littered with examples. Further, corporate labs frequently create products I enjoy immensely.

Oddly enough, the person defending industry-funded research sent me a link to a paper to support the contention that FCOIs are not a strong predictor of bias. I say it is odd because the paper didn’t seem to support that position. The paper analyzed the associate between industry funding and the likelihood that the researchers would find an association between sweetened beverages and obesity. The authors of the paper found that “Those reviews with conflicts of interest were five times more likely to present a conclusion of no positive association than those without them.” It is perhaps the conclusion of the paper that gives hope to those advocating for industry funding:

They [results of the study] do not imply that industry sponsorship of nutrition research should be avoided entirely. Rather, as in other research areas, clear guidelines and principles (for example, sponsors should sign contracts that state that they will not be involved in the interpretation of results) need to be established to avoid dangerous conflicts of interest.

In other words, it would reduce bias if sponsored researchers were limited to collecting data without analyzing it. This is hardly a ringing endorsement of industry-funded research, but so be it.

So, I do not think all industry-funded research should be banned. Rather, I think we (as a society) need to ensure that we have ample researchers who are free of FCOIs. In other words, we need substantial funding for independent research centers where researchers can work for the advancement of knowledge without a constant concern for the production of profit. Forcing our public universities and research labs to turn to corporations for funding corrupts our pursuit of knowledge and the advancement of society. We must restore public funding to education and research.

For more on the possible risks of funded research, read about Dan Markingson here. Or read about Jesse Gelsinger here.

Sunshine disinfects nothing

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.

Tea Party Fights Corporate Abuse

The East India Company, chartered in 1600, was the first corporation in the modern sense. Members would invest capital, management would conduct the operations, and investors would receive repayment in proportion to their investments. For the first time, investors and mangers were separate persons. At this time, it was unclear who would be responsible for wrongs committed by the corporation.

As this and similar ventures developed, investors were increasingly separated from the actions of the corporations, and limited liability (investors could only lose the amount they invested in the corporation) became the norm by the end of the nineteenth century. This also made corporate immortality possible as corporations could outlive their owners.

The British East India Company (BEIC) rapidly gained economic power and exerted global influence. It formed the largest standing army in the world at the time, gained control of India and the surrounding islands, controlled the opium trade in China, and managed slave trading out of Madagascar. One-third of British parliament members held stock in BEIC, 10 percent of British tax revenues came from tax on BEIC tea, and the King depended on loans from the company. In exchange for these benefits to the British government, BEIC was granted many favors, including monopoly rights.

The company conscripted thousands of British for forced labor in Jamestown, a colony set up in America by BEIC. Eighty percent of these laborers died before completing their seven-year tenure. Because of its rapid expansion and competition from small colonial business, though, BEIC was almost bankrupt. It was able to overcome this setback with more favors from the British government, which expanded its monopoly and led to the 1773 Tea Act, lifting tariffs on tea and enabling BEIC to flood the market with cheap tea and destroy its competition.

This was the catalyst for the Boston Tea Party. During the Boston Tea Party, protestors dumped more than 90,000 pounds of tea into the harbor, which was then closed for more than a year and a half. This led to the battles of Lexington and Concord; as a result, America’s founders vowed to protect the United States from corporate power and corruption.

The Boston Tea Party is an enduring symbol of America’s popular resistance to the collusion of corporations and government against the interests of the people.

Information for this blog came from:

1. Christopher D. Stone, Where the Law Ends: The Social Control of Corporate Behavior (New York: Harper & Row, 1976).

2. Shelley K. White, “Corporations, Public Health, and the Historical Landscape that Defines Our Challenge,” in The Bottom Line or Public Health: Tactics Corporations Use to Influence Health and Health Policy, and What We Can Do to Counter Them, ed. William H. Wiist (New York, NY: Oxford University Press, 2010).

What can ethics courses achieve?

In a Houston Chronicle commentary titled “Where’s Right and Wrong in Ethics?,” Donald Bates explores why required university courses in ethics fail to produce ethical business practices. Bates lists many familiar examples of unethical behavior in public life (Enron and WorldCom, for examples) and blames them conveniently on the separation of church and state.

Bates claims that ethics is taught from a position of Utilitarianism (the greatest good for the greatest number), egoism (what most benefits the long-term interest of the individual), rights (deontological forms of duty to others or entitlements for oneself), or abstract principles of justice. This is his first mistake. University ethics courses teach the theories listed by Bates, although his list is far from exhaustive, but ethics instructors are not wont to teach “from a perspective.” To understand the study of ethics, students must be familiar with competing theories, but universities provide education, not indoctrination.

Bates goes on to say, “Trying to teach ethics without a religious underpinning means absolutes do not exist, everything is situational.” This is his second mistake. The fact that many competing ethical theories (and religions, for that matter) have emerged over the centuries is not evidence that absolutes do not exist. It is evidence only that absolutes are extremely difficult to discover and agree upon. Teaching ethics from the standpoint of a “religious underpinning” is to teach from a standpoint of absolute knowledge of right and wrong and good and bad, which would require professors to claim to know the mind of God, a claim that would be met with suspicion for good reason.

Expecting ethics courses to make the world more ethical is a little like expecting professional athletes and pop stars to be good role models. Ethical solutions and agreement are not easy to come by. Claiming that the state should enforce morality founded in religion begs the question of which religious perspective is correct and who will decide on the proper perspective. Rational people of good will disagree on ethical practices each day, and this is a good foundation of a pluralistic society.

If we are lucky, we might be able to teach a few students a little humility and respect for the efforts of others to discover right from wrong. Many students will claim that ethics is just a matter of common sense. Oddly enough, Bates seems to agree. In each case he presents, he believes there is a universally accepted opinion of what is right and wrong. If he is correct, students do not need to be taught what is right, they need to be prevented from being evil. It is unlikely that the leaders of Enron and WorldCom made a mistake in ethical thinking. More likely, they decided to do something that showed no concern for the harm it caused others.

An ethical society requires skeptical humility from its leaders and educators, recognition of the humanity of others, and a desire to limit harm to all. This lesson is not easily taught but it is easily shared by the way we live.