Sunday, September 30, 2018

Blasey Ford, Kavanaugh, bias and arrogance: present in medicine, not just politics

Mostly it is pretty easy for me to think of things I want to write about in the area of medicine and social justice; there is so much awful stuff going on there. But today it was harder; I want to write about the bravery of Christine Blasey Ford, and how powerful the calm, collected testimony that she gave was, especially given the fact that she had nothing to gain except harassment for herself and her family, and even death threats that required her to go into hiding.

I want to write about the atrocious behavior of Brett Kavanaugh, who has a lot to gain -- a lifetime appointment to the Supreme Court of the United States – but chose to take the low road, not just denying the charges but displaying aggrieved entitlement, snarling and attacking and refusing to give straight answers to straight questions. Right out of the Donald Trump playbook. And absolutely not the behavior we want on the Supreme Court, or even that we heard about his control in his current Appeals Court job. Much more, in fact, like the 17-year old Kavanaugh that Dr. Blasey Ford described.

I want to write about the tone-deaf but mission-focused hubris of the 11 white men who formed the majority on the Judiciary Committee. Ten of them having made up their minds in advance, they were not going to be derailed by anything, certainly not the testimony of the witnesses. Led by their chair, Sen. Grassley, who never made eye contact with Dr. Blasey Ford but kept his eyes on the paper he was reading from, and their attack dogs (Lindsey Graham, harsh, and John Cornyn, snide) they had a woman prosecutor question the female witness so as not to look like they were who, in fact, they were. That the format never allowed Rachel Mitchell to pursue a line of questioning was irrelevant, since it was all a charade for them. It is a shame that they made old men look so dumb and evil; remember that Grassley (85) and Hatch (84) were arrogant misogynists when they were younger, and that those (like Crapo and Cruz and Sasse) still in the 40s already are the same.

But this is a blog about medicine and social justice, and while there are certainly social justice lessons to be learned (in the negative) from the disingenuous cavorting of racist, sexist, we’ll-do-this-because-we-can behavior of white men in the hearing room, it has little to do with medicine or public health. Except, of course, to the extent that this entitled behavior is so frequently seen in those fields.

I recently wrote about an example of entitled corruption in José Balsega, the former Chief Medical Officer of Memorial Sloan-Kettering Medical Center (“Baselga, graft and corruption in medical research: why should we tolerate it?”, September 16, 2018), and we just learned that their vice president in charge of corporate relations has been required to pay them back the $1.4M he made from, essentially, insider trading.

I have also written about other corrupt executives, mainly in the pharmaceutical industry (e.g., “Epi-Pen® and Predatory Pricing: You thought our health system was designed for people’s health?”, September 3, 2016). These “Masters of the Universe” (h/t Tom Robbins) think they deserve everything they can get, and the rest of us be damned. Thanks to women like Heather Bresch of Mylan (Epi-Pen®) and criminal mastermind Elizabeth Holmes of Theranos, they are not all men. But mostly they are, and even these women had the protection of old men; Bresch’s father is Sen. Joe Manchin (D-WV) and Holmes attracted rich old white guys like Riley Bechtel of Bechtel, George Schultz, former Secretary of State and Bechtel CEO, and William Foege, former head of the CDC and hero of the anti-smallpox crusade, in a real-life parody of a bad thriller femme fatale.

Bad behavior is rife in the medical and public health communities, motivated, like that in the pharmaceutical sector and politics, by self-interest, a desire for money and power. Aaron Carroll, in “The Upshot” in the New York Times on September 24, 2018, writes about the many forms of bias in scientific and medical publication. He takes off from an article in Psychological Medicine, The cumulative effect of reporting and citation biases on the apparent efficacy of treatments: the case of depression”, but he points out the many forms of bias affect research and research papers in general. These include publication bias, which means journals are more likely to publish papers with positive results (our study showed this new treatment worked!) rather than negative (well, we thought this would work but it didn’t, 😞); outcome reporting bias where only the positive outcomes are published and the negatives are left out; spin where, when unable to avoid reporting results that are negative, you use language to make them seem more positive; and citation bias, whereby other authors are much more like to refer to (“cite”) papers with positive results than those with negative, thus increasing their visibility. He does not specifically discuss confirmation bias, in which researchers are much more likely to notice and report on findings that confirm their prior ideas and dismiss those that contradict them, but this is also very insidious.

Sometimes the stakes, seen by the really rich and powerful, are minor – status and reputation in the academic scientific community (recalling the old adage “competition in academics is so vicious because the stakes are so low”). However, it is not just the researchers who are at fault. Journal editors and publishers are motivated by their own metrics of success, such as the “impact factor” based upon how often articles in their journals are cited by others. And, of course, our old “friends”, the pharmaceutical companies, are behind much of this bias, suppressing negative results for the drugs they make and emphasizing secondary outcomes (unethical!). For them, the stakes are financial and very high.

Carroll does a masterful job, supported by research published in a number of journals. He ends by discussing the ways in which these practices hurt we, the people, by getting false or misleading information out to other physicians and scientists. This can lead to us receiving treatments that don’t actually work, or work as well as they are portrayed as doing, or may even be more likely to harm us than help us. He emphasizes the important fact that not all, or even most, published scientific research is not to be trusted, but that these scurrilous articles are out there, and depend upon not only reporters and the public, but doctors not reading them carefully. Sadly, many medical (and other) professionals often hear only the reports of research in the popular press or, if they read the study, read only the Summary, or the Discussion section (most easy to “spin”) instead of carefully looking at the reported Methods and Results and drawing their own conclusions. Carroll makes a series of suggestions as to how the discipline might change this culture of bias; they are good and should be pursued.

I am not sure where the blame originates, whether from our leaders like our politicians and businessmen who see truth as an option which can be disregarded in the pursuit of money and power, or our scientists who take these illegitimate roads to further their own careers, or the public which has become agnostic about truth and searches only for confirmation of their own preconceived notions (or biases). But I am sure that, at all these levels, it is a bad thing and corrosive of the progress that should come from new knowledge.

Most of us will never get the chance to publicly put ourselves out there on the line like Dr. Blasey Ford, and very likely wouldn’t if we could. We can, however, stand for the idea that truth is not “revealed” but emerges from continuing work, from confirmation by replication of studies, from more work that further elucidates the truth. And that the enemy of truth is the kinds of biases that Dr. Carroll discusses.

In talking about his suggestions for correcting them, Carroll writes “These actions might make for more boring news and more tempered enthusiasm. But they might also lead to more accurate science.” And that would be good for us all.

Sunday, September 16, 2018

Baselga, graft and corruption in medical research: why should we tolerate it?

On September 8, 2018, the NY Times reported that José Baselga, MD, Chief Medical Officer at the prestigious Memorial Sloan-Kettering Cancer Center in New York, and a world-renowned cancer researcher, had received at least hundreds of thousands of dollars in payments from drug companies and manufacturers of radiation equipment bought by his hospital. The number of companies from which Dr. Baselga was receiving payments turned out to be in the dozens. The emphasis in this article was not so much that he had received the money, for him personally, but that he had not reported this conflict of interest (COI) to the many journals that had published articles he had written. These articles were often studies of drugs produced by the companies that had paid him money.
 ‘Dr. Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional. He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech startups. “I acknowledge that there have been inconsistencies, but that’s what it is,” he said. “It’s not that I do not appreciate the importance.”’
He in fact DID let it affect his science, as the article reports:
‘At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.’

This is important stuff. He took bribes from drug companies and spun the data to make their drugs look good. This is corruption. It is important to separate this from conflict of interest. COI, as I discussed on August 20, 2010 (“The AAFP, Coca Cola, and Ethics: Serving the public interest?”), exists when you have – surprise – conflicting interests! As when you receive money from your employer, and also money from some other company, thus creating a conflict. As medical ethicist Howard Brody, MD, pointed out in his article on the AAFP:
imagine that a judge who is sitting on a case involving a contract dispute between two companies is discovered to own $100,000 worth of stock in one of the companies. The judge cannot divert criticism of this conflict of interest by saying, ‘But you haven’t waited until I delivered my verdict—how do you know that I won’t rule against the company in which I own stock?
He has a conflict of interest. You don’t have to actually do anything to the detriment of one of your funders to be in COI; most journal policies require reporting it so that readers can be aware of the COI, but it does not necessarily mean that if impacts your work. In Baselga’s case, however, it obviously did.

I guess he realized it. On September 13, 2018, the Times reported Baselga’s resignation from Memorial Sloan-Kettering. You can just imagine the Sloan-Kettering board of directors holding their breath to see if this would just blow over, and I am sure mostly that it would not affect donations from rich people. On that same day, the Times also published several letters from readers about the topic, all of them critical of Baselga, but emphasizing different issues. Charles Fried, a law professor from Harvard, notes that Baselga received $1.5 million in income from his employer, Sloan-Kettering, and wondered “Why isn’t $1.5 million enough?” Of course, for some people, nothing is ever enough. But the important point here is that Baselga was scarcely a penniless medical researcher barely scraping by and thus in need of this graft to pay a mortgage on a modest home, or buy a second bass boat. He was just really greedy.

Other letters emphasize other aspects of this practice, noting that Baselga may be a famous and particularly corrupt example, but that he is far from the only one receiving payoffs. Daniel J. Brauner, MD, a geriatrician and ethicist from the University of Chicago, notes that revealing COI is insufficient, observing that ‘The sad fact is that the current system of medical research and care conducted by physician-scientists like Dr. Baselga is fundamentally flawed and does an extreme disservice to patients, who deserve an unbiased accounting about the true worth of potential treatments.’  Frances M. Visco, president of the National Breast Cancer Coalition, bemoans the fact that ‘Breast cancer patients are tired of “breakthrough” therapies that do not extend life for even a day but do bring millions of dollars to industry, medical institutions and the doctors who care for us,’ and demands that researchers and journals ‘Just stop circling the wagons, focusing on financial gain and fame.’

On September 16, 2018, the Times published a full-column editorial on the issue in its widely-read Sunday Review. It notes how common the practice of paying corporate money to doctors and researchers is, observing that ‘A 2015 study in The BMJ found that a “substantial number” of academic leaders hold directorships that pay as much as or more than their clinical salaries.’ In addition, it report that ‘nearly 70 percent of oncologists who speak at national meetings, nearly 70 percent of psychiatrists on the task force that ultimately decides what treatments should be recommended for what mental illnesses, and a significant number of doctors on Food and Drug Administration advisory committees have financial ties to the drug and medical device industries.’ In its analysis of the problem, the editorial leaves out one major issue: much, or most, of the basic research that is done and leads to the production of these hugely-profitable drugs is funded by the federal government through the National Institutes of Health (NIH); that is to say, you and me. The drug companies pick up the work later when they think that the drug may represent a big financial boon for them.

The Times calls for greater safeguards to protect the public, with several suggestions including: 1. Ban paid appointments to outside boards, 2. Create uniform reporting standards, 3. Establish real consequences for violations, and 4. Build a culture of transparency. These are good suggestions, and should be implemented, although how one does #4 is not entirely clear, and the likelihood of #1 happening is low. But the real issue is the degree to which we, the American people, are willing to tolerate graft and corruption. We may – or may not -- dislike it when it occurs in the private sector (certainly President Trump was a major practitioner in his pre-Presidential years). We condemn it when it involves politicians, though it is rampant in federal, state, and local government (although what is illegal graft for state legislators is legal, if sometimes embarrassing, for Congressmen), but we expect it when it comes in the form of “campaign contributions”. And we should not be surprised when it infects medical researchers and physicians, who we hope have our health interests, not their own financial interests, at heart in what they do.

Corruption and graft is corruption and graft. It happens, and shouldn’t, and won’t stop until we demand it. And it won’t stop in health care until we get the profit incentive out of it.

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