More Opaque than Transparent: Drug Industry Just Does Not Get It

Boston Globe lays into the pharmaceutical industry on its failure to deliver openness on data from its own clinical trials. -- Art Caplan

Perfect People: the Grudge Match

Perfect people: is it a good aim? Art Caplan and Carl Elliott debate in Public Library of Science. It is fun to read but the argument is pretty much what you expect. Caplan discharges the debate as somewhat silly:

Beating up on the pursuit of perfection is silly. As Salvadore Dali famously pointed out, “Have no fear of perfection—you'll never reach it.” Critics of those who allegedly seek to perfect human beings know this. While often couching their critiques in language that assails the pursuit of perfection, what they really are attacking is the far more oft-expressed—albeit far less lofty—desire to improve or enhance a particular behavior or trait by the application of emerging biomedical knowledge in genetics, neuroscience, pharmacology, and physiology.

And Elliott responds that it isn't a conservative defense of human nature that motivates him, rather he is concerned about misplaced energies devoted to enhancement instead of more important aims; in particular Elliott is as always primarily fighting against big pharma's promotion of enhancement:

Caplan does not defend medical enhancement so much as attack its critics. Or rather, he attacks a small group of conservative critics who want to preserve “human nature.” He dispatches those critics with admirable precision, but I am not sure why he believes that group of critics includes me. My worry about enhancement technologies has little to do with human nature. My worry is that we will ignore important human needs at the expense of frivolous human desires; that dominant social norms will crowd out those of the minority; that the self-improvement agenda will be set not by individuals, but by powerful corporate interests; and that in the pursuit of betterment, we will actually make ourselves worse off.

Still, it is a fun read. And maybe it will get a few more copies of Better than Well and The Perfect Baby into circulation. Come to think of it, maybe we could stage a series of these wrestling matches ... yeah ... that's the ticket ...

Reports of Bioethics' Demise Seem a Bit Premature

Writing in the November 13th issue of The Lancet (Vol. 364, no 9447, p.1749) Roger Cooter of the Wellcome Trust Centre for the History of Medicine at University College London offers an amazing assessment of the field of bioethics;

“Hardly wet behind the ears, bioethics seems destined for a short lifespan. Conspiring against it is exposure of the funding of some if its US centres by pharmaceutical companies; exclusion of alternative perspectives from the social sciences, retention of narrow analytical notions of ethics in the face of popular expression and academic respect for the place of emotions; divisions within the discipline (including one over its origins and meaning); and collusion with, and appropriation by, clinical medicine. To many its embrace of everything bearing on human life renders it, paradoxically, bankrupt."

I could go on (and he does a bit more) but you get the point. We are all familiar with the sad state of British University life as cut after cut decimates the ranks of the professoriate there but have things really degenerated to the point where a hack is offering this sort of loony assessment as serious analysis (and getting it published to boot)?

Every so often British physicians and university purists and their publications try to pronounce bioethics dead. This latest declaration seems to have been penned by someone who cannot, however, diagnose the difference between a field (not a discipline!) entering into middle age with all its attendant crises of self assessment and self-doubt and a field that has never been more firmly entrenched within colleges, medical schools and other institutions not only in North America but, if the numbers showing up for the International Association of Bioethics meeting in Australia are any indication, worldwide.

Just to put things right in case Professor Cooter is having a hard time seeing what is going on in the field by what must be a very dim light underwritten by the laundered drug money funding that provides his full career support;

there are no academic bioethics centers in the United States funded by pharmaceutical companies, the only centers/programs/persons funded by private sources involve right to life or political orientations inclining to the right;

it is fairly easy to find out which centers/programs, persons have accepted grants or contracts or gifts by asking them (no EXPOSURE –insert Cooter’s heavy breathing here—required),

no academic bioethics center or medical ethics program has received more than a tiny percentage of funding from drug companies (some think they ought to be providing more funding in the way of general, unrestricted gifts),

the social sciences are not excluded from bioethics and, in fact, there is some danger that empirical bioethics may come to dominate all other modes of inquiry although quantitative social science may lie outside Cooter’s ken,

there is no intolerance of the emotions on the part of bioethicists—there is however an intolerance of using emotional responses as a form of argument (what I many years ago dubbed the Yuk factor) as well there should be,

there are divisions within the field (again not discipline) as again well there should be—it is a sign of intellectual vitality perhaps not recognized among the few remaining British historians of medicine,nor is there collusion with academic medicine unless talking to one’s colleagues if one works in a medical school happens to constitute cooptation or collusion.

Cooter’s worry about bioethics' “embrace of everything bearing on human life” I leave to more level-headed students of the sexuality of intellectual life than myself.

Cooter’s bizarre screed follows hard on the heels of Carl Elliot’s discovery of a new form of argument in a just out piece in the Hastings Center Report—arguendo ad Pfizer. By intoning Pfizer repeatedly Professor Elliot seems to think he can confirm Professor Cooter’s contention that bioethics has sold itself out to Big Pharma.

Cooter, Elliot and others seem so irritated by bioethics or some bioethicists that they either have to pronounce the field finished or irrevocably tainted. My hunch is that this sort of nonsense is a sign that whatever else it is doing, bioethics is being appropriately irritating to pedants everywhere. - Art Caplan

Merck and Ethics

Raymond Gilmartin, CEO of Merck, spoke at Michigan. Gilmartin took the occasion to defend the timing of his company's decisions about Vioxx.

He said that although some Merck insiders urged him to inform the FDA of the findings and keep Vioxx on the market, he acted decisively, withdrawing the drug within a week.

The Merck CEO reserved his most enthusiastic comments for his corporate bioethics efforts:

After taking the reins in 1994, Gilmartin said within a year he had established the company’s first ethics office. He said Merck had established numerous ethics systems during his tenure — including a confidential phone number employees can call for advice concerning their ethical dilemmas.

Merck’s commitment to ethical behavior goes beyond complying with U.S. and international laws, he said. “As Plato put it, good people do not need laws to tell them how to behave responsibly; bad people always find a way around the laws.”

Gilmartin said Merck’s code of ethics is displayed in 25 different languages at company headquarters in Trenton, New Jersey. “Over time, ethical behavior turns into a competitive advantage,” he said.

Merck's CEO did well by Michigan business students: "The capacity audience, mostly Business School students, treated Gilmartin to a loud and spirited ovation after he concluded remarks."

Votes & Values (Multiple Sources)

Just about enough time has passed for the Monday morning quarterback essays to come out in earnest about the election. Equally notable are the essays proclaiming victory. One of my favorite essays is Jeff Weiss' in the Dallas Morning News which analyzes the rhetoric of values in the election. The most read blog on the Internet, Daily Kos, summarizes his take on the most prevalent theories as to what the election means, and the discussion includes almost 400 responses many of which are from health policy analysts. Also around the blogs, Matthew Holt of Health Care Blog opines on winners and losers. The quite conservative San Francisco Chronicle discusses the role of celebrity endorsements, which really have reached an unprecedented pitch in this round of elections. Christian Science Monitor discusses the demonization of big pharma, which is interesting since the discussion of drug companies does not seem to have played a significant role in the election.

w-2: Searching for Good News in a Bush Victory

It is difficult to overstate the damage that George Bush can do to the nation's health care and biomedical science in his second term. Long after the shock of a Bush victory - yes, he did win this time - has faded in the minds of Americans, the world will have to cope with this election. What are the implications for medicine and science? Hint: you won't like any of them ... this term, Bush is empowered, under pressure from conservative protestants, and a lame duck to boot.

Kiss pharmaceutical reform goodbye. There is no way George Bush will do any less for pharmaceutical companies than he has done for oil companies. In fact, if anything, the election will draw a more direct analogy between oil and drugs: Bush now has no reason to fear reprisals from those who oppose the drug industry's extraordinary pricing structure in the United States. Bush's cronies may not yet directly profit from the drug industry in the way that they do from Haliburton, but you can bet plenty of Bush appointees are thinking seriously about their future in biomedical lobbying. Pharma will need the President as its collusion with FDA officians and others comes to the fore. Pharma knew what it was buying with Bush, "make no mistake." Any reform effort that included drugs from Canada, including the one Bush said he was "looking at," and any effort to seriously curtail the price of drugs for seniors, will fall prey to the three million vote margin of victory. Drugs will cost more and fewer people will be able to afford them.

International efforts to, well, do anything that Bush opposes are in real trouble. Unfettered international drug research is part of the bargain. Advocates for research subjects have lobbied the WHO and the UN - and those organizations have lobbied the US - to stop the most lopsided and colonialist drug industry research efforts in developing nations. How many research programs in Africa have really rewarded research subjects with any kind of improvement in healthcare quality, even for the disease being researched? Not many.

Healthcare access and insurance reform? Look, no one wants to be pessimistic. Health insurance reform is long-overdue and we in the U.S. have to find a way to provide affordable healthcare to tens of millions of U.S. uninsured. Here's a great Bush solution that lots of Americans seem to support: tort reform! All we have to do is stop those big lawsuits against physicians, and we can save a whole lot of ... wait ... what? Only 3% of the cost of healthcare is in any way related to lawsuits? Ok, wait, so maybe stopping patients from recovering the damages juries want to award them in cases of malpractice won't have much financial effect ... except on physician and lawyer salaries. But Republican voters aren't weeping about that. What they will cry about is the bills that they, and all of us, will have to pay as we watch emergency rooms continue to be the provider of healthcare for the poor, the sick and the legions of uninsured - hundreds of millions of dollars in unnecessary treatment. Those costs have to come out of somewhere. Just watch your premiums skyrocket, guys. Red states will also bleed red ... ink. Maybe there will be a direct correlation between insurance increases and prices at the gas pump! Who knew anything but college tuition could go up so fast?<[> Enough has been written about Bush's war on science to establish beyond question in the mind of anyone in a blue state that Bush, as a final-term president with uniform control of the U.S. government, will be able to quietly support all sorts of insidious efforts around the nation. Just as gay marriage is quietly being outlawed around the nation, look for Bush to lend support of several kinds to state efforts to roll back protection of women's reproductive healthcare. Bush could care less about evolution, but the "intelligent design" movement can rest easy that Oklahoma's new senator and many other new elected officials around the nation are supporters of creationism in the classroom.

There is still one winable battle, although I fear it is not in Ohio or Iowa. The battle is to reform or reject the President's Council on Bioethics. Leon Kass is no doubt gearing up to lead all the President's ethicists for another term of 'moral seriousness'. He must be put on notice that bioethics cannot afford four more years of feckless, xenophobic neocon posturing, even if it is delivered with austerity. Kass should have apologized to the nation for selling the proceedings of his Council through a for-profit, conservative commercial press. He should not have abused the reputation of one of the world's most prestigious biomedical scientists, Elizabeth Blackburn, named by Bush to the PCB and then shown the door under the pretense that she did not attend enough meetings. Blackburn was by all accounts one of the most active participants in the dialog about stem cell research, emailing Kass and others constantly. Kass could not find another way to defend the PCB against the charge that it sat idly by while the Bush administration (or he) fired one of two moderate scholars, and "retired" the other one, replacing both with ultraconservatives. So Kass resorted to distortion and blame in broad public view. To this day he has neither apologized nor attempted any kind of rapprochement with Blackburn or for that matter with anyone more moderate than William Kristol.

The new generation of conservative bioethicists seems dedicated to the proposition that debate is the enemy, or more accurately that opponents are best left ignored. The PCB virtually ignores the bioethics literature in its writing and anthologies. There are passing references to those who agree with them on matters at hand, most noticeably Carl Elliott, but it has become a hallmark of Bush Bioethics that no position is argued by the PCB while there are people 'in the room' with whom one must argue, unless absolutely necessary. This Council must go, or at least be made to play a peripheral role in the bioethics scene, unless it is radically remade with voices from both sides of the aisle. Supposedly even Wesley Smith agrees that there should be such voices. Now it is time for the American Enterprise Institute's Hertog Fellow Leon Kass to act with courage so that we really can have a "richer" bioethics.

It is a pretty terrible day for those of us in bioethics who supported the right to choose, hES research, and dozens of other areas I have not taken the space to discuss. But the real tragedy would be if bioethics did not take from this mess the lesson that not all battles must be fought nationally. State-by-state we will see the new changes made in bioethics-relevant law. California's Proposition 71 is just the beginning of some very important new shifts that deserve some real pragmatic consideration. Bioethics may not be as prestigious when it is fought out in the states, but that is where the battles now lie, at least for four more years. - Glenn McGee (UPDATED 11/3;11/20 )

Failing to Reveal Conflicts of Interest

A Sunday story that wasn't picked up very much by Marilynn Marchione does a great job of ransacking the current wave of denials concerning how conflict of interest affects physicians engaged in drug consultation and in other ways affiliated with drug companies.

Drug Industry Ghostwriters

The Health Care Blog noted some new analysis and numbers about drug firms writing major articles on behalf of clinicians - articles that continue to make their way into major peer reviewed journals. David Healy is quoted. Industry Veteran fumes about THCB's seeming moderation on the issue.