Bill Gleason

Bill Gleason is an Associate Professor at the University of Minnesota in the Department of Laboratory Medicine and Pathology. He's also a fellow at the U's Supercomputer Institute. Read more about Gleason.

Do People Have a Moral Obligation to Be Research Subjects?

Posted by: Bill Gleason under Society, Education and literacy, Continuing education, Government Updated: October 22, 2011 - 4:35 PM

 

Figure used with permission of the University of Minnesota Bioethics Center.

 

I didn’t want to attend this conference because I knew that it would be difficult and painful. Like having your wisdom teeth pulled without anesthesia.

As my colleague, bioethicist Carl Elliot, put it: “Only 16 percent of academic health centers in this country will pay the medical bills for research subjects who are injured in clinical trials.  None will pay for lost wages and suffering.  And an ethicist is arguing that we all have a duty to sign up for these trials?  Give me a break.”

But Carl was not able to attend this conference and I knew that Mary Weiss, the mother of Dan Markingson, would be there. Her son died in connection with a clinical trial at the University of Minnesota that has become notorious. I wanted to offer moral support. I met her – for the first time – before the start of the conference. She seemed in control, and we had a pleasant conversation, but I was concerned.  After the first talk, on the pro side, she had to leave.  I could understand why.

My original intention was to try to present a dispassionate description here of the pros/cons of the question outlining the case made by each side. But I can’t.  At first I was offended that my university would put on such a conference given our terrible record with clinical trials in the past.  It seemed hypocritical. But in retrospect, I thank the Center for Bioethics for broaching the subject. During the conference most of the points that needed to be made came out. Professor Joan Liashenko did the heavy lifting of organizing and running the conference.

I was particularly impressed by two African-American women who persistently questioned the claim that treating research participation as a moral obligation would actually help the minority community. Henrietta Lacks came up during the discussion.  I later learned that one of these women is a bioethicist and the other the president of the Minnesota Black Nurse’s Association.

Which brings me to the first problem I have with the title proposition.  Cui bono?  And I maintain that the answer is overwhelmingly the pharmaceutical industry. This proposition finds support in the Lysaught presentation cited below.

But what really frosted me was the “moral obligation” business. Thou shalt not steal, thou shalt not kill, thou shalt not covet thy neighbor’s wife, thou shalt participate in clinical research?

The argument that it’s just like paying taxes or giving to charity seems absurd to me. As one of the participants put it, the consequences of paying taxes are not nearly as great as losing one’s life, or being blinded.  And for what?  Mostly to justify supposedly new clinical therapies for pharma?

And as for charity… Most of us believe, even if we don’t believe in a God, that we are our brother’s and sister’s keepers. When we give to charity, if we are so inclined, we can do a little investigation.  We can find, if we wish, something about the percent of money that actually goes to use in a charity and how much goes to administration.

Most patients are not capable of making scientific judgments about whether a clinical trial is worthwhile. Many doctors and people who sit on institutional review boards are not. To claim that people should risk themselves, out of beneficence, to participate in a clinical trial is unreasonable. Certainly to declare it to be a moral obligation is wrong.

I was upset by the use of the term “moral obligation” because I think this means something far beyond “this would be a good idea.” I don’t think there is support for the proposition in the works of, for example, Kant or John Stuart Mill. But these arguments are dense and not easily capsulized for this forum.

I did find a wonderful talk by Professor Susan Wolf of the University of North Carolina, who gave the Frumke lecture at NYU entitled: “Moral Obligations and Social Commands.” This talk examines the concept of what a moral obligation is and gives examples. To claim that participation in research is a moral obligation does not seem to pass the Wolf Test.  This outstanding lecture is available in hard copy here and even, mirabile dictu, on YouTube.

It was an exhausting day.  Certainly caused a Brainstorm. I drove one of the speakers to the airport and came home. Took three beers to return to earth.

This piece originally appeared in the Chronicle of Higher Education.   For those interested in more details, that version includes some references and links to the slides used by the conference speakers.

HPV Vaccination: More to It Than Soundbites

Posted by: Bill Gleason under Society, Education and literacy, Government, Politics Updated: October 17, 2011 - 6:48 PM

 

Capsid Protein L1 of Human Papilloma Virus type 16 - using UCSF Chimera

What Have We Learned From Bachmann’s Recent  Gardasil/HPV Eruption?

Being a scientist makes spontaneous blogging on some topics problematic. A couple of weeks ago, Michele Bachmann made the unsupported claim that HPV vaccination led to “mental retardation.”

At the time two bioethicists— professors Steve Miles at the University of Minnesota and Art Caplan at the University of Pennsylvania—called out Bachmann and challenged her to provide evidence in support of her claim. Miles was first and offered to contribute $1,000 to a charity of her choice. Caplan upped the ante by $10,000. The offer expired with no response from Bachmann. Some right-wing luminaries, including Rush Limbaugh and Ed Morrissey, also came down hard on Bachmann for this claim.

Lesson 1

1. Bachmann is not fit to be president.

Since I am interested in biological structure, I wanted to look a little more into the science of the HPV vaccines. Fascinating. Proteins from a  variety of human papilloma viruses are produced by genetic engineering. The menu includes viruses that lead to cervical cancer as well as genital warts and other baddies. Such vaccines are a scientific tour de force. I also learned that the adjuvant used to make the vaccine contains aluminum. An adjuvant makes a vaccine more effective for reasons that are not crystal clear. It is possible that this adjuvant is responsible for the pain of injection experienced by those vaccinated.

Lesson 2

2.  A lot of good and nontrivial science has gone into this vaccine. Producing it is expensive.

Which leads into the final lesson.  Or at least into a discussion of what makes the HPV/Gardasil controversy not simply a soundbite matter.

I need to give all credit to Alison Bass for calling this fact to my attention in her excellent essay “Coverage of Rick Perry’s vaccine misadventure misses the point.”

The problem is that the public health benefits of providing HPV vaccines to relatively affluent children may not make a lot of financial sense. Merrill Goozner has explored this idea in his post: “The Gardasil Hustle.”

To put things in perspective, the mortality for cervical cancer is approximately 4,000, for breast cancer 40,000, and for cigarette smoking 500,000.

As Bass points out: “Merck itself estimated it would cost $1.4- to $1.6-billion to immunize young girls from the disease, which can be picked up fairly easily (and much more cheaply) with regular pap smears.”

The distribution of cervical cancer is loaded heavily against the poor. The highest incidences may be found in African-American women and in white women living in Appalachia (see Cancer Health Disparities).

The poor are either uninsured or cannot afford Pap smears.

Lesson 3

It may make more sense to use the money spent on HPV vaccinations for Pap smears for poor women who cannot afford them.

There is a lot of money on the table here. The Web is a nightmare for a truth seeker. You can find people claiming that HPV is more cancer causing than cigarettes or that the HPV vaccine is contaminated with HPV DNA. And it is sometimes difficult to know what to make of some of these Web sites. They look plausible. Some are even written by medical doctors, and some doctors put links to them in their tweets. What is the average parent in search of information to do? I’ll post some thoughts on this in the future.

Endnote: Thanks to Alison Bass for her always thought-provoking work.

 

This piece was first published on the Chronicle of Higher Education Brainstorm blog.

 

 

News From Lake Wobegon's Birchwood Cafe: Iowa Straw Poll Breaks Pawlenty’s Back

Posted by: Bill Gleason under Society, Government, Politics Updated: August 21, 2011 - 1:41 PM

 

 

 Picture Credit: Tracy Singleton

 

(This post originally appeared in the Chronicle of Higher Education on  the day after the Ames straw poll.)

Dombey and Son
“As the last straw breaks the laden camel’s back”

Mr. Keillor frequents the Side Track Tap, but there is another place in town, the Birchwood Cafe.  It is inhabited by a bunch of lefties, elderly hippies like me, vegans, people with nose-rings and purple hair.  You know, that type.  They buy food locally and hate Monsanto.

So this morning there was much discussion at the ‘Birch over Mrs. Bachmann’s disembowelment of Mr. Pawlenty, our beloved former governor.  Some even felt sorry for TeaPaw but there was a great deal of Schadenfreude. It was the coffee special of the morning.

Yuh see, TeaPaw was the victim of really bad timing.  He had cultivated his garden in Iowa for the last two years much to the annoyance of people who wanted him to show some leadership in fixing our budgetary problems in Minnesota.  He left us about six billion dollars in the hole.  Mrs. Bachmann pointed out some of his other shortcomings in the swordfight, er debate, prior to the so-called straw poll.

Another mistake that Pawlenty made – hindsight being 20/20 – was making such a fuss about Iowa. The Ames straw poll is basically a farce.  It costs thirty bucks to vote.  Talk about a poll tax.  The Ron Paul web site generously offered a free ride from anywhere in Iowa as well as a free ticket.  Of course someone had to pay for the ticket, didn’t they?

Intelligent folks—like Romney—didn’t participate.  Except Romney was smart enough to show up for the debate and the nation-wide publicity. He didn’t do very well in the straw poll, but no one is asking him to step aside. And of course Rick Perry waited for the day of the straw poll to toss in his Stetson.

The timing thing with Bachmann was remarkable. Pawlenty and Bachmann have never been friends.  She did a quick conversion to Iowaism.  Everything I need to know I learned in Iowa. Probably kindergarten. That sort of stuff. Pawlenty was also in a bad spot because of his previous encounter with Romney where he wussed out. So when Bachmann put the pin in his balloon, he unwisely struck back. Bachmann is absolutely a master at making critics look bad.

So we’ve basically been spared of both Pawlenty and Bachmann in Minnesota politics for the foreseeable future.  Wow, does that feel good.

So now it is on to Perry vs. Romney.  Can’t wait.  The ‘Birchers think that  Perry will do to Bachmann what she did to Pawlenty.  Wouldn’t doubt it.

Could I have another cuppa that Schadenfreude, please? (The ‘Birch has wifi.)

PS: I see that Paul Krugman is unhappy that he is losing his whipping boy. He had previously described our beloved governor as an “embarrassing ignoramus.”  Krugman had this to say earlier today: “What made Pawlenty fun was that he was supposed to be the smart, capable candidate, someone who actually knew stuff; and yet every time he opened his mouth on policy issues, he revealed that he didn’t know a blessed thing.”

Adam and Eve Help Out At The University of Minnesota

Posted by: Bill Gleason under Society, Education and literacy, Continuing education, Government, Politics Updated: August 4, 2011 - 6:58 AM

Wikimedia: Adam and Eve
Lucas Cranach The Elder (1528)

 

(Originally posted on Brainstorm at The Chronicle of Higher Education.)

 

Those ethically challenged folks at the University of Minnesota are at it again… A couple of years ago we had a dean who served on the Pepsi board even though it seemed a little incongruous for a med school dean to be involved with a company that made products that rotted children’s teeth.  But of course we were assured by the Vice President of the Academic Health Center that this conflict had been declared manageable.  Then we had the spectacle of a different dean pointing out that after all what was happening with respect to conflict of interest policies was not illegal: “We’re not violating a legal statute.”

And then there have been a number of bimbo eruptions at the Carlson school.  An older one involved a faculty member who said of a potential speaker “It’s one thing if you’re bringing in a criminal to speak. But if someone’s under investigation, that’s fair game.” To what should be no one’s surprise given such an environment a student group has recently demonstrated what seems to be, at least, unethical behavior. A Missouri start-up is accusing students in a University of Minnesota class of copying its idea for a business.

So now what?  The University of Minnesota has just announced a sizable donation from an outfit called Adam and Eve, purveyors of among other things, porn and hard-core DVDs.  The press release announcing this happy marriage contains a link to the Adam and Eve site where wares may be inspected (probably NSFW and must be 18 to log on).

When asked about hardcore porn – something that’s believed to distort a person’s view of sexuality, Eli Coleman, director of the university program on human sexuality replied:

“If this was a company that was into child pornography or something like that, that was illegal, I don’t think we could morally accept something from people who are involved in illegal activities. But this is a company that’s responsible and is law-abiding…”

It is a sad day at a university when the ethical standard is: “If it is not illegal, we can do it.”

A Journal Shows Its Spine Against Industry - Medtronic - Sponsored Research

Posted by: Bill Gleason under Society, Education and literacy, Government, Politics Updated: July 10, 2011 - 1:16 PM

 

Image Credit: Wikimedia Commons

Choirboy Defense: Could these lads do anything wrong?

 I realize that many Medtronics employees are heart sick over this situation. I extend my sympathies to them. I once had the honor of visiting with Earl Bakken in my lab  on a snowy morning when we were the only ones who made it into work. I took the bus, and he crossed the street from the Radisson.   Medtronic is a wonderful company and this situation is disgraceful. My bet is that the people responsible for this will soon be gone. Live long and prosper, Medtronic. Our state depends on innovative companies like yours.

Earlier published in the Chonicle of HIgher Education. and used with permission.

Something remarkable has happened. A whole issue—June—of a prominent journal, The Spine Journal, is devoted to destroying industry-funded research supporting the use of a bio-therapeutic agent for spinal fusion, so-called  recombinant human bone morphogenetic protein form 2 (rhBMP-2) in the Medtronic product, Infuse.

This remarkable issue features an editorial that is available for download as a pdf: “A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors.”  It initially cites seven research publications for scrutiny. Altogether these studies report zero, nada, side effects in 780 protocol patients. The authors dryly add another citation (from Hemingway’s The Sun Also Rises)  to the list: “Yes, isn’t it pretty to think so.”

Since then the side-effects of rhBMP-2 have become widely known. These include conditions related to unregulated bone growth as well as other disorders including sterility in males and cancer.

And what did these criticized studies have in common: Megabucks for the investigators from, primarily, Medtronic. Some of the authors of these studies have financial involvements with Medtronic that run in the tens of millions of dollars.

Sadly, this story is nothing really new to those who have been following the medical-industrial complex for years.  At our own place one of the docs got in trouble for testifying in favor of Infuse® research before Congress without letting his audience know that he was a consultant for Medtronic. Senator Grassley was annoyed.  I’d also point out that Dr. Carl Elliott (against type if one of my Brainstorm colleagues is correct in her aspersions against the cowardly tenured) has been valiantly crusading against using clinical trials for marketing exercises and other unethical practices in clinical trials.  Various administrative attempts to discredit him have been unsuccessful,  but he is being criticized even to this day by a flack for the Academic Health Center at the University of Minnesota.

The writers of this piece were really on their game. They point out that one of the openings often used by these shills is the choirboy defense: “We are an honest profession; our integrity is unimpeachable; our ethical standards are not in doubt; potential conflicts of interest are only ‘potential’…”  I’ve heard these same arguments used by three medical-school deans so far.

The editorial ends with the primum non nocere statement of the Hippocratic Oath. First do no harm.  It admits that harm has been done.  At first I was a little disappointed in this argument, but on reflection it really is that simple.  I’ve heard a medical school dean justify behavior based on the fact that something was not illegal.

Is ethical behavior too much to ask of the medical profession?

ps. Since the first draft, the matter has gone viral. Paul Thacker—who until recently rode shotgun for Grassley—writes “War Breaks Out Over Medtronic’s Infuse®” and The New York Times chips in with: “Spine Experts Repudiate Medtronic Studies.” The Chronicle now has: “Researchers Paid by Medical Company Missed Flaws in Its Spinal Implant, Study Finds.”

 

Minnesota and Gay Marriage

Posted by: Bill Gleason under Government, Politics Updated: July 4, 2011 - 2:38 PM

 

 

Image credit: Wkimedia Commons

Originally published  (June 26, 2011) in the Chronicle of Higher Education on the Brainstorm Blog upon New York state's passage of the bill making gay marriage legal.

 

Meanwhile, back in flyover land…

Our state legislature has been taken over by the crazies.  Most of the damage has been averted by an adult governor, but nevertheless they have managed to come up with ways to get around his good sense and veto.  Putting a constitutional amendment on the ballot only takes a simple majority, which they have. They do not, thank God, have enough votes to override the governor’s veto. However, the constitutional amendment route can still be used to damaging effect. Case in point, they have passed a bill to put what is effectively an anti-gay marriage constitutional amendment on the ballot for 2012.

Their bet is that homophobia will overcome good sense in Minnesota. Events in New York make me hopeful that they will lose this bet. Minnesotans seem to be finally realizing that gay marriage is not a threat and is essentially a matter of human rights. Even the younger Republicans…

Thank you, New York.

 

So there is no doubt: My personal opinion.  I do not speak for University of Minnesota

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