The very nature of antiquated government kluge organizations guarantees this level of (service). It's the core nature of far left politically correct dehumanizing dystopian organizations, such as the U of M. It's what they are. It's what they do..
Being on the Univ of Minnesota faculty, I've read this Op-Ed piece and reader comments with much interest. It seems to me that, sometimes, to correct problems forthrightly it may be wise to invite outside oversight into an
institution -- at least temporarily -- in a spirit of "trust but verify". Our university president has used these very words (along with 'transparency')
in connection with the grand 'fix it all' plan to be announced in about two weeks.
Perhaps with the help of the State Legislature or Governor, the words "trust but verify" may come to a prudent fruition. It seems to me that it would be a win-win.
institution -- at least temporarily -- in a spirit of "trust but verify". Our university president has used these very words (along with 'transparency')
in connection with the grand 'fix it all' plan to be announced in about two weeks.
Perhaps with the help of the State Legislature or Governor, the words "trust but verify" may come to a prudent fruition. It seems to me that it would be a win-win.
5
this is precisely the type of behavior that should result in penalties and fines, much like the NCAA (inconsistent and hypocritical) occasionally deprives schools of scholarships, post-season appearances, and extremely rarely, the death penalty. and I'm guessing this is linked to the medical school, rather than the vague behemoth of the university (one of the largest in the country).
analogies to the NCAA's punishment options? first, suspend all research in the department for a period of years. second, the head of the department, and perhaps the dean of the medical school should be fired with cause, along with any underlings directly involved. third, fine the university a substantial amount for every research subject harmed or misled, with monies going directly to the victims. fourth, let the university and medical school know that if similar abuses occur going forward after appropriate checks and balances have been installed, the medical school will lose accreditation and the attached teaching hospital all federal dollars that pay for residency training programs.
AOA graduate, SUNY-Brooklyn medical school, class of 1995.
analogies to the NCAA's punishment options? first, suspend all research in the department for a period of years. second, the head of the department, and perhaps the dean of the medical school should be fired with cause, along with any underlings directly involved. third, fine the university a substantial amount for every research subject harmed or misled, with monies going directly to the victims. fourth, let the university and medical school know that if similar abuses occur going forward after appropriate checks and balances have been installed, the medical school will lose accreditation and the attached teaching hospital all federal dollars that pay for residency training programs.
AOA graduate, SUNY-Brooklyn medical school, class of 1995.
2
Follow the money and you'll follow the breakdown in ethics. It works in all fields, politics, corporations and yes, schools. Good for exposing the vested interests that distort and corrupt a valid need for medical studies.
10
One of the many problems with fraudulent research is the lack of any kind of serious consequences for it. When this sort of thing happens, the worst that can be expected is that the researcher will see his name in the weekly NIH bulletin ("Findings of Research Misconduct"), along with a note saying that he won't be applying for federal research funding for three years.
This leaves zero incentive for the university administrators to police the problem and minimal incentive acting on ethically challenged researchers.
I'd like to see a policy requiring that grant money, plus interest (including those golden indirect costs) be returned to the NIH or NSF in cases of fraud. If enough malfeasance occurs (seems to be the case here), the entire department should be banned from getting federal funding, and for a lot longer than 3 years. Getting fired (administrators too, where appropriate) would be another good idea.
And maybe someone could figure out a way to reduce the influence of big pharma's money.
Wouldn't all that be nice?
This leaves zero incentive for the university administrators to police the problem and minimal incentive acting on ethically challenged researchers.
I'd like to see a policy requiring that grant money, plus interest (including those golden indirect costs) be returned to the NIH or NSF in cases of fraud. If enough malfeasance occurs (seems to be the case here), the entire department should be banned from getting federal funding, and for a lot longer than 3 years. Getting fired (administrators too, where appropriate) would be another good idea.
And maybe someone could figure out a way to reduce the influence of big pharma's money.
Wouldn't all that be nice?
7
Lets be clear here, the IRB has a job to do; insure that the study -as proposed- is ethical and legal.
The PI, Dean of School and more widely the University administration are responsible for insuring that the study is conducted as proposed. The failure described here is not of the IRB or even the IRB system but of the administrators at the University and more widely those providing state and federal oversight.
This is a serious problem but it isn't caused by IRB's per se.
The PI, Dean of School and more widely the University administration are responsible for insuring that the study is conducted as proposed. The failure described here is not of the IRB or even the IRB system but of the administrators at the University and more widely those providing state and federal oversight.
This is a serious problem but it isn't caused by IRB's per se.
10
Could Dr. Elliott be onto something? Lets see.
As the CEO of a pill company, what is my goal?
To sell the most pills at the highest price to make my bonus and 500 times more cash than my employees and bail out in a year.
Oh, right, the pills should be safe and better, but whatever.
Would it be a great idea to arrange for a stable of bought and paid for medical research doctors to churn out adverlisements, I mean studies? And dress it up with IRBs.
Yes indeed, a capital idea.
How about supporting medical research in general without controlling the data and writing the "studies"? Not so good. [for my bonus].
Presto change, you have the US pharmaceutical industrial complex.
Looks like the doctor hit the bull's eye.
As the CEO of a pill company, what is my goal?
To sell the most pills at the highest price to make my bonus and 500 times more cash than my employees and bail out in a year.
Oh, right, the pills should be safe and better, but whatever.
Would it be a great idea to arrange for a stable of bought and paid for medical research doctors to churn out adverlisements, I mean studies? And dress it up with IRBs.
Yes indeed, a capital idea.
How about supporting medical research in general without controlling the data and writing the "studies"? Not so good. [for my bonus].
Presto change, you have the US pharmaceutical industrial complex.
Looks like the doctor hit the bull's eye.
12
Capitalistic greed run amok.
3
when the purpose of higher education was to find researchers to bring money in, instead of educating, the game was lost. publish or perish isn't a witty little motto, it is the pledge of allegiance to the almighty dollar. and when university presidents are getting 8 figure salaries/ severance, you had better believe that people will choose not to perish
11
There seems to be some start differences in sympathies from the "Reader's Picks" to the NYT Picks. The later seemingly giving the 'floor' mostly to researchers who do not agree with the author's assessment of the IRB system.
To them I say, "read University Inc., by J. Washburn." It lays out the corruption of our university-based research by powerful corporations.
To them I say, "read University Inc., by J. Washburn." It lays out the corruption of our university-based research by powerful corporations.
4
I recommend against taking everything you read in the New York Times at face value. Sounds like Dr. Elliott is advertising for his book. No conflict of interest there!!
7
Needed are medical researchers and doctors who have a reasonable code of ethics.
One has to wonder where the licensing boards are dropping the ball for letting such ethically challenged "professionals" practice within the state.
One has to wonder where the licensing boards are dropping the ball for letting such ethically challenged "professionals" practice within the state.
1
I am the local PI on about 15 studies in a disease with no cure, and have a personal understanding of IRBs. I would hope the Times couls be more clear that this problem cuts both ways. The role of an IRB is to assure that the rights and welfare of humans participating as subjects in research are protected. To do this, the IRB must weigh risks and benefits of each study.
Here, the authors provide specific examples where patents where injured. They imply that IRBs shirked key responsibilities or researchers were unethical. But you must realize that risk-benefit analyses cut both ways. An overzealous IRB also creates problems that slow down research or make it too costly. There are so many aspects of analyzing risk and benefit, from drug toxicity to privacy to psychological aspects to cost that these are very hard questions. The typical IRB has 10 or more people sharing thoughts, and it is easy for them to raise numerous obscure and useless concerns.
On the other side, here in CA, and in many other states, there is a movement to give patients who are dying the "right-to-try" treatments. They see risk as the last thing that matters. This movement is about less regulation, more access, and fewer impediments.
So, to give specific examples is a dirty way of making this look like a one sided argument. Good decisions can have bad outcomes. I would hope for much more balance from the press, that would lead to better solutions by those involved.
Here, the authors provide specific examples where patents where injured. They imply that IRBs shirked key responsibilities or researchers were unethical. But you must realize that risk-benefit analyses cut both ways. An overzealous IRB also creates problems that slow down research or make it too costly. There are so many aspects of analyzing risk and benefit, from drug toxicity to privacy to psychological aspects to cost that these are very hard questions. The typical IRB has 10 or more people sharing thoughts, and it is easy for them to raise numerous obscure and useless concerns.
On the other side, here in CA, and in many other states, there is a movement to give patients who are dying the "right-to-try" treatments. They see risk as the last thing that matters. This movement is about less regulation, more access, and fewer impediments.
So, to give specific examples is a dirty way of making this look like a one sided argument. Good decisions can have bad outcomes. I would hope for much more balance from the press, that would lead to better solutions by those involved.
19
Large universities, that are involved in all aspects of teaching and research, have internally and externally allowed development of an atmosphere of pressure to perform, broadley characterized by the "publish or perish" phrase from the early 1900s. The effect this has on the integrity of individuals, as well as the institution, is well known. Inividuals vying for tenure-track positions have little else to improve their standing in the highly competitive world of academics, other than publishing academic articles. Some research can result in scores, if not hundreds, of articles spread across many journals involving basically the same subject matter; so-called "salami publications". Add to this old form of pressure on individuals is now the pressure of money and profits of the biomedical industry, as well as the financial status of the institutions, and it is no wonder what has been happening, as outlined by the author.
1
We keep forgetting or distorting the genius of our nation's founders: all systems (& the people within them) need checks & balances. Our current rhetoric assumes any checks either -- in the case of business -- thwart all progress and therefore should be banned, or -- in the case of government -- are weapons that each side can turn on the other in power game that has nothing to do with better governance, but only with scorched earth power grabs.
There are known problems for regulatory or oversight bodies. One is that members get co-opted by those they regulate. Another is that academic medicine itself is changing -- doctors are required to spend more time performing billable tasks (i.e., patient care) & less time I would be interested to hear how Dr. Elliot proposes working around some of those problems. I think Dr. Elliot has good idea -- & if he has not already thought of including such ideas, I hope he expands his plans to include bans on industry attempting to control who does research or to censor research that turns out adversely for industry.
There are known problems for regulatory or oversight bodies. One is that members get co-opted by those they regulate. Another is that academic medicine itself is changing -- doctors are required to spend more time performing billable tasks (i.e., patient care) & less time I would be interested to hear how Dr. Elliot proposes working around some of those problems. I think Dr. Elliot has good idea -- & if he has not already thought of including such ideas, I hope he expands his plans to include bans on industry attempting to control who does research or to censor research that turns out adversely for industry.
3
I was the director of the IRB at a major medical institution for 11 years. The IRB was vigilant in its review of the research protocol: the study design, the consent process, and the consent form itself. But not once did the IRB ever monitor the research studies it approved. And, despite the clear statement in the consent form that a subject was free to contact the IRB if (s)he had a question or a concern, our office never received a call from a subject. I had great respect for the integrity of our institution's investigators, and also for the members of our IRB. That said, I believe that a comprehensive review ought to include monitoring. Perhaps the alarm raised by Dr. Elliott's courageous op-ed will encourage more institutions, as well as HHS and the FDA, to require just that. Pharmaceutical companies have clinical trial monitors of their studies. Shouldn't IRBs?
8
Professor Elliott is selling a book entitled, "White Coat, Black Hat: Adventures on the Dark Side of Medicine." Anyone willing to bet that he has to take the side he's taking to sell his provocatively titled book? Some of his suggestions -- that IRBs be independent of the institutions they are overseeing -- may be reasonable (although funding them is would be a problem to overcome), I worry about the muckraking tone of his overall piece. Elliott clearly has an agenda, and it is not at all certain to me that it is patient safety that it is his greatest concern. Where is the oversight body to police writers like this?
9
I have been a major fan of you and Dr Fugh-Berman for over a decade. Keep up the good work! We need a system that does not reward fraud. If we are ever going to have that, it will be because of the good work done by professionals who care. Thank you!
4
Those of us who have been or who have been close to participants in research studies welcome Dr. Elliot's raising the curtain between what we see and what the administrators of the studies see. Whether we were participating in studies through a doctor or through a for-profit company, a significant level of trust was required from us.
The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.
More is required from Dr. Elliot's target audiences. I expect administrators at the U of M will need to respond in some public fashion to this NYT OP-ED-- whether they take any action to correct the problems Dr. Elliot sees time will show. Other researchers certainly have opinions --some expressed in comments--that their institutions do use I.R. B.s appropriately and don't have problems/scandals. I doubt the independent regulation of medical research will happen: too much money, too little honor.
The instances--especially the horrific death of Mr. Markingson--of failures in his department at the U of M are shocking to me because of the violations of trust between patients and researchers. His anger and strong language about the violations of the I.R.B.s and its "honor code" while apparently not new to others doing research are not able to rouse me to action since the control is totally within the research community and not sensitive to public pressure. If I agree to be a participant in any future studies, I will certainly ask more questions, but that seems to be all I can do.
More is required from Dr. Elliot's target audiences. I expect administrators at the U of M will need to respond in some public fashion to this NYT OP-ED-- whether they take any action to correct the problems Dr. Elliot sees time will show. Other researchers certainly have opinions --some expressed in comments--that their institutions do use I.R. B.s appropriately and don't have problems/scandals. I doubt the independent regulation of medical research will happen: too much money, too little honor.
4
I've peered into the same system, working in companies that make the tools researchers use. Yikes, the stories I could tell. As with everything else you need checks and balances, and as institutions get bigger problems grow exponentially.
The native Americans in Northern California, prior to Europeans wiping them off the face of the earth, built long houses out of sticks and mud. After five years or so they became vermin infested and they simply burnt them to the ground and started over. It's not a bad system.
The native Americans in Northern California, prior to Europeans wiping them off the face of the earth, built long houses out of sticks and mud. After five years or so they became vermin infested and they simply burnt them to the ground and started over. It's not a bad system.
5
Thank you very much sir, We need more people like you shedding light on this subject.
It's nothing short of amazing how the people who claim the disease, also produce the medicine, and pay for the research to prove their point.
Thank you NYT for publishing this article.
It's nothing short of amazing how the people who claim the disease, also produce the medicine, and pay for the research to prove their point.
Thank you NYT for publishing this article.
3
Honor codes are of little use when they are managed by dishonorable people. When private interests and sponsorship drive an institution's research agenda, ethical practice will rank very low on the totem pole of priorities, even if students or research subjects are knowingly harmed.
Although some universities concern themselves with ethical behavior, they get short-changed in the money mill for their integrity. Many more institutions sadly follow the scent of status. Status stems largely from private research sponsorship because public support is becoming as drought-stricken as the state of California.
I have lived the life of academic disintegration. It's ugly. Corporations do not sponsor research for the advancement of knowledge; they sponsor it for the advancement of interests: their own, ethics be damned. The sponsored institutions fall right in line.
Although some universities concern themselves with ethical behavior, they get short-changed in the money mill for their integrity. Many more institutions sadly follow the scent of status. Status stems largely from private research sponsorship because public support is becoming as drought-stricken as the state of California.
I have lived the life of academic disintegration. It's ugly. Corporations do not sponsor research for the advancement of knowledge; they sponsor it for the advancement of interests: their own, ethics be damned. The sponsored institutions fall right in line.
9
Thank you very much Dr. Elliot. Some things seem never to change. More than 40 years ago I was placed in the U of M hospital after complaining about depression. As part of an experimental program, I was given a powerful anti-psychotic medication (though there were no signs of psychosis) with almost nothing in the way of explanation. Long story short, I was extremely lucky to have survived and did so only by leaving the facility against the will of the doctor conducting the study who threatened me with "commitment" for leaving the program against his wishes. It appears that someone has finally summoned the courage to stand up to the Department of Psychiatry at the University of Minnesota.
17
This is a devastating missive on a highly reputable institution, The University of Minnesota, known internationally for its research prowess. Obviously there has been little or no priority given to investigative research at that institution! Additionally, there is another aspect of this scandal that is very much part of the responsible oversight committees that are involved, i.e. industry sponsored research that often involves Phase II and III studies or trials. These studies are frequently fraught with biased results favoring the beneficial effectiveness of the agent being used in the trial of study. One only needs to see the disclosures listed by the authors or investigators of the trial and unfortunately, the reader is sometimes referred to the journal's website for this information. Even some of the high-impact medical journals fail to recognize a possible conflict of interest in the manuscript or study being submitted for publication.
Having been involved in clinical trials in the past and noting the evolution of these types of practices gives on pause and suspect to the ethics of such protocol. Research should be done without monetary incentive or notority, and be reviewed and scrutinized by an appropriate body or committee as to its design and held to the bioethical standards of the institution.
Having been involved in clinical trials in the past and noting the evolution of these types of practices gives on pause and suspect to the ethics of such protocol. Research should be done without monetary incentive or notority, and be reviewed and scrutinized by an appropriate body or committee as to its design and held to the bioethical standards of the institution.
3
This article is a textbook example of the importance of tenure. Dr. Elliott has made a valuable contribution to cleaning up the mess of scientific research. No doubt he will pay a price for it, but if he has tenure, his job won't be at stake. And he is an example of the importance of professional ethics, and the need to teach every emerging professional about ethical professional behavior.
15
It is true that Dr. Elliot reflects on what is overall only a minuscule representation of all the research projects undertaken within university walls at any given times. However, he puts his finger right on the pulse of a recurring theme regarding the the struggle institutions of higher education sometimes have with transparency. Having just come from a focus group from my own alma mater where an overriding theme was lack of communications from the institution to its alumni around the critical issues of the day, it would serve institutions well to step out from behind the wall of legal and PR public speak and say, when appropriate: "We didn't do this right, here's why, we are sorry, we are fixing it." Or some version thereof.
5
The source of the problem is the same as the source of most of our problems: money.
We've turned what professors into greedy capitalists, when they system they're working under has always been socialist. From Minnesota's Mission: "We partner with communities across Minnesota to engage our students, faculty, and staff in addressing society's most pressing issues."
We've turned what professors into greedy capitalists, when they system they're working under has always been socialist. From Minnesota's Mission: "We partner with communities across Minnesota to engage our students, faculty, and staff in addressing society's most pressing issues."
1
It's not just the University of Minnesota that needs an independent IRB. Every medical study needs an independent IRB. IF the current unpaid voluntary IRB members cannot be truly responsible for their signatures, the FDA has to take it upon themselves. Your elected Congress has to budget for the new IRB job for the FDA. If you are an IRB member, I recommend that you resign ASAP. Perhaps nobody ever holds IRB members responsible before, but that will change. We need changes for better medical research no matter if it's funded by pharmaceuticals or taxpayers.
3
This all reminds me of the movie, "The Fugitive", starring Harrison Ford, who ends up identifying his best friend and fellow doctor for falsifying medical results to promote a pharmaceutical company, Devlin MacGregor, that Dr. Nichols had a vested interest.
3
In my extensive research experience over the past decade, I have been audited multiple times, and found the IRB to be scrupulous, helpful and fair, the investigators had only the best interest of the patients in mind, and with few exceptions the pharmaceutical sponsors acted with integrity.
More recently, the IRB that monitored our research began raising their fees, and now requires 33% of entire research budgets for "overhead", which can be hundreds of thousands of dollars paid by the pharmaceutical companies. For every form that the investigators were required to fill out, the IRB received additional fee payments, leading to more and more forms until the research became unmanageable and secondary to the bureaucracy.
An IRB that is no longer independent, but is heavily funded by pharmaceutical research sponsors presents inherent conflict of interest. In our case, the IRB made decisions dictated by a pharmaceutical company that went against the investigators’ wishes since it was not in the interest of protecting the patients.
Our research allowed patients with progressive diseases to receive potentially life-saving treatments, and significantly improved their quality of life. Research can greatly benefit patients, so it is imperative to resolve these conflicts with the goal of protecting patients, increasing medical and scientific knowledge and decreasing human suffering.
More recently, the IRB that monitored our research began raising their fees, and now requires 33% of entire research budgets for "overhead", which can be hundreds of thousands of dollars paid by the pharmaceutical companies. For every form that the investigators were required to fill out, the IRB received additional fee payments, leading to more and more forms until the research became unmanageable and secondary to the bureaucracy.
An IRB that is no longer independent, but is heavily funded by pharmaceutical research sponsors presents inherent conflict of interest. In our case, the IRB made decisions dictated by a pharmaceutical company that went against the investigators’ wishes since it was not in the interest of protecting the patients.
Our research allowed patients with progressive diseases to receive potentially life-saving treatments, and significantly improved their quality of life. Research can greatly benefit patients, so it is imperative to resolve these conflicts with the goal of protecting patients, increasing medical and scientific knowledge and decreasing human suffering.
37
Excellent article, but it barely touches the surface. In reality, vast percentages of the American people are subjects in medication experiments.
Does it make sense that 1/4 of Americans over 40 are on statin drugs, or that 10-12% of Americans "have" ADHD and qualify for amphetamine drugs like Adderall? Does anyone sincerely think that there won't be and aren't now serious and sometimes deadly adverse effects from the massive over-medication of Americans?
I suggest reading a short book, winner of the British Medical Association first prize, called Deadly Medicines, by Peter C Gotzsche.
The drug industry is involved and often in control of vast part of our healthcare. What do you think when you are forced to share your doctors' waiting rooms with a bunch of drug salespeople, often bringing lunch? Do you know that that every dollar spent on a sales rep yields $10 to the pharma industry? Obviously, our doctors are being influenced.
Prescription drugs are the 3rd leading cause of death in the US (after heart disease and cancer).
Just google "statin myopathy" or check https://plus.google.com/102631385922452069974/posts/EAu1sWEBjyX
Does it make sense that 1/4 of Americans over 40 are on statin drugs, or that 10-12% of Americans "have" ADHD and qualify for amphetamine drugs like Adderall? Does anyone sincerely think that there won't be and aren't now serious and sometimes deadly adverse effects from the massive over-medication of Americans?
I suggest reading a short book, winner of the British Medical Association first prize, called Deadly Medicines, by Peter C Gotzsche.
The drug industry is involved and often in control of vast part of our healthcare. What do you think when you are forced to share your doctors' waiting rooms with a bunch of drug salespeople, often bringing lunch? Do you know that that every dollar spent on a sales rep yields $10 to the pharma industry? Obviously, our doctors are being influenced.
Prescription drugs are the 3rd leading cause of death in the US (after heart disease and cancer).
Just google "statin myopathy" or check https://plus.google.com/102631385922452069974/posts/EAu1sWEBjyX
9
Without wishing to minimize the abuses described here, I'd say a more general problem in medical research involving human subjects is that the concept of "informed concept" for clinical trials is itself redolent of self-serving hype. Typically a cancer patient is asked "how would you like to participate in a drug study that may be the breakthrough we all earnestly want ?". What are the odds that the average patient will say "no" to this kind of phraseology even after hearing a litany of side effects, plus the "may" in the question provides a hedge for lawyers to later say "well the clinician never promised a cure." And, of course, the average patient would have no way of knowing the advantages that accrue to the clinician. On the off chance that the therapy actually works, that's a Nobel Prize. On the more likely chance that the therapy doesn't work, it's still a publication that the clinician adds to his CV ("as we suspected from the outset, drug such and such proved inefficacious") to get funding for the next clinical trial.
It's the Billion$. And manifestly; according to 100% of all history, in all nations and cultures- the only way to prevent the corruption of all ethical safeguards- is to get the Billion$ out of the picture.
The University of Minnesota- and all others I'm familiar with (many) was founded for the public benefit, paid for by public funds. It now operates- for it's own benefit, almost exclusively; patenting and profiting from the ideas of its professors, allegedly still for "public benefit" but actually so they can afford more and more insanely expensive administrators, and "the best", i.e. the most expensive, professors.
The cries of "There's no other way!" - are transparently self-serving. Money corrupts. And Big Money- corrupts completely.
The University of Minnesota- and all others I'm familiar with (many) was founded for the public benefit, paid for by public funds. It now operates- for it's own benefit, almost exclusively; patenting and profiting from the ideas of its professors, allegedly still for "public benefit" but actually so they can afford more and more insanely expensive administrators, and "the best", i.e. the most expensive, professors.
The cries of "There's no other way!" - are transparently self-serving. Money corrupts. And Big Money- corrupts completely.
5
"Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners."
This is the reality, not your imagination.
This is the reality, not your imagination.
9
It is standard for IRB's to perform post-approval monitoring, which includes audits and on-site inspections. These are done quite aggressively at the institution where I work. Pretty much the exact opposite of an honor system. If this is not happening at UM, then they are lagging national standards by at least a decade.
7
This is not a new problem for the department of psychiatry at Minnesota. Nearly 20 years ago as a graduate student, I reported several very serious instances of fraud and misconduct by a principal researcher, to the chair of the department. Despite the fact that I had concrete evidence (from a paper trail) all that every came of it was a severe lecture to me about the immorality of going behind said researcher's back. I was never allowed to conduct research at that department again.
I assume my experience was not unique, because I was warned ahead of time that something like this might happen. I was dumb enough to go ahead anyway.
I assume my experience was not unique, because I was warned ahead of time that something like this might happen. I was dumb enough to go ahead anyway.
15
Aren't the University of Minnesota hospitals owned by a Corporation, Fairview Health Services? Does Fairview have a direct say in the acceptance and oversight of research studies? Do its attorneys determine how to respond to potential scandal? If yes, are Fairview attorney responses similar to that of similar non- profit Medical Centers?
5
Very sad to learn of the abuses at the U of Minn. More can be done to strengthen the rights of participants when they enroll in medical studies which can cause significant harm to the participant. Yes, it will up the costs somewhat, but the outcome is worth it if it leads to both better safety for the participants and more honesty in the research process.
1
Form a regulatory system if you think that is the answer. But who will pay for it?
The NYT and other publications have been running articles about how administrative costs at universities are out of control. Much of those administrative costs are to implement what are essentially good ideas. In essence, students will end up paying for another layer of bureaucracy.
I believe that a better, and cheaper solution is to utilize mechanisms already in place. Unethical conduct happens once, the president slams the researchers so hard that nobody would dare do anything unethical or sloppy again. Happens twice, the Board governing the university slams the president so hard that no other president would dare let anything bad happen again.
The NYT and other publications have been running articles about how administrative costs at universities are out of control. Much of those administrative costs are to implement what are essentially good ideas. In essence, students will end up paying for another layer of bureaucracy.
I believe that a better, and cheaper solution is to utilize mechanisms already in place. Unethical conduct happens once, the president slams the researchers so hard that nobody would dare do anything unethical or sloppy again. Happens twice, the Board governing the university slams the president so hard that no other president would dare let anything bad happen again.
5
The real ethical problem seems to be that industry can buy academics in (mostly) public institutions to do their work at a subsidized rate. This isn't academic research -- its short-term profit-driven product development operating under the veneer of unbiased research -- and real academics need to speak out against this.
5
The morning I arrived for an academic urology job at the Minneapolis V.A. in the low '90's, the Chairman of Urology resigned under pressure from the student newspaper. They had found questionable accounting in the Dept. of Urology. At the same time, the Chairman of Surgery was under indictment by the FDA for selling a drug across interstate lines without FDA approval. He was acquitted. The board of trustees had approved the business plan and there was a resignation there. So, the problems at U. Minn. Dept. of Psychiatry are not new.
4
The author asked: "In what other potentially dangerous industry do we rely on an honor code to keep people safe? Imagine if inspectors... gave approvals based entirely on paperwork filled out by the owners.
The answer: You don't have to imagine. Medical device manufacturers self regulate using an 'honor code'. So does the auto industry. There are many other self-regulating industries, as well.
Every regulatory compliance engineer knows the pressure to get the product out the door, and how easy it is to create a paper trail that the FDA will accept as due diligence in the unlikely event that the FDA even requests the documentation. As with exploding Takata airbags, or GM ignition switches, industry self regulation guarantees that nothing is critically examined until someone dies.
The answer: You don't have to imagine. Medical device manufacturers self regulate using an 'honor code'. So does the auto industry. There are many other self-regulating industries, as well.
Every regulatory compliance engineer knows the pressure to get the product out the door, and how easy it is to create a paper trail that the FDA will accept as due diligence in the unlikely event that the FDA even requests the documentation. As with exploding Takata airbags, or GM ignition switches, industry self regulation guarantees that nothing is critically examined until someone dies.
9
I am a researcher whose work is somewhat related to human exposure to toxic chemicals. I have avoided moving my research in a direction that would require IRB approval because it is such a huge hurdle. The author suggests that we make it an even higher hurdle, and his arguments make sense. But just keep in mind what we are doing, with this initiative and many others related to federal rules on grant accounting, data management and oversight, etc. We are eliminated small players like me from the market and making it so that only the largest grants, most of which come from private companies these days since the federal funding agencies are all broke, can marshal the resources necessary to comply with these mandates. The world of academia (like the rest of the economy) is rapidly moving toward a winner take all system in which a few researchers bring in giant grants while the rest bring in almost nothing. Your ability to raise money via research grants has long been a critical factor determining whether you get tenure. Under this system, fewer people will get tenure, and small research projects will essentially disappear. Are you sure that is what you want?
68
I was at the University of Minnesota for a year in 1986. My father had a chance to study under one of the pioneers of open heart surgery, Dr. Clarence Walton "Walt" Lillehei there in the 60's. There are a lot of great people there in medicine, and thank you no less to professor Carl Elliott, of whom I'm also so proud to have read his NYT column.
The illusion of money from the industry is the opportunity for research. This brings out the worse of fallacies among our fellow researchers. It is a human one, no less importance as the ignorance from one's ego over the basic directives of ethics and morality.
There are stop-valves in place, but the eyes and ears of the boards, the deans are no match for the lobbying power and persuasiveness from the representatives from the industry. They probably outnumber the university personnel by a factor of 10. The bucks do stop at the dean and the board but you don't know what you don't know. In these days of regulatory complexity, it is impossible to know it all. So most of the time, any forward action is based on a hindsight, 20-20 perspective. It that sense, it's a crime to have covered up. To be proactive, preemptive, preventative, I no longer have faith in this current generation of leaders with hopes that the cultural shift, the generational shift will do what's right, not what's necessarily best for oneself nor for the university. There is a lot of risks and it may be too much for one woman, and it will take a generation to change.
The illusion of money from the industry is the opportunity for research. This brings out the worse of fallacies among our fellow researchers. It is a human one, no less importance as the ignorance from one's ego over the basic directives of ethics and morality.
There are stop-valves in place, but the eyes and ears of the boards, the deans are no match for the lobbying power and persuasiveness from the representatives from the industry. They probably outnumber the university personnel by a factor of 10. The bucks do stop at the dean and the board but you don't know what you don't know. In these days of regulatory complexity, it is impossible to know it all. So most of the time, any forward action is based on a hindsight, 20-20 perspective. It that sense, it's a crime to have covered up. To be proactive, preemptive, preventative, I no longer have faith in this current generation of leaders with hopes that the cultural shift, the generational shift will do what's right, not what's necessarily best for oneself nor for the university. There is a lot of risks and it may be too much for one woman, and it will take a generation to change.
3
There’s no question about the corrupting influence of money.
The extreme lapses in ethics at the University Of Minnesota are very much the exception, not the rule. Most research is conducted without the frank breeches described here, including studies funded by the pharmaceutical industry. The rules governing IRBs are strict, with requirements that members of the public as well as scientists participate. The process the government imposes for supervising research involving human subjects is vigorous.
The government requires that extensive studies be conducted before a drug can gain FDA approval. These studies are usually conducted at universities, medical research institutions, and by private contractors. They are usually funded by the companies that have a strong financial stake in the outcome.
But what are the alternatives? The money needs to come from somewhere. Direct federal funding for research through the NIH and other agencies is very limited, and the costs of the research are very high. A strong case can be made to increase the NIH budget.
The system we have of industry funded research that is independently regulated and supervised is imperfect, but most often it works. It is far more than an “honor code,” the phrase used in this op-ed. Imposition of many more rules may do more harm than good, by impeding the science that society needs to have done.
Research institutions need a culture of integrity. Most have one. A few do not.
The extreme lapses in ethics at the University Of Minnesota are very much the exception, not the rule. Most research is conducted without the frank breeches described here, including studies funded by the pharmaceutical industry. The rules governing IRBs are strict, with requirements that members of the public as well as scientists participate. The process the government imposes for supervising research involving human subjects is vigorous.
The government requires that extensive studies be conducted before a drug can gain FDA approval. These studies are usually conducted at universities, medical research institutions, and by private contractors. They are usually funded by the companies that have a strong financial stake in the outcome.
But what are the alternatives? The money needs to come from somewhere. Direct federal funding for research through the NIH and other agencies is very limited, and the costs of the research are very high. A strong case can be made to increase the NIH budget.
The system we have of industry funded research that is independently regulated and supervised is imperfect, but most often it works. It is far more than an “honor code,” the phrase used in this op-ed. Imposition of many more rules may do more harm than good, by impeding the science that society needs to have done.
Research institutions need a culture of integrity. Most have one. A few do not.
7
This is the job for the government. Corporations should not be funding research when their own interests are at stake. Corruption is the reason government oversees areas for the public good and not for profit. Governments should not be bought by corporations and wealth citizens. Overturn Citizens United and make elections last only 4 - 6 weeks. This is the sad state of our country.
3
I have been principal investigator on IRB-approved protocols and must say that my IRB was strict with enforcing regulation. IRBs are powerful bodies as is. Without approved protocols, investigators cannot apply for federal government funding nor can they conduct a study, no matter who pays for it. Perhaps the University of Minnesota's IRB must learn how to step up to the plate.
As principal investigator I felt it was my duty to discuss the consent forms in person with every participant in my study to be clear that she/he understood the risks. Then we both signed the forms. More often than not, the medical community loves to delegate what is perceived as time-consuming chores. However, make no mistake. In the end of the day the one who signed the consent forms will be held accountable.
As principal investigator I felt it was my duty to discuss the consent forms in person with every participant in my study to be clear that she/he understood the risks. Then we both signed the forms. More often than not, the medical community loves to delegate what is perceived as time-consuming chores. However, make no mistake. In the end of the day the one who signed the consent forms will be held accountable.
28
I monitor clinical trials for a living, I can tell you that none of the suggestions here will work unless there are additional changes. These changes need to be 1) fully fund the FDA, including inspections with the power to immediately halt research at sites AND impose criminal sanctions. 2) tie the validity of the medical license of the physician to their behavior as a PI or Co-PI on a clinical trial. If they are debarred by the FDA, they should lose their medical license.
When physicians sign the FDA Form 1572, that is a contract with the federal government to run the trial on an ethical basis. When they fail to do that, time after time, nothing happens except "retraining". Guess what counts as "retraining"? Reminding them not to do it again. What is repulsive and shameful to me, is to take a name from the FDA's list of debarred investigators and then do a Google search on them. Without fail, they are still practicing medicine even if they were debarred for placing experimental devices into patients without their consent. The debarment often has no effect on whether or not they can continue to practice medicine, and often the public knows nothing about this. And these practitioners are making tons of money.
Here is the FDA Debarment list: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm2005408.htm
Read through some of the Debarment letters describing the findings by the FDA. It will sicken you. Then tell me if we give a damn about ethics in this country.
When physicians sign the FDA Form 1572, that is a contract with the federal government to run the trial on an ethical basis. When they fail to do that, time after time, nothing happens except "retraining". Guess what counts as "retraining"? Reminding them not to do it again. What is repulsive and shameful to me, is to take a name from the FDA's list of debarred investigators and then do a Google search on them. Without fail, they are still practicing medicine even if they were debarred for placing experimental devices into patients without their consent. The debarment often has no effect on whether or not they can continue to practice medicine, and often the public knows nothing about this. And these practitioners are making tons of money.
Here is the FDA Debarment list: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/ucm2005408.htm
Read through some of the Debarment letters describing the findings by the FDA. It will sicken you. Then tell me if we give a damn about ethics in this country.
12
Studies sponsored and paid for by the pharmaceutical industry will do anything to make their studies look good. I was accepted in a study of a new medication at a local university for a while. After the industry supervising representative looked at some of the preliminary data, I was kicked off. My case was sufficiently serious so that if there was no improvement, it would make the resulting data look less favorable. Doctoring the data by removing potentially unfavorable results amounts to fraud. - The university staff should never have agreed to removal of all potentially unfavorable data. But, a study paid for and supporting the students and staff that work on it is more important than a valid, ethical assessment of a new medication.
9
While these kinds of scandals are partly caused by unethical individuals,they are also a completely predictable outcome of the decline of public funding for universities in this country. As state dollars and federal dollars (NIH, NSF, etc) have dried up, school increasingly turn to drug companies, big ag companies, etc - none of which are going to support research that goes against their interests.
Of course, deeply unethical efforts to control and bias research can happen at the state level as well -- witness the Oklahoma politicians who have tried to pull state funding from geologists whose research shows links between fracking and the recent swarms of earthquakes in that state.
Of course, deeply unethical efforts to control and bias research can happen at the state level as well -- witness the Oklahoma politicians who have tried to pull state funding from geologists whose research shows links between fracking and the recent swarms of earthquakes in that state.
15
First, funding dollars increase every year. Second, so do the layers of bureacracy. Second, the federal government is full of the same ethical problems, at just about every level. CDC hasn't passed their audit in years.
Lastly, as long as 'progressives' and 'conservatives' drive this country, we are in trouble at all levels. It is the moderates that work together, comprimise, and are more willing to slowly steer the ship. The extremists work on the philosophy that the means justify the ends. Not true.
but, you cannot sit back and blame the pharmaceutical companies. Fraud and/or unethical behavior happens to any area of work where human beings are involved. And it continues when those human beings are not held accountable.
Today, it's not humans we hold accountable. It's agecies, companies, and other difficult to define 'institutions' that are merely fined for bad behavior. And that fine is paid by the people, not those individuals responsible. U of MN is not alone, but given the constant history of nonsense, they should lose access to both public and private grants for at least 2 years. I realize this impacts graduate students, and the others that are innocent. But without punishing the actual people, with jail time and fines, how else can you curb this?
You cannot regulate good behavior, you can only punish bad. But our government has moved over the decades to trying to regulate good behavior, and fining the bad. It's cheaper to pay the fine.
Lastly, as long as 'progressives' and 'conservatives' drive this country, we are in trouble at all levels. It is the moderates that work together, comprimise, and are more willing to slowly steer the ship. The extremists work on the philosophy that the means justify the ends. Not true.
but, you cannot sit back and blame the pharmaceutical companies. Fraud and/or unethical behavior happens to any area of work where human beings are involved. And it continues when those human beings are not held accountable.
Today, it's not humans we hold accountable. It's agecies, companies, and other difficult to define 'institutions' that are merely fined for bad behavior. And that fine is paid by the people, not those individuals responsible. U of MN is not alone, but given the constant history of nonsense, they should lose access to both public and private grants for at least 2 years. I realize this impacts graduate students, and the others that are innocent. But without punishing the actual people, with jail time and fines, how else can you curb this?
You cannot regulate good behavior, you can only punish bad. But our government has moved over the decades to trying to regulate good behavior, and fining the bad. It's cheaper to pay the fine.
1
This is a remarkable article. Those of us who have been medical practitioners know how rare it is and how risky for a reputable clinician to come forward, stating that scandalous behavior by physicians both persists and is minimized by a University administration. "Go along to get along" has been an expectation among physicians. Consider that there are students within the University of Minnesota Department of Psychiatry, residents fellows. Their training there may now raise some eyebrows, to be sure, but what about their attitudes and values, learned from the behavior of their mentors? Perhaps Dr. Elliott's Center for Bioethics can influence them in a long-lasting way as they head out into a world where more corners are often cut: corporate medicine.
64
Advances in science are built upon knowledge obtained from previous research, and when this foundation is corrupted by unethical behavior (whether through lax IRB's, inadequate supervisory oversight, unchecked conflicts of interest, or superficial and inadequate peer review processes), progress is undermined and society loses trust in the process. Much more stringent research oversight is needed, and professional organizations as well as government agencies should be mandating and then evaluating new checks and balances. This kind of verification is needed to support and demonstrate the validity of scientific studies.
17
Thank you Dr. Elliott. A decade ago I was in a doctoral program in management with a research project that had to pass the I.R.B. scrutiny. I thought then as I do now it made no sense that my research, which asked business people questions about technology in their company, had to meet the same requirement of medical research. Perhaps if the I.R.B.'s would rethink levels of human impact they could spend time really looking at the abuses you named.
3
As long as it is acceptable that medical care and medical research are money-driven, harm to patients by ambitious or simply greedy physicians will occur. It is easy to imagine that the University of Minnesota administration - and their colleagues - admired these psychiatrists for the outside (pharmaceutical corporation) money they brought in.
With supposedly not-for-profit medical institutions like the University of Minnesota now calling themselves "enterprise," and with higher administration officials making 7-figure salaries, what can we expect?
We, the public, have tolerated for-profit hospitals taking over, we have tolerated the hollowing-out of NIH funding for medical research and thus driven ambitious medical academics into the arms of the pharmaceutical industry, yet we still expect progress in medical science and lots of publications by medical academics.
All the incentives in the current system are set for breaches of medical ethics to get worse.
With supposedly not-for-profit medical institutions like the University of Minnesota now calling themselves "enterprise," and with higher administration officials making 7-figure salaries, what can we expect?
We, the public, have tolerated for-profit hospitals taking over, we have tolerated the hollowing-out of NIH funding for medical research and thus driven ambitious medical academics into the arms of the pharmaceutical industry, yet we still expect progress in medical science and lots of publications by medical academics.
All the incentives in the current system are set for breaches of medical ethics to get worse.
7
You can't rely on IRBs for compliance; their job is to vet protocols. Where is your Office of Compliance? You should have, as our research center does, an Office of Compliance which follows up every submission to make sure the protocol is followed.
5
The author fails to cite the fact that the University of Minnesota was placed on the NIH "exceptional institutions" list in 1997 (not a good thing) for their failures to monitor Dr. John Najarian"s research and clinical trials on organ transplant drugs for immunosuppression. The University supposedly recruited a senior official to oversee clinical research. We can see how successful these efforts were.
2
I had to check out the author and here he is.
http://www.bioethics.umn.edu/bio/bioethics-grad-prog-fac/bruce-elliott
This is when a tenure-track professor can be protected by tenure and speak the truth for all to see and improve.
http://www.bioethics.umn.edu/bio/bioethics-grad-prog-fac/bruce-elliott
This is when a tenure-track professor can be protected by tenure and speak the truth for all to see and improve.
3
I use the University of Minnesota medical center for my health needs, sometimes in conjunction with the Mayo Clinic. My medical care here is superb, and I have participated in life-saving clinical studies run by the U of M. Having said that, this far harsher assessment than anything that appeared in local media is horrifying. There is a puzzling disconnect here between the U of M's medical research ethics, on the one hand, and patient care, on the other.
4
Thank you for this article! As a psychiatrist myself, this is more personal. I agree with the author that an honor code is a fragile thing and yet most organizations and businesses run on an implicit honor code. How can we know that apple juice is really apple juice? I don't know how many of you remember the scandal in the 80's when Mott's Baby Apple Juice was found to contain NO apple juice. Republicans are constantly chipping away at and defunding all regulations and regulatory agencies -- which leaves only honor. And frankly, in this culture, it's not enough.
15
Do we really expect this situation to get better when university presidents are being paid, or at least offered, seven-figure salaries (and those with less princely incomes can make up the difference by accepting appointments to corporate boards of directors)?
"Publish or perish" is becoming a bygone byword, more recently replaced by "Bring in some big grants for big studies or perish."
No university or its affiliate institutions should be permitted to conduct research related to products or services manufactured, distributed, or sold by its corporate donors, their subsidiaries, or any entity in which those donors might also be shareholders. If we want honest, independent research run within universities, then donations must be just that -- not quid pro quo payments [bribes?] in exchange for favorable studies and reported outcomes.
"Publish or perish" is becoming a bygone byword, more recently replaced by "Bring in some big grants for big studies or perish."
No university or its affiliate institutions should be permitted to conduct research related to products or services manufactured, distributed, or sold by its corporate donors, their subsidiaries, or any entity in which those donors might also be shareholders. If we want honest, independent research run within universities, then donations must be just that -- not quid pro quo payments [bribes?] in exchange for favorable studies and reported outcomes.
9
Honor code ! What a joke nowadays. I remember as a medical student the shame we experienced to learn that the Simpson family kept secret the new forceps that could help difficult birth. Yesterday I was reading about a medical student who right away took a lawyer to secure a patent. I forgot what exactly he had discovered but I am sure it was because he attended lectures or read from other people work.
Sic transit gloria mundi !
Sic transit gloria mundi !
2
Both for his book and this column, Dr. Elliot should be lauded most vigorously. His concerns are completely relevant to this situation in which Big Pharma will do most anything to get positive research-study outcomes for its new products. Starting with Vioxx, there are numerous examples of the failure of this model to account for the complexity of human physiology, where side-effects are the rule rather than the exception.
3
A lot of the ethical problems happen after a research proposal gets through the IRB. So who does the oversight while a research project is in progress at an institution? Also, can a person/office within an institution be as effective as an outsider? Why do I say this?
Because money, business, status, and organizational politics exercise much too strong an influence on education and research these days.
Which brings up the question: What is the institutional response if someone reports their suspicions or knowledge about ethical breaches and wrongdoing regarding a well-funded research project in progress?
Now retired from an academic medical center, I witnessed several whistle blowers treated horribly by administrators for daring to report what was really going on and perhaps jeopardizing the grant cash flow.
How refreshing! Professor Elliott brings us back to truth-telling, which is the hallmark of science--instead of caving to the pressures of university administrators and some researchers who pursue the money-status model at academic institutions. How will Prof. Elliott treated now at the Un. of MN?
Instead of academic institutions adopting the business model (based on money & profits, garnering market share, and image), I think we would all be better off if businesses adopted the scientific model (based on the pursuit of truth, objective testing, verification, caution, ethical treatment of others, and healthy skepticism).
Because money, business, status, and organizational politics exercise much too strong an influence on education and research these days.
Which brings up the question: What is the institutional response if someone reports their suspicions or knowledge about ethical breaches and wrongdoing regarding a well-funded research project in progress?
Now retired from an academic medical center, I witnessed several whistle blowers treated horribly by administrators for daring to report what was really going on and perhaps jeopardizing the grant cash flow.
How refreshing! Professor Elliott brings us back to truth-telling, which is the hallmark of science--instead of caving to the pressures of university administrators and some researchers who pursue the money-status model at academic institutions. How will Prof. Elliott treated now at the Un. of MN?
Instead of academic institutions adopting the business model (based on money & profits, garnering market share, and image), I think we would all be better off if businesses adopted the scientific model (based on the pursuit of truth, objective testing, verification, caution, ethical treatment of others, and healthy skepticism).
9
Unfortunately, this isn't confined to the U of M. It is an institutional trait, extending from police departments to Congress to centers of higher learning.
One thing is clear: internal reviews are all-but-worthless. Independent boards, or boards with such membership, are the only hope for objectivity.
One thing is clear: internal reviews are all-but-worthless. Independent boards, or boards with such membership, are the only hope for objectivity.
10
I think that maybe soul searching is out of fashion. Thank you for this opinion piece by Carl Elliot.
4
1. There flaws in three studies among tens of thousands at U. Minnesota, which itself represents a tiny drop in the millions of studies conducted in the United States in the last few decades.
2. Therefore, an intrusive regulatory regime must be imposed on all studies across all places, creating debilitating costs and strangling hugely important research--often life saving research--under a mountain of regulatory approvals.
Even a freshman in the first week of a Critical Thinking course can see how flawed Elliot's proposal is. C'mon Professor, you owe us a more careful argument.
2. Therefore, an intrusive regulatory regime must be imposed on all studies across all places, creating debilitating costs and strangling hugely important research--often life saving research--under a mountain of regulatory approvals.
Even a freshman in the first week of a Critical Thinking course can see how flawed Elliot's proposal is. C'mon Professor, you owe us a more careful argument.
42
Where will you find, and who will finance "bodies that are fully independent — both financially and institutionally — of the research they are overseeing." You want people who will do serious work for free, and not care about the outcome?! Good luck with that. There is no substitute for ethical people in an organization, from top to bottom. Otherwise, every level of the organization needs policing, not just the researchers.
40
Dr. Elliot is a bioethicist, and as such he directly benefits form an expanded role of IRBs in his institution. Nobody with a significant stake in patient oriented research would be eligible to operate within the type of institutional IRB he's asking for, as they would be in conflict. Bioethicists however would be ideal. Paraphrasing this article: "I can point to a (very) few big problems that the current system let slip through. Therefore you should build an unaccountable empire that will ensure a lifelong career for me and my colleagues".
1
For all the negative press it seems to receive (fairly or unfairly, it certainly is a lightning rod for every grievance), I'd like to give a big shout-out to the V.A. for the oversight I have seen it give to research studies. At times maddeningly slow and seemingly "picky", the IRB I worked with was extraordinarily attentive and vigilant about EVERY aspect of the research, right down to the clarity, wording, and even the commas in every protocol and consent form; in overseeing the rights and protections of participants; at all times insisting on accountability and transparency. Micromanagement? - Ok with me, and good for all subjects concerned.
41
Congratulations to Dr. Elliott for his years of work in shining light on these abuses, and much more difficult, actually moving the institution to action. In the past few weeks the New England Journal of Medicine published a series of articles defending financial compensation of academic physicians by drug companies. The author asked for instances of harm stemming from such relationships. The U of Minn provides plenty, and I supplied more in a blog last week: http://www.healthnewsreview.org/2015/05/responding-to-parts-2-3-of-new-e...
8
Medical studies are governed by many more rules, regulations, and requirements than they were in the past. Many were implemented in response to scandals, cases of research misconduct, or discoveries of biases such as when drug companies hide negative results instead of publishing them.
U of M seems to be falling down on the job. I don’t know how many other institutions have similar problems, but I do know that the one where I work does everything it possibly can to ensure that the research that is conducted under its aegis is ethical, rigorous, and in compliance with many different rules and regulations.
My university is not alone in its diligence, and there are many other layers of protection against fraud, misconduct, conflicts of interest, and unscrupulous research practices. To cite a few examples: NIH grant reviewers are required to consider ethical issues when evaluating research proposals, the NIH Office of Research Integrity investigates research misconduct and punishes offenders, clinical trials now have to be registered in advance on public websites which makes them hard to hide, independent data and safety monitoring boards govern the ethical conduct of individual clinical trials, and scientific journals maintain ethical standards for the studies they publish.
Besides, most medical researchers have high ethical standards of their own. Despite U of M’s problems, it’s not the Wild West out here.
U of M seems to be falling down on the job. I don’t know how many other institutions have similar problems, but I do know that the one where I work does everything it possibly can to ensure that the research that is conducted under its aegis is ethical, rigorous, and in compliance with many different rules and regulations.
My university is not alone in its diligence, and there are many other layers of protection against fraud, misconduct, conflicts of interest, and unscrupulous research practices. To cite a few examples: NIH grant reviewers are required to consider ethical issues when evaluating research proposals, the NIH Office of Research Integrity investigates research misconduct and punishes offenders, clinical trials now have to be registered in advance on public websites which makes them hard to hide, independent data and safety monitoring boards govern the ethical conduct of individual clinical trials, and scientific journals maintain ethical standards for the studies they publish.
Besides, most medical researchers have high ethical standards of their own. Despite U of M’s problems, it’s not the Wild West out here.
4
Actually, in most industries these days, regulation is accomplished through voluntary self-reporting more than direct inspection by oversight agencies.
7
Tenure protects Professor Elliott from reprisal from his institution. Another reason to reinforce that safeguard for critics. There are too few who feel safe enough to speak truth to money.
9
Something is wrong with culture at the author's University. I'd look first at his Department's Chief of staff or College's Dean. Rot spreads down from the top.
It is true that the problem with IRBs is that they are honor system based. Ditto the peer-reviewed basis for manuscript acceptance in scientific journals. Nevertheless, my experiences with Big Pharma has been somewhat different from what the author describes. When involved with a new drug investigation (especially Phase II or III studies) I found industry supervision and review of my results has been has been extremely thorough. Auditors were constantly looking over my shoulder. Probably because all this data would eventually go to the FDA.
On the other hand I can cite multiple examples of Pharma funding basically useless studies which are mundane and repetitive. The purpose: if the paper is published it acts as advertising for their product. I can also cite marketing efforts to promote "me to" drugs that are vastly more expensive than the perfectly good generic alternatives.
It is true that the problem with IRBs is that they are honor system based. Ditto the peer-reviewed basis for manuscript acceptance in scientific journals. Nevertheless, my experiences with Big Pharma has been somewhat different from what the author describes. When involved with a new drug investigation (especially Phase II or III studies) I found industry supervision and review of my results has been has been extremely thorough. Auditors were constantly looking over my shoulder. Probably because all this data would eventually go to the FDA.
On the other hand I can cite multiple examples of Pharma funding basically useless studies which are mundane and repetitive. The purpose: if the paper is published it acts as advertising for their product. I can also cite marketing efforts to promote "me to" drugs that are vastly more expensive than the perfectly good generic alternatives.
5
If you talk to doctors in the Twin Cities, you sense they believe the Minnesota medical school is in a state of decline.
9
It seems to me Mr. Elliott has an ax to grind in presenting a narrow "analysis" of what's wrong with medical human subject research and IRBs. Sure, some good points, but its easy to criticize from the peanut gallery, and typical, no concrete suggestions on how to fix it or the next logical steps. Elliott should do some actual research on the matter then blather on about easily accessible information/opinions.
3
Wow. I hope / trust that Dr. Elliott checked with a good whistle-blowers' attorney before he submitted this article for publication. More frontline, ground level employees should be willing to tell it like it is. But we live in fear of losing our jobs.
4
What a grim story! All the cartoons of the mad scientist and the evil psychiatrist suddenly given flesh and writ large! I just hope Prof Elliott has tenure, lest he finish his working life asking Do you want fries with that!
4
Cover ups and lack of oversight also exist in many of our most powerful institutions: the Catholic Church, Wall Street, the CIA, local police departments, etc.
How hard it is for a society to value and ensure oversight and integrity when those in power are able to prevent it.
How hard it is for a society to value and ensure oversight and integrity when those in power are able to prevent it.
8
Very true. Don't forget the widespread corruption throughout our nation's family court system, where parents are routinely fleeced for everything they own and more than 58,000 kids each year in America are taken from a safe protective parent and forced to live with their identified rapist, batterer or molester. The divorce courts is this country operate above all oversight as well.
It's the same everywhere; just better-hidden.
3
In today's world an entire agency (like the FDA)—with muscle and manpower and teeth—is needed to oversee research. [And while we're at it, we can also give the FDA the necessary muscle, manpower, and teeth to do its job, and that would also include a separate division for regulating the often fraudulent supplement industry.]
A physician MD
A physician MD
3
Hopefully, the Patients are able to gain substantial settlements for their damages. That should demand the attention of the University and their insurance company who will pay the damages. The Insurance company should send in their Auditors and dictate higher standards before they insure the University again. However, the insurance industry is a Capitalist industry which translates into a different insurance company agreeing to insure the University if the first Insurance company refuses. There is always a salesman waiting to take over a risky client and gain a commission.
In the end, the Government needs to make the penalty sufficiently severe to seriously hamper the program and punish the institution. Unfortunately, this is the formula that works. I personally wish we did not need a big Government but without it, the schemers will scheme and unethical will do harm. It's disheartening.
In the end, the Government needs to make the penalty sufficiently severe to seriously hamper the program and punish the institution. Unfortunately, this is the formula that works. I personally wish we did not need a big Government but without it, the schemers will scheme and unethical will do harm. It's disheartening.
1
Thank you to Carl Elliott to shining a light on these problems! I left the world of academic research for exactly these reasons, and I can attest that academia is just as corrupt, if not more so, than industry research.
"It’s also that researchers themselves are often given powerful financial incentives to do unethical things"
In academia, it's not just financial incentives, but ability to obtain tenure, and then prestige. People are just as greedy as the private sector, but instead of just chasing money, they want influence, connections, security, and other lavish perks that are not accessible to people outside of academia.
Academia is just as corrupt as the worst parts of our society, but they live in an exalted space because the powerful media, spurred by liberals, refuse to look at the problems that occur there.
The NY Times even points this out in this excellent article:
http://www.nytimes.com/2015/05/26/science/maligned-study-on-gay-marriage...®ion=top-news&WT.nav=top-news
Everyone who condemns republicans for being "anti-science" should realize that the "science" they are holding up as gospel is often as worthless as an advertisement or an infomercial. That occurs most often in the "soft sciences" like psychiatry, sociology, economics, etc, which are the sources of most of the research that the left uses to advance their agenda.
"It’s also that researchers themselves are often given powerful financial incentives to do unethical things"
In academia, it's not just financial incentives, but ability to obtain tenure, and then prestige. People are just as greedy as the private sector, but instead of just chasing money, they want influence, connections, security, and other lavish perks that are not accessible to people outside of academia.
Academia is just as corrupt as the worst parts of our society, but they live in an exalted space because the powerful media, spurred by liberals, refuse to look at the problems that occur there.
The NY Times even points this out in this excellent article:
http://www.nytimes.com/2015/05/26/science/maligned-study-on-gay-marriage...®ion=top-news&WT.nav=top-news
Everyone who condemns republicans for being "anti-science" should realize that the "science" they are holding up as gospel is often as worthless as an advertisement or an infomercial. That occurs most often in the "soft sciences" like psychiatry, sociology, economics, etc, which are the sources of most of the research that the left uses to advance their agenda.
2
Ah, yes - the corruption of academia by powerful corporate interests, that believe in profits above all else. Obviously the work of the liberals!
2
The good and brave Dr. Elliott might ask a broader question, namely whether or not the entire medical establishment has come to be directed by economic interests over the needs of patients. Whenever I pass a hospital, sadly I see a factory.
10
Lack of integrity seems pretty widespread in our nation. Example after example can be seen by just reading the Times each day. Recently a CEO of one of our large banks responded to exposure of the bank's stealing by saying it was an embarrassment. Really! steal a loaf of bread and go to jail. Steal billions of dollars and pay a fine but simply be embarrassed.
16
Until the cost of drugs is tied to their proven effectiveness in *independently-funded studies*, the madness will continue.
11
At the U, there have been other whistle-blowers, including a dear friend whose career was all but destroyed because she chose to speak up. While Carl Elliot's remarks are most welcome and so necessary, they are too long in coming.
When big money is involved, ethics go out the window. We here in L'Etoile du Nord know all too well that academic integrity takes a back seat to funding. We see it in the athletic programs, we see it in departmental politics, and we see it in the medical school....endlessly. And even with all that exposure, no one does anything to call a halt to the institutional abuse.
How can we educated the next generation of scientists if they are being taught their research depends on pleasing the funding commercial interests instead of tell them the truth?
There are lives at stake, people. This is not harmless.
http://wifelyperson.blogspot.com/
When big money is involved, ethics go out the window. We here in L'Etoile du Nord know all too well that academic integrity takes a back seat to funding. We see it in the athletic programs, we see it in departmental politics, and we see it in the medical school....endlessly. And even with all that exposure, no one does anything to call a halt to the institutional abuse.
How can we educated the next generation of scientists if they are being taught their research depends on pleasing the funding commercial interests instead of tell them the truth?
There are lives at stake, people. This is not harmless.
http://wifelyperson.blogspot.com/
31
Sadly, we already have a geat deal of "self-certification" in the meatpacking and coal mining industries--as well as construction and food "supplements." That's one of the reasons we have regular scandals, such as the murderous mining and E. coli deaths. While there are claims that there's too much regulation, it often applies to the paperwork that companies mush file rather than the actual number of *random* (rather than occasional forewarned) inspections). These scandals will continue until corporate money is taken out of political elections and the abilities of poor, working-, and middle-class people who are the most affected by these morally abhorrent act are heard.
10
The author "...hope[s] the situation at..Minnesota..is exceptional..." It's not. Nor is money an exceptional motivation. Ego and prestige work just as well. I know. I'm a former math professor.
I have taught at an "elite" school and at a state regional school. In both instances, I have seen outrageous unethical behavior. I have seen:
students fooled that they were getting an education;
a young professor's reputation attacked by established professors who wanted to quiet the young professor - while they stole his groundbreaking work;
professors grant totally unwarranted doctorates - only so they could bring in grant money to meet a critical "national need" for American math PhDs.
It goes on from there.
The problem of the capture of higher education by scoundrels comes from the free ride we give people in academics, thinking that they are seekers of truth. Some are, but as I tell my students, people who seek truth as a career are not necessarily truthful people.
It takes an inside observer to see all the dots, but then it is easy to connect them. That's why I write a blog inside-higher-ed . That is where you will find the documented story of how and why students get fooled (A Tale Out of School), or the documented story of "The Purloined Proof".
It is time people outside the academy become outraged. It 's not a parochial phenomena. As the op-ed above this one tells, it effects all of us. (The connection is made clear on my site.)
I have taught at an "elite" school and at a state regional school. In both instances, I have seen outrageous unethical behavior. I have seen:
students fooled that they were getting an education;
a young professor's reputation attacked by established professors who wanted to quiet the young professor - while they stole his groundbreaking work;
professors grant totally unwarranted doctorates - only so they could bring in grant money to meet a critical "national need" for American math PhDs.
It goes on from there.
The problem of the capture of higher education by scoundrels comes from the free ride we give people in academics, thinking that they are seekers of truth. Some are, but as I tell my students, people who seek truth as a career are not necessarily truthful people.
It takes an inside observer to see all the dots, but then it is easy to connect them. That's why I write a blog inside-higher-ed . That is where you will find the documented story of how and why students get fooled (A Tale Out of School), or the documented story of "The Purloined Proof".
It is time people outside the academy become outraged. It 's not a parochial phenomena. As the op-ed above this one tells, it effects all of us. (The connection is made clear on my site.)
12
As an escapee of The Academy, I can verify all your observations. It's a genuine disaster and emergency- we live now in a world entirely dependent on "technology", in all it's various incarnations; and we can no longer trust the word of our designated authorities. They lie; often.
Personally I cannot disentangle "money" from "ego" and "reputation" now. While there are still true scholars whose reputation depends on their work, the great majority of professors' egos and reputations are now entirely dependent on their salary. "Mine is bigger than yours" is easily established in that world, whereas comparing scholarship across fields is vastly more difficult; made more so by the fact that most (I believe) genuine scholars are deeply uninterested in their reputation; it's the work that's important.
Personally I cannot disentangle "money" from "ego" and "reputation" now. While there are still true scholars whose reputation depends on their work, the great majority of professors' egos and reputations are now entirely dependent on their salary. "Mine is bigger than yours" is easily established in that world, whereas comparing scholarship across fields is vastly more difficult; made more so by the fact that most (I believe) genuine scholars are deeply uninterested in their reputation; it's the work that's important.
1
It is quite possible to have adequate review and protection using the IRB model, IF the university's administration is willing to support the IRB's efforts, administratively and financially. At the institution where I chaired the IRB we had a major scandal, not unlike what occurred at Minnesota. It did serve as a wake-up call for the school. The President and the deans provided facilities and funds for an infrastructure that not only enhanced initial review but follow-up reviews and announced and unannounced audits of the studies.
Having said that, we got what we needed because of the scandal and by convincing the university that the alternative would be much worse. The old proverb makes the point.."hit them over the head with a 2x4. Once you have their attention, show them what you want." The system developed has been refined and improved, but make no mistake, it requires constant vigilance.
Having said that, we got what we needed because of the scandal and by convincing the university that the alternative would be much worse. The old proverb makes the point.."hit them over the head with a 2x4. Once you have their attention, show them what you want." The system developed has been refined and improved, but make no mistake, it requires constant vigilance.
46
IRBs have the right to monitor research and the consent process. They have the right to impose restrictions and suspend research protocols. The fact that the UM IRB did not perform its duties is not a reason to do away with the IRB system; it is a call for the UM IRB to function as it is supposed to function. Unfortunately, institutional support is essential to the proper functioning of an IRB. Clearly that institutional support was completely missing here.
54
The institutions are only as good as those manning them. The IRB system works well at my institution. I think the reason it does is that it has the support of the university and a group of committed people staffing the system.
2
As taxpayer contribution to biomedical research dwindle (NIH budget adjusted for inflation keeps coming down year after year) universities and medical schools are depending more and more from pharmaceuticals and biotech companies to keep research going. There is an obvious conflict of interest between reporting unbiased scientific facts and a company need to hype their products. Thus, an increase in cases of unethical or questionable research is to be expected. At the end you get what you pay for and the companies that fund research certainly want something in return.
133
Industry sponsored clinical research is now requiring universities to use one of their "central" IRBs in order to qualify for participation. The university's IRB reviews the central IRB to see if it's acceptable and then signs an agreement turning over that function to the pharmaceutical's contracted IRB services company. Sure sounds like a great big work around the entire IRB concept to me. The more bureaucratic we become, the more slippery ethics become....."we're not in charge so what can we do?"
4
As a former biotech executive, I take great exception to the ever popular assumption that companies basically buy positive results from researchers and institutions performing clinical trials on their drugs. Perhaps some companies do this, but they are only fooling themselves if they seek misleading or fake results from poorly treated trial participants or subjects who don't meet diagnostic criteria. In addition to being completely unethical and possibly illegal, these studies cost a fortune and results from mistreated or misdiagnosed subjects or faking data is a very short term strategy that will nearly always lead to even greater wasted costs on subsequent failed trials. Just like most researchers don't do these things, neither do most companies.
23
California (UC) has rolled the dice and thrown in with commercializing, allowing professors to start companies. I'd bet my house shorting UC stock if I could, it's not if, but when that decision will foster a disaster of biblical magnitude, or many smaller ones.
The image that comes to mind is the guy in Catch 22 reaching for his parachute and finding a stock certificate in it's place, then finding the same thing in the first aid kit while the airman bleeds to death.
The image that comes to mind is the guy in Catch 22 reaching for his parachute and finding a stock certificate in it's place, then finding the same thing in the first aid kit while the airman bleeds to death.
3
Thank you Dr. Elliot for the peek up the pedalogical petticoat. Unfortunately the cited rot in medical research is pervasive in many other universities and is not limited to any one sector. At the core is the system of tenure and the abuse of so called academic freeedom that insulate the bearers from the consequences of their actions. The far left political agenda is rewarded and dissenting opinions are punished with impunity. The high salaries subsidized by government loans and grants have led to a system of debt ridden students. College atheletics rife with abuse and scandal are driven by independent jock sniffing Athletic Associations. Meanwhile the students are taught by incoherent and underpaid OPS foreign graduate students while the faculty is away at conferences, meetings, university politics or sucking up to the federal or private fund largess. Universities do not exist for the sole benefit of the faculty, but voice that at a faculty meeting and you will be targeted as a traitor.
1
Of course they don't exist for the benefit of faculty. Administration is more like it.
1
Mr. Schwartz seems to blame faculty for almost all problems at universities, including corrupt sports programs--yet almost all faculty I know are against corrupt sports programs. Tenure, which Mr. Schwartz condemns, is indeed one of the only things that protects faculty who dare to speak out against problems at universities--like the author of this article has done here...
1
Institutional corruption is an epidemic and it all follows the same pattern. Corruption, fraud, negligence take place. A few brave souls bring it to the attention of those running the Institution who immediately go into protecting the Institution from outside review, most often going after the whistle blowers. The single overriding goal is protecting the Institution at the expense of integrity, truthfulness and to put it in lay terms, doing what they are really supposed to be doing.
Look at the NSA (or VA, or UNC, or police etc.). It broke the laws for decades, spying on its citizens, while its head lied to Congress and the People at a hearing under oath. Seems pretty serious right. So how did the Chief Executive--Pres. Obama--respond. James Clapper remains dutifully employed with a shout out of full confidence in his performance. The man who exposed the lies and law breaking--Ed Snowden--he is in exile in Russia facing Espionage Charges.
The lesson learned--if you expect to make it up the food chain in an Institution understand your only responsibility is protecting the Institution and destroying anyone who tries to expose corruption, lying, etc. The survival of the Institution is paramount.
Institutions are merely a collection of individuals. Unfortunately, the vast majority forget, or don't care, about what they are really supposed to be doing for the public good.
Look at the NSA (or VA, or UNC, or police etc.). It broke the laws for decades, spying on its citizens, while its head lied to Congress and the People at a hearing under oath. Seems pretty serious right. So how did the Chief Executive--Pres. Obama--respond. James Clapper remains dutifully employed with a shout out of full confidence in his performance. The man who exposed the lies and law breaking--Ed Snowden--he is in exile in Russia facing Espionage Charges.
The lesson learned--if you expect to make it up the food chain in an Institution understand your only responsibility is protecting the Institution and destroying anyone who tries to expose corruption, lying, etc. The survival of the Institution is paramount.
Institutions are merely a collection of individuals. Unfortunately, the vast majority forget, or don't care, about what they are really supposed to be doing for the public good.
2
The fraud, chicanery, the operation of state institutions as businesses rather than state funded entities for the common wealth of the people is a microcosm for the macrocosm we all know as the United States of America.
3
How can you have just IRBs and no compliance office? IRBs review protocols; the complince office makes sure the protocols are being followed.
2
Dr. Elliot appears to be calling for greater power for IRBs to regulate, or a greater role within the institution, but I fear his concerns may be applicable only to the University of Minnesota, which by his description, is seriously flawed. Any researcher (Principal Investigator or Co-I) who broke IRB rules where I've worked was fined, placed on administrative leave, or fired. My experience is that IRBs exist less to protect subjects and more to protect the institutions with which researchers are affiliated. Maybe the issue isn't the lack of power within the IRB, but the lack of will at Univ. of Minn to confront the culture within the department of Psychiatry within the college of Medicine. Its easy to blame a body with oversight duties for the failings of a research culture that reside within the college of medicine.
66
" Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners."
That is a fairly apt description of how banks and financial institutions are regulated. They report numbers to the government, and the government assumes the numbers are true. The government couldn't verify the numbers if they tried, because unlike the coal mine there is nothing physical to see.
That is a fairly apt description of how banks and financial institutions are regulated. They report numbers to the government, and the government assumes the numbers are true. The government couldn't verify the numbers if they tried, because unlike the coal mine there is nothing physical to see.
183
I think that's a fairly apt description of how we actually do regulate meatpacking and coal mines, sadly. Some inspections, but way too few.
3
Guess what? The Dept. of Transportation, the Federal Railroad Agency, the Federal Mine Safety Inspection system, on and on are and have been run this way for many years. I worked an underground uranium mine that was inspected for required air flow and the mine knew the inspectors were coming every time. So miners were told to stay out of the main drift tunnels and raises so as to maximize air flow while the monitors were measuring. Also, blatantly fraudulent data was sent in to the DOT when I worked for a major railroad that was required to participate in a large environmental impact study years ago. There was no secret about what was going on.
That is what is most disgusting: when regulatory capture reaches the point where all are expected to take part in an ongoing sham, including agencies and government organs with oversight and police powers.
[Note: see the CBS interview of Scott Pelley with the Director of the FBI Comey several months ago where Comey states for the record that he will not be dragged into any investigation that might be sensitive to Congress UNLESS he has appellate court decisions protecting his agency from possible Congressional ire. His budget is what is important.]
That is what is most disgusting: when regulatory capture reaches the point where all are expected to take part in an ongoing sham, including agencies and government organs with oversight and police powers.
[Note: see the CBS interview of Scott Pelley with the Director of the FBI Comey several months ago where Comey states for the record that he will not be dragged into any investigation that might be sensitive to Congress UNLESS he has appellate court decisions protecting his agency from possible Congressional ire. His budget is what is important.]
3
It is important is to find better ways to distinguish the risk level of different studies. I have submitted studies at my current and other R1 universities. IRBs vary, but I have found an extraordinary amount of scrutiny for voluntary survey research on healthy, non-incarcerated adults (e.g. low risk). Every line of a recruitment email is scrutinized and it can take months for a very simple study to be approved. If similar rigor is applied to high risk studies (e.g. where a substance is ingested, or medical procedure, or a high risk population), it is shocking to me that the studies described here were approved.
59
The answer to all this madness is in the lyrics of that catchy Cabaret number, "Money makes the world go 'round." Follow the money, folks. it's where most of the madness is happening.
27
"A great grey mediocrity" it was call by Dean of the Institute of Technology Athelstan Spilhaus, The university has alway been a mess. I have little interest in going back there as an alum. There was much to be said for the quality of the staff and the overall experience, yet it was dumbed down by bureaucracy. Evidently not much has changed.
13
"In what other potentially dangerous industry do we rely on an honor code to keep people safe?"
Well, actually, just about every industry, but most notably, the prison industrial complex.
This is understandable when one considers that the Western mode of thinking is to categorize things as either good/bad. Honorable people behave well, and some people are just bad.
It's true that some people are without conscience, but the majority of people want to do the right thing. The problems start when we further assume that humans are RATIONAL beings; in fact, humans are RATIONALIZING beings with a strong impulse to maximize their own self-interest.
Once you change the underlying flawed assumption about how humans operate, it becomes absurd to assume that any industry should engage in self-policing, whether one is talking about law enforcement, Wall Street, education, politics, etc...
I really doubt there is anything unique about the University of Minnesota.
Well, actually, just about every industry, but most notably, the prison industrial complex.
This is understandable when one considers that the Western mode of thinking is to categorize things as either good/bad. Honorable people behave well, and some people are just bad.
It's true that some people are without conscience, but the majority of people want to do the right thing. The problems start when we further assume that humans are RATIONAL beings; in fact, humans are RATIONALIZING beings with a strong impulse to maximize their own self-interest.
Once you change the underlying flawed assumption about how humans operate, it becomes absurd to assume that any industry should engage in self-policing, whether one is talking about law enforcement, Wall Street, education, politics, etc...
I really doubt there is anything unique about the University of Minnesota.
28
Carl Elliott is absolutely correct in his condemnation of the University of Minnesota's culture of coverup. This continuing disgrace is, in part, a result of University administrations and their attorneys that are interested in protecting the reputation of the institution, the U, as Minnesotans refer to it, as well as protecting their own positions of power and their exalted salaries. With few exceptions, faculty members do not give a damn and the Faculty Senate's Consultative Committee serves as a shill for the administration. It is time for genuine reform and serious change, from the top down.
22
as an alum of U of M, and someone who knows the byzantine waysmof university cultures, I would suggest that the only hope for change comes not from the top ranks who have denied, lied and hidden, but from the bottom up -- faculty, students, alumni and DONORS -- unified and individually demanding that the governing Boatd and the governor mandate change. Those who spent years hiding are not the ones who will now suddenly see the light and change their ways. U of M's destruction of its reputation affects all of us at the grass roots, and the taxpayers of Minnesota as well. The masses must speak.
3
"The ethical problem today is not merely that these corporations have plenty of money to grease the wheels of university research. It’s also that researchers themselves are often given powerful financial incentives to do unethical things" This is by design, there is no such thing as corporate ethics.
9
How much does the so called Christian Community interferes with real science?
1
The writer is correct.
An independent body with the authority to monitor research by speaking with real researchers, research coordinators, subjects and directly observing procedures is the only way to truly protect research subjects.
Look what the writer is saying;
Some investigators already make subtle comments about the IRB intruding into their work, implying a contempt and an egocentricity that can be dangerous to subjects. Investigators with ego problems can communicate contempt for IRB members, implying that they can't possibly understand the science at a required level of sophistication.
Tenure decisions rest on successful completion of research studies, and a researcher can say to a research coordinator--don't ask questions. Do your job.
The comment near the end is especially true. What happens to make university officials, probably nice, intelligent people, frozen and unable to act to censure and remove an investigator for misconduct? What ever might be the psychological explanation, the current system doesn't work reliably every time.
Possibly the Joint Commission might have the muscle and the structure to take on this independent monitoring function. Have they solved the situation of health care workers reluctance to speak up about problems because jobs will be in jeopardy? Maybe you get around that by having very informed investigators, capable of imagining the worst, asking pointed questions, including questions for research subjects themselves.
An independent body with the authority to monitor research by speaking with real researchers, research coordinators, subjects and directly observing procedures is the only way to truly protect research subjects.
Look what the writer is saying;
Some investigators already make subtle comments about the IRB intruding into their work, implying a contempt and an egocentricity that can be dangerous to subjects. Investigators with ego problems can communicate contempt for IRB members, implying that they can't possibly understand the science at a required level of sophistication.
Tenure decisions rest on successful completion of research studies, and a researcher can say to a research coordinator--don't ask questions. Do your job.
The comment near the end is especially true. What happens to make university officials, probably nice, intelligent people, frozen and unable to act to censure and remove an investigator for misconduct? What ever might be the psychological explanation, the current system doesn't work reliably every time.
Possibly the Joint Commission might have the muscle and the structure to take on this independent monitoring function. Have they solved the situation of health care workers reluctance to speak up about problems because jobs will be in jeopardy? Maybe you get around that by having very informed investigators, capable of imagining the worst, asking pointed questions, including questions for research subjects themselves.
14
It is unclear how the fundamental working mechanics of IRB or other established general regulatory systems have been inadequate and led to the examples at U of Minn. More unique/ specific for the stated examples rather than general failure that mandates across the board changes at all other places and instances?. It is a gross mischaracterization and sensationalist attempt to say all regulations while performing studies are based only on initial IRB 'honor code' system. Besides the IRB, the PRCs, ongoing QARC audits, DSMBs etc add to the the well-known layers of regulatory shackles that while being onerous clearly help to minimize ethical and regulatory mistakes. An article that could benefit from a more balanced perspective.
16
A horrifying piece. Thank you for this honest description and assessment of the bad and worsening consequences of having allowed medical and other academic research to be bought by industry. Those who continue to insist that unfettered private sector captalism is the best solution for all things should take careful note of this peek into a very small part of a huge, nation-wide crisis.
40
Peoples’ judgment at higher levels of education, from corporations, governments and their agencies remain mostly infected with a THINKING VIRUS that they are right, so anything else must be wrong. However, peoples’ motivation at all levels live infected with a GREED VIRUS that they are entitled. What is theirs is theirs and what is yours is theirs. Governments and corporations perpetuate the idea by drawing lines and saying this is yours, until we can take it away from you.
The Greed virus is in all segments and classes of the people in the world. It amazes me how many see them, but feel they only exist in their discipline. These viruses are everywhere and globally out of control. It takes something more than knowledge and experience to move ahead wisely. We need strategies and tactics that can only come from a moral culture dedicated to improving our world. Currently it does not exist, but we have to reset somewhere. Let's start in our homes, schools and places for teaching values.
The Greed virus is in all segments and classes of the people in the world. It amazes me how many see them, but feel they only exist in their discipline. These viruses are everywhere and globally out of control. It takes something more than knowledge and experience to move ahead wisely. We need strategies and tactics that can only come from a moral culture dedicated to improving our world. Currently it does not exist, but we have to reset somewhere. Let's start in our homes, schools and places for teaching values.
9
I am ashamed of my specialty of psychiatry. All too often, our leaders prostitute themselves to Big Pharma. Even our diagnostic manual (the "DSM") is influenced by the pharmaceutical industry, which promotes the lie that psychiatric illnesses are purely "brain diseases," along with downplaying the important psychological dimensions of these illnesses.
Clinical Professor of Psychiatry, Georgetown University School of Medicine
Clinical Professor of Psychiatry, Georgetown University School of Medicine
155
Like Dr. Elliott, you are one of the good guys, Dr. Waugaman--not afraid to stand and be counted when you point to malfeasance. People are selling their souls way to readily and much to cheaply--for dollars.
2
It's why I would refuse treatment for myself or my children with any kind of psychoactive medication.
Thank you, doctor. Unfortunately the prostitution to Big Pharma is endemic to the entire heath care system. Psychiatry is the easiest target, but when even medical journals carry drug ads and pre- "sell" reprints to the drug industry, we are all lost.
I'm a victim of this system in the form of massive overprescription of statin drugs. You can google "statin myopathy" and find my initial crude attempt at a blog--which gets over 1000 views a month. (Can anyone help me with designing a blog or something?)
Recently I got briefly hospitalized due to statin damage, and since I don't want TV at home, I was absolutely shocked by the amount of Big Pharma advertising on TV. From these ads, I discovered that I have at least a dozen diseases that require medication. At the end of the ads it told to "ask my physician if this drug is right for you." Tell me doctor, are these drugs right for me?
I'm a victim of this system in the form of massive overprescription of statin drugs. You can google "statin myopathy" and find my initial crude attempt at a blog--which gets over 1000 views a month. (Can anyone help me with designing a blog or something?)
Recently I got briefly hospitalized due to statin damage, and since I don't want TV at home, I was absolutely shocked by the amount of Big Pharma advertising on TV. From these ads, I discovered that I have at least a dozen diseases that require medication. At the end of the ads it told to "ask my physician if this drug is right for you." Tell me doctor, are these drugs right for me?
4
"Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners."
I take it the author was being sarcastic, because in the case of slaughter houses (more deceptively labelled "meatpacking,") this most certainly happens.
The author also fails to mention the lack of oversight and unbounded cruelty inflicted on non-human animals in the name of research. Those horror stories would stay with you forever.
I take it the author was being sarcastic, because in the case of slaughter houses (more deceptively labelled "meatpacking,") this most certainly happens.
The author also fails to mention the lack of oversight and unbounded cruelty inflicted on non-human animals in the name of research. Those horror stories would stay with you forever.
32
"In what other potentially dangerous industry do we rely on an honor code to keep people safe?"
Unfortunately, the anti-regulation trends pushed as too expensive for business have brought us to the brink of unsafe food, dangerous power plants and pandemics from people afraid of vaccination. The University of Minnesota is just the tip of the iceberg and we are the Titanic...
Unfortunately, the anti-regulation trends pushed as too expensive for business have brought us to the brink of unsafe food, dangerous power plants and pandemics from people afraid of vaccination. The University of Minnesota is just the tip of the iceberg and we are the Titanic...
53
I believe we rely on the auto industry to issue recalls on vehicles. That often doesn't happen until someone -- or many people -- die as a result of a mechanical failure they had known about for years. That's the price we pay for the pro-profit, pro-industry deregulaters.
1
Finally, some insider has the courage to point out the problems and corruption we are facing in medical "research".
Industry and researchers hide the results in plain site behind the jargon like NNT, and our blind faith in "studies", is the cause of so many drugs and tests ending up causing more harm then good, and provide fuel to litigation industry.
Thank you for doing that.
Industry and researchers hide the results in plain site behind the jargon like NNT, and our blind faith in "studies", is the cause of so many drugs and tests ending up causing more harm then good, and provide fuel to litigation industry.
Thank you for doing that.
42
These sorts of transgressions harm us all in that they cast doubt on all research and researchers, and give ammunition to those who would deny science in favor of their own prejudices, belief systems, and political interests. If scientists want to protect their own reputations, and not be tarred with the failures of their more ambitious and less ethical colleagues, they must do a better job of rooting out and casting out those who "sell their birthright for a bowl of porridge" at the hands of the drug companies, and other big money interests.
51
It's sad that at the same time the university officials were hiding the internal investigation, they were piously preaching the principles of academic honesty to their undergraduates and threatening them with expulsion. What a sham!
Institutions that behave this way forfeit their public trust. Therefore, I suggest that before we choose the nuclear option and impose fully independent oversight bodies on academic research, we simply publish incidents of fraud and abuse for each institution in the college rankings along with graduation rates and teacher/student ratios. Then let college applicants decide whether they want to be forever associated with a disgraced alma mater (Penn State, anyone?).
Another remedy might be to penalize the institution in the federal granting process. Any grant application coming from an institution with a record of recent abuses automatically gets points deducted from it. That should get someone's attention -- and fast.
Institutions that behave this way forfeit their public trust. Therefore, I suggest that before we choose the nuclear option and impose fully independent oversight bodies on academic research, we simply publish incidents of fraud and abuse for each institution in the college rankings along with graduation rates and teacher/student ratios. Then let college applicants decide whether they want to be forever associated with a disgraced alma mater (Penn State, anyone?).
Another remedy might be to penalize the institution in the federal granting process. Any grant application coming from an institution with a record of recent abuses automatically gets points deducted from it. That should get someone's attention -- and fast.
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Why are fully independent oversight bodies on academic research a "nuclear option"?
2
Thank you Dr. Elliott for blowing the whistle loudly and clearly. This mistreatment of the participants in these drug studies is appalling, if not criminal. As a person who conducts research with human subjects, I consider the treatment of each individual to be sacrosanct and if there are researchers who are mistreating their subjects they should be banned from conducting research.
It also does sound like the University of Minnesota needs an independent IRB that actively oversees the proper use of human subjects in research, or the research should be outsourced to research companies that monitor and perform quality control on the field work as it is occurring.
It also does sound like the University of Minnesota needs an independent IRB that actively oversees the proper use of human subjects in research, or the research should be outsourced to research companies that monitor and perform quality control on the field work as it is occurring.
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@swm
The time for "independent IRBs" is past, and it is time for more government control and oversight. It is ironic that universities, the fuel for our country's liberalism, call for greater government control of the private sector at the same time that they resist government oversight, let alone accountability, for their activities.
The time for "independent IRBs" is past, and it is time for more government control and oversight. It is ironic that universities, the fuel for our country's liberalism, call for greater government control of the private sector at the same time that they resist government oversight, let alone accountability, for their activities.
I applaud the bravery of Dr. Elliot for writing this piece. Ethics in research is becoming a scarce commodity. Simultaneously, more and more professionals of every stripe are parroting the phrase "evidence-based," which is truly meaningless in the way it is being used. It will take more people like Dr. Elliot, willing to stand up and speak the truth, because we can no longer rely on self-regulation. After all, the therapeutic world has done away with shame, labeling it all as toxic. But there are times when people need to feel the sting of shame, which gives them an opportunity to ask: "Is this who I want to be?"
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This story appears on the NYTimes website on the same day an article about a controversy about a paper that appeared in Science about an influential study on polling. In that case, all of the independent protections that are supposed to prevent esteemed scientific publications from publishing nonsense were cast overboard for one reason or another.
You can have independent or dependent boards, industry or government funded studies, but no system will work if those who manage it are not vigilant, approach all study results with healthy skepticism, and, especially in small scientific communities, do not let their friendships or ambitions get in the way of good scientific practice, and most importantly, they turn in those whom they know are bending the rules. Good luck with that last one, by he way.
You can have independent or dependent boards, industry or government funded studies, but no system will work if those who manage it are not vigilant, approach all study results with healthy skepticism, and, especially in small scientific communities, do not let their friendships or ambitions get in the way of good scientific practice, and most importantly, they turn in those whom they know are bending the rules. Good luck with that last one, by he way.
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Unfortunately, this will continue to be a problem, now that SCOTUS has given us "Citizen Pharma", with all the rights of an individual.
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"It’s also that researchers themselves are often given powerful financial incentives to do unethical things: pressure vulnerable subjects to enroll in studies, fudge diagnoses to recruit otherwise ineligible subjects and keep subjects in studies even when they are doing poorly."
Worse than all of these are the consequences of dishonest research, its impact on regulatory bodies like the FDA, and its impact on the millions of unsuspecting ultimate drug consumers. Think of all the drug scandals, drugs that got to market, and in many cases stayed there, despite growing questions about efficacy or even harm. Think about the current manufacturer-induced mania for prophylactic use of statins to suppress serum cholesterol, worth billions of dollars annually to the various manufacturers in "powerful financial incentives".
Also, dishonest research results lead other researchers down blind alleys in a cruel waste of time, money, and talent.....science is complex structure of work where we depend on the honesty of previous workers in determining our own courses of research....fortunately, fraud will ultimately out in science; unfortunately, not so in some other fields, like politics.
Worse than all of these are the consequences of dishonest research, its impact on regulatory bodies like the FDA, and its impact on the millions of unsuspecting ultimate drug consumers. Think of all the drug scandals, drugs that got to market, and in many cases stayed there, despite growing questions about efficacy or even harm. Think about the current manufacturer-induced mania for prophylactic use of statins to suppress serum cholesterol, worth billions of dollars annually to the various manufacturers in "powerful financial incentives".
Also, dishonest research results lead other researchers down blind alleys in a cruel waste of time, money, and talent.....science is complex structure of work where we depend on the honesty of previous workers in determining our own courses of research....fortunately, fraud will ultimately out in science; unfortunately, not so in some other fields, like politics.
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Wow, I bet the author is about as welcome as a case of hives around the Center for Bioethics these days. I adore people who can and will speak courageously and with little regard for their own security.
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I agree that Dr. Eliot was courageous in speaking the truth. Like you, I have no doubt that there are faculty members who are avoiding him like the plague. I'm also sure that he probably has tenure and was therefor empowered to say whatever he wanted without fear of losing his position and/or salary. Tenure might keep some of the deadwood around beyond their time, but it also provides the insurance necessary for faculty to become whistle blowers and truth tellers. Even with its flaws, the tenure system has to be kept in place.
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My first thought, after reading the first two paragraphs, was "This guys is SO. FIRED."
Large institutions -- police departments, the military, and, alas, universities -- are so often more interested in protecting their own reputations than in protecting the people they are meant to serve. The handling of rape cases on campus and in the military is one shameful example. Several questions come to mind: Have there been, or will there be, any criminal charges filed against any of the "researchers," particularly in the case of the young man's death? And how will the University punish you, Dr. Elliott, for your unusual honesty? Never mind the ethics code; you have broken the code of silence.
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Lisa, you ask to what can we attribute the author's 'unusual honesty'? I'll tell you. In addition to possessing a very fixed moral and ethical backbone the author has TENURE. It seems that anachronistic privilege that those on the right like to carp about actually serves a purpose. Come to think of it, this case is precisely why those folks don't like the concept of academic freedom; it allows those of us in the fact-based community to speak truth to power.
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Unfortunately, as the number of tenure-track professors is being reduced by contract adjuncts to save university lots of money, fewer people at universities can speak truth. Democracy in higher education diminishes as we speak. Naturally universities will need more administrators to hold the fire down. And yet, college tuition continues to rise along with textbooks. What do students and taxpayers benefit from this?
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