"Study ethics, NIH!"

The government agency tasked with funding crucial life science research needs to focus more attention on ethical quandaries and nefarious business practices that often obscure the path from discovery to public benefit, says a strongly worded linkurl:letter;http://www.pharmedout.org/NIHLetter.pdf to linkurl:Francis Collins,;http://www.nih.gov/about/director/index.htm the director of the National Institutes of Health (NIH), signed by more than 100 biomedical researchers, journal editors, and healt

By | November 17, 2009

The government agency tasked with funding crucial life science research needs to focus more attention on ethical quandaries and nefarious business practices that often obscure the path from discovery to public benefit, says a strongly worded linkurl:letter;http://www.pharmedout.org/NIHLetter.pdf to linkurl:Francis Collins,;http://www.nih.gov/about/director/index.htm the director of the National Institutes of Health (NIH), signed by more than 100 biomedical researchers, journal editors, and health care administrators in the US. "...we ask that you acknowledge the research gap on the effect of conflicts of interest and commercial influence on medical decision making," the letter reads, "and set in motion a process that leads to recognition of the importance of funding studies on research ethics, the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge." "It would be great to raise [the NIH's] awareness, and maybe have them actually do an RFA [request for applications] on this," said linkurl:Adriane Fugh-Berman,;http://fugh-berman.com/index.htm director of PharmedOut, a group seeking to educate physicians on how the pharmaceutical industry influences prescribing practices, which spearheaded the writing and dissemination of the letter. linkurl:PharmedOut,;http://www.pharmedout.org/ based at Georgetown University's School of Medicine, launched three years ago with the help of a chunk of the $430 million settlement drug maker Pfizer paid in 2004 after pleading guilty to encouraging the off-label prescription of its anti-seizure drug Neurontin. Fugh-Berman, who is also an associate professor in Georgetown's department of physiology and biophysics, admitted that part of the impetus for the letter was the PharmedOut project's empty coffers. "We've been out of money for a year," she told __The Scientist__. "It's been very difficult to get money for [ethics research] projects." An NIH spokesperson said this morning that the agency has not yet "officially received" the letter, though a copy of it can be accessed at PharmedOut's linkurl:website.;http://www.pharmedout.org/NIHLetter.pdf Collins is expected to review the letter sometime today or tomorrow, the spokesperson told __The Scientist__. "I think there's just so much evidence out there that this is a problem area, there probably should be increased funding there," linkurl:Kay Dickersin,;http://faculty.jhsph.edu/default.cfm?faculty_id=1695 director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health and a signatory on the letter, told __The Scientist__. "In any budget -- whether you're the head of NIH or anywhere else -- there's always discretionary money for things that come up," she said. "NIH has had funding from the Office of Research Integrity, via small grants, for a number of years" to look into such ethical issues, she added, but the amount of money allocated to study them has been "fairly small." The letter is signed by several other prominent figures in the biomedical community, including linkurl:Jerry Avorn,;http://www.medsoc.harvard.edu/node/585 the Harvard MD who invented "academic detailing," the widely-employed practice of educating doctors in cost-effective prescribing practices, linkurl:Virginia Barbour,;http://www.plos.org/about/people/medicine.html chief editor of __PLoS Medicine__, and linkurl:Howard Brody,;http://www.utmb.edu/imh/faculty.asp?FacID=53 director of the Institute for the Medical Humanities at University of Texas Medical Branch. Fugh-Berman added that the strong support for the letter, which ended up being passed around and posted on listservs by researchers, was a surprise. "The response to it was amazing when we sent it out to scientists," she said. "It was really sort of unexpected." The letter's signers also include a handful of researchers and administrators outside of the US -- from the UK, Canada, India, Australia, and South Africa. "It jumped the pond," Fugh-Berman said.
**__Related stories:__***linkurl:NIH may start policing conflicts;http://www.the-scientist.com/blog/display/55400/
[5th February 2009]*linkurl:NIH to act on conflicts within 1 year;http://www.the-scientist.com/blog/display/55264/
[5th December 2008]

Comments

Avatar of: Bernard Carroll

Bernard Carroll

Posts: 4

November 18, 2009

I am one of the signers of this initiative. Just the same, I am not sure how much research is needed ? the facts are widely known, the rollover time from grant submission to completed project and publication is years, and whatever is learned will be challenged by vested interests with hypocritical calls for confirmation. Any change will be glacial.\n\nWhat we need urgently is enforcement of existing standards by NIH, by academic institutions, and by professional societies. For too long the people whose job it was to rein in the ethical outliers looked the other way. Senator Grassley had to do it for them. Our letter to Francis Collins quotes his predecessor Elias Zerhouni saying about academic medical centers, ?People flouted the rules, didn?t disclose, and did it for years on end, repeatedly.? I consider it disingenuous of Dr. Zerhouni to wait until he was safely out of the hot seat before making such a statement.\n\nMy preference has been for case studies that expose systemic problems through deconstruction of specific instances of corruption. I guess I feel that corruption in biomedicine is like pornography ? we know it when we see it.\n

November 18, 2009

\n\nDear Bernard,\n\nNice to meet you. Thank you for your post and for signing the initiative. I would also like to use this forum to thank Senator Grassley for his work and commitment.\n\nI am not sure about Dr Zerhouni being disingenuous. I remember sometime in 2004-2005 having read in some journal Dr Zerhouni's statement on conflict of interests at NIH. I remember it because I sent his office a note of support. I am not sure if he ever received it. He did not acknowledge it.\n\nThis is only to say that some times leaders remain silent, inactive and cooperative with wrongdoing, some other times leaders try to fix it but, unfortunately, they do not have enough support or there are strong forces impairing positive and effective action. I only hope that Dr Collins and NIH leadership have stronger support.\n\nThanks again.\n\nRafaela
Avatar of: anonymous poster

anonymous poster

Posts: 20

November 18, 2009

Getting grants and publications are tied to academic promotions and salary, so there is always potential for COI. Allowing people to patent discoveries made with public funds and collecting royalties can be a COI, but laws allow this.
Avatar of: anonymous poster

anonymous poster

Posts: 2

November 18, 2009

I'd be all for diverting some previously awarded grants or having people take this on "pro bono" - but there already aren't enough research funds to go around, particularly for something so nebulous with such ill-defined goals. I would be firmly against money being used for this that could be going to basic research or new investigators.\n\nMaybe this is better served for NSF?
Avatar of: Martha Stokely

Martha Stokely

Posts: 8

November 18, 2009

The letter in question (posted on the Pharmedout website) reads like a thinly veiled grant request (or demand) instead a letter of concern. The ethical issues raised are important issues that legitimately fall within the jurisdiction of the FDA, since they have the potential to negatively influence drug/device safety. However, the authors did not choose to address their letter to the agency with regulatory authority over the pharmaceutical industry (the FDA). Instead they are asking for money to study the pharmaceutical industry's conflicts of interest, from an agency (NIH) that doesn't oversee Big Pharma and has no authority to change the status quo. - Triage.

November 18, 2009

\n\n**Allowing people to patent discoveries made with public funds and collecting royalties can be a COI, but laws allow this**.\n\nHello anonymous,\n\nI think that if I understand your post, you are raising the issue of ** legally permitted conflict of interests**. Perhaps, the concept of conflict of interests needs to be rigorously scrutinized, studied and attuned to the present societal situation. I have the feeling that laws, by definition and precedence, are not unchangeable.\n\nThanks for your post.\n
Avatar of: ed goodwin

ed goodwin

Posts: 11

November 18, 2009

Studies on ethics are not necessary,its simple.\n1. Avoid "publish or perish" bias.\n2. Avoid present or future personal financial gain\n from publically funded projects. \n3. Avoid harm to subjects.\n4. Close down ORI and establish external oversight of the entire grant process by investigators who are not part of the NIH system. \n
Avatar of: Nancy Bowling

Nancy Bowling

Posts: 2

November 18, 2009

I don't think what the NIH, the FDA or the CDRH needs just "study ethics". I think what they really need are some "balls". Let's take the Cyberonics' VNS Device for example. That device nearly killed my sister, and according to the Maude Data Base, it has actually killed and severely injured many, many others. According to the P970003 Post Approval Requirements that company was suppossed to conduct a 450-patient post-market dosing study and a 1,000 patient 5 year outcome registry. In that document it clearly states that "FAILURE TO COMPLY WITH ANY POST APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA." According to a F3Q09[Qtr End 01/23/09]Earnings Call Transcript, not only have they NOT met those requirements, but Daniel J. Moore is discussing his request submitted to the FDA to change the enrollment of the TRD POST APPROVAL STUDY from 460 patients to roughly 330. Excuse me, but shouldn't these requirements have been close to completion? Were they told they could complete these requirements at their own leisure? People are dying from this thing. Is this going to be another Vioxx or Guideon fiasco? After what my sister and my entire family has gone through with all this, I'd trust something that said MADE IN JAPAN way before I'd trust something that says FDA APPROVED on it.
Avatar of: Brian Lee

Brian Lee

Posts: 15

November 18, 2009

If such research is needed, it should be done by persons independent of the agencies studied to prevent a conflict of interest or the appearance of a conflict of interest. That means the research should NOT be done by NIH.
Avatar of: ed goodwin

ed goodwin

Posts: 11

November 18, 2009

Yes, Brian, They would be better to get a group of mothers who have raised ethical children rather than "head in the clouds"\nPhD and MDs who seem to forever think everything is complex.\nBut then again "complexity" fosters funded studies and publishing.\nSome things in life are just obvious, but there is no funding for the obvious.
Avatar of: anonymous poster

anonymous poster

Posts: 10

November 18, 2009

Please don't lump scientists who patent or start biotechs with those who take money from Pharma etc.\n\nHow does writing an RO-1 competing renewal place a scientist in any less conflict than say involvement in a startup from his lab ?\n\nWhy is institutional conflict any less pernicious than the conflict of individual scientists?\n\nIndustry interests and universities would love researchers to be tied down with more stringent COI rules - all the better to maximize the extraction of value from the creative efforts of scientists.\n\nIMO the US needs to encourage more scientists into activities, such as patenting or biotech startups, not less. If there is conflict, then there must be something valuable worth fighting over.\n\nDon't let Pollyanna-ish thinking on ethics etc help industrial or institutional interest's who'd would prefer all money flow to their own pockets rather than into research labs.\n\nThe burden of increased COI restrictions will fall on the shoulders of those whose need them least - i.e., us generally well-behaved bench scientists
Avatar of: Peter Aleff

Peter Aleff

Posts: 3

November 19, 2009

Congratulations to the PharmedOut group for addressing this conflict-of-interest stain on the reputation of medical science. A similar problem is the lack of honesty in non-pharma clinical research where medical doctors have committed blatant frauds against science to defend a long outdated and debunked doctrine about the routine blinding of premature babies. Admitting the iatrogenic origin of this long continued baby-blinding epidemic would be embarrassing to the profession and open the doors to costly liability suits. For a detailed documentation of these research frauds and their cover-up, see retinopathyofprematurity.org/01summary.htm. \n\nIf these patient-harming frauds committed in the name of science remain unacknowledged much longer, despite the alleged self-correction mechanisms that give the scientific method its legitimacy, they are likely to further diminish the public trust in all pronouncements by scientists, even the honest ones.\n\nRespectfully submitted,\nPeter Aleff
Avatar of: anonymous poster

anonymous poster

Posts: 1

November 21, 2009

I agree with a previous poster who said the letter read like a thinly disguised grant application. What makes "ethicists" like Howard Brody above the fray, and immune to the effects of money and position and need to modulate their views in order to stay in the good graces of the grant givers and other influential bodies?\n\nWhat is needed is internal enforcement of good ethical practices, and punishing of bad ones. Science has no police, and a lot of things go unpunished.\n\n
Avatar of: Peter Kissinger

Peter Kissinger

Posts: 3

November 21, 2009

Our society is optimized by COI. Buyers want to pay less;sellers want to charge more. Scientists select experiments (and sometimes data) to prove a hypothesis. Other scientists can select experiments to prove it wrong. Professors seek promotions secured by there productivity - real better than imagined. Society wants medical innovation and entices entrepreneurs to start companies using the results of federal grants to do so. This optimizes the return on the taxpayers investment. A free market enables a congruence of interests, bench to bedside. Nothing else has been shown to work but a COI.\nOn the other hand, cheating, making stuff up, hiding relationships, side deals, payoffs and bribes are wrong. Transparency is very helpful to enabling a judgement of potential bias. A COI on one hand is an incentive to success, both the cancer patient and the researcher win. More often than not COI is a Commonality Of Interest. Sure there are egregious exceptions,but they are exceptions.
Avatar of: Jim Wilson

Jim Wilson

Posts: 1

November 22, 2009

If medical research is to move forward in a fashion that the public will buy, then medical ethics and transparency must be high on the agenda of those in charge of handing over our money in the form of research grants.\n\nFunding research into the effects a lack of transparency and the lack of ethics has had, is critical to stopping the erosion of public trust.\n\nThe recent H1N1 flu vaccine rollout is a prime example of the cost of mistrust of the general population in the present system of secret meetings, medical literature manipulation and control, media hype, and unfair research money grant processes in favor of relatively few players.\n\nIf this swine flu was the potential pandemic with serious consequences far and above the norm as we were led to believe, then the world would be in a mess because the majority of people did not trust what was written or said in the media by our so called medical leaders. The vast majority of people refused the vaccine, and rightly so given historical events.\n\nI for one certainly doubt most of what I read from the land of the medical money machine and more people join in my skepticism every day.\n\nThe most important loss to mankind has been the research we haven't done, in favor of contrived, designed, profit-driven research.\n\nThe new multiple sclerosis announcement by Dr. Zamboni of Italy with a potential cure for so many, is such a great example of how drug and vaccine driven research has had a stanglehold on common sense and back to basic's research looking for a true fix that doesn't necessarily come with a method of selling something for a future steady stream of income.\n\nThe unprecedented investigation by the Attorney General of Connecticut into the Infectious Disease Society of America, which uncovered corruption in the drawing and marketing of the Lyme disease guidelines wherein the authors specifically excluded reams of research that contradicted their desired outcome, is another example of the control given to so few. \n\nAs in the case of the Infectious Disease Society of America, this lobby group also controls some of the most influential medical journals who publish shoddy papers without due diligence. Our medical front-line doctors, in their defence, have no recourse but to trust the medical text books and journals from which they educate themselves, all too often at the expense of their patients.\n\nIt is up to the people to fix this. We are the tax payers. Stop the river of money that runs with no oversight, no common sense. Insist that medical ehtics become the golden rule, and that they strictly be enforced with severe penalties in place for those who choose to ignore them.\n\nJim Wilson\nPresident \nCanadian Lyme Disease Foundation\nwww.canlyme.com\n

November 29, 2009

\nReading your newspaper everyday is not only good for your brain but also for keeping your eyes open to the world surrounding you. When I was a scientist, I used to read the newspaper in a rush. Way too busy to pay attention to the details of life. Experiments, papers, grants, you name it. The unexpected encounter with the FBI, before dawn in the 2007 season of falling leaves, took my life to an entirely different dimension.\n\nMy knowledge on the FBI guys was the one coming from American movies. Seeing them in your living room, with their guns in hand was disconcerting but not frightening. They were all young and very polite. For some weird reason, I thought of my students making a joke. When they knocked the door, I was already in my computer working on an assignment and my husband, a very early bird, had already gone to the lab. They put me in a car, that they had parked in my own building parking lot, and took me to the Federal Facility close to Independence Hall. After being questioned and requested urine samples for analysis, I was placed in a jail cell for a couple of hours and then transported to a Maryland jail. While in the car to Maryland, I called my husband and he looked for the most outstanding lawyer in the area. The story is too long for details but the incident gave me the opportunity for an 18 month's vacation alternating between jail, house arrest wearing an electronic device, inpatient acute psychiatric treatment, outpatient therapy program and a final home rehabilitation program. Eventually, my lawyer succeeded in sending me to my country of origin and family?s country on March 4, 2009. I am an American citizen, residing in Spain.\n\nSummary:18-month's vacation was the return for: a) my requesting to my Ivy League University an 18-month leave of absence without salary with a defined scientific program and b) my persistent protest to NIH.\n\nOn-going questions:\n\nIs questioning yourself and others always a challenge?. Yes. Questions are most of the time challenging. Answers, in turn, can be unsubstantiated, inefficient, inappropriate and/or dehumanizing.\n\nWere the approaches adequate to the questions being posed?. Most of them were inadequate, to say the least.\n\nHas the overall strategy advanced the field?. This is for you to judge. Here is the data:\n\nJail time: more than 3 months. What did I learn? \n\na) I learned about causes and effects of illegal immigration, drug and alcohol use and abuse, prostitution, embezzlement, domestic violence. Most of my colleagues were young, some middle age, whose only privilege had been to have to resort to break the law to compensate for their lack of opportunities for education. They were wonderful people and it was easy to love them. One of my dreams, if I could ever locate them, is to have a JAIL REUNION and share our life experiences after that common training.\n\nb) I learned that jails are not to rehabilitate people but an ?awesome? opportunity to make money out of the disadvantaged and waste public resources.\n\nc) I saw some wonderful correctional officials and some abusive correctional officers.\n\nInpatient Psychiatric Treatment (close to 4 weeks). What did I learn?\n\na) Effects of antipsychotic treatment: Following admission to the Acute Unit of a Psychiatric hospital, I was seen by the psychiatrist on duty who wrote my clinical history. I told this doctor that I was on Lipitor for high cholesterol and preventative baby aspirin since I had a strong family history of heart disease. I have never taken anything else in my entire life other than Wellbutrim, temporarily prescribed by a family doctor, to overcome profound sadness after the sudden death of my mother in 2004. \nI was assigned a psychiatrist and he put me on Geodon (Geodon is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old). After an hour of having ingested the drug the first day, I was at the nurse station with another patient and suddenly I felt a terrible nausea and dizziness. I said: ?Nurse, I am feeling very sick, I am going to die?. I fell down and lost consciousness but while fainting I saw the nurse looking at me and saying: ?She is not faking?. The doctor on call was called and I was awake when she arrived. It turned out that Geodon can alter the QT (QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.). After that, they put me on Risperdal, another drug for treatment of the same symptoms. This one seemed to be innocuous but did have side effects on my metabolism since I gained quite a bit of weight. Many times, I have wondered if the assigned psychiatrist read my clinical history before deciding to put me on a drug with the potential for compromising heart function.\n\n\nb) Do all these antipsychotic treatments work?. I don?t have an answer. Some patients were there for weeks ?to rationally optimize their medication? . I am not a psychiatrist but my 24 hours observational activity of these colleagues/patients (talking, playing, sharing food and room) did not reassure me that these treatments were doing something major for them.\n\nc) Health Care Plans. There were some 30-35 patients at the Acute Unit. I heard a lot of stories about what their insurance was or was not covering. An interesting observation was that some patients with true psychiatric problems were sent home after a short period of time (they had medicare). I was on my husband?s premium insurance. I did not need psychiatric treatment but they kept me there for almost 4 weeks. \n\nThe overall functioning of this hospital was good though.\n\n\nOutpatient Intense Therapy Program (4 weeks)\n\nA hospital van came to my house 3 days a week to pick me up. We picked up 7-8 more patients in a 90-120 minutes drive to the hospital. This was an opportunity to hear people's stories as they join the crew in therapy. Very revealing stories about real life. There were 9 of us in my therapy group, a heterogeneous group. We just talked about our past and present experiences and felt bonded by the circumstances of life. It was a communication experience and I learned a lot from my colleagues/patients. I felt, most of the time, mesmerized by the ability of the therapist leading us to lead our own lives. The program works!!!.\n\nHouse arrest totaling 7 months (with and without bracelet monitoring device)\n\nI was in my home and permitted to go out from 9 a.m. to 8 p.m. I stayed home most of the time reading, talking over the phone, watching C-SPAN programs, having friends joining for snacks or dinner. The FBI had confiscated my computer because ?I was a computer device stalker? and I was forbidden to touch a computer. \n\nI used to go with my lunch bag to The Square in the well-off neigborhood every day. A beautiful square surrounded by European looking cafes and restaurants, with jazz bands playing, art exhibits and a variety of human activities. The beautiful Square provided me with unexpected encounters: seniors asking me to buy them a soup in the nearby Wawa. I learned from them that there are dry soups and a hot water container on the counter. You can make an instant soup for $1. Young and middle people approaching me when seated on a bench eating my sandwich: ? Could you please share a piece of your sandwich?. Women literally screaming and crying: ?Life is not fair? without being noticed. \n\nOn Saturdays, there were long lines of people, from all walks of life, in front of a beautiful church in Locus Street waiting for the church to open. It turned out that the church gave soup and cookies for people in need on Saturdays. These people chose to fast for the rest of the week. Most frequently, Poverty and Poor Health go together.\n\nIn conclusion, my 18-month vacation was finally over on March 4, 2009. I packed and took my flight Philadelphia-Madrid.\n\nThe FBI nightmare gave me the opportunity for a Master in "Real Life and Self-Personalized Medicine". Tuition costs (legal and medical expenses) were very high. But now I know much better. \n\nThanks FBI young guys !!!.\n\n

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