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IRBs, Conflicts of Interest, and Witch Hunts

When beginning a discussion of a controversial topic I like to establish the common ground upon which most or all people can agree. Everyone seems to agree that real conflicts of interest in medical research and practice is a bad thing and steps should be taken to minimize, eliminate, and illuminate any such conflicts. The controversy revolves around what constitutes a real conflict of interest.

There is broad agreement that researchers should not have a personal financial stake in the outcome of their own research – they should not make more money if their research is positive than if it’s negative. That creates a clear and powerful bias.  There is also now broad agreement and adoption of standards that speakers, authors, and researchers should disclose any potential conflicts of interest – primarily the source of their funding. If someone is being paid by a drug company to say that their drug is effective for a particular disease, they should disclose that up front.

These same standard are now being applied to IRBs – institutional review boards, and that seems apprpriate. Every institution that does biomedical research must have an IRB, which is a committee of appropriate professionals (and there are rules as to the IRB’s constitution) that review all human research proposals to make sure they meet ethical guidelines and that subjects are adequately protected. This is a good system that generally works.

A recent paper, however, discusses the fact that the same disclosure of conflicts of interest required for researchers is lacking when it comes to IRBs. This is a “who’s watching the watchers” type of concern. This is easy enough to fix – simply require IRB members to disclose their conflicts of interest to the institutions that appoint them. There are already stringent ethical guidelines for IRB members, so this would be, in my opinion, a small but necessary tweak to the system.

This is not to suggest that big problems with IRBs do not at times occur. For example, Mark and David Geier formed their own institute and therefore their own IRB, packed with friends and supporters, to approve their highly dubious and ethically questionable study of lupron and chelation therapy for autism.  The hole here seems to be that IRB regulation is largely left to institutions – but what if those institutions are bogus?

Conflicts and Witch Hunts

While there is much common ground regarding conflicts of interest, there is also much controversy.  The British Medical Journal recently published five contrasting views on what the relationship should be between industry and academia. Marcia Angell, former editor-in-chief of the NEJM and professor of social medicine at Harvard, takes the most extreme view – none. She feels that there should be no ties between industry and academia, doctors, or patients, because all such ties constitute marketing on the part of the pharmaceutical industry, and the purpose of marketing is to distort the practice of medicine (specifically to increase drug sales).

Others propose allowing but regulating industry-academic collaboration. These regulations would include eliminating direct to consumer advertising, funding continuing medical education (CME), and forgoing all industry gifts.

And at the pro-industry end of the spectrum Gordon Coutts, Vice President and General Manager at Schering Plough UK, argues that collaboration between academia and industry has the potential to foster innovation.

This is an important conversation to have, and I think it needs to be recognized that there are trade offs to consider – hence the conflict. I think the radical view of eliminating all ties will throw the baby out with the bathwater. On the other hand the medical profession and the pharmaceutical industry has to regain some lost public trust, and that might entail eliminating not only true conflicts of interest but the appearance of conflict.

The accusation of potential conflict of interest easily turns into a witch hunt, however, and can be used as a weapon – where the mere accusation of conflict is equated with guilt. Legitimate scientific opinions and research is often dismissed because of trivial connections to industry that do not constitute a legitimate conflict (anti vaccinationists are famous for this).

The “baby” in the bathwater of industry ties includes, in my opinion, CME. There are times when the interests of the industry and of good medicine are in line, and these include educating physicians as to the existence of a new drug and its proper use. There is just as much underprescribing going on in medicine as overprescribing – many patients are losing out on the preventive benefits of proven drugs because of inadequate education. Education is therefore a win-win that we should not casually dispense with.

The legitimate concern is that industry interests will drive the content of education – but that can be managed without eliminating industry funding. Pharmaceutical companies already have divisions between marketing and research. Educational activities could also be segregated from marketing. Funding for CME activities can be unrestricted. Buffers could also be put into place. For example, funding can only be directed at diseases, not drugs. So a manufacturer of a migraine drug can fund CME into migraine education, but not education about their specific drug. In order to avoid hand-picking academics known to be favorable to their products, perhaps funding can be restricted to departments, who then can decide which individuals will provide the content. In other words – the content of the CME needs to be buffered from industry influence. If the industry wants to pay for CME activities, they have to allow academics to completely determine the content. They will do this (and already do in many cases) because there are many win-win situations where increasing education and awareness helps everyone.

I and many others also think it is important to allow acadmics to consult for industry researchers. This is a vital flow of experience and information from those on the cutting edge or in the trenches of practice to the industry, to help guide future research and spawn innovation. If academics become paranoid about any industry ties, however, they will be reluctant to provide the industry with their expertise, and patients will ultimately suffer.

Conclusion

We are currently in a transitional phase. Conflicts of interest in the system are being exposed and purged, but this is also leading to a bit of a “witch hunt” mentality and risks purging the good with the bad just for the simplicity of having a clean slate. Hopefully in the end we will settle on a balanced and nuanced system, where legitimate conflicts are exposed and eliminated, but constructive collaboration between academia and industry is allowed to flourish.

I also think the playing field needs to be leveled. Right now there is a asymmetry where accusations of conflict are targetted at some industries (like the pharmaceutical industry) far more than others (like the supplement, malpractice, and CAM industries) – even though in many cases conflicts of interest in these latter industries are far worse than what it being criticized in the former.

As we develop a sophisticated system for revealing and minimizing conflicts of interest, the system needs to be applied fairly and universally – not selectively, politically, or punitively.

Posted in: Medical Academia, Medical Ethics, Politics and Regulation

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19 thoughts on “IRBs, Conflicts of Interest, and Witch Hunts

  1. David Gorski says:

    Best example of a quack IRB: Mark and David Geier’s “IRB” that they used to “approve” their Lupron protocol for autism.

    See:

    http://scienceblogs.com/insolence/2006/06/antivaccination_warriors_vs_re.php

    http://neurodiversity.com/weblog/article/98/an-elusive-institute-significant-misrepresentations-mark-geier-david-geier-the-evolution-of-the-lupron-protocol-part-two

    Basically, the Geiers stacked an IRB with cronies and fellow antivaccine activists. The IRB was even chaired by Mark Geier himself, who was the principal investigator of the study! But that’s not all. His wife was on the IRB, as was the parent of a child participating in the study.

    Truly, the lack of ethics boggles the mind.

  2. tmac57 says:

    One thing that particularly bothers me, is when I walk into a doctors office, and everywhere you look are advertisements for drugs on pens, notepads, charts, mouse pads, calendars, etc etc.
    Then your Dr writes you a prescription for the ‘latest and greatest’ (and most expensive) drug, and you later find out that an older and cheaper drug that has a long track record for safety and effectiveness would have and should have been the 1st one considered.
    This kind of thing has me doubting whose best interest is being served. Is it the patient or the drug company? It also makes me wonder if the Dr is really doing their homework when it comes to making the best choices for their patients.

  3. Dr Benway says:

    There are things the pharmaceutical companies do that I like and things I don’t like. Marketing directly to patients bothers me as patients lack the context of treatment alternatives.

    As a med student I liked the toys. I scammed some nice books, a reflex hammer, and one of those due date OB wheels from a national specialty meeting. If you’d told me these gifts would corrupt me I would have laughed. Without looking at the stamp on the item I’m sure I couldn’t have said which company sponsored it. Why would my brain care about that?

    My husband argues, “Well, subliminally it must have an influence or they wouldn’t spend the money.”

    I agree that exposure to a company or product name can increase a doctor’s feeling of familiarity with the product, and that familiarity no doubt results in more prescriptions collectively over a large group of doctors. I think the effect is not significant enough to be obvious in the habits of most individual practitioners. Too many other, more substantial variables, play a role.

    I guess what I’m saying is: pens, notepads, magnets, books, and other similar low-value crap are not worth worrying about. Seriously. I’d have no problem with a ban personally as I’d rather have less clutter in my life. Filling up the recycle bin is tiresome.

    BigPharma is a business and like any business it will struggle with the need for short-term profit verses long-term public trust and good will. But since when did seeking after profit become something shocking or shameful?

    The profit motive is not the root of all evil. It’s simply energy. It can be managed responsibly to do great things or it can be used to take advantage of others. Life without it (see USSR) seems more evil than life with it.

    Executives in government agencies can have their COIs, too. Career advancement may depend upon cutting costs or bringing money into a department. Getting the Medicare-Medicaid schizophenics off Zyprexa and onto Thorazine or Haldol might be personally important to some. Getting the underinsured to buy into chiropractic + nutritional supplements as a form of primary care coverage might also have its appeal.

    Oh hi tmac57, I wrote my “don’t fear the pens” bit before seeing your comment.

    I’d simply ask your doctor about the cheaper alternative, see what he says. The price often is a back-burner concern, as many insurance companies pick up most of the prescription cost. Formulary restrictions, side effects, drug interactions usually are larger concerns.

  4. qetzal says:

    Dr. Benway,

    I don’t fully understand your point drug familiarity and docs’ prescribing habits. If pharma marketing does result in more prescriptions collectively (and I’m virtually certain that it does, overall), then what does it mean to say it’s insignificant at the level of an individual doc?

    It’s possible that marketing pays off for pharma by greatly influencing a few docs while having little/no effect on the rest, but I doubt that. More likely, a large fraction of docs are significantly affected (even if it’s difficult to detect that effect at the level of a single doc).

    Also, I suspect the degree to which pharma marketing affects scrips is substantial, as evidenced by the amount they spend on it. Your husband is right – pharma wouldn’t spend what they do on marketing if they didn’t think it had a positive return. Two of my kids are pharma reps, so I have some feeling for how closely pharma monitors the effect of marketing on scrip rates.

    All that said, I agree that marketing isn’t automatically evil, nor are pens and pads worth much worry. However, even though I’m generally pro-pharma, I think it’s appropriate to recognize that their marketing efforts probably do have a large effect on prescribing habits.

  5. marilynmann says:

    “There are times when the interests of the industry and of good medicine are in line, and these include educating physicians as to the existence of a new drug and its proper use.”

    In my opinion, it is in the interest of the manufacturer of a product to maximize its profits. In most cases, this involves selling as much of the product as possible. I think we would all agree that pharmaceutical companies are profit-making enterprises. From the standpoint of industry, the purpose of funding CME is to influence the prescribing habits of physicians so as to sell more drugs. The purpose of CME requirements, on the other hand, is increase the skills and knowledge of physicians so as to achieve better outcomes for patients. These two goals are not necessarily the same.

    For example, there are many cases where it is better to use a drug that has been on the market for some time than to use a newer, and in many cases more expensive, drug. In addition to being less expensive in many cases, older drugs may have more information available with respect to their side effect profile, making a calculation of the risks and benefits of the drug more reliable. There are also cases where it is better not to prescribe a drug at all, something that could hardly be to the advantage of a pharmaceutical company.

    “There is just as much underprescribing going on in medicine as overprescribing.”

    I think there is both overprescribing and underprescribing going on. However, I would like to see the evidence that, in the aggregate, there is as much underprescribing as overprescribing. Please cite the studies you are relying on in this regard.

    Thanks,
    Marilyn Mann

  6. ImperfectlyInformed says:

    I applaud you for broaching this issue, although I’m troubled by the way that it starts off with “witch hunts” in the title — planting in the mind, to begin with, the dubious right-wing proposition that the poor pharmaceutical industry and the physicians it pays are, if not the victims already, then fast becoming the victims. Maybe you have a point there, but it doesn’t seem well-made. I’ll preface my comments by saying that I’ve read Angell and other books critical of the industry, and although I’ve looked for defenses, I haven’t found most of it convincing. I’m interested in hearing a well-researched defense of the industry, however. Note that of the 5 editorials, several of them seem to be from industry shills. Gottlieb from AEI makes the dubious assertion that “increasing regulation of the drug industry is restricting its ability to disseminate the results of its clinical studies” (doi:10.1136/bmj.b234).

    It’s worth noting that this is a perennial issue. The pharma industry’s high profitability dates way back — from 1960 to 1991, the average return on equity was 18.4% vrs 11.9% for the 500 industrials (http://www.jstor.org/pss/2138445). While the standard economic justification for high profits is high risk-taking, Finklestein and Temin noted in Reasonable Rx that large pharma companies seem to go out of business very rarely and are perhaps the least risky sector. It seems that their high profits can be attributed to market power. Citing “recovering drug development costs” as a reason for high profitability seems, at least to me, like a non sequitur. Return on equity is calculated after drug development costs. High profitability is an incentive for other businesses to enter, but the monopolistic way the industry operates makes that difficult. Small research firms are a separate issue.

    The industry generally spends about 30% on advertising, which can be verified through SEC filings (marketing and administration are around 36%, according to Angell). They spend, at a generous estimate, about 18% on research and development. It’s difficult to say how much of that 18% is actually spent on seeding trials. The high amount of money spent on marketing suggests that their drugs are not prescribed based on efficacy but advertising, since when something works, it presumably sells itself.

    Perhaps one of the most intriguing areas that I haven’t looked into closely is how much our basic government-funded research supports the drug industry’s new drugs, and how much we receive for that valuable research. Angell noted that a review of patents found that only 15% cited industry-funded studies (http://healthaff.highwire.org/cgi/content/full/20/5/202#F2). It’s well-known that some of the most important breakthroughs for the most famous blockbuster drugs were discovered by public researchers (e.g. Taxol, Epo) then licensed for a relative pittance.

    As far as continuing medical education, that seems like the absolute worst area to keep up an industry-physician relationship, and I can’t imagine the industry funding “migraine education” without plugging its migraine drugs. Studies have shown that even mentioning advertisements to physicians increases how much they’ll prescribe them — actual exposure to the advertisements after receiving free education could only be worse. I can’t see why industry-funded education is preferable to a review of recent new drug literature by a neutral academic.

    By the way, in Angell’s book she says that if she could implement one reform, it would be to require head-to-head testing of new drugs before FDA approval. Has this happened? The recent JAMA debacle suggests that, at the least, “high-quality” journals are not insisting on proper comparisons between treatments.

  7. qetzal says:

    ImperfectlyInformed,

    My career is in biotech, not pharma, but I have spent many years on new drug development. No doubt I’m more pro-pharma than average. Just to admit my biases. ;-)

    Regarding Angell, some of her critiques are certainly valid, but a lot of what she’s claimed is frankly laughable, particularly regarding what it costs to bring a drug to market, and to what extent pharma takes advantage of publicly funded research. If you’re unfamiliar with Derek Lowe’s blog In the Pipeline, try this piece for an explanation of the typical contributions of public research vs. pharma R&D. Bottom line, academia’s contribution is most often to discover and characterize targets and systems that are critical to various diseases. Pharma’s contriubtion is most often to discover lead compounds for those targets and systems and develop them into drugs. Neither group is very good at doing what the other does best.

    Angell’s point about citations in patents strikes me as uninformative. It assumes that citation rates accurately reflect overall contributions by the various sectors. I’d argue that’s not even approximately true.

    OTOH, I agree that Gottlieb’s comment is a bit embarassing, given the clear evidence that pharma tends to publish only the studies that are favorable, and to present what data they do publish in the most favorable light. Note that this is not the same as saying the pharma routinely hides bad results from FDA, as some claim. While that clearly does happen, I think it’s pretty rare. Pharma is required to provide all such data to FDA, good or bad. They are not required to make all such data public. I think one can make a good case that they should be required to publish all trials, or maybe all trials beyond Phase 1. Some forum would likely be needed to accommodate those trials that aren’t suitable for publication in a major journal.

    I agree with you that pharma is substantially more profitable than the average industry. That doesn’t mean that drugs are actually cheap and easy to develop, of course, but clearly pharma’s overall return is pretty good. Like you, I don’t really buy the argument that such returns are required due to the high risks. Clearly the overall risk isn’t that high.

    The barriers to entry in the pharma industry are (arguably) not pharma’s fault. They’re due to the high regulatory burden imposed by congress through the FDA. That’s also a big part of why drugs are so expensive to bring to market.

    I only see two ways to dramatically reduce drug development costs. First, we could decide as a society that we will lower the bar on what’s required to develop and market a drug. Some people think that’s a good idea, but I doubt it’s politically possible.

    A better solution would be if we got much, much better at eliminating failures at the very beginning of the development process. That wouldn’t change the direct costs spent on the successful drugs, but it would dramatically reduce the money that’s currently sunk into drugs that ultimately fail prior to market. This will require a MUCH better understanding of human biochemistry, cell biology, physiology, etc. I expect we’ll get there, but VERY slowly.

    I agree with you that pharma spends significantly on marketing, and that this surely affects prescribing habits. I’m less sure of the relative magnitude of marketing vs. research. It’s not appropriate to compare M&A to research, since M&A includes administration. Pharma generally refuses to disclose numbers for marketing alone. Nevertheless, I take it as given that it’s substantial, and of a similar magnitude to research expenses. I definitely agree that pharma’s motivation is profit, and it’s essential to maintain appropriate controls on how they can market their drugs. I’m not sure what changes to the current regs might be needed. I do think strict enforcement of existing marketing regs is needed. I also agree that it’s nearly impossible to have pharma-sponsored CME without bias.

    Regarding head-to-head testing, I’m not aware of a formal written requirement across the board. However, there are de facto requirements in many cases, simply based on what FDA expects to see. For example, I don’t think you’ll get a new insulin analog approved unless you show that it controls HbA1c at least as well as an existing product. In general, new drugs rarely get compared only to placebo, unless there really is no generally accepted treatment for the targeted condition. The bigger question, I think, is deciding which existing drugs one must compare to.

    Part of Angell’s gripe here is that industry spends too much effort on “me-too” drugs. She seems to think that head-to-head comparisons should require that the new drug be better than the current best drug. She also thinks that if pharma stopped pursuing me-toos, we’d get more novel drugs for untreated conditions.

    I think she’s wrong for a variety of reasons. As this is already overlong, I’ll simply point you to this series of posts by Alex Tabarrok.

  8. Evidence for underprescribing as common as over – here’s one: under was 64%, over was 65%. http://www.ama-assn.org/amednews/2006/11/20/hlsb1120.htm.

    To clarify – I never said the interests of Pharmaceuticals was the same as good medicine or academics. They are purely to make profits – we agree on that. They should be highly regulated, I think we all also agree on that (meaning the commenters, I know extreme libertarians disagree).

    My point is that if more physicians know about a drug that is effective in preventing a disease, then more will prescribe it. Reducing underprescribing for preventive treatments is both good medicine and increases profits. So Pharmaceutical companies would still be willing to fund such educational efforts, even if they are prevented from manipulating it through regulation.

  9. ImperfectlyInformed says:

    qetzal:

    Sorry, Angell makes the point that there is only 1 company that separates marketing and administration in their regulatory filing, and that is (or was) Novartis. Their filings show that administration is only a small percent of the profits — around the 6% I said, or maybe 8%. So she’s right there.

    I glanced at Tabarrok’s series and they didn’t seem awfully meaty. I’ll look at Lichtenberg and that book Powerful Medicines though.

    Novella:

    Since the AMA is not nice enough to show even the title of that paper, I can’t pull it up. And I’m skeptical that “reducing underprescribing for preventive treatments is both good medicine and increases profits”. Maybe it’s good medicine, but quite possibly it isn’t good economics. If every aging person was prescribed statins — particularly ones under patent — this country would be in even more financial trouble. And if old generic statins are prescribed, there’s little profit increase for the pharma companies.

    Why not make the pharmaceutical industry’s funding of such education completely unallocated? They dump money into a pot and it gets spent on doctor’s education. That’s the type of proposal Angell would have, and it’s reasonable.

    Anyway, statins are another example of where the pharma industry is granted a patent for something it didn’t discover. Endo, the discoverer didn’t profit from them; they were already naturally occurring in red yeast rice, the well-known herbal drug, and doi:10.1016/j.lfs.2003.10.018 says RYR could actually be less costly.

  10. ImperfectlyInformed says:

    By the way, qetzal, Tabarrok does not engage Angell on her fundamental point: that me-too drugs are typically not tested correctly (head-to-head vrs old drugs). He makes the crack that “I have 12 different options of peanut butter” and seems to think that’s exactly the same as having different drugs available to the doctor. The situation is entirely different. When a patient goes to the doctor, they aren’t given a brochure listing each drug with their relative efficacy, cost, and side-effects laid out side-by-side in tables. Doctors are lucky if they have those. Further, doctors generally are the ones deciding which drug to prescribe. In many cases, neither of those involved are paying the costs. At the grocery store, the consumer pays the full cost, and the person making the choice isn’t being paid by the producer. Advertising occurs, but generally advertised products actually take more money out of the end-user’s pocket.

    The fundamental lack of good comparisons (according to Angell, in 2004) is clearly highlighted by Angell as the biggest issue, and Tabarrock doesn’t engage it at all.

    I had to go back and read again to make sure I wasn’t missing something and hitting Tabarrock with strawmen. But I don’t think I am.

  11. marilynmann says:

    Dr. Novella,

    Access to that article seems to be limited to AMA members, of which I am not one.

    Marilyn

  12. qetzal says:

    ImperfectlyInformed,

    The point of Tabarrok’s piece was not to show that good comparisons really do exist. I agree that in many cases they don’t.

    But Angell goes beyond arguing for head-to-head testing. She thinks me-toos have little intrinsic value, and that they shouldn’t be approved unless they’re clearly better than existing drugs. I disagree. Tabarrok’s piece outlines some of the reasons why I think Angell’s wrong on that point.

    Moreover, it’s not necessarily a simple matter to run head-to-head comparisons. Take Lipitor as an example. Their placebo-controlled studies included ~ 1500 up to ~ 5000 patients in each group, just to show a significant difference between Lipitor and placebo. Imagine how many patients per group would be needed to prove that Lipitor is non-inferior to another statin, much less to prove that it’s better.

    Of course, you may think the benefits of having such data would outweigh the excess costs, but requiring such studies across the board would undoubtedly add hugely to clinical development expenses. More realistically, it would mostly eliminate me-toos. Angell thinks that would be a good thing. I disagree.

  13. Skip says:

    Here is a link to the AMA article that Dr. N was referencing. I got it through google’s cache, that’s why the url looks all funky.

    http://209.85.173.132/search?q=cache:w6NQdgn0HcIJ:www.ama-assn.org/amednews/2006/11/20/hlsb1120.htm+http://www.ama-assn.org/amednews/2006/11/20/hlsb1120.htm.&cd=1&hl=en&ct=clnk&gl=us&client=safari

    -Skip

    Studies: Underprescribing, overprescribing both common

    This problem is particularly difficult for older patients on multiple medications.

    By Victoria Stagg Elliott, AMNews staff. Nov. 20, 2006.
    Finding the right fit for the prescription drugs taken by patients — especially those who are older and on multiple medications — is a difficult balance, according to a pair of studies published in October.

    One, appearing in Medical Care, was based on the results of researchers’ interviews and reviews of the records of 3,457 adults across the United States. They found that nearly 17% were prescribed a drug they did not need, but more than 37% didn’t receive what they should have.

    “Overuse and underuse is a problem everywhere,” said William Shrank, MD, MSHS, lead author and an instructor at Brigham and Women’s Hospital and Harvard Medical School in Boston.

    The second paper, this one in the Journal of the American Geriatrics Society, found that 65% of the 196 older patients studied were on a drug they shouldn’t have been taking and 64% were missing an important medication from their regimen. Many were both lacking a drug and taking one that was unnecessary.

    “It’s an issue of quality,” said Michael Steinman, MD, lead author on that study and a geriatrician at the San Francisco VA Medical Center. “We need to be attentive to both of these prescribing problems.”

    Experts say some of these deficiencies, though not all, may be accounted for by individual factors associated with either the patient or doctor. These include variables such as concern about side effects or the preference to be less aggressive with a patient with a shorter life expectancy.

    “There may be some mitigating factors specific to the doctor-patient relationship,” said Joseph Keenan, MD, professor in the Dept. of Family Medicine at the University of Minnesota Medical School, Minneapolis. “But this is a high percentage who are over- or undertreated. This is not all due to some unique situation.”

    Many are particularly concerned about this phenomenon in seniors, who tend to be on multiple medications and are likely to have more than one chronic medical condition. For them, taking unnecessary drugs can add to the already significant cost burden of their prescription medications. Also, elderly physiology can be more sensitive to a drug’s effects — adverse or otherwise — making this age group more likely to be harmed by the wrong mix.

    “It’s concerning at any age,” said Dr. Keenan, who represents the American Geriatrics Society at American Medical Association meetings. “But the problem we find with under- or overprescribing in the very young or old is that their body’s resources for dealing with it are limited.”

    Labor-intensive solutions

    But while the problem is increasingly recognized, a solution is not clear. Those who work with this patient population say a comprehensive electronic medical record would be an enormous help. Until that is a possibility, many talk of a periodic visit devoted to reviewing what a patient is taking and why.

    “There’s no easy answer, but what this article encourages us to do is set aside some time for a detailed review of the prescription list for appropriateness,” said Jane F. Potter, MD, president of the American Geriatrics Society and chief of the geriatrics and gerontology section at the University of Nebraska Medical Center, Omaha.

    This strategy gives physicians an opportunity to discontinue a patient’s drugs that are duplicative or were once necessary to treat symptoms that have disappeared. Other drugs can be changed for options that may be better suited to a geriatric patient. For instance, some medications, such as tricyclic antidepressants, which were on Dr. Steinman’s list of inappropriately prescribed drugs, are not usually recommended in this age group.

    “Many elderly patients have so many things wrong with them,” said John Piette, PhD, a career scientist with the Ann Arbor VA Medical Center and associate professor of internal medicine at the University of Michigan. “It’s hard to keep track of everything that’s been started. They were probably appropriate when they were put on that drug, but some conditions do resolve. Overuse creeps in.”

    This review also could allow doctors to add new drugs to the mix — even though the patient might not request it. While many drugs on the overuse list treated symptoms that a patient once may have had, quite a few on the underuse list were for conditions such as hypertension and hyperlipidemia that often show no signs but have long-term implications.

    “There’s a lot of medications for silent diseases that don’t provide immediately tangible benefit for the patient,” Dr. Steinman said. “[They] are not being taken.”

    Experts note, however, that this type of review is easier said than done. It can be tough to fit into a visit when patients often want many other concerns addressed.

    “It’s an almost overwhelming problem for the 15- to 20-minute visit,” Dr. Keenan said.

    Also, no single record of the medications may exist because they may have been prescribed by numerous physicians working in several different health systems and come from a variety of sources. They may even be leftover from deceased relatives.

    “Prescribing for the elderly is a really complicated business,” Dr. Steinman said. “The potential for overuse and underuse is great, and there are no systems to help to minimize these kind of problems.”

  14. Versus says:

    Dog named Trooper heads IRB
    Investigators win approval of fake medical product

    from Yahoo News

    By JIM ABRAMS, Associated Press Writer – Thu Mar 26, 3:15 pm ET

    WASHINGTON – Government investigators looking into lax screening of medical research said Thursday they easily won approval from a private review board of a fake product to be used in medical testing on human subjects.

    The Government Accountability Office also said it was able to register with the Health and Human Services Department a fictitious institutional review board, a panel of doctors and scientists that must approve any medical drug or device to be used in federally funded testing on humans. The president of this fake review board was a dog named Trooper.

    The GAO said its investigation showed that they system “is vulnerable to unethical manipulation, particularly by companies or individuals who intend to abuse the system or to commit fraud.”

    Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce Committee’s oversight and investigations panel, said the findings “raise serious questions” about both the specific IRB that approved the fake product and “the entire system for approving experimental testing on human beings.”

    Officials from HHS and the Food and Drug Administration assured lawmakers that there were substantial protections in place to ensure that testing is done in a responsible and ethical manner.

    The review board that fell for the GAO ruse, Coast IRB, LLC., of Colorado Springs, charged that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license.

    “We got hoodwinked,” said Daniel Dueber, Coast IRB’s chief executive officer.

    “You didn’t get hoodwinked,” Stupak replied. “You took the bait, hook, line and sinker.”

    According to the GAO, two independent review boards rejected the fake medical protocol, which called for a full liter of a fictitious product to be poured into a woman’s stomach after surgery. An employee of one called it “junk” while a board member of another said it was the “riskiest thing I’ve ever seen on this board.”

    But Coast IRB approved it ananimously and minutes of the meeting obtained by GAO showed that board members thought the bogus protocol was “probably very safe.”

    Stupak also questioned whether the investigation revealed a tendency of “IRB shopping,” where clinical researchers choose the review boards based on how quickly and inexpensively they approve studies.

    The GAO said it also registered its own fictitious IRB with HHS using an online registration form. It ran ads for its “HHS-approved” IRB with emphasis on the speed of its review process. A research coordinator who responded to the ads said it was because of the low price and quick turnaround time.

    Dr. Jerry Menikoff, director of HHS’s Office for Human Research Protections, told lawmakers that the registration process does not mean the HHS is giving a stamp of approval to a review board. “Right now we think we have a well-functioning system,” he said, adding that there was room for improvement.

    Dueber said his company was taken in because they had “never had the experience of having a fraudulent group lying to us about their existences and about their licenses.” He said the company has since changed its operating procedures.

    The GAO said that historically IRBs, which are formally designated to review and monitor biomedical and behavioral research in clinical trials, have been been located at academic institutions. But it said IRBs not affiliated with an institution are playing an increasingly prominent role in protecting human research subjects.

    http://news.yahoo.com/s/ap/20090326/ap_on_go_ot/congress_human_testing

  15. tmac57 says:

    One point that I would like to expand on from my original post near the top “when I walk into a doctors office, and everywhere you look are advertisements for drugs on pens, notepads, charts, mouse pads, calendars, etc etc.” is that while it might not be a big influence from the Dr’s perspective , it is the patients perception that there is undo influence on their Dr that gives one pause. Alternatively, since there are so many “ask your Dr about..” commercials out there, the patient is coming into the office often primed to ask about a specific drug, and then sees Merck , Pfizer etc. ads all over the place touting that same drug, well draw your own conclusion.
    Very few of the people that I know are sophisticated enough about prescription drugs to advocate for themselves or the ones in their care, so they are putting their trust into physicians to do what is truly in our their best interests.

  16. quiact says:

    IRBs are in fact not working, I’m saddened to say. Most utilized IRBs are for profit, and in collusion with for profit CROs and their sponsor. So, you obey those who pay you, and objectivity to its fullest extent is absent, if not entirely.

    The DHHS registers IRBs. They have yet to decline a registration for an IRB that reqests registration from DHHS.

    The CRO business now exceeds 20 billion dollars a year. Clinical trials are dangerously autonomously at this time. 80 percent of clinical trials are now conducted by CROs with pharma,

    Dan Abshear

  17. David Gorski says:

    As an academic surgeon who actually develops clinical trials, I disagree that IRBs are not working, at least in university settings. I will admit, however, that the proliferation of for-profit IRBs is a disturbing trend.

  18. qetzal says:

    I agree with Dan Abshear. As someone who’s been intimately involved with clinical trials in biotech, I can confirm that there’s a lot of truth to what he says.

    In my experience, most for-profit IRBs do take their responsibilities seriously. But they also know that retaining a company’s business is strongly influenced by how quickly they review submissions, how often they require full versus expedited review, and how much change they require in the clinical protocols and informed consents.

    I don’t think anything unethical ever went on with any of the trials I was involved with, and I certainly don’t think there were any shortcuts on patient safety. Nonetheless, there’s a lot of potential for problems. People are too good at rationalizing their actions when profits are at stake.

    I think it would be better if there were some way to support non-academic IRBs that didn’t require direct payment by the clients who want to run trials. I’m not sure what that would be, but I think it would eliminate a lot of potential for problems that might otherwise not get caught until someone gets hurt. I expect such a system would be a bigger pain for the small biotechs, but eliminating the conflict of interest would be worth it, IMO.

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