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Senator Dodd Proposes Sweeping Drug Safety Reform

<blockquote>Forbes.com, <a href="javascript:fdcBioWindow(">Matthew Herper</a>, 01.21.05NEW YORK - Doers and doings in business, entertainment and technology: Connecticut Senator Christopher J. Dodd, a Democrat, is proposing a sweeping set of drug reforms that would give the Food and Drug Administration the muscle to force pharmaceutical companies to study drug safety after the medicines are approved. If drug companies ran afoul of the FDA, they might be fined as much as $10,000 per day. The bill, called the Patient Protection Act of 2005, would have no effect on the approval process for drugs. Instead, it gives the FDA more power to regulate medicines after they are approved, filling what he said were "gaping holes" in the agency's ability to enforce its decisions. "'FDA-approved' is just about as good a brand as we have," said Dodd. The point of the bill is to make that brand stronger. He said the bill would "put some real teeth into the FDA." </blockquote>Dear Senator Dodd, The NIH has trained a growing cadre of physician/informatics specialists whose specialty includes electronic medical records; clinical outcome improvement initiatives; biomedical data, information and knowledge management; and optimal approaches to implementing clinical information technology in patient care settings. For some reason, Sen. Dodd, the pharmaceutical industry nearly ignores this NIH-sponsored specialty. I managed to get in - running a science library while reporting to computer people whose knowledge of medicine did not extend past the local CVS pharmacy - until it was determined that due to budget cuts, first a financial guy and then an IT technologist without a medical background were sufficient for the purpose. I was told by a number of pharma companies that "medical informatics was not needed here", including in an adverse-events reporting department led by a former FDA adverse events official. It was a peculiar observation that this person's reports, the clinicians and scientists involved in adverse events day-to-day data management, felt 100% differently than their boss. It was also kind of funny when I showed them 10-year-old technology I gave the Saudi Arabians back in 1995. They thought it would be great if they had similar technology - in 2004 - to solve the problems they sometimes had in dealing with data in that good old reliable 1970's format, paper, or else via that other wonder of advanced technology, Microsoft Access. If I didn't know better, I might think that big pharma is trying hard to avoid incorporating new thinking and doing everything in its power to maintain its ossified practices -- practices that have worked so well in recent years that there are more lawsuits over drug side effects than there are computers in CompUSA. So, Sen. Dodd, by all means, knock yourself out. -- SS

Senator Dodd Proposes Sweeping Drug Safety Reform

Forbes.com, Matthew Herper , 01.21.05 NEW YORK - Doers and doings in business, entertainment and technology: Connecticut Senator Christopher...

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Those Government Health Care Blues

A few recent examples of mismanagement in the government health care sector: Cuts in Ontario The province of Ontario, Canada planned to lower hospital expenses by moving more patients into improved primary and community care settings. The improvements are not complete, the care as not yet been transferred, yet as <a href="http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1106088611550&call_pageid=970599119419">the Toronto Star reports</a>, the province is pushing cuts in the hospital budgets now. As <a href="http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_Type1&c=Article&cid=1106088611555&call_pageid=970599119419">this editorial </a>suggests, the result is likely to be drastic nursing shortages and longer queues for care. An IT Flop in the UK The UK is spending 6.2 billion pounds sterling to improve its health care information technology (IT). An early, key project was a system to improve general practitioners' (GPs) abilities to refer patients to specialists. By now, this 196 million pounds sterling system was supposed to have scheduled over 200,000 patient referrals. In reality, it has handled 63. It turns out that very few GPs were familiarized with the system, which lead to an "information vacuum." Furthermore, the system was apparently not designed to handle such situations as patients who needed referrals to more than one professional for treatment. (See reports in the Manchester Guardian <a href="http://politics.guardian.co.uk/publicservices/story/0,11032,1393356,00.html">here</a> and <a href="http://politics.guardian.co.uk/publicservices/story/0,11032,1394028,00.html">here</a>.) US VA Researcher Busted A former cancer researcher at the Stratton Veterans Affairs (VA) Medical Center just plead guilty to negligent homicide, and several other charges, as <a href="http://www.newsday.com/news/local/state/ny-bc-ny--drugtrials0118jan18,0,969450.story?coll=ny-region-apnewyork">reported by Newsday</a>. Paul Kornak had proclaimed himself to be a doctor, although he never completed medical school. He was hired by the VA despite a previous criminal record stemming from forgery of a previous medical licensing application. <a href="http://timesunion.com/AspStories/story.asp?storyID=324713&category=REGIONOTHER&BCCode=HOME&newsdate=1/19/2005">Per the Albany Times-Union</a>, co-workers alleged that they were punished after trying to report irregularities in the cancer research program he ran to hospital administrators. An attempt by hospital pharmacists to involve the Federal Bureau of Investigation was stymied when VA officials told the FBI that one of the pharmacists was under investigation, although he was never charged with doing anything wrong. Kornak was finally tripped up when his commercial sponsor, Ilex Oncology, found more "irregularities" in his reports. The moral of the stories is that government is not immune to health care mismanagement. Maybe more transparency, accountability, and involvement of medical professionals and the public could prevent some of these problems.

Those Government Health Care Blues

A few recent examples of mismanagement in the government health care sector: Cuts in Ontario The province of Ontario, Canada planned to lowe...

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A School of Chiropractic for Florida State?

The Florida state legislature and Governor Jeb Bush have <a href="http://msnbc.msn.com/id/6835571/">approved a proposal to set up a school of chiropractic at Florida State University</a>. The President of the State Senate conceded that "political patronage" was behind the proposal. Such a school would become the first school of chiropractic affiliated with a major US university. In response, some Florida State faculty members have been distributing a satiric map of the future university campus, including a Bigfoot Institute, School of Astrology, and Crop Circle Simulation Laboratory. The creation of the new school is now up to the University Board of Governors. Here is a pithy comment from Prof. Norman Levitt, author of Higher Superstition: <blockquote>"I found this story very disturbing because of its implications for scientific medicine in an era swamped by politicians who are not very bright and "alternative" hucksters who are very adept at taking advantage of that kind of stupidity. I think the chiropractic school at FSU (or any major university for that matter) has to be stopped dead in its tracks. I don't think physicians and scientists should be at all coy about putting forth the argument that there's a vast gulf between science--even highly speculative science--and pseudoscietific dogma of whatever persuasion. It would be too much to expect most pols to become epistemologically sophisticated, of course, but maybe it will penetrate that there are, eventually, painful social and economic costs to trampling on scientific judgment in the name of pet theories." </blockquote>

A School of Chiropractic for Florida State?

The Florida state legislature and Governor Jeb Bush have approved a proposal to set up a school of chiropractic at Florida State University ...

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Curiouser and Curiouser - the Case of the Allegedly Missing Prozac Documents

The case of the <a href="http://bmj.bmjjournals.com/cgi/content/full/330/7481/7?ehom">BMJ news article about missing Prozac documents</a>, which <a href="http://hcrenewal.blogspot.com/2004/12/another-facet-of-ssri-suppression-of.html">we have discussed before</a>, just gets curiouser and curiouser. Today, the NY Times published a news article that seems to suggest something big went wrong at the BMJ. <a href="http://www.nytimes.com/2005/01/17/business/media/17journal.html">"Dispute Puts a Medical Journal Under Fire," by Barry Meier</a>, asserted "the staid, usually methodical world of medical journals could suffer its own black eye," and that "the incident may prove to be a messy one for the BMJ." But Meier produced little evidence to support these apparently quasi-editorial conclusions. Let's go back to the <a href="http://bmj.bmjjournals.com/cgi/content/full/330/7481/7?ehom">original BMJ article</a>. Its key assertions were that "confidential drug company documents ... went missing during a controversial product liability suit more than 10 years ago;" "the documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence;" and "Eli Lilly officials were aware in the 1980's that fluoxetine had troubling side effects and sought to minimise their likely negative effects on prescribing." <a href="http://www.nytimes.com/2005/01/17/business/media/17journal.html">Meier's NY Times news article </a>reported that Eli Lilly vigorously contested the content of the BMJ article. Specifically, its lawyers "notified the publication that the company considers the article to be 'inaccurate and defamatory,' asserting that the records were not missing and that all their relevant data had been previously submitted to the FDA. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims." Yet Meier's article does not give any specifics of how Lilly disputed the main points of the BMJ article. So apparently Meier concluded that the BMJ deserved a "black eye" just because Lilly did not agree with it. Why he seemed to think that Lilly was right and the BMJ was wrong, especially without seeing the documents in question, is not clear. Furthermore, other statements by Lilly, available on <a href="http://www.lilly.com/">its web site</a>, muddy things further. <a href="http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=151873">Lilly's press release of January 4, 2005</a>, asserted that the "documents reveal no new clinical or scientific information," and that "the information in the documents has already been shared with the U.S. Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals, or produced through legal discovery and available for use at various legal trials for more than a decade." Of course, this did really address the BMJ's assertion that specific documents went missing. Furthermore, information produced through legal discovery may not be sufficiently available to physicians to affect their prescribing decisions. <a href="http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=152743">The second Lilly press release of January 13, 2005</a>, contains an assertion by Lilly CEO Sidney Taurel that "it is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators." Lilly complained about "the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants" as "patently false." The BMJ news article, however, contained no such claim. Taurel's statement seems to be an attempt to declare guilt by association. (Perhaps Taurel was referring to a <a href="http://i.cnn.net/cnn/2005/images/01/03/eli.lilly.pdf">document posted by CNN </a>that purports to show a suicide attempt rate of 3.7% for fluoxetine vs. 0.8% for amitryptiline, and 0.2% for trazadone.) More curiously, the press release stated "Lilly is calling on the BMJ to make the full documents available to the media and other interested parties." However, in its <a href="http://www.lilly.com/news/pdf/pz_annotations_1_12_05_final.pdf">accompanying "analysis"</a>, Lilly itself declined to make the actual documents public, stating "due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to relsease the 52 pages of documents." But then did Lilly mean to call on the BMJ to violate a court order? This statement, of course, also contradicts Sidney Taurel's assertion that all relevant information in the documents was freely available to doctors and regulators. How were doctors supposed to access information that was rendered "confidential" by court order? Thus, there is nothing I can find so far in Lilly's media barrage that refuted the claim made by the BMJ news article that Lilly had tried to prevent data on adverse effects of fluoxetine from affecting doctors' prescribing decisions. And I cannot figure out why a NY Times reporter decided that it was the BMJ, not Lilly, who figuratively earned a "black eye." Finally, let me state again, we should not let smoke and mirrors distract us from the fundamental issue that suppressing and/or obfuscating information about adverse effects of drugs is bad for patients, bad for doctors, bad for science, and bad for society.

Curiouser and Curiouser - the Case of the Allegedly Missing Prozac Documents

The case of the BMJ news article about missing Prozac documents , which we have discussed before , just gets curiouser and curiouser. Today,...

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Should statins be OTC?

<a href="http://biz.yahoo.com/rb/050114/health_merck_cholesterol_5.html">FDA Panel Rejects Merck OTC Drug</a><blockquote>BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales of Merck & Co. Inc.'s cholesterol-lowering drug Mevacor because of doubts the medicine could be used safely without a doctor's guidance.</blockquote>An interesting outcome, no doubt affected by the VIOXX controversy and the negative publicity in the form of appearances of conflicts-of-interest between Big Pharma and government regulators. As a physician, medical informaticist and son of a pharmacist (I'd worked in my father's store throughout high school and into college), I am in agreement with the FDA's decision. Knowing the trouble that patients get into with OTC medications and with prescription ones through misuse, disuse, abuse, etc., selling drugs with the profile of a statin - even with dependence on a pharmacist to play "policeman" or "policewoman" - is a bad idea. Why not make antibiotics OTC? Why not anticoagulants and antiarrhythics? Anxiolytics? After all, *most* people don't get into trouble with those. Further, why not make chiropractors the gatekeepers on these meds? Or hospital administrators? Where does the slippery slope end?As I once wrote in a Wall Street Journal letter, if you want to play doctor, then get yourself to medical school. I also wonder how much of this proposal was a move of desperation led by marketing to generate revenues by a company in financial difficulty, as opposed to the "altruistic" move led by clinical scientists and clinicians it was made out to be by the industry. DISCLAIMER: Being the only formally-trained Medical Informaticist at this company, who'd provided significant assistance in improving research support but was then summarily laid off by a no-biomedical-credentials computing exec to cut costs when the pipeline suffered difficulties (as a result of decisions made long before my arrival), I would be the first to admit my thoughts on this issue may not be entirely objective. -- SS

Should statins be OTC?

FDA Panel Rejects Merck OTC Drug BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday urged regulators to reject over-the-counter sales...

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Extry! Extry! EMR invented!

Yesterday <a href="http://hcrenewal.blogspot.com/2005/01/letter-how-fda-can-prevent-another.html">I wrote</a> that my <a href="http://yahoo.businessweek.com/magazine/content/05_02/c3915011_mz004.htm">letter published in BusinessWeek </a>(suggesting that the EMR held a potential solution to postmarketing drug surveillance) might have been the first time such an opinion appeared in the general business periodical literature. After I wrote that, I was then concerned that may have I made an overstatement. In today's Forbes article "<a href="http://www.forbes.com/healthcare/2005/01/12/cx_mh_0112fda3.html?partner=yahoo&referrer=">FDA Fix No. 3: Track Side Effects</a>", however, I was reminded that perhaps my statement was indeed close to the truth. Note the absence of mention of the EMR: <blockquote>NEW YORK - One of the clearest lessons from the Vioxx debacle is that the Food and Drug Administration's side effect tracking system is woefully inadequate. Its current system relies on doctors to voluntarily report when a drug causes a problem. This works great for finding rare side effects that would be unlikely to happen without the drug, such as liver or kidney problems or allergic reactions. But it doesn't work well for picking up common problems such as heart attacks and strokes--exactly the ills Vioxx and its kin may have caused. ... One solution, proposed by Raymond Woosley, the Vice President for Health Sciences at the University of Arizona, is to carefully track the first 100,000 patients who take a drug in order to look for higher rates of common health problems. That might be prohibitively expensive. A similar idea is to start what are known as patient registries. People who either take a drug or have a particular disease are put into a database and monitored for side effects and potential benefits. Richard Gliklich, a Harvard professor, runs a profitable, closely-held business called Outcome that develops such prospective databases for big drug companies and organizations like the American Heart Association. "There are going to be drugs that are going to be toxic to some segments of the population, and very beneficial to other segments of the population," he predicts Another fix: make the Office of Drug Safety, currently part of the FDA, a separate agency. Experts like comparing such a step to the creation of the National Transportation Safety Board. The NTSB makes recommendations to the Federal Aviation Administration, for instance, and thought they are not binding, they are often followed. In the same way, a separate drug safety office could create a public watchdog that makes sure studies into side effects of commonly prescribed drugs are getting done. Even some drug executives have backed doing more studies of the type done by FDA safety expert David Graham, who was one of those to warn about Vioxx. "While I don't think that a separate office for post-marketing surveillance is likely, a strengthened Office of Drug Safety is almost a certainty," says David Kessler, a former FDA commissioner who is now a dean at the University of California, San Francisco. "In the past, we have seen examples of the accelerated approval of drugs without the appropriate follow-up, and I think that will be a thing of the past."</blockquote> In a setting where the NIH has been <a href="http://www.nlm.nih.gov/pubs/factsheets/trainedu.html">funding postdoctoral-level training</a> in Medical Informatics to produce EMR experts for well over a decade, and where a long-range national EMR initiative (coined the <a href="http://www.hhs.gov/news/press/2004pres/20040721a.html">Decade of Health Information Technology</a>) has been launched in the U.S. by the Department of Health and Human Services to: <blockquote>"bring information tools to the point of care; build an interoperable health information infrastructure; use HIT to give better access to patients and more involvement in decision making; and improve public health monitoring and quality care assessments with faster application of research advances in actual medical practice", </blockquote>the lack of mention of the EMR as a possible solution for enhancing postmarketing drug surveillance (possible right now, this minute via pilot projects with existing EMR installations) is a strong sign of a pernicious compartmentalization of the pharmaceutical industry from the healthcare delivery sector, and a severe strategic blindness to EMR developments in pharma. The scarcity in Big Pharma of formally-trained Medical Informatics experts with insights in implementation and leveraging of EMR technology is another symptom of this apparent blindness. -- SS

Extry! Extry! EMR invented!

Yesterday I wrote that my letter published in BusinessWeek (suggesting that the EMR held a potential solution to postmarketing drug surveil...

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Medical Schools Charge More for Tuition, but Pay Less for Teaching

<a href="http://content.nejm.org/cgi/content/short/352/2/117">A commentary in the latest New England Journal of Medicine</a>, "Mortgaging Our Future - The Cost of Medical Education," [Morrison G. New Engl J Med 2005; 352: 117-119] documented the alarming rise in medical school tuition, up 319% at public schools, and 151% at private schools in the last 19 years (an average of 16.8% and 7.9% a year, respectively). These increases were far more rapid than inflation, (81.8% over that time span, using <a href="http://inflationdata.com/Inflation/Inflation_Rate/InflationCalculator.asp">a web-based calculator</a>) and are associated with a rapidly rising debt load on the average medical student. This data becomes all the more alarming when juxtaposed with a <a href="http://jama.ama-assn.org/cgi/content/extract/292/9/1060">recent JAMA editorial </a>[DeAngelis CD. Professors not professing. JAMA 2004; 292: 1060-1.] Its argument was that due to financial pressure, medical school faculty are devoting less and less time to teaching. Particularly, "few medical schools provide adequate, if any, reimbursement for teaching time." So this suggests that medical schools are charging students more and more, while less and less money goes to clinical faculty to teach. But what should tuition pay for, if not teaching? And exactly where are all the tuition dollars going? Methinks there is something rotten here, but not in Denmark...

Medical Schools Charge More for Tuition, but Pay Less for Teaching

A commentary in the latest New England Journal of Medicine , "Mortgaging Our Future - The Cost of Medical Education," [Morrison G....

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