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Are Ill-Informed Leaders the Cause of Drug Manufacturing Mishaps?

Fundamental Corporate Failures In the last few years, there seems to have been an epidemic of once revered companies suddenly unable to perform the most basic functions necessary for their businesses.  Finance firms ran out of money and ended up bailed out or bankrupt.  An automobile firm produced cars that seemed to accelerate out of control.  Another automobile company, once the world's biggest, went bankrupt and had to be bailed out by the government. An oil company took months to cap a blown out well.  In the health care world, drug companies which could no longer manufacture pure and unadulterated drugs.  Baxter International sold deadly contaminated heparin (post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>). Johnson and Johnson sold contaminated or wrongly dosed over-the counter childrens' medicines (post <a href="http://hcrenewal.blogspot.com/2010/05/19-million-means-never-having-to-say.html">here</a>). Another Troubled Johnson and Johnson Factory Now yet more problems have surfaced at a Johnson and Johnson factory.  As <a href="http://www.google.com/hostednews/ap/article/ALeqM5gKNufIGxLdxRyZ8TPAzFIe83oA1gD9H3M2B00">reported</a> by the AP: <blockquote>A dozen recent federal inspections of a Johnson & Johnson factory for heartburn and other nonprescription medicines show a host of violations that could affect the quality and makeup of the drugs. A new report on inspections at the Lancaster, Pa., factory in the past month indicates a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping. In some cases, medicine batches made during equipment failures were not checked for quality. Food and Drug Administration investigators had to ask for information many times in some cases, and then wait days to get it.</blockquote> The scope of the problems was large: <blockquote>The inspection report, released Wednesday, lists 12 different types of violations, from not determining the impact of equipment failures 'on the manufacturing process and products' to incomplete records of investigations into 'unexplained discrepancies' in manufacturing. The latter problem occurs 'whether or not the batch has already been distributed,' the report states.</blockquote> Some examples were: <blockquote>_'Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality and purity.' _Procedures to prevent 'objectionable microorganisms' from getting into medicines appear not to have been followed. _'Deviations from written test procedures are not justified.' _Staff were not following up 'to determine the causes for repeated mix-up of tablets.' _Written procedures for cleaning and maintenance did not have enough detail about the methods, equipment and materials to be used. _The plant did not have recent drug production and quality control records readily available to the inspectors, as is required. _Samples of drug products taken to determine if they met written specifications were not properly identified. _There was no preventive maintenance program for at least five types of complex manufacturing or testing equipment.</blockquote> Previous Problems at Johnson and Johnson Factories Note that just a few days before this hit the news, the Philadelphia Inquirer <a href="http://www.philly.com/inquirer/business/20100721_McNeil_faces_grand-jury_probe_over_problems_that_spurred_drug_recall.html">reported</a> this follow-up from the problems at the plant in Fort Washington, PA run by Johnson and Johnson's subsidiary McNeil Consumer Healthcare <blockquote>A federal grand jury is investigating problems at the now-shuttered McNeil Consumer Healthcare plant in Fort Washington that triggered the recall of children's Tylenol and other popular pediatric medicines, according to the company. The existence of the investigation was made public Tuesday by Louise Mehrotra, vice president for investor relations for Johnson & Johnson, McNeil's parent company.</blockquote> That report reminded us that there have been problems at a third Johnson and Johnson plant: <blockquote>[Johnson and Johnson subsidiary] McNeil is now dealing with FDA issues at three drug-making facilities, including one in Las Piedras, Puerto Rico. Problems at the Las Piedras plant last year set in motion the investigation at Fort Washington. At Las Piedras, FDA inspectors were chiefly concerned about why it took McNeil more than a year to respond to consumer complaints of a musty smell associated with Tylenol caplets produced at the plant. The smell was traced to a chemical used to treat wooden pallets at the plant.</blockquote> So three Johnson and Johnson manufacturing plants have recently allegedly failed to uphold basic quality standards, and thus have made medicines that ranged from musty smelling to contaminated. Clearly, the most basic responsibility of a drug manufacturer is to supply fresh, pure, unadulterated drugs, and now Johnson and Johnson, a once iconic American drug and device company, seems to be having trouble fulfilling this responsibility. Caused by Leadership Shortcomings? It seems that health care firms, like so many others, have been distracted by financing fantasies and marketing marvels from the most fundamental parts of their business. One wonders how responsible are leaders with little understanding of the fundamentals of the fields in which their firms operate, and who seem to just get richer no badly how their firms perform. Note that the current Johnson and Johnson CEO William C Weldon's background is in "sales,marketing and international management," not manufacturing, engineering, chemistry, or the biological sciences, per the <a href="http://files.shareholder.com/downloads/JNJ/974545981x0x359543/AA8DC9C8-C2E9-406E-9BC4-9BCBC25DF730/y81646_d-i001_a_UC.pdf">company's 2010 proxy statement</a>.  In 2009, with one factory already under investigation, his total compensation was over $30,000,000. The Johnson and Johnson board of directors all get more than $200,000 per year in compensation.  The board does include two biologists and two physicians  (Prof Mary Sue Coleman, is "professor of biological chemistry" at the University of Michigan; Michael M E Johns, MD, a physician; Susan L Lindquist, Professor of Biology at Massachusetts Institute of Technology; and David Satcher, MD a physician.)  However, while it also contains the retired CEOs of a telecommunications company, an electronics company, an airline, a food company, and an bank/ finance company,  it does not seem to contain anyone with experience in manufacturing, much less pharmaceutical manufacturing.   On the other hand, it includes several people with leadership positions in non-profit health care institutions  with whose primary responsibilities their Johnson and Johnson board membership may conflict.  (Mary Sue Coleman is President of the University of Michigan; Michael M E Johns, Chancellor of Emory University, member of the Institute of Medicine, member of the editorial board of JAMA, and chair of the publications committee of Academic Medicine; Susan L Lindquist, member of the Institute of Medicine; Leo F Mullin, Chairman of the Board of the Juvenile Diabetes Research Foundation; William D Perez, Trustee of Cornell University, and Trustee of Northwestern Memorial Hospital;  and David Satcher, board member for the Kaiser Family Foundation.)    Note that leaders of non-profit academic health care institutions who also serve on boards of for-profit health care corporations often justify the apparent conflict by the need to "have a voice and interact with the business world," as explained (see post <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html">here</a>) by a spokesperson for Mary Sue Coleman.  A university president who sits on a corporate board to "understand what the commercial world is doing," may have not learned enough about that world to make sure it is doing it well. Finally, several Johnson and Johnson board members are former or current leaders of some of the financial firms whose problems lead to the global financial meltdown, or "great recession," (Anne M Mulcahy has been a member of the Citigroup board since 2004, and was on the FNMA board from 2000 to 2004, both nearly failed, and required government bailouts to survive; Leo F Mullin, currently Senior Advisor to Goldman Sachs Capital Partners, a subsidiary of Goldman Sachs, which just settled charges by the SEC that it misled investors; and Charles Prince, CEO of Citigroup from 2003 to 2007.)   Are these the sort of people we should trust to uphold the fundamental quality of drug manufacturing?  Health care organizations are increasingly saddled with leaders who do not understand the fundamentals of the health care environment, are not pledged to support their missions, and may be distracted by conflicts of interest.  Such leaders may be increasingly responsible for the dysfunction of modern health care.  True health care reform requires leadership that understands the context, and supports the mission without conflict.

Are Ill-Informed Leaders the Cause of Drug Manufacturing Mishaps?

Fundamental Corporate Failures In the last few years, there seems to have been an epidemic of once revered companies suddenly unable to perf...

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An Open Question on Moral Authority and Healthcare IT

<div dir="ltr" style="font-family:arial;">I recently had the chance to observe a relative's care in a small community hospital. This was a hospital that, in my relative's last several days there before going back to a nursing home for rehab, went live with a major vendor CPOE. Just by passing the nursing station/doctor's charting room on my relative's floor and opening my eyes and ears, I saw doctors and nurses struggling to take care of patients while "getting the bugs out of the system." They had had received some classroom "training" in a static environment, but it was clear they were learning about a lot of "gotcha's" and unanticipated glitches in vivo. The fact of problems were predictable; I told several of my relative's physicians about my work in studying these issues. There was some skepticism (maybe in my nearly being in tears about my relative, I came off as a bit melodramatic). However, several later told me they "now knew what I was talking about" upon my relative's discharge, just several days into the go-live. One story I overheard during go-live especially sticks out in my mind. A newly-admitted patient who needed urgent heparinization did not receive the medication promptly. The patient's physician could not order it, and could not enter the required weight needed to order it, due to some type of 'glitch' or system malfunction. Physicians found no way to override, despite calls to the help desk, attempts by on site IT people and users from the parent hospital, etc. In the end, the pharmacist simply provided the med using a weight estimate despite no "official" order having been entered into CPOE. I heard that the delay was on the order of "several hours." Clearly, both technology and people issues were involved ... but I assure the reader, injured or dead patients really don't care exactly how their injury occurred, after the fact (other than in litigation, which doesn't fix the damage or remediate the suffering). Here, then, is my question: Where does the moral authority come from to subject live, unsuspecting, uninformed patients to the type of risks the patient whose heparin was delayed was subject to? What right did the hospital have to NOT inform this patient before admission that a new critical CPOE system was going "live" that day, and that the patient could consider going to another hospital a few miles down the road instead that had no such potential problems? From the <a href="http://en.wikipedia.org/wiki/Belmont_Report" target="_blank">Belmont Report</a> (also see <a href="http://ohsr.od.nih.gov/guidelines/belmont.html" target="_blank">http://ohsr.od.nih.gov/guidelines/belmont.html</a> ), the six fundamental ethical principles for using any human subjects for research are: </div><div dir="ltr" face="arial"></div><div dir="ltr" face="arial"><ul><li>(1) Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent; </li><li>(2) Beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and </li><li>(3) Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.) </li><li>(4) Fidelity: fairness and equality. </li><li>(5) Non-maleficence: Do no harm. </li><li>(6) Veracity: Be truthful, no deception.</li></ul></div>I would like a straight, unspun answer to this simple question:On the basis of Belmont Report and other medical ethics regulations, where does the moral authority come from for hospitals to put patients through such risks without informing them ahead of time and offering them an opt-out, even if only the continued use of paper in their care?I have passed this question on to major American Medical Informatics Association mailing lists and await replies. -- SS

An Open Question on Moral Authority and Healthcare IT

I recently had the chance to observe a relative's care in a small community hospital. This was a hospital that, in my relative's las...

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If Our Honored Military Personnel's Medical Care Was Not Involved, This WSJ Letter Might Have Been Considered Oddly Funny

In the WSJ today, a letter to the editor was published extolling the major strides made by the U.S. military in voice recognition technology for electronic health records: [Note: this is not to denigrate the military, and I am very thankful to all who serve and defend our country and freedoms. Health IT problems seem unfortunately universal - ed.] <blockquote><a href="http://online.wsj.com/article/SB10001424052748703467304575383621906130434.html"> Shared Information Can Give Better Medical Results</a> Wall Street Journal JUly 26, 2010 There is no question that medical information, notes and all, belong to both the patient and the provider, helping each of them to manage a medical condition ("The Informed Patient: What the Doctor Is Really Thinking," Personal Journal, July 20). In the U.S. Army in Europe, we are taking the concept a little further, from "what the doctor is really thinking" to "what the doctor is saying." For the last two years, we have been evaluating voice-recognition technology to improve the provider's experience with our electronic medical record. During the process, we came across a wonderful discovery: As doctors dictate medical notes into the record during patient visits, patients are paying much more attention to what doctors are saying, prompting them to ask important follow-up questions, add statements about something else that may be bothering them, or, most importantly, correcting the doctor when a dictation error is made. It's the type of patient-safety feedback loop that would otherwise be absent. The more we allow our patients behind the curtain to see and hear how we work, the more we will see patients become true partners in their own health care. Robert Walker, M.D. Chief Medical Information Officer Europe Regional Medical Command Heidelberg, Germany </blockquote> Here's the problem, as I outlined at my July 1, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">$4 Billion Military EMR "AHLTA" to be Put Out of Its Misery? Also, Does the VA Have $150 Million to Burn on IT That Was Never Used?</a>": <blockquote>I have heard from numerous reliable sources that the military's $4 billion+ EMR known as "Armed Forces Health Longitudinal Technology Application" (<a style="font-weight: bold;" href="http://dhims.health.mil/userSupport/ahlta/about.aspx">AHLTA</a>) is to be declared a failure, and replaced. I'd written about AHLTA's considerable problems at the post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at <a href="http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html" target="_blank">http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html</a> . From that post: <blockquote> [AHLTA has been described as] difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse? Yes ... When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT. </blockquote> </blockquote>Read my June 2009 post on the AHLTA failure at <a href="http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html" target="_blank">http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html</a>, and the May 2009 piece I referenced from "US Medicine - the Voice of Federal Medicine" entitled "<a href="http://www.usmedicine.com/articles/electronic-records-system-unreliable-difficult-to-use-service-officials-tell-congress.html">Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress</a>" by Sandra Basu, in their entirety. Extolling voice recognition advances in a failed $4+ billion EMR debacle due to severe unusability of most of the information system is akin to extolling the virtues of improving screen-door aesthetics on submarines being flooded by water entry. It could almost be considered funny, in a dark-humor sort of way - except the results are anything but humorous. "Dead serious" is a more apt term. Finally, while "shared information can give better medical results", there seems to be little shared information about others' healthcare IT failures. Organizations seem to be constantly re-learning that which others have learned years or decades in the past, repeating the same IT mistakes. The cost of this self-education is not at all cheap. (This failure to learn from others is one reason I write that health IT lacks the science and rigor of the field it ostensibly serves: medicine.) -- SS

If Our Honored Military Personnel's Medical Care Was Not Involved, This WSJ Letter Might Have Been Considered Oddly Funny

In the WSJ today, a letter to the editor was published extolling the major strides made by the U.S. military in voice recognition technology...

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Stifling Whistle-Blowers: Old and New Approaches

We have frequently discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  We have discussed many possible causes of the anechoic effect, but one particularly obvious cause is the silencing of dissenters and <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">whistle-blowers</a>. Three recent stories illustrate old and new tactics to reinforce the anechoic effect. A Classic Case - ValleyCare Medical System Nurse Fired <a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/07/23/BA6H1EJ0NA.DTL">From the San Francisco Chronicle</a>, <blockquote>An Alameda County jury awarded more than $344,000 in damages this week against ValleyCare Medical System for refusing to rehire a Castro Valley operating nurse who claimed the hospital was retaliating against her for complaints she made about patient safety issues, including concerns about surgical equipment left inside patients. Kristeen Klaas, a 15-year veteran at ValleyCare and a registered nurse for more than 30 years, sued the hospital system, which has services in Pleasanton and Livermore, after she quit in distress in May 2008 and hospital managers failed to respond to her request to be rehired days later. The 54-year-old Klaas, who now works at Alta Bates Summit Medical Center in Oakland and San Leandro Hospital, had brought numerous safety complaints about the Pleasanton hospital to the attention of ValleyCare's management over the two years prior to her resignation. Klaas complained about a fellow nurse who brought a dog into the operating team's break room and jumped rope with an electrical cord in the operating room, as well as a surgical technician who brought a rifle into the operating room office to sell. She also complained that a tip of a surgical instrument went missing during a surgery and was never found, and that an instrument was left in a patient because the hospital did not have a formal policy of counting instruments after surgery. She also accused a supervisor of forging her signature on a performance evaluation after she refused to sign an evaluation that was backdated to comply with state regulations.</blockquote> Here is the tactic allegedly used to silence the whistle-blowing nurse: <blockquote>On her last day on the job, Klaas got permission from her supervising nurse to leave work because she was in distress after a colleague, the subject of three of her complaints, screamed at her. 'She realized, for the patient's safety, she couldn't continue to go forward that day in the operating room because she was so upset,' he said. But then a supervisor called her at home and accused her of leaving without permission, prompting Klaas to resign, he said.</blockquote> This is the classic, rather blunt way to do it: just make the would-be truth-teller's job experience so miserable that she quits. Now we will present two examples of a more subtle approach, one directly from health care, one at least from a sphere with major health care implications. A New Approach: A Contract Preventing Communication "Inimical" to a Pharmaceutical Company's Business This case was documented by a personal narrative by Marc Lipsitch, a Professor of Epidemiology and the Harvard School of Public Health, <a href="http://chronicle.com/article/The-Hidden-Risk-to-Academic/66050/">published in the Chronicle of Higher Education</a>, <blockquote>I received a request from a large pharmaceutical company to assist in the design of a clinical trial, and the proposed terms seemed to require that I sign away my right to criticize the product. One provision would prohibit me from entering into 'any agreement or relationship to render services as ... adviser or consultant to, any other individual, firm, or corporation that would be inimical to or in conflict with' the aspects of the company's business covered by the agreement. Another would forbid me to engage, in any capacity, directly or indirectly, in "any business," with or without compensation, relating to the class of products under discussion—not just for the term of the contract, but for the year after as well. Those provisions could restrain me from providing candid advice to a regulator, a government official, or the editor of a peer-reviewed journal about the class of products on which I was consulting, even if the advice were based on publicly available information. I objected to those terms, as did a colleague who was offered the same arrangement.</blockquote> Prof Lipsitch also noted that government research funding agencies and universities may not provide any protections to their faculty against such agreements. He also noted that the contract he was asked to sign was not one of a kind: <blockquote>Discussions with my colleagues suggest that the problem is not limited to one pharmaceutical company ....</blockquote> We and many others have frequently discussed the conflicts of interest that may be generated by physicians or health care academics having financial relationships with industry. The Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">Conflict of Interest in Medical Research, Education, and Practice</a>, is: <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....</blockquote> Thus the concern is that a faculty member,for example, who is paid to consult for a drug company might tend to favor the company, its products, or policies to its advantage in his or her clinical teaching, scholarly talks and writing, or public policy opinions. That might happen even if the consulting work is technical or scientific and not directly related to the particular topic about which communication might be influenced. However, the situation described by Prof Lipsitch is much worse. Were he to have signed the contract, he would have been constrained by this legal agreement from writing or saying anything "inimical to or in conflict with" the company's business. Last week, a similar, but more wide-spread example surfaced (pardon the pun) in a domain that is at least related to health care. Another Version of the New Approach: the BP Consulting Contracts Making Any Communication Between the Company and the Consultant Confidential Originally <a href="http://www.bbc.co.uk/news/world-us-canada-10731408">reported by the BBC</a>, <blockquote>The head of the American Association of Professors has accused BP of trying to 'buy' the best scientists and academics to help its defence against litigation after the Gulf of Mexico oil spill. 'This is really one huge corporation trying to buy faculty silence in a comprehensive way,' said Cary Nelson. The BBC has obtained a <a href="http://news.bbc.co.uk/2/shared/bsp/hi/pdfs/22_07_bp_contract.pdf">copy of a contract</a> offered to scientists by BP. It says that scientists cannot publish the research they do for BP or speak about the data for at least three years, or until the government gives the final approval to the company's restoration plan for the whole of the Gulf. It also states scientists may perform research for other agencies as long as it does not conflict with the work they are doing for BP. And it adds that scientists must take instructions from lawyers offering the contracts and other in-house counsel at BP.</blockquote> Here are some examples of the wording of<a href="http://news.bbc.co.uk/2/shared/bsp/hi/pdfs/22_07_bp_contract.pdf"> the contract</a> as obtained by the BBC about confidentiality. <blockquote>Confidentiality. All communications (including non-public information disclosed in such communications) between you (and your agents), BP Attorneys and/or other BP representatives in the course of your performance of the BP NRDA Services are deemed to be incidental to the rendering of legal services and are to be privileged and confidential. You shall maintain a strict confidentiality of such non-public communications and information unless or until a person from whom you are authorized to take instructions informs you in writing that this restriction is no longer applicable to any particular non-public communications and information. In the event you are required to disclose such privileged and confidential non-public communication and information by an order entered by a court or by similar judicial process, or by a judicial or administrative subpoena, you shall notify a person from whom you are authorized to take instructions as soon as practicable, and you are required to cooperate with BP if BP decides to seek relief from such required disclosure, including commencement of a legal or administrative proceeding to prevent or limit disclosure of such privileged or confidential information.</blockquote>Here is the description of those from whom the signer of the contract must take orders. <blockquote>Instructions. You agree to take your instructions only from me, from other lawyers in my firm, from Brian Israel or other lawyers in the Arnold & Porter law firm, and from Donna Ward or other in-house counsel at BP (collectively 'BP Attorneys').</blockquote> Note that the contract defines privileged, confidential information as any communication between BP and its representatives and the contract signer. Thus, to make something confidential, all BP would have to do is mention it in a communication. It appears that this would allow BP to render off-limits any topic it chose. Also, since by the same mechanism, it appears that the contract itself, once signed, would also become privileged and confidential. Summary I submit that ideally medicine and health care ought to be a very transparent calling.  Physicians are obliged to keep confidential the information disclosed to them by patients, enabling the patients to trust physicians sufficiently to provide them the accurate information needed for optimal care.  However, it is hard to think of much other information or communication in health care that ought to be kept secret, (other than the processes used by commercial firms to manufacture drugs or devices.)  Yet as health care becomes more of a business and less of a calling, businesspeople's proclivity to keep as much as possible secret to avoid giving any advantage to a competitor has become more influential.  Furthermore, those leading big organizations have realized that it is easier to maintain their power if they can keep their mistakes, if not misconduct secret.  So businesspeople's proclivity to mount overwhelming legal defenses of their interests may lead to persuading or fooling people who might be inclined to delve into such mistakes and misconduct to sign contracts to keep them silent through confidentiality clauses, requirements to protect privileged or proprietary information, non-disparagement clauses and the like.  The result will be better coddled self-interests, but more opacity that is inimical to good patient care, teaching, research, and public policy discussion. To truly reform health care, we need more transparency.  To produce more transparency, we need constraints on contracts that inhibit needed clinical, teaching, research and public policy communication. Meanwhile, as my father, who was an attorney, done told me: "don't sign a contract you don't understand, and don't sign a contract giving away any right you need to keep."

Stifling Whistle-Blowers: Old and New Approaches

We have frequently discussed the anechoic effect , how it is just not done to discuss certain topics, particularly those related to the adv...

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More About What We Don't Know About the Contaminated Heparin from China

We last blogged about the case of Baxter International's adulterated heparin <a href="http://hcrenewal.blogspot.com/2010/07/prosecuting-doctors-for-importing-iuds.html">here</a>.  (For a more detailed summary of the case, look <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.) In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product. Now, <a href="http://online.wsj.com/article/SB10001424052748703954804575381540372921432.html">an article</a> in the Wall Street Journal by Alicia Mundy tells us more about what we don't know, <blockquote>The Chinese government didn't pursue an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. for help, according to a congressional probe. Two House Republicans said Food and Drug Administration officials recently told them that the agency has been "severely hampered" by the lack of cooperation from China in finding those responsible.</blockquote> Furthermore, <blockquote>'It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,' said Mr. Barton, the top Republican on the House Energy and Commerce Committee. He called on ... [FDA Commissioner Margaret] Hamburg to air the issue with Chinese officials.</blockquote> Chinese officials denied there is a problem, <blockquote>Yan Jiangying, spokeswoman for China's State Food and Drug Administration, said the congressmen's accusations are 'not true.' Ms. Yan said her agency 'did a very thorough investigation, including very detailed inspection and testing, and surveys of enterprises as well. We signed an agreement with the FDA on drug safety in the end of 2007, and strengthened the monitoring of heparin.' </blockquote> Note that their investigation, such as it was, did not appear to identify any misconduct or wrong-doing by anyone. So now we know more about what we do not know about the deadly adulterated heparin from China. But remember this is a case about heparin sold in the USA by Baxter International, an American company as an American product, resulting in the death of Americans.  Also, remember that the American company obtained the heparin from another American company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co.  Since Baxter International sold the heparin under its own label, should not its leaders be responsible for the safety and purity of the product?  Since Scientific Protein Laboratories LLC furnished the active pharmaceutical agreement to Baxter, and obtained it from a factory it partially owned in China, should not its leaders also be responsible for the safety and purity of the product? It would be important to find out ultimately where in China the adulterated heparin entered the supply chain, but the current uncertainty about the initial origin of the contamination does not absolve those in the US who sold the active pharmaceutical ingredient, and then sold that ingredient in bottles with a US company label of responsibility for the safety and purity of the drug. Why have we heard nothing more from Baxter International's and Scientific Protein Laboratories' leaders about the deadly heparin which they had sold?  Why have we heard nothing more about any investigation of these US based participants in this case?  Both US companies doubtless saved money by buying the heparin from the cheapest Chinese sources they could find, by not directly inspecting and supervising its production, and by at best ignoring the lack of regulation of producers of active pharmaceutical ingredients in China.  They and their leaders benefited from this out-sourced, off-shore production.  (Note that Baxter CEO Robert L Parkinson Jr received total compensation of $14,361,305 according to the company's <a href="http://www.baxter.com/downloads/investors/reports_and_financials/2010_baxter_proxy.pdf">proxy statement</a>, and six named officers all received more than $2,200,000.) Why aren't they being held accountable for its bad results? As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them. To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large). Hat tip to Ed Silverman <a href="http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/">on the PharmaLot blog</a>.

More About What We Don't Know About the Contaminated Heparin from China

We last blogged about the case of Baxter International's adulterated heparin here . (For a more detailed summary of the case, look here...

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Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we've met twice. The first time was at the <a href="http://www.sciencebasedmedicine.org/?p=4100" mce_href="http://www.sciencebasedmedicine.org/?p=4100">Yale "Integrative Medicine"</a> Symposium in March. The second was in April, when Drs. Novella, Gorski and I <a href="http://www.sciencebasedmedicine.org/?p=4575" mce_href="http://www.sciencebasedmedicine.org/?p=4575">met with you</a> for an hour at the NCCAM in Bethesda. At the time I concluded that you favor science-based medicine, although you are in the awkward position of <a href="http://www.sciencebasedmedicine.org/?p=4671" mce_href="http://www.sciencebasedmedicine.org/?p=4671">having to appear 'open-minded'</a> about nonsense. More about that below, but first let me address the principal reason for this letter: it is disturbing that you will shortly appear at the <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363">25th Anniversary Convention</a> of the American Association of Naturopathic Physicians (AANP). It is disturbing for two reasons: first, it suggests that you know little about the tenets and methods of the group that you'll be addressing; second, your presence will be interpreted as an endorsement of those methods and of that group---whether or not that is your intention. If you read nothing more of this letter or its links, please read the following articles (they're "part of your education," as my 91 y.o. mother used to say to me): <a href="http://www.medscape.com/viewarticle/465994" mce_href="http://www.medscape.com/viewarticle/465994">Naturopathy: A Critical Appraisal</a> <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed" mce_href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed"></a> <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed" mce_href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140750/?tool=pubmed">Naturopathy, Pseudoscience, and Medicine: Myths and Fallacies vs Truth</a> The first article is an introduction to the group to which you will be speaking; the second is my response to complaints, from that group and a few of its apologists, about the first article. It was a surprise to me that the editor, George Lundberg, preferred that I make my response a comprehensive one. Thus the second article inevitably became the crash course---call it CAM for Smarties---that your predecessors never offered you, replete with examples of useless and dangerous pseudoscientific methods, real science being brought to bear in evaluating such methods, proponents' inaccurate or cherry-picked citations of biomedical literature, bits of pertinent but little-known history, the standard logical fallacies, embarrassing socio-political machinations, wasteful and dangerous 'research' (funded---unwittingly, I'm sure---by the NCCAM), bait-and-switch labeling of rational methods as "CAM," vacuous assertions about 'toxins' and "curing the underlying cause, not just suppressing the symptoms," anti-vaccination hysteria, misleading language, the obligatory recycling of psychokinesis claims, and more. Please excuse me if this sounds preachy; I admit that it does, but understand that I'm writing in good faith. My own views of "CAM" did not dawn on me overnight, but were the result of years of research. My 'internship,' as it were, consisted of <a href="http://www.sciencebasedmedicine.org/?p=115" mce_href="http://www.sciencebasedmedicine.org/?p=115">sitting on a state commission</a> from the fall of 2000 until the spring of 2002, listening to AANP members (including at least <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#shiva" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#shiva">one </a>with whom you will share the podium), reading about 'naturopathic medicine,' and attempting (unsuccessfully) to engage its advocates in rational discussion. I began that task open to forming opinions based on whatever information became available; by its end it had become abundantly clear that the group is best characterized as a pseudoscientific cult, and nothing since has altered that opinion. Regarding your presence at the convention being tantamount to an endorsement of 'naturopathic medicine,' this is so obviously true that it ought not be necessary to mention it. Previous experience, however, has taught me to expect an air of---please don't take this personally---<a href="http://www.sciencebasedmedicine.org/?p=438" mce_href="http://www.sciencebasedmedicine.org/?p=438">utter cluelessness </a>whenever I've raised such an issue. If you've read the second naturopathy article linked above, you already know that according to proponents, <blockquote>The validity of naturopathic medicine is demonstrated by its support in government (including accreditation of its schools and NIH-funded research), on medical school Web sites, and in other parts of the public domain.</blockquote> An appearance at their annual convention by the most important "CAM" administrator at the NIH surely has the <a href="http://www.naturopathic.org/content.asp?contentid=62" mce_href="http://www.naturopathic.org/content.asp?contentid=62">political arm</a> of the AANP licking its chops. NDs, as they call themselves, are currently licensed in 14 or 15 states and a couple of provinces, and aggressively seek licensure throughout the U.S. and Canada. They appear to wield political clout well out of proportion to their numbers, no doubt thanks in part to the <a href="http://nccam.nih.gov/about/naccam/charter.htm#jump4" mce_href="http://nccam.nih.gov/about/naccam/charter.htm#jump4">legislative language</a> that created the NCCAM's National Advisory Council for Complementary and Alternative Medicine (NACCAM): <blockquote>Of the 18 appointed members...Nine...shall be practitioners licensed in one or more of the major systems with which the Center is involved. Six of the members shall be appointed by the Secretary from the general public and shall include leaders in the fields of public policy, law, health policy, economics, and management. Three of the six shall represent the interests of individual consumers of complementary and alternative medicine. </blockquote>Thus there have been 1-3 NDs on the NACCAM since its inception in 1999, although their numbers in general are, by any measure, miniscule: I reckoned there were about 2500 in the U.S. in 2003; the AANP now places that number at 6000. By comparison, there are about 800,000 MDs and 50,000 DOs in the U.S. NDs <a href="http://www.naturopathic.org/content.asp?pl=16&sl=60&contentid=60" mce_href="http://www.naturopathic.org/content.asp?pl=16&sl=60&contentid=60">claim to be well trained</a> to practice what most people think of as family medicine or primary care medicine, although their version of training is chock full of pseudoscientific nonsense and lacks a true residency program. They began by purporting to use only "natural medicines," but in regions where they've become politically connected they've sought, and been granted, the license to <a href="http://www.oregon.gov/OBNM/rules/850-060-0225.-0226_1.pdf" mce_href="http://www.oregon.gov/OBNM/rules/850-060-0225.-0226_1.pdf">prescribe numerous drugs</a>. Predictably, they've recently begun to <a href="http://www.sciencebasedmedicine.org/?p=143" mce_href="http://www.sciencebasedmedicine.org/?p=143">bump people off</a> with such exotic choices as intravenous colchicine and disodium ethylenediaminetetraacetic acid (that pesky <a href="http://www.ncbi.nlm.nih.gov/pubmed/18596934?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum" mce_href="http://www.ncbi.nlm.nih.gov/pubmed/18596934?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum">TACT </a>drug), in addition to more folksy nostrums such as acupuncture, vitamin B12, and an "herbal tincture" for a teenage girl who would shortly <a href="http://www.seattleweekly.com/2005-06-08/news/death-by-natural-causes.php" mce_href="http://www.seattleweekly.com/2005-06-08/news/death-by-natural-causes.php">die of asthma</a>. I see that your talk is titled "Complementary and Alternative Medicine: Promising Ideas from Outside the Mainstream." I imagine that it will cover some of the material that you covered at the Yale Symposium, where you used the similar phrase, “Quirky Ideas from Outside the Mainstream.” Without reading more into that word substitution than is warranted, let me assure you that there are no promising ideas emanating from naturopathy, even if there are plenty of quirky ones, e.g., <a href="http://www.sciencebasedmedicine.org/?p=62" mce_href="http://www.sciencebasedmedicine.org/?p=62">inflating balloons in the nasopharynx</a> to effect a “controlled release of the connective tissue tension to unwind the body and return it toward to its original design." Regarding the implicit requirement of your office that you appear open-minded even to medical absurdities, you made that clear in <a href="http://nccam.nih.gov/about/offices/od/2010-04.htm" mce_href="http://nccam.nih.gov/about/offices/od/2010-04.htm">your own account</a> of our NCCAM meeting and of <a href="http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=650&Itemid=189" mce_href="http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=650&Itemid=189">another </a>that you'd had a few weeks earlier, involving a group of <a href="http://www.theness.com/neurologicablog/?p=41" mce_href="http://www.theness.com/neurologicablog/?p=41">homeopaths</a> and associated <a href="http://www.theness.com/neurologicablog/?p=40" mce_href="http://www.theness.com/neurologicablog/?p=40">crackpots</a> who called themselves "the leading scientists in the field": <blockquote>Recently, I hosted two meetings with groups that represent disparate views of CAM research. These meetings have given me a renewed appreciation for the value of listening to differing voices and perspectives about the work we do. My NCCAM colleagues and I know there are differing views of the value of doing CAM research. On one side, we have stakeholders who are staunch CAM advocates, and on the other side, we have CAM skeptics. Each group has its own beliefs and opinions on the direction, importance, and value of the work that NCCAM funds. The advocates would like to see more research dollars supporting various CAM approaches while the skeptics see our research investment as giving undue credibility to unfeasible CAM modalities and want less research funding. As I've stated before, our position is that science must remain neutral, and we should be strictly objective. There are compelling reasons to explore many CAM modalities, and the science should speak for itself. (emphasis yours) </blockquote> Certainly science must remain neutral in the face of not-yet-seen data from rigorous studies, but that is different from what you, in your dual roles as "CAM" Explicator-in-Chief and Steward of Public Funds, must remain. You typically face questions that are, for all purposes relevant to the NIH, to modern medicine, and to the American citizenry, already settled---whether by basic science, clinical studies, rational thinking, or all three. I've offered several examples in the two naturopathy articles linked above. Consider homeopathy, a <a href="http://www.homeowatch.org/policy/aanp.html" mce_href="http://www.homeowatch.org/policy/aanp.html">core claim</a> of "naturopathic medicine" and the subject of your meeting with the "staunch CAM advocates." It makes no more sense for you to remain neutral on that topic than it would for the NIMH Director to remain neutral on exorcisms, or for the NCI Director to remain neutral on Krebiozen. Edzard Ernst, a one-time homeopath whose own portfolio of <a href="http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ernst%20E%22%5BAuthor%5D" mce_href="http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ernst%20E%22%5BAuthor%5D">"CAM" investigations</a> dwarfs the entire output of the NCCAM, puts it <a href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-4XHJVNN-2&_user=6396456&_coverDate=11%2F30%2F2009&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000069771&_version=1&_urlVersion=0&_userid=6396456&md5=30c4f7ae24e5f3dc1403ca0972baf838" mce_href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TDC-4XHJVNN-2&_user=6396456&_coverDate=11%2F30%2F2009&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000069771&_version=1&_urlVersion=0&_userid=6396456&md5=30c4f7ae24e5f3dc1403ca0972baf838">this way</a>: <blockquote>Should we keep an open mind about astrology, perpetual motion, alchemy, alien abduction, and sightings of Elvis Presley? No, and we are happy to confess that our minds have closed down on homeopathy in the same way. </blockquote> Science and skepticism, moreover, are not distinct. Good science involves, first and foremost, skepticism. This is true for the design of any experiment, in which the primary goal is to attempt to falsify the hypothesis, and also for scientific thinking in general. Bruce Alberts, the editor of Science, <a href="http://www.sciencemag.org/cgi/content/full/319/5870/1589" mce_href="http://www.sciencemag.org/cgi/content/full/319/5870/1589">discussed this</a> in a 2008 editorial titled "Considering Science Education": <blockquote>...society may less appreciate the advantage of having everyone acquire, as part of their formal education, the ways of thinking and behaving that are central to the practice of successful science: scientific habits of mind. These habits include a skeptical attitude toward dogmatic claims and a strong desire for logic and evidence. As famed astronomer Carl Sagan put it, science is our best "bunk" detector. Individuals and societies clearly need a means to logically test the onslaught of constant clever attempts to manipulate our purchasing and political decisions. (emphasis added) </blockquote> I believe that you know all this at some level, but that your current job demands that you bend over backward to frame skeptics as extreme---distinguishing them from "neutral" scientists. Thus you, like many <a href="http://www.sciencebasedmedicine.org/?p=150" mce_href="http://www.sciencebasedmedicine.org/?p=150">reporters</a>, have placed skeptics of homeopathy or naturopathy at one end of a contrived belief spectrum, and "staunch CAM advocates" at the other. Please indulge me while I compare this <a href="http://www.sciencebasedmedicine.org/?p=319" mce_href="http://www.sciencebasedmedicine.org/?p=319">version of 'neutrality'</a> with others that exist in the popular domain: <ul><li>Some people feel strongly that the moon landings were a collective hoax. Others feel just as strongly that they really happened.</li><li>Some people believe that the Holocaust didn't happen. Others believe that it did.</li><li>Some people believe that the variety of species on earth is a product of Intelligent Design (ID). Others believe in the theory of evolution by variation and natural selection. </li></ul>This could go on and on, but you probably get the point. The last bullet is more pertinent to your tacit endorsement of the AANP than you might imagine. What follows is a representative <a href="http://web.archive.org/web/20030518030621/http:/www.scnm.edu/news/uploads/ms.pdf" mce_href="http://web.archive.org/web/20030518030621/http:/www.scnm.edu/news/uploads/ms.pdf ">view of herbalism</a> offered by Thomas Kruzel, with whom you will also <a href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#thomas_kruzel" mce_href="http://www.naturopathic.org/content.asp?admin=Y&contentid=363#thomas_kruzel">share the podium</a> at the convention (he will discuss "Emunctorology"; don't ask). Kruzel is <a href="http://www.aznma.com/viewbulletin.php?id=115" mce_href="http://www.aznma.com/viewbulletin.php?id=115">Past President of the AANP</a> and the former Vice President of Clinical Affairs and Chief Medical Officer at the Southwest College of Naturopathic Medicine. He was selected Physician of the Year by the AANP in 2000, and Physician of the Year by the Arizona Naturopathic Medical Association in 2003: <blockquote>Herbal Medicine: Naturopathic physicians have been trained in the art and science of prescribing medications derived from plant sources. The majority of prescription drugs are derived as well from plants but are often altered and used as single constituents. What makes herbal medicine unique is that plants have evolved along with human beings and have been used as non-toxic medications for centuries.If there is any problem with herbal medicines it is that unless one knows how to prescribe them, they may not be effective. Herbal medications should be prescribed based on the symptoms that the person presents rather than for the name of the disease. Herbal medications are much more effective at relieving the patients symptoms when prescribed in this manner. When prescribed the medicines act with the body’s own innate healing mechanism to restore balance and ultimately allows healing to occur.What’s nice about plant or herbal medicines is that because they are derived from the whole plant they are considerably less toxic to the body. The plant medicine has evolved to work in harmony with the normal body processes rather than taking over its function as many drug therapies do. Because of this herbal medicines may be taken for longer periods of time without the side effects so often experienced with drugs. </blockquote>You are particularly impressed, I hope, by the magical, ID-like claim that "plant medicine has evolved to work in harmony with the normal body processes." Other curious assertions include the conflation of herbal medicine with the core claims of either homeopathy or the non-existent 'allopathy' (we can't tell which)---"...should be prescribed based on the symptoms..."---demonstrating that the author doesn't know much about even the fanciful methods for which he claims expertise; and the dangerously false statement that medicines "derived from the whole plant are considerably less toxic" (than are well-researched and precisely dosed "prescription drugs").Dr. Briggs, please consider the possibility that you no longer must hide your considerable <a href="http://nccam.nih.gov/about/offices/od/briggsCV.pdf" mce_href="http://nccam.nih.gov/about/offices/od/briggsCV.pdf">scientific prowess</a> in order to be a good NCCAM Director. Your 'stakeholders' include not only very small numbers of naturopaths, homeopaths, and other fringe practitioners, but also far larger numbers of citizens who wonder about the validity of what those practitioners are peddling. It is to those citizens that you should be directing your efforts, which ought to begin with sober, objective, skeptical, scientific considerations of the various claims, the vast majority of which can, like balloons in the nasopharynx, be deflated in milliseconds by anyone with even a modest understanding of nature. They don't require clinical trials.Things are changing elsewhere. My colleague Steve Novella has <a href="http://www.sciencebasedmedicine.org/?p=6146" mce_href="http://www.sciencebasedmedicine.org/?p=6146">just written</a> about substantial efforts to deny insurance coverage for homeopathy in the land of its birth, Germany. In the UK, homeopathy has been far more popular than it is here, even to the point of its being funded by the National Health Service. One of the "staunch CAM advocates" who reportedly attended your meeting by teleconference was <a href="http://www.homeopathyworldcommunity.com/video/everyday-homeopathy-lectures" mce_href="http://www.homeopathyworldcommunity.com/video/everyday-homeopathy-lectures">Peter Fisher</a>, Homeopath to the Queen. Yet both the British Medical Association and the House of Commons Science and Technology Committee have seen through the ruse of pseudoscience that is homeopathy, the former declaring it "<a href="http://www.telegraph.co.uk/health/alternativemedicine/7728281/Homeopathy-is-witchcraft-say-doctors.html" mce_href="http://www.telegraph.co.uk/health/alternativemedicine/7728281/Homeopathy-is-witchcraft-say-doctors.html">witchcraft</a>" and latter making this <a href="http://www.parliament.uk/business/committees/committees-archive/science-technology/s-t-homeopathy-inquiry/" mce_href="http://www.parliament.uk/business/committees/committees-archive/science-technology/s-t-homeopathy-inquiry/">statement</a>:<blockquote>The Committee concurred with the Government that the evidence base shows that homeopathy is not efficacious (that is, it does not work beyond the placebo effect) and that explanations for why homeopathy would work are scientifically implausible.</blockquote>American citizens want and deserve, for their tax money, exactly that sort of definitive evaluation of such claims. Your first responsibility, Dr. Briggs, is to them---it is not to the AANP, other "CAM stakeholders," Tom Harkin, Orrin Hatch, or Dan Burton, and certainly not to the members of the NACCAM. Yes, we "skeptics see [the NCCAM] research investment as giving undue credibility to unfeasible CAM modalities," because the <a href="http://www.csicop.org/si/show/ongoing_problem_with_the_national_center" mce_href="http://www.csicop.org/si/show/ongoing_problem_with_the_national_center">evidence is overwhelming</a> that this is the case. We also see your appearing at conventions of <a href="http://www.sciencebasedmedicine.org/?p=247" mce_href="http://www.sciencebasedmedicine.org/?p=247">pseudomedical pseudoprofessional organizations </a>as giving undue credibility to unfeasible and dangerous claims.Sincerely yours,Kimball C. Atwood, M.D. SkepticThis letter has been cross-posted on <a href="http://www.sciencebasedmedicine.org/">Science-Based Medicine</a>.

Open Letter to Dr. Josephine Briggs

Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we've met t...

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Duke Scientist Bringing Millions from NIH and Pharma Suspended Over Rhodes Scholar Claims

The New York Times reports that a medical researcher faked claims to being a Rhodes Scholar, and that a major scandal that has erupted. The scenario is very familiar to readers of Healthcare Renewal, with universities collecting millions from public sources and the pharmaceutical industry, turning a blind eye to credentials discrepancies of faculty "taxpayers", and the public possibly put at risk through faulty research and suspect "reviews": <blockquote><a href="http://www.nytimes.com/2010/07/21/health/research/21cancer.html">Duke Scientist Suspended Over Rhodes Scholar Claims</a> New York Times July 20, 2010 Duke University School of Medicine has suspended a researcher and stopped patient enrollment in three cancer studies upon learning of reports that the researcher had overstated his academic credentials. One of the lead investigators on the cancer studies, Dr. Anil Potti, was placed on administrative leave, said Douglas J. Stokke, a spokesman for Duke, while the university investigates allegations that Dr. Potti had falsely claimed that he was a Rhodes scholar. The controversy erupted late last week after <a style="font-weight: bold;" href="http://cancerletter.com/tcl-blog/CL36-27.pdf" title="Article in The Cancer Letter. (PDF)">an article published in The Cancer Letter</a> (PDF), a weekly publication for cancer specialists, reported that Dr. Potti, an assistant professor of medicine, had on occasion exaggerated his credentials. (A spokeswoman at Rhodes House at Oxford confirmed on Tuesday that Dr. Potti had not received the scholarship.) </blockquote> The scientist, Anil Potti, was engaged in cancer clinical trials using questionable and possbily erroneous analytical methods (prediction models). <blockquote>In addition, several dozen biostatisticians and cancer researchers at Harvard, Princeton, Johns Hopkins and other academic institutions are now questioning the methodology behind the three clinical trials, urging a halt to the Duke studies — two on lung cancer and one on breast cancer — in a letter sent to the director of the National Cancer Institute.</blockquote> He'd used the fake credentials to get American Cancer Society money: <blockquote> When questions about Dr. Potti’s credentials became public, the American Cancer Society suspended payments of a five-year, $729,000 grant awarded to Dr. Potti to study the genetics of lung cancer. The society awarded the grant based in part on a résumé from the doctor that included the Rhodes honor, said Dr. Otis W. Brawley, the chief medical officer of the cancer society. </blockquote> According to The Cancer Letter's exposé linked above: <blockquote>A high-profile cancer genomics researcher at Duke University claimed in multiple grant applications that he had been a Rhodes scholar, when, in fact, the Rhodes Trust states flatly that he was not. Documents obtained by The Cancer Letter show that in biographies submitted to NIH, Duke oncologist and genomics researcher Anil Potti claimed variously to have won the prestigious scholarship in 1995 or 1996, depending on the version of the biography. Potti also made the Rhodes claim in an application that resulted in a $729,000 grant from the American Cancer Society. “We don’t have any record that Anil Potti was a Rhodes scholar,” spokesman for the Rhodes Trust said to The Cancer Letter.</blockquote> Assuming the fabrications are proven, a number of questions arise: <ul><li>How can a Duke scientist have gotten away with exaggerated credentials on a CV used in a grant applicationa to NIH, the American Cancer Society, and perhaps other organizations, claiming to be a Rhodes Scholar? </li><li>Did he make similar exaggerations in his application to Duke itself?</li><li>Do the exaggerations made in NIH and/or other federal grant applications constitute a crime, e.g., under Title 18 of U.S. Code, Section 1001 which makes it a federal crime to make a false statement to the government, according to one contributor to The Cancer Letter article? </li><li>Will Duke act on fabrications as criminal matters? </li><li>What were the Duke grants office and/or credentials-checking staff doing during their working hours?</li><li>Why did this exaggeration come out in The Cancer Letter? </li></ul> Patients may be at risk: <blockquote> [MD Anderson Cancer Center biostatisticians] Keith Baggerly and Kevin Coombes said they devoted about 1,500 hours to checking Potti’s and Nevins’s work. These efforts—dubbed “forensic bioinformatics”—resulted in a paper in the November 2009, issue of the Annals of Applied Statistics. “Unfortunately, poor documentation can shift from an inconvenience to an active danger when it obscures not just methods but errors,” the paper stated. “Patients in clinical trials are currently being allocated to treatment arms on the basis of these results.” The two raised questions about Duke’s randomized phase II single-institution trials that used the Nevins and Potti technology to assign patients to treatment (NCT00545948, NCT00509366, and NCT00636441). Baggerly and Coombes argued that these trials “may be putting patients at risk.”</blockquote> Duke initially suspended but then restarted the trials after an "investigation" by outside scientists. However: <blockquote>Experts asked by The Cancer Letter to review these [investigation] documents [obtained under the FOIA] noted that Duke deans Cuffe and Kornbluth were inaccurate in their description of the document’s substance and conclusions when they announced completion of the investigation and resumption of the clinical trials earlier this year. “Having read the committee’s report, we must disagree with Duke’s representation of the committee’s findings,” Baggerly and Coombes said in an email after reviewing the documents released under FOIA. The committee stated that “In our review of the methods … we were unable to identify a place where the statistical methods were described in sufficient detail to independently replicate the findings of the papers,” and further noted that the Duke investigators “really need” to work on “clearly explaining the specific statistical steps used in developing the predictors and the prospective sample assignments."</blockquote> Duke has apparently now decided to stonewall: <blockquote> ... The Cancer Letter sent an email with questions to Potti, his collaborator Joseph Nevins, and Duke administration officials. The questions focused on the Rhodes claim, but also touched on other apparent discrepancies. Responding to everyone on the email CC list, including this reporter, Potti wrote: “Sounds like I need to call him to clarify ...... and probably also talk with you all to clarify. I was a nominee..... and several of the others can also be explained. –Anil.” After that email, Potti and Duke officials didn’t respond to questions seeking details that could substantiate this response. Multiple calls and emails from The Cancer Letter were not acknowledged.</blockquote> One reason is that this escapade appears to have many twists and turns regarding credentials claimed by their researcher in the past. See the full <a href="http://cancerletter.com/tcl-blog/CL36-27.pdf" title="Article in The Cancer Letter. (PDF)">article published in The Cancer Letter</a> (PDF). The tale is stunning. Another reason appears to be this: <blockquote>Genomic research led by the two scientists [Potti and senior collaborator Joseph Nevins] has brought millions of public and private dollars to Duke. The duo’s connections with the industry are considerable. According to a recent disclosure, Potti is a member of the scientific advisory boards of Eli Lilly and Co., GlaxoSmith-Kline, and CancerGuideDx.</blockquote> This also raises the questions: <ul><li>Did Potti misrepresent his credentials to these pharmas?</li></ul><ul><li>Was Nevins aware of these exaggerations himself? </li></ul> Of course this author is familiar with laxity in Duke's management and academics, and their not replying to pointed questions on their failures. Perhaps at the time of this grant application, Duke personnel were busy checking the credentials of the <a href="http://en.wikipedia.org/wiki/Duke_lacrosse_case">Duke Lacrosse team</a>, or of academics such as myself, maligned by Duke professors for having a strong sense of ethics (see link below). I then found myself "stonewalled" by Duke's President <a href="http://www.duke.edu/president/">Richard H. Brodhead</a> on the issues. (See my Jan. 2008 post "<a href="http://hcrenewal.blogspot.com/2008/01/truly-disturbing-lawsuit-against-duke.html">A Truly Appalling Lawsuit Against Duke University</a>" for more on that affair.) -- SS

Duke Scientist Bringing Millions from NIH and Pharma Suspended Over Rhodes Scholar Claims

The New York Times reports that a medical researcher faked claims to being a Rhodes Scholar, and that a major scandal that has erupted. The ...

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