Friday, September 30, 2005
City Councilor (and candidate for mayor) Maura Hennigan has just called for a State Ethics Commission investigation, according to another Globe article. "As an elected official, Mayor Menino has an obligation to disclose any donated services that have a value placed on them. The $5,000 value far exceeds the guidelines set by the state conflict-of-interest law or under ethics guidelines issued by the city's Office of Human Services."
In an op-ed column in the Providence Journal, David A. Mittell Jr. wrote, "Mayor Menino received two free passes to Shapiro Pavilion, in 2003 and 2004, at a time when the [Brigham and Women's] hospital's $315 million redevelopment of the Longwood Medical Area was pneding before the Boston Redevelopment Authority [BRA]. The BRA finally approved the plan in January 2005." Mittell noted that the hospital "says it upgraded the mayor to a room in the Shapiro Pavilion because the many visitors to his private room in an open ward were endangering his medical treatment and personal secruity. But this is absurd: The mayor is provided with continuous police security, at taxpayer's expense." So, " What I think 'courtesy' (as Mr. Menino puts it) translates into is 'non-specific bribe.'" Furthermore, although "the hospital notes that two other unnamed prominent political leaders also received free pampering in Shapiro Pavilion .... But that confession doesn't get the hospital off the hook. Rather, it shows a pattern of favoritism."
The Brigham and Women's Hospital has an international reputation. Thus, it's a sad day when it is accused of bribery and favoritism.
Then again, we have argued that concentration and abuse of power have become endemic in health care, so we shouldn't be surprised when even our most revered institutions find some mud clinging to them.
The big question is, when will we start cleaning them up.
To summarize her findings.... Eli Lilly manufactures the selective serotonin reuptake inhibitor (SSRI) duloxetine under the brand name Cymbalta to treat depression in the US. However, Lilly also was developing the same compound, duloxetine, under the brand name Yantreve as a treatment of urinary stress incontinence.
During a trial of Yantreve, Traci Johnson, a young study participant who had no history of depression, committed suicide. An FDA investigation of her death was done, but could not determine whether it was due to the drug. Lilly later abandoned its testing of Yantreve as a treatment of depression.
Under current FDA procedures, data submitted to the FDA about drugs that are never marketed are considered "trade secrets," and cannot be revealed even under the Freedom of Information Act. The rationale, as described by Lenzer, is that "failed efforts at drug development need protection lest entrepreneurs suffer a competitive disadvantage when other companies aren't forced to expend the same time and money exploring dead ends." The FDA apparently applies this policy even when the withdrawn drug is chemically identical to other drugs on the market (and hence data about adverse effects of the withdrawn drug ought to apply to the same compound marketed under different names.)
Lenzer was able to obtain information, at least partially from anonymous sources, about suicides by patients in trials of Yantreve or Cymbalta that were not available publicly from the manufacturer or the FDA. Her anonymous sources also told her that "duloxetine causes suicidal tendencies in patients who took the drug for incontinence - and who were not depressed."
Only after Lenzer published an article in The Independent (UK) about the issue, did the FDA add information to its web-site that the rate of suicide attempts by patients taking duloxetine in trials of stress urinary incontinence was double that of patients taking placebo.
Lenzer's conclusion is worth quoting:
The use of trade-secret laws to conceal deaths and serious side effects linked to drugs has the obvious flaw of putting profits before public health. It also subverts the covenant between researchers and study volunteers. Subjects like Traci Johnson are told that even if they do not personally benefit from a new drug, the scientific knowledge gained from the study in which they've participated will benefit others. The volunteers should be told instead that scientists will learn about their experiences only if it's good news for the drug they're helping to test.Please see our related posts on keeping drug trials secret here.
Thursday, September 29, 2005
In particular, "UMDNJ's policy in fact specifically provides cars for the president, senior vice president, all deans, the head of University Hospital and the CEO of University Behavioral HealthCare. At least six have drivers.... Overall, 20 administators are currently provided with cars."
Those at the very top get luxury automobiles, and chauffeurs to drive them. For example, Darlene Cox, the CEO of University Hospital, rides in a "new, $36,485 Chrysler 300M, provided by the institution. The car - a favorite of hip-hop moguls - [note, probably indicating it is a 300C, not 300M] is chauffeured by an EMS worker." Vivian Sanks-King, vice president for legal management, only gets a "late-model Buick Park Avenue luxury seda that cost the university $33,149." Also, "the school provides [President John] Petillo with a Lincoln Navigator that costs $58,000."
I think this issue is of particular importance because providing a car and driver is the sort of perk that isolates leadership from the real world in which their constituents live. UMDNJ is a state-supported school, and hence partially funded by taxpayers. In addition, its primary constituents are students and patients. Nearly all taxpayers, students, and patients have to think about how they will get to work, or anyplace else. Of course, they also have to pay for this transportation. Top UMDNJ officials just have to snap their fingers (figuratively) for their drivers. Leaders who lose sight of the day to day lives of their constituents are less likely to uphold the mission of their not-for-profit organization to serve these constituents.
Wednesday, September 28, 2005
A previous post described the allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals.
Our next post described a mysterious burglary at an UMDNJ administrative office that raised suspicions of criminal activities meant to remove incriminating documents, and lead to colorful editorial comments. A Star-Ledger editorial noted, "at least two definitions come to mind when considering the term 'black bag.' First, there's a doctor's medical bag. Then there's the slang meaning a secret, illegal break-in, usually by a government agency. Now, thanks to the latest jaw-dropping incident at New Jersey's University of Medicine and Dentistry, there's no need to make the distinction between the two."
Another post described allegations about serious conflicts of interest affecting five UMDNJ board members, which threatened the university's educational accreditation.
In the last month, there has been more and more trouble.
No-Show Consultants- According to the Bergen Record, UMDNJ filed two lawsuits alleging that two of its previous consultants did no work for the money they were paid. They were Patrick H. McCarthy, who dealt with "Medicare and Medicaid reimbursement issues," and International Brokerage Concepts Inc., and the estate of its former president, Ronald White, who were supposed to "apprise the university of [then incoming New Jersey Governor James E.] McGeevey's 'health vision.'"
Questionable Donations- According to the Newark Star-Ledger, the UMDNJ vice president for government affairs, Christy Davis Jackson, reimbursed the university for three small contributions she had authorized to Newark Mayor Sharpe James, the Democratic State Committee, and the Hispanic American Political Action Committee. Davis Jackson had been previously reported to have made a $10,000 donation to an unregistered charity, Women With Hats on for the Cure, run by Newark Councilwoman Gayle Chaneyfield-Jenkins. Davis Jackson had worked as a lobbyist for Babyland Family Services, which was run by Chaneyfield-Jenkins' mother. The latter contribution has not been reimbursed.
Board Conflicts of Interest- Two Republican candidates for the NJ General Assembly filed a formal ethics complaint against five UMDNJ trustees, alleging serious conflicts of interest, according to the Bergen Record. (See our previous post here for details of the alleged conflicts.)
More "Black-Bag Jobs"- It turns out there have been a lot more than one burglary of the UMDNJ administrative offices. The Newark Star-Ledger reported at least 10 "reported break-ins, thefts and attempted burglaries in the administrative offices at the University of Medicine and Dentistry of New Jersey since the start of a federal corruption investigation...." Alexander Menza, a UMDNJ trustee, reacted, "Some of the stuff that's taken is so petty, so miniscule it doesn't make any sense." He thought they might be part of a "cover up," noting, "these things are done all the time. People would commit a major crime and take a tin of pennies to indicate it was something else."
Bonuses to Administrators- While all these events reminiscent of a lurid crime novel have taken place, the Newark Star-Ledger reported that UMDNJ administrators are pushing to award extremely generous bonuses to themselves. Some incentive bonuses were for more than $100,000. After a contentious meeting, the UMDNJ trustees voted to delay a proposal to rescind the bonuses, and get yet another consultant to evaluate them. Said trustee Frederic C. Sterritt, a dentist, "we're running a billion-dollar business here and it's going great." Furthermore, UMDNJ president, John Petillo argued that it would be "unethical to withhold payments that many now consider part of their annual pay package." Newsday reported that State Health Commissioner Fred Jacobs, a non-voting board member who represents the Governor, responded, "we need to take steps to restore credibility to the administration and accountability to the university.... There are board members who do not acknowledge the serious problems going on, and I do not know why." And the Star-Ledger reported that Interim New Jersey Governor Richard Cody said that Sterritt "seemed to be on another planet."
These bonuses inspired more colorful editorial writing, e.g., in the Bergen Record, "The University of Medicine and Dentistry of New Jersey might want to consider a name change to the University of Pay to Play and Stay." The editorial advised Sterritt to consider working for Tyco, the scandal-ridden company headed by the now convicted Dennis Kozlowski. The editorial also likened board members to "bad teeth [that] are pulled. You would think at UMDNJ there would be a dentist when you needed one."
My heart goes out in sympathy to my friends and colleagues, and all the dedicated, honest people who toil at UMDNJ despite these lurid events.
It is outrageous that a major American health care university could be run this way. Again, all those who bemoan poor health care quality, rising health care costs, and decreasing health care access need to pay attention to the mismanagement now rampant at American health care organizations, from pharmaceutical and device makers, to managed care organizations and insurers, to hospitals, medical centers, and universities.
Tuesday, September 27, 2005
Last week , the New York Times reported yet another recall of cardiovascular devices made by Guidant, this time, pacemakers in its Insignia and Nexus lines. Although Guidant got its first reports that these models could fail in 2003, a US Food and Drug Administration (FDA) inspection noted that "the products continued to be distributed and users have not been informed of a potential no-output failure mode."
This is just the latest case of Guidant seemingly delaying making information about device failures available to doctors and the public. (See our most recent post on Guidant here, with links to earlier ones.) Senator Charles E. Grassley (R-Iowa) now is calling for his Senate Finance Committee to review Guidant's compliance with a corporate integrity agreement with the US Department of Health and Human Services (DHHS). This, in turn, was part of a settlement Guidant made after it had plead guilty to 10 charges that it failed to notify the FDA about malfunctioning aortic stents made by its Endovascular Technologies subsidiary.
A related Indianapolis Star story noted that the pacemaker recall is the fifth by Guidant since May, 2005. The Pioneer Press added noted that the latest recall is of 170,000 pacemakers, and 80% of Guidant's "heart products are [now] under recall or advisory."
On top of all that, the New York Times just reported how Guidant seems to have conflated research and marketing efforts, based on company documents and emails about a project to ostensibly evaulate a new electrical lead for cardiac resynchronization devices, essentially sophisticated pacemakers, priced at $29,000. Doctors received $1000 for implanting the leads in three patients and completing five surveys. However, the Times concluded that "the initiative also had another apparent goal - increasing sales of the company's most sophisticated and expensive heart devices." One email message said:
It generated 300+ implants. Let's say that just 25% were incremental ... that yields >$2 million in new sales with physicians who are not necessarily Guidant friendly. We paid each physician who completed all five surveys $1000 so our total cost was $80,000.As the Times said, "Guidant documents and recent interviews suggest that the line between research and product promotion may also be blurring where heart devices are concerned."
So, in summary:
- Guidant has repeatedly kept information from physicians and the public about failures of its devices, some of them potentially life-threatening. Guidant first plead guilty to such offenses in 2003.
- Guidant has also allegedly cloaked its marketing efforts for expensive pacemakers in the guise of a research project.
Monday, September 26, 2005
Eventually the County of Los Angeles brought in Navigant Consulting to run the hospital. But now that company appears, as per the Los Angeles Times, to have exhibited "a pattern of liberal spending normally off-limits to those working on the public dime." The County Department of Health Services plans to reject about $300,000 of the firm's $1.3 million in travel and related billings. The Times uncovered instances of bills submitted for the wrong person, for trips that were never taken, twice for the same trip, for apparently personal travel, and for first-class seats. The Navigant project executive for King/Drew, Kae Robertson, blamed it on Navigant's own accounting office, and the County's insistence on paper recipts.
Meanwhile, Navigant was supposed to "re-instill a sense of accountability among employees...."
Furthermore, "many of Navigant's stated goals at King/Drew remain unmet," including restoring the hospital accreditation from the Joint Commission on Accreditation of Healthcare Organizations.
It is amazing that a second generation of hospital administrators, specifically hired to clean up past abuses at a hospital which serves a predominantly poor patient population, felt they deserved to fly first-class at the taxpayers' and patients' expense.
Friday, September 23, 2005
In health care there have been all too frequent examples of secrecy, censorship, and retaliation against whistleblowers of various types. I know there are quite a few people out there who have important information about abusive practices, yet are justifiably afraid to speak up. Such people may want to look at the Handbook for Bloggers and Cyber-Dissidents.
As my former boss's boss and perhaps the most prodigious individual user of the department I managed, the Merck Reseach Labs (MRL) scientific libraries (other than the remarkable late Dr. Maurice Hilleman, that is), I can opine that I do not believe these emails and actions were presented entirely in context by the newspapers and plaintiffs.
It is my personal belief that Dr. Scolnick would not have let a drug on the market that he truly believed had significant risks. While he was indeed tough-talking (as were many senior people in MRL), in my conversations with him I sensed very strong scientific and medical ethics.
In fact, it was he who expressed concern to me over lunch circa late 2000 that the appx. 6,000 scientists of MRL varied in their ability to use scientific information searching tools, and that this could impair their ability to engage in the best science possible. His belief in conducting the best science was strongly evident in this conversation. Proficiency in using these informatics tools, we both agreed, were essential to scientists staying abreast of the latest developments in their fields. He requested an educational initiative be developed. I suggested a worldwide, intranet-based training program in literature searching proficiency.
As a result of that conversation, my staff and I developed an online training program in scientific literature search proficiency that Dr. Scolnick personally approved and promoted, and I expanded access to the most critical of those tools via a rigorously-researched request for additional departmental funding that he supported. (The non-scientist, non-clinician IT execs controlling my budget were noticably not quite so eager to spend on such 'intangible' assets as informational tools where ROI, while obvious to scientists, was difficult to quantify.)
I believe problems ascribed in the articles and in the courtroom likely originated elsewhere, such as in the scientific approach to the issue of rare adverse event detection itself. In addition, articles like this recent one in PLoS point out that even the best approaches can fail when studying low-incidence events with studies of low positive predictive value. As mentioned in this article, the 'biases' fostered by scientific competition, the profit motive, etc. can make the situation even worse, even in the absence of deliberate errors of omission or commission.
These are personal beliefs, of course.
As far as Star-Ledger accounts of his calling FDA staff "devious," "antagonistic," filled with "bastards" and "grade D high school students," I have little to say other than an anecdotal incident involving a former high-level FDA official that occurred after my time at Merck, when I was seeking new positions. This former official, only recently out of FDA in an adverse events capacity, was now running a pharmaceutical company adverse events data management group. I'd been interviewed by the hiring manager of the department, an Executive Director whose wife I'd worked with years prior at a hospital, and who had found my prior work of great interest to the department. A final interview was set up with his boss, the former FDA official, who worked at a distant branch of the company. My interview was to occur locally, at a company facility near me. However, just prior to the interview the ex-FDA official decided he could not travel due to a family member's illness. I therefore offered to drive the nearly 100 miles to his out-of-town pharma office office instead, and did so.
When I arrived, the former FDA official offered me no thanks or acknowledgement for having gone to the trouble, only asking me with somewhat of a smirk what "I had been doing since being unemployed." (To which I politely withheld the obvious answer "looking for a job, [meathead]...") I began showing him my relevant prior work, e.g., development from the ground up of a comprehensive cardiology dataset of hundreds of data elements, accompanying institutional information system, analytics and reporting system for invasive cardiology device/intervention outcomes and adverse events. This was built for a regional center performing over 6,000 procedures per year and was evaluated by national cardiology figures as "outstanding."
During my explanation of the project, the former FDA official rudely cut me off and stated "we don't need Medical Informatics specialists in our adverse events department." I had to hide my astonishment and dismissed myself from the presence of this SOB. Others told me this former FDA official had interviewed literally a hundred others in the preceding year and hired nobody despite an open position, and was basically devoid of social graces, not even greeting his staff when passing them in the halls.
Devious? Antagonistic? Bastards? Grade D high school students? Sample size of one, but a spectacular example nonetheless. What can I say?
Now, if only Dr. Scolnick had talked equally tough with the computer exec who decided upon laying me off as part of the 4,400-person reduction-in-force in late 2003...
Addendum: I should add that the biggest complaint of several clinicians and statisticians in the pharmaceutical adverse events data management department (the one presided over by the humble, well-mannered former FDA official above) was that access to the global adverse events database was often difficult and basically controlled by non-clinical IT personnel. This interview really ranked up there in the Annals of the Absurd.
The pricing of orthopedic devices is a closely guarded secret.
Prices paid by hospitals vary widely, yet information is so scarce that hospitals say they are often unaware if they are overpaying, and impotent to negotiate a better price.The hospital managers seem clueless about the costs of devices.
In the modern health care market, prices and fees are increasingly determined by negotiation. Yet when it comes to implantable devices, that dynamic often barely exists.
Part of the blame lies with the hospitals, which often seem to lack the financial sophistication to negotiate lower prices for the devices. While hospitals have been succesful at cutting costs for standard supplies like light bulbs and bandages, many hospital's accounting systems are so inadequate that they have little idea what they actually pay for more complex devices.What information is available suggests that the devices are often variable, but very expensive.
With manufacturers guarding pricing information closely, the price of a given device may vary by thousands of dollars from one hospital to the next. One hospital in the New York area, for example, paid $8000 more for a DePuy hip than a competitor.... The price of the latest artificial knee approaches $10,000. A single screw used in spinal surgery can cost as much as $1,6000.The companies that make devices are very profitable
Rising prices have made device companies unusually profitable: according to an analysis by Medicare, they enjoyed net profit margins of nearly 20 percent at the end of 2003; more than tice the average for the Standard & Poor's index of 500 companies.Extensive company marketing efforts aimed at physicians have lead to major conflicts of interest.
For the device company, the most important relationship is with the doctors, and they spend considerable money and energy nurturing it.The Times reported on the case of one Dr. William Overdyke of the Louisiana State University Health Sciences Center in Shreveport, LA.
The extent and precise nature of the relationships remain largely hidden. The companies and doctors are unwilling to discuss specific arrangements. Hospitals are often unaware of them....
[He] oversaw operations to replace worn-down knees. From 2000 through the middle of 2001, whenever a patient needed an artificial knee, he or the residents he supervised implanted one made by Sulzer Medical....
Dr. Overdyke has said he used the Sulzer implant because it was the best available. But Louisiana state officials say he had another incentive as well: the $175,000 a year that he stood to make from contracts with the company. The contracts called for him to consult on product design and 'promote and educate other surgeons' on the virtures of Sulzer products.
Before signing with Sulzer, Dr. Overdyke said, he had never used the company's artificial knee. Earlier he had a contract with another company, Wright Medical. And during that time, he and his residents largely used Wright's artificial knees.
Dr. Overdyke paid $10,000 in fines after investigators determined that his consulting arrangements with Sulzer were an improper conflict of interest under the state ethics code.Some hospitals are now insisting on more transparency.
The hospital industry says that one essential factor for ending the cost spiral is the free exchange of information about prices.But the industry does not agree.
These efforts at transparency are drawing fierce resistance. A major device maker Guidant, has sued two consultants, including a unit of MedAssets, accusing them of sharing confidential price information . Med Assets countersued, saying Guidant has tried to buy doctor's loyalty through consulting agreements and other inducements.Yes, that's the same Guidant that has been prominently featured in Health Care Renewal because of allegations it hid information about the failure rate of its implantable cardiac defibrillators. (See recent post here, with a link to earlier posts.)
So here we have the classic Health Care Renewal mix: clueless hospital administrators, physicians with large conflicts of interest fueled by commercial interests, secrecy and censorship, and ridiculously high prices.
All that is missing are the roles of managed care organizations/ insurers and the government. They set the rates the will reimburse hospitals and physicians for procedures that implant orthopedic devices. They could try to find out what prices are charged, what the devices might actually be worth in some sense, and then exert downward pressure on reimbursement rates where appropriate. It is, of course, managed care and the government who always complain about high costs. But here they seem to be doing nothing about them.
But someone will probably find a way to blame generalist physicians for the whole mess.
Thursday, September 22, 2005
Finally, the Star-Ledger also reported that David Anstice, a Merck marketing executive in the late 1990s, that Merck marketing executives set up the ADVANTAGE study as a "seeding" study, that is, one meant to primarily to "promote the drug," rather than to be a serious scientific study. Anstice also seemed to admit that Merck marketers had attempted to "neutralize" or "discredit" physicians who were "problems," apparently because they were not supporters of Vioxx. He objected that "neutralize" somehow meant "persuade doctors to prescribe more Vioxx," but admitted "neutralize is not the best term to use." This is more evidence that Merck put marketing ahead of science and patient welfare.
We have posted frequently about the sorry tale of Vioxx (see this post, and its links.) Stories like this raise concerns that pharmaceutical companies, and many other health care organizations, have put their own financial interests ahead of patients' welfare. These concerns are amplified by the financial ties these companies have developed to government agencies (like the FDA and the NIH), and with physicians' organizations (like the AAFP, whose exhibition hall has been characterized as a "truly massive marketing event.")
How are we going to re-organize health care to put the focus back on the patients, not the dollars? Until we do, is it any mystery why costs continue to go up, access continues to go down, and the physicians and nurses in the trenches continue to get more dissatisfied?
Almost simultaneously, the Senate also passed an amendment that would require the FDA to publicly disclose conflicts of committee members who receive waivers, according to Reuters.
As we have said before, having people with financial ties to pharmaceutical, biotechnology, or device companies helping the government make decisions that affect those companies raise questions about whether these decisions serve the public or the companies' interests.
Wednesday, September 21, 2005
What is happening to me should not happen to anyone else. Congress and state legislatures need to send a message to local governments that this kind of abuse of power not only won't be funded, it won't be tolerated.A reminder: as we previously posted, the NLDC's leadership had multiple conflicts of interest that involved ties to Pfizer. One board member was a Pfizer vice-president. The board president was married to another Pfizer vice-president. Pfizer wanted the part of New London that included Kelo's house made more attractive to complement its new research facility. The husband of the NLDC president had said, "Pfizer wants a nice place to operate. We don't want to be surrounded by tenements."
Special interests - developers and governments that benefit from this use of power - are working to convice the public there is no problem, but I am living proof there is.
Although we have frequently discussed conflicts of interest affecting the leaders of health care organizations, this is one case in which the downside of such conflicts is not worse health care outcomes, but loss of civil liberties.
I was able to find two randomized controlled trials, one small, the other smaller, comparing conventional and minimally invasive surgery. Neither found any difference in outcomes (although neither had much statistical power to find such differences.)
So this is yet another story of advertising directed at patients which goes beyond the available clinical evidence. Although most of the criticism of direct to consumer advertising is directed at pharmaceutical companies, this is not the only case of potentially misleading advertising done by hospitals (see post here).
Lest anyone think that this is an issue exclusive to the US, last week the London Times reported that the UK government has charged executives of six UK based generic drug companies of conspiring to defraud the UK National Health Service (NHS). Allegations involve price-fixing for some widely used drugs, such as penicillin based antibiotics and warfarin. The defendants worked for Kent Pharmaceuticals, Norton Healthcare, the Goldshield Group, Generics UK, Ranbaxy Laboratories UK Unit and Regent-GM Laboratories Ltd. Two firms, Generics UK and Ranbaxy, have already settled.
This is just the latest of many stories about bad behavior by leadership of pharmaceutical companies. (This is not to say that we haven't also seen many stories about bad behavior by leadership of biotechnology and device companies, managed care organizations and insurers, and hospitals, academic medical centers, and medical schools.) Nonetheless, stories like this should be contrasted with the the laissez faire attitude some physicians' assocations (see posts here and here) and medical schools and academic health centers (see post here) have about taking pharmaceutical companies' money. Bernard Carroll's proposal that physicians' associations should apply ethical standards when deciding which drug companies' money they should accept deserves serious consideration.
The email stated,
Following an outcry from among its members, the American Academy of Family Physicians has reversed its earlier decision to deny a booth to No Free Lunch and has invited the organization to exhibit at its meeting next week in San Francisco.Good for AAFP for reversing course here. The issue, as the above AAFP members' emails made clear, was not whether AAFP should adopt No Free Luncrecommendationsomendations. The issue was a free speech issue, whether AAFP was willing to give No Free Lunch the opportunity to speak out about recommendationsomendations, even if their mode of expression is not as gentile as the AAFP might prefer, and everecommendationsomendations may upset some people. The AAFP already allows commercial interests to speak out about their wares. Their mode of expression may be polished, but is backed by plenty of money and marketing muscle.
In August, The AAFP rejected No Free LunchÂ’s application to exhibit at its annual meetingÂ—which will be attended by some 5,000 family physicians and slightly fewer exhibitorsÂ—stating that No Free LunchÂ’s position was Â“not within the character and purpose of the Scientific Assembly.Â” This despite the fact that the Coca-Cola Company, The McDonaldÂ’s Corporation, and The Distilled Spirits Council of the U.S. were all allotted space in the hall, as were countless pharmaceutical companies.
Many members were upset and even outraged that a society which they had supported for many years, and which gives industry almost unlimited access to physicians at its meetings, would not allow a small organization of health professionals to voice an opposing view. Allen Pelletier, for example, a family physician from Memphis, Tennessee, a long time AAFP member and newly elected fellow of the Academy, in an e-mail to AAFP CEO Dr. Douglas Henley, wrote Â“To my embarrassment, the organization that represents me as a practitioner and teacher of family medicine has shut down the possibility of open (and yes, critical) dialogue about how our practices are influenced by the pharmaceutical industry.Â” A family physician and AAFP member for 25 years from East Lansing, Michigan, wrote Â“. . . if an organization like No Free Lunch, well known for the role that it has played in encouraging awareness among physicians of the negative impact of pharmaceutical marketing, is denied the opportunity to set up a booth at the meeting, while commercial sponsors are encouraged to pay extra for more access to members and attendees, then the professional values of our specialty society have truly reached a new low.Â”
Finally, the reasons the American College of Physicians (ACP) banned No Free Lunch from their last meeting remain murky. The public documentation about this decision only includes press releases by No Free Lunch and the ACP, and an article in the Wall Street Journal (available here). The ACP contended that No Free Lunch "caused trouble at its 2001 meeting, even sneaking in an undercover TV crew. Dr. Goodman [the leader of No Free Lunch] says that even if there were some problems, which he isn't sure is[sic] the case, that they weren't orchestrated by the organization" (per the Wall Street Journal). Again, in my humble opinion, an organization with an ethical and academic mission (like the ACP) ought to bend over backwards to ensure free expression and open communication , especially when one side of the argument is made by large, rich, and powerful organizations like big pharma corporations.
Tuesday, September 20, 2005
[posted with his permission]
Discussion of Pharma influence at medical society meetings often overlooks the real but unused power of physicians to make changes happen.
No one would argue with the need for increased attention to our corporate relationships and to transparency. Few would argue, either, for a radically new relationship that involved severing ties between professional medical societies and industry.
Nevertheless, we are viewed unfavorably for our increasingly publicized reliance on corporations, not because these relationships are intrinsically unethical but because the profession has no record of taking action against corporations that are found to be crooked. For example, the drug industry has been censured for reneging on pledges to list clinical trials in a federal database, with Merck, GlaxoSmithKline and Pfizer being singled out as recalcitrant corporations. A New York Times editorial concluded, "the best hammer would be federal legislation.. with stiff penalties for noncompliance."
Physicians and professional medical societies have an alternative "hammer" that they have never used: disengagement from corporations that flout their commitments and abuse public trust. Corporations that receive adverse court rulings with financial penalties, regulatory fines, cease-and-desist orders for false advertising, and that pay millions of dollars in plea bargained settlements have so far been immune from the consequences of these ethical failures. They continue to have unimpeded access to professional medical groups. The professional societies maintain a double standard, indulging crooked corporations in ways that do not apply to individual members. The by-laws of professional medical associations provide for the censure and expulsion of individual members who fail to act in accordance with ethical codes. Sufficient cause for such adverse action can include clinical or scientific fraud, as well as criminal conduct that need not be related to a member's clinical practice or professional work. Any felony conviction, for example, will result in termination of membership in most professional medical societies. The corporations that enjoy access to our professional organizations are immune from similar treatment.
In some medical societies, companies pay for the status of Supporting Corporations. These corporations and their designated liaison employees are prominently listed, along with company descriptions (infomercials), in membership directories. Supporting corporations typically send several employees to the annual meetings, where many deals are struck for clinical trials, research projects, educational programs, and professional consulting, accompanied by much wining and dining. In giving their support, the corporations are not motivated by altruism. They are buying access.
Likewise, many professional medical societies sponsor huge exhibit halls at their annual conventions, with lavish, high-tech displays operated by pharmaceutical corporations. These events are unparalleled opportunities for the corporations to influence practitioners and "thought leaders." The corporations also support continuing medical education symposia at the conventions through "unrestricted educational grants", while having every confidence that featured speakers are "on message."
Our medical societies have every right and, I believe, the duty to terminate or suspend their association with corporations that receive criminal judgments or adverse regulatory rulings or that agree to judicial settlements for negligence, violations of good manufacturing practice, fraud, misrepresentation, and suppression of scientific data in the interest of marketing. That would send a powerful message from us to back up any legislative hammer. A 5-year suspension-of-access period per incident would get the attention of the corporations more than the penalties typically negotiated by Pharma with regulators. Likewise, individual academic physicians could send a powerful message by resigning from the advisory boards and speaker panels of corporations that receive judicial and regulatory penalties.
When academic physicians and professional medical societies simply shrug off these corporate behaviors, they collude in the cynicism of the corporations, for whom the monetary penalties, that may run to hundreds of millions of dollars, are viewed as just part of the cost of doing business.
The fundamental issue in this evolving scandal is the distinction between professional and commercial ethics. As the sociologist Jane Jacobs observed, the most rudimentary civic morality is the line between these two. Physicians have to understand that when they work in the service of the public or as advocates for patients, they cannot also be in service to clients who seek to influence legislation or regulatory decisions or who simply want to maximize profits.
Many professional medical organizations have tried to straddle this line, using predictable rationalizations such as money for operations, expanded educational programs, and strategic inclusiveness. The straddle has become increasingly uncomfortable, however, and the professional societies would do well to reassert their independence by treating corporations as they would treat any individual member who violates ethical and criminal codes. There is no reason for the professional medical societies to give multi-billion dollar corporations a pass on ethics. As the saying goes, when you sup with the devil, use a long spoon.
To state this more bluntly, it can be said that the people who set such strategies are, or have become, complacent, intellectually ossified, incompetent, or a combination thereof.
It is also true that leadership starts at the top. In terms of setting such strategies, I believe the management mysticism that says anyone with an MBA and some experience running a company of some kind or other can run a pharma is a fool's recipe for disaster. And an investor's nightmare, unless the person, politics, and leadership structure including the Board is very, very good. Of course, if the Board itself is compromised with people whose biomedical backgrounds are nil, then all bets are off.
It should be noted that if articles such as this one reflect reality ("Why Most Published Research Findings Are False", John P. A. Ioannidis, PLoS Medicine, 10.1371/journal.pmed.0020124 ), then pharma is really in trouble.
Big Pharma needs to overhaul risk assessment
Investing in the pharmaceuticals industry carries 50 per cent more risks than in the overall S&P 500, because Big Pharma's management of operational risks has lagged behind dramatic business and reputational shifts, a new report says.
Drugmakers' comparative riskiness, influenced by factors such as price controls, litigation, sales practices, restructuring and product safety, underscore investor concern that the pharmaceutical sector is no longer a defensive investment. For decades, investment in drugs companies was considered safe in all economic climates, because people always fall ill.
The report by KPMG, the consultancy, to be released later this week, says drugmakers must change their risk management processes quickly. It argues that the industry has become too intellectually rigid in assessing risks, thinking in terms of compliance instead of risk prevention ... "Positive and negative events in this industry are extraordinarily pronounced, with a dramatic effect on shareholder value and reputation," the report says. "The challenge now for the industry is that the upside seems harder to achieve, while on the downside there are a growing number of risks and potentially greater impact."
... Two recent problems highlight the industry's challenge. The biggest is Merck's withdrawal of Vioxx a year ago after finding increased heart attack risk, forgoing $2bn in annual sales and potentially attracting billions of dollars in liability. The company faces questions over its actions to market the drug since its launch in 1999. The other is Bristol-Myers Squibb's restatement of $2.5bn in revenues after inflating wholesaler inventories to meet profit targets a few years ago, ending with a settlement to avoid federal criminal charges.
KPMG's report says the industry must move to a more comprehensive risk strategy, to foresee problems that could emerge anywhere in a company.
For it would mean that new discovery techniques such as bioinformatics, where multiple groups are seeking low pretest-probability low relative-risk data/clinical relationships under situations of intense financial and other forms of pressure that can cause bias, are - to put it bluntly once again - basically an expensive fraud.
Monday, September 19, 2005
Lost in much of the media coverage was the issue that the confidentiality agreements (usually between pharmaceutical company trial sponsors and medical schools and academic medical centers) were of questionable ethicality, given that most research subjects in clinical trials are lead to believe that they are participating to advance science, not the commercial interests of the trial's sponsor.
The indefatigable Robert Steinbrook has written a nice summary of all these issues, just published in the New England Journal of Medicine (Steinbrook R. Wall Street and clinical trials N Engl J Med 2005; 353: 1091-3). In particular he notes that the ethics of confidentiality clauses in contracts governing clinical trials are open to question,
These confidentiality agreements - which are meant to protect the business interests of drug companies - can also be the gag clauses that may prevent investigators from examining clinical trials data independently or submitting a manuscript for publication without first obtaining the consent of the sponsor.I am very glad to see that this made it into the New England Journal, because the furor over revealing "drug secrets" and the evils of insider trading threatened not just to obscure the questionable nature of the confidentiality clauses that defined the "drug secrets," but to make these clauses appear legitimate.
Saturday, September 17, 2005
A report in the trade journal Brandweek.com, and a press release by No Free Lunch, describe how the American Academy of Family Physicians (AAFP) has barred No Free Lunch from exhibiting in the Exposition Hall at the annual AAFP Scientific Assembly.
AAFP Manager of Sales and Services Sharon Hutinett stated that the No Free Lunch exhibit was "not within the character and purpose of the Scientific Assembly." Moreover, AAFP Executive Vice President Douglas Henley stated, "while the AAFP respects the mission of No Free Lunch, their desire to eliminate information-sharing by exhibitors with our members clearly negates the purpose of the Exposition Hall. Therefore, No Free Lunch is not in keeping with the character and purpose of the Scientific Assembly Exposition Hall and it would not be appropriate for AAFP to accept their exhibit application."
The character and purpose of the meeting may be indicated by the large number of exhibits sponsored by pharamaceutical companies in the Exposition Hall. Furthermore, No Free Lunch noted that even corporations such as Coca-Cola and McDonalds were allowed to exhibit. Brandweek.com characterized the character and purpose of the AAFP meeting as "a truly massive marketing event: 5,000 of the top-prescribing physicians in the country are expected to attend the San Francisco shindig."
An AAFP prospectus listed the variety of marketing opportunities for sale, from a "freebie" in every doctor's "gift bags" for $7500 "per piece per day," to, of course, free lunch, "$60,500 pays for the food vouchers that physician-attendees will use for lunch each day at the conference."
So although the AAFP is happy to expose their physician members to a "truly massive marketing event," AAFP leadership apparently cannot tolerate the dissent provided by a single No Free Lunch exhibit.
How such suppression of honest difference of opinions serves the AAFP's mission, "to improve the health of patients, families, and communities by serving the needs of members with professionalism and creativity," is beyond me. Whether the AAFP's membership condone such censorship, or even know that it is going on, are also open questions.
Since all development and most research and regulatory costs are expended prior to the time a drug is first marketed, and given all the current interest in controlling health care costs, why these drugs' prices should go up faster than inflation is a mystery.
Soon after these reports were printed, Klausner announced he was resigning from his current position, Director of Global Health for the Bill & Melinda Gates Foundation. (See the Seattle Times story here.) Klausner and a foundation official denied the resignation was related to the allegations made about Klausner. Joe Cerrell, Director of Global Health Advocacy for the Foundation, said "this is an unfortunate coincidence of timing. The decision has been in the process for some time now. While he [Klausner] is a brilliant scientist and visionary, Rick and the president decided the program was at a point where it could benefit from a new vision."
Meanwhile, according to the Washington Post, the House Energy and Commerce Committee has asked the Government Accountability Office (GAO) to investigate Klausner. The post article notes that this could "lead to a painful new chapter for the health agency [NIH], which just finished rewriting its rules on employee conflict of interest after a series of difficult congressional hearings. While the recent policy changes were implemented to minimize employee financial conflicts, the new questions relate to thow the agency procures scientific goods and services through contracts."
The new questions also appear to relate to the revolving doors between the NIH, universities, and private foundations. Stay tuned.
As stories of failing ICDs have received more attention, more editorials are calling for improved behavior by device manufacturers and a revamp of how the FDA regulates these devices.
The Indianapolis Star stated its editorial position, "medical device makers need to better disclose malfunctions to doctors and the public."
The St. Petersburg Times charged that "the Food and Drug Administration once again has demonstrated a level of incompetence that threatens public health." Already, "Americans have lost faith in the FDA for the agency's lax policing of prescription drugs and failure to share information about drug safety with consumers. This episode makes the government look inept even if it wanted to be more responsive." So Congress "needs to reform an agnecy that serves as a critical watchdog for Americans."
And just to add more fuel to the fire, the FDA just released a report that the failure rate of ICDs is increasing. According to the Washington Post, "in the mid-1990s, some 7.9 ICDs per 1000 implants were replaced because of malfunctions. That rose to a high of 38.6 per 1000 implants in 2001 before dropping slightly to a rate of 20.7 the following year. " Of these failures, "eighty percent were device hardware problems, such as with electrical connections."
Again, physicians and patients need accurate data about benefits and harms of treatments, especially expensive, invasive treatments that are meant to prevent future problems, not immediately treat disease, like ICDs. Information that such devices fail more frequently in clinical use than they did in controlled trials performed in ideal conditions is important in the clinical decision-making process. Neither the financial self-interest of device manufacturers nor the bureaucracy of government regulatory agencies should keep this information from doctors and the public.
Thursday, September 15, 2005
We have posted frequently about the ongoing Guidant saga. A recent post is here, with links to earlier ones.
Before I had a chance to write some blustery prose about this latest part of the saga, the New York Times editorial page beat me to it.
The deplorable story of how a medical-device company sat information about a flawed heart defibrillator while a hapless recipient died has now engulfed the Food and Drug Administration as complicit in the silence.The bigger points are:
What is disturbing is how long it took the company, the Guidant Corporation, and the regulators to get a meaningful warning to doctors and patients.
The agency's excuse for not making the failure data public right away is too feeble to withstand scrutiny.
The FDA needs to rededicate itself to protecting the health and safety of the public as its first mission. Being nice to pharmaceutical and device manufacturers is a distant second.
Pharmaceutical and device manufacturers must remember that if they want physicians and patients to trust them enough to buy their products, often offered at very handsome prices, they must be absolutely honest and transparent in how they present data about their products' performance to them. Insisting on the confidentiality of data about clinical results of using devices will not inspire such trust.
Sunday, September 11, 2005
Thus I liked this headline, "Call for more therapists to end Prozac nation." This news report summarized a talk to be given tomorrow at the Sainsbury Centre for Mental Health about continuing "gaps for the provision of mental health." A survey to be released tomorrow showed that only 40% of patients had "any access to talking therapies over the past 10 months." Professor Richard Layard noted "Many people do not get treated at all [for depression] because they don't want drugs. There is a huge demand for therapy because people want to understand what is wrong with them. We have such a heavy prescription of drugs because there is no choice."
I would have suggested that this is yet another example of a dysfunctional US health care system which puts cost-cutting on the back of primary care and cognitive practitioners (including specifically those who practice cognitive therapies, in this case, for a bad pun, I suppose), seemingly in order to pay lavishly for expensive drugs, high-tech devices, and invasive treatments.
However, the problem is broader than that. The clue is in the spelling of "Centre" above. The story is from the Manchester Guardian, and the talk will be given in the UK, and is about the UK National Health Service.
This mismanaged priorities we see in the US are similar to those in many other countries, and hence cannot be blamed, as we often do here, specifically on our mixed up system of financing health care.
In my humble opinion, the problem of bad health care leadership is global, not dependent on an individual country's system of financing health care, and will not be fixed by changing how health care is financed.
But I also have to give credit where credit is due. CVS has apparently put a tremendous amount of effort, and money into continuing to provide services along the flood-ravaged gulf coast, and into trying to find their lost employees in this area. (See the Boston Globe story here.)
Although we frequently criticize the leadership of health care organizations, that does not mean we believe these organizations are inherently bad, in fact, far from it. But bad leadership can be improved, and bad leaders can be replaced. Meanwhile, good leadership needs to be recognized and rewarded.
On the other hand, the Pargluva panel's one cardiologist did not attend the meeting, because he had a potential conflict of interest. Although I could find no controlled trials of Pargluva yet available on Medline, this summary of the panel's meeting indicates concerns about increased rates of congestive heart failure and cardiac death in patients who received Pargluva. (The cardiac death rate was roughly 0.3% in patients receiving Pagluva, but 0% in those receiving Actos during the time of observation, which was not stated. Similarly, the incidence of congestive heart failure [CHF] was 0.75% for Pargluva, and 0% for Actos. The absence of deaths or incident CHF cases in the comparison group suggests that the observation period was short, or that the patients were selected for low risk of cardiac disease.)
A list of conflicts of interest affecting the Exubera panel is available in this press release from the Center for Science in the Public Interest (CSPI).
As Merrill Goozner, director of the CSPI Integrity in Science project put it, "The public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval."
Saturday, September 10, 2005
The story is centered on Dr. Richard D. Klausner, former director of the NCI from 1995 to 2001. While Klausner was a candidate for two jobs at Harvard University, the university was competing for a $40 million contract from the NCI. Klausner eventually did not get a job at Harvard, but after leaving the NCI, "joined the board of a for-profit Boston company, Infinity Phamaceuticals, which was co-founded by a Harvard researcher who won the NCI contract, according to the Times.
The congressional committee concluded that "'documents and witness statements provide reasonable grounds to believe that NCI director participated personally and substantially as a government employee in matters affecting Harvard' in 1999."
In 2003, Klausner had told the Cancer Letter, "I had zero interaction during any point during the review and decision process. To this day, I have no idea who was on the [review] committee." However, the congressional committee wrote that Klausner "claimed in an e-mail that he personally recruited three of the ten member of the [above review] panel, according to records and interviews."
Klausner is currently Executive Director of the Global Health Division of the Bill & Melinda Gates Foundation.
This adds to the increasing number of stories about conflicts of interest at the NIH from the 1990's through the beginning of the 21st century. Such stories, in my humble opinion, highlight the need for the more stringent policies on conflict of interest that have been put in place by the current NIH director, despite ongoing opposition by NIH staff who seem to prefer how things were in the 1990's. (See most recent post here.)
The NIH has tremendous influence on biomedical science, clinical medicine and health policy. The conflicts of interest reported in this and previous stories raise strong suspicions that some of this influence has in the past been wielded unfairly to benefit outside organizations rather than the general public, patients, and science.
For this once proud organization to regain the public trust, such conflicts need to be eliminated, even if some current NIH employees will have to do without fat consulting fees, and might even have to learn how to invest somewhere other than health related stocks.
A report in the Seattle Times showed that the medical center's physicians had previously complained about these charges. One physician, who himself had a procedure there, was charged more than a $1000 facilities charge. He wrote, "I call it obscene. There has to be some sense of appropriateness/fairness/reasonableness to our charges." Another doctor wrote on behalf of a patient charged a $754 facilities fee, "These charges are not only excessive, but an embarassment to me and the medical center."
This is yet another story about hospitals and medical centers charging fees that on their face are far more than the services rendered were conceivably worth. Why don't cost cutters target such fabulous fees, rather than the ever-shrinking reimbursement that generalist and cognitive physicians get?
(Note that Medicare is slated to cut all physicians' fees by 4.3% next year, while it raises the premiums patients pay by 12%. But such a cut, imposed on reimbursements that have not kept up with rising overhead rates, may drive some generalist and cognitive physicians out of the Medicare program. [See article in Philadelphia Inquirer here.] Yet apparently Medicare sanctions thousand dollar fees hospital fees for clipping toenails.)
Friday, September 09, 2005
More on drug safety surveillance from the Medical Informatics perspective: the drug 'risk portfolio'
He asks: "It’s not clear EXACTLY what information in the EMR will distinguish the MI caused from Vioxx from the one caused by pre-existing factors. Is EMR adoption really going to help pharma? ... What, aside from EMR and pharmacogenomics, might allow sponsors to make product-withdrawal decisions quickly when necessary and stick to their guns when the drug is not causing problems? Will this always take 5-10 years to figure out?"
My response was:
Patients know there is inherent risk to medical treatment. Rather than trying to minimize notification and availability of data about risk, I think pharma needs to create up-to-date 'risk portfolios' of their drugs that clinicians and consumers could access via the web. it's a constrained version of the idea of putting RCT results on the web (see below).
Think about it. Consumers can access gambling data and odds online e.g., Off Track Betting at sites such as http://www.nycotb.com/. But they cannot access up-to-date risk information categorized by adverse event type on drugs. Even clinicians must rely on package inserts, PDR, the detail people with their likely dated material, etc. and the occasional call to a pharma company's clinical information people.
The risk information needs to come from numerous sources. MedWatch, clinical trials, existing national registries (e.g., Genentech National Registry of MI) etc.
The question about the use of EMR in adverse event detection is a good one. It is here that statistical techniques and data mining could provide the associations. Retrospective cohort studies and other methodologies are useful. This is what Graham at FDA and others do with retrospective data such as claims data; such work would be more credible if the data utilized was decent clinical data from EMR. Further, the adverse events (AE's) could be partitioned into directly observed (e.g., Medwatch) vs. derived (e.g., from EMR data analysis) categories.
The results are not RCT-perfect, but clearly the public is unhappy with the current minimizing of facile access to concurrent information about drug AE's, as represented by those fast-pitched warnings at the end of the ad with the pretty girl and the farm that says how the medicine will turn an arthritic cripple into a champion figure skater. (/sarcasm off) ...
The problem right now is one of pharma intransigence towards non-RCT data. Graham hit the nail on the head here. As I mentioned, there is a marked asymmetry between testing drugs for effectiveness vs. for low-level AE's via clinical trials using the p<.05 constraint. It would be a wonderful world if we could do RCT's on tens of thousand or millions before drugs hit the shelves, but we cannot. RCT's will always take time to show low-incidence AE's and need supplementation if we are going to avoid the "5-10 years to figure out" problem.
If such concurrent drug 'risk portfolios' data were readily available via the Web, clinicians would have an easier time explaining the best-of-our-knowledge risks more granularly to patients. And putting full clinical trials results online is not the answer, either (and is probably not necessary), because the AE data of use at the business end of clinical encounters might get lost in the details. I envision a virtual "package-insert AE table" that can be used by clinician and patient to decide if they want to take the risk of using a particular drug.
If such a facility were available, VIOXX might still be on the market. I believe many would be willing to take it even knowing the risks. What caused the problem was the sudden turnabout and the perception of concealment of risk information.
It would, of course, be assumed that companies would do their utmost to keep the AE clinician/consumer tables updated, and when new low-incidence risks are discovered, the openness might prevent the need to have to suddenly withdraw a drug from the market. Of course, it would also minimize the risks of lawsuit for AE's that were reported via the site.
Transparency via 'risk portfolio' information (i.e., up to date, "virtual package insert", web-available AE tables) is the key concept to avoiding spectacular pharmaceutical company "ELE's" a.k.a. extinction level events, as in those asteroid-hits-earth movies...
In my opinion, faith in RCT's has become somewhat of a religion. By this, I mean that it is sometimes forgotten that accepting results as reflecting truth when "p is less than .05" is a convention for a commonly-accepted level of uncertainty regarding the meaning of experimental results. The p value of .05 is not a universal constant such as c (the speed of light, 299,792,458 m/s), or a proof of reality outside the scope and limitations of a particular trial. Marketing people would perhaps have us believe otherwise...
It must also be asked regarding clinical trials: "what is the p[robability] that due to trial scope and limitations, findings of importance were missed?"
The chronology of Vioxx clinical trials and the latest industry statements that Vioxx risks only exist after 18 months of consumption is likely a sign that this question is not being asked, especially since retrospective data hint otherwise. To trust the latest APPROVe trial regarding the 18-month period, when earlier trials (e.g., "Study 090") were conflicting regarding whether Vioxx was associated with cardiac adverse events at all, are evidence that faith in individual clinical trials may have become dogmatic and short-sighted. What will the next, even larger trial show?
Albert Einstein had a saying: Insanity is doing the same thing over and over again and expecting different results -- which in this situation means depending only on progressively-less limited (but limited nonetheless) RCT's, in concert with a very broken postmarketing surveillance "system", over and over again for drugs sold to millions.
In any case, regarding the Web-based 'risk portfolio' mentioned earlier based on a number of sources of data, if pharmas won't do it, then someone else will. That "someone" will be government or private entrepreneurs, or a combination. Perhaps an independent authority would be best for such an endeavor, anyway.
Thursday, September 08, 2005
To: Faye Flam
Inquirer Staff Writer
Re: A Familial Trail, the Genographic Project (Philadelphia Inquirer, Mon, Sep. 5, 2005, http://www.philly.com/mld/inquirer/living/health/12563313.htm )
Dear Ms. Flam,
As you document in your article “A Familial Trail, the Genographic Project”, Philadelphia Inquirer, Sep. 5, 2005, DNA evidence is indeed revealing a history of human migration, filling in the details of human spread over the earth. This is a fascinating endeavor, although as I question later, perhaps this initiative is an indulgence whose resources might be better spent finding treatments for disease.
I also take this opportunity to amplify the fact that the Genographic project itself has a familial trail, a trail somewhat littered with controversial and unappealing debris. This project is following in the tarnished footsteps of the Human Genome Diversity Project (HGDP), which your article points out became known by the indigenous peoples that it purported to study as the “vampire” project. It received the mark of the fabled Transylvanian parasite, perhaps not without good reason.
You quote Yale geneticist Ken Kidd, Professor of Genetics, Psychiatry, and Molecular, Cellular & Developmental Biology at Yale, one of the HGDP project's founders, as stating that he “never fully understood what went wrong” with the HGDP.
Perhaps this statement reflects Dr. Kidd’s assumptions about intellectual capabilities of uneducated, often poor, indigenous peoples. Does he or other scientists believe them stupid or naïve? These indigenous people, while undoubtedly not educated to the level of a Dr. Kidd, are also unspoiled by the privileges of status, power, and the other accoutrements of wealth and Ivy League tenure. They have survived as indigenous people through their wits. Their instincts are pure and untainted by Western decadence. They are, first and foremost, excellent judges of people and people’s intentions, because they’ve had to be, in order to survive under often harsh natural and increasingly man-made conditions.
Let me remind Dr. Kidd just what “went wrong.” The HGDP was very strongly opposed by a number of indigenous populations around the world. Despite promises to the contrary, the indigenous populations feared misappropriation of their genetic material and of commercial discoveries made from their blood and tissues. The Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project, for example, as recorded at the website of the South and Meso American Indian Rights Center, states:
In the long history of destruction which has accompanied western colonization we have come to realize that the agenda of the non-indigenous forces has been to appropriate and manipulate the natural order for the purposes of profit, power and control. To negate the complexity of any life form by isolating and reducing it to it's minute parts, western science and technologies diminishes its identity as a precious and unique life form, and alters its relationship to the natural order. Genetic technologies which manipulate and change the fundamental core and identity of any life form is an absolute violation of these principles, and creates the potential for unpredictable and therefore dangerous consequences.
As observed by Silvia Ribeiro of the Action Group on Erosion, Technology and Concentration (ETC Group), the Human Genome Diversity Project was a project of various universities begun in the early 1990s, intended to search for the genetic differences – called Single Nucleotide Polymorphism (SNP) – in 722 communities throughout the world, many of them indigenous groups defined as “in danger of extinction.” The HGDP tried to “conserve the genetic material for research” before these groups disappeared. Not conserve the people, just their genetic material. The people sampled did not know toward what ends the samples were used, and the information was placed on the Internet and in repositories similar to that of the Coriell Institute, later giving rise to many patents over them, held by corporations and universities. Thanks to denunciations by RAFI (Rural Advancement Foundation International, now called ETC Group), together with the indigenous peoples of the world, the Vampire Project, as they called it, had to be watered down, but it has never accounted for the samples obtained.
I should indicate at this point that I did work related to HGDP in the early-to-mid 1990’s, and when these statements were made, I too felt the indigenous populations might have been overreacting.
However, when my own intellectual property came under attack (a computer program called SAYGR designed to improve the care of Middle Eastern children with birth defects), my understanding of their feelings and identification with their judgments became crystal clear.
A tenured senior faculty person strongly involved in HGDP tried in a disingenuous manner to obtain documentation and source code to software I’d written as untenured junior Yale faculty. This senior faculty person attempted to obtain this material from a visiting foreign scientist.
The senior faculty person and a colleague of his, another senior tenured faculty member, desired my computer programs for their own research and sought to simply take it from me without negotiation. I had for a number of reasons denied my programs to them until legal agreements could be worked out for sharing potentially valuable code with them. Such agreements were under discussion with Yale’s Cooperative Research Office, as both of them were well aware after being informed both verbally and in writing.
Note: by Yale intellectual property policy, copyright ownership of faculty work, including software, explicitly remained with the faculty author:
Copyrightable works of authorship include, among other categories, books, articles and other written works; musical and dramatic works; pictures, films, videos, sculptures and other works of art; computer software; and electronic chip designs. It is traditional at Yale … for books, articles and other scholarly writings by a faculty member to be deemed the property of the writer, who is considered to be entitled to determine how the works are to be disseminated and to keep any income they produce.
The University's existing copyright policy addresses ownership issues. Under existing policy the University disclaims, except in defined circumstances, any ownership of the copyrights in books, articles, and other scholarly works created by faculty, students and staff.
Nonetheless, when a professor from Saudi Arabia with whom I had shared the documentation and computer code was visiting at Yale, I received these somewhat frantic emails from him regarding the senior faculty person's behavior. The emails speak for themselves (names are omitted):
Subj: I need help
Date: 96-06-12 14:24:09 EDT
From: [name withheld]
I hope you will find this message in the next 30 minutes and you will reply.
I have a meeting with [senior faculty person involved in HGDP] at 3:00 pm and he wants me to give him the SAYGR manual (I told him that I do not have a hard copy, and I will look at my disks at home to see if I have a soft copy) and he wants to see whether my version of SAYGR is the same as his and if it is he wants my version. I will erase all version indications so he would not know what version it is. He says his version has a bug in the pedigree template? and is difficult for him to use.
I did not want to let him know that I know what is being going on. What do you want me to do if he insists getting a copy of my SAYGR? I hope he does not. If you do not respond I will try my best to make it look like our versions are identical so he would not want what I have. He has not said anything about any legalities that he is involved with SAYGR so I pretend not to know anything. I do not want to put you or myself in a compromizing position and let him know that we are friends and we talk. I will for sure not give him the manual and I will do the impossible not to give him the program.
I will let you know what happened.
It should be interesting.
Subj: READ, READ
Date: 96-06-12 16:39:23 EDT
From: [name withheld]
I just got out from my meeting with [senior faculty person involved in HGDP]. He insist in getting my copy of SAYGR because he knows you were making some improvements for me. He also insists in getting the manual. I managed the manual issue by saying that I do not have it with me. I have a lot of interesting information that we need to discuss. Do you have the version that you gave [other local colleague] so I can give that to [senior faculty person involved in HGDP] instead of mine? He did not mention anything about being in dispute with you on the rights to use it. Please advice as soon as you can.
He has his own copy and [other local colleague] has one too. They had a problem figuring out which is the most updated and he felt that mine probably was and that is why he wanted it.
Let me know what you want me to do
I will stay here late in case you try to get in touch with me.
The embarrassment and insult suffered by the visitor, who was put on the spot in a most unpleasant manner, led to him reporting these events to his boss back in Saudi. The senior faculty person attempting to misappropriate my IP apparently lost access to Saudi blood samples he was promised as a result.
One lesson I learned is that the fears of the indigenous peoples towards Genome projects that sample their blood are not inappropriate, considering how one person involved in the project apparently regarded his own junior and foreign colleagues and property rights. Ironically, of all people, Human Genome Diversity personnel had an obligation to conduct themselves in a manner beyond reproach.
These issues bring up a series of questions that must be asked prior to the initiation of new international studies of indigenous genomes:
(1). Should academia alone be entrusted to collection and stewardship of indigenous populations’ genomic data and of the inventions discovered as a result of such possession?
Academics, especially those with tenure, are less accountable than even industry and governmental officials (as, for example, FDA’s and Merck’s current trials and tribulations illustrate). Of all people, genome information is perhaps least safe in the hands of academics. A significant portion the public in the U.S., let alone indigenous people, is not entirely trusting of the potential for misuse of clinical and genetic data. At least in profit-driven industry those in possession of the data face the threat of litigation and financial ruin for misuse of such data.
Academia itself lacks a pristine reputation on handling of intellectual property matters. For example, several years ago bitter authorship disputes were found to be increasingly frequent by the Ombud of Harvard Medical School and felt to affect other academic institutions as well. Even worse, the Harvard Ombud wrote that “it is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures.” In my response in JAMA I indicated alarm at the latter opinion. If universities admittedly cannot protect their own, I ask, how can they possibly protect their research subjects’ interests when disputes arise?
(2) Does Ivy-League academia intrinsically respect the notion of individual or collective intellectual or genetic-information property? The Free software movement began in the "hacker" culture of U.S. computer science laboratories (Stanford, Berkeley, Carnegie Mellon) and is an academic concept designed to block corporations from capitalizing on the advantages of intellectual property ownership. This movement considers free software a matter of “liberty” as in "free speech". While trying to deny Bill Gates and Microsoft the benefits of intellectual property protection may not seem like a bad idea to some, and while free software such as the Linux operating system has enabled a lot of useful research, disrespect towards the property rights of indigenous populations via such widespread academic ideologies would be, quite frankly, a risk of a renewed Genome project under any name. It would be an atrocity if harm actually occurred.
(3) Has it ever been possible to hold academia accountable for anything in front of any authority? Some in academia make the most outlandish of statements or engage in questionable activities and rights abuses, often without significant loss of career or income. [10,11,12,13,14,15,16]
(4) Do academics respect minorities and act out of selfless nature, or do some in academia exploit minorities and act out of self-aggrandizement for their own egos? What does the widespread exploitation of graduate students, often foreign-born, say about academic ethics in this regard?
Those good people in academia who respect others and honor social justice are often reluctant to speak out against abuses. I believe the caution of indigenous people in being subjects of genomics research, especially "vanity" projects such as the Genographic project is well-placed. I suggest that we need to have global, binding, enforceable agreements regarding the use of indigenous genomes and any inventions such data may generate. A world body such as the WHO or UN, via the UN Working Group on Indigenous Populations, should be engaged in formulating such agreements. This would avoid the “misunderstandings” quoted by Dr. Kidd, as well as minimize the risks of exploitation of indigenous populations that such an initiative raises by those faculty more interested in their own careers than in social justice.
I also suggest we look at the possibility of devoting the resources of this Genographic study (considering that its parental Human Genome Diversity Project was delayed for years and then cancelled without major repercussions) to areas of research endeavor more likely produce actual treatments of value to patients. It is well documented that the promises of genetic medicine are far from realized. Although the combined effort of publicly funded genome projects and private investments resulted in rapid identification of essentially all genes of the human genome, harnessing this information to enable drug discovery has turned out to be more challenging and time consuming than initially anticipated.
Let’s make sure we as a society have our scientific priorities in order.
1. Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project, South and Meso American Indian Rights Center (SAIIC), http://www.indians.org/welker/genome.htm
2. Action Group on Erosion, Technology and Concentration (ETC Group), "Human Biopiracy as Entertainment", Silvia Ribeiro, http://www.americas.org/item_20607
3. Yale University Copyright Policy, Office of Cooperative Research, Yale University, http://www.yale.edu/ocr/indust_policies/copyright.html
4. Position Paper on Yale University Copyright Policy, Yale University, http://www.library.yale.edu/~llicense/bennett.html
5. U.S. Department of Health and Human Services, Office of Civil Rights, National Standards to Protect the Privacy of Personal Health Information (HIPAA Act), http://www.hhs.gov/ocr/hipaa/
6. "The Coin of the Realm, The Source of Complaints", Linda J. Wilcox, EdM, CAS, Ombud, Harvard Medical School, Journal of the American Medical Association. 1998;280:216-217, http://jama.ama-assn.org/cgi/content/full/280/3/216
7. "Academic and Legal Aspects of Authorship Disputes" (letter), Journal of the American Medical Association. 1999;281:135-136, http://jama.ama-assn.org/cgi/content/full/281/2/135-a (subscription required)
8. "A Brief History of Free/Open Source Software Movement", Open Knowledge.org, http://www.openknowledge.org/writing/open-source/scb/brief-open-source-history.html
9. Free Software Foundation, http://www.fsf.org/
10. "University resists lawmakers' call to fire instructor who called for A Million Mogadishus”, CNN, http://www.cnn.com/2003/ALLPOLITICS/04/08/sprj.irq.professor.congress/
11. "Teaching Terrorism: US Higher Education System Alluring to Terrorists", Paul Teske , The Michigan Review (Campus Affairs Journal of the University of Michigan), http://www.michiganreview.com/article.php?id=1180
12. "Fallout continues over 'little Eichmann' remarks", Associated Press, http://msnbc.msn.com/id/7233416/
13. "Indian Hunt" At University of Indiana, Front Page Magazine, http://www.frontpagemag.com/Articles/ReadArticle.asp?ID=19081
14. The Foundation for Individual Rights in Education, numerous cases of rights violations by universities of faculty, students and employees, http://www.thefire.org/
15. Injustice and abuse of power against a Kuwaiti student at The Ecole Supérieure de Physique et Chimie Industrielles (ESPCI), Paris, http://justice4t.freeservers.com/
16. "Gene therapy tragedy: The story of Jesse Geslinger as written by his father", by Paul Gelsinger, http://www.1million.com/jesse-gelsinger/jesses-intent.html
17. "GESO denounces treatment of grad students", Yale Daily News, http://www.yaledailynews.com/article.asp?AID=1045
18. UN Working Group on Indigenous Populations, Office of the United Nations High Commissioner for Human Rights (OHCHR), http://www.unhchr.ch/indigenous/groups-01.htm
19. "Genomics: success or failure to deliver drug targets?" Betz et al, Current Opinion in Chemical Biology, 2005 Aug;9(4):387-91, http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15990354&dopt=Citation