Health Care Renewal Bloggers to Speak About Changing Physician Behavior

And tooting our own horn a bit more....
Health Care Renewal blogger Wally Smith and I will be giving an advanced course at the Society for Medical Decision Making meeting in San Francisco, CA, on "Changing Physician Behavior." We will give the course on Friday afternoon, October 21. The meeting itself runs from October 21 to Monday, October 24.
This course has evolved to address techniques used to change physicians' behavior that "may not be used in patients' best interests, or may drive physicians to violated their core professional values." We hope to teach how to recognize "behavior techniques that risk conflicting with physicians' core values," as the first step in teaching physicians a defense against these techniques.
I should note that Dr. Smith and I are willing and eager to take this course, and a workshop on external threats to physicians' professionalism based on the special symposium we gave at the 2005 Annual Meeting of the Society of General Internal Medicine, on the road, either as individuals, or together, schedule permitting. Anyone interested in having us present should contact me, rposes AT firmfound DOT org, or Dr. Wally Smith, wrsmith At vcu DOT edu.

External Threats to Physicians' Professionalism

Tooting my own horn a bit.... I just published a commentary entitled "External Threats to Physicians' Professionalism: What Is To Be Done?" in the Summer 2005 issue of the Rhode Island Chapter (of the American College of Physicians) Governor's Newsletter (on pages 6-7).
It includes a quick summary of how threats to professionalism may be manifested: cross-fires and double-binds; perverse financial incentives; deception, disinformation, and propaganda; and intimidation and coercion. It notes some recent examples: not-for-profit hospitals violating their missions by charging uninsured patients inflated list prices; managed care executives who receive seven-to-nine figure compensation blaming patients for rising costs of health care; and pharamaceutical companies manipulating the medical research literature. Finally, it includes a brief pitch for this blog, and FIRM (the Foundation for Integrity and Responsibility in Medicine.)
Commenst and questions are welcome, of course.

On unqualified decision-making in healthcare

I recently re-read a piece I'd initially written around 1998 entitled "Unqualified decision-making: a major obstacle to clinical computing progress" and realized that the piece was still very relevant to an issue beyond computing, an issue that recurs often in the postings on Health Care Renewal. The issue is the leadership of healthcare organizations by the unqualified or incompetent.

The piece, once a part of a larger website on healthcare computing obstacles, is here. Some of the links are outdated, but the topic is not.

-- SS

Conflicts of Interest Revealed on the UMDNJ Board of Trustees

The hits just keep on coming for the University of Medicine and Dentistry of New Jersey.
The latest was reported by the Newark Star-Ledger, this time involving conflicts of interest affecting the university's board of trustees. The newspaper found multiple possible conflicts.

• Sonia Delgado, the chair of the board, is a health lobbyist for Princeton Public Affairs Group, "whose clients include Robert Wood Johnson University Hospital in New Brunswick, a teaching hospital affiliated with UMDNJ. Records show her firm also represents Bon Secours Health System Inc., a Catholic health care system ... that is currently to sell St. Mary's Hospital in Hoboken to UDMNJ."
• "John P. Ferguson is the president and CEO of Hackensack University Medical Center, also affiliated with UMDNJ...."
• "Christopher Paladino is president of New Brunswick Development Corp... which is building a new dorm on the Newark Campus of UMDNJ."
• "John A Hoffman is a managing partner of the law firm of Wilentz, Goldman & Spitzer in Woodbridge, which served as special counsel in the financing of $87.4 million for the dorm project...."
• "Donald Bradley is the Newark City Council president. The city has contracts with UMDNJ."

Potentially very significant is that the the Liason Committee for Medical Education (LCME) "found the Newark-based institution in violation of its accreditation standards because of conflicts involving business affiliations of several trustees...." Apparently, LCME rules require medical school governing boards members must have "no personal or pecuniary interest, or other conflicts of interest, in the operation of the medical school, its associated hospitals, or any related enterprises." The LCME does not simply allow members with conflicts to recuse themselves from specific board activities, "while this process may effectively manage the conflict, it does not satisfy the (accreditation) standard."
It is not too hard to imagine that a board of trustees including multiple members with conflicts of interest may not due the best job keeping a medical school (or other health care organization) focused on its mission.

Tufts Health Plan: Back to the Managed Care Future

The Boston Globe reported how Tufts Health Plan (in Massachusetts) is going back to "old-fashioned managed care" as a way to cut costs, and try to reduce its chronic double-digit rate increases. The methods it plans to use include requiring prior authorization for a variety of interventions, not only imaging tests, as we noted earlier, but also now back surgery and hysterectomy.
Dr. Allen J. Hinkle, the Plan's chief medical officer, noted, ''We're getting push-back from providers."
That seems to be an understatement. Dr. Alan M. Harvey, the President of the Massachusetts Medical Society commented, ''Their blanket programs for hysterectomy and back surgery are unacceptable. We're mindful of costs, but if every procedure has a hoop you have to jump through, it's an incredible hassle. At some point you'll have physicians saying to patients, 'You need to change your insurance, because we can't keep up with all the hoops we need to jump through.' "
Hinkle countered, 'They don't like when we infringe on their office practice. They don't like the radiology and prior authorization plans. But if costs are left unmanaged, it will break the system."
True, but once again, I wonder why the Plan doesn't seem to want to address the price it pays for individual services, preferring instead to increase bureacracy to try to decrease across-the-board utilization of these services. (See previous post here)
In that context, let me finish with a letter sent by Health Care Renewal blogger Cathleen Hood to Dr. Hinkle.

Dear Dr. Hinkle,
This letter comes in response to your announcement that effective 9/26/05,we will be required to get prior authorization for all CT, MRI, PET, and Nuclear stress tests.
I am writing to strenuously object to being subjected to yet anotheradministrative burden in the course of caring for our Tufts patients. This new program will materially impact my ability to do my job. I am sick and tired of being second-guessed at every turn, and required tojustify my recommendations to some functionary at a hired agency before mypatients can get what they need and have already paid for. I have been dealing with the same agency, NIA, under protest, for my Harvard/Pilgrimpatients and it has been costly, time-consuming, and has obstructed thetimely care of my patients. In addition, Harvard has failed to stream-line the process after 2/05 as promised initially on implementation last Fall.
If you have unmanageable imaging expenses, talk to those who set the prices. Cease attempting to economize on the backs of your already beleaguered and thoroughly disgusted primary care doctors.
We've had enough! We want new contracts. To whom do we speak?

A "Black Bag Job" at UMDNJ

The stories about the University of Medicine and Dentistry of New Jersey (UMDNJ) just become more and more surreal. 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. The University had been under investigation by the US Federal Bureau of Investigation (FBI).
This month, the Newark Star-Ledger described how a burglar made away with a variety of records, but almost no cash, and little of pecuniary value, from a UNDMJ administration building. This burglary occurred days after a memo from a UMDNJ staff lawyer asking employees to secure all documents and destroy none of them. The initial story said that the records included documents subpoenaed by the FBI, and personnel records probably also related to the investigation, according to an additional report. The President of UMDNJ, John Petillo, even said that to him "it looks like it may very well have been an inside job." After the burglary, the FBI stepped up their investigation, interviewing several UMDNJ employees in pre-dawn visits.
Later, there was confusion about what was actually taken. Another Star-Ledger article included a statement by UMDNJ officials that "no documents requested of UMDNJ by any outstanding subpoena are missing due to the break-in." Yet, according to the Star Ledger, "stolen personnel records could factor into the federal probe."
The story inspired some 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."
Doug Forrester, the Republican candidate to be New Jersey Governor, wrote the Secretary of the US Department of Health and Human Services (DHHS) demanding an investigation, "it is clear that nothing short of the full involvement of your office will ensure that federal and state tax dollars are not being misspent, misappropriated, or otherwise misused." (see link here)
An editorial in the Bergen Record described UMDNJ as "a dead skunk in the middle of the road."
The tragedy is, as perusal of Health Care Renewal will show, there are a lot of dead skunks in health care. But each of them seems to be treated as a unique, local problem. In fact, the growing stench from health care organizations' increasingly common leadership problems (including incompence, self-interest, and even corruption) may be the missing link, explaining why costs keep rising, access keeps falling, quality is not progressing, and health care professionals are demoralized.
But cleaning up the mess will take some concerted action by health care professionals to make the public and the policy-makers aware that this stench is everywhere.

More Smoke from the "Drug Secrets" Story

The Seattle Times "Drug Secrets" series about researchers being paid to talk to investors about ongoing clinical research continues to generate smoke that seems to be obscuring some important underlying issues.
To me, the biggest such issue is that clinical research should be open, transparent, not confidential or secret (except for the identities of the research subjects, and perhaps in some special cases involving national security).
Let me reiterate four reasons why keeping information about and data from ongoing clinical research secret is bad.
1.It may cause patients to suffer.
Recent examples suggest that commercial research sponsors may try to keep secret data about hazards of medications, devices, and toxic exposures. Such data can at times be apparent before a study is complete. Keeping such data secret allows people to continue to be unknowingly exposed to such hazards. Two of the classic cases of research suppression in the 1990's demonstrated this issue.

• In the "David Kern case," a textile manufacturer, Microfibres Inc., tried to prevent Dr. David Kern, a general internist and occupational medicine physicians at Memorial Hospital of Rhode Island and faculty member at Brown University, from presenting an abstract that described a case-series of a new pulmonary disease, flock-workers lung, that affected workers at Microfibres Inc. factories. Kern did present the abstract, but under a threat, never carried out, of law-suit, Memorial Hospital of Rhode Island removed Kern as head of the Occupational Medicine program, and refused to renew his contract, even though he was an Associate Professor. Brown University was unable to reverse these moves by the hospital, and Brown officials blamed Kern for signing an agreement to protect trade secrets, even though the agreement was unrelated to the research Kern did on the disease, and his research did not obviously reveal any trade secrets. [1-4]
• In the "Nancy Olivieri case," Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri for revealing preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report)

2. It violates the promise made to research subjects that their participation will advance science.
I have never heard of patients in trials run by academic institutions being told that their participation is solely for commercial product development or marketing purposes. As Steinbroook put it, "a basic tenet of research ethics is that the data from clinical trials should be fully analyzed and published. If the knowledge gained from trials is not shared, subjects have been exposed to risk needlessly."[5]
3. It conflicts with the core mission and values of medical schools and universities.
Gagging researchers violates their academic freedom. Gagging researchers is in direct conflict with universities' missions to promote free enquiry. (For example, the mission of Brown University includes "discovering, communicating, and preserving knowledge and understanding in a spirit of free inquiry...." (link here).
4. It may violate the free speech clause of the First Amendment of the US Constitution.
At least for state universities in the US.

So paying researchers to talk to investors about on-going research is bad if this discussion, too, is kept confidential, e.g., restricted only to a few investors (so that the research is still being kept secret from the general public, other researchers, physicians, etc.); or if the amount paid to the researchers is excessive, suggesting that they are being paid to influence the research in some way, not to just talk about it.
But it is not obviously worse than paying researchers (or more likely, the organizations that employ them) to keep the research confidential in the first place.Recent cases of suppression of medical research seemed to have spurred movement to ban what Robert Steinbrook accurately called "Gag Clauses in Clinical Trial Agreements."[5] For example, the American Association of Medical College put out a statement in December, 2004, that it "strongly supports the elimination of restrictive confidentiality clauses in clinical trial contracts between pharmaceutical companies and academic or physician researchers." (link here) In same month, the American Medical Association also resolved "to eliminate from research contracts the confidentiality clauses that prevent medical scientists from communicating their findings in clinical trials." (link here )
Yet most of the discussion of the Seattle Times series seems to focus only the evil of paying researchers to talk about research, and not the evil of paying to keep research secret. In fact, most mentions of gag clauses are as something that it is bad to violate.
For example, we have previously posted on how members of congress have focused on this issue as one involving insider trading.
The Seattle Times' own editorial on the their news series did as well.
But most curious is the response of the American Association of Medical Colleges (AAMC). The Times' reported last week that a memo sent by the AAMC to all medical schools directing them to "tell their doctors to scrupulously honor' confidentiality agreements forongoing research."
Fearing that the news article may have not fully described this message, I secured a copy of it from another medical school, whose dean had put it in wide circulation. It, indeed, did not include a reminder of the AAMC's previous condemnation of the very confidentiality agreements it now called to be "scrupulously" honored.
To badly mix metaphors, we risk taking our eyes off the ball here. Gag clauses for researchers are bad. While urging researchers to adhere to current clauses to avoid personal legal liability, we should urge institutions to explore whether there are legal means to nullify such clauses, and certainly not to sign new ones in the future. Simon Cameron, President Lincoln's Secretary of War, reputedly said, "An honest politician is one who, when he is bought, will stay bought." I hope the confusion now surrounding the "Drug Secret" series will not lead people into saying that about physicians and medical researchers.

References
1. DG Kern, RS Crausman, TH Durand et al. Flock worker's lung: chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med 1998; 129: 261-272. (link here)
2. Shuchman M. Secrecy in science: the flock worker's lung investigation. Ann Intern Med 1998; 129: 341-344. (link here)
3. Marsh DJ. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337: 1317-1318. (link here)
4. Shuchman M. Consequences of blowing the whistle in medical research. Ann Intern Med 2000; 132: 1013-1015. (link here)
5. Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med 2005; 352: 2160-2162. (link here)

A Little Good News About Evidence-Based Medicine

The Wall Street Journal recently reported (see free link here) about the increasing use of techniques based on evidence-based medicine (EBM) by organizations who pay for medical care in the US. The article focused on the efforts by the Kaiser Permanente managed care organization. As best as I can tell, this organization may actually be doing something that at least approximates a true evidence based process.
My working definition of EBM "making medical decisions based on a systematic search for, and then systematic, critical review of the best evidence available from clinical research." EBM involves considering clinical experience and the clinical context on one hand, and the patient's values, on the other hand, when making such decisions.
There are a variety of frameworks available for teaching and applying the principles of EBM. I like to use the original Users Guides first published by JAMA (available free here). There are several formal definitions of evidence-based medicine, (for example, see this link), and good web-based resources, for example, see this site at Oxford, this site at Sheffield, and its guide to web-based resources.
Of course, there are concerns that any time a managed care organization says it is using EBM, it really is trying to use evidence selectively to cut costs. The Journal article noted that the American Medical Association (AMA) had accused some state Medicaid programs of doing exactly that. Furthermore, in my humble opinion, if costs are the issue, it might be better to use EBM and principles of medical decision making (as promoted by the Society for Medical Decision Making) to decide how much a particular test or treatment might be worth, rather than simply making up/down decisions about whether to use that treatment at all. But it looks like what Kaiser is doing might be a step in the right direction.

The Anechoic Effect and Protocol 126

One of my fellow bloggers alerted me to the extensive web-site, entitled "Uninformed Consent," maintained by the Seattle Times. The web-site includes a series of articles the focus on the unfortunate Protocol 126, a series of trials run at the Fred Hutchinson Cancer Research Center in Seattle from 1981 to 1993. The story is long and convoluted, but I will try to summarize, because it is important, and seems to have provoked the anechoic effect yet again.
Protocol 126 - was a series of experiments to test whether monoclonal antibodies against T-cells would improve outcomes of bone marrow transplants for patients with leukemia, mainly by preventing graft-versus-host disease (GVHD). The protocol went through several versions over 1981 to 1993.
Genetic Systems Inc. - The monoclonal antibodies came from Genetic Systems. The company was set up by David Blech, a young entrepreneur with little money and no apparent biotechnology background. The company enlisted several researchers at the Fred Hutchinson Cancer Research Center: Dr. Robert Nowinski, who actually ran Genetic Systems; Dr. E. Donnall Thomas, who had won the Noble Prize for the development of bone marrow transplants, who received 100,000 shares of stock and sat on Genetic Systems board; Dr. John Hansen, who got 250,000 shares, and served as the Medical Director of Genetic Systems for an $18,000/year consulting fee; and Dr. Fred Martin, who got 10,000 shares and served as a consultant.
The First Version of the Protocol - This group of scientists submitted a research protocol to the Hutchinson Human Subjects Review Committee. They did not divulge their business relationships with Genetic Systems. The committee initially rejected the protocol for reasons including insufficient prior animal research; choice of good rather than poor prognosis subjects; fears that T-cell depletion might prevent bone marrow grafts from "taking;" and problems with the informed consent document including minimizing the risk of graft failure, and not discussing alternate approaches to GVHD.
The Revised Protocol - After the committee was reconstituted, it approved a revised version of the protocol. The revised committee still did not hear of the investigators' financial relationships with Genetic Systems. Neither did it hear that the company had agreed to give the Hutchinson a share of royalties from the antibodies.
Protocol 126 in Operation - The protocol began with Dr. Martin, then a post-doctoral student, as Principal Investigator. Initial results showed no decline in the rate of GVHD. The protocol was revised in 1983 to increase the potency of the antibodies against T-cells, but the consent form was not revised, even though the Committee wanted it to include "the risk of fatality from an additional malignant process," that had been observed in other studies of anti-T-cell antibodies.
In 1983 the Hutchinson adopted a conflict of interest policy forbidding researchers from working on projects "in which the member has an economic interest." Yet Hansen and Martin continued their work on Protocol 126. Later they claimed not to have heard of the new policy.
The protocol then came under the jurisdiction of the Hutchinson's new Institutional Review Board (IRB), with Dr. Henry Kaplan as chair, and including Dr. John Pesando. "Kaplan wrote to Thomas asking about rumors that researchers had financial intersts in a company that would use the findings from Protocol 126." Thomas denied this, but posited that the IRB had "an obligation to assist us and impede our research." Kaplan then felt "it certainly didn't appear that we had the power to investigate anything once I got that letter from Dr. Thomas." Dr. Pesando heard that "Thomas and others were enraged with the challenge to their research." Kaplan and Pesando continued to have misgivings. Kaplan appealed for help from the NIH but got no response. Kaplan asked Hutchinson President Dr. Robert Day for an independent review of the protocol, but Day refused. Dr. Thomas challenged Pesando in a staff meeting, "who the hell are YOU to question what we do around here?"
The IRB began to receive reports of engraftment failures affecting patients in the then current version of Protocol 126, 7/20 died of graft failure from June 1983 to March 1984, while 5 more suffered leukemia relapse. The consent form was changed to acknowledge the possibility of graft failure, but then only said "a second marrow transplant would be necessary," without acknowledging that a second transplant would be unlikely to succeed.
The Later Stages - The investigators kept making changes to the protocol, but graft failures continued. For the duration of the protocol, the graft failure rate was 24%. The relapse rate overall was also unusually high, 100% for chronic leukemia. Martin eventually said, "a lot of rejection, a lot of recurrent malignancy. And so it didn't work. It was a bad idea." There was no final report from Protocol 126. Martin said he discarded his files in 1998. The Times reported that 80 of 82 patients in the protocol had died by 2001.
Pessando Protests - Dr. Pessando left the Hutchinson in 1987 after his contract was not renewed. He wrote to the Office of Protection from Research Risks (OPRR) in 1991.

Basically, senior clinicians at the Fred Hutchinson Cancer Research Center in Seattle conducted clinical trials with high therapy-induced mortality rates while they were major stockholders in the company with commercialization rights to those therapies.

In 1993, OPRR began an investigation. It send questions to the President of the Hutchinson, who sent a written response, which included the assertion that conflict of interest problems were addressed by the organization's new conflict of interest policy in 1983, which "was not enforced and resulted in no changes in Protocol 126," according to the Times. The OPRR investigation was plagued by delays. The OPRR never conducted a site visit, and apparently relied on no documents other than Pessando's initial complaint and the Hutchinson's written reply. The Times stated that internal OPRR emails indicated that the office early on concluded that his complaints were baseless, so then decided on manuevers to "sort of CYA (cover your ass)."
Frustrated by their lack of response, Pesando wrote to Department of Health and Human Services (DHHS) Secretary Donna Shalala and Director of the National Institutes of Health (NIH) Harold Varmus

In late 20th century America, prominent physicians at a major cancercenter knowingly risked the lives of unsuspecting patients in pursuit of financial gain, sucessfully bypassed regulatory bodies, and repeatedly silenced opposition.... Yet there could hardly be less concern if laboratory rats had died instead.

Pessando also complained to the State Department of Health, but the investigation was not completed after the staff member who was involved left.
The Fall of Genetic Systems - Genetic Systems went public in 1982, and was eventually bought out by Bristol-Myers-Squibb in 1985 for about $300 million, who in turn, sold part of it for $20 million in 1991, and closed the rest, taking a $274 million loss. Genetic System's' Founder David Blech was involved in many other biotechnology start-up companies, and in 1992 was listed as one of the 400 richest Americans. As his losses mounted in 1993, however, he started executing sham stock transactions to hide them. His firm, D. Blech and Co., closed in 1994. In 1998 he plead guilty to two counts of fraud. He was fined and censured by the Securities and Exchange Commission.
The Aftermath - The Seattle Times series provoked a local uproar. Families of four deceased patients who had participated in Protocol 126 sued the Hutchinson, but a jury found against them in 2004. The Hutchinson developed stringent regulations about conflict of interest in 2002. The Office for Human Research Protections re-reviewed the case, and found that the Hutchinson violated multiple DHHS regulations during the conduct of two protocols, In Protocol 126, violations included enrolling a subject in a revised version prior to IRB approval; and improperly using expedited review of modifications of the protocol.
The Anechoic Effect and Protocol 126 - Several searches (PubMed, Google Scholar, and Web of Science) revealed very little about Protocol 126 in the medical and health care literature. There was a one page news item in Science in 2001, which prominently featured rebuttals by Hutchinson officials. An article in IRB: Ethics & Human Research concentrated on issues relevant to IRB members. I could find no other articles that included more than one sentence on this case, in particular, none in any large circulation medical journals.
Summary - A series of trials, called Protocol 126, at the Hutchinson Cancer Research Center were run by researchers who had extensive, major financial relationships with the the Genetic Systems, the company that developed the treatment used in the protocol. The investigators failed to divulge these relationships, despite institutional rules to the contrary. They are alleged to have intimidated other physicians and IRB members who tried to review questionable elements of their protocol. The patients enrolled in the protocol did very badly, probably worse than had they had conventional treatment. Efforts by Hutchinson physicians to have an on-site local or federal investigation of the conduct of the protocol did not succeed. Even though Protocol 126 ran from 1981 to 1993, the controversy surrounding it was not revealed until the Seattle Times series in 2001, and it has received little attention in the medical and health care literature since.
Comments - This appears to be yet another case involving major conflicts of interest, at least one person who eventually proved to be a criminal, alleged intimidation of whistle-blowers, and patients with poor clinical outcomes. Yet because it took place at a revered institution, it has received less attention than the facts would seemingly demand.

Adventist Hospital System's Charges to the Uninsured: "There is Nothing Healing About Charging Someone Quadruple"

The Washington Post reported yet another tale of allegations that a health care system abandoned its mission by charging uninsured patients far more than insured ones.
The article chronicles the struggle of an organization called Consejo de Latinos Unidos (Council of United Latinos) against the pricing practices of the Adventist Health System. The organization accused the system of failing to uphold its mission. Given that it is a religiously-affiliated health care system, B. K. Forbes, the leader of Consejo de Latinos Unidos, charged, "it's offensive these hospitals market themselves as providing the healing mission of Christ. There is nothing healing about charging someone quadruple and then sending the bill collectors after them."
Poster child (literally) for the challenge is Rodney Vega, a 7-year old boy who suffers from a brain tumor. His parents, Venezualans and practicing Adventists, claim that Florida Hospital, part of the Adventist Health System, refused to do surgery on Rodney without an upfront payment in the tens of thousands of dollars. "Florida Hospital officials blame the Vegas' plight on miscommunication and misunderstanding." But Ms. Vega said, "the real mission of the church is to help people like Christ did. I don't like Florida Hospital saying they are Adventists."
Forbes' background is interesting. His mother was a Chilean immigrant. He has experience as a Republican political operative, and was involved in the campaigns of Pat Buchanan and Steve Forbes (no relation). "Critics say K.B. Forbes (no relation to Steve Forbes) is a front man for insurance giant and GOP donor J. Patrick Rooney." K. B. Forbes apparently previously challenged the for-profit Tenet Healthcare Corp over the same issue, and according to the Post, was able to get it to agree to discounts for the uninsured. Tenet agreed to help Rodney at St. Christopher's Hospital for Children in Philadelphia at discounted rates.
The article also stated that "Forbes has compiled an avalanche of data on huge compensation packages for Adventist Health executives and the hospital's partnership with the National Basketball Association's Orlando Magic." One of his flyers includes,

We turn people away who need help, price gouge those without health insurance, and use the profits to help millionaire basketball players? Is this what Jesus wants?

A hospital vice-president countered that such ventures are a common "way for hospitals to get involved in the health side." I guess that's one way to put it.

The Vioxx Case: An Argument for Better Regulation

The enormous damages award by the jury in the first Vioxx case has provoked a lot of editorial discussion. I have seen a number of arguments that the huge award is unfair, and will have a number of unintended consequences. For example, a commentary in the Boston Globe by two Harvard economists suggested it could raise prices for drugs; discourage development of new drugs; and make drug companies excessively cautious. As a physician, I am have to have some sympathy for these general arguments against large damages awards. However, they fail to acknowledge that what made the jury most upset in this case was not the probablility that the patient was harmed by adverse effects of the drug, but that this was made possible because the company aggressively marketed the drug while it hid its knowledge about the drug's adverse cardiac effects.
A more balanced approach appeared in an editorial in the Philadelphia Inquirer. It characterized the Vioxx case as a regulatory failure. It noted that the US Food and Drug Adminstration (FDA) greatly relaxed its scrutiny of drug companies in response to changes Congress made in the laws in the 1990's. In a more stringent regulatory environment, Merck would have had greater incentives to reveal Vioxx's adverse effects earlier, and not to market the drug as a nearly risk free pain killer for the masses. But in the absence of meaningful FDA scrutiny, and the behavior changes awareness of that scrutiny would have induced, the only way to prevent drug companies from hiding adverse effects, or marketing drugs to patients who don't need to run such risks, is to make them fear huge damage awards. As the Inquirer put it,

As things stood, Carol Ernst had nowhere to go for redress of the harm Vioxx caused her, other than civil court. Thus, the jury's anger on her behalf. They wanted to send a message, and they saw her as David against the Goliath of Goliath's
[But,] if proper regulation had been in place, this lawsuit and award might have been averted.
The balance is tricky but not impossible. The trick is not to allow ideology to rule out reasonable adjustments. Get the balance right, and companies can innovate and make money without recklessly hurting consumers.

Sounds about right to me.
And I think the point is generalizable. Our health care system is now dominated by large organizations, not only pharmaceutical companies, but device manufacturers, information technology companies, hospitals and hospital systems, managed care companies, etc., etc. We have shown on this blog how their leaders all too often misbehave, and act in ways that threaten physicians' professional values, and more importantly, the health and safety of our patients. As long as health care is so dominated by large organizations, our best option for restraining their behavior may be stronger, better, and smarter regulation.

Merck Loses Its First Vioxx Case

It would have been hard to miss the news that the first trial of a civil suit against Merck that claimed patient injuries due to the now withdrawn drug Vioxx yielded a huge verdict for the plaintiff ($24.5 million) , and an immense punitive damages award ($229 million) against Merck. (See the NY Times version here.)
Although Texas law will cap the amount of punitive damages that can be awarded, and many will just dismiss these results as another case of a jury awarding outsized damages to a sympathetic plaintiff, I think there is another message here.
Several news accounts told of the jurors' strong feelings about Merck's conduct:

• From the Times article above, summarized, as "jurors said they had made the large punitive award to send a message that drug makers must disclose the risks of their medicines. 'Respect us, that's the message,' said Derrick Chizer, a juror."
• In a Houston Chronicle article, "A majority of jurors said Merck's aggressive marketing of Vioxx led to their decision." Chizer was again quoted, "marketing was a big part of the case." "'It's not the money,' added Marsha Robbins, 53, of Freeport, who served as the presiding juror. 'It's accountability.'" "Chizer said the message jurors wanted to send to Merck was for the company to take their responsibility seriously. 'Every life counts to us. They should be responsible. If they care, then show it.'"

A NY Times news analysis attributed the verdict to "bad facts," i.e., that the plaintiff's attorneys made a convincing case that Merck knew that Vioxx had cardiovascular risks, but then concealed these risks from the public.

The documents showed that scientists at Merck were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before Merck began selling the drug. 'The possibility of increased C.V. events is of great concern,' Dr. Alice Reicin, a Merck scientist, wrote in a 1997 e-mail message. 'C.V. events' is scientific shorthad for cardiovascular problems like strokes or heart attacks. 'I just can't wait to be the one to present this to senior management,' Dr. Reicin's message continued.
The documents also revealed that Dr. Edward M. Scolnick, who at the time was Merck's top scientist, said in March 2000 that the largest clinical trial ever conducted of Vioxx confirmed that Vioxx had heart attack risks, as he had feared. They showed Dr. Scolnick later referring to scientists at the Food and Drug Administration as untrustworthy. And they revealed that Merck had stridently resisted the F.D.A.'s efforts to add warnings to Vioxx's label, and that it eventually complied only in ways that the Texas jury found unacceptably obscure.
Mr. Lanier [the plaintiff's attorney] also introduced a marketing videotape that showed Merck sales representatives being trained to view doctors' concerns about Vioxx's heart risks as 'obstacles' to be avoided, or dismissed. Another marketing document taught representatives to play 'Dodgeball' when doctors voiced concerns.

So the jury concluded that Merck's leadership deliberately suppressed information about its drug's adverse effects, over the objections of its scientists, thus putting marketing ahead of patients' welfare.
Thus the Vioxx case becomes another sorry example of how leaders of major health care organizations may threaten health professionals' core values.

The Imaging Test Pre-Certification Blues

The Philadelphia Inquirer reported on the movement towards more restrictions on imaging tests by managed care organizations. Independence Blue Cross (of Pennsylvania) has noted that their payments for "diagnostic radiology" grew by 57% from 2001 to 2003. So on October 1, the company will begin to require that physicians obtain authorization before ordering (apparently all) outpatient diagnostic imaging tests. Aetna Inc. has required pre-certification for "high-technology diagnostic imaging" in the Philadelphia area for two years. Horizon Blue Cross Blue Shield of New Jersey started requiring pre-certification on January 1.
The Inquirer noted some down-sides of pre-certification, including adding to the bureaucratic burden on physicians, and the possibility that pre-certification will lead physicians to forego tests that would actually benefit patients. One physician noted that the pre-certification requirements are overly broad, not particularly targeted on specific kinds of over-use, and appear to be meant to discourage testing across the board, "pre-certification is meant as something of a roadblock to ordering imaging."
I was particularly fascinated by an aside in the article about the amounts Blue Cross is paying for imaging tests: $500 - $700 for CT scans, $700-$900 for MRIs, and $2000 for PET scans.
We had posted here about how generously insurers and managed care organizations reimburse for diagnostic imaging tests,. This article suggests that the cost to a hospital or radiology center of doing a CT scan is now only about $102 per procedure. So at least 80% of Blue Cross reimbursement for CT scans is pure profit for the owners of CT scanners. The reimbursement rates of CT scans in Philadelphia seem to be yet another example of "Wooden-Headed Health Care Reimbursement."
If health insurers and managed care companies are so concerned about health care costs, inquiring minds want to know why they keep paying so lavishly for imaging servicies? And why oh why don't managed care organizations and insurers bargain down reimbursement rates for these procedures to something more reasonable?
This cost-cutting approach would make a lot more sense than their continuing heavy-handed efforts to heap bureaucracy on doctors to discourage them from ordering radiology procedures.

ProCare Claims SLAPP By North Carolina Blue Cross

One of our faithful correspondents alerted me to this developing story in North Carolina.
ProCare is a group initially founded by physicians and pharmacists to oppose the proposed conversion of North Carolina Blue Cross to for-profit status. The conversion did not take place, but ProCare, run by two well-known NC political operatives, one a Democrat, one a Republican, continued to operate. (See story here.)
In June, 2005, it released copies of internal Blue Cross documents revealing that Blue Cross had spent about $500,000 on expenses related to the US Open golf tournament. ProCare had previously revealed that Blue Cross spent about $600,000 on a Caribbean cruise for its brokers and sales agents. The context of these revelations included Blue Cross' large surpluses, estimated to be around $350 million in 2003 and 2004, which had inspired state legislators to write bills constraining its surpluses and the size of its reserves. (See story here.) Parentheticaaly, Blue Cross Chief Executive Officer [CEO] Bob Greczyn earned $900,000 in 2002, and more than $2 million in 2003. (See this link.)
Blue Cross' response to ProCare's revelations was to file a law-suit against ProCare. A news release quoted CEO Greczyn, "our customers depend on us to safeguard sensitive information every day. We're left with no choice but to act swiftly to protect our company against unlawful schemes to take and misuse confidential business information to further a narrow political or economic agenda." (See stories here and here.)
Carter Wrenn, one of the leaders of ProCare, disagreed, "If you want to call this what it really is, it's harassment. They don't want to have anybody debating whether they're acting like a nonprofit." ProCare leader Gary Pearce added, "how can disclosing the fact that they sponsored the Open be private business information? They boasted about sponsoring the open." (See story here.) On its web-site, ProCare referred to the suit as a SLAPP (strategic lawsuit against public participation.)
In my humble opinion, it appears that Blue Cross may have been spending more lavishly than befits a not-for-profit, and is far too uncomfortable having this publicized. Threatening a lawsuit that contends that confidential business information was released, unfortunately, seems to be becoming an all too common tactic for health care leaders who don't want to look bad in public.
More transparency would be a wonderful thing for health care.

"The Dirty Little Secret of University Medical Research"

The Wall Street Journal reported several cases in which US federal prosecutors charged major universities with misusing National Institutes of Health (NIH) grant funds. (See temporarily free link here.)
The story focused on the case of Cornell University's Weill Medical College. The school's former "research subject advocate," Dr. Kyriakie Sarafoglou, had noticed irregularities in a $23 million grant for pediatric research. Dr. Sarafoglou alleged that nurses supported by the grant were caring for patients who were not involved in research projects; no children had been hospitalized or seen in outpatient clinics in programs that were funded for 180 hospital days and 600 outpatient visits; and "patients were being billed to the NIH tab even though they weren't taking part in clinical studies."
Dr. Sarafoglou complained to the program director, Dr. Maria New, and then to her "replacement as head of pediatrics at New York-Presbyterian." An internal investigation by Dr. Adam Asch found "no evidence that the budget was exorbitantly inflated," but criticized Dr. Saraglofou for her "confrontational and accusatory posture." Meanwhile, Dr. Saraglofou alleged she was being subject to retaliatory treatment, socially ostracized, and her office moved away from her colleagues.
So she then complained to the NIH. No NIH official was willing to act, but one informed her about "qui tam," lawsuits, in which individuals may sue for fraud on behalf of the federal government. Dr. Saraglofou's qui tam suit was taken over by federal prosecutors. They agreed with most her her allegations, and added more, e.g., that the Cornell pediatric research program enrolled adult subjects and charged the NIH for treatments that were reimbursed by Medicaid. In June, Cornell settled the suit for $4.4 million, admitting no wrong-doing. Cornell's lawyer declined to discuss details with the Journal.
The Mayo Clinic, University of Alabama at Birmingham, Harvard University, Johns Hopkins University, and Northwestern University have settled similar suits for multi-million dollar amounts since 2004. The Journal noted that "all the cases except Harvard's began with whistle-blowers."
Thus, as the article said, this case may illustrate the "dirty little secret of university medical research."
However, the responsibility for this secret should be attributed more to university administrators than scientists and doctors. To add a bit of context, when NIH makes a grant, responsibility for the conduct of the project is shared. The Principle Investigator (PI), the project's head scientist, takes responsibility for the scientific integrity of the project. However, an administrator of the organization for which the PI works takes responsibility for the project's financial integrity.
What also is distressing is the passive attitude of NIH officials to charges that the Institutes' money was being diverted. When the Journal approached Norka Ruiz Bravo, the NIH deputy director for extramural research, she responded "if people are going to cheat, they are going to cheat." That practically invites university officials to take research money for whatever they want.
Dr. Bravo added that the NIH prefers to work quietly with schools to solve problems so research can keep moving forward. Of course, research would move forward faster if the money meant to support it was not being siphoned off.
(An additional report on the Cornell case is available in Nature Medicine here.)

An Addition to our Catalog of Conflicts of Interest

Chicago Alderman Edward M. Burke, as Chair of the Finance Committee, sits on the city's Benefits Committee, which "chooses health insurance administrators, reviews their performance, and hears appeals from city employees whose claims have been denied." Blue Cross/Blue Shield was paid $10.5 million to administer preferred provider organization (PPO) and point of service (POS) insurance plans, and an additional amount to administer a health maintenance organization (HMO).
The Chicago Sun-Times, however, reported that Blue Cross/ Blue Shield is also a client of Burke's law firm. As Dan Sephe, of the Better Government Association said, "representing a company that has large contracts with the city given out [and reviewed] by the committee you serve on - it raises a huge red flag."
Just another addition to our catalog of conflicts of interest affecting health care leadership....

Evaluating the SilverHawk by Depending on Doctors Who Own Its Manufacturer's Stock

The Wall Street Journal reported (subsequently re-published by the Pittsburgh Post-Gazette) about FoxHollow Technologies' questionable strategy for studying the performance of its single product, a catheter system (SilverHawk) used to remove atherosclerotic placque from limb arteries.
The Journal reported that the only research that FoxHollow has sponsored to evaluate their product was a patient registry, i.e., an ongoing case-series. The article reported that FoxHollow "doesn't want to conduct [randomized controlled] trials to test SilverHawk's effectiveness against other procedures because that would be expensive and unnecessary, given the positive registry data."
A quick PubMed search indeed revealed only a few articles that described small case-series of patients on whom the device was used, (for example, see this link). I could find no controlled trials of this device.
Case-series, however, are subject to selection bias, since the patients physicians select to undergo treatment with the intervention of interest may systematically differ from those they choose not to treat in ways that could affect the outcomes measured. Controlled trials that randomly assign patients to treatment by the intervention of interest or a comparison intervention make it likely that the two groups will be similar in all aspects that might affect the outcomes of interest other than the treatment assignment.
Making the situation more murky is that many of the physicians who are involved in the registry have conflicts of interest. Most have received consulting fees from FoxHollow, some of which were provided in the form of stock or stock options, and many own substantial amounts of FoxHollow stock, some of which the company provided them at discounted prices. The article gave the example of Dr. R. Stefan Kiesz, identified as a cardiologist who supplied data to the registry, who owns options to buy 10,000 - 20,000 FoxHollow shares, and has sold options for another 8,000, all of which were granted as payment "for advice he gave to help develop the device."
Thus, FoxHollow's reliance on positive data from its registry ignores the possibility that the registry data was positive due to selection bias, and perhaps also the bias of investigators with a financial stake in the company and its one product.
This is yet another unfortunate variation on theme of conflicts of interest affecting medical research, with both physicians and company leaders bearing responsibility.

Attack of the BlogBots

Unfortunately, we seem to have come under attack by blogbots. The result has been lots of irrelevant comments hawking other peoples' web-sites added randomly to our posts. I have had to remove all such comments manually.
For the time being, I have changed the comment option on the blog to restrict comments only to registered blogspot users. Unfortunately, this will not allow anonymous comments to be posted directly.
I regret having to do this. I hope that the folks at blogspot will come up with a better solution soon.

Lawsuit faults insurer in death

Healthcare rationing? Slow euthanasia via denial of care? An example of the complex systemic dysfunction created by profit-driven MBA's in control of healthcare?

I report. You decide.

Lawsuit faults insurer in death
Philadelphia Inquirer, Mon, Aug. 15, 2005

Sandra S. Lobb, a 57-year-old high school teacher, was divorced, living alone, and killing herself with gin.

Her family urgently wanted to place her in a residential alcohol-treatment program. The family says that Independence Blue Cross rejected that treatment as being "unnecessary" in August 1997 - at a time when Lobb was hospitalized for alcohol related health problems and her doctor strongly recommended that she receive intensive rehabilitation treatment. Eighteen months later, the Kennett Square woman died of alcohol-related causes.

In an unusual lawsuit in U.S. District Court, Lobb's older daughter, Kimberly P. Johnson, the executor of her estate, blames Blue Cross for her mother's death and accuses the giant health insurer of usurping the role of Lobb's doctor in deciding what treatment was "medically necessary" for her.

Lawrence M. Otter, the lawyer who filed the suit, contends that the company, the largest health insurer in the Philadelphia area, engages in the "unauthorized practice of medicine" when it trumps doctors' recommendations for their patients.

Blue Cross denies this:

Blue Cross denies making medical decisions for Sandra Lobb or any of its other 2.6 million subscribers. The company also denies responsibility for Lobb's death. Its lawyers contend that Lobb's doctor never specifically asked for residential treatment, a claim that the doctor emphatically disputes. Blue Cross lawyers are seeking dismissal of the suit, which was filed in May.

I. Steven Udvarhelyi, chief medical officer at Independence Blue Cross, said the company's medical staff does make rulings on what is "medically necessary" in some cases, such as a doctor's recommendation to hospitalize a patient or to prescribe alcohol treatment. He said those decisions are based on accepted medical standards and are made solely for the purposes of insurance coverage, not to dictate treatment.

Yet as we see below, sixty percent of appeals are resolved "in favor" of subscribers. That means that the company is wrong in its denials 60% of the time. Further, if denied, the company relates that a person can "get whatever treatment they want by paying for it themselves." (As most people cannot afford expensive care without destroying themselves financially, this reminds me a bit of the infamous "let them eat cake" line uttered by a monarch who later lost a valuable body part.) That's an insurance company's service attitude? In fact, as below, even that "right" is in question. My question is: who needs insurance companies?

Udvarhelyi said the company provides a three-tiered appeals process - improved since 1997 - for doctors or patients to challenge decisions when coverage is denied, and about 60 percent of appeals are resolved in favor of subscribers.

Further, he said, patients always can obtain treatment when coverage is denied - assuming that they are willing to pay for it themselves.

Otter contends in his suit that subscribers do not have the right to privately pay for treatment ruled medically unnecessary. The suit seeks a court order guaranteeing that right.

A 30-day stay in an alcohol rehabilitation center in the Philadelphia area would cost $7,500 to $13,500, based on current rates cited Friday by several facilities. Sandra Lobb's former husband, Frank H. Lobb 3d, of Nottingham, Chester County, said he and his three adult children volunteered to pay for that type of residential treatment themselves, but were barred from doing so by a provision in the contracts that Independence Blue Cross has with doctors and hospitals.

Finally, the statements I've bolded below are troubling. Do they represent de facto healthcare rationing based on value judgment about the likelihood of recovery from addiction and the "worth" of a human life?

... Sandra Lobb's doctor, Cecile M. Pileggi, of Chadds Ford, also considered the time ripe for treatment because the troubled woman, while in the hospital, acknowledged her drinking problem and agreed to accept treatment.

Pileggi testified in a 2003 deposition that she believed Lobb had a good chance of recovery if she received "skilled care" to stabilize her physical condition and got residential treatment for her alcoholism.

Those services were, theoretically, available under Lobb's insurance."The primary problem here was the alcohol, and that was the priority, to get the alcoholism treated," Pileggi testified.

Doctors at Independence Blue Cross ruled in early August 1997 that only "custodial care" - a service not covered by Lobb's insurance - was appropriate.

Pileggi appealed, declaring in a letter to the insurance company: "Sandra Lobb deserves more than custodial care. She will benefit from a skilled level of care."

The appeal was denied. Marie Hatam, a company medical director, replied to Pileggi in an Aug. 25 letter, saying: "The evidence presented did not establish that a skilled level of care was necessary."

Another medical director, Catherine Dratman, later testified in a deposition that coverage was denied because Lobb's prospect for improvement, based on a review of her hospital chart, seemed "poor."

Lobb was discharged from Chester County Hospital in mid-August and placed in a custodial facility in West Chester.

Two months later, she went home. Blue Cross agreed at that point to pay for an outpatient alcohol program. But after two weeks, the coverage was cut off. Company lawyers said in legal pleadings that Lobb did not appear to be "benefiting" from the program.

Lobb attempted to return to work (as a teacher) but reportedly resumed heavy drinking. She died of alcohol-related complications a little more than a year later. Very troubling, indeed.

Very troubling, indeed.

-- SS

"Awash In Information," and Without Primary Care

The NY Times just ran a prominent front-page story entitled "Awash in Information, Patients Face a Lonely, Uncertain Road."
It's basic focus is on patients forced to make their own decisions about health care in the face of conflicting information and disagreeing sub-specialists. The first vivid story it chronicles was of a patient with metastatic ovarian cancer given conflicting opinions by medical and surgical oncologists. One of the latter told her, "none of us knows what you should do. So you have to make the decision, based on your values."
The patient responded, "'I'm not a doctor!' she shouted. 'I'm a criminal defense lawyer! How am I supposed to know?'"
Furthermore,

The job of being a modern patient includes not only decision making, of course, but often coordinating doctors, medical records and procedures, as well as negotiating with insurance companies, who are often the ultimate arbiters over which treatment options will be covered.
Like many patients, Ms. Gaines did not turn to a primary care doctor to help coordinate her care or aid with decisions. Increasingly, that soul-healing doctor-patient relationship has become harder to sustain. Whipsawed by insurance plans, patients frequently switch physicians. Pressed by diminishing reimbursements, those doctors are building ever larger, more unwieldy practices, with less time for each patient.
The strain has left doctors themselves feeling exhausted, angry and heartbroken.
"My visits are almost ludicrous," said Dr. John Russo, an internist in West Orange, N.J., who sees 5,000 patients a year. "But economically you have to see so many more patients than you should, just to keep the lights on. You can't sit and talk and really get an entire history. So you do what you were taught as a resident: do more tests, don't spend more time with patients, getting to know them."

Read the whole thing. It's a vivid reminder of why having a personal, generalist physician is important, and yet that fewer and fewer patients have one.
Unfortunately, it doesn't deal very well with why this is happening:

But though that primary relationship is so fundamental for patients, the medical establishment is gradually turning away from it. The number of medical students eschewing careers in internal and family medicine and instead pursuing specialties is increasing. Among the reasons they give are the declining prestige of primary care doctors, the eroding doctor-patient relationship, the financial hardships of maintaining a practice and the drain on family life.

Maybe later the Times will get to how concentration and abuse of power in health care seems to have had a disproportionate impact on generalist physicians. One cause is probably the wooden-headed reimbursement policies of government agencies and managed care organizations we discussed previously. With any luck, the general public will notice this problem before there are no generalists left.

Addendum: See the Medical Rants take on this, "What This Patient Needs is a Doctor," here.

Protecting "Research Integrity" By Keeping "Drug Secrets?"

The latest follow-up to the stories about "selling drug secrets" has just appeared in the Seattle Times. Washington state congressman, Rep. Jay Inslee (D), has called for congressional investigation. His rationale was, "we in the Northwest have a great stake in the integrity of the biomedical-research process." Referring to reports that physicians charged consulting fees to talk about ongoing drug trials to Wall Street analysts, he said "this alleged practice violates the ethical and legal walls that needs [sic] to exist between doctors with insider knowledge about clinical drug trials [italics added] and Wall Street. We have a responsibility to protect the integrity of medical and scientific research."
This mirrors what Sen. Charles Grassely (R-Iowa) wrote, "the potential violations of the law and scientific ethics challenge the fundamental integrity of how scientific research is performed and how we proect our financial markets from manipulation."
I agree that it may have been unseemly for the scientists mentioned in the original Seattle Times series to charge large consulting fees to talk about their current research. But, OK, folks, hold the phone here. Since when does protecting "research integrity" mean preventing researchers from talking about their work?
On the contrary, it clearly is unethical to suppress the results of research done on human subjects. Let me quote Dickersin and Rennie from their article calling for registration of all clinical trials. (Dickersin K, Rennie D. Registering clinical trials. JAMA 2003; 290: 516-523.)

Patients who agree to participate in clinical research do so with the understanding that they are contributing to medical knowledge. If the knowledge gained in a trial is never communicated to others, then their contribution is unrealized and the covenant between researcher and patient, indeed, between ethical review boards and patients, is broken.
A crucial question is whether the distortion of available evidence, aside from being unethical, actually harms patients. There is evidence that it does.

If it is unethical to suppress "knowledge gained in a trial," how can one ethically suppress even preliminary, informal conversation about a clinical trial (setting aside whether someone is paid for having such a conversation)?
Part of the issue here is the curious double-standard we now seem to have for research funded by commercial sponsors, as opposed to that funded by government agencies and charitable foundations (see previous post here). Somehow, it seems to have become acceptable to silence researchers who perform research on human subjects but with commercial funding. Amazingly, this censorship is now being done in the guise of "protecting research integrity."
Maybe Congress should be investigating how much the physicians charged the Wall Street analysts to talk about their research. But what they really should be investigating are the confidentiality agreements that commercial research sponsors foisted on universities, academic medical centers, and by extension, the researchers who work for them.
However, if we let suppressing discussion of commercially funded clinical research become acceptable under the guise of protecting "trade secrets," woe to us and our patients.

Legislation That Made Government-, But Not Industry Funded Research Easier to Challenge

A new article in the American Journal of Public Health showed that industry's priorities may adversely shape legislation affecting how science, including biomedical and health care science gets done. (Requires subscription, full citation is: Baba A, Cook DM, McGarity TO, Bero LA. Legislating "sound science": the role of the tobacco industry. Am J Pub Health 2005; 95: S20-S27.)
Using documents revealed by litigation, the article narrates the history of the tobacco industry's influence the enactment and operation of legislation about government-funded science. The relevant legislation was:

• The 1999 Omnibus Appropriations Act contained a provision that made all the raw data obtained in all government funded research projects available to anyone.
• An amendment added to the 2001 Omnibus Appropriations Act required the Office of Management and Budget to develop government-wide standards for data quality, including "objectivity of presentation" and "objectivity of substance." The latter required that any data disseminated by the government meet quality standards, and that "influential data," which is "scientific, financial, or statistical information that will have or does have a clear and substantial impact on important public policies or private sector decisions" must be reproducibe upon reanalysis by "qualified third parties."

The article described the Philip Morris "'sound science' public relations campaign [designed] to create controversy regarding evidence that environmental toxins [e.g., second-hand smoke] cause disease." The company allegedly developed a complex legislative strategy to address "contested interpretation of underlying data in published studies." However, the company made every effort to "remain in the background" while its strategy was implemented. Once Congress enacted the above legislation, whose provisions about scientific data never were subject to committee hearings or public discussion, Philip Morris engaged a high-powered consulting firm to "work with federal agencies to encourage implementation." The article also alleges that Philip Morris, through this consulting firms, "contributed to the language of the model data quality guidelines."
Since the enactment of the legislation, "corporate interests have initiated the vast majority of data quality act challenges." Furthermore, some have charged that new "peer review" guidelines proposed by the Office of Management and Budget "politicizes science by giving the White House unregulated power to expedite or delay the release of scientific information."
The importance of all this was outlined by author Lisa Bero in an accompanying news release. Of particular importance is that the legislation and accompanying guidelines and rules make it very easy for outside parties, including large organizations with specific financial interests, to challenge government-sponsored research. Privately sponsored research, including, obviously, research sponsored by these same parties, however, is not affected by the legislation and not open to such challenges. As Bero put it, "if we are going to have laws that force greater scrutiny on research related to public health, they should apply to industry-funded research at least as much as to government-funded research." As an example, she noted that most of the recent controversy about the US Food and Drug Administration (FDA) focused on "bad government science." But there should be equal focus on "bad industry science." She summed it up thus,

What is really ironic is that the data quality law applies only to government-sponsored research (such as NIH research), but not industry-funded research. So, industry-funded research does not have to adhere to the standards. This is particularly relevant with all the transgressions we've seen lately related to the quality or failure to publish industry science. The public health community cannot use the data quality law to challenge industry science.

In my humble opinion, her concerns make sense.

Wooden-Headed Health Care Reimbursement

The physicians whom I interviewed for my article on health care dysfunction(1) frequently spoke about perverse financial incentives, particularly those favoring high-technology and invasive procedures, and disfavoring primary care and general acute care. An example I cited in the article was that device manufacturers could get away with charging $1500 for a bare metal coronary artery stent, which resembles a small stainless steel spring or mesh cylinder, even though its manufacturing cost cannot be as much as $1.
When the physicians I interviewed formed the nucleus of an email list, one of the frequent topics of conversation was also the worsening contrast between lavish reimbursement for again, high-technology and invasive procedures and penny-pinching for primary care. The Health Care Renewal blog has provided some vivid examples of this contrast. Some recent ones were:

• Implantable cardiac devices, specifically pacemakers and implantable cardiac defibrillators (ICDs), remain very expensive (about $25,000 for the latter), despite progressing technology that ought to bring down manufacturing costs, and evidence that the quality of the manufactured devices has been lacking (see post here and the links in it.)
• Cancer drug pricing continues to increase rapidly without any obvious basis in the costs needed to produce the drugs. One particular example is thalidomide, a drug that costs $25,000 a year, even though it was first developed in the 1950's and available as a generic in South America. (See post here.)
• Cardiac drug pricing also continues to soar. One particular example is BilDil, a combination product of two drugs that are both at least 40 years old, but which is now being aggressively promoted with a racial angle. (See post here.)
• Hospitals charges for routine services often exceed superficially rational limits. For example, hospitals may charge thousands for individual physical therapy sessions (see post here). In at least one instance, UnitedHealth, whose stated mission is to "make health care more affordable (while paying its top executives hunders of millions, see post here), was willing to reimburse a hospital $1275 for a single physical therapy session, for which physical therapy experts would charge, at most, $200. (see post here).
• Diagnostic technology reimbursement has increased far faster than any reasonable costs estimates. For example, from 1974 to 2004, inflation was over 300%, the (unadjusted) cost of CT scanners has gone up over 400%, but Medicare reimbursement for a head CT scan has gone up over 700%! (See post here.)

However, up to now, there has been very little discussion in the medical, health care research, and health policy literature of pricing discrepancies between different kinds of health care services.
Thus, a new commentary now available on-line in Health Affairs is very significant (link here)(2) The article was based on analysis of limited financial data, and interviews with a variety of people in government and industry. (Note that the article did not deal with charges for pharmaceuticals and devices, which sometimes are reimbursed as part of physicians or hospital services, but sometimes are reimbursed separately. It also did not deal with the prices physicians and hospitals pay for goods and services.)
Its main points , written in a very understated academic style, were:

• There are major discrepancies in reimbursements provided for different kinds of health services -"Unintended relative overpayment of some services and the relative underpayment of other services, in combination with other market factors, is driving increased use of expensive care, which in turn could become an important driver of health care cost trends."
• These discrepancies "do not accurately reflect the relative costs of providing different services" - and thus create large differences in profitability among different services.
• Much of Medicare's reimbursement rates are based on charges, not on any assessments of the costs of providing the services - In particular, Medicare's system for reimbursing hospitals, which uses diagnosis related groups (DRGs), bases its reimbursement rates on what hospitals charge, not on any assessment of the costs of providing services.
• When Medicare reimburses based on cost estimates, these estimates are very old - The relative value based system used to reimburse physicians is based on data from the mid-1980s. Although the amounts paid have been adjusted for inflation, the underlying cost estimates have not been rechecked in more than 20 years.
• Managed care, when its reimbursements differ from those of Medicare, is content to simply discount what providers charge - "Private payers, despite not placing a priority on more accurate payment measures, often follow Medicare payment policies...." "Many private payers pay negotiated per diem rates for a large portion of inpatient care, and these per diems are typically adjusted for high-cost or 'outlier' cases based on charges for those admissions. In addition, some inpatient care and much outpatient care other than for physician services are paid for on the basis of negotiated discounts from provider charges. Plans are mostly likely to use prospective payment methods besides negotiated per diems or discounted charges for hospital-based surgical procedures, emergency department visits, and laboratory and imaging services provided outside the hospital. In developing these payment systems, private plans also typically rely on charge data to set relative values."
• Updates to reimbursements again rely on charges, not cost assessments - "Respondents stated that they focus primarily on controlling upward trends in aggregate payments and rarely gather market information to identify and adjust payments for specific services that are paid too much or too little."
• These policies favor reimbursement for high-technology - "A likely result of these practices is that charges for services with the most rapidly advancing technology tend over time to have the highest markups over cost."

The authors did not address why organizations whose main purpose is to pay for health care services have seemed uninterested in the prices they are charged, only noting "historically, a political constituency to drive improvements in payment mechanisms has been lacking."
Now, let's see. The rising cost of health care has been a major national (and international) issue for at least 20 years. Health care has become a trillion dollar business, and health care costs have been rising at double-digit rates, much faster inflation, for longer than most people can remember. Medicare, the US national single-payer system for the elderly and disabled, has been focussed on cost-cutting since then. The major rationale for the rise of managed care was to deal with increasing costs. And yet these organizations have paid very little attention to what services actually cost when making reimbursements. What is wrong with this picture?

In The March of Folly, historian Barabara Tuchman described how the amazing wooden-headedness of political leaders lead to huge disasters. I cannot think of a more charitable way to described how Medicare officials and managed care organization executives decided to pay for health care than as wooden-headed. Given that controlling health care costs is a central component of managed care organizations' missions, making reimbursement decisions without any effort to determine what health care services actually cost suggests something much worse than wooden-headedness on the part of managed care leaders.

Ginsburg and Grossman have noted that the emperor has no clothes. Its too bad that, as they wrote, "The United States has probably lost a decade in addressing these payment problems." We need to start addressing them no, with a vengeance. This will require health care researchers pulling their heads out of the sand, aggressive investigative reportings, and big-league conggressional inquiries.

And if we don't do something soon about this metastatic, malignant wooden-headedness, our foolish and irrational payment policies will probably drive primary care, general medicine, and general hospital acute care right out of business.

References
1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14: 123-130.
2. Ginsburg PB, Grossman JM. When the price isn't right: how inadvertant payment incentives drive medical care. Health Affairs 2005.

A Murky Research Tale

The Seattle Times series that alleged physician researchers were leaking "drug secrets" to Wall Street (see post here) has already had repercussions. US Senator Charles Grassley (R- Iowa), head of the Senate Finance Committee, is already calling for a Securities and Exchange Commission (SEC) investigations, saying "Selling drug secrets violates a trust that is fundamental to the integrity of both scientific research and our financial markets," as reported again by the Seattle Times.
Yet although I acknowledge that the behavior of the physician researchers described in the Seattle Times series does not look too pretty, I contend that this story may be a bit murkier than it first seemed. Some additional questions to consider are:

• Were There Really "Drug Secrets?" - I previously posted about a New England Journal of Medicine article that described how medical school administrators entered into research contracts with commercial research sponsors. Half or more of schools permitted contracts that allowed the commercial research sponsor to "own" the data and to control of the writing of articles describing the research findings; and required the school to keep research results and the provisions of the research contract itself confidential. Such contracts appeared to be in conflict with medical schools' scientific and humanitarian mission. In particular, allowing research sponsors to suppress research results violates the implicit promises made to research subjects that their data will advance science. Thus, clinical research on humans ought not to produce any "drug secrets." Whether researchers who work for schools which agreed to these contracts ought to be bound to keep such "drug secrets" is unclear. Whether it is unethical to violate these contracts' confidentiality agreements is similarly unclear. Although disclosing research data to investment analysts does not give the physician researchers the moral high ground, establishing the confidentiality agreements within the contract does not give the research sponsors or the medical schools any moral high ground either.
• Of What Value is the Information Revealed by the Physicians? - The physicians in the Seattle Times series generally claimed that the information they revealed included general impressions of how the research project was going, and their "gut feelings" about which drugs involved in the comparisons was likely to be better. Consideration of some principles of evidence-based medicine suggest that this information is unlikely to accurately to predict the results of the clinical trials: 1) Double-blinding should have prevented the physicians from telling which patients got which drug. 2) In multi-center trials, results from one center may not predict results from the whole trial. 3) In long-term trials, short-term results may not predict final results. Although the stock analysts cited by the Seattle Times claimed that they could predict trial results based on the information revealed to them, they supplied only anecdotal data about their performance. In fact, their predictions may have been no better than chance alone. So the Wall Street analysts had no claim to the moral high ground either.

Although I cannot strongly defend the conduct of the physicians recounted by the Seattle Times, it would be far too simplistic to interpret it as yet another tale about greedy doctors. Rather, it should provoke us to re-think how we currently fund and practice clinical research.

Medical ethics tunneling through earth's mantle, heading straight for the core

In the Seattle Times yesterday, I was quite literally stunned to see the article "Drug researchers leak secrets to Wall Street".

This story represents the culmination of an ever-increasing fall in medical ethics, replaced by moral relativity and rationalizations for the inexcusable. Medical ethics are tunneling through earth's mantle, and heading straight for the core (and perhaps out the other side).

I recall in medical school in the late 1970's that ethicist George Annas taught my class (Boston University School of Medicine class of 1981) that only bad consequences would come from concentrating on money; that income would take care of itself and our primary concern should be the patient. At the time, I dismissed this as socialist prattle, thinking my colleagues and I would know better than to be corrupted by temptation. Ah, the days of youth and idealism....

At Merck & Co., Inc., corporate ethics called for "avoiding impropriety or even the appearance of impropriety", and to follow both the letter and the spirit of the law, making decisions regarding "gray areas" by the "acid test" of what we would be comfortable with in print or other public media. Those were wise words indeed ...


Assuming this is true, here are the issues as I see them:

(1) Today, it seems many physician-scientists' concerns regarding impropriety (or even the appearance of impropriety) can be alleviated by a green substance administered in non-homeopathic doses. This green substance is certainly not listed in The Merck Index, the (not-for-profit) encyclopedia of medicinal chemistry whose authors I once managed, except perhaps on a sticker bookstores might place on the cover page.

(2) Statements that selling information about drugs undergoing clinical trials to high-paying speculators (e.g., hedge funds) "serves a clinical purpose" is a rationalization for lining ones' pockets.

(3) When the clinician has signed a confidentiality agreement, then by even talking to major investment companies, they are literally dancing on the precipice of impropriety. It does not take much for some to push them over the edge. If the organization where the clinician works has signed the confidentiality contract, the issue is murkier; however, that "appearance of impropriety" problem rears its head very hard at $5,000+ per day of chats to investors. (The public may think the term 'bribe' is a more accurate term for this level of compensation. Merriam-Webster definition: 1. money or favor given or promised in order to influence the judgment or conduct of a person in a position of trust; 2. something that serves to induce or influence.)

Of note, the honorarium for, say, critical scientific evaluation of incoming grant proposals at NIH (which is actually hard work) is something like two hundred dollars for an 8-hour working day. Clinicians should approach talking to investor and speculator groups for high dollars with the utmost of caution. Personally, I'd avoid it like the plague, but that's my own opinion.

(4) While the information "sold" by clinicians might reflect their isolated opinion(s) on a drug undergoing testing, and might lead investors in the wrong direction as easily as the right direction, there is the possibility - especially in clinical trials going very well or going very poorly - that an additive effect could give private investors (a.k.a. privileged speculators) an edge. By doing so, the sellers of the information are giving those investors a potential advantage over the common (a.k.a. non-wealthy and non-connected) investor that is destructive to truly free markets. This hurts us all. Justifications that such information "might have little likelihood of being correct" are ethically irrelevant if the information is deemed confidential by contract. To use a somewhat extreme example, it does not justify shooting at passers-by to one's home by saying that "my aim is so poor that I'm unlikely to hit anyone."

When the clinician-salesperson actually has direct access to priviliged RCT information such as blinding, adverse events, or partial results, the transgression of ethics is ever more egregious.

(5) Where there's smoke, there's fire. Just how widespread are these practices?

(6) The statement that "drug company executives know about the practice but can't crack down on the doctors they rely upon for conducting patient testing" makes one wonder if the real situation is that pharma "won't crack down", i.e., it makes one wonder if a quid pro quo contaminates clinical trials. You do the trials, we look the other way whenever you get lucrative opportunities to 'talk to investors' [for $500/hr or $5000/day].

(7) This possibility also raises the question -- on what other issues in the conduct of clinical trials do pharma companies "look the other way?"

(8) Such activities further harm public confidence in clinical researchers and the pharmaceutical industry (assuming public opinion could go much lower).

(9) If as this article claims there are "60,000 doctors" engaged in this process, that represents a pretty high percentage of doctors involved in clinical trials. It also represents a significant % of doctors in practice in the U.S. That is very, very disconcerting regarding the effects of the commercialization of medicine.

(10) Ultimately, a lot of people pay for stock market fraud either directly or indirectly. This is not a "no-victim" or "it just hurts the rich" problem by any means.

(11) Claims that clinicians "were hounded" by investment companies for information are not going to be received well by the Vioxx, Fen-Phen etc.-tarred public as an excuse for giving in and taking fees-for-information. I used to get calls soliciting me for information of one type or another at Merck. My simple response: "sorry, can't talk, company confidential, good bye."

(12) Claims that a clinician doesn't know how the information they sell will be used or care about it strike me as cavalier. The public will not react well to such attitudes.

I've now listed twelve thoughts on this issue. I can think of others, but I think my point is made: physicians are selling out to speculators for high 'fees' that would be construed by many as bribery.

Medicine needs a strong dose of what Dr. Annas prescribed so many years ago to a class of very idealistic medical students.

-- SS

Seattle Times investigation found at least 26 cases in which doctors have leaked confidential and critical details of their ongoing drug research to Wall Street firms.

The practice involves doctors at top research universities from UCLA to the University of Pennsylvania, and powerful financial firms including Citigroup Smith Barney, UBS and Wachovia Securities.

In 24 of the 26 cases, the firms issued reports to select clients with detailed information obtained from doctors involved in confidential studies. The reports advised clients whether to buy or sell a drug stock.
... Until now, the selling of drug secrets has been hidden from securities regulators and the public, but biotech and Wall Street insiders said the practice is widespread. "Everybody does this.... It's now common practice," said the chief executive of California biotech company Valentis, Ben McGraw, a former Wall Street analyst.

... The practice of selling drug secrets, The Times found, is being driven by hedge funds, the largely unregulated investment pools that cater to the super-rich. Hedge funds can make money with aggressive strategies that exploit quick price swings in stocks, and the volatile biotech industry provides many such opportunities.
... Matchmakers typically pay doctors $300 to $500 an hour to talk to elite investors. Some doctors said they can make tens of thousands of dollars a year from such talks. [is 'bribe' a better term for these payments? The public may think so -- SS]

... Such information is so valuable that elite investors pay up to $1 million a year to firms known as matchmakers, which pair Wall Street firms with doctors involved in ongoing drug research. Gerson Lehrman Group, the largest matchmaker, claims to have 60,000 doctors available to speak to Wall Street, double the number from three years earlier.

How the FDA Hid Data About Failures of Guidant's Devices Under the Cloak of "Trade Secrets"

The New York Times has produced yet more revalations about how data about Guidant's implantable cardiac defibrillators (ICDs) has been witheld. A reporter asked the US Food and Drug Administation (FDA) for results of the reports Guidant has been sending annually about device failures. According to the Times, "under little-known FDA regulations, the makers of defibrillators and pacemakers must provide detailed data each year to the agency, including the frequency of failure in individual models, the cause of such failures and the number of deaths and injuries."
But in response to the Times' inquiry, an "agency official," Joy B. Lazaroff, said "this information is a trade secret and exempt from release."
A Guidant spokesperson, Steven Tragash, "declined to respond to written questions on the frequency of the risk assessments of the Prizm 2 DR [a model of an ICD]...." Furthermore, Mr. Tragash would not let the CEO of Guidant, Ronald W. Dollens, submit to an interview on the topic.
I can't comment on the legal aspects of this case, but surely from a policy perspective, the FDA, which is charged with protecting US citizens' health and safety, should not be hiding data on potentially life-threatening failures of cardiac devices as "trade secrets."
The Times editorial staff apparently now also agrees that the Guidant issue is an important one. On Sunday, a Times editorial entitled "When a Heart Device Short-Circuits," based on the Guidant case, called for improved regulation of medical devices.