Who Investigated the Case of the Deadly Contaminated Heparin?

A year and a half ago, we posted quite a bit about the case of the deadly contaminated heparin. In retrospect, what is most amazing is how quickly this case fell off the radar screen.

Summary of the Case of the Deadly Contaminated Heparin

Here is a summary:

- We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
- Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."
- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)

Since we last posted about the case, three prominent articles by one research group appeared that addressed how contamination of the heparin with oversulfated chondroitin sulfate lead to adverse reactions, some fatal (1-3). An editorial in the New England Journal of Medicine congratulated all the scientists on quickly figuring out the nature of the problem, "allowing heparin to come clean," but did not comment on what the case might mean for drug regulation, or the leadership of health care organizations.(4) The case was used to illustrate the difficulties of national regulation of an increasingly out-sourced pharmaceutical industry.(5) Dr Jerry Avorn did call for more effective, better funded and up to date pharmaceutical regulation.(6)

At the time, I thought that the most striking feature of this case, beyond the deaths of many real patients, was how every leader involved tried to dodge accountability for it. Now, in August, 2009, I have been unable to discover whether any of them subsequently took accountability for it. And in this post global financial collapse world, I would now add that the case also exemplifies the adverse effects of the single-minded pursuit of short-term profit and economic efficiency.

However, in retrospect, the most distressing aspect of this case is its lack of repercussions, specifically, the lack of any inquiry into how the oversulfated chondroitin sulfate got into the supposedly pure heparin given to patients, and how such adulteration of pharmaceuticals could be prevented in the future.

Allegations of Conflicts of Interest Affecting the Scientific Investigation of the Case

This week, however, the case has an eerie echo. The Wall Street Journal just reported allegations that the US FDA official involved in the case has conflicts of interest.

The investigation of Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.

Amphastar contends that Dr. Woodcock's collaboration with Momenta is a conflict of interest and has asked that she recuse herself from the entire matter at the FDA.

Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA. Amphastar applied in 2003, two years before Momenta.

Lovenox, a low-molecular-weight heparin, is a blockbuster biologic drug that brought in $3.5 billion in world-wide sales last year.

The specific allegations were:

Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta's founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts were their attendance at an international medical conference in Thailand in November 2007.

Mainly, however, Amphastar points to Dr. Sasisekharan's appointment to lead an FDA task force in early 2008, which put him and Momenta in regular contact with the agency. That task force was investigating tainted Chinese-made heparin, a crisis that led to nearly 100 deaths.

Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific -- as well as Wall Street -- kudos for Momenta.

It is unusual for FDA officials to co-author journal articles with industry researchers....

In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta's FDA connection as a 'game-changer,' and Momenta's stock jumped 17% in a day.

So, Dr Woodstock arranged for the scientific investigation of the contaminated heparin to be carried out mainly by people employed by or with financial relationships with Momenta Pharmaceuticals. The (actually three) articles published as a result of this investigation (1-3), disclosed most of these relationships, but seemed to minimize the relationship of the senior author of all three articles, Dr Ram Sasiskekharan, to the company. Although he was actually a co-founder of the company, and has been on the board of directors of the company since 2001,
none of the articles mentioned the former relationship, and only one specifically mentioned the latter. Although the two New England Journal of Medicine articles referred to Momenta Pharmaceuticals' abilities to analyze "complex mixtures, including heparin," none mentioned that the company is developing two anticoagulant products, M-enoxaparin and M118, which could compete with heparin (as described in the company's investor relationships web-page).

On the other hand, the Nature Biotech article(3) noted that Dr Sasiskekharan and one other author have "served as scientific advisors to Scientific Protein Laboratories," and a third author was a scientific advisor to Baxter International. The relationship between Dr Sasiskekharan and SPL was noted by two of the New England Journal articles(1-2).

Questions Raised

So the complaint about Dr Woodcock by Amphastar raises multiple questions about the investigation of the case of the deadly contaminated heparin.

• Why did the FDA put the scientific investigation of Baxter International/ Scientific Protein Laboratories / Changzhou SPL contaminated heparin in the hands of multiple employees, and the co-founder and board member of Momenta Pharmaceuticals, a company that applied to market a product to compete with heparin?
• Was the nature of this apparent conflict clear to the federal agencies that also funded the investigation, which included the National Institutes of Health (NIH) and the Centers for Disease Control (CDC)?
• Did the federal agencies involved also realize that several of the investigators, including the apparent senior investigator, also had ties to two companies (Baxter International and Scientific Protein Laboratories) involved in the production of the contaminated heparin?
• If the federal agencies did not know of the conflicts, why not? And what will they do about them now?
• If the federal agencies did know of all the conflicts, why did they allow such a conflicted group of scientists to investigate one of the most important cases of drug adulteration of the new century?

Although there has now been a scientific investigation into the nature of the contamination of the deadly heparin, there has not been any formal inquiry of which I am aware into the actions, decisions and events that allowed the case to unfold. Now that the case seems to involve not only questionable business management decisions, but also a conflicted scientific investigation, maybe someone in authority will see to it that such an investigation occurs.

Finally, the case of the deadly contaminated heparin now becomes another illustration of how the complex web of conflicts of interest that pervades our health care system may muddle efforts to protect the public from adulterated medicines, one of the more fundamental public health responsibilities of the government.

Hat tip to and see further comments by Prof Margaret Soltan in the University Diaries blog.

References

1. Kishimoto TK, Viswanathan K, Ganguly T, Elankumaran S, Smith S, Pelzer K et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med 2008; 358: 2457-67. [Link here.]
2. Blossom DB, Kallen AJ, Patel PR, Elward A, Robinson L, Gao G et al. Outbreak of adverse reactions associated with contaminated heparin. N Engl J Med 2008; 359: 2674-84. [Link here.]
3. Guerrini M, Becaati D, Shriver Z, Naggi A, Viswanathan K, Bisio A et al. Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events. Nature Biotech 2008; 26: 669-675. [Link here.]
4. Schwartz LB. Heparin comes clean. N Engl J Med 2008; 358: 2505-9. [Link here.]
5. Schweitzer SO. Trying times at the FDA - the challenge of ensuring the safety of imported pharmaceuticals. N Engl J Med 2008; 358: 1773-7. [Link here.]
6. Avorn J. Coagulation and adulteration - building on science and policy lessons from 1905. N Engl J Med 2008; 358: 2429-31. [Link here.]

Whose Voices do US Congresspeople Hear on Health Care Reform?

Earlier today, we posted about the final version of the settlement of lawsuits against the global health care insurance company/ managed care organization, UnitedHealth Group. The lawsuits charged that the company had deceptively backdated stock options given to its former CEO.

We previously wondered whether the tawdry leadership exemplified by this backdated stock option scandal had lead to UnitedHealth's reputation for patient-, employer-, or physician-unfriendliness. For example,

• as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
• UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
• UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
• UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
• UnitedHealth frequently violated Nebraska insurance laws (see post here);
• UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).

One would think that such a reputation would decrease the company's influence on health policy. However, last week, Business Week reported that UnitedHealth has developed a powerful voice on health care reform in the US.

As the health reform fight shifts this month from a vacationing Washington to congressional districts and local airwaves around the country, much more of the battle than most people realize is already over. The likely victors are insurance giants such as UnitedHealth Group (UNH), Aetna (AET), and WellPoint (WLP). The carriers have succeeded in redefining the terms of the reform debate to such a degree that no matter what specifics emerge in the voluminous bill Congress may send to President Obama this fall, the insurance industry will emerge more profitable.

The industry has already accomplished its main goal of at least curbing, and maybe blocking altogether, any new publicly administered insurance program that could grab market share from the corporations that dominate the business. UnitedHealth has distinguished itself by more deftly and aggressively feeding sophisticated pricing and actuarial data to information-starved congressional staff members. With its rivals, the carrier has also achieved a secondary aim of constraining the new benefits that will become available to tens of millions of people who are currently uninsured. That will make the new customers more lucrative to the industry.

UnitedHealth has managed to cozy up to many pivotal congresspeople, like Representative Jim Matheson.

Impressing fiscally conservative Democrats like [Jim] Matheson, a leader of the House of Representatives' Blue Dog Coalition, is at the heart of UnitedHealth's strategy. It boils down to ensuring that whatever overhaul Congress passes this year will help rather than hurt huge insurance companies.

Matheson, whose Blue Dogs command 52 votes in the House, can't offer enough praise for UnitedHealth, the largest company of its kind. 'The tried and true message of their advocacy,' he says, 'is making sure the information they provide is accurate and considered.'

Also, Representative Mike Ross,

an Arkansas Democrat who leads the Blue Dogs' negotiations on health reform, also welcomes input from UnitedHealth. 'If United has something to offer on cutting costs, we should consider it,' says Ross, a former small-town pharmacy owner. 'We need more examples that work, and everything should be on the table.'

Not to mention Senator Mark R Warner (D- Virginia),

UnitedHealth's relationship with Democratic Senator Mark R. Warner of Virginia illustrates the industry's subtle role. Elected last fall, Warner, a former governor of his state and a wealthy ex-businessman, received a choice assignment as the Senate Democrats' liaison to business. The rookie senator landed in the center of a high-visibility political drama—and in a position to earn the gratitude of a health insurance industry that has donated more than $19 million to federal candidates since 2007, 56% of which has gone to Democrats.

UnitedHealth has periodically served as a valuable extension of Warner's office, providing research and analysis to support his initiatives. Corporations and trade groups play this role in all kinds of contexts, but few do it with the effectiveness of the insurers. In June, Warner introduced legislation expanding government-backed Medicare and Medicaid coverage for hospice stays for the terminally ill and other treatment in life's final stages. The issue isn't a top UnitedHealth priority. But the corporation wanted to help Warner with his argument that in the long run, better hospice coverage would save money. UnitedHealth prepared a report for lawmakers finding that 27% of Medicare's budget is now spent during the last year of older patients' lives, often on questionable hospital tests and procedures. Expanded hospice coverage and other services could save $18 billion over 10 years, UnitedHealth asserted.

When Warner went to the Senate floor on June 15 to offer his bill, he cited those exact figures. He thanked the company for its support and put a letter from UnitedHealth applauding him in the Congressional Record.

Warner acknowledges in an interview that he worked on the hospice-care legislation with UnitedHealth executives. But he stresses that he has long experience with health issues and has formed his own views. The senator echoes UnitedHealth's contention that a so-called public option could be a 'Trojan horse for a single-payer system,' meaning government-run medical care. Warner has heard from some of UnitedHealth's largest employer clients, such as Delta Air Lines (SWY). Delta CEO Richard H. Anderson, a former UnitedHealth executive, has told Warner and other lawmakers that big companies don't want government to limit their flexibility in crafting employee health benefits.

Despite the fact that UnitedHealth subsidiary Ingenix just settled lawsuits alleging it had manipulated data, legislative leaders have come to rely on data it produced,

Warner and other opponents of a public plan have relied on an estimate by John Sheils, an actuary who says that 88 million people, or 56% of those with employer-provided coverage, would desert private insurance for a government-run program. That would destabilize the marketplace and potentially kill the private insurance industry, according to Sheils, who works for the Lewin Group, a corporate consulting firm in Falls Church, Va.

UnitedHealth lobbyists routinely cite Lewin's work, as do Senator Orrin G. Hatch (R-Utah), the second-ranking Republican on the Senate Finance Committee, and Eric Cantor (R-Va.), the House Republican Whip. Left out of these testimonials or buried in the fine print is that a UnitedHealth unit owns the Lewin Group and thus is ultimately responsible for Sheils' paycheck. In an interview, Sheils says UnitedHealth gives him and the Lewin firm complete independence: "We call it like we see it," he adds.

Why UnitedHealth wields such influence despite the numerous questions raised above about its leadership and ethics remains a mystery.

However, the clout of UnitedHealth and other large health care organizations with questionable leadership and ethics over US health care policy certainly explains why almost nobody talks about restraining concentration and abuse of power, or improving health care organizations' leadership and governance as parts of health care reform.

However, on Health Care Renewal, we have shown numerous examples of unrepresentative, unaccountable, opaque and ethically unconstrained governance of health care organizations. Such governance enables ill-informed, incompetent, conflicted, or even corrupt leadership. Such leadership may use tactics including deception, dishonesty and disinformation; intimidation and coercion; creation of perverse incentives; development of conflicts of interest; and outright fraud and corruption. We believe these are major causes of increasing costs, worsening access, declining quality, and demoralized health care professionals. (See our archives for numerous examples.)

As long as the foxes advise and influence the hen house guards, the likelihood of health care reform that will actually improve health and health care remains low.

Are EMR's More Secure and Trustworthy Than Paper Records?

Contrary to utopian praise of EMR's as more secure than paper records:

Routine complication from surgery turns fatal
Lance Williams, Chronicle Staff Writer
Monday, August 10, 2009

A hospital patient suffers excruciating pain from what turns out to be a routine complication from elective surgery.

As her condition deteriorates, she and her family plead to see the doctor. But no doctor examines her until the next morning, when she goes into shock, is rushed into intensive care and dies.

Then, after her death, the hospital deletes portions of the woman's medical file in what the woman's family says is an attempt to cover up its horrendous mistakes.

Is this possible? Read on:

The allegations, contained in a lawsuit filed in Santa Clara County Superior Court, describe events that seemingly could occur only at an institution that provides medical care at its worst. Instead, the claims concern a 2007 fatality at what is regarded as one of the best hospitals on the West Coast - Stanford University Medical Center in Palo Alto.

The case of Diane Stewart, 70, who died of a bowel obstruction after knee replacement surgery, shows that bad mistakes and worst-case outcomes are possible even at world-renowned hospitals, said her family's lawyer, Christopher Dolan of San Francisco.

Medical errors occur because "we have corporatized medicine and marginalized the professional's role," Dolan said. "We took the same principles used in automation, to do the job cheaper and faster, and applied it to medicine."

Healthcare IT notwithstanding, I believe those observations are accurate. However, a more serious issue is the role of HIT in marginalizing the medical professional with respect to the IT professional, in what I've called (in this blog and elsewhere) a cross-occupational invasion of medicine by the IT profession.

"I believe Stanford is making a concerted effort to obstruct our family from learning the truth about what happened to our mom," he wrote in a complaint to the state Medical Board. In 2008, investigators from the state Department of Public Health found that "relevant" portions of Diane Stewart's computer file had been deleted after her death and that a supervisor instructed a nurse to make postmortem "late entries" to describe her care.

This may be a case where the CIO and other IT leaders need to be called to the stand to testify, possibly on criminal charges, since some cooperation from such personnel would be required if there is merit to allegations of post-death EMR alterations/erasures.

In a written statement, the hospital said that only temporary notes that were never intended to become part of Diane Stewart's permanent record had been discarded.

Never intended to become part of her medical record?

This "Watergate 18 minute gap"-reminiscent explanation raises a number of questions:

• How did these "Temporary Notes" come to be discarded?
• What was temporary about them?
  
• Does Stanford's EHR have a "Discard Temporary Notes" button?
• What authority and authentication is required in order for "Temporary Notes" to be discarded?
• What is Stanford's definition of a "Temporary Note" in an EHR?
• What might such notes contain?
• Who might they have been written by, and for what purpose(s)?
  
• If they involve decisions made in healthcare, why are they considered "temporary?"
• Are there notes made in a paper record that are considered "temporary" that can legitimately be discarded after a suspicious patient death?
• Are there backups that contain these notes, or were they erased too?
• Was such backup erasure initiated manually (e.g., by a human) or automatically?

Since these notes were discarded (erased), of course, we may never know what they contained.

Electronic records leave no erasure marks, and with collusion of the appropriate personnel, reality can be whatever one wants it to be in the electronic world. This represents yet another sociotechnical obstacle standing in the way of achieving a computer-based utopia in healthcare.

-- SS

Final Settlement of UnitedHealth Backdating Case

Last year, we discussed a preliminary settlement of allegations against the leadership of one of the US (and the world's) biggest health care insurance companies/ managed care organization. Now the settlement appears final, as reported by the AP (and published in the NY Times),

UnitedHealth Group Inc. moved closer to finally putting its stock options backdating problems behind it Tuesday, when a federal judge approved a class-action settlement of more than $925 million.

Minnetonka, Minn.-based UnitedHealth will pay $895 million toward a settlement for shareholders. Former Chairman and CEO William McGuire contributes $30 million and cancels 3.6 million stock options.

The insurer's former general counsel, David J. Lubben, will pay $500,000.

The parties first agreed to this settlement more than a year ago, and U.S. District Court Judge James M. Rosenbaum granted preliminary approval in December. He then approved it in an order filed Tuesday.

The settlement is one of the largest involving options backdating cases if not the largest, said Peter Henning, a law professor at Wayne State University in Detroit.

The lawsuit centered on a scandal over stock options backdating that forced McGuire to step down from both roles in 2006.

The litigation claimed investors were hurt because UnitedHealth and McGuire didn't really grant stock options when they said they did in the late 1990s and early 2000s.

Backdating involves manipulating the timing of options grants so they look as though they were made on days when the stock's value was lower. Doing this can boost a recipients' windfall when they sell the stock.

The practice is not illegal if it is properly disclosed. But concealing it can hide the true costs a company incurred, inflating its profits and possibly its stock price.

UnitedHealth wiped out more than $1.5 billion in past profits when it acknowledged that it backdated stock options.

This was the second approval granted this summer for a large settlement involving UnitedHealth stock options. Last month, Rosenbaum also approved the resolution of a derivatives case that pitted UnitedHealth shareholders against McGuire and several other company executives.

The shareholders had accused the executives of failing to fulfill their fiduciary duties by allowing the backdating. They recovered mostly options and cash for the company.

Court papers put the value of that settlement, which also was approved by a Minnesota state judge, at around $718 million in January.

Note that this year we discussed a settlement made by UnitedHealth's Ingenix subsidiary.

Here on Health Care Renewal, we discuss problems afflicting the leadership and governance of health care organizations. So, we have discussed a seemingly endless parade of legal settlements of allegations of unethical behavior by health care leaders, and even outright criminal behavior. These cases suggest that the leadership culture of many health care organizations accepts unethical, and sometimes even criminal behavior, at least as long as their leaders bring in money in the short-term. Yet shouldn't health care organizations, which are supposedly about helping patients, improving health, preventing disease, etc, be held to a higher standard of ethics than, for example, garbage hauling firms? The parade of stories about misbehavior among health care leaders suggest that some of their organizations do not even rise to the ethical standards of trash haulers.

Further, it is reasonable to hypothesize that unethical and at times criminal leadership is bad for health care, bad for patients, and bad for the public health. It likely is an important cause of rising health care costs, declining health care access, and poor health care quality.

However, despite the ongoing storm of discussion and opinion about health care reform here in the US, few would-be health care reformers are addressing these issues. What discussion there is of "fraud and abuse" seems to be about low-level offenses, not about leadership. In fact, influential voices in the discussion come from leaders of some of the same organizations that have made huge settlements of allegations of bad behavior, accepted deferred prosecution agreements, or have seen previous leaders resign in disgrace or go to jail.

I respectfully suggest that meaningful health care reform is unlikely unless we deal with the problem of conflicted, unethical, and sometimes corrupt leadership of health care organizations.

Shareholders Take Notice That Patients Used As Unconsented Guinea Pigs, Physicians as Bank by Health IT Vendors

At my Jan. 2009 post "Waste Feared in Digitizing Patient Records: Wall Street Journal" and others I have written about the illegitimacy of the abuse of patient rights, as well as abuse of clinician trust committed by health IT vendors using patient care settings as an unconsented software development laboratory and beta testing site. I wrote:

The IT industry uses hospitals, doctor offices and patients as alpha and beta test sites and subjects, unregulated by the FDA or other agency. When HIT fails, there is no central agency to report the failures to, only the vendor. Fixes go into a "queue" for remediation, with priority level decided by the vendor.

Clinicians are also used by HIT vendors as a form of bank and insurance company. HIT vendors depend on (free!) physician and nurse ingenuity in finding workarounds to the ill-conceived design and user experience (link to my eight part series on this issue) that their products usually present so that their products can even be salable. This, of course, taxes and tires clinicians at the expense of patients and hampers and complicates EHR diffusion. Clinicians become, in effect, unpaid development consultants to HIT companies (or, perhaps more accurately, since EHR's do become essential to medical practice, indentured servants to the HIT vendors).

Also, under the unethical, Joint Commission-violating and executive fiduciary responsibility-violating "Hold Harmless" and "Defects Nondisclosure" HIT contracting clauses, clinicians pay the price for bad patient outcomes, even if the causative factor was HIT errors. (See Health IT Hold Harmless and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?, and my July 22, 2009 JAMA letter to the editor on this issue.) Thus, clinicians become an insurance company, bank and risk safety net (a term that might not be inappropriate is "suckers") for the HIT vendors. This is not an optimal way to treat one's ultimate customers.

HIT is a mess, but that doesn't stop HIT vendors from simply lying about their financial status and future projected business to the investor community.

Now, HIT company shareholders are taking note of these industry (mal)practices. These (mal)practices are hitting shareholders where it really hurts - in the pocketbook. My comments in [red italics]:

Allscripts shareholders file class action suit
Healthcare IT News
August 05, 2009 | Bernie Monegain, Editor

CHICAGO – Allscripts shareholders have filed a lawsuit alleging the company broke federal securities laws when it went live with the newest version of its EHR clinical software, Touchworks [i.e., a "version" that had not been thoroughly tested and validated outside hospital walls, a practice HIT vendors get away with due to the near spinelessness of regulators such as the Joint Commission, FDA, and others - ed.] .

Allscripts officers say the suit is without merit.

[As I pointed out at "Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?" regarding the lawsuit my own organization filed against this company and its partner Medicomp Systems (civil complaint PDF here), where incomplete, untested and non-functional software was sold by this company for use by our physicians, I'd say the allegations do deserve further investigation - ed.]

"We are aware of the lawsuit and have reviewed the complaint," Allscripts officials said Wednesday. "While it is our policy not to comment on the substance of pending litigation, we believe the lawsuit is without merit and will vigorously defend the allegations."

The lawsuit, which seeks class action status, has been filed in the United States District Court for the Northern District of Illinois on behalf of those who purchased the common stock of Allscripts-Misys Healthcare Solutions, Inc. (formerly known as Allscripts Healthcare Solutions, Inc.) between May 8, 2007 and Feb. 13, 2008. It names Allscripts-Misys Healthcare Solutions, CEO Glen Tullman and Chief Financial Officer William J. Davis as defendants.

At a user conference in Orlando, Fla., July 30-31, Allscripts CEO Glen Tullman told some of the attendees that Allscripts might have rushed version 11 of Touchworks to market too quickly.

["Might have" rushed it out too quickly? It had, in fact, been delayed several months according to the lawsuit. "Perhaps" the delays needed to be lengthier. In other words, f*** the doctors and patients, we're getting this cr** out the door so as to not further injure our profits with further delays - ed.]

He said the company was caught off guard by providers who found new uses for the product.

["New uses?" (We all know that when companies sell broken HIT, it's always the doctors' fault) ... Likely translation: clinicians tried to practice medicine the way they saw best, not the way the Allscripts software designers saw best or "approved of." (Arrogance, anyone?) The clinician users tried to use the software in a real-world setting while applying the improvisations needed for proper patient care in a poorly bounded, uncertain environment (per Nemeth and Cook) and found the software's support of the uncertainties and realities of the clinical environment, and likely the software's stability itself, poor - ed.]

Tullman and Faisal Mushtaq, the company's senior vice president of product development, said Allscripts has invested roughly $14 million to improve stability and performance [after throwing the doctor and patient test subjects to the wolves after a "might have rushed it out" premature rollout - ed.], and they expect the next version, to be rolled out soon, to work more smoothly.

[I really despise the "version 1.1 will be much better" in healthcare settings, as it goes back to the issue of sick patients as unconsenting subjects in a software testing lab, and physicians as a bank and insurance company for the vendors when things go wrong -ed.]

The complaint alleges that defendants failed to disclose the following adverse facts:

* Allscripts lacked the necessary resources [i.e., smart, a.k.a expensive, people who actually know what they're doing thanks to the appropriate informatics education and expertise. Were the ones they did have tied up in patchwork remediation and crisis management? - ed.] to install V-11 software at customer sites; Allscripts had no historical basis to estimate the completion of V-11 or the impact V-11 sales might have on the company's 2007 revenues and earnings [if they made stuff up, that would not be too uncommon in today's financial environment. Also, the "lack of necessary resources", not unique to Allscripts, portends quite poorly for the planned, manic rush to national EHR by the cavalierly short deadline of 2014 - ed.]

* The complexity of V-11 had materially and adversely lengthened the sales cycle and revenue recognition cycle for the company's V-11 sales contracts [Another instantiation of my belief that business IT sales practices are inappropriate for clinical IT, where there are unconsenting "customers" with special rights - patients. One also wonders: did clinicians balk at a Rube Goldberg contraption but hospital executives purchase it anyway? - ed.];

* Allscripts was currently experiencing adverse and continuing delays in the installation of V-11 software systems [which were perhaps not revealed by clients, thanks to secrecy clauses regarding defects and problems as noted by Penn's Koppel and Kreda in JAMA? - ed];

* Based on the foregoing, defendants had no reasonable basis for their statements concerning Allscripts' current and future financial performance and projections.

The law firm of Izard Nobel LLP, based in West Hartford, Conn. announced the class action lawsuit on Wednesday.

Click here to read the complaint: http://www.izardnobel.com/allscriptsmisyshealthcare/ .

The PDF of this class action complaint is here.

So, it seems entirely possible the defects nondisclosure clauses promulgated by these vendors, and accepted by meek hospital executives and CIO's, may have supported and/or led to a situation of shareholder fraud.

It would be ironic indeed if these cavalier HIT practices end, and the HIT vendors began to adhere to principles of responsibility and resilience engineering, not due to regulatory pressures but due to shareholder lawsuits.

Finally, Allscripts CEO Tullman was a campaign adviser to the President on healthcare. It's perhaps due to advisers like this that national plans for healthcare reform are sinking like the Titanic. As per my Feb. 18, 2009 Wall Street Journal letter:

... it is the government that has been deceived [rather than the public] by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants ... The government has bought the IT magic bullet exuberance hook, line and sinker.

-- SS

addendum:

Perhaps I should self-turn in this post as "fishy" to the healthcare reform snitch line at "flag@whitehouse.gov"?

Sixth International Congress on Peer Review and Biomedical Publication

I just found out that the program of this year's Sixth International Congress on Peer Review and Biomedical Publication, to be held on September 10-12, 2009, in Vancouver, BC, Canada is likely to be of great interest to Health Care Renewal readers. The conference is held every four years on topics relevant to medical journal editors and reviewers, but previous conferences emphasized topics as impact factors, blinded review, open publishing, etc. This year, however, there will sessions on:

• Authorship and Contributorship - including 3 of 4 presentations on ghost-writing
• Data Sharing and Conflicts of Interest - including 4 of 5 presentations on conflicts of interest in research
• Publication Bias - including 3 of 3 presentations which appear to discuss research manipulation and suppression
• Rhetoric - including 3 of 3 presentations apparently about how articles reporting original research may exaggerate or distort the results

There will also be poster presentations on relevant topics. See this link for further information and registration information.

This conference program seems to have a higher concentration of Health Care Renewal relevant topics than any conference of which I am aware to date.

AFL/CIO Interested in Healthcare IT Failure?

In today's Wall Street Journal, in a piece entitled "You Are Terrifying Us" about the growing opposition to the administration's healthcare reform plan, columnist Peggy Noonan writes:

... But every day the meetings seem just a little angrier, and people who are afraid—who have been made afraid, and left to be afraid—can get swept up. As this column is written, there comes word that John Sweeney of the AFL-CIO has announced he’ll be sending in union members to the meetings to counter health care’s [i.e., the reform plan's - ed.] critics.

Massive expansion of healthcare IT is one of the cornerstones of the healthcare reform initiative. I have expressed my concerns in an open letter to the President on this blog about the dangers of too rapidly pushing health IT in its present underdeveloped and experimental condition.

With that in mind, I've just noted several "hits" on my Drexel website on healthcare IT failure from the following IP number (internet digital address):

06 Aug, Thu, 16:22:42 12.4.17.250 Netscape 7 Windows XP
06 Aug, Thu, 16:45:53 12.4.17.250 Netscape 7 Windows XP
06 Aug, Thu, 17:03:07 12.4.17.250 Netscape 7 Windows XP

These occurred as a result of someone at IP 12.4.17.250 searching Google on the phrase "drexel university health information tech."

I cannot tell what they looked at besides the site's main page at 16:22, but at 16:45 and 17:03 the referring URL's were:

http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=about

In other words, my biographical information was being reviewed.

IP 12.4.17.250 translates as follows:

AFL-CIO AFLCIO-17-0 (NET-12-4-17-0-1)
12.4.17.0 - 12.4.17.255

Perhaps someone at AFL-CIO is interested in pursuing a graduate certificate in healthcare informatics at Drexel, or perhaps someone there is conducting background research on potential or perceived IT-related "impediments" to healthcare reform. (Such as my writings?)

I don't know which, but I thought the hits interesting.

-- SS

Aug. 11 update:

This "hit" just in on unknown referrer:

Aug, Tue, 08:13:39 12.32.3.194 Netscape 7 Windows XP

IP 12.32.3.194 translates to:

UNITED STEELWORKERS OF AMERICA UNITED-S 21-3-192
(NET-12-32-3-192-1) 12.32.3.192 - 12.32.3.199

A lot of hits on my HIT failure site with union labels lately.

-- SS

SGIM Urges "Chuck the RUC"

This week, Society of General Internal Medicine (SGIM) members received the 5 August, 2009, Update in Health Policy that urged we "chuck the RUC," (quoted in its entirety below, italics added for emphasis):

Who will assign the value of primary care services? Chuck the RUC!

How does Medicare determine physician payment rates? The answer to this question is a core element of the ongoing debate about health care reform. Changing how Medicare sets payment rates for physicians is especially critical since Medicare rates also guide the rates set by private insurers. Since 1992, Medicare has paid physicians according to the Resource Based Relative Value Scale (RBRVS), a fee schedule that multiplies relative values for physician services by a conversion factor to determine the amount of payment. The Centers for Medicare and Medicaid Services (CMS) has historically used the Relative Value Scale Update Committee, or RUC, as the sole source of recommendations. This committee within the AMA performs broad reviews of the RBRVS every five years. Twenty three of the RUC's twenty nine members are appointed by major national medical specialty societies, including those that account for high percentages of Medicare expenditures for procedures. All meetings are closed and discussions are confidential. The over-representation of procedure-driven subspecialties and under-representation of generalist physicians in the RUC has contributed to the current undervalued cognitive services (especially for primary care) and over-valued reimbursement for procedures. In March 2007, the Medicare Payment Advisory Commission (MedPAC) identified the RUC process as a major reason for undervalued primary care services and a significant contributor to the crisis in primary care. MedPAC has recommended that an independent expert panel of economists, technology experts, physicians and private citizens be created to supplement the RUC's recommendations to CMS regarding fee schedules. Health reform discussions have included moving MedPAC into the executive branch and giving it authority to review and recommend Medicare payment policy, thus reducing the RUC's influence. Not surprisingly, both the AMA and the American College of Surgeons have opposed this proposal. Groups representing primary care physicians, including SGIM, are in favor of this proposal which could ensure fair and unbiased assignment of work RVUs to all the service codes used by physicians. We believe that this will correct the payment inequalities of the current fee scale and ultimately renew trainees' interest in primary care. In the coming weeks, SGIM may ask you to act on this issue and contact your legislators to urge them to support these transformative proposals for primary care. Please monitor your e-mail for action alerts and be prepared to act.

We have previously posted (most recently here in considerable detail) about the perverse incentives given US physicians by the payment schedule dictated by the US Medicare system. These incentives have been largely responsible for the increasingly dire status of primary care/ generalist care in the US. Revisions to the Resource-Based Relative Value System (RBRVS) disproportionately reward physicians for performing procedures and diagnostic tests instead of talking with, examining, thinking about, diagnosing, recommending decisions for, and counseling patients. The US Center for Medicare and Medicaid Services (CMS) uses the RBRVS Update Committee (RUC) de facto as its sole source for advice on revising the system. The RUC is dominated by representatives of medical societies whose members predominantly perform procedures and do diagnostic tests. The RUC is secretive. The identities of its individual members are difficult to ascertain. Its proceedings are secret.

Thus, the RBRVS updating process run by the RUC is opaque, unaccountable, and not representative of patients and "cognitive" physicians. The result of this process has been perverse incentives that have driven up health care costs without obvious improvements in quality or outcomes.

I applaud SGIM for being the first medical society to challenge how the RUC controls payments to physicians, and the perverse incentives the RUC process has generated.

As the Update above says, meaningful health care reform in the US will not occur unless we address the perverse incentives that drive up costs without improving care.

Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?

I could have titled this piece "have the deceivers been themselves deceived?"

Recent revelations have shown that biomedical ghostwriting is a scourge that some physicians and scientists -- who are clearly lacking ethics, insight and perhaps an understanding of psychiatric defense mechanisms such as rationalization -- engage in all too often, as it taints the corpus of worldwide scientific literature.

(I covered the issues related to ethical and justified claims of provenance for scientific writing in my post "Wyeth: Ghostwritten Papers Fake, But Accurate" here along with a discussion of why lay leadership of biomedical R&D organizations was not a good idea. Such leaders cannot vouch for the scientific fairness and accuracy emanating from their own organizations.)

One should examine the evidence in a first-person manner. The New York Times has made available secret documents and emails secured by Senator Grassley on Wyeth's ghostwriting practices. These documents were unsealed by a judge in a personal injury lawsuit and chronicle Wyeth's use of a medical writing company to prepare articles for publication in medical journals.

Wyeth said all the articles are "scientifically accurate" and that "it is a common practice in the pharmaceutical industry to work with such firms" (and, by implication, to falsify claimed authorship). As justification for clearly unethical practices, this is a rather poor argument, being a classic logical fallacy known as the Appeal to Common Practice:

Description of Appeal to Common Practice
The Appeal to Common Practice is a fallacy with the following structure:

1. X is a common action.
2. Therefore X is correct/moral/justified/reasonable, etc.

That said, these documents raise an important question of a systemic nature:

Have the scientific ghostwriting deceivers themselves been deceived regarding biomedical reality by these practices?

Might they genuinely believe they are contributing to the scientific literature based on their own erroneous notions, the latter based upon a scientific literature contaminated by other ghostwriters?

To illustrate this point, in the New York Times online document pool, we discover that Dr. Gloria Bachmann, Associate Dean for Women's Health and Professor of OB/GYN and Medicine at UNDNJ-Robert Wood Johnson Medical School was presented with a tidy ghostwritten article entitled "The Importance of Treating Vasomotor Symptoms" (in peri- and post-menopausal women) by authors "TBD" (to be decided):

(Original ghostwritten draft. Authors "TBD." Click to enlarge)

about which Bachmann wrote the following in an email to the true authors' organization:

"Outline is excellent as written. I would like to try for publication as a review article in Obstetrics and Gynecology. We would have to change the title to "Vasomotor Symptoms: Evidence Based Treatment Options" or a title that emphasizes the data driven writing style."

Here is an image of the email:

(Approval email. Click to enlarge)

She found the content OK and agreed to review it.

Apparently, only minor changes were made. (Bachmann should have received accreditation in the acknowledgments section for reviewing the article, and/or a position far down the authorship hierarchy if she actually added some material).

Instead, the reverse occured.

The published document appeared with Bachmann as first (and only) author after Bachmann submitted it to a medical journal under her name, itself unethical. See what "Authors TBD" morphed into in the image below:

(Article submission cover page. Click to enlarge)

Here is how the true authors, medical writers for DesignWrite, the medical writing and communications company retained by Wyeth to write the article, received credit:

(How the "ghosts" received credit for writing the paper. Click to enlarge)

Unbelievable.

Bachmann has since stated that she believed she was adding to science by engaging in this deceit. From the New York Times:

The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies.

The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said. ["May have made?" This gossamer excuse is embarrassing to me, as an academic myself - ed.]

“There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”…

She is quite off base regarding scientific authorship and "this being her work", but what also needs examination is her "lending her expertise" and her agreeing with the paper as "reflective of her view."

The paper itself lists many references, for example these:

(References: click to enlarge)

Here is, then, the dilemma, another major problem posed by ghostwriting:

How many of the cited references, which contributed to Bachmann's beliefs regarding these drugs, were themselves ghostwritten and potentially biased, or otherwise influenced by drug companies?

For that matter, how many studies with different ("negative") conclusions on these subjects were suppressed from publication by industry pressure? 

Bachmann's own "expert opinions" about these matters may be based upon false or misleading information she's read in other journals, the percentage of which are genuine vs. ghostwritten or industry-influenced being an unknown at this point in time.

While I believe Bachmann is most likely rationalizing away the unethical nature of attribution without fair and justifying contribution, perhaps fueled by additional motives of academic portfolio building and perhaps present and future potential pecuniary gain, it is possible she is being genuine about agreeing with the "science" in the paper.

However, her agreement may be predicated upon her own tainted expertise -- tainted by reading ghostwritten or industry-influenced articles in her area of specialty.

Will we ever be able to peel back all the layers of the ghostwriting onion to get to the core of impartial and objective scientific articles related to drugs and medical devices? Perhaps not, but the practice must stop going forward.

Tainted literature creates tainted scientific knowledge, the carriers of which may then further taint the knowledge base (with the best of intentions and with firm belief in the fairness and accuracy of their activities, of course).

Practitioners of evidence-based medicine may be unwittingly practicing "evidence-tainted medicine", or "pseudo-evidence based medicine" as described by others on this blog.

Such are the systemic risks of the scourge of ghostwriting.

-- SS

Aug. 31, 2012 Addendum:

I was made aware of the following 2011 paper thanks to a post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog:  "Why Does Academic Medicine Allow Ghostwriting?  A Prescription for Reform" by Jonathan Leo, Jeffrey R. Lacasse, and Andrea N. Cimino

The paper also observes:

Due to its secretive nature, it is difficult to quantify how many invisible corporate authors haunt the medical literature.

The paper is worth reading in its entirety and as of this writing is available free at the link above.

-- SS

Guest Blog - On the Need to Get Ethical

Guest blog by Dr William Tierney -

This is old news. I'm the Co-Editor-in-Chief of the Journal of General Internal Medicine, and in our June 2005 issues we reported in detail a case of medical ghostwriting that had the particular target of showing the hazards of the oral anticoagulant drug warfarin, supporting a drug company's new oral anticoagulant. This article was accompanied by an editorial by me any my Co-Editor and a position statement by the World Association of Medical Editors decrying such practices.

I am a practicing general internist who prescribes drugs regularly that help my patients. I want and need new drugs to be developed, and I believe that users of those drugs should pay for the necessary research and development through both drug pricing and funding of NIH. I am also a patient and similarly want there to be effective drugs to prolong my life and healthy living. But they should be described in an evidence-based manner, and the evidence must be unbiased. The drugs should be priced so the drug company recoups its costs and makes a profit. I have no problems with any of that. But when they try to enhance their profits through illegitimate means -- by essentially lying through advertisements masquerading as scientific articles sneaked into peer-reviewed journals -- then these drug companies are behaving unethically and need to be punished.

I also am a clinical epidemiologist, and as such I do research investigating the positive and adverse outcomes of drugs. I have worked with and been funded by drug companies to do this work, collaborating with company scientists. To a person, I have found them to be honest, careful, and caring people who truly want to positively impact people's lives. It is the marketing divisions of these drug companies that operate in an atmosphere of "anything goes that helps the bottom line."

My father was a purchasing agent for a factory that made automobile parts. We used to get "presents" every Christmas, tickets to Broadway, etc. from suppliers, blatant attempts to influence his decision-making. I can't say whether it ever did, but in the end he had to live with his decisions and so did the company for which he worked. But as a physician, I don't receive the benefits of the drugs I prescribe for my patients, nor do I pay the costs. I act as an agent of my patients, and as such I need to balance benefits, adverse effects, and costs of everything I order. If I have bad information, or if I succumb to company bribes in the form of honoraria, meals, or gifts, my patients pay the price both directly (through my ordering an expensive drug they might not need) and indirectly (through inflated drug prices in general).

It is time for the drug companies to get ethical. Cut out the ghostwriting. Cut out the bribes. Cut out the marketing to patients that inflate drug benefits and minimize their costs and risks. Charge prices that recoup their drug development costs and stop paying billions to "push" drugs on physicians and patients, adding those costs to their drug prices. And we physicians likewise need to get ethical, stop taking bribes, stop reading propaganda or listening to drug detailmen, and base our decisions solely on what is best for our patients, without ignoring costs. (Nobody benefits if we bankrupt our system -- but that's another story...)

We are seeing changes. Eli Lilly now lists all payments they make to physicians (honoraria for speaking, meals, trips, etc.). Many medical schools and large practice organizations have outlawed meals and gifts by drug companies. Journals are more vigilant for ghostwriting and other conflicts of interest among authors. We are seeing a change, and hopefully the abuses by Wyeth, DesignWrite, and other companies involved in ghostwriting will become a thing of our (sordid) past. We can only hope and maintain our diligence as caring health care providers.

Dr Tierney is Co-Editor-in-Chief, the Journal of General Internal Medicine, and Professor of Medicine, Indiana University School of Medicine. This was also posted as a comment here on the NY Times article about Wyeth's sponsoring of ghost-writing of articles on hormone replacement therapy. See our most recent post on this topic here.

Wyeth's Industrial Scale Ghost-Writing

MedInformaticsMD noted the impending release of documents about how Wyeth engineered ghost-writing of articles about hormone replacement therapy (HRT) here. Now the NY Times has had a chance to review the documents, with fascinating results.

The scope of the ghost-writing campaign was on an impressively industrial scale: 26 articles published over 7 years in 18 medical journals.

The details were ably covered by at least three other blogs. Dr Adriane Fugh-Berman, guest- (not ghost-) blogging on PharmaGossip discussed how the documents reached the public domain. Dr Daniel Carlat on the Carlat Psychiatry Blog, Prof Margaret Soltan on the University Diaries offered some choice comments -

By Dr Carlat

As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company's version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it's a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It's essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.

By Prof Soltan

This filthy practice incorporates just about everything people rightly revile about some precincts of academia: Plagiarism. Fakery. Arrogance. Laziness. Cynicism (Wyeth was promoting drugs that turned out to be dangerous.).

People make fun of postmodernists by talking about the Postmodern Generator, a program that automatically generates articles full of obscurantist rhetoric. But that’s only generating words. Ghosting whores among our medical faculties are generating real sickness.

These are hard acts to follow, so my comment is: ghost writing is also corrupt. Transparency International defines corruption as abuse of entrusted power for private gain. Medical academics are entrusted to discover and disseminate the truth. Practicing physicians, patients and the public entrust medical academics to provide honest, informed, unbiased information and opinions.

When academics allow marketing hacks to write supposed scholarly articles in their name, they abuse this entrusted power (and privately gain by padding their CV, and often by direct payment as "consultants.") Of course, as noted above, this sort of corruption deceives the public, patients, and physicians into thinking that drugs and devices are better and more valuable than they actually are, denying patients preferable treatments, increasing the risk of needless adverse effects, and driving up the costs of health care.

Those who are pushing for meaningful health care reform ought to put fighting health care corruption at the top of their agendas, starting with the blatant corruption of academic medicine and medical research of which ghost-writing is but one species.

Harvard Cut Money for Primary Care "Step-Child"

This story, about cuts in the funding for Harvard Medical School's minimal program in primary care, has received little attention in the US. I was alerted to an article about it in the Harvard Crimson by a news article in the British Medical Journal that was picked up by Medscape.

Here are the main points, from the Crimson article,

Harvard Medical School has suspended funding for its Primary Care Division as part of a broader departmental restructuring effort, prompting students and faculty to circulate a petition calling on HMS Dean Jeffrey S. Flier to reaffirm the School's commitment to primary care education.

According to Nancy J. Tarbell, dean for academic and clinical affairs at HMS, the School had provided roughly $200,000 in funding each year to the Division. She said that the Division, which has not been disbanded but whose structure and administration is being reviewed, will remain affiliated with HMS. The Division has always been funded exclusively by the Medical School, according to HMS spokesman David J. Cameron.

'The reorganization of this division is really a narrow administrative issue,' said HMS Dean of Medical Education Jules L. Dienstag. 'It has nothing to do with the commitment of HMS to primary care, which is unchanged, undiluted, and undiminished.'

Nevertheless, as of Thursday afternoon, over 450 individuals had signed the online petition, including students, residents, faculty, and physicians from HMS and its affiliated hospitals. The petition calls for the School's administration to present a detailed plan of action for expanding institutional support despite the budget cut, expand loan forgiveness initiatives that financially enable students to pursue primary care specialties, support efforts to strengthen primary care in a reformed national health care system, and solicit and implement proposals from the HMS community to improve primary care education.

The Division was previously part of the HMS-HPHC jointly administered Department of Ambulatory Care and Prevention (DACP), which Tarbell said was recently restructured and renamed as the Department of Population Medicine and placed solely under HPHC's administrative purview in order to better reflect its core research and teaching activities.

Tarbell, who seemed unclear about what actual services were provided by the Division, said that the HMS administration is conducting a 'comprehensive review' of the its programs and that the Division has historically been 'relatively small.'

'When you look at [HMS's primary care initiatives] as a whole, at the big picture, you can't make the argument that funding has decreased for primary care training at HMS,' Tarbell said, adding that the school is expanding its funding this year for a required third-year medical clerkship from $600,000 to $800,000.

But despite administrators' reassurances that primary care education remains a top priority at the Medical School, some students and faculty maintain that the cut sends a negative message about the School's priorities, which they say have traditionally centered on specialty medicine and research. And the petition expressed concern about the future of outreach activities previously coordinated by the Division, including a Primary Care Mentorship Program, if funding or a Divisional home were to be eliminated.

'Primary care, from the perspective of the Medical School, was sort of a stepchild [in the past], and not much was done to provide students with information about primary care careers or to connect them with role models in primary care,' said Susan Edgman-Levitan, executive director at The John D. Stoeckle Center for Primary Care Innovation.

'Harvard's goal has always been to create leaders in medicine, with regards to basic science and new developing fields. Primary care has never really been a major emphasis, although I think on a global basis, Harvard has put a major emphasis on reaching out to the rest of the world,' said Martin P. Solomon, an assistant clinical professor of medicine at the Brigham. 'People like Jim Kim and Paul Farmer are all very important and have had an enormous impact on primary care worldwide, but in our own backyard, Harvard has had very little impact. [Primary care] is not ... glamorous....'

Indicating where the medical school's priorities lie, during the month in which the cuts were announced, Dean Flier took the time to open, and thereby endorse the meeting of ACRE (the Association of Clinical Researchers and Educators). The grandiosely named group promotes unrestricted financial relationships among medical academics and health care corporations, and dismisses those concerned with the effects of these relationships (see our posts here and here).

It is true that the cuts in primary care occurred at a time of general belt-tightening, due to the sudden decline in the value of Harvard University's endowment. However, as reported in a muck-raking article in Vanity Fair by Nina Munk, even the reduced endowment is still the largest of any university in the US.

Furthermore, primary care generated relatively small costs to the university. However, as reported by Vanity Fair, the current financial crisis was generated on the University's tremendous building binge during the years the endowment seemed like it would grow forever:

... the university is facing the onerous financial consequences of over-building. Consider this: Over the 20-year period from 1980 to 2000, Harvard University added nearly 3.2 million square feet of new space to its campus. But that’s nothing compared with the extravagance that followed. So far this decade, from 2000 through 2008, Harvard has added another 6.2 million square feet of new space, roughly equal to the total number of square feet occupied by the Pentagon. All across campus, one after another, new academic buildings have shot up. The price of these optimistic new projects: a breathtaking $4.3 billion.

The University also rewarded the managers of the endowment with pay sufficient to make them very rich.

By the early 2000s, Harvard’s top moneymen were making as much as $30 million to $40 million a year. Finally, in 2003, seven members of Harvard’s class of 1969 wrote a strong letter of protest to the university’s president, Larry Summers. They spoke out loudly, publicly, informing any member of the media who would listen that compensation at Harvard Management Company was 'obscene.'

At other American universities, where investing money for the institution is regarded as a kind of public service, Harvard’s swagger raised deep suspicion. 'Harvard became a bunch of mercenaries,' the chief investment officer of another big private university told me.

Most of these managers decamped, taking the money with them, before the endowment value crashed.

By 2005, Jack Meyer had had enough. After 15 years at Harvard Management Company, frustrated by the circular fights about compensation, and sick of justifying himself to Summers and Rubin, he walked out and started his own giant hedge fund. Shamelessly, he took many of Harvard Management Company’s best people with him, about 30 portfolio managers and traders, along with the chief risk officer, chief operating officer, and chief technology officer. Harvard’s trading floor was decimated.

No one in the current or past Harvard leadership has yet been held accountable for the overspending that seemed predicated on the absurd (at least in retrospect) assumption that the endowment would continue to grow indefinitely.

At some point in the last five years, the men and women who run Harvard convinced themselves that the endowment would grow at double-digit rates forever. If Harvard were a publicly traded company, those people would have been fired by now.

Because of the case of the Harvard endowment, the US Internal Revenue service is reportedly investigating how university endowments were run (e.g., see Reuters).

But meanwhile, primary care, already a step-child, was cut.

The case of primary care at Harvard shows how the leadership of academia, and academic medicine in particular, has become entranced by the glamorous, the glitzy, the high-tech, and the prospects of wealth to be made by their pursuit, while neglecting the core academic and health care missions that are the reasons for the existence of universities and medical schools.

No wonder US health care is in a crisis. Those who want meaningful health care reform should find a way to push academic medicine to uphold its mission rather than enrich and glamorize its leaders, and to allow health care professionals to reaffirm their professionalism (regardless of past interpretations of US anti-trust law to the contrary).

ADDENDUM (5 August, 2009) - see more comments on Harvard's failed governance here on the ACTA Blog.

HIMSS: Hospital CIO's Should Not Only Manage Healthcare IT, But Also Biomedical Engineering

I have written in the past about the territoriality of the IT department in hospitals, observing that the departments I was exposed to seemed more political than the clinical departments themselves. This territoriality came at the expense of clinicians' and patients' best interests.

This phenomenon seems to go beyond the confines of the hospital IT shop, perhaps as a manifestation of the IT culture. For example:

Other have observed - unapprovingly so - how the health IT trade group HIMSS, via a massive lobbying effort and via its offspring, the CCHIT, has sought to gain hegemony over health IT through a "certification" process, a service for which CCHIT desires to be the sole provider.

It's become worse. Now control over biomedical instrumentation (which includes such safety critical devices as ventilators, cardiac and other physiologic monitors, heart-lung machines, radiological devices, etc.) is sought.

In the June 2009 HIMSS analytics report "Devices in Hospitals" (link to PDF):

Page 7:

... It appears that the IS department [a.k.a. IT department, or Management Information Systems department - ed.] is becoming the key support department for interfaced intelligent medical devices. This is a natural extension as IS departments build and support a cadre of interfaces to improve the collection and use of data within the hospital.

Then at the end of the report, in the Conclusion, a leap of logic of gargantuan proportions:

What is less clear at this time is whether the biomedical operations will be placed under the IS department for management. We believe that it should be , ala the movement of responsibility for telecommunications to the CIO when telecommunications and information technologies merged in the last 15 years .

Au contraire ... it is very clear to those who know what they're doing that this is a very bad analogy and suggests HIMSS does not understand the vast differences between the discipline and functions of biomedical engineering, versus the IT department role of management of computer and other ICT's (information and communications technologies). I find this astonishing.

Having done a clerkship in biomedical engineering in medical school, and being somewhat knowledgeable about electronics as an FCC-licensed radio amateur at the Extra class (highest certification attainable by a series of FCC examinations), I find the HIMSS Analytics position risible and dangerous. It suggests a desire to expand territory even further into an area for which CIO's and hospital IT personnel are even less qualified - indeed, far less qualified - than clinical IT.

Apparently, CCHIT wants to have hegemony over "certification" of clinical IT, and the parent organization HIMSS through its research arm opines IT should also take over "medical devices" (while still excluding clinical IT from that categorization to avoid regulation, of course).

As I first asked over ten years ago after observing IT personnel in hospitals :

Who, exactly, are the IT personnel in hospitals, and what, exactly, in their backgrounds qualifies them for major involvement in clinical affairs, let alone leadership roles regarding safety-critical clinical devices?

Perhaps the Joint Commission, FDA, and other regulators need to start asking the same question.

-- SS

Pfizer Settles Trovan Case with Kano State

As reported by the Washington Post, and many news sources outside of the US, Pfizer Inc has settled another lawsuit,

Pfizer signed a $75 million agreement Thursday with Nigerian authorities to settle criminal and civil charges that the pharmaceutical company illegally tested an experimental drug on children during a 1996 meningitis epidemic.

Nigerian authorities say Pfizer's test of the antibiotic Trovan killed 11 children and disabled scores more. Pfizer says the deaths and injuries were the result of meningitis.

An attorney for the state of Kano, where the charges were lodged, said the settlement was a long time in coming but welcome because it set the record straight about Pfizer's culpability. 'People and entities can and must be held accountable for the consequences of their conduct,' the attorney, Babatunde Irukera, said. 'People around the world are no different and must be accorded the same levels of protections, always.'

Pfizer is not quite done with this case.

Charges filed against Pfizer by Nigeria's federal government, which is seeking about $6 billion in damages, are unaffected by the settlement, Irukera said. Two lawsuits related to the Trovan experiment also remain pending in New York.

The Post's article summarized the issues in the case, thus:

Details of the drug trial were first made public in December 2000 in a Washington Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter.

Five years later, in May 2006, The Post obtained and published a confidential report that concluded that Pfizer violated Nigerian and international law in the experiment. That set in motion the criminal charges.

We first posted about this case in 2006, here. We posted about Pfizer's heretofore most recent legal settlement, here. I wonder again whether multi-million, or even billion dollar settlements have that much effect on the leadership of a company as big as Pfizer? Such settlements do not affect the leaders directly, and their financial effects one a company so big are negligible.

Be that as it may, do we need more examples to remind us that strong skepticism should be the rule when evaluating clinical research done or sponsored by pharmaceutical companies, or other health care corporations with vested interests in the research turning out a certain way? Such skepticism is warranted whatever the clinical context, whatever the product being evaluated, and whatever country in which the research is done.

Here in the US, debate has been swirling about health care reform. Many of the arguments have been about how costs can be controlled while health care quality is increased. Better research about the benefits and harms of specific drugs, procedures, devices and tests might enable physicians to choose the most appropriate care for each patient, potentially improving quality while also reducing costs. This example, plus many others discussed on Health Care Renewal, suggests that putting at least an arm's length between companies which sell drugs and devices and the clinical research meant to evaluate these drugs and devices has the potential for making better quality, less biased, more accurate clinical research available (see the topics: suppression of medical research and manipulating clinical research.)

Maybe putting this topic on our local US health care policy radar would increase the chances of achieving meaningful health care reform. Maybe if the US took the lead in separating clinical research meant to evaluate drugs, devices, procedures, or tests from the corporations selling them, the result would be a movement that would benefit health care around the world?

Making Hospitals Safer by Making Healthcare IT Safer

At my July 24, 2009 HC Renewal post "Inquiry to Joint Commission on points raised in my July 22, 2009 JAMA letter on HIT", I reproduced a letter I sent to the Joint Commission seeking their opinions on the issue of Health IT "hold harmless" and "defects nondisclosure" contractual terms. (See "Health Care Information Technology Vendors' Hold Harmless Clause - Implications for Patients and Clinicians", JAMA 2009;301(12):1276-1278 and my HIT difficulties website essay here.)

Those contractual terms cause hospital executives to violate Joint Commission safety standards and their own fiduciary responsibilities to people both providing and seeking care in hospitals. My inquiry was acknowledged, and I await a reply.

In Making Hospitals Safer for Patients, New York Times, Aug. 2, 2009 , Mark R. Chassin, president of The Joint Commission, wrote:

To the Editor:

Jim Hall makes an important point about the costs and preventability of harm caused by medical errors, but his suggestion for a National Medical Safety Board is not the answer. It is not sufficient to investigate health care “crashes” one at a time and hope to transform the health care system into one that performs more reliably.

Too often, the lessons learned are not easily transferable to other hospitals or even to other problems within the same organization.

The key to transforming our health care system into a safer one is to use proven quality improvement methods — already in use in high-risk fields like aviation and nuclear power — as part of everyday work ...

In a followup email to the Joint Commission, I pointed out to Dr. Chassin that this is the same key to improving the quality and safety of EHR, CPOE and other information technology-based medical devices.

I also pointed out that "Hold harmless" and "Defects nondisclosure" -- a.k.a. "gag clause" -- contractual methods (unless I'm mistaken, in which case we're all in jeopardy) are not used in building and deploying safety-critical devices found in the aviation and nuclear energy industries.

-- SS

An Outsider’s Take on American Medicine

Jonathan Kaplan’s The Dressing Station was published in 2001, but I am only reading it now. Much of the book is about battlefield medicine, but one part concerns his coming from Britain to America in the late 1980s. Born in South Africa, he attended medical school there, then went to Britain rather than be drafted into the military. With research budgets cut under Thatcher, he came to America to be able to pursue his medical career.

After his dreary British experience during a period of budget cutbacks, he greatly enjoyed the cheerful commercialism and general prosperity of American medicine. He promptly found a research project to work on that would enable him to write a Master’s thesis, and the work was fun and went swimmingly.

Nonetheless, Dr. Kaplan was quite disconcerted by some of the differences between British and American medicine. Working on another study, he reviewed hemorrhoid surgery results. He was startled to realize how much more surgery was done for minor piles in the U.S. than in Britain, though results were unimpressive – then “I found the payment invoices in each patient’s folder. These were met by the health insurers, who paid out a lot more for an operation than injections. . . . The logic of a for-profit system appeared to lead to expensive solutions and spiraling costs.”

He was also startled by anecdotal reports of how the stock market crash of 1987 led one surgeon to actually shed tears mid-surgery when he heard the news. As well, the serious, money-oriented medical students surprised him, as he was used to quite a number of more arty, intellectual types among medical students in other countries.

Still, he was thrilled about his promising research results on a heated balloon angioplasty device. Later, he was disillusioned to hear that after the device received FDA approval, the main competitor, a laser manufacturer, bought out the idea and shelved it to keep it off the market.

I thought his observations fit well with Dr. Poses’ concern about insidious corruption in medicine and too many physicians who don’t feel the expected fiduciary responsibility to patient welfare. As well, it makes Maggie Mahar’s term of “money-driven medicine” seem – well – on the money.