Corruption and the World Bank's Health Care Projects in India

On this blog, since all our bloggers are based in the US, we tend to focus on health care corruption, conflicts of interest, and mismanagement within our own country. However, we know these problems are global. Anyone doubting that in the least should read the 2006 Global Corruption Report by Transparency International, which dealt solely with health care corruption. (For a quick summary, see our post here.) The report asserted that:

Corruption - alongside poverty, inequity, civil conflict, discrimination and violence - is a major issue that has not been adequately addressed.... It leads to the skewing of health spending priorities and the leaching of health budgets, resulting in the neglect of diseases and those communities affected by them; it also means that poor people often decide against life-saving treatment, because they cannot afford the fees charged for health services that should be free. Corruption in the health care sector affects people all over the world.

Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care.

But the scale of corruption is vast in both rich and poor countries. Corruption deprives people of access to health care and can lead to the wrong treatments being administered.

Corruption in the health sector is not exclusive to any kind of health system. It occurs in systems whether they are predominantly public or private, well funded or poorly funded, and technically simple or sophisticated.

No other sector has the specific mix of uncertainty, asymmetric information and large numbers of dispersed actors that characterise the health sector. As a result, susceptibility to corruption is a systemic feature of health systems, and controlling it requires policies that address the sector as a whole.

Yet, it seems that the lackadaisical approach to health care corruption, conflicts of interest, mismanagement and related issues found in the US is not unusual.

For a reminder about the scope of global health care corruption and mismanagement, see an article in today's Wall Street Journal about the results of a recent investigation by the World Bank's Department of Institutional Integrity.

On Friday, the World Bank president announced in a press release that the bank had 'joined forces' with the government of India to 'fight fraud and corruption' in that country's health sector.

Corruption is an endemic problem in bank projects, swallowing unknown but significant chunks from its $30 billion-plus annual portfolio.

Yet nothing we've seen so far can compare to what has now been uncovered about five health projects in India, involving $569 million in loans. The projects were the subject of a 'Detailed Implementation Review,' a lengthy forensic examination undertaken by Ms. Folsom's Department of Institutional Integrity, known within the bank as INT. As of this writing the bank has not publicly released the review, though it's been shared with the bank's board. But we've seen a copy and are posting its executive summary on wsj.com/opinion and OpinionJournal.com (click here to see it). We are also posting photographs that show the real price that corruption in bank projects exacts on the poor. Here are some of the lowlights:

• In the $54 million 'Food and Drug Capacity Building Project,' for which money is still being disbursed, the INT found 'questionable procurement practices, some of which indicate fraud and corruption, in contracts representing 87 percent of the number of pieces and 88 percent of the total value of equipment procured.' That is nearly $9 of every $10 in aid funds.

• For the $194 million 'Second National AIDS Control Project,' the INT discovered that 'some of the test kits supplied by particular companies often performed poorly by producing erroneous or invalid results, potentially resulting in the further spread of disease.'

• In the $114 million 'Malaria Control Project,' the review found 'numerous indicators of poor product quality in the bed nets supplied by the firms.' And in the $125 million 'Tuberculosis Control Project,' the INT discovered 'bidders sharing the same address and telephone numbers, unit prices showing a common formula, and indicators of intent to split contract awards among several bidders.'

• After visiting 55 hospitals connected to the bank's $82 million 'Orissa Health Systems Development Project' (Orissa is one of India's poorest states), INT investigators found 'uninitiated and uncompleted work, severely leaking roofs, crumbling ceilings, molding walls, and non-functional water, sewage, and/or electrical systems.' It also found 'neonatal equipment that lacked adequate electrical grounding, potentially exposing babies and their medical staff to electrical shocks.'


All this would be bad enough if Indian companies or officials were making off with ill-gotten gains behind the backs of World Bank staff. Instead, the INT found evidence of the bank repeatedly looking the other way. In the case of Orissa's 55 'hospitals,' the INT found that the 'construction management consultants (CMCs) who supervised the work certified that 38 of these hospitals to be complete to project specifications.' In the AIDS Control Project, 'the bank appeared to pay scant attention to the performance and quality of the goods supplied to the blood banks and testing centers, instead focusing on the number of such facilities being erected.'

It's not a pretty picture. For some even less pretty pictures, the WSJ supplied a slide show of some of the more striking physical examples of deficiencies in health facilities covered by the report.

Such vivid anecdotes suggest the US and the world obviously need more capacity to investigate health care corruption. However, in my humble opinion, physicians and other health care professionals, sworn to put the needs of patients before all other concerns, should also be in forefront of the fight against health care corruption, conflicts of interest, and mismanagement, whether on a local or a global scale. We need more help from law enforcement, but we should not sit back and let law enforcement make the only efforts.

Of course, if physicians think that corruption, conflicts of interest, and mismanagement are only local problems, they may not be inclined to see the need for such efforts.

Thus, our goal for Health Care Renewal continues to be to make health care professionals aware of the scope and severity of these problems, in the hope that the resulting outrage will be a spur to action.

ADDENDUM (18 January, 2008) - The New York Times reported that the head of the World Bank anti-corruption unit, the Department of Institutional Integrity (INT), Suzanne Rich Folsom, has resigned, and that it was likely several of her aides would also resign. An anonymous World Bank official "said that many in the bank remained 'allergic' to efforts to prosecutie cases of fraud." Exposing vested financial interests in health care always seems to be a risky business, even, or maybe especially at a global level.

BLOGSCAN - Macy Foundation Reports Suggests Ending Commercial Sponsorship of CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat discussed a report sponsored by the Macy Foundation that suggests ending all commercial support of continuing medical education (CME). A summary of the report is here, and should be required reading.

Maggie Mahar Takes on the RUC

We have posted frequently, most recently here, here, and here about the RBRVS Update Committee's (RUC) responsibility for Medicare's relatively poor reimbursement of primary care and other "cognitive" physicians' services compared to procedures. Although the AMA claims that the RUC is just an "expert panel," it appears de facto to be the only source of input to Medicare about how to revise physicians' reimbursement. However, rather than operating transparently so as to represent the views of at least the broad physician community, the committee's proceedings are secret, as are the names of its current members, who mainly represent surgical sub-specialties. Concern about the RUC has been more evident in the blogsphere, if not openly anywhere else. Most recently, the issue was noted on the Health Beat blog. Blogger Maggie Mahar recapped the history of the RUC, discussed how its machinations boost fees paid for procedures at the expense of other Medicare spending, particularly for primary care, and suggested the need for an entirely different way to reimburse physicians

Who Decided to Change the Outcome Variable of the ENHANCE Trial of Ezetimibe?

We have posted before (as have many others, see below) about problems with the ENHANCE trial of ezetimibe (Zetia, by Schering-Plough, and one component of Vytorin, by Merck), and how the trial was designed and implemented seemed meant to increase the likelihood of a favorable result for the sponsors' interests. Particularly controversial was the sponsors' decision to change the definition of the trial's outcome variable after the data was collected. That decision was then reversed.

Today, Matthew Herper, writing in Forbes, described how the decision to change the outcome variable was made. First, the decision was made apparently entirely without any involvement by the ostensible principle investigator of the study.

Forbes has learned that the lead investigator charged with conducting the study, John J. P. Kastelein of the University of Amsterdam, was not even present when the companies made the controversial decision to change its goals, an unusual circumstance in such situations.

It's 'shocking' that Kastelein would not be party to discussion of the ENHANCE trial, says Harlan Krumholz, a cardiologist at Yale University. 'There should be a scientific committee that's independent running a study. He should be taking a leadership role.'

Asked about Kastelein not being present, Lee Davies, a Schering-Plough spokesman, said only, 'I will confirm that this was an independent expert panel.' Kastelein could not be reached for comment Wednesday or Thursday, but in the past he has said he disagreed with the company's decision to change the endpoint of the trial. In an interview with The Wall Street Journal in December, he said he breathed a 'sigh of relief' when it was changed back.

Next, Herper listed the members of the supposedly independent panel.

The list of those on the panel, obtained by Forbes, is filled with well-regarded experts in the field and should satisfy critics left wondering who was behind the recommendation to change the goals. It's not a wide-ranging committee of experts on clinical trials, but instead a group with expertise on studying the arteries with imaging technology. Four are top experts in the field of using ultrasound to take pictures of artery plaque. David Orloff, as a former Food and Drug Administration official, has expertise in exactly what regulatory challenges might be posed by changes to a clinical trial.

The panel: J. Robin Crouse and Gregory W. Evans of Wake Forest University, who conducted a study using Crestor, a rival cholesterol drug from AstraZeneca; David G. Orloff, medical director of Medpace, a company that conducts clinical trials for drug firms and the former head of the FDA division that handled the approvals of Zetia and Vytorin; Michiel L. Bots of the Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Netherlands, who has worked on similar studies and James H. Stein of the University of Wisconsin, who has conducted studies on the treatment of heart disease in patients with HIV and how various substances affect artery walls.

But is this panel really so independent? Using PubMed, I searched for conflict of interest disclosures made by its members. Guess what - you can see this one coming, can't you -

• J. Robin Crouse - "Dr Crouse reported receiving grant or salary support from Merck, Merck-Schering Plough, Pfizer, AstraZeneca, and Kos Pharmaceuticals; and giving lectures for Merck, Merck-Schering Plough, Pfizer, AstraZeneca, Abbott, and Kos Pharmaceuticals." (1)
• Gregory W. Evans - "Mr Evans reported receiving grant support and honoraria from AstraZeneca, Organon, and Pfizer; and being a consultant to AstraZeneca and Pfizer."(1)
• David G. Orloff - "David G. Orloff, MD, serves as a consultant to Amylin, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, Glaxo-SmithKline, ISIS, Merck & Co., Inc., Novo Nordisk, Pfizer Inc, Roche, Takeda Pharmaceuticals, Vivus, and Wyeth; and owns stock in Abbott Laboratories Inc., Amgen, Genentech, Genzyme, Johnson & Johnson, Eli Lilly, Merck & Co., Inc., Pfizer Inc, and Wyeth."(2)
• Michiel L. Bots - "Dr Bots reported receiving study grants for studies on carotid intima-media thickness and/or honoraria for professional input on carotid intima-media thickness issues from AstraZeneca, Icelandic Heart Foundation, Organon, Pfizer, the Netherlands Heart Foundation, the Netherlands Organisation for Health Research and Development, Servier, and Unilever."(1)
• James H. Stein - " Dr Stein has received research or grant funding from AstraZeneca, Bristol-Myers Squibb, Kos, LipoScience, PreMD, and Sanofi-Aventis, in addition to serving as a consultant to or on the speakers’ bureau for Kos, LipoScience, Merck, Pfizer, Schering-Plough, and Takeda."(3)
  

I presume that all the panel members were paid by Merck or Schering-Plough for their service on it. But all five panel members had other financial arrangements with multiple pharmaceutical companies, and three had other financial arrangements with Merck, or both Merck and Schering-Plough. So this panel may have been independent of the principal investigator of the study, but it did not seem independent of the two corporate sponsors of the study.

Thus, the case of the ENHANCE trial of ezetimibe appears to be an even stronger example of how commercial sponsors of clinical research may try to manipulate studies in ways likely to produce results favorable to their products and vested financial interests. We have posted frequently about cases in which a sponsor manipulated the design, implementation, analysis, or dissemination of clinical research to increase the likelihood that the results would favor the sponsor's product (e.g., recently here and here). One important study showed the contractual basis for such manipulation when studies are done in academic medical environments (see post here). In extreme cases, sponsors have attempted to suppress the research results entirely when they turn out to be unfavorable to their interests (e.g., see recent post here). Such manipulation, of course, is bad for patients and doctors, since it impedes their ability to make decisions about tests, treatments etc based on the best clinical evidence. It also betrays the trust of people who volunteer to participate in research thinking that the goal is to improve health care and advance science.

Although this case is striking, and has received considerable attention in the media and the blogsphere, it has been largely ignored in the health care and medical literature, the dominant source of information for physicians and health care professionals. On the Scientific Misconduct Blog, Dr Aubrey Blumsohn cataloged how extensively this case has been discussed on blogs, listing 35 related posts in the top 100 medical blogs since November. But he could find not a single mention of it in the best known English language medical journals, the British Medical Journal, Lancet, JAMA, or the New England Journal of Medicine. He asked, "One wonders how long our key medical journals will retain any credibility as honest impartial portals for discussion of science and the principles of good medicine." Thus this case also seems to be yet another example of what we have called the anechoic effect, the failure of stories about questionable ethics or bad leadership in health care to create the echoes one might expect (see post here).

See also coverage on the PharmaLot blog, updated here.

References

1. Crouse JR, Raichlen JS, Riley WA, Evans GW, Palmer MK, O'Leary DH, Grobbee DE, Mots ML, for the METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: The METEOR Trial. JAMA. 2007;297:1344-1353. (Link here.)

2. Orloff DG. Regulatory considerations in the development of high-density lipoprotein therapies. Am J Cardiol 2007; 100[suppl]: 10N-14N.

3. Keevil JG, Cullen MW, Gangnon R, McBride PE, Stein JH. Implications of cardiac risk and low-density lipoprotein cholesterol distributions in the United States for the diagnosis and treatment of dyslipidemia: data from National Health and Nutrition Examination Survey 1999 to 2002. Circulation. 2007;115:1363-1370. (Link here.)

Amgen reps instructed to poach medical records?

I very much hope the following accusations prove to be inaccurate or exaggerated. If not, what is described here is almost unbelievable.

After all the efforts by many different communities to promote the need for medical records privacy, security and confidentiality; with the penalties specified in HIPAA (albeit still rarely enforced); and with the increasingly common instances in the news of medical information misappropriation or stealing, one would think the pharma industry would be ultra sensitive to such matters.

This is not to mention that the drug in question, Enbrel, is anything but innocuous, compared to simpler remedies. This medicine interferes with the immune system, an immensely complex system whose pathways and regulatory mechanisms are not entirely understood, to say the least. There are associated complications including severe infections and malignancies such as lymphoma, to name a few.

This story, if true, also would implicate physicians, who most certainly would have known what they were doing was ethically wrong.

If the story is true, heads need to roll (figuratively speaking).

Ex-Reps Say Amgen Used Patient Records

LINDA A. JOHNSON

The Associated Press

TRENTON, N.J. - Two former sales representatives for Amgen Inc. are suing the biotech company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of a drug used to treat psoriasis.

The two former representatives, who are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece, allege they objected to superiors and refused to go along with the scheme, which legal experts say violates federal patient privacy law.

In addition, the veteran sales reps were encouraged to get insurance companies to approve reimbursement for Enbrel for patients with mild psoriasis, their attorney, Lydia Cotz, said Wednesday.

Enbrel, an injected, genetically engineered drug, is only approved for use in patients with moderate to severe psoriasis; it has severe side effects in some patients, including occasionally fatal infections. The drug is also used to treat rheumatoid arthritis.

... Amgen spokesman David Polk said in a statement that the company "does not comment on pending litigation or personnel matters. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency." ... Jim Cohen, a Fordham University law professor specializing in legal ethics and criminal law, and John Thomas, a health law professor at Quinnipiac University School of Law, said that accessing patient medical files violates the federal Health Insurance Portability and Accountability Act, known as HIPAA.

[Surely nobody in 2008 needs experts to tell us that - ed.]

Cotz said the scheme started in 2005 or sooner, after new drugs competing with Enbrel came on the market. Enbrel, one of Amgen's top sellers, had sales of nearly $3billion in 2006.

"Amgen stepped up their marketing practices to ... get all these people who were not indicated for Enbrel" to start taking the drug, she said. "Patients didn't even know what was going on."

Cotz said her clients were instructed to go into dermatologists' offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which Cotz said costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition.

"They would get on, and they wouldn't identify themselves as Amgen representatives. They would say, 'I'm calling on behalf of Dr. so-and-so,'" Cotz said.

She said representatives also were told to write letters on behalf of doctors, seeking advance approval so doctors could write prescriptions for Enbrel. Doctors writing prescriptions would benefit from frequent patient visits to have the drug injected.

"Respondents (Amgen) unethically and in contradiction of the available scientific data, promoted the prescription of Enbrel for "mild" cases of psoriasis by reinterpreting "moderate" cases" as mild, the lawsuit states, in "a total disregard of the proper care of patient recipients of Enbrel."

Cotz said sales representatives from the northeast to Hawaii have confirmed the scheme's existence.

Thomas said the allegations, if true, implicate any physicians who went along with the scheme for authorizing "marketing of medication not designed to treat their patients."

One also wonders, if true, if there were other "incentives" to physicians to go along with this scheme, besides the hope of more frequent patient visits for injections.

-- SS

CellCyte's Wild Ride

Several newspaper articles in the last month chronicled the wild ride of a tiny biotechnology company called CellCyte Genetics. CellCyte's web-site claims it to be "an emerging biotechnology leader focused on the development and commercialization of breakthrough stem cell-enabling therapeutic products." A somewhat different story was first told in the Vancouver Sun by David Baines:

CellCyte began as a nondescript Vancouver exploration company called Shepard Inc. The two senior officers were Michael Eyre, owner of a Richmond car dealership, and Glen Macdonald, a Vancouver geologist who is actively involved in creating shell companies.

The company, with the help of Vancouver chartered accounting firm Morgan & Co. and Vancouver geologist Bill Timmins, filed a registration statement with the U.S. Securities and Exchange Commission in 2005 as a prelude to trading on the OTC Bulletin Board.

It was difficult to believe this was an earnest business endeavour. Shepard had only one mineral claim in the Northwest Territories, costing just $2,500. By all appearances, it was being created for some ulterior purpose.

Sure enough, in January this year the company announced it would acquire CellCyte, a Kirkland, Wash.-based company 'engaged in the discovery and development of breakthrough stem cell enabling therapeutics.'

In June, CellCyte -- with the help of filing solicitor Thomas Deutsch of Vancouver law firm Lang Michener -- filed a disclosure statement showing, among other things, that one of its major shareholders was Newport Capital Corp., a Zurich company controlled by Brent Pierce, who is currently serving a 15-year stock market ban in B.C. for fraud.

For years, Pierce has been able to tip-toe around his ban by promoting U.S. over-the-counter companies like CellCyte -- which are not B.C. reporting issuers and therefore outside the jurisdiction of B.C. securities regulators.

His other promotions have included Lexington Resources (high $7.46, now one cent); Uranium Energy (high $9.25, now $3.30); Morgan Creek Energy (high $5.40, now 30 cents); GeneMax (high $47, now 21 cents); and Geneva Gold (high $3.50, now $1.50).

Now Pierce is focussing on CellCyte. In October, he hired U.S. pen-for-hire James Rapholz to tout the stock:

'Now, a practical 'pill-in-a-bottle' application puts the miracle of regenerative medicine within immediate reach!' Rapholz gushed in a 12-page report.

At the time, the stock had levitated to $5.70, but he clearly expected much more: 'Invest just $5,000 now . . . and you could have $7 million.'

To produce and distribute this piece of hysteria, Pierce (through his private company, Stockgroup AG) paid Rapholz a stunning $445,000.

The story was then picked up by the Seattle Times. Its reporter, Angel Gonzalez, also found out that,

CellCyte's auditor also has regulatory issues. Just months after the firm, Williams & Webster of Spokane, signed off on CellCyte's 2006 financial statements, the national Public Company Accounting Oversight Board in June took the unusual step of barring one of its two name partners from associating with any accounting firm, and suspended the other for a year, over inadequate scrutiny of a different public company.

At that point, Ed Silverman began a post on the story on the PharmaLot blog with this introduction, "This is the sort of tale that gives biotech a bad rap, in our view." (Predictably, an anonymous commentator on that post claimed, without documentation, that Angel Gonzalez based the whole story on the ramblings of a disgruntled former employee, conveniently ignoring the Vancouver Sun version.)

Yesterday things came somewhat unglued. Angel Gonzalez again wrote in the Seattle Times,

Shares in fledgling biotechnology company CellCyte Genetics, whose market value soared to more than $400 million last fall after being hyped by offshore shareholders, plunged 55 percent Monday and Tuesday in heavy selling.

The sharp drop coincided with changes made on the company's Web site after The Seattle Times inquired late last week about the accuracy of statements in the biography of CellCyte chief executive and co-founder Gary Reys.

Claims removed from the Web site include statements that Reys had led his previous company 'from conception to early human clinical trials in 18 months,' and that he had helped an early generic pharmaceuticals company through an initial stock offering and a sale to a drug-industry giant.

Reys said any inaccuracies in his profile were unintentional.

But other misleading statements remain on the company's site and in the filing it made with the Securities and Exchange Commission to begin trading its shares.

• Both documents state that he 'attended the University of Washington and majored in finance.' According to university records, however, he enrolled in autumn 1965 and withdrew within weeks; he did not receive any credits toward a degree.

• Both documents say Reys received a 'CPA designate,' and until late last week the Web site said he was a past member of the Washington Society of Certified Public Accountants. But the Washington state Board of Accountancy says he is not registered as a certified public accountant, nor does it have any record that Reys took the CPA test in the state.

As was noted widely in the news, a Health Affairs article (see this Health Affairs blog post and its links) documented that US health care spending now exceeds $2 trillion dollars. The enormous flow of money through health care seems to be attracting far too many people who are more interested in money in their own pocket than the serious business of helping patients get better, or at least better endure their illnesses. This depressing little case of a company that seems to be operating in the Wild West of health care is a sobering reminder of why we need to be skeptical of all those "innovative entrepreneurs" who have invaded health care and medicine.

But let's hope that all this is merely a flash in the pan, and CellCyte ends up producing some wondrous applications of "regenerative medicine."

New company explicitly recognizes need for clinical and informatics leadership of health IT

In 1969, EMR and Medical Informatics pioneer Donald A. B. Lindberg, M.D., now Director of the U.S. National Library of Medicine at NIH, observed that:

"Computer engineering experts per se have virtually no idea of the real problems of medical or even hospital practice, and furthermore have consistently underestimated the complexity of the problems…in no cases can [building appropriate clinical information systems] be done, simply because they have not been defined with the physician as the continuing major contributor and user of the information" (Lindberg DAB: Computer Failures and Successes, Southern Medical Bulletin 1969;57:18-21).

Many others have made this (fairly axiomatic) observation over the intervening years, and have put detailed information about these issues in journals and on the web such as my academic site here. That site was originally named "Medical informatics and leadership of clinical computing" back in 1998 or so in recognition of the need for a change in leadership of clinical IT initiatives.

In 2008, this issue is starting to get credible traction. A new organization has appeared that bases its business model on this issue of knowledge gap between clinician and IT. This is a very "in-your-face" challenge to the often dogmatic, heavily-ingrained standard operating practices of the software industry, and particularly the management information systems field, that would find true end user leadership of design and implementation an alien concept. (I bear battle scars inflicted by MIS professionals in hospitals from my promoting this concept in health IT.)

I thus consider the company's forthrightness remarkable (I wryly add that it is remarkable that this 'innovation' in thinking about health IT even needs to be called remarkable):

Champions in Healthcare Has ‘Soft’ Pre-HIMSS Launch

By Neil Versel January 09, 2008

A new consulting firm founded by clinicians hopes to overcome one of the greatest barriers to widespread use of health-IT by concentrating on how physicians and nurses think and work ... “We’re not supporting the way that physicians are comfortable assessing data,” [Sam Bierstock, M.D., founder of "Champions in Healthcare", and previously chief medical officer at IBM and an executive at EHR vendor Eclipsys] explains.

“It’s time for the clinicians to be orchestrating this process.” “We have a lot of square technical pegs being crammed into round clinical holes,” Bierstock says, noting that doctors and nurses often are left out of the process of selecting and implementing systems. “We want to represent the physician’s voice to anyone,” including hospitals, health insurers, and vendors, Bierstock adds.

The explicit recognition of this issue is a welcome development. There are some well-known medical informatics experts acting as consultants to this initiative.

Champions in Healthcare call their process “thoughtflow.” Bierstock explains: “That’s how physicians access, assess, prioritize, and act on information.”

Here is where the vision of this company and I diverge. First, this neologism represents a new 'buzzword' with which the IT industry is overflowing. Many serious managers dislike buzzwords. Second, inventing cute new names for the information flow models of healthcare, while understandible from a branding perspective, adds an element of weakness to the initiative. It is a term that those with vested interests in the status quo - where IT leads and clinicians follow - can and likely will disparage. It might have been better to use more formal, less "creative" terminology to describe the problems and proposed solutions. However, this may be a matter of taste.

My major concern is that the new company Champions in Healthcare seems to present it solutions to these issues as one of applying logical, experiential knowlege to the problem and advising clients on how to change the culture of IT-dominated clinical IT. However, the assumption seems to be that there will be little pushback on this issue. If this were the case, perhaps others would have solved these problems years ago, well known not just in health IT but in all areas of IT, namely the inadequate involvement of end user domain experts in IT design and implementation. Yet in 2008 it's still more common than not, industry-wide, along with other issues causing IT project difficulty and failure. For example, see:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. link to pdf

The company mentions in its site under the heading "The Challenge" the problems that occurred in the UK's national EMR project:

In July 2007, the departing head of the National Health Service in Britain stated he was "ashamed" of some of the IT systems developed during his tenure, that they were unusable because they were built "without listening to what end users want. They have taken some account but then they had to take a lot more." It is critically important to engage experienced clinicians in a rigorous research and development process that also involves the computer and information science communities. Their collaboration is key to formulating an algorithmic understanding of what clinicians need.

(More on that issue is here in my post "Is clinical IT mayhem good for [the IT] business? UK CfH leader Richard Granger speaks out.")

However, what is omitted is mention of the varied sociotechnical issues that create this lack of collaboration. It's not just a "knowledge gap." It also involves politics, power, influence, territoriality, money, deeply ingrained ideologies about IT (e.g., MIS practices), ego, pride, and other human, sometimes irrational, emotional factors. One wonders if the new company will be effective if it takes what might be described as a milquetoast academic/consulting stance with potential clients regarding these all too human, reactionary factors maintaining the status quo.

One other area of concern is the company's stated service of evaluating candidates for CMIO (chief medical informatics officer) roles. I've written extensively on hcrenewal and elsewhere on this issue. Many CMIO candidates will be known to the principals and consultants of this company, and healthcare informatics is itself a highly political field. One wonders if their recommendations about specific candidates to healthcare organizations will have objectivity and transparency.

In all, however, I view this development positively and wish the new company success. It has set its focus on what I consider one of the strongest impediments to effective healthcare information technology.

(I add that I have no connections whatsoever to the company.)

-- SS

Will MinuteClinics be a Wash?

We have blogged several times, (most recently here, here, and here) about one of the latest health care fads, in-store clinics. Such clinics are situated in retail stores, such as drug stores, staffed by nurse practitioners, but usually not doctors, and claim to treat a limited number of ailments quickly for reasonable prices. They have been touted as the latest business-like solution to the decline of primary care.

A lot of people have objections to this concept. My concerns center around how the clinics will be able to manage patients whose problems are not so simple as they first seem.

Sometimes what a patient thinks is a simple problem is not. For example, a patient may come to the clinic for the treatment of a sore throat, but actually have an exacerbation of chronic obstructive pulmonary disease.

Sometimes a patient with a simple problem has other, not so simple problems of which they are unaware. For example, a patient with a bladder infection may also have undiagnosed, but uncontrolled diabetes.

Why would in-store clinics not cope well with such patients? One reason is that nurse practitioners, no matter how able and well intentioned, do not have as extensive training and experience as most primary care physicians. They may not know all the possible causes of common complaints, and not recognize subtle symptoms and signs that indicate more complex problems.

Another reason is that the people who developed the in-store clinic model may not understand the health care context well enough to appreciate these issues. Many people pushing in-store clinics seem to be business executives with no on the ground health care experience. For example, we previously noted that Michael Howe, the CEO of MinuteClinics, a subsidiary of CVS Caremark, was "recruited for his leadership experience," but this experience mainly seemed to be in the restaurant business. Howe was the former CEO of Arby's Inc./Triarc Restaurant Group, and before then an executive for KFC, according to this article in the Minneapolis/ St Paul Business Journal.

My concern about how well the people designing in-store clinics understand the health care context was highlighted by today's Boston Globe article that described how Massachusetts state regulators have just cleared CVS Caremark to open MinuteClinics in the state. Here are the crucial two sentences:

The panel's members also wanted hand sanitizer available at the clinics and restrooms adjacent to the facilities so that patients don't have to walk across the store. All these provisions were incorporated in the regulation adopted yesterday.

This article implies that CVS Caremark MinuteClinics will not have any plumbing within the clinics proper. They will not have sinks and soap dispensers, and they certainly will not have toilet facilities. How adjacent such facilities would be is unclear.

Why is this a big problem?

Take a look at the list of conditions which MinuteClinics claim to be able to treat. They include "bladder infections," "pink eye and styes," and a variety of skin infections.

Diagnosis of bladder infections requires a urinalysis, and usually a urine culture. How will MinuteClinic patients provide urine samples? If patients are required to go out into the CVS store to find a bathroom, produce their sample, and go back to the clinic, how many would refuse out of embarrassment? If patients with bacterial urinary tract infections fail to provide urine samples, they might not get needed treatment. If patients without such infections fail to provide urine samples, they might get unneeded antibiotics. Also, would waiting for patients to provide urine samples slow down patient flow so that MinuteClinics become HourClinics?

It gets worse. "Pink eye" is often caused by viral conjunctivitis, which can be highly contagious. Health care professionals can cut down on its spread by thorough hand washing after seeing affected patients. (This is one of many reasons that you will almost never see an American doctor's office examining room without a sink and soap.) But MinuteClinic nurse practitioners will not have a sink and soap within their clinic, and will have to go out of the clinic, and wash their hands in whatever facilities CVS provides. Because of this inconvenience, and the time pressure inherent in the MinuteClinic concept, would the nurse practitioners sometimes fail to wash their hands when indicated? If they would not wash their hands, they would be at risk of transmitting viral conjunctivitis to other patients, and acquiring it themselves.

It gets still worse. MRSA (methicilin-resistant staphylococcus aureus) infections have been on the rise. MRSA can cause skin infections that are not specific in appearance. It is likely that some patients going to MinuteClinics for one of the common skin infections that the clinics are supposed to be able to treat will really have MRSA. For the reasons above, would the nurse practitioners fail to wash their hands after every such patient they see? If they would not wash their hands, they would be at risk of transmitting MRSA to other patients, or acquiring it themselves.

The failure of the executives of MinuteClinics to make sure that every one of their clinics has an in-clinic sink and toilet suggests that these executives really do not understand the health care context well enough to appreciate what they are getting into. I worry about what unrealistic assumptions have gone into the development of the in-store clinic concept.

The common business school notion that an executive does not need to know anything specific about the nature of the business he or she leads will continue to plague health care, maybe this time, literally.

Health Care Renewal Bloggers to Present

Health Care Renewal bloggers are scheduled to make some presentations this spring.

First, I will be participating in a special symposium on comparative effectiveness research at the Society for General Internal Medicine (SGIM) annual meeting in Pittsburgh, PA, USA. The session will be on Friday, April 11, 2008 from 10:30 AM - Noon, co-sponsored by the Sydenham Society, entitled, "Comparative Effectiveness: What, How, and Who?" I will be emphasizing the importance of transparency and avoiding conflicts of interest.

Second, Dr Wally R Smith and I will be presenting a short course on challenges and threats to evidence-based practice at the European meeting of the Society for Medicine Decision Making (SMDM) in Engleberg, Switzerland. The session will be on Sunday, June 1, 2008, and is entitled, "Why Aren’t Physicians’ Practices Evidence-Based? - Cognitive and Environmental Challenges to Evidence-Based Practice."

A Skeptical Look at a Dire Warning: Is Medicare "Willing to Let Seniors Suffer and Die Sooner from Cancer?"

Yesterday's Providence Journal included an op-ed by Robert Goldberg, entitled "Fewer Drugs, Fewer Seniors," featuring this dire warning:

Now, to save money, America’s Medicare program is willing to let seniors suffer and die sooner from cancer....

How in the world could Medicare do that?

As a first step, the Center for Medicare and Medicaid Services (CMS), which runs Medicare, decided to restrict reimbursements for erythropoiesis stimulating agents (ESAs) — drugs that prevent the fatigue from chemotherapy-induced anemia.

In this case, CMS came up with a new standard for paying for new drugs called the Precautionary Principle. This principle, developed by environmental extremists in Europe nearly 20 years ago, states that anything unknown is unsafe and should not be used. CMS asserts that it does not know enough about the safe use of ESAs beyond achieving a specific hemoglobin level. So it won’t pay for anything above that point. No exceptions. If seniors feel fatigued or confused they can pass the hat like Chantelle Hill.

And why in the world would they do that?

The CMS decision has nothing to do with safety and everything to do with cost.

But before hitting the panic button, consider how the author of the op-ed, Robert Goldberg, identified as "Vice President of the Center for Medicine in the Public Interest," tried to support his contention.

First, he ignored the most relevant evidence while criticizing less relevant studies.

CMS says that ESAs cause cancer and heart problems beyond hitting a hemoglobin target of 10 g/dL. But that claim is based largely on two studies that examined the experimental use of extremely high dosages of ESAs in patients without cancer.

Goldberg ignored six studies that used different doses of different erythropoetin products (or ESAs, to use his terminology) to achieve different target hemoglobin levels in patients with various kinds of cancer. Four were published, and all six were summarized last June in the New England Journal of Medicine [Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer. N Engl J Med 2007; 356:2445-2448. Link here.] Five of the studies showed shorter average survival in patients given erythropoetins. One showed increased progression of disease and a statistically insignificant trend towards decreased survival. This set of studies raise the concern that erythropoetins, rather than preventing early death, may hasten early death.

Next, Goldberg turned to the US Food and Drug Administration (FDA) for support.

The Food and Drug Administration, its European counterpart the European Medicines Agency, and physician groups such as the American Society of Clinical Oncologists recognized the value of these studies in guiding clinical decisions but not restricting them.

It is very rare for the FDA to restrict use of a drug already on the market. Actually, the FDA has emphatically warned about the possibility that erythropoetins may hasten death, rather than increase survival. The FDA considered the six studies summarized in the Khuri article above, and issued the following official "black box" warning for these drugs (for example, see label for Epogen below).

WARNINGS: Erythropoiesis-Stimulating Agents

Use the lowest dose of EPOGEN® that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion (see DOSAGE AND ADMINISTRATION).

EPOGEN® and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL (see WARNINGS: Increased Mortality, Serious Cardiovascular and Thromboembolic Events).

Cancer Patients: Use of ESAs
• shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL;
• shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL;
• increased the risk of death when administered to target a hemoglobin of 12 g/dL in patients with active malignant disease receiving neither chemotherapy nor radiation therapy. ESAs are not indicated for this population.

Finally, Goldberg asserted,

Seniors who are stronger and don’t have to spend time shuttling to the hospital are better equipped to endure newer and more powerful combinations of cancer drugs in the elderly. Indeed, a recent study conducted by Columbia University’s Frank Lichtenberg found that an aggressive chemotherapy regimen for seniors extends life expectancy by 8 to 12 months.

Lichtenberg's study seems so irrelevant that I wonder if it was raised as a deliberate distraction. Goldberg's original warning was about restrictions on payments for erythropoetins, not about chemotherapy. That Lichtenberg's study is not yet published, and that Lichtenberg is an economist at the Columbia Business School, just add to the irrelevance.

So to summarize, Robert Goldberg's dire warning that Medicare is out to make sure, as implied by the title of his article, there are "Fewer Drugs, Fewer Seniors," seemed to be based on a mixture of half-truths and irrelevancies. So why did he make this warning?

I don't know, but what the Pro Jo article did not reveal is some relevant background information about the ties of Goldberg's organization to pharmaceutical companies. We have noted before that Goldberg works for the Center for Medicine in the Public Interest, whose president is Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee has many big pharmaceutical accounts, as listed on the CommuniqueLive.com site. This suggests at least an indirect conflict of interest, favoring the interests of the pharmaceutical industry, that should have been revealed in this op-ed article. Furthermore, in a post on CMPI's DrugWonks.com blog, Goldberg acknowledged "CMPI accepts grant from drug companies -- and we do so proudly because they actually invent things that help people."

We have previously posted about other stealth health policy advocacy coming from CMPI (here and here.)

If CMPI really accepts money from pharmaceutical and biotechnology companies "proudly," its officers should not be afraid to make this and any other financial ties they may have to these companies clear when they write op-eds in major newspapers. That might at least alert readers who are not trained in evidence-based medicine to be a bit skeptical about the apparently scientific, but actually mostly irrelevant references with which they adorn their writing, and to wonder how much relevant evidence they did not bother to include.

That health care in the US is now in a crisis is now a cliche. Finding our way out of this crisis requires logical discussion based on evidence, not half-truths and irrelevancies promulgated by people with hidden financial ties.

BLOGSCAN - $57.5 Billion Spent Yearly on Pharmaceutical Marketing

PLoS Medicine just published an article that compared US pharmaceutical company expenditures on marketing with those on research [Gagnon MA, Lexchin J. (2008) The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Med 5(1): e1 doi:10.1371/journal.pmed.0050001.] Based on Gagnon and Lexchin's analysis, the estimated expenditures on marketing, $57.5 billion, were almost double estimated expenditures on research and development, $31.5 billion, and amounted to nearly 3% of the estimated $2 trillion spent on health care in the US.

Let's repeat that. Marketing of pharmaceuticals accounts for about 3% of total US health care spending.

Two bloggers presented more detailed and interesting takes on this study. This post on the Clinical Psychology and Psychiatry blog focused on how pharmaceutical companies and their supporters have capitalized on exaggerated perceptions of their spending on research and development. Although this spending is hardly trivial, it no longer seems so large in comparison to their spending on marketing. This post on the Hooked: Ethics, Medicine and Pharma blog explained how difficult it is to estimate drug companies' marketing spending, and noted how this difficulty exemplifies theses companies' lack of transparency.

BLOGSCAN - Pharmaceutical Marketing and Physicians

A press release for a new study about pharmaceutical company marketing said, "When it comes to giving samples and writing prescriptions, doctors are swayed by science -- not by cozy relationships between themselves and pharmaceutical marketing reps or by advertising aimed at patients, new research shows." Dr Howard Brody, writing on the Hooked: Ethics, Medicine and Pharma blog, looked at the study, and came to some different conclusions.

Neurosurgeon Admits Kickbacks from Medical Device Manufacturers

I used to read a lot of detective and mystery novels when I was a kid, but I never thought as a physician I would end up devoting so much time commenting on true crime news.

This story, which has its lurid aspects, was reported with various local slants by newspapers in Arkansas, Massachusetts, and Canada. It may have implications that go beyond these local angles. Let me try to piece it together. For an overview, we start with the Canadian National Post,

A Canadian neurosurgeon pleaded guilty in an Arkansas court yesterday to taking hefty kickbacks from medical-device suppliers and agreed to pay the U.S. government and a whistleblower $1.5-million in compensation.

Dr. Patrick Chan could also face up to five years in jail when he is sentenced later in the dramatic case, which involved an undercover sting operation, hidden FBI video cameras and envelopes brimming with cash.

Pressure is now mounting on him to testify against one company that, according to newly divulged allegations, offered him stock options worth at least $1-million as part of a kickback arrangement. Lawyers say Dr. Chan's guilty plea may be just the first step to opening the window on a much broader kickback program.

He also still faces several lawsuits for allegedly performing spine operations that were unnecessary and severely damaging to patients.

Dr. Chan was charged in late 2006 with accepting thousands of dollars in kickbacks from device suppliers. Kelley Yielding, a sales representative for a number of manufacturers, wore recording equipment at the request of police as she handed over cash payments to him. In a strange twist, Ms. Yielding died suddenly the night before she was to testify at a grand-jury hearing, though police have ruled out foul play.

Dr. Chan pleaded guilty yesterday to one count of the kickback charges, while three others were withdrawn in a plea bargain with prosecutors that did not address his sentence.

The coverage in the Boston Globe focused on Chan's involvement with one medical device company, but suggests that he was involved with multiple companies.

The Massachusetts subsidiary of an international surgical device manufacturer is under federal investigation for allegedly paying kickbacks to doctors to use its equipment, according to court documents and company disclosures.
more stories like this

The federal case against Blackstone Medical of Springfield got a boost yesterday when an Arkansas neurosurgeon pleaded guilty to soliciting and accepting kickbacks from a salesman who worked for Blackstone's parent company, Orthofix International, based in Netherlands Antilles, as well as three other companies.

Orthofix purchased Blackstone in 2006, and has set aside $50 million of the purchase price to pay for possible settlements of allegations involving improper payments to doctors. Blackstone manufactures and sells devices used in spinal surgery.

The Boston Globe story also noted that allegations were made about how the companies paid Chan.

Yesterday, Chan also agreed to pay $1.5 million to settle allegations against him in the whistle-blower suit, which alleges Blackstone and another company provided kickbacks in the form of bogus consulting contracts, fake research studies, and gifts to Chan and doctors across the nation who agreed to use the companies' devices in back surgeries. The whistle-blower suit, filed on behalf of the government, alleges that the scheme led to false claims by hospitals where the operations were performed that defrauded the federal Medicare and Medicaid programs.

I should note here that we posted extensively, most recently here, about how manufacturers of orthopedic devices paid orthopedic surgeons often huge amounts, ostensibly for consulting, speakers' honoraria, royalties, or research expenses. The new case of Dr Patrick Chan at least raises the possibility that sometimes payments labelled in this way made by commercial health care companies to physicians may be not merely sources of conflicts of interest, as we have discussed (here and here), but also kickbacks and bribes.

The Globe supplied some more details about the alleged kickbacks.

In the whistle-blower suit, Thomas alleges that Chan stopped buying equipment from him after Chan signed a $25,000 consulting agreement with Blackstone. Thomas had earlier rebuffed a request from Chan for cash kickbacks, even after Chan said salesmen for competing companies were providing them, according to the suit. Thomas also alleges that Blackstone, through a sales agent, offered similar bogus consulting contracts to other doctors in Arkansas, Missouri, Mississippi, and other states. The suit also alleges that Chan performed unnecessary surgeries. While he admitted guilt in the criminal matter, Chan did not admit wrongdoing in settling the whistle-blower case.

Finally, a story in the Searcy, Arkansas, Daily Citizen suggests other companies that may be involved.

A class action suit was filed against Chan and the medical supply companies Orthofix, Osteotech, Alphatec [presumably Alphatec Spine Inc] and Signus [presumably Signus Medical LLC] by attorney John Ogles of Little Rock in the case of Scotty Foster of Searcy.

A civil suit was filed by Eddie Don Glenn of Searcy against Chan and Orthofix, Osteotech and Alphatec Spine by attorney Watson Bell of Searcy.

The Rollins, Foster and Glenn suits were filed in White County Circuit Court and are assigned to judge Bill Mills.

A $2 million federal civil suit was filed by John Thomas in an attempt to recover money for the federal government which Thomas claims was illegally billed and collected.

That case will be heard by judge Leon Holmes and defendants are Chan, Michael M. Bailey, Bailey Management Group, the Foundation for Orthopedic and Spine Education and Research, Innovative Health Solutions, Motiontek, Blackstone and Synthes, Inc.

Again, what makes this story important is that it seems implausible that the case of Dr Patrick Chan was unique. If he in fact was being paid kickbacks, possibly by multiple companies, disguised as consulting payments and research funding, it is likely that many other doctors received such payments. At least the National Post story suggested some people are already thinking along these lines. Thus, this small cloud could presage a huge storm.

And again, the story reminds us of the pervasiveness of conflicts of interest in health care. Further, more of these conflicts may cross the line to criminality than we heretofore believed.

ADDENDUM (4 January, 2008) - See also comments on the Managed Care Matters blog by Joe Paduda, and on the WSJ Health Blog.

Former Leader of Now Bankrupt Institute for Cancer Prevention Pleads Guilty

A brief AP story published in Newsday alerted me to a significant story of malfeasance that destroyed a once prestigious medical research institution, but till now has remained surprisingly anechoic. Let me piece it together chronologically.

The Institute for Cancer Prevention (IFCP), formerly the American Health Foundation, was hailed (in a press release by New York Senator Charles Schumer) as "the only National Cancer Institute designated cancer center exclusively devoted to cancer prevention research." The Institute was described in a New York Post article (not on the web, Edelman S. Cancer scandal: bankrupt institute blew $5M. NY Post, Oct 3, 2004.):

Known for its early research linking smoking and cancer, the IFCP was the only government-supported center that focused solely on prevention.

It was respected for groundbreaking work on how diet can prevent cancer, touting the benefits of soy, garlic, zinc, tea and low-fat foods.

The institute boasted Rudy Giuliani as guest speaker at its last fund-raising gala, and Bill Clinton came to accept an award given to his wife, Sen. Hillary Rodham Clinton. Whoopi Goldberg hosted an event in 1998.

In February, Sen. Chuck Schumer called IFCP 'one of the world's very best research facilities.'

But in 2004, the Institute abruptly and unexpectedly declared bankruptcy, again per the NY Post,

Financial problems cropped up in 2000 when the institute had to repay the government's National Cancer Institute $4 million in overspent grants.

But the problems continued, culminating in a terse letter to [ICFP President Dr Daniel] Nixon from the institute on Sept. 9.

The letter, written by NCI grant manager Leo Buscher, said the IFCP 'improperly withdrew $5.7 million and inappropriately used those funds for non-grant-related expenses.'

He told The Post the funds should have been used only for researcher salaries, animals and lab supplies, but were diverted to cover the institute's overhead expenses.

'It was a surprise it had gotten so bad and so big,' Buscher said of the overspending.

Increasingly generous executive pay and high rent were biting into the institute's $18 million budget.

Nixon raked in $403,000 in salary and benefits in 2002, according to the latest tax returns filed.

A half-dozen other managers and consultants got $150,000 to $286,000 a year, the records show.

Last year, the institute left a cramped office on the East Side near 42nd Street and leased 15,000 square feet at the Gorham Building on Fifth Avenue and 36th Street.

A subsequent NY Post story suggested that the Institute's President lived the good life at Institute expense while the money was being diverted (not on the web, Edelman S. Wine-&-Dine cancer doc; his institute hits bottom $. NY Post, Oct 10, 2004.)

Dr. Daniel Nixon, a noted cancer doctor whose patients included Jimmy Carter's mom and Atlanta Braves players, was living high as New York's prestigious Institute for Cancer Prevention collapsed around him, The Post has learned.

Nixon, 61, the IFCP president who was paid more than $400,000 a year, enjoyed a full-time chauffeur and leased a car at the institute's expense.

A nutritionist who touted raspberries and strawberries to prevent certain cancers, Nixon jetted around the country to wine and dine 'potential donors,' said sources familiar with his expense vouchers.

Note that the bankruptcy of the Institute was covered in a news item in Science. As far as I can tell, it was never covered in the national media, particularly in the NY Times or the Washington Post, or in any medical or health care journals.

In early 2007, the US Attorney for the Southern District of New York announced a settlement:

Michael J. Garcia, the United States Attorney for the Southern District of New York, announced today that Dr. Daniel Nixon, former president of the Institute for Cancer Prevention ('IFCP'), IFCP’s former officers, and the former members of IFCP’s Board of Trustees have agreed to pay $2,300,000 to resolve civil False Claims Act charges and any other civil claim arising from IFCP’s alleged unlawful receipt and use of federal grant money. In addition, Tatum, LLC ('Tatum'), a financial services firm, has agreed to pay $400,000 to resolve civil claims arising from its services to IFCP. Finally, Weiser, LLP ('Weiser'), IFCP’s outside auditor, has agreed to pay $500,000 to resolve negligence claims relating to its audits of IFCP.

The settlement acknowledged:

During calendar years 2002 and 2003, however, IFCP drew down approximately $5 million of federal grant money to pay bills that were not eligible for reimbursement under its federal grants. In addition, IFCP submitted false financial reports regarding its draw downs to the United States Department of Health and Human Services ('HHS').

But of course,

The settlement does not release any of the parties for any violation of the criminal laws. None of the parties making payments under the settlement agreement has admitted any liability or wrongdoing in connection with the settlement.

As far as I can tell, the settlement received no local, much less national news coverage.

What brought all this to my attention was yesterday's AP story (in Newsday).

A bankrupt cancer research center's former finance chief has admitted lying to FBI agents investigating whether the institution misused federal money.

'I am truly sorry, and I accept responsibility,' Roy Victor said as he pleaded guilty in U.S. District Court Wednesday to obstruction of justice. He faces a possibility of up to 10 years in prison at his sentencing, set for April 18.

Victor, 44, was the Institute for Cancer Prevention's chief financial officer from November 2001 to May 2003. Federal authorities started questioning him in November 2004, two months after the Valhalla-based institute filed for bankruptcy. Federal auditors had found that the research center had improperly sought to use grant money for expenses not related to the grant's purpose, according to court papers.

Victor acknowledged lying when he told federal investigators the institute had not submitted false statements to hide improper requests to draw on $6 million in Health and Human Services Department grants.

This sad tale illustrates what I suspect is an all too common phenomenon. In a go-go, get rich quick, narcissistic culture, in an economy in which health care has become a $2 trillion a year "industry," and in a business climate that worships the "imperial CEO," many respected health care organizations and institutions have been taken over by the wrong sort of people. Their leaders often at best have no understanding or sympathy for the health care mission and health care ethics. At worst, some of their leaders are criminal (see, for example, Mr Victor above) and corrupt. Leaders interested first in short-term financial gain and lining their own pockets are weakening, and in this case of the Institute for Cancer Prevention, have destroyed, some of our best and most revered health care institutions.

Until we make the governance of health care organizations more transparent, accountable, ethical, and respectful of the organizations' missions, things will continue to go down hill. And until physicians, policy makers and the public become aware of the damage being done by ignorant, conflicted and corrupt leadership of health care organizations, nothing will be done at all.

ADDENDUM (5 January, 2008) - Also see more background, links, and comments in this post on the Junkfood Science blog.

BLOGSCAN - Brody on Jarvik

Have you been annoyed by those television ads for Lipitor (atorvastatin, made by Pfizer Inc) featuring Dr Robert Jarvik? Have you wondered why TV viewers should listen to his advice? On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody cited investigative reporting by Robert Bazell on MSNBC about Jarvik's (lack of) qualifications to market Lipitor. Although he has an MD, he never did an internship or residency and never practiced medicine. And his Jarvik 7 artificial heart was not a big success.

More About the Inexplicable Shutdown of a Quality Research Project

We have posted twice about the inexplicable decision by the US Office for Human Research Protection (OHRP) to shut down an observational study which meant to assess possible effects of a quality improvement initiative aimed at reducing hospital infections (here and here). Maggie Mahar, who also posted about the story in the Health Beat blog, did a little follow up investigation, which she initially reported in a comment on her initial post, and then, in somewhat more detail, on a post on the Health Care blog. It turns out that the history of the OHRP is somewhat questionable, and may be a surprise to many. I, like I am sure others, actually confused the OHRP with the Office of Protection from Research Risks (OPRR). But it turns out, according to Mahar,

As for the ORHP itself, I'm told its a 'strange creature' that was created in 2000 to replace the Office of PRotection from Reserarch Risks. Allegedly, the Office of Protection from Research Risks, which reported to the NIH, had been doing its job too zealously.

The OHRP would report directly to the assistant secretary of health--giving the administration more control over its activities.

Furthermore,

When ORHP began writing letters to Johns Hopkins and Michigan the head of OHRP was Bernard Schwetz. (He suddenly resigned in August, but this all happened on his watch.) Schwetz is a veterinarian. I'm not kidding. He's a DMV. He also has a Ph.D. and is a toxicologist.

When you look into his background, you find out that he seems to be a political appointee. At the very beginning of Bush's first term, Schwetz was made deputy acting commissioner of the FDA. That's right a vet was deputy acting commissioner of the FDA for a year. (I have nothing against vets, but this doesn't make a lot of sense.)

This was not a bright period in the FDA's history. During Schwetz's tenure, Dan Troy, who was the FDA's counsel, began running the FDA from behind the scenes. Troy had a been long-time enemy of the FDA-- representing Brown & Williamson in its fight against the FDA and, just a few months before he joined the agency, Troy was representing Pfizer in another battle with the FDA. As one magazine (U.S. News?) put it 'Mr. Outside Goes Inside' and proceeded to do his best to dismantle the FDA.(This is all documented in my book, Money-Driven Medicine. Congressmen protested and eventually Troy was forced to resign.)

The FDA Counsel was a former lawyer for the tobacco industry? It turns out that was true. He had also previously represented Pfizer. He was also accused of being far too cozy with the pharmaceutical industry while he was at the FDA (see this news article from the BMJ). Apparently Troy was also the first FDA Counsel who was a political appointee (see this news article from JAMA).

A veterinarian was running the Office of Human Research Protection? Curiouser and curiouser. I hope that Maggie Mahar and others will look further into this. Stay tuned.

ADDENDUM (4 January, 2008) - Ms Mahar updated her discussion of the background of the OHRP and OPRR here on the Health Beat blog.

ADDENDUM (18 January, 2008) - Ms Mahar has added several more updates, the most recent here. Also see this post from the Comarow on Quality blog. Comarow interviewed OHRP officials, but still was unable to figure out the reason they shut down the research project.

Why Pharma Fails

... from the Medical Informatics perspective.

(I've previously written on this issue at "Drug industry officials see room to improve safety - or do they?" and at "FDA's hefty bonuses seek to retain workers.")

The following job ads appeared recently for a Business Analyst (BA), Clinical Research Information Services and a Business Analyst, Clinical Data Repository Services at a major pharmaceutical company. They are similar to ads that have appeared at least for the past several years from multiple pharmas.

First and foremost, conflation of the term "business analyst" with "clinical research information" suggests a profound lack of understanding of the difference between information technology (especially mercantile, manufacturing, and management computing applications) and information science (including scientific computing applications, of which clinical computing is a subspecialty area).

The mission of the Business Analyst (BA), Clinical Research Information Services is:

Working as a Business Analyst (BA) within the CRIS organization — Business Analysis & Product Management team, the incumbent is primarily responsible for collaborating with colleagues to develop business cases, defining requirements specifications, and assisting business colleagues with the adoption of new capabilities for Clinical Development. The primary clients for this area are Clinical Research, Clinical Operations, Data Management, and other areas responsible for the execution of clinical trials ... The primary clients for this area are BARDS, WCDMO, Clinical Research, Molecular Profiling, etc. The incumbent will work with business colleagues to define new capabilities for the CDR, inclusive of data deviations and the instantiation of business standards/rules.

There seems a major disconnect between the issue of developing "business cases" and the needs of clients "responsible for clinical trials." Exactly what is a "business case" regarding the conduct of a clinical trial, a scientific endeavor used to detect drug efficacy and hazard?

The requirements for the Business Analyst, Clinical Research Information Services:

Required:Minimum of 5 years of business analysis experience in an Information Technology or Business Process Re-engineering role.

Say What? business analysis IT or business process re-engineering experience? Isn't that once again saying that experience in "merchant" computing is a qualification for clinical trials computing? How does "business process re-engineering" figure in? Exactly what qualifies an IT person to "re-engineer" anything related to conduct of clinical trials?

Lean/Six Sigma Green-belt or Black-belt certification is strongly preferred. Demonstrated ability in the practical application of business analysis techniques and tools is required, e.g. Rational Unifed Process, Unified Modeling Language ... Leadership experience a strong plus, ability to serve as a mentor and/or process consultant is required ...

Six Sigma is a set of practices originally developed by Motorola to improve processes by eliminating defects, largely regarding manufacturing of widgets. How is that a key requirement for "adoption of new capabilities for Clinical Development?" Just as no management fad or "process fanaticism" can turn an amateur pianist into a Beethoven, "Six Sigma" is no substitute - not even close - for people who actually know at its core, at a fine-grained level, exactly what they're doing, and not only in general or "working knowledge" terms. "Six Sigma" in this domain is one of many "fad" solutions promoted by IT biomedical information science amateurs as solutions to the wrong issues. Put succinctly, a hundred generic workers following the finest of process will always be outperformed by one person who actually knows what they're doing:

Desired: Working knowledge of clinical development work processes is preferred. Education Requirements:B.S.degree is required. M.S. degree with concentration in Information Management/Information Technology or related scientific discipline is a plus.

M.S. degree with concentration in IM/IT a "plus?" "Related scientific discipline" such as ... what? Do scientists labor in the conduct of clinical trials so that bachelors-level or masters-level computer geeks can have good jobs?

Finally - and this is critically important - where is a mention of expertise in biomedical science/biomedical informatics?

It is nowhere, because the people hiring for this position likely know nothing of it themselves, nor do they think it important. I conjecture that this position description was likely written by person(s) of an IT background with little input from biomedical scientists, the people they are supposed to serve. I know as a medical informaticist and IT professional that I would have flunked a student in my informatics classes who came up with such a requirements list for this type of position.

A job description for 'Business Analyst, Clinical Data Repository Services" is not too different.

Working as a Business Analyst (BA) within the CRIS organization — Business Analysis & Product Management team, the incumbent is primarily responsible for collaborating with colleagues to develop business cases, defining requirements specifications, and assisting business colleagues with the adoption of new capabilities for patient data management. The incumbent will have a primary focus on the ongoing development of the Clinical Data Repository and the associated standards that define the data structures used within the repository. These capabilities will be driven by the needs for both clinical development and external partnerships involving the use of collected patient data.

There's that conflation of "business cases" with "patient data management" issue again. As far as "defining the data structures used within the [clinical data] repository" I wrote a decade ago that knowledge of biomedicine was an essential competence for defining data elements and structures in a biomedical database, NOT information technology or database experience.

The requirements for this Clinical Data Repository position:

Required:Minimum of 5 years of analysis experience in a Business Analyst and/or Systems Analyst role. Demonstrated ability in the practical application of business analysis techniques and tools is required. Minimum of 7 years of pharmaceutical industry experience, including a minimum of 5 years working in a Clinical Development Information Technology role is required. A working knowledge of industry standards for Clinical Development Information, e.g. CDISC is required.

Desired: Knowledge of ORACLE databases, data warehousing technologies and web technology, is highly desirable. Education Requirements:B.S.degree is required. M.S. degree with a concentration in Information Management/Information Technology or related scientific discipline is a plus.

That's perhaps slightly better, althought he focus is still on IT and specific experience in biomedicine (beyond "a working knowledge of industry standards for clinical development information" as opposed to first-hand expertise in biomedicine) is not mentioned.

As far as Oracle databases, in "Essential Value of Medical Informatics Expertise in High-Risk Areas: an Invasive Cardiology Example" I wrote that:

... the informaticist [a.k.a. me - ed.] jettisoned the traditional MIS [i.e., merchant computing - ed.] approach of viewing a person's skills in using a specific database application (e.g., Oracle) as a critical factor. The informaticist identified as crucial the data modeling process for the cardiologist's needs. This process has very little to do with software or computer science and much to do with medical informatics. The finest technical expert in the world in database development systems such as Oracle, client-server tools, etc. is not very useful in such a function, since it is a high-level cognitive function requiring clinical experience combined with medical data modeling expertise, not computer or MIS expertise. The lack of recognition of the need to partition strategic, high-level, cognitive informatics functions such as healthcare data modeling from more mundane, low-level programming and implementation tasks in clinical projects inhibits progress in healthcare and biomedical IT. It is with amazement that informaticists such as the one in this story observe a blindness to this issue in biomedicine, including healthcare and the pharmaceutical industry. The highest levels of informatics expertise should be sought for any clinical initiative in busy clinical settings. In such settings, the data development and customization process is an essential competence.

I imagine support for clinical trials is not considered very high risk:

... When [two companies] delayed results of a clinical trial aimed at showing the benefits of Vytorin, a top cholesterol drug, they said more time was needed to ensure the validity of the data.

But for years, cardiologists questioned the study, wondering if it could ever prove the drug worked as marketed. Does the drug reduce heart attacks as the companies say it does? Maybe, experts say. The study just may not be able to prove it.

The study, called ENHANCE and started in June 2002, intended to prove that adding Zetia to Zocor caused less heart-attack-causing plaque to build up in patients' arteries than Zocor alone. The combination of Zetia and Zocor is marketed as Vytorin and represents sales of $3 billion. Zetia generates another $2 billion for the companies. But though treatment of patients in the trial ended in 2006, the results are not available 20 months later.

The companies say they have been legitimately engaged in ensuring the quality of the data from the study, raising concerns with consultants as early as April 2006 and struggling to get things right since. But from the design to the technology it uses, ENHANCE has long been riddled with problems, cardiologists say. A [company]spokesman acknowledged that the study "sets a high hurdle."

A big flaw, says Michael Davidson, director of preventative cardiology at the University of Chicago's Pritzker School of Medicine and an adviser to [the companies]: Patients in the study had been treated with cholesterol drugs like Zocor for so long it might be difficult to remove plaque from their arteries. "I was not really a big fan of the design in the first place," says Davidson ...

I was formerly a pharmaceutical company employee at the company that posted these ads. I lost my position during a mass layoff of 4,400 in 2003, and now my local community's economy is imperiled via the company's misfortunes, as they are the major employer in the area. While there I tried to reinforce the value of cross-disciplinary Medical Informatics expertise and provided considerable examples of its value.

The lessons from all this are as follows:

1. Pharma is far too much an information technology-dominated industry, with suboptimal results - the results that should be, after all, expected by the wise (but not the merely clever) when undue influence over vital scientific and clinical matters is held by computer geeks and process zealots with no knowledge of biomedicine - usually due to conflation of "IT expertise" with biomedical information science/informatics expertise. (E.g., the current CIO of the company that posted the above job ads came from a paper company and based on his corporate bio, his knowledge and experience in biomedicine are nil);

2. Pharma is still largely oblivous to the IOM's recommendations (either passively or deliberately, i.e., for reasons of IT reaction and territorial protectionism) on Medical Informatics expertise. Roles such as the above should be specifically calling for such experience;

3. Many pharma problems are not due to evil people, but to backwardness and stupidity;

4. The executives/board of pharma companies should consider downsizing the people responsible for such job ads - for failure to stay current with advancements in information technology and biomedical information science, and/or incompetence. These issues result in suboptimal staffing in research IT and other areas, harming the company.

Perhaps the IT-led debacle called the "CRISP" clinical trials database in the late 1990's at one major company was insufficient learning material (even though its victims were referred to as "crispy critters"):

In the 1990s, [this company] struggled to erect a modernized clinical data system known as CRISP (Clinical and Regulatory Information Strategic Program), a project that current and former information systems workers came to regard as a $100 million fiasco.

5. Personnel in pharma - or perhaps in healthcare overall - who can comprehend these issues are rare, as most still have their heads stuck in 1940's IBM card punch-plug board paradigms of "data processing." This brings to mind the "process recommendation" by the author of the Effect Measure Blog in "Who will protect us from our protectors", namely:

Step One: Remove head from up your [slang term for anatomic rear end].

Finally:

6. These issues affect not just clinical trials and data management but also R&D and the pipeline. Pharma has not yet properly learned the wise lesson, told to me by an elderly jewelry, coin and stamp dealer in business for decades who has just about every date, mintmark and condition of coin ever asked for in stock in multiple quantities, that "You can't do business from an empty wagon."

-- SS

Addendum: the last pithy quote from the coinshop becomes even more relevant considering the findings of this article on pharma marketing vs. R&D expenditures, as commented on at this HCRENEWAL post and its links to other blogs.

BLOGSCAN - The Case of the Liver Transplant that Wasn't

On the Health Beat blog, Maggie Mahar dissected the complex and unfortunate case of a teenager who died shortly after her family's health care insurer rejected paying for a proposed liver transplant in desperate circumstances. Ms Maher brought up a host of issues and questions that did not surface in discussion in the main stream media. The one I thought was most relevant to Health Care Renewal: given how sick this patient was, if the physicians and hospital administrators involved thought a transplant was so urgently needed, why weren't they willing to go ahead with the procedure in the absence of a $75,000 down-payment by the patient's family?

BLOGSCAN - Allegations About Lipitor Marketing

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody discussed at length the allegations made in the whistle-blower lawsuit that claimed that Pfizer deceptively marketed atorvastatin (Lipitor) for patients for whom there was no evidence that the drug would do more good than harm.

BLOGSCAN - Anomalies of ARISE-RD Trial Summarized

On the Clinical Psychology and Psychiatry blog, this post summarizes some numerous curious anomalies of the ARISE-RD study of rispiridone, [Risperdal, by Janssen, a subsidiary of Johnson and Johnson] which were recently summarized by a letter to the journal Neuropsychopharmacology by Health Care Renewal blogger Bernard Carroll [Carroll B. Effects of risperidone augmentation in patients with treatment-resistant depression: results of open-label treatment followed by double-blind continuation. Neuropsychopharmacology 2007, advance online publication]. This is yet another example of how the design, implementation, analysis and dissemination of clinical research studies may be manipulated by research sponsors who have vested interests in having the studies reflect favorably on the sponsors' products.