DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

DR. PANGLOSS AS NIH INSTITUTE DIRECTOR

JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.

Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.

Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look here and here for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.

Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?

In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes?

Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.

Members of the Board of Now Bankrupt Lehman Brothers as Leaders of Health Care?

In our own Providence Journal, Michael Hiltzik commented about the Valukas report on the fall of the once proud Lehman Brothers.  He asserted that one of the lessons learned from the case is the "folly of relying on self-discipline and self-regulation in the financial markets," particularly given the irresponsibility of the top leaders of financial corporations. In particular,

I’d love to hear an argument for allowing any of Lehman’s independent directors, who seem seldom to have asked a penetrating question, ever to serve on a corporate board again.

As I write, those 10 directors, who pulled down better than $100,000 cash a year to sit jointly in the driver’s seat for Lehman’s race to disaster, still boast at least 15 company directorships among them. Does this make you confident that corporate America is in good hands? Me neither.

It also should not make us confident that health care, and academic medicine, in the US and elsewhere, are in good hands. Hiltzik declined to name the members of the Lehman board, or identify the other organizations that they lead.  One can find a list of the directors who presided over the demise of Lehman in the company's 2008 proxy statement. It turns out that while they were presiding over Lehman's collapse, they also were presiding over the direction of some major health care organizations, to wit:

MICHAEL L. AINSLIE Director since 1996

Trustee of Vanderbilt University [including the School of Medicine]

JOHN F. AKERS Director since 1996

ROGER S. BERLIND Director since 1985

MARSHA JOHNSON EVANS Director since 2004

Ms. Evans served as President and Chief Executive Officer of the American Red Cross from August 2002 to December 2005.

RICHARD S. FULD, JR. Director since 1990

serves on the Board of Trustees of ... New York-Presbyterian Hospital

SIR CHRISTOPHER GENT Director since 2003

Non-Executive Chairman of GlaxoSmithKline plc.

JERRY A. GRUNDHOFER

Mr. Grundhofer is a director of Ecolab, Inc ["As a leader in infection prevention, Ecolab provides products, tools, training and service to healthcare facilities to help prevent the spread of healthcare acquired infections.]

ROLAND A. HERNANDEZ Director since 2005

HENRY KAUFMAN Director since 1995

a Member of the Board of Trustees of New York University [including the School of Medicine]

a Member of the Board of Governors of Tel-Aviv University [including the Sackler Faculty of Medicine]

JOHN D. MACOMBER Director since 1994

[Also, a member of the board of directors of Warren Pharmaceuticals, "a privately held biotech company, incorporated in 2001 for the purpose of developing proprietary tissue-protective technologies."

So, collectively, the confidence uninspiring members of the board of the now defunct Lehman Brothers also were on the boards of two major US and one major Israeli university that include well-known medical schools, one major health care related charity, one major British multi-national pharmaceutical company, a prestigious academic medical center, a large public for-profit US company with major health care interests, and a small, privately held biotechnology company. 

We have another vivid illustration in the aftermath of the global economic collapse, and in an ongoing health care crisis, how some of the problems of health care, and academic medicine in particular, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission. All health care organizations, for-profit and not-for-profit, those in the US and those in other countries, need leaders who value their health care and academic missions more than simply the money they may bring in.

New Review of Controlled Trials Replacing Saturated fat with Industrial Seed Oils

Readers Stanley and JBG just informed me of a new review paper by Dr. Dariush Mozaffarian and colleagues. Dr. Mozaffarian is one of the Harvard epidemiologists responsible for the Nurse's Health study. The authors claim that overall, the controlled trials show that replacing saturated fat with polyunsaturated fat from industrial seed oils, but not carbohydrate or monounsaturated fat (as in olive oil), slightly reduces the risk of having a heart attack:

These findings provide evidence that consuming PUFA in place of SFA reduces CHD events in RCTs [how do you like the acronyms?]. This suggests that rather than trying to lower PUFA consumption, a shift toward greater population PUFA consumption in place of SFA would significantly reduce rates of CHD.

Looking at the studies they included in their analysis (and at those they excluded), it looks like they did a very nice job cherry picking. For example:

• They included the Finnish Mental Hospital trial, which is a terrible trial for a number of reasons. It wasn't randomized, appropriately controlled or even semi-blinded*. Thus, it doesn't fit the authors' stated inclusion criteria, but they included it in their analysis anyway**. Besides, the magnitude of the result has never been replicated by better trials, not even close.
  
• They included two trials that changed more than just the proportion of SFA to PUFA. For example, the Oslo Diet-heart trial replaced animal fat with seed oils, but also increased fruit, nut, vegetable and fish intake, while reducing trans fat margarine intake! The STARS trial increased both omega-6 and omega-3, reduced processed food intake, and increased fruit and vegetable intake! These obviously aren't controlled trials isolating the issue of dietary fat substitution. If you subtract the four inappropriate trials from their analysis, which is half the studies they analyzed, the result disappears. Those four just happened to show the largest reduction in heart attack mortality...
  
• They excluded the Rose et al. corn oil trial and the Sydney Diet-heart trial. Both found a large increase in total mortality from replacing animal fat with seed oils, and the Rose trial found a large increase in heart attack deaths (the Sydney trial didn't report CHD deaths, but Dr. Mozaffarian et al. stated in their paper that they contacted authors to obtain unpublished results. Why didn't they contact the authors of this study?).

The authors claim, based on their analysis, that replacing 5% of calories as saturated fat with polyunsaturated fat would reduce the risk of having a heart attack by 10%. Take a minute to think about the implications of that statement. For the average American, that means cutting saturated fat nearly in half to 6% of energy, which is a real challenge if you want to have a semblance of a normal diet. It also means nearly doubling PUFA intake, which will come mostly from seed oils if you follow the authors' advice.

So basically, even if the authors' conclusion were correct, you overhaul your whole diet and replace natural foods with bland unnatural foods, and...? You reduce your 10-year risk of having a heart attack from 10 percent to 9 percent. Without affecting your overall risk of dying! The paper states that the interventions didn't affect overall mortality at all. That's what they're talking about here. Sign me up!


* Autopsies were not conducted in a blinded manner. Physicians knew which hospital the cadavers came from, because autopsies were done on-site. There is some confusion about this point because the second paper states that physicians interpreted the autopsy reports in a blinded manner. But that doesn't make it blinded, since the autopsies weren't blinded. The patients were also not blinded, so the study overall was highly susceptible to bias.

** They refer to it as "cluster randomized". I don't know if that term accurately applies to the Finnish trial or not. The investigators definitely didn't randomize the individual patients: whichever hospital a person was being treated in, that's the food he/she ate. There were only two hospitals, so "cluster randomization" in this case would just refer to deciding which hospital got the intervention first. Can this accurately be called randomized?

The National Program for Healthcare IT in the United States, 2015

Here is what I predict the the National Program for Healthcare IT in the United States will likely resemble in 2015 - namely, the National Programme for IT in the NHS in 2010:

Delays with £12.7bn NHS software program bring it close to collapse
Sunday 21 March 2010 18.47 GMT
Simon Bowers
guardian.co.uk

The government's ailing £12.7bn IT programme to overhaul paper-based NHS patient records in England is close to imploding, potentially triggering a deluge of legal claims against the taxpayer running into billions of pounds, which could start to emerge weeks before a general election.

The Guardian has discovered that mounting chaos and delays in installing core care records systems across the country is reaching a tipping point, with intense political pressure from Whitehall now falling on Morecambe Bay NHS Trust and a software "go-live" deadline set for the end of this month.

Morecambe Bay is intended to be the first acute trust to take a new patient administration software package called Lorenzo, which has been delayed for four years. After a string of missed deadlines, the Department of Health set a deadline of March 2010 for Lorenzo last April. "If we don't see significant progress... then we will move to a new plan for delivering infomatics in healthcare," Christine Connelly, the Department of Health's director general of IT, said at the time.

Problem #1:

A problem of leadership. As I mentioned here, Christine Connelly knows as much about "informatics" as I know about candy making.

She was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Candy experience? More than Willy Wonka. Experience producing gas? Plentiful. Medical informatics expertise? Not so much. Predecessors also lacked genuine medical informatics expertise. This lack of appropriate expertise is all too common in healthcare leadership, and no exception is made for healthcare IT.

Preparatory testing at Morecambe Bay is believed to have failed some weeks ago, though iSoft, the firm behind Lorenzo, last week insisted testing was "on track" and dismissed as "media speculation" suggestions that the deadline was in jeopardy.

Problem #2:

Claiming everything is going just fine. This initiative has been a debacle from the start, partly due to it being rushed for purposes of governmental grandstanding. Don't take my word for it. Take the word of these people:

• The UK Public Accounts Committee report on problems in the £12.7 billion national EMR program is here.

• Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are here (released under the UK’s Freedom of Information Act), and a summary of 16 key points is here.

• ComputerWeekly.com - Blair Rushed NHS IT

• Telegraph.co.UK - more on rushing - Patients' medical records go online without consent

Back to the article:

The BMA (British Medical Association) echoed calls for greater public scrutiny of contracts. "Changes to NHS IT should be driven not by financial or political expedience, but by a commitment to improving clinical care. If any new system is rushed through too quickly, there can be a negative impact on patient care."

Problem #3: The obvious as stated by clinicians is ignored by project leaders and politicians.

Failure at Morecambe Bay could see the largest regional contractor on the 10-year programme, US outsourcing firm Computer Sciences Corporation (CSC), come under renewed pressure to book heavy provisions against the value of three £1bn NHS contracts – a move likely to send the group's share price tumbling.

It would also be bad news for iSoft, the Australian firm formerly called IBA Health, which in 2007 acquired crisis-stricken iSoft plc, the British firm behind Lorenzo, and took its name. It has told investors: "iSoft expects the milestone at Morecambe Bay to be met according to the timetable agreed between its partner CSC and the NHS, and expects this achievement to trigger a cash payment to the company."

A Morecambe Bay delay could also push mounting tensions between the Department of Health and CSC into the hands of lawyers, as a squabble breaks out over who should foot the bill for seven years of underperformance since the National Programme contracts were signed in 2003. The government is already facing a reported £700m legal dispute with CSC's fellow regional contractor Fujitsu after the Japanese consultancy firm walked away from a £1bn contract to supply and install IT systems at NHS trusts across the South of England and the West Country three years ago.

If CSC, an $11bn (£7.3bn) Virginia-based group listed on the New York stock exchange, were to enter into a parallel legal battle, it would leave 80% of care records IT contracts – the heart of the National Programme – in the hands of lawyers. After the departure of Fujitsu, and Accenture a year earlier, the only remaining regional contractor aside from CSC is BT, responsible for the London area. It was forced last year to wipe between half and 70% from the value of its £1bn contract with NHS London because of delays and software failings.

Problem #4 (if you can follow all that nonproductive but expensive mayhem that does little beyond consuming precious healthcare resources better spent elsewhere):

Too much outsourcing to a musical-chairs confederacy of management consultant firms rather than use of local expertise.

... Disappointing results from the National Programme – once a flagship NHS modernising push for then prime minister Tony Blair – have become an embarrassment for Labour, and the project has lost the confidence of many NHS staff. Up to now, however, ministers have sought to stress that the taxpayer has not lost out. Earlier this month, health minister Mike O'Brien told BBC Radio 4's File on 4: "Yes, there have been delays. These delays have not cost the tax payer. They have cost the companies – they have taken the risk... Some of these companies have been more ambitious than they should have been." [In other words, they promised far more than they could deliver with the talent on hand - ed.]

Problem #5:

Incompetence, talent mismangement and not knowing what they do not know about healthcare IT.

Read the rest of the article at the link above.

Also note the UK's healthcare system is far smaller, far more monolithic, and far more easily controlled by government than that in the U.S.

My belief is that the US program for health IT will likely resemble the UK's in just a few years' time, for the very same reasons. Unless, that is, major changes in the approaches to design and implementation occur, and soon, and the purpose of HIT reigned in to clinician support, not support of massive bureaucracies. I consider the necessary changes unlikely due to the intransigence of the IT culture and of the leadership behind the effort.

Again, don't take it from me, take it from the U.S. National Research Council and other writers at this link.

-- SS

Effort to Make Health Insurance Reimbursement Fairer Lead by Director of Insurance Company Accused of Unfair Practices

We previously discussed a legal settlement of charges that UnitedHealth's Ingenix subsidiary manipulated its database of payments to physicians so as to reduce its and other insurers' payments to "out-of-network" physicians. 

One aspect of the settlement was a new initiative to better determine such payments.  Now that effort has been caught up in the web of conflicts of interests that has ensnared health care.  As reported by the Syracuse (NY) Post-Standard,

[New York state Attorney General Andrew] Cuomo obtained $100 million in settlements from 13 insurers, including Excellus, that used the defective reimbursement data supplied by Ingenix, a subsidiary of United Health, the nation’s second biggest insurer. Cuomo’s investigation showed insurers such as Excellus used that data to shortchange New York consumers by as much as 28 percent.

Also, the settlement included

money ... to create FAIR Health Inc., a New York City-based nonprofit that is supposed to come up with a new, fair reimbursement system that will be used by insurers nationwide. FAIR Health has contracted with SU [Syracuse University] to help create that database.

The effort was lead by SU Professor Deborah Freund, "a distinguished professor of public administration and economics. She also is an adjunct professor of orthopedics and pediatrics at Upstate Medical University."

However,

Freund also happens to be listed on the health insurance company’s payroll.


Excellus paid Freund $61,378 last year for serving on its board of directors, according to a financial report Excellus filed with the state last week.

After The Post-Standard spent several days investigating her ties to the insurance company, Freund quit the Excellus board Friday afternoon.

The Post-Standard noted,

But some consumer advocates said it was odd that a paid director of Excellus, one of the companies targeted in Cuomo’s investigation, was playing such an important role.

[Art] Levin, of the Center for Medical Consumers, said it was ironic that one of the people helping to fix a payment system riddled with industry conflicts of interest may have had a conflict of her own.

'This makes no sense whatsoever given that Excellus is part of the settlement,' Levin said.

Chuck Bell, programs director of Consumers Union, publisher of Consumer Reports and an outspoken supporter of the payment reform project, was unaware of Freund’s ties to Excellus.

'I think it’s a concern because consumers do want this to be an entity that is independent of the insurance industry,' Bell said.

Among Freund's defenders was

Dr. Nancy Nielsen, immediate past president of the American Medical Association and a board member of FAIR Health, [who] said the AMA looked closely at Freund’s qualifications and her Excellus affiliation. She said the doctors’ group concluded her expertise is important to the project and was comfortable that there were enough safeguards in place to avoid any conflicts. Nielsen said FAIR Health would have independent experts not tied to the insurance industry review any recommendations from Freund’s research team.

But to add another level of irony, and perhaps conflict of interest, the Minneapolis - St Paul Business Journal just announced

The American Medical Association will use an electronic health records system from Ingenix, the company said Monday.

The Eden Prairie health care information technology said its Web-based CareTracker software will run on an AMA platform currently in beta testing with the Michigan State Medical Society and will launch nationwide later this year.

The platform is touted as a way to improve patient care, clinical efficiency and make administration simpler. CareTracker is the first such system that the AMA will provide to physicians online.

'Ingenix and the AMA will help doctors adopt health IT systems that reduce time spent on administrative tasks and enable them to devote more of their time to patient care,' said Bill Miller, Ingenix executive vice president of health care delivery systems, in a news release. 'Ingenix CareTracker integrates patient medical records and e-prescribing tools into the physician’s workflow. By selecting CareTracker for its platform, the AMA is helping physicians make smarter, more practical decisions about technologies to support their practice.'

Although we often discuss conflicts of interests involving physicians or health care academics who moonlight for drug and device companies, and the effects of these relationships on clinical research and medical education, it seems like the pervasive web of conflicts of interest in health care has entangled just about every kind of health care organization, health care decision-maker, and health care opinion leader.

Thus, we need to be extremely skeptical of just about everyone and every organization claiming to provide health care related goods and services, or whose goal is to improve any aspect of health care. The danger is that such skepticism will lead to cynicism and distrust.

At the least, comprehensive, detailed disclosure of all even indirectly relevant financial and other relationships by all health care decision-makers and opinion leaders at any level, whether they be individuals or organizations, would make it somewhat easier to assess their decisions and opinions.