Is Someone at Jefferson Regional Medical Center Lying About EHR Safety?

This curious story appeared about apparent clinician health IT safety concerns at Jefferson Regional Medical Center near Pittsburgh:

Switch to electronic records alarms Jefferson Regional physicians

By Walter F. Roche Jr.
PITTSBURGH TRIBUNE-REVIEW
Friday, October 30, 2009

Jefferson Regional Medical Center's attempts to convert to electronic medical records have some doctors concerned about patient safety.

In a memo issued this month, the hospital's Health Information Technology Committee announced the 373-bed facility in Jefferson Hills would revert to printed versions of patients' consultant reports "due to patient safety concerns from the majority of physicians."

Jefferson executives downplayed the memo and said they found no evidence that patient safety has been impacted, arguing a small group of physicians expressed concerns and not a majority, as the memo claimed.

"It was a very small number that were concerned. It wasn't the majority," said Dr. Richard F. Collins, Jefferson's vice president for medical affairs. "To this point, we haven't identified any issue of patient safety."

Now, one or the other must be true. Either a majority of physicians expressed concerns, or a small number did. Both cannot be true. Assuming the account in the Pittsburgh Tribune Review is accurate, someone is lying.

I should point out that the numbers ultimately do not matter - patient safety issues should never be determined via a headcount, and in fact hospital governance obligations under the Joint Commission and their own fiduciary responsibilities mandate the utmost conservatism and due diligence on safety concerns.

Perhaps the executives did find "no evidence" of safety issues. Regardless, I raise the following questions:

• How was such a study performed, how were physicians and other clinicians involved in the study, and was it a rigorous study using validated methodologies, or cursory?

• Who is most motivated to find an HIT system "safe", the HIT Committee and clinicians, or the administration?

I have served on HIT Committees; led them, in fact. Those committees "have the pulse" of clinician sentiment, even when they do not conduct formal surveys. In hospitals, the walls have ears, and the clinicians on HIT Committees understand what their colleagues are feeling - usually via direct and sometimes confrontational conversations.

HIT Committees charged with making HIT successful do not generally pull back from HIT projects without very good reason.

On the other hand, hospital executives who have signed off on investments of millions or tens of millions of dollars in IT investments do have a strong motive to ensure all goes well - either in reality or in the narrative they proffer.

This is especially true when conflicts of interest exist.

According to [VP for Medical Affairs] Collins and James Witenske, Jefferson's chief information officer, the transition [to EHR] began about a year ago and was completed in May. The hospital uses a system developed by Siemens, Collins said. He declined to disclose the cost.

I find this an interesting finding. After a short Google search, the following appeared:

Western Pennsylvania Hospital News

20 Years of Hospital Information Technology
by John Fries
(December 2005)

... James Witenske is chief information officer at Jefferson Regional Medical Center, having left Arthur Andersen four years ago to accept the position. Before working at the Big Eight firm, he served as chief information officer at UPMC Health System.

At Jefferson, IT takes place a bit differently that at other healthcare institutions. Where most hospitals have an IT department with staff, Witenske works almost exclusively with outside experts, one of whom is Ron Forys, a Siemens site executive who is based at Jefferson. It’s a complementary relationship – Witenske’s role is strategic and Forys’ is operational. Both are longtime technology professionals who have seen huge changes take place during the past two decades.

The hospital had/has its own vendor representative in a front line role, and apparently shied away from having its own IT staff. A person who comes from a consulting firm uses consultants whose loyalty is to the vendor, not the hospital, one of them as his operations guy.

This raises a number of questions:

• Who paid/pays the Siemens Site Executive? The hospital, the vendor, or both?
• Who did/does the Site Executive report to?
• Did/does not the Site Executive have a conflict of interest with regard to physician opposition to the vendor's system?
• What was/is the financial relationship between hospital executive leadership and the Site Executive? Between hospital executive leadership and the vendor?

These type of arrangements do raise my eyebrows, and the discrepancy between the HIT Committee's memo and the hospital executive's account, both of which cannot be true, could certainly be a symptom of conflicts of interest.

I have noted that a Congressional investigation of the health IT industry is now underway. This would not be a good time for hospital governance to downplay physician concerns about HIT, overruling their own HIT committee. For if a patient is injured or dies as a result of physician HIT concerns that were ignored, the executives could likely find themselves in a very unpleasant situation - and not just from malpractice attorneys.

Collins and other hospital officials who support the conversion say that once adopted and accepted, electronic records will increase patient safety and efficiency, and eliminate "piles of paper."

He apparently forgot the word "perfected." HIT in an experimental medical device. This VP for Medical Affairs makes no mention of the unintended consequences of poorly designed or implemented HIT. He either doesn't know about them (i.e., is dyscompetent regarding HIT) or is suffering the syndrome of inappropriate overconfidence in computers in the face of what seems like his own staff's concerns.

This is typical of the Wild West environment of Health IT.

-- SS

2009 a Pivotal Year in Healthcare IT

2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my academic website on HIT difficulties started over a decade ago, in 1998, freely available to the industry.

These articles and reports have ultimately led to a U.S. Senate investigation of the healthcare IT industry initiated in Oct. 2009 (link below).

2009 may be the year that healthcare IT vendors will finally begin to understand that not lending credence to decades of teachings from Medical Informatics professionals on healthcare IT design, implementation, lifecycle support, involvement of end users, and sales and marketing has been harmful to their businesses and to their investors. Instead, the commercial health IT companies took a simplistic management information systems-based approach to building medical devices in an incomparably complex environment they did not -- or did not care to – understand.

These devices are, in fact, virtual medical devices that happen to reside on a computer, not business computing systems that happen to be used by clinicians. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

The teachings of Medical Informatics about such devices have been documented in the extensive literature of Medical Informatics. For example, the book “A History of Medical Informatics in the United States, 1950 to 1990” by informatics pioneer Morris F. Collen (published in 1995) explicitly demonstrates the progression of the field and the wisdom of the pioneers dating back to the 1950’s, as in the bons mots here.

The 2009 articles and reports below demonstrate numerous undesirable outcomes of the management information systems approach to development and implementation of virtual clinical devices:

• The Joint Commission’s “Sentinel Event Alert on Healthcare IT” is here.

• The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" and link to a full report on an investigation of healthcare IT lack of progress is here.

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

• The Washington Post’s article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is here.

• Hoffman and Podgurski’s paper from Case Western entitled “e-Health Hazards: Provider Liability and Electronic Health Record Systems” on EHR medical and legal risks is here.

• My commentary on the May 2009 AMIA workshop report on healthcare IT failure with free PDF is available here.

• My commentary on a sentinel Mar. 2009 JAMA article by University of Pennsylvania researchers Ross Koppel and David Kreda “Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians” on unsafe contract terms demanded by healthcare IT, and the violations of Joint Commission safety standards and fiduciary responsibilities committed by hospital governance personnel who agree to such terms, is here.

• A link to the Oct. 25, 2009 Washington Post article “Electronic medical records not seen as a cure-all” and my commentary are here.

Finally, and perhaps most importantly, the Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).

I have used this medieval illustration in a prior post on these pages, but sadly in this case it is probably even more highly appropriate:

"Margaritas ante Porcos" - click to enlarge

Not to be gratuitously impolite, but hard truths are often an unpleasant medicine, especially when ignoring those truths results in adverse consequences to patients and their caregivers.

-- SS

Did a Yakuza Boss Pay "A Million Dollars for One Liver?"

One of the more bizarre stories to appear on Health Care Renewal just resurfaced.  To summarize, in June, 2008, we posted about the strange case of four Japanese men, allegedly affiliated with Yakuza criminal organizations, who received liver transplants from the UCLA Medical Center, apparently with some alacrity. All likely paid full list prices for their procedures, and two later donated $100,000 each to the medical center. The case raised concerns by several notables (including Senator Charles Grassley, and Professor Arthur Caplan) about the integrity of the transplant system. Presumably these concerns were based on suspicions that the four may have received a higher priority than others on the list. More concerns should have been raised after it was revealed that shadowy characters threatened a reporter who started to investigate the case in Japan, and the reporter's family (see post here).  Later, the Chancellor for Medical Sciences and Dean of the David Geffen School of Medicine's public response to the case side-stepped all the important concerns while deploying a series of logical fallacies (see post here).

Then, despite all the colorful details and ethical concerns presented by this story, it faded from view for a year and a half. 

Last night, the US investigative reporting television show "60 Minutes" aired a follow-up on the Yakuza transplants, following closely on the publication of a book, Tokyo Vice, by Jake Adelstein, the reporter who first broke the story.

The web-based version of the 60 Minutes story reprised the main points, but added emphasis to a few of interest to Health Care Renewal. 

First, the 60 Minutes piece raised suspicions that the Yakuza members paid a premium to jump the UCLA liver transplant priority list:

Getting into the U.S. was one thing, but getting a liver transplant at a leading American medical center like UCLA was something else altogether.

'What's the average waiting time for someone in California waiting for a liver transplant?' [CBS correspondent Lara] Logan asked California attorney Larry Eisenberg.

'It's probably realistically three years. And it could be much longer,' he replied.

Not for Tadamasa Goto, who got a liver in just six weeks. Eisenberg finds that surprising, especially since Goto was number 80 on the waiting list.

'It should not be possible that an unsavory character from out of the country, with ties to organized crime, comes into the United States and gets a priority and obtains a transplant,' Eisenberg said.

Two families, Eisenberg's clients, both lost loved ones waiting for livers at another transplant center in the same area: Salvador Ceja was number two on the waiting list; John Rader was number five.

'Do you think, for one second, that this was legitimate? That they stood in line and waited just like your husband did?' Logan asked Rader's widow Cheryl.

'Absolutely not,' she replied. 'No. Because nobody gets a liver that quickly.'

'I think they were playing God,' Yolanda Carballo, Ceja's stepdaughter, added. 'Now, I think they were picking and choosing who they wanted to give a liver to.'

'So, in your minds, what was this about?' Logan asked.

'Money,' Rader said. 'Spoke loud and clear. And they listened.'

'That's what it was all about. Money,' Carballo agreed.

Three of Goto's Yakuza cronies also got liver transplants at UCLA. For them, money was no object. UCLA says each of their transplants cost about $400,000 dollars; the Yakuza all paid cash.


The hospital also acknowledged Goto and another Yakuza each made $100,000 donations to the transplant center.


Adelstein says Goto paid even more. 'According to police documents and sources, a million dollars for Goto. A million dollars,' he told Logan.

'A million dollars for one liver?' she asked.

'A million dollars for one liver,' Adelstein said.

Second, 60 Minutes emphasized the risk Mr Adelstein faced after he drew attention to the story of the Yakuza liver transplants at UCLA:

Tadamasa Goto returned to his life of crime as a Yakuza godfather and it all stayed hidden until Adelstein was tipped off. It took him years to piece together the details for a newspaper story. Then, when word got out that Adelstein knew, the Yakuza tried to buy his silence, offering him half a million dollars.

Asked if he was tempted by the cash offer, Adelstein said, 'Of course I'm tempted. You know? When someone offers you half a million dollars not to write something, but then again, you know I don't want to be owned by organized crime the rest of my life.'

Adelstein wrote the story for 'The Washington Post' and it eventually made its way back to Japan. The news infuriated the Yakuza bosses. For Goto, it was a humiliating blow from which he would never recover.

'I heard from someone very close to him that as he was leaving and getting in his car he said, 'That goddamn American Jew reporter, I wanna kill him,'' Adelstein said.

Japanese and U.S. law enforcement agents took Goto's threat seriously.

Adelstein now lives alone, under Tokyo police protection; his wife and children are in hiding.

'Are you concerned that there is an American citizen here whose life is at risk?' Logan asked the U.S. Embassy's Mike Cox.

'Very much so. I mean, we think the Japanese police are doing what they can to make sure that no harm comes to Mr. Adelstein. I mean, we certainly don't want to see anything happen to him,' Cox said.

'What do you have to do in your daily life to stay alive?' Logan asked Adelstein.

'You have to keep your rooms shuttered, because you don't want a sniper to pick you off across from somebody’s house,' he said.

Asked if he lives in darkness, Adelstein said, 'When I'm up in my room typing, yes. All the rooms are shuttered. You gotta be very careful on rainy days. Because when Yakuza take people out, they like to do it on rainy days, because fewer people are on the streets and the rain washes away trace evidence.'

Even in disgrace, Tadamasa Goto still has a small army of loyal soldiers and a hit out on Jake Adelstein. The Yakuza say he will never be safe.

'When someone does something that causes them (Yakuza) to lose face, they will use any means possible, legal or illegal, to crush the person who has gotten in their way, who has humiliated them,' the disguised Yakuza boss told Logan.

Finally, 60 Minutes found that the UCLA Medical Center continued to be uncooperative, cloaking its refusal to categorically refute allegations that it sold a liver for a million dollars in concerns with patient confidentiality:

Asked if UCLA knew who these people were, Adelstein said, 'When you see guys with lots of tattoos, missing fingers, wouldn't it occur to you, like, 'Oh, this guy is a gangster.' I can't believe they didn't know.'

Attorney Eisenberg says transplant rules require extensive background checks on every patient. Yet, UCLA insisted to federal investigators they had 'no knowledge' that Goto or his cronies had ties to Japanese organized crime.

UCLA declined all of 60 Minutes' requests for interviews. The only thing the medical center will say on the record is that their program has been reviewed and found to be in 'total compliance' with liver transplant rules.

The hospital told us, 'state and federal patient confidentiality laws prohibit UCLA from responding to the…issues raised by 60 Minutes.'

'In my opinion, the medical center has a moral and ethical obligation to determine the source of those funds,' Eisenberg said.

'A moral and ethical obligation, but apparently no legal obligation?' Logan asked.

'Well, it's not addressed in the rules specifically,' Eisenberg said

As I wrote in my first post on this case, you just can't make this stuff up...

However, the colorfulness of the case should not distract from its very serious implications.  We have written a lot in this blog about the anechoic effect, how cases with important implications about ethics, governance and leadership in health care often fail to attract the attention they deserve.  We have opined that academics and professionals have realized that it is simply "not done" to discuss cases which might offend the powerful leaders of health care organizations.  We have written about whistle-blowers who have lost jobs or been theatened with lawsuits.  But in this case, the journalist who wrote about the case allegedly has received death threats and lives in hiding under police protection.  This may be the most serious case of the anechoic effect known.

Furthermore, we have written a lot in this blog about how leaders of health care organizations ought to uphold their organizations' mission and the core values to which physicians and other health care professionals have sworn devotion.  The continued disinclination of UCLA leadership to respond to charges that its medical center accepted $1 million to put Japanese gangsters at the head of the liver transplant list may reflect fear of gangsters who also allegedly threatened the life of the journalist who reported the case.  But by failing to rebut such charges, the leadership leaves the impression that they cannot claim to be better than the moral equivalents of gangsters.  Institutions that aspire to join "the ranks of the nations [sic] elite medical schools" ought also to aspire to have leaders that have better ethics than Yakuza bosses.  

Transparency International has suggested that health care corruption is a global scourge that costs lives.  Serious health care reform cannot ignore health care corruption as a cause of excess costs, denied access, and poor quality.  Health care organizations ought to be held to a higher standard of ethics, and be less prone to corruption than, for example, garbage hauling firms.  Health care organizations ought to subscribe to rigorous codes of ethics, impartially enforced, which apply to all within the organizations, including top leaders.  While the accused need to be afforded due process, whistle-blowers must also be protected.  In my humble opinion, true health care reform requires so confronting health care corruption.  Maybe the leadership of the Gefen School of Medicine might want to consider setting an example in this regard. 

Note: Jake Adelstein's book is available here, and it was reviewed by Reuters here and by the AP (via the Canadian Press) here.

A Bridge in Brooklyn and an Electronic Medical Records Bargain: Only One Hundred Nineteen Million Dollars Per User - Tolls Included

One of the favorite debates people involved in IT seem to like to have is over the meaning of "failure" of IT projects.

Merriam-Webster dictionary:

Main Entry: fail·ure
Pronunciation: \ˈfāl-yər\

Function: noun

Etymology: alteration of earlier failer, from Anglo-French, from Old French faillir to fail

Date: 1643

1 a : omission of occurrence or performance; specifically : a failing to perform a duty or expected action b (1) : a state of inability to perform a normal function <kidney failure> — compare heart failure (2) : an abrupt cessation of normal functioning c : a fracturing or giving way under stress
2 a : lack of success b : a failing in business : bankruptcy
3 a : a falling short : deficiency b : deterioration, decay
4 : one that has failed

The UK House of Commons Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

Only the most stubborn would argue that this case and the latest data is not representative of a "failure" in the truest sense of that word:

Only 175 people using flagship NHS software, says minister

Lorenzo care records system is likely to be costing taxpayer hundreds of thousands of pounds per user per year

Written by Tom Young

Computing.co.uk, 30 Oct 2009

There are only 174 clinicians using Lorenzo patient software across the five early adopter trusts, according to Mike O'Brien, minister for the National Programme for IT (NPfIT).

Five Boroughs Partnership, Bradford Teaching Hospitals NHS Foundation Trust, University Hospitals of Morecambe Bay, Hereford Hospitals and South Birmingham have only ever had 19 clinicians using the systems at the same time.

Lorenzo is one of two software packages being used to set up centralised electronic health records as part of the £12.7bn National Programme for IT. This part of the programme is already running four years late.

Lorenzo is being supplied by services company CSC to trusts in the north of England and by its developer iSoft directly to trusts in the south after Fujitsu was fired from the programme.

The other patient software package is Cerner Millennium, being supplied by BT in London and a handful of trusts in the south.

By Google:

£12,700,000,000 = USD $20,770,850,000

By my calculations, that works out to:

£72,571,429 or USD $118,690,571 per user of this software.

While a somewhat satirical and sardonic calculation, that's about 73 million pounds or 119 million dollars per user, after almost a decade of work.

What more can be said than "stunning?"

The information came from a parliamentary question tabled by Richard Bacon MP.

Last week in the Commons he said:

"I tabled a question yesterday about the number of hospital trusts where Lorenzo has been partially deployed, asking how many users — how many concurrent users — of Lorenzo there are.

"It is literally just a handful, which means that the cost per user is not what one would expect… the cost is going to be many hundreds of thousands — possibly even more than a million — pounds per user per year."

Bacon said there has not been a single deployment of Lorenzo in 2009 because these early adopter trusts were having such problems.

"The reason is that the handful of deployments attempted have been an absolute mess, causing chaos in the hospitals where they were tried," he said.

Operations of entire hospitals were disrupted by software. This represents unconsented IT experiments on human subjects gone massively awry. Whether the "chaos" caused anyone harm seems never to be stated.

Deployments of Cerner Millennium have also caused problems, with St Barts in London now facing fines of £400,000 a month for missing patient care targets as a result of problems with the system.

Bacon also points out that the recently signed contracts with BT to deploy Cerner Millennium at hospitals in the south require BT to be paid even if the hospitals refuse the systems – a possibility if they think they will not work.

I would suggest someone in the UK provide screen shots and/or a YouTube video of these systems in operation so others can understand how such results can occur. (Oh, wait: the vendor contracts probably prohibit that, the hospital executives having signed such contracts also having signed away their fiduciary responsibilities to patients and clinicians.)

... Junior Treasury minister Sarah McCarthy-Fry defended The NPfIT in the debate.

She said: "We all acknowledge that the NHS IT project is hugely ambitious [profoundly overambitious would perhaps be more accurate - ed.] and that it is essential that we get it right. [The Minister appears to be a master of the obvious - ed.] It is obvious to everybody that many challenges remain.

"We still believe that Cerner Millennium and Lorenzo will be able to support the NHS in the long term."

Right.

I have a bridge in Brooklyn, NY for sale. Perhaps the UK teams responsible for this debacle would be interested. After all, the cost per user of the bridge would be remarkably low, far less than USD $118 million - and the users could even be made to pay a toll for each use:

For sale: a bridge in Brooklyn.

Perhaps in our own U.S. national health IT initiative, we'll come in at a lower cost per user than $118,690,571 - perhaps about $118,690,570.99 ?

After all, those Medical Informatics specialists act like know-it-alls about healthcare IT, and since domain-specific education and expertise are irrelevant in healthcare management, why should anyone listen to them?

-- SS

AstraZeneca Settles

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times,

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,

AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here).  If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are.  Is it any wonder that we over-use and over-pay for these products?  Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment. 

(However, there may be hope.  Perhaps in the future there will be more effective deterrence.  A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)

An Alliance on Mental Illness or for Pharmaceutical Companies?

A recent article by Gardner Harris in the New York Times focused on the financial links among health care corporations and not-for-profit disease (or patient) advocacy groups.

A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators.

The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private.

But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.

Even the group’s executive director, Michael Fitzpatrick, said in an interview that the drug companies’ donations were excessive and that things would change.

However, he tried to downplay the influence of the pharmaceutical industry on the Alliance.

'I understand that NAMI gets painted as being in the pockets of pharmaceutical companies, and somehow that all we care about is pharmaceuticals,' Mr. Fitzpatrick said. 'It’s simply not true.'

Note the careful wording of this denial, though. He did not deny that most of what NAMI cares about is pharmaceuticals.

Moreover, the article suggested how cozy pharmaceutical companies and the Alliance's leadership have become.

The close ties between the alliance and drug makers were on stark display last week, when the organization held its annual gala at the Andrew W. Mellon Auditorium on Constitution Avenue in Washington. Tickets were $300 each. Before a dinner of roasted red bell pepper soup, beef tenderloin and tilapia, Dr. Stephen H. Feinstein, president of the alliance’s board, thanked Bristol-Myers Squibb, the pharmaceutical company.

'For the past five years, Bristol-Myers has sponsored this dinner at the highest level,' Dr. Feinstein said.

He then introduced Dr. Fred Grossman, chief of neuroscience research at Bristol-Myers, who told the audience that 'now, more than ever, our enduring relationship with NAMI must remain strong.'

Documents obtained by The New York Times show that drug makers have over the years given the mental health alliance — along with millions of dollars in donations — direct advice about how to advocate forcefully for issues that affect industry profits.

In a letter today to the NY Times, NAMI Executive Director Fitzpatrick tried again to correct "misimpressions."

First, the National Alliance on Mental Illness, or NAMI, has always disclosed corporate and foundation sources of revenue. Until this year, specific amounts remained private for competitive fund-raising reasons.

Second, your estimate that pharmaceutical companies account for three-quarters of “donations” has been misinterpreted as a share of NAMI’s total annual budget — which is actually about 50 percent.

Perusal of the 2008 NAMI Annual Report does include this impressive list of "Corporate Partners":

Abbott
Alexza Pharmaceuticals
Amazon
AstraZeneca
Blue Cross Blue Shield
Bristol-Myers Squibb
College of Psychiatric and Neurologic
Pharmacists
Corcept Therapeutics
Cyberonics
Delivery Agent, Inc.
Forest Laboratories
GEO Care
GoodSearch.com
The Health Central Network
Janssen Pharmaceutica
Eli Lilly and Company
Magellan Health Services
McNeil Pediatrics
Neuronetics
Novartis
Otsuka America Pharmaceuticals
Pfizer
PhRMA
RF Binder
Sanofi-Aventis
Shire
Solvay
Validus Pharmaceuticals
WellPoint
Wyeth
YTB Travel Network

The NAMI web-site now includes lists of specific corporate donations that individually exceeded $5000 since the beginning of 2009. So far this year, the biggest pharmaceutical corporate donors appear to be AstraZeneca ($350,000), Bristol-Myers-Squibb ($506,205), and Eli Lilly ($675,500). 

Looking at the latest Form 990 filed on behalf of NAMI with the US Internal Revenue Service (available from GuideStar here)  provides more interesting detail. (Keep in mind that the 2008 form covers July 1, 2007 to June 30, 2008.)   This form listed the organization's total revenue as $13,788,288, and expenses as $12,796,205.  These expenses included $1,785,060 (13.9%) for management and $1,520,637 (11.9% ) for fund-raising.  The form listed eight NAMI executives who made more than $100,00 a year, including Mr Fitzpatrick ($210,685 total compensation).

So, in summary, it appears that corporate donations, mainly from a few large pharmaceutical companies, supply a substantial portion, (maybe half, if I read the letter by Mr Fitzpatrick correctly) of the annual budget of NAMI. About one-quarter of that budget is spent on administration and fund-raising, including six-figure salaries for at least eight executives.  So who do you expect would more easily get access to the $200K+/year NAMI Executive Director, an executive of a pharmaceutical firm that supplies more than $500,000 a year, or a NAMI member who pays $35 dues?

Here we have another example of a respected patient advocacy organization which gets a substantial portion of its revenue from (presumably the marketing departments of) a few large pharmaceutical companies.  (See another example here.)  Its well-paid executive director can at best bring himself to deny that the only purpose of the organization is to support pharmaceutical marketing and lobbying.  It seems reasonable that for supplying half the budget, the pharmaceutical companies expect considerable help not only with marketing but also with advocacy of policies that favor their corporate goals. 

As I have said before, I do not have a problem with pharmaceutical and other health care corporations marketing their products, and expressing their views on policy. I do have a problem with corporate marketing or policy advocacy is disguised as grass-roots, not-for-profit education and advocacy.  If ostensibly not-for-profit disease (or patient) advocacy organizations like NAMI want to continue to accept corporate money, they should make it clear that they speak for their corporate donors as well as, and probably with priority over their members and patients with the diseases of interest.  Well-intentioned people who pay their dues, and/or make small contributions to NAMI to help the mentally ill might want to consider whether they are likely to have any influence compared to the individual pharmaceutical executives who oversee $500,000+ a year corporate donations.

ADDENDUM (2 November, 2009) - See also comments on the Furious Seasons blog.

Failing to Report Adverse Effects of Treatments

We have frequently advocated the evidence-based medicine (EBM) approach to improve the care of individual patients, and to improve health care quality at a reasonable cost for populations. Evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.

One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient's clinical characteristics and personal values.

When making decisions about treatments for individual patients, the EBM approach suggests using the best available evidence about possible benefits and harms of treatment, so that the treatment chosen is most likely to maximize benefits and minimize harms for the individual patient. The better the evidence about specific benefits and harms applicable to a particular patient, the greater will be the likelihood that a particular decision based on this evidence will result in the best possible outcomes for the patient.

A new study in the Archives of Internal Medicine focused on how articles report adverse effects found by clinical trials. [Pitrou I, Boutron I, Ahmad N et al. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169: 1756-1761. Link here.] The results were not encouraging.

The investigators assessed 133 articles reporting the results of randomized controlled trials published in 2006 in six English language journals with high impact factors, that is, the most prestigious journals, including the New England Journal of Medicine, Lancet, JAMA, British Medical Journal, and Annals of Internal Medicine. They excluded trials with less common designs, such as randomized cross-over trials. The majority of trials (54.9%) had private, or private mixed with public funding.

The major results were:
15/133 (11.3%) did not report anything about adverse events
36/133 (27.1%) did not report information about the severity of adverse events
63/133 (47.4%) did not report how many patients had to withdraw from the trial due to adverse events
43/133 (32.3%) had major limitations in how they reported adverse events, e.g., reporting only the most common events (even though most trials do not enroll enough patients to detect important but uncommon events).

The authors concluded, "the reporting of harm remains inadequate."

An accompanying editorial [Ioannidis JP. Adverse events in randomized controlled trials: neglected, distorted, and silenced. Arch Intern Med 2009; 169: 1737-1739. Link here] raised concerns about why the reporting of adverse events is so shoddy:

Perhaps conflicts of interest and marketing rather than science have shaped even the often accepted standard that randomized trials study primarily effectiveness, whereas information on harms from medical interventions can wait for case reports and nonrandomized studies. Nonrandomized data are very helpful, but they have limitations, and many harms will remain long undetected if we just wait for spontaneous reporting and other nonrandomized research to reveal them. In an environment where effectiveness benefits are small and shrinking, the randomized trials agenda may need to reprogram its whole mission, including its reporting, toward better understanding of harms.

Pitrou and colleagues have added to our knowledge about the drawbacks of the evidence about treatments that is publicly available to physicians and patients when making decisions about treatment. Even reports of studies with the best designs (randomized controlled trials) in the best journals seem to omit important information about the harms of the treatments they test.

It appears that the majority of the reports that Pitrou and colleagues studied received "private" funding, presumably meaning most were funded by drug, biotechnology, or device companies and were likely meant to evaluate the sponsoring companies' products. However, note that this article did not analyze the relationship of funding source to the completeness of information about adverse effects.

Nonetheless, on Health Care Renewal we have discussed many cases in which research has been manipulated in favor of the vested interests of research sponsors (funders), or in which research unfavorable to their interests has been suppressed. Therefore, it seems plausible that sponsors' influence over how clinical trials are designed, implemented, analyzed and reported may reduce information about the adverse effects of their products reported in journal articles. Trials may be designed not to gather information about adverse events. Analyses of some adverse events, or some aspects of these events may not be performed, or if performed, not reported. The evidence from clinical research available to make treatment decisions consequently may exaggerate the ratios of certain drugs' and devices' benefits to their harms.

Patients may thus receive treatments which are more likely to hurt than to help them, and populations of patients may be overtreated. Impressions that treatments are safer than they actually are may allow their manufacturers to overprice them, so health care costs may rise.

The article by Pitrou and colleagues adds to concerns that we physicians may too often really be practicing pseudo-evidence based medicine when we think we are practicing evidence-based medicine. We cannot judiciously balance benefits and harms of treatments to make the best decisions for patients when evidence about harms is hidden. Clearly, as Ioannidis wrote, we need to "reprogram." However, what we need to reprogram is our current dependence on drug and device manufacturers to pay for (and hence de facto run) evaluations of their own products. If health care reformers really want to improve quality while controlling costs, this is the sort of reform they need to start considering.

NB - See also the comments by Merrill Goozner in the GoozNews blog.