King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again.  The latest settlement in the parade was made by the Alpharma subsidiary of King Pharmaceuticals, as reported by Reuters:

Alpharma Inc, a unit of King Pharmaceuticals (KG.N), has agreed to pay $42.5 million to resolve allegations that it gave kickbacks to doctors to prescribe the pain drug Kadian and misrepresented its safety and effectiveness, the Justice Department said on Tuesday.

Kadian, which is based on morphine [that is, a long-acting preparation of morphine], is used to treat chronic moderate to severe pain.

We have ranted frequently about how settlements like this, which simply impose costs on large organizations that can easily be regarded as costs of doing business, but impose no penalties on the people who authorized, directed, or implemented bad behavior, do nothing to deter future bad behavior. Now at least we have company (see recent example of rant here). Last week, a commentary by An Woolner on Bloomberg, included:

Examples abound that these companies keep breaking rules and violating laws to make and market their products, no matter how many times they are caught, fined and forced to promise to go straight.

Yet,

The biggest fine ever imposed in U.S. history, $2.3 billion against recidivist Pfizer, represented a mere 14 percent of the revenue stream from selling the drugs at issue over seven years. [see our post here.]

So immune to criminal sanctions was the New York-based company that it launched its off-label Bextra campaign at the same time the company was pleading guilty to doing precisely the same thing with other drugs. The anti-inflammatory medication was later yanked from the market because of increased risk of heart attacks and stroke.

So,

What’s to be done?

The government can essentially kill a company by pushing for the parent firm to be barred from government work, which would include Medicaid and Medicare.

Teaching a Lesson

That would teach the company a lesson. But it would also hurt the millions of people who depend, in Pfizer’s case, on products from Accupril to treat congestive heart failure to Zyvox when you have certain pneumonias or infections.

And then there are those thousands of company employees who do good, honest work and who would suddenly find themselves in already massive unemployment lines.

Instead,

The challenge is to find a way to make it not worthwhile to break the rules.

Executives Behind Bars

Throwing a few company executives in jail might do the trick. On occasion, sales managers and physicians have been prosecuted.

As for top managers at pharmaceuticals, six have been convicted or pleaded guilty, mostly for misbranding or promoting off-label uses, according to the Justice Department.

Winning felony convictions is tough to pull off because you have to prove they had specific intent to commit fraud. As with any white-collar crime, that is tricky.

But there is a way around that obstacle, and the FDA announced this month that it would go that route to focus on pharmaceutical executives, the Wall Street Journal reported.

The Food and Drug Act allows misdemeanor convictions without proof of intent to do wrong.

That is an awesome power and it can be easily abused. The timing of the FDA announcement suggests that it’s a response to critics in Congress and a brutal Government Accountability Office report that the division operates without scrutiny or, well, accountability.

And yet, used for the right cases, the misdemeanor prosecution of an executive or two who set up incentives for the sales force to push drugs illegally and withhold information about devices from regulators just might do the trick.

Nothing else has yet.

To which I say, amen.

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (query link).

One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry.

One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review" (BMJ 2010;340:c1344).

Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the Philadelphia Inquirer:

"We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.

From the BMJ article itself, free full text available as of this writing at link above:

For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.

The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing.

Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's.

As to results (see the full article for statistical details I am omitting here):

Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.

While causality is not proven, these results are still stunning. Per the Inquirer's summary:

... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.

Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.

The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy).

The authors observe that:

In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest.

Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements:

Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.]

One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist.

... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]

So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue.

Finally, the pharmaceutical company's view, also published in the Inquirer article cited above:

A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site.

"It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure."

"Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view.

The Mayo researchers wisely conclude:

Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.

Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers.

We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues.

These practices also simply need to be abolished, for as I have written before on these pages ("Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already.

-- SS

Gruber at MIT to Senators: "I Promise To Be Good ... Next Time"

Frequently expressed on this blog are concerns about conflicts of interest and their corrosive effects upon healthcare (query link). We also have expressed concern about the mental gymnastics used by the privileged or those in positions of power to rationalize these COI's and/or justify keeping these COI's from the public's eye.

In a stunning display of academic arrogance, MIT economics professor Jonathan Gruber, who promoted and defended the administration's health care policies before the U.S. Senate Committee on Finance as well as the Health, Education, Labor & Pensions Committee, while collecting $400,000 from HHS for his services, literally blew off a letter of inquiry from Senators Grassley and Enzi regarding possible conflicts of interest. (See this Google search on the terms "jonathan gruber conflict of interest HHS".)

The professor has been a source of support for what many consider improbable arguments of the impact of current health care reform efforts, while being on the HHS dole.

Sen. Grassley and Sen. Enzi have thus written Dr. Susan Hockfield, President of MIT, to "encourage" the professor to be a little more forthcoming in his replies.

The letter to Hockfield and a copy of the original letter to Prof. Gruber can be downloaded here (PDF).

On Jan. 26, 2010 Gruber was asked some very specific questions by letter (summary below, see full letter at link above for details).

He was asked by the Senators:

• To identify each contract, grant or cooperative agreement he has executed with the federal government, including the White House and HHS and its operating divisions, during the past five years. For each contract, he was asked to respond to a series of detailed questions on: specifics of work performed, federal official serving as contact, start/end dates, amount of compensation, plus a request for copies of the contracts, grants, cooperative agreements, and a copy of the deliverables;
• To identify which of the contracts are "sole source", and provide the reasons the contracts were sole source, what official made that determination, and who is the federal official with whom he negotiated the sole sourcing;
• To answer similar questions about contracts with state and local governments and private entities and individuals he had executed in the past five years;
• To identify all interviews or statements made to the media on healthcare reform since the federally funded work began, and if asked during the interview or if he did so voluntarily, to state if he revealed the HHS relationship; and
  
• To answer similar questions on all speaking engagements.
  

To these detailed inquiries, the response was this (emphases mine):

February 23, 2010

Dear Senators Grassley and Enzi:

This letter responds to your letter to me dated January 26, 2010.

I appreciate your commitment to the principle of transparency in government and can assure you that I never intentionally withheld my two HHS contracts from Congress. Indeed, my contracts were publicly disclosed on the federal government website, www.usaspending.gov.

[Prof. Gruber seems to confuse the passive "publicly disclosed" with active "public disclosure," and apparently misses the point that a possible conflict of interest is an obligation of the principal(s) to disclose when they publish or speak, not an obligation of the audience to discover ex post facto via governmental or other websites - ed.]

As you know, my professional research focuses on public finance and health economics and throughout my career I have worked with Democrats and Republicans alike on the critical issue of health care reform. I served as a consultant to then-Governor Mitt Romney in connection with health care reform efforts in Massachusetts and have also testified before the Congress on these issues.

[That worked out rather poorly, according to Massachusetts Treasurer Tim Cahill - ed.]

I was invited to testify jointly by the Majority and Minority Members of the Senate Finance Committee in the Summer of 2008 on the interaction of health insurance and the tax code and have testified more recently as well. In addition, over the past year in connection with my economic analysis work for HHS, I have worked closely with the staffs of both the Senate Finance and the Senate HELP Committees in evaluating various health care reform proposals and assessing how such proposals might be scored by the Congressional Budget Office.

To the best of my recollection, during the course of my health care reform work with Congress, no Member or staffer ever asked me whether I held any government contracts. Given that the staff saw the time that I was devoting to this effort, in retrospect, I suppose I assumed they understood I was being paid for that work.

[Assumed you were being paid ... to the tune of nearly half a million dollars? - ed.]

Both my congressional testimony and the health care opinion pieces that I have authored reflect my longstanding policy views -- and were in no way influenced by my contracts with HHS, which related to technical economic modeling designed to determine the costs of various health care reform policy options.

[Which raises another question: was that 'modeling' influenced by the HHS money? - ed.]

It certainly did not occur to me that anyone would view my HHS contracts as relevant to my independent, long-held opinions regarding the economics of health care reform. [Really? - ed.] I regard the contract work I performed for HHS and my public speaking and writing as being independent and unrelated. But I do recognize the public interest in these disclosure issues and will certainly consider them in the context of future appearances on the Hill or in the media.

[I note that "I will consider them" (i.e., disclosure 'issues') is an ambiguous statement, as opposed to "I will disclose my possible conflicts" - ed.]

Thank you for your work on these issues.

Sincerely,

Jonathan Gruber

In other words, I guess the public does have a right to know about my possible conflicts of interest when a major portion of the US economy's about to be up-ended, and I'll be a good boy and team player - next time. By the way, regarding your detailed questions, you do good work, but get lost.

Academic contempt for disclosure of conflicts of interest seems to know few bounds. I doubt the letter to the MIT President will accomplish very much.

Let's hope the responses from the healthcare IT vendors to Sen. Grassley's inquiries are more forthcoming than this academic one.

Finally, it occurs to me that profligate spending of almost a half million dollars for the sole-source consultation of a single (already salaried) professor raises a concern about cherry-picking for theories supporting a certain point of view, and shows questionable governmental fiscal responsibility.

That is the size of a research grant that could support, say, a significant fraction of the time of a half dozen academic collaborators with a diverse set of theories and views.

-- SS

Disclosure: I have not received a penny from HHS, government, academia, industry, or even Tinkerbell or the Tooth Fairy for these views.

AMA And Almost 100 Physician Societies Sound Off To CMS On Health IT, Use "F" Word

In a remarkable development, the American Medical Association and nearly one hundred other physician specialty societies submitted a letter to CMS on Mar. 15 (in PDF at http://www.ama-assn.org/ama1/pub/upload/mm/399/meaningful-use-comments-15mar2010.pdf).

These organizations wish to prevent physicians from purchasing ill conceived and poorly designed HIT that does not support better practice. The organizations also express deep concern about ominous reporting requirements and overly aggressive timelines, the latter an issue I've written about repeatedly such as in my formal reply to ONC's "Proposed Establishment of Certification Programs for Health Information Technology" at this link.

The entire letter is available at the PDF link above and is quite lengthy, but the section of the letter that immediately caught my eye is this:

... Aggressive timelines and criteria during the initial stage of the incentive program will only serve to undermine this effort. Some government officials have relayed that complex measures and high reporting thresholds are needed to discourage EPs ["eligible professionals" eligible for ARRA money -ed.] from switching back to the use of paper during this transition to EHRs.

We are very troubled by this assertion. Physicians are deeply supportive of and committed to incorporating well-developed EHRs into their practices to improve quality of care delivery, enhance patient safety, as well as support practice efficiencies. [Some are - many are not - perhaps the medical specialty societies need to stop acting as if they speak for all physicians - ed.]

It is also very unlikely that after physicians make a significant up front investment in health IT and changes to their workflow that they will revert back to manual processes.

That assertion, in fact, is not quite true, as in "Failure, De-installation Of EHRs Abound" here. However, coercion through ominous reporting requirements is not going to improve adoption rates and will undermine HIT efforts as well, for example via physician fear of the uses to which the data will be put by a coercive, authoritarian-leaning government.

Now comes what I believe is the most critical passage where the "F" word ("failure") is used:

We believe that the larger concern should be deterring the purchasing of costly EHR products that fail to improve physician workflow, patient care, and practice needs. Industry experts have cited that such failures have adversely affected EHR adoption rates ranging from 50 to 80 percent. [Mission hostile health IT falls into that category - ed.]

Note the acknowledgment of healthcare IT failure.

The letter was a bit weak in the area of patient safety related to HIT. Further, it presented physicians as monolithic eager adopters of HIT (a characterization that is most assuredly false), and minimized the issue of the messiness and Murphy's Law nature of IT installation and maintenance that often make IT a nightmare.

The fact, however, that a letter from the major medical societies challenged the irrational exuberance and beliefs in technological determinism that surround health IT (i.e., that computerization 'automagically' fosters improvement), and used the "failure" word is itself somewhat astonishing.

I was not inventing anything when I began writing about HIT difficulties over ten years ago using the "failure" word, merely reporting the obvious (to those sober about IT) from observation and reports of many colleagues.

It's good to see the rest of the medical world start to catch up with common sense.

-- SS

Addendum: the letter was also signed by the following groups:

American Academy of Dermatology Association
American Academy of Family Physicians
American Academy of Home Care Physicians
American Academy of Neurology Professional Association
American Academy of Ophthalmology
American Academy of Otolaryngology – Head and Neck Surgery
American Academy of Pain Medicine
American Academy of Physical Medicine and Rehabilitation
American Academy of Sleep Medicine
American Association of Clinical Endocrinologists
American College of Cardiology
American College of Chest Physicians
American College of Gastroenterology
American College of Obstetricians and Gynecologists
American College of Osteopathic Family Physicians
American College of Osteopathic Internists
American College of Osteopathic Surgeons
American Academy of Pediatrics
American College of Physicians
American College of Radiation Oncology
American College of Rheumatology
American College of Surgeons
American Gastroenterological Association
American Geriatrics Society
American Medical Association
American Osteopathic Academy of Orthopedics
American Osteopathic Association
American Psychiatric Association
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Radiation Oncology
American Society of Anesthesiologists
American Society of Clinical Oncology
American Society of Hematology
American Society of Nephrology
American Society of Plastic Surgeons
American Thoracic Society
American Urological Association
Heart Rhythm Society
Infectious Diseases Society of America
Joint Council of Allergy, Asthma and Immunology
Medical Group Management Association
North American Spine Society
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Hospital Medicine
The Endocrine Society
Medical Association of the State of Alabama
Alaska State Medical Association
Arizona Medical Association
Arkansas Medical Society
California Medical Association
Colorado Medical Society
Connecticut State Medical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Association, Inc.
Medical Association of Georgia
Hawaii Medical Association
Idaho Medical Association
Illinois State Medical Society
Indiana State Medical Association
Iowa Medical Society
Kansas Medical Society
Kentucky Medical Association
Louisiana State Medical Society
Maine Medical Association
MedChi, The Maryland State Medical Society
Massachusetts Medical Society
Michigan State Medical Society
Minnesota Medical Association
Mississippi State Medical Association
Missouri State Medical Association
Montana Medical Association
Nevada State Medical Association
New Hampshire Medical Society
Medical Society of New Jersey
New Mexico Medical Society
Medical Society of the State of New York
North Carolina Medical Society
North Dakota Medical Association
Ohio State Medical Association
Oklahoma State Medical Association
Oregon Medical Association
Pennsylvania Medical Society
Rhode Island Medical Society
South Carolina Medical Association
South Dakota State Medical Association
Utah Medical Association
Wisconsin Medical Society
Vermont Medical Society
Medical Society of Virginia
Washington State Medical Association
West Virginia State Medical Association
Wyoming Medical Society

A Simple Lesson for the Health IT Industry

From an Op Ed "Living with the Electronic Car" in today's Wall Street Journal:

"A Toyota executive recently explained to a Congressional committee investigating claims of uncontrolled acceleration: "We need to reduce the number of things we ask our customers to do correctly." In fact, the exec was describing the essence of responsible engineering - though perhaps the balance in auto design has gotten out of whack."

Considering the feedback from physicians on the needless complexity of electronic medical records and other computerized medical devices for example at "An Honest Physician Survey on EHR's", it seems the healthcare IT industry has yet to learn this simple lesson.

I'm frankly not convinced there's "anyone home" in this complexity-loving industry who could fathom such advice as a good business practice.

It also seems that industry may not give a damn about such lessons, even in the most safety critical of environments, the intensive care unit, as long as profits are maintained.

See for example "A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge: Malin v. Siemens Healthcare." Also see "Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation" on political maneuvering by this industry to avoid the federal regulation other healthcare drug and device sectors have been subject to for decades (largely as a result of public health disasters such as this and this, I might add).

The interesting aspect of these issues is that the executives and officials behind these decisions and machinations are setting themselves up as near-indefensible defendants in future litigation by patients (and their estates) harmed or killed by healthcare IT-related problems.

For instance, I had communications with the Joint Commission leadership over issues I raised in my July 22, 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards." Namely, on how hospital executives were violating their fiduciary and Joint Commission safety standards obligations, and jeapardizing patient safety, in signing the traditional health IT contract calling for confidentiality about health IT malfunctions and defects. The JC Leadership is quite well aware of this letter and my more thorough essay here.

Nothing has been heard from the Joint Commission on these issues since.

Perhaps never before have the malpractice lawyers been provided a better scenario for taking the houses and personal property from irresponsible and/or conflicted healthcare and health IT regulators and other officials via lawsuits as health IT diffusion increases, with its "tip of the iceberg" injury and death occurrences now firmly established.

-- SS

Abbott's TriCor Fails To Beat A Sugar Pill in Diabetics - And In Pharma's Current Death Spiral, Forget About a Drug That Will

In numerous national publications today, we are once again reminded that lowering the risk of diabetics for vascular events (MI/heart attack, CVA/stroke etc.) and death is far more complex than lowering measures such as cholesterol and blood pressure.

Note these articles:

Abbott's TriCor Fails To Beat A Sugar Pill
March 14, 2010 - 9:58 am
Matthew Herper
Forbes.com

ATLANTA -- A popular triglyceride-lowering drug that has been taken by millions of Americans failed to prevent heart disease in a big federal study being presented today.

The drug, TriCor from Abbott Laboratories, has been used for over a quarter of a century to lower levels of fatty particles in the blood called triglycerides. The presumption has been that doing so would prevent heart attacks or heart-related deaths. TriCor has annual sales of more than $1 billion.

But the new study being presented at the American College of Cardiology meeting casts doubt on this. In the study, funded by the National Heart, Lung and Blood Institute, 5,500 patients with diabetes got either TriCor or a placebo. After five years, there was no difference in the rate of heart attacks, strokes and deaths in the patients who got Tricor versus those who took a sugar pill.

and

Search for Better Diabetes Therapy Falls Short
Mar. 14, 2010, 9:39 P.M. ET
Ron Winslow
Wall Street Journal

Current Treatments, While Effective, Failed to Also Help Prevent Heart Attacks and Stroke

ATLANTA—New strategies to prevent and treat diabetes and heart disease failed to improve care in two major studies, frustrating researchers' efforts to find more-effective approaches to the world's burgeoning diabetes epidemic.

The studies are among the first large trials to test whether treatments recommended for diabetes patients also reduce the risk of heart attacks and strokes. Diabetics are between two and four times as likely to die of cardiovascular causes as nondiabetics. The lack of data on whether strategies to treat diabetes actually lower heart risk is of growing concern to physicians, researchers and regulators.

One new study, called Accord, found that treating blood pressure to lower levels than recommended in current practice doesn't further reduce risk of death, heart attack and stroke among people with diabetes. The same study also found that the drug Tricor, marketed by Abbott Laboratories, failed to prevent such events even though it lowered levels of blood fats called triglycerides that are associated with high diabetes risk.

In the other report, dubbed Navigator, a diabetes drug called Starlix failed to prevent people at high risk of diabetes from progressing to the disease. The blood-pressure medicine Diovan did modestly reduce risk of developing diabetes in the same study, but neither drug significantly cut the risk of heart-related deaths, heart attacks and strokes. Both pills in this study are sold by Novartis SA of Switzerland.

There is a meta-issue I wish to bring up:

It's clear there are many phenomena going on in diabetes and other metabolic disorders that we simply do not understand.

It's also very likely that there are new drugs, yet undiscovered, that could be developed and that would improve mortality and morbidity.

It's too bad the pharmaceutical industry is now largely run by dyscompetents, incompetents, and other management charlatans, not to mention those responsible for questionable or outright criminal behaviors (such as here, here).

This privileged class has apparently so demoralized pharma rank and file including the very soul of drug discovery (chemists) - based for example on "layoff thread" comments on a very popular blog for medicinal, synthetic and other chemists such as here - that these new drugs are increasingly unlikely to be developed at all.

The industry in its current anti-intellectual, "lay them off and watch the stock price rise", short-term narrow-minded idiocy-driven death spiral is basically good for nothing except money games.

Pity.

-- SS

Third-Party Reviews of Medical Devices Come Under Scrutiny at the FDA - Except Healthcare IT Medical Devices, Which Get Special Accommodation

This WSJ article caught my eye:

Third-Party Reviews of Devices Come Under Scrutiny at the FDA
March 15, 2010
By ALICIA MUNDY and JARED A. FAVOLE

WASHINGTON—When medical-equipment makers like Philips Electronics NV, Siemens AG and General Electric Co. need approval for some new devices, they don't always have to start at the Food and Drug Administration. They can pay companies to do the reviews, which are then routinely approved by FDA officials most of the time.

Now this third-party outsourcing program has come under fire at the FDA, and the agency is weighing whether to end it. Agency officials question the quality of the reviews and whether they have served the program's original purpose: saving U.S. taxpayers money.

The "real value to industry may be that this is perceived as a way to 'sneak things,'" said an FDA official at a December meeting on device approvals, according to minutes reviewed by The Wall Street Journal. Some third-party reviewers advertise speed and a friendlier process.

At a time when the FDA is moving against third party device reviews, HHS and its Office of the National Coordinator for health IT (ONC) are soliciting to create third party EHR "certification" bodies for healthcare information technology (HIT) medical devices such as electronic medical records systems, decision support tools, clinician order entry and alerting, etc. (see RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology", PDF available at this link.)

This comes at the same time as FDA admitting this technology harms and kills patients, but the extent is unknown (existing FDA data is likely the "tip of the iceberg" reports Jeffrey Shuren MD JD at the HIT Policy Committee, Adoption/Certification Workgroup, special meeting on health IT safety on February 25, 2010).

See:

"FDA on Health IT Adverse Consequences: 44 Reported Injuries And 6 Deaths, Probably Just 'Tip of Iceberg'" at http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html

and

"On ONC's "Proposed Establishment of Certification Programs for Health Information Technology" at http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html

More from the WSJ article:

... The agency's concerns about the third-party reviews come as the FDA is re-evaluating its entire device-approval process. In addition, the agency has recently announced tighter regulation of some machines that deliver radiation in the wake of reports of more than 300 cases of overdoses from CT scanners at four hospitals.

Changes under consideration at the FDA include terminating the third-party program, limiting the kinds of devices that it covers, or giving the outside reviewers more data on devices to improve the quality of their work, according to the minutes and interviews with agency officials. Jeffrey Shuren, the device division director, said the FDA will release proposed changes later this year and cautioned that no decisions have been made.

To qualify for an outsourced review, a new device must be similar to a device already on the market, and it must carry low or moderate risk to the patient.

The December 2009 minutes say "third parties often don't have appropriate expertise." The minutes cite "poor quality of review documents— they often just repeat what is in the submission, and don't provide any analysis of the data."

(The point on lack of expertise is a point I raise in my aforementioned commentary on ONC's "Proposed Establishment of Certification Programs for HIT." I wrote: HHS should not be creating new, potentially (likely?) amateur organizations and bureaucracies overseeing these new virtual medical devices that will have variable (or no) experience in software validation, certification, regulation, postmarketing safety surveillance, etc. Rather, HHS should be leveraging existing governmental expertise in certifying, validating and regulating mission critical IT.)

The industry as always is looking out for - itself, patients coming in second:

Terry Sweeney, vice president of clinical affairs at Philips Healthcare, said the third-partyprogram benefits industry and helps relieve the FDA of a burden. "Every week's delay [i.e., in rigorously assuring medical device safety - ed.] can cost the company a large sum of money," he said.

It's not like the time differential is enormous:

It takes an average of about 72 days for a company to get final clearance for a device when it goes the third-party route, according to the FDA. That includes the time for the agency to sign off on the outside reviewer's conclusion and compares with an average 109 days for similar applications that go directly to the FDA.

So, the vendors seem to be saying, let's compromise the device safety evaluation process via third party reviewers so we can get to market a month sooner.

The FDA is having serious second thoughts about this state of affairs.

Worse, on health IT devices, the HHS itself via ONC is soliciting for the creation of third party reviewers for HIT, while the FDA itself seems marginalized or even unwilling to shoulder the burden of patient protection from faulty HIT.

Odd. Why do computerized HIT medical devices such as EMR's get special government accommodation?

-- SS

For more on HIT challenges see "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" - http://www.tinyurl.com/healthITfailure

City Hospital System Board Member Fined for Conflict of Interest Involving Proprietary, Off-Shore Medical School

Sometimes I think I have now seen every type of conflict of interest that could afflict health care, but then some amazing new variation on the theme comes along...

Last year, the New York Times reported on an unusual deal between the New York City Health and Hospitals Corporation and a proprietary (for-profit) Caribbean medical school that attracts US citizens who were not admitted to US medical schools:

New York City’s Health and Hospitals Corporation has signed a 10-year, $100 million contract with a profit-making medical school in the Caribbean to provide clinical training for hundreds of students at the city’s 11 public hospitals.

The unusual deal, proposed by a member of the corporation’s board who has long worked for the Caribbean school, has been met by an outcry from New York medical schools fearing that clerkship slots will grow scarcer and that they might have to increase tuitions to compete.

Critics worry that the hospital corporation, whose mission is to serve the city’s poor, is conferring prestige on a foreign school whose curriculum, they say, is more vocational than research-based and often caters to affluent students who could not get into schools in the United States.

They say that the contract, with St. George’s University School of Medicine on the island of Grenada, has turned a meritocracy into a bounty system in which struggling city hospitals collect more for every St. George’s student they take, and could squeeze out local students.

'This changes the whole dynamic from an academic relationship to a dollar-based relationship,' said Dr. Michael J. Reichgott, associate dean for clinical affairs and graduate medical education at Albert Einstein College of Medicine in the Bronx.

Traditionally, medical schools have sent third- and fourth-year students into city hospitals to work — and learn — alongside doctors without being charged.

Under the contract, which was signed last year but never publicly announced, St. George’s pays the hospitals $400 to $425 per student per week — St. George’s charges students about $1,000 a week in tuition — on top of an annual fee of $50,000 for hospitals that take 24 or more St. George’s students.

The contract also bans the hospitals from providing clerkships to other Caribbean medical schools — a critical provision to St. George’s, which has faced heightened competition in recent years, particularly from Ross University on the island of Dominica, part of DeVry Inc., a publicly traded educational company, since 2003.

Note that the contract was unusual in several ways.  Not only did it permit a for-profit, proprietary medical school which is not accredited in the US pay hospitals to provide clerkships which they traditionally had provided without a fee to not-for-profit, US medical schools, but also it included a clause that apparently prevented other for-profit, proprietary medical schools from competing for these training physicians by also paying fees, and was signed in secret, only becoming public because of the Times' reporting. 

Furthermore, not only was the contract unusual, but the processes that lead to its approval were also unusual:

The board member who first proposed the exclusive contract, Dr. Daniel D. Ricciardi — a 1981 graduate of St. George’s and a rheumatologist affiliated with Long Island College Hospital in Brooklyn — said he had recused himself from deliberations involving St. George’s. Dr. Ricciardi, who has been on the 16-member corporation board since 2000 and on the St. George’s faculty for about 15 years, said he did not benefit financially from the deal. He was promoted to St. George’s dean of clinical studies and put in charge of United States clerkships shortly before the contract was signed.

'I don’t have to go to confession on this one, I really don’t,' he said. 'Everybody’s saying there’s a conflict here, and it comes back to me. They’re disgruntled, jealous. A report was written on the school, and the judgment was made based on merit, not on political push.'

Dr Ricciardi may or may not have felt obligated to discuss this issue during confession, but three days later, the NY Times again reported:

A board member of New York City’s Health and Hospitals Corporation resigned on Thursday, after the agency began an inquiry into his role in securing a 10-year, $100 million contract for a Caribbean medical school where he has long had a paid position.

The board member, Dr. Daniel D. Ricciardi, submitted a brief letter of resignation to the president of the corporation, Alan D. Aviles.

Dr. Ricciardi did not give any reasons for his resignation in his letter, saying only that he had been proud, 'as a first-generation New Yorker,' to support efforts to provide affordable quality health care to city residents. He had been a board member since 2000. But in a brief telephone interview on Thursday, he expressed bitterness, saying: 'You know what? The elite of the 0.1 percent that you represent have won once again. God bless.'

And just to provide the icing on the cake, despite Dr Ricciardi's denial that his job at St George's constituted a conflict of interest, two weeks ago, the NY Times further reported:

A former board member of New York City’s public hospital system has been fined $13,500 for his role in soliciting coveted training spots in city hospitals for students from a Caribbean medical school, the city’s Conflicts of Interest Board said Tuesday.

The former board member, Dr. Daniel D. Ricciardi, agreed to the fine in a settlement in which he admitted that he had held high-ranking paid positions at St. George’s University School of Medicine in Grenada while soliciting clinical clerkships — a critical part of medical education — from personnel in the city hospital system, which he also helped to lead.

Dr. Ricciardi, a rheumatologist and 1981 graduate of St. George’s, acknowledged that from January 2000, when he was appointed to the board of the Health and Hospitals Corporation, to August 2008, when he resigned after The New York Times disclosed the potential conflict, he had served in positions at St. George’s including dean of clinical studies, chairman of medicine and director of medical education.

During the same period, he said, he had contacted personnel at Kings County Hospital Center, Metropolitan Hospital Center, Woodhull Medical and Mental Health Center, Lincoln Medical and Mental Health Center, and Elmhurst Hospital Center to try to get them to increase the number of placements available to St. George’s students, a violation of prohibitions against representing a private interest before his public agency.

'I now acknowledge that my dual capacities created at least the appearance that the actions I took as an H.H.C. board member were done in part to benefit the school,' Dr. Ricciardi said in the settlement, dated Feb. 24.

Ana Marengo, a spokeswoman for the Health and Hospitals Corporation, said Tuesday that the contract was granted through competitive bidding, and that Dr. Ricciardi had recused himself from the board’s deliberations.

But Dr. Ricciardi admitted that he had violated city law prohibiting a public servant from having a position in a company that he knows is doing business with his city agency. Dr. Ricciardi said in the settlement that he had disclosed his affiliation with St. George’s to the hospitals corporation, and that he had not intended to violate any laws.

We constantly hear from its advocates that commercialized health care will lead to wonderful innovation.  At least, it certainly seems to lead to innovation in the creation of new variants of conflicts of interest.  Here, we see a board member of a municipal, not-for-profit hospital system also working for a for-profit off-shore medical school, and apparently using his board position to provide competitive benefits to that medical school, by means of a contract that was meant to be secret.  Each time we think we have begun to understand the extent that conflicts of interest pervade health care, we find new examples suggesting we have underestimated.

As we have now said ad infinitum, an important reason for rising costs, declining access, stagnant quality, and disgruntled professionals are health care leaders who undermine the missions of their own institutions in pursuit of self-interest, often driven by their own conflicts of interest.  We have now seen an amazing set of variations on this theme.  If we truly want to reform health care, we need to ensure that its leaders put their organizations' missions, and the fundamental values of health care, ahead of their own self interest.