Wednesday, September 18, 2013

FDA Medical Device Regulator Resigns: Should Health IT Vendors Be Nervous? And, Do They Still Feel "Medical Informatics Not Needed Here?"

I believe HIT vendors should be getting nervous.

HIT vendors have long enjoyed a protected status and uncritical accommodation relative to other medical device industries and pharma, with contracts that gag medical professionals from disclosing defects that can mislead and cause patient harm, and that absolve the HIT vendors themselves from liability. HIT is, in fact, a virtual medical device that other important countries (e.g., in the EU) are already moving towards regulating in a manner similar to physical medical devices.

The HIT vendor "special status" may be coming to a close, and here is a sign in that direction:

Wall Street Journal
August 12, 2009
FDA Medical-Device Regulator Resigns


WASHINGTON -- The Food and Drug Administration's top medical-device regulator said Tuesday he is resigning.

The departure follows internal dissent over device-approval decisions that the regulator's critics said were too friendly to industry.

Daniel Schultz said his move comes "by mutual agreement" with FDA Commissioner Margaret Hamburg, who took office in May. [In other words, he was asked to leave - ed.]

An FDA spokesman said Dr. Schultz's decision came as the result of talks with Dr. Hamburg, and had nothing to do with any specific issue related to a device's approval process.

Drug Chief at the FDA Is Accused of Conflict

Dr. Schultz has worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years.

Sen. Chuck Grassley (R., Iowa) held hearings two years ago on Dr. Schultz's approval of a nerve stimulation device to treat depression, approval that came over the objections of several FDA doctors. Mr. Grassley complained at the time that science was being ignored in favor of industry. Dr. Schultz said his decision was based on sound medical data.

In March, Sen. Grassley opened an investigation into a knee-surgery device made by ReGen Biologics Inc., after The Wall Street Journal reported that Dr. Schultz approved it over the objections of numerous FDA scientists and reviewers.

FDA Deputy Commissioner Joshua Sharfstein said in May that the agency would re-examine the approval process for the ReGen knee device to see if proper procedures were followed.

A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division's leaders had approved devices despite formal safety and efficacy concerns raised by FDA. They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. [This sounds much like the world of health IT, where whistleblowers on HIT safety may find themselves persona non grata - ed.] The FDA at the time declined to comment.

These are serious matters, and under the Obama administration I see a replacement as being far less friendly and far less likely to accommodate both physical and virtual (i.e., HIT) clinical device makers.

The irony is that Medical Informatics specialists such as myself and like minded colleagues have offered help to the HIT and medical device vendors and purchasers repeatedly over the years to improve quality of their products in a substantive, medical informatics-driven manner, and thus reduce the chances for strong government regulation.

We were repeatedly ignored, or told "we don't need medical informatics here" or equivalent, or patronized (e.g., being told by some corporate bureaucrat out of a Dilbert comic strip that "you don't have enough experience" or the equivalent in buzzword compliant corporate mumbo-jumbo. See example letter below.)

Seeing increasing risks to patients from cavalier, business IT-based approaches to HIT design, development, implementation and lifecycle, I and like minded colleagues are now using our talents to bolster the case for more robust government regulation of HIT. We feel it's well past the point of helping this industry, and protecting patients, from within.
If I were an HIT vendor used to generous accommodation of sloppy products and lack of regulatory oversight, I'd be re-examining my assumptions about the HIT business.

I will further amplify the "you don't have enough experience" issue experienced by Medical Informaticists:

** Disclaimer: The following elements in this post are about personal observations and experiences (my "narrative"), always difficult to write about without generating skepticism, and I admit possible non-objectivity in that regard. You, the reader, are free to ignore my observations:

(Click to enlarge. Example of a buzzword compliant, corporate IS "don't need medical informatics here" letter. Did its writer even read my CV?)

The above letter, from last year, has an interesting origin. I find it appropriate to write about now for reasons explained just below regarding a recent Philadelphia Inquirer report.

It is from the CIO at the hospital where I performed my medical residency and graduated with honors in the late 1980's, Abington Memorial, once
(pre-informatics postdoctoral fellowship) even fixing a broken CT scanner computer in the middle of the night when repair was not available, thus saving a young man's life. It is from the very same organization I wrote of (in anonymized form) in my Oct. 2007 post "Informaticist can't escape clinical IT issues even on personal business."

Does the letter demonstrate confusion about strategy vs. tactics vs. operations, about what Medical Informatics is and is not, and lying to justify a capricious decision not to even talk to me about a Director of Clinical Systems opening, I wonder? Was this based on CIO
political ambitions, and/or a preselected favored candidate, at the expense of physicians and patients, I also wonder? Did the CIO even read my CV? Was the almost exact same scenario at the same hospital ca. early 2000 a coincidence, or symptomatic of some other issue?Related to the typical IS department-generated "you don't have enough experience" letter above, ironically, the hospital's cardiac surgery program was recently "dinged" in quality by the Pennsylvania Health Care Cost Containment Council, as reported in the Philadelphia Inquirer on Aug. 6, 2009.

The hospital explained in the Philadelphia Inquirer that the quality variance, an apparently high death rate, was due to missing items in the information submitted to the state about the heart surgery program's patients, in a hospital with an extensive medical records system no less.

Having led the building of world-class information systems from the ground up for invasive cardiology and cardiac surgery a decade ago for one of this hospital's regional competitors, Christiana Care in nearby Delaware, against the "best" efforts towards obstructionism and mismanagement by another business computing CIO, I find this explanation heartrending (no pun intended).

As a result of my Medical Residency at Abington, I know many of the clinicians at the hospital for decades, and they are generally excellent. They saved my father's life and gave him the gift of six additional years of life, after severe malpractice in 1994 at another Philadelphia hospital - in part due to failed communication of important patient data - nearly led to his demise. Some have told me they are quite unhappy with the organization's EHR efforts.

Regrettably, the bad publicity in the Inquirer and other outlets as a result of this data irresponsibility will likely tarnish the Abington cardiac surgery program's reputation for some time to come, even if (as is likely) the high mortality rate was spurious. This was needless and avoidable.

But, of course, according to this hospital's CIO, (in essence) I didn't have enough experience for Director of Clinical Systems.

This raises a question:

Who is responsible, ultimately, for information in a hospital?

How about: the Chief Information Officer (CIO)?

Finally, I repeat, the latter elements in this post are about personal observations and experiences. I admit possible non-objectivity in that regard, although informatics colleagues in the trenches also report similar observations.

I report, you decide.

-- SS

1 comment:

Anonymous said...

In the same edition f the WSJ with the lead on the front page of the Marketplace section we find the bulk of this article below the device chief article: Conflict-of-Interet Alleged With FDA Drug Chief. Take together these articles are four columns wide and cover over half the page.

In the Conflict-of-Interest article we find questions regarding Dr. Janet Woodcock's relationship with Momenta regarding a generic low-molecular weight heparin. At the same time of the Momenta application Amphastar applied for approval of a similar drug.

Troubling is the attendance of Dr. Woodcock at a Thailand conference with Momenta personnel, personal emails with Momenta leadership, co-authoring journal articles during the approval process with Momenta staff and finally we have this:

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

One really does have to ask about the conflicts of those who are suppose to be above reproach and protecting the public's interest.

Steve Lucas