Dr. Silverstein and Dr. Poses in WSJ: "The Literature Is Hardly Pristine"

I have considered Dr. Roy Poses' Dec. 14, 2010 post "The Lancet Emphasizes the Threats to the Academic Medical Mission" (with its hyperlinks to source posts and articles) an excellent summary of many of the pathologies we address at Healthcare Renewal, especially with regard to the academic mission and the disruption of the integrity of the medical literature by commercial interests. His post is consistent with what might be considered our mission statement:

Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

The Wall Street Journal published the following letter to the editor authored by me today in which I cited and summarized Dr. Poses' accounting of the medical literature's ills.

Unfortunately, the print version cannot contain the hyperlinks as in the aforementioned source post, but I have included them in the reproduced letter below in [brackets]. They are worth reviewing, along with additional links at the aforementioned source post "The Lancet Emphasizes the Threats to the Academic Medical Mission":

April 8, 2011
Wall Street Journal
Letters to the Editor

The Literature Is Hardly Pristine

I find it unfortunate having to inform reader James Reichmann, (Letters, April 1) who prefers his physician to recommend only treatments proven in the "synthesized medical literature," that the very literature on which he wishes his life to depend may be tainted.

As Dr. Roy Poses points out on the Healthcare Renewal Blog, numerous factors common in today's culture can and do corrupt the literature.

The factors include but are not limited to: rampant commercialization of medicine [here, here, here and here], research universities with lax conflict of interest policies [here], faculty as de facto employees of industry through grants [here], academics paid to be "key opinion leaders" to stealth-market drugs and devices [here], control of clinical research given to commercial sponsors [here], conflicts of interest allowing manipulation and suppression of clinical research [here and here], academics taking credit for articles written by commercially paid industry "ghost writers," [here and here], whistleblowing discouraged [here and here], leadership of academic medical centers by business people [here] and medical school leaders becoming stewards (as members of boards of directors) of for-profit health-care corporations [here, here, here and here].

As for me, until the medical literature can be freed of these contaminants, I'd rather trust a well-trained personal physician's good judgment in my own medical care.

Scot Silverstein, M.D.

Drexel University

Philadelphia

I believe it's also worth reviewing my own views on the subject, that the degree of contamination of medical literature is unknown and may be unrecoverable, due to spread of the contaminant vectors to the "experts" who then propagate the disease.

See my Aug. 2009 post "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?" where I raise these questions.

At that post I suggest that while the damage might not be easily recoverable, the practices that lead to contaminated literature must be stopped going forward if true evidence-based medicine is ever to be a reality.

-- SS

4/12/2011 addendum:

Almost predictably, some anonymous person, this time over at the Respectful Insolence blog in commenting on a post there that attacks "naturopathic" medicine, proffered strawman arguments about my piece above in comment #26.

... So Dr. Silverstein thinks that the defects he cites (many of which have been revealed by and hotly debated within the scientific community) are ample justification for tossing out the entirety of research in favor of the sort of "clinical intuition" that's repeatedly been found false over the years

This binary, two-dimensional thinking is quite sad to read, if real. I'll be charitable in saying that the comment does have the "feel" of something contrived, such as received before from corporate sockpuppets.

-- SS

4/13 addendum:

The proprietor of Respectful Insolence assures me that "anonymous" quoted above is not a sockpuppet. My response was basically that before attacking non-anonymous authors by name on the web who in fact (as is clear from my writing here) share similar views on medical quackery, one should contact them first to ensure you truly understand their views.

(In my case, my view is that the "well-trained physicians" of good judgment I wrote of consider the literature critically but are not bound to it, in consideration of the unknown level of its commercialization-based contamination and the variability of individual patient situations. They treat the patient, not the guideline.)

-- SS

Fat-ten-u

I recently bought the book Food in the United States, 1820s-1890. I came across an ad for an interesting product that was sold in the late 1800s called Fat-ten-u. Check your calendars, it's not April fools day anymore; this is for real. Fat-ten-u was a dietary supplement guaranteed to "make the thin plump and rosy with honest fleshiness of form." I found several more ads for it online, and they feature drawings of despondent, lean women and drawings of happy overweight women accompanied by enthusiastic testimonials such as this:

"FAT-TEN-U FOODS increased my weight 39 pounds, gave me new womanly vigor and developed me finely. My two sisters also use FAT-TEN-U and because of our newly found vigor we have taken up Grecian dancing and have roles in all local productions."

I'm dying to know what was in this stuff, but I can't find the ingredients anywhere.

I find this rather extraordinary, for two reasons:

• Social norms have clearly changed since the late 1800s. Today, leanness is typically considered more attractive than plumpness.
• Women had to make an effort to become overweight in the late 1800s. In 2011, roughly two-thirds of US women are considered overweight or obese, despite the fact that most of them would rather be lean.

A rhetorical question: did everyone count calories in the 1800s, or did their diet and lifestyle naturally promote leanness? The existence of Fat-ten-u is consistent with the idea that our bodies naturally "defended" a lean body composition more effectively in the late 1800s, when our diets were less industrialized. This is supported by the only reliable data on obesity prevalence in the 1890s I'm aware of: body height and weight measurements from over 35,000 Union civil war veterans aged 40-69 years old (1). In that group of Caucasian men, obesity was about 10% of what it is today in the same age group. Whether or not you believe that this sample was representative of the population at large, I can't imagine any demographic in the modern US with an obesity prevalence of 3 percent (certainly not 60 year old war veterans).

Here are two more ads for Fat-ten-u and "Corpula foods" for your viewing pleasure:

Fat-ten-u

I recently bought the book Food in the United States, 1820s-1890. I came across an ad for an interesting product that was sold in the late 1800s called Fat-ten-u. Check your calendars, it's not April fools day anymore; this is for real. Fat-ten-u was a dietary supplement guaranteed to "make the thin plump and rosy with honest fleshiness of form." I found several more ads for it online, and they feature drawings of despondent, lean women and drawings of happy overweight women accompanied by enthusiastic testimonials such as this:

"FAT-TEN-U FOODS increased my weight 39 pounds, gave me new womanly vigor and developed me finely. My two sisters also use FAT-TEN-U and because of our newly found vigor we have taken up Grecian dancing and have roles in all local productions."

I'm dying to know what was in this stuff, but I can't find the ingredients anywhere.

I find this rather extraordinary, for two reasons:

• Social norms have clearly changed since the late 1800s. Today, leanness is typically considered more attractive than plumpness.
• Women had to make an effort to become overweight in the late 1800s. In 2011, roughly two-thirds of US women are considered overweight or obese, despite the fact that most of them would rather be lean.

A rhetorical question: did everyone count calories in the 1800s, or did their diet and lifestyle naturally promote leanness? The existence of Fat-ten-u is consistent with the idea that our bodies naturally "defended" a lean body composition more effectively in the late 1800s, when our diets were less industrialized. This is supported by the only reliable data on obesity prevalence in the 1890s I'm aware of: body height and weight measurements from over 35,000 Union civil war veterans aged 40-69 years old (1). In that group of Caucasian men, obesity was about 10% of what it is today in the same age group. Whether or not you believe that this sample was representative of the population at large, I can't imagine any demographic in the modern US with an obesity prevalence of 3 percent (certainly not 60 year old war veterans).

Here are two more ads for Fat-ten-u and "Corpula foods" for your viewing pleasure:

Mission Hostile Health IT Obstructs Physicians From Ordering Life Saving Drugs In Critical Emergency

"You should not have to work around something that is not in the way" - SS

This post can be considered Part 9 of my multi-part series on the mission hostile user experience presented by commercial healthcare IT.

Note: Part 1 is here, part 2 is here, part 3 is here, part 4 is here, part 5 is here, part 6 is here, and part 7 is here, and part 8 is here.

Special K® Red Berries is one of my favorite cereals.




In this context, however, "Special K Red Berries" is a metaphor for cerebral and other hemorrhages caused by health IT getting in the way -- actually obstructing -- physicians ordering emergency medications such as vitamin K given via the fastest route, intravenously.

A cerebral hemorrhage at post-mortem (obviously). Note the "red berry." Similarities in appearance to above cereal bowl ironic.

This EHR system has been deployed for approximately a half decade in a hospital I'll leave unnamed.

It is stunning to me that no clinician has apparently ever complained about the following informatics/relational database integrity "glitch" regarding a not-uncommon clinical scenario, over-anticoagulation (too much blood thinner). If they did complain, however, it would be criminally negligent if the following issue was not corrected.

Atrial fibrillation (Afib) is a heart rhythm disturbance that makes a person prone to throw blood clots from the heart and suffer strokes, and is treated in part by anticoagulant drugs such as heparin and coumadin.

Atrial fibrillation is a disorder found in about 2.2 million Americans. During atrial fibrillation, the heart's two small upper chambers (the atria) quiver instead of beating effectively. Blood isn't pumped completely out of them, so it may pool and clot. If a piece of a blood clot in the atria leaves the heart and becomes lodged in an artery in the brain, a stroke results. About 15 percent of strokes occur in people with atrial fibrillation. The likelihood of developing atrial fibrillation increases with age. Three to five percent of people over 65 have atrial fibrillation

A patient with Afib on coumadin was found to be over-anticoagulated, with a dangerously high INR value, greater than 5. This patient already had a history of a life threatening subdural hematoma (bleeding hemorrhage under the lining of the brain, potentially fatal) a few years prior.

This, the patient was at great risk of catastrophe.

The international normalized ratio (INR) test is a measure of the extrinsic pathway of blood coagulation. It is used to determine the clotting tendency of blood...A high INR level such as INR=5 indicates that there is a high chance of bleeding.

Vitamin K (Aquamephyton) reverses the blood-thinning effects of coumadin. It acts most quickly and is most effective when administered intravenously.

That is, if the computer, now mediating and regulating an increasing amount of healthcare operations, allows the physician to order it that way.

It takes perhaps 3 seconds to write an order such as "aquamephyton 10 mg IV STAT", and a minute or less for the order to be called down to pharmacy by a clerk.

The computer version of the same task worked a bit differently for a very ill patient:

A hospital resident physician, when told to order IV Aquamephyton for urgent administration to this over-anticoagulated patient with atrial fibrillation who had already suffered a subdural hematoma, could only order it subcutaneously due to computer restrictions.

A half-hour of investigation, IT experimentation and phone calls needed to be made to the attending physician and the pharmacy to override that limitation, while the patient lay at critically high risk for another life threatening bleed.

Here are actual de-identified screen shots displaying the mayhem:

Screen 1. Click to enlarge. The physician typed the partial search term "aquam" to locate "aquamephyton", but the order menu stated that "no matching entries found."

Screen 2. Click to enlarge. The physician as a guess then typed "aqua" (instead of "aquam") and the drug and dosing options are listed (but spelled wrong in 2 ways - "aquaAMEPHYTOIN" - which is why "aquam" failed to match anything).

Screenshot 3. Click to enlarge. The physician clicked on the drug to override the fixed options presented in the listing, but the IV route of administration was not available in the drop down box, nor could it be entered in any way.

Screenshot 4. Click to enlarge. Same as #3 but with dose "10 milligrams" filled in. Still no option for IV route on the drop down.

Screenshot 5. Click to enlarge. Continuing the doctor's waste of time and IT misadventure, the doctor typed in "aqu", which leads to the same options. Still no IV route available! Note that there is no automatic reference for the drug offered by the computer.

Screenshot 6. Click to enlarge. After consultation on phone with pharmacist, more time wasted, physician now typed in "phy" (part of the generic name for the drug, i.e., "phytonadione"). BINGO! More options are now available, that are continued on screenshot 7 after scrolling down.

Screenshot 7. Click to enlarge. Med list has been scrolled down. Finally, an IV option is located after a bit of wild goose chasing. ("IVPB" stands for intravenous piggyback). Why were these choices not available under the drug's brand name? It's the same drug!

I won't even go into the computational-linguistics and HCI backwardness of forcing clinicians to go on a distracting 'treasure hunt' through a list of permutations of drug doses and routes, or a menagerie of widgets for parameter specification, for each drug they order, as compared to more advanced methods of command entry. Such methods would have the computer (via the programmers) algorithmically do the bulk of the work. The concept of "parsing" seems alien to health IT vendors, who seem stuck in the paradigms of an earlier data processing era.

Screen shot 8. Physician typed in "vitamin K" and the same options appeared as with "phy." The computer response and administration options to the physician for any of these synonymous drug names should have been exactly the same (even with the "aquaamephytoin" misspelling, once the physician located the drug by luck).

The simple has been turned into the complex, with misspellings, delays and frustration, while a patient at great risk for literal red berries accumulating in his or her head lay in bad, waiting for treatment.

There are parallels between this "glitch" and glitches reported in a competitor's EHR reported by Dr. Jon Patrick in Australia at these links, e.g., regarding faulty data and linkages, user interface problems obstructing clinical work, etc.:

• Analysis of Cerner Problems Defined by ED Directors, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116

• A study of an Enterprise Health information System, http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146

Several questions:

• Is this a configuration/formulary problem local to this organization, or is it a generalized problem with this system originating at the manufacturer? (I've personally reported health IT defects in this software I'd observed in hospitals to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example of a possible systemic problem is in MAUDE here.)
  

• What other drugs are misspelled, and/or listed under different names with different (and incomplete) ordering options, with no easy and quick override?

• How did these errors get into the system, and why were they not corrected earlier?
  

• Were patients ever injured by this or other similar IT defects within this system?
  

• Is this the technology that will reduce errors and "revolutionize medicine"?
  

• Would you, the reader, want to be that patient waiting for the vitamin K or other critical drug while the doctors fritter away their time and energy on mission hostile computer systems?

Some day you or your family member might be.

-- SS

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE?

Ghostwriting Charges and Stonewalling at the American Psychiatric Association

The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from Daniel Carlat, 1boringoldman, Ed Silverman, and Alison Bass.

The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a denial of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in.

The coup de grâce was administered by blogger Daniel Carlat’s withering review of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed before, because it misses the ethical forest for the legal trees.

Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics.

Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been posted today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency.

For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what.

Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt reply from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.