Wednesday, March 25, 2009

Psychiatrists Get Religion, to a Degree

When I was doing research for HOOKED, one of my all-time favorite quotes came from a great press expose about the excesses of commercial sponsorship at the annual meeting of the American Psychiatric Association (I believe in 2004). A member of the board was quoted as saying that if the APA could not call upon industry money to support the meeting, they would have to endure the indignity of "meeting in the basement of the YMCA."

I never did find out what the reaction to that comment was from groups that actually do meet in the basement of the YMCA. But it indicates the extent to which consciousness has been raised about commercial influence and conflicts of interest to compare that statement with this press release:

The APA has now gone well out in front of most of its peer organizations by choosing to ban industry-sponsored symposia and meals from its national meeting.

This is a major step in a positive direction and so I hate to raise any skeptical questions. But the news release is silent on the nature and form of other industry funding that the APA will rely on to help support its national meeting. It does not report what percentage of total industry support the meeting will sacrifice by this move. It does not appear that the APA is ready for the basement of the YMCA quite yet. I'll be interested to see what our psychiatry colleagues like Danny Carlat and Doug Bremner have to say about this on their blogs.

Monday, March 23, 2009

JAMA Editors Need to Come Down off their High Horse--and 'Fess Up

The story about JAMA has been brewing for some days now, and every time I go to write about it, a new chapter emerges. Let me try to walk you through what's happened so far.

The story goes back to this article (note: subscription may be required to access some JAMA links):

Dr. Robert Robertson (Univ. of Iowa) and colleagues studied two treatments for patients who had just had a stroke (and who were therefore known to be at high risk for depression)--counseling and escitolapram (Lexapro). As the study showed that Lexapro was superior to placebo, Robinson gave a number of interviews and made several statements urging that all patients post-stroke be considered for drug therapy.

Enter Jonathan Leo and Jeffrey Lacasse, a couple of PhD's who had previously published very nice work about the excesses of the serotonin theory of depression. They first published a letter in JAMA pointing out a problem in interpreting the original study:

In reply Robinson admitted their main point:

That is, while the investigators had shown that the drug treatment was better than placebo, they did not show that it was better than counseling. On review of the data Robinson admitted that the drug and counseling showed no difference. This of course was hardly the pro-drug message that had been put out through the media.

Leo and Lacasse then dug a bit deeper and wondered whether Robinson had received financial support from Lexapro's makers. No such conflict had been revealed in the original JAMA paper, but it took them a few nanoseconds on the internet to discover numerous financial links between Robinson and Forest Labs. Leo notified JAMA of this omission in the stated conflicts.

After time had gone by and no response had been received from JAMA, Leo and Lacasse decided to write a letter to the "Rapid Response" section of BMJ describing the incident and raising their concerns (in notably temperate language that did not accuse JAMA of anything bad and that indeed recognized JAMA for its strong editorial stance in favor of disclosure and avoidance of conflicts). Leo later reported that they had sent JAMA copies of their letter to BMJ and generally had checked with JAMA about the progress of the matter, without initially receiving any reply. The "Rapid Response" appeared in BMJ on March 5:

And then the stuff started to hit the fan.

The same week, JAMA published a letter from Robinson admitting that there had been incomplete disclosure of conflicts, and citing "erroneous recollection" as the excuse:

We next heard about the fallout from the BMJ letter in the Wall Street Journal health blog, in a posting by their veteran reporter, David Armstrong:

JAMA told Armstrong that the appearance of the letter from Robinson in that particular issue had been planned for some time previous, and that JAMA felt it a major violation of good editorial practice that Leo and Lacasse had gone to another journal to air their charges instead of letting JAMA complete its internal process. Armstrong reported further that JAMA deputy editor Phil Fontanarosa had called Leo and basically threatened him with permanent banishment from ever having an article published in JAMA. Editor Catherine DeAngelis then called Leo's dean to complain about his unprofessional behavior. Things got really juicy, as far as journalism is concerned, when DeAngelis told Armstrong that he should not waste time on this story because Leo is "a nobody and a nothing."

As this story gained legs in the blogosphere (though the regular media seems to have been pretty quiet about the whole thing, not surprisingly--who really cares about a spat between journal editors and academics who wrote a letter?), JAMA apparently felt mistreated, and so this rather odd editorial appeared on its website:

In the editorial the editors basically deny Armstrong's account of their phone conversations and deny that anyone was threatened. DeAngelis said flat out that she never said that Leo was "a nobody and a nothing"--we are waiting for the next WSJ blog to see what Armstrong thinks about being called a liar. The main point of the editorial is that JAMA has a perfectly good internal system for dealing with allegations of incomplete disclosure of conflicts. Leo and Lacasse, once they notified JAMA, should have sat by quietly and let that process work. Above all else they had no business writing to BMJ, talking to any of the media, or in any way raising their voices. Doing so constituted a serious breach of confidentiality and was therefore something to be complained of to Leo's dean, for example.

The editorial has given rise to rebukes from other present and former journal editors:

In turn, Leo has put his own account of the timeline of events on line to compare with the allegations in the JAMA editorial:

Comment: In preparing their editorial response to the WSJ blog post, the editors seem to have consulted the well-known PR firm, When You're in a Hole, Grab a Shovel and Dig Yourself In Deeper. They started out in a pretty bad position. They appeared to be throwing around their weight and power to intimidate a couple of relatively minor academics at some minor institutions. Let's be really clear what it means to call up a professor's dean to complain--you are saying to the world, "I have no reasoned arguments or facts to offer against what this fellow has been saying. Instead I have power and muscle, and I will use that instead of reasoned argument, to show the guy that I am not the sort of person he can mess with." (To his credit the Dean seems to be backing up Leo.) Anyone who says this is really about professional standards and confidentiality is blowing smoke; it's about power.

The main proposal of the editorial, that authors should let JAMA carry out its supposedly infallible investigation process and impose a gag on themselves for however long JAMA chooses to carry it on, has correctly earned the hoots of other editors and academics, who refer instead to the value of academic freedom and freedom of speech.

It is also unfortunate that the editors have undone so much of their former good work. When you take a strong editorial stand against commercial conflicts of interest, you set for yourself a high standard. You proclaim to the world that you anticipate being brought to task if you fall from that standard in the future. If you act later on as if you deserve a free pass for having said all those nice things previously, and so expect that no one will beat you up if you later fall off your pedestal, you show that you never really had committed yourself to that high standard in the first place. No one ever recommended a life of virtue because it's easy.

I can relate to what Leo and Lacasse are going through because of the treatment I received at the hands of JAMA's editors a few years ago when I was doing the research for HOOKED. I became curious about the background to the CLASS study. Readers will recall that that study was notorious for claiming that Celebrex was highly effective in preventing serious gastrointestinal bleeds, when it was later disclosed that the authors had reported only on the first six months of data, and ignored the second six months of the study when the apparent benefit attributable to Celebrex was reversed. On the face of it, that sort of manipulation of the data amounts to presumptive research fraud. I was curious as to why JAMA, on finding out that these data were withheld (admitted by DeAngelis in an interview with the Washington Post), did not demand that the article be retracted.

I e-mailed Dr. DeAngelis for an explanation and, upon receiving no answer that I was aware of, I next tried contacting another member of the editorial board, Dr. Drummond Rennie. That brought a very angry e-mail from Dr. DeAngelis, noting (correctly) that she had indeed replied but that I had missed her e-mail, and that she was now accusing me of violating JAMA policy by going behind her back to quiz other editors and apparently trying to sow dissent among the editorial board. I apologized for having missed her e-mail and explained once again that all I wanted was some information and had no desire to violate board policies. The only explanation regarding CLASS that I received (and that I included in the endnotes in HOOKED) was that all such decisions are private and confidential within the editorial board.

No one, as I recall, told me that I was banned from JAMA. But the tone of Dr. DeAngelis's e-mail gave me the very strong impression that I should not be surprised if none of the papers I might submit to that journal in the future ever found their way into print.

I cannot help but note now that the full story on CLASS has never yet been revealed by JAMA and despite what would appear to be blatant research fraud, the original study has never been retracted--nor has any explanation been given for the non-retraction. (By contrast, JAMA has called for Leo and Lacasse to retract their BMJ letter, without offering any substantive reason why it is flawed.)

Accordingly my advice to JAMA's editors would be as follows:
  1. Get off your high horse and stop acting like demigods.
  2. Stop pretending as if JAMA's internal editorial policies are somehow sacrosanct and unchallengeable.
  3. Set the record straight on CLASS, finally.
  4. Stop beating up on Leo and Lacasse. Be big and apologize.

Sunday, March 22, 2009

The Seroquel Story--There They Go Again

Veteran reporter Shankar Vedantam gave us the main scoop earlier in the week in the Washington Post:

Bottom line--lawsuits over Seroquel causing diabetes and weight gain have revealed internal company documents from AstraZeneca discussing Study 15, released to the FDA in 1997 but never published or publicized. Study 15 showed that Seroquel, a "second generation" antipsychotic, performed no better than its older counterpart, Haldol, but caused considerable weight gain. Study 15 found much the same thing as a larger, publicly funded comparison of the two generations of drugs that was not published till a decade later.

The internal documents show very clearly that it was the opinion of company medical experts that the data from Study 15 were reliable and that, if released, would cause physicians to lose confidence in Seroquel's safety and efficacy. Perhaps the most damning single passage:

Within the company, meanwhile, officials explicitly discussed misleading physicians. The chief of a team charged with getting articles published, John Tumas, defended "cherry-picking" data.
"That does not mean we should continue to advocate" selective use of data, he wrote on Dec. 6, 1999, referring to a trial, called COSTAR, that also produced unfavorable results. But he added, "Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR."

What I found most intriguing about Vedantam's article was his frank acceptance as a reporter that this story is really pretty ho-hum--that the suppression of unfavorable results is hardly a newsworthy scandal but is rather the normal operating procedure for a major drug firm.

Vedantam mentions in passing that AstraZeneca, at the same time as they were suppressing Study 15, were publicizing aggressively the findings from a study that showed favorable comparisons between Seroquel and Haldol, despite internal documents showing that they thought little of the scientific merit of the latter study. The author of the flawed study was Dr. S. Charles Schulz, now head of psychiatry at the University of Minnesota--a school already rocked with notoriety due to its dean's apparent blase attitude toward industry conflicts of interest. The Minneapolis papers took off after Dr. Schulz:

You have to feel a little bit for Dr. Schulz (who says he has learned his lesson and will no longer take industry funding). AstraZeneca bigwigs were writing memos to each other disparaging his study and its methods--memos that are now released for the world to see. But apparently believing that Schulz was a "KOL" (key opinion leader) on whose good side they wished to stay, the company never shared any of their internal concerns with him--leaving him now holding the bag to defend the integrity of his work against the word of his former corporate sponsors. This in a very small way illustrates the ultimate corruption of science at the hands of commercial forces.

Friday, March 20, 2009

Let's Cut Dr. Biederman Some Slack--Just a Little

The text for this sermon is Gardiner Harris's article in today's New York Times:

The spotlight is back on Dr. Joseph Biederman of Harvard, under fire for urging the extensive diagnosis of bipolar disease in young children and then treating the condition with potent drugs usually reserved for adults, based on shaky evidence from some drug-company-sponsored trials--and also for taking $1.6M in drug company money but reporting only $200K to his employer.

Perhaps the juciest bit of this article is the exchange reported at the end (referring to lawsuits filed by states' attorneys general against the manufacturer for fraudulently marketing the drugs that were then billed to their Medicaid programs):

In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.
“What’s after that?” asked a lawyer, Fletch Trammell.
“God,” Dr. Biederman responded.
“Did you say God?” Mr. Trammell asked.
“Yeah,” Dr. Biederman said.

I have for a long time suspected that all faculty at Harvard are required to go through an orientation that consists of attending a seminar, Arrogance 101; and it appears that Dr. Biederman not only attended but wrote the syllabus.

Juicy, however, is not what this blog is about, and so I must now change sides and cut Dr. B. some slack. In the final analysis what this article seems to be all about is what Dr. Biederman told Johnson & Johnson about his proposed research trial (for which he was seeking funds from the company): The trial, the slide [prepared by Dr. Biederman] stated, “will support the safety and effectiveness of risperidone in this age group.”

This leads to an interesting question. To what extent does a scientist seeking funding for her research tell the truth, the whole truth, and nothing but the truth to the funding source? And what does the internal code of conduct among scientists say about this behavior?

Is what Dr. B. told J&J substantially different from what many of the rest of us write in our National Institutes of Health grant proposals? Of course we don't say what the outcome will be; we know how flat that would fall with an NIH study section. But don't we say how absolutely certain we are that we could get the work done in a certain period of time with certain levels of resources? And when we tell them that to do the work in that time, we need $600,000, and they come back to us and say that they like our idea but that they'll only fund us at $400,000, do we then say, "Well, take your $400K and stuff it because I just told you that we needed more than that to do the work right"? Or do we suddenly discover that we were wrong after all and that really we can do the work just fine for $400,000?

In other words, does the actual working moral compass of the scientist say that lying (if I can use the blunt language to drive the point home) to a grant-giving agency is wrong? If so, then why does the vocabulary of the science community include the word "grantsmanship"?

I know these will be very unpopular questions in many circles; but before we get on our moral high horses about Dr. Biederman's behavior in this specific instance, maybe we should address these sorts of questions.

On any other aspect of Dr. B's behavior, hey, it's open season so far as I am concerned.

Monday, March 16, 2009

Celebrex--What Don't We Know Yet about Its Risks?

As summarized in HOOKED, Celebrex (celecoxib) is the only COX-2 selective nonsteroidal antiinflammatory drug left standing in the marketplace, though its sales are way down from its heyday, before its cousins Vioxx and Bextra got yanked. As you no doubt know, the other COX-2s bit the dust due to their excessive risks of cardiovascular disease due to increased blood clotting--the downside of the beneficial mechanism of the COX-2s by which they were supposed to have prevented bleeding from the gastrointestinal tract (a fond hope that was never realized in practice to the extent predicted in the lab).

Pfizer, who makes Celebrex, would love to believe, and to have us believe, that because it's chemically different from Vioxx and Bextra, the big-time cardiovascular risks attendant upon those drugs are either much reduced, or virtually non-existent, with Celebrex. The position I took in HOOKED was that the bulk of the evidence showed that the CV risk is a class effect, and that while Celebrex might be relatively safer than Vioxx or Bextra, it's still riskier than the non-COX-2s like ibuprofen and naproxen. Given that Celebrex has never been shown to have superior pain-relieving properties, and given that it costs ten times as much as the generic nonsteroidals, it seems a no-brainer not to prescribe it. So who's right--me or Pfizer?

The Dynamic Duo of journalists Jeanne Lenzer and Shannon Brownlee recently weighed on the Center for Public Integrity website: Their cogent analysis is well worth reading in its entirety. Here are some highlights.

Quite independent of the scientific question of whether Celebrex is heart-risky or not, Pfizer has managed to stage two major public relations coups. The first was handed to them by the FDA. The FDA's scientific advisory panel agreed with my point of view back in 2005. The FDA bigwigs then caved to commercial interests and obscured the issue, by demaning that all nonsteroidals (even naprosyn and ibuprofen who were not part of this dogfight in the first place) carry a warning of increased heart risk. If, by virtue of equal labeling, Celebrex appears to be no more risky than over-the-counter Motrin, then that seems to send a strong message to physicians and the public that whatever low risk Celebrex might carry is not worth worrying about. This, L&B quote an insider, is standard industry strategy. If you can't get the FDA label you want for your own drug, then at least be sure that the bad label is slapped on all your competitor drugs too.

The other big coup for Pfizer, Lenzer and Brownlee continue, is a study called PRECISION. Its lead investigator is Dr. Steve Nissen, cardiologist at the Cleveland Clinic, who is often a hero to the skeptical-of-Pharma crowd, as he was for his work in exposing the heart risks of the diabetes drug Avandia (rosiglitazone). Here he gets to be the goat. PRECISION is designed to answer the question of the relative cardiovascular risks of Celebrex, ibuprofen, and naprosyn, by enrolling 20,000 subjects at 637 international sites (at a cost of a whopping $100M). Subjects will be selected from groups known to be at high risk for heart disease, to make sure that enough adverse events occur to be able to get a good read on which drug causes the most.

Dr. Nissen's take on this according to L&B: there remains a valid open question as to which drug is the lowest risk and so should be preferred in practice. L&B's rejoinder: this issue was settled by the FDA advisory committee back in 2005. The only advantage to doing the PRECISION study now is Pfizer marketing. While the study is ongoing, Pfizer can claim in rebuttal to anyone who accuses Celebrex of carrying excess heart risks, "the data are not in yet." When the data finally are in, and even if PRECISION then shows that Celebrex clearly has higher risks, guess what--that's just about the time that Celebrex is scheduled to go off patent, so the study is low-risk for Pfizer marketing (even if high-risk for the hapless research subjects).

L&B's most telling criticism: the consent form for PRECISION (which Pfizer, Dr. Nissen, and the Cleveland Clinic all refused to release, but which the journalists obtained via a leak) says flat out, “At this time, no studies have shown that celecoxib [Celebrex] causes more heart attacks or strokes than prescription ibuprofen or naproxen in the treatment of patients with chronic arthritis.” That statement, as L&B document and as I showed in HOOKED a couple of years ago, is simply not accurate. If you have to falsify the data to get people to enroll in your study, that says something about how valid the study is.

Wednesday, March 11, 2009

Psychiatry: Looking in the Mirror?

A recent editorial in the American Journal of Psychiatry--

--is notable for a number of features. First, it is signed by every editor of the journal and also by every member of the editorial board. That is very unusual for editorials in medical journals. So obviously it is supposed to indicate a serious discussion that has the buy-in of all involved parties.

Next, the editorial frankly admits the problem (thoroughly documented here in too many posts to summarize) of conflicts of interest among academic psychiatrists and the resultant loss of trust in the specialty as well as medicine more generally. Here and there a minor quibble or excuse is inserted, but the overall tone of the editorial is, folks, we have a real problem here, no more pretending that it's all OK.

Finally, the editorial presents the bald and unwelcome solution--if we are going to free ourselves from the tentacles of industry entanglements, we have to stop expecting the industry to foot the bill for our various dalliances. No more having our professional societies and all our CME paid for by the drug companies. We need to step up and to be willing to pay for a heftier chunk of our own professional obligations.

In all these ways the editorial seems to be a serious statement of the need for reform in one medical specialty that has been especially subjected to unwelcome publicity. For a more cynical take see that of my fellow blogger and academic psychiatrist, Dr. James Bremner:

As he responds as a psychiatry insider, it's hard to disagree with what he says. Form your own opinion.

Freedman R, Lewis DA, Michels R, et al. Conflict of interest: an issue for every psychiatrist. American Journal of Psychiatry 166:274-277, 2009.

Students at Harvard Gain National Press Coverage with Protest

This story has been unfolding for a while and I regret being too busy with my day job to get to it till now.

It began with a story in the New York Times: (very kindly first sent to me by a Harvard student who said he reads this blog regularly). The story reports the activism of a group of students who have become pretty concerned with the heavy dose of pharmaceutical industry influence they get along with their med shcool classes, due to a policy that gained Harvard an F on the American Medical Students' Association report card for allowing nearly unrestricted pharmaceutical industry influence and gifts. The article also provided the interesting news that there is a smaller rival student group that has emerged to defend Pharma's role in medical education, at least partially egged on by the numerous Harvard faculty (estimated 18 percent of total) who are "on the take" from industry.

The story grew considerable legs and later the same week made it into Time:,8599,1883449,00.html. The good news is that Dr. David Korn, who helped to craft the strict AAMC policy on limiting Pharma influence as dean at Stanford, is now vice provost for research at Harvard and is aiding the creation of a new, stricter conflict of interest policy. The bad news for Harvard is that Sen. Charles Grassley wants to know not only about the details of 149 Harvard faculty who appear to have received payments from Pfizer, but also why that drug firm had a staffer taking photos of the med students at Harvard who protested against Pharma influence (see the Grassley letter at

Two Excellent Essays from the Front Lines

The very nice feature that appears in each issue of Health Affairs, called "Narrative Matters," in the current issue features two excellent essays on medicine's relationships with Pharma. Both provide a great vantage point from "in the trenches" (and I admit to being biased because the vantage point in each case stresses my own field of family medicine, even if in an embarrassing light in one instance).

First, Dr. Jonathan Han, director of a satellite family medicine clinic in a Pennsylvania steel-mill town that is affiliated with a large university center, tells us about the problem of drug samples for his indigent patients: He provides a carefully nuanced analysis of the reform policy approved by the big university center, restricting the influence from drug reps and eliminating "free" samples--and how it blew out of the water the carefully crafted compromise plan that his clinical had cobbled together a few years previously, both recognizing all the dangers and downsides of relying on samples for their neediest patients, and yet also recognizing the reality that some of these patients simply could not be helped without access to samples.

In what I take to be a happy ending to the story, docs like Dr. Han complained, and the big U center eventually modified its strict policy so as to allow for these local efforts. Before anyone declares this a victory for the pro-industry side ("see! this just proves that Pharma is helpful and it makes no sense to cut off contact with them") , I challenge you to read all the fine print about how carefully crafted the sample policy was that these front-line providers developed. They agonized over every detail and every downside--a far cry from the casual "let's just run down to the sample cupboard and give you a few pills" approach taken in most offices--including the office described by medical student Melinda Morton.

Before Melinda, one more point on Dr. Han. I was struck by how he managed to include virtually every relevant viewpoint in this brief essay--including how he feels angry at being made an enabler, that by putting his finger in the dyke and giving samples to some of the neediest patients, he's indirectly aiding the persistence of a broken national health non-system that refuses to fix what needs to be fixed. We could use a lot more docs with his breadth of vision.

Now for Melinda Morton's essay: She portrays her typical days working in a family medicine clinic rotation. She idealistically had taken the No Free Lunch pledge as a pre-clinical medical student--refusing to take any gifts, including food, provided by drug reps. As she works hard all day with no time to grab lunch till late in the afternoon, and as she finds lavish lunches daily spread out in the break room in the clinic, with enough tantalizing food to feed all the staff and half the Russian Army, she finds her principles and resolve gradually waning. (She might have appreciated a rule once explained to me by a family medicine colleague in a residency clinic where I worked. According to the Robert Darios Timed Evaporation Rule, if you let the drug lunch sit out on the counter for at least two hours, all the deleterious industry influence has evaporated; and so you can then chow down with a clean conscience. How much salmonella has grown in that time period I leave others to calculate.)

Ms. Morton is most eloquent on what an uphill struggle it is for her to try to maintain her principles. (As she runs out the door of the clinic to grab a snack at a local food store, so that she does not have to eat the drug lunch, staff members keep trying to remind her about the lunch, as if she must be at least mildly demented.) Why, she wonders, does her own medical school seem dedicated to perpetuating the status quo and to making it so hard for students like her not to go along? This is a "must read" for medical students and all who teach them.

Tuesday, March 3, 2009

Get the Goods on Drug Industry Marketing--Only $2295 If You Hurry!

My esteemed colleague Marilyn Mann, who has been a great help in highlighting items for my attention, was so kind as to send me the 8-brochure for this conference:

--to wit, eyeforpharma's Sales Force Effectiveness Summit, to be held May 4-5 in Princeton, NJ.

I wanted to give you the link to the brochure itself. But when you click on "download brochure" on the homepage above, you are asked to fill in a series of questions, including name, position, and company you work for. Only then can you access the brochure. I am not sure if that is designed to keep out snoops like me, who are not really part of Pharma marketing, or of it's just part of their own marketing campaign to expand their e-Rolodex. Anyhow, being sufficiently paranoid that I did not want to tell them who I am, I did not access the brochure myself and will rely on the copy Marilyn kindly sent me.

First thing that jumps out at a pore ole academic like me is the price tag-- if you want the Platinum package, which gives you access to the most bells and whistles, this 2-day event will cost you $2295--it goes up to $2695 if you miss the "early bird" window. (If you're a skinflint, you can make do with the Silver pass for a mere $1795.)

More seriously, though, I scanned the program to see if I could find any clues about what impact efforts at reform of Pharma marketing, such as the new PhRMA code of conduct that bans pens and coffee mugs, etc., is having on the way that the marketers themselves think about their work. Answer--not much, apparently. There are a number of vague references to the "changing climate" (for instance, "Understand how the role of the rep has altered in light of economic and political change to refocus your targets and objectives"). But for the most part it seems to be business as usual.

Sessions on "Sales Tools and Technology" and "Physician Access," for instance, will instruct you on how to "teach your reps to 'target within their target' at key sales periods to further optimize sales and establish relationships"; "recognize the barriers to entry that reps face"; "learn to communicate with your physician demographic to understand their thought process"; "web based promotion, e-detailing and tele-detailing."

What industry outsiders like me learn from this program, mostly, is the way that big fleas have little fleas to suck their blood and so forth. Pharma wants to sell drugs to patients, meaning that physicians must write scripts, so they have to sell to physicians. In turn, marketing know-how companies (like eyeforpharma, and most of the companies that are putting on panels at the conference) want to sell their consulting services and technologies to the Pharma firms. It would all be laughable if all of this blood-sucking (including the exhorbitant conference registration costs) did not end up on the tab of the poor patient who has to pay for the drugs.

Monday, March 2, 2009

Suppression of Data: From Pharma to Health Information Technology

Over on our friends, the Health Care Renewal Blog, Dr. S. Silverstein, known as "MedInformaticsMD," has been doing quite a number on electronic records and health information technology (HIT)--for instance:

Now, this blog is about the pharmaceutical industry and not electronic records, correct? So the reason I am mentioning this is because the same issues seem to be popping up in both places--all suggesting the dangers of the over-commercialization of health care.

Basically, Dr. Silverstein has been beating up on a number of commercial HIT products. He agrees that the electronic record is a great idea, and that the technology exists to make it work very well. The problem is that all too often it does not work well at all. The problem is a manufacturer that assigns a bunch of computer geeks to design the medical record, without working to create a seamless interface bwetween the software and the expert human users who have to practice with it. Result--a hospital can spend millions on a new electronic record only to find they have actually increased patient errors, and driven the staff totally bonkers with a user-unfriendly system that requires you to take 15 minutes to do electronically what you used to do in three seconds with a pen and paper.

What does this have to do with Pharma? Dr. Silverstein's post mentions two issues. First, he has a great deal of difficulty showing illustrations of the actual glitches in the electronic record systems that he is writing about--because the user contracts forbid copying any part of the record display or even talking publicly about any of the problems with the system. In short, the HIT industry is working just as hard as Pharma to suppress any data that show its products in a bad light and that could hurt sales--and patient safety be damned.

Second, Dr. Silverstein found that on complaining about the crappy record systems to industry insiders, and pointing out what research among the physicians and nurses would have allowed the system to be designed properly from the start, he gets the response that there's no business advantage to doing it that way. It is much cheaper for the manufacturer to sell the crappy system to a hospital, then enroll the staff of the hospital as the unconsented-to experimental guinea pigas to spend their valuable time debugging the system at no cost to the manufacturer. The only hope, as noted, is that not too many patients die while the system is being brought up to minimal standards.

This is all very sad because the policy wonks and politicos have bought the propaganda about the wonders of electronic records hook, line and sinker--not surprising, since the electonic record, when well designed at the software-user interface, is truly a thing of beauty. That was the way it was with the first generation of electronic records, which had to be built by the hospital systems as there was no ready-off-the-shelf commercial product, so they had no choice but to design the system from the ground up with full buy-in from the end users. People have failed to note that in the hand-off from the build-it-yourself to the off-the-shelf generation, a lot changed. And one thing that has clearly changed is that big profits are to be made by concealing unpleasant data; and by heavily marketing a bad product instead of taking the time and research to design a good product.

More from Family Physicians President on Sunshine

A little while back I posted a comment critical of Dr. Ted Epperly's position as President of the American Academy of Family Physicians:

Dr. Epperly has sent me a statement and asked that I share it, which I am pleased to do immediately below. After his statement I shall add a couple of my own comments.

Says Dr. Epperly:

Communication is key to high quality health care, and family physicians have consistently advocated for transparency not only in the physician-patient relationship, but also in interactions between physicians and other members of the health care community.
Nowhere is this transparency more important than in the dealings between physicians and the manufacturers of pharmaceuticals, medical supplies and devices, and biologicals that form the foundation of many patients’ treatment plans.
The American Academy of Family Physicians and I personally hold the tenet of transparency to be among the most important elements of professionalism. That’s why I was somewhat surprised by the response to my recent comments about the Physician Payment Sunshine Act of 2009, a bill that requires manufacturers to disclose gifts, financial agreements and other dealings they have with physicians.
The intent of my comments was to emphasize the need for legislation that provides for reasonable reporting on physicians, allows recourse if mistakes were made in that reporting, and ensures that physicians would not have yet another law demanding unnecessary or redundant administrative paperwork. The AAFP continues to study the bill and will be following its progress through the legislative process.
The AAFP is not disparaging the Sunshine Act and we are not taking the industry side on this. We are looking for transparency legislation that
● minimizes the administrative burden that reporting requirements
would place on physicians;
● enables the physician to correct incorrect reporting data before
the companies releases it for publication; and
● ensures the reporting requirements do not have a chilling effect
on efforts to educate physicians about research and new developments in diagnosis and treatment.
Such provisions will improve an already important legislative effort.

Ted Epperly, MD
American Academy of Family Physicians

OK, it's me again... I want to report to you first that since my initial post, I was privy to some correspondence between Dr. Epperly and some of my esteemed colleagues who are very critical of medicine's relationships with Pharma. I was impressed by Dr. Epperly's openness to our critical input and his apparent surprise that we had initially seen the AAFP position as being so close to industry apologetics. I think we were reassured of his good will and genuine desire to see AAFP back sound legislation. I also think we were able to educate him a little as to the dangers appearing to be too cozy with the industry side. (Until very recently, no medical organization had to worry about looking bad because it was leaning too close to the industry side. Now, thankfully, it's an issue for active discussion and debate.) So I want to give Dr. Epperly, as the president of my specialty academy, full credit on those scores.

Now, that said, I continue to dissent from the tone and tilt of these new comments. The substance is hard to debate--we don't want busy family physicians further hassled by bureaucracy; we don't want to impede real education; and we don't want lies about people posted on the web. But none of these issues really seem to be serious concerns of the proposed Federal sunshine legislation, and these feared repercussions have not happened in those states that have already enacted sunshine provisions. The fact that the AAFP is very worried about these things happening still seems to suggest a pro-industry tilt that its members ought to be concerned about. It still appears that AAFP is listening very carefully to the critics of the sunshine legislation, and relatively less to its advocates, even those advocates within AAFP ranks. I look forward in the future to support by AAFP for this legislation, not lukewarm willingness to study it and carping about improbable consequences.