Wednesday, October 30, 2013

An Epidemic Out of Control: Poor Children and Psychiatric Drugs

An excellent, but in its own way truly horrifying presentation was given at the recent annual meeting of the American Society for Bioethics and Humanities in Atlanta by Dr. Melody J. Slashinski of the Center for Medical Ethics and Health Policy at Baylor College of Medicine up the road in Houston. Her account of some of the fallout from intensive marketing of psychotropic drugs suggests a serious public health threat to the well-being of children.

Dr. Slashinski presented the findings of a participant-observer study of African-American single moms trying to raise their kids in a public housing project in Houston. The material she reported was impressive in showing the extent to which she gained the trust of this community and got her informants to reveal things they would normally keep hidden from outsiders. In response to a question about this Dr. Slashinski said that the nickname given to her among this community was “the keeper of secrets.”

Dr. Slashinski reported an effective folk-knowledge network that linked these mothers and that conveyed information about the dangerous side effects of drugs commonly prescribed for kids today for ADHD, bipolar disorder, etc. I doubt these mothers had read Robert Whitaker’s Anatomy of an Epidemic:
--but they might well have for the accuracy and incisiveness of what they seemed to be aware of. The net result was that many felt they had a critical obligation as good mothers—save their children at all costs from these medications.

That might sound easy to do, but the data went on to show that it’s extremely difficult in this population especially. The mothers also feared, quite realistically, that any evidence of “medical noncompliance” on their part would end up with a report to Protective Services and eventually losing custody of their children. So the stories Dr. Slashinski told generally depicted a delicate balancing act—moms on the one hand certain that they would not give these medicines to their children, and on the other hand going through as many hoops as they could to appear compliant and submissive to the medical system so as not to set off alarms.

There was another group of mothers who were intent on protecting their children—but they elected to do so by giving the medications despite their fear of side effects. This strategy was based on a sort of pact with the devil—if they gave the children meds then the outer world might be compassionate and regard their children as sick, whereas if they withheld the medications, the world was almost sure to regard their children as bad. Being seen as bad was viewed by these moms as much more dangerous for the kids than being sick.

The other reason saving your kids from the harms of these drugs is difficult was illustrated by an account Dr. Slashinski gave of one pediatrician office check-up visit with a mom, a 9-year-old son, and 8-year-old daughter that she personally witnessed. The son had already been diagnosed with ADHD and the mom had not admitted to the pediatrician that she was not giving the son his meds (even though overall the mother liked and trusted this pediatrician a lot). As the doctor entered the exam room, she wheeled in a cart laden with equipment such as tongue depressors, and the son immediately went to the cart and started rummaging through it. The doctor used this as a launch for a lecture to the mom on how the son clearly had serious ADHD and really needed his medications.

The doctor then examined the daughter and said something at one point about her “boobies.” The daughter apparently became offended by this comment and stopped cooperating with the exam. The doctor immediately asked the mother how often the daughter had these “tantrums” and started talking about the possibility of bipolar disorder. The visit ended with a psychiatric referral to evaluate the daughter and a new prescription for the ADHD medication for the son. The mom told Dr. Slashinski that she would continue to withhold the son’s medicine, but felt she needed to take the daughter to see the psychiatrist for fear of the consequences of being “noncompliant” if she didn’t.

OK, that’s the data presented by Dr. Slashinski; here’s my comment. Whitaker and others have demonstrated that the sheer number of kids now being prescribed medicines for ADHD, bipolar disorder, and other psychiatric diagnoses is so massive that there can be no biological explanation for how such a huge percentage of the pediatric population of the U.S. suddenly became crazy. The only possible scientific explanation for this phenomenon is overdiagnosis and consequent overuse of medicines whose long-term safety in kids has never been shown, and whose short- and long-term adverse consequences are legion. It is not only psychiatrists but my fellow primary care physicians (as shown by the pediatrician in the case study) who have bought into this insane model of diagnosis and treatment—not the least because of how quick it is to slap on a diagnosis and write a prescription, and how hard (indeed, in cases like this, nearly impossible) to fully inquire into the child’s psychological and social environment and then identify helping interventions if needed. Are things truly so bad that the only way parents can protect their kids is by not taking them to the doctor?

Everything I just said applies to the American society at large. But now, back to Dr. Slashinski’s data, we see that when American society gets the sniffles, poor minority populations come down with pneumonia. It appears to be the new social campaign to get all kids to be as passive and submissive as possible, no matter how much we have to drug them. But this is especially true of black kids, especially black males, who as shown by the Trayvon Martin case can be thought to pose a threat to the lives and safety of the white community merely by existing—let alone by acting curious and assertive. So the call goes out even more shrilly to diagnose this group of children and medicate them, and the parents have even less social authority and credibility to question this.

In short, the epidemic of psychiatric overdiagnosis and overtreatment that Whitaker identified is truly out of control, if Dr. Slashinksi’s findings are in any way representative. And the medical and medical-scientific community bears major responsibility for this state of affairs.

Friday, October 18, 2013

Controlling the Channels: The VA and Diabetes

A study and a commentary (subscription required) from last November illustrate a phenomenon we have previously discussed called “controlling the channels”:
--as it applies specifically to diabetes:

A group from the Pittsburgh VA looked at variability across their system’s outpatient facilities in prescribing two expensive drugs for Type 2 diabetes—the glitazone-type drugs, and long-acting insulin analogues. They selected these categories because a) the best evidence shows no advantage for the vast majority of patients compared to much cheaper drugs; and b) the VA’s own formulary discourages their use.

The authors found that despite the evidence and VA policy, nearly 9 percent of the patients received a glitazone, with an incredibly wide range of 1.5-26 percent among facilities. Of those taking some sort of insulin, about 40 percent were getting the high-priced versions, with again a very wide range of 4 to 71 percent. (If we looked at non-VA practices, these percentages would no doubt be higher.)

Drs. Timothy J. Wilt and Amir Qaseem, also of the VA, commented on the study and speculated on why these results. It is notable that one factor that would normally have loomed large in data from standard community practice was not mentioned here as a possibility—enthusiastic drug marketing—since the VA, among all healthcare settings in the US, may be the most insulated against drug detailing. However, a factor that was identified was specialty guidelines and pay-for-performance criteria that reward trying to reduce the patient’s blood sugar to the lowest possible levels, regardless of what harm that might cause the patient, and regardless of the evidence that reducing sugar does not prevent major diabetic complications.

This in turn drives home the point about “controlling the channels”—that the way drugs are marketed in the US, the people who write the clinical practice guidelines and the pay-for-performance rules end up being brainwashed by the industry “line” on diabetes. This means that even physicians who are safely kept in a cocoon and protected from the wiles of detail people may still end up practicing in a way that’s heavily influenced by Pharma-think. We can run but we can’t hide.

Wilt and Qaseem have what seems a good idea about guidelines and pay-for-performance—it’s not enough to promulgate guidelines that only talk about ideal treatment. When in a case like diabetes, overuse of various drugs has been identified as a specific problem, guideline writers ought to pick criteria for overuse and specifically identify, and penalize, physicians who meet those criteria.

Gellad W, Mor M, Zhao X, et al. Variation in the use of high-cost diabetes mellitus medications in the VA healthcare system. Archives of Internal Medicine 172:1608-9, Nov. 12, 2012.

Wilt TJ, Qaseem A. Implementing high-value, cost-conscious diabetes mellitus care through the use of low-cost medications and less-intensive glycemic control target. Archives of Internal Medicine 172:1610-11, Nov. 12, 2012.

Thursday, October 17, 2013

Drug Money Down Under

I was recently alerted to a series that The Global Mail in Australia has been running during this past year:

The various stories recount how the industry spends its money wining and dining physicians, paying consulting fees to prominent specialists, and lobbying aggressively. No real surprises for those of us who've been following the story all along, but a chance to see what specific issues arise in Australia--and discouraging to learn that some experts there who think things are totally out of control look to the US as a model of much better regulation of industry-professional relationships.

One story that seems particularly worrisome is:

Presumably the Royal Australasian College of Physicians has long had an exemplary ethics committee and democratic review process for its ethical guidelines. As a result, the committee recently proposed new guidelines that came down much harder than previous versions on questionable practices related to the pharmaceutical industry. As was the custom, the proposed changes were put up on the web for public comment. Then in a couple of days, the draft was taken down, and the College announced that it was changing its procedure, to replace the open public comment period with an internal review; and apparently in the process the College also disbanded its ethics committee. It is not clear in the article whether this was a move intended directly to water down the strict guidelines against Pharma conflicts of interest, or just a move by a more corporate, and less professionally-minded organization to exercise tighter control over its own activities.

Tuesday, October 8, 2013

Update: What Drug Reps Know About Docs’ Prescribing—and Patients

A colleague just alerted me to a New York Times business article by Katie Thomas from last May:
--which provides an update on the data that drug reps can download on the prescribing habits of the physicians they are selling to.

To briefly recap:

  • The old old days: Drug reps would schmooze with the local pharmacist to get a sense of what docs were prescribing what drugs.
  • The old days: Firms such as IMS Health would buy up prescription lists, in which physicians were identified by code number, and with patient names presumably redacted. The firms would then turn to the AMA and buy their master file of physician identifiers, allowing them to match the docs with the prescriptions they wrote. Before going into Dr. Welby’s office, the rep would download the records of how often Dr. Welby prescribed both the rep’s company’s drug and the competitor’s drug in the last month or so, with a lag time of about 1-2 weeks to get the data.
So what about today? Thomas reports that IMH Health recently bought out a firm called SDI Health, which is able to match insurance claim data with individual patients. Again presumably without divulging patients’ names (which would be illegal), these insurance data allow the rep to see the patient’s key health history, including lab tests and hospital admissions. This allows the rep to create a much fuller profile of when and on whom the doc prescribes that particular drug.

The article is somewhat complicated and notes several recent trends. First, Thomas reports that (good news for people like me), more and more docs are refusing to take time to see reps. Companies in cost-cutting moves have on their side laid off a lot of reps. So some of what drives this data searching is the felt need to be a lot more targeted once a rep is able to get a foot in the door.

But another trend noted is that a lot of this data-searching seems not to be about the rep-physician relationship at all; some claim that what is going on is how drug companies are marketing themselves not only to docs, but more to the big insurers, trying to show that the insurer would save bucks if they used more of a certain drug on certain groups of patients, or that some of their patients are going off their drugs too soon, or whatever.

The bottom line seems to be that drug marketing is the proverbial balloon which, pushed in at one spot, bulges out someplace else. You never hear of companies cutting back on marketing, maybe to go back into the laboratory and discover a new generation of true breakthrough drugs. Instead they stop marketing one way and spend even more money marketing in some other way, always trying to push their existing drugs, which far too often are merely more expensive without being any better or safer.


Monday, October 7, 2013

No Decency? Pharma-UK on How to Collaborate

While attending to events on this side of the ocean, I seem to have been late learning about a kerfuffle set off by the Association of the British Pharmaceutical Industry, which I gather is the UK equivalent of our PhRMA.

The ABPI last year issued a 4-page "Guidance on Collaboration between Healthcare Professionals and the Pharmaceutical Industry":
On its face this is quite an impressive document--it features the logos not only of ABPI but also such august organizations as the Royal College of Physicians, the Royal College of General Practitioners, the Royal College of Nursing, the British Medical Association, and The Lancet. It claims to have been produced by a conjoint effort of all these organizations "with the aim of promoting positive collaboration between industry and healthcare professionals to support high quality patient care."

Since The Lancet was prominently listed as a collaborator in this effort, several physicians actively critical of Pharma penned a letter to the editor of that journal which was published last July, regretting that the journal had allowed its name to be put onto a document that played fast and loose with the truth. Among the statements contained in the report that we have previously demonstrated to be either blatantly untrue or highly doubtful:
  • "Healthcare and industry professionals are able to manage their relationships with each other without compromising clinical decision making."
  • "Information about industry-sponsored trials is publicly available."
  • "Industry plays a valid and important role in the provision of medical education."
  • "[Industry] Medical representatives can be a useful resource for healthcare professionals."
  • "The industry takes its responsibility to monitor adverse events very seriously."
  • Anything negative about industry behavior in the past is solely due to "historical practices that are no longer acceptable, or the actions of a few individuals that are not typical of the working relationships between healthcare professionals and the industry."

And the report adds a list of "Dos and Don'ts for Healthcare Professionals"--
  • "Don't establish blanket policies denying interaction with industry..."
  • "Don't be tempted to accept the negative myths about cooperating with industry. Undertaken appropriately, working with industry will not harm objectivity..."

So-- how did The Lancet react to being challenged? Its editor, Richard Horton, published a revealing comment earlier this year, in which he retracted the journal's endorsement of the report: "The statements made in the 'guidance' certainly do not match  the latest evidence about the behavior of pharmaceutical companies today. Indeed, this evidence undermines the principles we originally signed up to, principles that attempted to forge a new and more constructive partnership between medicine and the pharmaceutical industry. It's time for us to withdraw our name from the 'guidance' as it currently stands."

A little bit of between-the-line-reading seems called for here. What I take Horton to be saying (based on past experience of similar efforts in the Pharma world) is that the ABPI invited all these other organizations to come on board by promising them that this time, the industry was really serious about finding new, more positive ways to collaborate, and perhaps indicating that they were finally ready to fess up to past wrongs and turn over a new leaf. Like Charlie Brown figuring that this time, maybe Lucy would actually hold the football for him to kick, those other organizations, all valuing the day (as I do, myself) when a real collaboration might become possible, signed on. And then, ABPI took advantage of its control over the writing process and inserted wording that served their PR purposes splendidly, but that were completely at odds with the cooperative spirit that had caused the other organizations to agree to become a part of the effort--in effect playing all the other groups for chumps.

The title of this post is taken from the incident in the Army-McCarthy hearings of 1954 which is usually cited as the turning point in the infamous career of Sen. Joseph McCarthy. With the nationally televised hearings not going the way McCarthy had hoped, he pulled out his usual trump card and without warning, accused a young lawyer in the firm of the Army's chief counsel, Joseph Welch, of once having been a member of a Communist-affiliated organization. Welch replied in defense of the lawyer and then, when the Senator continued his character assassination, turned on McCarthy with obvious regret, "Have you no sense of decency, sir? At long last, have you left no sense of decency?" It appears that Pharma-UK, offered a chance to finally show a sense of decency and admit that its past behavior has made it impossible for any health professional of integrity to trust them or to engage in any direct financial dealings with them, could not in the end change its stripes, but had to once again demonstrate its lack of decency and its insistence on substituting PR fluff for substantive change.

Braillon A, Bewley S, Herxheimer A, et al. "Marketing versus evidence-based medicine [letter]." Lancet 380:340, July 28, 2012.

Horton R. "Offline: falling out with pharma." Lancet 381:358, February 2, 2013.

Saturday, October 5, 2013

Corporate Drug Pushers and Their Blame-Avoidance Techniques

I’m in the process of reading Deadly Medicines and Organized Crime: How Big Pharma Has Corrupted Healthcare, by the Danish trials expert, physician, and epidemiologist, Peter C. Gøtzsche. I hope soon to have a book report for this blog. In the meantime I am going to comment on a New York Times article that Dr. Gøtzsche cites and that I apparently missed first time around back in 2006:

Brief background: In early days pharmaceutical firms got insulin from pig and beef pancreas from slaughterhouses; that led to some problems with allergies. The next big advance was the ability to synthetically manufacture human insulin, which ended those problems. However, not content to stop there, various folks kept tinkering with insulin and came up with supposedly new and improved bioengineered forms, which are questionably better than plain human insulin, but of course are much more expensive. Gardiner Harris and Robert Pear summarized for the Times how Eli Lilly had at first cornered most of the U.S. insulin market, but that recently the Danish-based firm Novo Nordisk was trying hard to capture a good chunk of the market for its own products. In 2006 an investigation was going on to see if Novo Nordisk had crossed any legal lines in pushing their products.

The revelations Harris and Pear recounted (based on internal company documents they obtained) included how Novo Nordisk reps had paid “anchors” in doctors’ offices, usually nurses or medical assistants, to be on the lookout for patients taking insulin who could be switched to the Novo product, paying them on the basis of how many prescription switches they achieved—while all the while claiming that these folks were simply being paid to “educate” patients about diabetes.  Novo also contracted with the Rite Aid pharmacy chain to give them special discounts on their drugs in exchange for help switching patients in their database to Novo insulin, and were found to have paid at least one Rite-Aid pharmacist what seems to be a kickback for patients who were switched.

What I most want to focus on here are two documents unearthed in the Times article. The first was a memo that Vikki Tolbert, a Novo district manager, sent to her staff of sales reps in March 2004:

Our goal is 50 or more scripts [switched] per week for each territory….If you are not achieving this goal, ask yourself if those doctors that you have such great relationships with are being fair to you. Hold them accountable for all the time, samples, lunches, dinners, programs and past preceptorships that you have provided or paid for and get the business!! You can do it!!”

This memo is great because it’s a laundry list of all the forms of bribes that reps pay to docs, and that when either the reps or the docs are challenged about them, insist that all these things are not bribes at all, but rather education, or else have some other fully legitimate purpose, and the last thing on the reps’ minds is that the docs are in any way beholden to them as a result of taking these things.  Here is as blatant a statement as I have ever seen that yes, it’s a bribe, pure and simple; if the docs take the money, they owe the rep the business in return.

So now we turn to Rite Aid. The corporation sent a letter to its pharmacists in February 2005, saying, “Each Novo Nordisk product we dispense brings us 20 to 40 percent better profit margin,” adding that these sales add millions of dollars to the corporation’s “bottom line.”

So what did Rite Aid have to say when told that one of its pharmacists was being paid by Novo to switch patients to their drugs? Well, of course they were shocked and had no idea that such a thing was going on.

Now, let’s back up a step. Last I heard, Rite Aid was a pharmacy chain, not a medical practice. I agree that pharmacists know a lot about drugs and it would be nice if physicians listened more to the advice that pharmacists could give them—as long as that advice was genuinely the pharmacists’ and not bought and paid for by the drug company. But bottom line is that doctors are supposed to prescribe drugs and the pharmacy is supposed to fill then script with the right drug, and help educate the patient about how to take it. If the doc has made a major error, such as prescribing Drug B to a patient already on Drug A where there’s a dangerous interaction between A and B, the pharmacist should call the physician immediately and warn of the problem—but that’s a far cry from switching equivalent drugs because Rite Aid makes a handsome bundle.

So the corporation is here sending a memo to pharmacists which is highly improper because it suggests a line of action that is quite contrary to the role of the pharmacy—but the company is simultaneously covering its own rear, so that if any pharmacist actually decides to cash in on this deal, and ask for an extra bonus from Novo for doing the switching, then the company can say it was all the fault of that one renegade pharmacist and had nothing at all to do with company policy.
Dr. Gøtzsche, in his intemperately titled book, more or less concludes that Big Pharma and everyone who’s in bed with them will say various things about their activities—and we cannot believe a single word of it because they routinely lie through their teeth. Maybe that’s a bit far even for a pharmascold like me to go—more on that when I get to the book review post—but from this particular set of examples, you can see where he’d get such an idea.

Wednesday, October 2, 2013

Diabetes, Drugs, and Cardiovascular Risk

The October 3 New England Journal features a “Perspectives” written by Drs. William R. Hiatt, Sanjay Kaul, and Robert J. Smith, all members of the FDA Endocrine and Metabolic Drugs Advisory Committee:

The basic thrust of their piece is to defend the drug rosiglitazone (Avandia) from the accusations we’ve reviewed widely in this blog, that it causes excess cardiovascular risk. These authors appear to believe that when all the data are in, the risk has been overblown. (According to the on-line disclosure forms, two of the three have some financial ties to the drug industry, but this group does not appear to be overloaded with conflicts of interest so far as I can tell.)

They then proceed to discuss two newer diabetes drugs that have been subjected to extra scrutiny by the FDA, which is now gun-shy over diabetes drugs since the Avandia affair.  These newer drugs also appear to be reasonably safe in terms of not causing excess cardiovascular risks. But the flip side of that was that neither drug decreased cardiovascular risks, either, as one would hope for from a drug that treated a condition that is a major cause of cardiovascular disease.

In previous posts I have hammered on about one of the major consequences of drug industry marketing on diabetes:
--which is the promulgation of a flawed disease model among both practicing docs and the general public. We now have a lot of evidence that Type 2 (adult) diabetes should not be viewed primarily as “high blood sugar,” that drugs that lower blood sugar very well may be useless for preventing the downstream complications of diabetes. Yet drug industry and device marketing still finds the big bucks in pushing tight sugar control and close sugar monitoring.

So I find it worthwhile noting these passages in the “Perspective” by Drs. Hiatt, Kaul and Smith, and if they have financial ties to companies that make diabetes drugs, these passages are all the more impressive:

“From a cardiovascular perspective, rosiglitazone, saxagliptin, and alogliptin appear to be relatively safe. It is disappointing, however, that neither intensive glycemic control nor the use of specific diabetes medications is associated with any suggestion of cardiovascular benefit. Thus the evidence does not support the use of glycated hemoglobin as a valid surrogate for assessing either the cardiovascular risks or the cardiovascular benefits of diabetes therapy….New therapies targeting glycemic control may have cardiovascular benefit, but this has yet to be shown. The optimal approach to the reduction of cardiovascular risk in diabetes should focus on aggressive management of the standard cardiovascular risk factors rather than on intensive glycemic control.”

Let me translate a bit: Drugs that lower blood sugar have not yet been shown to prevent heart and blood vessel disease in adult-type diabetes. Treating Type 2 diabetes today should focus on proven methods for preventing such diseases, which is to lower cardiovascular risk factors. Simply showing that a drug lowers blood sugar says nothing about its value for preventing the serious complications of diabetes and should not be accepted by the FDA as a reason to market a new drug. And there you have it, from the (supposed) experts.