Nice Article on the Zyprexa Debacle

In the course of this past month I have been blogging about Eli Lilly and Zyprexa (olanzapine) and how the company marketing managed to make a silk purse out of this medication, which we now know to have been massively overhyped both as to its efficacy and its safety. We are now onto their tricks, and Lilly is being hit with record fines--just as Zyprexa is about to go off patent anyway and as Lilly is taking the $16 billion it made on the drug to the bank. A new article, generally very good, on the history of this debacle, called to my attention by a loyal ally of this blog, is:

http://www.rollingstone.com/politics/story/25569107/bitter_pill

Some great quotes-- after starting off talking about how medical investigators have to be wary of placebo effects among the subjects which could produce misleading results, the author goes on: "The story of how Zyprexa and other atypicals [newer drugs for psychosis] became a multibillion-dollar market suggests that the medical community — doctors, researchers, the institutions that back them — may be themselves prone to a placebo effect: the willed conviction that a new drug, presented as a breakthrough, must in fact be one, that a product sold as healing must in fact do good."

And: "[Allen] Jones, [an inspector for the PA inspector general's office turned Zyprexa whistle-blower] an outsider gazing in, thought he saw a basic quid pro quo, a corrupt transaction between two parties that stood to benefit. But it is possible that he missed a more complex and fundamental truth: that the system of developing and marketing drugs is so broken that it can coax corruption out of well-meaning doctors who think they are doing good. Every incremental permission that the atypical makers allowed themselves, and the regulators allowed them — structuring their studies in the most advantageous ways, omitting studies unhelpful to their cause, publicizing only the most supportive data — helped shift the medical perception of the atypicals. The companies didn't need to pay off doctors. They just needed to put the grant money out there and wait for the true believers...to walk through the door."

Indeed if I had one criticism of this otherwise insightful article by Ben Wallace-Wells, it is his readiness to excuse physicians as being subject to a "placebo effect" rather than a "basic quid pro quo." As this blog has documented numerous times, there is sadly enough evidence of the latter to balance out the undoubted occurrence of the former.

Wallace-Wells ends his article with a plea for a return to the older days of psychiatry--when psychiatrists actually spent time with their patients, talked with them, got involved with the events in their lives, and monitored them carefully enough so that no drug side effect was likely to get out of control. He makes a good case that since those days, we have decided that it was too expensive for psychiatrists to spend that sort of time with patients with diseases such as schizophrenia. Let the lower-paid psychologists and social workers hold the patients' hands and let the MD simply show up once a month and write the prescriptions. Unfortunately, that assumes that the newer antipsychotics are rifle bullets that worked directly on the causes of schizophrenia, when based on what we now know they are much more like shotgun shells, if they hit the target at all. Wallace-Wells also cites a WHO study that hints that patients with schizophrenia in other parts of the world, where treatment is short on medications but long on social support, actually do better than in the US.

Compassion or Conflict of Interest? New Medicare Cancer Coverage Rules

Check out these sources on the recent Medicare rules change for coverage of cancer drugs:

http://online.wsj.com/article/SB123302745342318667.html
http://blogs.wsj.com/health/2009/01/27/cosy-world-of-cancer-drug-compendia-draws-questions/#more-5055
http://www.nytimes.com/2009/01/27/health/27cancer.html?_r=2&pagewanted=1&hp

Basics: Medicare has relied in the past on a single drug compendium as its authority for choosing which cancer chemotherapy drugs are covered. Critics have charged that this is wrong because some promising new drugs are excluded and patients who have exhausted all other hope are unable to get coverage for these reasonable drugs. The new rule allows many more drugs to be covered by expanding to four the number of compendia that might be viewed as authoritative. Clinical oncologists (who at least until recently earned a percentage commission as it were on chemo drugs that they administer) praise this move.

Problem: this seems less a boon for desperate patients than a boondoggle designed to help out the drug companies. The new compendia that have been added to the list include those that are compiled by people who have serious conflicts of interest with the drug industry, and even a compendium that for all intents and purposes is written by the drug companies. (One outfit that essentially sells itself to the drug industry in return for listing their products in its compendium has the nerve to call itself the "Foundation for Evidence-Based Medicine.")

As a sign that this is intended for the oncologists' and drug makers' incomes rather than real patient benefit, it seems significant that representatives of the patient advocacy groups interviewed for these press accounts generally were skeptical about the new rules.

If the Obama Administration is serious about holding down health care costs while maintaining quality care, this is one rule they will have to tackle.

The Outsourcing of Drug Supply: Market Failure

I would have thought that this article by Gardiner Harris would have stirred up more of a fuss:

http://www.nytimes.com/2009/01/20/health/policy/20drug.html?_r=1

It contains this interesting quote from one of India's top generic drug manufacturers: “If tomorrow China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse.” The article adds that if America were to decide tomorrow that it is a top national priority to be able to make our own supply of penicillin, it would take at least two years before the first fermentation apparatus could come on line.

The fact that the rest of the world has become totally dependent on China for the ingredients needed to make almost all drugs represents a smart business move by Chinese leaders over the past two decades. It also represents the irony that the reason it costs so much more to make drugs in the US and Europe--making outsourcing financially attractive--is because plants in those nations are so thoroughly regulated and inspected.

A part of the reason Harris's article comes as news is that the pharmaceutical industry has always treated its supply sources as part of its web of business secrets, and has generally been very unwilling to come clean on just where it gets its materials.

As my wife astutely commented when I mentioned this article to her, it shows how much of a joke it has been that people are worried about Americans buying drugs from Canada, where supposedly quality might be a problem and we could end up with counterfeit drugs. Given that both America and Canada in the end get all their drugs from China anyway...

Jokes aside, and not to engage in anti-Chinese sentiment (I gave some lectures in Beijing in December and people treated me very nicely and fed me excellent food), but let's for a minute make the assumption that it is not good public policy for us to be completely dependent on one other nation for our pharmaceutical supply. It then seems to follow that just in case there is a person, in these post-subprime-mortgage-financial-meltdown days, who honestly still believes that the "free market" is ideally self-regulating and always produces the maximum good for humanity when left alone, that we seem to have yet another example of "market failure," with which the road of the drug industry in recent years has been thickly strewn.

Is Device Industry Shaping Up?

According to Barry Meier in the New York Times--

http://www.nytimes.com/2009/01/24/business/24device.html?ref=health

--the medical device industry has started to get the message that they have an ethics problem on their hands and need to clean up their act.

Admittedly the message might be hard to miss, when the nation's biggest manufacturers of surgical-implant hip and knee prostheses are all under Justice Dept. monitoring and ordered to post on the Internet how much they are paying each physician with whom they consult or contract. Nonetheless, if Meier's story is to be believed, the industry is taking a hard look at itself and actually changing its practices--at least in the direction of greater disclosure and transparency.

Meier reports that the Justice Dept. investigations showed that the majority of financial contacts between the makers and the docs were on the up and up. An example, apparently, from the article, was an orthopedist in Kingston, PA, who had previously given courses in which he trained his peers how to use the implants manufactured by Zimmer Holdings. In 2007, Zimmer abruptly called him and cancelled his next set of scheduled training workshops. Only recently did they call him back and start to reschedule him. In other cases, consulting fees are apparently paid for legitimate consulting that leads to new product development or old product improvement.

Nonetheless, Justice found enough evidence of illegitimate payments--basically bribes for using large volumes of a company's product exclusively--that the firms caved in and did not oppose the settlement. Perhaps today, the legitimate contacts will continue and the others will start to go by the boards. (Comments welcome from those who have any insider experience, which I certainly do not!)

Protecting Prescription Privacy from Industry Marketing

So much recent legislative attention has been focused on sunshine biils, requiring disclosure of physician payments from the drug companies, that other issues may have been forgotten. An article from Seattle--

http://seattlepi.nwsource.com/local/397259_pharmacyprivacy24.html

--shows us that in Washington State, legislators are attempting to close a loophole in the HIPAA privacy law, that has been exploited by both drug companies and pharmacy benefits managers.

The loophole arose because the Bush administration added language stating that HIPAA could be extended to cover communications among physicians and pharmacists and their "business associates" so long as the communication had something to do with "patient care."

The result is that a patient whose prescription is about to run out may receive a letter saying one of two things. If it's the drug company footing the bill, the letter reminds the patient that they should get a refill, and then launches into a marketing pitch for a newer, more expensive medication for the same problem.

If it's the PBM, the pitch goes in the other direction--after the obligatory reminder to get the refill (that makes it "patient care"), the pitch becomes switching to a cheaper generic drug.

The scam is that most patients assume that their prescription information is private, and so they figure that the letter must have come either from their physician's office or from their pharmacy. They may not realize that the letter lacks this authority and did not come from anyone personally familiar with their medical or medication history.

HIPAA fortunately allows individual states to pass more stringent privacy requirements, so the bill in Washington is designed to close the loophole for that state's residents.

My own view of this is that I am completely unsympathetic to marketing to patients to get them to buy more expensive drugs. I must admit to having a lot more sympathy with an effort to get more docs to prescribe generic drugs when they are medically equivalent. But this ought not be done by ads directed to the patient. Instead, the doc can get reminder letters from the insurer urging a generic switch; and the pharmacy plan can give the patients a price break on generics that will incentivize them to ask their docs whether a generic would work.

Change in Washington and Elsewhere--Latest News

Several news items in the last 24 hours' worth of e-mail. Our friends at Integrity in Science Watch report on the reintroduction by Sens. Grassley and Kohl of their Physician Payment Sunshine Act in Congress, and mention in passing that several more academic medical centers appear to be moving in the direction of ordering fuller disclosure of faculty members' payments from the drug and device makers: Harvard joins Cleveland Clinic and Duke in pursuing more sunshine, as does a major health provider in Minnesota, Park Nicolett.

My recent mailing from the American Academy of Family Physicians urges me to write my congressman to support the Obama economic stimulus package, in part because it contains a number of health care investments friendly toward primary care-- one of which is said to be increasing the amount of research the Feds can conduct comparing drugs head to head to determine which is more effective.

Lilly Fine for Zyprexa Off Label Marketing: $1.4B

When it came to fines paid for illegal marketing practices, the big drug companies had for some time been stuck in the mere hundreds of millions. Give Eli Lilly credit--they stole the lead with total fines of $1.4 billion for Zyprexa (olanzapine) marketing.

Specifically, the company tried to push its second-generation anti-psychotic drug well beyond its FDA-approved uses for schizophrenia and bipolar disorder. Perhaps the most extreme use detailed in these recent charges was a campaign to get docs to use Zyprexa as a--get this--sleeping pill, since sedation is a common side effect. Lilly reps were schooled in a "5 at 5" campaign, by which docs working in nursing homes were urged to prescribe a 5 milligram dose of the drug at 5 pm to assure a good night's sleep. This occurred well after Lilly knew of the drug's serious side effects, particularly obesity and an increased incidence of Type II diabetes. The settlement also cites Lilly's efforts to assure that the drug was heavily marketed to primary care physicians, despite the fact that relatively few primary care docs would be treating the major indications for which the drug was labelled.

As I alluded to in a previous post (http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html), the basic problem here seems to have been the aggressive marketing of all the so-called "second generation" or "atypical" antipsychotics as extremely safe, free of the horrible side effects of tardive dyskinesia and the zombie-like state often seen with high-dose, continued use of the older antisychotics. There seems to be a two-step process. First you convince the medical community that a drug is extraordinarily free of side effects. Then you engage in "indication creep"-- since the drug is so safe, why not try it for patients who are less and less sick, or for patients who suffer from conditions less and less closely related to the major indications for the drug. In the case of Zyprexa, the creep was away from major psychosis and toward milder and milder mental health problems in the elderly, including depression, sleep disorders, and problem behavior such as wandering associated with dementia. In the case of the serotonin antidepressants, the creep took the form of prescribing antidepressants only in severe depression, to prescribing the drugs for any patients who had a bad hair day. Finally the research is done, very late in the day, revealing that the supposed absence of side effects was actually mythical (along with the mythical reports of the drugs' real efficacy), the creation of flawed research and aggressive marketing rather than pharmaceutical science.

Kmietowicz Z. Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine. BMJ 2009, 338:b217. (Subscription required)

Update on Drug Samples: What Part of "Marketing" Don't You Understand?

Since HOOKED was published, the relatively sparse literature on the effects of drug samples on physicians' practice has been expanded somewhat. My apologies for having come across these relatively old articles only just recently.

David Miller and colleagues from Wake Forest University had a sort of natural experiment occur in 2000 when a large, mostly resident-run internal medicine clinic moved to a new building which lacked an appropriate storage space for the former drug sample closet, and the managers decided to end the practice of stocking samples. It also happened that they had a good computeratized tracking system for all prescriptions. They tracked prescriptions written in the 9 months before and after the switch in four major medication categories (antihypertensives, oral diabetic agents, peptic ulcer/reflux drugs, and nonnarcotic analgesics) in relation to the patients' insurance status. (Presumably these four classes of drugs were chosen because they included both brand-name and generic drugs, and there was little evidence if any that the brand-name drugs were superior to the generics.) They found that once the samples were gone, no significant changes occurred in the Medicaid patients' prescriptions, but nearly three times as many prescriptions for generic drugs were written for the uninsured patients. They suggested that by prompting docs to give uninsured patients expensive brand-name drugs rather than generics, samples drive up the costs of care overall for that group.

Sarah Cutrona and colleagues at Cambridge Hospital looked at data on 32,681 Americans from the 2003 Medical Expenditure Panel Survey (MEPS). MEPS offers the advantage of being a population-based community survey, so its contents are not dependent on differential access to medical care. The investigators compared whether a patient had received a drug sample with insurance and income level. They found that people who had higher incomes and who had continuous insurance were more likely to have received samples. This, of course, makes sense if you figure that to get a sample, you have to get into the door of a physician's office, and the physician has to have a stock of samples to give you; and those are more likely to occur if you're higher income and/or insured. Cutrona and colleagues conclude that samples are for marketing and do not provide for any sort of effective "safety net" for getting drugs to the indigent or uninsured. Well, duh, but it's nice to have confirmation from another source.

Nothing earthshattering here but a few more pieces of the puzzle to document what we have long thought about so-called "free" samples.

Miller DP, Mansfield RJ, Woods JB, et al. The impact of drug samples on prescribing to the uninsured. South Med J 101:888-893, 2008.

Cutrona SL, Woolhandler S, Lasser KE, et al. Characteristics of recipients of free prescription drug samples: a nationally representative analysis. Am J Public Health 98:284-289, 2008.

Are "Second-Generation" Antipsychotic Drugs Better?

It might seem that by calling your attention to this post on Dr. Doug Bremner's blog--

http://www.beforeyoutakethatpill.com/2009/1/spurious_antipsychotics.html

--I am being incredibly self-serving, as the post includes a nice plug for HOOKED, which Dr. Bremner has just begin to read. (Hey, better late than never. He's been busy writing his own book as you'll see from his blogsite.) However, read past that and you'll see a useful commentary on an article and editorial that recently showed up in Lancet (cited at end of this post; subscription required to access article).

The so-called first generation antipsychotic medications, of which one of the most widely known is probably haloperidol (Haldol), were reasonably effective in treating the symptoms of schizophrenia and other psychoses--indeed, the arrival of those medications in the 1950s was seen as the main reason why the inmates of the old state psychiatric hospitals could be let out into the community, though what really happened there is a whole different story. However, the doses required to effectively treat serious psychosis, and the life long nature of many psychoses, led to the major downside, the severe side effects resembling Parkinson's disease.

Along came the "second generation" antipsychotics, among which the best known is probably risperidone (Risperdal). The word on the street was that these drugs work as well as, or even better than, their first generation cousins, but are much kinder and gentler in terms of side effects--thus making them worth the high cost (the new kids on the block being brand name while the old guys had gone generic ages ago). The word on the street was dashed recently with revelations that meds like Risperdal were causing humongous weight gain and new onset diabetes among many psychiatric patients.

Leucht and colleagues from Munich set out to do a meta-analysis of all the available studies that compared first-and second-generation drugs directly, and summarized what they had found from 150 such studies. Tyrer and Kendall added a pithy editorial comment.

In typical British fashion, the editorialists do not mince words:

Stefan Leucht and colleagues [suggest] that what was seen as an advance 20 years ago—when a new generation of antipsychotic drugs with additional benefits and fewer adverse effects was introduced—is now, and only now, seen as a chimera that has passed spectacularly before our eyes before disappearing and leaving puzzlement and many questions in its wake.

Importantly, the second-generation drugs have no special atypical characteristics that separate them from the typical, or first-generation, antipsychotics. As a group they are no more efficacious, do not improve specific symptoms, have no clearly different side-effect profiles than the first-generation antipsychotics, and are less cost effective. The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug industry for marketing purposes and only now being exposed.

On present evidence from all sources it is difficult not to conclude that the trials of the second-generation antipsychotics seem to be driven more by marketing strategy than to clarify their role for clinicians and patients.

How, ask the editorialists, did the marketers accomplish this subterfuge? The meta-analysis by Leucht et al. shows that the major strategy was first, to always compare the newer drug to haloperidol, known to cause more Parkinsons-like symptoms than others; and second, to choose whenever possible the highest dose of haloperidol to maximize its side effects. (Strategies that Dr. Bremner kindly notes were discussed in HOOKED.)

What all of these authors agree on is that both first- and second-generation (so-called) antipsychotics are a motley crew of individual drugs. Instead of throwing them in wastebasket categories, the smart physician should be carefully distinguishing among them and choosing the right one for each individual patient based on benefits, side effects, and costs.

The tragedy here is that had any of this hot-shot science been invested in issues of clinical importance rather than used as marketing (recall that we are talking about 150 clinical trials, which is not exactly chopped liver), by now we would have a sizeable database on what drug works best for which type of patient, allowing the dedicated doc to choose based on decent evidence. Because the exercise was taken over by marketing hype from the get-go, we are more or less back to square one. "Old drugs bad, new (expensive) drugs good"--maybe an excellent marketing message, but lousy science.

Leucht S, Corves C, Arbter D, et al. Second-generation vs. first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet 373:31-41, 2009.

Tyrer P, Kendall T. The spurious advance of antipsychotic drug therapy. Lancet 373:4-5, 2009.

Series on U-Wisc. Docs on the Take: Milwaukee Journal-Sentinel Series

Check out:

http://www.jsonline.com/features/health/37397284.html
http://www.jsonline.com/features/health/37421114.html

This two-part series (plus several sidebar stories) by John Fauber of the Milwaukee Journal-Sentinel contains no surprises for us hardened old-timers, but it is a generally good survey of the shenanighans of academic physicians taking company bribes as "key opinion leaders." The notable feature is the background indication of the changing times-- there are more physicians willing to speak out against these practices, and the deans of both Wisconsin med schools are quoted as saying they favor stricter policies to outlaw such practices as company speakers' bureaus. (This may or may not have to do with the Wisconsin Medical Society's notably terse and forthright stance on just-say-no to drug company money:

http://brodyhooked.blogspot.com/2008/10/wisconsin-medical-society-avoid-drug.html)

I feel the need to point out one flaw in this otherwise well-done series of articles. The writer mentions in several places that the drugs these docs are shilling for have dangerous side effects. For instance, the danger of tendon rupture with fluoroquinalone antibiotics is mentioned. Now, the possibility that company over-promotion will cause harm to patients via incrased adverse reactions is a legitimate point. But the hint in the articles seems to be that a physician should never advocate the use of a drug that has any dangerous side effects, which of course is nonsense, as many of these drugs have legitimate uses for which the benefits clearly outweigh the risks. For that matter, as the writer did not know the content of any of these talks, how could he be sure that the speakers did not in fact spend all their time warning the audience about dangerous side effects of the drugs? (Since the company paid for the talks and approved the speakers' slides, we can hazard a shrewd guess that side effects were not emphasized; but I take it that journalists ought to deal with facts and not shrewd guesses.)

The unprofessional behavior of academic docs acting as shills for drug company marketers is sufficiently blantant as it is--there is no need for undue piling on.

Getting in Its Last Licks: The Bush FDA and Off Label Marketing

A little less than a year ago I posted on the FDA's new proposed rule on off label marketing:

http://brodyhooked.blogspot.com/2008/02/fdas-new-rule-on-off-label-marketing.html

I said then it was a rotten idea. Apparently the FDA agreed as they are now rushing to slip the rule into force during the last days of the outgoing Bush Administration:

http://www.sltrib.com/health/ci_11436747

Presumably the only way to get this measure through was to speed it up before the Obama people rolled into town with their generally less-compliant attitude toward the large dug companies. The measure primarily addresses giving docs reprints of medical journal articles that describe off-label uses of a medication. (See my previous post on why I thought the rule was generally misguided.)

The FDA claims that these rules tighten up the process because they discourage ghostwriting. How do they discourage it? Well, the rules recommend that companies disclose any financial relationships between them and an article's authors. Yeah, I am sure that will be a water-tight safeguard.

An ABG Campaign for Surgeon General?

There seems to be something of an ABG campaign brewing with regard to rumors of President-Elect Obama's pick for Surgeon General of the U.S.

Anybody But Gupta.

At first there seemed to be generally positive reviews of CNN's Dr. Sanjay Gupta, based on his proven abilities as a public communicator regarding medical information.

Then protests began to be registered--but interestingly, mostly on what I'd regard as less important issues.

Rep. John Conyers (D-MI), for one, has objected to the possible nomination on the grounds that Gupta did a hatchet job on Michael Moore's movie Sicko, despite the fact that Moore had his facts straight and Gupta didn't. See http://www.pnhp.org/news/2009/january/conyers_obama_shoul.php

Gupta also later presented a report on John McCain's health reform plan that didn't square with the facts and seemed heavily biased in the plan's favor. He also has no administrative experience that would seem to qualify him to lead the U.S. Public Health Service.

So far, however, it has been only an e-mail from the Physicians for a National Health Program that has nailed Dr. Gupta on what seems to me to be perhaps the strongest reason to oppose his nomination. After discussing his clear lack of enthusiasm for a single-payer health plan, the pet goal of PNHP, the e-mail went on: As a media figure, he has been disturbingly cozy with Big Pharma. He co-hosts Turner Private Networks' monthly show "Accent Health," which airs in doctors' offices around the country and which serves as a major conduit for targeted ads from the drug companies. Another example: In 2003, despite mounting evidence to the contrary, he publicly downplayed concerns about the dangers of Vioxx. It was removed from the market a year later by its manufacturer, Merck. (Full disclosure: I am a PHNP member and am sympathetic with the call for single-payer.)

The candidates that the Obama Team have been rumored to be considering for FDA commissioner generally have been known for their strong stance of skapticism or criticism of the pharmaceutical industry (though as to whether those reputations are deserved, see Shannon Brownlee and Jeanne Lenzer, http://www.huffingtonpost.com/jeanne-lenzer-and-shannon-brownlee/a-new-years-resolution-fo_b_156571.html). It would seem a major contradiction to put somebody with those credentials in the FDA post and then pick Dr. Sanjay Gupta, who doesn't seem to know a conflict of interest when it bites him in the whatever, to be Surgeon General.

Sadly, Back to Nemeroff

I had dearly hoped that my most recent post about Dr. Charles Nemeroff of Emory would be my last:

http://brodyhooked.blogspot.com/2008/12/maybe-end-to-laffaire-nemeroff.html

All that was predicated on two very optimistic assumptions--first, that Emory had finally grown a backbone and intended to rein him in; and second, that Dr. N himself actually realized that he had to clean up his act.

Here is our friend Danny Carlat on his psychiatry blog, claiming that more recent events show that neither of the above is true and that Dr. N is merrily going about his business as usual:

http://carlatpsychiatry.blogspot.com/2009/01/charles-nemeroff-unleashed.html#links

Are UK Medical Schools Turning Classes Over to Pharma?

Thanks to some of our friends at the Healthy Skepticism listserv for calling my attention to this recent news item from the BMJ:

http://www.bmj.com/cgi/content/full/338/jan05_2/a3179

The gist of it is that some of the UK medical schools are finding themselves lacking faculty in clinical pharmacology and are filling the gap by inviting in speakers from the drug industry.

The industry folks interviewed insist that they are treating these sessions responsibly and avoiding anything that would give the appearance of promoting their products. (One even said that initially they had brought along lunch and drinks for the students--old habits die hard, I guess--but then realized it sent the wrong message and quit doing so.) To their credit, some of the students have used the sessions to air concerns, such as the failure of the industry to address the therapeutic needs of the developing world.

The obvious concern is not with how the industry speakers act but why medical schools would fall down so badly in their own educational responsibilities to their students so as to have to call on the industry to fill the void.

2007: Slowing the Rise in Health Care--and Prescription Drug--Costs

You might say that what happened in 2007 is pretty old news, but it's the latest year for which the bean counters have crunched the numbers-- see a useful summary with numerous references in the Kaiser Daily Health Policy Report:

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=56280

The bottom line is--while costs still went up for health care overall, the 6.1% increase for 2007 was the slowest rate of growth in nine years. A good chunk of that was fueled by the lower rate of growth in prescription drug costs (4.9% compared to a yearly average of 9.4% between 2001 and 2006). The gurus attributed that in turn to three factors--more use of generics; slower growth in drug prices; and increased black box warnings and other safety concerns scaring people off from some of the previously popular high-cost drugs.

The purpose of this blog is to explore the ethical issues at the interface between the medical profession and the pharmaceutical industry, not to fight for lower drug prices. But it would seem that at least some of what we are trying to do is having a measureable effect.

Living Up to Worst Expectations: Scientology DVD, "Making a Killing"

Regular readers of this blog may want to stop here as the remainder of this post has little to do with my main theme, the ethics of the relationship between medicine and the pharmaceutical industry. Rather the post is a neeeded follow-on to my previous post on my inclusion in a DVD, Making a Killing: The Untold Story of Psychotropic Drugs, produced by the Citizens Commission on Human Rights, an offshoot of the Church of Scientology:

http://brodyhooked.blogspot.com/2008/11/public-announcement-regarding-new.html

I explained in that post that I regretted being drawn into a video whose main purpose was to attack and undermine the practice of psychiatry. Any reader of HOOKED or this blog knows that there are many practices within psychiatry today with which I strongly disagree. That, I hope, does not make me an anti-psychiatrist or a denier of the reality of mental illness. I admitted that I was frankly insufficiently informed about the methods used by the Church of Scientology to draw people into its misinformation campaign about mental illness.

The follow-on is necessitated by challenges that came to me from the Citizens Commission--how could I condemn the video without even seeing it? They apologized for not sending me a copy right off and promptly made up the deficiency.

It took me until the holiday break but I finally did have time to view the video. It is every bit as bad as I feared.

First, to keep the record straight, I am not misquoted or quoted out of context in the several brief appearances that I make. I stand behind any specific things I am shown as saying. Second, there are a number of correct facts and assertions made in the DVD. I will not take up space listing them as they are, as noted, well known to any reader of this blog. I will instead defend my claim that the video is basically wrong, and that it is wrong in a deliberately sneaky way.

Many years ago I read the then-popular and controversial book by psychiatrist Thomas Szasz, The Myth of Mental Illness, first published I believe in 1961. The good Dr. Szasz is still going strong, as evidenced by his appearance in this video. What seems extraordinary is that his ideas from that book are still taken as credible today and seem to form the philosophical basis for the entire case against psychiatry.

Szasz attacked the "myth" of psychiatry by a combination of extreme Cartesian dualism and logical positivism, two positions philosophers today widely regard as untenable. In plain English that means that he made mental illness into a "myth" first by asserting that the mind and the body are two vastly and completely different things, and then by elevating bodily illness to an impossible level of objectivity and scientific predictability and control. According to Szasz (and this video), when you are physically ill, you are in a state that is defined by precise scientific knowledge and where human values and human subjectivity have no role. We know exactly what causes this illness state down to the last molecule. We have precise blood tests and x-rays that provide 100% accurate diagnoses, and when we have drugs or surgery for the disease, they cure it completely, not merely managing or masking the symptoms.

I practiced family medicine for 26 years and nothing I ever did was remotely like this idealized image. Yet it is by derogatory comparison with this impossible (and indeed undesirable) ideal state that mental illness is said to be a "myth," and psychiatry said to be a cross between a scam and war crimes.

What this means in practical terms--moving away now from the philosophical basis of the anti-psychiatry position--is that this video had open to it a fully defensible and reasonable attack on the practice of psychiatry today, under the influence of heavy-duty Pharma marketing. It would be perfectly reasonable to say that there are serious mental illnesses like psychoses, bipolar disease, and severe depression. The drugs that are prescribed for these disorders do indeed help a good many of the sufferers from these diseases to a substantial degree. The drug companies cannot make their hoped-for profits by selling drugs only to this small group of severely afflicted people. So all the companies then try to persuade docs that the drugs work equally well, and with an acceptably low level of adverse effects, for moderate and mild cases of mental illness. In this quest they are aided by the "key opinion leaders" among academic psychiatrists who are the paid shills of the industry. The result is much less effective treatment and a great many more people exposed to adverse reactions, some potentially fatal (as heart-rending personal accounts in the video describe).

The above is as I say reasonable and I believe true--and a serious indictment of today's practice of psychiatry. But the Scientology crowd cannot make this reasonable claim, apparently, because they are wedded to the idea that there is no such thing as mental illness and that none of these psychiatric drugs ever helped anyone. Since they have to deny both the reality of mental disease and the possible efficacy of the drugs even in occasional cases, they start with a dishonest position from the get-go.

Further notes I jotted down to myself while watching the video:

• The video discusses adverse reactions to psychotropic drugs without a single mention of any benefit. In the end it advocates "informed consent" which requires a balanced discussion of both benefits and risks.
• Psychiatry is referred to constantly as "the psychiatric industry." If I did an expose of how orthopedists take a lot of money from device makers and have serious conflicts of interest, and I referred to the specialty of orthopedics as "the orthopedic industry," critics would immediately conclude that the film was terribly biased against the orthopods--and the critics would be right.
• "Half of all people who commit suicide were on psychotropic drugs." Come on--the logical fallacy is obvious. Much more than half of all asthmatics who die of their disease were on anti-asthma drugs. Does that mean the drugs killed them? (In a few cases, apparently yes, but only in a very few.)
• The DSM contains "hundreds of fictitious disorders invented by psychiatrists," and is a tool to label anyone on earth with a psychiatric diagnosis. Now the DSM may be deeply flawed, and probably is, but anyone making this charge has not read it. Any disorder in the DSM comes with a long list of exclusion criteria to assure that it is not applied to just anyone. From the few well-publicized cases of commercial "disease mongering" like "social phobia," the video generalizes to all psychiatry as fictitious.
• Somehow it is a black mark against psychiatrists that they need to cite a DSM diagnosis or they will not get paid. By innuendo, DSM is nothing but a financial scam. News bulletin--in all my years in family medicine, when I saw a patient with a physical problem, I had to write down an ICD-9 code or I did not get paid. Some of those ICD-9 codes were as flaky, and as commercially motivated, as some DSM categories.
• PTSD and bipolar disease are said to be "made up disorders."
• "The psychiatric industry is engaged in crimes against humanity...psychiatric practice is a hoax...pseudo-science." Come on-- this is informing anyone?
• Psychiatrists are caught red-handed admitting that prescribing in their field often involves trial and error--as if there is no trial and error in the rest of medicine.
• Similarly, the narrator ominously intones how Phase IV studies turn the entire US population into involuntary guinea pigs. The producers apparently never heard of Vioxx, Avandia, and the numerous drugs for physical complaints that were found to be dangerous only via post-marketing surveys.
• Psychiatrists are attacked as witch doctors because they admit that they cannot predict precisely which patients will develop which side effects--again, as if this is SOP in physical illness.
• Psychiatrists make a "fat living" by precribing multiple drugs for each patient. First, did these guys check the income levels of different medical specialties, and notice that psychiatry was very near the bottom? Second, did anyone let them in on the secret that docs are not paid per drug dispensed?
• Finally, toward the end, we get to the real whopper--that apparently up to 75% of so-called mental illness is caused by some underlying but undiagnosed physical disease. Huh? Where do they get this stuff? If I had spent my time as a family physician looking for the undiagnosed physical disease that caused the mental distress in all the patients who came to me with some sort of emotional problem, I guarantee first that I would have spent all my time in practice doing just that one thing, and second, that maybe in 26 years of practice I would have actually helped two people, while making thousands more miserable and wasting a boatload of money.

I have a couple more pages of notes, but no more patience to write further comments.

So my conclusion remains--this is a hatchet job on psychiatry, based both on false philosophical premises and false facts. Certain true facts are presented and then stretched out of recognition to cover the preferred theories of this group. I am sure that many of the people interviewed for this film, like me, do not agree with the film's underlying theme or message, and nowhere is it claimed that each person interviewed agrees with everything said in the video. Still, my sense of having been drawn into something basically slimy remains, and I regret very much allowing myself to be used in this way.