Monday, September 26, 2011

Same Song, I Lost Count of Which Verse

Time to get out the ol' standard form again:

Drug Company: Scios Division of Johnson & Johnson
Drug: Nesiritide (Natrecor)
Settled Federal charges of: Misbranding, off label marketing
Fine paid: $85M
Fine as % of Sales of Drug during Peak Year: 37% (2004)
Company Admits Guilt?: Can't tell from news report

The above from Bloomberg News:

Hat tip to the Health Care Renewal Blog which also provides good backstory analysis:

Now, you may ask, why am I bothering even to mention this judgment involving the chump change of $85M, when the record for settlements in such cases is now well upwards of $1B? As HCR informs us, the reason is well summarized in two commentaries by cardiologist Dr. Eric Topol:

What we have here is a drug (brand name Natrecor) that was approved by the FDA based on very slimsy evidence involving surrogate endpoints and despite considerable suggestion of risk of harm, for congestive heart failure, a condition for which many other treatment options exist. The company then aggressively marketed the drug for an off label use, weekly "tune-ups" by injection, and instructed cardiologists how to get big bucks in reimbursement for these "tune-ups," similar to what cancer docs get for injecting chemotherapy. Dr. Topol wrote in 2005 that more than 600,000 patients were getting these tune-ups despite the lack of any evidence that this use of the drug was helpful and despite these being off-label.

Finally, a company-sponsored trial was published in July, 2011, showing no excess deaths or cases of renal failure from nesiritide, but no benefits either when added to a regimen of other drugs. In short, Scios was making a lot of money for several years (before warnings such as Topol's took hold around 2004-5) on a drug that could not have helped and may very well have hurt a lot of folks.

If you wanted firm evidence of the Inverse Benefit Law in action--
--I can't think of a more obvious case.

Thursday, September 22, 2011

The French Have Been Reading Our Blogs

For a good while now I have been occasionally posting on a regular theme from Dr. Roy Poses's Health Care Renewal Blog, for instance:
--that we cannot expect drug/device industry wrongdoing to cease so long as the corporation merely has to pay a fine for legal transgressions; they merely budget the looked-for fine as a cost of doing business and go merrily on their way. Only if individual execs are held accountable under criminal law can we expect behavior to improve.

Well, at least one French judge seems to have gotten the message (not sure if non-subscribers can access but here goes anyway):

Basic bottom line-- a drug (benfluorex) was approved for use in Europe but not the U.S. that seems to be a cousin of the fen-phen combo that I discussed in HOOKED, marketed as a weight loss drug and then shown to cause deadly adverse reactions including heart valve damage and pulmonary fibrosis. The head of Servier, France's second-largest drug company, has been charged with involuntary manslaughter, aggravated deception, and fraud for marketing the drug despite known risks. The CEO has had to post $5.5M bail (which, if French CEO compensation is anything like the U.S., he probably was carrying around as loose change).

My own comment is that the French more or less have the right idea, but I'm an old softie. I would have been happy with just the aggravated deception (whatever that is) and fraud charges. I would not have seen the need to add manslaughter.

Monday, September 12, 2011

From GoozNews: Doing the Right Thing on New Devices?

Apologies if you cannot access this post by Merrill Goozner; I am not sure if you need to be a subscriber to reach his blog:

"Gooz," author of the excellent book, The $800 Million Pill, offers a comment on the recent NIH study showing that stents for arteries in the brain do not prevent strokes and indeed worsen the stroke risk. The good news was that Medicare-Medicaid had held off paying for these stents even with an earlier, smaller study funded by the stent company (Stryker) that was much more promising. (The definitive study, that was stopped early due to the poor outcomes, was funded by NIH.) This was billed as a success story for evidence-based medicine. Medicare-Medicaid insisted that any patient who wanted such a stent had to be enrolled in a proper clinical trial so that the evidence could be collected.

Gooz says-- not so fast. Why wasn't Stryker required to do the large-scale study right from the get-go? He even suggests that the US taxpayers ought to get a refund for the NIH study.

Gooz may be counseling perfection on some matters, but I concur with his general point that the FDA requirements for approving new devices need to be tightened up generally, as we have addressed in previous posts such as:

Thursday, September 8, 2011

Colorado Institutions Riding Herd on Doctors

I said in my last post to expect that local news media (at least the handful that still have an investigative reporter on staff) would be eagerly mining the ProPublica Dollars for Docs database to see what till their local physicians had their hands in. When I wrote that post I had not yet scrolled my e-mail down to my Kaiser Family Foundation Daily Health Policy Report. On that site I found just such a story by Michael Booth of the Denver Post:

What's most intriguing here to my mind is the reports of how two institutions, the U. Colorado School of Medicine and National Jewish Health, have taken on the task of prohibiting many practices that constitute conflicts of interest and demanding oversight of other relationships between their physicians and pharmaceutical companies. The U. was especially embarrassed by how many of their docs were listed on the first ProPublica database when it came out last year and so vowed to take action.

The upshot is that suppose you read on the database that Dr. House at one of these centers took $100,000 from Eli Lilly. You are not sure just what to make of that. But the institution can now tell you that it looked over the contract and that Dr. House is doing legitimate research with that money, not putting it in his own pocket, and not shilling for Lilly.

This seems to be another example to demonstrate that while mere disclosure of conflicts of interest cannot make everything ethically pristine-- a song I've been singing since this blog started--disclosure can lead to other steps that constitute a true ethical advance.

ProPublica's Updated Sunshine Database

The good folks at ProPublica:
--announce that they have updated their "Dollars for Docs" database:

They note that they are offering a sneak preview of 2013 when the Federal sunshine provisions in the health reform law take effect, and disclosures that are now semi-voluntary become required. (I say "semi" because some of the companies now disclosing are doing so under orders from court settlements.) The total database accounts for $760M betweeen 2009 and 2011. Given Gagnon and Lexchin's estimate several years ago that the US pharmaceutical industry spends a total of $57B annually on marketing, and given that at least some of the money on the database is in the form of research grants which at least officially is not marketing, we still have to ask how much of the total picture we are seeing.

To my mind the big news from ProPublica's initial analysis of their data is the possibility that sunshine is having an impact. There is some evidence of cutting back on the amount companies pay to speakers, in particular. The companies pitch this as a purely business decision, but it has several twists:

  • A mini-scandal erupted when the media noted that a number of drug company speakers were in trouble with their state licensing boards. This has led some companies both to pare back and also to be more selective about paid speakers. (They also mention it's smarter from a business point of view to pay fewer speakers to give more talks each; saves on training.) But that scandal was indirectly due to the sunshine of Dollars for Docs, as that provided the database for enterprising journalists to compare to the lists of in-trouble docs.

  • Some universities with policies prohibiting their faculty from being paid speakers had not been enforcing those policies, but Dollars for Docs makes them look pretty silly and has emboldened more of them to search the database for names of their own faculty. Apparently anticipating this scrutiny, some of those docs have chosen to withdraw from speakers' bureaus.

Indirect evidence that the Dollars for Docs is having an impact is the fact that PhRMA seemed to feel it necessary to come out with a preeptive-strike news release just before the update was announced, in which they defended their payments to physicians.

Expect to see more stories from the database as journalists around the country now start peering into their local doctors' names and tracking down what they are up to.

Wednesday, September 7, 2011

None Dare Call It Corruption

Warning: Strident, intemperate post follows (at least at the end).

Exhibit A is a great summary from our friend Dr. Roy Poses at Health Care Renewal of the case of the contaminated heparin:

Bottom line: As most people have by now forgotten, 21 Americans died in 2007 due to contaminated heparin sold by Baxter Laboratories and made from ingredients manufactured in China. Dr. Poses shows that even recently written reports and news summaries dodge the tough questions of corporate responsibility. If a madman had slipped poison into bottles of an over-the-counter medicine and 21 people died, there would be a huge hue and cry and demands that heads roll. As Dr. Poses lays out in detail, various people made some important corporate decisions, all in the name of saving money, that predictably resulted in an unsafe drug being inflicted upon US patients. If you buy a Rolex at a certain discounted price, we all assume, with justification, that you ought to know that it's been stolen. Similarly, if Dr. Poses's summary is factual, anyone buying the heparin or the raw ingredients at the discounted prices being charged ought to have known that the chemicals came from unsupervised and unregulated workshops where purity and safety could not be assured. Not to have carefully tested and monitored the chemicals thus obtained, even assuming it was OK to get the chemicals from those sources at all, was another deliberate corporate decision. Yet no one, apparently, is accountable.

Exhibit B is an investigative reporting piece published by the AP today:

Ricardo Alonso-Zaldivar, who's written many good pieces on the pharmaceutical industry, here reports on a recent study of campaign contributions to the twelve members of the Congressional "supercommittee" charged with coming up with a deficit reduction plan. Not surprisingly, deep-pockets health care interests, including Pharma and doctors, are near the top of the list. Not surprisingly, the offices of the involved congresspeople deny that any of these saintly individuals is ever swayed by mere campaign cash. Not surprisingly, if you believe that line, you have to believe that smart people who manage to make large bundles of money are completing wasting millions of dollars of it by giving campaign donations that produce no results for them at all.

As we have commented on previously:
--the smart Washington money is currently betting that these health-care special interests want the supercommittee plan to fail, based on their assumption that the across-the-board cuts that would automatically be triggered by that failure would be easier for them to live with than targeted and really smart Medicare and Medicaid cost reductions that were aimed at those things that don't help patients. (Given that doctors, hospitals, and drug and device companies all make billions off tests and treatments that fail to provide health benefits according to the best scientific evidence.) Is it possible that all the supercommittee members who take such major campaign contributions from these special interests are not going to be influenced by this preference of their corporate handlers?

The above was all reasonably temperate. Here comes the intemperate part. If all this was happening in Afghanistan or India, and corporations were getting away with murder and the media was keeping quiet about it just because it was corporate and not individual behavior, and politicians were being bought (or even appeared to be bought) by big money, the word we would use for it is "corruption." So my question is--why are people so reluctant to use this word when this happens right in front of us in the USA? Why don't we admit flat out that we have a corrupt corporate system, and that with the Citizens United Supreme Court decision opening the door wide to unrestricted corporate campaign contributions, we have let the corruption flow unhindered from the corporate world into government; and that the media, owned by large corporate interests, has little desire to shine much light at least on the corporate side of the equation?

Saturday, September 3, 2011

Journal Conflicts: Drilling Down Farther

When I was writing HOOKED, one of the most frustrating subtopics that I encountered was the financial aspect of medical journal publication. I found it nearly impossible to gather data about the degree to which most journals were entangled with the drug industry. Andreas Lundh and his colleagues at the Nordic Cochrane Center were able to do a better job than I at uncovering some key data but still came up partly empty-handed:

In this somewhat older article (hat tip to Primary Care Medical Abstracts and Drs. Bukata and Hoffman for pointing it out) the authors tried to gather data on how many studies in six of the top medical journals in English are industry-sponsored, what impact these articles have on the impact factor of the journal; and how much money the journals make from industry ads and from sales of reprints to drug companies. The impact factor is key; journals are in cutthroat competition over this measure of how widely cited their articles are in the rest of the medical literature. Impact factor plays a role in determining where important studies are submitted, how many libraries subscribe to the journal, and how easily the journal can attract advertising.

When Lundh and colleagues went looking for the financial data, they adopted the excellent initial strategy of asking. Of the six journals they were studying, BMJ and Lancet replied, while JAMA, Archives of Internal Medicine, New England Journal, and Annals of Internal Medicine refused to supply any data. When the authors then obtained tax reports and tried to calculate some of the relevant numbers, and sent their calculations to the publishing organizations for confirmation, American College of Physicians (publishers of Annals) responded but the others again refused to divulge any financial information.

Bottom line: most medical journals keep their financial numbers very close to the vest--even journals that have editorial policies that encourage full disclosure of financial conflicts among other parties.

So with what they could get their hands on, Lundh and colleagues noted that the percentage of clinical trials supported solely by industry varied from a low of 3% in BMJ to 32% in New England Journal. Industry-funded trials were more widely cited than other studies (a phenomenon noted in a number of previous surveys; being sure to write more articles that cite a successful study, and then placing those articles in turn in higher-impact journals, is standard industry marketing practice). Therefore as one would expect, publishing more industry-sponsored studies has an effect on the journal's impact factor. Had those studies not been published the impact factor would have dropped only by 1% at BMJ, the low end of the scale, but by 15% for NEJM. In other words, journals have a significant financial interest in publishing industry-sponsored studies on the grounds of impact factor alone even before we get to ad and reprint sales.

For the only two journals for which they could raise the data, Lundh et al. found that journal reprints made up only 3% of revenue for BMJ but all of 41% for Lancet. Tax returns indicate that the AMA, publisher of JAMA and Archives, derives 12% of revenue from reprint sales and a whopping 53% from ads.

The authors end with the following sensible recommendation: "We suggest that journals abide by the same standards related to conflicts of interest, which they rightly require from their authors, and that the sources and the amount of income are disclosed to improve transparency."

Placebo Effect and Adherence: A Challenge to Pharma?

As all four of the regular readers of this blog are aware, I am an avid listener to Rick Bukata's and Jerry Hoffman's monthly audio recordings, Primary Care Medical Abstracts (free advertising for them: So here I am all innocently driving my car and listening to the CD for their August 2011 issue, when I am shocked to hear the CD shouting out my name. Jerry is asking that I respond to a query about one of the papers he and Rick had been discussing, in my capacity as someone who has a long-standing interest in the placebo effect.

So here is my answer to Jerry. You'll naturally wonder why it's here on this blog which is about ethics and Pharma and not about placebo effect. In the end I'll suggest an important connection.

The paper that started all this is a thoughtful editorial by Wilson (subscription required) about the placebo effect and adherence. There have now been a good number of studies that show that when you do a double-blind trial with a placebo arm, there is quite often (indeed rather consistently) a significant improvement of outcomes among those who take their placebos faithfully, compared to those who are relatively non-adherent to taking their placebos. Wilson does a neat analysis of what we know, and what we don't yet know, about this adherence phenomenon, and suggests linkages to what we are learning about placebo effects and why this phenomenon might be viewed (at least as a working hypothesis) as a variant of placebo effect.

Jerry then raises the question: what's the message here for clinicians? Should we give patients pep talks to try to both encourage and energize them about the treatments we're prescribing (whether drug or nondrug) to try to enhance their expectations of a good outcome, which has been shown to be positively associated with a placebo response? Should this pep talk include advice to be sure to take their pills (or other treatments) faithfully? Or might it be the case that the adherence research shows that what really matters is what's already inside the patient's head, not what we say--that those in the trials that were more adherent were simply that sort of person, and being that sort of person is what matters in terms of triggering a placebo effect--and our pep talk is worthless?

OK, Jerry, here's my answer, followed by my hunch.

My answer, as Wilson's nice review suggests, is: we don't know. No one has yet done the sort of fine-grained study of the more-adherent research subjects, analogous to some of the latest generation of placebo-effect research done in the last decade with brain imaging etc. So the underlying psychological and neurochemical factors that might explain the adherence-placebo effect link are unknown.

Now my hunch. The placebo effect is almost certainly multifactorial. Indeed, Fabrizio Benedetti of Turin titled his excellent 2009 book Placebo Effects (rather than Placebo Effect) to make the argument that continued research will almost certainly reveal multiple underlying mechanisms that may operate in different diseases and different organ systems.

The best available evidence that we have suggests two very general psychological mechanisms for most placebo effects--expectancy and conditioning. Expectancy is basically forward looking--your body is likely to heal itself when you think it will get better in the future. Conditioning is backward--your body is more likely to heal itself when you associate the circumstances you're in now with circumstances in which your body experienced healing previously.

The adherence effect probably partakes of both. Subjects who take their medicines regularly probably anticipate a good outcome with greater confidence. These same people probably got better in the past when they religiously took their pills, and so conditioning can contribute to their getting better this time by reactivating the same neural pathways.

Now what happens if a physician acts enthusiastic and encouraging about the nature of the treatment? This is likely to increase both expectancy and conditioning effects--expectancy for obvious reasons, conditioning because the patient probably associates an emotionally supportive environment with past healing (going as far back as when Mommy kissed your boo-boo and it got better afterwards). So I cannot see how the encouraging physician could detract in any way from the patient's inner tendency to experience an adherence-placebo reaction, and I can see several ways that the former might enhance the latter. So: bring on the pep-talk.

I have recently become interested in the connection between placebo response and medicine viewed as ritual/performance/theater. We scientific types are used to dismissing ritual as meaningless superstition, but the current placebo research indicates the neuroanatomical and neurochemical reasons why ritual can be efficacious in changing bodily function as well as in altering our cognitive and emotional views of the world. Much of medicine, when we think about it, is ritual and/or performance. (Science writer Nicholas Wade once wrote something like, "All medicine is a form of theater.") Rituals include taking one's pills once or several times a day and can readily trigger both expectancy and conditioning responses. Smart physicians who prescribe exercise and other lifestyle changes try whever possible to suggest rituals to patients to increase adherence, in some cases going so far as to write the instructions on a prescription pad, which when in practice I always found especially powerful. All of these measures seem well calculated to increase placebo effects, as well as to make patients healthier by way of the drug or the exercise or whatever.

I promised in the end to bring this back around to Pharma, so here goes. I suggest that you read Wilson's article and look especially at the effect sizes reported for the adherence-placebo effect. Just for example: Mortality difference between adherent and nonadherent placebo group subjects in the Coronary Drug Project (1980): 15% vs. 25%. More recently, adherence effect in mortality in heart failure, based on the SOLV-TT and SOLV-PT trials: hazard ratio 0.52 (Avins 2010). And remember, according to the body of data Wilson reviews, these are not one-time flukes. And remember too we are talking here about people keeling over dead, not some meaningless surrogate endpoint.

Why is this of importance? The drug companies would kill to come up with a new drug that had efficacy numbers this good. So you could spin this in a pro- or anti-industry fashion. On the side of the industry, have a pity--look what they have to overcome to show that a new drug is better than placebo, when the placebo effect alone can be this powerful. But on the other side of the coin, when mere encouragement and positive thinking can have this much beneficial effect on patient outcomes, why in heaven's name would we want to give drugs that have dangerous side effects and that cost an arm and a leg, unless the drugs had been clearly shown to be really superior to cheap and safe encouragement?

Wilson IB. Adherence, placebo effects, amd mortality [editorial]. Journal of General Internal Medicine 25:1270-1272, December 2010.

Avins AL, Pressman A, Ackerson L, et al. Placebo adherence and its association with morbidity and mortality in the studies of left ventricular dysfunction. Journal of General Internal Medicine 25: 1275-1281, December 2010.

Friday, September 2, 2011

Does the Drug Industry Trust the "Super-Committee"?

The New England Journal of Medicine's online-first includes an opinion piece--
--by former Clinton health adviser Christopher C. Jennings, on why a lot of special interests in the health field will do their best to torpedo any proposals coming out of the Congressional "super-committee." The political wisdom seems to be that the threat of $1.2 trillion in automatic budget cuts, that would be triggered by a rejection of the committee's proposals, is so scary that everyone will rush to embrace what the committee proposes, Jennings says--no, if you go by the old adage of better the devil you know, then most healthcare special interests have every reason to choose the fallback across-the-board cuts.

Jennings proceeds to list all the various special interests and explain why they'd be better able to cope with the fallback cuts, from their self-interested point of view--despite the fact that public policy and public health goals would clearly be better served by avoiding such cuts and adopting proposals that the super-committee is likely to propose. (In other words, our dysfunctional political process, far from having discovered the way to get beyond the present partisan impasse, has once again assured gridlock.)

What role does the drug industry play in all this? Jennings has little to say about them as a specific player in this game except to point out that there seem to be two options open. One is the automatic fallback cuts. These are likely to amount to 2% overall in Medicare, but Medicaid would be protected from these cuts. The other option would be a sensible plan to reduce costs of both Medicaid and Medicare without cutting useful services for patients, and almost for sure, any such deal would call for extending to Medicare the privilege now enjoyed by Medicaid of using its bulk purchasing power to force discounts in drug prices. The specter of Medicare being able to bargain from a position of real strength has always sent shivers of the spine of the drug industry. So they'll take the fallback cuts, thank you very much.

Accuracy of Drug Ads: Glass Half Full?

A recent study in PLoS One by Korenstein and colleagues:
--addresses how well drug ads in major medical journals adhere to FDA guidelines, and whether, secondarily, the ads tell physicians what they need to know to prescribe properly. Is the glass half empty or half full? You be the judge.

The authors looked at 83 unique ads appearing in 9 high-impact medical journals during November 2008. They found that only 18% clearly met all the FDA criteria, 49% were clearly nonadherent in at least one criterion, and the rest were uncertain due to missing information. (half empty) But the articles that were clearly nonadherent failed, on average, to meet only 1-2 of 21 FDA guidelines. (half full)

Where were the ads most likely to fail? The chief deficiencies identified by the authors were:

  • Unbalanced literature citations making the drug sound better than the evidence shows

  • Misleading use of headlines or pictures

  • Implying doses recommended for one class of patients also safe and effective for other classes
One example given of a misleading photo is an ad for a drug recommended in advanced lung cancer, showing a hunk windsurfing.

The authors went on to assess whether the ads provided important prescribing information. They found few ads that met this goal, mostly due to failure to quantify either safety or efficacy. (half empty)

So, what's the take-home message? The ads may be deficient according to FDA guidelines but most ads seem adherent to most of the guidelines. On the other hand, any physician trying to figure out how to prescribe drugs for patients should never trust drug ads to tell what she needs to know. On the other other hand, who didn't know that?

A few comments. First: the FDA is probably always destined to be toothless regarding ads unless it were to be equipped with SWAT teams. Ads have a natural and limited life cycle, somewhere just upward of the May fly. They are run for a few weeks or months and then replaced by a new round of ads. Almost always, by the time the FDA gets wind of a major violation in an ad and can gather itself to take formal action, the ad has already run its course and the damage is done.

Second: As I tried to describe in HOOKED, drug companies never market a drug in just one way. A drug marketing campaign is a carefully orchestrated symphony. Not only are there a lot of sections, but great care is taken to precisely coordinate the timing of all the different elements. So looking only at one section of the orchestra--the journal ads, the TV DTCA ads, the drug rep visits, the dinner talks, etc.--is almost certainly to miss the forest for the trees (to mix metaphors shamelessly).

Third, having said all that, it would be wrong to blow off journal ads as not worth powder and shot. Korenstein et al. cite industry data to show that the drug companies estimate return on investment for journal ads at $5 in drug sales for every $1 spent on ads, making this one of the best returns in any area of marketing.

Thursday, September 1, 2011

FTC Goes After New Generic Sweetheart Deals

In HOOKED I described one way that the brand-name drugmakers collude with generic drugmakers to "evergreen" a lucrative blockbuster drug about to go off patent. The process starts with the usual abuse of the patent system that seems standard these days, where the original company patents every aspect of the drug they can think of down to the color of the capsule. When the first generic manufacturer appears, the brand-name company immediately sues them for patent infringement, threatening to tie the whole thing up in court for years and keeping the price of the drug for consumers high. But (knowing that they are unlikely to win any of these basically frivolous patent claims) the brand-name company then offers a deal to the generic company--just delay the entry of your cheap drug into the market, and we'll pay you a sum about equal to what you could have made by selling the generic for that many months (but well below the profit we expect to make with the brand-name drug having no competition during those months). The winners--both drug companies. The loser--US consumers and taxpayers.

According to Duff Wilson at the New York Times:
--the FTC has just reported that companies have figured out a new twist. To evade regulations, apparently, the brand-name firm no longer comes out with a blatant payoff to the generic firm. Rather the payoff is indirect. The brand-name firm simply agrees to postpone for the requisite length of time its own generic version of the drug. I know this gets complicated when we start talking about the apparently self-contradictory term "brand-name generics." The FTC claims in its report that when in the first 6 months of competition (during which by law a single generic firm can have a monopoly on the generic side of the trade), if the brand-name company (the only company legally entitled to compete during that time window, as I gather) puts it own generic out on the market, the overall cost savings to the consumer is 4-8%. So if the brand-name company can promise the generic company that it won't compete, that amounts to the same thing as handing over cash, but without handing over any cash.

At least I think that's the way it works. Anyone among the four regular readers of this blog who understands the law better than I or who can explain it better, please send us a comment.

The FTC report struck a nerve because both the brand-name drug industry, in the person of PhRMA, and the generic industry association are grousing. Each insists that agreements that prevent extended patent fights in court are good for consumers and the FTC should take a hike. Of course they are partly right--if the patent laws were effectively enforced as they were intended, all of these lawsuits would get tossed out of court from the get-go. But the FTC is certainly right in claiming that sweetheart deals by which both drug firms make a bundle at the consumers' expense is not the answer.

Pharma, Science, and Drug Reps--an Update

I commend to your attention a blog post and the related comments--

Dr. Stephen M. Stahl, "award-winning author and psychiatrist" according to the website, founded the Neuroscience Education Institute and is a paid consultant and/or speaker for numerous pharmaceutical firms. He wrote the initial post bemoaning the activities of "pharmascolds" and accusing them of causing drug companies to be putting less research effort into finding valuable new paychiatric drugs because of the grief they are causing the industry.

This led Dr. Danny Carlat, of Carlat Psychiatry Blog and a well-known critic of Pharma, to comment that Dr. Stahl was not quite correct on a number of his facts, and that the real reasons why there are not more new and powerful psychiatric drugs now on the market is because the drugs being promoted by the industry don't work very well, and the companies prefer financially less risky me-too drugs over genuine innovation.

So that has led to a lot of back-and-forth commentary and I don't want to get involved in who said what to whom or who called whom what name, but I do want to pull out a couple of comments from the blog that struck me as illuminating.

First: One of the regular bloggers on Dr. Stahl's site is Dr. Debbi Ann Morrissette, a medical writer who I gather is employed by their firm. Dr. Morrissette took issue with a number of Dr. Carlat's objections to Dr. Stahl's statement. Here is a part of her comment:

CARLAT ASSERTION:3. Drug companies have introduced many psychiatric medications over the last two decades, but they have made the business decision to invest heavily in me-too agents, some of which, such as Pristiq and Invega, are embarrassingly blatant patent-extenders with no clear advantages over existing agents. Perhaps if companies had invested more resources into developing truly novel compounds, they wouldn’t be in the pickle they are in.


Okay, so let me see if I get this. Here is a highly trained medical writer trying to defend the drug industry from the supposedly uninformed anti-psychiatry rants of Dr. Carlat. She lists a variety of novel compounds being studied recently by the drug industry, that involve molecular mechanisms different from existing psychiatric drugs. (Real innovation--so far, so good.) She then lists the unfortunate fate of these compounds in clinical trials--they don't work very well, or they cause nasty adverse reactions. She then makes the astounding claim, that on this basis, "industry is punished for pursuing truly novel compounds and rewarded for me toos."

If you consider discovering a new chemical, subjecting it to clinical trials, and finding out that it does not perform as well as you have hoped "punishment," then you seem to be saying that normal, routine clinical research is punishment--which makes Pharma's claim that that's the business they are in rather odd. Are you saying that Pharma ought to be "rewarded" by being allowed to sell useless and dangerous drugs for huge profits? Pharma is indeed "rewarded" when it makes and markets me-too drugs, but the reward is solely economic; by definition, patient care is not significantly advanced. So are you saying that Pharma is really all about profits and not about patient care? Funny, that's what the pharmascolds have been saying.

Second: Here is a comment signed "Former Pharma sales rep":

As a former sales representative for a major international pharma company, I learned firsthand clinician and patient attitudes toward the pharma companies. Patients eyed pharma reps suspiciously in waiting rooms, the front-desk staff treated us miserably, and the doctors refused time with us. Even my acquaintences, some of whom owed their lives to modern pharmaceuticals, could not understand why pharmaceutical companies promote their products or sell them at any significant price. All education efforts, sales efforts, or marketing was considered questionable. As sales representatives, we had a hard time recruiting attendance for educational events because by this time, we were prohibited from providing lunch to go with the presentation. Soon, sales reps were banned from most clinics in the area, and we could no nothing more than drop off copies of clinical studies with scowling front-desk staff. It wasn't long before my entire sales team was laid off due to shrinking sales budgets. Any luxury item is heavily promoted and nobody complains. But a drug that saves lives is expected to be available for free and without sales or marketing behind it. I feel that the clinics in my sales territory did get what they asked for. The absence of up-to-date drug information and education from live representatives.
I am unable to say whether this is an accurate report of the status of being a drug rep in today's world, or some combination of bellyaching and sour grapes, or some of each. But if this is even partly true then I think the important take-home message is the incredible attitude shift that has occurred in this whole field since I started doing the research for HOOKED a little more than a decade ago. Back then the drug rep business was flying high, physicians rolled out the red carpet for reps, and the whole crew was fat and sassy and thought critics of these arrangements were completely crazy. If things have changed as much as "former rep" says, can we pharmascolds actually be responsible? As Dr. Carlat suggests in his reply to Dr. Stahl, it would seem odd that a bunch of generally powerless folks like us could have somehow engineered such a huge change. But hey, we'll take it.

This former rep says that the downside of these changes has been "The absence of up-to-date drug information and education from live representatives." Is that so? Of course this is nonsense in terms of the reps being a reliable source of up-to-date information, or that docs don't have far better evidence-based sources than reps. But that would take us back into far too many previous posts on this blog about how the industry thinks marketing is education.