Duff Wilson of the New York Times (full disclosure: we were in journalism school together over a quarter century ago) has a heart-rending tale of child abuse by pill-prescribing psychiatrists in today's paper. Not far into the story, there is this telling anecdote about Johnson & Johnson's marketing of Risperdal, the atypical psychotic many of today's psychiatrists order for young children prone to temper tantrums.

Even the most reluctant prescribers encounter a marketing juggernaut that has made antipsychotics the nation's top-selling class of drugs by revenue, $14.6 billion last year, with prominent promotions aimed at treating children. In the waiting room of Kyle's original child psychiatrist, children played with Legos stamped with the word Risperdal, made by Johnson & Johnson. It has since lost its patent on the drug and stopped handing out the toys. Greg Panico, a company spokesman, said the Legos were not intended for children to play with - only as a promotional item.

Alas, that's the only element of the story about the marketing of these drugs. It doesn't mention the systematic effort by J&J and other marketers of atypical antipsychotics to influence state Medicaid programs, for which the Texas Medication Algorithm Project is the poster child (for a complete rundown of the marketing and abuse of these drugs in children and others, search the archives of journalist Philip Dawdy's excellent blog, Furious Seasons). It didn't even mention Louisiana's suit against J&J (the kid lived in Louisiana) for allegedly illegal marketing Risperdal to seniors.

Curious readers would like to know: What's the latest on the lawsuits by state Medicaid officials against J&J? On a day when the Justice Department's settlement with Allergan over the allegedly illegal off-label marketing of Botox is in the news, what is the status of whistleblower lawsuits against psychiatric drugmakers? This isn't just a debate about how psychiatrists treat young kids whose parents can't deal with extreme behaviors -- the ultimate focus of Wilson's story. When it comes to psychiatric drugs, no story is complete without a full discussion of their marketing. I would like to know if and how every physician mentioned in the story came in contact with the drug industry marketing machine.

Allergan, maker of Botox, will cough up $600 million to the feds for illegally marketing the drug for unapproved uses. The biggest off-label use was for migraine headaches. Ironically, Great Britain recently approved it for that purpose, and the Food and Drug Administration has it under consideration, according to the New York Times.

Like the other drug industry miscreants who signed corporate integrity agreements (Pfizer's $2 billion settlement earlier this year marked the high point in the Justice Department crackdown on illegal marketing), Allergan will have to reveal past payments to physicians and the scope of its investment in continuing medical education. Anybody want to start a pool on which zip codes get the most hits? I'll take Beverly Hills, Miami Beach and the Upper East Side of Manhattan.

The following appeared today in The Fiscal Times:

By Merrill Goozner, The Fiscal Times

Medicare last week finally leveled a pre-emptive strike against smoking and agreed to pay for counseling for senior smokers who are not yet sick. The new smoking cessation program for seniors might seem a tad late. People usually smoke for decades before they get cancer, emphysema, heart disease and other smoking-related disorders - just in time for Medicare to pick up the tab. But the Center for Medicare and Medicaid Services (CMS) decision memo noted that even older smokers who quit can see fairly quick payback in terms of reduced illness.

Smoking costs the U.S. economy $97 billion annually in lost productivity, in addition to the $96 billion a year in direct health care costs, according to CMS. Counseling coupled with smoking prevention drugs and devices are among the most cost-effective interventions in the disease prevention arsenal.

(To read more, click here.)

A new study says moderate drinkers live longer than teetotallers or people who go on occasional benders, even if they are moderate drinkers the rest of the week/month. More proof, as if any were needed, that nothing is bad for you and may even be good for you if done in moderation. 

Lately I've been reading about one exception to this rule -- economic stimulus. Martin Wolf writes in yesterday's Financial Times (registration required) that President Obama and the Federal Reserve Board were too cautious in stimulating the economy and pumping up the money supply in the wake of the 2008 financial collapse.

Debate is emerging on how much of the surge in unemployment is structural. My answer, from European experience, is that one way to ensure it becomes structural is to let it linger. In the short run, the simplest way to prevent that from happening is to expand demand and so output. Since there is huge slack in the labour market, not the slightest threat of inflation - far more a risk of deflation - and no constraint from bond or foreign exchange markets on further monetary and fiscal stimulus, these are the policies that have to be pursued. Yet, alas, the Fed seems to have decided to fall asleep and the administration has lost the initiative.

Annals of rising health care costs, part ad infinitum:

The medical literature is lit up today with news from a European cardiovascular disease meeting in Stockholm. In the eye of the storm: the latest clinical trials for blood thinners used to prevent heart attacks and strokes in people with serious heart disease, especially after receiving stents to prop open clogged arteries. The pin cushion is Plavix (clopidogrel), a $9.8 billion drug marketed by Bristol Myers Squibb and Sanofi-Aventis, which comes off patent next year.

The Food and Drug Administration earlier this year slapped a warning on Plavix because it believed about a third of people with certain genetic variations failed to metabolize the drug.

The latest news comes from a study (PLATO) funded by AstraZeneca, which has an alternative (Brilinta or ticagrelor) under development. This is a classic and well-timed me-too drug. It is coming to market just as Plavix' patent expires. Their trial showed Brilinta was superior to Plavix in outcomes, even though it did lead to more spontaneous bleeding (these blood thinners inhibit platelet action).

Here's the data. After 30 days, Brilinta reduced deaths from heart attacks and strokes to 3.8% of patients compared to 5.7% on Plavix. What the trial sponsors didn't emphasize was the fact that after a year, the death rates were 9.4% and 10.7%, respectively, and the difference wasn't statistically significant. In other words, any difference between the two drugs after a year could have been purely by chance.

A second study released in Europe involved a reanalysis of old data from another study (TRITON-TIMI 38). The reanalysis was conducted by researchers that included scientists from Eli Lilly and Daiichi Sankyo, which market Effient (prasugrel). This study found the Lilly-Daiichi Sankyo drug was not affected by the genetic variations that reduced Plavix' effectiveness.

And, lest you think BMS and Sanofi were taking all this sitting down, a third study those two companies funded came out over the weekend. The makers of Plavix found no difference in outcomes for users of their drug between those who had the genetic variation and those who didn't. I'm guessing the the FDA will cast a skeptical eye on this study, since just 18 percent of the two groups of heart disease patients in the trial had received stents, compared to 64 percent in the PLATO trial and 100 percent in TRITON-TIMI.

Let's step back for a moment from this truckload of new data on this heavily advertised drug (Plavix) and its wanna-be replacements. Four years ago, in a study in the New England Journal of Medicine, researchers found that adding Plavix to aspirin made no difference for people who had already suffered a heart attack or stroke. In fact, there were more serious bleeding complications for people on Plavix.

That contradicted some earlier trials that came out in the mid-1990s, shortly after Plavix came on the market. One, dubbed CAPRIE, found a statistical improvement from taking Plavix instead of aspirin. Deaths in the first year among the 19,185 patients in the two arms of the trial fell from 5.83% on aspirin to 5.32% on Plavix.

In other words, if 10,000 people took Plavix for a year, it would improve outcomes by one-half of one percentage point or one death prevented for every 200 people on the drug for a year. Do the math. At $1,000 a year (conservatively) for the drug, that's $200,000 to save one life. A generic Plavix would cut that in half or more.

Now we have a replacement drug that after a year doesn't do any better, but the company can wave around some short-term results suggesting it does. Alfred Bove, immediate past president of the American College of Cardiology who has no ties to any drug makers, according to MedPage Today, discounted the BMS-Sanofi counterclaim that genetic variations made no difference. In his comments to journalists in Stockholm, he said "physicians don't like complications. If I told you there was an alternative to clopidogrel that worked the same way without the variations, they would jump on it."

I hope he was referring to its use after patients receive stents, which accounts for only a small fraction of Plavix' sales. For the millions of people being prescribed Plavix as primary prevention of a first heart attack or stroke, isn't aspirin nearly as an effective option?

Reed Abelson over at the New York Times' Prescription blog has an interesting report on a new study questioning Detroit's strategy of relying on health care to bolster its lagging economy. I posted the following comment:

Detroit is merely a microcosm of the nation as a whole. Health care is the only sector that has added jobs throughout the Great Recession, just as it added jobs throughout the previous two decades (see my article in The Fiscal Times here).

What nobody wants to look at is how it continues to do so regardless of economic conditions. The answer is simple. There are no constraints on spending. Providers through insurers pass on rising costs to businesses and consumers in a marketplace where demand elasticity is very low because demand is dictated by the supply side (i.e., doctors/hospitals/input industries prescribe, patients obey).

It's like Keynesian stimulus with one vital exception, which turns it into its opposite. When the government engages in deficit spending to stimulate demand, it borrows from the future. When the health care sector engages in automatic demand-driven cost increases, it takes its cash in real time from every other sector of the economy, including the government. That may be acceptable when the rest of the economy is growing. During recessions, like now, it becomes a major drag that hampers economic recovery.

It's rare when chairmen of Food and Drug Administration advisory committees speak out after a meeting. They and the committees' members usually let the votes speak for themselves.

Last month, the FDA's joint safety and metabolic drugs advisory committee meeting declared the diabetes drug Avandia (rosiglitazone) posed a serious heart attack risk to patients. But the committee was split on how to deal with that conclusion. Slightly less than half called for removing the drug from the market, while slightly more than half wanted tougher controls on prescribers. That could be nothing more than a stronger black box warning than the one put there in 2007 in response to a similar conclusion.

This week, Clifford Rosen, the Maine Medical Research Institute physician who chaired the meeting, felt compelled to offer the FDA his own interpretation of the vote. Writing in the latest New England Journal of Medicine, Rosen declared:

Despite what may have seemed an ambiguous vote, I would argue that the EMDAC (Endocrinologic and Metabolic Drug Advisory Committee) clearly indicated that the FDA must do more than provide additional black box warnings. The vote may reflect a desire to balance patient protection with the availability of the broadest possible range of therapies for a complex, chronic disease, but the clear risk demonstrated by the aggregate data calls for serious measures. Thus, in my view, the FDA must consider only two choices: either stronger warnings plus the use of informed consent and a registry for compassionate use of rosiglitazone or removal of the drug from the market.

The controls he describes -- requiring an informed consent agreement from patients PLUS creating a registry -- would be one of the most stringent Risk Evaluation and Mitigation Strategies (REMS) adopted to date. Congress gave the FDA the power to adopt REMS in 2007 in response to the Vioxx disaster.

Avandia sales would no doubt suffer another downward plunge if the FDA opts for a tough REMS. At this point, given the usually moderate Rosen's outburst, that's probably the best that drug sponsor GlaxoSmithKline can hope for.

No surprises this morning in a report that revealed the money behind the rightwing Tea Party movement is the Koch Foundation, a Texas/Oklahoma oil money outfit that has funded conservative grass roots movements since the early 1980s. But this description in today's New York Times of how it trains the 20- and 30-something organizers staffing its Washington headquarters (!) was a jawdropper:

New employees receive a required-reading list that includes "Rules for Radicals," by Saul Alinsky, the father of modern community organizing, and "A Force More Powerful," about 20th-century social movements, as well as Frédéric Bastiat's "The Law," which argues that governments are essentially stealing when they tax their citizens to spend on welfare, infrastructure or public education.

Using Saul Alinsky to teach people how to oppose welfare, infrastructure and public education spending. He wouldn't be pleased.

The National Press Foundation is sponsoring a four-day, all expenses paid trip to Washington for 15 reporters to learn how to improve their coverage of cancer issues. Pfizer is funding the seminar.

Former University of Minnesota journalism professor Gary Schwitzer writes:

Even if National Press Foundation staff choose the speakers and set the agenda, even if the Pfizer "guy never even showed up" last year, even if one reporter doesn't recall Pfizer even being mentioned once at last year's session, one fact remains. Some journalists will have taken Pfizer money to attend this session. Journalists are taught to avoid even the perception of conflict.

There's one other point that needs to be made. Pfizer dictated the overall agenda (not its specific content). Pfizer didn't make an unrestricted grant to a journalism training organization. The money is being spent to train journalists in how to cover cancer.

Frankly, if there is one issue in medicine that doesn't need more attention right now, its cancer (I make one exception: we need more journalists who know how cover the cost-effectiveness of new cancer drugs that extend life by less than three months). How about the economy? How about the environment? How about low-income housing? How about financial regulation? How about education? How about job training? How about higher education? How about the courts? How about a half dozen other beats that used to have full-time reporters a generation ago and now go uncovered except for occasional stories in the nation's largest newspapers?

Despite the valiant efforts of the Knight Foundation, the Reynolds Center for Business Journalism at Arizona State University and a few other eleemosynary endeavors, journalism spends less on training than almost any other profession. In these difficult economic times, newsrooms have no resources for training and reporters have almost no chance to leave the newsroom for even a day, much less a week for professional education. Moreover, the industry's financial base -- its advertisers -- has no interest in the quality of the product that builds the audiences they seek to reach.

So corporate contributions to journalism professional training would be welcome -- if they truly came with no strings attached. But the way the National Press Foundation set up the program with Pfizer, it has all the same problems as programs the drug industry funds in continuing medical education. The issue isn't that the company dictated the specific content of the session. Pfizer and the NPF insist that didn't happen. Rather, the company got to dictate the shape of the vessel into which that content got poured.

If Pfizer wants to help create a better press corps in the U.S., it should give a totally unrestricted grant to the National Press Foundation -- and let them decide what seminars to hold. Or better yet, the money should go to a totally independent entity that isn't in the business of conducting journalism training seminars. Let that independent entity evaluate proposals from training groups, each of whom can make their own case in their proposals for what areas are most in need of additional education and coverage.

Of course, Pfizer probably wouldn't contribute to such a system, just as the drug industry has no interest in setting up an independent entity to receive corporate contributions for continuing medical education. If I were a working journalist in a newsroom who covers health care issues, I'd think twice about participating in the NPF seminar this October.

Disclosure is enough, the nation's leading organization of oncologists says.

The American Society of Clinical Oncologists last week joined university officials in protesting the National Institutes of Health's new rules for managing the financial ties between federally-funded researchers and private firms. The group complained NIH's definition for "managing" conflicts of interest overemphasized reduction or elimination of those financial ties.

Disclosure to university officials, colleagues and patients can deal with the situation, ASCO's Aug. 19th letter said. Peer review also protects the integrity of the process, according to the group's comments. "A conflict of interest is not evidence of wrongdoing," ASCO said. The group also wants industry-supplied travel money exempted from the new conflict-of-interest rules.

Last week, the Association of American Medical Colleges and the Association of American Universities made similar arguments in their brief against tighter standards for conflicts of interest.

I've been reading University of Minnesota bioethicist Carl Elliott's new book on conflicts of interest in medicine. In "White Coat, Black Hat," he writes that "studies suggest that, far from remedying the bias created by conflicts of interest, disclosure may actually make the bias worse." As proof, he offered experiments conducted at Carnegie Mellon University showing that advisors became more brazen about touting strategies that advanced their own financial interests after disclosure.

It was as if the advisors had decided: All bets are off now. I've disclosed my conflicts so now I'm free to say whatever I like. The Carnegie Mellon group summed this finding up nicely when they said: Coming clean means playing dirty.