Smooth Pebbles

Rumblings and worries about Obama's FDA options

As Obama solidifies his teams on science, education, and environment, attention -- and not a little worry from the drug industry -- is turning toward his hunt for a new FDA commissioner. The WSJ Health Blog reports that the FDA Commissioner Coalition, which is heavy with groups financed by the drug industry, appears increasingly concerned that Obama will appoint outspoken critics of drugmakers and the FDA, such as Cleveland Clinic cardiologist Steven Nissen or Baltimore health commissioner Joshua Sharfstein, who is heading Obama's FDA assessment team.

While the coalition prominently talks about the need for an FDA chief who can withstand some kinds of outside pressure, there’s no mention of an ability to withstand pressure from industry. Yet undue industry influence is at the heart of concerns from both parties in both houses of Congress, from FDA officials, from doctors and many medical researchers.

A copy of the Coalition's letter (to Secretary of Health Designate Tom Daschle) can be found at Pharmalot.

Study: Internet addiction a bunch of bunk

Is there such a thing as internet addiction? Mind Hacks says the debate should be over:

A study just published in the journal CyberPsychology and Behavior has reviewed all of the available scientific studies on internet addiction and found them to be mostly crap. And not just slightly lacking, really pretty awful.

To quote from the research summary:

The analysis showed that previous studies have utilized inconsistent criteria to define Internet addicts, applied recruiting methods that may cause serious sampling bias, and examined data using primarily exploratory rather than confirmatory data analysis techniques to investigate the degree of association rather than causal relationships among variables.

Rather disappointingly though, the authors just suggest that better research is needed when it's quite obvious that the whole concept is fundamentally flawed.>

Whole (not very long) post is worth a read, as is most everything at MH.

Other commentary (also via Hacks) resides at Dr. Shock and PsychCentral. The study is here.

Is Obama for real on health-care reform?

It appears Obama is going to make a health-care system overhaul a top priority in his first year.

from the Tribune:

"The time is now to solve this problem," Obama said at a Chicago news conference where he announced that former Senate Majority Leader Tom Daschle would head his health-care team. "It's not something that we can sort of put off because we're in an emergency. This is part of the emergency."

And as many have pointed out, his selection of Tom Daschle as Secretary of Health and Human Services shows serious intent as well.

This should be quite interesting to watch. As Obama pointed out, the current recession, which can seem an argument not to take on health-care reform, is also a good argument for doing so. People are losing health-care access along with their jobs, and runaway health-care costs are adding extra strain, and more by the year. Probably just as important is Obama's recognition that the first year is the time to get big things done -- and his seemingly sincere conviction that the combination or rising per-capita expenditures and a growing number of un- and underinsured is a deadly serious problem and a blight on the country. Yet to get something done that is both truly reforming -- in the sense of a recognizable reshaping -- may well be the most difficult and ambitious thing he hopes to accomplish.

Except for maybe education reform ... on which more later.

More pebbles: items I (wanted to but) didn't get to

Boing boing spots Virgin Mary in MRI

Bird flu round-up, from Great Beyond touches a few stories reporting some unsettling human deaths from bird flu. I think people are scared to cover bird flu these days: There was so much about it 2-3 years ago, then the epidemic didn't come (we're so impatient!), and now a lot of journalists feel they were out shouting wolf. Maybe wolf is still out there.

Jonah Lehrer on Governor "Show Me the Money" Blagojevich, greed, and a version of the ultimatum game called -- I love this -- the dictator game. "When the dictator cannot see the responder - they are isolated - the dictator begins acting with the kind of unfettered greed expected by economists." (Special bonus: Andrew Sullivan's Quote of the Day is also about Blagojevich.)

Daniel Carlat on "It's not about Goodwin. It's about disclosure."

The Extensible Obama: How the POTUS-elect will use web tools to power his next presidency. From MIT's Technology Review.

Why we still need newspapers

From Knight Science Journalism Tracker:

Phil. Inquirer: Four part series disembowels the Bush White House version of the EPA

Many reporters have dived pretty deep into the legal and regulatory changes wrought at the EPA in the last eight years and into the scientist-administrator Stephen Johnson who imposed them at the behest of the George W. Bush administration... But no other newspaper that the Tracker knows of has torn into the agency with as thorough, focussed and full-hearted a pummeling as seen in the Philadelphia Inquirer for four days this week. ....

Sometimes it’s good to let one’s anger show and these reporters do. The pace, enthusiasm, and rhythm of the prose is like that of a flogging of a misbehaving crewman in an old Royal Navy sailing ship.

Oh, that Lucky Jack should have such luck.

It Gets Worse: Harvard Research Center Tied to Drug Company

More wheels coming off the bus.

Research Center Tied to Drug Company - NYTimes.com:

By GARDINER HARRIS
Published: November 24, 2008

When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were "solely in the advancement of medical treatment through rigorous and objective study."

But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to "move forward the commercial goals of J.& J." The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.

Carlat: How Drug Companies Hid Millions in Physician Payments in Vermont

This one hits close to home, as I live in Vermont. As Daniel Carlat notes, Vermont is one of the few states to actually require drug companies to disclose drug-company payments to MDs, but the state allowed exception for payments related to 'trade secrets.' The companies apparently made the most of this.

The Carlat Psychiatry Blog: How Drug Companies Hid Millions in Physician Payments in Vermont:

Vermont is one of a handful of states that requires drug companies to disclose their payments to physicians. But the law contains a loophole as big as the Ritz%u2014companies are allowed to withhold information on payments that they consider %u201Ctrade secrets.%u201D

Ever since the Vermont law was passed, many have wondered what on earth these %u201Ctrade secrets%u201D might be. A research letter published in this week%u2019s edition of JAMA (Journal of the American Medical Association) finally provides the answer.

The non-profit group Public Citizen sued to obtain information on the trade secret payments, and here it is. During the two year period from the summer of 2002 to the summer of 2004, drug companies made 21,409 payments, primarily to doctors, totaling $4.90 million. 42.9% of these payments, totaling $2.72 million were labeled %u201Ctrade secrets.%u201D

The researchers, led by Dr. Joseph Ross at Mt. Sinai School of Medicine in New York, focused their analysis on those payments to physicians of more than $100 (the Vermont law requires disclosure of all payments of at least $25). There were 4743 payments that exceeded $100, totaling $3.2 million. 49% of these larger payments were trade secrets. The median trade secret payment was $500 per doctor, far greater than the median non%u2013trade-secret%u2013designated payment of $177.

What kinds of payments were considered trade secrets? One would assume these would be for consulting arrangements in which doctors give advice about secret new products in the pipeline. But %u201Cconsulting%u201D constituted only 8.2% of trade secret payments.

By far the majority of trade secret payments were for promotional speaking (43.2%) and for %u201Ceducational%u201D activities%u2014presumably CME (41.7%). Most such gigs are well-publicized by mailings to doctors' offices, and they are typically for products that are already FDA-approved.

Calling promotional speeches and CME events %u201Ctrade secrets%u201D is Orwellian double-speak at its finest. Luckily, the Physician Payment Sunshine Act, likely to be passed by Congress in the coming year, does away with this loophole.

How big is the placebo effect in depression?

The evidentiary landscape regarding antidepressant efficacy seems to grow ever more slippery. Now comes a study, drawn to my attention by the busy-eyed Philip Dawdy at Furious Seasons, that finds that the beneficial effects of placebo treatment of depression last longer than generally thought.

As the study's authors note, "The assumption that the placebo response in depression does not endure is widely held and often stated in writing." In particular, many seem to assume that placebo effects fade while effects of actual medications persist -- another argument for antidepressants.

The point here is not that antidepressants never work. It's that the strength and breadth of the placebo is so strong -- placebo helped 80% as many patients in this study as did real antidepressants -- that it greatly complicates evaluating real antidepressants at either the individual or population level.

I've not had time to closely the study in question, which was authored by a team dran from Duke, Brown, and Tufts. As the authors note, their meta-analysis drew on a fairly large patient base -- 3063 patients -- but included only 8 studies, apparently because they could only find that many that ran the trials long enough to test the question whether placebos worked long-term. (In this case, long-term means 12 weeks. Most antidepressant trials run pretty short, which is another of their many significant limitations.) Even with those caveats in mind, however, this seems a pretty startling and significant finding.

Furious Seasons's take:

Via Furious Seasons

Placebo Effect In Depression Treatment Much Larger Than Previously Thought

CL Psych made me aware of an explosive study in the August Journal of Psychiatric Research which contends that the placebo effect in anti-depressants is much larger than I think anyone in the research world expected. It's a meta study re-analyzing eight anti-depressant trials comprising 3,063 people diagnosed with depression. The study was done by Arif Kahn et al. Kahn is well known in the research world and runs a large clinical research facility in the Seattle area. So he's a long way from being an anti-meds advocate.

In the study, which looked at trials that went longer than 12 weeks (some went as long as 12 months), Kahn found that 79 percent of patients on placebo remained well compared to 93 percent of anti-depressant responders. That would give an overall effect size of the anti-depressants studied of 14 percent, well under the usual 25 percent to 30 percent in shorter anti-depressant trials. I cannot tell from the abstract what specific anti-depressants were involved, but for a sugar pill to perform nearly as well over time is astonishing. Eye-opening even.

Dawdy at Furious Seasons further notes:

In his study, Kahn offered this assessment:

"The widely held – and probably erroneous – belief that the placebo response in depression is short-lived appears to be based largely on intuition and perhaps wishful thinking."

That was the study's final sentence. It'll be interesting to see if this gets replicated.

GIN, TELEVISION, and COGNITIVE SURPLUS

Hi Readers.

Wanted to clue you in to a couple web pleasures. One is Edge: GIN, TELEVISION, AND COGNITIVE SURPLUS A Talk By Clay Shirky, in which Shirky talks about how society's "cognitive surplus" -- the time and brain power contained in the free time created by the Industrial Revolution and the 40-hour work week -- has moved from building cultural infrastructure (libraries, democracies, museums) in the 19th century to TV in the post-War 20th century and the Internet (at least for many people) in the 21st century.

The benefit of this last move, Shirky argues, is that the Internet can actually put some of this cognitive surplus to work, as it does on, say Wikipedia. (This all came to Shirky's mind, he explains, when a TV producer he knew said of people writing and editing Wikipedia ,"Where do they find the time?" and Shirky thought, "They take it from your TV programs!")

It's a good riff with some interesting implications -- though, as someone who didn't even have time to watch Shirky's whole 16 minute video lecture (I read the transcript instead), I can't quite relate to the free time thing. But then, I don't get TV, and I'm a freelancer, so no 40-hour work week, and these kids ... Oy. Time?

But apparently some people have it, and while some watch TV, Shirky has interesting things about the ones who are using the Internet to apply their cognitive powers by producing rather than just consuming.

Tags: ClayShirky, Very Short List, internet, industrial revolution, leisure time, cognitive surplus

More questions on cell phone/DNA data

You want mail, write about cell phones and DNA.

Earlier today, when I posted a heads-up to a Science story about questions raised about data-tampering in what Science called "The only two peer-reviewed scientific papers" showing strong links between cell phone use and DNA mutations, I noted I was surprised at the lack of press coverage about this, given how heavily most papers on the subject are reported. Two hours later I got a note from Louis Slesin, who blogs on such issues at Microwave News, asserting that the Science story oversimplified the situation. Slesin pointed me to his Sept 3 blog post:

Making sweeping statements about scientific knowledge is always challenging, especially when writing about an unfamiliar field of research. Take, for example, this opening sentence from an article, "Fraud Charges Cast Doubt on Claims of DNA Damage from Cell Phone Fields" by Gretchen Vogel in this week's Science magazine:

"The only two peer-reviewed scientific papers showing that electromagnetic fields (EMFs) from cell phones can cause DNA breakage are at the center of a misconduct controversy at the Medical University of Vienna."

Sweeping ... and wrong. Not counting the two papers from Hugo Rüdiger's lab in Vienna, here are 11 papers that point to changes in DNA breaks following exposures to cell phone radiation:

Slesin then lists those papers as well as some others before concluding:

None of this should be interpreted as indicating that the cell phone–DNA issue is closed. Others have failed to see such genetic effects and the jury is still out. But clearly to state that only two papers have shown DNA breaks is grossly misleading —no, simply wrong. We have been closely following the University of Vienna story for some months and we will be reporting on it in detail sometime soon. The Science story gives but a glimpse of some of the maneuvering going on behind the scenes; in this case, manipulating the media to influence public opinion. At the moment, we are still trying to sort out who is doing what.

Did Science cut to the chase or oversimplify? As I'm trying to finish another story right now, I lack the time to run all this down. But this latest wrinkle in the Do cell phones harm you? debate strengthens my impression that a tangle of passionate interests (profits, reputations, righteousness, and a world of ambivalent feelings about connectedness, technology, and the risks posed by the human-made environment) are at work here, greatly complicating the supposedly-but-rarely-straightforwardly-objective path of science and its understanding.

I'll try to keep up with this and report further. Feel free to keep me posted or chime in via the comments section.

Tags: cellphones, fraud, Science magazine, Louis Slesin, Gretchen Vogel, Medical University of Vienna, cell-phone study, DNA mutations, Hugo Rüdiger, scientific misconduct