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.

Antidepressant toll on sex worse than thought

As time goes on, it seems the benefits offered by modern antidepressants seem to drop while the downsides seem to expand. A story in today's Boston Globe -- excerpted below -- suggests that up to half of people who take SSRIs suffer significant sexual side-effects.

Sexual "numbness." Lack of libido. Arousal that stalls.

Such sexual symptoms have long been known side effects of the popular Prozac class of antidepressants, but a growing body of research suggests that they are far more common than previously thought, perhaps affecting half or more of patients....

Current warnings on the labels of selective serotonin reuptake inhibitors, or SSRIs, cite early studies in which the prevalence of sexual side effects was lower: 4 percent for Prozac, for example, and ranging from 0 to 28 percent for Paxil.

But more recent studies, in which patients were more likely to be asked about specific sexual side effects and thus more likely to report them, suggest that the ballpark range of those affected by SSRIs is between 30 percent and 50 percent, said researchers including Dr. Richard Balon, a psychiatry professor at Wayne State University who studies the symptoms.

That would translate into millions of affected sex lives among the estimated 1 in 8 American adults who have tried these antidepressants in the past decade or so. Some studies have found the range still higher.

Why the rising costs and flattening benefits? Among other things, it's becoming clear, as the wide use of these drugs runs through time, that many drugs prove less effective and more troublesome when prescribed to sick people (many of whom have other health problems and take other drugs) than when used in clinical trials, which usually take care to use patients with fewer problems. It doesn't help that drug companies often fail to report or publish their less flattering results -- and that they didn't investigate the sexual side-effects more aggressively during the trials.

In this case the differences between side effects in trials and in real life is startling, both for the scale of the difference and, of course, for the high-impact nature of sexual side-effects. As Aline Zoldbrod, a Lexington psychologist and sex therapist quoted in the Globe article notes:

"This is such an upsetting issue. There are people for whom SSRIs are really life-saving, I think, but the idea that someone would have to choose between getting out of the darkness of depression and having a good sex life is horrible."

Hat tip: The ever-watchful Furious Seasons

Get your doughboys here (aka Vegetarian dilemma)

Looks like a special effects lab, but it's a bakery that makes bread in the shape (and look) of body parts. Via Biomedicine on Display, where you can find more photos as well as a link to this YouTube video of the baked goods.

My wife is an ace baker as well as a vegetarian. Not sure what she's going to think of this.

Pebble Collection

A few that rolled away with the tide ...

PsychCentral not impressed with Outliers

Look Who's in the Operating Room

From the Deutches Museum, tractors as core culture

And from Boing Boing, a Studley tool chest. And I was all excited to get my little canvas toolbag yesterday.

-

Technorati Tags:
Malcolm Gladwell, Medtronics, Deutsches Museum, Wildlife

Pebble collection

A few that keep slipping out of my hands:

It's All in Your Head -- Sally Satel, in the Wall St Journal, on a recent study showing about half of American doctors use placebos in practice. Satel, who wrote an interesting piece NY Times Magazine piece a while back on her search for a kidney donor, also has an interesting piece on a Senate bill designed to allow states to reward organ donors.

PhamaLot on Pharma's Influence on the Media.

On a related note, a Columbia Journalism Review piece on Science Reporting by Press Release

Andrew Sullivan on The AP's Cowardice.

Hospitals Fail to Take Basic Steps to Stop MRSA’s Spread, from the Wall St Journal's Health Blog. MRSA -- the antiobiotic resistant germ -- killed my uncle on October 1. Man had survived being shot down and crashing in Vietnam, but was no match for MRSA.

Boing boing on awareness after decapitation

Mouse bites snake to death. I also watched a video where a wild pig turned tables on a lioness and butted her till she ran away ... but I can't find it now.

I better stop there.

Technorati Tags:
Sally Satel, Big Pharma, Columbia Journalism Review

Obama to bring cheaper meds, universal coverage, pharma nightmares?

So says the Wall St. Journal's Health Blog:

Obama Presidency Could Bring Cheaper Medicines, Universal Coverage

Disclosure of interest: I spent about $10,000 this year on health insurance, $6000 out of pocket; owe $1200 to doctors and hospitals; and still haven't gone through my deductible.

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.

Minds of Babes, Agony of Defeat, Ocean Modeling, Oh MY

This week's Science is particularly rich in stories, it seems. These stories require a paid subscription, alas -- but the write-ups here, in Science's weekly mailing, make pretty good reading on their own for those without a subscription. My favorites:

From the Minds of Babes

I became fascinated with baby cognition when I did a story on Liz Spelke's work with infants while also raising a couple. Spelke and others have focused on the wee'ns's innate or very early powers of cognition, including numerosity and early logic and perception. Here, though, is an interesting study that proposes that at least one baby-logic error may occur not because baby's logic is poor but because baby is so intensely focused on being led socially by his or her playmate/mentor/teacher. Given the power and primacy of social connections and trust (a subject I took interest in while writing about Williams syndrome, this seems a viable hypothesis and a wonderful notion: I'd love to see it explored some more.

From Science:

Human babies between 8 months and a year of age cannot perform certain cognitive tasks. In one of these, called the A-not-B error, an object is hidden under a container and the infant repeatedly reaches for it. Then the experimenter hides the object under a different container, in full view of the infant, but the baby still looks under the first container to find it. Topál et al. (p. 1831) propose a new explanation for this error, suggesting that the socially intense "teaching" interaction that usually accompanies the repeated hiding of the object under the first container ensures strong association of the object with that location. When the object is hidden without any communication between the experimenter and the infant, the baby's error rate is reduced. Previous explanations for the phenomenon suggested that it was due to the immaturity of the infant's executive motor control or his or her limited cognitive capacities.

The Agony of Defeat

Maurice Delgado, formerly a post-doc at Liz Phelp's lab at NYU and now with his own at Rutgers, picks up one of the juicier fruits to fall from the neuroecon tree of late: the notion that people in auctions often bid less to experience the pleasure of winning (or owning) that to avoid the regret of losing.

From Science:

Auctioneers take advantage of human nature to increase the sale prices of items. But are they banking on the successful bidder's enjoyment of winning, or are they instead relying on the bidder's aversion to losing? Two sides of the same coin, one might say, but Delgado et al. (p. 1849; see the Perspective by Maskin) argue that it is the latter that drives the phenomenon known as overbidding. When participating in an auction, brain areas sensitive to loss became active. When the authors modified the ground rules of the auction so as to emphasize the potential for loss, without altering the basic possibility of winning, the tendency to overbid was magnified.

http://www.sciencemag.org/content/vol321/issue5897/twis.dtl

Modeling Ocean Circulation

I've loved ocean modeling since I spent way too much time looking at current models while writing The Great Gulf. A major challenge -- and a major need for modeling fish population dynamics, like whether zillions of cod larvae will grow to fish on Georges Bank or be swept into the abyss just to the south -- is modeling the currents in 3-D. Apparently someone has made progress on that front:

From Science:

Hydrothermal systems along ocean ridges help control the chemistry of the oceans and alter and hydrate the upper oceanic crust; this, in turn, returns water to the Earth's mantle at subduction zones. Hydrothermal systems also foster deep ocean ecosystems. Observations seem to indicate that although ocean ridges are broadly linear, outflows are spaced out along them. Comou et al. (p. 1825) have developed a three-dimensional numerical model of this flow to help reveal the dynamics. Their model shows that optimizing heat transfer causes the flows to self-organize into narrow pipe-like upflows, spaced about 500 m apart, fed by zones of warm downflow that recirculate up to a quarter of the heat.

Finally, for the part of you that loves cell phones and pure geekery:

Working Together to Get the Job Done

Bob tries to make a call to Alice but finds that the line is too noisy. Picking up his second phone (he's a very busy builder), he finds that line is also too noisy and so gives up trying to contact her. With two bad lines, Bob wouldn't be able to make that phone call, at least using the classical communication channels of his provider. Had he had access to quantum communication channels, Smith and Yard (p. 1812, published online 21 August; see the Perspective by Oppenheim) show theoretically that the situation is quite different. Two quantum channels, each with zero capacity to transmit information independently, will allow information to be carried across them when used together. Not only of theoretical interest, this counterintuitive result may be of practical use in the design of quantum communication networks.

(Can't be long before Clive Thompson is all over that one.)

Tags: MauriceDelgado, social brain, infant cognition, Liz Spelke, ocean modeling, cell phones, quantum communication channels

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.

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