big pharma on trial

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Zen Gamma Researchers at the University of Wis- consin–Madison have found that dur- ing meditation, Zen Buddhist monks show an extraordinary synchronization of brain waves known as gam- ma synchronya pat- tern increasingly asso- ciated with robust brain function and the syn- thesis of activity that we call the mind. Brain waves are produced by the ex- tremely low voltages involved in transmitting messages among neu- rons. Most conscious activity produces beta waves at 13 to 30 hertz, or cycles per second. More intense gamma waves (30 to 60 or even 90 Hz) generally mark complex operations such as memory storage and sharp concentration. The Wisconsin study took electro- encephalograms (EEGs) of 10 long- time Buddhist practitioners and of a control group of eight college students who had been lightly trained in medita- tion. While meditating, the monks pro- duced gamma waves that were ex- tremely high in amplitude and had long- range gamma synchronythe waves from disparate brain regions were in near lockstep, like numerous jump ropes turning precisely together. The synchrony was sustained for remark- ably long periods, too. The students’ gamma waves were nowhere near as strong or tuned. Such results connote more than spiritual harmony; they reflect the co- ordination of otherwise scattered groups of neurons. Gam- ma synchrony increases as a person concen- trates or prepares to move. And lack of syn- chrony indicates discor- dant mental activity such as schizophrenia. Finally, a growing body of theory proposes that gamma synchrony helps to bind the brain’s many sensory and cognitive operations into the mira- cle of consciousness. That hypothesis cer- tainly agrees with the monks’ gamma read- ings, seemingly con- firming that Zen medi- tation produces not relaxation but an intense though serene attention. Trained musicians also show superior gamma synchrony while listening to musicanother form of calm but intense focus. David Dobbs www.sciammind.com 9 opposite page: MICHAEL SCHMELLING ( hoarding ); GETTY IMAGES ( jogger ); STUART WESTMORLAND Corbis ( monkey ) ; this page: GERALD HERBERT AP Photo ( David Graham); PETER ESSICK Aurora Photos ( monks ) Big Pharma on Trial It has been a depressing season for the drug industry, fol- lowing reports of an alleged cover-up concerning suicidal risks in adolescents who take the widely prescribed selective serotonin reuptake inhibitors (SSRIs) to fight depression. In October, a month after highly pub- licized advisory committee hearings about hiding data from drug trials [see “Antidepressants: Good Drugs or Good Marketing?” by David Dobbs; SCIENTIFIC AMERICAN MIND, Premier, 2004], the Food and Drug Administration required that SSRIs carry a “black box” label warning consumers of increased suicide risk among children and adolescents. At the same time, Merck was pulling from the market its lucrative arthritis medica- tion, Vioxx, amid accusations it had failed to convey data about heart attack risks. And in December, GlaxoSmith- Kline, already accused of cherry-picking drug trial results about its antidepres- sant Paxil, faced reports from ABC News about additional documents sup- porting those charges. Nearly lost amid this noise was fresh research about SSRIs. In October, Science reported that one SSRI given to young mice made them more anxious as adults, possibly by weakening the brain’s mood-modulating abilities. Then, in November, Endocrinology described how Prozac slowed bone growth in young mice, lending experimental support to human studies suggesting that children who took SSRIs grew less than their peers. For damage control, several drug companies and their trade group, the Pharmaceutical Research and Manufactur- ers of America, announced plans to publish all drug trial re- sultsa measure critics dismissed be- cause the practice would be voluntary. But David Graham, a chief drug safety offi- cer at the FDA, had said at the Vioxx hear- ings that nothing less than an indepen- dent office would be needed to oversee the safety of drugs after their approval. Many observers have since recom- mended that Congress require investiga- tors to register every trial at its inception so doctors, journal editors and the public can assess all results for a given drug, not just positive ones that companies seek to publish. Industry watchdogs have been demanding such a registry for 25 years. Leading the charge, 11 high-profile medical journals stated that they would not publish the outcome of trials that had not been registered at the outset. In an attempt to bring this activity to a head, Represen- tatives Henry Waxman of California and Edward Markey of Massachusetts plan to reintroduce the Fair Access to Clini- cal Trials Act, which would create a federal registry. Its fate, observers say, will hinge on whether public and media pres- sure for change continues. David Dobbs David Graham of the Food and Drug Administration testifies at U.S. Sen- ate hearings that the American public is “virtually defenseless” if certain medications prove to be unsafe after they are approved for sale. Monks tune their gamma waves at Eiheiji Temple in Japan.

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Zen GammaResearchers at the University of Wis-consin–Madison have found that dur-ing meditation, Zen Buddhist monks show an extraordinary synchronization of brain waves known as gam-ma synchrony—a pat-tern increasingly asso-ciated with robust brain function and the syn-thesis of activity that we call the mind.

Brain waves are produced by the ex-tremely low voltages involved in transmitting messages among neu-rons. Most conscious activity produces beta waves at 13 to 30 hertz, or cycles per second. More intense gamma waves (30 to 60 or even 90 Hz) generally mark complex operations such as memory storage and sharp concentration.

The Wisconsin study took electro-encephalograms (EEGs) of 10 long-time Buddhist practitioners and of a

control group of eight college students who had been lightly trained in medita-tion. While meditating, the monks pro-duced gamma waves that were ex-tremely high in amplitude and had long-

range gamma synchrony—the waves from disparate brain regions were in near lockstep, like numerous jump ropes turning precisely together. The synchrony was sustained for remark-ably long periods, too. The students’

gamma waves were nowhere near as strong or tuned.

Such results connote more than spiritual harmony; they refl ect the co-ordination of otherwise scattered

groups of neurons. Gam-ma synchrony increases as a person concen-trates or prepares to move. And lack of syn-chrony indicates discor-dant mental activity such as schizophrenia. Finally, a growing body of theory proposes that gamma synchrony helps to bind the brain’s many sensory and cognitive operations into the mira-cle of consciousness.

That hypothesis cer-tainly agrees with the monks’ gamma read-ings, seemingly con-fi rming that Zen medi-

tation produces not relaxation but an intense though serene attention. Trained musicians also show superior gamma synchrony while listening to music—another form of calm but intense focus. —David Dobbs

www.sc iammind.com 9

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Big Pharma on TrialIt has been a depressing season for the drug industry, fol-lowing reports of an alleged cover-up concerning suicidal risks in adolescents who take the widely prescribed selective serotonin reuptake inhibitors (SSRIs) to fi ght depression.

In October, a month after highly pub-licized advisory committee hearings about hiding data from drug trials [see “Antidepressants: Good Drugs or Good Marketing?” by David Dobbs; SCIENTIFIC AMERICAN MIND, Premier, 2004], the Food and Drug Administration required that SSRIs carry a “black box” label warning consumers of increased suicide risk among children and adolescents. At the same time, Merck was pulling from the market its lucrative arthritis medica-tion, Vioxx, amid accusations it had failed to convey data about heart attack risks. And in December, GlaxoSmith-Kline, already accused of cherry-picking drug trial results about its antidepres-sant Paxil, faced reports from ABC News about additional documents sup-porting those charges.

Nearly lost amid this noise was fresh research about SSRIs. In October, Science reported that one SSRI given to young mice made them more anxious as adults, possibly by weakening the brain’s mood-modulating abilities. Then, in November, Endocrinology described how Prozac slowed

bone growth in young mice, lending experimental support to human studies suggesting that children who took SSRIs grew less than their peers.

For damage control, several drug companies and their trade group, the Pharmaceutical Research and Manufactur-ers of America, announced plans to publish all drug trial re-

sults—a measure critics dismissed be-cause the practice would be voluntary. But David Graham, a chief drug safety offi -cer at the FDA, had said at the Vioxx hear-ings that nothing less than an indepen-dent offi ce would be needed to oversee the safety of drugs after their approval.

Many observers have since recom-mended that Congress require investiga-tors to register every trial at its inception so doctors, journal editors and the public can assess all results for a given drug, not just positive ones that companies seek to publish. Industry watchdogs have been demanding such a registry for 25 years. Leading the charge, 11 high-profi le medical journals stated that they would not publish the outcome of trials that had not been registered at the outset.

In an attempt to bring this activity to a head, Represen-tatives Henry Waxman of California and Edward Markey of Massachusetts plan to reintroduce the Fair Access to Clini-cal Trials Act, which would create a federal registry. Its fate, observers say, will hinge on whether public and media pres-sure for change continues. —David Dobbs

David Graham of the Food and Drug Administration testifi es at U.S. Sen-ate hearings that the American public is “virtually defenseless” if certain medications prove to be unsafe after they are approved for sale.

Monks tune their gamma waves at Eiheiji Temple in Japan.