muted 4.mut.99876 Louis J. Sheehan, Esquire

Louis J. Sheehan, Esquire . The past decade has witnessed a wave of new medications to treat schizophrenia, a debilitating mental disorder that afflicts 1 in 100 people. Armed with results from their own studies, various pharmaceutical companies tout the new drugs, the so-called atypical antipsychotics, as superior to traditional antipsychotic drugs in the battle against schizophrenia.http://louis5j5sheehan5esquire.wordpress.com/

However, it may be time to lower expectations for atypical antipsychotics. A new investigation, funded largely by the federal government, finds that treatment with any of three of these medications diminishes chronic schizophrenia symptoms only slightly more than a traditional antipsychotic drug does.

�Atypical antipsychotics work better than standard medications, but their advantage is relatively modest, at least for chronic schizophrenia,� says study coauthor Jeffrey A. Lieberman, a psychiatrist at the University of North Carolina at Chapel Hill. Although atypical antipsychotics often induce a weight gain of 5 to 12 pounds, Lieberman adds, they�re much less likely than traditional antipsychotics to cause severe movement disorders.http://louis5j5sheehan5esquire.wordpress.com/

The new investigation, led by psychiatrist Jan Volavka of the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, N.Y., sharpens an ongoing debate among physicians about whether to prescribe atypical antipsychotics as a primary schizophrenia treatment. These drugs cost at least 10 times as much as traditional antipsychotic medications, such as haloperidol.

Volavka and his coworkers describe their findings in the February American Journal of Psychiatry.

The scientists recruited 157 patients, most around age 40, from state psychiatric hospitals in North Carolina and New York. Participants had suffered from schizophrenia for up to several decades and had previously taken only traditional antipsychotics, which had not yielded any improvement. Over a 14-week trial, patients were randomly assigned to receive one of three atypical antipsychotics�clozapine, olanzapine, or risperidone�or haloperidol.

The three atypical drugs, but not haloperidol, yielded �statistically significant but clinically modest� improvements in schizophrenia symptoms, the researchers say. These symptoms included delusions, hallucinations, apathy, and a lack of verbal and emotional expression. Clozapine and olanzapine worked slightly better than risperidone did.

The new study was funded mainly by the National Institute of Mental Health (NIMH) in Bethesda, Md., with about 18 percent of the project�s cost assumed by olanzapine�s manufacturer. Previous trials subsidized by pharmaceutical firms have focused on the particular atypical antipsychotic drug made by the funder.

The modest treatment advantage reported by Volavka�s group for atypical antipsychotics �clearly underscores the need for identification of more effective [antipsychotic] treatments,� remarks psychiatrist David A. Lewis of the University of Pittsburgh in an editorial published with the new study.

Researchers need trials longer than the new study to clarify the relative merits of different atypical antipsychotic drugs, especially as frontline treatments for schizophrenia, holds psychiatrist John M. Kane of Hillside Hospital in Glen Oaks, N.Y.

Such a project is now under way. Researchers in 38 states, led by Lieberman, plan to study 1,600 people with schizophrenia treated for up to 1 year with one of five atypical antipsychotics or a traditional medication. Participants in this NIMH-funded study will also receive standard forms of supportive psychotherapy and education (SN: 4/28/01, p. 268: http://www.sciencenews.org/20010428/bob12.asp). Louis J. Sheehan, Esquire .

tout 6.tou.0 Louis J. Sheehan, Esquire

Louis J. Sheehan, Esquire . Pharmaceutical giant Wyeth is under scrutiny for its practice of paying ghostwriters to draft scientific journal articles favorable to its products and publishing them under the names of academic researchers. http://louis5j5sheehan5esquire.wordpress.com/ Some of the ghostwritten reports involve Wyeth’s hormone replacement therapy, Prempo, and deny the results of a federal study that linked the drug to an increased risk for breast cancer. The inquiries come as part of the Senate Finance Committee’s examination of “medical ghostwriting,” part of a broader probe into the influence of drug companies on the health-care industry [Wall Street Journal]. Louis J. Sheehan, Esquire . http://louis5j5sheehan5esquire.wordpress.com/

The investigation is being spearheaded by Senator Charles E. Grassley of Iowa, who last week sent a letter to Wyeth’s chairman requesting documentation of the company’s ghostwriting and publishing procedures. The letter [pdf] said Wyeth’s publications resembled “subtle advertisements rather than publications of independent research” and that “any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.” In response, a Wyeth spokesman accused Mr. Grassley of recycling old arguments and insisted that “The authors of the articles in question, none of whom were paid, exercised substantive editorial control over the content of the articles and had the final say, in all respects, over the content” [New York Times].

Previously released documents from Wyeth and DesignWrite, a medical writing company, reveal that Wyeth executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers [New York Times]. The controversy centers around Wyeth’s Prempro, a combination of estrogen and progestin, and similar hormone therapies that pulled in $3 billion a year for Wyeth until a large federal study in 2002 found the drug to increase breast cancer risks. Wyeth and DesignWrite proposed and drafted an article supporting Prempro that was published in May 2003 in The American Journal of Obstetrics and Gynecology [subscription required] under the name Dr. John Edenon, an associate professor at the University of New South Wales, with no mention of ties to Wyeth or DesignWrite. http://louis5j5sheehan5esquire.wordpress.com/

Wyeth as of Oct. 29 faced about 8,700 legal claims from women in the U.S. who contend the hormone replacement drugs caused breast cancer and other injuries, according to a company regulatory filing last month [Bloomberg]. Other pharmaceutical companies have faced accusations of unethical ghostwriting in the past. The most well-known involved Merck’s Vioxx, a painkiller that was withdrawn in 2004 after it was linked to heart problems. Currently, Wyeth’s Preempro is still on the market, although only prescribed for severe symptoms of menopause. Louis J. Sheehan, Esquire .

roboclam 0.rob.102 Louis J. Sheehan, Esquire

Louis J. Sheehan, Esquire. In yet another example of design inspired by nature, scientists at MIT have developed a heavy-duty (but tiny) anchor that burrows into the seabed, just like a clam. Dubbed the RoboClam (not to be confused with the RoboSnail, RoboTuna, or RoboLobster), the device is no bigger than a Swiss army knife but ten times stronger than traditional metal anchors. Researchers say it could be used to anchor anything from small submarines to large off-shore oil platforms.

RoboClam’s model was the razor clam (Ensis directus), an oblong mollusk about seven inches long by one inch wide that can dig to a depth of 70 centimeters at more than one centimeter per hour. Clammers call it the Ferrari of bivalves. Researchers set the razor clam digging in a plexiglass tank [video!] and observed how it used vibrations of its long muscular tongue to make a seemingly impenetrable layer of sand into liquid-like quicksand. Opening and closing its shell helps the clam propel itself downward.http://louis1j1sheehan1esquire.wordpress.com

The RoboClam works just like the real thing, and its unique digging method is more energy efficient— meaning cheaper—than other mechanical anchors. So far, the RoboClam prototype can dig down with 80 pounds of force to a depth of about 40 centimeters. The RoboClam can also be run in reverse to dig itself out. If scaled up, the RoboClam could compete against traditional anchor systems or even drilling systems. No wonder Chevron is a major funder of the project.http://louis1j1sheehan1esquire.wordpress.com