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Scientists Debate Possible Viagra-Aggression Link

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    Message 1 of 1 , Dec 12 1:15 PM
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      By Todd Zwillich
      Friday, December 6, 2002


      WASHINGTON (Reuters Health) - A debate has begun among scientists about
      whether Pfizer Inc.'s impotence drug Viagra (sildenafil) can be linked to
      aggressive behavior and sexual violence.

      One researcher has concluded that doctors should begin warning Viagra users
      about the possibility of psychological and emotional side effects.

      But other scientists, as well as officials at Pfizer, reject the claim as

      In July of this year, Dr. Harold A. Milman, a toxicologist based in
      Rockville, Maryland, published a report in the Annals of Pharmacotherapy
      examining more than 12,000 reports of adverse events in men who took Viagra.

      More than 270 of the reports, collected and archived by the US Food and Drug
      Administration (FDA), detailed psychological side effects, including
      dizziness, disorientation and amnesia. The drug was also listed as a suspect
      in 22 reports involving aggression, 13 involving rape and 6 involving
      murder, according to Milman's article.

      FDA officials said that they have no plans to change Viagra's labeling in
      light of Milman's report. But one top agency official said that the study
      was important to scientific debate about the drug.

      "(The report) had a lot of information that hadn't been pulled together in
      one place before," Dr. Bernard Schwetz, FDA's senior advisor for science,
      said in an interview.

      Milman acknowledged that the adverse-event reports are anecdotal evidence.
      "But it's clear that these men are behaving abnormally," he told Reuters

      The theory that the drug may cause aggression has formed the basis of the
      so-called "Viagra defense," a claim made by half a dozen defendants since
      1998 that the drug caused them to commit violent crimes. Milman was hired as
      an expert witness in one such case.

      The Viagra defense has not been successful so far, but an Israeli court did
      mention in a 1999 ruling against a rapist that the drug had played a role in
      the attack.

      Viagra causes erections by working directly on the blood vessels of the
      penis, not through actions in the brain. Clinical studies in more than 8,000
      men showed that the drug caused central nervous system effects in less than
      2% of users, none of whom became violent or disoriented, according to

      "I'm not saying Viagra causes anything, but there is evidence to suggest an
      association," said Milman, who noted that he is not an expert in Viagra's
      biological mechanisms. Milman spent 18 years as a senior advisor at the US
      Environmental Protection Agency and 10 as a cancer-drug expert at the
      National Institutes of Health.

      Scientists don't consider adverse-event reports to be hard evidence of a
      causal link between a drug and an event. The reports don't always show which
      other drugs patients were taking or note their state of health when taking
      the medication.

      "You could take any product and connect individuals who use it with certain
      behaviors. I think it's a coincidence," said Geoff Cook, a Pfizer spokesman.
      "We don't think there is any credible medical evidence linking Viagra with
      violent or aggressive behavior."

      Still, adverse-event reports are often used as a way to flag side effects in
      the general population that may have been missed during clinical studies.
      Effects that fail to show up in several thousand test subjects have a better
      chance of being noticed when millions of people have taken a drug.

      Milman cited research in his report showing that sildenafil can enter the
      brain and that the drug could affect biological pathways in parts of the
      brain controlling sexual responses and aggression.

      In interviews, other scientists rejected Milman's claims about a link to
      aggressive behavior. "To me, it is an extremely remote hypothesis," said Dr.
      Raymond C. Rosen, a professor of psychiatry and medicine at the University
      of Medicine and Dentistry of New Jersey.

      Rosen and Northwestern University toxicologist Dr. Kevin E. McKenna wrote to
      the Annals of Pharmacotherapy this month challenging Milman's article.

      Rosen told Reuters Health that there is no clinical evidence in humans that
      the biological pathways affected by Viagra can cause aggression or violence.
      He said that no patient he has ever evaluated has shown such symptoms.

      "Changing anything clinically or legally because of this is stretching the
      point totally beyond credibility," said Rosen, who is recognized as a
      leading expert in sexual dysfunction. He noted that he has served in the
      past as a paid consultant for Pfizer.

      McKenna acknowledged that sildenafil could affect parts of the brain that
      control sexual behavior, including the hypothalamus and parts of the
      medulla. But studies in mice show that the drug would probably make
      aggression less likely, not more likely, he said.

      Milman said his paper was intended to encourage more scientists to look
      directly at whether Viagra can cause problems. "There are a lot of question
      marks," he said.

      On that point, McKenna agreed. "I still believe behavioral effects of
      sildenafil should be studied more closely," he said.


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