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[Fred A. Baughman Jr., MD:
Eli Lilly, Novartis, Shire-Ridgewood, the American Psychiatric
Association and the Food and Drug Administration are fully aware that
ADHD is not a diagnosable disease having a defined abnormality which can be examined or
tested for, proving that children thus-labeled are other than normal. They know, whether the
drugging is with addictive, dangerous, deadly, Schedule II stimulants
or otherwise, that their is no abnormality--that the children made into "patients" and
drugged, are normal until "treatment" begins.]

ADHD drug’s approval powers Eli Lilly

By Mike Maynard, CBS

Last Update: 10:52 AM ET Nov 27, 2002

INDIANAPOLIS (CBS.MW) — Shares of Eli Lilly & Co. rose more than 6 percent Wednesday in reaction to the Food and Drug Administration’s approval of Strattera, envisioned a new-style therapy aimed at attention-deficit/hyperactivity disorder.

Separately, the FDA cleared Eli Lilly’s application for Forteo, a treatment for severe cases of osteoporosis.

Both approvals came more quickly than Wall Street analysts had been predicting, and Eli Lilly’s shares climbed as high as $68 — canceling out losses experienced in Tuesday’s session — before backing off lately to $67.75, up $3.75.

Strattera’s approval, announced after Tuesday’s close, marks the first time in three decades that a new drug has been granted U.S. marketing clearance to address ADHD, a condition seen most commonly in young people characterized by inattention, hyperactivity and impulsiveness.

Eli Lilly (LLY) expects Strattera to hit pharmacies in January. It will be marketed as an alternative to such prescription drugs as Ritalin, produced by Novartis (NVS), and Adderall, produced by Shire Pharmaceuticals (SHPGY).

Strattera itself is classified as a prescription drug but isn’t a simulant as defined under the Controlled Substances Act and thus could be more easily and widely prescribed, according to Eli Lilly.

Clinical studies overseen by the FDA showed that Strattera “significantly improves” patients’ symptoms compared to a placebo, the agency said.

Strattera also is believed to enjoy an advantage in terms of side effects. The FDA identified several side effects seen in youths — lack of appetite, upset stomach, nausea and fatigue — but these may turn out to be less pronounced than those seen in other ADHD treatments.

The potential market for Strattera appears quite sizable. According to the American Psychiatric Association, up to 7 percent of young people have ADHD.

Besides announcing the FDA approvals for Strattera and Forteo, the Indianapolis-based company affirmed its profit outlook at 68 cents to 70 cents a share for the fourth quarter and at $2.55 to $2.57 a share for the full year, excluding items.


Mike Maynard is a news editor for CBS in Washington.

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