Archive for the 'In the News' Category

Women Win with Multitasking?

“The first query [in a survey of women] on  was: What intrinsic qualities do women have that give them a competitive edge over men? By an overwhelming margin, the trait they touted most was their multitasking expertise.

“‘I challenge any man to talk on the phone, send a fax, reply to an e-mail, change a diaper, get a toddler a snack, monitor what your school-age children are watching on TV and add to the grocery list — all at the same time,’ wrote Heather Lawrence, owner of Texas Stork in Hickory Creek, Tex.(http://www.texasstork.com), which rents ’stork announcement’ yard signs for new parents. Ms. Lawrence, who has two children aged 2 and 6, says her business makes about $1,000 a month, most of it pure profit.

“…Of 80 replies, 34 used the word ‘multitasking.’

“Aside from their juggling prowess, women say they are more intuitive than men, and thus more sensitive to nuance; are better problems solvers; have more energy; are more patient, and are more likely to share their know-how with one another.”

– Brent Bowers, in Women Take Off the Gloves and Come Out Multitasking, New York Times, July 18, 2007

Cell Phones, Car Accidents, and Corporate Liability

ADDexec summary: Danger Ahead — Entrepreneurs, don’t let employees talk and drive in Entrepreneur magazine, May 2007.

Full article: Cell phones are useful, but pull over if you need to use the phone while you’re driving. Same for your employees — whether or not they have attention deficit disorder. Why worry?  For starters:

Under the doctrine of vicarious responsibility, employers may be held legally accountable for the negligent acts of employees committed in the course of employment. Employers may also be found negligent if they fail to put in place a policy for the safe use of cell phones.

Insurance Information Institute, February 2007.

The science now verifies that cell phones impair driving performance. States and cities across the US are now prohibiting or limiting cell phone use by drivers. And the courts are awarding ample damages for injuries caused by drivers who were talking on cell phones at the time of an accident. What’s the dollar risk?

In a suit against lumber wholesaler Dykes Industries in December 2001, a Miami jury awarded $21 million to a woman who was severely injured by one of the company’s salesmen involved in an accident while he was talking on his cell phone.

In Pennsylvania, a Smith Barney stockbroker–who was talking on his cell phone on the way to a non-business dinner–hit and killed a 24-year-old motorcyclist. Testimony revealed that the firm expected its employees to make “cold calls” on personal time. The plaintiff alleged that the firm was negligent because it encouraged employees to use cell phones without providing training on the potential hazards and risks.

Smith Barney settled with the victim’s family for $500,000.

And in an action involving a state employee who was allegedly talking on her cell phone when she hit a tourist, causing permanent brain damage, the state was found partially liable and paid $2.5 million.

California CPA, May 2003.

And of course, those are just the monetary risks — never mind the actual injury to persons and reputation.

Read the Insurance Information Institute article for detailed and current information about US and state laws on corporate cell phone liability.

FDA Approves New ADD Medicine Vyvanse

New medicine on the market — from the makers of Adderall XR. Their press release, below:

FDA Approval of VYVANSE™ as a Novel Treatment for ADHD

23 Feb 2007 - Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d-amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication’s unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at www.ShireADHDTreatments.com.

ADHD Drug Makers to Warn of Side Effects

ADHD Drug Makers to Warn of Side Effects

The Associated Press

Wednesday, February 21, 2007; 7:01 PM

WASHINGTON — Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

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On the Net:
Food and Drug Administration ADHD drug information: http://www.fda.gov/cder/drug/infopage/ADHD/default.htm