Posts Tagged ‘ Off-label ’

Tribeca Film Festival Must-See: “Off Label” Looks at Big Pharma’s Human Guinea Pigs

April 15th, 2012. By AbiK

If you’re lucky enough to be in New York City later this month, try to make it over to the Tribeca Film Festival for a showing of “Off Label”. The movie, by Michael Palmieri and Donal Mosher, takes a look at America’s drug culture—how drugs are tested, marketed, sold and consumed. And it reveals an oft times less-than-pretty picture of big pharma’s ‘twilight zone’, where drugs are tested by human guinea pigs and the results can be shady at best, devastating at worst.

Just as LawyersandSettlements.com brings you the stories of victims who’ve had their lives irrevocably changed by harmful drug side effects, “Off Label” brings you up close and personal with its subjects’ narratives–and it’s definitely worth seeing. Here are the times & venues where you can catch the film:

4/19 – Thursday, 7:00pm, at AMC Village 7, located at 3rd Ave and 11th St.
4/20 – Friday, 7:30pm, at ClearCinemas Chelsea, located at W 23rd @ 7th and 8th Ave
4/23 – Monday, 10:00pm, at AMC Village 7, located at 3rd Ave and 11th St
4/24 – Tuesday, 3:30pm, at ClearCinemas Chelsea, located W 23rd @ 7th and 8th Ave

Tags: Donal Mosher, Drug Side Effects, Michael Palmieri, Off Label Marketing, Off-label, Tribeca Film Festival
Posted in Drugs/Medical | 1 Comment »

Allergan and Botox or FDA: Who Has the Last Word?

September 30th, 2010. By janem

As you may know, Allergan Inc. recently pled guilty to off-label promotion of its product Botox and dished out $600 million to resolve its criminal and civil liability suits. Allergan apparently made it a top corporate priority to maximize sales of Botox for headaches, pain, spasticity and juvenile cerebral palsy from 2000 to 2005—the time the FDA hadn’t approved Botox for marketing. Oh yeah, and Botox wasn’t approved to treat wrinkles either. So what was it approved for?

In 1989, Botox was FDA-approved to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction). In 2000 and 2004, it was approved to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating). Then in 2010, approval was given to treat adult upper-limb spasticity. That’s it.

But greed got the better of Allergan and it concocted a plan in 2003 to tap into the headache and pain market: It came up with the “CD/HA Initiative” (CD standing for on-label cervical dystonia) as a “rescue strategy”, it claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.” So the FDA steps in and justice is served.

The civil penalties will be divided between federal and state health plans that were billed for unapproved uses of Botox, and five whistle-blowers who filed lawsuits in Georgia under the False Claims Act.

EXCEPT that Allergan seems to get the last word in:  As part of the agreement, the company was required to drop its lawsuit filed against the FDA in October challenging a government rule that prohibits companies from marketing “off-label” promotions, i.e., unapproved uses.

“This is a good outcome that protects the American people,” said the FDA Commissioner. “The off-label promotion of drugs threatens public health and the regulatory framework of the FDA.”

HUH? Why did the FDA make a deal to drop Allergan’s off-label promotions suit—is the agency that unsure of its legal position,  or does Allergan have deeper legal pockets? Or?? Curious minds would sure like to know…

Tags: Allergan, Botox, Off-label
Posted in Drugs/Medical | 1 Comment »

What the Heck Does “Off-Label” Mean, Anyway?

January 7th, 2010. By Kristine B

One of the phrases we at LawyersandSettlements.com see frequently is “prescribed for off-label uses.” In fact, we see it a lot. But, we realized that not everyone understands what “off-label uses” actually means, or what its implications are. So, this week’s Pleading Ignorance examines the off-label use of drugs. (I promise this won’t be too painful). 

When a drug is approved by the FDA it’s approved for specific circumstances (meaning, for specific health problems) and, often, for specific people (usually defined by an age range, e.g. adults). That’s because the drug has been tested and shown to be beneficial in treating those health problems in that group of people. 

When a drug is prescribed for off-label use, the drug is being used either for a condition that it was not approved to treat or for a person outside the group listed in the prescribing information or both. 

According to a report at USA Today (11/25/08), a study published in Pharmacotherapy listed 14 drugs that should be studied further regarding their off-label use. Those drugs include Seroquel, an antipsychotic medication that is approved to treat schizophrenia and short-term manic or depressive episodes in bipolar disorder. However, according to researchers, in three out of four cases, the drug has been used off-label, for maintenance therapy of bipolar disorder. Other drugs included on the list, as cited at The Wall Street Journal blog (11/25/08) were Coumadin, Lexapro, Risperdal and Singulair. 

It’s not illegal to prescribe drugs for off-label uses. Doctors are allowed to prescribe an FDA- Read the rest of this entry »

Tags: Drugs, FDA, Off-label, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »