Author Archive

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 »

FDA vs Attorneys: Who Really Protects Us?

September 27th, 2010. By janem

There’s always some whining going on about how much money lawyers make from pharmaceutical class actions. But do those whiners ever think about how safe we would be were it not for the lawyers, lawsuits and the courts? Let’s add advocacy and consumer groups too—their actions have also kept us safe from dangerous drugs and their side effects.

Relying on the FDA for post-market surveillance once it has approved a drug reminds me of this old adage: Close the stable door after the horse has bolted. All too often it takes consumers and their attorneys—like a band of Davids against the Goliath drug company—to resolve adverse drug events that occur by underhanded tactics such as off-label promotion and false advertising.  Case in point: the diabetes drug Byetta.

The FDA received reports of adverse health events (kidney problems and pancreatitis) from Byetta users since the beginning of 2005 but they did diddly squat until last November, when in their infinite wisdom, finally said, “Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.” But not before attorneys were filing class action lawsuits against the manufacturer.

And what about Avandia? In 2007, a report in the New England Journal of Medicine, linked Avandia to a 43 percent increased risk of heart attack, and more than 700 lawsuits—with GlaxoSmithKline agreeing to a $60 million settlement. Yet it took the FDA until September 2010 to severely restrict sales of the drug (sales have been completely suspended in Europe).

And let’s consider Zyprexa. Class action lawsuits alleged that the manufacturer, Eli Lilly and Co., negligently made, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007. Eli Lilly paid out approximately $1.5 billion to settle civil and criminal claims alleging illegal marketing—promoting the drug for use in seniors with dementia when it is not approved for that use.

As well, Eli Lilly paid millions of dollars to settle claims alleging the increased risk of diabetes and related health problems, but the settlement does not imply liability or wrongdoing, so are we safer as a result? The drug is still sold, but with the labeling clearly showing diabetes-related side effects. But Zyprexa treats psychosis—how many people with schizophrenia or bi-polar disorder are going to read the label? Attorneys have taken the drug company to court; now isn’t it up to the FDA to take the drug off the market? Or at the very least, the agency should be more diligent with post market surveillance.

Tags: Avandia, Byetta, Zyprexa
Posted in Drugs/Medical | 2 Comments »

Pepsi, Coke, FRS “Energy” Drinks—Nothing more than Snake Oil?

September 17th, 2010. By janem

If it weren’t for lobbyists such as Public Citizen, Coca-Cola and Pepsi Co. would rule the world. Or at least control everything we consume. Hmm, I guess that does mean ruling the world.

I recently read an article in the NYT about Plumpy’nut—an edible paste comprised of peanuts, vitamins and calories—that is given to starving children and is believed by many to solve worldwide malnutrition. In fact it has been credited with greatly decreasing mortality rates in Africa during famines. Wouldn’t you know that the all-reaching arm of Pepsi wants part of the action!

According to the Times, Pepsi recently talked about playing “a more decisive role” in bringing ready-to-use foods to needy populations. The article refers to three nutritionists who warned that Pepsi-branded therapies could become “potent ambassadors for equivalently branded baby foods, cola drinks and snack foods.” This is precisely what Nestle did years ago when it muscled into the baby formula market in India. Baby formula was given to young mothers in hospitals, right after they gave birth, and guess what? They were given the formula for too long, they couldn’t produce breast milk so they had to buy Nestle’s stuff.

Anyway, back to Pepsi and how my rant began…

I was looking into the “FRS healthy energy drink” made by the good people at FRS Read the rest of this entry »

Tags: Coca-Cola, Energy Drinks, FRS company, Pepsi, VitaminWater
Posted in Consumer Fraud | No Comments »

Take My Mother-in-Law, Please! (Lawsuit vs Comic Tossed)

September 8th, 2010. By janem

 

Well, comedian Sunda Croonquist likely had the last laugh—all the way to the bank! She’s almost a household name these days after being sued by her in-laws for spreading “false, defamatory and racist lies” (see the video above to make your own opinion). I’d never heard of her before Ruth Zafrin, the mother-in-law, demanded a cash settlement for her “pain and suffering.” Anyway, U.S. District Judge Mary L. Cooper threw the suit out of New Jersey’s U.S. District Court April 30^th.

Croonquist alleged that Zafrin joined the action just to keep the issue out of Federal Court (where it landed because Croonquist lives in California and her in-laws live in New York and New Jersey). The stated causes of action included: false light, defamation, intentional infliction of emotional distress, negligent infliction of emotional distress and unjust enrichment.

Her sister-in-law, Shelley Edelman, and her husband Neil (the brother of Croonquist’s husband, Mark Zafrin) were first to sue over the comedian’s schtick—which revolves around jokes about their heritage and her own–claiming Shelley is a racist. ( In her New Jersey accent: “Oh my God, Neil, look at her. She’s got light eyes and light hair, what kind of black person is she?”) And, “My sister-in-law’s voice sounds like a cat in heat.” (Croonquist is half African-American and half Swedish.)

Fortunately for Croonquist, Judge Mary Cooper had a better sense of humor than the in-laws and found the cat in heat comment to be “mere colorful, figurative rhetoric that reasonable minds would not take to be factual”. Cooper held that Croonquist’s jokes are Read the rest of this entry »

Tags: comedian lawsuit, Sunda Croonquist
Posted in Discrimination | No Comments »

Quebec Asbestos Mine Gets Government Backing

August 31st, 2010. By janem

It’s unfathomable and despicable that the Quebec government will guarantee a $3.5-million line of credit for the Jeffrey asbestos mine in Asbestos, Quebec. Now the mine will be able to pump out more asbestos for the next month while it hunts for asbestos investors. The Jeffrey mine is looking for a cash injection of $58 million for a new underground mine at the site.

Ironically, The Canadian government recently announced it will spend C$600,000 on two studies at mining sites in the city of Thetford Mines in Quebec, to look at potential waste management strategies. Thetford was one of the world’s biggest asbestos-producing regions, until asbestos dust was linked with cancer and lung disease. Natural Resources Canada said the study “will help determine if post-mining activities can be conducted on the site to minimize waste and transform it into environmentally friendly resources for other uses.” The project falls under the federal government’s new C$8-million green mining initiative, which aims to improve the mining sector’s environmental performance and create green technology opportunities.

Who are they kidding? Does the Canadian government think we are naïve enough to believe that anything green and “environmentally friendly” can stem from asbestos?

In August, mine owner Bernard Coulombe told The Sherbrooke Record that the Jeffrey asbestos mine faces permanent shutdown if financing by the Quebec government is not granted. According to the Record, Coulombe told Economic development minister Clement Gignac that all he needed was a loan guarantee of $58 million.

Gignac agreed in principle to that guarantee, but said the mine needs another financial partner to pay an extra $15 million to the project that was not part of the loan. “The government hired industry auditor KPMG to do an audit of our operation and they stipulated that to complete work on the underground shaft would require special contractors, instead of allowing us to do the work ourselves,” he said.

Coulombe said two potential investors, one from London and another from India, will be visiting the premises next month. China already backed out.

Poor Coulombe. He says he cannot find other partners because of the negative publicity his fiber has been getting by anti-asbestos critics who want to shut down the industry in Quebec permanently. He argues that the Chrysotile-type fiber is not dangerous if handled properly.

“When you get people like (federal Liberal party leader Michael) Ignatieff saying Canada should ban all exports of chrysotile, then investors get scared that their money will be lost if the Liberals come to power,” Coulombe said.“It is difficult for me to convince them otherwise.”

Tags: asbestos Quebec, jeffrey mine
Posted in Asbestos Mesothelioma | No Comments »