FDA Lashes Back at Latisse

September 23rd, 2009. By AbiK

If you’ve been following what’s hot in beauty, you’ve seen the ads for Allergan‘s (also maker of Botox) Latisse where Brooke Shields lends her face to promote the eyelash enhancer. And you’ve probably caught the onslaught of vibrating mascaras. Yes, all this to “play up” what amounts to 1/1,000,000,000,000,000th of the surface area on a woman’s body.

But those tiny lashes are big business. Allergan had estimated pre-launch of Latisse that the previously-only-known-as glaucoma treatment could rake in over $500 million a year. Who knows just how much a mascara wand that needs batteries could bring in. I admit to owning one, but I also admit it was a gift and after thoroughly cleaning it, it actually makes a handy gizmo for cleaning tile grout (beauty tip!).

The FDA, however, is not so wowed by all the hoopla surrounding Latisse. In fact, it appears the Read the rest of this entry »

Yasmin/Yaz Recall Way Overdue

September 22nd, 2009. By janem

What comes first: will Bayer issue a recall of Yasmin/Yaz or will the drug company simply stop making its wildly popular and extremely dangerous birth control pill? For Bayer, the decision likely boils down to cost: can more claims be settled by taking the drug off the market? Poor Bayer has plenty to worry about these days. Not only are Yasmin/Yaz lawsuits related to life-threatening side effects stacking up, it was also served a warning letter from the FDA regarding quality control problems.

If and when Yasmin is taken off the market it will surely affect Bayer’s bottom line: In 2008 Yaz brought in $616 million for the company and Yasmin sales brought in $382. And sales increased from the previous year, mainly due to aggressive marketing campaigns that have since been called “deceptive” and “misleading” by the FDA. Advertising is a powerful tool: according to numerous Yasmin users I have spoken with, they had no knowledge of these side effects nor did they hear of any warnings: after all, if you knew Yasmin was life-threatening, you certainly wouldn’t be taking it!

So what’s taking the FDA so long to issue a recall? The agency must act on the countless reports of thrombosis, heart attack and stroke and even gallbladder disease associated with Yasmin and Yaz.

It wasn’t long ago that several fatalities were directly linked to the Ortho Evra birth control patch and it never did get recalled, even though last May the Public Citizen Health Research Group filed a petition on behalf of 80,000 consumers urging the FDA to recall Ortho Evra within six months. I wonder how many deaths it  will take to remove Yasmin and Yaz from the market…

Another Whistleblower Movie: A True Story, But Is It Real?

September 22nd, 2009. By Hunter West

The whistleblower has come to the big screen yet again, although the movie starring Matt Damon that debuted Friday—The Informant—was hardly the same story as whistleblower John Kopchinski, whose six-year battle with Pfizer recently ended with a “qui tam” lawsuit settlement of $51.5 million for him.

 

For all his trouble in blowing the whistle on Archer Daniels Midland (ADM), Mark Whitacre got 9 years in prison. But that’s not just because he worked with the FBI for three years, wearing wires and employing other surveillance devices in an attempt to expose alleged price-fixing of lysine, a food additive. Where Whitacre went wrong was losing his trust in the FBI, and going off the bipolar deep end by abandoning his quest to bring down the company, instead drifting down the embezzlement sinkhole, defrauding  $9 million from his own employer.

 

In the end, the whistleblower did more time for his own misdeeds, than the price-fixing executives he initially sought to expose.

 

In contrast, John Kopchinski had a slightly easier time, and a much bigger reward at the end of his struggle. The former soldier was earning $125,000 a year at Pfizer when he was fired in 2003 after he complained to his superiors about the underhanded marketing tactics the pharmaceutical giant was using to vend its drug Bextra. Read the rest of this entry »

Construction Workers and Asbestos Mesothelioma

September 21st, 2009. By LucyC

A new study out this month gives a whole new meaning to the term “Dirty Energy.” It turns out that construction workers who were employed at the Department of Energy’s (DOE) Hanford site back in the 1970s are dying at higher than normal rates of asbestos mesothelioma. 

The study, published this month in the American Journal of Industrial Medicine (Sept 2009), shows 94 of the 266 workers who had worked at the Hanford site had died of asbestos-related cancer. The study looked at data from the Building Trades National Medical Screening Program for Hanford, WA, and three additional Department of Energy sites. 

One of the authors of the study, Knut Ringen of Stoneturn Consultants in Seattle, told a Washington state newspaper, “The most significant finding at Hanford was a very high rate of mesothelioma.” And that was in addition to deaths from asbestosis, which was 30 times higher than that seen in the general population. According to the study, the workers were exposed to the asbestos between 20 and 30 years ago, and their average age at the time of volunteering for the study was roughly 60. Read the rest of this entry »

In View of Past Misdeeds, Unum is Playing it Smart

September 21st, 2009. By Hunter West

It’s time to give credit where credit is due: for a corporation oft-painted as a villain, Unum Provident is one smart company. 

Unum Provident has been dragged through the mud in recent years over various charges and allegations that the company goes out of its way to deny legitimate disability claims. A claim, after all, is a drag on an insurer’s bottom line. The fewer claims an insurer is required to process, the less money it has to pay out while premium revenue remains a constant. 

Thus, there are basically three ways to improve the performance of an insurance company: sell more policies; reduce the number of claims, or any combination of the two. 

All you hear about are the horror stories from policyholders who have allegedly been cut down at the knees by a seemingly uncaring and unfeeling insurer. However, any corporation will tell you that the road to profitability is paved with cost reductions. There isn’t an insurer worth its’ salt that doesn’t cast a wary eye every time a claim is made against a short-term disability (STD), or long-term disability (LTD) policy. Unum Provident is no different. 

If insurers have been cast as villains, so too are a handful of policyholders who really do try to take advantage and pull a fast one on their insurer by making a claim for disability when they are, indeed quite healthy. 

Be that as it may, Unum Provident—easily a global leader in the provision of insurance products—is doing a lot of things right, in spite of what its critics are saying. You can’t have 11 profitable quarters in a row without some degree of savvy. 

Here’s what Unum Provident is doing well…  Read the rest of this entry »