HipSaver: Diss Us and We'll Sue You

In an amazing and highly troubling move, HipSaver, a corporation that manufactures hip protection gear, is suing the authors of a study who had the temerity to write in their article: "These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents."

Though this is not my area of expertise, my loose familiarity with the research indicates that the above statement appears to be true. The study in question did not examine the HipSaver product, and the offending statement was made in the discussion section, where authors offer opinions about their findings.

HipSaver said that such claims are a slander upon the field of hip protectors. If we are going to start suing authors based on the discussion sections of their articles, then we may as well stop doing science immediately. Of course, much of what passes for science these days is iffy, so maybe nobody would notice if we just stopped doing clinical trials.

Read more at the WSJ Health Blog. Thanks to the reader who alerted me to this bizarre development.

Arkansas Unleashes The Razorbacks on Risperdal

As documented at Furious Seasons, the state of Arkansas has leveled some very serious allegations at Johnson & Johnson, manufacturer of Risperdal via its subsidiary Janssen. Furious Seasons was kind enough to post a copy of the lawsuit. Here's a partial listing of the allegations:

• J & J hid the extrapyramidal side effects of the medication through conducting scientifically bogus studies which covered up the risks of Risperdal
• J & J marketed Risperdal off-label for such conditions as ADHD, depression, anxiety, and aggression associated with dementia
  
• J & J falsely represented Risperdal as cheaper and more effective than older antipsychotics
• J & J did not represent their own knowledge that Risperdal is associated with weight gain
• J & J offered kickbacks to physicians to prescribe Risperdal for "non-medically necessary" uses

The lawsuit makes for interesting and inflammatory reading. Keep a couple of things in mind when considering these charges

• Zyprexa was clearly marketed off-label for various conditions (1, 2, 3)
  
• It seems that Lilly was involved in hiding the risks associated with Zyprexa (1, 2)
  
• Bristol-Myers Squibb just settled a large lawsuit, partially regarding claims that it promoted Abilify off-label
• Take a look at a couple studies (1, 2) that were designed to encourage off-label prescription of antipsychotics as well as a "scientific review" of relevant literature on antipsychotic off-label use.
• And of course, there are several states (I've lost count of exactly how many) that are suing Lilly for its promotion of Zyprexa and its alleged concealment of risks associated with the drug.
  

I don't know about you, but I think I'm seeing a pattern emerging here. And while we're talking about weight gain, diabetes and the like, I hope you all have a fantastic Thanksgiving.

The Zyprexa Whitewash

Furious Seasons has another tidbit from the Zyprexa documents. It involves the terms "diabetes" and "whitewash." You can read the internal Lilly document yourself at Furious Seasons and decide for yourself.

If you've been living in a cave for the past 10 months or so, here are some other features regarding the infamous Zyprexa documents:

• Zyprexa: Off-Label Promotion?
• Demented Marketing of Zyprexa?
• Zyprexa: The New Mood Stabilizer and Downplaying Risks
• Zyprexa: Off-Label Marketing Part 2

And then there is Abilify. Read Brandweek NRX's piece here. Oh, and Seroquel? Read here and here. The lawsuits will keep coming, and there will be large payouts. I'm not a fan of suing the pants off everyone, but if there is no other way to fight off-label marketing and other dubious promotion tactics, then so be it.

AstraZeneca: Sued Over Seroquel

Over 10,000 US patients have filed lawsuits against AstraZeneca, alleging that AZ hid dangers of its bestselling atypical antipsychotic quetiapine (Seroquel). The lawsuits allege that AZ was not forthcoming about side effects such as significant weight gain and diabetes. In addition, the lawsuits focus on Seroquel allegedly being promoted for unapproved uses, a point I have suspected (here and here) for a while on this site.

Here's some snippets from the latest story from Bloomberg:

AstraZeneca said in a preliminary annual report filed Feb. 1 that it knew of about 1,200 lawsuits containing the claims of about 8,000 plaintiffs. The company ``has not determined how many additional cases, if any, may have been filed,'' AstraZeneca said in the filing. The company said in May it faced 232 Seroquel suits, including those with multiple claims.

--SNIP--

Seroquel, approved for use for schizophrenia and bipolar disorder, is part of a class of newer antipsychotic drugs including Zyprexa and Johnson & Johnson's Risperdal. Seroquel passed Zyprexa last year as the top-selling atypical antipsychotic, [AZ spokesperson] Minnick said.

AstraZeneca has been sued by 9,956 individuals in U.S. courts over Seroquel, according to a Feb. 5 filing in federal court Orlando, Florida, where the lawsuits have been consolidated in a multidistrict litigation for evidence-gathering and pre- trial hearings.

This includes claims by 7,171 plaintiffs in federal courts, primarily. The claims are made in about 1,500 lawsuits, many of which have multiple plaintiffs.

The suits claim that AstraZeneca knew the risks of Seroquel and didn't warn patients in the U.S. ``until they were finally forced to do so by the FDA,'' according to a complaint filed in federal court in Massachusetts, on behalf of 997 plaintiffs.

--SNIP--

The growth in sales of the drug, from $66 million in 1998 to $2.75 billion in 2005, was spurred by ``AstraZeneca's aggressive marketing of Seroquel,'' according to these patients, whose cases have been transferred to federal court in Orlando.

The marketing ``consisted chiefly of overstating the drug's uses and benefits (including massive off-label promotion), while understating and consciously concealing its life-threatening side effects,'' their complaint said.

Lawyers representing Seroquel users have agreed to limit the claims filed to people who said they developed serious health problems after taking the drug, said attorney Paul Pennock, lead plaintiffs' counsel in the multi-district litigation.

``Everybody involved took a blood oath that we were only going to pursue cases where there was a real injury, like pancreatitis, diabetes or severe exacerbation of existing diabetes,'' said Pennock of Weitz & Luxenberg in New York. ``This was as opposed to the Zyprexa litigation where a lot of people took on all comers,'' he said.

Pennock represents more than 1,700 plaintiffs, about 67 percent of whom were prescribed the medication for off-label uses, including insomnia, depression, anxiety, post-traumatic stress disorder and Alzheimer's, he said.

I'll be keeping my eye on this one. Given that AZ has been studying Seroquel as a treatment for virtutally everything, I strongly expect they "educated" physicians about the results from these studies on conditions other than bipolar and schizophrenia (which have yielded, from what I've seen, not overly impressive results) via doctor dinners, journal article dissemination, continuing medical misinformation, er, education, and the like.