Heartburn that gives you lawsuits

So what does heartburn have to do with diabetes? Funny you should ask. Big Pharma giant AstraZeneca is being sued by 15,000 people who claim that their atypical antipsychotic, Seroquel, causes diabetes. Seroquel is approved for bipolar disorder, but unless there are a lot more people with bipolar disorder than we know, it is clearly being use off label because it is AstraZeneca's second best selling drug. What's the best seller, at least for now? The heartburn/ulcer drug, Nexium:

Seroquel, used to treat bipolar disorder, brought in $4.03 billion last year, making it AstraZeneca's second-biggest seller after its ulcer treatment Nexium. The company is trying to broaden the medicine's use to offset revenue lost as pricing pressure in the U.S. reduces demand for Nexium. (Joe Schneider and Margaret Cronin Fisk, Bloomberg)

The implication that the atypical antipsychotic agents (not just AstraZeneca's) increased risks of diabetes was strong enough that the FDA required the makers of these drugs to warn doctors as long ago as 2003. The claimants allege that the drug makers knew about the risk much before that but failed to disclose it to doctors and patients. Why kill a Golden Goose, right?

Whenever the subject of consumer lawsuits against drug companies comes up we start hearing the same talking points about "frivolous lawsuits," greedy trial lawyers and "junk science." The truth is, however, that all personal injury claims, of all sorts including traffic accidents, account for only about 10% of civil litigation. Most cases are plain old business cases where one company is suing another over some contract dispute or similar business issue. The all-time champions of frivolous lawsuits are the recording and movie industries, who don't even bother to verify accurate identities of those they accuse of "stealing" from them. Greedy trial lawyers. There is no denying that there are greedy and sometimes dishonest people in any profession, but trial lawyers at least take a risk when they work. The corporate defense lawyers make their $500 an hour with no risk at all. They get their dough, win or lose. And since they are being paid by the hour (unlike trial lawyers), they have every incentive to drag out the proceedings in red tape and baseless legal proceedings. "Junk science"? That's just science the corporations don't like. In this case, one of AstraZeneca's own scientists, Global Safety Officer Wayner Geller, wrote in an internal review of the matter that there was "reasonable evidence to suggest Seroquel therapy can cause" diabetes or related disorders.

With the Bush administration FDA overseeing and regulating drug safety in the same fashion as the Bushies regulated the financial industry, civil claims become the only form of redress and behavior modification for the bad behavior of corporations whose motive is to make up for loss of revenue caused by increased competition for their heartburn drug. These "frivolous lawsuits" protect us all.

Which I presume is the reason Big Pharma has put so much effort into making it legally difficult or impossible to sue them.

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Alison Bass directs our attention to the tragic story of Denis Maltez, a 12-year-old Miami boy who died of serotonin syndrome after being given two anti-psychotic medications (Seroquel and Zyprexa) plus an anti-seizure drug and tranquilizer. Serotonin syndrome occurs when a combination of drugs…

One of my new patients developed depression and anxiety after repeated surgery for breast cancer. She's on Effexor and Abilify-the manufacturer is pushing Abilify as a sort of enhancer for antidepressants. I didn't know her before her surgeries and can't decide if her admitted memory loss and objective 'spaciness' (I'm blocking on a more professional term) is a result of the surgeries, the subsequent chemo, or the drugs. And it's going to take time to work out b/c the behavioral health branch of her insurance is billing her for thousands of dollars of "out of network" therapy and she's afraid to see a therapist or change psychopharmacologists (and don't start me on that one). She's put on weight due to the atypical antipsychotic and I'll bet her blood sugar will be high when I get her labs back. OK, if you have a psychosis, and nothing else works, maybe you need an Abilify or Seroquel. But using these drugs for depression just compounds many patients' problems.

My 81.5-year-old father has expressive aphasia (from a hemorrhagic stroke a year ago) on top of fairly significant dementia (multi-infarct, not Alzheimer's) and anterograde amnesia. He has also been frequently agitated, even combative, in institutional settings. Now he's being cared for at home, with round-the-clock aides. A very long list of anti-seizure or anti-psychotic drugs were tried, without success, to limit or eliminate the violent agitation. Now he is on Seroquel (his blood glucose is being monitored regularly). The Seroquel is the only drug that has worked. The press and web reports of lawsuits and side effects, has, on the whole, not been helpful (not that I'd advocate censorship), because my sisters read such reports, freak out, and decide that my father's meds must be changed -- again.

Jeff: I understand your dilemma. Powerful drugs almost always have side effects and it is important to know what they are. Medical therapies with drugs are inherently balancing acts, where there are trade-offs that have to be made, so to find the right balance for an individual requires complete information. Regarding the negative publicity of the lawsuits, I'd point out that if there hadn't been a cover-up there would be o lawsuits and no negative publicity. This would just have been another known side effect, like the many disclosed ones the drug has and that aren't the subject of lawsuits or publicity. But the pressure to extend the use of this drug beyond those cases where the balance is favorable for the patient (like your father) produced the lawsuits, which are really about a cover-up.

A little Nexium anecdote:

I was at a client site which is a doctors' office (working on their phone system) and there was a drug company rep on site.

The drug company rep offered me a coupon for a free supply of Nexium. Without even knowing me.

I don't even have heartburn.

And Nexium isn't even a happy-pill, though you'd think otherwise from their ads.

Yes, this really happened.

I suffer from bipolarism and PTSD. Long story short as soon as I started researching my own treatment options after 20 years of MD's DO's PhD's etc. I found what works for me, at least better than I ever was. No where near perfect but survivable.

The problem still remains that I have to answer to SSA and Medicare. So now the next issue is when do they cut my benefits because I don't follow the rules laid down by insurance and the DSM IV. What works for me I found through a willing GP after hours of research and years of hell. Imagine that.

Seroquel is just another thorn. Trust your mind and soul: they still work if you go deep enough to listen to yourself.