we don’t need it…

Posted on Monday 30 August 2010

Maybe this is why this blog is called 1boringoldman. I get stuck on topics. I’m currently stuck on  the drug Seroquel, "the fifth best-selling drug in the world" and "the VA’s second-biggest prescription drug expenditure since 2007"…
Questions loom over drug given to sleepless vets
Associated Press

WASHINGTON — Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel. Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department’s top drug expenditures and the No. 5 best-selling drug in the nation. Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug’s risks. They want Congress to investigate…

It’s unclear how many soldiers have died while taking Seroquel, or if the drug definitely contributed to the deaths. White has confirmed at least a half-dozen deaths among soldiers on Seroquel, and he believes there may be many others. Spending for Seroquel by the government’s military medical systems has increased more than sevenfold since the start of the war in Afghanistan in 2001, according to documents obtained by The Associated Press under the Freedom of Information Act. That by far outpaces the growth in personnel who have gone through the system in that time…

But the drug’s potential side effects, including diabetes, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits. While on Seroquel, White gained 40 pounds and experienced slurred speech, disorientation and tremors — all known side effects…

The VA’s spending on Seroquel has increased more than 770 percent since 2001. In that same time frame, the number of patients covered by the VA increased just 34 percent. Seroquel has been the VA’s second-biggest prescription drug expenditure since 2007, behind the blood-thinner Plavix. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001. Spending on Seroquel by the Department of Defense, has increased nearly 700 percent since 2001, to $8.6 million last year, according to purchase records

The only published study on use of Seroquel for PTSD-related insomnia involved just 20 patients who were followed for six weeks at a VA medical center in South Carolina. The study, which showed moderate improvement in sleep, was funded by AstraZeneca at the request of VA psychiatrist Dr. Mark Hamner, who has studied the use of Seroquel for PTSD. In his written conclusion, published in 2003, Hamner urged caution in interpreting the results because of the study’s small size and short duration…

The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $4.2 billion last year. But that success has been marred by allegations that the company illegally marketed the drug and minimized its risks. AstraZeneca agreed to pay $520 million in April to settle federal allegations that its salespeople pitched Seroquel for numerous off-label uses, including insomnia. Pharmaceutical companies are prohibited from marketing drugs for unapproved uses. AstraZeneca also faces an estimated 10,000 product liability lawsuits, most alleging that Seroquel caused diabetes…

AstraZeneca Pays $198M To Settle US Seroquel Claims
Wall Street Journal

By Simon Zekaria
August 9, 2010
LONDON (Dow Jones)–U.K. pharmaceutical group AstraZeneca PLC (AZN.LN) said Monday it has reached a $198 million settlement over claims regarding its best-selling antipsychotic drug Seroquel in the U.S. AstraZeneca has faced thousands of product-liability lawsuits alleging that the use of Seroquel caused diabetes and other injuries, and that the company failed to adequately warn of the drug’s risks. The group has also faced long-running allegations it improperly promoted the drug, which is approved to treat schizophrenia, bipolar disorder and depression.

The settlement relates to 17,500 product liability claims, and the company said the mediation process over claims is ongoing in both federal and state jurisdictions. "We remain committed to a strong defense effort, but will also continue to participate in good faith in court-ordered mediation," the company said in a statement.

Federal prosecutors and authorities from several U.S. states have been probing allegations AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. In April, the company announced a settlement of $520 million with the U.S. Justice Department over the matter. Astrazeneca Monday said that, as of June 29, approximately 2,900 additional claims had been dismissed by order or agreement.

In March, the company said it would not appeal a preliminary ruling by a British regulatory panel, the Prescription Medicines Code of Practice Authority, that found the drug maker failed to accurately reflect side-effects of Seroquel in an advertisement to doctors, published in 2004. AstraZeneca reported global Seroquel sales of $4.9 billion last year, and drug-data tracker IMS Health ranked it as the fifth best-selling drug in the world. At 0759 GMT, AstraZeneca shares rose 25 pence, or 0.8%, to 3280 pence, valuing the company at GBP47.64 billion.

Analysts said the settlement figure is small. "If you look at the settlement (value) per patient, it is very low compared to what is typical for this industry," Matrix Corporate Capital analyst Navid Malik said. Malik also said it is difficult for patients to prove liability, which is positive news for the stock. Shore Capital analysts said that "while there may be additional outstanding liability claims in other geographies … the agreement in principle today confirms the limited nature of any financial exposure." The company said its core earnings per share guidance for 2010 remains unchanged at a range of $6.35 to $6.65. AstraZeneca posted global revenues of $32.8 billion in 2009.
Settlements of $198,000,000 or $520,000,000? Small potatoes when you’re bringing in $4,900,000,000 a year. As the financial analysts say, "If you look at the settlement [value] per patient, it is very low compared to what is typical for this industry", "it is difficult for patients to prove liability, which is positive news for the stock" , and "while there may be additional outstanding liability claims in other geographies … the agreement in principle today confirms the limited nature of any financial exposure." That is a sad testimonial on the pharmaceutical industry deserving further comment. And yet David Brennan, AstraZeneca’s Chief Executive Officer says on their website:

As we navigate our business through the challenging times ahead, I am determined that we will not lose sight of our commitment to doing the right thing, not the easy thing. We will continue to focus on delivering enduring value for our stakeholders and society through both what we do and how we do it.

Here are the facts as I know them:
  • There is no real reason for Seroquel to be on the market at all that I can see. It is primarily an atypical antipsychotic drug introduced for the treatment of Schizophrenia. It is less effective than the drugs it was purported to replace in that condition. In many ways, it is more toxic than the drugs it was supposed to replace. It’s other uses are either fabricated or simply because it is anxiotytic. We have more than enough anxiolytic drugs.It has no real niche.
  • Besides being no more effective than the alternatives, it is much more expensive. This is no time for us to be driving up the cost of medicine.
  • For any psychiatric drug, particularly this one, to be "the fifth best-selling drug in the world" is absolutely absurd. If people don’t like how life feels and we’re going to go along with that, legalize marijuana – it’s safer and a lot cheaper.
  • By any report, AstraZeneca is near the top for bogus stunts in marketing, and that’s saying a lot in light of the overall corruption in the psycho-pharmaceutical industry [see this particularly clear summary of stunts].
If David Brennan  wants to do "the right thing, not the easy thing" he should simply take the drug off the market. We don’t need it. And it hurts lots of people, apparently killing some…

Further Thoughts: I suppose that the other alternative would be for AstraZeneca to stop fighting to hold on to their patent protecting and allow Seroquel to join the ranks of the "generics." Without all the hype and marketing, will Seroquel find a place in the therapeutic pantheon, or just dribble away?
    August 30, 2010 | 11:37 PM

    I’m as stuck as you are on Seroquel, and the way I see it, is until they stop giving me something to write about, then I’ll change topics. It just keeps on coming, the scandals, the deaths. The Carl Elliott story brought Dan Markingson’s death back to discussion, a by product of the CAFE trial. His mom is leaving comments on my blog, where I wrote about current Seroquel XR trial happening at UMN by the same doc, the same sponsor. (AstraZeneca) and the drug is going up agains placebo…not a real reason to trial it for BPD or blushing, menopausal depression, anorexia, etc unless it’s for corportate profit.

    Thanks for the posts, great to see.

    August 31, 2010 | 9:51 AM

    Every single thing I’ve heard directly from wounded warriors and the medication that is tossed at them substantiates your observations. Everything one hears, sees and reads about the practices and current status of mental health professions in the military is bad. I wonder how it is even possible for the “volunteer” force to pull it off with anything close to efficacious clinical practice. I can envision the value of front lines tactical counseling, tactical emotional processing…that sort of thing. After that…? Where in the hell is your APA in all this? Don’t they have a leadership role to play in helping a greviously hobbled system get it as right as possible?
    The VA statistic you cite is an abomination, a cop out, a symptom itself of a system that simply does not work, a bureaucracy all-too-willing to drink the silver-bullet flavor Kool Aid advanced by bonehead practitioners like your favorite Charlie. It’s discouraging frankly.

    August 31, 2010 | 2:54 PM

    I love your word, “Pharmatrocities ” at the Carlat blog. That is exactly what this is. My daughter was given 800mg of Seroquel in 2006 by a chief of staff at a prestigious children’s hospital and she went completely psychotic, was awake for 10 days, locked down as a result, and after nurses and I demanded the doctor stop giving it to her, he said “I have no idea why I couldn’t help your daughter”. That was the pharmatrocity that happened to her (she was only 18 and is autistic spectrum)–the drugs gave her symptoms, and psychosis and doctors will not listen to that as a side effect. They only acknowledge weight gain and diabetes, of all things. This drug is a menace to society at needs to be removed from the market.

    It is a known street abusable drug, snorted and abused by prisoners, it is being marketed to dozens of new dx just in time for the DSM5 to arrive w all of those new “expanded” labels for drug patent extension use.

    AstraZeneca has proven to be “too big to punish” by the DOJ, the company has committed a crime, an assault on children and adults via the corrupt and unethical marketing of Seroquel.

    August 31, 2010 | 3:01 PM

    AZ already won in court against TEVA for generic, they prevented it from going generic in 2011, extended it to 2012. The push for their Seroquel XR approvals via placebo studies is their last part of the grand marketing scheme. The billion dollar wonder drug that will end up doing more harm to more people of all ages than any other antipsychotic in the world. Great marketing job AZ.

    September 1, 2010 | 6:11 AM

    “Where in the hell is your APA in all this?”

    You know what? That’s a great question. I’m a bit embarassed I didn’t think of it myself. I guess that says something about how I feel about the APA [the outgoing president of the APA is Alan Schatzberg, coauthor of a psychopharmacology textbook with you-know-who Charles Nemeroff]. But the APA should be carrying a torch. I’ll look into it. Tonight, I listened to Obama’s speech. He was clear about our obligations to our military and I thought he meant it, but I don’t think he had Seroquel soup in mind.

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