1 Boring Old Man

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
By MATTHEW PERRONE
08/31/2010

^{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.}

• 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].