Articles Posted in AstraZeneca

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womanNexium, or esomeprazole, is a drug that is used to treat heartburn and excessive amounts of acid in the stomach. Specifically, it is used to treat duodenal and gastric ulcers, esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Other drugs that are in the same class as Nexium include Prevacid and Prilosec. Approximately 15 million Americans use PPIs that are sold both as prescription and over-the-counter.  Nexium sales exceed $3 billion a year.

Nexium is a controversial drug.  At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks.  We believed many of these cases were meritorious.  But the litigation did not get very far.

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Our attorneys are investigating potential lawsuits involving Crestor and its possible side effects. There are two types of Crestor cases in particular that have gained the interest of many mass tort lawyers: Crestor induced cardiomyopathy and Crestor induced diabetes.

Crestor is a statin that treats dyslipidemia. Crestor is intended – and probably does – reduce “bad” cholesterol while increasing “good” cholesterol. But Crestor lawsuits allege that Crestor can cause cardiovascular injuries leading to cardiomyopathy and diabetes.

As if that was not problem enough, rhabdomyolysis has also been linked to Crestor which may lead Crestor patients to suffer kidney injuries.

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According to a new study in Cancer published Monday, tamoxifen (Nolvadex, Istubal, and Valodex) may prevent breast cancer in women who are at risk. The study found that tamoxifen, which reportedly causes only minor sides for most patients, may prevent 29 breast cancer cases and nine breast cancer deaths for every 1,000 women.
AstraZeneca has gotten a lot of heat on this blog and elsewhere from drug injury lawyers. But this may be one where they deserve a lot of credit (even if they bought the company that developed the drug).

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We’ve been getting a lot of questions over the past few days about Seroquel. That usually means I need to put up a new post, especially in light of recent events.

Earlier this week, AstraZeneca (the manufacturer of Seroquel) agreed to pay $520 million to settle a federal inquiry into Seroquel marketing practices. As we have stated before, Seroquel is approved to treat schizophrenia and bipolar disorder. However, investigators and plaintiffs believe that AstraZeneca marketed the drug for myriad other unapproved uses, including depression, obsessive-compulsive disorder, dementia, and post-traumatic stress disorder.

whistle.jpgThere are no criminal charges associated with the deal. Giving credence to plaintiffs’ claims (aside from the credibility arising from the mere fact of a whopping large settlement), is that federal investigators got much of their information from AstraZeneca whistleblowers, drug sales rep, James Wetta (who had some involvement in the whistleblowing at Eli Lilly around 2003).

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This is something every blog must struggle with. What voice should the blog have? First-person (or the blogger variant–the royal first-person, where everything is about “we” and “us,” though the blog is written by one person), or third-person?

SciFi.jpgCorporations frequently choose a corporate voice, making everything about the corporation. The voice of the blog is often the “voice” of the corporation (corporations are legal entities with rights, of course). But, this can be tough to read sometimes, and still manages to lose the personal flair of a first-person narrative.

So, when my Google Reader blog-feed listed AstraZeneca’s recent post, “Connections for Cardiovascular Health,” I was interested to see that they are gravitating toward a first-person voice. The side panel shows that the main contributor and “voice” is Earl Whipple, the blog editor and senior director in the AZ corporate communications group. The sidebar mentioned that others would contribute (the CEO had a post on March 23), but perusing the posts, it looks like Earl is the only contributor except for occasional guests.

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The Seroquel cases are not going well for plaintiffs.

On April 6, the Eleventh Circuit Court of Appeals affirmed the summary judgment ruling of the Massachusetts federal trial court in a Seroquel case. The plaintiff alleged that Seroquel caused her to gain weight and develop diabetes, but at the trial level (and affirmed on appeal), she lost her specific causation expert on a Daubert ruling. The trial record showed that the excluded expert did not have sufficient medical history upon which to base her conclusions—at deposition, she lost points by not knowing the full history of plaintiff’s weight gain and loss. The Court stated:

In fact, Guinn’s weight fluctuated before, during, and after her use of Seroquel, with her highest recorded weight during each period being roughly equivalent. Guinn also had a sedentary lifestyle, a poor diet, a significant family history of diabetes, hypertension, hyperlipidemia, schizophrenia, and prediabetes, all of which, in addition to her age of 61, put her at an increased risk for developing diabetes.

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Drug Recall Lawyer Blog Round-Up (03-22-10)

Here are this week’s stories:

  • Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
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To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com.

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Seroquel%20Logo-03-10-10%29.gifThe New Jersey Superior Court Case (Middlesex County) of Baker v. AstraZeneca Pharmaceuticals LP is now focusing on the drug manufacturer’s advertising strategy. The plaintiff in that case is alleging that he should have been better warned about the risks for weight gain and developing diabetes.

On the plaintiff’s side is Dr. Wayne Geller, a former AstraZeneca employee—a global safety officer—who testified that the company rebuffed his efforts to strengthen internal documents describing the weight gain issue. He testified that “I found out there were people from the commercial side” who opposed the changes. This is another indication of marketing trumping. AstraZeneca is defending the case, noting that it adequately warned about the risk of diabetes, and that Seroquel doesn’t cause diabetes, anyway. They rely on several studies that showed favorable data, but other reports show average weight gain for users on Seroquel is 27 pounds.

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AZ%20Social%20Media-03-02-10%29.JPGUp until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).
Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

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