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From the News Editor
Big Drama for Big Pharma
 Several major pharmaceutical companies have become the target of various civil suits this week—the effects of which can be financially crippling. While the verdict is still out on the U.S. Supreme Court’s decision in Warner-Lambert (now Pfizer) v. Kent, which could protect FDA-approved drugs from state product liability lawsuits, the lawsuits continue to mount and the lawyer fees continue to rack up. Many of these cases attempt to prove these companies wanted to keep moneymaking drugs on the market despite evidence that they perhaps shouldn’t have, by establishing at what point they learned of their product’s adverse events.
In the California Superior Court, a wrongful death suit has been filed against GlaxoSmithKline, charging that the troubled diabetes drug Avandia led to heart attacks, congestive heart failure and other fatal cardiovascular events in seven individuals.
Falling quickly on the heels of an updated FDA warning for the injectable diabetes drug Byetta, a Virginia man filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the drug against manufacturer Amylin Pharmaceuticals and its co-marketer, Eli Lilly.
While Actavis is tied up in a recall of all drugs manufactured at its New Jersey plant, law firms are seeking plaintiffs to join a class-action suit against the company over its recently recalled heart failure drug Digitek.
Such costly endeavors have led the pharma companies to seek industry partners. This week, AstraZeneca, which recently settled a legal fight over its stomach ulcer medicine Nexium, inked a co-promotional deal with Abbott Labs for Crestor.
On the clinical side of pharmaceuticals, the phase III results of the TRITON-TIMI trial were published today, indicating that prasugrel continues to outperform Plavix in reducing cardiovascular events in post-PCI patients. The FDA has given prasugrel an action date of Sept. 26.
Also, two studies stand out in this week’s cardiology-specific issue of Lancet. The ON-TIME trial found that giving heart attack patients a high-dose of the anti-clotting drug tirofiban in the ambulance before they reach the hospital improves their clinical outcome, reinforcing the importance of first medical contact. Another trial, ON-TARGET, revealed that the combination of ramipril and telmisartan worsens major renal outcomes overall, despite a reduction in proteinuria as a monotherapy in patients at high vascular risk.
On these topics, or any others, please feel free to contact me.
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Justine Cadet, News Editor
jcadet@cardiovascularbusiness.com |
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| Top Stories |
Vioxx ADVANTAGE trial revealed as a marketing scheme; docs prepped for media
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GlaxoSmithKline, McKesson sued over Avandia ‘wrongful deaths’
 A wrongful death suit has been filed in California Superior Court against GlaxoSmithKline, SmithKline Beecham and McKesson, charging that Avandia, prescribed for type 2 diabetes, led to heart attacks, congestive heart failure and other fatal cardiovascular events in seven individuals. |
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Lawsuit filed on heels of updated warning for diabetes drug
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FDA inspection spurs recall for troubled Actavis
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Industry News
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The American Heart Association (AHA) issued a scientific statement Aug. 13, stating that their guidelines now recommend that paramedics perform and evaluate a prehospital ECG routinely on patients with chest pain suspected of having STEMI.
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ACS: Fully synthetic heparin could be available in five years
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Medicare P4P initiative nets $17M results, better CV care
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Virtual hearts help cardiologists plan treatment
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Financial News
Cardiovascular sales boost Medtronic Q1 income
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Usage of ultrasound contrast agents in echoes declines sharply
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Abiomed to offer 2.4M shares of common stock
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Clinical Studies
EHJ: Prasugrel outperforms Plavix in reducing CV events, bleeding hard to gauge
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Radiology: Ultrasound technique spots high-risk vulnerable plaques in carotids
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Lancet: Tirofiban administered en route to hospital helps MI patients
Giving heart attack patients a high-dose of the anti-clotting drug tirofiban in the ambulance before they reach the hospital improves their clinical outcome, according to the On-TIME trial published in the Aug. 19 cardiology special issue of The Lancet.
Lancet: Dual angiotensin blockade may harm kidneys
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AIM: Appropriateness criteria can assess which patients require angiography
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New Releases
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Regulatory News
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ATS Medical nets CE Mark, ISO for cardiac ablation products
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Partnerships & Alliances
AstraZeneca, Abbott ink co-promotion Crestor deal
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Axela teams with John Hopkins for cardiac research
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Contracts & Installations
NASA blasts Physio-Control AED into outer space
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Association News
New ACC educational alliance addresses healthcare disparities
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Executive Announcement
Renz joins NewCardio as president
Vincent W. Renz has joined NewCardio, a cardiac diagnostic and services company, as its president. |
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