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TRIALS AND TRIBULATIONS

U.S. Regulators Lag European Counterparts in Protecting Patients, Report Says

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

The U.S. Food and Drug Administration failed to protect people from dubious medicines and remove drugs approved in part on faulty trial data, says a new report published by ProPublica. Nearly 100 approvals for drugs, ranging from blood thinners to chemotherapeutics and painkillers, relied on falsified data from the contract research organization, Cetero Research, according to the publication. While the European Medicines Agency has recalled seven of the drugs, the FDA has done little to address the problem, according to ProPublica. Although the FDA asked the companies to repeat critical testing, two deadlines for those data have passed with no consequences. Many of the questionable drugs, nearly 80 percent of them generics, are still on the market and the FDA won’t reveal which ones they are. ProPublica identified five of the drugs: Temodar IV Injection from Merck, Torisel Injection from Pfizer, Lazanda Nasal spray from Archimedes Pharma, Generic Ibuprofen Gelatin Capsules from Banner Pharmacaps, and Generic Tramadol Extended-release capsules from Cipher Pharmaceuticals. Only Banner has satisfied the FDA requirement.

AbbVie, the prescription medicine spinoff of Abbott Laboratories, will lay off hundreds of employees in response to projected losses from competition for its cholesterol-lowering drugs by generics manufacturers. Generics for TriCor, Niaspan, and TriLipix, all prescribed to reduce triglycerides and elevate HDL-C, have either already entered the market or are expected to by the end of 2013. Employees and contract salespeople working with these drugs will be affected by the proposed layoffs. AbbVie has not officially announced the job losses, but in January 2013 chief financial officer William Chase projected 2013 and 2014 as “a time of transition for AbbVie.” Adelle Infante, an AbbVie spokeswoman, declined to comment to Bloomberg on the firings.

The first of more than a dozen lawsuits against California-based Intuitive Surgical went to trial this week in Washington state. The wife of a man who died following robotic surgery is suing the maker of the Da Vinci surgical system. The lawsuit indicates a tension between adequate physician training and aggressive marketing by Intuitive. In this particular case, a doctor chose to use the robot for a patient in a non-recommended class; the patient weighed 280 pounds and had a body mass index of 39, great enough to make him ineligible for robotic surgery according to the training Intuitive provided to the doctor. The lawsuit claims that aggressive marketing overpowered any training the doctor received. The lawyer for the widow, Richard Friedman, said that although Intuitive had a training program for its robot as a requirement of FDA approval, over time the training was “watered down,” allowing Intuitive to sell more units. The robots were used in more than 300,000 U.S. operations in 2011.

AstraZeneca’s new CEO, Pascal Soriot, may not receive the complete sign-on bonus originally promised to him by the company’s board of directors. Shareholders are upset at the $1.5 million portion of his offer package, described as compensation for having to forfeit a bonus from Roche when he left in October 2012. In particular, a pension group that owns 2 percent of AstraZeneca shares has sent a letter to its members asking them to oppose the remuneration report. Kieran Quinn, chairman of the Local Authority Pension Fund Forum, says the organization doesn’t agree that executives “be paid for performance they have not actually achieved. That means we will challenge such awards whenever we see them, and will advise voting against the company’s remuneration report.”

A committee of the European Medicines Agency placed restrictions on Protelos, the osteoporosis drug, in response to a review of safety data from clinical studies in 7,500 patients that showed an increased risk of heart attacks and other cardiovascular adverse side effects. These data, in combination with concerns from 2012 regarding blood clots and rare serious skin reactions, warranted the new restrictions. The EMA recommended that patients with heart disease, vascular disease or untreated hypertension discontinue the drug. The drug, which is not sold in the U.S., is prescribed to both men and women to reduce the risk of fracture and is effective since it has two mechanisms of action; it increases deposits of new bone cells, called osteoblasts, and also reduces the degradation and remodeling of bone by cells known as osteoclasts.



April 18, 2013
http://www.burrillreport.com/article-u_s_regulators_lag_european_counterparts_in_protecting_patients_report_says.html

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