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News
Reanalysis of Old Study Results Shows Striking News
The primary objective of reanalyzing SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001) was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomized controlled trial would have clinically relevant implications for evidence-based medicine.
Neither paroxetine nor high-dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harm with both drugs, including suicidal ideation and behavior and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.
The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigor of the evidence base.
http://www.bmj.com/content/351/bmj.h4320
FDA Warns Pfizer Chinese JV Partner Zhejiang Hisun Pharma
The Chinese half of a Pfizer joint venture has found itself crosswise with the FDA, which has banned products from one of its plants and written it up in a warning letter. According to a translated version of the announcement, China's Zhejiang Hisun Pharma said that during a March visit FDA inspectors found a "lack of integrity" at the plant and cited 29 products for which it had not received prior approval to ship to the U.S. The ban encompasses 15 products but excludes the tuberculosis treatment capreomycin and 14 others.
http://www.reuters.com/article/2015/09/11/idUSL4N11H3AM20150911
FDA Castigates Indian Drugmaker over Mess
If the holes in the ceiling and walls allowing pigeons to fly around manufacturing equipment at India's Pan Drugs were not enough to warrant an FDA warning letter, then the fact that it also was not thoroughly testing its APIs did the trick.
During the most recent inspection, FDA inspectors said that the plant was in disrepair, with holes and gaps that not only allowed the pigeons to fly in but also allowed other contaminants into manufacturing areas. Equipment was rusty and dirty and had lubrication leaks and there was exposed insulation material around manufacturing lines.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/
ucm462075.htm
FDA Bans Still Another Indian Drug Plant Over Quality
The FDA has banned imports from another India-based drug manufacturing plant over quality-control concerns, making it the 10th site in the country this year to face such action. This action involves the Mumbai-based Polydrug Laboratories manufacturing plant, and it comes two months after Canada banned the same site, citing data integrity issues.
This FDA action comes less than two weeks after Svizera Labs, a major Indian supplier of tuberculosis drugs to developing countries, was criticized by the World Health Organization for inadequate manufacturing standards and poor testing procedures.
The ban on Polydrug takes the total number of Indian drug manufacturing facilities that currently stand barred from exporting to the U.S. to 44 between 2011 and now, according to the FDA website.
http://www.reuters.com/article/2015/09/14/us-polydrug-india-drug-idUSKCN0RE1NY20150914
Brooklyn Target Store Workers Vote to Join Union
Pharmacy workers at a Brooklyn Target have voted to unionize, the first time in the retailer's history that its workers have decided to join a labor union. Target had argued against the vote, saying it shouldn't have been allowed given the pending sale of the company's pharmacy business to CVS. Target plans to appeal the NLRB's decision.
The Brooklyn employees decided to pursue a union vote after CVS agreed to buy Target's pharmacy business, according to a pharmacy employee at the location. Staffers were worried about potential layoffs, reductions in their hourly wages, or other labor changes after the CVS deal, the employee said. "We were all happy with our jobs at Target. That wasn't the problem. It's more that we didn't like being thrown into uncertainty," said the employee.
http://www.wsj.com/articles/target-workers-at-brooklyn-store-vote-to-join-union-1442445420?cb=logged0.8109348749972611
Califorinia Proposed State Law Could Require 5 Languages for Labels/Instructions
A bill awaiting the governor's signature would mandate six language choices at all pharmacies in California. California's pharmacists would be required to provide prescription drug labels or medication instructions in five languages besides English under a bill passed unanimously Thursday by California lawmakers.
The bill would take effect January 1 if signed into law. The measure would make California the second state in the nation, after New York, to require pharmacists to provide non-English materials for patients to take home. New York's law only applies to pharmacy chains with eight or more stores, while California's would apply to all pharmacies regardless of size.
http://www.ocregister.com/articles/california-682764-english-medication.html
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