The Burrill Report


The first person to be prosecuted by British regulators and convicted of violating the U.K.'s Good Laboratory Practice law was found guilty of manipulating results of experimental tests on animals to exaggerate the benefits of drugs under development. Steven Eaton, a former employee at the contract research organization Aptuit, selectively reported positive data from analysis on blood samples in order to ensure the assays appeared as if they were always working properly and that the experiments were always successful. The Medicines and Healthcare Products Regulatory agency ultimately found that the false results did not invalidate the preclinical safety studies involving drugs from companies such as AstraZeneca and Roche. However, Gerald Heddell, director of inspection, enforcement and standards at the agency, said “Mr. Eaton’s actions directly impacted the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. This conviction sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.” The falsifications were ongoing since 2003, prompting a review of several hundred safety studies.

OrbusNeich is expanding its lawsuit against device company Boston Scientific for patent infringement on its novel stent designs. The company alleges that six of Boston Scientific's coronary stent system lines violate two European patents held by OrbusNeich. In February, the company commenced patent infringement actions in Germany and The Netherlands against Boston Scientific and its distribution affiliates in those countries. The current lawsuit was filed in Ireland and in addition to seeking damages asks for an injunction to prevent Boston Scientific from manufacturing, marketing, selling, or even stocking products that infringe the patents in Ireland. Earlier this year the European Patent Office ruled in favor of OrbusNeich against Boston Scientific on one of the two patents covered by the current lawsuit.

Aeterna Zentaris will halt a late-stage trial of perifosine in combination with Velcade and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. An independent data safety monitoring board made the recommendation to stop the trial after no effect was detected in an interim analysis of efficacy and safety. No effect might have been predicted in this trial since the company also found no difference between perifosine and placebo groups in overall disease control or tumor response rate at one year post-treatment follow-up in a mid-stage trial in non-small cell lung cancer concluded in 2009. Perifosine is structurally similar to the lipids that make up the cell membrane, and when incorporated into the membrane has the potential to disrupt membrane organization and modify key signaling pathways necessary for cell growth. The company did not comment on existing development plans for the drug in breast cancer or neuroblastoma.

An investigation to uncover plagiarism in proposals funded by National Science Foundation in fiscal year 2011 revealed that 1 percent to 1.5 percent of the proposals had substantive plagiarism issues. The National Science Foundation’s Office of the Inspector General applied plagiarism detecting software to NSF's portfolio of roughly 8,000 awards made in FY2011 and the analysis tagged approximately 1,000 proposals. James Kroll, head of administrative investigations within the Inspector General's office, now says his group is busy investigating nearly 100 cases of suspected plagiarism drawn from that one year's worth of proposals funded by the agency. In a 2005 pilot study of nearly 1,000 pending proposals, the NSF Inspector General found that roughly 2.5 percent contained “significant amounts of unattributed text,” NSF’s code words for plagiarism. In testimony before the House of Representatives science committee on February 28, NSF Inspector General Allison Lerner said, "extrapolating across the 45,000 proposals NSF receives annually suggests 1,300 proposals could contain plagiarism.” Plagiarism is one of three categories, together with fabrication and falsification, that federal research agencies label as research misconduct.

Baxter notified Puerto Rico government officials that beginning this summer it plans to lay off workers at its Aibonito, Peurto Rico facility. According to Puerto Rico Industrial Development executive Antonio Medina Comas, the manufacturing site for injectable drugs will not close and Baxter plans to invest $35 million more between that site and a second site in order to create a new production line for the manufacture and packing of intravenous solutions. “This isn’t a closure,” Medina said. “As part of its more than 50 year commitment to Puerto Rico, Baxter’s new operations in Aibonito require more advanced, automated technology.” Baxter Puerto Rico has been in operation since 1958 and has nearly 4,000 employees on the island, divided among five sites.

A federal jury ordered Illumina $96 million to Syntrix Biosystems for damages resulting from a patent infringement. A Washington state federal jury agreed with Syntrix in their allegation that Illumina’s BeadChip products for microarray analysis of RNA and DNA infringe on its patents. The district court judge did not, however, agree that the infringement was willful nor that Illumina misappropriated Syntrix's trade secrets. "We strongly disagree with this verdict and plan to appeal the present finding of infringement,” said Illumina president and CEO Jay Flatley. “We will continue to sell the products that are the subject of this suit and no damages will be payable to Syntrix until all appropriate appeals have been taken, which may take a number of years.” Illumina asserts that their BeadChip products are based on technology licensed from Tufts University when the company was founded in 1998.


March 15, 2013
http://www.burrillreport.com/article-u_k_regulator_finds_man_guilty_of_falsifying_preclinical_data.html