{"id":49606,"date":"2014-09-11T09:49:44","date_gmt":"2014-09-11T13:49:44","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=49606"},"modified":"2014-09-11T10:19:02","modified_gmt":"2014-09-11T14:19:02","slug":"in-need-of-another-british-invasion","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/09\/11\/in-need-of-another-british-invasion\/","title":{"rendered":"in need of another British Invasion<\/em>…"},"content":{"rendered":"
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UK Agency Will Ask Regulators for Trial Data if Drug Makers Refuse<\/a> <\/div>\n
Pharmalot: WSJ<\/font><\/strong><\/div>\n
by Ed Silverman<\/div>\n
September 11, 2014<\/div>\n

In yet another sign of frustration with drug makers that do not release clinical trial data, the U.K. agency that is responsible for recommending coverage of medicines will ask European regulators for data if companies refuse to do so. The U.K.’s National Institute for Health and Care Excellence issued a statement yesterday calling for increased transparency from the pharmaceutical industry, which has often resisted calls to release some data over concerns that trade secrets and patient confidentiality may be breached.<\/p>\n

Some drug makers, however, have recently taken steps to release data and make the information available to researchers. GlaxoSmithKline, in particular, has tried to lead this effort in the wake of a $3 billion settlement with U.S. authorities that was paid, in part, over allegations that some trial data was never disclosed. “We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information in hand to help them do so safety and efficiently,” Carole Longson, the director of the Health Technology Evaluation Center at NICE, says in a statement<\/a>. In explaining its decision, NICE pointed to a recent controversy surrounding Roche and its battle with researchers, who accused the drug maker of refusing to release data about its Tamiflu medication. The researchers from the Cochrane Collaboration subsequently released a study showing the treatment was not proven to reduce the spread of the flu or its complications. Roche later called the analysis “seriously flawed<\/a>” and has since agreed to provide greater disclosure.<\/div>\n<\/blockquote>\n
The persistence of Peter Doshi, Tom Jefferson, and the Cochrane Collaboration in their quest for the Tamiflu data, the BMJ’s campaign in that fight, the AllTrials petition, and Fiona Godlee’s and Ben Goldacre’s appearances in Parliamentary hearings have apparently had an solid impact on the British government – now stepping up to the plate for data transparency. <\/div>\n
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NICE has actually been in favor of full disclosure for some time and, in fact, is one of the supporters of the AllTrials campaign, which was created last year to pressure drug makers for greater disclosure. The effort came about in response to the Tamiflu flap. The agency notes that, so far, nearly 80,000 people and 507 organizations have signed the AllTrials petition calling for increased trial data disclosure. Whether NICE would obtain the kind of data from regulators the agency imagines is uncertain. Next month, the European Medicines Agency is expected to release a policy<\/a> on trial data disclosure, but the regulator has been accused of back pedaling on its commitment to transparency in the wake of settling a pair of court actions with drug makers that attempted to prevent the EMA from releasing data about certain drugs. As we have reported previously, European Ombudsman Emily O’Reilly claimed the EMA revised its policy in order to adhere to “the wishes” of the pharmaceutical industry and is now reviewing redacted records from those court cases – which involved AbbVie and InterMune – for clues to the EMA change in policy.<\/div>\n<\/blockquote>\n
While those suits from AbbVie and InterMune are still discussed as if they represent the actions of two individual companies, that’s not altogether correct. Remember the leaked memo from a year ago [appended to the end of this post]. Those suits were part of an industry-wide initiative that seems to have become something of a lead balloon<\/em>. At least in my case, they made me aware that the whole idea that the data from the pharmaceutical clinical trials were their proprietary property was not based on any particular law or decision. It was more something they had seized, but treated as if it were in the Magna Carta. Their arguments about Commercially Confidential Information and Patient Confidentiality began to melt and the tide began to turn. And as things are playing out, the EMA "U turn" seems to have thrown gasoline on the fire rather than put it out [see a crushing setback…<\/a>, repeal the proprietary data act…<\/a>, except where necessary to protect the public…<\/a>]. <\/div>\n
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NICE is not alone in seeking greater transparency. A recent survey<\/a> found that an overwhelming number of members of the Royal College of Physicians in the U.K. also believe that such information should be disclosed and accessible. To wit, 81% agreed that drug makers have a moral duty to make completed data available to trial participants, the public and the scientific community. “My personal view on this is I can see no reason whatsoever not to publish all the data, and I think there’s a moral imperative from the point of view of the patients who’ve been part of the trials that their time, their effort shouldn’t be ignored,” NICE chair David Haslam told the U.K. House of Commons last week, according to NICE. “I think everything should be in the public domain.” As part of new guidelines<\/a> for product reviews, he noted that NICE has strengthened procedures to ensure that medical directors from drug makers sign a declaration when they make submission to the agency and declare they have identified all clinical trial data.<\/div>\n<\/blockquote>\n
And as I noted in in praise of anonymous, contactable members of the public<\/em>…<\/a>, the actions of the ABPI [the British PhRMA] are pretty surprising [and welcomed]: <\/div>\n
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A spokesman for the Association for the British Pharmaceutical Industry sent us this: <\/div>\n