out of my league…

Posted on Thursday 23 July 2015

By Ed Silverman

The investors, which collectively manage about $3.8 trillion, plan to meet with drug makers in which they invest to ensure that trials are registered and results are reported, according to Sile Lane, campaign director at Sense About Science, a non-profit that launched the AllTrials campaign. In an unprecedented move, a group of 85 asset managers and pension funds is teaming with a U.K. non-profit campaign to pressure drug makers to disclose clinical trial data. The effort is likely to escalate a closely watched battle that has increasingly placed the pharmaceutical industry on the defensive as researchers and regulators call for increased disclosure in the U.K. to agitate for greater trial data disclosure.

Drug makers will be asked to retrospectively register past and ongoing clinical trials, and register all future trials before they begin; publish methods and full results of all trials, include information on adverse events; post objective summary results within one year of completing a trial, and support efforts to provide independent researchers access to anonymized individual patient data, according to a statement. “We believe this is going to be game changing,” Lane tells us. To facilitate the process, the AllTrials campaign is conducting an audit of disclosure policies for the 50 largest drug makers and will score each one. The results are expected to be published in September. “This will become a tool readily available to investors,” she says.

The move comes amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. At issue is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better health and lower costs. Concerns have been heightened following various safety scandals that revealed trial data for some products was never fully published or disclosed. In recent months, regulators in the U.S. and Europe have responded by releasing new rules designed to widen access. And several drug makers, in varying degrees, have taken steps to release trial data.

For instance, GlaxoSmithKline created a website where data requests are made to 10 different drug makers, Johnson & Johnson is working with Yale University to provide access to data, and Bristol-Myers Squibb will grant access to academics as part of a collaboration with Duke University. AstraZeneca formed a panel to review requests for data, although questions were raised about its independence. But critics say such efforts are few and far between. Helena Vines Fiestas, who heads sustainability research at BNP Paribas, says there is increasing concern that a lack of transparency about medicines – past and present – is having a negative impact on stock valuations. BNP got involved as an outgrowth of a broader effort to rate and benchmark companies in different industry sectors.

For instance, she says fines paid by 21 drug makers for marketing malfeasance between 2007 and mid-2015 was $40 billion, and 43% was directly related to minimizing side effects that were identified during clinical trials but not properly reported. Her team also queried analysts and discovered that an average of about 30% of drug company stock valuations directly relate to results of Phase III clinical trials.

“The lack of complete and unbiased information can mislead decisions made not only regulators and doctors, but also investors,” Fiestas tells us. “We think if the companies become more transparent and take the issue around auditing and reports more seriously that the decisions made by analysts can be more closely aligned with reality”…
So if appeals to common sense and common decency move too slowly, where else to turn but to big money. It makes an odd kind of sense, but who’d have thought it? I suppose the next question is obvious, "But will the backing of the representatives of investors’ money bring the same corrupting influence that caused the problem in the first place?" Answering that is way out of my league, that’s one thing I’m sure of…
    July 23, 2015 | 8:52 PM

    It doesn’t seem entirely implausible. The Wall Street Journal’s editorial page is full of cranks, but their reporting (at least pre-Murdoch) is some of the best there is. And people pay for it. Why? Because they make or lose money on the basis of how good that information is.

    July 23, 2015 | 9:03 PM

    And CalPers (which manages the pension fund for the employees of the State of California) has done a lot of good corporate activism because of its size.

    Winge D. Monke, Ph.D.
    July 24, 2015 | 3:53 AM

    Does this mean the fines have hurt, ot

    July 24, 2015 | 7:28 PM

    Investors might consider settling of lawsuits and governmental fines to be an undesirable financial risk taken on by corporate management inclined to obscure findings bearing on drug safety.

    James O'Brien, M.D.
    July 26, 2015 | 10:29 AM

    BTW, sort of related, Grassley may have been right about pharma COI, but he’s hardly an angel on the issue of COI and cronyism:


    Anyone who thinks the government is going to solve these problems isn’t looking carefully at who is in running the government.

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