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‘Open science’ could open doors for pharma

J&J’s deal with Yale gives industry chance to rebuild its social capital

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    When Johnson & Johnson agreed to make its clinical trial data available to outside parties through the Yale School of Medicine, proponents billed it as a victory for transparency in drug research.

    Those same advocates of so-called “open science” hope it will encourage more pharma companies to do the same.

    “It sets a remarkable example,” said Harlan Krumholz, a Yale cardiology professor and director of the Yale Open Data Access project, or YODA. “I think every time someone does something like this, it creates a new normal.”

    Krumholz said the movement toward data sharing gives the pharmaceutical industry, which has seen its reputation battered over the past decade by product recalls and contentious litigation, an opportunity to rebuild its “social capital.”

    “This can fundamentally reshape the way the public thinks about these companies,” Krumholz said.

    J&J has agreed to release clinical trial data of all approved drugs in Europe and the United States to YODA. That information includes clinical study reports and patient data, though individual identities will be kept anonymous. YODA will field requests for that data from third parties, such as doctors, scientists or academics.

    Krumholz said YODA, a Yale faculty project formed to broaden public access to such data, will retain full control of whether to grant such requests according to its contract with the New Brunswick pharmaceutical giant. YODA will appoint an external panel of non-J&J advisers to help assess requests.

    “We have a library, a treasure trove of data,” J&J spokeswoman Seema Kumar said. “We're making it available to YODA, and YODA is like a curator. They will decide what to share and who to share it with.”

    The industry has long been prodded to disclose more data regarding its drugs; critics say patients and doctors need access to more information to make better informed choices regarding medicine.

    YODA says researchers until now have relied on data summaries and published manuscripts, an inherently spotty process because much data is left out.

    Mahmud Hassan, a Rutgers Business School professor who studies the pharmaceutical industry, said the public record on clinical trial data currently is sparse. Clinical trials are registered, but the data disclosed has been at the discretion of pharmaceutical companies.

    Hassan said he would like to see more information about drug costs, their efficacy and their reliability, as well as the scope of patients involved in clinical trials.

    “The proof will be in the pudding,” Hassan said of the agreement. “I would like to see what they ultimately release.”

    Hassan said this move will also be beneficial if it encourages more drug companies to do the same, noting that GlaxoSmithKline and Pfizer Inc. have begun to broaden access to information.

    Kumar, the J&J spokeswoman, said the company has shared clinical trial data before but typically on an individual basis. The agreement provides a more comprehensive and organized format, she said.

    For example, if someone wants to research why a certain population responds differently to a drug than others, or why African-Americans are more vulnerable to high blood pressure, a wider range of data will become available, she said.

    The agreement with YODA involves J&J's Janssen subsidiary and its family of drugs. J&J said it is also developing plans to share clinical trial data involving its medical device and consumer products businesses.

    Kumar and Krumholz cautioned that while the data is free, the agreement does not constitute a free-for-all. J&J's agreement with YODA stipulates that those requesting access indicate why they are seeking clinical information, such as to test a hypothesis.

    “We're not in a position to deny access, but we want people to declare before they start what they want to do,” Krumholz said.

    Lawrence Downs, CEO of the Medical Society of New Jersey, said more readily available data should inspire further research, which will circulate back into the medical community and prompt more discoveries.

    “Once data gets out there, additional doctors will research and write about it,” Downs said. “You get different perspectives other than the pharmaceutical industry.”

    Since the agreement was announced, Krumholz said inquiries from scientists have been “coming out of the woodwork.” It is also creating a “murmuring” within the pharmaceutical industry itself, with companies debating how to release more information.

    The agreement with J&J provides a clearer template, he said. Plus, granting an outside entity full autonomy to assess such requests should remove questions of bias, he said.

    “By going through us rather than the company, that should allay any concerns of an ulterior motive,” Krumholz said.

    E-mail to: tomz@njbiz.com
    On Twitter: @biztzanki

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