“Give the Data to the People”

Kermit Cole
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Harlan Krumholz, director of Yale University’s Open Data Access Project (YODA), writes in the New York Times about YODA’s agreement to oversee release of Johnson & Johnson’s clinical trial data. User of the data will sign “an agreement that restricts them to their proposed research question. Most important, they must agree to share whatever they find. And we exclude applicants who seek data for commercial or legal purposes. Our intent is not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to overall scientific knowledge.”

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Kermit Cole
Kermit Cole, MFT, founding editor of Mad in America, works in Santa Fe, New Mexico as a couples and family therapist. Inspired by Open Dialogue, he works as part of a team and consults with couples and families that have members identified as patients. His work in residential treatment — largely with severely traumatized and/or "psychotic" clients — led to an appreciation of the power and beauty of systemic philosophy and practice, as the alternative to the prevailing focus on individual pathology. A former film-maker, he has undergraduate and master's degrees in psychology from Harvard University, as well as an MFT degree from the Council for Relationships in Philadelphia. He is a doctoral candidate with the Taos Institute and the Free University of Brussels. You can reach him at [email protected]

7 COMMENTS

  1. No Sale.

    If there’s one single nickle of Govt. – meaning belonging to the people, not the bureaucrats – Money involved in these trials, not JNJ, Yale, GSK, nor anyone else has any right to decide Who gets access to that data and Who doesn’t.

    The issue of irresponsible end use of said data has been raised here.

    Fine. If they don’t want it used irresponsibly, as in editorializing against the drugs being studied, and they want to maintain complete control over their research/economic advantage, then they can get their hands Out of everybody else’s pockets and pay for 100% of whatever they’re researching.

    • I’d go further dbunker. Any company that develops trials to prove the efficacy of a medical treatment/drug should, by law, have to provide the data for all their trials (not just 2), whether there is government money involved or not. Why?

      Because otherwise, if many of their trials show that the treatment is no better or worse than placebo, they are involved in obfuscation, false advertisement and are potentially causing grave harm to anyone who buys their “product”.

      I would actually prefer that all trials are done by independent scientists that have no ties to the corporation who wants to sell a treatment.

      The results can then be published in independent medical journals. No advertising should be allowed. No doctors should be able to promote the treatment for company money. If it works, it will be made abundantly clear in the medical journals and that information can then filter down to doctors who can then make the choice to prescribe the treatment or not.

      • Mr. Keyes;

        E-High Fives and a resounding “Yeah, What He Said!”

        “I’d go further”

        “if many of their trials show that the treatment is no better or worse than placebo, they are involved in obfuscation, false advertisement and are potentially causing grave harm to anyone who buys their “product”.

        What you’ve just done here is to define criminal fraud.

        As I said in my reply to Mr. Cole:
        It is Legally Impossible for anyone to Volunteer To Be Defrauded: be they Research Subject or the Taxpayer being defrauded into Paying for that research.

        “If it works, it will be made abundantly clear in the medical journals and that information can then filter down to doctors who can then make the choice to prescribe the treatment or not.”

        Dear Veterans Administration, An Open Letter
        http://psychroaches.blogspot.com/2010/12/dear-us-department-of-veterans-affairs.html

        ‘It’ does not work now, has never worked, and is never going to work.

        No Positive Outcome.

        Given that the VA is admitting they’re working over at least 53,000 people a year as schizophrenics alone (while defrauding far more than $1 Million Tax Payer Dollars at it) – without a positive outcome – the drug makers and the entire supply chain – inside and outside the VA – down to the nurse with their little Dixie cup of pills and Dixie cup of water, need to be prosecuted under these following Statutes on top of 18C95 Sec 1958.

        Us Title 18 Part 1 Chapter 19 Sec. 371 Conspiracy To Defraud The United States: 5 years

        Us Title 18 Part 1 Chapter 47 Sec. 1031 Major Fraud Against The United States: 10 years

        Us Title 18 Part 1 Chapter 47 Sec. 1035 False Statements: 5 years

        Us Title 18 Part 1 Chapter 63 Sec. 1341 Mail Fraud: Frauds and Swindles: 20 years

        Us Title 18 Part 1 Chapter 63 Sec. 1347 Health Care Fraud: 10 years

        Us Title 18 Part 1 Chapter 63 Sec. 1349 Attempt and Conspiracy

        Us Title 18 Part 1 Chapter 95 Sec. 1957 Engaging In Monetary Transactions In Property Derived From Specified Unlawful Activity: over $10,000, 10 years.

        And those US Title 18 Statutes are only a fraction of Federal Statutes which this Industry can be convicted of violating.

        “But, But, this is ridiculous, Bunker, you’d have Everybody in the Mental Health profession tossed into prison for centuries.”

        Envision a housecat being offered a fresh opened can of tuna.

        If I violated these Federal Statutes I would be incarcerated for it.

        Everybody delivering these drugs knows they don’t produce any ‘Positive Outcome’ and Everybody in Medicine looks the other way as they continue Taking/Defrauding Other Peoples Money to do what they do.

        Less Than 1% of Patient Harm Events Are Ever Reported.

        US 18C3 Accessory After The Fact
        US 18C4 Misprision Of Felony

        “Whoever, having knowledge of the actual commission of a felony cognizable by a court of the United States, conceals and does not as soon as possible make known the same to some judge or other person in civil or military authority under the United States, shall be fined under this title or imprisoned not more than three years, or both.”

        Time and again I see Authors and Commentators here at MIA bemoaning the lack of patient empowerment to uphold Human Rights in the Mental Health system.

        Human Rights is a Philosophy just as Mental Health/Illness is a Philosophy.

        American Citizens own Civil Rights, not Human Rights.

        US 18C13 Sec 241 & 242.

        What makes HC workers so specially Above all of the above Federal Criminal Statutes and protected from them? 1 item and 1 item only: Money: mountains of Dirty, Defrauded/Obtained under False Pretenses and therefore Stolen, Money.

        They’ve even got Illegal (Sec 1 of the 14th Amendment), Trade Guild purchased exemptions to protect themselves from being mined by having to wear their own thieving, life wrecking Opinions.

        California Diversion Programs.
        http://psychroaches.blogspot.com/search/label/California%20Diversion%20Programs

        There’s 7 Illegal, Fed Civil Rights Statute Violating sections of Ca. State Law under that label.

        Housecat, tuna.

        Nothing in the Mental Health system is going to change until our Courts start tossing the Fraudsters – from Top to Bottom – into locked cages with iron bars on them and throwing away the key.

        First step down that road for people who’ve been victimized by the Mental Health system is to get Off the Human Rights bandwagon and get On the Civil Rights bandwagon because all the empowerment they seek – and much more – is already theirs in existing Criminal Law.

        Let’s ask someone, Anyone, to even Define/Justify inducing ‘Mental Health’ through brain damage into other people as Healthcare, when the people dispensing ‘Mental Health’ have reversed the outcome of the Civil War/14th Amendment to avoid having to wear their own ‘Mental Health’.

      • I agree Jonathan. The drug companies can do all the research and come up with all the new chemicals they want, but the clinical trials must absolutely be at arms length. The trials should be managed either by the government itself or by non-profit institutions with absolute transparency and subject to regulation or government supervision. And how would the trials be funded? Well, by a special tax/charge to the drug companies, of course.

        I can already see the initial reaction of horror to such idea by the libertarian crowd. But if you think about it a little, it’s not as radical a solution as it might appear. The drug companies would still have patent protection which enables them to monopolize their intellectual property and which incentivizes them to innovate. They would still control research/development, production and distribution, i.e. everything except the power to judge the safety of their own products.

        The current drug approval system is broken. The drug companies control the trials, cherry pick the ones the FDA can consider and hide any evidence against their product. I can think of plenty of good analogies to the current drug approval process. For example, companies could certify their own financial audits. The cop that makes an arrest could also be the judge at trial. The food safety inspector could be an employee of the meat packer. The list can go on and on with hypothetical situations like the all too real drug approval process and which the libertarian and the socialist would equally condemn.

        Letting the drug companies determine which trials can be considered for approval and hiding the rest is tantamount to letting their auditors only see and certify one side of their accounting ledger. Now, analogies with the financial system can be tricky, because, as the world has recently experienced, fraud is capable of jeopardizing the whole system. One can argue, however, that most legislators honestly try to make financial fraud illegal. Unfortunately, with regards to the pharmaceutical industry, they have no problems with a fraudulent drug approval process which is perfectly legal.

        The YODA project is a step in the right direction. It may even be an important step. But it will only be relevant if it ultimately contributes to a major shift in the balance between the interest of drug company shareholders and the broader public interest.

  2. @Pablo-

    When it comes to psychiatric medications, this issue gets compounded because these trials are not longitudinal studies. What are the potential health complications that could arise from taking a drug over a period of time. Many of these studies do examine side effects, but they are only for a very short length of time.

    Finally, what is deeply problematic is the prescription of these drugs for off-label conditions. The atypical antipsychotics, which carry a wide side effect profile, are routinely prescribed by GPs for a multitude of conditions without any substantiating evidence for their efficacy.