first order solution…

Posted on Thursday 19 June 2014

There are things one misses by going to medical school and having a medical career. People like me know next to nothing about business or legal matters. Pre-Med was all science. Medical School was all science, A couple of residencies and psychoanalytic training didn’t fill in any legal blank spaces. And frankly, most doctors are too busy to have time to do much sin or have brushes with the law. I’ve never even been picked for a jury. So when it comes to the legal stuff, many of us are dumb as posts [take me for example], and it takes us a while to get up to speed with matters legal. I finally figured out what Dr. Poses of Healthcare Renewal has been talking about for years, the anechoic effect – why stories of great fraud in medicine just die out. I finally got it that by settling a suit, a drug company seals the evidence, walks away saying "we admit no wrongdoing," and puts a damper on any publicity for the incriminating evidence [see with no echo…]. And they go to any lengths to keep it that way, as in this story…
By Ed Silverman
Jun 16, 2014

A federal judge may sanction a physician who served as an expert witness in the ongoing litigation over the Vioxx painkiller for describing confidential documents to The Wall Street Journal. Earlier this month, U.S. District Court Judge Eldon Fallon issued a restraining order saying David Egilman, who is a Brown University clinical professor of family medicine, “may have acted in derogation of his responsibilities.” Egilman was an expert witness with access to documents in litigation over the Merck pill that took place in various courts around the country. Vioxx was withdrawn a decade ago over links to heart attacks and strokes. Fallon, who presides over Vioxx litigation that was consolidated in federal court in New Orleans, had issued an order in 2005 that marked swaths of documents as confidential. Much of the documentation was filed as evidence in litigation in both state and federal courts.

Three months ago, though, a Kentucky state judge permitted Egilman to challenge the confidentiality of the documents, since he had standing as an expert witness which gave him previous access to the materials. As we noted at the time, the judge wrote that “important public policy questions regarding consumer protection and public health have been raised. The public has an interest in evaluating Dr. Egilman’s opinions and the documents on which they were based.” Egilman was a paid expert witness for plaintiffs in a lawsuit that had been filed by the Kentucky Attorney General, who alleged Merck violated consumer protection laws by failing to disclose to doctors and patients that taking Vioxx significantly raised the risk of a heart attack. The lawsuit was settled last November for $23 million, although the drug maker did not admit to any wrongdoing.

Egilman maintains that some documents demonstrated a failure to properly inform research subjects of side effects and risks, and thus he believes the information should be publicly available. “In general, there’s information on the toxicity of the drug that’s not been previously published by Merck and there is information that Merck published that misrepresents the health effects of the drug,” he told us three months ago, which prompted the drug maker to complain to the federal judge. At the time, he added that, in his role as an expert witness, he reviewed raw study data, company emails and internal analyses that “provide new information on the health hazards of the drug and evidence of fraud in the conduct of the studies. I’ve been able to see documents few others have”…
Healthcare Renewal
by Roy Poses
June 17, 2014

We have written often, and most recently this week, about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations.  At best, official action often results in legal settlements which let companies pay fines, sometimes large, while the individuals who profited most from the alleged wrongdoing do not suffer any negative consequences.  Worse, the legal settlements often allow the companies to continue to deny any culpability, and the legal evidence underlying the settlement, which might let the public at least estimate culpability, is often kept sealed, or confidential.  As Judge Rakoff wrote in turning down such a settlement involving a financial, not health care company, sealing evidence hides "any proven or admitted facts upon which to exercise even a modest degree of independent judgment,"  and prevents courts and presumably anyone else from trying to determine whether the government endorsement of such a settlement serves any public purpose [look here]…

We have long talked about what we have called the anechoic effect, how inconvenient truths that might reflect badly on the current health care status quo and especially those insiders who are making so much money from it are treated as recent unpleasantness that one just should not talk about. The anechoic effect does not arise merely from politeness, or desire not to discomfit the powerful, but from active measures the powerful take to keep dissent down. Here we have an example of a huge drug company, apparently helped by US law enforcement and US courts trying to keep truths about how it marketed a drug out of the public eye, even after so much information suggesting that its marketing was deceptive and unethical, and lead to patients dying has come out.

As we have said endlessly, until health care professionals, policy makers, and the public can obtain and openly discuss information about health care dysfunction, even if that information and its discussion may threaten those who lead health care and make so much money doing so, health care dysfunction will continue. True health care reform would improve transparency and put an end to the anechoic effect.
In with no echo…, I suggested several reasons that the plaintiffs settles…
Lots of reasons. A lot of these are whistle blower suits and the whistle blowers want their money [there’s no appeal to a settlement]. The same holds for the lawyers who take such cases on contingency. Whether it’s civil or criminal, settling avoids the lengthy appeal process and gets the case off the books. They all go out and celebrate, ignoring the fact that they’ve played into the hands of the companies.
But I came up short with ways to solve this problem that badly needs solving. Another outrageous example came from GSK after settling a record breaking $3+ B suit. They went out of their way to "admit no wrongdoing" [after signing a settlement saying they admitted to all charges – charges of many wrongdoings including those related to Paxil Study 329][see the only enduring contract…]. This settling thing is a mammoth loophole – maybe more like one of those huge sinkholes that eats houses.

People are harmed when these suits settle and there’s no definite verdict. They’re harmed when the transcript and the testimony doesn’t get to see the light of day, doesn’t get a full hearing in the press. A quick mention on Pharmalot or in Reuters doesn’t alert them to the danger specific to the suit or the general problem of how the pharmaceurical industry works – the echo doesn’t reverberate. Patients are as vulnerable two weeks later as they were before the trial started. Usually, when there’s something that happens that causes harm repetitiously, we do something. We add speed humps to high wreck-prone streets. We put up stop-lights. We pass laws. We do something to keep the harm from happening over and over again, even if it means infringing on someone’s privacy. We list pedophiles on the Internet. My medical or psychiatric patient has the right of privacy, confidentiality, but if she says she’s going to kill someone, or herself, or is being abused, I am mandated by law to pass that on to someone who can act preventively:
    Tarasoff v. Regents of the University of California, 17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14 [Cal. 1976], was a case in which the Supreme Court of California held that mental health professionals have a duty to protect individuals who are being threatened with bodily harm by a patient. The original 1974 decision mandated warning the threatened individual, but a 1976 rehearing of the case by the California Supreme Court called for a "duty to protect" the intended victim. The professional may discharge the duty in several ways, including notifying police, warning the intended victim, and/or taking other reasonable steps to protect the threatened individual.
Withholding the raw data from Clinical Trials has caused enormous harm to patients because the published articles have frequently been jury-rigged. In the suggested amendments to the Canadian Food and Drug Act, it has been proposed that the new law be very explicit that the raw information needed to check the work of the authors and sponsors is not proprietary. It should be in the public domain. That suggestion is being made to prevent secrecy and an inability to verify the results, in order to protect patients from being harmed by distorted studies.
    Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

    International treaties simply require Canada to protect trade secrets and confidential business information without specifying the scope of those types of information. No Canadian court decision indicates that information about the safety or efficacy of a drug is proprietary, and current case law casts doubt on any such assertion. In principle. Health Canada can at present disclose greater amounts of safety and efficacy information. However, to clarify and to overcome manufacturers efforts to resist disclosure. Bill C-17 should explicitly state that the results of clinical trials, including de-identified patient-level data, postmarket studies, and adverse drug reactions reported by drug manufacturers and health care institutions, are not proprietary and therefore should be publicly disclosed…
And even in the World Trade Organization TRIPS Trade agreement, it says that data should be kept from disclosure except where necessary to protect the public. Contingencies to keep people out of harms way are the rule.
PART II — Standards concerning the availability, scope and use of Intellectual Property Rights
Article 39

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.
Protection from harm trumps privacy in every venue I can think of. We have the right to life, liberty, and the pursuit of happiness – but not to privacy, confidentiality, and secrets if it hurts or kills other people. It’s part of the Social Contract that inspires most of our laws.

I frankly doubt that there’s any way to completely interrupt the cycle of settling out of these suits and silencing the echo. As they say, the barn door has been left open and the cows are long gone by the time these suits get to court. Many are Civil suits and the tradition of settling is a time-honored resolution. Even the criminal suits are the stuff of corporate fines rather than direct punishment of the individuals involved. The one obvious thing that occurs to me has to do with, "issued an order in 2005 that marked swaths of documents as confidential." Apparently, that’s in the realm of judicial discretion. It’s the Achilles heel in this story. I can see sequestering evidence or silencing experts if the defendant wins the litigation. That’s the best we can do to determine innocence. But settling is neither winning nor a declaration of innocence. It implies the opposite. If they want to continue on with any rights of privacy, let them win that right by being exonerated in a court of law. If they are found guilty or settle out of the suit, squashing the evidence shouldn’t be on the table. That bit of judicial discretion is abetting harm and needs some serious rethinking, because it has given them a way to win by choosing how to lose – over and over.

Each of my three examples represents a legal solution that places limits on secrecy based on the risk of future harm. In this case, secrecy is actually the conduit to future harms by blocking independent confirmation of trial results. There’s nothing about the results of Clinical Trials of a medication that reveals Trade Secrets or anything about the manufacturing process. The studies are only about efficacy and risk – nothing more. Given the stakes and the loud lessons of history, the obvious first order solution is data transparency in Clinical Trials. The only viable alternative is the Godlee solution:
    "… we have to recognize that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing. And unless we can resolve this in a way that is more in the public interest and in patients’ interest, I would argue that drug companies should not be allowed to evaluate their own products."
We can’t continue to wait for the echo that never comes…
    June 19, 2014 | 4:23 PM

    That bit of judicial discretion is abetting harm and needs some serious rethinking, because it has given them a way to win by choosing how to lose – over and over.

    Mickey–You’ve got the proper solution. The problem is, as an “outsider” (not one with a legal pulpit) you are like most of us. We can preach to the choir; we can write to local papers; but how do we get LAWYERS and JUDGES, with the experience and a bully pulpit to press for needed changes?

    (BTW, you know me and my Eli Lilly aversion. I believe Lilly ‘led the way’ [1996] of winning by losing [settling] with their Prozac. On a Friday, it appears that Lilly would have to open its records in court, and in all likelihood, lose the case of Prozac-related violence. Over the ensuing weekend a very large–though undisclosed–settlement was reached. Everyone ‘went away happy’ except those who subsequently were harmed by the drug. A quick synopsis of the book The Power to Harm can be found here:

    June 20, 2014 | 11:52 AM

    Given the proven and persistent malfeasance and conspiracies mounted by major pharmaceutical companies, I can only wonder why it is that none of their corporate executives have been successfully prosecuted in the US under Racketeer Influenced and Corrupt Organization (RICO) laws. Can it be that they’ve bought themselves some judges, District Attorneys, and State Attorneys General? Or even some Congressmen and Senators? This type of purchase is after all, the ultimate purpose of political campaign contributions — and one directly aided and abetted by recent Supreme Court decisions.

    I can only applaud your efforts to bring common sense and medical ethics to the otherwise thoroughly corrupt profession of psychiatry. Please continue to cast light into dark corners.

    Richard A. Lawhern, Ph.D.
    Resident Research Analyst
    Living With TN — an online patient community within the Ben’s Friends cluster for patients with rare medical disorders.

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