What do Women Want ?

Editorial Note: This is cross-posted from 1boringoldman - Reassure Us. It tackles the most important issue in healthcare and one of the most important in politics. GSK have clearly persuaded Ben Goldacre, Iain Chalmers and David Cameron, and J&J have persuaded Harlan Krumholz and Barack Obama that their model of Data Access – the AbbVie model – is the only game in town. See The House of GSK.

This smells like the advice formerly given by the real powers behind the thrones (now GSK, J&J) to a pair of monarchs (now DC and BO) under siege. “My Lord, the people are revolting”. “You can say that again”. “Here’s what you should do – give the vote to property owning white men”.  

Which gives all revolting men and women a slogan “Women Want the Vote”. We just need a President from Illinois to champion the cause.

Give the data to the people

New York Times

By HARLAN M. KRUMHOLZ,  FEB. 2, 2014

LAST week, Johnson & Johnson announced that it was making all of its clinical trial data available to scientists around the world. It has hired my group, Yale University Open Data Access Project, or YODA, to fully oversee the release of the data. Everything in the company’s clinical research vaults, including unpublished raw data, will be available for independent review. This is an extraordinary donation to society, and a reversal of the industry’s traditional tendency to treat data as an asset that would lose value if exposed to public scrutiny. Today, more than half of the clinical trials in the United States, including many sponsored by academic and governmental institutions, are not published within two years of their completion. Often they are never published at all. The unreported results, not surprisingly, are often those in which a drug failed to perform better than a placebo. As a result, evidence-based medicine is, at best, based on only some of the evidence. One of the most troubling implications is that full information on a drug’s effects may never be discovered or released. Even when studies are published, the actual data are usually not made available. End users of research — patients, doctors and policy makers — are implicitly told by a single group of researchers to “take our word for it.” They are often forced to accept the report without the prospect of other independent scientists’ reproducing the findings — a violation of a central tenet of the scientific method.

To be fair, the decision to share data is not easy. Companies worry that their competitors will benefit, that lawyers will take advantage, that incompetent scientists will misconstrue the data and come to mistaken conclusions. Researchers feel ownership of the data and may be reluctant to have others use it. So Johnson & Johnson, as well as companies like GlaxoSmithKline and Medtronic that have made more cautious moves toward transparency, deserve much credit. The more we share data, however, the more we find that many of these problems fail to materialize…

This program doesn’t mean that just anyone can gain access to the data without disclosing how they intend to use it. We require those who want the data to submit a proposal and identify their research team, funding and any conflicts of interest. They have to complete a short course on responsible conduct and 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.

There are many benefits to this kind of sharing. It honors the contributions of the subjects and scientists who participated in the research. It is proof that an organization, whether it is part of industry or academia, wants to play a role as a good global citizen. It demonstrates that the organization has nothing to hide. And it enables scientists to use the data to learn new ways to help patients. Such an approach can even teach a company like Johnson & Johnson something it didn’t know about its own products. For the good of society, this is a breakthrough that should be replicated throughout the research world.

1BoringOldMan

It feels like we’re only going to have one shot at Data Transparency, and we need to get it right. And at least in the realm of psychoactive medications, the level of misbehavior by the pharmaceutical industry is the stuff of legend. When and if the history is ever written, Johnson & Johnson will probably have a whole chapter all to themselves. The TMAP Program in Texas alone would qualify them, but there were other things including the nearby Excerpta Medica that ghost wrote Risperdal® articles faster that J&J could recruit KOLs to sign them, the J&J Center at MGH for Dr. Biederman’s Childhood Bipolar fantasies, Omnicare contracts for over-medicating the elderly, etc. Before getting a warm glow about this article, read the Rothman Report from the J&J trial in Austin several years ago. Their track record defines the word ruthless. So pardon me if I approach the plan above with a skeptical eye.

Dr. Harlan M. Krumholtz is in charge of the Yale Center for Outcomes Research and Evaluations[CORE] and its Yale University Open Data Access [YODA] Project. I have no reason to doubt his credentials, but there are a couple of things that need to be thoroughly investigated:

Harlan M. Krumholz, MD, SM

Editor-in-Chief  NEJM Journal Watch Cardiology

About the NEJM Journal Watch Cardiology Board

Harlan M. Krumholz, MD, SM, is the Harold H. Hines, Jr., Professor of Medicine in the Section of Cardiovascular Medicine at the Yale University School of Medicine, New Haven, Connecticut. He serves as Director of the Robert Wood Johnson Clinical Scholars Program and Director of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CORE). Using methods of outcomes research, he has sought to illuminate the balance of risks, benefits, and costs of specific clinical approaches and to implement strategies to improve the prevention, diagnosis, and treatment of cardiovascular disease. He is an elected member of the American Society of Clinical Investigation, Association of American Physicians, and the Institute of Medicine. He has been an Editor for NEJM Journal Watch Cardiology since the publication’s launch in 1995 and Editor-in-Chief since 2000.

 

Disclosures

Consultant / Advisory board United Healthcare
Speaker’s bureau Centrix
Equity ImageCor
Grant / Research support FDA; NIH-NHLBI; Commonwealth Fund; The Catherine and Patrick Weldon Donaghue Medical Research Foundation; Robert Wood Johnson Foundation; Medtronic
Editorial boards American J Managed CareAmerican J Medicine; Archives of Medical Science; BMJ.com/US; Central European J MedicineCirculation: Cardiovascular Quality and OutcomesCongestive Heart FailureCritical Pathways in CardiologyCurrent Cardiovascular Risk ReportsJACC: Cardiovascular ImagingJ Cardiovascular Medicine
Leadership positions in professional societies American Board of Internal Medicine;  American College of Cardiology;  American College of Physicians;  American Heart Association;  Centers for Medicare & Medicaid Services;  Oklahoma Foundation for Medical Quality;  VHA, Inc.

 

The Robert Woods Johnson Foundation is “the United States’ largest philanthropy devoted exclusively to health and health care.” “Robert Wood Johnson II built the family firm of Johnson & Johnson into the world’s largest health products maker. He died in 1968. He established the foundation at his death with 10,204,377 shares of the company’s stock.”

And I say good for him. But the Board is built from J&J former executives as I recall from the testimony in the TMAP Trial where the chairman was deposed because they financed the start-up of that infamous program in Texas. While no connection was established, it wasn’t disproved either. No allegations here. It’s just something that needs thorough checking.

The pharmaceutical companies have insisted on talking about what I call Data Transparency as if it is a synonym for Data Sharing. It’s not. Data Sharing is a magnanimous act on the part of the company to allow other researchers access to the data from their clinical trials for further research for the good of mankind. I’m all in favor of the good of mankind, but that’s not what I’m interested in here. I want us [some us] to be able to check their work independently starting from the same place they do – the instant the blind on a clinical trial is broken – the raw data itself. And the reason I want to do that is the outrageous record they have for cheating in the way they handle that raw data. Here’s just one example where the Risperdal® data was hidden or distorted:

In the South Carolina penalty settlement the Judge noted that they had evidence that the manufacturer knew that Risperdal® was associated with metabolic side-effects of some magnitude:

… then, when instructed to send a “Dear Doctor” letter about those side effects in 2003, they sent out an advertisement instead:

So this bothers me -

‘We require those who want the data to submit a proposal and identify their research team, funding and any conflicts of interest. They have to complete a short course on responsible conduct and sign an agreement that restricts them to their proposed research question.’

- in two ways:

  1. Those of us who want to “check their work” aren’t necessarily academics, particularly in psychiatry. We might not have any funding at all, and may be voluntarily operating with a PC, Excel, and a free copy of “R.”
  2. We need some recognition that our goal is considered a research topic – namely, Are they telling the truth in the published paper or are they presenting the data in a way that misleads the reader [like so many have done before]? Are they withholding data to make their drug look more efficacious or safer than it really is [like so many have done before]?” Putting the “re” in research!

Those are topics aimed at the good of mankind too! I don’t care if the pharmaceutical companies want to save face with the way this is presented to the world, as a generous humanitarian act, so long as the process allows for the kind of Data Transparency we need to prevent the kind of shameful criminal behavior J&J engaged in with Risperdal®.

Dr. Krumholz needs to prove to us that his program knows what I’m talking about here…


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Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Re: Harlan Krumholz: You might have a chance to engage him on Twitter, would get some attention if done right. He is not a pop star like Ben Goldacre, more a classic medical wonk — possibly more open to a public dialogue. Worth a try anyway.

    His handle is @hmkyale The investigation he led of Medtronic’s INFUSE back-surgery disaster was the real thing, and an important contribution. It did give me a slight chill to see it described in such “positive” terms in the NYT since as I read them, neither study was all that reassuring to INFUSE users. (Neither study discounted the risk of cancer, and the Times did not mention the far more common risk of uncontrolled bone growth into the wee spaces of the spinal column, causing excruciating pain …)

    Of course, the key was that Medtronic turned over their data with FBI guys in flak jackets at the door. J&J may have come mighty close to that. What happens when the cops go home?

  2. The patients are revolting……always loved that…..made me laugh…..

    Obama could have lost his life when the woman tried to drive her car into the White House, off ‘er ‘ead and how nobody has taken Witty out, on a rage off Seroxat, I don’t know.

    NEW FEARS OVER DANGER PILLS is the headline today.

    Is it about Seroxat?

    Noooooo. It is about Mortal Kombat, A pill which has a red devil imprinted on it.

    It is a combination of ectasy and mephredone and Ketamine – a horse tranquiliser.

    How long has Ectasy been around? Now it is tweaked.

    CONFUSION, SWEATS, THEN HOURS LATER YOU COULD BE DEAD

    Dr. Richard Stevenson, a specialist in emergency medicine at Glasgow Royal Infirmary said:

    “After taking any Ecstasy style drug, the human body is at risk of suffering a devastating chain of reaction than can kill in only a few hours.
    Doctors have to reverse the potential lethal effects of highly toxic substances contained in drugs such as Mortal Kombat.

    Patients normally present with agitation, confusion, their heart rate is fast and they feel anxious.
    We sedate patients with anything from Diazepam to powerful anti-psychotic drugs.
    We have to use quite serious medications.
    It is for their own safety and it is not a pleasant experience.

    Ectasy causes a release of SEROTONIN in the body.

    When people start presenting with signs of severe toxicity their chances of survival are low.”

    Black, white, the north and south divide, civil war and all that…..voting for data transparency, and, all that…..

    When is anyone going to realise that our leeeeeetle ad, happy pills, have the just the same toxic qualities as anything resembling Ecstasy.

    Ecstasy is such a good word.

    Isn’t this what the psychiatrist who advised me to take Seroxat was sort of saying.

    My friend, the doctor, Rosemary, used to confide to me.

    “Patients are revolting. They come in, sad and depressed and a day out shopping would cure all their ails.”

    She was so right in so many ways.

  3. Today at 5:55 PM
    Ben, have you been cuckolded – you are nice and brave and I like you, but where are you really coming from?
    Have you really sold your soul or however much we like you, you are doing us GSK, litigants, no favours.

    Dear Friends

    On Thursday Johnson & Johnson announced that it would give all the pharmaceutical clinical trial data it holds to researchers. This is a big step forward for the AllTrials campaign. Read a great New York Times piece on the J&J announcement, Give the Data to the People. J&J is following the lead of GSK who last year pledged to give researchers access to data from trials it has done since its formation as a company. GSK has developed an online portal to share this data and earlier this month this was joined by other companies. We’ll be asking for your help soon to make sure lots of other companies, and non-commercial research funders too, commit to making information from past trials available this year.

    January is barely over but already there’s lots of news:

    •The new EU Clinical Trials Regulation is now only one step away from final agreement. Let your MEP know that you want them to vote on 3rd April in favour of the good changes to the regulation that would mean clinical trials in Europe are registered and results reported. Find MEP’s details and a sample letter here.
    •The UK’s Public Accounts Committee of MPs published a report calling on Government to ensure that all data from all clinical trials, past and present, is made available to regulators and researchers for independent scrutiny. Read more here.
    •Thanks to your donations and fundraising we have been able to start filming an AllTrials campaign video. We will be asking for your help to spread the word about the campaign with the video soon, in the meantime you can see some behind the scenes photos from the video shoot here.

    Best

    Síle

    Síle Lane
    Director of Campaigns
    Sense About Science

    http://www.alltrials.net

    Please donate at https://www.justgiving.com/alltrialsappeal

    Email information: This email was sent to anniebevan@yahoo.co.uk.
    If you no longer wish to receive our periodic emails, please unsubscribe. Thank you.

  4. I hope all persons with brains and guts in psychiatry can organize to demand the proof of this pudding, in the form of a full dish of Risperdal data without preconditions. If you actually succeed, it could strike a blow against the entire deadly plague of antipsychotic over-prescribing, from Zyprexa to Abilify (still the #1 selling drug in the US). And if you don’t, well at least you’ve tested and exposed a false “reform”. That’s valuable too.

    In the case of Risperdal, some of the AUTHORS of the studies might want the chance to see the company’s data for the first time! See this semi-confession from Risperdal coauthor Dr Denis Daneman of Toronto:

    http://chronicle.com/blogs/percolator/major-fraud-plea-has-university-scientists-regretting-journal-article/33713

    If this guy is truly penitent, he needs to be first in line to publicly demand a complete look at the data he “signed off on.”

  5. “It has hired my group, Yale University Open Data Access Project, or YODA, to fully oversee the release of the data.”

    So why does Yale so easily give in to the purchasing of their brand name? I’d love to know how much money Harlan’s group gets. I’m offended his title is Give the Data to the People.

    And I think we can see how this is going to play out. A pharma sponsored group of (brand name) scholars will write a request. It will be granted by YODA. They will make a report confirming the results of the original study. It will all look “independently done”. And still we won’t see the data.

    Not that it really matters but I’ll bet Harlan was handed that article to sign his name to. Ghost written PR.

    Would be nice to see Yale’s journalism school take issue with this, or if there’s any open source advocates in their CS department.

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