Category Archives: scholarly journals

BMJ: Clinical trial data for all drugs in current use must be available for independent scrutiny

In an impassioned editorial, BMJ editor Fiona Godlee calls on the pharmaceutical industry to release clinical trial data on all approved drugs, and on medical journals to publish industry-funded trials only when there is a commitment to make patient-level data available on reasonable request.  She states that the BMJ will require this commitment for all clinical trials of drugs and devices, whether industry-funded or not, beginning in January 2013.  In addition, BMJ is publishing online all correspondence between Roche and the Cochrane Collaboration researchers regarding the oseltamivir (Tamiflu) data.  More on the battle for Tamiflu data here.

Addendum 11/2/2012:  read Pharmalot’s coverage here.

Article in Korean Circulation Journal retracted for plagiarism

In March of this year, Larry Husten reported on CardioBrief that a review article in the Korean Circulation Journal by Chang Gyu Park and Ju Young Lee appeared to plagiarize from a review article in the Journal of the American College of Cardiology by Franz Messerli and Gurusher Panjrath.  In April, Husten reported that the article was being investigated by the publishing committee of the Korean Society of Cardiology and Korean Association of Medical Journal Editors.  It has just come to my attention that the KCJ article has been retracted.  Here is the notice:

On July 31, 2011, Korean Circulation Journal (KCJ) published a review article by Park et al. regarding the J-curve in hypertension and coronary artery diseases. However, a possibility of plagiarism has been raised in this article.

The Editorial Board of KCJ has examined the review article and has requested the Committee for Publication Ethics of Korean Association of Medical Journal Editors (KAMJE) to provide an adequate conclusion. After thorough investigation, the Committee for Publication Ethics of KAMJE and the Editorial Board of KCJ have concluded that the article is seriously plagiarizing from an article by Messeri (sic) et al.

In this regard, on May 8, 2012, the Executive Committee of the Korean Society of Cardiology has finally decided to retract the article completely. We apologize for any inconvenience this may have caused.

My earlier post on this is here.

Harvard Faculty Advisory Council: cost of journals “prohibitive,” situation “untenable”

I’m taking the liberty of posting the entire text of this memo from the Harvard Faculty Advisory Council.  The suggested actions are particularly delightful.  H/T @PLoS.

To: Faculty Members in all Schools, Faculties, and Units
From: The Faculty Advisory Council
Date: April 17, 2012
RE: Periodical Subscriptions

We write to communicate an untenable situation facing the Harvard Library. Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive. This situation is exacerbated by efforts of certain publishers (called “providers”) to acquire, bundle, and increase the pricing on journals.

Harvard’s annual cost for journals from these providers now approaches $3.75M. In 2010, the comparable amount accounted for more than 20% of all periodical subscription costs and just under 10% of all collection costs for everything the Library acquires. Some journals cost as much as $40,000 per year, others in the tens of thousands. Prices for online content from two providers have increased by about 145% over the past six years, which far exceeds not only the consumer price index, but also the higher education and the library price indices. These journals therefore claim an ever-increasing share of our overall collection budget. Even though scholarly output continues to grow and publishing can be expensive, profit margins of 35% and more suggest that the prices we must pay do not solely result from an increasing supply of new articles.

The Library has never received anything close to full reimbursement for these expenditures from overhead collected by the University on grant and research funds.

The Faculty Advisory Council to the Library, representing university faculty in all schools and in consultation with the Harvard Library leadership,  reached this conclusion: major periodical subscriptions, especially to electronic journals published by historically key providers, cannot be sustained: continuing these subscriptions on their current footing is financially untenable. Doing so would seriously erode collection efforts in many other areas, already compromised.

It is untenable for contracts with at least two major providers to continue on the basis identical with past agreements. Costs are now prohibitive. Moreover, some providers bundle many journals as one subscription, with major, high-use journals bundled in with journals consulted far less frequently. Since the Library now must change its subscriptions and since faculty and graduate students are chief users, please consider the following options open to faculty and students (F) and the Library (L), state other options you think viable, and communicate your views:

1. Make sure that all of your own papers are accessible by submitting them to DASH in accordance with the faculty-initiated open-access policies (F).

2. Consider submitting articles to open-access journals, or to ones that have reasonable, sustainable subscription costs; move prestige to open access (F).

3. If on the editorial board of a journal involved, determine if it can be published as open access material, or independently from publishers that practice pricing described above. If not, consider resigning (F).

4. Contact professional organizations to raise these issues (F).

5. Encourage professional associations to take control of scholarly literature in their field or shift the management of their e-journals to library-friendly organizations (F).

6. Encourage colleagues to consider and to discuss these or other options (F).

7. Sign contracts that unbundle subscriptions and concentrate on higher-use journals (L).

8. Move journals to a sustainable pay per use system, (L).

9. Insist on subscription contracts in which the terms can be made public (L).

Data sharing as a moral imperative

In the USA at least, the data legally belong to trialists on the grounds that it requires work to create knowledge from data. But science, particularly medical science, is essentially an enterprise conducted for moral reasons. We need to do not just what is legal but what is right. As such, we must take into account the probable wishes of the patients who give us their blood, fill in our questionnaires and die on our trials. It is difficult to believe that any patient on my trial, who completed complex questionnaires so diligently over such a long period of time, would really have wanted me to keep the data for myself rather than share it with others for the benefit of medical science in general.  Vickers AJ.  Whose data set is it anyway?  Sharing raw data from randomized trials.  Trials.  2006;7:15.

Every day, patients and their caregivers are faced with difficult decisions about treatment. They turn to physicians and other healthcare professionals to interpret the medical evidence and assist them in making individualized decisions.  Unfortunately, we are learning that what is published in the medical literature represents only a portion of the evidence that is relevant to the risks and benefits of available treatments. In a profession that seeks to rely on evidence, it is ironic that we tolerate a system that enables evidence to be outside of public view.  Krumholz HM. Open Science and Data Sharing in Clinical Research: Basing Informed Decisions on the Totality of the Evidence. Circulation: Cardiovascular Quality and Outcomes. 2012;5: 141-142

We are all patients, and will all face questions about what medical treatments to pursue.  Some questions are trivial and unimportant, others can mean the difference between life and death.  We rely on evidence-based medicine to give us reliable information about the risks and benefits associated with medical interventions, but a disturbing amount of evidence indicates that the medical literature is not always reliable.  Many clinical trials are not published within a reasonable time after completion or are never published at all.  Missing data leads to systematic reviews that are based on only a portion of the trials that were conducted, which can affect the results in unknown and unpredictable ways.  Missing data may in some cases hold important information about risk, as in the case of Vioxx (rofecoxib).  Merck had data several years before Vioxx was withdrawn from the market that showed the drug increased the risk of heart attacks, but most of the data was unpublished and out of public view.  In other cases, clinical trials are published but the data are reported in a misleading and biased way, as when a negative trial is presented so as to appear positive, or analyses showing harm are omitted.

What is to be done?  What can we do to make evidence-based medicine more evidence-based?  Four commentaries in the March 2012 issue of Circulation:  Cardiovascular Quality and Outcomes discuss how making clinical research data available outside individual drug and device companies or research groups could greatly add to the depth and reliability of our knowledge.  Currently, with certain exceptions, access to most clinical trial data is restricted to the investigators or the funders.  Harlan Krumholz, in an editor’s perspective, outlines the key concepts:

Now is the time to bring data sharing and open science into the mainstream of clinical research, particularly with respect to trials that contain information about the risks and benefits of treatments in current use. This could be accomplished through the following steps:

    1. Post, in the public domain, the study protocol for each published trial. The protocol should be comprehensive and include policies and procedures relevant to actions taken in the trial.

    2. Develop mechanisms for those who own trial data to share their raw data and individual patient data.

    3. Encourage industry to commit to place all its clinical research data relevant to approved products in the public domain. This action would acknowledge that the privilege of selling products is accompanied by a responsibility to share all the clinical research data relevant to the products’ benefits and harms.

    4. Develop a culture within academics that values data sharing and open science. After a period in which the original investigators can complete their funded studies, the data should be de-identified and made available for investigators globally.

    5. Identify, within all systematic reviews, trials that are not published, using sources such as clinicaltrials.gov and regulatory postings to determine what is missing.

    6. Share data.

It must be acknowledged that there are many obstacles — political, cultural, financial — to accomplishing these goals.  Some of these obstacles are discussed in the other three commentaries, which are open access and which I urge you to read:

Spertus, JA.  The Double-Edged Sword of Open Access to Research Data.  Circulation:  Cardiovascular Quality and Outcomes.  2012;5;143-144.

Ross JS, Lehman R, Gross CP.  The Importance of Clinical Trial Data Sharing:  Toward More Open Science.  Circulation:  Cardiovascular Quality and Outcomes.  2012;5;238-240.

Gotzsche PC.  Strengthening and Opening Up Health Research by Sharing Our Raw Data.  Circulation:  Cardiovascular Quality and Outcomes.  2012;5;236-237.

Whatever the difficulties, the current situation is clearly intolerable.  Patients deserve reliable information on the risks and benefits of medical treatments and the subjects of clinical trials deserve that their contributions be fully used to benefit other patients.

Addendum March 26, 2012:  Please also see these posts by Jim Murray and Gary Schwitzer.

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