Clinical Oncology News - Zoledronic Acid Debate in Breast Cancer Continues

Clinical Oncology News - Zoledronic Acid Debate in Breast Cancer Continues

San Antonio—Long-term results of the ABCSG-12 trial and subanalyses of two recently presented Phase III trials provide further evidence that bisphosphonates can improve survival in breast cancer patients with low estrogen levels. The results of the studies, presented at the recent San Antonio Breast Cancer Symposium (SABCS), have convinced some doctors of the low estrogen hypothesis, but for others the water is still very murky.....


Weighing the Evidence
In recent years, some oncologists have been prescribing bisphosphonates off-label to treat breast cancer, and the new studies may sway more doctors to do so.
“The anticancer effects of adjuvant zoledronic acid are now well established in endocrine-responsive patients,” said Dr. Gnant.
Dr. Paterson added that “inhibition of osteoclast function with bisphosphonates has an effect on cancer growth in older women, and little effect in premenopausal women.”
For other doctors, however, the jury is still out. “Subanalyses are suspect,” said Dr. Vogl. “This is interesting, but we need to study it some more. But if they study it some more, Novartis will have lost its patent protection by the time that study comes out. Novartis has some interest in it [being approved] now.”

Dr. Paterson is a consultant for GlaxoSmithKline, Amgen, Roche and Nicomed and has received a grant for a clinical trial involving denosumab. Dr. Gnant disclosed relationships with AstraZeneca, Novartis, Pfizer, Sanofi, Roche, Schering and Amgen. Dr. Möbus disclosed relationships with Amgen, Novartis and Roche. Dr. de Boer disclosed a relationship with Novartis. Drs. Ingle and Dr. Vogl have no relevant disclosures.

open access: PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

PLoS Medicine: A Comparison of DSM-IV and DSM-5 Panel Members' Financial Associations with Industry: A Pernicious Problem Persists

 Introduction

All medical subspecialties have been subject to increased scrutiny about the ways by which their financial associations with industry, such as pharmaceutical companies, may influence, or give the appearance of influencing, recommendations in review articles [1] and clinical practice guidelines [2]. Psychiatry has been at the epicenter of these concerns, in part because of high-profile cases involving ghostwriting [3],[4] and failure to report industry-related income [5], and studies highlighting conflicts of interest in promoting psychotropic drugs [6],[7]. The revised Diagnostic and Statistical Manual of Mental Disorders (DSM), scheduled for publication in May 2013 by the American Psychiatric Association (APA), has created a firestorm of controversy because of questions about undue industry influence. Some have questioned whether the inclusion of new disorders (e.g., Attenuated Psychotic Risk Syndrome) and widening of the boundaries of current disorders (e.g., Adjustment Disorder Related to Bereavement) reflects corporate interests [8],[9]. These concerns have been raised because the nomenclature, criteria, and standardization of psychiatric disorders codified in the DSM have a large public impact in a diverse set of areas ranging from insurance claims to jurisprudence. Moreover, through its relationship to the International Classification of Diseases [10], the system used for classification by many countries around the world, the DSM has a global reach.........

Summary Points

• The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
• The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
• Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
• Gaps in APA's disclosure policy are identified and recommendations for more stringent safeguards are offered.

open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....

Introduction

"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]....."

Summary Points

• Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
• In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
• For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
• In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
• Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
• Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

Author Insights: Some Clinical Trials Intended for Drug Marketing, Not Advancing Science « news@JAMA (seeding trials)

Pharma: Pain Therapeutics - SMi Group - Event Details - UK - Overview

This conference seeks to address Recent successes and failures for new drugs in development Translational pain R&D Current human and animal pain models Pain managment methodologies Pain treatment Clinical trial design considerations

Cost recovery (handouts) trumps concerns about conflicted interest -- Canadian Medical Association Journal

Although there's widespread variation in the policies that Canadian medical schools have toward pharmaceutical and medical devices industry handouts for medical education and in some cases, seemingly no policies at all, administrators say there is no need for restrictive guidelines ....cont'd

Session Overviews Pharma-Nutrition 2011 Conference Netherlands conference notice/program