A Study of High Frequency Editorialists Favoring Hormone Replacement Therapy

Partisan Perspectives in the Medical Literature, Journal of General Internal Medicine, 2010

2010 Study Abstract

Background
Unfavorable results of major studies have led to a large shrinkage of the market for hormone replacement therapy (HRT) in the last 6 years. Some scientists continue to strongly support the use of HRT.

Objectives
We analyzed a sample of partisan editorializing articles on HRT to examine their arguments, the reporting of competing interests, the journal venues and their sponsoring societies.

Data Sources
Through Thomson ISI database, we selected articles without primary data written by the five most prolific editorialists that addressed clinical topics pertaining to HRT and that were published in regular journal issues in 2002–2008.

Main Measures
We recorded the number of articles with a partisan stance and their arguments, the number of partisan articles that reported conflicting interests, and the journal venues and their sponsoring societies publishing the partisan editorials.

Key Results
We analyzed 114 eligible articles (58 editorials, 16 guidelines, 37 reviews, 3 letters), of which 110 (96%) had a partisan stance favoring HRT. Typical arguments were benefits for menopausal and related symptoms (64.9%), criticism of unfavorable studies (78.9%), preclinical data that showed favorable effects of HRT (50%), and benefits for major outcomes such as osteoporosis and fractures (49.1%), cardiovascular disease (31.6%), dementia (24.6%) or colorectal cancer (20.2%), but also even breast cancer (4.4%). All 5 prolific editorialists had financial relationships with hormone manufacturers, but these were reported in only 6 of the 110 partisan articles. Four journals published 15–37 partisan articles each. The medical societies of these journals reported on their websites that several pharmaceutical companies sponsored them or their conferences.

Conclusions
There is a considerable body of editorializing articles favoring HRT use and very few of these articles report conflicts of interest. Full disclosure of conflicts of interest is needed, especially for articles without primary data.

Sources and Press Releases
  • Partisan Perspectives in the Medical Literature: A Study of High Frequency Editorialists Favoring Hormone Replacement Therapy, Journal of General Internal Medicine, September 2010, Volume 25, Issue 9, pp 914–919, 2010.
  • More naming and shaming, ripe-tomato, APRIL 17, 2012.
  • Editorials or review authors with financial ties to hormone therapy (HT) manufacturers, in which there appeared to be bias in favour of HT featured image credit Jim Thornton.

What Public Health Practitioners Need to Know About Unhealthy Industry Tactics

Industries’ Tactics to Protect their Business Wealth while Undermining Public’s Health and Global Environment

…”there are examples of governments trying to introduce policies that improve health, and protect the environment only to find their efforts undermined by unhealthy corporations, and their industry associations.”…

7 Tactics used by Unhealthy Industries

  • Attack legitimate science
  • Attack and intimidate scientists
  • Create arms length front organisations
  • Manufacture false debate and insist on balance
  • Frame issues in highly creative ways
  • Fund industry disinformation campaigns
  • Influence the political agenda
Find Out More

Quelle formation à l’indépendance pour les étudiants en médecine?

Thèse de Paul Scheffer, docteur en sciences de l’éducation, 2017

Les travaux de Paul Scheffer, membre actif du Formindep, ont insufflé une dynamique au sein des facultés de médecine puisque l’élaboration de sa thèse a été le point de départ d’un classement des facultés de médecine en fonction de leur indépendance vis à vis de l’industrie pharmaceutique.

Résumé

L’influence systémique de l’industrie pharmaceutique en médecine est étudiée depuis des décennies. La recherche et la clinique sont fortement touchées, avec des enjeux sanitaires, économiques et éthiques majeurs. La faiblesse des études médicales, en termes de formation à l’indépendance, est régulièrement identifiée comme l’un des secteurs prioritaires où des changements conséquents sont à apporter. Ceci serait d’autant plus nécessaire que les étudiants sont eux-mêmes soumis à l’influence des firmes tout en se croyant immunisés face à cette dernière.

Cette thèse cherche à comprendre ce qui peut freiner et surtout favoriser la formation à l’indépendance et l’indépendance de la formation elle-même des étudiants en médecine. Cette recherche a ainsi donné une place particulière aux initiatives sources de transformations à la fois personnelle et institutionnelle en faveur de l’indépendance chez les acteurs (doyens, enseignants, étudiants, associations) de la formation initiale des médecins.

Ce travail s’articule autour de quatre niveaux :

  1. les politiques globales conditionnant l’enseignement supérieur,
  2. les positions des différents acteurs de la formation,
  3. les enjeux curriculaires,
  4. et les dispositifs pédagogiques.

Les étudiants en médecine se forment dans différents lieux au cours de leurs études, il est ici principalement question des facultés, même si l’hôpital et les stages chez des médecins généralistes sont aussi abordés. Enfin, tout en se focalisant sur la France, ce travail met à contribution les expériences réalisées à l’international en lien avec notre question.

  • Quelle formation à l’indépendance est-elle possible pour les étudiants en médecine, par rapport à l’influence de l’industrie pharmaceutique ?, formindep, présentée et soutenue publiquement par Paul Scheffer le 24 mai 2017.

SUR LE MÊME SUJET

What happens when drugs are designed based on treating symptoms only ?

Shane Ellison, Award-winning scientist, masters degree in organic chemistry

Video published on 8 April 2015, by David Singer Enterprises.

Diagnostic tests : how to minimise harm

We must develop new diagnostic tests to tackle real health problems, not to generate them

New diagnostic tests: more harm than good, BMJ 2017;358:j3314,
06 January 2016.

Defenders against overdiagnosis, BMJ 2017;358:j3487, 20 July 2017.

Although new diagnostics may advance the time of diagnoses in selected patients, they will increase the frequency of false alarms, overdiagnosis, and overtreatment in others.

Bjorn Hofmann, professor of medical ethics at Norwegian University of Science and Technology, explains how to minimise harm. Press Play > to listen to the recording.

Key messages

  • Innovative technologies and ample venture capital are combining to produce new disease biomarkers and mobile monitoring devices
  • These new diagnostics are technologically advanced but do not automatically provide improvements in clinical care and population health
  • They have the potential to help some but also to increase the frequency of false alarms, overdiagnosis, and overtreatment in others
  • Excessive testing and false alarms may increase healthcare workload and shift clinicians’ focus towards the healthy
  • Misleading feedback at both the population and individual levels tends to favour further market growth
  • Clinicians must provide a strong counterbalance: educating patients, respecting baseline risk, thinking downstream, and expecting misleading feedback

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How big data’s big bias is bringing noise and conflicts to US drug regulation

Jeanne Lenzer investigates, The BMJ, July 2017

A little known private foundation to support FDA’s “regulatory science” takes money out of the FDA’s coffers to support analyses using levels of evidence recommended by industry; many of the foundation’s directors have financial links to the drug and device makers that the FDA regulates.

Overview
  • No drug risks identified
  • Reagan-Udall Foundation
  • Directors’ ties to industry
  • Panel stacking
  • Funding the foundation
  • Funding the Medical Evidence Development and Surveillance (IMEDS)
  • Light touch FDA

Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety. For example, it has been used to identify overuse of some interventions and can show drug and device complications in real world settings rather than idealized controlled trials.

However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).” …

continue reading Jeanne Lenzer investigation Big data’s big bias: bringing noise and conflicts to US drug regulation on The BMJ, 18 July 2017.

Plus de transparence dans l’industrie pharmaceutique et des technologies médicales

Belgique, Ministère des Affaires sociales et de la Santé publique, 23/06/2017

BRUXELLES, 23/06/2017– A l’initiative de la ministre des Affaires sociales et de la Santé publique, Maggie De Block, l’obligation de transparence des firmes pharmaceutiques et des technologies médicales est ancrée juridiquement. La décision d’exécution a été publiée au Moniteur belge, aujourd’hui, 23 juin 2017. Les firmes devront rendre publics tous les avantages et primes qu’elles octroient aux associations de patients et aux professionnels et organisations du secteur de la santé. Il s’agit par exemple du soutien à la formation des professionnels de la santé.
En 2015, les transferts de valeurs provenant de l’industrie pharmaceutique s’élevaient à plus de 138 millions d’euros.

Cette obligation de transparence est inspirée de la loi américaine « Physician Payments Sunshine provision » de 2010, mieux connue sous le nom de «Sunshine Act». Elle est inscrite dans le Pacte d’avenir pour le patient avec l’industrie pharmaceutique et le Pacte des Technologies médicales. La ministre De Block a conclu ces pactes avec les secteurs concernés, respectivement le 27 juillet 2015 et le 5 octobre 2016, dans l’intérêt du patient.

Les deux secteurs ont déjà pris des initiatives dans le passé pour communiquer ce type de données. La ministre De Block fixe maintenant cette obligation de transparence légalement et l’étend à l’ensemble des acteurs des soins de santé. La ministre De Block :

« Le citoyen a le droit de savoir si l’industrie pharmaceutique ou celle des technologies médicales ont un lien avec un prestataire de soins, et si c’est le cas, ce que comprend ce lien. »

Publication
Les citoyens peuvent consulter tous les transferts de valeur de manière simple sur le site internet betransparent.be. Ils sont classés par professionnel de la santé, par organisation de la santé, par association de patients et par entreprise.

L’ensemble des transferts de valeurs octroyés pendant l’année calendrier 2017 devront être rendus publics au plus tard le 30 juin 2018. Les firmes devront communiquer ces données chaque année. A côté de ces infos, les données suivantes seront également mentionnées : les investissements en Recherche & Développement, les frais de séjour lors de congrès scientifiques, les rémunérations de consultance, le soutien financier apporté aux associations de patients, etc.

Gestion
Le site sera géré par beTransparent.be, qui regroupe l’ensemble des acteurs concernés. L’agence fédérale des médicaments et des produits de santé (afmps) est chargée de la supervision des activités de beTransparent.be et du respect de la législation.

En Savoir Plus

Post-marketing studies are not transparent enough and do not improve drug safety surveillance

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

BMJ 2017;356:j337 Study (Published 07 February 2017)

Our findings do not support the aspiration of the German Medicinal Products Act that post-marketing studies serve to improve long term drug safety surveillance.

In contrast, we found evidence that drug safety could be jeopardised by the current practice, as post-marketing studies are expected to contribute to pharmacovigilance, but in reality their data and results are treated as business secrets.

Our data support the view that the high remunerations paid by the sponsor to the participating physician could be serving commercial purposes rather than transparent and effective pharmacovigilance.

In our opinion the major problem with post-marketing studies is the confidentiality clauses in the contracts between physicians and sponsors. These contracts impose a major obstacle to scientific evaluation and discussion of post-marketing studies. In the interest of drug safety and public health, post-marketing surveillance should become more transparent. Data about and from such studies should no longer be considered confidential business information but should be made available to independent scientific evaluation and public scrutiny. Such increased transparency would allow future researchers to evaluate whether the changes in 2012 to EU pharmacovigilance legislation have been associated with any material improvements in the situation.

The importance of advising GPs and clinicians on their indispensable role in detecting, diagnosing, and reporting adverse drug reactions cannot be overestimated.

What is already known on this topic

  • Systematic evaluations of post-marketing industry funded trials are sparse
  • The few studies available have criticised post-marketing studies for their low scientific value and lack of scientific integrity and for being seeding trials masking marketing interests of the sponsors as research
  • Current legislation relies on post-marketing studies for drug safety surveillance

What this study adds

  • Post-marketing studies are not serving as a key tool for drug safety surveillance, at least among those registered in Germany
  • Sample sizes are generally too small to allow for the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor about all data, including adverse drug reactions
  • The post-marketing studies analysed are doing no measurable good to patients and could be taking resources away from more effective pharmacovigilance systems
Abstract

Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies, BMJ 2017;356:j337, 07 February 2017.

Objectives
To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.

Design
Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.

Setting
Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.

Main outcome measures
Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.

Results

Image credit The BMJ Fig 3 : Example of confidentiality agreement for post-marketing study (source: notification sent by Merck Serono on 18 March 2010 regarding post-marketing study of cladribine)

Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.

Conclusions
Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians’ reporting behaviours of adverse drug reactions.

Pharmaceutical industry payments and oncologist drug selection

Payments linked to higher odds of doctors prescribing certain cancer drugs

In preliminary findings that will be presented at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on Saturday, June 3, researchers show that when physicians had to choose between multiple, on-patent drugs for metastatic kidney cancer and chronic myeloid leukemia, they were more likely to prescribe drugs from companies they had received general payments – for meals, talks, travel, etc. – from.

2017 Study Abstract

Background
Financial relationships between physicians and the pharmaceutical industry are common, and have the potential to influence clinical practice in potentially inappropriate ways. Oncology may be an ideal setting to study the influence of industry payments on physician drug choice given the high levels of competition for market share and high prices commanded by orally administered oncologic drugs.

Methods
We linked the Open Payments database of industry-physician financial transactions with the Medicare Part D Prescriber file by physician name and practice location. We used McFadden’s conditional logit model to determine whether receipt of industry payments was associated with higher odds of using a drug manufactured by the same company. We applied this model to clinical scenarios in which oncologists may choose between multiple, on-patent drugs: metastatic renal cell cancer (mRCC) (sunitinib, sorafenib, and pazopanib) and chronic myeloid leukemia (CML) (imatinib, dasatinib, and nilotinib). The primary, binary independent variable was receipt of payments from a manufacturer of one of these drugs in 2013; the primary dependent variable was choosing that manufacturer’s drug in 2014. We divided industry payments into two categories, research payments and non-research “general” payments (including meals, travel, lodging, and speaking/consulting fees), and analyzed each payment type separately.

Results

More evidence that drug companies are able to influence prescribing practices through gifts to physicians.

Physicians who received general payments from a manufacturer had increased odds of prescribing that manufacturer’s drug for both mRCC (OR: 1.78, 95%CI 1.23-2.57, mean payments $566) and CML (OR: 1.29, 95%CI 1.13-1.48, mean payments $166). Research payments were associated with an increased odds of manufacturer drug use for mRCC (OR: 2.13, 95%CI 1.13-4.00, mean payments $33,391) but not CML (OR: 1.10, 95%CI 0.83-1.45, mean payments $185,763).

Conclusions
Receipt of general payments from pharmaceutical companies is associated with increased prescribing of those companies’ drugs. An association between research payments and prescribing was less consistent. This study suggests that conflicts of interest with the pharmaceutical industry may influence oncologists in high-stakes treatment decisions for patients with cancer.

Sources and Press Release

Many children with bi-polar and ADHD symptoms can be helped without the use of dangerous off-label drugs

Let’s try to find ways to relieve illness without the use of drugs

Video by dr rapp, published on 22 February 2008.

Many children with bi-polar and ADHD symptoms can be helped without the use of dangerous off-label drugs.

There are fast, easy and inexpensive answers available.

Each individual is different and the treatment is rarely identical.

Dr. Doris Rapp has dedicated her life to identifying and providing simple solutions to these and other behavior problems.

Our challenge for physicians is to find fast, easy, safe, effective and inexpensive ways to heal.