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

Are junior doctors reluctant to speak up about unprofessional behaviour ?

Speaking up about traditional and professionalism-related patient safety threats: a national survey of interns and residents

New doctors are less likely to speak up about a colleague’s unprofessional behaviour than they are about traditional threats to patients’ safety, even when they perceive high potential for harm to patients, a US study has found.

The study found that junior doctors reported “fear of conflict” as a barrier to speaking up about unprofessional behaviour. The authors said that their findings, published in BMJ Quality and Safety, showed “important safety deficits” and the need to provide more supportive clinical environments to foster open communication.

…continue reading Junior doctors hesitate to speak up over unprofessional behaviour, study finds, on The BMJ Careers, 05 Jun 2017.

2017 Study Abstract

Background
Open communication between healthcare professionals about care concerns, also known as ‘speaking up’, is essential to patient safety.

Objective
Compare interns’ and residents’ experiences, attitudes and factors associated with speaking up about traditional versus professionalism-related safety threats.

Design
Anonymous, cross-sectional survey.

Setting
Six US academic medical centres, 2013–2014.

Participants
1800 medical and surgical interns and residents (47% responded).

Measurements
Attitudes about, barriers and facilitators for, and self-reported experience with speaking up. Likelihood of speaking up and the potential for patient harm in two vignettes. Safety Attitude Questionnaire (SAQ) teamwork and safety scales; and Speaking Up Climate for Patient Safety (SUC-Safe) and Speaking Up Climate for Professionalism (SUC-Prof) scales.

Results
Respondents more commonly observed unprofessional behaviour (75%, 628/837) than traditional safety threats (49%, 410/837); p<0.001, but reported speaking up about unprofessional behaviour less commonly (46%, 287/628 vs 71%, 291/410; p<0.001). Respondents more commonly reported fear of conflict as a barrier to speaking up about unprofessional behaviour compared with traditional safety threats (58%, 482/837 vs 42%, 348/837; p<0.001). Respondents were also less likely to speak up to an attending physician in the professionalism vignette than the traditional safety vignette, even when they perceived high potential patient harm (20%, 49/251 vs 71%, 179/251; p<0.001). Positive perceptions of SAQ teamwork climate and SUC-Safe were independently associated with speaking up in the traditional safety vignette (OR 1.90, 99% CI 1.36 to 2.66 and 1.46, 1.02 to 2.09, respectively), while only a positive perception of SUC-Prof was associated with speaking up in the professionalism vignette (1.76, 1.23 to 2.50).

Conclusions
Interns and residents commonly observed unprofessional behaviour yet were less likely to speak up about it compared with traditional safety threats even when they perceived high potential patient harm. Measuring SUC-Safe, and particularly SUC-Prof, may fill an existing gap in safety culture assessment.

Sources and Press Releases

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.

HPV vaccination not recommended by 1/3 of doctors

Primary Care Physicians’ Perspectives About HPV Vaccine

Around one third of doctors surveyed do not strongly recommend the HPV vaccine to parents. Researchers used a national survey asking approximately 600 paediatricians and family doctors, between October 2013 and January 2014, to outline their stance on the HPV vaccine.

January 2016 Study Abstract

BACKGROUND AND OBJECTIVES
Because physicians’ practices could be modified to reduce missed opportunities for human papillomavirus (HPV) vaccination, our goal was to:

  1. describe self-reported practices regarding recommending the HPV vaccine;
  2. estimate the frequency of parental deferral of HPV vaccination;
  3. and identify characteristics associated with not discussing it.

METHODS
A national survey among pediatricians and family physicians (FP) was conducted between October 2013 and January 2014. Using multivariable analysis, characteristics associated with not discussing HPV vaccination were examined.

RESULTS
Response rates were 82% for pediatricians (364 of 442) and 56% for FP (218 of 387).

  • For 11-12 year-old girls, 60% of pediatricians and 59% of family physicians (FP) strongly recommend HPV vaccine; for boys,52% and 41% ostrongly recommen.
  • More than one-half reported ≥25% of parents deferred HPV vaccination.
  • At the 11-12 year well visit, 84% of pediatricians and 75% of FP frequently/always discuss HPV vaccination.
  • Compared with physicians who frequently/always discuss , those who occasionally/rarely discuss(18%) were more likely to be FP (adjusted odds ratio [aOR]: 2.0 [95% confidence interval (CI): 1.1–3.5), be male (aOR: 1.8 [95% CI: 1.1–3.1]), disagree that parents will accept HPV vaccine if discussed with other vaccines (aOR: 2.3 [95% CI: 1.3–4.2]), report that 25% to 49% (aOR: 2.8 [95% CI: 1.1–6.8]) or ≥50% (aOR: 7.8 [95% CI: 3.4–17.6]) of parents defer, and express concern about waning immunity (aOR: 3.4 [95% CI: 1.8–6.4]).

CONCLUSIONS
Addressing physicians’ perceptions about parental acceptance of HPV vaccine, the possible advantages of discussing HPV vaccination with other recommended vaccines, and concerns about waning immunity could lead to increased vaccination rates.

Sources and Press Releases
  • Primary Care Physicians’ Perspectives About HPV Vaccine, pediatrics, January 2016.
  • ANOTHER MOTHER WANTS YOU TO SEE WHAT AN HPV VACCINE INJURY LOOKS LIKE, collective-evolution, APRIL 24, 2017.

Association between physicians’ interaction with pharmaceutical companies and their clinical practices

A systematic review and meta-analysis, 2017

Abstract

Background
Pharmaceutical company representatives likely influence the prescribing habits and professional behaviors of physicians. The objective of this study was to systematically review the association between physicians’ interactions with pharmaceutical companies and their clinical practices.

Methods
We used the standard systematic review methodology. Observational and experimental study designs examining any type of targeted interaction between practicing physicians and pharmaceutical companies were eligible. The search strategy included a search of MEDLINE and EMBASE databases up to July 2016. Two reviewers selected studies, abstracted data, and assessed risk of bias in duplicate and independently. We assessed the quality of evidence using the GRADE approach.

Results
Twenty articles reporting on 19 studies met our inclusion criteria. All of these studies were conducted in high-income countries and examined different types of interactions, including detailing, industry-funded continuing medical education, and receiving free gifts. While all included studies assessed prescribing behaviors, four studies also assessed financial outcomes, one assessed physicians’ knowledge, and one assessed their beliefs. None of the studies assessed clinical outcomes. Out of the 19 studies, 15 found a consistent association between interactions promoting a medication, and inappropriately increased prescribing rates, lower prescribing quality, and/or increased prescribing costs. The remaining four studies found both associations and lack of significant associations for the different types of exposures and drugs examined in the studies. A meta-analysis of six of these studies found a statistically significant association between exposure and physicians’ prescribing behaviors (OR = 2.52; 95% CI 1.82–3.50). The quality of evidence was downgraded to moderate for risk of bias and inconsistency. Sensitivity analysis excluding studies at high risk of bias did not substantially change these results. A subgroup analysis did not find a difference by type of exposure.

Conclusion
There is moderate quality evidence that physicians’ interactions with pharmaceutical companies are associated with their prescribing patterns and quality.

Treat You Better – Pay For Performance Initiatives in Health Care

Parody of the 2016 Shawn Mendes song

Video by James McCormack, published on 22 January 2017.

For those healthcare providers who struggle with adhering to Pay For Performance measures this may resonate somewhat.

Many pay-for performance initiatives in health care have some major limitations – most importantly P4P initiatives typically forget that individual patients should be involved in heath care decision-making activities.

Dissenting Diagnosis

Voices of Conscience from the Medical Profession

dissenting diagnosis book cover image
Dissenting Diagnosis,
Voices of Conscience from the Medical Profession, by Dr Arun Gadre and Dr Abhay Shukla.

Complaints about the state of medical care are increasing in today s India; whether it s unnecessary investigations, botched operations or expensive, sometimes even harmful, medication. But while the unease is widespread, few outside the profession understand the extent to which the medical system is being distorted.

Dr Arun Gadre and Dr Abhay Shukla have gathered evidence from seventy-eight practising doctors, in both the private and public medical sectors, to expose the ways in which vulnerable patients are exploited by a system that promotes unscrupulous medical practices. At a time when the medical sector is growing rapidly, especially in urban areas, with the proliferation of multi-specialty hospitals and the adoption of ever-more sophisticated technologies, rational and ethical medical care is becoming increasingly rare. Honest doctors feel under siege, professional bodies meant to regulate the medical sector fail to do so, and the influence of the powerful pharmaceutical industry becomes even more pervasive.

Drawing on the frank and courageous statements of these seventy-eight doctors dismayed at the state of their profession, Dissenting Diagnosis lays bare the corruption afflicting the medical sector in India and sets out solutions for a healthier future.

  • See more DES books on this Flickr album.
  • Read How Pharmaceutical Companies Entice Doctors Into Prescribing Expensive Medication, the Caravan, 16 April 2016.
  • Read Customer Reviews on Amazon and GoodReads.

How to eliminate the risk of the third leading cause of death

Dr Peter Gøtzsche’s views on prescription drugs

Video published on 1 April 2015 by John McDougall.

Peter C. Gøtzsche, MD is a Danish medical researcher, and leader of the Nordic Cochrane Center at Rigshospitalet in Copenhagen, Denmark. He has written numerous reviews within the Cochrane collaboration.

Dr.Gøtzsche has been critical of screening for breast cancer using mammography, arguing that it cannot be justified; His critique stems from a meta-analysis he did on mammography screening studies and published as Is screening for breast cancer with mammography justifiable? in The Lancet in 2000. In it he discarded 6 out of 8 studies arguing their randomization was inadequate.

In 2006 a paper by Gøtzsche on mammography screening was electronically published in the European Journal of Cancer ahead of print. The journal later removed the paper completely from the journal website without any formal retraction. The paper was later published in Danish Medical Bulletin with a short note from the editor, and Gøtzsche and his coauthors commented on the unilateral retraction that the authors were not involved in.

In 2012 his book Mammography Screening: Truth, Lies and Controversy was published. In 2013 his book Deadly Medicines and Organized Crime: How Big Pharma has Corrupted Healthcare was published.

Doctors need to solicit input from patients too

“I don’t think listening is enough” says Suzanne Gordon

Suzanne Gordon on soliciting input not just listening, The BMJ Blog, 26 Jan, 17.

Image credit @bmj_latest.

Want to be a better physician or nurse leader? Enhance patient safety? Effectively lead teams? One of the current consultant prescriptions is the recommendation that leaders spend more time listening than talking. Whether in the larger management literature or in the articles and books that specifically target healthcare, listening is portrayed as a key to leadership.

I am all for listening. Of course people have to listen to each other rather than silence, ignore, dismiss, or denigrate one another. When it comes to the implementation of genuine teamwork and patient safety within the hierarchical environment of health care, I don’t think listening is enough. As Amy Edmondson has written in her book Teaming, “Research shows that hierarchy, by its very nature, dramatically reduces speaking up by those lower in the pecking order. We are hard-wired, then socialized, to be acutely sensitive to power, and to work to avoid being seen as deficient in any way by those in power.”

Whether it’s nurses dealing with doctors, junior doctors dealing with senior ones, or patients dealing with the “team” that is supposed to be centered around their needs, subtle or overt manifestations of power hierarchy all too often defeat admonitions that people should speak up. To remedy this requires more than active listening, it requires actively soliciting input from those on the team, particularly those lower on the totem poll—which includes not only staff but patients.

Frontline staff are often reluctant to speak up, tell higher ups when something is wrong, or warn them about a potential catastrophe or even just an everyday glitch. They are equally hesitant to cross-monitor members of the team and help maintain situational awareness by providing new, and not always welcome, information. As for offering their ideas for innovation and quality improvements, they may feel no one is interested or will listen. To counter these entrenched beliefs and perceptions—which are often based on past experience—requires a leadership commitment to aggressively solicit input rather than waiting for staff—whether professional or non-professional—to tell leaders something they need to know.

Soliciting input—and then actively welcoming it—can do a lot to help people see that it is safe to admit error, provide a needed warning or heads up, convey new information and update their colleagues and co-workers about the latest developments or changes in a situation. Asking people—and this must include patients—what they think, what they’re worried about, if they agree with, or understand a plan of care, and then respectfully responding to the need for clarification or further information gives people permission to speak up. This is critical when working with professionals or other healthcare workers and even more so when dealing with anxious, frightened, and vulnerable patients. In an environment in which people may be reluctant to speak up because they have not traditionally felt that it was psychologically safe to do so, soliciting input as a kind of “standing order” builds the foundation upon which effective listening is built.

In healthcare, which has staunchly resisted systematic teaming training, anecdotal evidence and research data document that leaders who do this are the exception not the rule. Which is why the skill of soliciting has to be both preached and practiced.

Consider a few examples.

A physician wants to discharge a patient to his home with a complex regimen of IV medication that the patient’s wife will have to administer at home. The patient’s nurse, and social worker, not the physician, have a great deal of information about the wife’s ability to deal with her husband’s medication regimen. The physician does not, however, solicit input from either nurse or social worker about the wisdom of his plan. Instead he simply orders nurse and social worker to prepare for the discharge. As a result, the patient’s wife becomes extremely upset, which generates a day long conflict in which the physician becomes increasingly frustrated as the nurses and social worker hint at, rather than clearly discuss, the problem and remedy—a delay of one or two days in the discharge.

Imagine what would have happened if the physician had gone to the social worker, and the nurse—as well as the patient’s wife—and solicited their input by asking if they thought his plan was reasonable? The result would have been the same—a delayed discharge—but the destructive conflict would have been avoided and all would have felt they were members of an effective team.

Or consider the dilemma relayed to me by several attending physicians on a neo-natal ICU at a major teaching hospital. The NICU attendings said they constantly tell their residents to call them with any problems they have on the weekend or at night. Because many residents are afraid they’ll get a bad mark if they express confusion or ask for help, they don’t get a lot of calls even though many residents have lots of questions. What’s the solution? Soliciting input. As my colleague neo-natalogist John Chou recommends, attendings can pick up the phone, call the unit, page the resident and then say, “hey, I know we have this very sick patient. We haven’t talked in a while, and I just wanted to know if you had any questions or concerns I can help with?”

When soliciting input is accompanied by a genuine offer of help—rather than appears in the guise of quizzing or passing judgment—Chou says, he always learns about critical details that can impact the course of a tiny patient’s life.

Finally, I can say as a patient, that when a physician asks me what I think about the treatment he or she is about to recommend (something I have occasionally experienced), wonders if I will have any problems with it, or follows up with a call asking me how things are going, my trust in that caregiver and willingness to follow the recommended treatment increases exponentially.

It’s pretty simple, when you ask you might hear something that is actually worth listening to.

Suzanne Gordon is a healthcare journalist and co-editor of  The Culture and Politics of Healthcare Work Series at Cornell University Press. Her latest book is Collaborative Caring: Stories and Reflections on Teamwork in Healthcare, which she co-edited and she is co-author of Beyond the Checklist: What Else Healthcare Can Learn from Aviation Teamwork and Safety. Most importantly she is a patient.