2018 measures to avoid valproate exposure in pregnancy recommended by the European Medicines Agency

PRAC new restrictions on valproate use; pregnancy prevention programme to be put in place

The European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in the womb. Babies exposed are at risk of malformations and developmental problems.

Main measures recommended by the PRAC

Where licensed for migraine or bipolar disorder

  • In pregnancy – valproate must not be used.
  • In female patients from the time they become able to have children – valproate must not be used unless the conditions of a new pregnancy prevention programme (see below) are met.

For epilepsy

  • In pregnancy – valproate must not be used. However it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.
  • In female patients from the time they become able to have children – valproate must not be used unless the conditions of the new pregnancy prevention programme are met.

Drugs Packaging

  • The PRAC has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy. In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level.
  • A patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.
  • Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.

New valproate pregnancy prevention programme

Assessing patients for the potential of becoming pregnant, and involving the patient in evaluating her individual circumstances and supporting informed decision making, pregnancy tests before starting and during treatment as needed, counselling patients about the risks of valproate treatment, explaining the need for effective contraception throughout treatment, carrying out reviews of treatment by a specialist at least annually, introduction of a new risk acknowledgement form that patients and prescribers will go through at each such review to confirm that appropriate advice has been given and understood.

Read the full press release.

Can pharmaceutical companies hold States hostage ?

Roche decided to withdraw an innovative oncology medicine from the Greek market, claiming that its price has fallen more than 50% because of the government’s regulatory interventions in the pharma area…

Roche decision to remove the drug from the prescribed medicines list means that its cost can no longer be covered by the state…

“There is a need to develop strong and systematic synergies in the policy area of pharmaceuticals, particularly on bargaining power in order to prevent unfair trading practices that are especially inappropriate in this very sensitive area,”

the Greek Council delegation said, adding that the case goes beyond narrow national interests.

More Information – Press Releases

  • Drug pricing debate to take place in heated atmosphere, euractiv, December 8, 2017.
  • Athens brings its dispute with pharma industry to the EU Council, euractiv, November 24, 2017.
  • Pharmaceutical company gives free access to drug after clash with Greek government, euractiv, Nov 2, 2017.
  • Greek health minister fumes at pharmaceutical company after drug withdrawal, euractiv, October 31, 2017.
  • Pharmaceutical company withdraws oncology drug from Greek market, euractiv, Oct 30, 2017.
  • Greek government on collision course with pharmaceutical companies over innovative drugs, euractiv, Oct 25, 2017.
  • New Commission study fuels generic drugs industry ‘manufacturing dispute’, euractiv, Oct 13, 2017.
  • Special Report – Protecting innovation in the pharmaceuticals market, euractiv, Oct 13, 2017.
  • Southern EU states present unified front in drug talks, euractiv, May 10, 2017.

Abus d’antibiotiques : une catastrophe annoncée

Bactéries résistantes, la guerre est déclarée – Enquête de santé le documentaire

Les antibiotiques sont l’arme la plus puissante contre les infections bactériennes. Mais à force d’en abuser, ces médicaments ont perdu de leur efficacité et les bactéries ont appris à s’en défendre.

A force d’abuser des antibiotiques, les bactéries ont appris à se défendre. Les médicaments ont perdu de leur efficacité. En France, chaque année, près de 12 500 personnes meurent des suites d’une infection causée par ces formes mutantes. Martelée depuis 2002, cette résistance pousse les plus pessimistes à envisager le pire pour les années à venir. D’autant que cette surconsommation se retrouve également chez les animaux d’élevage dont les bacilles résistantes peuvent se transmettre par la chaîne alimentaire.

Médicaments dangereux : à qui la faute ?

Ce que les missions d’enquête ne vous diront jamais

Sang contaminé, hormone de croissance, Distilbène, cérivastatine, Vioxx, Acomplia, Avandia, Di-Antalvic, vaccins contre l’hépatite B, la grippe ou le cancer de l’utérus : les gens n’en peuvent plus de constater que rien ne change malgré l’accumulation des scandales pharmaceutiques, et qu’en plus, tout semble s’aggraver dans une ambiance révoltante d’impunité.

Il s’agit donc de dire aux citoyens qu’ils ont raison d’être inquiets, de leur montrer que les réformes qu’on leur propose n’ont d’autre objectif que d’aggraver les conditions qui ont rendu possibles tous ces scandales, de les convaincre enfin qu’ils n’ont aucun motif sérieux de retrouver la confiance. Bref : de leur donner des éléments de fait suffisants pour inspirer leur protestation et alimenter leur résistance.

On partira le plus souvent d’expériences concrètes dont l’interprétation saute déjà aux yeux du plus profane, pour en tirer matière à une réflexion plus abstraite, tout en essayant de caractériser le rôle des principaux acteurs à l’œuvre : les médecins, les experts, les journalistes, les fabricants.

Les affaires associées à des médicaments dangereux se succèdent et ébranlent toujours plus la confiance des consommateurs dans l’industrie pharmaceutique.

Table des matières

Chap. 1 – Les médecins
– Dérive vers le préventif
– Information médicale
– Sens des sources
– “Le roman de la médecine”

Chap. 2 – Les experts
– Conflits d’intérêts
– Rôle des décideurs
– Impunité et inamovibilité
– Incompétence
– L’illusion du processus collégial
– Erreur et obstination

Chap. 3 – Les journalistes
– Déontologie
– Formation intellectuelle
– Vérification des sources
– Conflits d’intérêts

Chap. 4 – Les fabricants
– Un monde méconnu
– Inflation réglementaire
– Innovation
– Un business insolent
– Associations de patients
– Risque zéro

En Savoir Plus
Site Web du Dr Marc Girard.
Commentaires clients sur Amazon.

Ostéoporose, il y a comme un os

Ostéoporose : vraie menace ou fausse maladie ? – Enquête de santé, le documentaire

Dans la plupart des cas, l’ostéoporose n’est pas une maladie mais un processus naturel lié au vieillissement.

Le mode de dépistage de l’ostéoporose conduit des milliers de femmes en bonne santé à prendre des traitements préventifs dont l’efficacité est remise en cause. Des médicaments censés prévenir le risque de fracture qui peuvent avoir de graves effets secondaires. Aux Etats-Unis, ils sont au cœur de retentissants procès.

Le documentaire “Ostéoporose, il y a comme un os“, réalisé par Bruno Timsit, est suivi d’un débat animé par Michel Cymes, Marina Carrère-d’Encausse et Benoît Thevenet.

The opioid crisis and the devastation caused by the pharma industry

Drug Dealers in Lab Coats

“The other day I was invited to a gala celebrating a leader of the pharmaceutical industry as a moral leader. I nearly threw up. That’s because the pharma industry bears huge responsibility for the opioid crisis that has killed more than 200,000 Americans.”

Nicholas Kristof, The New York Times.


… “One reason our efforts have failed is we ignored the biggest drug pushers of all: American pharmaceutical companies.
Our policy was: You get 15 people hooked on opioids, and you’re a thug who deserves to rot in hell; you get 150,000 people hooked, and you’re a marketing genius who deserves a huge bonus.” …

… “Today, 75 percent of people with opioid addictions began with prescription painkillers. The slide starts not on a street corner, but in a doctor’s office.”…

…”Our pattern of opioid addiction points to a tragedy, driven by the greed of some of America’s leading companies and business executives, systematically manipulating doctors and patients and killing people on a scale that terrorists could never dream of.”…

Industry gifts to doctors linked to their branded and costly prescriptions, and should be banned

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia

Health care professionals who received gifts from the pharmaceutical industry not only wrote more prescriptions, but also more costly ones (including more brand name medications), than colleagues who did not receive such gifts.

2017 Study Abstract

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Gifts data from the District of Columbia’s (DC) AccessRx program and the federal Center for Medicare and Medicaid Services (CMS) Open Payments program were analyzed with claims data from the CMS 2013 Medicare Provider Utilization and Payment Data.

Washington DC, 2013

Physicians, nurse practitioners, physician assistants, podiatrists, and other licensed Medicare Part D prescribers who participated in Medicare Part D (a Federal prescription drug program that covers patients over age 65 or who are disabled).

Gifts to healthcare prescribers (including cash, meals, and ownership interests) from pharmaceutical companies.

Main outcomes and measures
Average number of Medicare Part D claims per prescriber, number of claims per patient, cost per claim, and proportion of branded claims.

In 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with more branded claims. Gift acceptance was associated with increased average cost per claim for PAs and NPs. Gift acceptance was also associated with higher proportion of branded claims for PAs but not NPs. Physicians who received small gifts (less than $500 annually) had more expensive claims ($114 vs. $85) and more branded claims (30.3% vs. 25.7%) than physicians who received no gifts. Those receiving large gifts (greater than $500 annually) had the highest average costs per claim ($189) and branded claims (39.9%) than other groups. All differences were statistically significant (p<0.05).

Conclusions and relevance
Gifts from pharmaceutical companies are associated with more prescriptions per patient, more costly prescriptions, and a higher proportion of branded prescriptions with variation across specialties. Gifts of any size had an effect and larger gifts elicited a larger impact on prescribing behaviors. Our study confirms and expands on previous work showing that industry gifts are associated with more expensive prescriptions and more branded prescriptions. Industry gifts influence prescribing behavior, may have adverse public health implications, and should be banned.

More Information

Why prescription drugs are now the third leading cause of death and the pharmaceutical manufacturers dominance of mental healthcare

James Moore interviews Professor Peter Gøtzsche, Nordic Cochrane Centre Director, 2017

James Moore was keen to talk to Prof. Peter Gøtzsche about his background in research, his views on antidepressant prescribing and how pharmaceutical manufacturers have influenced mental healthcare.


  • Professor Gøtzsche’s background in clinical trials within the Pharmaceutical industry.
  • How the pharmaceutical manufacturers were manipulating clinical trial data for their own gain.
  • How drug manufacturers have denied for more than 20 years that benzodiazepines and antidepressant drugs cause dependance.
  • How the UK drug regulator (MHRA) also denied this in 2003 at the same time that the World Heath Organisation reported that 3 antidepressants were in the top 30 list of drugs that create dependance.
  • That surveys of patients show that between 50% and 66% of those taking antidepressants experience dependance.
  • The similarities between the pharmaceutical industry and the tobacco industry.
  • That stopping an antidepressant suddenly can be very dangerous.
  • How prescription drugs have become the third leading cause of death behind heart disease and cancer.
  • How pharmaceutical manufacturers have used their power and influence to the detriment of patient safety.
  • That the best science shows that there is no doubt that psychiatric drugs have killed millions of people over the years.
  • How psychotherapy is shown to reduce the risk of suicide but instead we prescribe pills that increase the suicide risk for all ages of patients.
  • That the chemical imbalance lie is still being propagated amongst psychiatrists even thought here is no scientific evidence whatsoever so support it.
  • How psychiatric drugs should be used for acute/emergency situations only.
  • That the medication centred approach of psychiatry does more harm than good.
  • How patients should avoid psychiatric drugs unless they are used for a very short time or that the patient really feels that they need them.
  • That when you look at the randomised controlled trials, there is a large risk of bias in these trials and that antidepressant efficacy has been overstated.
  • That the Cochrane Collaboration undertook the most rigorous meta analysis ever undertaken of 131 trials involving 27,422 patients taking SSRI’s, this analysis showed that antidepressants do not have any meaningful effects and their harms outweigh any benefits there might be.


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

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.

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.

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