PARIS, 15 Feb (APM) - It is not just Bayer’s Androcur (cyproterone acetate) that can cause meningioma, benign brain tumours, reported Le Parisien on Monday (p.15).
France’s drug regulator ANSM noted Friday 8 February that other drugs used to treat the menopause, endometriosis and period-related problems such as Aventis’ Luteran (chlormadinone acetate, Sanofi group) and Theramex’s Lutenyl (nomegestrol acetate) and their generics can also cause the disease.
The link has not been formally established, but while waiting for more targeted studies, ANSM recommends that women taking these drugs be informed of the risks, and that the drugs should be prescribed for as short a time and at as low a dose as possible.
French HTA body not in favour of reimbursing predictive breast cancer treatment tests
France’s health technology assessment body (HAS) is not in favour of reimbursing genetic tests that predict the risk that a woman whose breast cancer is detected at an early stage will relapse after treatment, reported Le Parisien on Tuesday (p.10), saying it is “premature” to do so.
These genetic tests evaluate the risk using a group of genes involved in the tumour’s development. They are used to detect whether women need chemotherapy after their tumour has been operated on. HAS says that in a great majority of situations, the healthcare team has enough information to make the decision without needing to use a test.
The HTA body has however identified a group of women for whom these tests might be useful (5%-10% of these patients, equivalent to 2,000-4,000 women per year), reported Le Figaro on the same subject on Tuesday (p.9), but it says that it will await the results of further studies as the tests are not always reliable.
France’s health ministry currently covers the cost of the tests when requested to do so by hospitals as part of an larger measure for medical innovations.
This decision has worried the French society of predictive and personalised medicine, reported Le Monde Science & Médecine (p.3) on Wednesday. The society points out that several countries belonging to the Organisation for Economic Co-operation and Development (OECD) have already decided to completely reimburse this test.
France’s Prescrire publishes drug blacklist
Every year, independent French pharmaceutical journal Prescrire publishes its blacklist of drugs to avoid, and this year there are 82 drugs on it, reported Le Parisien on Monday (p.14).
The drugs Prescrire does not recommend include several painkillers, such as Menarini’s Ketum (ketoprofen 2.5%) and GlaxoSmithKline’s Voltarene (diclofenac sodium). Instead, Prescrire recommends paracetamol and ibuprofen (APMHE 61716
There are advantages and limits to Prescrire’s black list, reported Libération on Tuesday (p.15). Professor Bernard Bégaud is quoted in the article as saying that the list “acts as an incentive… which is a good thing” and adds that nothing on the list this year is going to cause a major scandal like Servier’s Mediator (benfluorex).
However, he and several others do wonder about the drawbacks of such a list, he continued. He pointed out that sometimes drugs are approved in France because they have a favourable benefit-risk ratio, and that doctors prescribe drugs because they believe they will be better than placebo. The article points out that these lists can hide the issue of product misuse, and that conflicts of interest can also be an issue.
Prescrire is an independent pharmaceutical review and its articles are not signed to further increase its independence, but Bégaud pointed out that conflicts of interest can also be of an individual nature.
Servier’s Pneumorel withdrawn from French market
Servier’s cough medication Pneumorel (fenspiride) was withdrawn from the French market on Tuesday, reported Le Parisien on Wednesday (p.8). It could cause heart rhythm issues, the paper continued
As a precaution, France’s drug regulator ANSM is asking patients to return all drug packages to their pharmacies.
Subcontractor Unither beats record for single-dose container production
Pharmaceutical manufacturing subcontractor group Unither has set a new record for single-dose container production, reports Les Echos on Friday (p.27). Unither grew by 10% last year and broke the record it had set itself 10 years ago for single-dose containers by manufacturing 2.6 billion single-dose drug containers in 2018.
An ageing population worldwide and the increasing buying power of developing countries is increasing demand, CEO of the group Eric Goupil told the economic daily. To meet demand, the company will be investing €400 million, notably in Blow-Fill-Seal technology. It is also looking to expand on the international market with a regulatory office recently being opened in China.
Sanofi CMO takes on extra role of chief digital officer
Ameet Nathwani, chief medical officer at Sanofi, will take on an extra role as chief digital officer, reported Les Echos in a brief on Wednesday (p.33) (APMHE 61834
). Nathwani has a doctorate in medicine, a degree in pharmaceutical medicine and an MBA. He joined Sanofi in 2016, after previously working at Glaxo, SmithKline Beecham, GlaxoSmithKline and Novartis.
Originally from Uganda, the British Nathwani’s mission is to “enhance Sanofi’s strategy to integrate digital technologies and medical science to ultimately improve patient outcomes,” reported Le Figaro in a brief on the same subject on Thursday (p.24).
New R&D head for Pierre Fabre Médicament
Maarten Kraan has been appointed head of research and development at Pierre Fabre Médicament, reported Les Echos in a brief on Thursday (p.33).
Kraan has a doctorate in medicine and joined the pharma industry in 2003, initially working for Schering-Plough as Global Medical Director for Immunology. He then worked at Bristol-Myers Squibb, Roche and AstraZeneca.
Sanofi increasing stocks ahead of Brexit
As a 'hard' Brexit could have repercussions on 3,000 drugs, Sanofi is increasing its stocks in the UK to cover all its patients for six weeks, reported Le Figaro on Tuesday (p.18).
Philippe Lamoureux, general manager for French pharma body Leem said that the French pharma industry is not worried but is being vigilant. Leem is asking for an agreement that avoids drugs being blocked at borders by custom regulations.
Diabetes support programme Sophia reduces health insurance spend
The Sophia diabetes telephone support programme has reduced health insurance spending since it was set up 10 years ago, reported Le Parisien on Monday (p.15).
Some 800,000 diabetes patients use the service, which has had encouraging results on public health and health insurance expenditure. The programme encourages patients to improve their everyday habits through testing, nutrition and physical exercise.
Call for more investment in rare skin diseases
Professor Christine Bodemer, head of the European reference network for rare skin diseases, is calling for research into rare skin diseases to be stimulated, in a op-ed published in Le Figaro on Monday (p.13).
She wrote that encouraging and participating in this type of research would lead to better understanding and innovative treatment of rare skin diseases, more than 500 of which have currently been identified.
She went on to say that this research must include promoting marketing authorisations for drugs already recognised as useful in treating these illnesses and paediatric marketing authorisations for drugs already approved for adults.
Propranolol used to cure heartbreak
Propranolol, a beta-blocker used to treat refractory-treatment migraine, is being used to cure heartbreak, reported Le Parisien on Thursday (p.8). Also known as ‘the forgetting pill’, it is already used to treat patients with post traumatic stress disorder, including survivors of the 13 November attacks in Paris.
Propranolol works with therapy to lessen the painful emotions associated with a memory. Alain Brunet, the Canadian researcher who pioneered this treatment, is training doctors how to use it in France.
Potential vaccine for emerging virus
Scientists from the Laboratory of Emerging Infectious Diseases at the Wistar Institute have designed a vaccine for the Mayaro (MAYV) virus, which was discovered in 1954 on the Republic of Trinidad and Tobago, reported Le Figaro on Monday (p.11).
The disease is spread by mosquitos, as are several other emerging viruses such as Dengue fever, Zika and chikungunya. It is proving difficult to develop vaccines against these diseases as sometimes the vaccines themselves can cause severe attacks of the disease.