Press review

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Specialists criticise growing prescription of Novartis’ Ritalin in France

PARIS, 8 Mar (APM) - Specialists are criticising the growing number of Novartis’ Ritalin (methylphenidate) prescriptions in France, reported Le Parisien on Tuesday (p.10).
According to France’s drugs regulator, ANSM, 26,000 boxes of Ritalin were sold in France in 1996 compared to more than 600,000 in 2014. The drug remains the best way to combat attention disorders and is relatively under-prescribed in France compared to other countries, the paper continued, but it raises the question of whether children always need to take it.
Psychoanalyst Roland Gori, quoted in the paper, said that diagnosing children with hyperactivity suits everyone, as it means society can shed its guilt, but it means the sense and source of these symptoms are ignored. The issue is that doctors prescribe the drug too quickly, as it would require a whole battery of tests to make a true attention deficit hyperactivity disorder (ADHD) diagnosis, said journalist Hélène Fresnel and head of psychiatry at Fernand-Widal hospital Franck Bellivier.

Merck summoned over failure to provide drug information to patients

Merck was due to appear in court on Tuesday, charged with failing to give drug information to patients, reported l’Humanite on Tuesday (p.16).
Merck changed the formula of its Levothyrox (levothyroxine) which was marketed between March 2017 and April 2018 and was subject to numerous complaints of significant side effects from patients, including tiredness and headaches.
Around 4,113 patients are now suing Merck for lack of information. Their lawyer, Christophe Lèguevaques is accusing the pharma of putting shareholder interests before patient wellbeing. Merck stated that it had not broken any regulations in reporting the change in the formula, the paper continued.

French court says Merck KGaA informed patients properly of new Levothyrox formula

The French justice system dismissed patient claims for compensation in a collectively filed complaint against Merck KGaA for failing to inform patients of the changes in its new Levothyrox (levothyroxine) formula on Tuesday, reported Le Parisien on Wednesday (p.12) (APMHE 62150).
Levothyrox’s new formula for thyroid problems was modified in 2017, following requests from the health authorities.
A few months later patients started to report adverse events including vertigo, hair loss and muscular and joint pain. Lyon’s court of first instance found that Merck KGaA acted correctly with the health authorities, reported La Croix on the same subject on Wednesday (p.8). It added that the quality and therapeutic value of the drug were sure and that its notice contained sufficiently relevant and precise information for patients.
Merck KGaA itself pointed out that legally pharma companies are forbidden from contacting patients directly, Les Echos reported on the subject on Wednesday (p.15). The 4,113 patients were claiming compensation of €10,000 each, the economic daily continued. On 20 December the French health ministry said that a study showed the new Levothyrox formula had not led to an increase in serious health problems, but an increase in doctors’ appointments.
Patients are not giving up as their lawyer Christophe Lèguevaques has not ruled out appealing the decision, Le Parisien reported. Libération also reported on the subject on Wednesday (p.15) as did Le Figaro (p.10).

Patients associations want to appeal court dismissal

Two thyroid patient associations want to appeal the decision taken by the French justice system regarding the new formula of Merck KGaA’s Levothyrox (levothyroxine), reports Le Parisien on Friday (p.9). The court of first instance in Lyon, southern France, dismissed complaints filed by patients against Merck KGaA on Tuesday, saying the pharma had indeed properly informed patients.
The two associations also said they want to join the judicial investigation relating to the Levothyrox affair regarding charges filed against X for aggravated deceit, endangering others, unintentional injury and involuntary manslaughter. The judicial investigation is ongoing in Marseille.

Sanofi facing charges in the Philippines for dengue fever vaccine

Sanofi is facing charges in the Philippines for the deaths of 10 children vaccinated by its dengue fever vaccine, Dengvaxia (dengue tetravalent vaccine), reported La Croix on Monday (p.10).
When the vaccine was launched in February 2016 in the Philippines, it was declared a historic moment. It was the first vaccine in the world for dengue fever and the Philippines government supported a mass campaign during which 837,000 school children were vaccinated.
However, at the end of 2017, it began to emerge that the vaccine caused fevers in people who had not previously contracted dengue fever. The Philippines government is now pressing charges against Sanofi for the deaths of 10 children it says are linked to the vaccine. However, Sanofi is denying any causality between the two, but Dengvaxia is now reserved for patients who have already contracted dengue fever, to protect them against further attacks of the disease.
The Philippines is also requesting the pharma reimburse it for the vaccines used in the campaign for a total amount of €49.73 million but Sanofi has told the local authorities it will not do so, reported Les Echos on Monday (p.19).
The pharma also told the economic daily that it profoundly disagreed with the conclusions drawn and that it will defend itself forcefully before pointing out that it would make no further comments on an ongoing legal procedure (APMHE 62107).

Concerns around adverse events of MSD's Propecia for baldness

Merck Sharp & Dohme’s Propecia for male pattern baldness has been associated with a myriad of adverse events from low libido to erectile dysfunction to depression and even suicide, reported Le Figaro on Monday (p.11).
This is causing patients to wonder if it is worth the risk, the paper continued. Alopecia affects one in five men between the ages of 25 and 30 and one in three 30-year olds. It can have a significant psychological impact, with 10% of men affected consulting their doctor.
Opinions are divided as to whether taking Propecia for cosmestic reasons is reasonable, with French independent prescribing review Prescrire and professor Bernard Begaud from the University of Bordeayx saying that the drug should not be taken for male pattern baldness.
However, others, such as doctor Caroline Semaille and doctor Pascal Reygagne, state that patients must be informed of the risks and doctors should avoid prescribing it to patients who are already depressed.

Prozac rival, J&J’s Spravato, approved in U.S.

The U.S. Food and Drug Administration has approved Johnson & Johnson’s Spravato (esketamine) for the treatment of major depression after at least two other antidepressants have failed, to be taken in combination with an oral antidepressant, reported Les Echos on Thursday (p.19). It is the first remedy with a new mechanism of action since Eli Llly’s Prozac (fluoxetine) was approved in 1987, the paper continued.
Spravato comes with conditions however. In addition to only being approved in certain conditions, it can also only be administered under close supervision, and comes with a list of potentially long, yet transitory side effects, including nausea and feelings of drunkenness.
Patients taking Spravato also run the risk of becoming addicted, after researchers last year discovered it affects opioid receptors. However, the advantage of esketamine-based rugs is that they act almost immediately, instead of the several weeks needed by traditional antidepressants (APMHE 62146).

Drug delisting triggers soaring prices

Most pharma companies increase drug prices to compensate for a fall in sales when their drug is delisted, reported Le Parisien in a brief on Monday (p.17). According to a study published by the French department of research, evaluation and statistics (Drees) at the end of last week (APMHE 62077).
On average the prices of drugs delisted at the end of 2011 increased by 39% over a year in 54% of cases. Some products including Tonipharm’s mouth wash Alodont 200 ml (cetylpyridinium chloride) and Juvise Pharmaceuticals’ muscle relaxant Lumirelax (methocarbamol) saw their prices more than double when they were delisted.

French drugs regulator rejects Ipsen’s Smecta for under twos

France’s drugs regulator ANSM is no longer recommending Ipsen’s Smecta (diosmectite) for children under the age of two, Le Parisien reported on Monday (p.17).
The clay-based product could contain traces of lead, and therefore the product is not recommended for children under the age of two, even for a limited amount of time.
For the same reasons, it is no longer recommended for pregnant or lactating women. ANSM recommends that good hygiene and diet practices are implemented in case of stomach upsets, the paper continued. If symptoms continue, ANSM recommends using an oral rehydration solution which can be bought in pharmacies over the counter (APMHE 62105).

UCB Pharma to pay compensation to patient’s grandson

UCB Pharma has been ordered to pay almost €3 million to a young man with a handicap linked to the Distilbène (diethylstilbestrol) his grandmother took, reported Le Parisien in a brief on Tuesday (p.10). Distilbène was prescribed between 1950 and 1977 to prevent miscarriages.

Danish study rules out link between vaccines and autism

A Danish study published this week in Annals of Internal Medicine proved there is no link between vaccines and autism, reported Le Monde on Thursday (p.12).
The idea that vaccines cause autism has been around since 1998, when The Lancet published a study carried out on 12 children suggesting a link between the measles, mumps, rubella (MMR) vaccine and autism. The study has been repeatedly disproved, but some parents are still reluctant to get their children vaccinated, as shown by the rise in measles cases.
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