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HEALTH

France halts sale of contraceptive pill

France has suspended sales of an acne drug whose use as a birth control pill has been linked to the deaths of four women.

France halts sale of contraceptive pill
File photo of pills. Photo: E-magine art/Flickr

It is the latest health scare to erupt in France, coming after controversies involving later-generation contraceptive pills, breast implants and a pill used as a dietary aid that was linked to heart failure.

On Wednesday, the National Agency for the Safety of Drugs and Health Products (ANSM) said it was suspending sales of a hormonal treatment called Diane-35, which is currently prescribed to 315,000 women in France.

The move will be phased in over three months to allow users to find an alternative drug, Dominique Maraninchi, the agency's director, told a press conference.

The product, made by the German firm Bayer, is authorized for treating acne in young women, but doctors have been prescribing it as a contraceptive because it stops ovulation, he said.

"This drug is not licensed for use as a contraceptive," Maraninchi said. "(…) But it is being used as such, in this secondary role… yet there are plenty of other alternative contraceptives that can be used in this country."

Maraninchi said the agency had also carried out a benefit-versus-risk assessment for Diane-35 on the basis of its use as an acne treatment. The assessment was negative, which explains why the drug is being suspended from the French market, he said.

Diane-35 is sold in 116 countries around the world, according to the ANSM website. Over 25 years, four women have died and 125 fallen ill from blood clots attributed to Diane-35, according to ANSM.

France has been shaken by a series of health scares in recent years. It has asked the European Medicines Agency (EMA) to change prescription guidelines for so-called third- and fourth-generation oral contraceptives after these drugs were found to carry a higher risk of blood clots compared to earlier versions.

In 2010, the French authorities called down breast implant manufacturer Poly Implant Prothese (PIP) after it was found to be using non-authorized silicone gel that caused a high rate of implant ruptures. Health experts disagree on the risks, though.

Another scandal concerns an anti-diabetes drug called Mediator, manufactured by the French pharmaceutical company Servier, which started being used as a slimming aid because it reduces hunger pangs.

The drug was pulled off the market in 2009 after evidence emerged of hundreds of deaths caused by damage to heart valves.

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HEALTH

When can doctors in Denmark refuse to continue treating patients?

General Practitioners in Denmark have the right to break off a patient-doctor relationship in specific circumstances.

When can doctors in Denmark refuse to continue treating patients?

Although doctors in Denmark have the right to decide not to continue treating a patient – requiring them to find a new GP – the circumstances in which this can happen are limited, and must be approved by health authorities.

The frequency in which the circumstances arise is also low. A doctor decided to no longer receive a patient on 375 occasions in 2016, according to the medical professionals’ journal Ugeskrift for Læger. The following year, newspaper Jyllands-Posten reported the figure at 458.

There are two main categories of circumstances in which a doctor can choose to take this step. The first is in instances of violent or threatening behaviour from the patient towards the doctor. 

The second (and most common) is when the doctor considers the relationship to have deteriorated to the extent that confidence has broken down, according to Ugeskrift for Læger.

It should be noted that patients are not bound by any restrictions in this regard, and can decide to change their GP without having to give any justification.

A patient also has the right to appeal against a doctor’s decision to ask them to find a new GP. This is done by appealing to the local health authority, called a Region in the Danish health system.

In such cases, a board at the regional health authority will assess the claim and if it finds in favour of the patient may order the doctor to attempt to repair the relationship.

Doctors cannot end a relationship with a patient purely because a patient has made a complaint about them to health authorities. This is because patients should have the option of making complaints without fear of consequences for their future treatment. 

However, if this is accompanied by the conclusion on the doctor’s part that there is no longer confidence in them on the part of the patient, they can remove the patient from their list.

The right to no longer see patients in the circumstances detailed above is provided by doctors’ collective bargaining agreements, the working conditions agreed on between trade unions and employer confederations under the Danish labour market system.

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