13 December 2011

The biggest scandal in pharmaceuticals

Scandalous Mediator will change the French healthcare system
Ilya Dugin, Farmvestnik

The New York Times on December 12 brings us back to the scandal surrounding the antidiabetic drug Mediator, developed by the French pharmaceutical company Laboratoires Servier. For 33 years of existence in the French pharmaceutical market, more than 5 million patients have been prescribed for therapy with this drug, most of whom simply wanted to lose weight.

The drug and its developer found themselves in the epicenter of the biggest public health scandal in at least 10 years.

Officials of the French Ministry of Health cite data that up to 2 thousand patients died as a result of taking the drug, and thousands more were hospitalized. The reasons for this were serious side effects, mainly heart valve dysfunction and pulmonary hypertension.

Politicians and the press accused Servier of concealing the risks associated with the use of not only Mediator, but also other drugs of the company. Many noted that two weight loss drugs developed by a French company and similar to Mediator were at the center of a scandal regarding the weight loss drug Fen-Phen in the late 1990s in the United States, when 360 to 720 thousand people suffered as a result of its use. As tests have shown, the drug increases the risk of heart valve damage.

French state investigative authorities have accused Servier of licensing Mediator as an antidiabetic to avoid closer scrutiny of the drug. At the same time, she promoted it among doctors as a means to lose weight in order to increase sales.

The magistrates' charges contain articles such as consumer fraud and murder, and the prosecutor saw fraud in the company's actions in relation to the French healthcare system.

Court hearings will begin in 2012.

In October 2011, senators approved a package of reforms in the healthcare system. In particular, the French Government intends to undertake radical changes in the regulation of the circulation of prescription drugs.

According to French Health Minister Javier Bertrand, the reform is designed to strengthen pharmacovigilance and transparency at all levels of regulation.

According to the BBC, more than a third of women taking aromatase inhibitors experience such severe side effects that they stop taking medications without waiting for the end of the course of treatment. The results of the corresponding study were published at the annual symposium on the treatment of breast cancer in San Antonio (USA).

Doctors usually prescribe a 5-year course to postmenopausal women after surgery, chemotherapy or radiotherapy.
 
In a study involving about 700 patients, it turned out that 36% stop taking medications after 4 years, 10% – after two.

Side effects include severe joint pain, hot flashes, decreased libido and weight gain.

Most often, patients who have undergone chemotherapy or radiotherapy, which causes a number of unpleasant side effects, stop taking medications.

Aromatase inhibitors increase the chance of survival in breast cancer patients by 30%. Doctors consider this an important reason to continue using them. However, the serious side effects reported by patients also need to be taken into account.

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13.12.2011

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