Sanofi

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Group.png Sanofi  
(Big pharma)Rdf-entity.pngRdf-icon.png
Sanofi.svg
Predecessor• Aventis
• Sanofi-Synthélabo
Formation2004
Headquarters54 Rue La Boétie, Paris, France
Interestsvaccines, COVID-19/Vaccine, swine flu

Sanofi is one of Europe's largest pharmaceutical companies and is based in Paris, France.

Products

The company manufactures the allergy medicine Allegra. Its six therapeutic categories are: internal medicine and allergies, cardiovascular, thrombosis (blood clots), central nervous system disorders cancer and metabolic conditions. The company's top selling drugs are the blood thinners Plavix (which it markets with Bristol-Myers Squibb) and Lovenox; the cancer drugs Taxotere and Eloxatine; insulin brand Lantus and Ambien for insomnia. It is also one of the largest vaccine manufacturers, through its Sanofi Pasteur subsidiary.

Criminal and unethical issues

H5N1 Influenza virus vaccine

In November 2006, sanofi pasteur announced an agreement—"valued at up to $117.9m, dependent on the number of doses that can be formulated from bulk material"—with the U.S. Department of Health and Human Services for "the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine." [1]

Although the majority of vaccine production for the U.S. will be at its Pennsylvania plant, "the increased capacity at one of the company's European plants suggests that Sanofi holds out hope for further demands for its vaccine on the other side of the Atlantic." [2]

Sanofi pasteur "also has several agreements within Europe, including a contract with the French Ministry of Health to produce a 1.4 million dose stockpile of H5N1 vaccine with a clause to be called upon to provide enough vaccine to protect 28 million people in France should a pandemic strike. The firm also has an agreement with the Italian Ministry of Health." [3]

Sanofi pasteur is not only the "only vaccine manufacturer", but also "the only pharma firm, involved in the Flupan project funded by the European Commission. The project aims to improve pandemic preparedness in the EU by producing and testing experimental vaccines, compiling libraries of reagents and investigating new cell culture vaccine production techniques.

"Sanofi itself is responsible for producing a vaccine to combat another flu strain with pandemic potential, H7N1, that will be used in a Flupan clinical study." [4]

Risks

The FDA stated "It is fortunate to have this vaccine during this 'inter-pandemic' phase. The benefit of having a licensed vaccine against a potential pandemic influenza virus strain, even with limited data, outweighs the risk of having no vaccine at the time of an inevitable influenza pandemic," states.

Additionally, "because the number of people studied was small, rare safety events may not have been identified, but given the potential risk of a pandemic, this is the only vaccine currently available and its benefits outweigh its risks. In addition, sanofi pasteur has agreed to work with the U.S. government to gather additional information on the safety and effectiveness of the vaccine should it be used in the event of a pandemic." [5]

Stamaril vaccine

Sanofi Pasteur has since 2011 been involved in a very public battle with BBC correspondent Malcolm Brabant after he developed a severe psychosis following a vaccine with the company's yellow fever vaccine Stamaril ( on the U.S. market as YF-VAX.) On May 25th 2013, the vaccine-manufacturer admitted to British newspaper The Daily Telegraph that Malcolm Brabant is not the only reported case of mental disorder relating to Sanofi Pasteur's yellow fever vaccine.

Toxic antibiotic trial

In 2006, an antibiotic from Sanofi continued to be used in drug trials with more than 900 children worldwide, even after it was found to cause four times the average rate of acute liver failure in adults. The continued trials of the drug Ketek (Telithromycin) were criticized by a U.S. Food and Drug Administration (FD) official and a study consultant.

Initially, Sanofi defended the antibiotic as safe when used as directed. [1] However, after a flurry of negative reports, the company announced on June 8, 2006, that it was voluntarily ceasing the Ketek trials involving children. The FDA also ceased recruitment for the study.

The criticism before Sanofi's reversal was scathing.

"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" asked Dr. Rosemary Johann-Liang, of the FDA's Office of Drug Safety, in a memo uncovered by the New York Times. [2]

Duke University infectious disease specialist, Dr. Danny Benjamin called the pediatric trial "hard to support." He also noted that antibiotics are less frequently recommended for pediatric treatment of routine ear infections. [3]

Overcharging

In May 2009, the Sanofi-owned subsidiary Aventis Pharmaceutical was fined more than $95 million, "after overcharging US and local health agencies for medications destined for indigent patients" according to U.S. federal prosecutors. Aventis "acknowledged that it violated the False Claims Act by misreporting drug prices for patients in the Medicaid Drug Rebate program for poor patients," reported Agence France-Presse. Aventis "deliberately misquoted the prices, underpaying rebates to Medicaid and overcharging some public health agencies for the medications. The fraud occurred between 1995 and 2000, and concerned the steroid-based anti-inflammatory nasal sprays Azmacort, Nasacort and Nasacort AQ. 'We will continue to be vigilant in investigating and prosecuting those who scam the Medicaid system -- a system that is meant to benefit the poor' said Michael Loucks, acting US Attorney for the District of Massachusetts, in the Justice Department statement. 'When a drug company agrees to be a provider to the Medicaid programs, it agrees to sell its drugs to them at the same price it gives its best customers. We will, as here, pursue those who break their promises.'" [4]

Public relations

Americans for Medical Progress's (AMP) board of directors consists of senior executives and other representatives employed by the pharmaceutical and vivisection industries. Board members represent multinational, billion dollar corporations as well as universities and institutions receiving government grants for vivisection. [5] AMP runs media campaigns targeting animal rights, welfare and health advocacy groups. See also Americans for Medical Progress.

In February 2007, PR Week reported that Sanofi's vaccine business, Sanofi Pasteur, had "awarded business for half its product lines, including its candidate 5-in-1 vaccine Pentacel, to Publicis Public Relations." The contract is "a joint collaboration between Manning Selvage & Lee and Publicis Consultants PR, Publicis' newly rebranded PR offering." The firms will also be promoting "Adacel, the new Tdap (tetanus, diphtheria, acellular pertussis) vaccine for adolescents and adults," added PR Week. [6]


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