“FRENCH police have made 21 arrests as part of an investigation into claims that meat from horses used for drugs testing found its way into the food chain,

The arrests were made at various locations in the south of France following a tip-off that hundreds of horses, including some that had been owned by pharmaceutical giant Sanofi, were sold to abattoirs after their veterinary papers were falsified, a police source said.

More than 100 officers were involved in raids at several Sanofi offices and at various abattoirs, including one in Gerona in northern Spain.

Among those arrested were at least three vets and several meat dealers, including one based in Narbonne in southwestern France who is suspected of being the ringleader of the illicit trade, police sources said.

Sanofi said it was cooperating with the investigation into "possible fraud" but played down the possibility of a threat to human health.

The company said it had sold around 200 horses in the last three years, generally to veterinary colleges, individuals or horse centres.

"The horses are all micro-chipped for tracability and they do not present any danger in the event of human consumption," a spokesman said.

A little horse... a butcher arranges different sorts of horse meat on sale at his shop in Bremen, northern Germany.

"It is specified in their sales certificates that these horses are not to be introduced to the food chain, but that is as a precautionary measure, not because there is any danger."

The company said that the horses had been used to provide blood for the manufacture of serums against tetanus and rabies and stressed they had not been used for drugs testing.

A police source also indicated that there was no evidence of a risk to human health "but they should never have found their way on to diners' plates".

The case follows a Europe-wide health scare earlier this year when horsemeat was found in millions of ready meals labelled as containing only beef.

Benoit Hamon, the French minister responsible for consumer affairs, said the latest episode was potentially more worrying than the labelling scandal, which centred on a French company, Spanghero.

"It's different. In this case there could be a health problem," Mr Hamon told RTL radio.

Horses as guinea pigs... Sanofi's horses would have been used either to provide blood for use in vaccines or for testing drugs still in development.

But Food Minister Guillaume Garot played down that idea. "At this stage there is nothing to indicate any health problem," he said.

Eating horsemeat is regarded as taboo in some European countries, notably Britain, but is still widespread in Belgium, France, Spain and Italy, although consumption is in long-term decline.”

Source: http://www.news.com.au/lifestyle/food/french-police-make-arrests-over-cliams-horses-used-in-sanofi-drug-tests-sold-as-meat/story-fneuz8wn-1226784504616

PERSONAL COMMENT 

Just to resume this scandal, in 2013, horsemeat has been found in different restaurant in France, Horse meat which has been treat in pharmaceutical laboratory from Sanofi. So, how is it possible? A multinational company as Sanofi cannot let something like that happening. During few years, Sanofi was experimenting new medicine on horse and then they sold horse to merchants, veterinary schools or individuals. 60 were returned to the circuit power. One of these merchants betrayed his word; Sanofi has decided to become a civil party.

This scandal was terrible for Sanofi because nowadays, horsemeat is in centre of attention. That’s the second time in 2013 that there is problem about this kind of meat in France. For sanofi, which really care about its corporate reputation it’s really serious, they decided to complain and participate in helping policy in their investigation.

Nicolas Toupin

Liver Failure Warning Upgraded for Telithromycin

The Food and Drug Administration has determined that the antibiotic telithromycin (Ketek) may be associated with serious liver injury and liver failure, and has been linked to four deaths and one liver transplant. The drug's maker, Sanofi-Aventis, has upgraded a caution in the drug's label on the potential for liver injury to a bolded warning that serious hepatic injury has been “observed during or immediately after treatment.” Injury has progressed rapidly after just a few doses, according to the company.

Ketek has not received a black box warning, and both the FDA and Sanofi say the drug's benefits outweigh its risks.

“We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

However, the drug maker has stopped enrollment in five pediatric trials investigating use of Ketek in acute otitis media, community-acquired pneumonia, and tonsillitis in children 6 months to 18 years old.

The new warning is based partly on an FDA analysis that found that Ketek may be associated with 12 cases of liver failure and four deaths since its approval in 2004. “We're engaged in ongoing discussions with the FDA regarding a detailed medical evaluation of hepatic events reported in connection with Ketek use,” confirmed Sanofi spokeswoman Melissa Feltmann, who would not comment further.

Ketek is currently approved for use in adults to treat community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis.

“We still believe that the benefit of Ketek outweighs any known risks of the drug when used for its FDA-approved indications,” said Emmy Tsui, another Sanofi spokeswoman.

Ms. Tsui said therapy will continue according to protocol in children already enrolled in the five pediatric trials, but that Sanofi would not enroll any new trial participants until it was certain that its development program “remains consistent with the current thinking of the FDA regarding the structure and design of antibiotic drug development in pediatrics.”

The Senate Finance Committee has been investigating Ketek's approval, as well as a postmarketing safety study that was later found to be fraudulent.

For several months, committee chairman Charles Grassley (R-Iowa), has been complaining that he's been stonewalled by the FDA in his attempts to meet with the agency's special agent who investigated the fraud. In mid-June, he visited the Department of Health and Human Services headquarters to demand such a meeting. Vince Ventimiglia, assistant secretary for legislation at HHS, said the agency has a policy of prohibiting access to lower-level investigators. Sen. Grassley, however, pointed out numerous instances of such investigators talking to the legislative branch, said a spokeswoman for the senator.

Source:  http://www.rheumatologynews.com/news/more-top-news/single-view/liver-failure-warning-upgraded-for-telithromycin/ac18d8d0a925168d6419771f94400f58.html

PERSONAL COMMENT 

        So, in this article Sanofi is taking the responsibility for the anthibiotic Ketek, that they have put on the market. The results have showen that this anthibiotic can make serious liver injory, and the medical assotiation wanted to forbid it on the phama market. Anyways, Sanofi had admitied the truth and said that they can prevent the liver injory, which, in my opinion is a good corporate tool, telling the truth in the public and take the responsibility about the problem. Ketek wasn`t took off the market.

With telling the truth, they are building an honest corporate relationship with their costumers, that is really important for the trust of your consumers.

Anyways, that is not enough, because, the cosnumers of Sanofi`s products can be scared of buying the products in the future, so I think that, beside taking the responsibility and being honest, a big company like Sanofi should present in public a proof about preventing the liver injures, or maybe a plan that is going to be realised.

Simona Markovska

Sanofi will share clinical trial data, but there is a caveat

Yet another large drugmaker has made a commitment to release clinical trial data. The latest to do so is Sanofi, which will join an effort begun last year by GlaxoSmithKline to establish a web site where researchers can request study information.

In announcing its decision, Sanofi also expressed support for a data sharing plan declared last summer by the pharmaceutical industry trade groups in the US and Europe, which want to offer an alternative to a more sweeping proposal being considered by the European Medicines Agency (read here andhere).

“Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers,” says Sanofi ceo Chris Viehbacher, who is also president of the European Federation of Pharmaceutical Industries and Associations, in a statement.

Whether the gesture will satisfy industry critics remains to be seen. Sanofi will make available trial data and related documents, including clinical study reports, for studies in human that were submitted to US and European regulators and the product must have been approved by both agencies – on or after January 1, 2014.

And for the Sanofi Pasteur vaccine division, the requested studies must have been submitted to either regulator and the product must have been approved on or after the same date. Although the drugmaker says it will continue to submit for publication the results from all company-sponsored clinical studies, regardless of the study outcome, trial data for older prescription drugs and vaccines will not be made available to researchers.

The move comes amid a growing clamor for wider access to detailed trial data in after years of controversy over the extent to which drugmakers disclose clinical trial data. The pharmaceutical industry has long been criticized for failing to fully make underlying patient-level data available to others who seek to verify results.

Drugmakers have long insisted data is proprietary, but critics say the reluctance to disclose such information can be a red herring for hiding unflattering results that may limit sales. They also argue that, without access to this underlying information, it can be difficult, if not impossible, for researchers to verify the safety and effectiveness of prescription drugs.

The debate has factored into numerous scandals in which drugmakers have been accused of withholding important information about side effects. Glaxo, in particular, was cited for such behavior with its Avandia drug, which figured prominently in a $3 billion settlement the drugmaker recently reached with the US Department of Justice for a number of infractions.

Last year, Glaxo became the first drugmaker to respond to the controversy by vowing to make data available and, more recently, involve its rivals. The effort reflects a deepening realization in the pharmaceutical industry that battling regulators and researchers over access is likely to further erode trust and could result in still more regulation.

At the same time, though, the EFPIA and PhRMA, the US trade group, have harshly criticized the EMA proposal to proactively make trial data available to researchers once an approval decision has been made. Their protests have had some impact. The EMA recently delayed plans to finalize its proposal.

For the most part, drugmakers have resisted any change, although since Glaxo launched its web site to provide patient-level data to researchers, upon request, several others have now agreed to participate, including Roche, Boerhinger Ingelheim, ViiV Healthcare – a joint venture between Glaxo, Pfizer and Shionogi to develop HIV medicines.

And last month, a deal was reached at the European Parliament that would require drugmakers and academic researchers to upload all results of their European clinical trials to a publicly accessible database (see this).

Just the same, industry efforts have so far yielded mixed reactions.

Pfizer last month expanded a policy and created a web site that will publish synopses of clinical study reports filed with regulatory agencies for approved products for which basic results are posted in the ClinicalTrials.gov registry, but only dating to September 2007. These CSR synopses will include summary results for all primary and secondary endpoints, but any data that could be used to identify individual patients will be removed (more here).

This qualification is one of two central sticking points that have defined the tussle over data. Drugmakers argue that patient level data should not be disclosed in such a way that patient privacy can be compromised. But some critics argue certain material can and should be released in order to detect safety signals and can be accomplished without breaching privacy.

The other area of debate surrounds what drugmakers call confidential commercial information. The industry argues they may suffer harm if rivals obtain certain data and are able to deduce insights into drug development or strategic thinking. AbbVie and InterMune cited this concern when they went to court to block the EMA from releasing trial data.

Meanwhile, Glaxo is haggling with a group of researchers who want clinical study reports for an infamous study of its Paxil antidepressant. They maintain Glaxo has balked at the request and has raised doubts about its commitment to releasing data. In the process, the dispute has raised questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data.

Another issue is independence. Both Glaxo and Pfizer maintain the panels formed to vet researcher requests are independent and, essentially, will function like Data Safety Monitoring Boards that review trial data for safety and effectiveness signals. However, the drugmakers are deciding on the composition of their panels, both of which contain people who have worked as consultants.

Source: http://www.forbes.com/sites/edsilverman/2014/01/02/sanofi-will-share-clinical-trial-data-but-there-is-a-caveat/

PERSONAL COMMENT

Because the trend of publishing clinical trial data of healthcare companies is on at the moment, Sanofi can’t ignore this. As the article says, Sanofi will join these companies as well.

This will be beneficial for the company, and for the whole healthcare business. First to start with the company Sanofi. Because Sanofi is releasing data like this, it becomes more transparent. You could say the communication towards all the shareholders will improve by this move of Sanofi. This way less scandals will happen.                                                                                                                                              

Besides this, it can be said that all the players in the market who are obeying to this trend, are helping each other. As the article mentions, there is the area of debate which concerns that the industry argues that they may suffer harm if rivals obtain certain data and are able to deduce insights into drug development or strategic thinking. I think they will make use of each other’s released data, but I don’t think this will affect the industry in a bad way. They will learn from each other, which brings me to my next point:

è The healthcare business will improve.

To conclude, I would say this move of Sanofi will improve the corporate communication:

·         By being more transparent. The shareholders will have more access to certain data

And besides the corporate communication, the reputation will improve as well:

·         By agreeing to improve the whole healthcare business together (this is the way I would look at it as a shareholder)

  

And to finish, drug makers have always been accused of withholding important information about side effects. By making the move like Sanofi does now, this will be prevented as well. And this concerns both the corporate communication and corporate reputation among shareholders and others. 

Ronald Nijenbanning

Speaking of Sanofi

Sanofi US has branched out in its blogging efforts and this week launched Speaking of Sanofi, its first corporate blog.

Managed by the company's corporate reputation and digital communications director Stacy Burch, the blog will include perspectives from Sanofi companies like its vaccine arm Sanofi Pasteur, biotech business Genzyme and animal health company Merial.

Alhough it's still early days for the blog, Sanofi already has an impressive list of contributors planned for Speaking of Sanofi.

These include the head of its North America R&D Hub Marc Bonnefoi, SVP of commercial operations at Sanofi Pasteur Damian Braga and CEO of Genzyme David Meeker.

Outlining Sanofi's plans in an introductory post Burch said Sanofi would also be inviting industry leaders to contribute guest posts.

The new blog adds to the Discuss Diabetes blog Sanofi launched in January 2011 and is further evidence of a resurgence of industry interest in the medium.

The time required to run a blog, certainly when compared with 'lighter' options -at least in terms of writing - like Twitter, has tended to keep their numbers down.

But this year has seen a higher than average number of pharma companies begin blogs, from AstraZeneca's Lab Talk and Lilly's expansion of its LillyPad blog, to Bayer UK's Diabetes Care blog and Boehringer Ingelheim's plans for The Future Just Happened.

Source: http://www.pmlive.com/blogs/digital_intelligence/archive/2012/december/sanofi_picks_corporate_voice_for_new_blogging_venture

PERSONAL COMMENT

Sanofi corporate communication efforts are once again highlighted by their new brand release. The multinational, leader on its sector in terms of external communication, has previous experience in this blog world. There is no doubt Sanofi knows how to engaged stronger relationhisps with its customers, reinforcing the contact and making it special and different from the competence.

Nowadays, with the huge increase of competence and the strong necessity of making the difference, it is extremely important for the companies to realize about the incredible benefits that social media and external communication bring to a company.

Opening a blog is a chance to publish not only the company discoveries and latest news but also interesting posts that catch customer’s attention or even collaborate with other firms in the industry, showing it to the world in just seconds. This is show Sanofi is working, appreciating the power of the new sites that make the firm visible worldwide, which is completely essential whn being a multinational.

The firm is doing a great job, after having made the difference with its work on the Diabetes field, opening a blog, launching a forum, and creating Twitter and Facebook profiles, through which it can mantain  direct contact with its patients. Now, with its new corporate blog, the company keeps on the correct direction to stand out from the crowd, taking the maximum benefit from the unlimited chances new communication model brings nowadays.

Itziar Barbón Carcedo

Sanofi launches a monster mobile diabetes game

Monster Manor iPhone and Android apps aim to encourage better management of 

the condition

Crazy monsters, bizarre furniture and weird pets are at the heart

of a new mobile game from Sanofi UK for children with diabetes.

Available on the iPhone, iPad and Android devices, Monster Manor is a 

collecting game with a built-in tracker that provides positive feedback 

the more regularly players test and log their blood glucose levels.

The company wants to encourage children with type I diabetes to better 

manage their condition through regular blood glucose testing in a move 

that builds on its mobile diabetes experiences with the 

iPhone-compatibleiBGStar meter.

The free game was developed as part of a partnership 

between Sanofi UK, Diabetes UK and behavioural change gaming firm 

Ayogo Health.

Michael Fergusson, CEO at Ayogo Health, said: “As game designers, 

watching children play Monster Manor has been very satisfying, as the 

kids tell us that it's fun and they want to keep playing. But for us, fun is 

only a means to an end; the goal ultimately is to improve health 

outcomes for the children we work for.”

Children between ages six and 13 with type 1 diabetes are expected to 

take on increasing responsibility for testing and logging their own blood 

glucose, but only 15 per cent achieve their blood glucose targets.

It is thought that just one extra test a day in teenagers could lead to a 

0.4 per cent reduction in blood glucose concentration or HbA1c, 

potentially making a significant difference.

Every time Monster Manor players enter their diabetes information they 

are rewarded with a piñata they can smash to collect a prize, and by logging children's blood sugar tests the app also serves as a tool for 

families and healthcare professionals to spot glycaemic trends.

Sanofi noted that the role of 'gamification' in the management of chronic

conditions has yet to be tested, but said the Monster Manor concept 

could an approach that soon catches on.

Andrew Hockey, medical director Sanofi Diabetes, said: “For children 

with type 1 diabetes who are resistant to testing this new app could help 

manage their condition with the promotion of better behaviours to 

supplement and support their daily regimen. We see this new app as a 

solution that promotes better outcomes.”

Pharma companies have explored games in diabetes before, notably in 

the form of Bayer's Knock 'Em Downs: Worlds Fair game for its Nintendo 

DS-compatible blood glucose meter, but to date there has been little 

rigorous assessment of their use.

Sanofi hopes to change this, and Monster Manor is set to be evaluated by

one of the NHS' Academic Health Science Networks, the bodies set up 

earlier this year to unite regional scientific and academic communities 

and industry.

Dr Katharine Owen, clinical lead for the Oxford Academic Health Science 

Network's Diabetes Network, said: “Technology is part of everyday life, 

so using it to help with balancing blood sugars and have fun at the same 

time is a brilliant idea!

“We are excited to be evaluating this project and hope our new diabetes 

network will come up with more bright ideas like this one that will make 

a big difference to patients of all ages."

Source: http://www.pmlive.com/blogs/digital_intelligence/archive/2013/october/sanof

i_launches_a_monster_mobile_diabetes_game_for_kids

PERSONAL COMMENT

Sanofi is, without doubts, very cared about their clients. This article 

shows one example of that. It talks about a new technological platform that 

the company launched and which the main goal is to improve the health of 

diabetic children. With this project I think Sanofi don’t profit neither directly 

or indirectly, because the target audience is limited, and the only way they 

can improve the profits are trough convincing children, or their parents or 

their doctors to buy Sanofi’s diabetes product.

This article is external to the company, it is well structured, and it is 

good to the firm image. It vogues the firm as a health care helper. The 

people that commented this article all support this project. I chose this article for a simple reason, because I am diabetic and I 

really care about all technologies related about. This is a good comment 

about a nice topic, diabetes during childhood is very upset thing, it can 

destroy a kid life. Whit this program it can be overtake better, turning the 

disease in a kind of game. 

Simão Lourenço Pereira