Deaths and serious side effects from multiple sclerosis drug „Zinbryta”

 

 

 

 

Animal experiments could not protect patients

 

The multiple sclerosis drug daclizumab (tradename Zinbryta) was withdrawn from the market worldwide in March 2018 after it had rapidly lost its patients’ deaths and serious side effects within a very short time. The symptoms were mainly meningitis and severe liver damage, up to acute liver failure. The previously conducted animal experiments on monkeys could not protect the patients from it, because they only fell ill with skin lesions. No other species was used for approval by the European Medicines Agency (EMA) because daclizumab is very specific only in humans and primates. There are no known animal experiments on other animal species during development – but they are likely. In the interest of humans and animals, the drug approval system must be put to the test.

Daclizumab (Zinbryta), a multiple sclerosis (MS) drug, was fully approved by the EMA in July 2016. This is despite the fact that serious side effects have already been reported in human clinical trials.

 

 

German market extremely attractive for the pharmaceutical industry

In contrast to other countries, German law allows a new drug to be sold directly after approval. And this at a price, that the manufacturer is allowed to determine. Only after one year does the manufacturer have to make a cost-benefit assessment.

The German market is therefore extremely attractive for pharmaceutical companies. They have a great economic interest in having a large number of patients prescribed their new medication in a short time. It is not surprising that Zinbryta was prescribed 2890 times in Germany alone. Throughout the rest of the EU there were a total of 400 regulations!

To achieve their goal, pharmaceutical companies are using a completely legal bribery method called application monitoring. Doctors and clinics are paid to prescribe a specific medicine and then document the application. For Zinbryta, this was 1.320.000 euros per patient over 5 years.

The benefit that one supposedly gets through such a pseudo study, namely the recording of efficacy, safety and tolerability in everyday clinical practice is just as much a farce as the study itself. Because according to experts, these industry-paid studies are worthless, as a very much of the results will never be published! Although declared as a study, a so-called application observation is nothing more than a marketing strategy of the pharmaceutical industry.

In 2016 alone, there were 500 observational studies, with at least 25 million euros being distributed to the doctors!!

 

 

Drug development from ground up renew.


In March 2017, Biogen and AbbVie Zinbryta withdrew from the market worldwide due to the devastating side effects, and ongoing clinical trials were discontinued. Far too late, considering the over 2,800 MS patients in Germany who have put their hope in this new therapy.

Those responsible have learned nothing from this new drug scandal.

This would be an appropriate time to innovate the drug development system from the ground up. Because before the studies on humans, extensive animal experiments are carried out, which are partly prescribed. And even with Zinbryta shows again that they fool the patient only a false security. Because the “long-tailed macaques” diseased “only” to skin lesions. No damaging effect on the liver or the meninges was found even after long-term administration.

No wonder, because animals and humans usually differ considerably in their metabolism and thus also in the effectiveness and harmfulness of certain substances. Thus, according to a study, only 43% of the side effects of substances on humans in mice or rats are comprehensible. So, a coin toss would provide more accurate results.

Artificial production of MS on mice

In 2014, the transferability of the results of three “animal models”, who used very frequently in MS research, was questioned at the University of Veterinary Medicine Hannover (Germany).

For example:  by injecting a special protein, which causes the immune system to attack its own nerve cells.

In another “model”, a virus infection of the central nervous system is caused in the animals.

And in the third case, mice are so genetically engineered that their bodies overproduce a certain substance that plays a central role in inflammatory reactions.

 

All these artificially produced symptoms of the animals, however, have nothing in common with the causes and history of the actual illness “multiple sclerosis” in humans. Even after decades of research, these are largely still in the dark, as they have hitherto relied almost exclusively on results from animal experiments. And so, it is not surprising that the mentioned study also comes to the conclusion that the results from the animal experiments have an extremely poor transferability to humans. And that not only on humans, but also the individual “animal models” differ considerably from each other.

There are now more meaningful, human-based methods. In the days of highly sensitive imaging, multi-organ chips, and computer simulation, multiple sclerosis research and the identification of potential drugs can be made much more effective, reproducible, and safer.

However, as long as animal testing in drug development as a so-called “security hurdle” are installed, as long as the application of new drugs in humans will be like a lottery game. A paradigm shift is long overdue!

https://www.aerzte-gegen-tierversuche.de/de/projekte/stellungnahmen/2674

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