Introduction
MS better known as multiple sclerosis is a very acute disease which affects the central nervous system because of the attacks by the immune system on the central nervous system. The disease causes many physical and mental symptoms. Young adults are more prone to this disease and especially women get affected by this disease. The disease mainly affects the brain and the spinal cord and this is known as white matter. The causes of the disease are not very clear till date; some believe it happens because of a virus called Epstein-barr, while the others believe that the disease is a metabolically dependent disease.
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Tysabri is the medication used in the treatment of multiple sclerosis, “TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.” (Tysabri, 13 September 2008).
The medication was released in a joint effort by Elan Pharmaceuticals and Biogen, Tysabri was previously known as Antegren. The medication was first launched in USA at the end of 2004. The medication was seen as a big breakthrough in the treatment of multiple sclerosis, but at a later stage it was realized otherwise. “At the end of February 2005, the drug was voluntarily withdrawn after three patients developed progressive multifocal leukoencephalopathy (PML), a rare but often fatal nervous system disorder.” (Drug Development, 2008).
The medication was reintroduces in the USA in the year July 2006 but this time came with warnings that it may affect the brain of the patients; the reintroduction of the drug was soon given clearance in Europe too. The drug was withdrawn because three people suffered from progressive multifocal leukoencephalopathy, which a fatal nervous system disorder. “Safety issues continue to haunt Tysabri with recent warnings from regulators in both the US and Europe of a potentially higher risk of liver damage (elevated hepatic enzymes and bilirubin) among patients taking the drug. As a consequence, patients taking Tysabri are required to have regular liver function tests and treatment discontinued in any patient judged at risk.” (Drug Development, 13 September 2008).
The manufacturers voluntarily withdrew Tysabri from the market; it was never made mandatory by any governing organization. Because of the three fatal cases which occurred upon using the medication, it was quite a sensible decision taken by the company to withdraw the medication from the market. The prevention of the withdrawal would have resulted in further problems for the companies, the goodwill of the people ones broken can never be got back, had the company prevented the withdrawal of the drug from the market, it would have had very few chances of re- launching the drug in 2006.
When the drug was launched, the price of the stock Biogen Idec Inc increased because the medication was very promising, after the three cases were reported in which one person died, the company voluntarily withdrew Tysabri and this had an obvious effect on the price of the company’s stock, the value of the company fell and the stock market reacted on the withdrawal of the drug by the company. “On February 28, Biogen’s stock price dropped from $67.28 to $38.65, a 42.5% drop. Some 118 million shares were traded, more than thirty times the average daily trading volume during the class period.” (Find Law, 13 September 2008).
The reintroduction of the drug came with a warning written in black to attract the attention of the customers, “On June 5, 2006, the FDA approved TYSABRI’s reintroduction into the market. The FDA’s approval restricted TYSABRI to use as a monotherapy for relapsing forms of MS; it was not approved for use in combination with other drugs or for other diseases. Because of the potential risk of PML, TYSABRI was recommended only for those MS patients who do not respond to other MS treatment. Every MS patient using TYSABRI must enroll in a risk management program run by Biogen which closely monitors patients for any signs of PML. In addition, the package insert label includes a “black-box” warning, the strictest warning the FDA can require, which warns of the risk of PML” (Find Law, 13 September 2008).
When it was discovered that the drug took away the life of a person, the hopes of the other patients’ dashed. This was a quite natural reaction because there were hopes of the patients that the drug would cure their multiple sclerosis but that was not to be the case and their hopes were dashed. Many patients were discouraged upon hearing that the drug has already caused a death. The reintroduction of the drug was a surprising decision and surprised many patients, the results have been positive and the drug has shown good results over the years but if taken by a person who has had hypersensitivity reaction to Tysabri, it can cause death, to avoid the same the drug carries safety instruction which should be stuck to.
References
Find Law. In Case Law.. Web.
Tysabri. In Drug development technology. Web.
Tysabri. In Tysabri.com. Web.