Navigation Links
Multiple Sclerosis Drug Trial Criteria to Be Redefined

The tragic death of Anita Louise, a participant of the experimental multiple sclerosis drug trial in 2002 has been brought back to focus by two neurologists from Stanford University//. The authors warn about the dangers associated with drug testing, more so when the adverse effects of the experimental drug is unknown.

The drug natalizumab, marketed under the brand name was granted fast track status by the FDA in 2004. Soon after the approval, the drug use was found to be associated with a potentially fatal infection, progressive multifocal leukoencephalopathy (PML). The observation of infection in a patient who was devoid of the disease prompted the researchers to investigate further.

The researchers argue that healthy volunteers should not be allowed to participate in such drug trials, as they do not derive any benefit out of it. Furthermore, they feel that drugs associated with a risk of death should only be used in patients diagnosed with the disease, after all possible treatments have been found to be ineffective.

Multiple sclerosis is the manifestation of myelin sheath destruction surrounding the nerve cells. The immune system cells attack the myelin sheath, eventually leading to loss of control over motor function and even paralysis. The drug was found to block this effect.

It was highlighted that the inhibition of immune cells, could lead to an increased susceptibility to infections. In fact, PML is an infection that usually affects immunocompromised individuals such as transplant recipients, AIDS victims etc.

The drug was withdrawn from clinical use three months following its approval. With this being the situation, the FDA has taken up the re-approving of the drug as a single therapy. The advisory panel members would get together on the 7th and 8th of March to discuss the issue.

'A big mistake was made in these trials that, in my opinion, is easily preventable. All they need to do is t ighten up entry criteria into multiple sclerosis clinical trials and we could avoid similar types of problems in other trials,' concluded Langer-Gould, one f the senior researchers involved in the study.


Related medicine news :

1. Naked DNA Vaccination May Conquer Arthritis and Multiple Sclerosis
2. Multiple organ disease cured by genes
3. Adult stem cells in treatment for Multiple sclerosis (MS)
4. Life Quality For Patients With Multiple Sclerosis
5. Effective Pain Relief For Patients Suffering From Multiple Sclerosis
6. The Link Between Hepatitis B Vaccine And Multiple Sclerosis Questioned
7. Hope For Patients With Multiple Sclerosis
8. Individuals Born In May At A Higher Risk Of Developing Multiple Sclerosis
9. Debating The Link Between Sex Hormones And Multiple Sclerosis
10. Warning Issued by FDA on consumption of the drug Tysabri used to treat Multiple Sclerosis
11. Decreasing Multiple Births By Single Embryo Transfers
Post Your Comments:

(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question ... from last year? , This question has not been an easy question to answer. ... retirement age and the younger workforce don’t share the same discipline around working long ...
(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... innovative online platform for mental health and wellness consultation, has collaborated with a ... will bridge the knowledge gap experienced by parents and bring advice from parenting ...
Breaking Medicine News(10 mins):
(Date:11/29/2015)... , Nov. 29, 2015   Royal Philips  ... driven radiology solutions at the 2015 Radiological Society of ... 4 at McCormick Place in Chicago ... will experience the company,s broad portfolio of integrated Diagnostic ... solutions to increase clinical performance, improve workflow and create ...
(Date:11/29/2015)... Germany , Nov. 29, 2015  At this ... attendees to experience the most complete mobile C-arm portfolio ... display is Ziehm Vision RFD 3D, the world,s only ... cm edge length per scan volume. In addition, Ziehm ... fully motorized mobile C-arm in four axes which is ...
(Date:11/29/2015)...  The GE Health Cloud 1 was unveiled today ... North America (RSNA) meeting in ... new cloud ecosystem and its applications will connect radiologists and ... multidisciplinary teams – both inside and outside the hospital setting. ... GE. "As the digital industrial leader, we are betting big ...
Breaking Medicine Technology: