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The drug was withdrawn from clinical use three months following its approval.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:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... To deal with these feelings, many turn to unhealthy avenues, such as drug or ... Center of Marne, Michigan, has released tools for healthy coping following a traumatic event. ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... 24, 2016 , ... People across the U.S. are sharpening their pencils and ... essay contest in which patients and their families pay tribute to a genetic counselor ... National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
(Date:6/23/2016)... 23, 2016  Experian Health, the healthcare ... the patient payment and care experience, today ... products and services that will enhance the ... offerings. These award-winning solutions will enable healthcare ... compliant in an ever-changing environment and redefine ...
(Date:6/23/2016)...  The National Pharmaceutical Council (NPC) today announced ... research organization as its newest member.  ... president and chief scientific officer, Mallinckrodt Pharmaceuticals, will ... Board of Directors. ... us in support of our efforts to conduct ...
Breaking Medicine Technology: