MS drug Tysabri back, but only under strict guidelines
Comment on this article | More story comments
http://qconline.com/archives/qco/sections.cgi?prcss=display&id=310119
By Amy Thon, athon@qconline.com
By Amy Thon, athon@qconline.com
A drug that was approved for multiple sclerosis patients two years ago but removed from the market because of the risk of brain infections is now back on the market under strict usage guidelines.
Dr. Daniel Johnson, of Neurology Consultants PC in Davenport, is certified to prescribe the drug, called Tysabri.
Tysabri is injected intravenously once a month.
Lindsey Wolf, 49, of Sherrard, took the drug for several months two years ago and began taking it again a month ago.
"Back then I found it was really helping me from getting worse," Mr. Wolf said. "I haven't really noticed anything yet (this time) because I only tried it once. I'm going to wait and see this next time to see how I do next month. I think it will be a pretty good drug."
Tysabri is an antibody that inhibits white blood cells from getting into the brain and attacking nerves. By keeping those cells from attacking nerves, Tysabri slows the worsening of disability that is common in patients with MS.
"It's a very powerful drug," Dr. Johnson said.
At the same time, the drug increases patients' chances of getting progressive multifocal leukoencephalopathy (PML), a rare brain infection that causes death or severe disability.
When the drug was on the market for a few months in 2004, three people got the virus and two died from it, Dr. Johnson said.
That's why when Tysabri came back on the market this year, it was made available only through a restricted distribution program called the TOUCH Prescribing Program. It only can be administered by approved doctors, infusion sites and pharmacies. To be approved, doctors, pharmacists and infusion centers must receive special training.
Genesis is the only hospital in the region and one of only four in Iowa that has been approved to deliver Tysabri. The Genesis pharmacy and infusion center at Genesis Medical Center, West Campus, are approved to offer Tysabri to patients.
Dr. Johnson said he does not know of other drugs that are as strictly controlled, although some chemotherapy drugs require special certification to administer.
Drugs previously approved to treat MS reduce flare-ups by about a third. Tysabri is twice as effective, reducing flare-ups by 67 percent and brain lesions by 80 percent.
In MS patients, flare-ups and lesions start to accumulate into permanent disability, Dr. Johnson said.
"We're really saving this for people who have more significant disease and have failed other therapies," he said.
Mr. Wolf said he doesn't believe drugs he's used previously have helped him. He is hopeful Tysabri will keep the disease from progressing and help him regain strength.
"I think this new drug will really be good," he said.
Multiple sclerosis at a glance:
-- More than 350 people in the Quad-Cities have MS.
-- Most people with MS are diagnosed between the ages of 20 and 50.
-- Women are twice to three times as likely to be diagnosed with MS.
-- Studies indicate that genetic factors make certain people more susceptible than others, but there is no evidence that MS is directly inherited.
-- MS is more common among people with northern European ancestry, but those of African, Asian, and Hispanic backgrounds are not immune.
Comments
4 comments on this article
Posted by HS from Winston-Salem at 6:26AM on Friday, 10/13/06
You need to get your facts straight on this:
"When the drug was on the market for a few months in 2004, three people got the virus and two died from it, Dr. Johnson said."
All three were trial participants, not takers of the drug in the market. Two were concomitantly on a drug called AVONEX which has effects of reducing Tysabri clearance from the body. The third patient was in the Crohn's trial involving Tysabri and was taking a host of immunosuppressants prior to Ty infusions.
Look the above up on your own time, the information IS out there. This drug is extremely remarkable since it allows people to regain physical mobility. Just see testimony from the FDA Advisory Committee meeting in March 2006. Give it time, patients WILL choose Tysabri over the other therapies.
Posted by some anonymous person at 6:59AM on Friday, 10/13/06
Your article is VERY misleading. The problem is not with Tysabri, but rather with the combination of Tysabri and Avonex. You really should read the New England Journal of Medicine articles before writing about Tysabri. Your article tends to frighten MS patients who could very well be helped by a drug that 1. has been shown to increase the quality of life, 2, is twice as effective as any other drug on the market, 3 reduces the cost of healthcare because of the reduction in remissions, and 4 has never had a case of PML when used in monotherapy on patients who were not taking other immunosuppressant drugs Unfortunately the same cannot be said of Avonex which had 1 patient report PML symptoms when taking Avonex in mono.
By the way, I would like to add that it is a shame that Biogen Idec insisted on initially marketing Tysabri as a combo with its Avonex drug rather than by itself. This was most likely a decision based on greed by the company.
Finally, you should read the article in the WSJ printed earlier in the year by a former FDA official who stated that Tysabri SHOULD NEVER HAVE BEEN TAKEN FROM THE MARKET and that there were more dangerous drugs being marketed everyday and he listed some of them.
Please before writing an article, make sure you know what you are talking about.
Posted by some anonymous person at 8:31AM on Friday, 10/13/06
Relax folks. SHe is quoting the doctor. It is an informative article that Tysabri is now available again. That is the key message.
Posted by JD from EM at 8:36AM on Friday, 10/13/06
The reporter just repeated the doctor's words. Sounds to me like Dr. Daniel Johnson needs to do his homework too. Get a second opinion?
http://qconline.com/archives/qco/sections.cgi?prcss=display&id=310119
By Amy Thon, athon@qconline.com
By Amy Thon, athon@qconline.com
A drug that was approved for multiple sclerosis patients two years ago but removed from the market because of the risk of brain infections is now back on the market under strict usage guidelines.
Dr. Daniel Johnson, of Neurology Consultants PC in Davenport, is certified to prescribe the drug, called Tysabri.
Tysabri is injected intravenously once a month.
Lindsey Wolf, 49, of Sherrard, took the drug for several months two years ago and began taking it again a month ago.
"Back then I found it was really helping me from getting worse," Mr. Wolf said. "I haven't really noticed anything yet (this time) because I only tried it once. I'm going to wait and see this next time to see how I do next month. I think it will be a pretty good drug."
Tysabri is an antibody that inhibits white blood cells from getting into the brain and attacking nerves. By keeping those cells from attacking nerves, Tysabri slows the worsening of disability that is common in patients with MS.
"It's a very powerful drug," Dr. Johnson said.
At the same time, the drug increases patients' chances of getting progressive multifocal leukoencephalopathy (PML), a rare brain infection that causes death or severe disability.
When the drug was on the market for a few months in 2004, three people got the virus and two died from it, Dr. Johnson said.
That's why when Tysabri came back on the market this year, it was made available only through a restricted distribution program called the TOUCH Prescribing Program. It only can be administered by approved doctors, infusion sites and pharmacies. To be approved, doctors, pharmacists and infusion centers must receive special training.
Genesis is the only hospital in the region and one of only four in Iowa that has been approved to deliver Tysabri. The Genesis pharmacy and infusion center at Genesis Medical Center, West Campus, are approved to offer Tysabri to patients.
Dr. Johnson said he does not know of other drugs that are as strictly controlled, although some chemotherapy drugs require special certification to administer.
Drugs previously approved to treat MS reduce flare-ups by about a third. Tysabri is twice as effective, reducing flare-ups by 67 percent and brain lesions by 80 percent.
In MS patients, flare-ups and lesions start to accumulate into permanent disability, Dr. Johnson said.
"We're really saving this for people who have more significant disease and have failed other therapies," he said.
Mr. Wolf said he doesn't believe drugs he's used previously have helped him. He is hopeful Tysabri will keep the disease from progressing and help him regain strength.
"I think this new drug will really be good," he said.
Multiple sclerosis at a glance:
-- More than 350 people in the Quad-Cities have MS.
-- Most people with MS are diagnosed between the ages of 20 and 50.
-- Women are twice to three times as likely to be diagnosed with MS.
-- Studies indicate that genetic factors make certain people more susceptible than others, but there is no evidence that MS is directly inherited.
-- MS is more common among people with northern European ancestry, but those of African, Asian, and Hispanic backgrounds are not immune.
Comments
4 comments on this article
Posted by HS from Winston-Salem at 6:26AM on Friday, 10/13/06
You need to get your facts straight on this:
"When the drug was on the market for a few months in 2004, three people got the virus and two died from it, Dr. Johnson said."
All three were trial participants, not takers of the drug in the market. Two were concomitantly on a drug called AVONEX which has effects of reducing Tysabri clearance from the body. The third patient was in the Crohn's trial involving Tysabri and was taking a host of immunosuppressants prior to Ty infusions.
Look the above up on your own time, the information IS out there. This drug is extremely remarkable since it allows people to regain physical mobility. Just see testimony from the FDA Advisory Committee meeting in March 2006. Give it time, patients WILL choose Tysabri over the other therapies.
Posted by some anonymous person at 6:59AM on Friday, 10/13/06
Your article is VERY misleading. The problem is not with Tysabri, but rather with the combination of Tysabri and Avonex. You really should read the New England Journal of Medicine articles before writing about Tysabri. Your article tends to frighten MS patients who could very well be helped by a drug that 1. has been shown to increase the quality of life, 2, is twice as effective as any other drug on the market, 3 reduces the cost of healthcare because of the reduction in remissions, and 4 has never had a case of PML when used in monotherapy on patients who were not taking other immunosuppressant drugs Unfortunately the same cannot be said of Avonex which had 1 patient report PML symptoms when taking Avonex in mono.
By the way, I would like to add that it is a shame that Biogen Idec insisted on initially marketing Tysabri as a combo with its Avonex drug rather than by itself. This was most likely a decision based on greed by the company.
Finally, you should read the article in the WSJ printed earlier in the year by a former FDA official who stated that Tysabri SHOULD NEVER HAVE BEEN TAKEN FROM THE MARKET and that there were more dangerous drugs being marketed everyday and he listed some of them.
Please before writing an article, make sure you know what you are talking about.
Posted by some anonymous person at 8:31AM on Friday, 10/13/06
Relax folks. SHe is quoting the doctor. It is an informative article that Tysabri is now available again. That is the key message.
Posted by JD from EM at 8:36AM on Friday, 10/13/06
The reporter just repeated the doctor's words. Sounds to me like Dr. Daniel Johnson needs to do his homework too. Get a second opinion?
posted by Bill at 2:14 PM
0 Comments:
Post a Comment
<< Home