The comment has been made that Tysabri's early release and subsequent withdrawl may prove to be a setback for future MS drugs going through the FDA approval process. I believe that the "Tysabri thing" will, in the end, have exactly the opposite effect.
The FDA has been INUNDATED with correspondance from MS patients urging the agency to hasten the process of re-release. I am sure that this has been the loudest collective voice the FDA has ever heard from the MS community. MS may be an orphan disease in terms of the per capita number of people affected, but living with it is brutal and we're tired of waiting for effective treatments.
Tysabri info
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better2gether
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May Smart Money Article
.
May Smart Money Article
It's author James B. Stewart writes:
"I continue to recommend diversification in the biotech and pharmaceutical sector, but at some point one has to wonder if the pendulum has swung too far and, indeed, whether everyone is overreacting to the recent drug scares.
The question is whether the benefits of a medication outweigh the side effects and associated risks. Elan and Biogen halted trials of Tysabri, the ms drug, after two patients in a trial contracted a rare central nervous system disorder, and one of them died.
The next day, a Wall Street Journal editorial worried that the hypercaution of terrified regulators is exceeded only by the hypercaution of terrified drug makers. The Journal noted that Tysabri has been shown to be twice as effective as other therapies and that thousands of participants in the trail had used it without side effects.
Multiple sclerosis is a potentially debilitating disease with no known cure. Surely Tysabri will find its way to market eventually, perhaps with stronger warnings of its possible adverse side effects".
.
May Smart Money Article
It's author James B. Stewart writes:
"I continue to recommend diversification in the biotech and pharmaceutical sector, but at some point one has to wonder if the pendulum has swung too far and, indeed, whether everyone is overreacting to the recent drug scares.
The question is whether the benefits of a medication outweigh the side effects and associated risks. Elan and Biogen halted trials of Tysabri, the ms drug, after two patients in a trial contracted a rare central nervous system disorder, and one of them died.
The next day, a Wall Street Journal editorial worried that the hypercaution of terrified regulators is exceeded only by the hypercaution of terrified drug makers. The Journal noted that Tysabri has been shown to be twice as effective as other therapies and that thousands of participants in the trail had used it without side effects.
Multiple sclerosis is a potentially debilitating disease with no known cure. Surely Tysabri will find its way to market eventually, perhaps with stronger warnings of its possible adverse side effects".
.
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better2gether
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Drug withdrawal a travesty for MS sufferers
.
Drug withdrawal a travesty for MS sufferers
Michael Fumento
April 28, 2005
The yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, both the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous, as multiple sclerosis sufferers using a recently-pulled drug called Tysabri can attest.
Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to slow or reverse diseases for which previously there had been nothing available but pain relievers and to be effective against multiple diseases.
Such appears to be the case with Tysabri, produced in partnership by Biogen Idec and Elan Pharmaceuticals and approved for MS in late November. About 400,000 people in this country have MS, in which the immune system attacks both the brain and spinal cord and causes a host of symptoms including blindness, paralysis, and sometimes death.
There are other MS drugs, but none seem nearly as effective as Tysabri or as well-tolerated. In fact, results released this month of two years of clinical trials showed a stunning a 42 percent reduction in the risk of disability progression and an even more amazing 67 percent drop in clinical relapses.
In late clinical trials Tysabri has also apparently been extremely effective against Crohn’s disease, a severe bowel disorder. Additionally, it was also in human testing for rheumatoid arthritis. So it came as a stunning blow to the approximately 8,000 patients using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.
The force behind that axe was a tiny virus that’s extremely common but that the immune system keeps locked up. If unleashed, though, it causes an often fatal disease of the central nervous system called progressive multifocal leukoencephalopathy. Unfortunately two MS patients on Tysabri contracted the disease and one died. When the drug makers scoured their databases they found another PML death in a Crohn’s patient. He also died.
It’s possible that in suppressing the immune system’s attack, Tysabri may have let loose the virus. But tremendously complicating matters is that all three patients were also on other immunosuppressive drugs at the time, leaving the real possibility that Tysabri alone is harmless. There are NO known cases of PML in patients using only Tysabri, according to the FDA.
What’s bizarre to Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami, is that less-effective MS drugs known to kill people have been used for years. “We allow Novantrone,” he says, “and yet take Tysabri off the market.” Novantrone’s side effects can include heart failure and leukemia.
Likewise all the drugs that slow the progression of rheumatoid arthritis carry FDA warning labels, and two have been implicated in several deaths. Yet sufferers practically worship the companies that make them.
“Tysabri is a great drug,” says Horstmyer. “My patients . . . were delighted with the lack of side effects and its effectiveness.” He adds they’re “really ticked” that it’s been pulled. In fact, New York Newsday headlined a recent story, “MS Patients Plead for a Recalled Medication” and the drug makers are being deluged with requests from desperate MS sufferers.
Horstmyer thinks the threat of lawsuits was primarily responsible for the drug being withdrawn, while the Competitive Enterprise Institute’s Sam Kazman blames government. “What we’ve apparently got is FDA reverting to its traditional operating mode of deadly over-caution,” he says. “That plays well in both Congress and the press but it’s murder on patients.” Yet both agree that but for the COX-2 calamity there would have been no withdrawal and it’s wrong for Vioxx’s tentacles to be reaching out and grabbing other drugs.
“The Biogen and Elan people were trying to demonstrate the highest level of scrutiny” in pulling Tysabri until all patients could be evaluated,” says Horstmyer. But, “All the MS drugs have serious side effects,” he adds. Moreover, patients with MS “are among the most well-informed,” he says, and best able to balance the risks of their disease versus the rewards and risks of various drugs.
Says Horstmyer, “I really hope they can bring Tysabri back.”
Michael Fumento is author of BioEvolution: How Biotechnology is Changing Our World, a fellow at Hudson Institute, and a nationally syndicated columnist with Scripps Howard News Service.
http://www.townhall.com/columnists/gues ... 0428.shtml
Drug withdrawal a travesty for MS sufferers
Michael Fumento
April 28, 2005
The yanking from the market of both Vioxx and Bextra, members of a new generation of pain relievers called COX-2 inhibitors, has critics ripping raw flesh off the Food and Drug Administration. Inevitably, both the agency and pharmaceutical companies are under intense pressure to over-scrutinize new drugs. But over-caution can also cause tremendous, as multiple sclerosis sufferers using a recently-pulled drug called Tysabri can attest.
Tysabri belongs to an incredibly promising new class of biotech drugs called monoclonal antibodies. Monoclonals have repeatedly shown an ability to slow or reverse diseases for which previously there had been nothing available but pain relievers and to be effective against multiple diseases.
Such appears to be the case with Tysabri, produced in partnership by Biogen Idec and Elan Pharmaceuticals and approved for MS in late November. About 400,000 people in this country have MS, in which the immune system attacks both the brain and spinal cord and causes a host of symptoms including blindness, paralysis, and sometimes death.
There are other MS drugs, but none seem nearly as effective as Tysabri or as well-tolerated. In fact, results released this month of two years of clinical trials showed a stunning a 42 percent reduction in the risk of disability progression and an even more amazing 67 percent drop in clinical relapses.
In late clinical trials Tysabri has also apparently been extremely effective against Crohn’s disease, a severe bowel disorder. Additionally, it was also in human testing for rheumatoid arthritis. So it came as a stunning blow to the approximately 8,000 patients using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.
The force behind that axe was a tiny virus that’s extremely common but that the immune system keeps locked up. If unleashed, though, it causes an often fatal disease of the central nervous system called progressive multifocal leukoencephalopathy. Unfortunately two MS patients on Tysabri contracted the disease and one died. When the drug makers scoured their databases they found another PML death in a Crohn’s patient. He also died.
It’s possible that in suppressing the immune system’s attack, Tysabri may have let loose the virus. But tremendously complicating matters is that all three patients were also on other immunosuppressive drugs at the time, leaving the real possibility that Tysabri alone is harmless. There are NO known cases of PML in patients using only Tysabri, according to the FDA.
What’s bizarre to Dr. Jeffrey Horstmyer, director of the MS Center at Mercy Hospital in Miami, is that less-effective MS drugs known to kill people have been used for years. “We allow Novantrone,” he says, “and yet take Tysabri off the market.” Novantrone’s side effects can include heart failure and leukemia.
Likewise all the drugs that slow the progression of rheumatoid arthritis carry FDA warning labels, and two have been implicated in several deaths. Yet sufferers practically worship the companies that make them.
“Tysabri is a great drug,” says Horstmyer. “My patients . . . were delighted with the lack of side effects and its effectiveness.” He adds they’re “really ticked” that it’s been pulled. In fact, New York Newsday headlined a recent story, “MS Patients Plead for a Recalled Medication” and the drug makers are being deluged with requests from desperate MS sufferers.
Horstmyer thinks the threat of lawsuits was primarily responsible for the drug being withdrawn, while the Competitive Enterprise Institute’s Sam Kazman blames government. “What we’ve apparently got is FDA reverting to its traditional operating mode of deadly over-caution,” he says. “That plays well in both Congress and the press but it’s murder on patients.” Yet both agree that but for the COX-2 calamity there would have been no withdrawal and it’s wrong for Vioxx’s tentacles to be reaching out and grabbing other drugs.
“The Biogen and Elan people were trying to demonstrate the highest level of scrutiny” in pulling Tysabri until all patients could be evaluated,” says Horstmyer. But, “All the MS drugs have serious side effects,” he adds. Moreover, patients with MS “are among the most well-informed,” he says, and best able to balance the risks of their disease versus the rewards and risks of various drugs.
Says Horstmyer, “I really hope they can bring Tysabri back.”
Michael Fumento is author of BioEvolution: How Biotechnology is Changing Our World, a fellow at Hudson Institute, and a nationally syndicated columnist with Scripps Howard News Service.
http://www.townhall.com/columnists/gues ... 0428.shtml
-
HarryZ
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Re: May Smart Money Article
Better,
If the drug companies, such as Biogen, conducted themselves in a more responsible manner when it came to the proper testing of these drugs, then we wouldn't have the kind of situation that ended up with Tysabri. But that lure of the $$$$ always changes people's thinking and when things get rushed and procedures don't get followed...well, we all know what happens.
Harry
If the drug companies, such as Biogen, conducted themselves in a more responsible manner when it came to the proper testing of these drugs, then we wouldn't have the kind of situation that ended up with Tysabri. But that lure of the $$$$ always changes people's thinking and when things get rushed and procedures don't get followed...well, we all know what happens.
Harry
-
better2gether
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Drug returned vitality patient desired
May 4, 2005
Drug returned vitality patient desired
OUR HEALTH
By DAVID RUMBACH
Tribune Staff Writer
SOUTH BEND -- Heather Smith watches her son zip around the house. He's a ball of energy, a typical non-stop toddler who flies between points of fleeting interest like a hummingbird in a flower garden.
His mother, Heather, does her best to keep up with 21-month-old Ezra.
But she's held up by multiple sclerosis. The disease forces her to plod with a walker. It saps her energy and makes her long for naps.
She especially hates the naps.
"You always feel like you're missing something when you have to leave in the middle of the afternoon,'' she says.
Smith made sure she was among the first local MS patients to receive a breakthrough drug called Tysabri after it won Food and Drug Administration approval last November.
She had been watching the drug from its early stages, when it was called Antigren and was being injected into rodents. She even bought some stock in Biogen Idec, the drug company behind Tysabri.
"I've known this drug since it was being given to mice,'' she says.
Tysabri did not disappoint her when she finally had a bag of it hanging by her side at Memorial Hospital and being infused into her arm through an intravenous line.
She received two treatments, one each in January and February. But then Tysabri was abruptly pulled from the market after two MS patients who were receiving it developed a dangerous brain disease. One of them died.
But Smith did not become sick on Tysabri. She got much better. Wonderfully, she no longer craved naps. It even reminded her what life was like before she was diagnosed with MS six years ago.
"I got a glimpse of my old body,'' she said.
She was able to leave the house by herself and go shopping at Walgreens -- parking in a handicapped spot and making it to the door with her walker.
"You know you're in the house too much when you're excited about a trip to Walgreens,'' she quips.
Smith was so disappointed with the withdrawal of Tysabri that, with the help of her younger sister, Hillary Beck, she wrote a letter to Biogen asking for a favor.
Smith asked the company if there was some way she could continue taking Tysabri. She'd even sign a statement saying she accepted the risk.
The company wouldn't let her do that. But it did invite her to join its national patient advisory board. It also asked permission to add her name to a list of patients available for media interviews. She agreed to both.
The media list led to an interview with The Wall Street Journal and a quote in a recent article on disappointed Tysabri patients from around the country.
She and her husband, Troy, were to fly to Boston today for her first meeting with the patient advisory group.
Life-changing diagnosis
MS has been shaping her life ever since she was diagnosed in 1998 at the age of 28.
The first tough decision was whether or not to take one of the three drugs available at the time of her diagnosis in the hope of slowing down the progress of the disease.
Such treatment decisions are tough to make for newly diagnosed MS patients. Half of patients diagnosed with MS will progress to a worse form of the disease.
But doctors can't predict whose symptoms will stay mild and whose will become severe. So patients are often unsure from week to week whether the drug is needed, or if it's doing them any good.
Smith chose Avonex, a medication that patients give themselves by intramuscular injection once a week.
The medicine's side effects were such that she felt like she had the flu for one day of every week, she said.
"I don't regret the decision, but it was frustrating to deal with the uncertainty (of whether the drug was making a difference),'' she said.
Every shot was a fearful reminder of her disease and the fact that it might progress, she said.
Smith stopped taking Avonex when she and Troy decided to have a baby.
Pregnancy often gives women a break from their MS symptoms, especially in the third trimester. But it didn't for Smith.
"I got gypped,'' she says.
Switching medicines
After Ezra was born, Smith decided to try another MS drug called Rebif, which requires three shots a week instead of one.
The advantage is that the shots are less painful because they go just under the skin rather than deep into the muscle.
The disadvantage was that she now felt sick three times a week instead of once.
Rebif also failed to prevent her worst MS attack, one that left her paralyzed and unable to move. After that she received five infusions of anti-inflammatory steroids to calm down her raging immune system and bring the exacerbation under control.
The good news is that an MRI scan last summer showed that the number of MS lesions in her brain is basically unchanged since her diagnosis six years ago.
Smith said she's taking a break from all MS medications for a while but will eventually resume taking Avonex.
That older drug helped keep her MS lesions in check.
But after her positive experience with Tysabri, the transition will feel like a step backward.
"Biogen did the right thing by pulling it,'' she said. "Even if they have to shelve Tysabri, I think they're on to something.''
Heather Smith, is disappointed that Tysabri, a breakthrough drug for multiple sclerosis, has been withdrawn from the market.
http://www.southbendtribune.com/stories ... turned.sto
Drug returned vitality patient desired
OUR HEALTH
By DAVID RUMBACH
Tribune Staff Writer
SOUTH BEND -- Heather Smith watches her son zip around the house. He's a ball of energy, a typical non-stop toddler who flies between points of fleeting interest like a hummingbird in a flower garden.
His mother, Heather, does her best to keep up with 21-month-old Ezra.
But she's held up by multiple sclerosis. The disease forces her to plod with a walker. It saps her energy and makes her long for naps.
She especially hates the naps.
"You always feel like you're missing something when you have to leave in the middle of the afternoon,'' she says.
Smith made sure she was among the first local MS patients to receive a breakthrough drug called Tysabri after it won Food and Drug Administration approval last November.
She had been watching the drug from its early stages, when it was called Antigren and was being injected into rodents. She even bought some stock in Biogen Idec, the drug company behind Tysabri.
"I've known this drug since it was being given to mice,'' she says.
Tysabri did not disappoint her when she finally had a bag of it hanging by her side at Memorial Hospital and being infused into her arm through an intravenous line.
She received two treatments, one each in January and February. But then Tysabri was abruptly pulled from the market after two MS patients who were receiving it developed a dangerous brain disease. One of them died.
But Smith did not become sick on Tysabri. She got much better. Wonderfully, she no longer craved naps. It even reminded her what life was like before she was diagnosed with MS six years ago.
"I got a glimpse of my old body,'' she said.
She was able to leave the house by herself and go shopping at Walgreens -- parking in a handicapped spot and making it to the door with her walker.
"You know you're in the house too much when you're excited about a trip to Walgreens,'' she quips.
Smith was so disappointed with the withdrawal of Tysabri that, with the help of her younger sister, Hillary Beck, she wrote a letter to Biogen asking for a favor.
Smith asked the company if there was some way she could continue taking Tysabri. She'd even sign a statement saying she accepted the risk.
The company wouldn't let her do that. But it did invite her to join its national patient advisory board. It also asked permission to add her name to a list of patients available for media interviews. She agreed to both.
The media list led to an interview with The Wall Street Journal and a quote in a recent article on disappointed Tysabri patients from around the country.
She and her husband, Troy, were to fly to Boston today for her first meeting with the patient advisory group.
Life-changing diagnosis
MS has been shaping her life ever since she was diagnosed in 1998 at the age of 28.
The first tough decision was whether or not to take one of the three drugs available at the time of her diagnosis in the hope of slowing down the progress of the disease.
Such treatment decisions are tough to make for newly diagnosed MS patients. Half of patients diagnosed with MS will progress to a worse form of the disease.
But doctors can't predict whose symptoms will stay mild and whose will become severe. So patients are often unsure from week to week whether the drug is needed, or if it's doing them any good.
Smith chose Avonex, a medication that patients give themselves by intramuscular injection once a week.
The medicine's side effects were such that she felt like she had the flu for one day of every week, she said.
"I don't regret the decision, but it was frustrating to deal with the uncertainty (of whether the drug was making a difference),'' she said.
Every shot was a fearful reminder of her disease and the fact that it might progress, she said.
Smith stopped taking Avonex when she and Troy decided to have a baby.
Pregnancy often gives women a break from their MS symptoms, especially in the third trimester. But it didn't for Smith.
"I got gypped,'' she says.
Switching medicines
After Ezra was born, Smith decided to try another MS drug called Rebif, which requires three shots a week instead of one.
The advantage is that the shots are less painful because they go just under the skin rather than deep into the muscle.
The disadvantage was that she now felt sick three times a week instead of once.
Rebif also failed to prevent her worst MS attack, one that left her paralyzed and unable to move. After that she received five infusions of anti-inflammatory steroids to calm down her raging immune system and bring the exacerbation under control.
The good news is that an MRI scan last summer showed that the number of MS lesions in her brain is basically unchanged since her diagnosis six years ago.
Smith said she's taking a break from all MS medications for a while but will eventually resume taking Avonex.
That older drug helped keep her MS lesions in check.
But after her positive experience with Tysabri, the transition will feel like a step backward.
"Biogen did the right thing by pulling it,'' she said. "Even if they have to shelve Tysabri, I think they're on to something.''
Heather Smith, is disappointed that Tysabri, a breakthrough drug for multiple sclerosis, has been withdrawn from the market.
http://www.southbendtribune.com/stories ... turned.sto
-
HarryZ
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Re: Drug returned vitality patient desired
Better,
Yet another reason why Biogen should have done their homework first and possibly avoided this mess.
Harry
I can appreciate the total frustration that MS patients are going through over Tysabri. But although Smith did not have any ill effects from Tysabri after two infusions and felt much better, the long term effects of the drug are not known and the PML situation has completely clouded the drug.But Smith did not become sick on Tysabri. She got much better. Wonderfully, she no longer craved naps. It even reminded her what life was like before she was diagnosed with MS six years ago.
Yet another reason why Biogen should have done their homework first and possibly avoided this mess.
Harry
-
better2gether
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Comments from an Neurologist
.
Comments from an Neurologist
1. Tysabri will be back, most likely Sept or Oct, 2005.
2. Most neurologists will welcome its return.
3. These neurologists are most likely to use it in CRAB failures and CRAB patients with significant side effects.
4. Some neurologists will not use Tysabri for a while. They will change as their patients demand it and as their confidence is rebuilt.
5. Just because 90% of neurologists see a role for tysabri does not mean that they feel the same about the drug as they did before 2/27/05. It does not mean these 90% will use it as much as they would have used it (if no PML)
6. Tysabris uptake curve will be moved to the right and reduced in amplitude. We were on track to see at least 40000 patients by year end 2005 on Tysabri. When will we get to 40000? It will not be until late 2006 or 2007 now. This is hardly a 'niche' drug, and still has an excellent chance to overtake the IFNs. Overtaking the IFNs was guaranteed in the pre-PML era. When you throw in Europe, we will see much higher numbers. Throw in Crohn's and the numbers are even better.
7. Combo is out. Mono numbers are good enough to recommend switching to many patients.
8. If a patient is clinically and radiologically stable, I would likely recommend that they stay on current treatment (but will gladly switch them if they understand risks)
9. Someday there will be another case of PML.
10. MS patients and doctors are not afraid of risk. They understand nothing is without risk or cost.
.
Comments from an Neurologist
1. Tysabri will be back, most likely Sept or Oct, 2005.
2. Most neurologists will welcome its return.
3. These neurologists are most likely to use it in CRAB failures and CRAB patients with significant side effects.
4. Some neurologists will not use Tysabri for a while. They will change as their patients demand it and as their confidence is rebuilt.
5. Just because 90% of neurologists see a role for tysabri does not mean that they feel the same about the drug as they did before 2/27/05. It does not mean these 90% will use it as much as they would have used it (if no PML)
6. Tysabris uptake curve will be moved to the right and reduced in amplitude. We were on track to see at least 40000 patients by year end 2005 on Tysabri. When will we get to 40000? It will not be until late 2006 or 2007 now. This is hardly a 'niche' drug, and still has an excellent chance to overtake the IFNs. Overtaking the IFNs was guaranteed in the pre-PML era. When you throw in Europe, we will see much higher numbers. Throw in Crohn's and the numbers are even better.
7. Combo is out. Mono numbers are good enough to recommend switching to many patients.
8. If a patient is clinically and radiologically stable, I would likely recommend that they stay on current treatment (but will gladly switch them if they understand risks)
9. Someday there will be another case of PML.
10. MS patients and doctors are not afraid of risk. They understand nothing is without risk or cost.
.
better2gether
Amen to point #10! The risk is minimal when weighed against the benefits.
One thing that can be said about the Tysabri delay is that MS patients are certainly being given enough time to do their own personal cost/benefit analysis. Even in light of that fact, there will no doubt be plenty of conspiracy theorists who will bash Biogen and the FDA when the drug returns.
I just don't get it. Nobody is holding a gun to their heads to take it.
Amen to point #10! The risk is minimal when weighed against the benefits.
One thing that can be said about the Tysabri delay is that MS patients are certainly being given enough time to do their own personal cost/benefit analysis. Even in light of that fact, there will no doubt be plenty of conspiracy theorists who will bash Biogen and the FDA when the drug returns.
I just don't get it. Nobody is holding a gun to their heads to take it.
Re: Comments from an Neurologist
better2gether wrote:.
Comments from an Neurologist
2. Most neurologists will welcome its return.
Would you please be so kind as to provide the source of this quotation? That way an objective, independent observer can better check up on and evaluate this neurologist's credentials, his or her potential conflicts, and other pertinent information.
Reed
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HarryZ
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Re: Comments from an Neurologist
Reed,
I can pretty well assure you that the neurologist who made these comments is being paid by Biogen to do so. They did the same thing just after Tysabri was approved by getting panels of paid MS docs together and doing webcasts showing how wonderful Tysabri was going to be. Biogen's marketing department is second to none!!
At the recent AAN conference, there were two "camps" of neuros that resulted...one that supported Tysabri and stated it would be back very soon. The second group stated that they doubted Tysabri would ever be back and if it were to return, it would be a very long time in coming.
Now here we have neuros who have all been trained the same way, deal with MS yet have two very different views of this drug. Now where does that leave the MS patient??!!
Biogen's marketing department is working overtime these days but from what I have heard (not yet confirmed) there may be some more devastating news about Tysabri coming soon. That department must be doing a very good job because there are still many people who are willing to take the risk and use Tysabri despite the fact that there hasn't been much info yet and just how mush a risk exists with getting PML and dying!
Harry
I can pretty well assure you that the neurologist who made these comments is being paid by Biogen to do so. They did the same thing just after Tysabri was approved by getting panels of paid MS docs together and doing webcasts showing how wonderful Tysabri was going to be. Biogen's marketing department is second to none!!
At the recent AAN conference, there were two "camps" of neuros that resulted...one that supported Tysabri and stated it would be back very soon. The second group stated that they doubted Tysabri would ever be back and if it were to return, it would be a very long time in coming.
Now here we have neuros who have all been trained the same way, deal with MS yet have two very different views of this drug. Now where does that leave the MS patient??!!
Biogen's marketing department is working overtime these days but from what I have heard (not yet confirmed) there may be some more devastating news about Tysabri coming soon. That department must be doing a very good job because there are still many people who are willing to take the risk and use Tysabri despite the fact that there hasn't been much info yet and just how mush a risk exists with getting PML and dying!
Harry
Harry,
Yikes! I can't believe your post. You are constantly quoting the opinions of anonymous neurologists, yet when someone else does the same you announce that they must be taking payola from Biogen. If you read the points made by the Anonymous Neurologist in better2gether's post, I hardly think that Biogen would "compensate" a physician for that opinion. It was anything but 100%-gung-ho-Tysabri.
As far as speculation on your part that Biogen must be doing a great job of reinforcing the public's positive impression of Tysabri through marketing, tell me where to find such propoganda. We all scour the same information, and I haven't seen anything from Biogen which targets the MS population.
Yikes! I can't believe your post. You are constantly quoting the opinions of anonymous neurologists, yet when someone else does the same you announce that they must be taking payola from Biogen. If you read the points made by the Anonymous Neurologist in better2gether's post, I hardly think that Biogen would "compensate" a physician for that opinion. It was anything but 100%-gung-ho-Tysabri.
As far as speculation on your part that Biogen must be doing a great job of reinforcing the public's positive impression of Tysabri through marketing, tell me where to find such propoganda. We all scour the same information, and I haven't seen anything from Biogen which targets the MS population.
-
HarryZ
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Denver,
All the drug companies have paid docs do the speaking for them. It's called trying to obtain credibility. Teva uses Dr. C. Smith in Washington State, the NMSS uses Dr. Alan Bowling, etc etc. So when a neruo comes out and states that Tysabri is going to come back by the end of the year when so many others state differently, I come to the conclusion that he has a pretty good chance of being "supported" by Biogen. I could be wrong and it wouldn't be the first time
What Biogen is doing is what EVERY pharmaceutical would do in these circumstances. They are in business for their shareholders and have to take as many steps as necessary to keep their bottom line black. Good grief, Biogen/Elan's combined stock lost $ 17 billion in one day after Tysabri was recalled. Elan is on the brink of collapse. These people have to react and get their marketing departments working full time to survive.
Harry
I've never said that any neurologist that I have quoted isn't being paid by some drug company. In fact, Dr. Lawrence Steinman, whom I have quoted a number of times, and has made several not-so-nice comments about Tysabri, is working for a competitive company to Biogen (I don't know which one). And my wife's neuro, who conducted trials for Tysabri (and indirectly got money from Biogen) has stated that he doesn't trust Biogen all that much.Yikes! I can't believe your post. You are constantly quoting the opinions of anonymous neurologists, yet when someone else does the same you announce that they must be taking payola from Biogen. If you read the points made by the Anonymous Neurologist in better2gether's post, I hardly think that Biogen would "compensate" a physician for that opinion. It was anything but 100%-gung-ho-Tysabri.
All the drug companies have paid docs do the speaking for them. It's called trying to obtain credibility. Teva uses Dr. C. Smith in Washington State, the NMSS uses Dr. Alan Bowling, etc etc. So when a neruo comes out and states that Tysabri is going to come back by the end of the year when so many others state differently, I come to the conclusion that he has a pretty good chance of being "supported" by Biogen. I could be wrong and it wouldn't be the first time
What I can say....simply scan the net and read. Also read many of the articles that are posted from press news releases in the financial market where Biogen is trying to prop up interest in their stock. One reader on another MS forum was upset because as she pointed out, most Tysabri articles she has read are number and financially related. She went on say that she has read little info about the medical situation of the drug. Even some of the Biogen reps in cafepharma acknowledge what is being done.As far as speculation on your part that Biogen must be doing a great job of reinforcing the public's positive impression of Tysabri through marketing, tell me where to find such propoganda. We all scour the same information, and I haven't seen anything from Biogen which targets the
MS population.
What Biogen is doing is what EVERY pharmaceutical would do in these circumstances. They are in business for their shareholders and have to take as many steps as necessary to keep their bottom line black. Good grief, Biogen/Elan's combined stock lost $ 17 billion in one day after Tysabri was recalled. Elan is on the brink of collapse. These people have to react and get their marketing departments working full time to survive.
Harry
Hi Harry,
Just been looking on for some time but I had to form an account here and respond to one of your quotes because it definitely caught my eye. Apologies because I haven't researched your posting history or stories so I can read more if necessary. So here goes...
You state the following:
"...what I have heard (not yet confirmed) there may be some more devastating news about Tysabri coming soon."
Who, where, and how did you hear about that. You seem to be no more reliable than some neurologist being paid by a Biogen competitor unless you can provide some type of verification. When you mention that the "lure of $$$ is to blame", well, that can also be said for the attorneys (perhaps you are one) out there looking for a quick class action buck with lawsuits against any drug company with data that show potential problems. Well, yeah, death attributed to Tysabri...until research is done on the reason why...maybe already immunosuppressed people, other immunosuppressant drugs involved, Avonex? How many other drugs out there have their significant risks and with Tysabri, risks that can be tested for now that they are known. My wife has MS, is a nurse, and has said, with her familiarity with all the drugs out there given as a nurse, and those taken by her (betaseron, Copaxone), she'd have no problems taking Tysabri.
Just been looking on for some time but I had to form an account here and respond to one of your quotes because it definitely caught my eye. Apologies because I haven't researched your posting history or stories so I can read more if necessary. So here goes...
You state the following:
"...what I have heard (not yet confirmed) there may be some more devastating news about Tysabri coming soon."
Who, where, and how did you hear about that. You seem to be no more reliable than some neurologist being paid by a Biogen competitor unless you can provide some type of verification. When you mention that the "lure of $$$ is to blame", well, that can also be said for the attorneys (perhaps you are one) out there looking for a quick class action buck with lawsuits against any drug company with data that show potential problems. Well, yeah, death attributed to Tysabri...until research is done on the reason why...maybe already immunosuppressed people, other immunosuppressant drugs involved, Avonex? How many other drugs out there have their significant risks and with Tysabri, risks that can be tested for now that they are known. My wife has MS, is a nurse, and has said, with her familiarity with all the drugs out there given as a nurse, and those taken by her (betaseron, Copaxone), she'd have no problems taking Tysabri.