Tysabri info

[HarryZ]

William,

Your questions are quite fair and I will attempt to answer them the best I can.

I've been following MS research now for some 40 years, ever since I had an uncle who had MS. My wife has had MS for 30 years. About 7 years ago I started to follow MS info on the internet and since then have developed a network of people who are MS patients, doctors, nurses, pharmacists, drug company contacts and more recently medical news reporters. I am told and come across a lot of information about MS. In some cases I can quote sources but in many, I'm told info in confidence and can't and will not give names. I am simply asked not to and I respect those requests.

I attempt to participate in about 9 different MS forums and many times people refuse to believe what I write. That's fine because like I state, you can choose to either believe me or not. My track record, however, is quite good. And I can honestly say that I have NEVER knowingly given false information in any of the forums that I participate.

Months ago, when I started to raise a lot of red flags about Tysabri, a number of readers on this forum and others called me a rumor monger and Biogen basher with a hidden agenda. Nothing could have been further from the truth. Almost all of the info that I posted came from my network sources and in the end, it proved quite accurate with Tysabri getting yanked!

You mention my comments about the lure of $$$ by the drug companies. Well, it's no secret that the drug companies' main purpose in life is to make money. Now there's absolutely nothing wrong with making money but when your business and the way you conduct it effects the health of millions, then I would hope that your standards are set a bit higher. But we know that isn't the case.

You also mention the risk posed by other drugs. Of course there are risks
with other drugs but in most cases, the company who produced the drug has done their homework and spent the appropriate amount of time learning these risks. Unfortunately, Biogen didn't do that despite the warnings they were given and that's a very different scenario!

Your wife may decide, when comparing Tysabri to other CRABs, that it is worth the risk. Well, my wife is also a nurse who has MS and she wouldn't touch the CRABs nor Tysabri. Same profession, same training but different opinons....kind of sounds familiar in the world of MS medicine, doesn't it?

Harry

[kostas]

Sorry to intervene to this value added exchange of information, but I could not stand to make a comment that could help, in order the value added to be positive and not negative (at least to my eyes). Most of us watching these posts, are aiming to learn more and more about MS so to find ways and plan how we will continue our life having the best outcome. Seems to me that all of you know what are you talking about. Please make it so us to understand that the goal is common.
Please believe me that I had no intention to insult anybody, but if I did it, I apologize in advance.

Kostas

[DenverCO]

Harry,

I am not trying to "stir the pot" by asking this question...I am just curious.
What do your physician contacts have to say about your wife's alternative treatment choices?

[HarryZ]

Denver,

I am not trying to "stir the pot" by asking this question...I am just curious.
What do your physician contacts have to say about your wife's alternative treatment choices?

Very good question!! And never be concerned about asking me a question...I know that we don't always agree on several items and if I don't agree with you, I'll say so. But I don't hold grudges against people because they don't agree with me

Her neuro prescribes the Prokarin BUT he is on record in stating that he really doesn't endorse its use...why?....because there isn't a whole lot of clinical trial data on it. However, this neuro treats the patient first and MS second and he has seen with his own eyes how Prokarin has benefited her. So he puts his personal beliefs aside and does what works for Marg.

The GP who rxs the LDN knew a bit about it when we saw him last year. He stated that he could theoretically understand how it worked while at the same time stating the very small dosage would not harm Marg.

Harry

[HarryZ]

Kostas,

Your comment is welcomed.

You'll find when any number of people discuss MS and the medications that are used to treat it, there will be a lot of different opinions expressed. Even the MS docs can't agree on several aspects of this lousy disease.

I would tend to think that all MS patients and their friends and relatives desperately hope that this disease is cured sooner rather than later. In the meantime you will read many different ideas expressed on this forum and others. While we all don't agree with one another all the time, eradicating MS is a common goal.

Harry

[JFH]

I attempt to participate in about 9 different MS forums ...

Harry

I'd be interested to know which others you find valuable - grateful for a PM with links.

Thanks

[HarryZ]

John,

I'd be interested to know which others you find valuable - grateful for a PM with links.

Thanks

OK...here goes and they really vary in content. I'll try and give a brief explanation of what they offer.

Brain Talk-- good topics, good posters. http://brain.hastypastry.net/forums/for ... .php?f=181

MS Foundation - a little bit of everything..good overview

http://www.msfacts.org/cgi-bin/dcforum/dcboard.cgi

Histamine-Alternative Medicines for MS....you won't find any conventional MS meds used by this group...good ideas for alternatives

http://disc.server.com/Indices/148285.html

Prokarin Board - mostly to do with Prokarin...very light participation

http://disc.server.com/Indices/148446.html


Montel Williams Spotlight - good cross section of ideas with a little bit of everything

http://www.spotlighthealth.com/common/f ... ?m=2&sb=12


Yahoo LDN Board...self explanatory

http://health.groups.yahoo.com/group/spotlight_ldn/


MS Sucks- very controlled board with absolutely no offensive posts allowed....you must register fully and prove your intent before being allowed to participate

http://www.hiregod.com/plaintalk/index. ... 09966f73fe


Getting Better - mostly alternative medicine for MS...close group who supports each other well

http://disc.server.com/Indices/226358.html


I think that's about it for now. In posting these links I accidently re-sorted all of my Favorites in IE and have to go back and sort them again back to easy access...what a pain

Harry

[JFH]

Thanks Harry

No time at the moment - busy day in office today and collecting family from the airport this evening - but will check these out later in the week.

Arron sure TiMS wil still come out on top

[Xenova]

I think Biogen is starting to map out their plan to reintroduce Tysabri to the market. I participated in a survey yesterday that Biogen commissioned. The questions seemed to be testing the waters of how ms patients would react if and when it is brought back. There were questions asking whether I had any fear about getting on tysabri and what my intent to get on it was. Other questions focused on my current therapies and my satisfaction with it. There were other questions as this was a 30 minute survey.

[Arron]

JFH- thanks, and no worries. Our site is dedicated to sharing ALL information about eradicating MS, so if that involves visiting other MS sites-- so be it! We have no issue with it.

Xenova... thanks for the information. How did they contact you? Through your neuro? Was it a phone interview? Were you on T or planning to be on T? Avonex?

[Xenova]

I'm on Avonex (read my name backwards) but never got on Tysabri. I assume they got my name through either being on their medicine, going to one of their events, or registering on their website. The survey was on line via HarrisPolls.

[Arron]

so THAT'S what xenova means! Thanks for the details.

[better2gether]

.
May 20, 2005 (The News & Observer - Knight Ridder/Tribune Business News via COMTEX)

Eleven weeks after Biogen Idec pulled its much-touted multiple sclerosis drug off the market because of health risks, two questions still loom: Will the drug return and how long will the company continue to make it at its Research Triangle Park facility?

So far, there are no clear answers to either.
The first new type of MS drug to become available in years, Tysabri promised new hope for patients and offered blockbuster potential for Biogen Idec. The company hired about 300 in the Triangle last year, a majority of them to manufacture Tysabri.

Now, patients, investors and Biogen Idec employees are waiting for the results of a safety evaluation that will help determine whether Biogen Idec brings the drug back to market.
"Everybody is trying to find out," the status of the drug, said Soham Pandya, an analyst with Susquehanna Financial Group in New York.

Meanwhile, the company's top local official gives carefully guarded answers to questions about whether production of the drug is ongoing.
"We're in a pause mode," said Glen Williams, general manager of Biogen Idec's RTP operations, in a phone interview. "This type of plant you don't just start and stop."

But he did offer a hint of what's to come.
This summer, Biogen Idec plans to test a method to increase the amount of Tysabri the RTP plant can generate without lengthening production time. If the test pans out, because of regulatory requirements, it would take about a year before the method could be used for commercial production.

Production levels of the drug signal the likelihood of Biogen Idec reintroducing it, said Pandya. That Biogen Idec plans to run the test indicates the company believes there's a good chance Tysabri will return to the market, maybe as early as next year, Pandya said.

"It's a difficult time for the company right now," he said. "But they seem to be doing the right thing." Biogen Idec took Tysabri off the market Feb. 29 because it was linked to a fatal nervous system disorder. The recall came just two months after Tysabri hit the market and the RTP facility had just started an eight-week production cycle.

While the company wrestles with the drug's future, MS patients remain in limbo. Lise Cagle worries about the possible side effects of Tysabri, but said she remains interested in whether the company will bring the drug back.

Cagle, who was diagnosed with MS in 1998 and has unsuccessfully tried three of the four older MS drugs, never received her first injection of Tysabri. But next week, the Raleigh woman plans to talk to her neurologist, who had recommended the drug before the recall.

"I want it to be safe, so if I really need something it would be available," Cagle said. "I'm doing really well now and I'm not taking any medication. If I had problems, I'd probably be more anxious for it to come back to the market."

About four months after the Food and Drug Administration approved Tysabri for sale, Biogen Idec received reports about possible side-effects. To date, three cases of progressive multifocal leukoencephalopathy have been confirmed among about 8,000 patients who took Tysabri. Also known as PML, the rare disorder causes mental deterioration, vision loss, paralysis and, within about four months, death.

Now, everything hinges on the safety .....

By Sabine Vollmer
.

[better2gether]

.
FDA Drug-Approval Process: Is Criticism of It Fair?

May 20, 2005

By Harold J. DeMonaco, M.S.
Massachusetts General Hospital

The U. S. Food and Drug Administration (FDA) has been roundly criticized for being too slow and cautious in its review and approval of new drugs in the past. It is now facing a torrent of criticism in exactly the opposite direction. This criticism misses the real issue. New drugs are approved only after the FDA is satisfied that the drug is reasonably safe and is effective for the condition it is approved for. The reality is that drugs are never completely safe.

The recent withdrawal of Tysabri for the treatment of multiple sclerosis from the U.S. market and revelations about problems with several other drugs, including Vioxx, Celebrex, Bextra, Strattera, and Remicade, raise questions about the ability of the FDA) to protect the public health. But is the criticism of the agency fair?

Approximately 350,000 people suffer from multiple sclerosis in the United States with 10,000 new cases diagnosed each year. Multiple sclerosis can vary in severity, with the relapsing-remitting type being especially debilitating. Tysabri was approved in November 2004 having been tested in approximately 3,000 patients with relapsing-remitting multiple sclerosis.

Tysabri has been evaluated in controlled clinical trials in patients with relapsing forms of multiple sclerosis. Tysabri reduced the frequency of relapses by 66% in the first clinical trial. Tysabri was tested in a second research study in patients who had been previously treated with Avonex (interferon beta-1a), but who had experienced one or more relapses while on treatment. Tysabri reduced the frequency of relapses by 54%. Combined the studies showed impressive results in a devastating clinical condition.

There were numerous side effects seen with Tysabri. Common adverse reactions were generally mild and included non-life-threatening infections (such as urinary tract, lower respiratory tract, GI system, and vaginal infections), headache, depression, joint pain, and menstrual disorders. There were a number of serious adverse reactions including pneumonia, temporary hypersensitivity reactions (such as rash, fever, low blood pressure, and chest pain), depression, and gallstones. These serious adverse reactions were uncommon.

Although the clinical trials were scheduled to continue for several years, the results of the two studies showed that the drug worked and had relatively few serious side effects. Tysabri was fast-tracked for approval. The drug was not simply approved, however. The approval letter from the FDA to the manufacturer included a host of conditions. The agency asked for a continuation of the two ongoing studies for a full two years. The approval letter from the FDA contained a total of 16 conditions, the majority directed toward a better understanding of the safety and effectiveness of prolonged treatment with Tysabri.

Sales of Tysabri were suspended by the manufacturer when two patients treated with the drug were diagnosed with a rare but serious brain disease called progressive multifocal leukoencephalopathy (PML). One of these patients has died and the other is seriously ill. PML is a viral infection that occurs in people with depressed immune-system function. Because of the way Tysabri works, it is reasonable to theorize the drug may have played a role.

This side effect was also easy to identify because PML is so rare. If Tysabri caused seizures, it would be very difficult to identify it as the cause during the research studies. That is because seizures are a known problem in people with multiple sclerosis.

Tysabri has been used in the treatment of an additional 5,000 patients since its approval in November. So, the number of people treated with Tysabri in the first 90 days after it was approved was greater than the number in the research studies. It is that power of the marketplace that allows for the true value of a new drug to be evaluated.

The FDA received a good deal of criticism for approving Tysabri prematurely, and statements abound that the agency is not doing its job. I disagree; the FDA is doing its job. And there is nothing wrong with the approval process. What is missing is an understanding of the nature of discovery. The fact that the problem was detected early speaks to the surveillance conducted by the company under the guidance of the FDA. Rather than being criticized, the company and the FDA should be applauded for its efforts. It is indeed unfortunate that the problem was not detected earlier. The reality is, however, that the problem was discovered and dealt with quickly.

Any drug that is useful also poses risks. And that includes so-called natural products. The risks may be minor such as a rash or nausea or diarrhea. Sometimes the risks can be serious, as we are now learning about Tysabri and the COX-2 drugs such as Vioxx, Celebrex and Bextra. Unfortunately, the only way to find out is to place the drug in the hands of clinicians and to establish a surveillance system that can identify problems as quickly as possible. One of the advantages of drugs that have been in the marketplace for a number of years is that we usually know a good deal about them. We know how well they work and usually know a good deal about the side effects.

Prescription drugs may be one place where newer is not necessarily better. I usually advise that newer drugs only be considered when the benefits outweigh the known and potential risks. Tysabri was a breakthrough drug and was effective where other drugs for a severe form of multiple sclerosis did not work. Unfortunately we now know that the risks were significant.



Harold J. DeMonaco, M.S., is senior clinical associate in the Decision Support and Quality Management Unit at the Massachusetts General Hospital and is currently a Visiting Scholar at the MIT Sloan School of Management. He is author of over 20 publications in the pharmacy and medical literature and routinely reviews manuscript submissions for eight medical journals.


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[HarryZ]

Sometimes you wonder if the FDA is hampered by the information that they "don't" get. All the data that they use is supplied to them by the drug company doing the trials.

If you look at Vioxx, there was apparently a lot of evidence that this drug harmed a patient's heart yet it wasn't until well after this was discovered that the FDA finally pulled the plug on Vioxx. The FDA even tried to muzzle their own employee who finally blew the whistle on Vioxx by going public.

And you look at the one Tysabri patient who died from PML but who originally was given a cause of death due to cancer. It wasn't until afterwards that they went back an revisited this patient's records and found PML as the culprit. You wonder what may have changed in the approval process if this was known in the first place.

Harry