Sometimes I see the unused wheelchair sitting at the back corner of my home, waiting to be donated. I'm so grateful not to need it, and I'll be glad to have it gone. But seeing the thing reminds me of the pain and the fear, and I get angry. Before I met Dr. Burt, and before I did HSCT, mismanagement of the drug Tysabri crippled and almost killed me.
I was one of the MS patients on Tysabri buying time, trying to keep the disease from getting worse. For many MS patients, Tysabri is still the best second-tier drug available, despite the risks. The problem with Tysabri is it's not meant to be used for more than two years, and until a better drug or HSCT gets approved there's really no good alternative for patients to transition to.
This excellent Bloomberg article summarizes why MS patients are willing to risk death with Tysabri to avoid disability. Risking death to stay mobile fit my attitude about MS. I feared disability more than death. Little did I know that Tysabri would ultimately give me what I feared the most.
FDA realized the danger of PML in 2005 when patients treated with Tysabri started dying. The drug was temporarily withdrawn from the market, but Biogen convinced FDA to allow the drug to be reintroduced with more precautionary testing of patients.
Long before I knew of Dr. Burt and HSCT, I was assured by my now-ex neurologist that the risk with Tysabri was manageable and that the drug was my best hope of avoiding disability, so I started monthly Tysabri infusions in 2010. But after two years on Tysabri, I went from success story to unfortunate statistic, when the risk management testing protocol discovered that I was at imminent risk of PML. The test that discovered I'd turned JC-positive may have saved me from death, but not the crippling nightmare that was to follow.
After my JC-positive test, my neurologist attempted to transition me off Tysabri and onto Biogen's (BG-12/Tecfidera), but delays in approval for that drug set me up for an MS rebound attack. Doctors still debate whether this attack was just the MS coming back hard, or a PML-related condition called immune reconstitution inflammatory syndrome (IRIS). When I called the neurologist with concern that my legs were getting rapidly weaker, he assured me that it wasn't due to IRIS. He had me on IV steroids twice a week and my recent MRI looked stable, so I should have been protected.
It wasn't until I dragged myself into his office with ski poles that he started to believe that I was having a serious MS rebound from coming off Tysabri. My legs were locked up in agonizing spasms, I had double vision, and I had developed bladder and fecal incontinence. A new MRI showed I had rapidly developing new lesions on my brainstem and motor strip areas of my brain. My condition had gone from moderate to serious in a very short time. The neurologist prescribed weekly plasmapheresis to remove some of the aggressive immune system antibodies from my blood. He also prescribed an electric wheelchair. I was still living independently, but just barely. I signed up for Metro Mobility van service for the handicapped and lived in misery with a semi-permanent catheter in my chest from June to December of 2013.
My neurologist advised me to wait for FDA approval of the drug Lemtrada (Campath). When I asked him about HSCT, he advised against it. But his statistics on HSCT mortality and efficacy didn't match the data I'd reviewed. Ultimately, our discussions turned combative, and I'd had enough of following advice that had crippled me. I made plans on my own to do HSCT in Chicago with Dr. Burt. Half-way through my HSCT treatment, I learned Lemtrada was rejected by FDA in December 2013.
It's quite possible I am an unusual case and most people on Tysabri will be fine. I'm no medical expert or statistician, so I really don't know. Looking back, though, I sure wish I'd never tried it. Following is a bit more information to chew on.
Inventor of Tysabri Says He Wouldn't Prescribe It
One of the creators of Tysabri, Dr. Lawrence Steinman, realized the potential dangers of Tysabri and warned the FDA not to approve it. Steinman now says Tysabri isn't worth the risk.
According to a New York Times article in March 2005, Dr. Steinman said he had expressed his apprehensions about the drug in speeches and in an article in the journal Science in July and had been asked by Biogen executives to tone down criticism of the drug.
Biogen sales of Tysabri have caused its stock to double in less than two years. An article in Forbes praised Biogen for managing the crisis that could have destroyed the company.The label change allowing its use may push Tysabri’s global sales to $2.5 billion to $3 billion by 2016,
While Biogen Thrives, How Many Patients Are Harmed?
According to e-healthme, a consumer site which compiles reports by the FDA,
On Mar, 5, 2014: 90,305 people reported to have side effects when taking Tysabri. Among them, 2,943 people (3.26%) have Progressive Multifocal Leukoencephalopathy.
665 people have died while on Tysabri.
Researchers are now discovering the JC Virus activated by Tysabri in neurons of the gray matter in people with MS. The virus does not just show up as a demyelinating disease in white matter. It is creating gray matter atrophy--literally, death of neurons. This brain tissue loss can be seen on MRI.
There have been an unknown number of Tysabri deaths linked to problems other than PML, including antibody reactions, lethal relapses after withdrawal, and cancer. Deaths and injury from central nervous system PML, herpes encephalitis, CNS lymphoma, metastic melanoma, cryptococcal meningitis continue. Most of these neurologic infections do not show up until after two years of Tysabri.
Dr. Steinman is still speaking out on Tysabri--no longer to the press, but in medical presentations at universities. He has explained the "massive failure" of Tysabri trials to show PML risk, since the mice could not develop this deadly brain disease. His online powerpoint presentation on this topic has been removed from the internet, but I did find this powerpoint link that shows the efficacy and side effects of various MS drugs, including Tysabri.
Hiya I'm english and am on Tysarbri can u tell me how I could move to up this drug all my neurologists and Secs are like this is working well 4 u and I'm asking could i be on a better treatment?.can anyone help/advise me
ReplyDeleteHollu, As my blog states, I'm a patient, not a doctor. I debated whether or not to say anything about my bad experience with Tyabri. I know it works for many people and it is a source of hope against a horrible disease. if your doctor does what my Tyabri-prescribing neurologist did, he will be doing regular MRI scans of your brain and spine to look for new active lesions. If none show up, he will likely say Tysabri is working for you. But my neurologist disregarded my complaints that mobility got consistently worse during my two years on Tysabri. In that time, I went from jogging a 5 K to barely being able to walk 1K without sitting down to rest. This was all before a blood test revealed JC virus antibodies had appeared. I cannot say what is best for you, but I would encourage you to pay close attention to your body and not only rely on MRI and blood tests to make sure you are safe. If you see that you are losing mobility while on Tysabri, it might be time to consider HSCT, or Lemtrada. I would not attempt to switch to a weaker MS drug like Tecfidera. That's likely what set me up for the horrible rebound attack.
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