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Tuesday, August 13, 2013 5:58 PM | CCSVI in Multiple Sclerosis Volg link

2,852.

Last night, I posted this as the number of people with PML due to Tysabri.

Is this possible?

Yes.

Out of the 90,168 people who have reported side effects while on Tysabri, 2852 have PML.

http://www.ehealthme.com/ds/tysabri/progressive+multifocal+leukoencephalopathy


eHealthMe.com, the site where I got the information--uses the FDA adverse events quarterly reports and reports from actual patients.  They have been recognized and utilized by medical journals, such as the Lancet, and medical groups, such as the Mayo Center.


eHealthMe.com was set up to provide a place for consumers to learn about side effects from drugs.  When the Vioxx tragedy happened, the FDA had the information that people were dying of cardiovascular events, but waited and kept the drug on the market.  Merck made sure that the drug remained for sale. link

Ehealthme was created by its inventor to make sure this never happened again.  He wanted to keep track of adverse effects and make sure the public had access to this information--immediately, not years later.



One of the company’s goals is to protect against drugs like Vioxx, an arthritis medication that was linked to thousands of deaths and pulled from the market in 2004 despite being an FDA approved drug. eHealthMe uses available data to study treatments on a large scale and make this information available to individuals.


Chen founded eHealthMe in 2008 after working as a senior healthcare consultant at Deloitte. He initially set out to make it easy for ordinary people to study large amounts of FDA data. Since then eHealthMe has worked with the Mayo Clinic, Northwestern University, IBM, Yahoo!, and the London Health Science Center. Its original studies have been referenced in medical publications including the Mayo Clinic Proceedings, European Association of Neurooncology, and the Annals of Pharmacotherapy.

The company is self-funded and based in Mountain View, California.

link



But doesn't the FDA issue these kinds of reports? Aren't they required to let us know?  No, and Yes.

The FDA issues quarterly FAERS (adverse effects) reports, which are about 25MB of data on ALL the drugs and all the side effects.  They do not have a searchable site. It is not for consumers.  They do not have a database.  Here are the files. link


Isn't Biogen responsible to let the public know about adverse effects?  Nope.  As we learned with the Vioxx tragedy, it is less expensive for them to pay out lawsuits after the fact, then pull a drug once it has comes to market.  And Biogen is committed to Tysabri, having purchased full rights to the drug from Elan just this year. link

Tysabri is their blockbuster MS drug.  

Second-quarter Tysabri sales jumped 38 percent year-over-year to $387 million due largely to Biogen Idec recording 100 percent of revenue for the drug following a deal with Elan in February to acquire full rights to the therapy.

link


This information is provided--not to scare anyone--but to serve as a reminder that patients are not given all of the facts.  Just as Dr. Sanjay Gupta stated this week--every 19 minutes, someone dies from a prescription drug overdose.  We need to look out for each other, talk about side effects, learn about what we're putting in our bodies.  Because knowledge is power, and it is the antidote to fear of the unknown.

Joan