How do MS drugs get approval from the FDA? A review of Gilenya

[Robbie]

Jaja, die hebben het god met ons voor:cool:
[quote]
October 7, 2013 at 9:30am
Who gets to advise the FDA on multiple sclerosis drugs?


There have been several new MS drugs brought to market in the five years since CCSVI research was first discussed in medical journals. We have to wonder whether the process of hastening these new drugs to market was aided by the influence of phamaceutical companies.


After today's revelation that there has been a concerted effort by [B]pharmaceutical companies to pay to attend FDA advisory meetings[/B] and submit their own recommendations on drugs to be marketed, [URL="http://www.facebook.com/l.php?u=http%3A ... HTnuNs&s=1"] link [/URL] I thought it might be a good idea to see what information is available to the public regarding who is recommending MS treatments to the FDA, and how they do this.


The group that looks at evidence for the MS community and advises on drug approval is the
[B]"Peripheral and Central Nervous System Drugs Advisory Committee"[/B]
There are many reports prepared by pharmaceutical companies to be submitted to this group, which are available for public disclosure without redaction on the FDA.gov site.



Here is one for [B]Fingolimod, now marketed as Gilenya[/B]-- prepared by Novartis- and submitted to the advisory committee for their June 10th, 2010 meeting.


The authors are free-lance biotechnicians who specialize in "bringing pharmaceuticals to market."
[URL="http://www.facebook.com/l.php?u=http%3A ... FDHTD4&s=1"]http://www.fda.gov/downloads/Advisory%2 ... 214675.pdf[/URL]



The FDA advisory committee decided[B] that day[/B] to approve Fingolimod/Gilenya and made the announcement to the press. They were giddy with the fact that this drug was the first FDA approved oral medication for people with MS.

[URL="http://www.facebook.com/l.php?u=http%3A ... GQ9ooV&s=1"]http://www.medscape.com/viewarticle/723361[/URL]



What is important to note is that by the time 2012 came around, the FDA had to issue a formal warning on Gilenya, due to several deaths and cardiac events reported after the drug was marketed to pwMS. These cardiac deaths and side-effects were not reported by the FDA, or Novartis---[B]but noted by a non profit watchdog group, the Institute for Safe Medication Practices.[/B]
[URL="http://www.facebook.com/l.php?u=http%3A ... FE7MyH&s=1"]http://www.ismp.org[/URL]


[I]Recently, the Institute for Safe Medication Practices, a nonprofit watchdog group, has urged the FDA to put more restrictions on the use of Gilenya. [/I][B][I]The group reviewed the number of side effects of the drug reported to the FDA MedWatch program in the second quarter of 2011, and it concluded that "the FDA and manufacturer should consider substantial restrictions on its use and enhanced monitoring."[/I][/B]


[B]Here is the strongly worded comment from the ISMP[I]--[/I][/B]
[B][I]It was a significant gamble for the FDA to allow unrestricted marketing of powerful but novel immunosuppressant drug [/I][/B][I]before determining the optimal dose and learning more about its long term risks. Only about 300 people were exposed to fingolimod for a period of two years prior to approval.[/I]
[URL]http://www.ismp.org/QuarterWatch/pdfs/2011Q2.pdf[/URL]

[B]So, the FDA issued a warning[I]--[/I][/B]
[URL]http://www.fda.gov/drugs/drugsafety/ucm284240.htm[/URL]


[B]But there would be more problems. The second FDA warning for Gilenya [/B]was issued this summer, after a patient contracted PML.

[URL="http://www.facebook.com/l.php?u=http%3A ... FBirNl&s=1"]http://www.fda.gov/Drugs/DrugSafety/ucm366529.htm[/URL]



Here's where is gets interesting and somewhat disconcerting. Novartis knew that there were serious side-effects with this drug, including changes in heart rate, liver toxicity, macular edema, and increased rates of infection--and these are discussed in their initial report to the FDA. The admit that this drug has serious implications for the "cardiac, ocular, infectious, hepatic and pulmonary systems." They prepared their own "prescriber advisory letter" and "prescriber package insert."


The FDA knew about these risks, but did not give any warnings to patients until a watchdog group became vocal about the number of side effects being reported.



Here is a[B] strategy report given to the FDA on how to [I]handle[/I] this Gilenya situation[/B]. It is called the "Risk Evaluation and Mitigation Strategy" and is a confidential paper, somehow made public on the FDA site. Good thing the US gov't is shut down, so you can all download this paper for yourselves and make copies for friends and family :)


[URL]http://www.fda.gov/downloads/drugs/drug ... 227965.pdf[/URL]



It's all about how Novartis plans to let healthcare professionals, patient groups and patients know about the [B]"serious risks"[/B] of taking Gilenya. They are advising the FDA.


But these serious risks were all known and documented in 2010.
Why did the FDA approve this drug for use in people with MS?


[/quote]