Wednesday, December 2, 2009

Ampligen "Death Blow" Another Tragedy for CFS Sufferers

In a shocking move, the FDA yesterday refused to approved Hemispherx's drug Ampligen.  It represents a devastating blow for Hemispherx who have in vain attempted to garner approval for Ampligen for over 20 years.  In their response letter, the FDA essentially demands that Hemispherx begin their clinical trials from scratch.  They site initial clinical trials fail to convince the review panel of Ampligen's efficacy, and that new clinical trials be conducted testing different doses for at least six months, on at least 300 patients, compared to the previous study which enrolled just 230 patients.  The FDA also goes on to cite unresolved manufacturing problems.  Considering that the previous study took 6 years to complete, approval doesn't appear likely any time soon, and likely won't be approved in other jurisdictions, as other nations have followed the guidance of the FDA, with a handful of exceptions of drugs that have gained approval by the European Medicines Agency before FDA approval is granted.

For persons suffering from ME/CFS, FMS, and Gulf War Syndrome it shows that government agencies continue to recognize these conditions as a real illness.  And research dollars earmarked for CFS/ME research gets misappropriated by CDC bureaucrats as a slush fund, where not one meaningful study has come out of it.  And it appears recent developments have not shifted the groupthink mentality of the CDC - but it will come a time when they will find themselves standing pretty well alone if replication studies on XMRV are in line with those of the Whittemore-Peterson institute, which I have reason to believe will be.

I believe that psychologically Ampligen represents a huge setback, but in the end it will amount to no more than a bump in the road.  Tests on antiretrovirals are going ahead full steam in pharmaceutical labs as we speak, and I've dug up a couple of other compounds that have demonstrated activity against other retroviruses: Lamivudine and emtricitabine - both have a far greater safety profile than Zidovudine (AZT), posing a low risk of anemia, nephrotoxicity, hepatoxicity, and pancreatitis.  I'm not particularly fond of Non-nucleoside Reverse Transcriptase inhibitors, due to their unfavorable side effect profile - distressing rash in as much as 20% of patients, and severe liver damage seen with Nevirapine and Etravirine - making patient compliance and adherance to treatment an issue in itself.  I also don't favor a single drug regiment - I would like to see a combination pill of either Lamivudine or Emtricitabine with raltegravir.


  1. While this is bad news for the company that makes Ampligen, I think the FDA has a valid concern about this drug. The clinical studies to date didn't exactly make me pin my hopes on a cure for ME. Then there is the drug delivery method, which is not realistic for most patients. Not even HIV patients take their treatment intravenously over long periods of time. Good to hear your opinions about possible retrovirals to use -- wonder if anyone is out there being treated with those right now. -- @prmros, twitter (USA)

  2. Dear Dr. Luckett,

    I enjoy reading your blog. Your posts have added much to our understanding of ME/CFS and XMRV.

    Would you be able to comment on the new study by Silverman et al? Entitled "Xenotropic murine leukemia virus-related virus is susceptible to AZT", it appeared in Virology December 1.

    Thanks! I hope your sister gets better soon.


  3. "In a shocking move, the FDA yesterday refused to approved Hemispherx's drug Ampligen. It represents a devastating blow for Hemispherx who have in vain attempted to garner approval for Ampligen for over 20 years."

    How in any way is this "shocking"? They've been trying to get this approved for 30 years, not 20, for a host of diseases, and have failed every time. The lied about the test results, and then they lied six months ago when they said FDA approval should come within 2 weeks.

    Hemispherx deserves to go out of business. And it probably will very soon.

    Just a shameful company.