Patients fight for FDA to approve drug application

Reported by: Alyx Sacks
Set Text Size SmallSet Text Size MediumSet Text Size LargeSet Text Size X-Large
Updated: 2/01/2013 7:57 am
RENO, Nev. (KRNV & -- It's a debilitating disorder that effects at least one million Americans and now patients are speaking out.

The drug they say that has changed their lives is up for approval with the US Food and Drug Administration.

"I can go to ball games, watch my kids play their sports, I can just interact with them and without the drug I cannot," Chronic Fatigue Syndrome patient Robert Miller says.

Janet Smith is urologist in Incline Village.

Robert Miller of Reno is a father of two, they both battle Chronic Fatigue Syndrome. CFS is a disorder according to the National Institute of Health causes extreme fatigue, but not the kind of tired feeling that goes away after you rest instead it lasts for long periods of time and limits ordinary activity.

Ampligen has changed their lives along with at least 70-percent of the patients they say their doctor has treated.

But now the drug is facing scrutiny and they say it's come down to now or never. The FDA has until February 2nd to approve the drug's application.

"It's time," Smith says.

But when we met with Robert and Janet they were unsure of where the FDA was leaning and it has pushed them to a point of what Robert calls affirmative action.

Robert has chosen to go on a hunger strike for the past two days and counting until the FDA makes a decision.

When News 4 arrived at the Miller's home Robert was on the phone with a representative with the FDA.

When asked how the phone call went Robert stated, "not reassuring."

There is no universally accepted drug that is approved for CFS, but Robert and Janet rely on Ampligen designed by Hemispherx Biopharma. The company has been trying for 20 years to get the drug approved with the FDA.

"In 20 years time there's been no question about his not being a safe drug. Now it comes D Day to make a determination and all of a sudden these issues are being raised about safety and there not being efficacy. It makes absolutely no sense to me," Miller says.

Robert and Janet both feel now could very well be the last chance to get Ampligen approved. If it doesn't the say the company simply can't afford it and brining on new investors after a drug isn't approved by the FDA. They say would be difficult at best.

Now all they can do is wait and time is running out.

News 4 did contact the FDA and they say they are not allowed to comment on pending applications.

We also spoke with Hemispherx Biopharma Executive Vice Chairman Tom Equels and he says the FDA does have the ability to push the date back and as of this afternoon they had not heard from the FDA.

27 Comment(s)
Comments: Show | Hide

Here are the most recent story comments.View All

goodstuph - 2/9/2013 3:36 PM
1 Vote
Repeat: Do any of the FDA staff and/or their families have CFIDS? FRANCES FLYNN BOYD

goodstuph - 2/9/2013 3:29 PM
1 Vote

glenp - 2/6/2013 9:34 PM
1 Vote
Please follow up on this and keep us updated. Many patients are dieing!

Mirry - 2/4/2013 2:33 AM
2 Votes
Robert miller cfs sufferer is on hunger strike in a quest to get Ampligen fda approved, its the ONLY drug treatment out there for sufferers. It has been thoroughly tested for over 20 years, it is a safe drug. Why wont they approve this drug for severe sufferers? Sufferers feel like they are being treated as second class citizens, other patients of vile illnesses have had drugs approved with no biomarkers of the disease (MS has been in the past). So why not CFS / M.E? Dont they think we're as sick? Is it acceptable for us to live our lives bedbound, tube fed, in insufferable pain? With no treatment or help? (Look up cases of sophia mirza, lynn gilderdale to see how bad this can illness can leave you) Im in the UK so its impossible to get ampligen in any way whatsover but for years ive been waiting & hoping for the day of approval of this drug which could help so many (tests show it helps 70% of sufferers) they cannot withdraw our hope now, we need this drug, there is no alternative & nothing in the pipeline. Please please please listen to robert millers hunger strike plea, we cant be left in the gutter any longer.

Janet - 2/4/2013 1:28 AM
2 Votes
Robert's video is hard to watch, he has chosen to go on hunger strike to draw attention to the neglect that ME/CFS patients suffer. There are many who are dying because there is no treatment, Ampligen could help them please don't let us die.

patfero - 2/3/2013 8:23 PM
2 Votes
At some point, people either sit down or stand up and cross a line. Every human being has seen and experienced injustice. Sometimes it is better to stand down, sometimes we all just keep looking forward to better days. However, there are times when some among us stand, cross a line and in the end lead a movement to correct an injustice. Bob is taking that action. We may not agree that AMPLIGEN should be approved for all. We may even agree with FDA findings, but we have people like BOB MILLER whose very life depends on getting this medication. There is precedent for conditional drug approval. Can we agree that collaborative study is needed as to why responders get their life back before AMPLIGEN is taken away? SOMEONE has to stop passing the buck - Oh well...there is nothing to be done - is not acceptable. Would it be if this were your brother or sister? Our patient community is 3 generations in and it is obscene that I have to look at my granddaughter and wonder if she will get sick. IF she does, will there be any help for her? People are dying. BOB and others who respond to AMPLIGEN and PAY FOR THE DRUG which is a hardship, can live.

susan - 2/3/2013 12:09 PM
2 Votes
Too many people have lost quality of life, jobs, families, homes, their very lives, to this illness, over the past 30+ years. Why do governments not recognize the compassionate use of this drug, when in the past so many HIV+ and Multiple Sclerosis patients were allowed use of drugs with shorter track records and lower efficacy rates?

matina - 2/3/2013 10:52 AM
2 Votes
Thank you for telling Robert Miller's story! Much appreciated because we never get media attention for a horrid debilitating disease. ME/CFS is, without a doubt, one of the most complex, multifaceted, enigmatic illnesses the medical world has encountered. Without this drug, many will live their lives in pain and myself. Is this a way to live...waiting to die. Please help spread this to a national level. Thank you for your time. T

Ash Wolf - 2/3/2013 9:54 AM
2 Votes
Thank you for airing this story. I hope you are planning a follow up on how Robert is doing. Please try to get national airtime for this very important story. ME/CFS is a serious & life-threatening illness, and yet it has been all but ignored by the Federal government's health agencies. Many of the 1 million+ patients are entirely bedbound, or housebound. Our illness is about far more than "fatigue," it is also about constant & widespread pain, headaches and migraines that last for months on end, immune systems that don't work, difficulty thinking clearly and memory loss, and a long list of even MORE symptoms. We have suffered for years while FDA/CDC/NIH does nothing but debate policy. We need real HELP! And we need the public to know we're here, laying in our beds, wasting away. Please help us get our message across!

Janet - 2/3/2013 9:49 AM
2 Votes
There are millions World wide who are are desperate for Ampligen to be licensed as the treatment of choice for ME. Many are concerned for Robert Miller who is on hunger strike, he feels he has no other means to draw attention to the lack of appropriate treatment for this patient group. The time to put right years of neglect

Featured Segments/Shows

All content © Copyright 2015 Intermountain West Communications, LLC. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms of Service.
You may also view our Sitemap

Inergize Digital This site is hosted and managed by Inergize Digital.
Mobile advertising for this site is available on Local Ad Buy.