FDA panel recommends approval for Contrave?!?!?

[alexk201]

The FDA is approving another weight loss drug......but Ampligen is taking 30 years to get on the market????

http://news.yahoo.com/s/ap/20101208/ap_on_he_me/us_orexigen_weight_loss_drug_fda


I cant stand this type of BS......what kind of country are we living in?

 

[Hope123]

I'm more annoyed at Hemispherix than the FDA. The FDA has to get adequate data from Hemi to appropriately decide whether to approve it or not. As much as Hemi seems to trumpet Ampligen in their business announcements, there isn't as much on the scientific end. Someone I know who has done trials with Hemi and might do so again in the future is concerned that Hemi has not released all data (including safety data) for analysis in the past and hopes that in future trials, they are more forthcoming with the data.

 

[jimbob]

I know what you're saying, FDA helping people who can help themselves! All they need to do is hit the salad bar once in a while and not scarf down half a cow. I see it in action, living in a state with one of the highest obesity ratings. Yet, we sit here completely ignored, while they waste billions of dollars on all these morons with zero willpower. We truly are the biggest losers!

 

[JohnnyD]

I'm more annoyed at Hemispherix than the FDA. The FDA has to get adequate data from Hemi to appropriately decide whether to approve it or not. As much as Hemi seems to trumpet Ampligen in their business announcements, there isn't as much on the scientific end. Someone I know who has done trials with Hemi and might do so again in the future is concerned that Hemi has not released all data (including safety data) for analysis in the past and hopes that in future trials, they are more forthcoming with the data.

Hi Hope123, I'm not sure what you mean by not releasing all the data, but if you mean released to the public, it needs to be remembered that HEB is under some strict FDA rules about releasing information for unapproved drugs. For a different perspective you might read Mary Switzers take, someone who has been dealing with the FDA and ampligen for a decade or so (see the comments section of the article). Thanks.

http://chronicfatigue.about.com/b/2010/12/04/another-delay-ampligen-chronic-fatigue-syndrome.htm

 

[Hope123]

No, Alex, by "release," I mean release to outside researchers (who might still be bound by confidentiality rules to Hemi but are somewhat more independent) and government officials.

I've read and heard Mary Switzer's take on it and if it works for her, fine, and she should do what she needs to do to get it. But there are also people who either have had no benefit from Ampligen or have had worse health after it. There are certain programs where people can get compassionate access to medications which have not been approved or have even been "black-listed" by the FDA (some for very good reasons). Not saying these programs are easy or if insurance will pay for meds obtained under these conditions but caution has to be taken.

If there were enough people interested in pursuing Ampligen, someone should look into the history and process by which HIV drugs were approved at the very beginning of the AIDS crisis. I believe there are some expedited paths for drug approval that can be looked at. There is an old saying thoough that "One should be cautious about what one wishes for." If Ampligen were truly an effective drug with minimal side effects, I think you would see a bigger push for it from ME/CFS clinicians who have used this drug.

I have both used and prescribed medications. Medications are useful in the right context but I have also seen bad and sometimes permanent side effects from them.

If Hemi can show that it work well with clinically signficiant outcomes and acceptable safety profiles for those who are XMRV+ say, then I might be more convinced.

 

[JohnnyD]

But there are also people who either have had no benefit from Ampligen or have had worse health after it. There are certain programs where people can get compassionate access to medications which have not been approved or have even been "black-listed" by the FDA (some for very good reasons).

Ampligen does not work for everyone, it is not a cure, but there are clearly patients who benefit, some remarkably so. According to Peterson, he can predict with about 70% accuracy those that will benefit. Ampligen is not “black-listed” by the FDA, it is still available under compassionate care and in fact compassionate care is being expanded in a number of US centers. Here’s one:

http://www.cfscentral.com/2010/11/2011-open-label-ampligen-trial.html

If there were enough people interested in pursuing Ampligen, someone should look into the history and process by which HIV drugs were approved at the very beginning of the AIDS crisis. I believe there are some expedited paths for drug approval that can be looked at.

Hemispherx asked for fast track status - perhaps if the FDA knew about XMRV when Hemi applied for their NDA in 2004, it would have made a difference. Unfortunately, one cannot go back in time. However, Hemi has requested an extension of their NDA in order to correlate XMRV data with data form their pivotal PHase 3 trial; AMP516.

There is an old saying thoough that "One should be cautious about what one wishes for." If Ampligen were truly an effective drug with minimal side effects, I think you would see a bigger push for it from ME/CFS clinicians who have used this drug.

I cannot think of anyone who has more experience, and treated more patients with ampligen than Peterson, Lapp, Cheney, Bateman and Klimas... with Peterson, Lapp and Cheney having more than 20 years experience each. They are under non-disclose agreements per FDA rules, e.g. the FDA does not allow one to promote unapproved drugs. Despite this, it is clear they all think ampligen is beneficial:
Dr. Lapp
http://ampligen-treatment.blogspot.com/2010/10/interview-with-dr-lapp-pioneer-and.html
Dr. Peterson
http://forums.aboutmecfs.org/content.php?211-Dr.-Peterson-Update
See Bateman link above, you can google the others.

I have both used and prescribed medications. Medications are useful in the right context but I have also seen bad and sometimes permanent side effects from them.

I presume you are a doctor then. According to Peterson, he has never seen a patient who has gotten worse on ampligen. Hemispherx has administered over 700 patients, 90,000 doses (big doses, 200mg, twice a week), over a period of 20 years, with few side effects and continued FDA approval for compassionate care - and yet those stats do not indicate a good safety profile? Surprising. Can you name one other company that is currently trying to develop a beneficial drug specifically for ME/CFS/XMRV? There’s another old saying. “Don’t throw the baby out with the bathwater”.

If Hemi can show that it work well with clinically signficiant outcomes and acceptable safety profiles for those who are XMRV+ say, then I might be more convinced.

Hemispherx is in the process of doing a retrospective analysis of the 516, their pivotal Phase 3 trial. They are correlating XMRV data, with serology and culture being done by WPI. It’s early, they don’t yet have all the data they need to meet with the FDA. But early data suggests they very well may have a surrogate therapeutic marker for XMRV+.
The demographics of the retrospective were presented at the 1st XMRV Workshop, Abstract P_15, (The WPI also presented a positive paper on ampligen and NK cells, Abstract P_14) here:

http://www.mecfsforums.com/wiki/Abs...ve_CFS_subjects_in_a_phase_III_clinical_trial

The correlating XMRV data from the above group, can be found here, in particular the graph labeled “XMRV Serology” (you might look at the QT interval paper as well, another positive for ampligen).

http://www.facebook.com/note.php?note_id=469940716796&comments&ref=mf

 

[mojoey]

Hey Johnny,

I am Dr. Peterson's patient (which you're aware of since you posted a link to my blog), but I have reason to believe there have been incidents of patients being harmed, and sometimes severely, by ampligen. For one, I know that Dr. Cheney is unimpressed by Ampligen largely because one of his patients suffered from interferon-induced seizures and was rendered unable to walk for 6 months after the drug.

However, I do not buy for a second that Ampligen is being held up by the FDA for safety issues. All one needs to do is take a cursory look at drugs that have been approved to see that "safe" is relative, and ampligen has a remarkable benefit-to-risk ratio. Instead I think Hemispherx is a truly incompetent company, and this is revealed not only by their dealings with the FDA, but also by their inability to close the deal outside of the US (Japan, India, China etc.) Yes they were able to license ampligen use to GP Pharm in Latin America, but that feather in their cap has gotten them nowhere internationally. That and that fact that approving an immune modulator for a disease would be recognition that it's a physiological illness.

With that said, there's now XMRV and perhaps no company has more riding on XMRV that HEB. Yet if you think about it, even ampligen with XMRV as an endpoint is a longshot because of off-the-shelf HAART. I insist that the only chance ampligen has of getting approved is if it gets bought out by big pharma, preferably one that does not have a long line of off-the-shelf HIV drugs it can deploy and forego the R&D costs. That or a company with HIV drugs that's smart enough to realize that a combo HAART+modulation trial will be necessary for a gammaretrovirus.

 

[JohnnyD]

Hi Joey,

Thanks for your response. Although I don't doubt that some patients have had problems tolerating ampligen, this is the first I've heard of interferon induced seizures, which is surprising since there are ampligen studies that show little interferon production. In fact, that is why it has a good safety profile, few interferons, short life in the body.

I disagree about the incompetence of the company, I think Carter has made some mistakes in the past, but I also think they have made remarkable progress, especially considering ampligen is an entirely new class of drug and odds stacked against small biopharmas (as Mary Switzer so eloquently points out). I think XMRV has put HEB back in the CFS game, possibly in a big way, and that a big pharma partner, rather than a buyout, is what may be in the cards. Time will tell.

I agree that HAART is the way to go - but trials will start small and take time. I also agree with you (and Peterson) that HAART plus an immune enhancer (and there are others besides ampligen that are promising) may be the ultimate treatment.

 

[dannybex]

Hi Joey,
I disagree about the incompetence of the company, I think Carter has made some mistakes in the past, but I also think they have made remarkable progress, especially considering ampligen is an entirely new class of drug and odds stacked against small biopharmas (as Mary Switzer so eloquently points out). I think XMRV has put HEB back in the CFS game, possibly in a big way, and that a big pharma partner, rather than a buyout, is what may be in the cards. Time will tell.

With all due respect Johnny, I have to agree with Joey, and perhaps go a little further. Carter hasn't "made mistakes" in the past, he's out and out lied to investors, and was caught doing so. He lied telling investors that the FDA was about to approve Ampligen in June 2009, which conveniently drove the price of the stock up to $4.40 or so. As months passed, the price of the stock declined, and crashed when indeed Ampligen was not approved in December 09. And a year later the stock is still stuck at about 50 cents, despite all the XMRV news, etc..

More on this thread: http://forums.aboutmecfs.org/showthread.php?20-Ampligen

(I think when Cort says "Dr. Bell", he means "Carter". ???)

Best regards,

Dan

p.s. I don't understand your description of Ampligen as an 'entirely new class of drug'. That may have been true 20-30 years ago, but today?

 

[JohnnyD]

With all due respect Johnny, I have to agree with Joey, and perhaps go a little further. Carter hasn't "made mistakes" in the past, he's out and out lied to investors, and was caught doing so. He lied telling investors that the FDA was about to approve Ampligen in June 2009,

Dan, with all due respect, I don't think you can show me where Carter ever said such a thing. It's not something Carter would know.

More on this thread: http://forums.aboutmecfs.org/showthread.php?20-Ampligen

(I think when Cort says "Dr. Bell", he means "Carter". ???)

If you are putting your faith in Adam Feuerstein - be aware that he is a known liar and stock manipulator, a puppet of hedge funds. He said HEB will pull their NDA, which they did not. But let's not argue the point. We'll know soon enough if HEB is still in the game - I say 3-6 months and we'll have a much better indication of where Hemispherx stands. There is a lot of misinformation out there -- despite ampligen clearly being a beneficial drug to some. I find it hard to understand why some patients would deny this benefit. Anyway, time will tell.

p.s. I don't understand your description of Ampligen as an 'entirely new class of drug'. That may have been true 20-30 years ago, but today?

Ampligen's mechanism of action was described and discovered in 2005 - it is a TLR-3 Agonist. The first TLR-3 agonist was approved in the US in 2009 (Cervarix) So, in effect, ampligen became a new drug in 2005 and they now understand how it works.

 

[dannybex]

Dan, with all due respect, I don't think you can show me where Carter ever said such a thing. It's not something Carter would know.

Good point -- perhaps he himself didn't "say" that the FDA was close to approving it, but he still allowed the company to suggest exactly that, which caused the stock to soar.

If you are putting your faith in Adam Feuerstein - be aware that he is a known liar and stock manipulator, a puppet of hedge funds. He said HEB will pull their NDA, which they did not. But let's not argue the point. We'll know soon enough if HEB is still in the game - I say 3-6 months and we'll have a much better indication of where Hemispherx stands. There is a lot of misinformation out there -- despite ampligen clearly being a beneficial drug to some. I find it hard to understand why some patients would deny this benefit. Anyway, time will tell.

I agree -- it's kind of pointless to argue about it. I will agree that Feurerstein has been tough on Hemispherx. I don't know about the NDA, but he was ultimately correct in his conclusions that the FDA would turn down Ampligen, at least six months before it happened. This is noted in the thread mentioned above. It certainly wasn't Feurerstein's fault that it wasn't approved.

If I actually had any money, I personally wouldn't invest a cent with them, but I never was good with investments, during the rare time I had any pennies.

Ampligen's mechanism of action was described and discovered in 2005 - it is a TLR-3 Agonist. The first TLR-3 agonist was approved in the US in 2009 (Cervarix) So, in effect, ampligen became a new drug in 2005 and they now understand how it works.

Thanks for the explanation Johnny. I still don't quite get it, but others probably will.

We'll just have to agree to disagree.

 

[George]

I just want to say thanks for having this discussion, diagreement, conversation or what ever cause I've learned a lot!!!!! Thanks Guys!! (ARF!, ARF!)

 

[JohnnyD]

Your welcome George. FYI, the FDA has granted Hemispherx an extension to their pending NDA due to XMRV findings. While an extension might be considered routine - I think it is significant in this case. We all know these are early days of XMRV and the research is in a state of flux.

http://finance.yahoo.com/news/FDA-Grants-Hemispherx-pz-245105787.html?x=0&.v=1

 

[mojoey]

HEB hasn't broken the $0.52 resistance level in some time now, and it's at $0.53 today. This is hardly surprising given the news, but it'll be interesting to see if there is a sell-off shortly after. I think the BWG findings will carry far more weight than the NDA given that HEB is finally narrowing in on an XMRV endpoint after advertising ampligen as a panacea to no end.

Johnny I know you are a fan of this company but I wager that few people that has investigated the company as thoroughly as you have, both in and out of the patient community, would agree with your sentiments.

The competence of a CEO has as much to do with EQ and IQ. Few doubt that Carter is a brilliant scientist, but he relationship with employees and employers (spying on them, suing them, arguing about money, and generally being an egocentric rager), his relationship with the media (cancelling a 1991 science conference in Chicago on the day of the meeting, a "notoriety" which the FDA cited as making their decision to fast-track ampligen CFS more difficult), and his relationship with patients (cutting trials short on multiple occasions, blackmailing patients with the drug, pressuring patients to do PR for his company) does not inspire confidence in investors or patients.

Talk about misleading investors: here is my post on their deceptive announcement of an IRS grant from 2009 in an article last month http://www.news-medical.net/news/20...or-Ampligen-Alferon-development-programs.aspx

We talked about this on another thread. This is old news from 2009. Check this out: http://www.irs.gov/businesses/small/article/0,,id=229011,00.html

Add up the amounts of the grants awarded to hemispherx in 2009 and you get $488958 which is the amount they announced in the article.

Seeing as hemispherx is the source of the PR release, is it then true that they lied or at least were being misleading by announcing old news as new news? In either case I wouldn't be at all surprised.

From wikipedia:

In June 2009, The Street alleged Hemispherx was "seeking to divert investors' attention away from the delayed approval of Ampligen as a treatment for chronic fatigue syndrome" by issuing three press releases in seven days about research from 2007 into possible applications for Ampligen as a flu vaccine booster. Hemispherx stated that Ampligen could be used against the H1N1 swine flu. The Street also alleged the Hemispherx press releases were misleading because they imply the research had been done in 2009.[12] Hemispherx's attempts to put Ampligen in the H1N1 market were unsuccessful. The company stated they were "shut out of the U.S. government's efforts to stockpile vaccine against the H1N1 flu."[36]

More misleading from Carter http://www.cfs-news.org/kitei.htm:

HEM continues to struggle, though Carter says the company will announce a "major corporate relationship" outside the United States this month and at least one other "corporate relationship" by the end of the year. (sound familiar? except this interview is from 1994!)

Carter also speaks of possible relationships with corporate entities from Japan or from "the Southern hemisphere." (it took approximately 15 years for the "Southern hemisphere" to license the drug, and Japan has still been red herring along with the rest of Asia and Europe)

More references from wikipedia:

Manuel Asensio, an investment adviser who reports on companies he considers to be overvalued, has criticized Hemispherx and its Ampligen results,[32] alleging a variety of misdemeanors including accusations of refusing to supply Ampligen after clinical trials have ended,[33] and issuing misleading results to widen markets for Ampligen.[32]

Here is a bit from Cort's article http://aboutmecfs.org/Trt/AmpHist.aspx

Despite producing a drug that has substantially helped some chronic fatigue syndrome (ME/CFS) patients, Hemispherx has gathered few friends in the past 20 years. In the early 1990s Kim Kenney (McCleary), now the President of the CFIDS Association of America , said “Ampligen is a good drug in the wrong hands". Daniel Hoth, then head of the National Institutes of Health's AIDS drug program, went further when he told the Wall Street journal that "no professional drug company with any degree of professionalism would ever develop Ampligen the way it was developed by HEM."

Also, why did a huge science-based company that had the opportunity to buy axe Carter and develop Ampligen on its own decide not to do it? What did they see that we don't see?? http://www.cfs-news.org/kitei.htm:

Jackson advised a HEM director to fire Carter, implying that DuPont would then enter into a new partnership with HEM. In a curious handwritten memo, Jackson proposed a restructuring of HEM; it read, in part: "In order to realize whatever value there is to Ampligen -- and there may be real value there in spite of lack of efficacy of (the DuPont-sponsored trial] -- HEM needs to turn over development of Ampligen, along with commercialization rights, to a single, large pharmaceutical company with worldwide capabilities ..."

In fact HEM did fire Carter, on October 28, 1988. But instead of renegotiating a joint venture, DuPont advised HEM's incredulous board that it was terminating its involvement with Ampligen.

Nancy Kaiser, the first patient to receive benefit from ampligen for CFS, had this to say about Carter (he denies it all) http://www.cfs-news.org/kitei.htm:

"Because I believe the drug saved my life, I put up with Dr. Carter's demands," she says. "Dr. Carter told me repeatedly that if I didn't write more letters to the FDA and Congress, I would lose the drug. It shouldn't be up to sick people to get a drug approved. It should be up to the drug company to do good studies and present data."

More pressuring from Carter (which he again denies) http://www.cfs-news.org/kitei.htm:

Judy Ewing, an Incline Village patient who is also a physician, says Carter pressured her as well.
"Carter may have thought my being an M.D. would have clout with the FDA," she says. "I've never spoken, to my knowledge, to Judy Ewing in my life," says Carter, who denies pressuring anybody to do anything.

More from summary Mindy Kitei's 1994 article on ampligen http://www.cfs-news.org/kitei.htm:

(Carter) has been described as an egocentric genius prone to explosive rages who can, if the occasion requires, turn on the charm.

In 1978, Carter rigged a hidden video camera in his laboratory and retained a private investigator. He was growing cell cultures, and a valve feeding carbon dioxide, which the cells needed to live, had been flipped off or malfunctioned. ."This happens from time to time -- there's a crimp in the line, or someone forgets to turn the valve back on after changing gas ranks," says Dr. Joel Huberman, who worked with Carter at Roswell. "But Bill was very paranoid. He believed there was some grand plot against him."

DuPont was itching to bankroll a winner, and invested $30 million in the small company..... But the money caused friction. "You couldn't put Carter and Gillespie and Brodsky together in the same room," says a former Hahnemann employee. "They screamed at each other at the top of their lungs. It was always about money. It would be like 'Fifteen percent, you're fucked!' 'One million, that's bullshit!' It never stopped."

Also in the spring of '91, the company cut the chronic fatigue trial back to 24 weeks because it believed it would soon have enough data for a fast-track limited drug approval from the FDA. One pharmaceutical executive recalls that at the time, Carter was sure Ampligen would be approved to treat chronic fatigue because he had seen an AIDS drug pass through the FDA with limited data...

A few of the chronic fatigue patients hedged their bets on approval. In a quixotic move, they tried to wrest control by stealing a bottle of the pricey drug. "We couldn't trust HEM anymore," says one of the patients involved. "That drug did for us what insulin does for a diabetic. It had given us hope." The plan failed because the chemist who had agreed to help the patients lacked an $80,000 piece of equipment needed to reproduce the Ampligen. Eventually the bottle was thrown out.

After two decades of controversy, there is a sense among patients, activists and others familiar with the company that Ampligen will never be approved as long as Bill Carter is in charge. Some are hoping he will sell the patent or get an outside party to take over management of the drug.

 

[JohnnyD]

Wow, that's quite a post Joey. I take it you decided not to try ampligen.

Johnny I know you are a fan of this company but I wager that few people that has investigated the company as thoroughly as you have, both in and out of the patient community, would agree with your sentiments.

It would be more accurate to say that I am a fan of the science. That is why the links I posted were the latest, some peer reviewed, papers and information on the science of ampligen. I doubt a patients are very interested in soap opera stories, some going back more than 30 years, the price per share, the CEO's quirky personality, or Manuel Asensio who has been convicted of fraud and expelled from the securities industry. You'd think patients would be more interested in the latest science of a potentially beneficial drug, one which has clearly helped some folks. Go figure, to each his own. I'll take the science any day.

 

[mojoey]

Johnny

First off we're all interested in the science here. You would only need to search ampligen in this forum to know most patients see the benefit of the drug and want to see the drug approved. That includes myself.

Hence, the discussion is about the chance of it getting approved, which goes hand in hand with the competence of the company. For the record, you did disagree with my statements about the incompetence of the company earlier, so that's what I was arguing against. Any professional long term investor worth his salt knows that managerial competence matters just as much as the product quality, if not more, when predicting long-term prospects and viability, so soap opera or not, it is worth investigating in my mind.

I'm not trying to tarnish anyone or anything. Like you, I'm just interested in the facts but my appraisal of the drug's chance of approval goes beyond scientific abstracts.

 

[JohnnyD]

First off we're all interested in the science here. You would only need to search ampligen in this forum to know most patients see the benefit of the drug and want to see the drug approved. That includes myself.

Joey, I have to wonder about this because instead of responding to any of the recent science papers I posted, some of which had never been posted on this site before, you preferred to repeat 15 year old short seller attacks and 30 year old innuendo on Carter's mad genius personality.

Hence, the discussion is about the chance of it getting approved, which goes hand in hand with the competence of the company. For the record, you did disagree with my statements about the incompetence of the company earlier, so that's what I was arguing against. Any professional long term investor worth his salt knows that managerial competence matters just as much as the product quality, if not more, when predicting long-term prospects and viability, so soap opera or not, it is worth investigating in my mind.

But any long term investor worth his salt would also look at the positive aspects of management as well, and where they stand today as opposed to 30 years ago. Volatile personalities and anecdotal stories aside --- here is a company that took a drug whose mechanism of action was unknown and applied it to a disease of unknown etiology, a disease that no one believed existed (the only company to take a chance on ME/CFS - remarkable in itself), survived short seller attacks, hostile takover attempts, specious law suits. They've got an open NDA, with a prelimarily identified XMRV sub-group that looks like a surrogate therapeutic marker. They've got no debt, 60 million in the bank, and a 45 thousand sq ft FDA approved manufacturing facility. Two drugs, FDA approved Alferon (management bought Alferon and the manufacting plant for a song) and Ampligen which is FDA approved for compassionate care basis and four other programs besides ME/CFS. Those are the kinds of facts I look at. Today, I could not be happier with management.

I'm not trying to tarnish anyone or anything. Like you, I'm just interested in the facts but my appraisal of the drug's chance of approval goes beyond scientific abstracts.

Like it or not Carter is the company. You cannot have it both ways - wanting a beneficial drug approved, but the company to fail. Otherwise, you are shooting yourself in the foot, throwing the baby out with the bath water... which is difficult for me to understand as ME/CFS patrients have so few beneficial treatment options.

 

[mojoey]

Joey, I have to wonder about this because instead of responding to any of the recent science papers I posted, some of which had never been posted on this site before

Frankly your logic is a bit flawed. I said I approve of the science behind the product, and you're saying my lack of response to the papers is evidence that I'm not interested in the science?

Everything you've said is valid. However, facts that I've mentioned are also valid. Your selection attention is rather impressive. You continue to say we should look at positive aspects "as well" but you seem to just brush off all the negativity as "soap opera" and "innuendo." Since when did testimonies from CFS patients become "innuendo"? Anyway, I remember reading that you're a stockholder right? Best of luck Johnny. I don't have a position in the stock anymore (I'm not short either so I have nothing to gain from bashing it).

Also, what is this throwing the baby out with the bathwater business? You make it sound like you're all about the patients, so if ampligen stands a better chance of approval in the hands of say, big pharma, you wouldn't want that for patients? Of course not, you have a stake in their success. I don't think I'd be shooting myself in the foot in that scenario, but your hands would certainly be tied.

 

[JohnnyD]

OK Joey, thanks for your point of view and best of luck to you too.