"Could there finally be a cure on the horizon for herpes sufferers?"
London Post, March 18, 2019
For anyone who suffers from herpes or has done antiviral research, the headline above is a serious attention grabber. Positive results announced by Synergy Pharmaceuticals about a potential breakthrough therapy that not only treated the symptoms but actually eradicated the virus from the volunteers. Amazing!
"What Synergy has achieved is perhaps the greatest medical breakthrough of the decade. This is the first time that evidence has proven that subjects who were infected by the Herpes Simplex Virus have undergone a treatment and then shown with further medical evidence that they have completely eliminated the disease."
Not so fast.
First, a grand total of zero cases of herpes have been cured in the history of the world. Second, the premise of the biological strategy for eradication of the virus was shaky, at best. Third, the stuff in Synergy's "cure" consists of "Rhodiola, Tribulus, Astragalus, Lysine and the Amino Acid Formula." Please.
Also, there's this, the kiss of death (emphasis mine):
"A recent study by Synergy Pharmaceuticals may set a new stream of thought on the topic by bringing back traditional natural medicine as an opportunity to make a difference."
My interpretation of the bolded phrase: "Well, this crap doesn't do anything, so let's at least sell it as a dietary supplement. They don't do anything either but plenty of people spend beaucoup bucks on them anyhow.
Still, I am nothing if not fair, so I could not help being intrigued by one of their claims:
Synergy’s investigations found that this has never been achieved before and it brings us one step closer to ending herpes worldwide.
Can this really be true? After all, the company also claims (emphasis mine):
The length of the treatment found to be most effective for a successful outcome was 4-6 months. The trials conducted proved that in 80% of subjects verified as being positive to herpes simplex virus at the commencement, were after 6 months shown to have negative blood test results to herpes. This therefore reflected that they were no longer infected, had no herpes related symptoms or outbreaks and were no longer carriers of the virus.
Well, if this is really true we're talking about a bunch of first-class tickets to Stockholm. It would represent a milestone in the history of medicine. So, naturally, I wanted to see the published results.
Well, there aren't any, which was made clear by the company's response to my inquiry.
Dear Dr. Bloom,
"...The journal results were submitted to a number of major medical journals however because of tight controls by the FDA and complications with the Pharmaceutical companies which sell the antiviral medication they blocked the release."
That nasty old FDA! How dare they block the release of unworthy papers? (1) Worse still, in December 2017 the agency sent the company a hurtful advisory letter.
I don't have the bandwidth to go into even half of the objections that the FDA had to the product. Here are a few:
- "Various claims and statements made on your websites and/or in other labeling establish that [the product is] intended for the treatment, cure, mitigation, or prevention of disease." [This is the FDA definition of a drug].
- " Before a new drug may be marketed or otherwise introduced into interstate commerce, it must be approved by FDA on the basis of scientific data demonstrating that the drug is safe and effective... Your drug products do not have FDA-approved applications..."
"We advise you to review all materials through which you communicate to consumers the intended uses of your products...[including] reviewing your websites, product labels, catalogs, brochures, flyers, package inserts, audio and video, e-commerce and social media accounts you operate (e.g., Amazon, eBay, Facebook and Twitter accounts)... and anything else that states or implies that your products are useful in treating, curing, mitigating, diagnosing, or preventing diseases."
After 30 days from the date of this letter, if your website or other labeling continue to demonstrate that your products are intended to treat, cure, mitigate, or prevent diseases, the name of your firm and this letter will be posted on the FDA webpage for unapproved new drugs illegally marketed for serious diseases.
And, perhaps most revealing is the letter's signature: "Health Fraud Team...U.S. Food and Drug Administration"
Just another day in Supplementville.
(1) The FDA has nothing to do with whether journals accept papers. This is the job of editors and reviewers. Apparently, no one took the bait.