PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

You state "I refute" (referring to a comment that nothing I have stated has been scientifically refuted). Fact is that the information I posted on Sucanons scientific results and studies can't be refuted as they are based on publicly available studies, both preclinical where Sucanon outperformed many oral diabetic agents including biguanides and sulfonylureas in rat muscle testing and outperformed Glyburide in a 6 month long double blinded placebo controlled study that formed the basis of Sucanons approval in Mexico in about 2005. All this prior testing was accomplished well before the death of founder Bob Rieveley and the later involvement of Irving, Hall, and even Dr Rojas, whose subsequent peer reviewed published testing in prediabetics confirmed the efficacy of Sucanon. The only thing you have unsuccessfully tried to refute or more accurately , criticize, was that Dr Rojas has been compensated as an advisor to the company. What is verifiable under the rules of any medical society, is that any relationship is declared at the presentation of the research study. Despite my extensive documentation on this subject, you have attempted to tarnish Dr Rojas with false statements that "he could lose his license" and threaten that "he will be held to account" among others. Similarly, it was falsely stated to me "you know it's against the rules to recommend as a doctor a product in which you have a financial interest." That notion is ridiculous on several levels.
1. I am simply posting verifiable publicly available information on Sucanon studies.
2. As a practicing physician in the US I certainly have no say in the approval of Sucanon in Mexico or any other country, but it has been approved for sale by relevant government authorities in Mexico.
3. The notion that my posting the results of Sucanon is a recommendation for someone to take Sucanon in another country is absurd on its face.
4. Even if I did publicly recommend Sucanon and personally profited from it, it would be far less ethically problematic than what Dr Oz does every day on a much grander scale.
The obvious conclusion here is that the science cannot be refuted as it is verifiable for anyone to see. The personal attacks outlined above have all occurred because the science can't be disputed.

You go on to say "so does the FDA who denied this scam"
Actually the FDA never refuted anything I said, and that is a FACT.
FDA didn't refute the Sucanon studies either, to the contrary, called them "substantial clinical investigations" and stated that they did not review the studies for safety, only that Sucanon is considered a drug under the food and drug act. Of further note, FDA comments do not include "unimpressed, scam, fraud". They do refer to Sucanon as a drug under the food and drug act, a drug subject to "substantial clinical investigations"

FDA states in the last sentence of the third paragraph in page 2 of their response letter that they did not review any of the safety data because Sucanon is not a supplement. As stated repeatedly in the first paragraph, FDA considers Sucanon a drug. FDA was also apparently impressed enough to state in the response letter that Sucanon is a drug that was subject to "substantial clinical investigations" and cite an example of the research, namely Dr. Rojas study in Latino prediabetics presented at the 2013 EASD annual meeting and published in thei EASDs peer reviewed journal.

As for the repeated misleading comment of a "ban", Sucanon was never sold in the US and cannot be sold as a supplement because the FDA considers it a drug per the food and drug act and one that had undergone "substantial clinical investigations". Sucanon would require an investigational new drug application in the US and therefore focus is on other markets where Sucanon is approved and sold (Mexico) approved but not yet sold (Canada) and in the regulatory process (India).

Jayyy posted a response to the above "NOT TRUE, they just DENIED this health (and financial) scam..."

For the complete FDA letter here is the link so readers can evaluate for themselves as opposed to incomplete and misleading excerpts:

https://www.regulations.gov/#!documentDetail;D=FDA-2014-S-0023-0011

In the middle of page 2 the FDA letter states:
"Moreover, the product to which you refer in your submission appears to be a drug under the Act and thus subject to the regulatory requirements of drugs."

So the FDA says Sucanon is a drug. They further state in the letter that Sucanon has been subject to "substantial clinical investigations" and reference the Sucanon study in Latino prediabetics presented at the EASD 2013 annual meeting and included in their journal. Even more evidence is listed and source attributed in my previous posts on this issue.

FDA is pretty clear when their letter is actually read in context, so much so that the so called fraud had to be manufactured by the editing and posting of a Consumer Reports article in post 4477 and many following posts to falsely indicate that Sucanon was among products whose companies were warned by FDA. The logical fallacy is astounding because the FDA themselves clearly said that Sucanon is not a supplement. It therefore can't be in the category warned against by Consumer Reports because per the FDA Sucanon is not a supplement, it is a drug and subject to the application and evaluation requirements of investigational new drugs. Unfortunately so much misinformation posted here requires readers to consult the source information like the entire unadulterated FDA letter and postings and the real unadulterated Consumer Reports article and Sucanon studies to do actual DD.

What is also lost in the continued misleading posting about an "FDA ban" is that logically:
1. Sucanon was never sold in the US.
2. Supplements, per FDA guidance, don't need an application for sale in the US market.
3. Out of an abundance of caution, ROTH sends FDA a letter to request review of proposed sale of Sucanon as a supplement since it contains a "natural product" and is based partly on Chinese herbal medicine.
4. As above FDA says Sucanon is a drug, we have not reviewed your safety data, but Sucanon would require a new drug application, citing publicly disclosed substantial clinical investigations.
5. Now logically, if a supplement doesn't require approval and safety information was not reviewed, the only reason FDA would have to say Sucanon can't be sold as a supplement in the US is because it is a drug.
6. The above is a reasonable conclusion based on Sucanons efficacy in published studies, namely outperforming (FDA approved prescription) Glyburide in a head to head double blinded placebo controlled trial.

Now don't just take my word for it. Read the source documents. All my facts are independently and publicly verifiable and I encourage all possible DD, including checking the accuracy of any information posted here.