Replies to post #3849 on PharmaRoth Labs, Inc. (ROTH)

[sweetlou]

"Science spelled S C A M"
Actually, no it it spelled science, and is in the form of preclinical studies where Sucanon outperformed Sulfonylureas and biguanides in lab and animal testing with a therapeutic index of >10,000, then randomized double blinded placebo controlled study in 370 adults 6 months in which Sucanon outperformed Glyburide (all well prior to involvement of those you take issue with at ROTH) followed up by a study in 97 prediabetics, 2 weeks, where 81% returned to normal HbA1C levels, and was presented at 2013 EASD annual meeting by a researcher that s now a company consultant. Perfectly allowable under disclosure guidelines.
"It's a drug"
That is what the FDA considers Sucanon in thier response to an application to sell as a neutraceutical in the US
"It's not a drug"
That is not a real quote from the company but a fabrication. It could be an assumption based on the FDA application but see above for clarification. The thing is it is approved for sale OTC per Mexican government approval and is available at many retail locations in the country including farmacias Similares if any care to check. In any case the application may ask for supplement consideration and the FDA can and did see it differently, which is positive in some ways as it is clear Sucanon has powerful therapeutic effects, and negative in others (lots of money to go through FDA evaluation)
"No side effects" though your quote says "All drugs have side effects...and can have effects on body processes"
The accuracy of this as with most statements depends on an accurate definition of "side effect". If one means that as observed during Sucanon testing in the above study with Glyburide, that Sucanon showed weight and visceral body fat loss as opposed to the weight gain observed with Glyburide (avg of 3-4 kg) which is well documented in other sources, Sucanon could be said to have an unintended effect in addition to the primary effect of improved short and long term blood glucose control, improved results in glucose tolerance testing and decreased urinary glucose. So tecnically Sucanon would have a side effect of weight loss, which is a helpful unintended consequence, in contrast to elevated risks of heart attack or stroke, liver damage in other alternative medications for type 2 diabetes. Those are negative unintended consequences to body processes and therefore side effects. As you pointed out, Sucanon has been out there for 14 years, and as I observed, has given plenty of time for previously unrecognized side effects to be identified. It just hasn't happened. Science, that is spelled s c I e n c e, really does matter.

[Jayyy]

So you guys disagree with world class experts like Brian Strom??
It's important for the public to realize all drugs have side effects. It doesn't matter if they're prescription, over-the-counter, herbals or nutritional supplements. If they have active ingredients, they have side effects and can interfere with normal body functions," says Brian Strom, director of the Center for Clinical Epidemiology and Biostatistics at the Perelman School of Medicine at the University of Pennsylvania.

[sweetlou]

IMO the key word here is any substance CAN interfere with body processes. Mr. Strom does not say WILL interfere with body processes. It is acknowledging that any should be aware even with taking supplements, that unintended consequences CAN occur. That is why the safety is studied. Sucanon, with a therapeutic index of >10,000 and no teratogenicity, mutagenicity has shown safety in preclinical and clinical studies and been out in use for 14 years for post clinical issues to be identified.
One example of concern identified with supplement use might be creatine used by athletes to help muscle growth. Creatine was loosely implicated in causing kidney failure in a group of wrestlers that trained in a hot room and became dehydrated and many were hospitalized with issues including kidney failure. Creatine was implicated as a cause even though they had signs of a condition called exertional rhabdomyolysis which was likely responsible for the kidney issues.
As a practitioner treating athletes, out of an abundance of caution, I recommend that they remain well hydrated IF they choose to use creatine, as many do anyway. There are 2 reasons that I mention the caution. One is to educate folks on the data, another is to mitigate any liability for the team doctor and the athlete's school.
There are few similarities between this example and Sucanon. One that comes to mind, though, is that my role is not to recommend,because I am not a regulatory entity, but to educate based on available data and scientific principles. Another is to do with the MDA endorsement of Sucanon. First it is a fact that the Mexican government regulatory body approved Sucanon for sale without a prescription. Second MDA endorsed Sucanons use and made a standard statement that they include for every endorsement that they recommend checking with your doctor before using it. This is very similar to the caution on the OTC 200mg ibuprofen in my own medicine cabinet that says among other cautions "ask a doctor or pharmacist before use if you are : under a doctors care for any serious condition, taking any other drug, taking aspirin for heart attack or stroke..." It also says "ask a doctor before taking if you are on a diuretic, have high blood pressure, heart disease, kidney disease, liver cirrhosis, or asthma..." So before a big deal is made of "not recommending" or "on the advice of a doctor" I suggest that we think about the ibuprofen warnings and for goodness sake call your doctor before taking ibuprofen with any of the above issues...