Hi-Tech Pharmaceuticals, Inc. Responds to What It Sees as A Witch Hunt by the Media on Acacia Rigidula

NORCROSS, Ga., April 7, 2015 /PRNewswire/ -- Hi-Tech Pharmaceuticals, Inc. (https://www.hitechpharma.com/index.htm) believes the Harvard-led study published online today by the journal Drug Testing and Analysis is similar to the recent testing performed by the New York attorney general on many herbal extracts. Jared Wheat, President of Hi-Tech Pharmaceuticals, stated, "Herbs are where many of the pharmaceuticals we use in daily life come from or originated from (e.g., White Willow bark is where Aspirin came from and Red Yeast Rice is where the first statin drug-Lovastatin came from). Herbal extracts are extremely valuable, but often are not tested correctly as there are a myriad of compounds found in these extracts, versus one pharmaceutical ingredients found in most drugs."

"Hi-Tech Pharmaceuticals has sold more than a billion doses of Acacia rigidula since 2003," Wheat continued.  The company has conducted three clinical studies on the effects of Acacia rigidula, Wheat said, and none have found any serious adverse events, "other than possibly a jitter or shake which is common amongst stimulants."  The 2013 study (https://www.erowid.org/archive/rhodium/pdf/acacia.rigidula.pdf) carried out by FDA scientists scrutinized the testing done and methods used by Texas A&M researchers and other scientists' studies on Acacia, and noted that amphetamine is a man-made compound. "Yesterday I responded to various news outlets seeking comment on the upcoming release of the Harvard led study by Pieter Cohen, the lead researcher and an assistant professor at Harvard Medical School. However, many of these news outlets did not give equal weight to, and in some cases did not even report on, the studies performed by Texas A&M finding various methylated Phenylethylamine alkaloids in Acacia Rigidula," said Wheat.

"The testing involved in acacia and other plants coupled with the DNA testing performed by the New York Attorney General Eric Schneiderman just leads to consumer concerns and bad science.  These government entities are very good at testing pharmaceuticals, but are not familiar with botanical extracts, and the factors surrounding extraction and soil conditions that can lead to different analytical results," stated Wheat.

In the study by Harvard, Cohen said consumers are victims of their own optimism, believing that a dietary supplement can help them safely lose weight. "I think a weight loss pill could work and be safe," he said. "We're just not there yet."  Wheat strongly disagrees, and believes the likes of Harvard and big pharmaceutical companies are trying to stifle research and advances in dietary supplements such as the studies performed by Hi-Tech. Hi-Tech Pharmaceuticals published its first study on Acacia in the Journal of the International Society of Sports Nutrition November 2012, 9:P10. "Acacia rigidula is a lifesaver for the weight loss market and could not have come at a better time, considering that more than a third of U.S. adults, 78.6 million, are overweight, according the federal Centers for Disease Control and Prevention," said Wheat. 

Hi-Tech Pharmaceuticals also has a raw material division within the company that sales ingredients to other manufacturers. Hi-Tech supplied VPX from approximately 2007 to 2011 with various compounds for the inclusion in their weight loss product Meltdown®, which underwent 5 University Clinical Trials at the University of Memphis. One of the compounds in that formulation was beta-methylphenethylamine (http://www.vpxsports.com/scientific-studies/university-studies/effect-of-the-dietary-supplement-meltdown-on-catecholamine).  Although the formulation has changed slightly, the studies found that the OTC dietary supplement Meltdown®, ingested at the exact dosage as recommended by the manufacturer, results in an increase in plasma Epinephrine, Norepinephrine, glycerol and Free Fatty Acids, as well as an increase in metabolic rate. Also, from approximately 2005 through 2009, Hi-Tech Pharmaceuticals supplied Nutrex with Acacia rigidula raw materials that included beta-methylphenethylamine in their diet aid Lipo 6X, which was awarded 2009 fat loss product of the year by Bodybuilding.com. It has since been reformulated but still contains several acacia alkaloids. "All of this information was widely available on the internet," said Wheat.

Wheat continued, "I also feel this is a joint effort by big pharma and institutions to rid the marketplace of acacia as they did with ephedrine in 2006. In a study years after the banning of ephedrine alkaloids by the FDA, the pharmaceutical giant Glaxo performed a study and confirmed that ephedrine is a reliable thermogenic compound against which comparison of novel thermogenic agents may be made after both acute and chronic administration (http://www.hindawi.com/journals/jobe/2011/210484/). The study found highly precise methods are paramount for detecting subtle differences in energy expenditure when evaluating the thermogenic properties of drugs that are being evaluated for the treatment of obesity. Our data confirms that modest drug effects, where present, can be detected by whole-body indirect calorimetry, and this technique should be considered when planning small experimental medicine studies to evaluate manipulations of energy balance. We have assessed ephedrine's merits as a comparator compound in the evaluation of novel thermogenic agents. Volunteers randomly given ephedrine hydrochloride 15 mg QID or placebo were studied at baseline and after 1-2 and 14-15 days of treatment. We demonstrate that overnight or 23-hour, 2% energy expenditure (EE) and 5% fat (FO) or CHO oxidation effects are detectable both acutely and over 14 days. Compared to placebo, ephedrine increased EE and FO rates overnight (EE 63 kJ day 2, EE 105 kJ, FO 190 kJ, day 14), but not over 23 h."

"Hi-Tech Pharmaceuticals fought the outlawing of ephedrine alkaloids and will not sit idly by while researchers and a biased media try to destroy acacia just so they can commercialize it into a prescription drug and ban it from the dietary supplement industry as they did with ephedrine alkaloids," concluded Wheat.