During a tumultuous period of turnover of federal agencies just prior to the inauguration of Donald Trump as the 45th President of the United States, the Federal Trade Commission appears to be taking a final shot at a company that in 2009 needled forgetful government officials who didn’t pay their taxes on time.
The hidden political agenda behind this government attack on a free enterprise in the U.S. is revealed by a 2009 press release published in the Milwaukee Journal Sentinel that offered a free bottle of its brain enhancing dietary supplement to any member of Congress or the Obama administration who had forgotten to pay taxes during the past 10 years. [Journal Sentinel Feb 24, 2009]
“We’re confident after 30-60 days of taking the supplement, most legislators and government officials will recall, without being reminded by aides or reporters, all tax periods for which they have forgotten to pay state or federal income taxes,” said Quincy Bioscience president Mark Underwood.” [Washington Times Feb 25, 2009]
In that same year (2009) the Washington Post published a long list of federal government employees who owed money to the Internal Revenue Service. The Federal Trade Commission had 35 employees who were in arrears on taxes at that time. Also 41 aides to President Obama were identified as delinquent taxpayers. [Washington Post; Financial Samurai]
Quincy Biosciences notes in a USA TODAY news report that the FTC action was taken by “two of the regulator’s commissioners, rather than the full complement of five commissioners ‘representing a diversity of political backgrounds’.” [USA TODAY Jan 9, 2017]
QUINCY BIOSCIENCE responded to the recent FTC attack by saying: “The FTC has not shown that Prevagen can cause or has caused harm to anyone. And hundreds of thousands of people tell us it works and improves their lives’.” [CNN Jan 9, 2017]
History of government interference
In 2013 Quincy Biosciences president Mark Underwood said the company had received a warning letter in 2012 they selling an “unapproved new drug” and had failed to verify claims Prevagen alleviates memory loss. But the company was responsive to FDA and “was in a fine place with the FDA” said president Mark Underwood at the time. [Isthmus Dec 5, 2013]
The circulating news report refers to a lone study on PREVAGEN but a more fair analysis is found at MEDSCAPE.
The proposed mechanism of PREVAGEN is reduction of calcium influx into brain cells. Note: calcium influx has nothing to do with calcium in the diet or from supplements. Calcium influx is a legitimate problem in addressing brain function. See SCI TECH DAILY for a scientific explanation.
Sales of PREVAGEN are reported to be $165 million over the past 10 years, or about $16 million/year.
Prevagen side effects are minimal
Medscape lists the reported side effects that PREVAGEN’s manufacturer listed in its self-affirmed GRAS (Generally Regarded As Safe) application.
Adverse effects, though not common, include headache, dizziness, nausea, diarrhea, memory impairment (?), insomnia, anxiety, confusion, itching, rash. Some of these are commonly experienced with any dietary supplement.
The company documented 26 reports of serious side effects including chest pain, seizures and tremors, unrelated to asoaequorin, its chief ingredient. All 26 of these adverse event reports are available for review. [FDA.gov appendix VI & VII] Most were attributed to pre-existing conditions or deemed to be unrelated to product use.
QUINCY BIOSCIENCES responsibly recorded adverse events up to 2014 in its GRAS application. There were 2200 reported adverse events or about 275 per year. The 26 serious adverse events that required a hospital or doctor’s office visit represents ~3 serious adverse event/year. There were no deaths reported and all events appear to be reversible with withdrawal from use.
If you go to ConsumerLab’s review of PREVAGEN you can read positive comments from consumers over its effectiveness. [Consumerlab.com] Ditto forAmazon.com where consumers generally give it a high rating. [Amazon.com] Most consumers didn’t feel bilked and even the dissatisfied were not harmed.
This author has heard directly from users of PREVAGEN of positive results and is aware of growing consumer demand because of shared testimonials by consumers. This isn’t entirely a smoke and mirrors product.
Will things change?
President Trump’s nominee for a new FDA commissioner is said to be Jim O’Neill, a libertarian who espouses free market reform of the drug approval process. In a 2014 speech O’Neill talked about FDA approval of drugs based on their safety only with effectiveness to be assessed by consumers. This would shorten the drug approval process. [Bloomberg News Dec 7, 2016]
There are obvious ramifications to the dietary supplement industry if such a free market policy were to be adopted for drugs. Dietary supplements are often criticized for lack of science to back advertising claims. But under such a reform, drugs would also be no better than dietary supplements from a regulatory standpoint.
Criminalizing the dietary supplement industry
In 2016 the Obama Administration criminalized the dietary supplement industry by engaging the US Department of Justice in a so-called crackdown of supplement companies. Dietary supplement executives would go to jail rather than just receive warning notices from the FDA or fines by the FTC.
The onerous 2016 attack against USP Labs, another dietary supplement company, by a bevy of federal agencies (US Postal Service, Department of Defense, US Anti-Doping Agency and the Department of Justice) has been criticized by this author. [LewRockwell.com July 7, 2016]
Under the new rules, bankers can arbitrarily dismiss online merchants who market dietary supplements with no opportunity for appeal. In other words, dietary supplement companies can be put out of business in ten days by bankers who disapprove online merchant accounts.
Targeting the dietary supplement industry and invoking jail time for alleged offenders of products that do no harm without legal recourse or appeal extends far beyond the American system of justice.
During the Obama administration political opponents, namely conservative groups, were targeted by the Internal Revenue Service. And despite investigations, the IRS never stopped targeting conservative groups. [The Federalist Nov 1, 2016]
Another targeted attack
One such conservative group that was targeted and unfairly attacked by the IRS was Creation Science Evangelism in Pensacola, Florida. Charges of failure to pay FICA employee taxes fizzled in Federal Court causing federal prosecutors to revert to allegations of “structuring,” that is, making bank deposits just under the Federal government’s $10,000 reporting requirements to avoid detection. [LewRockwell.com Jan 8, 2010]
Structuring charges have been roundly criticized from various quarters of government and even the banking industry. [Free Beacon May 26, 2016]
The signature of Lois Lerner, who had oversight of the IRS’ tax-exempt office at that time, was all over documents in the Creation Science Evangelism case. The attack against this conservative group was being managed from Washington DC when it was a local case in Florida. Kent Hovind and his wife Jo went to prison for “structuring.” The latter was imprisoned for 10 years. In retrospect, Kent Hovind’s words were prescient of future travesties invoked by the Federal government. [YouTube.com]
When will government tyranny end?