A new white paper claims that the FDA’s claims that Kratom is a dangerous and even deadly substance are nothing more than junk science. Kratom is a naturally occurring substance that comes from a tree in southeast Asia and yet every day the FDA seems to have a new claim about the dangers of Kratom, even wanting the DEA to schedule Kratom as a Schedule 1 drug.
Let’s give it a Reality Check.
Check out our sponsor SmartCash at https://smartcash.cc
Washington, D.C. — An advisory committee for the Food and Drug Administration (FDA) on Thursday recommended approval of the first pharmaceutical grade cannabidiol (CBD) medicine to treat severe epilepsy. In a unanimous decision, the committee voted to recommend GW Pharmaceuticals drug Epidiolex for approval.
Cannabidiol, commonly referred to as CBD, is a non-psychoactive cannabis derivative. The approval of Epidiolex would be limited to treating seizures in patients aged 2 and older caused by Lennox-Gastaut syndrome and Dravet syndrome.
“Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.
[Related: In CBD-Legal Tennessee, Cops Raid Shops Selling Non-THC CBD Gummies]
Taking a natural product such as CBD oil and turning it into a FDA approved drug has the potential to limit the avenues that people have to access the natural product. Motherboard reported last year on the drug industry lobbying for legislation that would outlaw CBD oil by turning it into a drug. South Dakota Senate Bill 95 had sought to exempt CBD from the definition of cannabis, thus taking it off Schedule I controlled substance list and becoming a Schedule IV substance.
GW Pharmaceuticals and its U.S. subsidiary, Greenwich BioSciences, lobbied for an amendment to the legislation to limit CBD rescheduling to only FDA-approved products— in other words, they wanted only CBD drugs to be legally obtainable.
A 2017 report from Motherboard explained:
Not surprisingly, GW Pharmaceuticals has just such a drug in the pipeline. Epidiolex, a ‘proprietary oral solution of pure plant-derived cannabidiol,’ has already been given to epileptic children in the U.S. as part of a federal investigative study documented recently in the New England Journal of Medicine.”
“Since no other pharmaceutical company has a CBD drug anywhere close to market, and the wide range of CBD products already available in medical marijuana states lack FDA approval, if the bill had passed with that amendment intact, patients in South Dakota would have been subjected to a virtual CBD monopoly …
More ominously, The Great CBD Battle of South Dakota appears to be but the opening salvo in a nationwide war between GW Pharmaceuticals and traditional medical cannabis providers …
[U]nder the amendment, South Dakota would … ban myriad CBD products already available in many other states. Even though they cost far less than Epidiolex, and are potentially more effective for patients, since in addition to CBD those ‘full spectrum’ cannabis extracts also contain small amounts of THC and other medicinal components of the plant.
Motherboard also noted that “corporate lobbyists in more than 20 states are currently pushing to make sure the pharmaceutical industry has the only legal supply of CBD.” Thus, it appears the big pharma takeover of CBD is underway.
“It’s incredibly important as a physician prescribing to patients that we know what we’re giving them and we know we give them one month will be the same that we give them three or six months later,” said Dr. Orrin Devinsky, director of NYU Langone Epilepsy Center, attempting to explain the importance of pharmaceutical intervention in the CBD market.
“It’s very important to highlight that the drug used in this study, cannabidiol, was derived from cannabis plants, and purified to 99 percent purity,” Devinsky told NBC News. “This is not something you can get from a dispensary today in the United States. It’s not something that you can get by smoking marijuana. It is a very specific pharmaceutical grade product derived from marijuana, but quite different than what is available anywhere else right now in the United States.”
NBC News reported that the FDA has indicated that it will likely approve Epidiolex. Although the recommended use for this particular product is very limited, doctors may prescribe it at their discretion.
“Both by Lennox-Gastaut syndrome and Dravet syndrome are rare, severe, refractory epilepsy syndromes with onset in early childhood,” the FDA stated.
“The results from these three studies provide substantial evidence of the effectiveness of CBD for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome (LGS and DS),” the FDA said in briefing documents given to the advisory committee ahead of Thursday’s meeting.
“In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders.”
Washington, D.C. – Democrats defeated “Right to Try” legislation in the House on Tuesday that would have allowed people with terminal illnesses greater access to experimental drugs. Although the vote for the measure was 259-140, it fell short of the required two-thirds majority. Republicans nearly unanimously backed the measure while Democrats were opposed by a margin of more than 4-to-1.
The U.S. Senate passed similar legislation in August 2017 which allows for the GOP to revisit the bill under House rules that require only a simple majority for passage. Although Democrats called the bill misleading and risky, House Republicans vowed to continue to fight for passage of the proposed legislation.
“The House will not let this be the end,” said Majority Leader Kevin McCarthy (R-CA).
House Democrats argued that the legislation would provide little relief for patients. Additionally, they claimed that rolling back FDA oversight would create additional risks. According to the New York Times, an existing Food and Drug Administration program approves patients to try experimental treatments 99 percent of the requests it receives annually.
“The last thing I want to do is give patients false hope and to put them at risk” by reducing the FDA’s powers, said Rep. Frank Pallone of New Jersey, top Democrat on the Energy and Commerce panel.
[RELATED: Oregon Enacts “Right to Try” Law Letting Dying Patients Try Experimental Treatments]
House Republicans resoundingly rejected that argument.
“There is no such thing as false hope. You either have hope or you have no hope,” said Rep. Andy Biggs (R-AZ).
The Associated Press reports that under the proposed legislation, a doctor and pharmaceutical company would no longer need FDA approval to allow terminally ill patients to try experimental drug treatments, but the agency would be notified after the treatment began. The bill would also widely shield doctors and drug makers from legal liability and require drug manufacturers to report any potential problems – but does not require pharmaceutical companies to supply the drug.
In October, FDA commissioner Scott Gottlieb told Congress that 70 percent of the experimental drugs his agency currently allows seriously ill patients to use experimentally are never approved.
“The vast majority of people” granted access to unproven treatments “are using a drug that doesn’t work,” he said.
Conversely, that means 30 percent of experimental drugs are eventually approved and do work – which gives a terminally ill patient a better chance than without any experimental treatment.
“If I had a terminal diagnosis, I’d even consider injecting monkey urine if I thought it would give me a few more months, a few more years with my children,” said Rep. Morgan Griffith (R-VA).
So why would the FDA crack down on a substance that may help save lives?
Some say the agency has actually been involved in a massive disinformation campaign against a substance called kratom. What is kratom, and why is the FDA fighting so hard against it?
Another White House administration is making fighting the opioid epidemic a top priority. And again, the focus is on the wrong thing.
What if, while ignoring the root causes of the opioid epidemic, the FDA is also fighting a substance that is saving people’s lives who suffer from opioid addiction?
Before we can answer that question, let’s talk about the substance the FDA is looking to ban. It’s called kratom.
Kratom is a tropical tree in the coffee family. It is commonly used in raw plant form, with the dried leaves used to make tea or crushed and mixed with food. Indigenous to Southeast Asia, the plant has become popular in the U.S. as a natural medicine.
Actually, millions of people around the world take it for chronic pain, alcohol addiction, weaning off opiates, depression, anxiety, PTSD and more.
But the FDA says kratom is actually just as dangerous as opioids. In fact, in November, the FDA Commissioner Scott Gottlieb recommended that kratom be scheduled as a Schedule 1 drug, meaning it is highly addictive and has no proven medical value.
In addition, the FDA claims that kratom is responsible for 36 deaths.
But here’s the problem: just days ago, nine leading scientists in substance addiction and safety wrote to the White House Opioid Crisis Team Leader Kellyann Conway and acting-DEA Administrator Robert Patterson.
They encouraged both to disregard the FDA’s claims about kratom, pointing out serious flaws in the agency’s claims.
“The scientists warned that ‘four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.'”
These scientists went on to challenge the claims by the FDA by pointing out that, “available science is clear that kratom, although having effects on opioid receptors in the brain, is distinct from classical opioids (e.g. morphine, heroin, oxycodone, etc.) in its chemistry, biological effects, and origin.”
The other important rebuttal these scientists made was to point out that the FDA used significantly flawed information when it claimed kratom was responsible for 36 deaths.
“…the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths. For example, it includes 9 fatalities in Sweden that resulted from an adulterated product that included the active substance of the prescription opioid tramadol…”
In response, the FDA commissioner released more information on those who have died, the agency says, from kratom. And that information is even more stunning.
According to HuffPo:
“Almost all of the FDA’s cases involve subjects who were found to be on multiple substances at the time of their death, with the vast majority including either illicit or prescription drugs that carry well-known fatal risks.
“FDA’s list of kratom-related deaths includes a 43-year-old man determined to have died from complications due to deep vein thrombosis.
“He had a long list of medical problems… At the time of his death, he’d recently been prescribed five different medicines.
“His toxicology test came back positive for opioids, Xanax, antidepressants and a medication apparently used to treat his Tourette’s syndrome. He also tested positive for kratom.
“One case involves a man who had fallen out a window, broken his arm and refused treatment before dying.
“He was ultimately found to have had nine different substances in his bloodstream, among them, the primary psychoactive substance in kratom.
“One case the FDA listed as a kratom-related death, which has been completely redacted in the document, appears elsewhere in an agency database as a death by homicide due to a gunshot wound to the chest.”
So why is the FDA doing this? We don’t know the motives of the FDA but as I have shown you in the past, the FDA suffers from severe conflicts of interest, especially when it comes to the revolving door between the agency and Big Pharma.
With the government spending more than $500 billion per year to fight the opioid epidemic, one could assume there are lines of pharmaceutical companies looking for product alternatives.
So what you need to know is that while I won’t speculate about what the FDA is ultimately trying to do, I can tell you what the FDA wants done.
The agency wants kratom to become subject to an FDA new drug application. To be clear, they say a naturally occurring plant taken in its raw form, that is helping millions of people right now, needs to be banned and become subject to a study that would take no less than 10 years and cost up to $2.5 billion dollars.
And so the question remains. If the FDA is successful, will the agency actually push millions of people toward more dangerous alternatives, including harmful opioids? If so, how is that making the fight against opioid abuse a priority?
The Truth In Media Project has released the last segment of of its newest series Truth In Media: Big Pharma, The FDA & Health Propaganda. Part 4, titled How Big Pharma Uses Off-Label Drugs, illustrates how pharmaceutical companies have made massive profits in spite of being ordered to pay enormous settlements related to harmful side effects of certain drugs.
Truth In Media’s Ben Swann first discussed the case of Peggy Ryan, a pharmaceutical sales representative for Endo Pharmaceuticals, who spent a decade undercover gathering information and ultimately blowing the whistle on corruption within the company.
Ryan, described as a rising star at Endo, said that she had been directed to push a product called Lidoderm, which was initially created to treat a specific condition called post-herpetic neuralgia. Since Lidoderm was approved to be prescribed only for this condition, the drug was classified as an “orphan drug,” which qualifies a drug to be subsidized by taxpayer dollars in its approval and production process to offset low profits related to producing a product that is prescribed to a limited number of patients.
Swann pointed out that the FDA does not monitor orphan drugs for side effects after their approval.
Ryan said she was instructed to sell the drug “off-label,” which means to sell the drug to be used for conditions outside of its intended use. Lidoderm ended up being prescribed for a plethora of health issues including back pain and carpal tunnel syndrome. Many of these prescriptions were covered by Medicare and Medicaid.
“She had access to a lot of information, and she provided that to the government. But then they asked her to wear a wire and obtain audiotapes of the people that she reported to telling her and other employees to essentially to break the law,” Judy Hoyer, a whistleblower attorney whose firm represented Ryan, told Swann.
Endo was ordered to pay $193 million in penalties in a settlement; $21 million was allocated to settle criminal charges, and $172 million was paid out under the False Claims Act. While $193 million is certainly a large sum of money to be paid, Endo made at least $1 billion selling the drug off-label; the penalty paled in comparison to the profits made.
In a separate case that also involved massive drug sale profits in light of little government oversight, highly-cited researcher, doctor and Emory University Professor Doug Bremner discussed the acne drug Accutane with Swann. Bremner, who has spent a great deal of time researching PTSD and depression and the brain, served as an expert witness in litigation proceedings associating depression and suicide with Accutane.
Bremner was asked by a concerned parent to research Accutane. “I was doing research on depression and the brain so I was working in a similar area. So the question was whether the same kind of changes that we see in the brain in depression would be seen in kids taking this medication. So the idea was if the same brain areas are affected, then that could explain why some teenagers were developing depression and even some of them killed themselves,” Bremner told Swann.
Hundreds of reports of depression while using Accutane were seen between 1982 and 2000, and included 37 suicides. Accutane ended up being recalled in 11 countries and at least 7,000 lawsuits were filed against Roche, the manufacturer of Accutane. Millions of dollars were paid out in settlements, yet the sales of Accutane had reached nearly $800 million and the FDA never pulled the drug or classify it as deadly.
During discussion of FDA oversight on drugs such as Accutane, Bremner told Swann that “in all fairness to the FDA, they have a budget to approve drugs and there’s a lot of political pressure for them to approve as many medications as possible, as quickly as possible,” and there is a limited budget for continued surveillance and oversight regarding medications after they’re approved.
Despite the challenges presented to the FDA regarding the costs and time spent on the drug approval process, Swann pointed out that when the agency “only studies cherry-picked information, has agents who are promised future jobs with big pharmaceutical companies, and doesn’t seal with a drug after it’s been approved— even then that drug is causing birth defects or even death— then, quite candidly, what good is the FDA in the first place?”
The Truth In Media Project has released Part 2 of its new 4-part Truth In Media episode Big Pharma, The FDA & Health Propaganda. In Part 2, Understanding Big Pharma’s Propaganda Machine, Ben Swann discusses the how companies within the pharmaceutical industry are able to attract positive media surrounding its drugs, regardless of whether or not their claims are founded.
Laurie Powell, a former medical brand strategist, spent a decade identifying drugs that would have the potential to treat prevalent and widespread medical issues, and persuading physicians to believe that these drugs were valuable, even if their effectiveness or overall safety was not yet proven.
According to Powell, ad agencies work with pharmaceutical companies to create ghostwritten articles that praise certain drugs utilizing cherry-picked data, and these articles are provided to medical journals. These “scientific articles” are not truly scientific, says Powell, but are actually forms of advertisements created to convince physicians to believe in a certain drug’s potential as well as influence their colleagues.
“It would start with New England Journal of Medicine, JAMA, those kinds of large publications,” says Powell, as well as communicating with smaller publications more specifically tailored to certain medical conditions. “We’d plan out over the next few years how we’re going to take the messages that come from the data— which we’d slice and dice that up— and disseminate those messages throughout those publications over a course of years.”
Marcia Angell, the former editor of the New England Journal of Medicine, strongly criticized this practice.
“This is corrupting research and making the public— and doctors— think that prescription drugs are much better and safer than they really are. I saw an enormous change in the relationship pf academic medicine and clinical research to the drug companies. And I saw more and more bias introduced into the research. And one of the worst forms of bias is that the drug companies will not permit researchers to publish negative results. If the drug doesn’t look good, it’s not published. It’s buried.”
It’s common knowledge that corporations have long created advertisements tailored to shining a positive light on their products in order to attract consumers. However, companies pushing to influence consumers to buy a certain brand of soda or shampoo is clearly not in the same realm as a pharmaceutical company controlling the entire message when it comes to the safety and effectiveness of its drugs, particularly when the FDA has been tasked with making sure that drugs are held under a high level of scrutiny.
The Truth In Media Project has released the first segment of its latest Truth In Media episode: Big Pharma, The FDA & Health Propaganda. The first segment of this episode, Big Pharma’s Influence Over The FDA, examines how the pharmaceutical industry exerts heavy influence over the FDA as well as the media and the medical community.
In this segment, Ben discusses the multi-million dollar lawsuit launched earlier this year by eight plaintiffs against Johnson & Johnson, former FDA Commissioner Margaret A. Hamburg and her husband, Peter F. Brown. The plaintiffs claim that Hamburg was the “instrumentality” in covering up the harmful, and sometimes fatal, side effects of the once-popular blockbuster antibiotic Levaquin to maintain a high number of the drug’s sales, as well as to secure and protect private financial interests.
This segment also illustrates the consequences of demanding faster drug approval from the FDA. Doug Bremner, a physician and professor of Psychiatry at Emory University, tells Swann that Congress has reduced funding of the FDA’s budget while also ordering the agency to expedite its approval of drugs. “The number of people working on new drug approval has been increasing at the expense of those who are supposed to be watching drugs after they come out on the market,” says Bremner.
Swann also examines the problems that arise when FDA regulators, who are tasked with maintaining oversight of the pharmaceutical industry, are wooed by these companies. Laurie Powell, a former medical brand strategist, says that a career in the pharmaceutical industry is much more lucrative than a lower-paying government job, and that pharmaceutical companies regularly approach FDA regulators hoping to attract them to serve on the industries’ regulatory committees.
According to Powell, working for the FDA is sometimes merely a “jumping off point” for some employees before moving on to work in the pharmaceutical industry, which leads to the question: should FDA employees be able to work for the very industries they were once in charge of scrutinizing?
Many Americans have become increasingly aware that U.S. government agencies often fall short in providing transparency to its citizens, leading to failure in fulfilling their mission to adhere to policies for the protection of the American people.
Over the last few years, Truth In Media has discussed multiple instances in which agencies including the IRS, DEA, FBI, NSA, VA and others have been placed under public scrutiny in recent years for numerous cases of questionable conduct.
Many of these agencies, funded by taxpayer dollars, frequently claim to serve as a crucial safeguard, yet far too often they have been found to be serving outside interests at the expense of citizens.
When it comes to providing transparency and following proper procedure in protecting the health of the American people, where does the FDA stand? Has this agency maintained its integrity in maintaining oversight of drug companies? Is this agency doing its job to the best of its ability in assuring that our medicines have been rigorously tested, and is it making sure that drugs found to be dangerous are assigned proper warnings or removed from the market?
Truth In Media will be asking these questions in a brand new series: Truth In Media: Big Pharma, The FDA & Health Propaganda, seeking to provide a more thorough look into the relationships between FDA employees and the pharmaceutical industry, as well as the ways in which big pharma holds an enormous amount of influence over not only the FDA, but also physicians, medical journals, politicians, drug research, and ultimately millions of Americans.
This 4-segment series begins with Part 1 premiering in the first week of June. Stay tuned!
Following several years of controversy surrounding the safety of genetically engineered (GE) salmon, the FDA has announced that AquAdvantage salmon is as safe and nutritious to eat as the non-genetically engineered variety.
The FDA stated, “The FDA scientists rigorously evaluated extensive data submitted by the manufacturer, AquaBounty Technologies, and other peer-reviewed data, to assess whether AquAdvantage salmon met the criteria for approval established by law.”
The FDA says the data shows “that the inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s claim about faster growth.”
Assessments of the environmental impact of the GE salmon found that “the approval would not have a significant impact on the environment of the United States.” Critics have long feared that GE salmon might escape from AquaBounty facilities and disrupt salmon in the wild. However, the FDA writes that “the multiple containment measures the company will use in the land-based facilities in Panama and Canada make it extremely unlikely that the fish could escape and establish themselves in the wild.”
Several consumer advocacy and anti-genetic engineering groups condemned the decision. The group Food and Water Watch has launched a petition asking President Obama to overturn the FDA’s approval.
A statement from the Consumers Union reads, “Unfortunately, the evidence of FDA’s evaluation of the AquAdvantage salmon suggests that FDA has set the bar very low.” The group accused the FDA of “sloppy science, small sample sizes, and questionable practices.” The organization also challenged the FDA’s analysis of growth hormone levels in the flesh, accusing the agency of making a decision “despite having no data at all on growth hormone levels due to use of insensitive test methodology.”
The FDA released two guidance documents discussing their position on labeling and outlining what types of voluntary labeling would be accepted for non-GE salmon. The agency said food manufacturers may use phrases like “Not genetically engineered,” “Not genetically modified through the use of modern biotechnology,” and “We do not use Atlantic salmon produced using modern biotechnology.”
Despite the FDA’s decision, AquaBounty has faced criticism and lawsuits for their products. On Tuesday the Guardian reported that several environmental groups are suing the Canadian government in an attempt to end the production of GE salmon eggs. The lawsuit claims AquaBounty is operating a “huge live experiment” with the genes of the wild Atlantic salmon. The Canadian government previously gave AquaBounty permission to create GE salmon eggs in Canada and ship them to Panama to be grown before selling them on the market in the U.S. and Canada.
In April 2013 Food and Water Watch reported:
“When FDA first announced its intent to approve AquaBounty’s application in the fall of 2010, the public sent more than 400,000 comments in opposition. Now that opposition has grown to nearly 1.5 million people.”
The following year Kroger and Safeway, the nation’s two largest grocery chains, announced they would not sell the genetically engineered salmon. The two chains joined Target, Whole Foods, and Trader Joe’s in their opposition to the GE salmon. So although the FDA has approved the fish for human consumption, it may be unlikely that Americans will encounter the product at their local grocer.
What are your thoughts? Will you eat the GE salmon?
This week, the Montana Senate unanimously passed Senate Bill 142, also known as a “Right To Try” bill. SB 142 would allow terminally ill patients to use experimental drugs or treatments not yet approved by the Food and Drug Administration (FDA).
If the bill becomes law, an “investigational drug, biological product or device” under the guidance of a health care provider would be allowed as treatment if the eligible patient:
An experimental treatment is defined in the bill as a “drug, biological product or device” that “has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a United States food and drug administration-approved clinical trial.”
The bill, introduced by Republican Sen. Cary Smith, also provides protection for health care providers who would administer experimental treatments. Section 8 of the bill prohibits licensing boards from revoking, suspending, or taking other retaliatory action against a health care provider’s license based on a provider’s recommendation to an eligible patient regarding experimental treatments. The Department of Health and Human Services is also prohibited from taking action against a health care provider based on advocating experimental treatments. State officials would be not be allowed to stop an eligible patient from pursuing these treatments.
Montana is one of many states that have pursued such legislation. Senate Bill 4 (SB 4), a bill that is nearly identical to Montana’s SB 142, was passed unanimously on Thursday by the Arkansas Senate and has been referred to the state’s Public Health, Welfare, And Labor Committee. Michigan, Colorado, Missouri, and Louisiana have passed similar “right to try” bills. Last November, voters in Arizona passed Proposition 303 with over 70% supporting the “right to try.” New Hampshire introduced a “right to try” bill, HB 446, in January.
While the FDA offers a chance for patients to seek “expanded access” to investigational drugs, their process requires patients to apply for approval from the agency. “Right to try” bills that have been considered and passed throughout the country could signify that terminally ill patients prefer making important treatment decisions with their health care providers without being required to wait for FDA approval.
Mineral Wells, TX – Last week, a publication in the Federal Register brought a glimmer of hope to a company that has been fighting for proper recognition and classification from the United States Food and Drug Administration for the last 33 years.
Electromedical Products International, Inc. or EPI, was founded by Dr. Daniel L. Kirsch in 1981. The premise of EPI revolved around the Alpha-Stim, a Cranial Electrotherapy Stimulation (CES) Device. It was originally cleared by the US FDA to treat the conditions of anxiety, insomnia, and depression. However, EPI ran into problems with the FDA, when it came to classifying their device.
While the Alpha-Stim is sold over the counter in Europe and Canada, the FDA in the United States has limited it to only being available to patients, by or on the order of a licensed healthcare practitioner. Also, whereas the Alpha-Stim is classified as a Class II device, according to the regulatory authorities in Europe and Canada, it is classified it as a Class III device in the United States. The main difference is that at Class II, the Alpha-Stim is subject to special controls, while at Class III, it is subject to the Pre-Market Approval Process.
According to EPI’s President, Tracey B. Kirsch, “Arbitrary actions by FDA were first experienced by EPI in 1990 for its 510(k) submission for CES indications. This statutorily mandated 90-day review process took 22 months, and more than once during this lengthy process FDA would request more valid scientific evidence to support the application on the 89th day of review, thereby restarting the FDA’s 90-day clock.”
It wasn’t until May 12, 1992, that EPI received its substantial equivalence letter from the FDA. “Years of hard work and substantiation had finally been completed, or so we thought,” said Mrs. Kirsch.
In 1993, the FDA issued a proposed rule to reclassify CES devices, which was finalized in 1995. EPI complied, and submitted a Pre-Market Approval, or PMA, in November of 1995, for its Alpha-Stim CES technology. EPI received a refuse to file letter in the following month, in which the FDA claimed that EPI’s PMA did not contain the required information, therefore the application could not be filed and EPI would have to cease distribution of its CES technology.
In 1996, EPI filed suit against the FDA in Federal District Court, and in 1997 there was a Federal Register notice published which revoked the FDA 1995 regulation requiring PMA’s for CES devices. This allowed commercial distribution through 510(k) clearances. According to Mrs. Kirsch, “There was no reason given for this revocation.”
“EPI was allowed to market and distribute its CES products in relative peace from 1998 until 2009, when FDA requested CES manufacturers again provide their research to FDA so that a proper final classification could be made,” said Mrs. Kirsch.
In 2012, representatives from EPI were called before with the Neurological Devices Panel of the Medical Devices Advisory Committee to the FDA. The FDA wanted to keep CES devices in Class III, but EPI presented their safety and effectiveness data in an attempt to reclassify the Alpha-Stim to a Class II device.
The FDA published a Proposed Rule in 2011, and then, after ignoring EPI’s compliance, they published a similar mandate in 2013, this time a “Proposed Order.” EPI responded with over 300 letters, filled with practitioner and patient testimonials. Sixteen of those letters were written by Dr. Kirsch, himself.
The subject matter in Dr. Kirsch’s letters ranged from wanting to know why the FDA was supporting studies that turned anonymous individuals into experts on the Alpha-Stim, to accusing the FDA of discarding 360 of the 392 studies on Cranial Electrotherapy Stimulation that were presented to the Neurological Devices Panel.
Dr. Kirsch wrote that the FDA had left the Neurological Device Panel with “no useful data upon which to make their recommendation as to effectiveness of CES in the treatment of anxiety, insomnia and depression.” He went on to write, “We ask that FDA review all of the valid scientific evidence and present it to the Neurological Devices Panel in a fair and unbiased manner so that the Petitions for Reclassification submitted on behalf of CES devices can be adequately considered.”
In the same Proposed Order where the FDA demanded that all Cranial Electrotherapy Stimulation devices be classified as Class III devices, it also suggested reclassifying sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, from Class III into Class II.
One of the largest things setting the two devices apart were the side-effects. While sorbent hemoperfusion devices had side effects such as blood loss, platelet loss, and Leukopenia, CES devices had a much smaller list, which included side effects such as headaches and skin irritation.
“We feel it is appropriate to highlight the standards FDA has imposed on CES manufacturers in FDA’s review of their petitions to reclassify CES as a Class II device and compare that with the standards imposed by FDA in its review of sorbent hemoperfusion devices,” explained Dr. Kirsch. “A review of the standards imposed for each device shows a clearly arbitrary and inconsistent process of review which FDA is implementing in its determination of a device’s classification.”
In regards to the Cranial Electrotherapy Stimulation Devices made by EPI, Dr. Suresh Kotagal, a member of the Neurological Devices Panel in 2012, said, “I just have a very simple comment, that the device is safe. There is really no convincing evidence of any potential adverse effects.”
The long, continuous battle has taken a toll on Dr. Kirsch. He told Benswann.com, “Every day for over 20 years when I woke up in the morning I worried what the FDA may do to us. Indeed they did a lot. I often thought I lived in a nightmare version of the movie Groundhog Day.”
The recent publication in the Federal Register showed that the FDA was finally taking steps to accept the multiple reclassification petitions submitted by EPI to put CES devices into their proper category. Dr. Kirsch sees this as great news, which will lead to removing uncertainty from EPI’s future. “Now while they still will regulate us with a harsh hand, they can not just make our 33 year history go away ever again and force us to start over,” said Dr. Kirsch.
Currently, the largest customer of the Alpha-Stim is the United States Government. The US Department of Defense and Veterans Affairs Medical Centers accounts for over 60% of EPI’s sales, using the CES Devices primarily for treatment of depression, anxiety, insomnia, and Post-Traumatic Stress Disorder. “More than half our business is with the same government that has lied and ignored their own rules to try to run us out of business,” acknowledged Dr. Kirsch.
Army Reserve Psychology Consultant, Dr. Kathy Platoni, testified, “In my experience, without exception, there is no more powerful form of therapeutic intervention, either as an adjunct or a stand alone treatment than Alpha-Stim CES.”
Dr. Kirsch tells Benswann.com that he looks forward to the majority of EPI’s profits no longer going to staying in business, but rather to more productive uses such as helping our Service Members come all the way home. “The FDA finally doing the right thing means more Service Members and Veterans will regain their optimism for life and more insurance companies will pay for Alpha-Stim,” said Dr. Kirsch.
Dr. Kirsch believes that the spreading of Alpha-Stim technology will lead to America becoming a safer place, due to the fact that the Alpha-Stim is a safe alternative to using anti-depressant drugs, which, according to the International Coalition For Drug Awareness, not only have horrendous side effects, but are also the main cause of all the school, church and mall shootings we have seen since there drugs became popular.
“Perhaps Alpha-Stim can now achieve my personal goal to make America a safer, kinder and happier place for all freedom-loving people,” said Dr. Kirsch.
According the U.S. Food & Drug Administration, the only acceptable cheese is not made by one of the many artisan cheesemakers from places like Wisconsin, New York and Vermont. Under a new interpretation of an old law, the FDA told artisan cheesemakers that their cheese cannot be cured on wood planks, though the process has been done for thousands of years.
According to Madison, Wis.-based blog, Cheese Underground, the FDA inspected several New York state cheesemakers and cited them for using wooden surfaces to age their cheeses. The New York State Department of Agriculture & Markets’ Division of Milk Control and Dairy Services, which (like most every state in the U.S., including Wisconsin), has allowed this practice, reached out to FDA for clarification on the issue. A response was provided by Monica Metz, Branch Chief of FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Dairy and Egg Branch.
In the response, Metz stated that the use of wood for cheese ripening or aging is considered an unsanitary practice by FDA, and a violation of FDA’s current Current Good Manufacturing Practice (cGMP) regulations. Here’s an excerpt:
“Microbial pathogens can be controlled if food facilities engage in good manufacturing practice. Proper cleaning and sanitation of equipment and facilities are absolutely necessary to ensure that pathogens do not find niches to reside and proliferate. Adequate cleaning and sanitation procedures are particularly important in facilities where persistent strains of pathogenic microorganisms like Listeria monocytogenes could be found. The use of wooden shelves, rough or otherwise, for cheese ripening does not conform to cGMP requirements, which require that “all plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained.”
The new scrutiny is due to the Food Safety Modernization Act, which is the most sweeping reform of American food safety laws in generations that was signed into law by President Obama on January 4, 2011.
This change could be devastating for artisan cheesemakers and their award-winning cheeses. American Cheese Society triple Best in Show winner Pleasant Ridge Reserve from Uplands Cheese in Wisconsin is cured on wooden boards. Likewise for award-winners Cabot Clothbound in Vermont, current U.S. Champion cheese Marieke Feonegreek, and 2013 Best in Show Runner-Up Bleu Mont Bandaged Cheddar.
“It’s just the latest in a pattern under [the Food Safety Modernization Act],” Walter Olson, senior fellow at the Cato Institute’s Center for Constitutional Studies, told The Daily Caller.
“When Congress passed the Food Safety Modernization Act three and a half years ago, libertarians and others warned again and again that the law would put traditional, local and artisanal food and farm methods at risk, and instead promote mass industrial food,”
He said that consumer groups and many progressives dismissed those concerns as alarmist.
The e-cigarettes and the e-cigarette business are booming, so now the federal governments is looking to impose regulations.
The proposed regulations including requiring approval for new products and health warning labels. The federal government also wants to ban the sale of electronic cigarettes to minors nationwide. Currently cities and states prohibit the sale of tobacco products to minors.
According to The Blaze, the U.S. Food & Drug Administration said the proposal sets a foundation for regulating the products but the rules don’t immediately ban the wide array of flavors of e-cigarettes, curb marketing on places like TV or set product standards.
Any further rules “will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits,” Commissioner Dr. Margaret Hamburg said.
Once finalized, the agency could propose more restrictions on e-cigarettes.
An e-cigarette can look very similar to a traditional cigarette. It heats a liquid nicotine solution instead of burning tobacco. The device creates vapor that a user inhales and then exhales the water vapor.
Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes. Some smokers use e-cigarettes as a way to quit smoking tobacco or to cut down. But, there’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.
Members of Congress and public health groups have raised concerns over e-cigarettes and questioned their marketing tactics as well at their safety.
“When finalized [the proposal] would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misconceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products.
Your thoughts: Is this another example of how government stifles creative innovation? Is this another attempt by Big Tobacco to use the government to eliminate competition? Is the government doing the right thing by regulating this new product?
Please comment below.
OPINION:
The United States is over 17 trillion dollars in debt, the national unemployment rate is over seven percent, and one-sixth of the American population is on food stamps. But fixing those problems is just so hard! So, some courageous politicians have decided to spend time and money dictating what we should be allowed to eat. They do this in the name of “keeping us healthy.”
The Food and Drug Administration (FDA) has announced a plan to ban trans fats because they are a “threat to people’s health.”
The FDA is moving forward with this power-grab despite the fact that the amount of trans fats in the average American’s diet has declined rapidly in the last decade.
The food industry will be required to gradually phase out trans fats. Once they have been completely phased out, anyone who wants to use trans fats will be forced to get special permission from the FDA.
The FDA’s deputy commissioner for foods, Michael Taylor, said, “We want to do it in a way that doesn’t unduly disrupt markets.”
As of right now, the exact timeline for the phase-out has not been decided on.
Michael Jacobson, the director of the advocacy group Center for Science, said, “Six months or a year should be more than enough time, especially considering that companies have had a decade to figure out what to do… [The ban is] one of the most important lifesaving actions the FDA could take.”
The FDA claims that trans fats are horrible for your heart — worse than saturated fat — and can contribute to heart diseases.
This is true… But when did it become the government’s job to control what we eat? Have we become a complete nanny state?
Smoking can cause lung cancer — so why don’t we ban cigarettes? Too much sugar often leads to diabetes — let’s go ahead and ban sugar, too! Alcohol can contribute to liver failure — ban it!
You get my point. The government simply cannot ban everything that is a “threat to people’s health.”
America is supposed to be the Land of the Free. If people want to make poor food choices, they should be allowed to. Of course, it is unfair to make the rest of us pay for their heart disease and diabetes. This is why ObamaCare (the biggest government power-grab in a generation) must be overturned immediately. In a free country, government cannot dictate lifestyle choices, nor can it become the overprotective mommy and daddy of its citizens.
Freedom means having the right to make bad choices and then deal with the consequences ourselves.
Transcript:
It is a name that Americans are hearing more and more, Monsanto.
An agriculture company that has become connected to the term GMO’s. So what is Monsanto? What exactly are GMO’s? and why are people so up in arms about a company that grows food?
And the big question, is Monsanto one of the best examples of America’s crony capitalist system?
The first step toward truth is to inform.
If the name Monsanto is not familiar to you, lets get you caught up.
According to Monsanto’s website,
“Monsanto is a sustainable agriculture company. We deliver agricultural products that support farmers all around the world. We are focused on empowering farmers—large and small—to produce more from their land while conserving more of our world’s natural resources such as water and energy. We do this with our leading seed brands in crops like corn, cotton, oilseeds and fruits and vegetables.”
Sounds pretty good.
In short, Monsanto is company that among other things, produces the herbicide roundup. But the controversy surrounding Monsanto begins with their development of genetically modified seeds or GMOs that are called “round up ready”. Round up ready crops are reportedly more resistant to weed killer and insects.
According to Natural News, a growing body of evidence does connect GMOs with health problems, environmental damage and violation of farmers’ and consumers’ rights.
According to professor John Fagan, an award winning geneticist:
“The process of genetic engineering always involves the risk of altering the genetics and cellular functioning of a food organism in unanticipated ways. These unanticipated alterations can result in (GMO) foods being allergenic, toxic, or reduced in nutritional value”. – Professor John Fagan, Maharishi University of Management, Iowa
Concerns like those have pushed millions worldwide into the streets to protest Monsanto and their GMOs. In May 2013, two million people in over 50 countries expressed outrage over a number of issues surrounding Monsanto.
The first issue with Monsanto is the safety of those GMOs. But there is more.
While there is growing concern over the safety of GMOs, the United States for all of the requirements placed on the food industry, requires no GMO food labeling.
Whether you agree or disagree on whether or not GMO’s are dangerous, 64 other countries require GMO labeling. Again, the United states does not. Could it be that most Americans just don’t care? Actually no. Despite the lack of political will on this issue, a poll, conducted earlier this year by The New York Times found that three-quarters of Americans are concerned about the number of genetically modified or engineered foods. What’s more, a staggering 93% support mandatory labeling of GMO foods.
So to recap, first, there is the concern over GMOs. Second the concerns over labeling and third, there is the issue of Monsanto holding a patent on all of its seeds.
Monsanto explains on their website the need for that patents saying,
“Monsanto patents many of the seed varieties we develop. Patents are necessary to ensure that we are paid for our products and for all the investments we put into developing these products. This is one of the basic reasons for patents. … Monsanto invests more than $2.6 million per day in research and development that ultimately benefits farmers and consumers. Without the protection of patents, this would not be possible.”
You see, when a farmer purchases these genetically modified seeds from Monsanto, they sign a signed a licensing agreement promising to use all the seed and not to use any regenerated seed for future.
So to recap… the issues with Monsanto, questions about the safety of GMOs are out there though we should be clear. there are those who argue that GMO’s are perfectly safe and no issues with consuming them. There are questions about labeling. Regardless of whether GMOs are good or bad shouldn’t the public have the right to know what they are putting in their bodies and have the right to consume or walk away? And questions about the ability of a corporation to be able to patent seeds, preventing farmers from replanting crops without paying a fee?
What you need to know, is that all those questions may actually be secondary to this one, is the biggest problem with a company like Monsanto its relationship with government?
In the early 1990’s the FDA took a look at these genetically modified foods. There were a lot of concerns including tests that showed rats were developing stomach lesions from the Genetically modified tomatoes they were fed. According to Jeffery Smith at the Huffington Post, in memo after memo, these experts “described toxins, new diseases, nutritional deficiencies, and hard-to-detect allergens,”
So what changed? In 1994 the USDA’s Food Safety Inspection Service hired a new administrator, Mike Taylor.
Taylor had worked for the FDA in the 1970’s and then in the 1980’s he became a private sector lawyer for a firm that represented Monsanto.
In 1994 Taylor takes over the FSIS and remains in that post until 1996.
1996, GMO foods began showing up on plates in American homes.
After 1996 Mike Taylor goes back into the private sector and goes to work for Monsanto itself.
For the next 16 months he works directly for the company.
In 2009 returns to the public sector now leading the food side of the FDA.
In fairness, Mike Taylor says he is not Monsanto’s man. That claims that he is bought and paid for could not be further from the truth.
In fairness, I don’t know if that is true or not. What I do know is that regardless of whether or not its true the revolving door of government and private sector and the advantages big corporations have in the system is undeniable.
Monsanto’s influence over food supply is troubling. Their ability to seemingly prevent GMO labeling also troubling. Their connections with people like Mike Taylor who have the ability to control what does and does not show up on our families tables, sure smells like crony capitalism
and that is Reality Check.
Sources:
Learn more: http://www.naturalnews.com/037678_michael_taylor_monsanto_fda.html#ixzz2bymPGQf3
http://www.pubpat.org/monsanto-seed-patents.htm
http://www.responsibletechnology.org/gmo-dangers/65-health-risks/1notes
When Michael Bloomberg started his anti-soda campaign in September 2012, there was an outrage. He cited the “obesity epidemic,” and the “statistic” that 2013 would be the first year that more people died from overeating than from hunger. The “big gulp ban,” which prohibited the sale of sodas more than 16 ounces in size, was struck down by the New York Supreme Court in July 2013 because of a violation of the city’s separation of powers doctrine.
Many people celebrated a victory for liberty in what seemed like an obvious issue. Soda may be unhealthy, but the government doesn’t have the right to dictate what people choose to consume. The government already does this nationwide though, and some of the strongest regulations involve products with tangible health benefits, like unpasteurized, or “raw,” milk.
The FDA controls the sale and consumption of raw milk because they claim that it poses a threat of foodborne illness. It can contain salmonella, lysteria and e-coli, much the same way that unpasteurized eggs, raw meat and even raw vegetables can, and which in all likelihood are a result of the commercial process rather than the milk itself.
Many people, however, believe that raw milk is significantly healthier and better tasting than milk processed according to FDA regulations. Pasteurized milk is heated, usually at extremely high temperatures, and then homogenized, which prevents the formation of a cream layer. This process destroys many valuable enzymes and vitamins, changes the taste and reduces culinary possibilities.
On the federal level, the sale of raw milk is forbidden across state lines, and most states have stringent restrictions, including 19 which have banned sales completely and an additional 14 which ban sales outside of the farm on which the milk was produced.
Recently, the FDA has also been involved in multiple lawsuits and controversial cases regarding raw milk. Earlier this year, one lawsuit was filed and another dismissed against the FDA regarding its regulations. The first, by the Farm-to-Consumer Legal Defense Fund, involved 100 gallons of milk which were embargoed and forced to be destroyed by the Georgia Department of Agriculture in 2010, but which the plaintiff argued was actually enforced by a present FDA agent instead of the state government. The case ruling established that the FDA would not take action against consumers who purchased raw milk, instead focusing their effort on farmers and distributors.
The second lawsuit took place in California, and involves Organic Pastures Dairy Company, which petitioned for the right to sell across state lines four years ago. The company’s goal is to force the FDA to take final action on the petition, which it should have decided on in 180 days. Both Arizona and California allow raw milk sales, but the Fresno-based company cannot sell its product to the Arizona-based Sprouts grocery stores because of the federal law.
Stories of FDA crackdowns on raw milk dairies, distributors and clubs have emerged across the country. Some people have bought shares in cows to get around regulations, because the government does not prevent people from drinking the milk produced by their own cows.
This battle is only a small part of a far bigger battle over agricultural freedom which involves everything from commercial drivers’ licenses to the estate tax – which will destroy the family farm – to Senate Bill 510, which makes it illegal to produce food valued over $5000 without submitting it for FDA testing.
Raw milk and agricultural freedom is an issue which goes beyond citizens’ right to decide what they put in their own bodies. The ability to grow one’s own food allows for independence and self-sufficiency, and the destruction of the family farm will make people dependent on centralized food supplies. The fight over raw milk and agricultural freedom is a fundamentally important one to the US.
