Monday, January 10, 2011

Big Pharma is King! FDA bows!

FDA Propaganda Attempts to Destroy the Dietary Supplement Industry
By Byron J. Richards, CCN
August 23, 2011
It is not surprising that FDA Commissioner Margaret Hamburg would use blatant and deceptive propaganda to attack the dietary supplement industry. As a self-proclaimed “zealot for the advancement of regulatory science,” Hamburg would like the consumer public to believe the earth is flat—and that dietary supplements cannot prevent and help treat disease. She is well-educated in science, especially neuropharmacology and the new genomic science, thus it poses a dilemma for her when study after study demonstrates the power of dietary supplement ingredients. These studies show that dietary supplement ingredients influence the human genome in ways that prevent disease as well as offer practical solutions to help treat most common, age-related diseases that afflict millions of Americans. Such diseases include type 2 diabetes, cardiovascular disease, and many resistant forms of cancer.
Instead of embracing the nutritional gene science and ushering in a new generation of health, happiness, and wellbeing for Americans, Hamburg has chosen a return to yesteryear, a not-so healthy, happy time. The U.S. Food and Drug Administration (FDA) is doing everything in its power to prevent the truth from being told. Logically, we ask, what are her motives? One of them is clear—facilitating pharmaceutical takeover of many ingredients sold by the dietary supplement industry.
For as long as a hundred years, FDA management has been in a constant revolving door with high-paying Big Pharma jobs and the large agribusiness/food companies it is supposed to be regulating. This corrupt corporate culture pays lip service to actual safety issues while it uses the FDA as a vehicle to secure profits and wipe out competition. It is a flagrant abuse of regulatory power.
The FDA’s “public health” battle front is invariably against those who offer any alternative to the elite “FDA profit club.” In modern times this includes the dietary supplement industry, family/organic farms, and health professionals engaged in complementary and alternative medicine (CAM). Indeed, the dietary supplement industry in the United States is booming, with sales of $28 billion in year 2010. When you add in the natural/organic food industry and functional foods, that figure hits $117 billion.
The aging, baby boomer population is better educated than previous generations. While they listen to what the FDA and their doctors have to say, they are far more likely to ask questions and plot their own self-determined course of action. Use of CAM in the U.S. now involves 41.8 percent of adults, and that number rises to 61.4 percent for those struggling with health problems. As you can see, profits from failed and dangerous remedies sanctioned by the FDA and its crony alliances are rapidly diminishing. Big Pharma companies are desperate to get their hands on nutrients to help replace their plunging profits from expiring patents and a skimpy new drug pipeline.
The current battle in this ongoing saga centers on the FDA’s newly proposed regulations. The new regulations, known as “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” were proposed on July 1, 2011. These regulations attempt to redefine which supplements can be on the market and potentially remove many of the best nutrients. Regarding their overall effect, these proposed regulations will cause many small and medium-sized American businesses to close and/or incur significant financial loss. Some large companies may survive, but with drastically reduced product offerings.
Big Pharma companies would be able to cherry pick numerous nutrient ingredients they desire. And most unfortunately, these proposed regulations will limit consumer access to affordable dietary supplements and dietary supplements in general. This is a diabolical regulatory proposal, falsely presented as a “needed” public health safety measure when, in fact, no such definable public health problem can be identified by the FDA that would otherwise be remedied by these regulations. The FDA’s illegal actions will be fought in court every step of the way.
I have explained the key points of this issue in two previous articles, “Senator Durbin & the FDA Viciously Attack Dietary Supplements” and “The FDA’s Scheme to Reclassify Nutrients as Drugs.”
The FDA’s Propaganda Toolbox
Propaganda is the intentional dissemination of false information to support or justify the self-serving actions of the individual or group. A central strategy of effective propaganda is something called the “Big Lie,” which if repeated often enough, people believe it to be true. In the case of dietary supplements, the “Big Lie” is the safety issue.
The American dietary supplement industry makes the safest products for human consumption in America or anywhere in the world—far safer than the food supply or FDA-approved drugs. This stellar safety record is now proven by the FDA’s own database of adverse event reporting for dietary supplements. It is an open and shut case; dietary supplements are the safest products consumers ingest. Thus, whether the propaganda attack against dietary supplements is coming directly from Hamburg, Senator Richard Durbin (D-IL), or the behind-the-scenes, Big Pharma masterminds, the “Big Safety Lie” is invariably the justification for their actions.
Understanding the FDA’s NDI Propaganda
Effective propaganda always contains a half-truth or out-of-context truth, serving as the “credibility” for the propaganda. In other words, for her to launch a destructive NDI campaign against the dietary supplement industry, she needed an excuse. She found that excuse in a small group of criminals who were spiking products with drugs and selling them as dietary supplements. The FDA identified the problem and shut down this handful of operations. Such work by the FDA is obviously supported by the entire dietary supplement industry, as 99.9 percent of companies would never make such illegal products.
It is important for consumers to understand two points. This was not an industry-wide problem; it was isolated to a tiny number of bad actors. The FDA already has the power and authority to take action in these circumstances. They do not need any new regulations to perform the job that is expected of them.
The FDA, however, has taken this out-of-context issue and trumpeted it up to wage war against the entire dietary supplement industry. It has done so in a manner that is a flagrant and unconstitutional abuse of regulatory power.
Hamburg’s NDI propaganda campaign began on October 22, 2009 when she sent FDA Deputy Commissioner Joshua Sharfstein to a supplement trade meeting to deliver a speech, telling the industry that the FDA would be using newly concocted NDI regulations for the entire industry to address this out-of-context issue, even though he freely admits that “this will not solve the problem of undeclared ingredients [meaning products tainted with drug substances].”
This convoluted attack on the supplement industry continued with a hostile and threatening letter sent by Hamburg on December 15, 2010. Echoing the same “safety” propaganda used by Sharfstein, she broadens her attack to include the 99.9 percent of safe products already on the market. She uses phrasing such as “other compounds…that do not qualify as dietary ingredients” [in her twisted opinion, for example, her ridiculous new definition for new dietary ingredients or NDIs], “deceptively labeled ingredients” [meaning the FDA’s suppression of commercial free speech when companies explain the science of how their products are effective], and “new chemical ingredients” [her code word for NDIs]. This is an aggressive, over-reaching attack on the entire dietary supplement industry, and it is unwarranted.
And then she uses the famous propaganda ploy of instilling fear by threatening the owners of dietary supplement companies with criminal prosecution if they do not do as she says. She declares, “Responsible individuals and companies should be aware that the government may initiate criminal investigations to hold accountable those who violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) [the dubious 1938 law that allows the FDA undue power to harass]… Responsible individuals, even if the individual did not participate in, encourage, or have personal knowledge of the violation, can be criminally prosecuted.” She actually has the audacity to threaten criminal prosecution for doing nothing wrong at all. What kind of a tyrant is she?
On July 1, 2011 the FDA actually issued its proposed new NDI regulations. In justifying the “need” for these regulations, the FDA states, “There are an estimated 55,600 dietary supplement products on the market, and FDA has received approximately 700 NDI notifications since we began reviewing NDI notifications approximately 16 years ago. Additionally, the Institute of Medicine has estimated that 1,000 new dietary supplements are introduced to the market each year. These figures, coupled with recent concern by both the agency and industry regarding the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the necessity for marketers of dietary supplements to submit NDI notifications as an important preventive control to ensure that the consumer is not exposed to potential unnecessary public health risks in the form of new ingredients with unknown safety profiles.”
In actuality, the reason there are so few NDI applications in comparison to the number of products on the market is because nobody, including the FDA for the past 17 years, has ever decided to interpret the 1994 DHSEA law to mean most products need an NDI approval. The FDA is now trying to create new law through regulatory interpretation in a manner that far surpasses its authority. Their interpretation is in direct conflict with the intent of the 1994 DSHEA law, concocting an unconstitutional regulatory framework.
Furthermore, making all companies spend tens of thousands, even millions, to comply with drug-like approval of ingredients that have been on the market for the past 17 years with a proven track record of safety will in no way stop anyone intentionally spiking products with drugs, which the FDA previously and openly admitted and already has the regulatory power needed to address any such problem. In other words, the premise for the need for these new regulations is based on bald-faced lies. The reasons the FDA is offering for needing new NDI regulations are pure propaganda. The actual reasons are financially and politically motivated.
The Iron Fist of FDA Commissioner Margaret Hamburg
On May 26, 2011, Hamburg was indoctrinating a group of aspiring public health students at Columbia University when she relayed her experiences dealing with the supplement industry during the H1N1 flu scare. She announces, “It was a little bit like playing Whac-A-Mole…you would shut down one and it would pop up somewhere else.”
And Hamburg is not just playing a game of hitting a mole over the head with a mallet, she is using Gestapo-style raids with armed U.S. Marshals against American companies—companies that have done no wrong, other than try to inform the public of the benefits of how nutrition can help them with their health.
On June 7, 2011, this was the fate suffered by a long-time, reputable manufacturer of acidophilus products, UAS Laboratories. It is very important for the public to understand that UAS Laboratories is a helpful and responsible America company—a small family business that over decades of very hard work has been able to help many people improve their quality of health.
Also in June, the FDA used federal force against an American company, Wyldewood Cellars, to seize an elderberry fruit juice based, again, on opinions and disagreements, and no evidence of any harm or threat to the public health.
Dietary supplement companies are not alone, as the FDA wrath has also spread to makers of natural foods with a special interest in raw milk. In May of this year, the FDA terrorized Amish dairy farmer, Dan Allgyer. And recently, they have been involved with a highly-publicized, federal-armed raid on Rawesome Foods in California, dumping milk down the drain.
Let’s delve deeper. The Obama administration’s Bureau of Alcohol, Tobacco, Firearms and Explosives (overseen by the Justice Department), through its gun-running fiasco known as “Fast and Furious,” has provided advanced weapons to Mexican drug cartels which has resulted in the loss of American life. All the while, the Obama administration’s FDA is busy using federal police force to terrorize supplement companies and steal their products, seize fruit juice, and pour their milk down the drain. Something is inherently wrong.
It is odd that Hamburg demonstrates such a hostile and aggressive—seemingly, even violent personality. After all, her elite psychiatrist father, David Hamburg, spent a great portion of his life trying to prevent aggression and violence in children so they would not grow up with such undesirable personality traits, in part hoping to prevent the next Hitler from emerging on the world scene. David Hamburg has also been a proponent of eugenics in this context, as he states in a speech as head of the National Institutes of Health, “The adverse effects of exceedingly rapid population growth are not only those affecting health, but also education, economic development, resource depletion, pollution, conflict and violence.” One might ask, where did he go wrong with his own daughter?
Furthermore, FDA “public health” campaigns are typically more about the hidden agenda than any real public health concern. For example, under Hamburg, the FDA has now taken on the “public health” initiative aimed at reducing the future population of U.S. children, embracing and acting on the political belief that an unwanted pregnancy (which by their estimates accounts for 46 percent of current pregnancies in our country) is a newly defined health condition. Taxpayers are slated to foot the massive bill for this public health agenda and will also get roped into paying for the same services in poorer, developing countries around the globe. The FDA will regulate who should live and who should not be born, all under the cover of public health propaganda.
A Brief Lesson in Health Regulatory History
Once upon a time there was a freedom-loving country whose scientists, engineers, and inventors were the envy of all other countries. A prosperous economy was built even though the country had scarce natural resources. It was powered by human ingenuity and free market competition, innovation that extended to the field of medicine. Doctors worked side by side with all manner of alternative and complementary health practitioners in a system of health that came to be known as the “freedom to cure.”
Along came a nasty war and that country lost its way. Defeated, its prosperous people were left in economic ruin. Out of the ashes of despair a “Pied Piper” emerged with a new plan, galvanizing large portions of the population to share a vision of a new world and restored prosperity. The good scientists, engineers, and inventors ran for cover.
This “Pied Piper” didn’t want a free people; he wanted a herd of followers. He wanted to control the health and mental health of a nation. Health freedom stood in his way. Natural health options were obliterated. He knew that if you could control the health of a nation, you could control the free will of that nation. An obsession with mind control followed, all in the name of the public health. Those with other thoughts and opinions lived in fear for their lives. Over the period of a few short decades the true freedom of an entire people vanished into thin air.
Yes, this is the history of Germany leading up to WWII, relying on the Gestapo’s use of fear, intimidation, and violence against its citizens to keep them in line.
More than a half century later the German people have never reclaimed their health freedom. Access to dietary supplements in Germany, and all of Europe for that matter, became a sinister regulatory joke—a joke that is not so funny, as the regulations are at the expense of their citizens’ health and wellbeing. This is the path that “regulatory science” has to offer, all in the name of “safety” and supposed support for the public health. The handwriting for health freedom in America is on the wall.
Freedom-loving Americans cannot afford to follow in the footsteps of German history. Unlike the Germans, we do have our rights granted by the U.S. Constitution. We must fight at every opportunity to see that those rights are preserved, and in so doing our freedoms, including our right to be healthy based on our own choices and preferences.
Take Action
Senator Orin Hatch (R-Ut), one of the original authors of the 1994 DHSEA legislation, is now providing wise leadership to the dietary supplement industry in the face of flagrantly illegal activity by the FDA, helping to organize industry leaders and companies. He is telling the industry to first file comments to the FDA until the October 3, 2011 comment period closes, then get ready to do battle in court with help from Congressional oversight of the FDA.
Additionally, the efforts of those in the industry must be widely supported by consumers for this course of action to be effective. If you value your access to a wide range of dietary supplements at affordable prices, do not just follow the herd. Rather, stand and be heard. Go to our TAKE ACTION page, file comments of protest with the FDA and let your Senators and Congresspersons know you will not tolerate what the FDA is doing. Spread the word and pass this and my previous articles on to anyone who values their access to dietary supplements, so they too can make their voices heard.
While there are some of us in the dietary supplement industry that will stand on principle and fight for what is right, there are many companies that need some friendly consumer encouragement to keep you as a customer of their products. Please bring this information to the attention of dietary supplement companies and health food stores where you purchase products. Ask them what they are doing to preserve their customers’ rights to a wide range of dietary supplements at affordable prices.
On September 8th 2011, once Congress has finished their summer vacation, grassroots organizations across America will launch a consumer protest campaign to the FDA and Congress, prior to the October 3rd deadline for public comments on the proposed NDI regulations. The FDA is listening and trying to gauge the strength of the opposition. Again, let your voice be heard and preserve the natural health options for yourself, your family, and the future generations of Americans.
TAKE ACTION NOW and AGAIN on September 8th.
Recent Proof FDA is Controlled by Big Pharma
By Attorney Jonathan Emord
Author of "The Rise of Tyranny" and "Global Censorship of Health Information"
January 10, 2011
If you harbored romantic notions that an Obama FDA would be less controlled by the pharmaceutical industry than a Bush FDA, think again. The case of Avandia proves once again that FDA will sacrifice the health of the American people to defend the economic interests of its favored regulatees, the big drug companies.
In an April 2, 1999 internal memo to his superiors FDA medical reviewer Dr. Robert I. Misbin objected to FDA approval of the GlaxoSmithKline Type 2 diabetes drug Avandia. He expressed concerns “about deleterious long term effects on the heart” from the drug. His criticisms were rejected by the agency’s political appointees. On May 25, 1999, FDA approved the drug for marketing without referencing the heart risks.
For identifying the heart risks, Dr. Misbin was not complimented at FDA. Far from it, he was ostracized and subjected to severe criticism and review by his superiors. He was told, flatly, by one of them that he just did not get it, that FDA was there to serve the industry. In a later interview, Misbin (now deceased) said: “One of my superiors said something to me that I have never forgotten, that we have to maintain good relations
with the drug companies because they are our customers.”
In February 2006 another courageous FDA medical reviewer raised objections to the drug. Dr. Rosemary Johann-Liang strenuously urged her superiors to require GlaxoSmithKline to include a black box warning on the drug, alerting people to its heart attack risks. Liang’s supervisor told her that FDA management was “upset with her recommendation” and “decided to act like her review never happened.”
Congresswoman Diane E. Watson (D-CA), a member of the House Energy and Commerce Committee with FDA oversight, was prescribed Avandia for her diabetes. She developed a heart murmur while on the drug. In an Energy and Commerce Committee hearing evaluating the drug, she told the FDA Commissioner that Avandia caused her heart murmur and demanded to know why the agency let such an unsafe drug remain on the market.
A meta analysis published in the May 2007 New England Journal of Medicine associated Avandia with a 43% increased risk of heart attack. In July 2007, an FDA advisory panel with conflicts of interest voted that Avandia did increase the risk of cardiac ischemic attack in Type 2 diabetics but ultimately ruled that the drug should remain on the market.
Under intense pressure from Congress, and having received over 83,000 adverse event reports of heart problems arising from Avandia, FDA reversed itself (not removing the drug from the market, as one would expect, but adding a black box warning over a year after medical reviewer Johann-Liang called for one). The
black box warning reduced Avandia’s market position but the drug still achieved $1.2 billion in worldwide sales for 2009.
In February of 2010 Dr. David Graham, FDA’s Associate Director of Drug Safety, recommended that Avandia be taken off the market. Graham said that Avandia causes 500 more heart attacks and 300 more heart failures than its leading competitor, Abbott drug Actos.
In June of 2010, Dr. Graham and his colleagues published a retrospective study in the Journal of the American Medical Association of 227,571 elderly patients. The study compared Avandia to its competitor, the Abbott drug Actos. He concluded that Avandia was associated with “an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of Acute Myocardial Infarction, stroke, heart failure, or all-cause mortality in patients 65
years or older.” Dr. Graham and his colleagues concluded that compared to patients taking Actos, patients taking Avandia experienced a 27% higher risk of stroke, a 25% higher risk of heart failure, and a 14% higher risk of death. In an interview for, he explained that for every 60 older patients taking Avandia instead of Actos there would be one extra heart attack, heart failure, stroke, or death. In that same interview he was quoted as saying: “If you are a patient currently being treated with Avandia, based on the data from our study it would be wise for you to contact your doctor and ask to be switched to a safer alternative.” He added, “even if you have been on Avandia for a while and have not had anything bad happen to you, why take those risks? They are completely unnecessary.” Dr. Graham is a meticulous and conservative FDA scientist but one possessed of tremendous courage, willing to speak out about unsafe drugs the agency has approved despite the ever present threat of agency retaliation.
In July of 2010, FDA reconvened its Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to reconsider Avandia cardiovascular risks. Following Committee. On July 14, 2010, following two days of deliberations, a majority of the FDA panel voted not to take the drug off the market. On July 20, 2010, it came to light that the panel had members with conflicts of interest,
including one who was a paid speaker for GlaxoSmithKline. That paid speaker voted to keep the drug on the market with no change in labeling.
On the eve of the agency’s re-evaluation of the drug, the Senate Finance Committee wrote a letter to FDA Commissioner Margaret Hamburg demanding that she remove the drug from the market. That committee had maintained an ongoing inquiry into Avandia. It found that GlaxoSmithKline withheld studies on Avandia from FDA and the public that called into question the drug’s safety and actively promoted the drug as comparatively safe and efficacious despite the known safety risks. The Committee wrote to Commissioner Hamburg: “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public . . . Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug Actos might reduce cardiovascular risk.”
The Senate Finance Committee based its findings, in part, on internal GlaxoSmithKline emails, revealing high level company awareness of the cardiovascular risks of Avandia as early as 2000. The Committee also identified a GlaxoSmithKline ghostwriting campaign where the company would solicit articles from medical professionals lauding the drug as comparatively safe and effective for publication in medical journals without the journals knowing of the company’s involvement. The Committee faulted FDA for letting the drug remain on the market despite the 83,000 adverse event reports FDA received between 1999 and 2007 tying the drug to cardiovascular risks.
This overwhelming evidence against Avandia would lead any reasonable person to conclude that the drug ought not be on the market, particularly because other drugs that are for the same condition pose far fewer
risks. Did Obama’s FDA Commissioner, Margaret Hamburgh (who prides herself on enforcement of the law) demand the drug be removed? Not at all.
She ensured that it could continue to be available to those now on it, and largely limited her restriction of its use to new patients. In other words, she gave GlaxoSmithKline an opportunity to wind down its affairs with Avandia while millions of people worldwide would remain at an elevated risk of heart attacks, heart failure, strokes, and death. And if a patient so suffers, who will account in the law for the homicide? Not Commissioner Hamburg, not GlaxoSmithKline, not anyone responsible. So much for law enforcement, Madam Commissioner.
On September 23, 2010, FDA required GlaxoSmithKline to submit a Risk Evaluation and Mitigation Strategy (REMS) for the drug. Under the REMS, the drug can remain available to patients already taking it with written informed consent. Future patients can receive the drug if they cannot achieve glycemic control on other drugs.
Once again we see that the FDA is a captive of the drug industry. The agency proceeds like a blind jockey atop the drug elephant. Wherever that beast takes it, FDA is sure to go.