The Natural Solutions Foundation has, as usual, led the health freedom community in sounding the warning about the fake food and supplement “safety” bills pending before the Senate of the United States. Our supporters have heeded that warning and delivered well over one million messages to Congress demanding NO fake safety bills and insisting that Congress provide protection for our supplements and natural remedies, not Codex HARMonization. Read about that recent history and how PUSH BACK is working – thanks to you through your activism and your dissemination of this information. http://drrimatruthreports.com/?p=4608
But we are not finished, not by a long shot. Others believe that the current partial victory for our Push Back efforts is enough for us to stand down, focus on other things. They may be well intentioned but, as we said when Sen. John McCain’s S 3002, a veritable poison pill for supplements, was abandoned, we were pleased, but we, as the old saying goes, “were not home yet”. Well, once again, we are not home yet. S. 510 must be defeated if we are to protect clean food, fend off total industrialization of our food supply AND protect our supplements.
And Now, Here Are the Details
Well, the Senate has reacted to your PUSH BACK yet again, and yet again, has given us dangerous half-way measures at best. WE SAY THIS IS NOT GOOD ENOUGH!
Take the Action Item above; ask everyone you know to tell Congress: “NO! to the forced industrialization of our food supply!”
Back in 2007 when Sen Ted Kennedy gave Big Pharma his dying bequest… what it wanted most, more power — as Dr Ron Paul puts it, “to abuse” — we warned everyone that the FDA could not be trusted. That was when we had been told by various politicians – and even some misguided “health freedom groups” that it wasn’t “necessary” to have protective language added to the Kennedy “FDA Enabling Act” because, after all, they solemnly (and naively) assured us in DC, dietary supplements were not even mentioned in the bill. We said we didn’t trust FDA and that we wanted Dietary Supplements and Natural Remedies protected from enhanced FDA power. We persisted – YOU persisted – and we prevailed in the conference committee, with the help of hundreds of thousands of your emails, in keeping Section 1011, which exempted, and thus protected, dietary supplements, in the bill.
Nonetheless, within a year or so of that bill passing, FDA used its new Section 301(11)* power to ban interstate commerce in any food substance that had ever been studied for medical use in order to ban Pyridoxamine, a non-toxic form of vitamin B6. What gives the FDA the power to do this? Can you imagine why the Congress of the United States would believe it had Constitutional authority to deny food substances to any free people? Perhaps to perpetuate a Pharmopoly (pharmaceutical monopoly…)? Corruption and bribery, campaign funding and favors, perhaps? From the largest single lobbying force in the United States, perhaps? Conflict of interest, perhaps? Hmmmmm…
So in January of 2009, Pyridoxamine was banned. That’s right, banned. A natural, non patentable, safe and historically proven vitamin was banned to the American public. Despite its long history of safe use as a dietary supplement, it was not protected by section 1011 because, FDA says, no one “proved” it was grandfathered under DSHEA (the Dietary Supplement Health and Eduction Act of 1994)… and just because the substance was on the Old Ingredients List didn’t prove anything, blah, blah, blah… (Substances on the Old Ingredient list had always been considered grandfathered in under DSHEA, which holds that nutrients and supplements are to be treated as foods and, as such, cannot be limited or banned unless they are unsafe.)
The Other Shoe? Wait No Longer!
The FDA, which Dr. Rima refers to as the “Fraud and Death Administration, is about to drop the other shoe and ban more forms of B6. This time, the Phamopoly intent is blatant, since the “Citizens Petition” by the drug company involved actually states:
“Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”
Go back and read that quote again. The enormity of this is literally mind boggling! Instead of tossing this absurdity out, the FDA is, as always, playing the tune its Big Pharma masters demand.
So what does this have to do with the Fake Food Safety Bill, S.510?
Everything. You may recall that your million+ email PUSH BACK recently defeated Sen John McCain’s attempt to force Codex Alimentarius dietary supplement restrictions on us via his fake dietary supplement “safety” bill, S.3002. That bill died one month and one day after it was introduced… a real PUSH BACK record!
But, as we predicted and feared, attempts were made to include the worst parts of S.3002 in a revised effort to get S.510 passed. We saw that one coming, although, once again, others who should have known better, told us we were crazy. Once again, we asked you to message Congress through the Natural Solutions Foundation Action Item. Many hundreds of thousands of emails later, it appears that S.510 will be amended to “protect” DSHEA products. That sounds good ….
But That’s Not Enough.
Here’s what IS good enough: We want natural remedies and holistic techniques (like Holistic Ear Candling, for example) and all natural, local, community, family and farm food production protected too… better yet, DEFEAT S.510!
Please use this revised Action Item to make sure the Senate knows we are not happy… yet! If you have taken action on this issue, take it again since the Action Item has been revised to reflect the newest ploy on the part of the food destroyers. Please take it once for each member of your household and then pass it along to everyone you can reach with a simple note saying that this issue is of grave importance to you and you hope it will be to the person you are sending it to as well. Ask them to take action in the same way and then forward it to their circle of influence in the same way.
PS * With referenced to Section 301(11) — where Congress violated our Constitutional and human right to freedom of choice in accessing any non-harmful food substance an individual chooses — our position is simple: this tyrannical power must be repealed by Congress (with apologies to We the People) or voided by the Courts!
Natural Solutions Foundation
The Voice of Global Health Freedom™
Fatal FDA Follies
You know that the FDA is so riddled with corruption and industry influence, that the good men and women who work there as scientists wrote to Obama after his election, but before his inauguration, pleading with him to clean house there1. Of course, no new broom swept the FDA clean.
New Users Fees will increase the ownership of the FDA by Big Pharma to the tune of a 65% increase, we have learned. All in all, the increase means the Fraud and Death Administration, which approves the leading cause of death in the US, properly used drugs and vaccines, will get a budget increase of a whopping 23% from $3.3 Billion to $4+ Billion.
Big Pharma, Big Chema, Big Agribiz and, even more horrifyingly, Big Biotech literally own the decision makers there. Big Pharma provides more than half of the FDA’s operating budget through “User Fees”, which are, in essence a tax on the end use, the patient, since the cost is passed directly on to the consumer. Worse, these User Fees turn the FDA, which is supposed to regulate the drug industry, into its client.
The User Fee hikes mean that Big Pharma’s contribution to its own regulatory agency will provide more than $1.1 Billion of the Agency’s 2011 budget.2
The LA Times Reports:
“The healthy increase in the face of the sagging economy and a debt-ridden federal government is a testament to 1) the FDA’s increasingly complex responsibilities monitoring a global supply chain in both food and drugs, 2) to a perception that the agency has been underfunded for many years, and 3) to its new duties as a regulator of tobacco. The FDA’s budget has swelled by 78% since 2008 and no agency programs are on an Office of Management and Budget hit list of line items slated for extinction or downsizing.
The increased spending would allow the FDA to add 1,200 jobs, expanding its workforce by 10%. Key boosts in spending for 2011 include $318 million to improve food safety, $215 million for anti-smoking programs and $100 million to improve the safety of drugs and medical devices.
More than one-third of the 2011 budget — about $1.5 billion — would come from user fees paid by businesses that make payments for FDA services such as evaluating new applications for drugs and medical devices. The FDA is collecting about $920 million in user fees this year, so the new figure represents a whopping 63% increase.
The increase in the “budget authority,” or tax-funded component of the budget, is relatively modest by comparison, rising 6% to $2.5 billion from $2.36 billion.”3
What does that mean for you? That more dangerous drugs and vaccines will be on shelves and in doctor’s offices, waiting to make a profit that is to die for.
Bill Gates Opens the Depopulation Floodgates
Oh, yes, the FDA, along with its playmate, the Phama Phunded WHO, has another little surprise in store for you: Permanent infertility without your knowledge or wish.4
Dangerous vaccines, approved at the behest of the FDA’s ownership, Big Pharma, are not only untested, unnecessary, unsafe and uninsurable (which is why we are suing the FDA to prevent any influenza shots, including the H1N1, from being used on people) but that they are knowingly designed to produce widespread permanent infertility and thus, population reduction against the wishes, and without the knowledge, of the women rendered infertile.
The Natural Solutions Foundation has been telling you this for quite some time and have so stated publicly. Many people have a hard time believing it, especially since it involves the World Health Organization, a seemingly high minded and benign organization. We know, of course that it is no more that than the FDA is.
“The idea of using vaccines to covertly reduce births in the Third World is also not new. Bill Gates’ good friend, David Rockefeller and his Rockefeller Foundation were involved as early as 1972 in a major project together with WHO and others to perfect another ‘new vaccine.’
The results of the WHO-Rockefeller project were put into mass application on human guinea pigs in the early 1990’s. The WHO oversaw massive vaccination campaigns against tetanus in Nicaragua, Mexico and the Philippines. Comite Pro Vida de Mexico, a Roman Catholic lay organization, became suspicious of the motives behind the WHO program and decided to test numerous vials of the vaccine and found them to contain human Chorionic Gonadotrophin, or hCG. That was a curious component for a vaccine designed to protect people against lock-jaw arising from infection with rusty nail wounds or other contact with certain bacteria found in soil. The tetanus disease was indeed, also rather rare. It was also curious because hCG was a natural hormone needed to maintain a pregnancy. However, when combined with a tetanus toxoid carrier, it stimulated formation of antibodies against hCG, rendering a woman incapable of maintaining a pregnancy, a form of concealed abortion. Similar reports of vaccines laced with hCG hormones came from the Philippines and Nicaragua.”5
AOf course, once the citizens of the developed nations stayed away in droves from the bogus H1N1 “Pandemic” vaccination, their governments came up with a plan to get rid of multi billions of dollars worth of useless vaccines: dump it on the third world!
“In the aftermath of the most recent unnecessary Pandemic declaration of a global H1N1 swine flu emergency, industrial countries were left sitting on hundreds of millions of doses of untested vaccines. They decided to get rid of the embarrassing leftover drugs by handing them over to the WHO which in turn plans to dump them for free on select poor countries. France has given 91 million of the 94 million doses the Sarkozy government bought from the pharma giants; Britain gave 55 million of its 90 million doses. The story for Germany and Norway is similar.
As Dr. Thomas Jefferson, an epidemiologist with the Cochrane Research Center in Rome noted, “Why do they give the vaccines to the developing countries at all? The pandemic has been called off in most parts of the world. The greatest threat in poor countries right now is heart and circulatory diseases while the virus figures at the bottom of the list. What is the medical reason for donating 180 million doses?” As well, flu is a minor problem in countries with abundant sunshine, and it turned out that the feared H1N1 Pandemic “new great plague” was the mildest flu on record.
The pharmaceutical vaccine makers do not speak about the enormous health damage from infant vaccination including autism and numerous neuro-muscular deformities that have been traced back to the toxic adjuvants and preservatives used in most vaccines. Many vaccines, especially multi-dose vaccines that are made more cheaply for sale to the Third World, contain something called Thimerosal (Thiomersol in the EU), a compound (sodium ethylmercurithiosalicylate), containing some 50% mercury, used as a preservative.
In July 1999 the US’ National Vaccine Information Center declared in a press release that, “The cumulative effects of ingesting mercury can cause brain damage.” The same month, the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) alerted the public about the possible health effects associated with thimerosal-containing vaccines. They strongly recommended that thimerosal be removed from vaccines as soon as possible. Under the directive of the FDA Modernization Act of 1997, the Food and Drug Administration also determined that infants who received several thimerosal-containing vaccines may be receiving mercury exposure over and above the recommended federal guidelines.”6
GMOs: Genocidally Modified Organisms
If you have been following the Natural Solutions Foundation’s health Freedom Action eAlerts for some time, you have read numerous articles and studies showing just how dangerous GMO “foods” really are. You know that they contaminate species other than their own, increase herbicide and pesticide use and intake, reduce genetic diversity, sow economic and social havoc, cause infertility, auto immune problems, loss of babies in the womb, and a host of other serious problems. You also know that they are approved for sale in the US without any labeling by the industry-friendly FDA. You recall that Dr. Barbara Schneeman told a Codex meeting on labeling GMO “foods” that the US knew that consumers overwhelmingly rejected GMOs but the FDA thought that was a mistake, so they forbade the labeling of GMOs to prevent people from rejecting them in error! (Oslo, 2008). You know that they are untested and that the FDA and USDA MAY NOT examine safety testing, or conduct any, yet they approve them for widespread human and animal use. If you visit our Health Freedom Blog and look for “GMO Files” in our search engine, you’ll find a great deal of scientific documentation making it clear that GMOs are astoundingly dangerous and shockingly untested.
You will also know well that GMOs are being pushed on Africa as a way of controlling the population there? Studies show that organ damage follows ingesting GMO corn for just 90 days7 and that fertility and successful pregnancies are strikingly reduced through eating GMO foods8 and that cancer is related to eating GMO “food” as well.9
“GMO crops have never been proven safe for human or animal consumption. Moreover, they are inherently genetically ‘unstable’ as they are an unnatural product of introducing a foreign bacteria such as Bacillus Thuringiensis (Bt) or other material into the DNA of a given seed to change its traits. Perhaps equally dangerous are the ‘paired’ chemical herbicides sold as a mandatory part of a GMO contract, such as Monsanto’s Roundup, the most widely used such herbicide in the world. It contains highly toxic glyphosate compounds that have been independently tested and proven to exist in toxic concentrations in GMO applications far above that safe for humans or animals. Tests show that tiny amounts of glyphosate compounds would do damage to a human umbilical, embryonic and placental cells in a pregnant woman drinking the ground water near a GMO field.
One long-standing project of the US Government has been to perfect a genetically-modified variety of corn, the diet staple in Mexico and many other Latin American countries. The corn has been field tested in tests financed by the US Department of Agriculture along with a small California bio-tech company named Epicyte. Announcing his success at a 2001 press conference, the president of Epicyte, Mitch Hein, pointing to his GMO corn plants, announced, “We have a hothouse filled with corn plants that make anti-sperm antibodies.”
Hein explained that they had taken antibodies from women with a rare condition known as immune infertility, isolated the genes that regulated the manufacture of those infertility antibodies, and, using genetic engineering techniques, had inserted the genes into ordinary corn seeds used to produce corn plants. In this manner, in reality they produced a concealed contraceptive embedded in corn meant for human consumption. “Essentially, the antibodies are attracted to surface receptors on the sperm,” said Hein. “They latch on and make each sperm so heavy it cannot move forward. It just shakes about as if it was doing the lambada.” Hein claimed it was a possible solution to world “over-population.” The moral and ethical issues of feeding it to humans in Third World poor countries without their knowing it countries he left out of his remarks.
Spermicides hidden in GMO corn provided to starving Third World populations through the generosity of the Gates’ foundation, Rockefeller Foundation and Kofi Annan’s AGRA or vaccines that contain undisclosed sterilization agents are just two documented cases of using vaccines or GMO seeds to “reduce population.”10
By the way, what makes people in the Third World sterile, sick and suffering when they eat it, makes you that way, too. This is not a problem of the haves and the have nots. This is a problem of they tyrants and the free men and women they are seeking to oppress and kill – us.
Natural Solutions Foundation
My nominee for the Hall of Shame: FDA with reference to its banning of Pyridoxamine, a form of Vitamin B-6.
Read on and see if you agree with me.
Big Pharma is part of a mega-cartel that makes its money when you are sick. We might want to call it “Big Sick.” The FDA serves the needs of that super cartel without so much as a second thought; it’s built into the bureaucratic structure. It is an agency that Dr. Ron Paul says engages in “abuses of power.” It is increasingly blatant about it, though, as if there is nothing that can be done to stop it.
The FDA has, for a long time, banned truthful claims and information about the health benefits you can expect from foods and nutrients. Nutrient benefits will cut into the drug pushers’ market substantially, after all. Unless you do not know the good things you can expect from those items, leaving you all the more vulnerable to the drug pushers who are permitted to sell their deadly wares to you over the TV, in magazines and through your doctor’s prescription pads.
Remember that the 1994 law which gives us the right to nutrients in whatever dose we want them, the Dietary Supplements Health and Education Act (DSHEA) also gives us the right to truthful information about nutrients, herbs and food components. In clear violation of that law, and the First Amendment of the Constitution, however, the FDA uses a variety of powers, real and assumed, to suppress both science and facts. Take away the information and you effectively kill the alternatives to the deadly drugs the Big Pharma cartel pushes…
To make matters worse, this same gag rule on truthful speech concerning nutrient health benefits has been brought — by the FDA, of course, to Codex Alimentarius (the “world food code”) where it has been globalized through the efforts of the US delegate (previous Hall of Shame “Honoree” Dr. Barbara Schneeman, head of the FDA’s Department of Dietary Supplements, no less!) and approved by the Codex Committee on Food Labeling and then by the Codex Commission.
Codex says that any information offered to consumers about the health benefits of food or food components is illegal because it is advertising as if advertising were banned. The whole thing lacks logic, but has reason: the reason is to kill nutritional medicine in favor of drugs. This process has gone dangerously far in the EU and is advancing through FDA “HARMonization” of US rules with Codex restrictions.
Remember, our video “Nutricide” is called that for two reasons.
First, “Nutricide” means the death of the body of knowledge of the relationship between health and food components
Second, “Nutricide” means the death of a large number of people through the manipulation of the food supply. You can watch this important lecture by going to www.HealthFreedomUSA.org and scrolling down the video section. It is well worth your time.
This effort to kill nutrients is blatant as blatant can be.
How blatant? This blatant. Read the excellent article below which discusses the absurd ban on a form of activated B6, Pyradoxamine, to see just how shameless this organization is. This form of B6 has been available for decades. Then remember that when we, in our numbers, push back against the FDA, experience shows that we deflect their plans. Yes, they come back again, but we do push them away from the brink time and time again. With your magnificent help.
We thank you for your activism. After reading this article, I am sure that you will agree that eternal vigilance is the price of protecting high potency nutrients and information about them, from those who want to take away our right to access natural health options, including foods that heal!
The Natural Solutions Foundation continues to fight for your health. Please “stay tuned” for action items to oppose the evil that FDA’s bureaucrats seek to perpetuate. Remember to open our Health Freedom Action eAlerts when we send them to you! Please give generously so that we can continue that fight, with you by our side.
————————————- Big Pharma and the FDA: Suppress the Science, Ban the Natural Substances, Sell the Drugs!
Michael D. Ostrolenk
Thu, Jun 11, 2009 at 12:31 AM
In 2005, an up-and-coming pharmaceutical company made a big mistake: they invested millions of dollars into developing a drug only to discover that the only active ingredient of the drug, pyridoxamine, was really a common, naturally occurring substance that has been sold for decades at low cost to consumers in the form of a dietary supplement, and has always been available in commonly consumed foods such as chicken and brewer’s yeast.
We’re taught as children that when you make a mistake, you should own up to it and face the consequences. Apparently the pharmaceutical company in question, Biostratum, Inc., has yet to learn that lesson. Instead of owning up to their mistake, Biostratum tried to game the system to their advantage by asking the US Food and Drug Administration (FDA) to declare supplements containing pyridoxamine “adulterated” and effectively ban anyone but Biostratum from selling pyridoxamine.
Sadly, Biostratum’s desperate ploy to save their investment worked. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement. They denied the request to declare products containing pyridoxamine “adulterated,” but instead they declared that such products are not dietary supplements at all—claiming they are excluded from the definition of dietary supplements under the “prior market clause” [21 U.S.C. 321(ff)(3)(B)(ii)] and so may not be marketed as such.
Please note that nowhere in the FDA’s response letter is anything said about safety concerns. In fact, the FDA’s letter specifically says that “to allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.” Fair to the pharmaceutical companies? What about fairness to consumers, some of whom rely on affordable pyridozxamine supplements to provide the levels of vitamin B-6 required for their survival? Is it fair to force those consumers to pay for expensive prescription drugs and doctors’ visits to supply their B-6 needs when they could get the exact same thing for a fraction of the cost in the form of a supplement? Isn’t this why our health care system is so ineffective?
This is hardly the first time the FDA has attacked naturally occurring substances. On October 17, 2005, the FDA banned information about the health benefits of cherries from appearing on websites—scientifically proven benefits, such as tart cherries’ ability to reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry. Cherries, according to the latest research, help ease the pain of arthritis and gout; reduce risk factors for heart disease and diabetes; help regulate the body’s natural sleep patterns, aid with jet lag, prevent memory loss, and delay the aging process; and helps lower body fat and cholesterol—risk factors associated with heart disease. Moreover, Scientists at Johns Hopkins have found that tart cherry anthocyanins reduced painful inflammation as well as a non-steroidal anti-inflammatory drug, indomethacin.
When the 2005 ban was instituted, the FDA sent warning letters to twenty-nine companies that market cherry products. In these letters, they ordered the companies to stop publicizing scientific data about cherries. According to the FDA, when cherry companies disseminate this peer-reviewed scientific information, the cherries become “unapproved new drugs” and are subject to seizure. The FDA warned that if those involved in “cherry trafficking” continue to inform consumers about these scientific studies, criminal prosecutions would ensue.
But fresh fruit and vegetables are not the FDA’s only target: As we reported in this newsletter recently, General Mills was recently issued a warning letter by the FDA for illegally marketing Cheerios Toasted Whole Grain Oat Cereal. The problem was the claim on the cereal box that Cheerios can lower cholesterol 4% in six weeks, and the statement on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, 2009, called the above claims “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations. FDA stated that based on the claims made, Cheerios is now an unapproved drug, and must go through FDA new drug approval process. Note that the FDA isn’t disputing the claim. It’s disputing the company’s right to make the claim.
As one newspaper columnist humorously put it, “One of these things is not like the others: morphine, penicillin, aspirin, Cheerios. Most drugs, if taken improperly, will kill the consumer or cause substantial bodily harm. An entire bottle of aspirin at one sitting will harm or kill. If Cheerios is a drug, therefore, one should be able to commit suicide by consuming the entire box.”
For years, the FDA barred health claims about the benefits of fish oil for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process. This type of enforcement effectively censors scientific information and greatly restricts consumer access to scientific studies that provide valuable information.
In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about money, and about a profit-seeking corporation taking advantage of what is supposed to be a public health organization in order to save their skins.
The careless, industry controlled FDA has been happy to approve drugs made from genetically modified molecules, including many from plants, since 1985 when it approved GMO insulin. These drugs are called “Biologicals”. A new analysis, published in the Journal of the American Medical Association, shows that biologicals are twice as dangerous as chemical (non GMO) drugs. We know how dangerous they are (over 100,000 deaths per year and 3 million hospitalizations per year for adverse events from properly used drugs in the US each year. Now multiply that danger by at least two and see what you get: a profit-driven disaster.
The excellent summary below makes it clear that while it is essential to divest the FDA and USDA of their food regulatory responsibilities, the dangerous and industry-supported FDA is not doing any better with their regulatory responsibilities on drugs than they are on food. At least with drugs, however, you have a chance, for the moment, of saying “yes” or “no” to their use. Food is compulsory. Drugs are [usually] voluntary. And that is why, of course, natural medicine options, in all their forms, are under such vigorous attack.
That is also why the Natural Solutions Foundation continually asks you to make sure that everyone in your contact list becomes aware of these issues and that you request that they take the actions that you take to prevent the loss of our health freedoms and to separate this dangerous agency (and the USDA) from your table and your health.
Protein drugs produced by genetic engineering cause adverse events including death more frequently than synthetic chemical drugs; yet they are being produced in transgenic crops grown in open fields Prof. Joe Cummins
‘Biologicals’ more dangerous than chemicals
‘Biologicals’ are drugs in which the active substance is produced by or extracted from a biological source (in contrast to synthetic chemicals). Biologicals are relatively recent, being for the most part, recombinant proteins produced by genetic engineering. The first biological was recombinant human insulin produced in recombinant bacteria and commercially approved in 1982. Currently, there are more than 250 biologicals on the market, including recombinant blood products, monoclonal antibodies and vaccines that have been approved by regulatory agencies in the United States and European Union (EU). Between 2003 and 2006 biologicals represented 24 percent of all new approvals in the US and 22 percent of new approvals in the EU . Ten biologicals are listed among the top selling ‘blockbuster’ drugs valued at 1 to 3.2 billion dollars in sales. These drugs included treatments for red blood cell disorders, immune system disorders, cancer and insulin analogues .
Newly approved drugs are frequently found to cause unexpected problems; but biologicals are incurring problems even more frequently than synthetic chemical drugs. A recent study published in the Journal of the American Medical Association confirms that the biological drugs have provoked significantly more regulatory actions than newly introduced synthetic chemical drugs. The researchers, based in The Netherlands, followed up a group of biologicals approved in the US and EU between 1995 and 2008, and found that 24 percent of these have prompted safety regulatory actions. New chemical drugs have an 8.5 percent chance of safety warning within ten years of approval, compared to 17 percent for biologics . The regulatory actions included warnings on general disorders and administration site conditions, infections and infestations, immune system disorders and cancers (benign, malignant and unspecified). Adverse events included many serious complications of the drug treatment such as increased mortality, anaphylaxis, cancer, heart failure, stroke, and infections . However, industry representatives implied  that the diseases being treated were very serious, and the drugs were efficacious and the adverse events relatively rare. The study concluded : “The nature of safety problems identified after approval for biologicals is often related to the immunomodulatory effect (infections). Because the biologicals first to be approved in a class were more likely to be subjected to regulatory action, close monitoring is recommended.”
FDA blaming the victims rather than the drugs?
A review of the Netherlands study published in Nature Biotechnology acknowledges the significance of the study and the problem of adverse events related to biologicals. The article mentions a caveat to the study’s conclusions added by Sandra Kweder, deputy director of FDA’s office of new drugs at the Center for Drug Evaluation and Research : “Biological therapeutics are more likely to be developed to treat serious illnesses, she points out, and serious illnesses themselves are fertile ground for ‘toxicity’ whether related to the drug or disease, so interpreting data on the drug’s or biological’s risk must take that into account.” That seems to lay the blame for the adverse outcomes on those being treated rather than the drugs; and looks like an attempt to protect the billion-dollar industry.
The Nature Biotechnology review  further comments that industry insiders agree long-term safety monitoring will be crucial for biologics. While the antibody producing company InNexux’s chief scientific officer is reported to have said: “That long-term use may lead to problems I think is a given,” – a suspicion borne out by the latest study – the company’s chairman and ceo Jeff Morhet, finds at least one important consolation: “the study showed that no biological was pulled from the market for safety reasons.”
Lax FDA regulation and a profit-hungry industry
If anything, Morhet’s remark should offer no consolation to those being treated; as it exposes the lack of adequate regulation to protect the public in face of ‘miracle cures’ being offered by an industry whose primary concern is profit.
Significantly, no one has commented on the 2005 case of the drug Tysabri (natalizumab) a treatment for multiple sclerosis that was suspended following two deaths of patients from leukoencephalopathy (progressive damage or inflammation of the white matter of the brain) . Nor indeed has anyone mentioned the catastrophic London drug trial of a biological monoclonal antibody drug that left six healthy young volunteers seriously ill  (London Drug Trial Catastrophe – Collapse of Science and Ethics, SiS 30).
The Institute of Science in Society (ISIS) has long been critical of the manner in which biological are tested and used in treatment. The adverse event, ‘cytokine storm’ unleashed in the immune system of the volunteers, was not exactly a surprise. The FDA had issued a long list of warnings on similar monoclonal antibody drugs  (Warnings on FDA Approved Monoclonal Antibody Drugs, SiS 30); but that seemed to have been ignored  (Post Mortem on the TGN1412 Disaster, SiS 30).
Pharm crops with dangerous biologicals in open field trials put the public at risk
Even more seriously, the secret trials of food crops (pharm crops) in open fields modified with mammalian genes expressing proteins used to treat human or animal disease continue unabated  (Drug Trial Catastrophe & Safety of Secretly Tested Pharm Crops, SiS 30). Pharm crops for vaccines and therapeutic antibodies have been trialed since 2004 and earlier  (Pharm Crops for Vaccines and Therapeutic Antibodies, SiS 24). Antibodies are produced in tobacco plants  (Antibodies from Hybrid GM Tobacco Plants, SiS 35) and in maize  (Transgenic Maize with Monoclonal Antibodies Grown in France, SiS 35). Biologicals are well known to have severe side effects on patients and on healthy people. There is no justification for exposing the unsuspecting public to these drugs produced in pharm crops grown in open fields.
1. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA. 2008, 300(16), 1887-96.
2. King J. JAMA casts cloud over biologic safety. Nature Biotechnology 2009, 27,11-12.
3. FDA Public Health Advisory Suspendec Marketing of Tysabri (natalizumab) 2005 updated 2007 http://www.fda.gov/cder/drug/advisory/natalizumab.htm
4. Ho M-W and Cummins J. London drug scandal catastrophe, collapse of science and ethics Science in Society 30, 41-43. 2006.
5. Cummins J. Warning on FDA approved monoclonal antibody drugs Science in Science in Society 30, 46-47. 2006.
6. Saunders PT. Post mortem on the TGN1412 disaster. Science in Society 30, 44-45+47,. 2006.
7. Cummins J and Ho M-W. Drug trial catastrophe & safety of secretlytested pharm crops Science in Society 30, 50, 2006.
8. Cummins J. Pharm crops for vaccines and therapeutic antibodies Science in Society 24, 22-23, 2004.
9. Cummins J and Ho M-W. Antibodies from hybrid GM tobacco plants. Science in Society 35, 51, 2007.
10. Cummins J, Ho M-W and Saunders PT. Transgenic maize with monoclonal antibodies grown in France Science in Society 31, 4, 2006.