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.
Here is the link to send to your contact list so they can sign up for the free, secure and vitally important Health Freedom Action eAlerts: http://drrimatruthreports.com/?page_id=187. And here is the link for you – and your contacts – to make a tax exempt donation to the Natural Solutions Foundation: http://drrimatruthreports.com/?page_id=189.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
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‘Biologicals’, Wonder Drugs with Problems
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 [1]. 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 [2].
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 [2]. 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 [1]. However, industry representatives implied [2] that the diseases being treated were very serious, and the drugs were efficacious and the adverse events relatively rare. The study concluded [1]: “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 [2]: “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 [2] 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) [3]. Nor indeed has anyone mentioned the catastrophic London drug trial of a biological monoclonal antibody drug that left six healthy young volunteers seriously ill [4] (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 [5] (Warnings on FDA Approved Monoclonal Antibody Drugs, SiS 30); but that seemed to have been ignored [6] (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 [7] (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 [8] (Pharm Crops for Vaccines and Therapeutic Antibodies, SiS 24). Antibodies are produced in tobacco plants [9] (Antibodies from Hybrid GM Tobacco Plants, SiS 35) and in maize [10] (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.
References
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.
ttp://www.i-sis.org.uk/biologicalsWonderDrugsWithProblems.php
Barbara Loe Fisher is a tireless advocate of both vaccine truth and choice and the Natural Solutions Foundation nominates her for our Hall of Fame. Barbara continues to examine carefully the vaccine industry, its products and its corruption. Her site, www.NVIC.org, is a mine of information and assistance on vaccine and vaccination issues. She is an ally and a resource of great value.
Barbara’s latest commentary on the corrupt – and corrupting – vaccine industry is a very important read.
In it she points out that vaccine safety and effectiveness have not been demonstrated by the studies published about them even in prestige journals. Those studies are of poor quality and show little that can be relied upon scientifically, but are, none the less, used as the evidence relied upon by vaccine courts to determine whether vaccines have harmed or killed anyone.
The Natural Solutions Foundation has filed a Citizens Petition with the Federal Trade Commission demanding hearings on whether vaccines are safe and/or effective and asking for a ban on any advertising or materials which suggest that they are either safe, effective or both until that fact is established.
And click here (http://drrimatruthreports.com/?p=2220) to read the latest news on the “accidental” Baxter International contamination scandal in which live, virulent Avian Flu H5N1 virus was somehow mixed with seasonal flu vaccine shipped to 18 countries. This mixture would allow re-assortment or mutation of the Avian Flu virus which currently is very ineffective in causing human disease. Such alteration of the virus could potentially allow it to become as deadly as the Avian Flu has been predicted to be when it causes the next “inevitable” pandemic. Of course, if it is mixed in with other flu viruses and injected “by accident”, the next pandemic really IS inevitable.
Please share this information as widely as possible, and make a tax deductible donation (http://drrimatruthreports.com/?page_id=189) as generously as possible so that the Natural Solutions Foundation can continue to bring you vitally important information and fight for your health and freedom.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
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Vaccine Studies: Under the Influence of Pharma
Barbara Loe Fisher
If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout.
It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn’t get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection.
It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC’s policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.
How Big Pharma Influences Medical Journals
A recent study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.
This analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety.
The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D. who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade, by both Pharma-funded special interest groups, as well as public health officials maintaining close relationships with vaccine manufacturers.
Study Finds No Correlation Between Quality of Study and Publication
This recent review identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles.
The researchers also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.
The authors commented: “The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding”.
The HPV Vaccine — Just One Example of Inappropriate Influence Endangering Public Health
Last month the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates.
In 2006, Merck’s Gardasil vaccine was fast tracked by the FDA at Merck’s request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.
The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.
Massive Increase in Number of Vaccines Given
In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six.
Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.
In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.
Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective — evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children — then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.
Government Vaccine Recommendations Based on Tainted Evidence
The U.S. Court of Claims vaccine injury compensation awards, and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.
Kudos to the British Medical Journal for having the integrity to publish Dr. Jefferson’s comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S.
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Think GMOs don’t impact you because you grow 100% of your own food in a closed environment greenhouse to control all pollination? Think again. If you live in the US, your world is being reshaped in the image of Monsanto. If you don’t like that image, get your head out of the sand in your greenhouse and get busy defending both the American value system and your food, along with your society, from this malign influence.
And, if you tend to think that the Federal Government won’t let this happen, recall that Secretary of Agriculture Vilsek is a Monsanto man.
This kind of atrocity is just fine with the GMO-friendly Federal Government which clearly cannot be trusted to regulate our food. It is imperative to divest the FDA and USDA of their food regulatory responsibilities and get food regulation back into the hands of those of us who eat the food, at the State level. Click here, http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405, to tell Congress to get the Federal Government out of our pantries and off our dinner plates before these agencies do even more harm.
So get involved now.
Sign up for the Natural Solutions Foundation Health Freedom Action eAlerts, http://drrimatruthreports.com/?page_id=187, and ride the Freedom Mouse hard.
And remember these battles against Big Pharma and Big Biotech cost money. Make your tax deductible donation to the Natural Solutions Foundation by clicking here,http://drrimatruthreports.com/?page_id=189 . Do it now. Time is short and the enemy is large.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
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Monsanto Investigator in Illinois Laughs They Are Doing ‘Rural Cleansing’
by Linn Cohen-Cole
www.opednews.com
As of last night, a US marshal, 2 state police and a county police are all over Mr. Hixon’s area, serving notices to farmers that they are being sued by Monsanto. They arrive in pairs, with two cars parked a quarter mile and half mile down the road. They’ve served 3 so far and said “a bunch more are coming.” No telling how many will be served since Hixon has between 200-400 farmers he cleans seeds for and these farmers have been repeatedly threatened by Monsanto thugs for the last two months, getting “visits,” letters, and calls daily.
Farmers report that a Monsanto investigator laughed that they were doing “rural cleansing.”
Steve Hixon is a seed cleaner in southern Illinois. He has equipment that takes the plant materials and “cleans” it so that the seeds are separated out and can be given back to farmers to save for the next season. It’s a mechanized step up from farmers hand picking seeds off their own plants, which, with hundreds of acres – or even 10 – would not be easy to do.
Mr. Hixon has the non-distinction of being attacked by Monsanto. He is far from alone. Monsanto has been picking off seed cleaners across the Midwest, having already done its thuggish thing in Pilot Grove, Missouri, and in Indiana, attacking Maurice Parr, destroying business for all of them.
Mr. Parr reports that when he was sued, the first think out of the judge said was how “honored to have a fine company like Monsanto in my courtroom.”
“Shortly after someone broke into Mr. Hixon’s office and he found his account book on his truck seat where he would never have left it, evey one of his remotely located and very scattered customers had three men (described as goons with “no necks”) arrived at each farm, going out onto it without permission … Mr. Hixon and state police who were called in, believe a GPS tracking device may have been put on Mr. Hixon’s equipment.” Click here.
In 2002, when Mr. Hixon was at the state legislature for a meeting, he said he told a Monsanto representative there, “If you guys wnt to tak over the seed industry so bad, you ought to buy guys like me out.” The Monsanto agent is supposed to have responded “We’d rather put you out of business, it’s more fun that way.”
Mr. Hixon says that when he is cleaning seeds, he is pouring $13,000 a hour into the local economy, which right now is being hit. A fence company has gone out of business and other businesses are in trouble. And in using seeds that have been cleaned, those seeds have carbon footprint, by Mr. Hixon’s figures, less than a fraction of 1% of that of GMO seeds delivered over 1000s of miles at 5 miles a gallon that semis require to run.
But Monsanto’s GM-soy and other seeds have a much heavier carbon footprint that the absurd transport of seed across the country by semis. Petroleum-based pesticides are the essence of genetic engineering, and Monsanto has a poorly known history of their relation to warfare.
“Huge excesses of nitrogenous compounds that accumulated during World War I provided the basis for the beginnings of the mass production of synthetic nitrate fertilizers. DuPont — now the sole owner of the world’s largest seed company, Pioneer HiBred — was the largest manufacturer of gunpowder in the United States during the early 19th century and the first World War. Monsanto increased its profits 100 fold during the World War, from $80,000 to well over $9 million per year, supplying the chemical precursors for high explosives such as TNT.
“In the 1930s, chemists working for the German company Bayer discovered the highly poisonous properties of organophosphate compounds. …. As all of German industry became absorbed into the growing Nazi war machine, Bayer’s organophosphate compounds were developed simultaneously as agricultural pesticides and as nerve gases for military use. These included such notorious chemical warfare agents as sarin, soman and tabun gases, all of which are still manufactured today. …
“In the 1930s, scientists at the Swiss J. R. Geigy Company were searching for new compounds to disinfect seeds and prevent moths from feeding on wool. … These researchers’ key discovery was that DDT … could accomplish both of their desired ends and more. … DDT was seen as the “atom bomb of insecticides,” capable of permanently eliminating various pest species.
“After World War II, DDT became the most widely applied chemical in human history …. The widespread use of DDT — for both agricultural and household uses — led to a dramatic shift in the chemical industry’s approach to pest control … was in many ways a direct outgrowth of its wartime origins. …
“During the 1960s, Monsanto was a leading manufacturer of the herbicide ‘Agent Orange,’ which was used by U.S. military forces to obliterate the dense jungles of Vietnam. Today Monsanto’s Roundup-family herbicides play a central role in the U.S. “drug war” via its widespread use to eradicate coca and poppy plants in Colombia and other countries….”
The shift to genetically engineered food seems a welcome change from such a history. But it appears there has been no change, only a more thorough and disguises means of ensuring its sales.
“Of all of Monsanto, DuPont and Dow’s agricultural products, genetically engineered food crops might appear to be the least tainted with immediate wartime origins. But this technology emerged from a period when the future of chemical agriculture appeared very much in doubt. With the rapid expansion of the agrochemical industry during the post-World War II era, these companies and their European counterparts had established a profound degree of control over agricultural practices. But as public pressure and the weight of scientific evidence curtailed the use of DDT and many other chlorinated pesticides in the 1970s, executives and corporate scientists saw the potential for limitless advances — and ever-expanding marketing potential — in the incorporation of technological advances into the genetics of seeds. During the 1990s, Monsanto alone spent nearly $8 billion acquiring leading commercial seed suppliers in the United States and internationally; DuPont and others quickly followed suit, leading to today’s widespread proliferation of genetically engineered food crops.” Click here.
Today, in Illinois, our federal agents and police, working on behalf of Monsanto, are terrorizing … whom? Drug dealers? Financiers who have stolen this country blind? The people who took us to war based on lies and have profited while thousands of American and 100s of thousands of Iraqi have died? No. Our tax dollars are being used to turn our marshals and police into Monsanto agents to terrorize our disappearing farmers.
Terror is palpable in rural America. It defines American farming communities now.
Monsanto, with its history of warfare and creating chemicals to “cleanse” both enemies and agricultural pests of any area desired, appears to bring this power and method of thinking to all it touches.
“Rural cleansing” is its stated goal, and our farmers the pests to be eliminated.
Where is the Illinois ACLU? Where is Amnesty?
Click here (http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405) to tell Congress to divest the corrupt and inefficient FDA and USDA of their food regulatory responsibilities before they kill more of us!
In the last in a long, long string of documented failures, shortcomings and tragic errors by the FDA, a recent report documents that the FDA is not only prejudiced and biased, but so riddled with conflits of interest, now not even considered a problem at the failed agency, that there is no way to trust the honesty or accuracy of the decisions of the agency.
While this study looks at one aspect of the impact on drug regulation, food regulation is the same, only worse.
There, the same problems apply, along with the intentional down-regulation of food to support the pharmaceutical markets which profit from the poor drugs approved by the drug regulatory side of the FDA house since degraded food makes people sicker quicker, and makes the profit picture derived from the drugs to treat those illnesses stronger longer.
The picture is a dismal one but there is at least one solution: divest the FDA (and its equally corrupt partner in food crime, the USDA) of all food responsibilities. Rather than creating an new agency, as is currently being discussed by Congress, which will not deal with the fundamental issues and their deadly consequences, the answer, be believe, is to divest the Federal Government of all food regulatory responsibility and instead turn those responsibilities over to the unit of government which the people can impact: State governments.
This is an urgently important concept and must be enacted, even as numerous States are asserting their soverignty from the corrupt and dangerous United States.
Please support the Natural Solutions Foundation in its efforts to make food save once again, protecting food and freedom.
You can donate to the Natural Solutions Foundation at http://drrimatruthreports.com/?page_id=189. All US donations are tax deductible.
Spread the word and ask everyone you know to join the Health Freedom eAlerts, http://drrimatruthreports.com/?page_id=187, for up to the minute information and Action Items.
Please take a moment to help us Divest the US Government of its food regulatory responsibilities here http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405 and then spread the word!
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
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FDA Not Effectively Monitoring Investigator Conflicts of Interest, HHS Watchdog Says
Neil Osterweil
Information from Industry
Assess clinically focused product information on Medscape.
Click Here for Product Infosites – Information from Industry.
January 16, 2009 — More than one third of new drug marketing applications approved by the US Food and Drug Administration (FDA) were missing information about potential conflicts of interest for clinical trial investigators, which could allow bias to creep into the approvals process, a government report released this week has found. The FDA has said that it agrees with most of the report’s findings.
Federal regulations require clinical trial sponsors to collect financial information from investigators at the outset of trials, and to report on their efforts to minimize the possibility that financial self-interest could color trial results, notes the report from the office of Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS).
Trial sponsors — usually the company developing or licensing the drug or device in question — only have to disclose this information when they apply for marketing approval, and even then there’s a loophole: they can claim that they “acted with due diligence” to collect financial information from each investigator to satisfy regulations.
Report Found Few Financial Disclosures
Yet 42% of new drug marketing applications filed in fiscal year 2007 were short on investigator financial disclosures, and in fully one fifth of cases where such information was disclosed, FDA reviewers took no action, the watchdogs reported.
“In FY 2007, only 1% of clinical investigators disclosed a financial interest,” the report’s authors write. “By way of comparison, the Journal of the American Medical Association reported that between 23% and 28% of academic researchers had financial interests in medical companies. Further, we found a number of limitations in FDA’s oversight, leaving FDA unable to determine whether sponsors submit financial information for all clinical investigators.”
In addition, the HHS inspector general’s staff found that FDA can’t verify whether relevant information has been collected on all investigators because of incomplete data and the lack of on-site verification procedures.
Collection and review of such information should be routine, as should appropriate action when required, and all of it should occur before a trial ever gets off the ground, contends a former FDA reviewer interviewed by Medscape Medical News.
“You want to intervene at a time when there’s an ability to do something about it,” said John H. Powers III, MD, now an assistant clinical professor of medicine at the George Washington University (GWU) and University of Maryland Schools of Medicine.
“To have a situation where the sponsor has already done the trial, submits the information, and then the FDA says ‘you have conflicts of interest with your investigators,’ puts the sponsor in a bad spot, the investigator in a bad spot, and it puts the FDA in a bad spot. It seems to me that if you’re going to regulate here that you should do it a proactive manner,” he said.
“Management Failure”
Federal regulations concerning drug marketing approvals require that “adequate measures are taken to minimize bias on the parts of the subject, observers, and analysts of the data,” Dr. Powers noted, yet one of the most common sources of potential bias — investigator relationships with industry — are overlooked or ignored.
“This is a management failure,” said David B. Ross, MD, PhD, a former FDA reviewer who is now a clinical assistant professor at GWU. “The managers who have set this policy have done nothing to enforce it and there are no consequences, and the reason is that nobody thinks it matters; they’re kind of doing this for show.”
When Dr. Ross was at the FDA, he and other reviewers warned agency management that a study used to support approval of the antibiotic telithromycin (Ketek, sanofi aventis) was marred by per-patient payments to investigators of up to $400, and, in at least one case, by fraud on the part of the investigator who enrolled the most patients (she was later sentenced to 57 months in federal prison), and by “serious violations in trial conduct” in 9 other trial sites, leading to 4 referrals for criminal investigation.
Despite the warning, and despite ongoing concerns about reported hepatotoxicity from the drug, FDA management failed to take substantive action in response to reviewer concerns, a failure that Dr. Ross said is emblematic of the agency’s apparent indifference to the possible influence of investigator financial relationships with industry.
“…CDER [the Center for Drug Evaluation and Research] is not doing that good of a job, and with what they do track, what are they doing with it? It’s like having laws against speeding and not writing any tickets,” Dr. Ross said.
Relationships Can Have Profound Effect
Eric G. Campbell, PhD, an associate professor at the Institute for Health Policy and the Department of Medicine at Massachusetts General Hospital and Harvard Medical School in Boston, said that financial considerations — whether honoraria, consulting fees, stock options, or direct payments — can have a profound effect on which trials get published or promoted.
“The important thing to remember is that relationships with industry — they may not always be conflicts — are ubiquitous in all aspects of medicine, medical research, and medical regulatory affairs,” Dr. Campbell said. “If a study is funded by a drug company to investigate its product and if the investigator also has relationships with that company, you can be darn sure that if the study makes it to publication, it’s going to favor that product,” he said.
Like Dr. Ross and Dr. Powers, Dr. Campbell pointed out that lax or absent regulatory oversight implies a lack of concern and a tacit acknowledgment of a lack of enforcement of existing rules.
“The bottom line is that if you don’t report stuff and nobody pays attention to whether it’s reported or not, you’re just signaling that it’s not important and that nobody cares, and clearly that’s the message that FDA is sending out,” he told Medscape Medical News.
Key Findings
The report, prepared by staff from the Chicago regional Office of Evaluations and Inspections in the HHS Inspector General’s Office, was based on reviews of financial forms, attachments, and accompanying FDA review notes for all 118 marketing applications approved by the agency in fiscal year 2007. The watchdogs also reviewed FDA regulations and guidance, conducted structured interviews with FDA officials, and surveyed FDA reviewers.
The key findings were:
* 1% of clinical investigators (206 of 29,691) disclosed a financial interest.
* FDA does not have a complete list of clinical investigators and does not use on-site inspections to confirm that submitted financial information is complete, meaning that reviewers cannot determine whether sponsors have submitted financial information for all clinical investigators
* 42% of FDA-approved marketing applications were missing financial information, 23% of approved marketing applications were missing a certification or disclosure form or required attachments, and in 28% of applications, sponsors used the due-diligence exemption to indicate that they were unable to provide complete financial information.
* FDA did not document a review of any financial information for 31% of marketing applications. Reviewers who followed a review template were more likely to include financial information than those who did not.
* In 20% of applications with disclosed financial conflicts, neither the FDA nor sponsors took action.
The Inspector General’s recommendations for the FDA were as follows:
* Ensure that sponsors submit complete financial information for all clinical investigators.
* Use a complete list of clinical investigators to check that sponsors have submitted financial information for all.
* Require that sponsors submit financial information for clinical investigators as part of the pretrial application process.
* Check that sponsors have submitted all required attachments to financial forms.
* Update guidance to sponsors regarding the due-diligence exemption.
* Add a review of financial information to the on-site inspection protocol.
* Ensure that reviewers consistently review financial information and take action in response to disclosed financial interests.
* Require that all centers consistently use a template that includes a prompt to document a review of financial information.
* Provide additional guidance and training to reviewers.
FDA Replies
In response to a request from Medscape Medical News for comment, FDA spokesperson Karen Riley sent a statement noting that the agency agreed with all of the HHS recommendations except the one stating that the FDA should request information from clinical investigators prior to trial initiation.
“The intent of clinical investigator financial disclosure is not to discourage investigators from being included in the study,” the FDA response says. “Rather, it allows sponsors to identify and manage potential conflicts throughout the development of a regulated product, from design through the conduct of the clinical trials.”
The statement goes on to say that this recommendation for financial disclosures before trial initiation could needlessly add to “the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of the data.”
This pretrial disclosure recommendation is not meant to be punitive or burdensome, Dr. Powers said, but it recognizes the fact that bias, whether intended or not, can slip into the process whenever money is involved.
“When people bristle at regulations, I always think of James Madison’s quote,” he remarked. “Madison said that ‘If all men were angels, no government would be necessary.’ The reasons why we do these things is not because everybody is inconsistent or immoral: it’s because some people are. It seems onerous to people who have no intention of doing the wrong thing, but unfortunately these rules are written for people who aren’t going to do the right thing.”
http://www.medscape.com/viewarticle/586980?sssdmh=dm1.423642&src=nldne
HIV kills people. Sure enough. HIV “Medications” kill people, too, and make a lot of money while they do. That’s sure enough, too. But what if the rumors circulating that the “HIV Virus” is not the causative factor in HIV/AIDS are true? What if HIV is another political tool, manufactured in the biological weapon laboratories of the US and its insane allies in bio-engineered death? And what if the proof were presented to you.
What would you do?
Where would you take that information?
If you continue reading, you may have to confront those decisions.
I hope you do continue reading.
Then let’s talk.
Write to us at dr.laibow@gmail.com with “HIV SCAM” in the subject line and let’s figure out collectively where to go from here.
And if you don’t think for a moment that this battle will take resources, think again.
So I am asking you to include in the email you send some suggestions for resources: human time (volunteer, research assistance, writing, website, etc.), financial resources (donations, fund raisers), dissemination strategies, resources to bring to the table (scientists, organizers, musicians, etc.).
You can donate to the Natural Solutions Foundation at http://drrimatruthreports.com/?page_id=189. All US donations are tax deductible.
Spread the word and ask everyone you know to join the Health Freedom eAlerts, http://drrimatruthreports.com/?page_id=187, for up to the minute information and Action Items.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.NaturalSolutionsFoundation.org
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www.GlobalHealthFreedom.org
www.Organics4U.org www.NaturalSolutionsMarketPlace.org”>www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
THE AIDS APOSTATES
Anthony Brink
“To overturn orthodoxy is no easier in science than in philosophy, religion,
economics, or any of the other disciplines through which we try to
comprehend the world and the society in which we live.”
Ruth Hubbard US biologist b.1924
Considering how AIDS saturates our public discourse, galvanises our
politicians, thrills our gee-whiz journalists, inspires our musicians,
worries our clergy, agitates our AIDS-activist lawyers, perturbs the judges
of even our highest court, engages the South African Law Commission’s
energies in cooking up imaginative new bills, dominates our medical research
effort, infuses exciting new relevance into tired careers in virology
departments, and siphons off our tax rands into the pockets of our condom
missionaries and ‘AIDS counselors’ proselytizing indefatigably to a stubborn
public, your regular guy might be excused for believing that our country and
the world were in the throes of a dire public health crisis, a new Black
Death, and for thinking that the fact of it was as certain as any in science
about which there obtains a universal consensus.
In fact, hundreds of scientists of the highest rank disagree with the
HIV-AIDS causation hypothesis. They think ‘AIDS’ as a medical construct is a
passing fad, a fashionable new name for age-old ills, and that boiled down,
AIDS is just money spinning political kitsch. In their most assiduous
dissents they emphasize that ‘HIV’ has never been isolated under the
well-settled rules for viral isolation, assert that ‘HIV’ has never been
shown to exist as an infectious entity of exogenous origin, and demonstrate
that every protein claimed uniquely to be constituent of ‘HIV’ is actually
cellular, not viral – in other words, that all HIV-positive test results are
false positives. In short, they consider the HIV-AIDS paradigm a scientific
blunder of biblical proportions, and its experts foolish quacks. These AIDS
dissidents include professors emeriti at the pinnacle of their specialities
in cell-biology, virology and related fields. They also include leading
mathematicians, actuaries, and law and history professors. Among them are
two exceptionally distinguished Nobel laureates in our time, Walter Gilbert
(Chemistry 1980), and the Einstein of modern biology, Kary Mullis (Chemistry
1993).
Dr Peter Duesberg, professor of cell-biology, University of California at
Berkeley, member of The National Academy of Sciences: Before Duesberg’s
wrecking-ball challenge to Gallo’s HIV-AIDS theory was published as an
invited paper in the prestigious journal Cancer Research in 1988, Gallo had
observed, “No one knows more about retroviruses than Peter Duesberg.” Once
acclaimed as a widely published and extensively cited Nobel candidate, but
now ‘delegitimated’ as a scientist, Duesberg was the recipient of the
largest annual research grant in biology for years – awarded for the pursuit
of whatever avenue of scientific enquiry took his fancy. Stripped of his
grant and his post-graduate classes, practically barred from researching and
publishing, and reduced to chairmanship of his faculty’s annual picnic
committee, he continues to point out the fundamental anomalies, deficiencies
and paradoxes of the 15 year old theory that the 29 old diseases renamed
AIDS in the presence of HIV antibodies could have any causal link to a
retrovirus. However, Duesberg finds himself increasingly alone in the AIDS
dissident camp too, eclipsed by Eleni Papadopulos-Eleopulos et al (below)
whose more fundamental tack in impeaching the HIV-AIDS theory is winning
over its best heterodox scientists, most recently, Kary Mullis (below),
pathology and epidemiology specialist Gordon Stewart (below), and Etienne de
Haarven, pathology professor emeritus at Toronto, renowned for his published
work in the electron photomicrography of viruses.
Eleni Papadopulos-Eleopulos, bio-physicist, department of medical physics,
Royal Perth Hospital, Australia: Collaborating with, among others, John
Papadimitriou, a practicing pathologist and professor at University of
Western Australia’s medical school, David Causer, senior physicist, head of
the department of medical physics and professor at Royal Perth Hospital, and
Valendar Turner, consultant emergency physician at the Royal Perth Hospital,
Papadopulos-Eleopulos has raised the most radical and dramatic challenges to
the HIV-AIDS theory, by highlighting the lack of a proper gold standard for
the HIV antibody tests, in that unlike other known viruses, HIV has never
been isolated according to the classical procedure for the isolation of
viruses, often referred to as the Pasteur Rules.
Dr Walter Gilbert, formerly molecular-biology professor at Harvard: One of
contemporary science’s most outstanding and accomplished scientists, Gilbert
won his Nobel for inventing the now foundational modern technique for DNA
sequencing. He considers Duesberg to be “absolutely correct in saying that
no one has proven that AIDS is caused by the AIDS virus. There is no animal
model for AIDS, and without an animal model, you cannot establish Koch’s
postulates (to prove the role of the suspected pathogen).” He observes, “The
community as a whole doesn’t listen patiently to critics who adopt
alternative viewpoints. Although the great lesson of history is that
knowledge develops through the conflict of viewpoints.”
Dr Kary Mullis, molecular biologist: Nobel winner Mullis’ watershed
invention of the Polymerase Chain Reaction technology for amplifying minute
DNA fragments for identification has so revolutionised biology that one
might fairly speak of two epochs, the dark ages before and the enlightenment
after it. He deplores the misapplication of his invention to measure “HIV
viral load.” He predicts that, “Years from now, people will find our
acceptance of the HIV theory of AIDS as silly as we find those who
excommunicated Galileo.” Endorsing Duesberg’s rejection of the orthodox
model of infectious AIDS, he says, “As applied, the HIV theory is
unfalsifiable, and useless as a medical hypothesis… I can’t find a single
virologist who will give me references which show HIV is the probable cause
of AIDS. If you ask…you don’t get an answer, you get fury.” The HIV-AIDS
hypothesis, he thinks, is “one hell of a mistake.”
Dr Harry Rubin, retrovirologist, professor of molecular biology, University
of California at Berkeley, member of National Academy of Sciences: “I don’t
think the cause of AIDS has been found. I think (that in) a disease as
complex as AIDS…there are likely to be multiple causes. In fact, to call it
a single disease when there are so many multiple manifestations seems to me
to be an oversimplification.”
Dr Richard Strohman, emeritus professor of cell-biology, University of
California at Berkeley: The HIV-AIDS hypothesis is “bankrupt.”
Dr Beverly Griffin, director and professor of virology, Royal Postgraduate
Medical School in London: “I do not believe HIV, in and of itself, can cause
AIDS.”
Dr Gordon Stewart, emeritus professor of epidemiology, University of
Glasgow, and former AIDS advisor to the World Health Organisation: “AIDS is
a behavioural disease. It is multifactorial, brought on by several
simultaneous strains on the immune system – drugs, pharmaceutical and
recreational, sexually transmitted diseases, multiple viral infections…
there is no specific etiologic agent of AIDS… the disease arises as a
result of a cumulative process following a period of exposure to multiple
environmental factors… Nobody wants to look at the facts about this
disease. It’s the most extraordinary thing I’ve ever seen. I’ve sent
countless letters to medical journals pointing out the epidemiological
discrepancies and they simply ignore them. The fact is, this whole
heterosexual AIDS thing is a hoax.”
Dr Albert Sabin, discoverer of live-virus polio vaccine, National Institutes
of Health: “The basis of present action and education is that everybody who
tests positive for the virus must be regarded as a transmitter and there is
no evidence for that.”
Dr Bernard Forscher, former managing editor of the journal, Proceedings of
the National Academy of Sciences: “The HIV hypothesis ranks with the ‘bad
air’ theory for malaria and the ‘bacterial infection’ theory of beriberi and
pellagra (caused by nutritional deficiencies). It is a hoax that became a
scam.”
Dr Simon Wain-Hobson, immunologist, Institut Pasteur, France: “… an
intrinsic cytopathic effect of the virus (HIV) is no longer credible…”
Dr Alfred Hassig, immunologist, former emeritus professor of immunology,
University of Bern, and former director of a Swiss blood transfusion
laboratory: “The sentences of death accompanying the medical diagnosis of
AIDS should be abolished.”
Sir John Maddox, editor, Nature Magazine: “(Luc) Montagnier said clearly
what he meant. HIV (alone) is… not… a sufficient cause of AIDS.”
Dr Fabio Franchi, specialist in infectious diseases and preventive medicine,
Trieste, Italy: “I am not an agnostic. I am well convinced HIV is harmless.”
Dr Charles Thomas, former professor of molecular biology at Harvard and
Johns Hopkins universities: “It is widely believed by the general public
that a retrovirus called HIV causes the group of diseases called AIDS. Many
biomedical scientists now question this hypothesis. We propose that a
thorough reappraisal of the existing evidence for and against this
hypothesis be conducted by a suitable independent group.” He himself has no
doubts. He rejects the HIV-AIDS hypothesis as a “fraud”.
Dr Phillip Johnson, senior professor of law, University of California at
Berkeley: “The establishment continues to doctor statistics and misrepresent
the situation to keep the public convinced that a major viral pandemic is
under way when the facts are otherwise.”
Dr Serge Lang, professor of mathematics, Yale University and member of the
National Academy of Sciences: “There does not even exist a single proper
definition of AIDS on which discourse or statistics can reliably be based…
the CDC calls these diseases AIDS only when antibodies against HIV are
confirmed or presumed to be present. If a person tests HIV negative, then
the diseases are given another name… I do not regard the causal relationship
between HIV and any disease as settled. I have seen considerable evidence
that highly improper statistics concerning HIV and AIDS have been passed off
as science, and that top members of the scientific establishment have
carelessly, if not irresponsibly, joined the media in spreading
misinformation about the nature of AIDS.”
Dr Joseph Sonnabend, South African born New York physician: “The marketing
of HIV, through press releases and statements, as a killer virus causing
AIDS without the need for any other factors, has so distorted research and
treatment that it may have caused thousands of people to suffer and die.”
Dr Harvey Bialy, editor of the science journal Nature Bio/Technology: “From
both my literature review and my personal experience over most of the AIDS –
so called AIDS centres in Africa, I can find absolutely no believable
persuasive evidence that Africa is in the midst of a new epidemic of
infectious immunodeficiency.”
Dr Charles L. Geshekter, professor of African History, California State
University: … From “Cameroon to California, sex education must no longer
be distorted by terrifying, dubious misinformation that equates sex with
death… African poverty, not some extraordinary sexual behavior, is the
best predictor of AIDS-defining diseases… A 1994 report in the Journal of
Infectious Diseases concluded that HIV tests were useless in central Africa,
where the microbes responsible for tuberculosis, malaria, and leprosy were
so prevalent that they registered over 70% false positive results…in
people whose immune systems are compromised for a wide variety of reasons
other than HIV…”
Dr Hiram Caton, ethicist, head of the School of Applied Ethics at Griffith
University, Brisbane, Australia: “The AIDS epidemic was a mirage
manufactured by scientists who believed that integrity could be maintained
amidst the diverting influences of big money, prestige and politics.”
Dr Ralph Moss: author of The Cancer Industry: “The paradigm that was laid
down for how to milk the cancer problem is basically the same paradigm which
is being followed in milking the AIDS problem.”
Dr Frank Buianouckas: professor of mathematics, Bronx New York: “I suspect
everything involved in this AIDS epidemic. If HIV causes anything, it
certainly causes fund-raisers. It sells stocks. It supports dances. It sells
condoms. And it keeps the AIDS establishment going.
http://aidsinfobbs.org/apostates.html