This is a special letter from friend and health freedom supporter Dr. Leonard Coldwell. His thirst for knowledge and love of freedom impelled him to ask if we would make this information available to the supporters of Natural Solutions Foundation. Please read this letter and consider it carefully.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
Dear Natural Solutions Foundation Supporter,
Thank you for being a loyal friend to health freedom!
As you know, I’m a very passionate person and burst at the seams to share information that I believe can benefit you. Today, I’m going to share information with you that can be life-changing if you take immediate decisive action.
If you’re lucky, maybe once in your lifetime, a day will come where you will have the chance to get in on the ground floor of a moneymaking opportunity that can almost guarantee your success!
Today is that day.
In 1996, a good friend of mine launched a multi-level marketing business opportunity.
The company was publicly traded on NASDAQ with a stock price of just 50 cents. In about 18 months, an estimated 200,000 people joined him in this MLM program. Gross sales exceeded $250,000,000. The stock price went to $35.
Many people that joined with him in the beginning made millions. I bet you wish you were one of the lucky people he invited to join him at the very beginning of that amazing launch.
I am writing to you now to announce that he’s doing it again!
This time, he and over 30 of his very wealthy friends from around the world, are launching a brand new ground floor opportunity of a lifetime…The Global Information Network (GIN).
The Global Information Network is a private exclusive club. It is a members-only organization. I’m a member and it is by invitation only. It helps its members create wealth and financial freedom.
I’m personally inviting you to join and become a member of The Global Information Network.
This private member-only organization can help you achieve wealth and have, be or do everything and anything you’ve ever desired.
The benefits of membership include an online, members-only library of written materials, audios and video information. There are virtually hundreds of thousands of dollars worth of training materials available for free to all members.
Members also have access to dozens of workshops, seminars, retreats, summits, symposiums and meetings that are put on all over the world. At these meetings, you can learn how to make money in real estate, investing, home-based businesses and a variety of other wealth creation topics. As a member, you will gain access to these exclusive private events (many that I personally speak at) absolutely free.
Members also have the benefit of networking with other members from around the world.
You can check out all the member benefits by going to…
https://www.globalinformationnetwork.com/Member-Benefits
For the first time in history, an opportunity of this type is being launched all over the world at the same time.
This is totally ground floor. This is brand new. You are among the very first people to be hearing about this. Already in just the last few months, people have joined as members of the Global Information Network in over 100 countries. Those who get in on the ground floor of these types of opportunities are said to have the chance to make the most money. I got in and I hope you do the same.
The benefits of becoming a member are beyond your wildest imagination. The “confidential” moneymaking component that is part of the Global Information Network is unique and groundbreaking in every respect.
90 days from today you could be making more money than you ever imagined.
This is the most revolutionary membership organization and moneymaking opportunity I’ve ever seen. Nothing like this has ever been done before. It has a multi-level marketing twist that could make this the fastest growing organization of its kind, of all time.
The most amazing part of this system is that you never have to bug friends, relatives, neighbors or coworkers. In fact, you virtually never have to talk to anyone. You could potentially make hundreds of thousands of dollars in your underwear, without ever leaving your house.
Remember, this just started a few months ago. I have met with members all around the world. I even personally appear and speak at Global Information Network meetings. This is the real deal. That’s how much I believe in it. You can get in at the beginning of the beginning like I did. This is a totally ground floor once in a lifetime opportunity.
I believe millionaires will come out of the GIN membership faster than any other organization of its kind…ever.
In just the last few months, people are already making huge money. One member made over $148,200 his first month and $288,600 in his second.
This is real and happening now.
I am personally inviting you to join and become a member of the Global Information Network. Remember membership is by invitation-only.
This membership invitation is only valid until April 30, 2010 You must go to www.globalinformationnetwork.com and submit your application no later than April 30th 2010 to be accepted. You must use affiliate code: USAFreedom
Don’t miss this once in a lifetime chance to get in on the ground floor launch of a major global moneymaking opportunity that can help you make more money than you ever imagined.
As a member of the Global Information Network, you could be making more money each month than most people make in a whole year.
You could be potentially developing a permanent monthly residual income. You could achieve financial freedom and independence. Imagine making $5000, $10,000, $20,000 or even $50,000 per month, without ever leaving your home.
This is not a get rich quick scheme and there are no guarantees. Review all the information for yourself. Go to www.globalinformationnetwork.com.
Read all the information on the website.
Listen to the audios on the website. They explain it all. You will understand what I’m talking about and why I’m so excited. It will only take a few minutes and you will thank me a thousand times.
The membership benefits of the Global Information Network are something that up until now has been reserved for the privileged elite class.
The moneymaking component of the Global Information Network is simple, powerful and it works.
Go to www.globalinformationnetwork.com right now. Submit your membership application today. You must use affiliate code USAFreedom and you must sign up by April 30th 2010
Once you sign up as a member, you will learn exactly how one member made over $400,000 in 90 days. What he did was simple. You will learn you how he did it.
Plus, if you join by April 30th 2010 you will get a free ticket (worth $5000) to attend a special one-day seminar, taught by my friend Kevin Trudeau, entitled “How Anyone Can Make Millions: The Moneymaking Secrets They Don’t Want You to Know About.” The seminar will be held on May 8th in Chicago. He will share exactly what he did to generate over 3 billion dollars in sales worldwide. These are moneymaking secrets he has never revealed before. If for some reason you cannot attend the event live, I will have him send you the audio recording of the event, so you can still get all the information presented.
Become a member of the Global Information Network today and start making all your dreams come true.
You are a champion! You can do it!
Dr. Leonard Coldwell
Information from www.globalinformationnetwork.com Referral Code: USAFreedom
PS: One more thing:
If you upgrade from an “Affiliate” to a full Global Information Network “Member,” before April 30th, you will get a virtually all-expense paid exotic trip to our upcoming Winter Leadership Weekend AND qualify for $5,000.00 in cash money.
On top of that, you will get an additional $4,500.00 in instant bonuses. This is a total value of over $10,000.00.
This is all part of our April Advantage Membership Drive and it’s our way of supporting the Natural Solutions Foundation and www.HealthFreedomUSA.org!
To learn more about the FREE Weekend Leadership Weekend, as well as the $5,000.00 cash incentive and more, please listen to an exclusive audio presentation by Mr. Kevin Trudeau by clicking on the button labeled “Get a free trip and $5000 cash” at www.GlobalInformationNetowrk.com.
To upgrade to a “Member,” (or to sign up ) all you have to do is…
1.Sign into your affiliate account here. Use referral code: USAFreedom
2.Go to the “Become a Member” link (on the left-side menu) and follow the directions.
Remember, to get all the special incentives, you have to upgrade to a full Global Information Network member by April 30th, 2010.
This offer will promptly expire on April 30th, 2010. If you were planning on joining or want to take advantage of over $10,000.00 in special incentives, this is the best time to join.
We hope to see you at an upcoming exclusive “Members-only” meeting.
Dr. Leonard Coldwell for The Global Information Network Council
PPS: I am so excited about all the possibilities that I can offer my patients and friends with the Global Information Network. You get all Seminars for FREE. You get a Free Membership to www.naturalcures.com Free access to all the information and Seminars on their website. Plus you have the opportunity to meet like-minded people. Do business together or to make a lot of money to help other people etc etc., etc.
Dr Leonard Coldwell – Author of: “The Only Answer to Cancer”
Urgent Action Step: Click Here (http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275) to Demand the Right to Self Quarantine in the Event of a Pandemic
Click here (http://drrimatruthreports.com/?p=2752) to read the Natural Solutions Foundation’s White Paper on Self-Quarantine.
Click here (http://drrimatruthreports.com/?p=2698) to read the Natural Solutions Foundation’s suggestions for safe and effective self-quarantine in case you are actually either infected with something that might make you sick or presented with the choice of vaccination or self-quarantine.
Bear in mind, however, that the genetically engineered, weaponized Swine Flu might, as of today, according to the CDC currently be infecting as many as 100,000 Americans. What kind of pandemic is that? An organism which is infecting hundreds of thousands of people who have no symptoms, virtually no deaths (and no reason to believe that those deaths ascribed to the organism are, in fact, associated with it) is not something to vaccinate against. In order to even halfway justify calling these events a “Pandemic”, the World Health Organization changed the meaning of “Pandemic” from a widespread communicable disease condition to which people have no previous immunity and which causes widespread disease and death to, well, uh, er, a disease which is transmitted from one person to another in more than two regions of the globe but without necessary disease consequences of any significance. But which may come back more unpleasantly this fall, JUST when we have a new vaccine ready which people will be forced to take so they can be protected against a disease which just about nobody dies from and which has never been shown to be a health threat of any major consequence anywhere in the world.
In fact, to make it clear just how little credibility the CDC, WHO and vaccine mafia actually have, it is worth remembering what the MMD, the Media of Mass Deception, appears to have totally forgotten: dying from Swine Flu may actually be good for your health if you are Mexican because of the 168 people confirmed dead of H1N1 Swine Flu by the US CDC, 152 of them came back to life in a miracle of biblical proportions.
Clearly, the rush to vaccinate, and to create a “Pandemic” is a political and economic one, not based on any public health threat whatsoever.
I believe that the real danger from this weaponized agent is the possibly lethal impact of the vaccine which will be presented to you and those you are responsible for along with the political danger of loss of liberty in the mad rush to “safety” from this non-pandemic pandemic. The other danger, of course, is what will happen to people who are quarantined in internment camps and what will happen to people who live through the events which will inevitably surround the creation of a phony “Pandemic” with all its attendant militarization and abusive controls.
This outstanding article which follows by William Engdahl makes a number of important points. The rush to mandatory vaccination Swine Flu, in the UK, France, Massachusetts, NY and elsewhere for Swine Flu, a disease which may not even exist (read on!), is madness.
Vaccines are extremely dangerous. No insurance company in the world will insure against the risks inherent in vaccination and they are, in fact, characterized as uninsurable risks which a special US fund (paid for by vaccine recipients) has paid out over 2billion dollars from to parents of children killed or maimed by vaccinations. The vast majority of vaccine damage are never compensated. The US Government has removed all potential liability from vaccine manufacturers making them totally invulnerable to legal repercussions for the dangerous and often deadly products they produce and sell at enormous profits.
In fact, vaccines are explicitly acknowledged not to protect against the diseases they supposedly are designed to prevent (read the Package Inserts for vaccines, available on line and in your doctors’ offices if you doubt that) and often to result in the very disease to which they are supposed to make you immune.
Vaccines are,however immensely, enormously and hideously profitable, however and so the Pharmaceutical Cartel, with virtually limitless amounts of money to bribe legislators and regulators (pretty inexpensive, all in all) and buy science (moderately expensive), public opinion (about 4 billion dollars a year) has bought for itself and its deadly products a respectability it does not deserve for products which should, in a rational society, be banned forever.
Vaccines are not automatically either safe or effective. In fact, they have never been scientifically found to be either safe OR effective. For that reason, the Natural Solutions Foundation has submitted a Citizens Petition (a law suit against the Government) to the Federal Trade Commission to compel them to prohibit advertising across state lines or via other channels which they control which suggests or implies that vaccines and their components have been found to be safe, effective or both.
Public health is, as William Engdahl points out, being militarized. But the Natural Solutions Foundation believes that forced vaccination, like forced drugging, is both wrong-headed and enormously dangerous. We therefore ask you to join us in urging decision-makers to rescind their dangerous, potentially lethal, rush to compulsory vaccination and involuntary quarantine for those who refuse vaccination with the far saner, safer and infinitely more freedom-saving
option of self quarantine. Instead of being forcibly detained for an indefinite period, self-quarantine allows you to protect yourself while staying at home, eating foods you have stockpiled for such an eventuality in your own surroundings, able to communicate with friends, family, etc.
Lawmakers in the US have already decided that in the event of a pandemic like the one that the World Health Organization says it is about to declare for the absurd and possibly non-existent “H1N1 Swine Flu” that you will be required to take whatever vaccine they throw at you or face incarceration under both the Emergency Medical Powers Acts passed by virtually every State AND the Patriot Acts I, II and II plus BARDA at the Federal Level.
The Natural Solutions Foundation believes that self quarantine, also known as “self-shielding”, is a much better, safer and well-regarded method for protecting both groups of people and individuals which you should have the right to select if you do not wish to be either vaccinated or incarcerated. We therefore urge you to take the following action step to inform decision makers and legislators of your strong desire to be permitted to use self-quarantine strategies by clicking Here (http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27275).
This novel option is both logical and time tested in other epidemic situations. The Natural Solutions Foundation is once again providing innovative solutions to the serious problems facing us around our health and our health freedom. Please take a moment to click here (http://drrimatruthreports.com/?page_id=189) to set up a recurring tax deductible donation to help keep the Natural Solutions Foundation active and working for you.
We appreciate our freedoms and appreciate your help in making it possible for the Natural Solutions Foundation to keep on keeping health freedom alive.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
Sarkozy’s Secret Plan for Mandatory Swine Flu Vaccination
F. William Engdahl, Global Research
June 3, 2009
The French Government is developing secret plans to impose mandatory vaccination of the entire French population, allegedly against possible Swine Flu disease according to reports leaked in a French newspaper. The plan is without precedent and even defies recommended public health advice. Pharmaceutical giants benefit from the move, as the Swine Flu increases the trend to militarization of public health and use of needless population panic to advance the agenda.
The Sarkozy government has authorized spending of an estimated €1 billion to buy vaccines allegedly to combat or protect against H1N1 Swine Flu virus.
According to a report in the May 30 edition of the French newspaper, Le Journal du Dimanche, the Sarkozy government has authorized spending of an estimated €1 billion to buy vaccines allegedly to combat or protect against H1N1 Swine Flu virus. The only problem is that to date neither the WHO nor the US Government’s Center for Diseases Control (CDC) have succeeded to isolate, photograph with an electron microscope and chemically classify the H1N1 Influenza A virus. There is no scientifically published evidence that French virologists have done so either. To mandate drugs for a putative disease that has not even been characterized is dubious to say the least.
Even more bizarre is the admission by the US Government’s Food & Drug Administration, an agency responsible for health and safety of its citizens, that the ‘test’ is approved for premature release to test for H1N1 is not even a proven test. More to the point, there is no forensic evidence in any of the deaths reported to date that has been presented that proves scientifically that any single death being attributed to H1N1 Swine Flu virus was indeed caused by such a virus. European epidemiologists believe the deaths reported to date are ‘coincidental’ or what are called opportunistic infections.
What we know conclusively is that the people who died often had prior respiratory complications of an undisclosed nature. People die every day with respiratory diseases. In the USA alone some 36,000 flu-related deaths are recorded yearly with no undue panic or alarm. Most are elderly or patients with lung diseases. To date in all France, 24 people have been identified by health authorities as even having ‘symptoms’ of H1N1. It is worth noting that the WHO and CDC list the symptoms of H1N1: temperature, coughing, headache, runny nose. Hmmmmm. Do you know anyone with such Swine Flu symptoms? Also worth noting is that in the counting of the more than 15,000 ‘confirmed’ H1N1 Swine Flu cases worldwide the vast majority made miraculous recovery within three to seven days, just as in the case of a bad cold.
The goal: Militarization of Public Health
Increasingly it is becoming clear that the successive waves of mass panic created in recent years by CDC, WHO and leading government agencies has an ulterior motive. We have been hit with mass panic over eating beef when cattle in the UK and elsewhere developed fatal illness that was called BSE or ‘Mad Cow’ disease. Later evidence emerged that BSE was the result of vaccination of the cows to kill harmless insects that got under the animal’s skin. More recently, after reports of incidence of what is called ‘Blue Tongue’ disease in cows, sheep and goats in Belgium and Holland in 2006, animal veterinary authorities in Germany, Switzerland and Austria imposed mandatory vaccination or treatment with drugs allegedly to protect the animals from bites by insects allegedly carrying the usually harmless illness.
The vaccinations of the animal herds has been made mandatory for an illness that typically was so mild as to go unnoticed and in only extreme rare cases could be tied to death. All animals after three months must be vaccinated. The vaccines, according to a report in the Swiss publication Aegis-Impuls from 2008, resulted in mass deaths, decreased birth rates, decline in milk yields, heart attack and other severe effects. The vaccines were used despite the fact none apparently had been previously certified as safe. They typically contained aluminium hydroxide and Thiomersol or mercury, as adjuvants and or preservatives, both highly toxic and both also used in most human vaccines.
Despite mass protests and reports to the veterinary authorities in Germany, Switzerland and Austria, the warnings went unheeded and mandatory mass vaccinations continued. Little wonder that farmers are taking their tractors to the streets to protest.
The report of a secret French government plan to vaccinate every French citizen over three months of age, over 100 million doses, is more than alarming. According to the French Le Journal du Dimanche, anticipating a probable return of the virus in the fall, the government will spend nearly a billion euros to buy vaccines. Authorities will announce in the fall if they decide to make the vaccine mandatory. “We will be ready to go in a very short time”, explains the Minister of Health. According to sources, the state wants to order 100 million doses of flu vaccine from three laboratories, GlaxoSmithKline, Sanofi and Novartis. The latter two are French companies.
The French report comes just after the State of Massachusetts State Senate passed a mandatory vaccination bill that authorizes mandatory vaccination against purported H1N1 Swine Flu. In New York State the state hospital planning authority is debating making mandatory annual vaccination against flu of all public health employees, despite the fact that no approved vaccine for H1N1 exists. More and more it is beginning to appear that the scare about pandemic from flying birds or flying pigs is an excuse to justify mandatory vaccination with substances whose harmful side effects are demonstrably worse than any flu they should guard us against.
Novavax, a US pharmaceutical company based in Rockville, Maryland, conveniently enough just announced it is developing a vaccine for H1N1 based on “virus-like particles” that contain three key proteins of the flu virus without the genes required for replication. The vaccine is produced by techniques of genetic modification of organisms or GMO. The announcement came within days of the company announcing losses for the fiscal year of $36 million.
The drug Tamiflu which is officially recommended by the WHO as treatment to ‘ameliorate’ the symptoms of possible Swine Flu or H1N1 Influenza A as it has been renamed, is itself highly toxic. Health Canada informed Canadians of international reports of hallucinations and abnormal behavior, including self harm, in patients taking the antiviral drug Tamiflu. In some cases death was the result and severe lung complications are widely reported associated with Tamiflu, the drug whose main financial benefactor is believed to be its largest stockholder, former Defense Secretary Donald Rumsfeld.
In 1976 in the US President Gerald Ford, nervous about winning a close election ordered mass immunization of the population in the face of a possible pandemic to show voters he was a ‘hands on’ President. The 1976 pandemic never came but a vast number of people suffered serious neurological side effects from the vaccine that was rushed into production, including 25 reported deaths from Guillain-Barré syndrome.
Mandatory vaccination with drugs whose side effects are unknown because they have not been rigorously and independently tested begins to smack of the kind of inhuman mass human experiments carried out in the United States with mentally retarded, prisoners and other disadvantaged people or in Germany during the 1930’s.
URL to article: http://www.infowars.com/sarkozys-secret-plan-for-mandatory-swine-flu-vaccination/
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
www.HealthFreedomUSA.org
www.NaturalSolutionsFoundation.org
www.ValleyoftheMoonCoffee.org
www.GlobalHealthFreedom.org
www.Organics4U.org www.NaturalSolutionsMarketPlace.org”>www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
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