News Target a obtenu des
documents de la FDA
(Food and Drug Administration)
et d'autres sources qui révèlent:
la FDA était tout à fait au courant depuis plusieurs années que le Virus Papilloma humain (HPV) n'a AUCUN lien direct avec le cancer du col.
|NewsTarget.com a aussi appris qu'il a été prouvé que le vaccin contre le HPV n'avait aucune valeur pour enlever le virus HPV des femmes qui avaient déjà été exposées au HPV (et qui incluent la plupart des femmes sexuellement actives), remettant ainsi en question la justification scientifique de la politique de "vacciner obligatoirement tout le monde". |
Cette histoire révèle l'évidence: le vaccin GARDASIL (de Merck, la même firm produisant le mortel vioxx) couramment administré pour le HPV peut augmenter le risque de lésions précancéreuses du col de l'utérus à un taux ALARMANT de 44,6% chez certaines femmes.
Il s'avère que le vaccin peut être de loin PLUS dangereux pour la santé des femmes que de ne rien faire. Cette information révèle des détails sur une énorme fraude à la santé publique qui est pérpétrée sur le peuple américain, incluant les responsables de la FDA, les promoteurs des industries pharmaceutiques et même les gouverneurs de certains états comme le Texas.
Près de 200 écolières de l'État de Victoria ont été touchées et 10 jeunes filles ont été admises à l'hôpital après évanouissement ou effondrement suite à l'injection de Gardasil.
Les experts chargés de conseiller les services de santé pour la mise sur le marché de tel ou tel médicament sont presque tous salariés des laboratoires fabriquant (pour le GARDASI® les deux experts John Bosnego et Alan Show étaient des biologistes employés par le laboratoire fabriquant le vaccin).
|2 Septembre 2006
Arrestation de Duilio Poggiolini membre influent des instances européennes du Médicament
|À l'étranger, un énorme scandale a dénoncé la corruption organisée par les laboratoires, prouvant ainsi qu'ils sont prêts à tout pour vendre leur marchandise. En effet, en 1991, Francesco de Lorenzo, ministre italien de la santé, a touché de nombreux pots-de-vin de plusieurs laboratoires, dont SmithKline Beecham . Le Président de cette firme, qui fabrique le vaccin anti-hépatite B, a avoué avoir donné au ministre 600 millions de lires quelques mois avant que ce dernier rende la vaccination obligatoire dans son pays. Francesco de Lorenzo a été inculpé et condamné à plusieurs années de prison ferme, ainsi que Paolo Cirino Pomicino, ancien ministre du Budget, et le Pr. Duilio Poggiolini, membre influent des instances européennes du Médicament, qui fut aussi à la tête de la Direction du médicament dans son pays et Président de l'Ordre des médecins.
Plus d'une soixantaine d'autres membres tout puissants du ministère de la Santé ont également été condamnés pour diverses fautes graves que le Giornale per la protezione della salute (n° 6, mars 1998) qualifi ait de « pratiques mafi euses ». Ce qui n'a pas empêché certains d'entre eux de revenir plus tard dans les coulisses des ministères.
Extrait de Sylvie Simon
|arrestation 2005 éxecution 2007
Arrestation de Zheng Xiaoyu ancien ministre du médicament
|L'ancien directeur de l'Administration d'Etat de l'alimentation et des médicaments en Chine, Zheng Xiaoyu, qui avait rang de ministre, a été exécuté mardi pour corruption, a annoncé l'agence Chine Nouvelle.|
Zheng, 62 ans (Bien: 62 ans), condamné fin mai, a été exécuté après le rejet par la Cour suprême de son appel, a précisé l'agence.
Il avait été reconnu coupable d'avoir touché 6,4 millions de yuans (620.000 euros) de pots-de-vin d'entreprises pharmaceutiques.
Zheng Xiaoyu avait été limogé en juin 2005 après huit ans à la tête de l'Administration de l'alimentation et des médicaments (SFDA), où il avait mis en place un système d'autorisation des médicaments particulièrement controversé.
Merck Committed Scientific Fraud in Delays, Distortions of Vytorin Drug Trial (opinion)
THE MASKING AGENT: DOCTORS
DECEMBER 29, 2004.
As a lot of people finally know, the FDA is completely unreliable when it comes to certifying drugs as safe and effective.
The agency is powerless to compel drug companies to run extensive surveys of patients' reactions after drugs have been approved.
The FDA's own system, which fields doctor and patient reports of adverse drug events, is broken. It was always broken.
But doctors shoulder a lot of the blame. After they prescribe a drug, if a patient comes back in with a complaint, the usual MD response is, "Oh you're not feeling that because of the drug. The drug is good."
At that point, a gullible patient is stymied.
Do you see where all these vectors are going? The patient, the person, has to make up his own mind about drugs.
Safe? Not safe? Effective? Not effective?
No nanny is going to do that for us.
It's pretty simple. If there are 13 people who are supposedly responsible for X, and you are one of those people, in this situation you can't trust the other 12.
If I had a dollar for every email I've gotten containing the phrase "my doctor said it was okay but it wasn't," I'd be in the South Pacific right now on a new yacht.
Most doctors don't study drug studies. Most doctors don't read drug studies. Most doctors don't consider that a great many of these studies are built on lies. Most doctors don't know or care that drug studies showing devastating effects of the drugs are often buried, not published, by the drug companies. Most doctors pretend that salesmen from drug companies know what they're talking about. An alarming number of doctors sell their souls and their patients' health for a few free key rings and free samples and vacation-conference perks doled out by drug companies.
JON RAPPOPORT nomorefakenews.com
CDC IS A DESPERATE AGENCY
FEBRUARY 22, 2005. Almost 20 years ago, while I was writing my first book, AIDS INC., I discovered the existence of so-called quackbuster groups.
These outfits were formed around the premise that medical alternatives to the mainstream were frauds.
So I phoned one group and told their representative I was prepared to send him evidence that HIV did not cause AIDS.
I briefly ran down the sources I had.
He was a bit puzzled. Finally, he said, "That's not the sort of thing we look into."
"We focus on other areas."
And that was that.
The conversation reminds me of the fix the CDC is in these days. What do they have to work with? The bald unproven assertion that one or two people have died from a new fast-acting super-strain of HIV? The idea that a new flu is brewing in Asia that will kill us all? After 40 people, globally, MAY have died from this flu?
Meanwhile, as the FDA scandal over the approval of dangerous and toxic drugs builds, as more and more mainstream media outlets calmly mention that about 100,000 people in the US die every year from the (correct) administration of medical drugs, the CDC is silent about the DISEASE THESE DRUGS ARE INDUCING IN THE POPULATION.
Can you imagine the level of warning and hysteria at the CDC if some flu bug were killing 100,000 people in the US every year like clockwork?
And what about the illness being caused by nutritional deficiency?
What about the deterioration of topsoil?
What about huge numbers of US soldiers in the last three wars coming back to the US with terrible illnesses? What about depleted uranium?
On these matters, the CDC is silent.
"Not our thing."
"We don't focus on that."
The CDC is, in fact, Germ Central. That has always been its mandate.
Forget the idea that immune deficiency from non-germ causes opens the door to the action of bacteria and viruses.
The CDC has saddled itself with something called EIS, the Epidemic Intelligence Service. This division is made up of doctors who are sent out to investigate reports of clusters of illness wherever they seem to pop up.
In every instance, the strategy is the same. Look for The Germ.
EIS is, in its own way, an example of the phenomenon in physics called the observer effect. What you observe changes by virtue of you looking at it.
In this situation, what the CDC investigates changes according to HOW the EIS doctors look at it.
They are hunters of the germ and only the germ.
Everything else is shunted off to the side.
The CDC is funded by the federal government. It is an agency under the US Public Health Service, which in turn falls under the Dept. of Health and Human Services. HHS, of course, is also funded by the feds.
So essentially we have a government which has decided The Germ is king.
I don't recall any precedent for that in the Constitution.
Here is an interesting sidebar. Among any list you'd care to compile of respected or revered or highly decorated mainstream reporters in America, you won't find one who attacks germ theory as the end-all and be-all of human disease.
This seems to be a clue that the government's position about germs is exactly mirrored in the press.
How did that happen?
Through major PR and propaganda, through intimidation.
A great deal of this PR comes out of the CDC. Which tells you something about the mission of that agency.
As part of the PR, the CDC punches up isolated cases of disease, calling these cases probable or definite instances of new killer germs on the loose.
Get it? It's really very simple.
JON RAPPOPORT www.nomorefakenews.com
MEDICAL RESEARCH FRAUD DOESN'T QUIT
DECEMBER 5, 2004.
Here are several more examples of gross lying and cheating and deception in the medical research/pharmaceutical community that have recently come to light.
This scandal, in all its glory, is busting wide open.
There is no longer any reason to take any drug study at face value. Doctors who remain gullible and purposely blind do so at their own risk and endanger the health and lives of their patients. The entire medical research arena is rotten to the core, and only a fool would believe otherwise. “Studies show…” now means nothing. It means, “We’d better dig very deep to see if these studies are real or faked or represent only a fraction of the real evidence that is out there.” First, a quick excerpt from The New York Times:
THE NEW YORK TIMES
November 30, 2004
Free the Academic Drug Tests
Academic medical centers represent the top rung of medical research in this country and are widely thought to be impartial and independent. So it is disheartening to find them signing restrictive contracts with pharmaceutical companies that allow the companies to dictate what drug testing data can be openly discussed and published. The manufacturers of drugs and medical devices are already under increasing pressure to list all of their clinical trials and results in public databases. Now academic medical centers will need to clean up their own practices to help prevent suppression of information about the safety and efficacy of drugs. The collaboration of academic institutions in industry practices that distort perceptions of important drugs was spelled out by Barry Meier in yesterday's Times ("Contracts Keep Drug Research Out of Reach"). The drug and device industries annually funnel millions of dollars into many medical institutions to pay for clinical trials of their products. The hitch is that contract clauses typically give the company that finances the trials enormous sway over when, how or even if trial results are made public. End of Times snip
The last sentence says it all. The drug company that finances a study of its new drug can decide, after the results are in, how much of the truth to release, if any. The results can be slanted, spun, buried, and what is left after the lying and cheating can be published in any reputable medical journal without a ripple. Here is a recent release on a related issue, from the Alliance for Human Research Protection. AHRP includes an article from AlterNet that backs up its statements. ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness and Full Disclosure
A newly released report by the Center for Disease Control—Health US 2004--reveals how effective the pharmaceutical industry is in marketing its drugs—whether or not they are beneficial; whether or not they cause severe harm--they sell. Antidepressants showed the largest increase in use—preSCRIPTions for children of both antidepressants and psychostimulants soared. See: http://www.cdc.gov/nchs/hus.htm
Confessions by insiders and an examination of the evidence leave little doubt that the that the promoters of these drugs claims are unsubstantiated, that integrity of medicine and the biomedical literature have been systematically corrupted thanks to collaborative efforts of the pharmaceutical industry and their paid prominent academic consultants.
Dr. William Pelham, a leading ADHD researcher for 30 years, is the latest insider to come forward: "In recent years, I have come to believe that the individuals who advocate most strongly in favor of medication – both those from the professional community, including the National Institutes of Mental Health, and those from advocacy groups, including CHADD – have major and undisclosed conflicts of interest with the pharmaceutical companies that deal with ADHD products."
Dr. Pelham was paid by McNeil to conduct one of three studies used to get FDA approval for Concerta, a stimulant prescribed for ADHD. But when the evidence was not favorable, he recounted in an interview with AlterNet, McNeil-Alza engaged in dubious methods to ensure that the published reports would be favorable for Concerta. He said “The company currently uses the three studies to claim that 96 percent of children taking Concerta experience no problems in appetite, growth, or sleep. But Pelham says the studies were flawed… two of the three studies, including Pelham's, required that the subjects had to already be taking MPH and responding well to it in order to enter the study. In other words, by stacking the studies with patients already successfully taking stimulants, McNeil ensured the subjects would be unlikely to register side effects.”
Dr. Pelham notes: "It's really misleading and I'm surprised the FDA is letting them use the studies to advertise no side effects. They had no side effects because they took only people with only a positive history of medication. This is really pushing meds without telling the full picture."
Pressure was also brought to bear to shape Dr. Pelham’s written report: When his paper was in the galley proof stage at the medical journal Pediatrics, Pelham says he joined a conference call with a number of senior people from the corporation who lobbied him to change what he had written in the paper. "The people at Alza clearly pushed me to delete a paragraph in the article where I was saying it was important to do combined treatments (medication and behavioral)." They also pushed him to water down or eliminate other sentences and words that did not dovetail into their interests. "It was intimidating to be one researcher and have all these people pushing me to change the text." In the end, Dr. Pelham says, they published a report with his name penned to it without his authorization.
Last week, the New York Times referred to the pillars of American psychiatry as “data-deprived academic researchers” when caught issuing an unsubstantiated report claiming that antidepressants do not increase the risks of suicide in children. These “data-deprived” researchers represent psychiatry’s elite research establishment—including a former director of the National Institute of Mental Health. The report was issued by the prestigious American College of Neuropsychopharmacology (ACNP)—whose members are by invitation only. Their dominance in psychiatric research practices-- and their influence on practice guidelines and public policy cannot be overstated.
The Alliance for Human Research Protection calls upon medical journal editors to disinfect the scientific literature by putting these authors’ other published reports through rigorous re-assessment—not by the authors’ collegial peers--but by independent scientists. Otherwise journals such as JAMA may be accused of publishing “junk science.”
See: Leo J and Cohen D. Broken Brains of Flawed Studies? Journal of Mind and Behavior, Winter, 2003, Vol 24, pp 29-56, available online at: http://psychrights.org/research/Digest/NLPs/criticalreviewofadhd.pdf
*Dr. David Cohen is a member of the board of directors of AHRP.
Contact: Vera Hassner Sharav
Here, Kiddie, Kiddie
By Kelly Hearn
Posted on November 29, 2004, Printed on December 3, 2004
For Gene Haislip, a former official of the U.S. Drug Enforcement Agency, the perennial debate over Ritalin, the stimulant commonly prescribed for children with "attention deficit hyperactivity disorder (ADHD)," is an aching reminder of a moral battle he fought – and lost – to big drug companies. For 17 years, the now retired director of the DEA´s Office of Diversion Control set production quotas for controlled substances like methylphenidate (MPH), the federally restricted stimulant commonly known as Ritalin. During that time, he fought hard to raise public awareness about over-prescribing of stimulants to children, about the drug's high rate of street diversion, and about its long-term health impact on young patients. "This affects the most sensitive part of our population," says Haislip, now a consultant for drug companies on issues of compliance to federal law. "When I was at the DEA, we created awareness about this issue. But the bottom line is we didn't succeed in changing the situation because this – prescribing methylphenidate, for example – is spiraling. "A few individuals in government expressing concern can't equal the marketing power of large companies," he adds. "I have doubts that the truth is driving this issue. It seems that market forces and money is behind it."
As public scrutiny of drug companies grows, so do questions about what critics say is a vast over-prescribing of MPH, especially as more adults are taking other MPH-based medicines such as Concerta. According to the DEA, production of the central nervous system stimulant, which is pharmacologically similar to amphetamines, grew from 5,000 kilograms in 1993 to 20,967 kilograms in 2002 – probably the largest ever prescribing explosion for a controlled substance, says Haislip. Echoing the sentiments of many in and outside the scientific community, Haislip says he suspects the dubious marketing tactics of big drug money have fueled the spiraled use of MPH. Specifically, he suspects the compromise of a small group of prolific ADHD researchers whose work is funded by corporate producers of ADHD drugs. He also suspects that one or more ADHD patient advocacy groups that receive drug company donations have essentially become fronts to push the prescribing of stimulants to children. And evidence suggests Haislip may be right.
"It Was Like A Whitewash"
Enter Dr. William Pelham, director of the Center for Children and Families at State University of New York at Buffalo (SUNY). A leading ADHD researcher for 30 years, Pelham is a former member of the scientific advisory board for McNeil Pharmaceuticals, which produces Tylenol and markets Concerta, a popular stimulant medication trademarked by Alza Corp. of Mountain View, Calif. Over his career, Pelham has penned over 250 research papers on ADHD, many with industry grants. In 2002, he was given a lifetime achievement award by the world's largest ADHD patient advocacy group, Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD).
In interviews with AlterNet, Pelham provided glimpses into the dubious methods drug maker McNeil-Alza uses to ensure that studies it funds produce favorable results for its ADHD medications. Between 1997 and 1999, he was paid by McNeil to conduct one of three studies used to get FDA approval. The company currently uses the three studies to claim that 96 percent of children taking Concerta experience no problems in appetite, growth, or sleep. But Pelham says the studies were flawed. The original intent of the studies was to measure both side effects and main effects of the drug. But two of the three studies, including Pelham's, required that the subjects had to already be taking MPH and responding well to it in order to enter the study. In other words, by stacking the studies with patients already successfully taking stimulants, McNeil ensured the subjects would be unlikely to register side effects, Pelham says.
"It's really misleading and I'm surprised the FDA is letting them use the studies to advertise no side effects," he says. "They had no side effects because they took only people with only a positive history of medication. This is really pushing meds without telling the full picture." There was also pressure from the company to tweak the findings, he says. Part of Pelham's study involved "providing parent training to parents, having a simple behavioral program in place on Saturday lab days, and establishing simple behavioral programs in the children's regular school classrooms." When his paper was in the galley proof stage at the medical journal Pediatrics, Pelham says he joined a conference call with a number of senior people from the corporation who lobbied him to change what he had written in the paper.
"The people at Alza clearly pushed me to delete a paragraph in the article where I was saying it was important to do combined treatments (medication and behavioral)," he says, adding that they also pushed him to water down or eliminate other sentences and words that did not dovetail into their interests. "It was intimidating to be one researcher and have all these people pushing me to change the text." McNeil offered no direct response to the allegations.
"We cannot comment on unsubstantiated allegations," says Gary Esterow, a spokesman for McNeil Consumer & Specialty Pharmaceuticals, in a written statement. "The protocols and full study reports for these clinical trials were reviewed by the FDA, and provided the basis for FDA approval. Prior to publication, there was ample opportunity for full discussion of the data among the investigators. Publication of the findings reflect the prevailing opinion of the authors and is further supported by the peer review process of the scientific journals in which these studies appear."
Pelham says McNeil didn't stop there. The company commissioned a follow-up study on the conversion study mentioned above. This time McNeil did the data analysis and coordinated the paper writing. "I insisted on seeing the analyses and having major inputs into the manuSCRIPT and it was like pulling teeth to get wording and analyses changed," he says. "It was like a whitewash, a praise to Concerta." Pelham says the company submitted the paper twice to the Journal of the American Academy of Child and Adolescent Psychiatry. Drafts were sent to Pelham several times but he says he never returned anything with his signature. In the end, however, he says the paper was accepted without his knowledge and published with his name on it. Sins of Omission
Besides pressuring researchers they fund, companies also seem to pepper their direct-to-consumer marketing materials with only the science that favors their products. Makers of stimulant medications fight hard to downplay several longstanding theories. One theory is that consistent use of stimulants suppresses a child's growth. Concerns increased in April when the journal Pediatrics published a federally-funded study, the largest yet investigating the long-term health impact stimulants have on children. That study, funded by the National Institutes of Mental Health and known as the MTA Follow Up Study, found that consistent use of the stimulants stunts growth in children at a rate of about one inch every two years. The study also questioned a theory, apparently one still promoted by drug companies, that children make up lost growth over time. Yet some seven months after the study was published, neither Novartis, the maker of Ritalin, nor McNeil mention the study in their web-based marketing materials. An information document for prescribing physicians found on the Concerta web site tells doctors that Concerta causes "no clinically significant impact on growth with long-term use."
Likewise, the Ritalin website says stimulants may cause "initial, mild slowing of growth," but tells consumers the effect is temporary, that children will make up the lost growth and eventually reach their normal height. "We used large, well-designed studies to provide factual easy-to-understand information to readers," says Denise Brashear, a spokeswoman for Novartis. "There are hundreds of studies conducted regarding methylphenidate treatment making it difficult to include every study on each topic."
In their written statement to AlterNet addressing questions for this article, McNeil officials did not respond to a question regarding the MTA Follow Up Study. Potentially most damaging to stimulant sales is that medications like Ritalin may not work over the long run and that behavioral modifications may serve just as well. According to Pelham, who is on the steering committee for the MTA studies, much of his research, as well as data gleaned from the MTA studies, shows the efficacy of medication declines over time. "No drug company in its literature mentions the fact that 40 years of research says there is no long-term benefit of medications," he says. "That is something parents need to know."
The pharmaceutical industry has long donated money to patient advocacy groups that critics say become conduits for spreading industry-friendly information. In the world of ADHD advocacy, CHADD, based in Landover, MD, is an 800-pound gorilla, claiming 20,000 members and 200 affiliates, even offering members a CHADD Visa Card. Though the organization, which also engages in lobbying, claims to provide "science-based, evidence-based information about ADHD" to parents and the public, critics say CHADD basically promotes stimulant medications manufactured by its corporate donors. Pharmaceutical companies – including Novartis and McNeil – donated a total of $674,000 in fiscal year 2002-2003, making up 17 percent of the group's budget, according to CHADD financial documents posted on its website.
Pelham, who is currently listed by CHADD as a member of its professional advisory board, came face to face with what he says are the group's glaring conflicts of interest. In 2002, after he received the CHADD Hall of Fame Award, he was subsequently interviewed for Attention!, the organization's magazine. In the interview, Pelham said, among other things, that stimulant drugs have serious limitations when employed alone and at high doses. He also pointed out that psychosocial treatments should be the treatment of first choice in ADHD, with adjunctive medication when necessary. But eight months later, after CHADD's board of directors tried to quash the article, CHADD published Pelham's interview – but with large swaths cut out, particularly his comments about the limitations of the stimulants.
"In recent years, I have come to believe that the individuals who advocate most strongly in favor of medication – both those from the professional community, including the National Institutes of Mental Health, and those from advocacy groups, including CHADD – have major and undisclosed conflicts of interest with the pharmaceutical companies that deal with ADHD products," Pelham wrote in a foreword to the unedited version of the article he provided AlterNet. "I believe that parents of ADHD children and the public at large should be made aware of this situation. That is one of the points that I was attempting to make in my interview. As I think is clear from examining the edited sections, the CHADD CEO and board of directors did not share my concerns."
Chadd officials say their board is not involved in any aspects of the magazine and that some of Pelham's claims "were not scientifically supported." "CHADD did not withhold information because of pressure from pharmaceutical companies," says Phyllis Anne Teeter Ellison, who chairs the editorial advisory board for the magazine. "After extensive review and consultation with the scientific community, CHADD took a responsible position by not publishing some of Dr. Pelham's unsubstantiated claims that were not supported by available data and were not supported by his colleagues on the MTA group."
But some drug makers no doubt find the magazine interesting: Peg Nichols, CHADD's director of communications and executive editor of Attention!, confirmed that Shire Pharmaceuticals, makers of the stimulant medication Adderall, buys 65,000 of the 100,000 copies each print run. Shire sales representatives, in turn, place them in doctors' offices. Pelhams suspects his comments in the article, while edited heavily, were still "conservative" enough to cause problems with his pharmaceutical industry contacts. For several years, Pelham has hosted a conference on treatment for childhood mental health disorders for which drug companies, including McNeil and Shire, have provided educational grants. Since the article ran, he says his former contacts have not underwritten the conference.
Other types of organizations are also targets for pharmaceutical industry contributions. Concerta.net, for example, references guidelines issued by the American Academy of Pediatrics and the American Academy of Child & Adolescent Psychiatry that recommend stimulant medications like Concerta as the first choice of treatment for children with ADHD. Those prominent trade groups also have links to Big Pharma. McNeil, according to a document from The American Academy of Pediatrics, has given at least $25,000 in donations to the academy. It could not be confirmed if AACAP receives direct donations but links do exist. Dr. Graham J. Emslie, a professor at the University of Texas Southwestern Medical Center and a consultant for McNeil, serves on the corporate contributions and research committee for the AACAP, according to the Center for Science in the Public Interest (CSPI).
Profitable Research Criticism of industry-funded research is growing.
But drug companies dismiss claims of conflicts of interest, saying industry needs experts and has long turned to them for clinical trials. Moreover, says Brashear of Novartis, "when the results of the trial are published or presented, there is transparency about the physician's involvement." But conflicts can clearly arise, especially with something so controversial and hard-to-define as ADHD. Dr. Russ Barkely, considered by some to be the world's leading ADHD expert, says he has taken money from drug companies and that problems can occur when financial connections run too deep. "Whenever there is a financial arrangement between people or organizations, there always exists the potential for a conflict of interest and to influence the outcome of that arrangement," he says. "That is just human nature. It does not mean that one always does exist or that the products of such arrangements are always biased adversely in some way."
Barkely recognizes potential conflict of interest can arise when findings from the study don't merge perfectly with the commercial interest of the drug company. But many researchers, he says, insist on "unrestricted" grants that give researchers a green light to conduct the study and promote the results in ways that don't just advance the company's financial interest. “Nevertheless, if the researcher wants subsequent grants from a drug company, there may be an indirect conflict of interest for researchers here," says Barkely. "But so long as consumers want drug companies to produce state-of-the-art, safe, and well-tested drugs for disorders, you cannot then restrict drug companies from having access to the world's leading researchers to help them in providing such products."
For Barkely, the real test is a matter of degree, that is the percentage of a researcher's income that's directly derived from grants or consulting arrangements, not simply whether or not such an arrangement exists. "I consult for four or five drug companies a year, yet I derive less than 10 percent of my income from such consultations and speaking engagements for them," he says. "It is the degree of support that can raise the specter of a conflict of interest and not just the existence of a relationship. And we especially want to know if the researcher has stock options, royalties, or other financial arrangements with the company such that results which are favorable to the drug in a research project result in a proportionate and direct financial advancement of the researcher."
Most scientific journals, Barkely points out, require researchers to say in their articles what, if any, financial arrangements they have with a commercial interest that supported the research or may be mentioned in the article. "The results from drug company-funded research are not essentially different from federal studies," says Eugene Arnold, an ADHD expert and Ohio State University researcher who has taken money from drug companies. "Much of the new research funding surge has been for development of better products, such as longer-lasting delivery formulations. In order to obtain FDA approval, the companies have to sponsor research to demonstrate efficacy and safety. Naturally, they turn to experts in the disorder and its treatment to help do that research." Arnold says that all researchers heavily involved in new product research take money from drug companies. But he points out that research supporting efficacy of MPH, amphetamine, and other FDA-approved drugs for ADHD was originally done in the 1930s, '40s, and '50s without drug company support and even now some studies are done solely with federal funding.
Sam Goldstein, a clinical neurologist and member of the faculty at the University of Utah who has in the past served as a general consultant for drug companies and authored educational materials for them, says the profit motive can hurt research in other ways. "The nature of our capitalist system is such that if there is a profit to be made it is much more likely a treatment will be investigated," he says. "There are many good psychosocial treatments that with sufficient research would probably benefit children with ADHD. No one is going to fund them because there is no profit to be made. I don't think this is a bad thing. It is just the way the system works." Goldstein notes that the system of industry funding has produced medications that have dramatically in a positive way altered the lives of millions of people. "For me the issue is not so much ethics but the fact that only those treatments that stand to lead to profit are funded for research," he says.
End of AHRP release and AlterNet piece.
JON RAPPOPORT nomorefakenews.com
'NO PROBLEM; WE'RE FIXING IT"
JANUARY 25, 2004. The release and article below illustrate a common practice at NIH, the US-government research facility that is the largest lab/bureaucracy in the world.
NIH execs receive monies from drug companies on the sly; NIH funds very, very expensive studies of drugs made by these companies, thereby saving the companies millions of dollars; the volunteers (human guinea pigs) in these NIH studies have no idea they are part of a program in which the controlling NIH execs have a conflict of interest which would predispose NIH toward a favorable judgment about the safety and efficacy of the drugs.
It's a grim picture and a RICO crime in progress. No one in the federal government seems to care about the criminal aspect. The PR assumption being floated is that, yes, "mistakes have been made," but the corrections are being applied. No president, no White House ever really cares about these matters. Everything is swept under the rug. ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness and Full Disclosure
The Associated Press has uncovered evidence of scientists and administrators at the National Institutes of Health flagrantly disregarding ethical and legal requirements of financial disclosure: “In all, 916 current and former NIH researchers are receiving royalty payments for drugs and other inventions they developed while working for the government.”
According to records obtained by the AP, among the 51 NIH scientists currently involved in testing products for which they secretly receive royalties, are Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and his deputy, Dr. H. Clifford Lane who “have received tens of thousands of dollars in royalties for an experimental AIDS treatment they invented [interleukin-2]. At the same time, their office has spent millions in tax dollars to test the treatment on patients across the globe.”
According to the AP, the government has licensed the commercial rights to interleukin-2 to Chiron Corp: “Fauci's division subsequently has spent $36 million in taxpayer money testing the treatment on patients in one experiment alone. Known as the Esprit experiment, it is one of the largest AIDS research projects in NIH history, testing interleukin-2 on patients at more than 200 sites in 18 countries over the last five years.”
Five years ago Donna Shalala, then Secretary of the Health and Human Services, issued federal requirements (2000) of financial disclosure requiring NIH scientists to disclose their financial interest in experimental treatments on informed consent documents reviewed by patients being recruited as test subjects. According to the Associated Press, NIH administrators did not even consider implementing the 5 year old federal requirement until AP filed a Freedom of Information request last week: "Quite frankly, we should have done it more quickly…”
Scientists at the nation’s premier research centers who violate ethical and legal requirements and use underhanded recruitment tactics, pose a very real and present threat to public safety: “hundreds, perhaps thousands, of patients in NIH experiments made decisions to participate in experiments that often carry risks without full knowledge about the researchers' financial interests.”
The scope of ethical / legal violations and corrupt human recruitment practices by researchers at America’s premier medical research institutions is reaching the proportions of a tzunami. Self-regulation and peer review have proven about as reliable at ensuring ethical and scientific integrity as expecting the Mafia to vouch for the honesty of one of its own…
It will take more than pledges and promises by the director of NIH—it will take more than TALK about “transparency” to restore moral integrity. It will take a law accompanied by specified penalties to fit the crime—like the Sarbanes Oxley law. And most important, it will take an external enforcement mechanism to keep scientists honest. Say, a “corrupt science practice” division at the Department of Justice. It will also require effective whistleblower protection laws.
THE ASSOCIATED PRESS
http://news.yahoo.com/news?tmpl=story&cid=542&u=/ap/20050110/ap_on_go_ca_st_pe/research_royalties_4&printer=1 Feds Failed to Disclose Financial Interest
Mon Jan 10, 4:17 PM ET
By JOHN SOLOMON, Associated Press Writer
WASHINGTON - Government scientists have collected millions of dollars in royalties for experimental treatments without having to tell patients testing the treatments that the researchers' had a financial connection, according to documents and interviews.
The personal royalties are legal, though the researchers developed the treatments at government expense. But the Health and Human Services (news - web sites) Department promised in May 2000 that scientists' financial stakes would be disclosed to patients, a pledge that followed an uproar over conflicts of interest and mistakes in federal experiments.
The National Institutes of Health (news - web sites) says it didn't implement a policy to order the disclosure until last week, shortly after The Associated Press filed a Freedom of Information Act request.
"Quite frankly, we should have done it more quickly. But as soon as Director (Elias A.) Zerhouni found out about it, he ordered it done immediately," NIH spokesman John Burklow said.
The nearly five-year delay means hundreds, perhaps thousands, of patients in NIH experiments made decisions to participate in experiments that often carry risks without full knowledge about the researchers' financial interests.
"It's hard for patients to make an informed decision when they don't have all the information," said Bill Allison of the Center for Public Integrity, which monitors the ethics of government employees.
"When a doctor says, 'Here, try this experiment, it is safe, or it will help,' and the patient isn't aware he has a financial interest in the outcome of that treatment, it in essence is taking advantage of someone by not letting them have all the information," Allison said.
In all, 916 current and former NIH researchers are receiving royalty payments for drugs and other inventions they developed while working for the government, according to information obtained by AP. They can collect up to $150,000 each a year, but the average is about $9,700, officials said.
In 2004, these researchers collected a total of $8.9 million. Only a dozen received the legal maximum.
The government owns the patents and the scientists are listed as inventors so they can share in licensing deals struck with private manufacturers. In addition to the inventors' take, the government received $55.9 million in royalties for the same inventions and put that money back into research.
The arrangements can create concerns about conflicts.
For instance, two top managers in NIH's infectious disease division have received tens of thousands of dollars in royalties for an experimental AIDS (news - web sites) treatment they invented. At the same time, their office has spent millions in tax dollars to test the treatment on patients across the globe, the records show.
Such research helps bring the treatment closer to possible commercial use, which could in turn bring the researchers and NIH higher royalties.
Except for patent records and scientific journals, the patients have had no easy way of learning about the researchers' financial stakes.
That's because NIH told doctors not to report royalties on their government ethics disclosure forms and did not require the royalties listed on patient consent forms until last week's policy.
Fifty-one NIH royalty recipients are currently involved in clinical research involving the inventions for which they are being paid, meaning they'll be affected by the new policy, according to the information obtained by AP. Among them are National Institute of Allergy and Infectious Diseases (news - web sites) Director Anthony Fauci and his deputy, H. Clifford Lane.
The two managers have received $45,072.82 each in royalties since 1997 for an experimental AIDS treatment known as interleukin-2 that they invented with a third NIH doctor, Joseph Kovacs, the records show. The government has licensed the commercial rights to that treatment to drug maker Chiron Corp., and Fauci's division subsequently has spent $36 million in taxpayer money testing the treatment on patients in one experiment alone. Known as the Esprit experiment, it is one of the largest AIDS research projects in NIH history, testing interleukin-2 on patients at more than 200 sites in 18 countries over the last five years. Both doctors said they were extremely sensitive about the possibility of an appearance of a conflict of interest and took steps on their own to address it even as they waited for their agency to do what they believed should have been done all along - fully disclose the payments to patients. A panel of peers from the National Cancer Institute (news - web sites) was brought in to approve the Esprit project because Fauci and Lane were in a position to profit. Fauci, an internationally known expert on illnesses from the flu to AIDS, said he originally refused to take the royalties but was told he legally had to accept them. So he has donated all the money to charity. "I'm going to give every penny of it to charity ... no matter what the yearly amount is," he said. Fauci also said he once tried to report his payments on his federal financial disclosure report, which is available to the public, but was told to remove them because NIH considers the money federal compensation, not outside income. Lane keeps his royalties but said he occasionally gave patients scientific journal articles that noted he was listed on the patent for interleukin-2. "I believe patients should know everything that might influence their desire to be participants in research," Lane said. Both acknowledged they were unwilling to tell interleukin-2 patients about the royalties on consent forms until NIH developed its policy. Both will do so from now on. "We were reluctant to make a formal policy until the broad policy came down from the department and NIH," Fauci explained. Their case illustrates the gulf between what the government promised nearly five years ago in the midst of controversy and what actually has been done. Then-Health and Human Services Secretary Donna Shalala pledged in May 2000 that the government would develop policies to require "that any researchers' financial interest in a clinical trial be disclosed to potential participants." Congress, concerned by reports of conflicts of interest and researchers' conduct in several high profile experiments, was told the changes would happen. The government first published guidance for the disclosure in January 2001. Current HHS Secretary Tommy G. Thompson issued new guidance this May that again clearly cited "compensation that may be affected by the study outcome" and "proprietary interests in the products, including patents, trademarks, copyrights or licensing arrangements."
NIH, however, didn't order the disclosure until last week's policy. end of release and article
JON RAPPOPORT www.nomorefakenews.com
MEDICAL SCANDALDECEMBER 16, 2003.
Last week I reported on the breaking scandal at the US National Institutes of Health. The outrageous acceptance of consulting fees and contracts and stock options from pharmaceutical companies by NIH government employees---and all of this legal, and all of this encouraged at NIH, and yet most of this hidden at NIH, because, well, ’It’s nobody else’s business,” and because NIH employees sign confidentiality agreements with their corporate employers.
"I’m a soldier in the army of Napoleon, but I’m also employed by Wellington, and I can’t discuss the terms of my contract with Wellington…" The LA Times broke this whole thing wide open last week.
The LA Times has its own wire service. It sends out stories to many press outlets.
Have you seen this story featured in any major press outlet?
Of course you haven’t.
Just as I predicted, it appeared for a few seconds and sank like a stone.
I want to record a central fact before this whole business is forgotten forever. The man at NIH who made sure to change government policy, who made sure everyone knew it was open season on landing corporate fees and stock options and so on---that man was the head of NIH under Clinton. His name is Dr. Harold Varmus.
Varmus, in 1993, also held out against calling Dr. Robert Gallo what he was, A CRIMINAL who had stolen French viral research on his way to positioning himself as the discoverer of the so-called AIDS virus.
Varmus did not want to admit, on behalf of NIH, any US government wrongdoing…but eventually he was forced to back down a little and agree to a more equitable sharing of proceeds from the highly lucrative HIV blood test. A sharing between the French and American governments.
Varmus was also one of the men, much earlier, who had fooled around in the lab with the question of the origin of cancer. His foolings earned him a Nobel Prize. However, it all had to do with a gene theory----there were special genes that ’turned on cancer.’ Varmus added to the research of others who had looked at oncogenes. But this research was really not relevant to the real world. It was only interesting and strange lab manipulation…in the ivory tower.
Varmus, at NIH, opened the door wide, wide open to the current corruption that infects department after department, as employees accept private money while they do government work on government salaries.
All in all, it’s a very neat and deadly game: the government illegally sets itself up as the arbiter of all things medical; then the government funds immense research (as it does at NIH); then the government researchers, who aid and abet this scheme of the government controlling the lion’s share medical research, open their pockets to accept corporate medical money…and another layer of corruption piles on the first layer of corruption.
JON RAPPOPORT www.nomorefakenews.com