Dr. Patrick Soon-Shiong: You’re Being Lied to About Cancer, How It’s Caused, and How to Stop It

 Dr. Patrick Soon-Shiong is a surgeon who made billions inventing cancer drugs. He says that Covid, and the vaccines that didn’t stop it, are likely causing a global epidemic of terrifyingly aggressive cancers.

"Medicating Normal"

 This full-length, award-winning documentary unearths the shattering truth that millions of people worldwide are injured by prescribed psychiatric medications. Interweaving stories of harm with expert testimony, the film reveals how a profit-driven industry hides the risks of long-term use. This untold story is a compelling call to examine the consequences of medicating normal human suffering.

Featuring Experts:

-Anna Lembke, MD, Professor, Psychiatry and Behavioral Sciences, Stanford University Medical School, Author, "Dopamine Nation"

-Peter Gøtzsche, Danish physician and medical researcher, Co-founder of the Cochrane Collaboration, Director, Institute for Scientific Freedom

-David Cohen, PhD., researcher, Professor and Associate Dean for Research and Development at Luskin School of Social Work, University of California Los Angeles, Co-author, "Your Drug May Be Your Problem"

-Robert Whitaker, Science Journalist, Author, "Mad in America" and "Anatomy of an Epidemic."

-Allen Frances M.D., Psychiatrist, Professor and Chairman Emeritus of the Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, co-chair of DSM-IV Task Force, Author, "Saving Normal"

-Mary Vieten, PhD., Psychologist, Executive Director of Warfighter ADVANCE, Chairman of the Board of Directors for the International Society for Ethical Psychology & Psychiatry, ISEPP

-Ellen Vora, M.D., psychiatrist and author, "The Anatomy of Anxiety"

For more information, visit https://www.medicatingnormal.com

What’s Actually in the COVID Vaccines, Vaccine DNA Contamination & Monkey Virus SV40 - Kevin McKernan

 SEE ALSO: DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.

AUTHORS David J SpeicherJessica RoseL. Maria GutschiDavid M Wiseman PhD Kevin McKernan - https://osf.io/mjc97/

Safe and Effective: A Second Opinion (2022) | Oracle Films | News Uncut

If youtube removes it, you can find it somewhere else. ;) 

Follow the link to the book. 

Breast Cancer Deception

By Mike Adams, Natural News

World Without Cancer - The Story of Vitamin B17 by G. Edward Griffin (1974)

The Cancer Cure Cover-Up (Conspiracy Documentary) - Real Stories

There are many non-conventional, non-toxic cancer treatments out there, this is just one of them.

"The modern biographical story of Stanislaw Burzynski, MD, PhD who discovered an innovative patent-protected cancer therapy currently enrolled in FDA clinical trials. This story sheds light on the current regulatory and industry roadblocks preventing these life-saving medications from reaching the market as of 2016."

SURVIVAL OF A WHISTLEBLOWER

To be a whistleblower is not easy. Particularly not in healthcare, which is riddled with financial conflicts of interest, corruption, political ambitions about becoming re-elected by promising people screenings that do more harm than good, and personal hobby horses.

Part of big pharma’s business model is organized crime, which envolves fraud, both in research and marketing. Our prescription drugs are the third leading cause of death, after heart disease and cancer, and I have estimated, based on the best research I could find, that psychiatric drugs alone are also the third leading cause of death. Yet, hardly anyone raises an eyebrow; in fact, we irrigate whole populations with psychiatric drugs as if they were mental fertilizers.

Most whistleblowers suffer a terrible fate. Peter Rost has described how things went for 233 people who blew the whistle on fraud: 90% were fired or demoted, 27% faced lawsuits, 26% had to seek psychiatric or physical care, 25% suffered alcohol abuse, 17% lost their homes, 15% got divorced, 10% attempted suicide and 8% went bankrupt. But in spite of all this, only 16% said that they wouldn’t blow the whistle again. I shall try to explain how it was possible for me to blow the whistle for 30 years and yet still have a highly rewarding career.

PETER C. GØTZSCHE Professor Peter C. Gøtzsche graduated as a Master of Science in Biology and Chemistry in 1974 and as a Physician 1984. He is a specialist in internal medicine; worked with clinical trials and regulatory affairs in the drug industry 1975-1983, and at hospitals in Copenhagen 1984-95. SUMMER INSTITUTE

The 2018 Summer Institute on Bounded Rationality took place on June 19 – 27, 2018, at the Max Planck Institute for Human Development in Berlin, Germany.

'Dr Mary's Monkey' Edward Haslam; The emergent cancer epidemic

Edward Haslam, author of the astounding book on the topic of the epidemic of soft tissue cancers of the last 50 years and the 'off the books' development of a cancer causing monkey virus that was 'allegedly' inserted into the polio vaccines of the 1960s; 'Dr Mary's Monkey' is a strange story and here Edward Haslam presents how he came to this story and the weird evidence that led to one of the most heinous crimes perpetrated against humanity, if it is true, and sadly, it is looking that way. The announcement from the health authorities in the late 20th century that AIDS was a mutation of a monkey virus had this author adopt a more vociferous investigative stance in bringing to light what is happening to 'us' and why a once upon a time infrequent fatal illness such as cancer has become an epidemic. The resultant evidence Haslam has brought to light is stunning. The Life magazine July 1959, via the ongoing virus research of Sarah Stewart, who proved the existence of cancer causing viruses in the 1950s, that there might be the possibility for a cancer vaccine..and here we are, all these decades later giving a vaccine the young women against cancer...however this one is rendering them sick or infertile...but that is another story, one that wont be mentioned at 6pm.

Deadly Deception, Exposing the Dangers of Vaccines, a film by Gary Null

There is an epidemic, the likes that we have never seen in the history of this country. One in 6 children in America is learning disabled, one in 9 has asthma, one in 48 are becoming autistic, and millions more are suffering with brain and immune dysfunction, which can not be explained. Children are now exposed to more vaccinations than earlier generations. The number of vaccines is expected to increase dramatically with over 250 new vaccines in the pipeline. While there is an untold number of children and adults that have been injured from vaccines, most Americans remain skeptical of the fact that vaccines can and do cause injury, disability and death.

What will happen when vaccine-injured children, with brain and immune system dysfunction, reach adulthood and are unable to function in society? It is a tremendous cost burden to care for someone with a disability over their lifetime and the American healthcare system is incapable of handling the larger cataclysm that awaits as vaccines become mandated. Conventional medicine claims that vaccines prevent infectious diseases and are proven to be effective and safe. We are that these diseases can be eradicated if the population is fully vaccinated to achieve “herd immunity.” However, does the science support these claims?

Edited by Valerie Van Cleve

Executive Producer, Gary Null Ph.D. Directed by Gary Null, Ph.D. Produced by Valerie Van Cleve Associate Producer, Richard Gale

THE MOST IMPORTANT INTERVIEW OF OUR TIME

HighWire re-airs it’s most important interview to date. Shocking new information, & candid admissions, reveal the real fraud in the case of Andrew Wakefield.

The Toxic Baby

http://www.ted.com 

Filmmaker Penelope Jagessar Chaffer was curious about the chemicals she was exposed to while pregnant: Could they affect her unborn child? So she asked scientist Tyrone Hayes to brief her on one he studied closely: atrazine, a herbicide used on corn. 

Sarah's Gardasil Vaccine Injury

Lifting the Veil with Sara Sotomayor

Sarah's blog:

https://sarashealingjourney.wordpress.com/?blogsub=confirming#subscribe-blog

Under Our Skin - The politics of chronic Lyme disease

In the 1970s, a mysterious and deadly illness began infecting children in a small town in Connecticut. Today it's a global epidemic. A real-life thriller, this shocking festival hit exposes the controversy surrounding chronic Lyme disease. Following the stories of individuals fighting for their lives, director Andy Abrahams Wilson reveals with beauty and horror a natural world out of balance and a human nature all too willing to put profits before patients.

Full statement by MMR scare doctor Andrew Wakefield: 'The Government has tried to cover up putting price before children’s health'

The Independent

The full statement from Andrew Wakefield, the discredited doctor whose Lancet article sparked the MMR scare 15 years ago, on the outbreak of measles in Wales

In the wake of further media distortion, misrepresentation, and ignorance in relation to the measles outbreak in Wales, it is important to clarify some key facts.

In 1998, following an analysis of all published pre-licensing studies of MMR vaccine safety I recommended the use of single measles vaccine in preference to MMR. This remains my position.

At that time, in contrast with the false assertions of many commentators, including Richard Horton, Editor of The Lancet, and vaccine millionaire Paul Offit, the single vaccines were licensed in the UK and freely available to the British public.

While MMR vaccination uptake fell from February 1998, there was a reciprocal increase in the uptake of the single vaccines – a fact that is never acknowledged in the press. Vaccination clinics administered many thousands of doses of measles vaccine and children were “protected”.

Six months later, in September 1998, the British government withdrew the importation licence for the single vaccines, effectively blocking this option for parents. 

Measles cases in the UK rose when the government withdrew the importation licence for the single measles vaccine leaving concerned parents with no choice. When I demanded to know why, if the government’s principal concern was to protect children from measles, it would prevent parents with genuine safety concerns over MMR from protecting their children, Elizabeth Miller of the Health Protection Agency responded, “…if we allowed parents the choice of single measles vaccines it would destroy our MMR programme.” The government’s concern appeared to be to protect the MMR programme over and above the protection of children. 

Despite the claim of David Salisbury, head of the UK’s Immunisation Division, that MMR has, “an exemplary safety record”, two of the three brands introduced in 1988 had to be withdrawn for safety reasons – they caused meningitis.

Government officials had approved these dangerous vaccines – Pluserix and Immravax – giving them the great majority of the UK market despite knowing that they were high risk and despite having been warned explicitly of their dangers. These government officials put price before children’s health and have been seeking to cover up this shameful fact ever since.

The US government has paid out millions of dollars to children whose autism followed vaccine-induced brain damage. A recent government concession in the US Vaccine Court confirms that the parents’ claims were valid all along. In a recently published December 13, 2012 vaccine court ruling, hundreds of thousands of dollars were awarded to Ryan Mojabi, whose parents described how “MMR vaccinations”, caused a “severe and debilitating injury to his brain, diagnosed as Autism Spectrum Disorder [‘ASD’]”.

Later the same month, the government suffered a second major defeat when young Emily Moller from Houston won compensation following vaccine-related brain injury that, once again, involved MMR and resulted in autism.

The cases follows similar successful petitions in the Italian and US courts (including Hannah Poling, Bailey Banks, Misty Hyatt, Kienan Freeman, Valentio Bocca, and Julia Grimes) in which the governments conceded or the court ruled that vaccines had caused brain injury. In turn, this injury led to an ASD diagnosis. MMR vaccine was the common denominator in these cases.

The more light that shone on this subject by way of informed, balanced debate, the better. I am offering to debate any serious challenger on MMR vaccine safety and the role of MMR in autism, live, in public, and televised

Source

Eleven Vaccine Myths No One Will Say to Our Face

By Carolyn Flannery

Age of Autism

According to the CDC, 1 in 50 children now have autism in the US. The rate of autism and autism spectrum disorders has been rapidly increasing.

Rosie

1) Because Your Child Got Autism, mine got off scott free. Hard to really feel bad about that.

Did your child really get off scott free? Then why are there so many neurodevelopmental disorders? Why is your child overweight? ADD? ADHD? Allergic? The same toxins and mechanisms that caused autism in our children may well have caused a lower IQ in yours. Especially if he's a boy. Don't you think it's worth finding out before it's too late? Oh--and AUTISTIC kids have a lack of empathy? ? I don't think so.

2) We have "always" had people who acted like Asperger's. We all have some relative back in the family tree who was a little quirky, right?

Yes, and as long as we've had recorded human history with enough detail to mention disorders, even the Bible, we've had gold mining (which uses mercury to free the gold), and in the mid 1800's, mercury dental fillings. In the early 1900's through the present, industrial pollution from steel mills through coal mining. Minamata (Japanese mercury poisoning) victims had many symptoms similar to autism. And it took their government decades to admit it, destroying many lives.

3) The kids who used to be institutionalized and called retarded are now labeled autistic.

First of all California disproved this recently. But sadly, there is another reason this is a total fallacy. Due to abortions of babies who have been detected with Down's and other disorders, the rate of mental retardation and the types of children we may have seen in the sixties, seventies, and eighties, have gone way down. This is not something widely publicized or reported. But Autism is NOT the same thing. If you don't believe me, visit a special ed classroom of severely autistic children who are sometimes writhing in pain on the floor. Compare these to any Down's syndrome child. Visit the Special Olympics ask someone to point out the mentally retarded children vs the autistic children. It is clearly different. Ask some older volunteers how many autistic kids they saw when they started Special Olympics. Also, retarded children did not regress. Think of your grandmother with Alzheimer's. She was there, now she isn't. That's autism. Except for the children poisoned in utero. They never had the chance.

There is an easy way to check this. Just find a preschool teacher or daycare owner who has been teaching for over 25 years and ask him or her if they remember seeing autistic children in the 70's or 80's at the rate they are seeing them now. Ask elderly people if they remember stories of children impossible to potty train and nonverbal or vastly behind developmentally at the age of 6, 7, 8. Find some elderly nuns who used to teach. Ask them if they remember classrooms with 60 children in them actually functioning. . . not ideal, but functioning, and ask if that could happen now.

4) If Vaccines really caused autism, why would my trusted nurse, doctor, tell me to get vaccinated?

Anyone who challenges the safety--let alone the practice--of current vaccination ends up Wakefielded--which means reputation destroyed, career ruined, exiled, for speaking truth to power . . Still, most doctors and nurses truly believe they are doing the right thing (except for the frightened nurses who don't want to take a flu shot, either). Just talk to a Defeat Autism Now doctor who inadvertently poisoned their own child with vaccines to hear the sorrow of those who have lost their belief and trust in a system they invested their life into. Just as the CDC once said smoking was 'good for you' in the early 60's, and magazines of the time are filled with cigarette ads compromising honest reporting and questioning, so is our media dominated by ads by the same pharamaceutical companies that also make vaccines.

5) If Vaccines really caused autism, why doesn't EVERY child who gets vaccinated have autism ?

If peanut butter can really kill a child who is wildly allergic, why doesn't peanut butter kill every child? 

If overdosing on toothpaste is dangerous for some children why can't we accept that the cumulative effect of too much mercury, aluminum, and other toxins can kill or poison people?

If mercury hurts a fetus if its from tuna, why is it a stretch to say it hurts a fetus if its from a flu shot?

If lithium, a metal type element, treats bipolar, why is it a stretch to say other metals such as mercury injected into a baby might not affect behavior?

Just one example: Research shows that some children make less glutathione, which helps process mercury and toxins. Normally this variation would not matter--it only matters if someone is exposed to large amounts of toxins. However, tylenol depletes glutathione. Give a baby who makes low glutathione tylenol so the shot won't hurt, and the lack of glutathione becomes tragic. Give that same baby glutathione before the shot and just maybe he might be okay. Google Jill James and glutathione for details.

6) Autism isn't so bad. Some people think Edison, Einstein, and others have/had autism.

Perhaps this is true. However, Edison and Einstein dropped out of conventional schooling. Just imagine what ELSE they may have invented had they not had the documented social skills deficits that came with the autism. And imagine what the world would have lost had they received some mercury-laden shots as infants that locked that talent in. Had they been born in 1997 when hep b at birth started.

Autism is progressive among each generation--more proof it is caused by toxins. Perhaps these genes would lead to a quirky uncle in the 1900s, exposed to mercury making hats like the Mad Hatter or working in the steel mills . The next generation would have some children with bipolar and quirky asperger traits along with gifts. That generation might have a child die of Pink disease from the mercury in the tooth cream of that time. The generation that got Hep B at birth and then one after another vaccine might have a child who is totally nonverbal, in constant gut pain, and still in diapers at the age of 15. These are the children you don't see. The ones you see out and about are literally the tip of the ice berg. Autism isn't "okay" just because some extremely talented people got less poisoned, had family resources that could afford treatment, and were able to overcome some of their deficits.

7) Well maybe vaccines are just weeding out the most weak and taking them out of the gene pool. Or they would have died or gotten sick anyhow from the diseases the vaccine prevented.

The fact is the infants with the BEST immune systems are the most likely to react to the vaccines, which stimulate the immune systems. We are harming the BEST among us, the best and the brightest. Why are the kids in our stereotypes, the brightest kids, the ones in our memories from the 60s and 70's, the ones with glasses and allergies? Could it be that the best brains have always been the most susceptible to vaccine injury ? These toxins have been in the vaccines since the early 1930's. Some research shows that a high metabolism brain--which can mean a higher IQ- is more sensitive to toxins because it takes more toxins in.

8) There is nothing we can do about autism. Some kids will just outgrow it.

15 years ago parents were told that it was hopeless and nothing could be done. Those parents figured out that their children had been poisoned by vaccines and treated them according to methods based on science about how this could occur and how it could be reversed. Some of those children recovered. Instead of just saying they "outgrew" it, why isn't the CDC trying to study the children who recovered and find out what worked, what didn't work, and if those parents continued to vaccinate. If they are not going to stop autism from happening, at least they could try to understand how to reverse it and prevent it in vulnerable children. How to identify which children are vulnerable. And why haven't they studied "vaccinated" vs unvaccinated. If our children got harmed for the "greater good" then they deserve to be compensated and honored for that sacrifice.

9) If your child doesn't get vaccines, it puts my vaccinated child at risk.

Huh? Isn't it the other way around? If you really believe vaccines work, your child getting injected with live viruses (in some cases) puts MY child at risk. My child, who reacts to vaccinations and cannot tolerate them. My child whose once exquisite immune system now looks like that of an HIV victim with NK killer cells at 7. Thanks to his vaccines.

10) Autism is caused by two quirky parents getting married --the "WIRED" theory

Wait-- Correlation does not equal causation, right?? This is a cute theory but all it proves is that if you are very bright and technically proficient, and as a child got injured by mercury or vaccines making you quirky or uncoordinated and thus more apt to be nerdy, then married another quirky person who was very bright and got injured by mercury and vaccines as a child, your child is more likely to get injured by mercury and vaccines, and more likely to be more damaged by those toxins. And if he gets ten times MORE vaccines than you did, it's almost a given he'll get ADD or autism.

11) People who question vaccine safety are wackos and despise science. They just can't accept the fate that happened to them

Okay folks, think of every warning you ever saw "don't eat fish, it causes fetal damage" . "Don't buy a house with lead paint" . "Be careful what you do in pregnancy--don't take cold medicine even." "Uh oh there is aresenic in rice". "If you dispose of these vaccines or tooth fillings, they have to go into a toxic waste dump because they are poison". "There is a liability protection for vaccine manufacturers in case a child gets harmed by vaccines".

Okay if those warnings and protections are out there, there must be babies and children out there who DID get exposed to mercury in fish, who DID get exposed to lead paint, who did get harmed by toxins in fillings or vaccines.. Why is it such a stretch to connect these dots? Why are we so blind? Where are all these injured children whose parents didn't see the warnings in time? Could it be they have been labeled autistic? And why isn't there any effort, at all, to figure out how to reverse the effects of these toxins? Don't tell me there is arsenic in rice, tell me how to get it out of my child, and other children who have difficulties excreting toxins.

Every one of us DID Vaccinate our children. Because we DID believe the science we had seen. However, after our child developed symptoms, after our child who had been bright and alive started to act like our grandmothers as they descended into Alzheimer's, lost language, lost continence, lost everything, we started scouring pubmed, the inserts in the vaccine manufacturers information sheets. We saw that, GUESS WHAT? Vaccines DO harm some children and the government admits it at the same time it pretends they are 'perfectly safe'. The GOVT admitted in 1999 that mercury should be taken out of vaccines, but its still in vaccines shipped overseas.. A decade later it is still in flu vaccines given to pregnant women in America. What we can't accept is that THIS HAPPENED FOR NO REASON. The toxin didn't have to be in the shot. The medical community could have figured out how to detect vulnerable children and not vaccinate them on the same schedule. It didn't have to happen. And it's STILL HAPPENING TO OTHER CHILDREN in our name, in other countries, and in our name, here in America. And there is very little research into how to reverse it and help our child recover, and very little insurance coverage for helping our children recover, even for the documented treatments such as ABA.

What can you do to help the person who sent this link to you?Spend an hour today. Go to generationrescue.org and ageofautism.com. Read the studies, all linked from sites such as pubmed. Read the parent stories. The same story. Over and over. Read it and weep. Read it and rage. We did. And then join us in our fight to prevent autism, treat autism, and green our vaccines. Thank you for reading. It's the first step. And please forward or share. 

Carolyn Flannery is a biomed Mom recovering her child, she thanks Dr. Wakefield and the biomed Moms who have come before her. 

Source

Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review

Emmanuel Stamatakis1,2,*, 

Richard Weiler3, 

John P.A. Ioannidis4,5

Article first published online: 25 MAR 2013

DOI: 10.1111/eci.12074

© 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by Blackwell Publishing Ltd.

Background

Expenditure on industry products (mostly drugs and devices) has spiraled over the last 15 years and accounts for substantial part of healthcare expenditure. The enormous financial interests involved in the development and marketing of drugs and devices may have given excessive power to these industries to influence medical research, policy, and practice.

Material and methods

Review of the literature and analysis of the multiple pathways through which the industry has directly or indirectly infiltrated the broader healthcare systems. We present the analysis of the industry influences at the following levels: (i) evidence base production, (ii) evidence synthesis, (iii) understanding of safety and harms issues, (iv) cost-effectiveness evaluation, (v) clinical practice guidelines formation, (vi) healthcare professional education, (vii) healthcare practice, (viii) healthcare consumer's decisions.

Results

We located abundance of consistent evidence demonstrating that the industry has created means to intervene in all steps of the processes that determine healthcare research, strategy, expenditure, practice and education. As a result of these interferences, the benefits of drugs and other products are often exaggerated and their potential harms are downplayed, and clinical guidelines, medical practice, and healthcare expenditure decisions are biased.

Conclusion

To serve its interests, the industry masterfully influences evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluations, clinical practice guidelines and healthcare professional education and also exerts direct influences on professional decisions and health consumers. There is an urgent need for regulation and other action towards redefining the mission of medicine towards a more objective and patient-, population- and society-benefit direction that is free from conflict of interests.

Read full study here

PDF here

Hepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997-2002.

J Toxicol Environ Health A. 2010;73(24):1665-77. doi: 10.1080/15287394.2010.519317

Gallagher CM, Goodman MS.

Source

PhD Program in Population Health and Clinical Outcomes Research, Stony Brook University Medical Center, State University of New York at Stony Brook, Stony Brook, New York, USA. cmgallagher@notes.cc.sunysb.edu

Abstract

Universal hepatitis B vaccination was recommended for U.S. newborns in 1991; however, safety findings are mixed. The association between hepatitis B vaccination of male neonates and parental report of autism diagnosis was determined. This cross-sectional study used weighted probability samples obtained from National Health Interview Survey 1997-2002 data sets. Vaccination status was determined from the vaccination record. Logistic regression was used to estimate the odds for autism diagnosis associated with neonatal hepatitis B vaccination among boys age 3-17 years, born before 1999, adjusted for race, maternal education, and two-parent household. Boys vaccinated as neonates had threefold greater odds for autism diagnosis compared to boys never vaccinated or vaccinated after the first month of life. Non-Hispanic white boys were 64% less likely to have autism diagnosis relative to nonwhite boys. Findings suggest that U.S. male neonates vaccinated with the hepatitis B vaccine prior to 1999 (from vaccination record) had a threefold higher risk for parental report of autism diagnosis compared to boys not vaccinated as neonates during that same time period. Nonwhite boys bore a greater risk.

PMID: 21058170 [PubMed - indexed for MEDLINE]

Source

Download full text:

http://www.tandfonline.com/doi/pdf/10.1080/15287394.2010.519317

Top scientists to Obama: Ban mutation experiments that will make avian flu more infectious

By RT

A group of leading scientists – including a Nobel Prize winner - has proclaimed that it is “ethically and morally” wrong to alter the deadly H5N1 virus to make it more contagious for research purposes, and have asked President Obama to ban it.

“The accidental release of an artificial, laboratory-generated, human-transmissible H5N1 virus into the community has the potential to cause a global pandemic of epic proportions that would dwarf the 1918 Spanish flu pandemic that killed over 50 million people,” read a letter to the Presidential Commission for the Study of Bioethical Issues.

The petition was drafted by the Foundation for Vaccine Research (FVR), a scientific advocacy group, and numbered world-leading biologists among the 17 signatories, including Lord May, the former chief science advisor to the UK government, and Sir Richard Roberts, the recipient of the 1993 Nobel Prize for Medicine, for genetics research.

Late in 2011, two groups of scientists courted controversy, when they prepared to publish studies showing a modified version of the avian flu virus that could be passed through the air between mammals. In its current form, the virus, which has killed 60 percent of those it infects, is not easily caught by people from birds, and is even more difficult to transmit from one human to another.

But, Ron Fouchier, of Erasmus Medical Center in the Netherlands, and Yoshihiro Kawaoka, from the University of Wisconsin, the scientists behind the purposeful mutations, known as gain-of-function studies, say the virus will itself change without lab research, and foreseeing its progression might enable a vaccine or cure to be developed sooner.

They had voluntarily placed a moratorium on gain-of-function research after their initial research created concern that details about how these modifications to a virus that has killed more than 350 people since its discovery in 2003, were achieved would fall in the hands of careless scientists or worse, terrorists and hostile governments.

The moratorium was lifted earlier this year.

“The recent calling off of the moratorium by 40 flu researchers alone – not funders, governments or international bodies – says it all. The flu community simply hasn’t understood that this is a hot-button issue that will not go away,” Professor Simon Wain-Hobson, one of the signatories, told UK’s Independent newspaper.

FVR hopes the further gain-of-function experiments – most of which are funded by the government - will be postponed, pending a more thorough scientific debate on the ethics.

The US government is currently making tentative steps to regulate the research. The White House has published a draft paper that would require government agencies to evaluate the potential risk of any study involving 15 most dangerous cultures, but it has no plans to curb gain-of-function studies altogether.

And even if the petitioners manage to persuade Barack Obama, their plea is unlikely to stem the tide of similar new manipulations around the world.

“The H5N1 studies represent the first of no doubt many such studies involving other potential pandemic pathogens. Gain-of-function studies with H5N1 virus are being conducted in China, and a team in The Netherlands is expanding their H5N1 studies to include studies with the H7N7 virus, and has announced plans to conduct similar gain-of-function studies with the SARS coronavirus,” admits the petition.

Source

Drugs giant Roche accused of sitting on trial data for flu treatment

Doubts remain about efficacy and safety of Tamiflu, stockpiled for use in pandemics

By Jeremy Laurance

The Independent

The pharmaceutical giant Roche is being accused of irresponsibly withholding key trial data about a vital flu drug on which governments around the world have spent billions of pounds.

The anti-flu drug Tamiflu has been stockpiled by countries against the outbreak of a flu pandemic since 2004. The UK alone has spent £500m.

Yesterday, the British Medical Journal launched a campaign to persuade Roche to give doctors and patients the full data on Tamiflu, three years after doubts about its safety and efficacy emerged.

In 2009, researchers from the Cochrane Collaboration found that results of eight out of 10 key trials of Tamiflu were never fully published and concluded there was "insufficient data" to show it reduced complications – a vital factor in a pandemic which could save lives.

Roche promised to release the full data, but then reneged on its promise, according to the BMJ. The journal's editor, Fiona Godlee, published an open letter to Sir John Bell, the Regius Professor of Medicine at Oxford University and a board member of Roche, in which she appeals to him to use his influence to persuade the company to release the data "for independent scrutiny".

The two trials that have been published, she says, "were funded by Roche and authored by Roche employees and Roche-paid external experts" and "could not be relied on".

There have now been 123 trials of Tamiflu but 60 per cent of the patient data "remains unpublished", she says. "I am appealing to you as an internationally respected scientist and clinician and a leader of clinical research in the UK to bring your influence to bear," she writes.

"In refusing to release these data of enormous public interest, you [the company's directors] put Roche outside the circle of responsible pharmaceutical companies. Billions of pounds of public money have been spent on [Tamiflu] and yet the evidence on its effectiveness and safety remains hidden from appropriate and necessary independent scrutiny."

The European Medicines Agency announced last week that it was investigating Roche's alleged failure to report side-effects of some of its drugs in as many as 80,000 patients, following a review by the UK Medicines and Health Products Regulatory Agency. If found guilty, the company could be fined up to 5 per cent of its sales in the EU – which amounted to 8.2bn Swiss francs (£5.4bn) in 2011.

In the Commons, the Conservative MP Sarah Wollaston, a GP, called last week for drug companies to publish all clinical trial results, saying it was "vitally important for patient safety" and would give a "completely different evidence base for medicine."

The UK was among the first countries to place bulk orders for Tamiflu (and smaller amounts of Relenza, a rival drug made by GlaxoSmithKline) for stockpiling when fears about a possible avian flu pandemic emerged in 2003 and 2004.

The stockpile was used during the swine flu outbreak of 2009, but because the illness was mild in most people demand remained low.

Dr Godlee said yesterday: "Tamiflu was licensed over 10 years ago and has been in widespread use since. Once a drug is licensed it becomes a drug on which public money is spent and lives may be put at risk. Inevitably if there is information we are not allowed to see we wonder what is in there. There is a legitimate scientific question [about its safety and efficacy] which can only be answered by looking at the data. It is just shocking."

A spokesman for Roche said: "Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered. Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu."

Sir John Bell was not available for comment yesterday.

Source