"It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine." "No one knows the total amount provided by drug companies to physicians, but I estimate from the annual reports of the top 9 U.S.-based drug companies that it comes to tens of billions of dollars a year in North America alone. By such means, the pharmaceutical industry has gained enormous control over how doctors evaluate and use its own products. Its extensive ties to physicians, particularly senior faculty at prestigious medical schools, affect the results of research, the way medicine is practiced, and even the definition of what constitutes a disease." - Marcia Angell, MD Drug Companies & Doctors: A Story of Corruption See also: The Ethical Nag and Dr Marcia Angell Speech (video)
A leading medical journal is launching a global campaign to separate medicine from big pharma, linking industry influence to the pelvic mesh scandal that injured hundreds of women.
The BMJ says doctors are being unduly influenced by industry-sponsored education events and industry-funded trials for major drugs.
Those trials cannot be trusted, the journal's editor and a team of global healthcare leaders write in a scathing editorial published on Wednesday.
The "endemic financial entanglement with industry is distorting the production and use of healthcare evidence, causing harm to individuals and waste for health systems", they write.
They are calling for governments to start funding independent trials of new drugs and medical devices, rather than relying on industry-funded studies. Sponsored research is more likely to find a favourable result compared to independent research, studies show.
Assistant Professor Ray Moynihan, a Bond University researcher studying the link between money and medicine, and is one of the leaders of The BMJ's campaign.
“When we want to decide on a medicine or a surgery, a lot of the evidence we used to inform that decision is biased," he says.
Dr Moynihan points to the example of medical giant Johnson & Johnson, which sold pelvic mesh to thousands of Australian women. It knew the mesh could cause serious harm, but never properly warned women of the risks.
In the US, a court found the same company deliberately played down the dangers and oversold the benefits of opioids, stoking the addiction crisis that claims the lives of 130 Americans a day. The company plans to appeal in both cases.
The FDA does not do independant safety studies, but instead, accepts study conclusions by vaccine makers. And often the raw data is not included, so there is no way for the FDA to verify if the stated conclusions match the data. Eli Lilly reported their conclusion that Thimerosal-containing vaccines are safe in spite of the fact that every study participant who received a Thimerosal-containing vaccine died.
When vaccine makers can't hide the data outright, they use statistical obfuscation to "hide the signal;" the evidence of harm. One way to do this is to remove from the study, participants who react bady, with the excuse the they had a pre-existing condition. Also, a study can be designed from the start to produce a desired outcome. One common technique is, instead of administering an inert (non-reactive) substance to the control group, they use another vaccine. Or they include the same toxic ingredients of the vaccine being tested and simply leave out the viral component and call it a placebo. Then, when the people in the control group have approximately the same number of adverse events as the people in the vaccine group, statisticians will say, "the vaccine did not increase the risk of getting the adverse event over placebo," and that is intrepreted as "the vaccine is safe." In other words, to vaccine makers, it's acceptable that 21 girls in the Gardasil group died, because 19 in the control group also died! But, the 19 in the control group may have died because they were injected with all the same aluminum as those in the vaccine group. See the fraud? It's criminal.
In addition, they will say that some of the deaths in the vaccine group were clearly not related to the vaccine because the deaths are listed as suicide or auto accident. But no one knows if the girls comitted suicide as a result of vaccine side effects, or fainted while driving as a result of vaccine side effects. Syncope (loss of consciousness) is now a known side effect and girls are warned not to drive immediately after the shot. But that warning was not given during the trial. So, perhaps the 40 deaths were indeed due to the shots received during the trial. Yet "scientists" assume they were not, and you are told the vaccine is "safe." And, yet another way vaccine-injury is hidden is by cutting off monitoring after a short time, such as 5 days. If a person dies on the 6th day after the vaccination, the death is assumed to be not related to the vaccination, and not reported in the study. And so, conditions that take longer to develop, such as autoimmune conditions, would never be reported in vaccine studies. The bottom line is that, they say their doing "science", but it's just fraud with a white coat.
"One of the hidden secrets of the medical literature is that the named authors on a paper's byline, particularly in the case of clinical trials, are not necessarily the individuals who wrote the paper. It is not uncommon for pharmaceutical companies, or medical product manufacturers, to write their own papers and then find university professors to agree to be the named authors of the paper. The company employees are then invisible to the readers. Presumably, the suggestion that a certain medication or medical product is safe and efficacious will carry more weight if it comes from an unbiased source, often called a Key Opinion Leader, rather than a company representative. With ghostwritten papers it is hard to know where to draw the line between science and marketing.Because of its secretive nature, the true extent of this practice is unknown." Full article: A Three-part Series on Medical Journal Ghostwriting
"It is a problem for me that I am part of a profession that is systematically lying to people." -Dr Mark Donohoe
"When you have power you don't have to tell the truth. That's a rule that's been working in this world for generations. And there are a great many people who don't tell the truth when they are in power in administrative positions." -Dr. Dean Burk co-founder of the U.S. National Cancer Institute
A lie told each year by the CDC and repeated by doctors (to sell flu shots) is the number of deaths from flu. In 2001 the CDC said there were 62,034 deaths from flu. But 61,777 of those deaths were from pneumonia. In how many cases had flu been positively confirmed? Only eighteen! If the public knew that, how many people would line up for a mercury-containing flu shot? Source: Peter Doshi - BMJ Online (December 2005)
The World Health Organization (WHO-GACVS) developed a two-tiered classification system for assessing and reporting adverse events following immunization (AEFI). The AEFI classification system used in Third World countries disqualifies Deaths following vaccination, as having any causal association with vaccines. The dubious rationale given by the WHO: if there was no statistically significant increase in deaths recorded during Phase 3 vaccine trials, death is not associated with vaccination. Those phase 3 trials are too small and too short to detect rare lethal adverse effects.
After a vaccine is licensed, all deaths and serious adverse reactions that had not been detected in Phase 3 trials are labelled as ‘coincidental deaths /events’ or ‘unclassifiable’. The association of death with vaccination is discounted.
WHO-AEFI classification is used only in Third World countries; those that rely on the WHO sponsored public health programs. One of the vaccines aggressively promoted in the world’s poorest countries by the WHO in collaboration with GAVI the Vaccine Alliance, which is bankrolled by the Gates Foundation, is the pentavalent vaccine — a combination of 5 viruses; diphtheria, pertussis, tetanus, H influenza b and Hepatitis B. This vaccine is a major investment for the WHO and GAVI.
An Exploratory Analysis (2018) by Dr. Jacob Puliyel, head of pediatrics at St. Stephens Hospital Delhi, India, and member of the National Technical Advisory Group on Immunization (NTAGI) of the Government of India, documented that in 2011 following the shift from the DPT (diphtheria, pertussis, tetanus) vaccine, to the pentavalent vaccine, the number of deaths rose precipitously.
Dr. Puliyel calculated that data from states with good reporting of adverse events, suggest that there are likely to be 7,020–8,190 additional deaths each year in India, because of the shift from DPT to Pentavalent vaccine.
The response of the WHO to the alarming death rate was to adopt a new AEFI classification system (in 2013) developed by the WHO with support by the Global Advisory Committee for Vaccine Safety (GACVS) that, in effect, disregards entirely infant deaths following vaccination with the pentavalent vaccine—as if they didn’t happen.
The new AEFI classification was developed by GACVS; it redefined the “cause and effect” relationship between vaccination and death. Whereas non-lethal adverse events following vaccination are recorded, the new WHO classification eliminated the very possibility that death can result from vaccination; death following vaccination is deemed to be only coincidental and not due to the vaccine.
Dr. Raeford Brown, a pediatric anesthesia specialist at the Univ of Kentucky Children’s Hospital and chair of the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics, has been openly critical of big pharma and the lack of proper oversight from the FDA. Despite many politicians beginning to speak out against big pharma, Brown does not think that anything will come out of it “because Congress is owned by pharma.” “The pharmaceutical industry pours millions of dollars into the legislative branch every single year,” he told Yahoo Finance. “In 2016, they put $100 million into the elections. That’s a ton of money.” "I’m really much more concerned because Congress is supposed to have oversight for the FDA,” Brown said. “If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress."
During the ‘17-’18 election cycle, Kevin McCarthy, now the House minority leader after midterms, received the second-highest amount of funds in Congress. The California-based politician received a total of $380,350 in campaign contributions, with a large sum coming from pharma companies such as Abbott Laboratories, Pfizer, Johnson & Johnson , Eli Lilly, Amgen, and Merck. Paul Ryan (R-Wis.), the former speaker of the House, was ranked 10th among members of Congress. He received $222,070, seeing most of the funds coming from Merck. Beto O’Rourke (D-Texas), a former congressman who almost upset Senator Ted Cruz (R-Texas) in the 2018 midterms, was 18th on the list. O’Rourke, seen as a potential 2020 Democratic presidential candidate, received $171,255. Source: Yahoo Finance See also: Pharma Cash To Congress - Campaign Contribution Tracker
DURHAM, N.C. — Duke University agreed to pay out millions in a settlement after the university was accused of falsifying research in order to get grant funds from government agencies, according to the U.S. Department of Justice.
The settlement means that Duke University will not be found liable for the alleged violation of the False Claims Act, but the university will still have to pay $112.5 million to the United States government.
“This settlement sends a strong message that fraud and dishonesty will not be tolerated in the research funding process,” said EPA Acting Region 4 Administrator Mary S. Walker. “We will continue to take appropriate legal measures to ensure a fiscally sound system that protects grant funds.”
Each year, Duke University receives millions of dollars across hundreds of grants from the National Institutes of Health and the Environmental Protection Agency, according to the USDOJ.
The U.S. government alleged that, between 2006 and 2018, Duke knowingly included fake data and statements in 30 grant claims submitted to the NIH and the EPA. As a result, the NIH and EPA paid out funds that they otherwise would not have.
The government specifically believes that there were falsified or fabricated results and statements in a Duke Airway Physiology Laboratory research technician’s research related to mice.
“Taxpayers expect and deserve that federal grant dollars will be used efficiently and honestly. Individuals and institutions that receive research funding from the federal government must be scrupulous in conducting research for the common good and rigorous in rooting out fraud,” said Matthew G.T. Martin, United States Attorney for the Middle District of North Carolina. “May this serve as a lesson that the use of false or fabricated data in grant applications or reports is completely unacceptable.”
Former Duke employee Joseph Thomas, the whistle blower who brought the allegations to the U.S. government, will receive $33,750,000 from the settlement.
Rare is the scientist who goes to prison on research misconduct charges. But on 1 July, Dong-Pyou Han, a former biomedical scientist at Iowa State University in Ames, was sentenced to 57 months for fabricating and falsifying data in HIV vaccine trials. Han has also been fined US$7.2 million and will be subject to three years of supervised release after he leaves prison.
Han was forced to resign from Iowa State in 2013 after the university concluded that he had falsified the results of several vaccine experiments supported by grants from the US National Institutes of Health (NIH). In some cases, Han spiked rabbit blood samples with human HIV antibodies so that the vaccine appeared to have caused the animals to develop immunity to the virus.
In a confessional letter sent to the university just before its investigation concluded, Han said that he began the subterfuge to cover up a sample mix-up that he had made years before. In February 2015, he pled guilty to two felony charges of making false statements to obtain NIH research grants.
Cell lines historically used for vaccine manufacture include human diploid cell lines from fetal lung tissue for rubella, polio, hepatitis A, rabies and varicella; diploid monkey cells for rotavirus and rabies; and kidney cells from African green monkey (Vero) for polio.
Tumorigenic cell lines came into use following consideration of the risks and benefits by the VRBPAC in 1998. PER.C6, an immortalized human fetal retinal cell, was the first tumorigenic cell line used in the production of a vaccine. It was used to produce a replication-defective adenovirus-vectored HIV-1 vaccine. Other tumorigenic cell lines have been approved on a case-by-case basis.
The proposed new cell lines are a CEM leukemia T-cell line, an A549 lung adenocarcinoma cell line and a HeLa cervical carcinoma cell line.
The CEM T-cell line is derived from a patient with leukemia, and is suitable for HIV-1 strains using co-receptor CXCR4. The A549 cell line is from a person with adenocarcinoma of the lung, and is amenable to growth of replication-competent adenoviruses for some investigational vaccines.
The HeLa cell line is derived from cervical carcinoma. HeLa has been used broadly for research purposes and is permissive to the growth of many human viruses, including adeno-associated virus (AAV) for gene therapy applications and for vaccines.
Concerns – and potential hazards – involved with the use of tumorigenic cell lines include the possible presence of residual live cells that could cause tumor growth, residual DNA from the cell substrate, and contamination with adventitious agents, such as viruses that contribute to the tumorigenic phenotype.