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Major drug research company faked thousands of documents to get drugs approved, FDA says no big deal
It is truly astounding to witness the utter corruption that takes place — and practically in plain sight — within the pharmaceutical drug industry. The US Food and Drug Administration (FDA) has announced that drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval. The FDA’s response to this, though is that this massive corruption is basically no big deal.
It is no secret, of course, that the FDA routinely works in illicit tandem with drug companies to get dangerous drugs on the market in exchange for cash. One example of this includes the Lexapro scandal in which the FDA approved this dangerous antidepressant drug for children at the same time as federal and state governments were suing Forest Laboratories, maker of the drug, for pushing it on children (www.naturalnews.com...…).
The FDA’s own scientists have even publicly indicted the agency for censoring truthful scientific data, intimidating and unfairly targeting supplement companies, and using the drug approval system to extort cash from drug companies in exchange for its rubber stamp of approval (www.naturalnews.com...…).
The entire racket between the FDA and Big Pharma is mind-bogglingly extensive, and it is even seen in the FDA’s recent announcement “against” Cetero. While it initially appears that the FDA is upset at Cetero for lying via its clinical trial documents, the agency’s solution is to tell the drug companies to go back and redo them themselves.....
FDA not interested in truly regulating drug industry, tells it to go regulate itself
In the FDA’s recent announcement concerning Cetero, the agency declared that both an internal company investigation and a third-party audit revealed “significant instances of misconduct and violations” in conducting clinical trials. Between April 2005 and June 2009, there were at least 1,900 instances of fraud and falsified studies, and each one of these instances was falsely used to prove that a drug was safe before it went on the market.
“The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame,” said the FDA, noting that drug companies may have to go back and perform new safety studies.
But the real kicker is that the FDA also stated that this is not really that big of a deal. Millions of people’s lives are on the line as potentially fatal drugs were approved with false data — but according to the FDA, nobody should be concerned. In fact, the FDA has known for years that Cetero has been falsifying data, and the agency has done absolutely nothing about it... internationalguy.wordpress.com...
Shouldn't they be hounding the COWS for supplying the raw milk?
Why do you drink milk?
Does cow nipple sweat taste nice?
If you want minerals like calcium and zinc and magnesium etc do what the rest of the developing world does.
Boil then grind up egg shells.. take one of those a day to meet all your needs, I think it contains about 20 minerals.
Better than milk better than any pill. Cheaper too.
U.S. Minerals Management Service (MMS). The program director who snorted speed off a subordinate's toaster oven, and made her give him a blow job while driving around the neighborhood. The two "MMS Chicks" who were notorious for getting plastered at conventions and having one-night stands with oil industry employees.
ALL of the US governments "regulatory" agencies are corrupt. They've all been
bought off. What we need is a blanket independent investigation of ALL regulatory
the agency ordered field staff --
• not to perform E.coli O157:H7 tests on ground beef because the company was
in compliance with Directive 10010.1 and was performing their own
• not to classify E. coli O157:H7 on beef trim as an "adulterant" violating
wholesome meat laws.xii
• to allow 16 square inches of fecal contamination on carcasses....
• not to condemn product dropped on the floor because they could not “prove”
the product fell on a pathogen.
• to accept a one percent positive rate for E. coli O157:H7 as “baseline” and
FSIS smashed anyone who challenged its efforts to protect ConAgra from accountability, not just Mr. Munsell. After Mr. Smith took charge of the Munsell dispute from Washington, every official was moved off the job who blew the whistle internally on harassment of MQF, or who sought accountability from ConAgra. The harassment victims ranged from inspectors to supervisory vets. In some instances the agency simply isolated them from the case. Numerous whistleblowers have reported that the Inspector General staff’s primary interest was to attack the critics, while discouraging or only grudgingly accepting evidence of agency misconduct to shield ConAgra. Agency management forced some of the agency’s most seasoned veterinarians out of the government through steady harassment.
This treatment is consistent with a wide ranging phenomenon since new Labor Management chief William Milton purged the long time career staff of that office, who had earned respect over the years even from critics for objective, constructive resolution in retaliation cases. Leaders from professional organizations and unions alike now express no expectation of fair play within the agency personnel system, claiming that the merit system has been replaced with a reign of terror at FSIS.
Scott Reuben MD has been sentenced today in federal court to 6 months in prison after pleading guilty in February to one count of health care fraud. Dr. Reuben, 51, former chief of the acute pain clinic at Baystate Medical Center in Springfield, Mass., was also ordered to pay a $5,000 fine, $361,932 in restitution to the drug companies that funded his research and to forfeit $50,000 in assets in the case. Once his prison term is up, Dr. Reuben must undergo three years of supervised release, the Justice Department said.....
officials uncovered evidence of wrongdoing following a routine audit. Falsified reports involved at least 21 articles dating back to 1996. The “research” was funded by grants from Pfizer, Merck & Co. and Wyeth/Rays of Hope for the drugs Celebrex, Vioxx and others.... lawmedconsultant.com...
The press has led us to believe that the recall of a medical research paper represents a rare, media-worthy event. Case in point: the week-long blitz announcing the retraction of a single, disputed paper, published in The Lancet in 1998.By comparison, the retraction of more than 100 papers by two medical researchers didn't even make the evening news.The enormity of that recall rattled the entire subspecialty of anesthesiology and pain management. The identification of many more recalled papers exposes the extent of scientific misconduct and the failure of peer review across the entire medical industry.
During the week of March 3, the editors of 16 international medical journals announced the retraction of "unethical" research carried out by German doctor, Joachim Boldt, a leading specialist on intravenous fluid management. Boldt has published more than 200 studies, many on a colloid product called hydroxyethyl starch, or HES.
Anesthesiologists rely on colloids to deliver nutrients to cells and to keep a patient's blood volume high during surgery, thus avoiding the risks that can come with blood transfusions. Boldt is under investigation for allegedly forging up to 90 of his studies, thought to contain bogus, fraudulent, manipulated and/or distorted data. However, an even more serious infraction is that it appearsBoldt did not have the approval of an Institutional Review Board (IRB), an ethics body required by law for all clinical research. Investigations done without the oversight of an IRB is a criminal offense.....
Scientific Misconduct All Around the World
Breached ethical research standards are not isolated occurrences. A search of online journals for "retracted" papers and reviewing the relatively new, important blog, Retraction Watch, reveals an alarming number of papers retracted for data manipulation and other malfeasances. For example, The American Society for Microbiology (ASM), publisher of Infection and Immunity, recently retracted five papers by researcher Naoki Mori, published between 2000 and 2009. ASM also banned Mori from publishing in any of its journals for 10 years. To date, 16 papers of his have been revoked, including studies published in Journal of Virology, Retrovirology, and Blood.
Last month, The Korean Journal of Otolaryngology-Head and Neck Surgery retracted 17 papers published between 1993 and 2006.... www.huffingtonpost.com...
...To highlight the inability to weed out bad research, “they focused on the 49 most highly regarded and cited research papers published in the past 13 years. Of those, 41% had later been disproved when tested, while 24% hadn’t even been retested.” Upon further examination, 3 of these studies, which were later firmly disproved, they “found scientists were more likely to cite the original inaccurate study, in one case for at least 12 years after it was discredited”.
One need look no further than Scott S. Reuben, MD, a Harvard researcher who falsified the VIGOR test on Vioxx and Bextra which resulted in more than 100,000 deaths. There were no patients and he forged the names of doctors to research data.
After more than 100,000 deaths, Dr. Reuben was sentenced to only ten years in prison. Since his fraud makes him the largest serial killer in the history of the U.S., the death penalty would have been more appropriate. The drug manufacturer was not indicted nor punished for using his fraudulent tests. Like all big corporations, the manufacturer claimed they didn’t know.
Another example is Dr. Alan F. Schatzberg, Chair of Stanford’s Psychiatry Department and President-elect of the American Psychiatric Association. Senator Grassley found that Dr. Schatzberg controlled more than $6 million worth of stock in Corcept Therapeutics, a company he co-founded that is testing mifepristone, the abortion drug otherwise known as RU-486, as a treatment for psychotic depression. One does not have to wonder what the findings in his studies said. Forget about drug safety. It is about money, profits and more money....