FDA Caught Covering-Up a Laundry List of Fraudulent Studies

www.realfarmacy.com/fda-caught-covering-laundry-list-fraudulent-studies/

Professor Charles Seife of the Arthur L. Carter Institute of Journalism at New York University recently uncovered some disturbing evidence about the United States Food and Drug Administration (FDA). This information came to light when he made a Freedom of Information request earlier this year. When Seife received his information, he learned that 22 clinical trials submitted to the FDA were falsified, and the results of these falsified trials were not revealed to the public.

With his students assisting him, Professor Seife compared the FDA’s actions regarding these trials against information on them in peer-reviewed studies. The results of Seife’s investigation were recently published in the online journal, JAMA Internal Medicine.

The FDA is keeping the public in the dark about scientific fraud

When clinical trials are found to have violated proper practices or to have been falsified, the FDA takes regulatory action against those conducting the trials. When this is required, paperwork regarding the trials is traditionally marked as “official action indicated (OAI).”

Seife’s investigation revealed that 57 trials received the OAI indicator for everything from bad record keeping (35 studies) to actual falsification of results (22 studies). The affected trials took place between 1998 and 2013. The FDA never informed the public of these findings or of any actions taken against the facilitators of the studies.

How could the FDA allow falsified studies to be published?

While the FDA did take ‘official action’ against clinical trial facilitators who falsified results, they allowed the results to be published. No retractions for these falsified results were ever required. Studies with blatantly falsified results remain in medical journals, misleading other researchers as well as the public about the truth.

It is no longer a ‘secret’, the FDA has violated the public trust.  This is the same organization that refuses to label seafood that has mercury – a known neurotoxic (heavy metal) substance; allows the deadly (artificial) sweetener aspartame to be sold in food products and gives its approval to drugs that cause harm.

By allowing falsified results of clinical trials to remain in publications with no retractions required, the FDA is violating the public’s trust. The public has a right to expect transparency from the FDA, as the health and safety of America’s people depend on it.

Professor Seife has stated that the FDA seldom takes any action to make sure falsified study results are corrected in the medical literature, even when it finds significant departures from good study practices. And, the only reason why the FDA has not been taken down is because the federal government, its regulatory agencies and the U.S. legal system work together to protect corporate interests – while minimizing its exposure to lawsuits.

The evidence is clear: The FDA does not care about public safety

When the FDA does NOT retract inaccurate and/or falsified research projects – this indicates a clear violation of their duties and obligations – both morally and professionally. In fact, the actions of the FDA are criminal – by NOT making every (reasonable) step to protect the population.

And, just in case you have any doubt how bad this organization really is – consider this quote from a credible source:

“The thing that bugs me is that the people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.” – Herbert Ley Jr., M.D., former Commissioner of the FDA.

The FDA consistently acts as the ‘protector’ of drug company profits and supports the monopoly-control that the pharmaceutical industry has over the world.  Not only does the FDA hide fraud, they actually censor quality health information from getting into the public domain. In fact, here are several examples of how the FDA deliberately withholds lifesaving information from the general public:

-Between 1992 and 1996, the FDA prohibited companies that sell folic acid from telling women of childbearing age that .4 mg of folic acid daily before pregnancy could reduce the incidence of neural tube defects (including spina bifida and encephaly) by 40%. FDA’s censorship contributed to a preventable 10,000 neural tube defect births.

-Between 1994 to 2000, the FDA prohibited companies that sell omega-3 fatty acids from telling Americans that those fatty acids found in fish oil could reduce the risk of coronary heart disease by as much as 50%. FDA’s censorship contributed to a preventable 1.8 million sudden death heart attacks.

-Between 2000 and the present, FDA prohibits companies that sell saw palmetto extract (the fruit of the dwarf American palm tree) from telling Americans that saw palmetto reduces enlarged prostates and relieves related symptoms. Approximately 50% of all men age 50 and older suffer from enlarged prostates and are denied access to this information.

-Between 2000 and the present, FDA prohibits companies that sell glucosamine and chondroitin sulfate from telling Americans that those dietary ingredients treat osteoarthritis and relieve osteoarthritic pain and stiffness. Approximately 20 million Americans suffer needlessly from osteoarthritis.

This criminal behavior must be stopped. Without the correct information, other researchers, as well as the general population, are being misled and allowed to go down roads regarding their own studies, health and wellness practices – that lead to nowhere, or eventual harmful outcomes.  The FDA has broken public trust; acted without regard to public safety and must be held accountable for their actions.

References:
http://www.medicalnewstoday.com/articles/289167.php
http://www.smnweekly.com/fda-possibly-hidden-22-fraudulent-clinical-trials/15039
http://archinte.jamanetwork.com/article.aspx?articleid=2109855
http://www.stopfdacensorship.org
Credit: http://www.naturalhealth365.com/clinical-trials-food-and-drug-administration-1328.html
Image Background: Wikimedia Commons

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US Drug Watchdog Urges Pharmacy Clients Who Were Given the Wrong Drug or a Prescription for Someone Else by a Pharmacist to Call Them About Compensation – Were You Injured?

https://www.prnewswire.com/news-releases/us-drug-watchdog-urges-pharmacy-clients-who-were-given-the-wrong-drug-or-a-prescription-for-someone-else-by-a-pharmacist-to-call-them-about-compensation—were-you-injured-300677164.html

WASHINGTON, July 9, 2018 /PRNewswire/ — The US Drug Watchdog says, “We are now urging persons to call us anytime at 866-714-6466 if their local pharmacy provided them with someone else’s prescription or a prescription with the wrong drugs or incorrect dosage. For some people, the outcome of receiving the wrong prescription or a drug prescription with incorrect dosage could be fatal. We would like to help you get compensated. The only catch we have is did you keep the medication and or keep the sales receipt that indicates the error?” http://USDrugWatchdog.Com

The US Drug Watchdog is now warning consumers using a pharmacy drive through in any state nationwide to confirm the drug they are picking up has the correct name on it, the drug is the correct medication prescribed by their doctor-dentist, and do the pills or medication look to be the same as what the consumer has taken before. If not-the group is urging the consumer to park their car and go into the pharmacy and ask the pharmacist about the issue. 

The US Drug Watchdog Is Urging Consumers Nationwide To Be on The Look Out for The Following Types of Pharmacy Errors:

• The pharmacy provided the consumer with the wrong drug medication
• The pharmacy failed to provide the consumer with the proper dosage and usage directions on the label
• The pharmacy filled a prescription for a child with the wrong drug medication.
• The pharmacy provided the consumer with someone else’s prescription
• Giving the young child an unintended drug
• The pharmacy failed to check for any potential medication interaction issues

The US Drug Watchdog says, “We are certain pharmacy prescription errors kill or seriously injure tens of thousands of US consumers every year.  If you possess proof a pharmacy gave you the wrong prescription, a prescription with the wrong dosage or someone else’s prescription, please call us anytime at 866-714-6466-especially if you were injured by the mistake.

“However, as mentioned we will need proof of the mistake either being you still are in possession of the incorrect prescription, or your sales receipt indicates the error. If you possess this type of proof-we will get you to qualified lawyers who have a track record of assisting consumers nationwide with these types of very serious pharmacy error issues. We also want to emphasize this is a national initiative for consumers in every state from Maine to California, Florida, Illinois, Oregon, Texas, Ohio, New York, Oklahoma, Minnesota, Washington, etc.” http://USDrugWatchdog.Com

Two pts take new prescriptions into a pharmacy… one walks away with the wrong medication – a mis-fill – and the second walks away with NO MEDICATION because the pharmacist on duty states that “they are not comfortable” or some other “excuse” … not a valid reason/fact…

Did both pts fail to get the medications that their prescriber intended for them to have… the first is technically considered a MIS-FILL – wrong medication

The second…  should it also being considered a MIS-FILL ?

Both pts walked away from the pharmacy without the medication that their prescriber wanted them to have for their medical/health issues.

If not… is there a DOUBLE STANDARD ?  The primary charge of the 51 Boards of Pharmacy is to protect the public’s health and safety… if these boards only take action against the former issue and not the latter… are they failing to meet their primary charge ?

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I-Team: Online pharmacy shutting down after selling fake cancer drugs

http://abc11.com/health/i-team-online-pharmacy-shuts-down-after-selling-fake-cancer-drugs/3733321/

There are fresh warnings from both state and federal health officials about the risks of buying prescription drugs online.

According to the Food and Drug Administration, 97 percent of online pharmacies are “illegitimate and unsafe,” involving “highly sophisticated criminal enterprises” that sell medicine that “does not work, or worse, is dangerous to your health.”

Elaine Marshall, North Carolina’s Secretary of State, explained to the ABC11 I-Team that online pharmacy schemes also target consumers’ credit card numbers and identities.

“It is a fallacy that they’re in Canada,” Marshall said, referring to the popular notion that cheaper prescription drugs are available north of the border. “You can have all kinds of websites, and put up nice pictures, storefront locations and what have you, and they just don’t exist. They’re made up things.”

Jonathan Harward, Pharmacy Manager at Josef’s Pharmacy in Raleigh, said counterfeit drugs pose significant health risks to consumers because it’s possible the drugs are not the proper dosage, not stored correctly, or may have unknown ingredients.

“If you were to get a counterfeit drug and you were to take it, and you had a side effect – even a life-threatening side effect – we don’t know what that was,” Harward warns. “So it’s going to take more time for the doctor to reverse the effects or treat the effects of what happened to you.

The recent case of CanadaDrugs.com further exemplifies the many risks involved with online pharmacies. The company, which boasts that it has filled more than 7,000,000 prescriptions since its founding in 2001, will shut down on July 13 as part of a plea agreement with federal prosecutors. The indictment, obtained by the I-Team, highlights how investigators found pill bottles with no instructions and labels only in foreign languages; further investigation found CanadaDrugs.com selling two counterfeit cancer drugs with no active ingredients.

Under the terms of the plea, the company must forfeit $29,000,000 of the proceeds of their illegal scheme and pay a fine of $5,000,000. The court also sentenced CanadaDrugs.com’s Chief Executive Officer individually to pay a fine of $250,000 and five years of probation with the first six months in home confinement.

“FDA regulations are in place to protect patients and help ensure the medicines they receive are safe and effective,” said Catherine A. Hermsen, acting director of the FDA’s Office of Criminal Investigations. “The U.S. drug supply is among the safest in the world, but when drugs from outside the FDA’s closed supply chain enter the U.S., patients are put at risk. For the protection of consumers, the FDA will continue to pursue and bring to justice those who attempt to evade FDA’s regulations.”

For consumers wishing to purchase their medicine online, both the FDA and the Federal Trade Commission identify the following signs of a safe online pharmacy:

*Require a valid prescription from a doctor or another licensed health care professional.

*Are licensed by your state board of pharmacy or equivalent state agency. (To verify the licensing status of a pharmacy check your state board of pharmacy.)

*Do not appear on the National Association of Boards of Pharmacy’s “List of Not Recommended Websites.” (Just because the online pharmacy does not appear on this list does not mean it is safe.)

*Have a U.S. state-licensed pharmacist available to answer your questions.

*Are in the United States and provide a street address.

Additionally, the N.C. Secretary of State’s Office is promoting the website VerifyBeforeYouBuy.org, which enables users to simply enter a web address into a search bar and the tool will quickly determine whether the online pharmacy is certified and from a safe source.

“This is directed to help individual citizens,” Secretary Marshall insisted. “It is intended for consumers, it is health and safety issues by the medical community.”

All medications – both OTC and Rx – have a mandatory storage temperature … typically 55F – 85F for most.  Manufacturer, wholesaler and pharmacies are required to maintain those storage temperature.  But… once a pharmacy hands a filled prescription over to a delivery carrier… they are not obligated to maintain that storage temperature.  It is my understanding that there is a 24 hr “grace period” for medications to be outside of the required temperature and any outside of that range for > 24 hrs… is considered adulterated/contaminated and should be destroyed.

Many years ago, I read a report where some entity did a test on a inhaled medication ( I think) that was shipped/mailed to a address in the SW of the USA in the summer and when the contents were analyzed – after being in the heat of summer – LOST HALF OF ITS POTENCY !

I wonder how many deaths, these sort of things have caused and the person’s death was determined to be the deterioration of their health issue as the cause of death and never considered the possibility that the pt was getting their medication via mail order and they could have been sub-potent and contributed to the pt’s death ?

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Florida Attorney General Candidate Ashley Moody Stops in Bay County

https://www.mypanhandle.com/news/florida-attorney-general-candidate-ashley-moody-stops-in-bay-county/1287678156

BAY COUNTY, Fla. – Ashley Moody, a republican candidate for for Florida Attorney General made a stop in Bay County.

The Plant City native is familiar with Bay County, her mother born and raised in Panama City. Moody is a former federal prosecutor and judge married to a DEA agent. She plans to fight opioid epidemic by continuing the conversation and focusing on synthetic drugs like fentanyl.

She said she doesn’t believe in the separation of families at the border but said the administration is doing their best to correct it, and still follow the law.

“If i’m given the chance to be attorney general I will do so in a way they can be proud of their support, and will be a strong, effective attorney general for Florida,” said Moody.

Moody will face fellow republican Frank White in the primary election in August. If she wins there she will face the winner of the democratic candidates in November.

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Kasich team’s CVS ties questioned amid pharmacy benefit manager inquiry

http://www.dispatch.com/news/20180708/kasich-teams-cvs-ties-questioned-amid-pharmacy-benefit-manager-inquiry

The administration of Ohio Gov. John Kasich has been less than forthcoming about critical aspects of CVS’s business with the state as the pharmacy giant faces scrutiny over its Medicaid-related operations.

Possible conflicts of interest between the Kasich administration and CVS are fueling skepticism over whether Ohioans will see changes in a Medicaid setup that gives the national pharmacy company up to six times its actual cost of providing prescription drugs to Ohio’s poor and disabled.

The relationships are shrouded in secrecy — in part because of confidentiality laws and in part because the administration of Gov. John Kasich has been less than forthcoming about critical aspects of CVS’s business with the state.

The concerns are heightened because Medicaid officials withheld key information from state legislators about CVS costs and displayed a reluctance to make substantive changes to a system that many lawmakers and pharmacists say is a ripoff of taxpayers.

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https://video.vice.com/en_us/embed/5b3e30aebe40770821623321

5 minute video… making healthcare AFFORDABLE

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But I’m about to do a live feed  ( https://www.facebook.com/iamafibrowarrior ) I need all chronic pain patients to make these signs and post them in fact maybe even put it as their profile picture so we let the legislators know that we’re damn voters and we count

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https://www.civilized.life/articles/jeff-sessions-sabotage-medical-marijuana-research/

Attorney General Jeff Sessions hasn’t been able to institute any marijuana crackdowns due to political pressures in Congress, but he has found one area where he can stymie marijuana growth: research.

It’s been nearly two years since the Drug Enforcement Agency (DEA) announced it would open up the process for producing marijuana for research by the federal government. The DEA contracts outside companies to grow or manufacture illegal drugs so they can study them further. And yet despite opening up the process, the DEA still hasn’t picked any companies to provide marijuana for the process, and that’s exactly what Sessions wants.

Historically, while the Attorney General does oversee the DEA, they usually stay out of the process of researching marijuana. And yet Sessions inserted himself fully two years ago, and he’s refused to authorize anyone to begin growing marijuana for research.

Several members of Congress have questioned Sessions about the situation, and he’s given no indication as to when (or possibly if) he will make a decision. In April, Senators Orrin Hatch and Kamala Harris gave Sessions a deadline of May 15th to give them a timeline. That deadline was ignored.

Sessions claims that the DEA cannot handle overseeing more applications for marijuana growers, which is why he needed to get involved. And yet, the DEA has approved 26 applications for manufacturing other illegal drugs to study in 2018 alone. 

Unfortunately it doesn’t seem Congress is to intent on forcing Sessions to make a choice as all they’ve done is send a few letters to him. 

But why is Sessions so reluctant to allow this marijuana research to continue? If marijuana has no benefits, as he claims, wouldn’t the research simply prove him right? Or does he know that the research proves his antiquated ideas about cannabis are wrong, and he knows if he allows more research it will only become more apparent how wrong he is?

Pres Trump has had such a dramatic turnover in his Cabinet and yet this BOZO… is still around…

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@CVS Health/Caremark/Silver Scripts screwing pts on Medicare Part D ?

I called Senator Donnelly’s DC office about the issue that I had made in the above blog post earlier in the week… and you can read the letter that I got back from his office.  Being overcharged by CVS Health/Caremark/Silver Scripts has NOTHING to do with the donut hole with Medicare Part D.

The fact that over a ONE YEAR period… Silver Scripts was going to OVER CHARGE us enough on ONE PRESCRIPTIONS that would pay for ONE YEAR’S cost of property tax and insurance on our home. – NO SMALL SUM…

Early this week both Sen Warren (Mass) and Smith (Minn) has a press release about PBM’s and their role of high prices.. I attempted to contact their DC offices as well… but.. since I am not one of their constituents… not interested… I guess only FACTS from their constituents or those lobbyists with contribution to their re-election campaign are worth talking to.

You can read Sen Donnelly’s letter… Sen Donnelly is up for reelection in Indiana this Nov.. a Democrat in a normally very politically RED STATE…

I fully realize that Sen Donnelly didn’t himself generate this email, but if this is representative of the quality and training of his staff… IMO.. he has a problem…

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