We Got Your Six: Hiram Ropson

With Marj Matchee and Special Guest Host Mike Rude.

One of our brothers needs our help. Click on the GoFundMe link below to donate.

We are asking for our veteran community to help out one of our own.!
The Rude Awakening Tour and We Got Your Six with Marj & Kentrina are promoting a GoFundMe page Veteran Hiram Ropson. Please listen and share his story so we can begin the process as this is a timely matter.

A little goes a long way #inthistogether

Hiram is raising money for reconstructive surgeries on his windpipe and voice box, resulting from prolonged intubation from pancreatitis in 2019.  Surgeries will be performed in late summer out of province and when the travel band is lifted, additional procedures out of the country. 

Hiram is a hardworking and giving man that typically would not ask others for financial assistance but unfortunately is in a position where he has no other option.  He has been unemployed since hospitalization, denied disability, and even after MCP reimbursement, he will still have to bare 80% of the cost. 

These surgeries are desperately needed to repair his speech and allow him to breathe…

Any help will be greatly appreciated. Thank You!

48844684_1592243483298119_r.jpeg

https://www.gofundme.com/f/xjay2-help-hiram-breathe?utm_source=facebook&fbclid=IwAR3o43QXx3K9dxut1XboxA1uhYHoTwD1vVEyTZATrAx4f_geplOyXZG9e_E

We Got Your Six: Colin Seymour

With Marj Matchee and Special Guest Host Mike Rude.

” I couldn’t leave it like that so I took it upon myself to fix it”

Colin Seymour

One person can make a difference,all you have to do is care enough to do something about it. For this gentleman it will last forever in over 400 veterans and service personal signature on boards from across Canada that created a very special “Bench”.
Colin Seymour thank you for honoring our Veterans and for the respect you have shown to our fallen hero and his family.
RIP Sgt Craig Gillam and our condolences to his family

We Got Your Six: Tom Anderson

With Marj Matchee and Special Guest Co-host Mike Rude.

Tom Anderson is an incredible inspiration who continues to act in the service of others. A very special thank you for your service, Tom, and for your courage and leadership.

Wounded in theater and left with lifelong disabilities Veteran Tom Anderson is one tough warrior, and after sacrificing so much this veteran still felt it important to reach out to other veterans in need. Tom does not know the word quit!!! Mike rude presents Tom with a well deserved Battle Buddy.

Mao’s Cold War: When India And Communist China Became Enemies

The history behind the tensions between the two most populous nations in Asia, and the world.

In light of the recent border incident between the PLA and the Indian Army, where a Chinese soldier reportedly had his ass kicked by Indian troops, I thought I would share this video with you. It provides a look into the history between India and China starting in 1949 and the border dispute between them that continues to this day.

Interviews with Chinese veterans of the conflict tell of the mindset of PLA troops and of the many hardships and sacrifices they had to endure, only to see them made in vain by Mao.

It’s an interesting watch whether you’re a student of international relations or not, and is an excellent opportunity for us to get to know just a little bit more about our enemy.

Clinical Drug Trials: Part Three, Toxic Therapies

Hydroxychloroquine (HCQ) and Mefloquine.

Coronavirus: FDA looking at therapies being tested against coronavirus

On March 19th, 2020, Donald Trump announced at a news conference that the anti-malarial drug hydroxychloroquine was going to be a “game changer” in the fight against COVID-19. It is not as benign as taking an aspirin as some are suggesting. This drug can cause serious side effects including a very dangerous heart arrythmia which can be fatal, as well as damage to the retina which can lead to loss of vision. In some rare instances severe psychiatric adverse events have also occurred. The president’s statement was, in my opinion, both dangerous and irresponsible.

In fact numerous studies of hydroxychloroquine around the world have been halted recently because of reports of cardiac arrythmia among test subjects. Cardiac arrythmia is serious in that it can quickly lead to cardiac arrest and death, and was one of my main objections to using hydroxychloroquine (HCQ) as a treatment for COVID-19.

So I decided to utilize covid-trials.org and ClinicalTrials.gov to see what studies I was able to pull up on the anti-malarial drugs hydroxychloroquine and mefloquine in relation to their use as a treatment for COVID-19.

Hydroxychloroquine (HCQ)

I go to covid-trials.org and click on “(Hydroxy)chloroquine” in the area labeled “Treatment” in the upper right hand corner, and 272 trials that come up out of a total of 1,476 today. As I scrolled through the list searching by country I noticed a lone study being conducted in Russia and clicked on it (link below).

When I read the title of the study I was absolutely stunned. The study would be testing both HCQ and mefloquine as potential treatments for COVID-19, both of which come with the possibility of causing severe adverse events. As I began reading through the protocol that would be used for the trial I was even more stunned by the dosages that are to be given to the subjects in this trial. From the knowledge that I have acquired over the last several months I surmised that the dosages were extremely high for both drugs and posed a very significant threat to the health and safety of the subjects in this trial.

Arm Intervention/treatment 
Experimental: group 1 cohort 180 patients who receive Mefloquine prescribed according to the following scheme:1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day – 1 tablet every 8 hours.Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day – 1 tablet every 12 hours.3rd – 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.Drug: Mefloquine1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day – 1 tablet every 8 hours.Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day – 1 tablet every 12 hours.3rd – 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
Experimental: group 1 cohort 280 patients who receive Hydroxychloroquine prescribed according to the following scheme:• 1st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day; 2nd – 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.Drug: Hydroxychloroquinest day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;nd – 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.
Experimental: group 2 cohort 1A concomitant therapy consisting of Mefloquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Mefloquine is same as for group 1 cohort 1.Combination Product: Mefloquine + azithromycin + / – tocilizumab1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day – 1 tablet every 8 hours.Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day – 1 tablet every 12 hours.3rd – 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time.
Experimental: group 2 cohort 2A concomitant therapy consisting of Hydroxychloroquine in conjunction with azithromycin and tocilizumab will be given for 80 patients. Dosage of Hydroxychloroquine is same as for group 1 cohort 2.Combination Product: Hydroxychloroquine + azithromycin + / – tocilizumabst day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;nd – 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day.

In order to confirm what I was thinking I sent the information to Dr. Remington Nevin, Vermont based epidemiologist and specialist in the quinoline class of anti-malarial drugs. This is what he had to say:

According to the summary, 160 subjects will be given mefloquine 750 mg on Day 1, then 500 mg on Day 2, then 250 mg on Days 3-7. This is, simply put, a recipe for psychosis. 
There are no apparent provisions for stopping the administration at the onset of prodromal symptoms such as insomnia or abnormal dreams. Nor does the summary appear to acknowledge the risks of this dosing schedule.

Dr. Remington Nevin
Director, The Quinism Foundation

A Study of the Effectiveness of an Off Label Mefloquine Use for the Treatment of Patients With COVID19

https://clinicaltrials.gov/ct2/show/NCT04347031

Mefloquine

ClinicalTrials.gov contains more than just information about COVID-19 testing, so I took the opportunity to do a search of all registered trials for the antimalarial drug mefloquine, finding a total of 74 worldwide. Some were completed while others were just in the process of recruiting volunteers. I scanned the list looking at the conditions that were to be treated and, as expected, most were for the treatment and prophylaxis of malaria and included routine studies for bioequivalence and safety profiles.

Row number 6 on the list caught my eye immediately however because it was to be used to treat Progressive Multifocal Leukoencephalopathy (PML) which is a very rare, very serious brain infection caused by the John Cunningham (JC) virus. It is typically seen in patients who are HIV positive and is often fatal.

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It was first registered in 2008 and the final results were posted in 2014. The tests were to be conducted at a dozen research hospitals across the US. Investigators were only able to to find a limited number of subjects and the trial was halted following the deaths of two of them. Of this study Dr. Nevin would say:

It’s hard to draw any conclusions from these results. PML is a serious and potentially fatal illness, and the number of subjects in each arm is very small. About the only thing that can be concluded is that mefloquine is not a miracle treatment for the condition. 

Dr. Remington Nevin
Director, The Quinism Foundation

A study of mefloquine treatment for progressive multifocal leukoencephalopathy: results and exploration of predictors of PML outcomes

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3758507/

The use of mefloquine as an adjunct to chemotherapy for glioblastoma has also been explored.

MD Anderson Cited For Patient Care, Safety Problems – Houston ...
M.D. Anderson Cancer Centre, University of Texas, Houston

This Phase I trial sponsored by the M.D. Anderson Cancer Centre in Houston, Texas, is studying whether mefloquine would be effective as part of the chemotherapy regimen for the serious type of brain cancer. A brief summary of the study reads:

This phase I trial studies the side effects and best dose of combination chemotherapy in treating patients with glioblastoma multiforme after radiation therapy. Drugs used in chemotherapy, such as temozolomide, memantine hydrochloride, and metformin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing them or stopping them from dividing. 

Mefloquine may help temozolomide, memantine hydrochloride, and metformin hydrochloride kill more cancer cells by making tumor cells more sensitive to the drug. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy

https://clinicaltrials.gov/ct2/show/NCT01430351?term=mefloquine&draw=2&rank=28

Worth A Look

Whenever we make decisions that will have an effect on our health, be it going on a diet or taking a prescription medication, it’s always best to have access to as much information as possible in order to make the correct decision. These databases contain a great deal of valuable information and I would encourage everyone to utilize these valuable tools.

Remember, stay informed and stay healthy.

We Got Your Six: Paul Miller

With your hosts Marj Matchee & Kentrina Jenkins

In response to questions from Paul Millers post this morning this is what Paul said to me “ We are just waiting to see if we proceed in the Federal Court or the Superior Court. The case will be going ahead one way or another. “ Paul talks about this coming up in this video. You can hear it explained. – Marj Matchee

For context the Facebook post that Marj is referring to is this one that Paul Miller made on May 27th, 2020, regarding a motion hearing in Federal Court.

Paul Miller discusses the case in this interview that was originally broadcast on February 22, 2020.

We Got Your Six: Derek Bodner

With your hosts Marj Matchee & Kentrina Jenkins

We Got Your Six is pleased to reach into our archives and present this interview that we did with Derek Bodner.

WGYS wanted to bring on this gentleman because he quietly entered the advocacy world with the only weapon he knew he could use to help spread the truth about the use of experimental drugs on the military in particular Mefloquine and the corruption and lies embedded in its legacy of horror.

Many have asked us who he was. So many in our mefloquine community asked “Who is this Derek Bodner”

Let us introduce you ….

A few months ago I had a conversation with Marj and Trina where I talked a little about myself and what motivates me to do what I do to help our veterans.

The Tiananmen Square Massacre Photo Series

Website commemmorates June 4th

On the sixth of March, 1989, an organization called China News Digest International, Inc. (CND) was established in the state of Maryland. The company’s website states the following:

China News Digest International, Inc. (CND) is a IRS-determined 501(c)(3) non-profit organization registered in the State of Maryland, United States. CND publications, including the first-ever online Chinese magazine, Hua Xia Wen Zhai (HXWZ), can be accessed free of charge. CND is independent of any other organizations and strives to be impartial on the issues and news it reports. (English translation of the original Chinese)

CND website
http://hx.cnd.org/about-cnd/

On March 6th, 1999, CND marked its ten year anniversary with a special issue. It contained a letter from the then Editor-in-Chief, Bo Xiong, in which he answered the question “What is CND?” He states:

CND is a volunteer news organization operating on the internet to disseminate news aboiut China.

The world is no longer what it was, the internet is no longer what it was and the free services provided by CND are greatly expanded.

CND maintains its voluntary and non-profit nature of the organization, continues to aim at providing news and other information services to readers who are concerned primarily about China-related affairs, remains independent and strives to be impartial on issues and news it reports.

Bo Xiong, Editor-in-Chief
http://www.cnd.org/CNDhistory.html

In the People’s Republic of China news is very strictly controlled and censored, such that Chinese citizens only get whatever information that the government allows them to have. In a society where harmony is paramount controlling the message is essential, and the Chinese Communist Party (CCP) will go to great lengths to see to it that this happens.

What CND offered its readers instead was unfiltered news about the issues that were important to them, from an independent and unbiased source. Although the website isn’t available in China, the people reading it were originally from there and likely as not some would have left family and friends behind in China. Chinese citizens could then potentially recieve news reports from abroad, which would at least give them a much better idea about what was really happening within their own country.

TAM Photo Series

In addition to the TAM Massacre Photo Series, CND also has a TAM Demonstration Photo Series on its website. These images were taken between April 19th, when the first act of defiance took place in Tiananmen Square, and the day of the massacre on June 3rd.

http://www.cnd.org/June4th/demo.html

June 3rd-16th, 1989

There were still a few western journalists in Tiananmen Square square, referred to by some as TAM, when the PLA began rolling in on the night of June 3rd, but Chinese security agents would be on the lookout for them. Their cameras and film would be confiscated in order to ensure that no photographic evidence would make it to the outside world. They faced the possibility of being held in detention, or perhaps even worse.

However, as the Chinese People’s Liberation Army began liberating the people from their time here on Earth, some very brave individuals decided to put their own safety in great peril in order to capture these events on film. A picture taken by AP photographer Jeff Widener, which would come to be known as “Tank Man”, would become one of the most iconic photographs of the twentieth century.

A warning however that some of the images are graphic in nature and may be disturbing to some people. Discretion is advised.

 A young man stands in front of tanks heading down Chang’an Boulevard on June 5, 1989, in front of the Beijing Hotel. The tanks stopped their advance momentarily as he pleaded for an end to the killing in China’s capital. (Photo by AP Photographer Jeff Widener)
A young girl presents flowers to the Monument to the People’s Heroes on TAM square.
A worker is helped through the crowd at TAM after being wounded in a clash with police outside the Great Hall of the People. The army helmet he is carrying fell off a soldier during the melee (6/3)..
Beijing citizens yell oaths against the Chinese government as they surround the body of a man who died when an armored personnel carrier on its way to Tiananmen Square crashed through a troop convoy.
 Tanks and a dead body on Tiananmen Square at dawn of June 4th.
With tears in their eyes, student withdraw from TAM (early morning 6/4).
Beijing citizens help remove an injured student from TAM following a clash with Chinese army troops (6/4).
A crowd of Chinese give way to a busload of foreign tourists to watch a dead body Monday morning, victim of the first night of violence as PLA troops shot their way into TAM (6/5).
Relatives and friends, covering their noses against the stench, try to identify the dead at Fuxing Hospital in western Beijing (6/5).
A rickshaw driver fiercely paddle the wounded with the help of bystanders to a nearby hospital. Soldiers again fired hundreds of rounds towards angry crowds gathered outside TAM (6/4).
Dead bodies, victims of last two days of violence in Beijing, lay in a makeshift morgue at the Post and telecommunications Hospital in western Beijing (6/5).
Relatives outside Beijing’s Post and Telecommunications Hospital Monday mourn the death of a Beijing University student killed during the last two days of violence (6/5).
A bloody dead body was removed from the street.
A seriously wounded student lying on a stretcher is transported to a hospital.
Students carry a gun-fire wounded classmate to the hospital.
A human body was crushed to pieces by PLA’s tanks.
PLA soldiers, with guns pointing at the students on TAM, stand in front of the Great Hall of the People. The gun fire from one of the guns can be seen in the picture.
Tiananmen Square, and the area of Chang’an Boulevard in front of it, became an armed camp after more than 200 tanks came into the city overnight (6/5).
Ten armed soldiers beating a student to death in TAM Square during the massacre (6/4).
Beijing citizens show bullets and shells to news reporters.
Two people hiding beneath a car as a military truck passes by (6/7).
Fang Lizhi, astrophysicist andChina’s most famous dissident, has been allowed to take refuge in the US Embassy in Beijing, a State Dept. spokesman in Washington announced Tuesday. Hard-liners have blamed Fang for instigating the China’s student democracy movement. This photo was taken on June 3rd.
A wall of tanks and APCs greet bicycle commuters near TAM Square (6/13).
China national TV reportedThursday(6/16/89) a Shanghai Court has sentenced three men to death in anti-government riot of June 6. He is one of the three (6/16).
PLA tanks on Jian Guo Men Wai Bridge after Tian An Men massacre.
Truckloads of PLA soldiers driving to TAM on Chang An Boulevard.

Clinical Drug Trials: Part Two, The Databases

Detailed Information On Over 300,000 Clinical Trials Worldwide Including COVID-19 Available Online

As the clinical trials for a treatment and vaccine for COVID-19 continue, the results of concluded studies are being released in the media on an almost daily basis. Last year I wrote a post that explained the processes that are involved in performing these trials as well as the phases of a clinical drug trial. Because trials are now very topical, I decided to republish some information from that post which explains how clinical trials work.

Part two will look at the legislation governing registration and reporting compliance for most clinical trials conducted in the United States. It will also examine the online databases that have detailed information about these trials and the tens of thousands of others conducted in over 200 other countries.

Finally, part three will examine the studies conducted for the antimalarial drugs hydroxychloroquine and mefloquine. These studies will include those for the treatment of COVID-19 along with other off-label uses.

The search for a treatment and a vaccine for COVID-19 has translated into an increased interest in clinical drug trials on the part of the general public. It isn’t uncommon nowadays to learn the results of one particular study or another in the newsmedia. For the most part however this information is of absolutely no interest to the vast majority of the general public, because these results will have no significance to them whatsoever.

But this pandemic has had a major impact on billions of people in one way or another, and so there has been a great deal of interest in clinical trials and studies relating to COVID-19. There are a number of websites available to the public that can provide detailed information on hundreds of thousands of clinical trials.

The average person will find academic research papers difficult to read because of the technical and scientific terminology and concepts within them, and thus they won’t be able to interpret the data. Every research paper however will have a summary, usually at the beginning, that presents the results in language that is easier for the public to understand.

Google Scholar

For a limited period a number of medical and scientific journals are opening up articles on COVID-19 to the public on Google Scholar. You can now access the most up to date information from a dozen sources including the New England Journal of Medicine (NEJM), the Journal of the American Medical Association (JAMA), and The Lancet without a subscription.

Clinical Trial Databases

There are a number of clinical trial databases to be found online when you do a Google search, so I’m only going to discuss the two that will be of the most help. Those being covid-trials.org and ClinicalTrials.gov.

covid-trials.org

This website is strictly dedicated to tracking COVID-19 clinical trials around the world and can be used to track them by country or by treatment. It’s a very informative website and lists the dozens of treatments that are being tested around the world, including a number of anti-viral drugs like remdesivir, biologic response modifiers such as avdoralimab, as well as corticosteroids and a large host of others.

There is also an eclectic mix of proposed therapies that include such things as Traditional Chinese Medicine, and a herbal concotion of marshmallows and licorice from Iran (click on the link to see it).

https://en.irct.ir/trial/46903

The site is fairly straightforward and easy to navigate allowing you to search by treatment, outcome, and country. Detailed information about each study can be found by clicking on the study you want at the bottom of the screen.

http://covid-trials.org

ClinicalTrials.gov

ClinicalTrials.gov is perhaps the most comprehensive with access to over 300,000 clinical trials from over 200 countries. For studies taking place in the United States, it is mandated that all clinical trials, with a few exceptions, be registered on the site as per the Final Rule (42 CFR Pt 11) set forth in FDAAA 801.

https://prsinfo.clinicaltrials.gov/

Purpose Of The Registry

Establishing the registry served several purposes and was of benefit to a number of groups. These are spelled out on the ClinicalTrials.gov website.

Registry Purpose

Registry PurposeGroup That Benefits
Fulfill ethical obligations to participants and the research communityPatients, the general public, the research community
Provide information to potential participants and referring cliniciansPatients, clinicians
Reduce publication biasUsers of the medical literature
Help editors and others understand the context of study resultsJournal editors, users of the medical literature
Promote more efficient allocation of research fundsGranting agencies, the research community
Help institutional review boards (IRBs) determine the appropriateness of a research studyIRBs, ethicists
https://clinicaltrials.gov/ct2/manage-recs/background#WhatIsThePurpose

Results Database Purpose

Results Database PurposeGroup That Benefits
Provide a public record of basic study results in a standardized formatResearchers, journal editors, IRBs, ethicists
Promote the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledgePatients, the general public, the research community
Reduce publication and outcome reporting biasesUsers of the medical literature
Facilitate systematic reviews and other analyses of the research literatureResearchers, policymakers
https://clinicaltrials.gov/ct2/manage-recs/background#WhatIsThePurpose

There is without a doubt an enormous benefit to the scientific and research communities in having this database, allowing information to be shared worldwide. However creating a sense of transparency and providing patients with more information was one of the primary purposes for establishing the registry.

Background

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a “registry and results database.”

ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 214 countries.

ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). See FDAAA 801 and the Final Rule for more information. However, the rate of study registration has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators have voluntarily registered their studies.

The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA (FDAAA 801) requires more types of trials to be registered and additional trial registration information to be submitted. The law also requires the submission of results for certain trials. This led to the development of the ClinicalTrials.gov results database, which contains summary information on study participants and study outcomes, including adverse events. The results database was made available to the public in September 2008. FDAAA 801 also established penalties for failing to register or submit the results of trials. In September 2016, HHS issued the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifying and expanding the registration and results information submission requirements of FDAAA 801. This regulation takes effect in January 2017.

https://clinicaltrials.gov/ct2/about-site/background

File:Food and Drug Administration logo.svg - Wikimedia Commons

Perhaps the most important pieces are information to be found in this or any database is the results of the clinical trials. It is in these results that the viability of a particular treatment is assessed and could determine whether or not a drug is approved by the FDA. Of particular signifigance are the reports of adverse events. Adverse event reporting is mandated in all clinical trials and any adverse events that occur during a clinical trial must be thoroughly documented and reported to the registry.

After a drug has been approved for use it also must undergo what’s known as post-marketing surveillance studies. These are necessary after a drug goes to market because these are a monitor for adverse event reports, which are relevant to patient safety. A large number of adverse event reports after approval could lead to a suspension of that approval pending further study. Something like this could cause a drug manufacturer to delay submitting the results, which is why they must be submitted by a particular date or face sanction. According to Section 801 they must be reported no more than one year after being approved.

Not Applicable Outside US

These regulations only apply to clinical trials performed in the United States. There is no legal obligation for studies done outside of the country to be registered on ClinicalTrials.gov, however most do in the spirit of scientific cooperation among researchers internationally.

Fraudulent Results

There have been instances in the past where studies have contained fraudulent results. This usually happens by means of omitting or witholding data that would effect the outcome of the study. For example adverse event reports are left out of a study in order for a drug to be approved by the FDA. While the FDA does perform an audit of the data in clinical trials, it doesn’t happen until sometime after a drug has been approved.

The FDA however has approved drugs in the past that it has KNOWN contained fraudulent research. An article in Scientific American from 2013 reads in part:

The health threat was potentially serious: About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests. The vast majority, 81, were generic versions of brand-name drugs on which Cetero scientists had often run critical tests to determine whether the copies did, in fact, act the same in the body as the originals. For example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation’s largest grocery-store chains for months before the FDA received assurance they were safe.

The rest were new medications that required so much research to win approval that the FDA says Cetero’s tests were rarely crucial.

Stone said he expected the FDA to move swiftly to compel new testing and to publicly warn patients and doctors.

Instead, the agency decided to handle the matter quietly, evaluating the medicines with virtually no public disclosure of what it had discovered. It pulled none of the drugs from the market, even temporarily, letting consumers take the ibuprofen and other medicines it no longer knew for sure were safe and effective. To this day, some drugs remain on the market despite the FDA having no additional scientific evidence to back up the safety and efficacy of these drugs.

FDA Lets Drugs Approved on Fraudulent Research Stay on the Market
https://www.scientificamerican.com/article/fda-let-drugs-approved-on-fraudulent-research-stay-on-market/
Arakoda Now Available for Malaria Prevention - MPR

Then there is the anti-malarial drug tafenoquine, which goes by the brand name Arakoda. In 2018 the FDA approved the drug on the strength of fraudulent and misleading clinical trial data. Critical adverse event reports were omitted from the results of a clinical trial performed on Australian troops in the early 1990’s, and there was evidence that the trial was also performed in an unethical manner. Despite there being a large body of evidence, the FDA ruled that the claims were unsubstantiated and approved tafenoquine for use.

https://onecalgaryvoter.com/2019/08/11/an-advocate-equalizer-international-exclusive-australian-defense-forces-brass-engineer-cover-up-of-a-drug-trial-that-tested-a-controversial-anti-malarial/

No FDA Enforcement

According to information provided by the FDAAA Trials Tracker only 69% of clinical trials have registered their reports on time, translating to over $10 billion in fines. These are only potential fines however since the FDA has not seen fit to levy any, despite having this ability for three years. There’s no fear in flouting regulations when you know you that can get away with it.

https://fdaaa.trialstracker.net/?status%5B%5D=overdue&status%5B%5D=overdue-cancelled&status%5B%5D=ongoing&status%5B%5D=reported&status%5B%5D=reported-late

It goes without saying that the amount of work that needs to be done by regulators during the drug approval process is enormous. That being said cutting corners and approving drugs without the proper reviews is potentially very dangerous for the public, with patient safety being put in jeopardy. We need to trust that the drugs we take are going to be safe and that there are agencies in place that will ensure this happens. Unfortunately consumers can’t entirely trust the regulators to do their job, and so are taking a risk with each prescription drug they choose to take.