No Oversight of Executive Agencies

For a few years now, I have been trying to get Congress to consider a particular question requiring the oversight of an executive agency, and congress simply says it is not their job. The job description of the Senate Intelligence Committee, on their website, assures us that they are there, on duty to protect the rights and the liberty of the American people. Yet when any question arises, we are sent to the agencies themselves that are in need of oversight, and are promptly dismissed. The FBI and the CIA, or the DHS as these are now called, simply do not even take complaints regarding the violation of privacy. liberty, free speech and such. State police will not examine any crime if they think it was done by a federal agency. A seven page letter to the Intelligence Committee detailing plenty of reason to raise a question has been simply ignored. Meanwhile, these are sensitive issues, and these need to be addressed somewhere other than the press, that fourth branch of government that does sometimes kick in when the other three are failing.

The mission of the Senate Intelligence Committee is:

About the Committee | Intelligence Committee

 

Mission:  The Committee was created by the Senate in 1976 to “oversee and make continuing studies of the intelligence activities and programs of the United States Government,” to “submit to the Senate appropriate proposals for legislation and report to the Senate concerning such intelligence activities and programs,” and to “provide vigilant legislative oversight over the intelligence activities of the United States to assure that such activities are in conformity with the Constitution and laws of the United States.”

Now, if, just for example, my former fiance was a person who was set on me in order to spy on me due to proximity to CIA and FBI persons in the course of my education- a PhD in politics- there is no one else that is going to do anything about this. Confidential Informants, not to mention hired agents, are routinely set on suspicious individuals, and it is fine with everyone if these agents commit what amounts to rape, allowing a targeted person even to fall in love with an agent for the purposes of spying on that person. And you know, one can never be too sure. One might, for example, have angered a certain powerful but rogue agent who has risen to a position of control in the agencies, and the chain of command will simply not allow any questions to be raised within these agencies themselves. Since the agencies are deeply and covertly involved in education, including spying on students in their proximity, a rouge agent is free to blacklist, set women upon, and destroy the career of any student they do not like. Agents in the positions of professors might simply ignore, and never speak to a certain student, making job applications and writing grant proposals useless. No questions will ever be raised, and the agencies have far reaching powers through the internet. They can commit murder, and no one will raise a question, let alone hold anyone accountable. They can make death threats if anyone presses a question, and carry these out if only someone in their agencies wants to do these things. They can slander with the epithet of madness anyone who raises questions, just like in the old Soviet Union, where political dissidents were considered “insane” for not believing the basic tenants of Marxism and Leninism. Any of this is just fine, and it does matter how many reasons or how much reason one brings forward to inquire into a particular matter- no one will do it. The President himself might do it, but as we tell our congressmen, the president is kind of busy.

I want the committees of Congress to ask these agencies to tell the truth regarding every single thing that has ever been done to me in the course of my education. At the University of Dallas, a woman who happened to work in the graduate records office also happened to pretend to like me, and want to hang around and study. Having access to my records, she told me- apparently after becoming satisfied with the orders of my private life- that there was something in my files I might want to know about. Thinking then that we were not supposed to have access to these files, I declined. I later learned that we do have access to academic files about ourselves, and so I asked her what it was. She said that she had then been lying.

When I asked my university to see these files, I was told that they had accidentally been destroyed when they were sent to be put on microfilm and the originals were thrown away. How convenient. The files contain my Comprehensive exams, eighty pages of writing done in a single weekend to fulfill the requirements of the PhD program and be permitted to write ones dissertation. This happens to include one unique piece, the best writing I ever did in my life, on Plato’s Allegory of the Cave.

My representative, Tim Walberg, and prior to him, Thaddeus McCotter, also made inquiry of the University of Dallas, and a Freedom of Information Act request was submitted and ignored. As soon as it became clear that federal agencies were indeed involved, no further inquiry was made. It is just as if someone at some point tells them “This is a matter under under continuing investigation,” or threatens them as they do the library, if they want to know what books a guy is reading, and the librarian is forbidden from telling the person that such an inquiry was made. The question could be resolved by questioning or subpoenaing two persons, though more might be helpful. But now I want the agencies to tell my representatives absolutely everything that was ever done to me through the course of my education, beginning way back at Grand Valley where, as a student of psychology and philosophy, I was already being spied upon, you know, along with that radical left. This was way back at the tail end of the seventies. There never was any warrant or reason, as I am neither a spy nor a mobster, although I have seen a few such about the neighborhood of late. Or is it just me? I sometimes think Kaspersky is a company handling security for 400 million persons, centered in Moscow and staffed by former KGB agents. Imagine, letting such a guy slip off his meds!

The consequences of the lack of oversight are decisive. I am about to lose the place where I live, and plan to leave the country because it is very difficult to live in permanent debt if one is in fact blacklisted, and if one says a word, oh, it is his fault, everyone knows it never happens, so he must be imagining it, and if he’s not imagining it, we better really stay away! Either way, true or false, we’d better drug him! What rubbish! No inquiry, with plenty of reason, because we want to pretend we know such things never happen! My former fiance just happened by coincidence to come here to Michigan from 1 1/2 miles away from my former university, and I met her up here! Go figure-no, rather don’t, just do Oxy and the pain will go away! Its all my fault, I probably deserved it all. Not a single person will even help or inquire. No one has the courage to ask a few simple questions. These do not have the courage to uphold American Liberty. I’ll go live in Canada, where there is less pretense and more genuine liberty, and leave you all here for such slavish treatment. Bunch of Sissies!

How many Doctors are on Oxycotin?

Medical errors were said to account for 251,000 deaths annually in the United States, a staggering number that I must just have wrong, five times mote than traffic deaths? This, though, raises the question of how many doctors are into their own medicine bag, since there are none with easier access, they have plenty of money, and work incredible hours required to perform at their peak.

I’m just glad they drug test all the employees at the Kroger, and that the poor have no access to the court, wherein I would prove that they have no right to drug test applicants, especially regarding an unconstitutionally criminalized herb. This testing keeps the cynical libertarians out, who might just raise a topic of conversation while they are putting up the tomatoes.

Antidepressants are Causally Related to the Public Shootings Epidemic

Once again, prescription anti-depressants are going to be found causally related to the epidemic of public shootings in the United States. The radio news will dot report the question, and the Lieutenant Governor will not raise the issue, because of the power of the prescription drug industry and their influence on politicians through “Campaign Contributions.” We have always had guns, though not quite so promiscuously. What is different is the prescription drug industry. Other nations have psychiatry and psychiatric medicine. What is different is our corruption and the power of money to obscure the common good in the United States. What is different, coinciding with the epidemic, is that most people in the United States are now on prescription drugs. And again, our enemies could not have devised a better way to weaken us or bring us down if they were literally behind this, as they seem to be behind the Oxy-heroin scandal. Hey Purdue, would you commit treason for 31 billion dollars? Someone else will only do it anyway if you do not, so hey, you might as well be the one making the money. These people already have more money than a person can spend in a lifetime, and may never notice the profits earned at the expense of their nation. But that is the result of the empty or easily perverted American view of “success.” You cannot serve both God and mammon, and it seems we have taken our choice.

Soon they will come to try to drug me, for saying such things. What an imagination! I am learning, though, as with the oil spill, that when I am beating my head against a wall because the world won’t see what seem to me alone to be the simplest things, there is usually a reason I could not imagine. They did not want to clean up the oil spill, but had already decided to use dispersants. That’s ok, the Gulf of Mexico is salt water anyway.

Student Loans

Last year, after sending in the tax forms that prove I do not earn subsistence, my lender Nelnet defaulted my loans anyway. It seems that in the pile of junk mailings I did not have time to open, they sent me a form I was supposed to fill out begging them, after I had dealt with them, to allow me to pay the income sensitive repayment amount, likely to be zero or five dollars. You see, I was working then, trying to pay my IRS debt on the subsistence level income I earned in previous years, while cat shepherding and caring for the hole household of a senior. I have not been out from under IRS debt in many years, and this precedes student loan debt. One must pay the tax on the money one earns with which one then repays debts.

Upon surreptitiously defaulting my loan, though I had done exactly as I had in previous years, and even have a whole ‘nother loan to deal with through the Department of Education, the loan was passed to a collection agency called MGA- which stands for Michigan Guarantee Agency, though it is a collection agency. They added 24% to the loan, which they apparently have given themselves the authority to do, and then proceeded to keep adding. What was originally about 30,000$ borrowed to achieve a PhD in politics, and had become 93,000$ with interest, was turned into 163,000 $, with them adding in four months more than double the cost of a phD, and I had no money going in. For all their hard work that they did to produce such value, I immediately complained to both my State Representative, Gretchen Driskell, and my state Senator, Rebekah Warren. MGA simply sent them a contract I had signed in “consolidating” the loan fifteen years age, which apparently gives them the power to charge me 70,000$ in four months, and they will not or cannot do a thing about it. Nor will they raise the question of who the “Michigan Guarantee Agency” even in, what their connection is to the Michigan Treasury Department, whether they do this to everyone or whether they just did this to me. If the latter, it is obviously a question for legislation, the former, a question for the Department of Justice. Nothing. That is the response of government.

I taught as an adjunct in American Government at a Community College, and after about ten years, an opening in the department arose. They hired a white female who did not even have a politics degree, she had a law degree. Everyone knows that the colleges worked this way for just the fifteen years that I was applying for full time, union jobs of the sort that might allow one to repay loans. White males could not be hired to teach either politics or philosophy because the departments were already white male dominated. All the adjuncts at these colleges were, and probably still are, white males, while all the full time positions go to white females. Black rarely study political science. But there are no Black or female PhD’s in politics that lack a full time job, none, in the entire nation. But, oh, you want to do something about this, who are you going to sue? The one college that would hire me when none others would? And have the taxpayers and students pick up the tuition increase?

I was also applying when the liberal arts were disregarded, and Catholic colleges went to the oath, meaning that those like me could not teach at Catholic colleges either. These pay the least, but are the most pleasant, with good students. I taught philosophy courses for four years at one. The rate of pay for a career adjunct is about minimum wage, like working at the 7-11 as a soda jerk, if four classes are a full time job or a full load. College teachers must do a lot to prepare a class, far more in hours than a grade school teacher per hour of class time. I also taught High and Middle school as a substitute, but here, despite a PhD with college teaching experience, we are “uncertified.” The unions made “certification” the only degree, and made a PhD worthless. I could teach American Government in place of the certified B.A. gym teacher in any High school, or even Shakespeare or “Social Studies,” if they would have me to repay my loans. The closest I ever came to a full time job was teaching eighth grade at a charter school, but then the principal got in trouble for hiring an “uncertified” relative. I did not want to take nicotine replacement drugs for them anyway! I got kicked out, ostensibly for third hand cigarette smoke, after obeying all the rules, and have not been back. It pays less than painting, is more slavish, and we do not get to teach in any case. I went then and finished my essay on Hamlet.

I worked also in the trades, not as a craftsman but as a laborer, and for a while even made some payments on my loans. My error was to pay some to the big one instead of paying off the small one, which I missed by 800$, now expanded to over 1100. I did painting and carpentry labor. In my life, I have ruined my body, first my knees in roofing, so that I could no longer roof, then my hands with digging and such, so that from carpel-tunnel syndrome-like wrist problems, I had to spin the blood back int my hands after three hours of sleep, then try again. I did painting and labor putting in windows, but eventually, at adjunct wages, I lost many teeth and have an eye that twitches, possibly from caffeine, and since my mind is alive, I say funny things, so that people do not want me around. Lately I do yard work for relatives and their friends, though yard work sends me into days of cramps, sciatic nerve agonies and such, but I can do a few days of it to get by.  My true place in the economy, as I have said, is to be a cat shepherd for old people, which I have been doing in exchange for rent on the shed, since I have not been able to pay rent in some time. With this comes an infinite number of hours of daily chores and cleaning messes that are not mine, but having no financial existence, I have been reduced to the condition of a slave, with no way to limit what work is required of me, any more than I can limit how much the loan people charge me. The women own all the property. This way true in America in the forties, but has become especially true now that the law has established inequality.

The past three years, I have earned less than ten thousand dollars, been charged 15% Social Security tax, and taken no food stamps, though I am eligible for these. I fear the paperwork and loss of liberty, and am given some food in exchange for work. A charity brings food to the senior, and mostly what she does not like I get, sometimes bread and peanut butter even! But I eat a yogurt for breakfast, PBJ for lunch, and then eggs and cheese or sometimes a real dinner, if there is cooking going on, and sometimes I get a bowl of mashed potatoes or cream of wheat left over. Lately, since I’v been so poor from the end of the winter, they bought me some honey, which is a big deal, since I was out for months and making maple syrup. I still have frozen mulberries to have with peanut butter when there is no jelly, and the mulberries are almost in again!

I have written and printed two books intended to be marketable, since I could no longer justify unmarketable projects. I should easily make a living off these, but they just cannot be produced or marketed as e-books, with Amazon and WordPress set up as they are, and publishing requiring the investment of debtors, through layers of IRS and student loan debt. I am no longer able to work a regular job nor to have a bank account, as any money will be seized, and paypal just tried to crank an empty bank account which the bank treated like a bounced check. Now to even pay a bill is a half-day project of envelopes, stamps and money orders. Soon I will lose car insurance, and not be able to do that.

All this could have occurred even if I were not basically blacklisted from all writing grants and assistance from my former professors, and even if the Catholics did not require oaths. But if such blacklisting did occur, say, because one did not go to work for the government in assumed exchange for tuition grants, or because one questioned having women set on them once they had become suspicious by not going along with the program, or even for not being “conservative” for the conservative funders of education, if such blacklisting were to occur, no one would do a thing about it, so that anyone who likes may do these things and call it academic preference- I just can’t spell! I never did misspell a word on the blackboard, and very rarely if at all on any papers for class. To give preference for non-academic reasons, like one did not go to work for the government or raised the wrong questions, seems yet another great corruption of education.

For a nation to allow these financial powers to complete the destruction of the liberal arts is a national catastrophe, and the root of coming national catastrophe.

Marijuana, Prescription Drugs and Driving

The Michigan legislature recently addressed the question of Marijuana and driving, attempting to devise a way of testing when medicinal and other weed smokers are too high to drive. This is a serious question, as it is possible to be too high to drive, though it is also a roundabout attempt by the Republicans, or what is left of them, to criminalize weed. The result of the medicinal law has been that, as occurred regarding tobacco, growers are given a volume limit, which they then enhance chemically by corrupting the plant. They use chemicals to make their limited amount produce more of the drug, so that 12 plants now, using chemical methods, can produce many pounds of very potent weed. Next time the legislature will think to require that the weed be organic, but then all those chemical companies contributing to campaigns just won’t be satisfied.

Marijuana and driving is a question different, of course, from alcohol and driving. Alcohol effects the motor functions, so that one becomes sloppy, and cannot keep one’s lane. With weed, one is likely to be twice as “paranoid,” and hence cautious, as any motor functions are effected. One is likely to keep one’s lane just fine, but lose track of where they were going! Reaction time slightly lower, but caution increased, so that, as Jack Herrer reported, driving stats for weed smokers are the same or even slightly better than non weed smokers (though that test was done before the age of medicinal weed). Habit is dissolved a bit, if attention is increased, and much of driving depends upon habit. But it is possible to become confused and make errors, especially in combination with alcohol or other drugs. Yet it is difficult or impossible to set a medical test, as unlike alcohol, the stuff stays in the system when one is no longer under the effects. It is just different, a different kind of thing.

It is however astonishing that it has not occurred to the Republicans to prohibit Prescription drugs and driving. If the Americans could not drive with prescription drugs in their systems, the nation would screech to a halt. Congressmen could not get to work in Lansing. And Oxy, being an opioid, is more likely to effect motor function and be responsible for traffic accidents. They made 321 Billion dollars off one version of Oxy and no one was driving on it? And what about antidepressants, with “Abilify”? What about Ritalin and Aderall, are these not a bit distracting? 50, 000 traffic deaths a year and what, no one has thought to keep these statistics? No one funded the study?

Our nation has entered a grave corruption, in part as the result of the attempt to prohibit Marijuana contrary to the Constitution. The paradoxical result of the prohibition of a non-toxic, nonaddictive herb for philosophical reasons, reasons of opinion or conservative opinion, has been the handing of our nation over to the drug dealers now powerful enough to legitimize the trade in the prescription drug industry. With drug money in Congress, and a system that just cannot say no to “Campaign finance,” these perversions are sure to continue, until the Americans “Just say No.”

Pharmabuse.com

So, hey, was Jason Dalton on Antidepressants? There is no answer yet? Mr. Thibault too understands the sudden grave government concern with the privacy of a mass murderer to be a part of a cover-up. People will do a lot for billions of dollars. But in the end, one will find the American FBI equal to corruption, and largely  above the ultimate power of money. Lets show the FDA and the drug companies who is America!

Hey FDA, you ought be ashamed, without redaction, though you cannot be. But you can be as unemployed as I am, and you won’t do half as much good with your time. The Food and Drug administration, at taxpayer expense, is simply on the take. This is not surprising, considering that the Americans might whore their own children for a few billion dollars, and the third prepared to vote for a tyrant just cannot say why one should not, prostitute their own children for money. “Success” this is called, the American Dream, the American way. My suggestion is that we the free Americans stand up and show them the American way, because if it were too late, they would not be required to have warning labels.

It is of course difficult to tell whether a troubled person was treated with antidepressants and just not given enough, or whether, as we think obvious to common sense, troubled persons are made suicidal and taken over the edge by the drugs that were supposed to help. A recent “study” cited on the radio assures us that antidepressants have no link to suicide, nor can radio personalities read either the label or the writing on the wall. Jason Dalton is said to have been on Prozac, and Purdue just pocketed 31 Billion dollars from Oxy, (not to mention the kickbacks from the heroin dealers!)

Again, the lack of scientific knowledge in the field of psychology allows these corrupt companies to use the power of their wealth with the broadest latitude in the field of psychiatric drugs. But the same has been done with Viagra and restless leg syndrome, abusing the Hippocratic oath which once guided medical ethics and bolstered trust in medical authority. The destruction of our confidence in medicine and psychiatry is an unfortunate, but warranted, result. I think, though, now the voters may just be getting a bit of that restless leg syndrome, and we can think of a nice, traditional, low tech way to exorcise the problem!

The abuse of prescription drugs, as well as the corporate control of speech and public opinion, must stop. It will stop when we the voters reform “campaign finance” to exclude bribery. We must stop electing politicians who prostitute the citizens to line their own pockets as a condition of employment. We must stop electing only used car salesmen. What, they snow us with that blow-dried look, and we call this a sign of the merit worthy of office in the United States?

 

P. S. Hello, Pharmabuse.com!

Are you aware that your website requires visitors to “sign in” before they can like anything, and given the whistle blower topic and documented cover ups, one cannot be sure that that is safe? WordPress does the same to me, and it is in violation of the First Amendment, though my Congressman has apparently been paid not to care. I re-blogged an article of Mr Thibault from the website of Juliethemadblogger.

Andrew Thibault: A Criminal Coverup On Antidepressants?

This article is here thanks to Julie, the only sane blogger, who was the guest-poster re-blogged for the last two articles. We hope Lt. Governor Calley and NPR are not oblivious.

 

The FDA Is Hiding Reports Linking Psych Drugs to Homicides

In my wildest dreams, I could never have imagined being drawn into a story of intrigue involving my own government’s efforts to hide, from the public, reports of psychiatric drugs associated with cases of murder, including homicides committed by youth on the drugs. But that is precisely the intrigue I now find myself enmeshed in.

The saga began several years ago. My child had the misfortune of being born during the last month of eligibility for kindergarten, and was subsequently labeled with A.D.H.D. – which stands for August Date Hikes Diagnosis. While other Americans with the same chronological impairment such as Man Ray and Robert Ringling managed to make something of themselves despite being born in the month of August, it seemed my child was doomed to failure from the get-go, unless provided lifesaving stimulant medication.

With an abiding uneasiness about both the alleged disorder and its miracle remedy, as they were presented to me, I set out to understand as much as I could about stimulant medications, prescribed disproportionately to the youngest children in the class.

It wasn’t long before I stumbled upon the FDA Adverse Event Reporting System (FAERS), also referred to as MedWatch. The FDA publishes quarterly FAERS data files on its website containing hundreds of thousands of reports of various drug adverse events. Though unencrypted, the FAERS files might as well be, as the data appear hieroglyphic to the average person who is not a database expert, including myself at the time.

With the aid of the internet and with a lot of trial and error, I taught myself to write Structured Query Language (SQL) code to decipher the FAERS files. I first plumbed the depths of the adverse event data searching for reports of pediatric fatalities associated with stimulant medications, and found hundreds of them. Expanding my queries to include all psychotropic medications, I eventually identified nearly 2,000 pediatric fatalities. (More on the pediatric psychotropic fatalities in a future post.)

As I contemplated the gravity and the scale of the human tragedy, I began to wonder what drug side effects these children experienced at the time of their deaths. The FAERS data files yielded answers: cardiac arrest, respiratory arrest, hepatoxicity, multi-organ failure, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Neuroleptic Malignant Syndrome, completed suicide, homicide . . . Wait, what?  Homicide, as a drug side effect? Then I saw it again: Murder.

The light bulb went off. I performed a query for homicide or murder as a drug side effect. To my astonishment, there were over 700 reports in FAERS of homicides linked to psychotropic medications.

In October 2014, I submitted a Freedom of Information Act (FOIA) request to the FDA to obtain copies of the FAERS homicide reports. After ten months of “Foot Dragging and Alibis,” which is what Rep. Joe Barton (R-TX) once suggested the agency’s acronym stood for, the FDA still had not produced a single report. Frustrated with the FDA’s stonewalling, I filed a federal lawsuit in August 2015. Within three months of filing the FOIA lawsuit, the FDA coughed up over 3,000 pages of FAERS reports.

However, hundreds of pages were completely redacted, while many hundreds more were heavily redacted. A letter from Deputy Director of Information Disclosure Policy Howard Philips attested that the records were redacted in accordance with the FOIA statute, and other applicable laws. The FDA claimed that the redaction of information was justified under FOIA’s privacy exemption.

To add some perspective, according to the HHS Freedom of Information Annual Report, among 10,145 FOIA requests the FDA processed during fiscal year 2015, the privacy exemption was applied only 24 times. Federal regulations require the FDA to “make thefullest possible disclosure of records to the public” in response to FOIA requests.

All but the case numbers were redacted in 47 of the FAERS homicide reports that the FDA released. The FDA had suppressed all of the report information for these cases: age, gender, drug name(s), reported drug reaction(s), case narrative, etc. The wholesale censorship of entire FAERS reports turned out to be an untenable action on the part of the FDA.

Pursuant to 21 CFR 20.81, the FDA cannot properly withhold any record that contains data or information that have been previously disclosed in a lawful manner to a member of the public. The age, gender, drug name(s), and reported drug reaction(s) had already been publicly disclosed in FAERS data files available on the FDA’s website. It was based on this publicly available information that I was able to ascertain and request the case reports involving homicide in the first place.

I fired off a letter to then-Acting Commissioner Stephen Ostroff, protesting the FDA’s improper withholding of public information, citing the federal regulation prohibiting such conduct. A month later, I received a second production of records totaling over 3,000 pages. The agency did not acknowledge any wrongdoing, or even explain what was different about the new document dump. This time around, though, the FDA had not redacted age, gender, drug name(s), and reported drug reaction(s), but the case narratives remained entirely redacted.

Insofar as the FDA had released the case narratives of hundreds of the other FAERS homicide reports, albeit heavily redacted at times, I surmised that the case narratives of these 47 reports in particular must contain information that was damaging either to the pharmaceutical companies, the FDA, or both.

Here are four examples of medication-linked homicide case narratives that were being withheld.

Case 10213469

The narrative in this case report, when it was initially sent to me, was completely redacted by the FDA. This is what I received:

10213469

However,  I knew from the FAERS data files that the case involved a 10-year-old taking Vyvanse (lisdexamfetamine), a stimulant drug prescribed to a million children in the U.S. for ADHD. The girl had reportedly experienced a drug reaction that led her to commit homicide. The FDA would eventually send me a lesser-redacted version of the report, confirming the information in the FAERS data files, but the case narrative was still completely redacted.

Then, on April 12th of this year, the FDA presented a Vyvanse pediatric safety review to the Pediatric Advisory Committee. In advance of the meeting, the FDA’s “Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review” was made public as part of the briefing materials posted on the agency’s website. The safety review contained abombshell case narrative summary.

Homicide (n=1) 

Case # 10213468, USA, 2014: A 3-month-old female infant was left alone with a babysitter’s 10-year-old daughter. Lisdexamfetamine was prescribed to the 10-year-old daughter of the babysitter; the 10-year old girl had ADHD, ODD, and attachment disorder. The infant sustained various injuries. The autopsy reported the cause of death was “asphyxia and suffocation,” as the result of “homicide.” Additionally, the infant’s blood contained traces of amphetamine (lisdexamfetamine).

In an appendix, I noticed that one of  the FAERS reports that I had requested (10213469), which had been completely redacted, was only one digit off from the FAERS report quoted in the Vyvanse pediatric safety review, and was also listed as a duplicate report.  And then I put one and one together:  The FDA had represented to the Court handling my FOIA lawsuit that the case narrative of the FAERS homicide report I had requested—number 10213469—was exempt from disclosure under a FOI request for privacy reasons, yet now the FDA had publicly disclosed the case!

On April 13th, the day after the Pediatric Advisory Committee met and considered the FDA’s Vyvanse pediatric safety and drug utilization review, I fired off an email to the Assistant U.S. Attorney on the case, copying the FDA’s Assistant Chief Counsel, demanding a lesser-redacted version of FAERS report 10213469, pursuant to 21 CFR 20.81, since the agency had publicly released a summary of the case narrative of a duplicate report.

I figured that the FDA would now have to cough up the report.

The next day, on April 14th, Shire submitted a New Drug Application (NDA) for a chewable formulation of Vyvanse, as if following a script written long before the Pediatric Advisory Committee meeting. The company wrote in its press release that the Vyvanse chewable tablets are intended for patients “who may have difficulty swallowing or opening a capsule,” which is likely targeting very young children.

A day later, on April 15th, the Assistant U.S. attorney sent me an email, indicating that rather than provide me a lesser-redacted version of FAERS report 10213469, the FDA had instead decided to remove the case summary detailing the homicide from its drug safety review on its website.   Just like that, Uncle Sam had covered up the homicide of a 3-month-old infant girl, by an amphetamine-addled child, as if the baby had never existed. Now you see the homicide, now you don’t.

Apparently, we can’t have a story made public about a 10-year-old girl on Vyvanse who forced the ADHD drug down a baby girl’s throat before suffocating her to death. That would be bad for business. Especially even as Vyvanse chewable tablets are being approved for the market.

There is one more part to this story of homicide linked to ADHD drugs. Earlier, after I had filed my FOIA lawsuit concerning the FAERS homicide cases, the FDA approved Adzenys XR-ODT, the first orally disintegrating amphetamine tablet approved for kids with ADHD.  Without fanfare, a homicidal ideation warning was added to the label of Adzenys XR-ODT: “Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed.”

Adzenys XR-ODT was approved as a bioequivalent of Adderall XR, another Shire-manufactured amphetamine drug that was formerly the most prescribed drug for ADHD prior to Vyvanse. Oddly, at this writing, Adderall XR does not have a homicidal ideation warning on its label, whereas its bioequivalent Adzenys XR-ODT does. I’ve emailed the FDA Division of Drug Information for an explanation of the inconsistent homicidal ideation label warnings for these bioequivalent drugs, and was told that a Subject Matter Expert (SME) had to be consulted before the agency could respond. Of similar interest, a homicidal ideation warning was added to the Vyvanse label as well.

Case 7979016

This case involves a 16-year-old male from Canada taking Prozac, who experienced the reported drug reaction of “homicide.”  The FDA initially released a completely redactedversion of this report, claiming in effect that public disclosure of any information whatsoever would constitute an unwarranted invasion of personal privacy. Once I reminded the FDA of 21 CFR 20.81, the agency produced a lesser-redacted version. This time, the FDA did not redact age, gender, nationality, drug name, or drug reactions disclosed in the FAERS data files, yet persisted with the redaction of the entire case narrative.

As it so happens, I had requested FAERS 7979016 twice, so the FDA produced yet another version of the report. This time, much of the case narrative could be read, and it contained a bombshell:

The reporting psychiatrist assessed the homicide, self-injurious behavior, manic symptoms, and worsening of his condition as related to fluoxetine, it drove him over the edge and it contributed to his actions.

Under the pretext of a phony privacy claim, the FDA had, in its previous redactions,  deliberately kept hidden a psychiatrist’s damaging causality assessment linking a popular antidepressant to homicide.

Case 8464514

This case involves a 35-year-old female from Australia, who took the antidepressant nortriptyline and killed her daughter. In one version of the report, the FDA as I subsequently learned, had completely redacted the following narrative:

My husband was drinking. I took small doses of valerian for a month and had weird dreams and premonitions. When I took nortriptyline, I immediately wanted to kill myself, talked myself out of it. I’d never had thoughts like that before. My husband was angry, shouting. I walked outside a lot, with palpitations, trouble breathing, and became more depressed. My smoking went up to 25 a day, no alcohol. I didn’t sleep for two nights, dreamt, then slept maybe three hours, felt awful. I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it. I felt like a zombie. I believed I had to help my daughter, that a bad spirit possessed her. I picked up a knife and stabbed her and woke up. I was not myself. I was looking on from the outside, controlled by dark forces. She said, “Mum, what are you doing here?” I realized what I’d done. I asked my husband to kill me. He called the police. I felt better in the police cells without the pills, but the pills started again, and thoughts of killing myself returned.

The FDA–and this is almost hard to believe–had redacted signs or symptoms of medication-induced suicidal ideation (“When I took nortriptyline, I immediately wanted to kill myself. I’d never had thoughts like that before” and “I asked my husband to kill me”); parasomnia or hallucinations (“I dreamt that my daughter had dark teeth and I saw a black halo around her head, a spear hanging over it”); delusions (“I believed I had to help my daughter, that a bad spirit possessed her); automatism: (“I felt like a zombie”);homicide, somnambulism, and parasomnia (“I picked up a knife and stabbed her and woke up”); dissociation (“I was not myself”); depersonalization (“I was looking on from the outside”); paranoia (“controlled by dark forces”); as well as positive dechallenge (“I felt better in the police cells without the pills”); and positive rechallenge – considered the gold standard with regard to causality (“but the pills started again and thoughts of killing myself returned.”)

The FDA then provided another version of the report to me, this time with bits and pieces of the above testimonial unredacted, yet with much of the passage still missing. However, this version contained another gem:

Ranbaxy medical reviewers comment: The case is deemed serious. Medical Reviewer considered the case to be possibly related to suspect drug due to its temporal association as per WHO UMC system for standardized causality assessment.

The FDA understood that there was likely a causal link to homicide. This was the finding that the FDA did not want to make public.

Case 6179785

This case report describes a 47-year-old male prescribed Prozac (fluoxetine), lithium, temazepam, and trazodone who committed homicide. The FDA redacted the type of place he entered, as well as whom or what he shot, but did reveal that the subject ultimately shot himself.  Only the report cited a BMJ article  entitled “FDA to review ‘missing’ drug company documents,” which contained the following passage:

The documents received by the BMJ reportedly went missing during the 1994 Wesbecker case that grew out of a lawsuit filed on behalf of victims of a work-place shooting in 1989. Joseph Wesbecker, armed with an AK-47, shot eight people dead and wounded another 12. He then shot and killed himself. Mr Wesbecker, who had a long history of depression, had been placed on fluoxetine one month before the shootings.

This is a well-known case, dating back to 1989, which has been the subject of a book, The Power to Harm, by John Cornwall. The survivors and relatives of the dead sued Eli Lilly, the manufacturer of Prozac. The jury ruled in favor of Eli Lilly, which–as this was the first such case to be tried in court over whether an SSRI could stir homicidal actions–proved to be a boon to the company. Its drug had been cleared, and Lilly’s stock price soared. However, as Cornwall later revealed, Eli Lilly had made a secret deal with the plaintiffs during the trial, paying them a huge sum of money to deliberately lose the case.

So here it is twenty-five years later, and the FDA, in its case report of this fluoxetine-related homicide, which was the subject of a book, redacted some of the pertinent information. And this leads to the obvious question: has the FDA attempted to hide, from the public, links between psychotropic medications and mass shootings? More on that subject in a future post.

Now the FDA Wants Some Case Reports Back

Besides antidepressants and homicide, the three preceding FAERS reports and many others like them share two additional commonalities: 1) The cases were widely publicized in news and scholarly publications; and 2) The FDA now wants the versions that spilled some of the narrative details back from me. Much like the FDA removed the evidence of a 3-month-old girl murdered by a ten-year-old on Vyvanse from its Vyvanse pediatric safety review, the FDA, in its efforts to get these documents back, apparently wants to conceal the details about other homicides linked to psychotropics.

It is doubtful that the legislators who passed the Freedom of Information Act intended for government redactors to be censoring media reports and scholarly publications.

Last week, consumer advocacy group Public Citizen also sued the FDA, alleging the agency has arbitrarily and capriciously redacted public information from the curricula vitae of advisory committee members, thus obscuring their ties to pharmaceutical companies. It seems as though the FDA views the redaction process as thwarting the intentions of the FOIA act, and keeping secret information that might damage commercial interests.

I’ll end with a prediction: more homicidal ideation warnings are coming to psychotropic drug labels. Pharmaceutical companies will need to protect themselves from failure-to-warn lawsuits, and the FDA will no longer stand in their way from doing so, like when they wouldn’t allow Wyeth to place a suicidal ideation warning on Effexor. Tellingly, a homicidal ideation warning was also added to the Effexor label in the premarketing evaluation adverse events section, i.e.,  the company received reports of homicidal ideation before the drug was even approved.

More reports linking psychotropic drugs to homicides can be found here.

Andrew ThibaultAndrew Thibault is an extremely curious, inconvenient parent.  He is Co-Founder of Parents Against Pharmaceutical Abuse (PAPA), a parent movement opposed to over-diagnosis and over-medication of children.  A frequent guest of The Justice Hour on South Florida’s Health Talk Radio, he has also been quoted and his research has appeared in the Orlando Sentinel, Tampa Tribune, Tampa Bay Times, and Christian Science Monitor.

Separation of church and state, separation of medicine and state

The pursuit of happiness enshrined in the Declaration is spelled out in the first two clauses of the First Amendment, and has been understood to imply broad liberties regarding science, art and publication, so that American liberty remains better than guarded in law than that of any other nation, despite our slipping recently in practice on certain issues (where they routinely violate the Fourth and Fifth in violating the First).

This Hunger Is Secret

We readily accept that separation of church and state is an excellent idea, that church and state can be run separately, and that our government has no business meddling into our spiritual lives nor dictating for us what we should believe nor which god we should worship nor how we should worship nor if we should worship. What a splendid idea!

How about applying that to medicine? Can’t we separate medicine and state? I, for one, do not want the government to run my individual body. I do not want the government deciding how I take care of my individual body nor what principles I use to guide myself along the journey of staying alive, if any. I don’t want the government deciding for me, as an individual, the meaning of health. I am an autonomous adult and I define for myself what makes me feel happy and fulfilled. If…

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Regarding jumping off of bridges

Here are a couple nice posts from Julie. I believe we may have begun to turn the corner on modern psychology/psychiatry and the prescription drug industry.

This Hunger Is Secret

I still get the local news from where I used to live. I still react in some fashion. Sometimes, a memory might pop into my head. “Oh, yeah, I remember that place.” Or maybe a building or a scene.

Today I read that a man jumped off of one of the Charles River footbridges. He was seen jumping by two witnesses. I suppose these were “bystanders,” a dog walker and someone in a boat. They contacted rescuers, who got to him and managed to get him to an ER. However, all efforts to save him failed. He died, or maybe he was dead on arrival. Do they know who he was? If so, they didn’t say.

I used to walk over one of those bridges regularly. I loved that bridge. An acquaintance of mine told me that once she had slipped there on ice and broken her wrist, so she had…

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Libertarianism and Peaceful Protest

Martin Luther King Jr saved our nation with the idea of peaceful protest. In the face of blatant injustice, as a Christian minister, he saw from Gandhi and Socrates that unarmed civil disobedience was the only way to win a victory worth having. The movement was concerned primarily with equality, but also secondarily with liberty. What I am suggesting is the conjunction of the idea of peaceful protest and the primary concern with our vanishing American liberty

The recognition of equality has now become so well established in popular opinion that its excesses are ignored. The idea that keeps recurring is to join the quest for the re-establishment of liberty with the methods and the idea of Martin Luther King and peaceful protest.

As a student at a conservative Catholic school. we studied the American founders in an exciting spirit of the recovery of our political tradition. Yet we did not study even Thomas Jefferson very much. The Bill of Rights was generally neglected, and we did not even begin to learn about Martin Luther King.

 So the obvious point that King found what may be the only way for Christians to participate in politics rather than withdraw from the world’s injustice to the peace and safety of the monastery. As it turns our, they were a government school, and St. Martin was still considered as J Edgar saw him, as a something closer to a communist than an American, despite King’s constant appeal to the Declaration and the Constitution, and to justice.

Whether the reader can realize it or not, our nation is facing some changes, and is headed for some serious internal dangers. Armed protest has broken out occasionally, with the blacks in Baltimore and the Whites in Oregon most recently. Violence at political speeches surrounding the presidential campaigns is becoming routine. The reason is that the Americans are missing something, and what appears is then drawn toward the emerging opposites or extremes. Meanwhile, in the face of blatant injustice, our politicians will do nothing, at least until complaints are converted into money and power. We could scream bloody murder, about the most obvious abuses, and its like the whole nation is on oxy, or has been so dumbed down that it goes in one ear and out the other, like we were speaking to a box of rocks.

But violent protest strikes those who are innocent, like the officers of the peace who daily risk their lives to protect the citizens, and are thrown into the front lines as in the protest in Baltimore. There is no addressing the hidden powers responsible for the problems, we can only scratch and claw at one another.

It always amused me, studying politics at that Southern Catholic Conservative School, that they did not appreciate the peaceful protest of St. Martin. They were into this idea like the problem with the Christians is that they are too meek and contemplative, and did appreciate the masculine idea of violence or fighting. Christianity turned mankind away from the body, and what we need to do in modernity here is to recover the concern with the things of the body, with wealth and power, and war in defense of liberty. They of course were thinking of our foreign enemies and the suppression of crime, and there is some truth to these Machiavellian thoughts, if it does not quite come out the way the Machiavellians would have it.

But it remained an enigma, why they were against St. Martin, or why they did not seem to notice what a blessing the idea of peaceful protest is, especially in domestic but also, when possible, in foreign matters.

Our Declaration of Independence states that it is our right and duty to rebel against our government when a tyranny is established, or when government fails “to secure these rights.” This idea is behind the advocates of the second Amendment, who see the government seizure of arms, or gun control, as the first step toward tyranny. But armed rebellion in our age will fail, and again, would harm innocents. The officers who work a peaceable assembly, where citizens exercise their constitutional right to petition their government for the redress of grievances, have nothing to do with the billionairs who devised the heroin-oxy scandal or the corrupt politicians who cannot even hold office anymore without “campaign contributions,” which are indistinguishable from legal bribery. We cannot get at the invisible internet billionaires who work to stifle free speech even as I write. Nor can we approach the drug companies that persuaded the doctors to set aside medicine for the practice of legal drug dealing. And as has been said regarding the armed opposition to federal property seizures, they do not have a George Washington to lead a rebellion, and the far right in armed rebellion is in fact the straightest road to tyranny.

What I am suggesting is that this idea be joined not with armed rebellion, but with peaceful protest. As Martin addressed injustice by taking blows like Jesus, without even striking back, so libertarian protest can proceed, and may only be able to proceed, by following Dr. King in non-violent protest.

The true revolution is within, within ourselves and in the soul, not the body of our nation. We are sliding toward tyranny, but bloodshed will only make things worse. The way to address this slide is within: we just say no to the profiteering doctors, the corrupt internet companies and the corrupt politicians, beginning with us, the people, or from within. We will simply stand upright. Then we will simply sit down, and not participate, like Rosa Parks and the Birmingham bus boycott. We will step aside from the corrupt world, and only live in the just world. We will leave aside the internet, the cell phones now useless because they are so marketed and hacked, and perhaps, for women, even the public restrooms. Much of modern technology has become useless, because without integrity these things do more harm than good. Then, perhaps the voters get off their opium couch and elect some representatives who are capable of more than selling used cars and lining their own pockets to the great applause of the many, when they look up between their serious pursuits of porn, drugs and video games. We will simply not participate, and we will say why, and keep saying why, whether or our speech is blocked and anyone ever listens, or not.