Harlan Krumholz, director of Yale University’s Open Data Access Project (YODA), writes in the New York Times about YODA’s agreement to oversee release of Johnson & Johnson’s clinical trial data. User of the data will sign “an agreement that restricts them to their proposed research question. Most important, they must agree to share whatever they find. And we exclude applicants who seek data for commercial or legal purposes. Our intent is not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to overall scientific knowledge.”
If there’s one single nickle of Govt. – meaning belonging to the people, not the bureaucrats – Money involved in these trials, not JNJ, Yale, GSK, nor anyone else has any right to decide Who gets access to that data and Who doesn’t.
The issue of irresponsible end use of said data has been raised here.
Fine. If they don’t want it used irresponsibly, as in editorializing against the drugs being studied, and they want to maintain complete control over their research/economic advantage, then they can get their hands Out of everybody else’s pockets and pay for 100% of whatever they’re researching.
Question: Is it only a matter of who pays for it? What is the responsibility of the study to the people who agree to be subjects? Can it be assumed that they are assuming that the information gathered will be used honestly, and for the greater good? Have they been fully informed as to how the data will be used? Or, if they are accepting money for their participation, is it allowable that they sign away any right to know how the data are used?
Does the government have a responsibility to be sure that people are not used in this way, even if they are willing to sign up for it? Does a pharma’s use of some citizens as study subjects obligate it make the data available to all citizens of that community, rather than use the data to build and exploit the market within that community? Does a government have a right and/or responsibility to guard against that?
“Question: Is it only a matter of who pays for it?”
No, it is not.
Govt. has a responsibility to protect Citizens from being victimized by being robbed (either openly through force or secretly through Fraud) and acts of physical violence.
Since Govt. cannot fulfill those responsibilities in a pre emptive fashion without resorting to a pre-crime investigation and enforcement Police State we are left with Govt. imposing after the fact penalties upon malfeasants who Do prey illegally upon other Citizens.
JNJ’s latest Fed buy out is illustrative. Of all the Federal Criminal penalties the DOJ could have imposed on JNJ, they fined them/let them buy their way out, again.
Ergo, we may understand that the Only thing our DOJ is going to Do anything about is Money (and for JNJ even $2.2 Billion is a token amount).
You have raised a number of insight filled issues, each deserving of an individual answer.
However, in the interest of concision, I am willing to group all of your subsequent concerns under the heading of the Citizen and Society At Large (The Greater Good, if you will) being Defrauded either out of money and/or into unlawful acts of physical and psychological violence being perpetrated upon them.
As such, an irrefutable principle comes to the fore. (And I care not one whit What that Citizen/Research subject may or may not be thinking or willing to agree to.)
It is Legally Impossible for anyone to Volunteer To Be Defrauded.
(Think Lemon Laws applied to car dealers. Very, very few automobile purchasers possess the specific technical knowledge to Diagnose whether or a not a car is going to be free of hidden defects. How much more difficult is it for the medical lay-person to know the issues involved in an investigative drug and how it will be affecting their physical, emotional, and perceptual equilibrium? And for how long?)
All of us as Citizens have specific and exactly circumscribed rights which Govt. can not revoke or even impinge upon. Among those rights is a right to Private, Personally Owned Property. Having that property damaged, destroyed, or stolen through acts of Fraud or Force is prohibited by Law.
Emotional and Perceptual Equilibrium (as functions of bodily integrity) is a Right:
Would you, or anyone else, agree to ingest a drug which has a track record of so distorting emotional and perceptual equilibrium that it has driven other consumers to violently murder their own family members?
Of course you wouldn’t.
But every prescriber in the state of California does commit the fraud of prescribing those murder causing drugs – In The FULL, and Criminal, FORE KNOWLEDGE that that is Exactly what they are Defrauding into the consumer and upon the people of the United States because every last one of them know that the drugs require State Police Registration.
Even without the State Law charge of Attempted Murder Every prescription for such drugs is already a Federal Felony under US 18C95 Sec 1958 punishable by up to 10 years in a Federal Correctional Facility.
The scope of this criminal undertaking is so breathtaking that while there are other legal means to stop it, temporarily, here and there, the Federal Racketeering Statutes are made to order.
Please don’t take the tone of this next explanatory section personally. I’ve copied and pasted it from previously explaining it to a woman who lost her son and another young man to murder/suicide from Psychiatric Drugging, which should accounts for the acerbity of my vernacular as it was targeted to someone sharing my disdain for this Industry.
This post ought to give the lawyers an epileptic fit.
Since J&J’s Risperdal carries State Police Registration In California, the CYA of denying its homicide factor ought to be a slam dunk perjury conviction in Any Court. The State Police don’t have time to concern themselves with diabetes, heart attacks, brain death, TD, or even suicide. They’re not going to hold everybody’s hand 24/7 just to be ready to ask them if they’d like to go see the nice Doctor again.
Murder however, Does interest the Police. US 18C95 Sec 1958 is a glaring denunciation of what the FDA’s safe and effective is actually worth, and what Psychiatric Denials are worth in Any Country because every last Medico in California knows the Police Registration/Homicide routine. They have to, to prescribe those “safe & effectives”.
FDA rules and regulations, the FDCA, and pronouncements of benevolent intent from the Council on Ethical and Judicial Butt Coverage do not supersede or over rule Federal Criminal Law. They are subordinate to and subject to Federal Law as clearly codified and expressed by Congress who are the Only people Constitutionally Empowered to craft Federal Law.
U.S. Title 18C95 sec 1958
US 18C95 Sec 1958 specifically criminalizes the use of Interstate Commerce Facilities in the commission of murder for hire.
1: Are Interstate Commerce Facilities in the US being used to distribute the drugs? Yes (commercial trucking, air freight, rail, UPS etc, ….. & using US mail, electronic mail to bill, pay for the product, pay the employees, Should have the US Postal Service prosecuting under this statute as well as for Federal Mail Fraud.)
2: Are people/employees being Paid/Hired to distribute the drugs using Interstate Commerce Facilities? Yes
3: Do the drugs cause Murder? Yes
4: Are the prescribers in possession of the Knowledge that the drugs cause Murders?
In California, Risperdal requires registration with the Cal. State Police and every prescriber Knows it.
No more proof is needed.
Once you walk through the 1958 door you find the doors to Sec 1957, 1956, and 1952 also unlocked.
To get a Court to hear your gripe, you need a legal peg to hang it on. The fact that you got a raw deal is irrelevant. They’ll tell you, We’re Sorry, and yes life IS unfair, but we’re not empowered to make it our concern.”
This Statute however is extremely specific as to what IS the Court’s concern/duty to address.
This Statute doesn’t specify that the victim be identified by name or in any other fashion, only that the end result be murder or its attempt. If the people involved in any aspect of these drugs are involving Interstate Commerce Facilities in any way, then there Are grounds and Courts do have jurisdiction to hear the argument.
The Racketeering Laws are the direct consequence of previous behaviorist Intervention/Social Engineering. In America the 18th Amendment criminalized alcohol. Bootleggers grew into very rich organized crime syndicates by providing alcohol. When the 21st Amendment repealed the ban those crime syndicates had scads of money which they put into other illegal activities, and Congress created the Racketeering Statutes to suppress the crime syndicates that the prohibition of alcohol created.
This Statute doesn’t state that violation even requires actually crossing a State Line. It criminalizes using Interstate Commerce Facilities. So, even if the attempt, (which doesn’t have to be completed: in this case the murder causing drug), meets the criteria of the “or conspires to do so” clause, so long as Commerce Facilities such as Banks, Savings & Loans, Wire Services for transferring money which as a part of their everyday, legal Commercial activities do transfer money across State Lines, and/or commercial shippers which engage in Legal Commerce across State lines become involved at all, the Racketeering Statutes make even the attempt a prosecutable offense punishable by up to 10 years in a Federal Penitentiary, per attempt/prescription.
As for the clause “or conspires to do so”, all That requires is proof that as few as two people cooked up a plan to sell the stuff which involves using Interstate Commerce Facilities of Any sort in Any way shape or form. So long as murder Can result, and it Has resulted in the past, this Statute fits.
You’ll notice it also includes the words “Foreign Commerce” so it Should grant the Government and Citizens of Countries other than the United States legal standing to prosecute any American Based company or company that does business in America in an American Court, for violating American law just for also Using Any Institution of already Lawful Commercial Activity in Countries Other than the United States.
And if any Medico claims the patient was a potential murderer to begin with and their chemical intervention hasn’t Unlawfully endangered the public’s safety, that tosses the skunk of prior restraint into the stew – pre crime policing and Star Chamber sentencing – which also runs counter to every civilized nation’s publicly assumed/perceived legal system.
So; “Is it only a matter of who pays for it?”
Most definitely not.
It’s a matter of the worst and most reprehensible type of Murder: Murder that doesn’t even have any reason beyond Money to commit it.
And that’s why Congress, not I but Congress, Made it all about Money, which they themselves are dishing out wholesale to Pay for it.
I’d go further dbunker. Any company that develops trials to prove the efficacy of a medical treatment/drug should, by law, have to provide the data for all their trials (not just 2), whether there is government money involved or not. Why?
Because otherwise, if many of their trials show that the treatment is no better or worse than placebo, they are involved in obfuscation, false advertisement and are potentially causing grave harm to anyone who buys their “product”.
I would actually prefer that all trials are done by independent scientists that have no ties to the corporation who wants to sell a treatment.
The results can then be published in independent medical journals. No advertising should be allowed. No doctors should be able to promote the treatment for company money. If it works, it will be made abundantly clear in the medical journals and that information can then filter down to doctors who can then make the choice to prescribe the treatment or not.
E-High Fives and a resounding “Yeah, What He Said!”
“I’d go further”
“if many of their trials show that the treatment is no better or worse than placebo, they are involved in obfuscation, false advertisement and are potentially causing grave harm to anyone who buys their “product”.
What you’ve just done here is to define criminal fraud.
As I said in my reply to Mr. Cole:
It is Legally Impossible for anyone to Volunteer To Be Defrauded: be they Research Subject or the Taxpayer being defrauded into Paying for that research.
“If it works, it will be made abundantly clear in the medical journals and that information can then filter down to doctors who can then make the choice to prescribe the treatment or not.”
Dear Veterans Administration, An Open Letter
‘It’ does not work now, has never worked, and is never going to work.
No Positive Outcome.
Given that the VA is admitting they’re working over at least 53,000 people a year as schizophrenics alone (while defrauding far more than $1 Million Tax Payer Dollars at it) – without a positive outcome – the drug makers and the entire supply chain – inside and outside the VA – down to the nurse with their little Dixie cup of pills and Dixie cup of water, need to be prosecuted under these following Statutes on top of 18C95 Sec 1958.
Us Title 18 Part 1 Chapter 19 Sec. 371 Conspiracy To Defraud The United States: 5 years
Us Title 18 Part 1 Chapter 47 Sec. 1031 Major Fraud Against The United States: 10 years
Us Title 18 Part 1 Chapter 47 Sec. 1035 False Statements: 5 years
Us Title 18 Part 1 Chapter 63 Sec. 1341 Mail Fraud: Frauds and Swindles: 20 years
Us Title 18 Part 1 Chapter 63 Sec. 1347 Health Care Fraud: 10 years
Us Title 18 Part 1 Chapter 63 Sec. 1349 Attempt and Conspiracy
Us Title 18 Part 1 Chapter 95 Sec. 1957 Engaging In Monetary Transactions In Property Derived From Specified Unlawful Activity: over $10,000, 10 years.
And those US Title 18 Statutes are only a fraction of Federal Statutes which this Industry can be convicted of violating.
“But, But, this is ridiculous, Bunker, you’d have Everybody in the Mental Health profession tossed into prison for centuries.”
Envision a housecat being offered a fresh opened can of tuna.
If I violated these Federal Statutes I would be incarcerated for it.
Everybody delivering these drugs knows they don’t produce any ‘Positive Outcome’ and Everybody in Medicine looks the other way as they continue Taking/Defrauding Other Peoples Money to do what they do.
Less Than 1% of Patient Harm Events Are Ever Reported.
US 18C3 Accessory After The Fact
US 18C4 Misprision Of Felony
“Whoever, having knowledge of the actual commission of a felony cognizable by a court of the United States, conceals and does not as soon as possible make known the same to some judge or other person in civil or military authority under the United States, shall be fined under this title or imprisoned not more than three years, or both.”
Time and again I see Authors and Commentators here at MIA bemoaning the lack of patient empowerment to uphold Human Rights in the Mental Health system.
Human Rights is a Philosophy just as Mental Health/Illness is a Philosophy.
American Citizens own Civil Rights, not Human Rights.
US 18C13 Sec 241 & 242.
What makes HC workers so specially Above all of the above Federal Criminal Statutes and protected from them? 1 item and 1 item only: Money: mountains of Dirty, Defrauded/Obtained under False Pretenses and therefore Stolen, Money.
They’ve even got Illegal (Sec 1 of the 14th Amendment), Trade Guild purchased exemptions to protect themselves from being mined by having to wear their own thieving, life wrecking Opinions.
California Diversion Programs.
There’s 7 Illegal, Fed Civil Rights Statute Violating sections of Ca. State Law under that label.
Nothing in the Mental Health system is going to change until our Courts start tossing the Fraudsters – from Top to Bottom – into locked cages with iron bars on them and throwing away the key.
First step down that road for people who’ve been victimized by the Mental Health system is to get Off the Human Rights bandwagon and get On the Civil Rights bandwagon because all the empowerment they seek – and much more – is already theirs in existing Criminal Law.
Let’s ask someone, Anyone, to even Define/Justify inducing ‘Mental Health’ through brain damage into other people as Healthcare, when the people dispensing ‘Mental Health’ have reversed the outcome of the Civil War/14th Amendment to avoid having to wear their own ‘Mental Health’.
I agree Jonathan. The drug companies can do all the research and come up with all the new chemicals they want, but the clinical trials must absolutely be at arms length. The trials should be managed either by the government itself or by non-profit institutions with absolute transparency and subject to regulation or government supervision. And how would the trials be funded? Well, by a special tax/charge to the drug companies, of course.
I can already see the initial reaction of horror to such idea by the libertarian crowd. But if you think about it a little, it’s not as radical a solution as it might appear. The drug companies would still have patent protection which enables them to monopolize their intellectual property and which incentivizes them to innovate. They would still control research/development, production and distribution, i.e. everything except the power to judge the safety of their own products.
The current drug approval system is broken. The drug companies control the trials, cherry pick the ones the FDA can consider and hide any evidence against their product. I can think of plenty of good analogies to the current drug approval process. For example, companies could certify their own financial audits. The cop that makes an arrest could also be the judge at trial. The food safety inspector could be an employee of the meat packer. The list can go on and on with hypothetical situations like the all too real drug approval process and which the libertarian and the socialist would equally condemn.
Letting the drug companies determine which trials can be considered for approval and hiding the rest is tantamount to letting their auditors only see and certify one side of their accounting ledger. Now, analogies with the financial system can be tricky, because, as the world has recently experienced, fraud is capable of jeopardizing the whole system. One can argue, however, that most legislators honestly try to make financial fraud illegal. Unfortunately, with regards to the pharmaceutical industry, they have no problems with a fraudulent drug approval process which is perfectly legal.
The YODA project is a step in the right direction. It may even be an important step. But it will only be relevant if it ultimately contributes to a major shift in the balance between the interest of drug company shareholders and the broader public interest.
When it comes to psychiatric medications, this issue gets compounded because these trials are not longitudinal studies. What are the potential health complications that could arise from taking a drug over a period of time. Many of these studies do examine side effects, but they are only for a very short length of time.
Finally, what is deeply problematic is the prescription of these drugs for off-label conditions. The atypical antipsychotics, which carry a wide side effect profile, are routinely prescribed by GPs for a multitude of conditions without any substantiating evidence for their efficacy.