Biden in his address to the Nation, talked about Health Care Research…DARPA… and why we should be concerned.
Informed consent for experiments? Not always what you have been lead to believe. They hawk this proposed agency as:
Federal investment is the fastest, most effective way to de-risk the marketplace. HARPA will disrupt the health technology sector to drive meaningful innovation that will save millions of lives and billions of dollars.
HARPA is modeled after the Defense Advanced Research Projects Agency (DARPA),
…. As part of a proposed $9 billion increase to the National Institutes of Health, the Biden administration has earmarked $6.5 billion to create the Advanced Research Projects Agency-Health.
Under the DARPA model, research projects would not be vetted by peer reviewers, but instead, funding decisions would be made by program managers. And instead of multiyear grants, the agency would disburse awards as milestone-driven payments; program managers could also cancel projects that they decide aren’t panning out.
Before we get to the gist of the dangers of this agency creation and its program managers and for those who have concern about the COVID vaccines let me give a refresher on “Informed Consent” and the Cures Act.
Jan 31, 2020 — The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. (Link) 21st Century Cures Act
The Cures Act was passed in the tail end of 2016 under Obama. Today I focus on Section 3023, 3024 regarding Informed Consent and why you should care. No longer is the Gold Standard of “Informed Consent” required if there are “no more of minimal risks to participants.” And who decides this? A previous post:
I am not sure I for one want the Biden administration in charge of:
Human research subject protections
The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order “to reduce regulatory duplication and unnecessary delays” and “modernize such provisions in the context of multisite and cooperative research projects.” – Wikipedia,
Be sure and take the time to watch the video at the end of the post for the finer details.
The Cures Act introduces the possibility of waiving or altering informed consent for some FDA-governed research. This decision could mark a major step in the required harmonization of regulations; the rules around waivers of informed consent are some of the significant differences between FDA and Common Rule requirements.
The law sets two requirements for waiving or altering informed consent:
- The research must pose no more than minimal risk to participants; and
- Other measures to protect study volunteers must be in place.
The bill does not specify who will confirm decisions about minimal risk or appropriate safeguards, but the requirements seem consistent with determinations that IRBs already make.
From Science Blogs:
Title:The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry. (Well worth the full read.)
Worse, the bill undermines informed consent, as discussed before. The provision is still there that would add another category of research for which it is acceptable to forego informed consent. Normally, it is only acceptable to skip informed consent when it is not feasible or it is contrary to the best interests of the subject.
Add to that now that it would be acceptable to forego informed consent when “the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”
As Merrill Goozner put it and agreed, even if the risk is minimal, why would the authors of this legislation waive a central tenet of international agreements designed to protect the rights of human subjects in clinical trials? I didn’t understand either (and still don’t), particularly since the act doesn’t define “minimal risk” or specify who determines whether a study is minimal risk
Worth a good look. Our lives may depend on it. An excellent review of the bill and the ramifications.
Now that we know where we are, let’s see where we have been:
Let’s take a look how the so called research projects went under Obama since we have the same cast of characters roaming around the White House. This research was conducted by Lisa Jackson, EPA administrator.
A federal judge decided to shut down the lawsuit rather than the government’s human experimentation program.
To Judge Trenga, however, the important thing apparently was to nitpick to death the effort to stop the experiments with a narrow reading of the federal rules of civil procedure.
Judge Trenga determined that the EPA’s decision to endanger the lives of its study subjects, including inducing them to sign a fraudulent consent form, did not constitute a “final agency action” under the Administrative Procedures Act. Judge Trenga also determined, as the American Tradition Institute was not being harmed by the experiments, it didn’t have standing to pursue the case. Now the story:
The suit accuses the EPA of paying as many as 41 participants $12 an hour to breathe in concentrated diesel exhaust, for as long a two hours at a time. The exhaust was directly piped in from a truck parked outside the Chapel Hill facility. According to the lawsuit, the fine particulate matter, called “PM2.5,” was piped in at levels 21 times greater than what the EPA calls its “permissible limit.”
Milloy added some historic perspective to the mix. “In the context of rules established after scientific horrors of World War II and the Tuskegee syphilis experiments, the notion that EPA would pipe high levels of PM2.5 and diesel exhaust into the lungs of unhealthy people to see what would happen is simply appalling,” he said in a press release announcing the lawsuit.
“Unhealthy” is an accurate assessment. The 41 subjects who took part in the experiment included people who were elderly or suffering from asthma, hypertension or metabolic syndrome. One of them, an obese 58-year-old woman with a history of health problems and family history of heart disease, experienced an irregular heartbeat (atrial fibrillation) and had to be hospitalized as a result. Another subject developed an elevated heart rate.
Then again, the study subjects really weren’t “asked” to risk their lives, since the EPA researchers failed — and, in fact, refused — to warn them that PM2.5 could kill them. At the very least, exposing study subjects to a dangerous and deadly toxin without their consent is also known as “assault and battery.”
Given that the EPA long ago determined that any exposure to PM2.5 could cause death (as well as a host of other serious health consequences) within hours or days of inhalation, the experiments are fundamentally illegal. Federal regulations and the Nuremberg Code strictly prohibit scientists from treating human subjects like expendable guinea pigs. In the experiment in question, the study subjects were asked to risk their very lives for $12 per hour.
The American Tradition Institute sued the EPA in October to stop an ongoing experiment in which the agency was exposing elderly study subjects (up to 75 years of age) to concentrated levels of a deadly (according to EPA) air pollutant known as PM2.5 (soot or dust much smaller than the width of a human hair).
The lawsuit claimed the experiments were illegal in that they blatantly violated virtually every major standard developed since World War II for the protection of human study subjects used in scientific experiments.
The EPA engaged in disturbing experimentation that deliberately exposed human beings to airborne particulate matter the agency itself considers lethal. The experiments were conducted at EPA’s Human Studies Facility at the University of North Carolina in Chapel Hill. “That EPA administrator Lisa Jackson permitted this heinous experimentation to occur under her watch shocks the conscience,” said Milloy.
Full story at Washington Times
Then there was this:
September 16, 2015
President Obama announced a new executive order on Tuesday which authorizes federal agencies to conduct behavioral experiments on U.S. citizens in order to advance government initiatives.
“A growing body of evidence demonstrates that behavioral science insights — research findings from fields such as behavioral economics and psychology about how people make decisions and act on them — can be used to design government policies to better serve the American people,” reads the executive order, released on Tuesday.
The initiative draws on research from University of Chicago economist Richard Thaler and Harvard law school professor Cass Sunstein, who was also dubbed Obama’s regulatory czar. The two behavioral scientists argued in their 2008 book “Nudge” that government policies can be designed in a way that “nudges” citizens towards certain behaviors and choices.
The desired choices almost always advance the goals of the federal government, though they are often couched as ways to cut overall program spending.
Read more: Daily Caller
New Law Could Eliminate Informed Consent for Human Experimentation with Vaccines and Drugs – Video done on March 26, 2017.
Time well spent with the details…
The best of the swamp today folks.