The following is from a recent article by Dr. Joseph Mercola.
In the U.S., 1 in 5 prescriptions is written for an off-label use. While sometimes this
allows medications to be overused or misused, it also protects doctors’ ability to freely
treat patients, and patients’ ability to use all available treatments after making an
informed decision.
That 20% of medications are used off-label also indicates “a degree of freedom
physicians currently have that will be foreclosed,” notes English comedian and actor
Russell Brand, if a little-noticed provision in the omnibus spending bill is passed.
“Literally, this will mean that your doctor will not be able to do what’s best for you
because they’ll work for Big Pharma now,” Brand says
19 Lines in 4,155-Page Bill Could Change Practice of Medicine
The 2023 omnibus appropriations bill — a 4,155-page tome involving $1.7 trillion in
spending — includes 19 lines that could give the U.S. Food and Drug Administration the
power to ban off-label use of approved medications. In a commentary for The Wall
Street Journal, Dr. Joel Zinberg wrote:
“Physicians routinely prescribe drugs and employ medical devices that are
approved and labeled by the Food and Drug Administration for a particular use.
Yet sometimes physicians discern other beneficial uses for these technologies,
which they prescribe for their patients without specific official sanction.
The new legislation amends the Food, Drug and Cosmetic Act, or FDCA, to give
the FDA the authority to ban some of these off-label uses of otherwise
approved products. This unwarranted intrusion into the physician-patient
relationship threatens to undermine medical innovation and patient care.”
FDA Wants Power to Regulate Practice of Medicine
“The new provision was enacted at the FDA’s urging,” Zinberg says, in response to a
2021 legal ruling that limited the FDA’s power to meddle with the practice of medicine. In
March 2020, the FDA banned the use of electric shock devices for particular uses,
namely to treat patients engaging in self-harm or aggressive behaviors that could harm
others.
The devices are FDA approved, and while the FDA banned their use for certain contexts,
it still allowed them to be used for smoking addiction and other purposes. This led to a
lawsuit — Judge Rotenberg Education Center v. FDA — in which the Judge Rotenberg
Education Center, a school for people with severe behavioral and intellectual conditions,
sued the FDA over the ban.
The court ruled in the school’s favor, stating that the FDA’s ban violated federal law
because it interfered with health care practitioners’ authority to practice medicine. As it
stands, the FDA does not have the power to ban medical devices for a particular use.
The school’s attorney, Mike Flammia, who also represented students’ parents in favor of
the device’s use, told CNN the decision “protects what all of us cherish, and that is the
ability to go to our doctor and have our doctor decide what is the best treatment.”
As it stands, Section 360f of the FDCA only gives the FDA authority to ban a medical
device if it poses “an unreasonable and substantial risk of illness or injury.” It can ban the
device outright, but it can’t pick and choose when it can and can’t be used.
“Barring a practitioner from prescribing or using an otherwise approved device for a
specific off-label indication would violate another FDCA section, which bars the FDA
from regulating the ‘practice of medicine,'” Zinberg says. The FDA is trying to change
that.
Pharma — Not Your Doctor — Would Dictate Medical Decisions
The omnibus amendment would change Section 360f so that the FDA could ban a
medical device if it poses an unreasonable risk for “one or more intended uses” while
leaving it approved for others. “Since the new provision lets the FDA skirt the ban on
interfering with the practice of medicine by banning devices for particular uses, the
agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as
well,” according to Zinberg.
This puts the FDA, and by proxy Big Pharma, at the helm of powerful health care
decisions that should be made on an individual, personalized level between a patient
and their health care provider.
Remember that in 1992, the Prescription Drug User Fee Act (PDUFA) was created, which
allows the FDA to collect fees from the drug industry. “With the act, the FDA moved from
a fully taxpayer funded entity to one supplemented by industry money,” a BMJ article
written by investigative journalist Maryanne Demasi explains.
Now, significant portions of regulatory agencies’ budgets come from the pharmaceutical
industry that these agencies are supposed to regulate. In 1993, after PDUFA was
passed, the FDA collected about $29 million in net PDUFA fees. This increased 30-fold —
to $884 million — by 2016.
It’s also revealing that at the FDA, 9 out of 10 of its former commissioners between
2006 and 2019 went on to work for pharmaceutical companies. As Brand noted:
“What they’re looking for is a crafty, sly, insidious way to be able to intercede in
your relationship with your physician. And as usual, it’s for your ‘safety’ and for
your ‘benefit’ … Why would you want Big Pharma and a regulatory body that they
fund interfering in your relationship with your doctor about your health?
Have they not found enough ways to extract revenue from you, to put your
health second, to put your well-being way, way behind their profits and their list
of priorities? Why is the bias moving even further in that direction? … This is not
about medicine. This is about licensing. This is about profits, patents, the ability
to extract revenue.”
Patients Suffer When Pharma’s in Control
During the pandemic, it became clear how patients suffer when health agencies are
allowed to dictate what medications doctors are allowed to prescribe to their patients.
Ivermectin — a generic medication that doctors had success treating COVID-19 with
early on — was quickly vilified, as were the doctors who attempted to prescribe it for
COVID-19 patients.
In his book, “The War on Ivermectin: The Medicine That Saved Millions and Could Have
Ended the COVID Pandemic,” Dr. Pierre Kory details Big Pharma’s suppression of this
drug when it was found to work against COVID-19. When he and colleagues first spoke
out about the drug’s potential, however, he was naïve. He said during our 2022
interview:
“I worked a lot and I got deeply expert on ivermectin. But what happened in the
next few months is that everything started going sideways, and I could not
figure it out. I saw hit pieces … The thing is, I didn’t know. I didn’t know that what
I was really doing — bringing forth data supporting the efficacy of a generic
drug — that is poking the bear.
And when I say poking the bear, what is anathema to the pharmaceutical
industry and their whole business model is they cannot have generic off-patent
drugs become standard of care. It obliterates the market for their pricing new
pills.
I didn’t know I was stepping into a war. In the history of pharma, I don’t think any
single medicine threatened as many [drug] markets and campaigns. The only
other medicine that did that was hydroxychloroquine, but they already killed
hydroxychloroquine in 2020.
I was coming out now with ivermectin, and it threatened hundreds of billions of
dollars in perpetuity for these insanely lethal vaccines, monoclonal antibodies,
remdesivir, paxlovid, molnupiravir — all of the markets for their novel new pills
to enter. I mean, I don’t think any medicine has ever threatened that much of a
market.”
‘A Problem for Many Reasons’
If the FDA is allowed to ban medications for certain uses, we’ll see more of what
happened with ivermectin. It’s a “problem for many reasons,” Zinberg explains:
“The statute gives the FDA the power, without any public input, to prevent
patients’ access to off-label therapies even though their physicians and their
patients have found the treatments to be beneficial or even essential.
… Allowing the FDA to ban certain off-label uses will impair clinical progress.
Off-label use enables physicians to assess their patients’ unique circumstances
and use their own evolving scientific knowledge in deciding to try approved
products for new indications.
If the treatment proves useful, formal studies are performed and published. If
enough evidence accumulates, the treatment becomes the standard of care,
even if the manufacturer didn’t submit the product for a separate, lengthy and
costly FDA review.
… Substituting regulators’ wisdom for the cost-benefit judgment of physicians
and their patients will discourage attempts to use approved products in new
and beneficial ways and deprive patients of valuable treatments. Congress
should reconsider this ill-advised legislation.”