T Nation

FDA Wants to Regulate Your Cells as Drugs


#1

In the last decade, the clinical use of autologous mesenchymal stem cells to treat orthopedic injuries has gained significant traction. In this procedure, a doctor extracts a patient’s own cells from tissues such as bone marrow or fat, isolates and possible expands them in the laboratory, and re-injects them into the injury site, where they exert a reparative effect. It is firmly documented to be safe and effective for many purposes, and has even been shown to heal degenerative conditions previously thought to be incurable, such as arthritis, damaged knee meniscii, herniated discs, and osteonecrosis. It can also accelerate the healing of bone and tendon injuries. This has huge implications for people into bodybuilding and S&C.

Prior to 2010, clinicians experimented with this technology freely as the unregulated practice of medicine. That year (conspicuously shortly after the ACA passed) the FDA moved to begin regulating the use of cells as drugs. While the agency succeeded at curtailing the use of cells that have been expanded in culture (i.e. grown to greater numbers in the laboratory), the Supreme Court did not grant it regulatory control over “same-day” cell procedures in which cells are taken out of the patient’s bone marrow, isolated, and re-injected in their original number. While the “same day” cell preparation is much less powerful, it is still useful for many conditions, and its popularity has increased rapidly in the last few years. Studies involving 2000+ subjects have been published showing it to be extremely safe.

Now, the FDA wants to put a stop to the free use of cellular medicine once and for all by passing yet more regulations. According to the FDA, once cells are isolated from their native environment (i.e. spun in a centrifuge to separate them from the bone marrow), they become “drugs” subject to its regulatory purview.

The implications of this are dire. The process of getting FDA approval for any new “drug” is extremely long (average time 15 years) and expensive (average cost over $1 billion). Due to the economics of regulation, what this means is that the current procedure of using a patientâ??s autologous cells becomes prohibitively expensive to commercialize, and thus the therapy will not become available again for decades, if ever. Instead we will wait 10-15 years for products made from allogeneic (donor) cells that have been mass-produced by drug companies.

These mass-produced products will be inferior (the cells become less “potent” each time they divide), pose graft-versus-host problems, and will be extremely expensive. It is likely that the biotech industry is pressuring the FDA to regulate the competition out of existence so that it can enjoy the privileges of a government-granted monopoly on cellular medicine. In other words, if the FDA goes forward with this and succeeds, it will destroy the most revolutionary development in orthopedic medicine in the last 100 years.

The FDA will have holding a public review of this issue later this year to solicit viewpoints. If you donâ??t want to lose access to something that could save your ability to stay active and strong throughout your life, please click on the link below:

https://kg236.infusionsoft.com/app/hostedEmail/85850/79214ccd9d246826/T


#2

[quote]belligerent wrote:
In the last decade, the clinical use of autologous mesenchymal stem cells to treat orthopedic injuries has gained significant traction. In this procedure, a doctor extracts a patient’s own cells from tissues such as bone marrow or fat, isolates and possible expands them in the laboratory, and re-injects them into the injury site, where they exert a reparative effect. It is firmly documented to be safe and effective for many purposes, and has even been shown to heal degenerative conditions previously thought to be incurable, such as arthritis, damaged knee meniscii, herniated discs, and osteonecrosis. It can also accelerate the healing of bone and tendon injuries. This has huge implications for people into bodybuilding and S&C.

Prior to 2010, clinicians experimented with this technology freely as the unregulated practice of medicine. That year (conspicuously shortly after the ACA passed) the FDA moved to begin regulating the use of cells as drugs. While the agency succeeded at curtailing the use of cells that have been expanded in culture (i.e. grown to greater numbers in the laboratory), the Supreme Court did not grant it regulatory control over “same-day” cell procedures in which cells are taken out of the patient’s bone marrow, isolated, and re-injected in their original number. While the “same day” cell preparation is much less powerful, it is still useful for many conditions, and its popularity has increased rapidly in the last few years. Studies involving 2000+ subjects have been published showing it to be extremely safe.

Now, the FDA wants to put a stop to the free use of cellular medicine once and for all by passing yet more regulations. According to the FDA, once cells are isolated from their native environment (i.e. spun in a centrifuge to separate them from the bone marrow), they become “drugs” subject to its regulatory purview.

The implications of this are dire. The process of getting FDA approval for any new “drug” is extremely long (average time 15 years) and expensive (average cost over $1 billion). Due to the economics of regulation, what this means is that the current procedure of using a patientâ??s autologous cells becomes prohibitively expensive to commercialize, and thus the therapy will not become available again for decades, if ever. Instead we will wait 10-15 years for products made from allogeneic (donor) cells that have been mass-produced by drug companies.

These mass-produced products will be inferior (the cells become less “potent” each time they divide), pose graft-versus-host problems, and will be extremely expensive. It is likely that the biotech industry is pressuring the FDA to regulate the competition out of existence so that it can enjoy the privileges of a government-granted monopoly on cellular medicine. In other words, if the FDA goes forward with this and succeeds, it will destroy the most revolutionary development in orthopedic medicine in the last 100 years.

The FDA will have holding a public review of this issue later this year to solicit viewpoints. If you donâ??t want to lose access to something that could save your ability to stay active and strong throughout your life, please click on the link below:

https://kg236.infusionsoft.com/app/hostedEmail/85850/79214ccd9d246826/T
[/quote]

Drug approval and cost is not that long nor expensive. An expensive grind for sure, but not that crazy…

Regardless, the FDA is just doing what the FDA does: injecting itself into everything it can.


#3

The FDA is merely a whipping boy for Big Pharma. They are not there to protect the public but rather to protect markets for the pharmaceutical industry. All of this bespeaks of the revolving door between the two, which ought to be illegal. However, this is how the fraud and scam works between politics and corporations. So you can sit and wait for real help while the FDA does what it can to slow the process down so that big pharma can make more money selling their side effect-laden drugs at the expense of those with unfortunate circumstances. This is why Peyton Manning and Kobe Bryant had to travel outside the U.S. to have this treatment done. Stem cells are being used now to treat far more than joint problems. For the most cutting edge work check out The Stem Cell Institute in Panama City Panama. So why is this readily available in other countries that have government healthcare? A healthcare system’s primary concern ought to be health not profits. So our system is fundamentally flawed.