Guide to FDA Hearing on “Draft Guidances” Regulating Cells and Tissues (Part 15)

[drusso]

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Good, basic overview for those following the regulatory issues in this field.

http://www.bioinformant.com/fda-public-hearing-part-15/

 

[drusso]

http://rickjaffeesq.com/2016/09/08/really-tough-day-stem-cell-advocates/

"The absolute, universal consensus of today’s workshop was that stem cells should only be available in the U.S. in FDA approved clinical trials, until such trials prove that there is a safe and effective non homologous use for them. And anyone who provides “unproven stem cell therapy” to patients outside of clinical trials is a greedy, unethical charlatan who should lose their medical license…That’s a tough message, but no doubt a welcome one for the FDA since the elimination of non-homologous autologous stem cell therapy outside of clinical trials is the purpose and end result of the four draft guidance documents."

 

[drusso]

http://rickjaffeesq.com/2016/09/08/really-tough-day-stem-cell-advocates/

"The absolute, universal consensus of today’s workshop was that stem cells should only be available in the U.S. in FDA approved clinical trials, until such trials prove that there is a safe and effective non homologous use for them. And anyone who provides “unproven stem cell therapy” to patients outside of clinical trials is a greedy, unethical charlatan who should lose their medical license…That’s a tough message, but no doubt a welcome one for the FDA since the elimination of non-homologous autologous stem cell therapy outside of clinical trials is the purpose and end result of the four draft guidance documents."

At the end of the day it will come down to a very nuanced argument of what is homologous versus non-homologous use for these tissues.

 

[Ligament]

Jesus Christ. The Biotech and Pharma companies are going to regulate this directly into their bank accounts, as expected. Follow the (big) money.

 

[Ligament]

Any updates? When will the FDA release their new laws?

 

[AbstractMonkey]

So far as I'm aware, these technically aren't laws, but guidelines. What are the repercussions for violating "guidelines"?

 

[Doctodd]

Of course there's no fat anywhere near the knee. The prepatellar fat pad is a figment of our imagination.

 

[GH253]

So far as I'm aware, these technically aren't laws, but guidelines. What are the repercussions for violating "guidelines"?

The FDA will file an injunction against anyone who violates their proclamations and sue them in Federal court, and liberal judges will side with the agency neither knowing nor caring anything about stem cells or the consequences of regulating them as drugs. Patients will suffer gratuitously and die on the sidelines while the agency's apologists gloat about how "safe" they're keeping everybody.

 

[GH253]

This hearing was a charade to make it look like the FDA is listening to outside opinions or anything other than completely indifferent to patients' well-being. I was registered to speak, but ended up not attending because I simply have nothing polite to say to the animals who run that agency. Nothing anyone said there will make any difference.

 

[GH253]

Jesus Christ. The Biotech and Pharma companies are going to regulate this directly into their bank accounts, as expected. Follow the (big) money.

but but THALIDOMIDE! the FDA has to protect us from teh snake oilz!

 

[Ducttape]

people die because we arent using stem cells? maybe a little hyperbole there?

not to say that they may not be helpful, but, oh my, how did human civilization ever make it to the 21st century without injecting stem cells?

 

[GH253]

people die because we arent using stem cells? maybe a little hyperbole there?

It's not in the least hyperbolepic. Not only do stem cells have the demonstrated potential to treat some directly fatal conditions like heart disease, but people with chronic pain from arthritis are 50% more likely to commit suicide. The health consequences of enforced inactivity due to chronic musculoskeletal pain is also the first step in a degenerative cascade that leads to eventual death. By inhibiting the development of cell therapy, the FDA is killing people.

oh my, how did human civilization ever make it to the 21st century without injecting stem cells?

The same way it made it to the 19th century without vaccines and surgical anesthetics and the 20th century without antibiotics—not without a lot of suffering and death.

 

[lobelsteve]

It's not in the least hyperbolepic. Not only do stem cells have the demonstrated potential to treat some directly fatal conditions like heart disease, but people with chronic pain from arthritis are 50% more likely to commit suicide. The health consequences of enforced inactivity due to chronic musculoskeletal pain is also the first step in a degenerative cascade that leads to eventual death. By withholding this crucial therapy, the FDA is killing people.



The same way it made it to the 19th century without vaccines and surgical anesthetics and the 20th century without antibiotics—not without a lot of suffering and death.

Time for your meds GH. Stem cells are proven for very few conditions. Pain is not a condition, it is a symptom. Myeloma, leukemia are the diseases.

 

[drusso]

Time for your meds GH. Stem cells are proven for very few conditions. Pain is not a condition, it is a symptom. Myeloma, leukemia are the diseases.

The issues more broadly concern what is considered "homologous use" and the threshold for minimal manipulation of a tissue. Right now FDA is literally making up science based on upon the concept of the "main function" of a particular tissue (if they can't define it, then I can't either), the threshold for manipulation of tissues as the practice of medicine/surgery versus drug manufacturing, and patient safety.

For a little fun, try defining the "main function" of blood plasma. adipose tissue, bone marrow, or skin...

What’s a “main function?”

"It was also pointed out that the guidance documents invented a new concept not existing in the statute or rule, namely the “main function” of a cell or HCT/P which is used as a way of forcing stem cell procedures from just registration under 362 into the IND/NDA drug approval path. It was argued persuasively by several regulatory experts that the creation of this new concept and its resulting transfer of many heretofore legal uses of stem cells into illegal new drug products turns the guidance documents into rulemaking without following federal administrative rulemaking procedures."

If you object to the Government regulating your tissues as manufactured drugs, then you only have two days left to get your objection on the record:

“Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2015-D-3719 for “Draft Guidance Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments.”

If you want to go the email route: do one or both:

[email protected]

Or go to Federal eRulemaking Portal: http://www.regulations.gov.

 

[Disciple]

Seems like it will just open the door to legal challenges.

 

[lobelsteve]

FDA has no business in human tissues. Not food, not drug. Unsure who should be looking out for the public good on this one. But the science isnt there yet for clinical applications that are being offered for cash. ED, OA knee, discs, hair loss, wrinkles, etc.

 

[drusso]

FDA has no business in human tissues. Not food, not drug. Unsure who should be looking out for the public good on this one. But the science isnt there yet for clinical applications that are being offered for cash. ED, OA knee, discs, hair loss, wrinkles, etc.

Logically, the same people who regulate the use of autologous epidural blood patches (transplants) for the treatment of spinal/dural leak headache: If you take FDA's opinion/draft guidance seriously, then autologous epidural blood patches would be considered non-homologous, non-main functional use of human tissue. Generally speaking, free blood does not belong in the epidural space and it has no known concordant, physiological "main function" being in the epidural space... in fact, spine surgeons spend most of their time trying to suck it OUT of the epidural space not put it in!

Raise your hand if you ever done an autologous epidural blood patch for the treatment of spinal/dural leak headache? That procedure would fall under purview of FDA regulation.

 

[hyperalgesia]

Raise your hand if you ever done an autologous epidural blood patch for the treatment of spinal/dural leak headache? That procedure would fall under purview of FDA regulation.

Excellent point

 

[Ligament]

Logically, the same people who regulate the use of autologous epidural blood patches (transplants) for the treatment of spinal/dural leak headache: If you take FDA's opinion/draft guidance seriously, then autologous epidural blood patches would be considered non-homologous, non-main functional use of human tissue. Generally speaking, free blood does not belong in the epidural space and it has no known concordant, physiological "main function" being in the epidural space... in fact, spine surgeons spend most of their time trying to suck it OUT of the epidural space not put it in!

Raise your hand if you ever done an autologous epidural blood patch for the treatment of spinal/dural leak headache? That procedure would fall under purview of FDA regulation.

Next time I have a patient with PDPH, I'll just tell them to live with it until the FDA gets some company to spend 1 billion dollars to study it and patent it and they can have the treatment then.

 

[drusso]

Excellent point

The real lesson for this group is that WHENEVER you let a special interest group "capture" a regulatory agency, someone's liberty is at stake. That goes for PROP lobbyists influencing CDC or Pharma and Mesoblast influencing FDA. Recommendations for medical treatment should come from broadly formed coalitions of specialty societies/physician experts not specialist interest groups.

 

[GH253]

Time for your meds GH. Stem cells are proven for very few conditions. Pain is not a condition, it is a symptom. Myeloma, leukemia are the diseases.

For OA the science is significant, and some groups have enough experience with it that one could reasonably decide to trust their expertise. In the context of the FDA controversy the whole issue is fundamentally about whether patients have the right to decide for themselves what level of risk and standard of evidence are acceptable. As long as the treatments are not marketed inappropriately and there is some good reason to think that they work, it's rational and ethical to proceed with them.

 

[Disciple]

I'll be surprised if there are not legal challenges to any one-sided decision on this issue.

One of the first major cases for the newly appointed justice to the Supreme Court?

What's the pulse of the country right now?

 

[hyperalgesia]

FDA has no business in human tissues. Not food, not drug. Unsure who should be looking out for the public good on this one.

Just to play the devil's advocate... If a drug is used to treat an autologous tissue sample, which is then reimplanted, is that drug not regulatable? If I took a blood sample and infused it with a research grade mu agonist and then reinfused the blood in my clinic/spa, would that come under FDA purview?

 

[lobelsteve]

For OA the science is significant, and some groups have enough experience with it that one could reasonably decide to trust their expertise. In the context of the FDA controversy the whole issue is fundamentally about whether patients have the right to decide for themselves what level of risk and standard of evidence are acceptable. As long as the treatments are not marketed inappropriately and there is some good reason to think that they work, it's rational and ethical to proceed with them.

I missed those articles in peer reviewed journals with quality evidence of efficacy, or even safety.

 

[lobelsteve]

Logically, the same people who regulate the use of autologous epidural blood patches (transplants) for the treatment of spinal/dural leak headache: If you take FDA's opinion/draft guidance seriously, then autologous epidural blood patches would be considered non-homologous, non-main functional use of human tissue. Generally speaking, free blood does not belong in the epidural space and it has no known concordant, physiological "main function" being in the epidural space... in fact, spine surgeons spend most of their time trying to suck it OUT of the epidural space not put it in!

Raise your hand if you ever done an autologous epidural blood patch for the treatment of spinal/dural leak headache? That procedure would fall under purview of FDA regulation.

But there is no modification to the tissues being used. Same as ACL reconstruction with autologous graft.

 

[lobelsteve]

Just to play the devil's advocate... If a drug is used to treat an autologous tissue sample, which is then reimplanted, is that drug not regulatable? If I took a blood sample and infused it with a research grade mu agonist and then reinfused the blood in my clinic/spa, would that come under FDA purview?

If drugs are added to tissue samples to modify them, the drug should be FDA approved/regulated.

 

[Ducttape]

As long as the treatments are not marketed inappropriately and there is some good reason to think that they work, it's rational and ethical to proceed with them.

oh. im sure no one would ever think of marketing something inappropriately or doing something solely for financial gain....

 

[GH253]

oh. im sure no one would ever think of marketing something inappropriately or doing something solely for financial gain....

Everyone works solely for financial gain. Are you a doctor who charges for your services? If so, you are no different from the proprietors of botique stem cell clinics who charge thousands of for their treatments that patients have to pay in cash.

 

[GH253]

I missed those articles in peer reviewed journals with quality evidence of efficacy, or even safety.

I know you did. You should be more conscientious about your work.

 

[Ducttape]

please go ahead and post those articles you are suggesting exist. lobelsteve and I would love to review these supposedly existent peer reviewed EBM.

fyi, im salaried, I do not get paid directly for any procedure or injection, so I do not do them solely for financial gain. I do them to make the patients better in a safe manner and, as far as possible, that has some level of nonbiased evidence.

 

[Disciple]

Most of us here would agree that a reasonable degree of regulation is necessary.

We just don't want further one-sided "rule-making" backed by political agendas.

 

[GH253]

fyi, im salaried, I do not get paid directly for any procedure or injection, so I do not do them solely for financial gain. I do them to make the patients better in a safe manner and, as far as possible, that has some level of nonbiased evidence.

You have to be pretty evasive to pretend there's any difference between charging a patient directly and drawing a salary from the revenues of a company that does so. If you're really such an alturist, open your own clinic and treat everyone regardless of their ability or intention to pay. Otherwise, you're a hypocrite. As for the evidence...first, what are you doing for OA patients that's "proven?" Giving them NSAIDs?

 

[GH253]

Most of us here would agree that a reasonable degree of regulation is necessary.

What degree of regulation is "reasonable" and with respect to whose agenda is it "necessary?"

We just don't want further one-sided "rule-making" backed by political agendas.

But this is all that any degree of regulation is—a particular group's political agenda to acquire monopoly control over a profession or industry, which it pursues under the ruse of "protecting the public" on the grounds that its own members are somehow the only people in society capable of determining the requirements to practice competently. In reality these groups are the modern equivalents of medieval guilds, acting to protect their own interests and their own ways of doing things.

 

[drusso]

fyi, im salaried, I do not get paid directly for any procedure or injection, so I do not do them solely for financial gain. I do them to make the patients better in a safe manner and, as far as possible, that has some level of nonbiased evidence.

Does your employer get paid for any procedure or injection? Are you compensated on an RVU-model? Are you party to a "risk-sharing" or "cost-saving" contract with your employer or health system? All are potential conflicts of interest. Farmers can be paid to plant their fields or let them be fallow. Both scenarios result in cash transfers to the farmer.

 

[Ducttape]

1. we have roughly 30 patients at the clinic that are on financial assistance from the hospital. from what I am told, the system foots the entire bill of any procedure. (and no one has accosted me as to not performing any procedures on these patients). of course, typically these patients do not benefit from procedurally oriented management.

the hospital system takes all patients, all insurances. we are the only provider to insurances such as M@# Option, or U@# Option, or the Exchanges. the nearby University hospital is not so lenient.


2. you do miss my point - that a significant portion of pain doctors would look at these interventions and only see financial gain. without some form of vetting - preferably through the pain organization guidelines or EBM but, unfortunately because we cannot seem to regulate ourselves, CMS or FDA. Otherwise, abuse will occur.

 

[GH253]

2. you do miss my point - that a significant portion of pain doctors would look at these interventions and only see financial gain. without some form of vetting - preferably through the pain organization guidelines or EBM but, unfortunately because we cannot seem to regulate ourselves, CMS or FDA. Otherwise, abuse will occur.

My point is that your point is wrong—financial gain is not antithetical to good medicine. It is the single reason any drug or procedure exists. The worst kind of abuse happens when patients lose access to something that they need because a group of parasitical cranks in government presumes the right to "protect" them from the only thing that can help them.

 

[Ducttape]

im sorry for being so naïve to think that the single reason that a drug or procedure exists is to make people better. for what its worth, I do not deny that financial reimbursement is not important, but that in and of itself is insufficient to be advocating for a treatment.


can you name me one of your "somethings" that has been shown to be effective, was removed by parasitical cranks, and that a person cannot currently pay for out of their own pocket?

 

[hyperalgesia]

I think FDA regulation should only be about safety, not about protecting people from fraud. People can sue for false advertising right? They need to look out for themselves to a certain extent when it comes to snake oil and the like.

When a company is taking a tissue sample (basically a part of the person) to their lab and doing god knows what to it, in a secret proprietary process, I think the FDA has a role to ensure the process is safe. And we need to ensure the FDA is independent.

 

[GH253]

im sorry for being so naïve to think that the single reason that a drug or procedure exists is to make people better. for what its worth, I do not deny that financial reimbursement is not important, but that in and of itself is insufficient to be advocating for a treatment.

That is indeed an extremely naive, emotionalist view. The fact of human nature is that people are basically selfish and act mainly for their own gain. Developing a product that makes people better is usually a means to the end of making money. The investors who put up the huge amounts of capital needed to develop and commercialize new therapies only do so for the sake of making returns.

can you name me one of your "somethings" that has been shown to be effective, was removed by parasitical cranks, and that a person cannot currently pay for out of their own pocket?

Intra-articular injection of autologous, culture-expanded MSCs has been shown in numerous small studies to be effective at regenerating cartilage and improving peripheral joint function in OA patients. According to this review, “intra-articular cell-therapy with culture-expanded MSCs appears to be safe based on 844 treatments in eight studies. Based on the reported AEs and their classification in this systematic literature review we conclude that there are no compelling arguments against proceeding with intra-articular stem cell application in human cases.”

The FDA’s 2010 injunction against Regenerative Sciences, and the subsequent Supreme Court decision in 2014 delivered a regulatory deathblow to this technology, not only by proscribing for the 10-15 years it would take to get a product through the arduous approval process, but because the economics of regulation will make it permanently impossible to sell profitably under the current framework even once approved. The FDA isn't helping anyone by altogether inhibiting science. If not for the agency's actions, voluntary networks of physicians would have produced far more data on this procedure by now, but trials have not moved forward because government has destroyed the incentive.

 

[lobelsteve]

8 of 3039 articles included.
844 patients includes.
AE includes infection, PE, 2 tumors.

AE discounted by authors.

I can get literature to prove anything i do works. Usually in KY.

 

[Ducttape]

3 points:

1. please clarify - could you post the article pertaining "the subsequent Supreme Court decision in 2014", or are you confusing the federal DC Court of Appeals with the Supreme Court? The Supreme Court ruling in 2013 did not stop stem cell research, but rather allowed such research to continue, instead of being stopped by abortion activists.

I see recent articles on mesenchymal stem cell research on pubmed, some of it quite favorable, but in the fine line where such research should be - in the hands of less biased researchers than those whose financial fortunes depend solely on the product succeeding.

2. and I am so sorry that you have such a pessimistic view of medicine. yes, I might appear naïve (I do know money is a major driver in almost everything) and I believe that altruism can actually exist.

you do realize that the greatest advancements in modern medicine have not come with someone focused on money? rather, the point of a gun is more apropos ...

3. I believe there are several places that I can go get stem cell injections to my knees right now if I pay cash. am I wrong on this?

 

[Gauss]

Intra-articular injection of autologous, culture-expanded MSCs has been shown in numerous small studies to be effective at regenerating cartilage and improving peripheral joint function in OA patients. According to this review, “intra-articular cell-therapy with culture-expanded MSCs appears to be safe based on 844 treatments in eight studies. Based on the reported AEs and their classification in this systematic literature review we conclude that there are no compelling arguments against proceeding with intra-articular stem cell application in human cases.”.

Most of these studies used cultured, expanded MSC lines which are now forbidden by current FDA restrictions. There is insufficient data to show that autologous, minimally manipulated MSC's per FDA restrictions can do anything close to what the older studies reported. Safety appears ok: "In conclusion, intra-articular cell-therapy with culture-expanded MSCs appears to be safe based on 844 treatments in eight studies."

 

[hyperalgesia]

Intra-articular injection of autologous, culture-expanded MSCs has been shown in numerous small studies to be effective at regenerating cartilage and improving peripheral joint function in OA patients. According to this review, “intra-articular cell-therapy with culture-expanded MSCs appears to be safe based on 844 treatments in eight studies. Based on the reported AEs and their classification in this systematic literature review we conclude that there are no compelling arguments against proceeding with intra-articular stem cell application in human cases.”

The last time I looked at it, the studies on OA were unimpressive and seemed inordinately biased. There are thousands of pain docs, orthopods, chiros, companies, etc who have a major interest in stem cells being the next big thing. One would expect the data/literature to be overwhelming. It's certainly not. It seems more likely that it's going the way of prolotherapy.

 

[GH253]

8 of 3039 articles included.
844 patients includes.
AE includes infection, PE, 2 tumors.

AE discounted by authors.

I can get literature to prove anything i do works. Usually in KY.

8 out of 8 clinical studies involving culture-expanded MSCs on human subjects that properly reported AEs included.
0 infections related to the injection of MSCs.
0.02% tumor rate including 0% related to treatment.
Cause of AEs carefully considered by the authors, who have no conflicts of interest.

Science means looking at all the facts, not cherry-picking the negative and blowing it out of proportion in your zeal to discredit.

 

[lobelsteve]

J Orthop Surg Res. 2016 Apr 12;11:42. doi: 10.1186/s13018-016-0378-x.
Stem cells in articular cartilage regeneration.
Filardo G1, Perdisa F1, Roffi A2, Marcacci M1,3, Kon E1,3.
Author information

Abstract
Mesenchymal stem cells (MSCs) have emerged as a promising option to treat articular defects and early osteoarthritis (OA) stages. However, both their potential and limitations for a clinical use remain controversial. Thus, the aim of this systematic review was to examine MSCs treatment strategies in clinical settings, in order to summarize the current evidence of their efficacy for the treatment of cartilage lesions and OA.Among the 60 selected studies, 7 were randomized, 13 comparative, 31 case series, and 9 case reports; 26 studies reported the results after injective administration, whereas 33 used surgical implantation. One study compared the two different modalities. With regard to the cell source, 20 studies concerned BMSCs, 17 ADSCs, 16 BMC, 5 PBSCs, 1 SDSCs, and 1 compared BMC versus PBSCs. Overall, despite the increasing literature on this topic, the evidence is still limited, in particular for high-level studies. On the other hand, the available studies allow to draw some indications. First, no major adverse events related to the treatment or to the cell harvest have been reported. Second, a clinical benefit of using MSCs therapies has been reported in most of the studies, regardless of cell source, indication, or administration method. This effectiveness has been reflected by clinical improvements and also positive MRI and macroscopic findings, whereas histologic features gave more controversial results among different studies. Third, young age, lower BMI, smaller lesion size for focal lesions, and earlier stages of OA joints have been shown to correlate with better outcomes, even though the available data strength does not allow to define clear cutoff values. Finally, definite trends can be observed with regard to the delivery method: currently cultured cells are mostly being administered by i.a. injection, while one-step surgical implantation is preferred for cell concentrates. In conclusion, while promising results have been shown, the potential of these treatments should be confirmed by reliable clinical data through double-blind, controlled, prospective and multicenter studies with longer follow-up, and specific studies should be designed to identify the best cell sources, manipulation, and delivery techniques, as well as pathology and disease phase indications.

 

[lobelsteve]

8 out of 8 clinical studies involving culture-expanded MSCs on human subjects that properly reported AEs included.
0 infections related to the injection of MSCs.
0.02% tumor rate including 0% related to treatment.
Cause of AEs carefully considered by the authors, who have no conflicts of interest.

Science means looking at all the facts, not cherry-picking the negative and blowing it out of proportion in your zeal to discredit.

How do you know these tumors were not related to the cells?

 

[GH253]

How do you know these tumors were not related to the cells?

The authors concluded as much because the 0.2% tumor rate among the research subjects was not higher than that which normally occurs in the general population and the tumors did not occur at the injection site. Why do you mentally zero in on a statistically trivial incidence of tumor development when this shows the clear promise to be the first disease-modifying treatment for one of the most miserable and expensive conditions plaguing mankind? Does it threaten your comfort zone of making a living ordering tests and referring patients around? Your Celebrex and opiod kickbacks? Do you envy the individuals who became successful pioneering the procedure? Which category of deadbeat doctor do you fall into? If as a result of your complacency, cynicism, and deference to the flunkies in government you fail to recognize your patients' most important treatment option, and they go on to suffer the adverse effects of NSAIDs, become reliant on opioids, have their knees amputated, and lose their ability to work, lead active lifestyles and enjoy life, your ****ty advice is harming those people.

 

[Ducttape]

The authors concluded as much because the 0.2% tumor rate among the research participants was not higher than that of the general population and the tumors did not occur at the injection site. Why do you mentally zero in on a statistically trivial incidence of tumors when this shows the clear promise to be the first disease-modifying treatment for one of the most miserable and expensive conditions plaguing mankind? It threatens your comfort zone because you want to make a living just ordering tests and referring patients around? It threatens your Celebrex and opiod kickbacks? You envy the individuals who became successful pioneering the procedure? Which category of deadbeat doctor do you fall into? If as a result of your complacency, cynicism, and deference to the flunkies in government you fail to recognize the most important treatment option for your patients...and they go on to suffer the adverse effects of NSAIDs and steroid shots, become reliant on opioids, have they knees amputated, and lose their ability to work, active lifestyles and quality of life, your ****ty advice is harming those people.

I seem to remember similar quotes from, oh, 15 years ago, referring to how safe and effective a new medication is for patients with chronic pain... it "gives them their lives back"... "minimal risks of side effects"... "tolerated very well"... "12 hour duration of potency"... "no increased risk of addiction"...

give science time to catch up with innovative treatments. if it is clearly helpful, and is good to combat the years of obesity, inactivity, and abuse Americans put on their knees, then eventually science will prove it. otherwise, it will go the way of, for example, antibiotics x 12 weeks or methylene bloe for discogenic pain, adhesionolysis, ITP for chronic noncancer pain, IDET, routine discograms, etc...

 

[VA Hopeful Dr]

The authors concluded as much because the 0.2% tumor rate among the research participants was not higher than that of the general population and the tumors did not occur at the injection site. Why do you mentally zero in on a statistically trivial incidence of tumors when this shows the clear promise to be the first disease-modifying treatment for one of the most miserable and expensive conditions plaguing mankind? It threatens your comfort zone because you want to make a living just ordering tests and referring patients around? It threatens your Celebrex and opiod kickbacks? You envy the individuals who became successful pioneering the procedure? Which category of deadbeat doctor do you fall into? If as a result of your complacency, cynicism, and deference to the flunkies in government you fail to recognize the most important treatment option for your patients...and they go on to suffer the adverse effects of NSAIDs and steroid shots, become reliant on opioids, have they knees amputated, and lose their ability to work, active lifestyles and quality of life, your ****ty advice is harming those people.

Are you really this stupid? Honest to God, I sometimes wish I got kickbacks from the number of prescriptions I write but I can't believe that anyone still thinks this is a widespread thing.

 

[GH253]

I seem to remember similar quotes from, oh, 15 years ago, referring to how safe and effective a new medication is for patients with chronic pain... it "gives them their lives back"... "minimal risks of side effects"... "tolerated very well"... "12 hour duration of potency"... "no increased risk of addiction"...

That episode only happened because the FDA, which too many people take as the final authority on all scientific matters, assured everyone that Vioxx was safe and effective. Complacent doctors acted on that government blunder and started prescribing. It is one of history's premier examples of regulatory failure, hardly an argument for regulating cells and drugs.

give science time to catch up with innovative treatments. if it is clearly helpful, and is good to combat the years of obesity, inactivity, and abuse Americans put on their knees, then eventually science will prove it. otherwise, it will go the way of, for example, antibiotics x 12 weeks or methylene bloe for discogenic pain, adhesionolysis, ITP for chronic noncancer pain, IDET, routine discograms, etc...

The issues that you and the others are refusing to acknowledge even though I've stated it repeatedly here is that the FDA's regulations are inhibiting science. There is no incentive to study something that can't be used clinically because the FDA considers it a drug, and it is not possible to raise the funding needed to get it approved as a drug because it cannot be sold profitably as such. People spout bromides about "science" but don't understand that progress requires that scientists have the freedom to act.