I’d like to sprinkle some on steak. I bet that would be amazing!
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Hi Zep,
Happy Friday. I have a couple of comments on this that I was hopeful you could please provide some insight on.
- The regulations you are referring to re: degree of manipulation are noted in 21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products.
The purpose of this section is to “…create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P’s.”
I’d like to review a few of these and see what, specifically, the impediments posed by these regulations are. For example:
- Creating a unified registration and listing system requires establishments to submit Form FDA 3356, a 2 page document that requires completion of only the first page. What information requested on this document is an impediment to stem cell therapy becoming a reality?
- Establishing donor eligibility requires establishments to perform tests in an accredited lab to make sure the donor is compatible and free of relevant communicable disease agents/diseases. It also requires establishments to document and follow their procedures and perform them near the area where their use will be indicated.
- Facilities must be suitable to prevent contamination, be in a good state of repair, and ‘must provide lighting, ventilation, plumbing, drainage, and access to sinks and toilets that are adequate to prevent the introduction, transmission, or spread of communicable disease.’ Establishments ‘must dispose of sewage, trash, and other refuse in a timely, safe, and sanitary manner’ and keep records of these activities.
- Equipment is held to essentially the same standard as the facilities; e.g., be of appropriate design, capable of producing valid results, cleaned/sanitized/calibrated/inspected on a regular basis.
- Safety monitoring requires that these establishments notify the FDA if there is a reaction to these products involving a communicable disease that is fatal, life-threatening, results in permanent impairment of a body function or permanent damage to body structure, or requires medical/surgical intervention. The FDA requires that they be informed within 15 days of receipt of this information, and that establishments investigate these adverse reactions ‘as soon as practical.’
I could go on, but I feel this is a good faith representation of the requirements. What do you think is unreasonable about requiring establishments that tinker with biological products before administering them to humans ensure compatibility, have established procedures, be clean, have working equipment, and investigate instances where their treatments kill, almost kill, or require additional intervention to protect the patient, etc.? Specifically, I mean.
What you might have noted about these regulations is that they are, though prolific, fairly ambiguous. What is ‘timely’? What is ‘adequate’? How often, specifically, is ‘periodically’, and how soon is ‘as soon as practical’?
Clinical trials are generally held to a similarly oppressive standard. I have maintained for some time now that regulatory compliance is more of an art than a science, because the verbiage of these expectations is purposefully vague. There needs to be a set of rules in place to safeguard the rights, safety, and well-being of patients/trial participants and to protect the integrity of the study, but we operate in the real world, where flexibility is required. Unfortunately, this ambiguity does allow inspectors a fair amount of leeway when auditing sites, but the contents of their warning letters (483s, or “Notice of Inspectional Observations”) are generally addressed fairly routinely except in cases of reckless non-compliance. They have some posted on their website.
So, what part of these regulations do you consider to be the most significant obstacle for stem cell therapy? We can then discuss the hardships imposed by the PHS Act if you’d like.
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Oops, forgot #2. This will be quicker, I promise.
Re: the claim that the FDA’s regulations are overly restrictive because they are in the pocket of Big Pharma: do you know the relationship between the Code of Federal Regulations (CFR) and the United States Code (USC)?
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The education never ends The Truth About Cancer: A Global Quest - Episode 4
This thread makes me want to stab a fork into my eyeballs. A fork laced with Tabasco sauce.
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Number 3 prescription painkillers. Oh this can’t be true because it is an approved drug by the FDA.
Few know that systematic reviews of hospital charts found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year.
This makes prescription drugs a major health risk, ranking 4th with stroke as a leading cause of death.
The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the U.S. and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.
Looking back, Jerry Avorn, an authority on pharmacoepidemiology, wrote that “laws designed to encourage and protect meaningful innovation had been turned into a system that rewarded trivial pseudo-innovation even more profitably than important discoveries.”
Risk for the major companies is much less than claimed for several reasons. First, they spread risk over many projects. Second, once inflators and public subsidies are taken out, net research costs are a fraction of the $1 billion to $5 billion per new drug claimed, and big companies largely invest after the public and others have paid for the high risks of research to discover new drugs. As new drugs enter clinical trials, their risks are just 1 in 5. Third, companies cut losses by stopping development of drugs whose profit potential is not as high as they want. We never will know how many beneficial drugs never get approved because companies estimated they would not be profitable enough.
The pharmaceutical industry refers constantly to its “R&D pipeline” of new drugs under development. But there is a second, parallel pipeline—the trial-journal pipeline. It consists of randomized clinical trials designed with the marketing departments to produce evidence that their drugs are more effective and safer than unbiased trials would show. Commercially funded clinical trials are at least 2.5 times more likely to favor the sponsor’s drug than non-commercially funded trials.
Pffffftttt. There goes the argument put forth by many to justify the high cost of pharmaceuticals.
Financially, the FDA is an extension of the pharmaceutical industry and plays a major role in expanding markets for more people to take more drugs.
Been saying this all along.
In response to drug disasters like Vioxx, which experts say caused about 120,000 traumatic cardiovascular events and 40,000 deaths, Congress and the FDA have set up monitoring and safety systems. But a review of results so far found little evidence they are identifying serious risks or altering prescribing practices.
An “approved” drug that wreaked havoc.
How many people have died of stem cell therapy vs. how many have gotten more improvement? It seems as the deaths you are reporting from stem cells had to do with the way they are administered or the mishandling of them and not the stem cells. Big difference. How many people have died from medicinal marijuana?
Being right has to do with truth and evidence not how many people espouse a philosophy,
And what does that have to do with the contents?
That is 50k a day being helped.
Just not in the U.S. as we wouldn’t want to dent the profits of Big Pharma. Because we have a healthcare system designed to make profits vs. helping people. This system sucks!
As usual you had nothing to add to the conversation just your immature comments.
Maybe that is a better question for you to answer since you are in the field.
When someone can go from the FDA to work, then to Big Pharma and then back to a position of power in the FDA. That is a revolving door that ought to be illegal. You can work for the FDA or Big Pharma but not both. It ought to be illegal. When the public’s health is at risk they should not be allowed to be taken advantage of by those with specialized knowledge.
Why is marijuana being legalized for medicinal usage?
Do you know that people go from positions of power in the FDA and go to work in Big Pharma and back to positions of power in the FDA. A conflict of interes if there ever was one. Laws will be subverted.
Most people move through life with the understanding that the more they learn the more they find out how little they know.
You are the exact opposite. You pack your skull fuller and fuller with half truths and outright lies that you are attracted to through confirmation bias. This actually makes you dumber and dumber as you plunge headlong into an abyss of self deception and intellectual complacency.
Put simply- the dumber you get the smarter you think you are.
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The main objection I see here is the double-blind studies on the subject. So tell me where are all the double-blind studies in the U.S. on medicinal marijuana? Are all of these people just imaging their benefits they are receiving? Should they wait around for science to catch up on something they already know all the while suffering.?
Hi Zep,
[quote=“Zeppelin795, post:291, topic:224450”]
Maybe that is a better question for you to answer since you are in the field.[/quote]
My field is drug development, specifically, the management of clinical operations for Phase II/III drug trials. By drugs, I generally mean conventional pills, potions, and powders, not stem cell therapies. I haven’t done bench work since my time handling conventional pills, potions, and powders in a compounding pharmacy, which is also the closest I have ever come to patient care.
Since I’m neither a healthcare professional nor a laboratory technologist, I could hazard some guesses… but I’m not the one arguing the ways in which these regulations have hamstrung the stem cell research, so I’d like to hear your thoughts.
[quote=“Zeppelin795, post:291, topic:224450”]
When someone can go from the FDA to work, then to Big Pharma and then back to a position of power in the FDA. That is a revolving door that ought to be illegal. You can work for the FDA or Big Pharma but not both. It ought to be illegal. When the public’s health is at risk they should not be allowed to be taken advantage of by those with specialized knowledge.[/quote]
Apologies if this has already been discussed, but could you 1) please explain the ways in which this affects patient safety, and 2) please provide examples of #1?
As well, please remember that, as talented as folks like ActivitiesGuy are, the biggest rate limiting step for generating compelling data within a new drug application (NDA) is… the data reported to the Sponsor by the investigative sites in the first place.
To this end, pursuant to 21CFR54.4(b), any relevant change(s) to the financial information reported by an individual listed on Form FDA 1572 at the start of their participation in a study requires the submission of a new financial disclosure form. This obligation remains in effect for the duration of their participation in this trial and for one year following its completion.
A review of 21CFR312.62(b) will illustrate an investigator’s record keeping responsiblities; 21CFR312.64(b) will illustrate an investigator’s responsibility for reporting safety information; 21CFR312.64(c) will illustrate an investigator’s responsibility to submit a “final report” (i.e., they sign off on the data reported in the system for each participant; this is part of their record keeping requirements, as well, since they receive this information at the conclusion of the trial); and 21CFR11.100(b) will illustrate the requirement of certifying, via a non-repudiation agreement submitted to the FDA, that digital signatures utilized in electronic systems are intended to be the legally binding equivalent of traditional handwritten signatures.
You can read all about the Sponsor’s responsibilities under the FDA in 21CFR312, as well.
[quote=“Zeppelin795, post:291, topic:224450”]
Why is marijuana being legalized for medicinal usage?[/quote]
I don’t research it, just smoke it.
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Zep, if you’re willing to put away the sword and have an honest conversation about this, I will be happy to do so.
To be honest, your post history here and the repetition of the same themes about Big Pharma is why I am reluctant; any time I try to give a legitimate answer about why a certain therapy or study went a certain way, it always comes back to the evils of Big Pharma instead of actually reading and comprehending my (legitimate) points.
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“Over 50,000 people around the globe are treated each year”
God, you are fucking stupid.
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Ways in which the FDA limit advancements in applicable stem cell treatments.
Procedure cell product constituted a “drug” under the Food Drug and Cosmetics Act[3] and a “biologic” under the Public Health Service Act
The marijuana question does not need to be researched to know the answer. It was initially fought by Big Pharma and since they couldn’t stop it are now trying to profit from it. Once the word of adult stem cell treatments are well known the bogus fear tactic will not work any longer. After this happens or during it’s course look for Big Pharma to get in on the act in a major way as they will see the writing is on the wall. So if you can’t beat’em, join’em.
A revolving door between FDA and Big Pharma needs to be explained? Fast track of drug approvals is obvious and doesn’t need to be explained. Are you denying this happens and that the revolving door has nothing to do with it?
The system IS the problem and Big Pharma plays a major role in the profits and legislation as they have a plethora of lobbyists to do their bidding and buy influence. When in doubt just follow the money.
Okay maybe I misread the article. But you call me stupid while you support policies that make the public suffer. If it was up to you and your ilk medicinal marijuana wouldn’t be legalized. Any criticism of a “free market” healthcare system is not allowed as an exposure of this will show what a failure it is. What matters most to you is an economic ideology not the truth. And you need to keep it going as long as you can otherwise your philosophy may come into question and that is too difficult for you to face.