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Post by lakon on Nov 16, 2018 22:41:51 GMT -5
Nov 17, 2018 0:36:09 GMT 9 awesomo said: Afrezza social media channels are still down as well, this board could probably do a better job than what’s currently going on with sales and marketing. Nov 17, 2018 0:46:31 GMT 9 goyocafe said: We should. I don’t believe the FDA can stop an independent group from saying what they want so long as they have no direct monetary ties to the company. And our posts could include statements like “no drama” without a rebuke from the FDA. Jmho Nov 17, 2018 5:11:59 GMT 9 goyocafe said: I think my point is getting lost in the details. Laura Kronen released a 10 minute video last week that said more than any ad MNKD could ever say due to all the restrictions the FDA and other agencies place on companies advertising their drugs. If Laura's video were to go viral, there is nothing that the FDA or OPDP or NASA  could do to stop it. I was suggesting that there'd be little any agency could do if an independent group did the same thing that Laura has done. --- A LONG time ago, I mentioned something similar. I won't bother to find the thread. Obviously, I agree with you. While IANAL, I think the Constitution is very clear on this matter. The FDA has NO legal authority to block free speech. They can regulate companies and what they say commercially. There is debate about the legality of preventing companies from saying what they believe to be true, even based on weak evidence. The original intent of the law WRT regulation was to prevent misleading and false statements that may result in real harm. It's morphed into a beast pretending to know it all. In the case of the FDA, after all the trials, people still get sick, addicted, and/or die from FDA approved medications. Why do they have any authority to regulate a human hormone and how people use it? It is apparently because the People have not objected too strongly, yet. We have seen this with HIV/AIDS. We have seen this with acne treatments. Cancer treatment is another big fiasco. That's just three across a broad spectrum to name a few. The People need to realize that they are not safe because any regulator or government says so. The People need to learn who they can and cannot trust, and that includes their current so called oracles. Trust is best evaluated over the long-term, and Al Mann and MannKind have a long record to be proud of. Now, that said, the FDA would be hard pressed to stop anyone, especially foreign sourced IF they were committed to getting the word out. As long as a regulated company is not involved, it should not be the concern of the FDA. There are other legal options available to citizens and the State to address malfeasance. We see how well the SEC is doing their job... If you are an investor, say so proudly. If you are an actual end user of the product, say so proudly. Do not give THEM an inch. Free speech is about having the freedom to say what you believe, even if it is wrong. There is no law against being wrong. There may be personal or corporate liability, but there is nothing criminal, unless you are knowingly committing a fraud. Even then, lying is not the crime. I dabbled with a lot of ideas WRT your idea. I think it is feasible to do WHAT MannKind MAY NOT; however, it is A LOT of effort and work. Significant resources are needed. The resources are not necessarily money, but it would help. A genius or two could see it through. I created this thread so like minded individuals can investigate legal tactics and strategies to mitigate commercial risks of regulation, such as how to spread the word about Afrezza, the best inhaled insulin marketed in the world today. (Did you see what I did there? Afrezza happens to be the only one so it's hard to make a legal argument against my opinion without running afoul of the First Amendment.) |
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Post by uvula on Nov 16, 2018 22:53:15 GMT -5
VDEX is kind of doing what you are suggesting. We can help steer people to the VDEX website.
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Post by stevil on Nov 17, 2018 1:50:05 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason.
However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective.
I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy?
Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner.
It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them.
The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations.
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Post by mango on Nov 17, 2018 11:30:12 GMT -5
FDA exercises their Constitution right all time, just look at FDA Commissioner Scott Gottlieb's Twitter page where it is full of threads he creates to advertise and market biologics to the Public using persuasive language that's full of deception.
The People are sheep?
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Post by mango on Nov 17, 2018 11:44:48 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason. However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective. I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy? Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner. It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them. The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations. FDA approves drugs without ever identifying the MOA. That is lunacy. FDA profits handsomely from the fees they require of tobacco companies in exchange for allowing them to play in US commerce. These tobacco companies, many of whom are also publicly traded on US stock markets, have the FDA's blessing to profit off induced illnesses, diseases, cancers. |
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Post by audiomr on Nov 17, 2018 16:13:06 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason. However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective. I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy? Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner. It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them. The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations. FDA approves drugs without ever identifying the MOA. That is lunacy. FDA profits handsomely from the fees they require of tobacco companies in exchange for allowing them to play in US commerce. These tobacco companies, many of whom are also publicly traded on US stock markets, have the FDA's blessing to profit off induced illnesses, diseases, cancers. By "MOA" I assume you mean "method of action," which can be much harder to pin down than efficacy. "Profit" is not really the right word in relation to the FDA, which in any event is chronically underfunded. If you're suggesting that tobacco products simply be banned, remember our experience with prohibition early in the last century. |
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Post by stevil on Nov 17, 2018 16:42:18 GMT -5
I'd be careful what you wish for. Medical doctors can prescribe any FDA approved medication that they want at any time and for any reason. However, if a doctor prescribes a medication for a condition that the medication was not intended to treat and ends up harming the patient, you want the doctor to be able to be held liable for damages... Generally speaking. If you take away those restrictions, you're leaving all the power in the hands of the individual doctor. That's not as safe of a place to be compared to a body of evidence that can prove a therapy is safe and effective. I think you're failing to understand that someone or something will always be in charge of regulations. Is it better for one mind to make those decisions or potentially thousands of minds that check each other to see if they all agree before deciding on proper indications for therapy? Personally, I'd send my family to an evidence-based practitioner who is up to date on the current standards of medical practice. Unless I'm out of options after the standards have been exhausted and they're in a life-threatening situation. I think that's the point one should jump to experimental medicine- and not a moment sooner. It also seems as though you're misunderstanding the role of the FDA. No one at the FDA is telling doctors not to prescribe Afrezza. The FDA has already given their nod of approval. It's the docs themselves that are choosing not to prescribe. Nothing is stopping them. The FDA does not allow for unsubstantiated claims to be made. Meaning, all claims by drug manufacturers must be based on standardized protocols during clinical trials. Until those trials have been run and produced said claims, they're not allowed to be used for marketing purposes. Drug reps are allowed to point docs to the stat trial though. There are all sorts of data collections that docs have to sort through to separate the wheat from the chaff. But that's extremely time-consuming and inefficient. It's better for that responsibility to be delegated to someone else. Docs want to spend time with their patients for the most part (at least in my experience). Some enjoy research, but the vast majority are content allowing data collectors do the grunt work to form recommendations. FDA approves drugs without ever identifying the MOA. That is lunacy. FDA profits handsomely from the fees they require of tobacco companies in exchange for allowing them to play in US commerce. These tobacco companies, many of whom are also publicly traded on US stock markets, have the FDA's blessing to profit off induced illnesses, diseases, cancers. I completely disagree. You mean to tell me that if a cancer researcher stumbled upon a cure to cancer that it should be kept off the market until the mechanism could be made known? If a drug is safe and proves to have a beneficial outcome, who cares about the mechanism? Is there increased risk involved without knowing the mechanism? Probably. Much of medicine is chemistry. They teach us in medical school that "All things are poison, and nothing is without poison, the dosage alone makes it so a thing is not a poison." -Paracelsus. I assume you're referencing metformin for your argument. It would be a shame if metformin were never FDA-approved simply because the mechanism wasn't known. Its active ingredient comes from the French lilac flower and people have been using it for centuries. As awful as tobacco is for health, I think it's criminal to take away someone's right to use it. Informed consent happens all the time and doctors are taught to appreciate their patients' autonomy in decision making. I would never want the government taking away any one of my rights that does not impinge upon my fellow man. In that same breath, I would not be opposed to charging parents who smoke in their children's presence with child abuse. The FDA makes it so that doctors cannot harm their patients. For diseases that have no other treatment options, the FDA grants more leeway, so long as the risks don't outweigh the benefits. Much of medicine is constantly making decisions balancing between the two. |
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Post by mango on Nov 17, 2018 17:58:35 GMT -5
FDA approves drugs without ever identifying the MOA. That is lunacy. FDA profits handsomely from the fees they require of tobacco companies in exchange for allowing them to play in US commerce. These tobacco companies, many of whom are also publicly traded on US stock markets, have the FDA's blessing to profit off induced illnesses, diseases, cancers. By "MOA" I assume you mean "method of action," which can be much harder to pin down than efficacy. "Profit" is not really the right word in relation to the FDA, which in any event is chronically underfunded. If you're suggesting that tobacco products simply be banned, remember our experience with prohibition early in the last century. Does this look under funded to you?  |
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Post by letitride on Nov 18, 2018 1:52:59 GMT -5
When there is a free market there will be free speech. Regulation is about money not medicine.
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Post by falconquest on Nov 18, 2018 8:17:30 GMT -5
When there is a free market there will be free speech. Regulation is about money not medicine. Not sure I totally agree with that statement although I wish it could be true. Discuss the idea of deregulation during your next airline flight. |
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Post by letitride on Nov 18, 2018 9:24:12 GMT -5
When there is a free market there will be free speech. Regulation is about money not medicine. Not sure I totally agree with that statement although I wish it could be true. Discuss the idea of deregulation during your next airline flight. Its always so much fun to see what I wrote the next morning. Who needs airlines when you fly my way. |
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Post by mnkdfann on Nov 18, 2018 13:25:59 GMT -5
Does this look under funded to you? How much of that taxation revenue actually flows to the FDA? Which seems to be your point, considering your comment about the FDA profiting off of tobacco. Where Does Tobacco Tax Money Go? bizfluent.com/about-5526865-tobacco-tax-money-go.html |
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Post by sportsrancho on Nov 18, 2018 16:43:44 GMT -5
My question is ..where is the marketing? And what has she been doing all these months! laborer7511/18/18, 11:45 AM @bigcheeze shadydep I'm pretty sure Garrett was brought on in July. Plenty of time for a SM campaign to get started. Still puzzles me. |
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Post by mango on Nov 18, 2018 19:05:35 GMT -5
Does this look under funded to you? How much of that taxation revenue actually flows to the FDA? Which seems to be your point, considering your comment about the FDA profiting off of tobacco. Where Does Tobacco Tax Money Go? bizfluent.com/about-5526865-tobacco-tax-money-go.html"Tobacco product user fees are the sole source of funding for FDA's regulation of tobacco products," stated the FDA "Therefore, FDA considers these fees to be critical to the agency's ability to achieve its mission to protect and promote the public health. User fees provide FDA with a source of stable, consistent funding that has made possible our implementation of the Tobacco Control Act." First, the FDA assesses how much the entire tobacco industry has paid in excise tax. Once that grand total is determined, FDA then assesses how much excise tax each individual class paid. The FDA then calculates what percentage of the grand total each category paid in excise tax. When that percentage is established, that becomes the fee rate the FDA expects from the category. User fees are then divided amongst companies based on each entity's market share. Each user fee is based on each regulated entity's respective total federal excise tax payment, FDA calculates the entity's portion of the category total payment. |
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Post by sportsrancho on Nov 24, 2018 10:37:35 GMT -5
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could do to stop it. I was suggesting that there'd be little any agency could do if an independent group did the same thing that Laura has done.
