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I 100% agree. My concern is with the slow track on drugs attacking dementia and advanced cancer. There is literally nothing to lose if on an informed basis those patients are receiving an unproven drugs. Yet the approval process ditzes along while people die.
I would prefer a somewhat faster track generally.
New drugs are more likely to cause harm than benefit, unless they're properly tested and vetted. Now, I know in the case of dementia, we might be willing to risk harms for the (very very) small chance of a cure since the trajectory of the disease is so ghastly. But there always exists compassion use legislation that allows people with terminal illnesses to use experimental drugs (not yet FDA approved).
New drugs are more likely to cause harm than benefit, unless they're properly tested and vetted. Now, I know in the case of dementia, we might be willing to risk harms for the (very very) small chance of a cure since the trajectory of the disease is so ghastly. But there always exists compassion use legislation that allows people with terminal illnesses to use experimental drugs (not yet FDA approved).
Then, why does my close friend have to fly to Germany for experimental preventative treatment for dementia? His father and his father’s brother both died of it. And why does his wife have to fly to Tijuana to get treatments for limes disease that are unavailable in the US? this is absolutely the triumph of process over progress.
Then, why does my close friend have to fly to Germany for experimental preventative treatment for dementia? His father and his father’s brother both died of it. And why does his wife have to fly to Tijuana to get treatments for limes disease that are unavailable in the US? this is absolutely the triumph of process over progress.
Lyme disease would not fall under compassion use. As for your friend's father, I don't know. It could simply because the clinic in Germany are expert's in this treatment or it never submitted a clinical trial with the FDA.
Then, why does my close friend have to fly to Germany for experimental preventative treatment for dementia? His father and his father’s brother both died of it. And why does his wife have to fly to Tijuana to get treatments for limes disease that are unavailable in the US? this is absolutely the triumph of process over progress.
Experimental? So patients are paying for experimental treatments and not the drug companies?
How much does antibiotics cost for the treatment of Lyme disease?
"More specifically regarding alternative, non-antibiotic treatments, the CDC warns:
Antibiotics are the only known effective treatment for Lyme disease, but a quick search on the internet will introduce you to other untested remedies that claim to cure Lyme disease or chronic Lyme disease. These products—available online or from some health care providers—may be dangerous, deadly, or simply a waste of money.
Nevertheless, according to US Weekly, ex-husband David Foster “shelled out nearly $5 million on Yolanda’s treatments.” The LymeScience herbs and supplements page explains why many of these treatments were unlikely to help."
Lyme disease would not fall under compassion use. As for your friend's father, I don't know. It could simply because the clinic in Germany are expert's in this treatment or it never submitted a clinical trial with the FDA.
Quote:
Originally Posted by Medical Lab Guy
Experimental? So patients are paying for experimental treatments and not the drug companies?
How much does antibiotics cost for the treatment of Lyme disease?
"More specifically regarding alternative, non-antibiotic treatments, the CDC warns:
Antibiotics are the only known effective treatment for Lyme disease, but a quick search on the internet will introduce you to other untested remedies that claim to cure Lyme disease or chronic Lyme disease. These products—available online or from some health care providers—may be dangerous, deadly, or simply a waste of money.
Nevertheless, according to US Weekly, ex-husband David Foster “shelled out nearly $5 million on Yolanda’s treatments.” The LymeScience herbs and supplements page explains why many of these treatments were unlikely to help."
Are you sure you want to make the argument that the country with the fastest drug approval process is the least corrupt? I would argue it is the most easily corruptible.
That's not what I said.
I said that medications that are proven to be helpful for many years, without any questionable side effects, shouldn't be undergoing new lengthy trials in the US again. Especially those from the EU or some developed countries, where the tests and quality controls are quite reliable.
Also, the FDA restricts the importing of drugs from Canada, or overseas (EU, Japan, Australia) if a version is available domestically, patients are stuck with the new, expensive version that costs several times more than overseas.
Experimental? So patients are paying for experimental treatments and not the drug companies?
It's quite common for terminally ill patients (usually cancer) where there is no effective SOC or SOC has failed them (and in oncology, they are now on 'salvage' therapy) to either enroll in a clinical trial or just pay for the drugs if they're not eligible to be enrolled.
That's not what I said.
I said that medications that are proven to be helpful for many years, without any questionable side effects, shouldn't be undergoing new lengthy trials in the US again. Especially those from the EU or some developed countries, where the tests and quality controls are quite reliable.
Also, the FDA restricts the importing of drugs from Canada, or overseas (EU, Japan, Australia) if a version is available domestically, patients are stuck with the new, expensive version that costs several times more than overseas.
A clinical trial can be conducted in Europe and approved by an IRB in the EU, and be considered by the FDA for approval provided the PIs apply for and are in compliance with IND regulations 21 CFR 312 .
The issue I guess is grandfathering in medicine approved in Europe and not in the USA. I have to ask which medicine you're thinking of.
That's not what I said.
I said that medications that are proven to be helpful for many years, without any questionable side effects, shouldn't be undergoing new lengthy trials in the US again. Especially those from the EU or some developed countries, where the tests and quality controls are quite reliable.
Also, the FDA restricts the importing of drugs from Canada, or overseas (EU, Japan, Australia) if a version is available domestically, patients are stuck with the new, expensive version that costs several times more than overseas.
Let's go over what you said.
" Medicine is plagued by untrustworthy clinical trials
Investigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up, warn some researchers. They urge stronger scrutiny.
It's not only corrupted FDA who manage our health. The whole system is rotten."
Your premise is that not only are clinical trials unreliable but the FDA is unreliable and the whole system is corrupt.
Wouldn't doing additional studies required by the FDA safeguard by detecting unreliable and made up invented faked studies? You say just accept other countries studies implying they are all reliable and safe because they come from EU.
There are regional differences that impacts the practice of medicine. There is no standardized environment that the world lives in. There are significant environmental differences and genetic differences. It's important that each country verify studies performed in one country if another country wants to adopt those practices.
"Original Investigation Health Policy
August 30, 2022
Availability of New Medicines in the US and Germany From 2004 to 2018
Conclusions and Relevance In this cohort study, fewer new medicines were available in Germany compared with the US between 2004 and 2018. In addition, drugs entered the German market later than in the US."
Wouldn't doing additional studies required by the FDA safeguard by detecting unreliable and made up invented faked studies? You say just accept other countries studies implying they are all reliable and safe because they come from EU.
While governments are shuffling papers and making work for themselves, people are suffering or dying. Perhaps have a class of approval that is less than full and let the doctors and patients make their own decision. I don't need some committee that meets a few times each year telling me what to do.
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