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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.
Not sure where you got that information.
I take three prescription drugs. All three are generics. Two of them pretty much always come from the USA manufacturer. The third one sometime comes from India, but there is an American manufacturer as well. I get whichever one the pharmacy goes with, and it can vary from month to month.
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.
I get it. But the problem exists the other way around as well. The more lax we're in approving new drugs, then we will have another problem of people getting harmed with ineffective and/or harmful medications. There is no solution where everyone benefits.
The way I look at it is this way - if some experimental drug really offered clear benefit, it would be rapidly brought to this country and used. I get that when patients are dying of some terminal illness they want hope and they want to try, but almost likely whatever this experimental protocol your friend's father is using in Germany is likely not to work.
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."
Many FDA approvals are based on MANUFACTURERS own tests, researches and trials. FDA blindly approves those, pockets bribes and later on, when patients experience serious side effects (not disclosed by manufacturers for an obvious reason) recalls those meds. After a lot of damage is done.
It seems that they approve first, they wait to see how it's working - making patients guinea pigs, then recalls it.
You know how many medications are recalled in the US? In average 1400 a year.
So, who cares that the FDA approves more meds than other countries, when they cause harm to patients and need to be recalled later? It's not about the quantity, but quality.
In the meantime lots of people are making lots of money on those meds.
So, how are the lengthy tests working for patients?? It's a scam.
The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.
Nuplazid, a drug for hallucinations and delusions associated with Parkinson's disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.
Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.
Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath.
Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited "insufficient" evidence of health gains from Folotyn, which shrinks some tumors but hasn't been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.
They surely amassed lots of money for the approvals. Who cares about patients health, when there is lots of money to make, right?
I take three prescription drugs. All three are generics. Two of them pretty much always come from the USA manufacturer. The third one sometime comes from India, but there is an American manufacturer as well. I get whichever one the pharmacy goes with, and it can vary from month to month.
Many FDA approvals are based on MANUFACTURERS own tests, researches and trials. FDA blindly approves those, pockets bribes and later on, when patients experience serious side effects (not disclosed by manufacturers for an obvious reason) recalls those meds. After a lot of damage is done.
It seems that they approve first, they wait to see how it's working - making patients guinea pigs, then recalls it.
You know how many medications are recalled in the US? In average 1400 a year.
So, who cares that the FDA approves more meds than other countries, when they cause harm to patients and need to be recalled later? It's not about the quantity, but quality.
In the meantime lots of people are making lots of money on those meds.
So, how are the lengthy tests working for patients?? It's a scam.
Yes, Phase 1-3 clinical trials are done by the manufacturers usually (unless its a generic being tested for another indication).
Phase 4 is where the drug is made available and the FDA monitors for side effects. The harsh reality is, many side effects are too rare to be seen by clinical trials. Europe has a similar process.
There is of course corruption in both Europe's and our system. There is probably more in ours because Europe negotiates the price of meds and Pharma companies make less releasing to European markets than they do here.
Where there is money and people, there is corruption. I know I asked this a few times already, any meds you're thinking of that are approved in Europe but not here?
More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in other countries, due to unfavorable benefit-to-risk profiles, uncertain clinical benefit, or unacceptably high price, according to a recent study published in JAMA Internal Medicine.
The European Medicines Agency (EMA) refused marketing authorization for 5 drugs approved by the FDA after an unfavorable benefit-to-risk assessment: abaloparatide for osteoporosis, betrixaban for venous thromboembolism prophylaxis, emapalumab for primary hemophagocytic lymphohistiocytosis, istradefylline for Parkinson disease and pexidartinib for symptomatic tenosynovial giant cell tumor. In four cases, the EMA cited inadequate study results as the reason for refusal.
“It has been argued that drugs for which there is unclear clinical benefit, such as those granted expedited marketing authorization in the US based on surrogate end points, should be discounted in cost accordingly with the level of uncertainty."
I can't copy/paste the entire articles for those who want to argue, but refuse to read them.
I know I asked this a few times already, any meds you're thinking of that are approved in Europe but not here?
Many. I am sure you could Google it.
For example lots of non-opioid pain killers that work very well. There seem to be many alternatives to substitute opioids, at least for mild to moderate pain.
The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease.
Nuplazid, a drug for hallucinations and delusions associated with Parkinson's disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.
Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.
Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath.
Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited "insufficient" evidence of health gains from Folotyn, which shrinks some tumors but hasn't been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.
They surely amassed lots of money for the approvals. Who cares about patients health, when there is lots of money to make, right?
The way corruption works is a little more insidious than a pharma company waltzing up to the DSOB table with a briefcase full of money. I can go in length on this. For example, the patient advocate groups to the opinion leader/expert physicians are usually all financially entangled with the Pharma world, and these people have a seat at a table.
Many FDA regulators are smart and well intentioned, but can be peer pressured (or sometimes even fired) for failing to approve new medications. And then there is the revolving door. All of this happens over at the EMA too, I'm sure.
This is why many physicians are very hesitant prescribing new drugs. Often times prescribing older options even though SOC and new guidelines call for the newer drugs.
But the FDA does extremely good work as well. Thalidomide was blocked in the USA while approved in Europe. Lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine are less known examples.
For example lots of non-opioid pain killers that work very well.
Can you give examples? Lumiracoxib was approved in Europe as a NSAID pain med, but blocked in the USA. Then Europe revoked its approval a few years later due to increase heart attacks, strokes, and hepatotoxicity.
Just because its approved in Europe, doesn't mean its safe. Novartis, a Swiss Pharma company, was the manufacturer of Lumiracoxib. So corruption of course. The European companies corrupt their governing bodies and ours do it here.
And dare I say, Lumiracoxib works very well! Just the side effects don't make it worth it.
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