The situation is very different in the US. Unless a treatment passes fairly thorough FDA testing, the treatment can only be marketed as a supplement rather than as a medication for treating XYZ. There are usually three phases to a drug trial and in each phase the drug must show statistically significant benefit and it must balance against side-effects. Higher side-effects are more tolerated for diseases with higher morbidity.
I’d bet that most of the 40% you suggest would never make it past phase 1 in the US.
Huh? Did you misunderstand me? Of course any medication needs to be tested first in a clinical trial before it can be sold as medication - that’s the part of the doctor(s) on the team. First you do cell cultures and computer models, and later blind test on volunteers.
Sure, sometimes when the popular press reports that X is a cure for Y they mean the first stage of petri dishes and not the third stage of clinical trials; but all official approved medicine is tested here as in any rational country.
If the medications you are referring to are FDA approved for use in the US, then please add them to the list. Those are precisely the ones I’m looking for.
I’m a bit confused about how one makes and sells “high strength” homeopathic medicine that has “a reliable amount of active ingredient” - when homeopathic “drugs” are generally so diluted that it is unlikely that a single molecule of the supposed active ingredient is present in the final product (which is actually plain water).
It should be noted that Germany’s public health insurance plan covered homeopathy as late as 2004, and according to Wikipedia there are still circumstances under which tax money will pay for your homeopathic treatment (some other European nations continue to fund this quackery under their health insurance plans).
What we’ll need to be vigilant about in the U.S. are attempts to get homeopathy and various other forms of quackery covered under government-mandated health plans.
By the way, marketers flagrantly misuse the phrase “FDA-approved” in their ads, thereby suggesting that the FDA has investigated and verified the efficacy of their products. All it generally means is that advertising and sale of the stuff supposedly falls within the boundaries of current federal law and that it can legally be marketed as supplements.
Um, how am I going to find out what has been approved by the FDA in the US, maybe under different names, any better than you can?
IAMNApharmacist with access to a special database, I’m a lay patient who sometimes gets medicine from the apothecary, and who reads articles describing projects.
The list of officially approved medicine is rather long and it’s not easy for laypeople to sort out the origins of where each medicine comes from.
The thread was specifically asking for medications approved by the FDA. I did not wish it to degenerate into a debate. You either know of these medicines or you do not, but a vague notion of stuff that may or may not be approved for use in other countries is not helpful.
OK, I take colchicine. Despite the asshats at the FDA granting a monopoly to a manufacturer, bumping the cost of the damned things from $.40 per pill to $4.98 per fucking pill, the ‘recipe’ for my pills has not appreciably changed in over 100 years. It is extracted from some stupid crocus found in Anatolia or somewhere. I could theoretically make tea from the damned things and hope I got my dosage right.
Once again, I’m not looking for a debate, I’m looking for a list of FDA approved drugs. I certainly wouldnt make the argument that the pharmaceutical companies are saintly or even above some pretty nasty behavior.
Amphetamine is not a natural product AFAIK, but has been in the public domain and widely studied for 100 years. Still coins it for some companies in things like adderall.
That case though clearly points out that the ban was on products that make specific medical claims. This seems to be the current status: and clearly as late as 2007 the FDA was still sending warning lettersto companies about promoting and selling red yeast rice as a drug, (and to consumers warning them about it), but again, the sellers were making specific claims and selling the product on the strength of it’s drug content – many other red yeast rice products (that don’t make such claims, or that explicitly remove the drug) are still on the market and being sold.
So in this case it seems my snap comment wasn’t accurate; reality lies, as usual, somewhere in the middle.
Also, patents are not forever. Something like apirin may have been patented once, but many years ago the patent expired. (plus with Bayer, IIRC, there was the whole “property seized by the US government during the war” issue. ) Thus, the window of opportunity to make serious money off a drug is less than 20 years, since the clock is ticking on the patnet even during the trials before it is approved.
(When does the patent on Viagra expire? Watch for a lot cheaper generics then.)
A company may sell several or a whole line of homeopathic or natural remedies that are not patentable. SO what? Companies sell bread and milk too. The problem is that unless you can fool the public into overpaying with slick advertising, unless there is no competition, the profit margin for such items will be well below the profit margin on a patented drug that doctors prescribe to patients, who don’t have much choice if they want to get better. Often, too, patients don’t care about the cost if their pharmaceutical coverage pays the bill instead.
As noted above, Asprin was patented, and the patent was effectively seized as part of the post WW1 reparations. But patented it was. Penicillin could have been patented. However a deal was struck between the UK and US over the effort needed to ramp up the production mechanisms, and part of the deal struck was that the US got rights to the drug production in return for the money and effort they put into the process. The drug itself was not patentable - Fleming didn’t patent it, and it was long in the public domain when Florey and Chain worked out how to make useful quantities of it. The process to make penicillin in industrial quantities would have been patentable. Chain wanted to patent it. One can also note that later chemical modification of penicillin was one of the first mechanisms used to make new (hopefully active against penicillin resistant bacteria) antibiotics. These are again patentable, and were patented.
The US patent on Viagra expires on March 27, 2012.
The usual argument about FDA (or other country’s government equivalent agency) approval is that this. If you you want to claim clinical efficacy you must get approval. This is hard and fast. No quack cures, no miracles. Approval requires rigorous scientific effort. Ever since disasters like Thalidomide, there are very significant barriers to get approval. This costs big money. If you can’t make enough money back to cover the approval process, there is no reason to bother. If you get approval for a non-patentable or otherwise unprotected drug you will simply be beaten out of business by competitors that can undercut you because they don’t have to pay off the approval costs you incurred. The FDA does not fund approvals. You can’t get research funding in a university or other insitution to get approval. Impasse.
You could usefully argue that there is a clear public benefit in a government funding the final step of research and approval for drugs that appear to offer clinical value that would otherwise be orphaned. However, it isn’t cheap, and you might imagine that getting such an idea past the usual set of highly funded industrial lobbyists that have the ear of many politicians might be rather hard.
As has been pointed out earlier. Some patents are not for the chemical itself. But rather the knowledge that the chemical can be used to treat a given condition may be. This can be a little strange. You can’t patent a gene - but you can patent a test for the gene that is used to diagnose a condition or risk, or indeed any other use of the gene. Even though the gene may be present in almost every member of the human population.
The logic of the anti-pharma crowd confuses me: “Companies can’t make money selling natural remedies. I read that in a book I bought next to a display of a natural remedies in a store”.
The really amusing thing is that most of those “natural cures” people buy are made by the same company as real drugs. There might be a step or two between GSK and “Bob’s Natural Home Remedies,” but the profits still go all the way up the chain.
The “asshats” at the FDA do not grant monopolies. The patent office does. And only for the life of the patent. The FDA does, however, require approval of the manufacturing process and the resulting pills. If only one company thinks it was worth the cost to get that approval, then they have an effective monopoly. But that isn’t the FDA’s fault. It’s the fault of other manufacturers not wanting to pay the cost.
