FDA Suddenly Bans Drugs That Have Been On The Market For Decades
As Techdirt recently discussed, the drug pipeline is running dry, as Big Pharma’s patents are beginning to expire, and the drug companies are freaking out. For years they have been spending more money on research and testing and getting fewer results. This year alone they are going to have 11 patents expire on drugs that bring in approximately $50 billion in revenue to the big pharma firms. Of course, the flip side to this is that consumers can start saving about 95% on the price of those drugs, as generics hit the market. The drug companies have gotten to a point where the incremental increases in efficiencies are so small as to be meaningless. What is coming is more personalized and targeted treatments for diseases — treatments that do not require bulk production of a specific chemical, but individual testing and personalized care, and not lifetime treatments and repeat sales, but cures. The treatments will be expensive to begin with, but they will become less expensive over time. The business model of healthcare is about to change dramatically, and Big Pharma needs to do something to maintain their profits. Unfortunately, they seem to have chosen the path of regulating the competition out of existence, rather than competing and innovating.
One way the drug companies have been coping is to repackage and rebrand health food supplements. Drugs like Lovaza, which is nothing more than the fish oil you can get in health food stores, and lovastatin which has been in use for roughly a thousand years (800 AD) in the form of red yeast rice. In the case of lovastatin, the FDA banned the supplements because they are “identical to a drug and, thus, subject to regulation as a drug.” That is very convenient for the drug company, which now charges monopoly rents on the product — which can increase prices at ridiculous levels.
More recently, the FDA banned 500 prescription drugs that had been on the market and working for years. To be fair, it was really 50-100 drugs (pdf), made by different companies, but that just highlights how there was actual competition in the marketplace for these drugs, which has now been removed. For all of the drugs, there is either a high-priced prescription version, or all the small manufacturers have been removed, leaving a virtual monopoly for one or more larger companies. This process began in 2006 when the FDA decided to remove marketed unapproved drugs (pdf).
The reasoning is that these drugs weren’t ever technically “approved” by the FDA. While the FDA has been around for about a century, the business of having the FDA first approve drugs before they could go on the market came about closer to fifty years ago, and a bunch of “unapproved drugs” that were in common usage before that never got approved. The FDA is targeting many of those, even if they have a long history in the marketplace. Conveniently, of course, there always seems to be a pharma company with a monopolized substitute ready.
In 2006 the first “new” monopoly that was created by this FDA process was for the malaria drug quinine sulfate. This left only Mutual Pharmaceutical Company to manufacture quinine in the US (pdf). While malaria is not a disease that affects many people in the US, it is big business worldwide. Malaria causes 300 to 500 million infections and over 1 million deaths each year. Treating this disease with quinine used to cost pennies a day. In fact, the British turned this treatment into a cocktail, the gin and tonic (quinine water).
Another drug removed was the antihistamine carbinoxamine, which was created prior to needing FDA approval, in the early 1950s. It was approved by the FDA in a slightly modified form in 2006. It is now sold exclusively by Mikart, Inc and Pamlab, LLC with no future competition because the FDA has banned all 120 other versions of carbinoxamine. You can imagine just how much that must increase the profits for Mikart and Pamlab on carbinoxamine, though that seems to come at the expense of consumers.
It’s really nice being granted a government monopoly.
As for the drugs now being banned in this latest purge, you can argue that it’s not really 500 drugs, because many are different combinations of the same 50 to 100 drugs. To be sold, these disapproved drugs will require drug trials and certification — a massive and expensive process. Under current law, after successful completion of FDA trials these drugs will be granted approval. But in every case these trials are almost certainly not necessary. And, “coincidentally” in almost every case, there is a chemically similar patented version ready to go. This is a pure money grab: replacing old tried and true drugs, with monopoly priced prescription drugs. It just requires removing competing drugs from the market to increase profits.
And with that, I’m off to go have a gin and tonic, while it’s still legal…
Re: Re:
Oh yeah I am a whitey ... may i take seat at the counter? Please sir I will not do anything bad ...
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"Regulation does not necessarily mean “banning people”, you know."
Of course it does, to answer your original post. Any regulation is a ban. Because regulating any speech, no matter how hateful, is a ban on free speech. And ....
niger, spik, whitey, kike ... etc, etc, etc,
which will get me banned here?
Which one will not get me banned here?
Double standard anyone?
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But regulation always mean government has control. And the words we are with the government, we are here to help always end poorly.
Lets start chanting one word, one nation, one goal for our great nation, we want to be like ... Venezuela, Venezuela, Venezuela, follow along with me.
Oh come chant it to me, it will be fun... sing it to the tune we are the champions of the world by Queen, with a broken record player ...
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you = your
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Okay, being slightly autistic, I need to say you two (1,2) sentences together do not make sense. Translation follows
s 1) Yeah the government threatened suspensions, regulation, and retaliation ... but ....
s 2) The government did not want to ban people ...but ... yeah look at the first sentence.
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It has been a while since I posted here. The way this is headed concerns me very much, so I thought it might be fun to play Advocatus Diaboli (devils advocate) along many, many paths... But... seeing as I know that I'm not the one putting together the list of what content will be allowed and what won't be, I'm a bit concerned about who WILL be making that determination And right you should, you speak out about copyright issues, limitations on copyright and corporate greed ... how soon until you are on the receiving end of being shadow banned on search engines, social media, and have your accounts deleted online? We have already seen what government agencies are capable of when left unchecked. There is this thing called the Streisand Effect maybe you have heard of it (nudge, nudge, wink, wink)? Since, Alex Jones was banned from Facebook, his app has become the most downloaded on Googles Play store (see NYT). He has added followers on Twitter 100 times faster than before. And he has become bigger than CNN, what am I saying I have more followers than CNN, so that is nothing, never mind. Banning him will make him disappear 400 years ago the catholic church had this list called the "Index Librorum Prohibitorum" (Index Of Banned Books). I believe every book on that list can be found today. You ban something people wonder what am I missing? what secrets are they trying to hide? ... well maybe I should take a look. This also goes to the Streisand Effect section. We are a private company and the first amendment doesn't apply It does if you banned certain people because the government pressured you to do so. Remind me again, how many hearings have the social media companies testified in front of? What was the implied threat, oh yeah regulation. We are a publicly traded company, we have lawyers, and nothing can happen to us, we have a EULA that allows us to ban anyone we want Until it comes out, that as a publicly traded company, you have alienated half your subscriber base, and made them wonder if they are being shadow banned because of their views or thoughts. Leading to your delete account pages being so swamped they no longer work. It is as if people had changed their names to Elvis and decide to leave the building. Which in the end causes investor lawsuits, because your job was to make money and not do politics. I could go on for hours on this. I will leave you with one final thought. Since Mason Wheeler already broke Godwin's law. First they came for (insert your least favorite group, racial, political, religious, sexual orientation, annoying neighbor, mother/father in-law, etc) I said nothing. Then they came for (insert your second favorite here, then third, then forth...) Then with no one left to speak for me ... they came for me. This is how this crap starts. Learn from history people.
An external group to decide what is censored, how do we solve the problem of who can we trust to do that editing of the national conversation for us. The answer to that being the depressing “no one”. As we cannot trust anyone to do that, we’d better not have anyone trying.
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My personal ROFLMAO moment is going to be when another nation, using a foreign law like this, subpoenas the information on politicians in the United States ...
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Look away if you do not wish to have an image in your head that will never go away.
For a video of a politician like Hillary doing a Katherine the great video ...
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To name a few reasons parody, political satire, and the first amendment it would be successfully challenged.
The UK seems to be leaning towards running their section of the internet in a very Chinese manner.
Funny how obvious this is ...
What was self evident from the beginning of this attempt to stifle speech, was that "Fake News" would be the new version of the Catholic "Index Librorum Prohibitorum" ....
https://en.wikipedia.org/wiki/Index_Librorum_Prohibitorum
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What I find amusing is, that "Fake News" is something called free speech and has been around since gossip and later the printing press.
What I find amusing is, that Fake News is a fear phrase, designed to make you give up more of your rights.
What I find amusing is, this is being promoted by every news organization in the West at the same time.
What I find seriously amusing is, the Chinese do the same thing to cause companies to self (over) censor.
What I find amusing is, the sheer quantity of Fake News the large media companies published this election cycle.
What I find amusing is, Fake New is Fake News.
FYI
http://www.npr.org/sections/thetwo-way/2016/12/30/507525510/russia-plans-to-expel-u-s-diplomats-in-response-to-u-s-sanctions
Also the only relevant line is this one
"The U.S. Government assesses that information was leaked to the press and publicly disclosed."
Which does not come close to saying that Russia did anything.
Re: Re: Re: Constitutional Bullshit
You are right, it is more like a war crime or terrorism. I mean if some foreign government flew drones over the US and blew up a couple hospitals that is what we would be calling it.
Re: Re: Re: Re: Again, I told you so!
"He can't act like a king, okay? Settle down."
Actually he can, or haven't you been watching for the past 8 years. Once the laws are written it is up to the agencies to implement them.
Who, by the way, can order the agencies to do things?
Stick a fork in it, its done ... for now
"... he's ready and willing to jack up tariffs and basically set off trade wars with some of our largest trading partners. That's bad, and will likely cause a lot more harm than good."
In the short run it will cause issues. In the longer run manufacturing will come back to the US, but all manufacturing will be done by robots and not humans. We are already seeing this in China/Taiwan with Foxconn replacing 100,000 workers with 100k robots.
Pretty much everything Trump can do over the next 4 years to bring back the good ole days is already obsolete due to the trends. Solar on rooftops and storage, will be cheaper than nat gas and coal in ~6 years. Manufacturing is slowly being brought back to the US due to automation being cheaper than shipping and labor in third world nations. And the cost will only go down as more automation is used.
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What I was saying was, on both sides, people have isolated themselves in groups of like minded individuals. They have sand boxed themselves into groups that believe, because everyone in their group is for a certain thing, that everyone is for that same thing.
On both sides of the isle, they have a distorted version of reality because all their friends think the same way, and they chase off anyone that doesn't think that way.
And to quote you "I love the way people think stupidity and insularity falls along ideological lines. What a hoot."
These people should blame themselves. They associate with like minded individuals, do not go outside of their comfort zone of ideas, and harp on the same things over and over. They have isolated themselves from anything that goes against their world view, and react with verbal violence, against anyone with a non politically correct view (in their opinion).
Re: This needs a name
Great historical reference