FDA Suddenly Bans Drugs That Have Been On The Market For Decades
from the perfect-gin-and-tonic-for-fun-and-profit dept
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...
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crade (profile), Mar 24th, 2011 @ 10:51am
You can order em from us. We still have your life-saving medicine at honest prices here in Canada and will ship to the U.S. please support Canadian companies! Thanks. :)[ reply to this | link to this | view in thread ]
The government says there's a problem:
(high health care costs)
The government proceeds to act in ways that aggravate the problem:
(Increase the cost of drugs by destroying competition)
Sounds about par for the course.Unless they can prove these competitors were making drugs that were harmful or unsafe, it's likely some form of veiled cronyism or misguided incompetence.
I eagerly await for the next mistake along this continuum:
(Government institutes price controls)[ reply to this | link to this | view in thread ]
sigh
weneedhelp (profile), Mar 24th, 2011 @ 11:53am
The Benny hill theme, with visions of our politicians with baseball bats running after pretty girls in pill costumes comes to mind.[ reply to this | link to this | view in thread ]
Wow, just wow...
John Doe, Mar 24th, 2011 @ 12:01pm
It is really hard to imagine that lawmakers, lobbyists and corporate execs can really put peoples lives and finances at risk just to line their own pockets.It is one thing to charge absurd prices for luxury items that people don't need and buy voluntarily. It is quite another to do this when people's health and even their lives are at risk. They better hope there is no hell because if there is, and I believe there is, there will probably be a special place for them.
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The FDA isn't a government agency.
Hiiragi Kagami (profile), Mar 24th, 2011 @ 12:14pm
It's now another corporation, since those who run the FDA are former employees of those very companies who benefit from monopolies.It's pretty bad when these corporations have infiltrated every office of government, from SCOTUS (which granted patent rights on nature), to the Dept of Justice (Hello, Neo RIAA), to offices like the FDA, now in the business of killing people rather than saving them.
I still have faith people will eventually wake up and make changes to government to fix it, but every year, and with every new law passed/introduced, such as the HCRA and COICA, I lose a piece that faith, especially when those very politicians use the very words as given to them by those who supplied their campaign contributions with more money than most of us will earn in our lifetime.
I'm going to go cry now.
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Finally, treating supplements which alter your body chemistry as drugs, since there is no fundamental difference. Who knows, maybe we'll start to condemn the wild west that is the supplement industry(which is mostly bunk, where they can claim what they want without retribution, proof or even telling you what concentration they sell) if we could get around some of crappy legislation that is out there.I can't wait for the time when the FDA requires the dose curves(i.e. showing that the drugs are the same as what's out there) to match what was originally filed before they allow the generics to come on the market, then we'll get the cry that Big Pharma is killing the generic industry by forcing them to show efficacy and safety for a product that acts differently.
You have a trade off with the FDA, we can either allow anyone in the market for little price and force regular people to decide which drugs work, or force companies to prove to the FDA that changing your body's chemistry is safe and efficacious.
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They are doing this..
cause the drug companies are slipping them money under the table. Most government agencies either get money from the groups they are supposed to regulate or the groups slip the money to Congressmen who then apply pressure on the agencies. In most countries this would be considered bribery, but here it's just business as usual.The big pharma companies and the health care insurance people are the biggest obstacles to affordable health care for all in the U.S..
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Re: And!
:Lobo Santo (profile), Mar 24th, 2011 @ 12:25pm
Generally true statements--unfortunately the trade-off appears to be that only the wealthy can afford to be healthy, as poor people cannot afford to pay hugely inflated prices.Or worse yet, MY science-damn tax dollars end up paying for over-price mutha-frucking drugs for the poor, which is an even less tenable situation.
No, thank you. I'll take the "wild west" you spoke of.
Or, to quote Thomas Jefferson:
"I would rather be exposed to the inconveniences attending too much liberty than to those attending too small a degree of it."The FDA can take their drug-money and shove it where to sun don't shine.
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Re: Wow, just wow...
rubberpants, Mar 24th, 2011 @ 12:26pm
"It is really hard to imagine that lawmakers, lobbyists and corporate execs can really put peoples lives and finances at risk just to line their own pockets."I wish I could say I felt the same way.
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That's what happens...
VancouverDave, Mar 24th, 2011 @ 12:28pm
...when you stop sending in your brown envelopes.[ reply to this | link to this | view in thread ]
Re: Wow, just wow...
"They better hope there is no hell because if there is, and I believe there is, there will probably be a special place for them."That place will be the ticket booth, charging admission.
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Re: Re: And!
Lobo,
If I link you too 1500 articles which all claim to fix the same problem, would you have the time(or know how) to decide what is best for you? Or even if any of those drugs are more than snake oil? Hell, even now we have scumbags who sell bracelets with a refrigerator magnet claiming they improve balance, health, etc. and people buy them up thinking they work. In the wild "west" all I'd have to do is put (2R,3S,4R,5R)-2,3,5,4,6-Pentahydroxyhexana and dihydrogen monoxide on the label and people's eyes would glaze over(my product is sugar water, for those non-chemistry people). It's safe, it works(as a placebo), and ultimately nobody would know differently.In your wild west we would degrade to selling products which are entirely safe, and could be marketed the best, not which compounds are shown to be safe and shown to work through scientific study. Sure, things cost more, but in this scenario we incrementally increase health, where your scenario we just spin our wheels with false advertising.
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Re: Re: Re: And!
Now, imagine competing private quality assurance corporations who say things like "this drug is just sugar water!" and who must earn the fickle publics' trust over time... Their business model involves having a pristine reputation and accepting fees from companies which wish to have their products tested and certified by said company(ies).To put it another way: there is a little truth in your fiction and a little fiction in your truth.
Snake Oil, by the way, has a bad reputation due to a propaganda campaign from Bayer (if I recall correctly) not because of any harmful effects of inefficacy.
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Re: Re: Re: And!
Anonymous Coward, Mar 24th, 2011 @ 12:50pm
End the hypothetical posturing.Most of the drugs on the list have been in use for decades; if there were any safety concerns I'm sure they would have come to light by now.
As for efficacy, perhaps you should read up on the pharmaceutical industry. Most drugs have inconsistent results and only a very small number of drugs could pass a test which compared their outcome to that of a placebo.
This is a money grab, not a safety issue.
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Re: Re: Re: And!
Hephaestus (profile), Mar 24th, 2011 @ 12:52pm
CarlWeathersForPres,The solution is multi fold. Allow any drugs that are no longer patented to become generic. Prevent the FDA from removing generic drugs from the market unless they possess some health risk. Allow anyone to produce generic drugs as long as they undergo USP standards testing every n months and on a random basis.
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It's sad for me to read this because someone very dear to me works at the FDA...approving generic drugs.[ reply to this | link to this | view in thread ]
Hi
Len, Mar 24th, 2011 @ 12:58pm
We need more articles like this out there. Like, WAY MORE.[ reply to this | link to this | view in thread ]
They did this with urokinase a few years ago. The new alternative tPA was too expensive compared to urokinase. Since urokinase was made from cultures of uroepithelial cells, someone suggested there might be a infection risk, although no had been reported in the 40 million administered doses.[ reply to this | link to this | view in thread ]
Re: Re: Re: And!
velox (profile), Mar 24th, 2011 @ 1:02pm
"In your wild west we would degrade to selling products which are entirely safe, and could be marketed the best, not which compounds are shown to be safe and shown to work through scientific study."The point of this article today is that most of the FDA action is NOT a case of "taming the wild west".
Many of the drugs which the FDA have removed had no history of problems after having been marketed for decades. Now if you are suspicious, you can believe that maybe connections between regulators and industry provoked these actions, but more likely its a matter of bureaucrats being bureaucrats and wanting to make manufacturers meet current standards, rather than the standards which were in place when the drugs first came to market.A few days ago the drug Delalutin = Makena was discussed on Techdirt, and I laid out what had gone wrong with the market in that situation. The sky-high prices with Makena didn't come about because of patents. The issue is exactly what is being discussed in this post --> Regulatory activity delivering a Monopoly to a manufacturer. Since I posted so late on that article, it missed the reading cycle so if you didn't see it, the explanation of what happened with Makena can be read here.
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Re: Re: Re: Re: And!
So your solution is to privatize it and hope that private companies won't fall into the same mold as you believe the FDA is in(I'm not really sure that it's filled with all the evilness that some on this site think). Really, we're trading one thing for the other.Snake oil actually has some use, but I don't believe it's for anything that it was actually marketed to cure. All I ask is that if you're making claims that what you sell(drug or "supplement") is somewhat verified by a 3rd party and it won't harm(or at least the harms are fully disclosed so those prescribing the medicines can use their best judgment).
To me, the story isn't taking these drugs off the market, it was originally allowing these supplements on the market. Let's give a hypo to show why I thought it was a problem: Supplement x contains aspirin, consumer buys it to cure his headache, since there is no concentration on the package(or instructions on how to take it) consumer takes too much an overdoses. The other problem is that with any supplement, the active ingredient is variable, so it's tough to actually use it to treat with the specificity that you want.
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Money literally is the root of all evil.
Frost, Mar 24th, 2011 @ 1:04pm
It's really getting to the point where having to give the same answer to every problem is getting to feel kind of repetitive, but the problem as always is our societal system, specifically it being based on money and profit. We have to transcend the primitive barter systems that are currently destroying the world and mankind (quite literally) and move on to some actual civilization - like a resource-based economy. That will solve a huge amount of our current woes, like this one. Perfection? Not even close... but certainly vastly better than our current mess.[ reply to this | link to this | view in thread ]
Re: Re: Re: Re: And!
My concerns aren't necessarily whether the low levels in the supplements will harm you, I'm sure they won't. My concerns are that concentrations can very, and interactions could dramatically change from dose to dose. I also think that a secondary effect is that it will bring to light that these things are actually drugs, so people will disclose them to doctors when they are ill, so Drs can make sure that other drugs won't interact with the supplement.I have my own griefs with what the pharmaceutical industry does, and honestly think that most companies should be fined out the yin-yang(double profits?) for lying about a drug to the FDA. I don't necessarily think that means most drugs have inconsistent results, or that in the right hands the studies can't be put into the proper context(I've heard clinicians say that you take pharma studies and subtract 20% from efficacy to decide whether you want to use it or not).
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Anonymous Coward, Mar 24th, 2011 @ 1:16pm
Please don't tell Mike that is actually costs money to develop drugs, or that big pharma companies are actually spending money to develop new drugs, or that it is getting harder and harder to develop them. That would ruin him.[ reply to this | link to this | view in thread ]
Re:
Troll Score
1/10[ reply to this | link to this | view in thread ]
EVIL
Brad, Mar 24th, 2011 @ 1:25pm
it's just amazing to me how much our government is corrupt and how much money changes hands via lobbyists so that this $hit happens. I agree with another post. I believe there is a hell and they will all be there together...with no perscriptions to fight off the eternal pain and suffering.[ reply to this | link to this | view in thread ]
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