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Critical drugs in short supply

This subject needs much more scrutiny than I have the energy to give it tonight, so I'll just throw it out for all to consider.

Apparently, supply shortages of widely used pharmaceuticals are fairly common in this country. Who knew? What with our righteously free markets and our famously efficient allocation of resources, how is this even possible?

Well, much of the constrained supply appears to be legitimately due to factors such as scarcity of raw materials and regulatory actions dealing with quality control issues. Other reasons include "production problems" and "corporate decisions to discontinue certain medications for financial reasons". The first of these latter two explanations got me to scratching my head. Having lived through the infamous California energy "crisis" of 2000-2001 I recall quite vividly that one of the major contributing factors that sent retail electricity rates soaring was an unprecedented number of power plants being taken offline for "maintenance" when demand was high, in other words production problems. Drug companies wouldn't do that, would they?

The other reason, financial considerations, sounds to me like a blatant abuse of market power:

If these medications are complex but generic and inherently less profitable - like older injectables or chemotherapy agents - some manufacturers stop making them.

[snip]

The shortages translate into a greater demand for alternative, often brand-name drugs, which means higher costs for pharmacies, hospitals, and ultimately the patients.

And (ahem) inherently higher profits for the manufacturers, of course.

If drug companies are withholding the production of relatively cheap generics in order to increase sales of name brand medications that are still under patent, and thus still providing monopoly rents to the patent holders, isn't some law or another being violated? I don't know, like I said I'm too tired right now to dig deeper.

If only we had a body of anti-trust laws. If only we had a Democratic president who would appoint a Democratic attorney general committed to yada, yada, yada. I'm going to bed.

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Submitted by JuliaWilliams on

I've seen shortages of such meds as anti-virals (used to treat flu), flu immunizations, tetanus immunizations, IV multiple vitamin preparations, IV ant-acids, and lately, a core drug used to treat heart attacks and hypertension (IV Labetolol), just as examples, and there have been many others. How do you get "around" a tetanus immunization shortage, for example? Well, you "tighten up"the reasons to give it, say, if a wound is less "likely" to be infected, or the victim is more "likely" to have extended immunity (eg, been re-vaccinated within a certain period of time). The effect on 'best practice" in medicine is devastating when core meds are in shortage, and needs to be addressed as a public health issue. If the government can quarantine, and forcibly medicate individuals, and populations, for "the public health', I think we can certainly nationalize the pharmaceutical industry as a "public good".

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Submitted by beowulf on

As long as one is ignorant of the history of the Reconstruction Finance Corporation that Herbert Hoover created.

As World War II loomed, Mr. Jones shifted the RFC’s focus from domestic economics to global defense and used the corporation’s enormous clout to build and equip more than 2,000 plants that manufactured everything from airplanes and battleships to penicillin and synthetic rubber, an industry the RFC developed from the lab.

http://www.houstonendowment.org/About/Fo...

Submitted by jawbone on

Hoover came into the presidency with rock solid credentials for strong accomplishments. He wanted, as I understand it, to do more stimulus as president, but was dissuaded by his financial advisers (who probably came from or listened to the banksters), so he did take some decent measures but they were much too small.

But, his RFC was probably a stronger measure for the non-wealthy than anything Obama has done. (What would the $2B put into the the initial RFC be in today's dollars?)

I like the Harding comparison, but fewer people get the meaning of such a comparison. Being over 6 feet tall is one similarity, but hardly despositive. Harding was a compromise Repub nominee, named because he "looked presidential." He brought with him to DC many of the Ohio Republicans who helped him get the nomination; their lack of a moral compass led to the scandals of his administration.

Obama? Brought or kept many of the FIRE types who helped him get his nomination, through their big donations. And he followed their advice. While the scandals of the Wall Street Gang Banksters have been kept covered up, when there is an administration which is not in league with them they may well be unearthed and become well-known to the public.

Obama carries his pre-compromising to amazing lengths, leading to revealing his Inner Republican. Does he "look presidential"? I'm not sure, but he has retained some of his popularity, as Harding had. A big difference is that Harding apparently loved interacting with voters, with the American people.

But Harding has been described as being in "over his head'; that fits Obama, sadly, much too well.

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Submitted by goldberry on

Disclaimer: I worked for big pharma for 2 decades in research. However, these opinions are my own and not that of any former or future employer.

Here's the deal: drugs are fantastically expensive to discover and sell these days. Each new drug entity that goes out on the market costs several billion dollars in research and clinical trials. That's before even one penny is recouped. There are several reasons for this. The most significant ones have to do with the FDA. don't get me wrong. We all want very safe drugs, even big pharma. But over the past two decades, the bar has been raised for the approval of new drugs. The number of safety profiles has jumped to something like 200 different tests. It makes it harder to.find a chemical compound that will fit all of these profiles perfectly. Sometimes, a company will spend a lot of money shepherding a drug through only to see it shot down at the FDA. THe FDA is also requiring more extensive and longer clinical trials. And I don't think anyone would argue that thus is a bad thing. Except that in this country, the patent clock starts ticking when the idea is scribbled down in a notebook. We are not a first to innovate country. So, the patent clock is ticking away while a drug is hung up at the FDA waiting for approval. That costs a lot of money, money that is passed on to you, the consumer.

Then there were the stupid, destructive, idiotic mergers of the last 20 years. Executives need to appease the shareholders. Since drug approvals are rare these days, it is easier to buy up someone else's pipeline and then downsize. Very short sighted but nary, that's why they get paid the big bucks. The problem is that since very few drugs are getting approved and the blockbusters are about to go off patent with very little coming out of devastated and screwed with research departments, all big pharma companies are about to swan dive off something called the "patent cliff". That is, their revenue is about to plummet in the next year or two. Astra-Zeneca is goig to get hit really hard but Pfizer is about to lose Lipitor, sanofi-aventis is going to lose allegra and plavix, etc, etc, etc. Very bad scene.

On top of this, the FDA is now reviewing drugs that were approved prior to 1938. Most of these do not make the companies very much money because they are not under patent anymore. To bring the production facilities up to FDA standards would cost a lot of money. That is a problem when the patent cliff is out there, just waiting....

So, these companies would rather shut the facility down. That way, they don't risk failing an inspection and getting huge fines. If you remember back to the 90's, a similar thing happened with the Today Sponge. The company that made it could never completely eliminate the source of contamination so the sucker was pulled from the market rather than build a new facility. And that was the genesis behind Elaine Benis' spongeworthy criteria. How many do you have left and is the guy worth it!

Anyway, those are the benign reasons why there are shortages. The malicious reasons might have to do with the nature of the patent system itself. So many companies are going to lose huge hunks of money soon that they may be looking to apply pressure on the US government to amend patent law so that the patents they still have will be extended. I imagine that having cancer patients not getting their chemo would be very effective pressure, but that is just a fantasy and I have no proof that that's what is actually happening. So ething like that would merit a criminal investigation. So, I think this possibility is remote, but not impossible.

I think it just has to do wit the whole industry being incredibly poorly manages by MBAs who are incentivized to make as much money for their shareholders as possible at a time when the FDA is making that very difficult. It wasn't always like this. When I first started in the industry, research had more value and that's where the money came from. Now, the money comes from mergers and accounting tricks- and shutting facilities down.

BTW, hundreds of thousands of scientists have lost their jobs since 2008. We didn't deserve it either. Biomedical research in the is country is disappearing very rapidly. Keep that in mind if the shortage of drugs accelerates in the next decade. And it will. Count on it..

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Submitted by goldberry on

...consider the consequences.
Do you have a degree in the sciences? If you don't, you have absolutely no idea how difficult getting one is. There is more math and science involved than most Americans would consider reasonable. It is a lot harder than getting an MBA or a law degree. That's why most people wouldn't touch these professions with a 10 foot pole. It also takes a lot of time. It takes more time to get a PhD in chemistry or chemical biology than it does to get an MD. Most PhDs spend 10 years in school before they're allowed to have a real job making real money.
The situation in our industry is already very discouraging for scientists. Companies are cutting positions left and right and lowering salaries and cutting benefits and only hiring contractors and splitting up families. You have no idea how bad it is. I have friends who have multiple degrees from very prestigious universities who will probably be permanently underemployed starting in their 40s. The lifestyles they once had are gone. This is the reward we give to people who dedicate so much of their lives to science and research. I don't have a PhD but I've put in my more than 10,000 hours and up until April of this year, I had a PhD level position. Gone. All gone. In the flash of an instant of a very bad management decision, my career is over. When I was laid off, the department I worked with closely tried to get me and my lab partner reinstated because they really needed us. But it wasn't possible. Even excellent performance evaluations can't save us.
So, you are now proposing that our industry become nationalized so that YOU will have all of the benefits of our work at rock bottom prices. And we get *what* exactly? Don't get me wrong. Many of us would gladly accept a government salary right now so we can save our houses and feed our kids. But is this really a good solution for people who are expected to give up so much of their young adult lives to pursue a dream?
I don't know what you do for a living but let's imagine that you were a lawyer or an accountant and somebody had spent two decades demonizing your industry while you struggled to play a game of musical employment chairs and then said, "Those accountants and lawyers are charging too much money for auditing the books and arguing cases in court. Let's nationalize them and then it won't cost us so much!"
I would assume that you're also going to get debt forgiveness for your mortgage so you can pay all of your bills, right?
Be careful what you wish for. We unemployed researchers who you depended on for modern medicine in a time when there were no drug shortages are being abandoned by our companies in the highest cost of living states in the union. We are highly trained and specialists in our fields. And we expect to be compensated accordingly. If you think anyone can do this work, try it yourself. Americans do not value scientists. And they are going to pay for this neglect in more drug shortages and fewer new drugs. When we were being attacked by our own management, all we ever heard from the public is how EEEEEVIL we were. You can't expect young people to go into a field where the work is hard, the learning curve is steep and the rewards very fleeting.
We have to eat too.

Submitted by lambert on

... who can simply determine their own lines of research. So I don't blame them for the direction of the industry as a whole, which seems to have forgotten the very notion of public purpose if it ever had it. But the executives and owners of Big Pharma are just corrupt and, yes, evil as the executives and owners of Big Food, Big Oil, etc. Rentier parasites all. Horrible and lethal misallocation of capital, and social capital, too.

Wouldn't it be great to do useful work? What's stopping that, anyhow?

Submitted by JuliaWilliams on

nationalize the pharmaceutical industry? The savings alone would be astronomical, and the research positions wouldn't be at the mercy of corporations that are willing to throw safety and efficacy out the window (just Google Johnson&Johnson), just to squeeze a little more profit for the rentiers.

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Submitted by goldberry on

... That government employees do not make as much money as people who work for private companies. True. No one I know wanted to work indefinitely for the NIH. at some point, you need to support a family and since research is disproportionately located in large metropolitan areas, the salary has to be decent.
Let me put it this way, how much would you expect to pay a person who has the equivalent of a PhD in the hard sciences in a place like Washington, DC? Would you pay them the same amount as a congressional staffer? An IRS agent? A congressman? Like I said before, getting a degree in science is not for sissies. It takes a long time, unusual insight and a lot of hard work. Expect to spend about 10 years going from undergrad to post doc.
Now, there are a lot of unemployed PhDs who would gladly take a goverment job these days. But it hardly makes the field attractive to perspective students, does it?
I'd locate the national labs in the Midwest and get rid of a lot of sales and marketing if I were going to do it. But the salaries have to be attractive or we'll all become plumbers.

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Submitted by NWLuna on

"the patent clock is ticking away while a drug is hung up at the FDA waiting for approval. That costs a lot of money, money that is passed on to you, the consumer."

No, I haven't worked in any position for Pharma, but I am a prescribing clinician in a specialty field (chronic progressive neuromuscular disease) with very few effective drugs. We frequently see (and read) research reports on results from Stage 1, 2, and 3 clinical trials. My impression is that after a successful stage 3 trial, the drug and trial info is then submitted to the FDA for approval. I've seen drugs get approved by the FDA in approx less than a year from submission through advisory board to actual approval. Sometimes longer if the FDA asks for more information before making a final decision. There's a Fast Track process option too, which I believe oral cladribine for MS was supposed to get but due to FDA concerns about adverse effects the process dragged on for much longer and ultimately oral cladribine was not FDA-approved due to risks.

Anyhow, actual time waiting for FDA approval seems to be about a year or less -- surely this is much less time than the 2-4 years x ea clinical trail stage before reaching stage 3 with endpoints reached. So it doesn't seem like the FDA's approval decision time takes up much, proportionate to the development and research time.

I agree that Pharma CEOs are short-sightedly focused on short-term profits and are too out of the trenches to know where their long-term profits and discoveries come from.

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Submitted by goldberry on

... Destroyed by ugly facts.
The number of drugs approved by the FDA hit an all time low a couple of years ago. I think it's up *slightly* in the past year. I don't have the link for the number of approvals but you can probably find the graph at Derek Lowe's blog In The Pipeline. He covers this subject regularly.
There are fast track approvals, generally for oncology. But this is only one therapeutic area. In CNS, the number of drugs approved was so low, the blood brain barrier so maddening and the probability of return so risky that most pharmad have abandoned the area. Same with antibiotics.
But don't take my word for it. Look it up.
I can't speak for the CEOs. By and large, we in the labs are not people to them. I know people who have had to deal with them in the past. They come across as aggressive, heartless assholes. It's nothing personal. It's just that they have incentives to maximize profit. That is in their performance objectives. It's a very short term goal that frequently pits them against research and consumers.
But I don't think they deliberately set out to poison anyone. And no one in research wants to do that at all.