Our mission statement, no I don’t like them either but they are helpful to keep everyone on the same page, is: To change the practice of medicine to incorporate the use of benign infectious organisms to prevent and treat disease, cheaply.
That last word is proving the hardest in a hard task. Everything, and I mean everything, is set up to almost guarantee healthcare is expensive. In this case absurdly.
One of the biggest costs is regulatory approval. By one estimate around a billion dollars for a patent medicine.
Why should an organism we co-evolved with, and that the parasitology texts and CDC say is harmless, one that cannot proliferate within you, one not worth treating in light infections (CDC), be regulated as a drug? Why are none of the outfits with the resources and experience required for developing them as therapeutics (drug companies) doing so?
Patents and control aren’t possible.
Witness the lengths drug companies go to to maintain monopoly profits, (PDF file) the only ones they are interested in, via patented drugs. Drug companies are just companies. Their interests are not in making you well, they are in producing profits. Most everyone agrees this is true, but does anyone look at what it means? (this is your cue to send me a link to something else I don’t want to read, thanks)
The drug companies benefit much more from this set up than they like everyone to think, the most profitable sector of the economy historically, four times as profitable as the average of the rest of the economy, because it is based on the artificial monopoly granted by a patent. Who cares if it costs a billion to get approval, if I can make that annually in profits for 17 years after being granted approval? That it costs a billion is just a barrier to entry and squashes innovation, by protecting the drug companies from competitors. Any industry where a hand of cards costs a billion is not going to have many players. A single hand of cards.
Then there is patent manipulation, the most cynical attempt, it failed mercifully, I read of was that of its’ owners to extend the patent on Subutex. Novel tactics, love it. Nice to see a British company displaying such innovation, too. Go team.
Quite rightly their exists (well, it exists anyway) an enormous regulatory, research and commercial apparatus, that intertwines and interconnects to produce healthcare products, primarily drugs for the last fifty years.
Given the fake cures sold in the past, often sold using fake scientific journals publishing fake studies promoting the efficacy and wonders of the latest product of the drug company that published the journal, this isn’t surprising. Merck say, when it was promoting it’s new drug Cocaine in the late 19th Century. One has to be grateful that all these well educated, earnest people, with it has to be said enormous debts to service for said education, are so devoted to our health in these modern times. I am sure human nature has changed profoundly since the 19 Century.
But has much changed? It costs money to publish your research in the Lancet, et al. I mean, they charge you. Then the journals charge the readers, too, to read your research. Those are publications I don’t think we have to worry about because of the rise of digital media. Or do we? If you can open source software why not peer reviewed publishing of science? Someone must be doing it, that would be something I would be interested in hearing about.
Then there are the medical disasters like Thalidomide, due to something called chirality* by the way, making me glad that drugs are rightly heavily regulated. But helminths, whatever the regulators say, (hey, invent another category to regulate!) are not drugs, and have none of the risky characteristics of a drug. That is, they are not novel molecules never seen before by our bodies, quite the opposite.
Regulation occurs in a weird and sometimes ineffective way, too. Witness Phen-Phen, the COX2 inhibitors, and the Statins (my favourite candidate for a disastrous withdrawal is Gilenya, of the new drugs). What happened with all the checks with those drugs? I seem to remember seeing a calculation that the excess deaths due to just one of the COX2s was 500 Americans a month, and this went on for years, with multiple drugs like it. Lets see, oatmeal, exercise and fewer cheeseburgers, (statins now), or a drug that can make all my muscles die or destroy my liver?
Perhaps numbers like 100,000 deaths due to hospital accidents annually in the US have just made us numb, or perhaps they are too large to really grasp and comprehend. Like the concept of infinity.
Or perhaps we just aren’t paying attention, Facebook and Twitter consume a lot of time, after all. We all need to get laid. Hey, we’re busy.
For instance a company developing a drug can conduct as many studies as it likes, but it does not have to submit the results from all of them. Hold that thought.
Having read a critique of the approval of Claritin, or Loratadine as the generic, which showed that the drug was only 9 points more effective than sugar, aka placebo, at suppressing the symptoms of seasonal rhinitis, one is lead to wonder which studies of that drug got omitted? What about for your heart medication, or for your antidepressant?
Take the ability of the company to be selective about the results it submits, add in positive results bias, and the undoubted corrupt behaviour, unbidden for sure, of scientists who understand upon which side their bread is buttered, and it appears to this commentator that some drugs might not deserve their big profits.
With the share of annual market in Claritin manufactured by it’s original patent holder in the US alone worth $401M in 2010, I say this one is based on bullshit. I should know, I took it long enough, it did bupkiss. If you doubt scientists will whore themselves look only so far as the tobacco industry and it’s scientific apologists. Fantasists might have been better. I don’t recall any apologies.
To get an idea of the scale of the market in just Claritin and it’s generics, see the news on just this drug alone in a typical online source focussed on generic drugs business and economics. If people are writing that many articles about a now generic hay fever pill you better believe there is money in it. And bullshit follows money as sure as night follows day.
We have been approached by a few drug companies, one massive. Their only concern, “are you (we) doing drug candidate identification”? I could make a lot of money in that, I have known that since the beginning. But it is different when your ass is being sniffed by someone with a lot of money. Anyway, we aren’t, so they didn’t, and neither did I.
Then there is the question as to why bother? Keeping it cheap I mean. Philosophically when I started out I was into the idea, I don’t need to be that rich after all, and why the hell not? It seems better for more people.
Thing is I am not sure it is what anyone wants. Even you probably don’t really want it, rational as you are, and smart, and all. Educated, I forgot educated.
First of all people tend to equate price with value or quality, particularly with products like healthcare. Never mind all the rest. I might have been better served charging a hell of a lot more, even by my metric of helping the most people the fastest.
Then there is the issue of having to change the practice of medicine, which means also changing the practice of regulation, in practice that is. It is proving to require a lot of practice.
It is a lot harder than simply introducing a pill, no matter how expensive that is. At least there is a map for that. That and I have never done anything like this before, and, you can depend on it, never will again.
By one estimate in one of the articles above I remember 800-1,200 million USD to replace a prescription drug on patent with a new one. Sell four pills to every American annually at that price for a dollar and you might break even, on R&D. Add in another $400M for marketing and distribution, television advertising (in the US at least), and manufacturing, including capital costs, ongoing regulatory compliance, or the penalties for failing in that respect, and the price per pill rises and rises. Wish I could afford a $3Billion USD fine, I might get to see my kids.
No one wants to do this, keep it cheap I mean. I wonder sometimes why I should. No one evens wants helminths around as a therapeutic. I am old now, 50. I do not get filled with a sense of excitement, interest and wonder considering spending the rest of that life sitting in meetings with over educated assholes from the regulatory bodies, universities, or drug companies.
I was quite rude to the woman at Astra Zeneca, I enjoyed that.
A lot of our clients got sick after emigrating to the west. When they go home they instantly see their colitis or Crohn’s, as one for instance, improve. By instant I mean they say they can feel the change within a few days.
I invariably say “then why not move back home?”. The reply is always associated with money. Apparently you can buy the bowels of a software developer for about $70K a year, which is what I am guessing is the delta in annual income between Silicon Valley and Mumbai.
You could do it as performance art, pay a migrant to sit in America for two decades and rot from the insides because their environment, like Western Europe’s, is so damaged that millions are being killed by environmental degradation already. Who needs to wait for Global Warming to play out, you are dying in droves now because of environmental damage. It just isn’t televised, yet, so perhaps that is the problem we need to solve?
You could even collect a pool of them and bet on the likely outcome, disease wise, before they even developed the diseases. I bet we would be oversubscribed for visas in a trice.
I would put that in the same company I want to start to televise executions. Hard to think of sponsors right away, but gun manufacturers do spring to mind.
Perhaps there is way to make it less tacky, we could sell them special insurance policies perhaps? That is a bet on someone’s health, or death, after all. So we already do it, so don’t get all moralistic on me.
This peculiar, to me, behaviour (the sticking around to be sick for money thing) is mirrored in an exercise I tried with people contacting us to try therapy initially. I did it until I lost interest, no scientific anything here, just an observation. I suggested to all comers for a while that they should try fresh water sources, as in surface water, and a few pinches of dirt, small, each day in their diet. Try that for six months, if you still need worms come back. I genuinely believe that for most it would be sufficient. I’ll admit that the urbanisation of the population in the developed world does present problems of access to fresh water and dirt anyone would want to ingest regularly. See my point about the environment earlier.
I had one taker, he gave it a desultory effort (he didn’t do jack shit) for a couple of months and contacted us again, saying: “I just want to take something, please just send me hookworm.” Which was the consensus view by the way. “Just send me the helminths.”
I have forgotten what I was trying to say at this point. If I sound cynical it is because I am, and I don’t like it either.
I guess what I am saying is that like in Cameroon where poverty guarantees poverty by making everyone corruptible, and therefore corrupt, we are the problem.
Your behaviours and choices guarantee healthcare is more expensive and complicated than it need be. Less effective than it could be. More toxic than it has to be. Because that is what you want.
We evolved for a different environment, it’s not our fault. And don’t worry, we’ll be back there soon enough, if we’re lucky. One way or another.
That’s right, I should have figured this out before I started.
*As I remember it in the small amounts required for the studies the drug was produced in a way to produce a left or right handed version of the molecule. Full scale production produced the opposite chirality, or handedness. Left became right, or right left. No one understood the importance of shape in biochemistry, or no one noticed, or perhaps cared, at that time. The result was birth defects on a massive scale, of the most awful kind.