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Discussion in 'Controversial Scientologists' started by Rene Descartes, Apr 2, 2014.
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We think we should be told.
This big donator to CoS is the CEO of a pharmaceutical company. At first glance one might say that contradicts CoS principals.
However it appears to me that his company specializes in some form of cancer treaments and probably has nothing to do with Psych drugs.
I was trying to remove the post using advanced but I didn't see the option so I edited the post to what is left there.
Aren't drugs of ANY kind (even aspirin) a no-no for scners? And, isn't cancer just a psychosomatic illness or an out 2-D sit or some shit anyways?
I'm sure there is some conflict existing somewhere in there however it is not the conflict that I was looking for.
Medical Marijuana is supposedly being prescribed for some cancer patients.
I do wonder what Mr Duggan would think of the cancer patients who mix his elixir with the herbal of essence.
If a patient did and died and the family sued Duggan's company I could picture Mr Duggan's lawyers arguing at his bequest that the person was mixing his elixir with herbal of the essence.
Things could get interesting in the not so near to distant future.
Weirder shit has happened, but this is not a likely issue to arise.
This is a cancer drug we're talking about. Sadly, many of these patients are going to die. Most, if not all, are going to be taking more than one chemo drug and undergoing radiation.
Medical cannabis has one advantage as a palliative in that cannabis has very, very few interactions with chemo drugs. So the person suing would have to show that of this cocktail the patient was taking, it was the particular combination of ibrutinib and cannabis that caused the death AND that the patient's cancer didn't kill them.
On top of that, Johnson and Johnson licensed the drug from Pharmacyclics, and they would bear the brunt of any lawsuits, having the deepest pockets. What amuses me is that Duggan is making most of his money not from sales of the drug, but from milestone payments from J&J, who are developing an anti-depressant, esketamine, which is a chemical derivative of Special K.
To give a minor example of the mind-set in Scn about drugs: (I am still so sorry to the family of Natalie Ellis, in my story, someone I have known all my life until her passing).
When Natalie was diagnosed with cancer, it was already nearly stage IV. They (her WOG doctors) offered her chemotherapy. As against drugs as Scientologists are, Sea Org members especially are "no case on post", which includes illnesses, we asked for a list of all of the drugs she would be given as part of chemo. I think the chemo drugs were ok, meaning they checked out as ok for a Scientologist to take. However, chemo makes you nauseated and the drug they give for THAT is also a psych drug.
So what happened? Natalie refused chemo. Sadly she passed shortly after.
I am curious if the cancer drug, or any other drug that they manufacture have ever been for use in mental conditions or prescribed by psyches. He is on a fine line. But money talks, eh?
Quite a lot, maybe most, Scientologists who die of cancer are treated with auditing and die some 10-15 years earlier than the American average. If they still have any money, that is. Otherwise they are off-loaded into the care of the community.
I also find the Duggan story full of fundamental contradictions.
Where is Smurf when you need him. Did the Duggans ever have a son named Chris? I am pretty sure that was his name. He passed away from cancer at the age of 17 or 18 in Los Angeles area, around 1995 - 1998. Smurf?
Not bloody likely.
Chemotherapy is poison.
I keep repeating that the difference between a medicine and a poison is the dose. This is even more poignant in Oncology. What most chemo does is kill off cells, killing the ones that divide the fastest, first. Since cancer cells are usually the fastest to divide, they die off. Many of the side effects come from the fact that chemo is also killing the slower-dividing normal cells, just at a slower rate. Hopefully the chemo kills the cancer before it kills you, but dosing is very tricky in Oncology.
So it's very, very unlikely this sort of chemo would be used for anything else except auto-immune diseases. It is possible that some hormone receptor blockers could be used when hormones are out of control in, say, a thyroid condition, and that might affect mood, too, but by and large chemo drugs are too toxic to use for run-of-the-mill psychiatric conditions.
[Edit - Tamoxifen is sometimes used at low doses for severe bipolar disorder. That is a) not a run-of-the-mill disorder and b) not at the cancer doses. That's the only example of an oncology drug used in a psych condition that I could find after several days of searching. And as I noted above, it is a hormone regulator, which is the one area where chemo and psych overlap. I still would not use it in a patient until they failed Lithium and every other treatment, though.]
Chemo drugs are used in auto-immune diseases, because there the immune cells are signaling and dividing out of control. But the chemo drugs like methotrexate are used at lower doses in auto-immune conditions than they are in cancer.
Ibrutinib, which is Pharmacyclics's cancer drug, is a BTK inhibitor. It could be used in auto-immune disease, except that it is likely too strong. It is what is referred to as an irreversible inhibitor - once it binds to its target it never comes off, ever. They are pursuing another BTK inhibitor for auto-immune diseases, likely RA and Lupus. It is not an irreversible inhibitor. All of their drugs are for oncologic or auto-immune conditions, no psych drugs at all. TG1 asked me to dig into them, and I have a bit, I will post my thoughts on that other thread in a few days.
Thank you Udarnik.
I think the specific question would be:
Is there any drug that the Duggans company manufacture or distribute (however you want to say it) that has ever been used for a mental condition? (whether cancer drug or not)
Pretty broad question.
No. I think Ibrutinib is their first marketed product. It is a small biotech with less than a dozen compounds in development, in about 5 different mechanisms of action.
Their partner, Johnson and Johnson, however, markets lots of psych drugs, plus opiate painkillers.
This is what Pharmacyclics admits to having in development.
One compound already launched in two diseases, with more diseases under investigation. You can not market a drug for a disease you have not finished studying yet. And you can't assume that because a drug is safe and effective in one disease, that it will be so in another. That is why there are so many arrows under ibrutinib. So, 4 - 6 compounds (notice they have not identified a compound number for the BTK inhibitor for auto-immune diseases, and may still be playing with a few different chemical entities before deciding on the one to go forward).
If they are any good, they will have some compounds in pre-clinical (petri dish) stages that may or may not be under patent protection, about which they are saying little to nothing.
Let me make a few things clear about the bio-pharmaceuticals industry.
Manufacturing an innovative drug is an incredibly complex process. There are thousands (literally) of moving parts. The part you see is only the tip of the iceberg, and if you are like most consumers, you ignore even most of the tip.
What you pay for (mostly), when you buy a drug is not the pill or protein itself. That costs from a few bucks to a few hundred dollars to produce. What you are paying for is the little slip of paper you likely throw out or ignore called the "package insert". That represents 15 - 20 years of testing that gives your doctor, and more importantly the FDA, the confidence to give the drug to you and know that the harm that this pharmacologically active poison is probably (highly probably) going to poison what we want it to, and not ... well ... the rest of you.
I gave up arguing with someone in another thread, but let me be clear in this one: every drug sold causes harm. Every one. There is no "safe" drug. That is why you will never see a legitimate drug being sold as "safe and effective". It's always "effective" caveated by that laundry list of side effects that people like to lampoon in fake drug ads. There is a good reason for this. I repeat myself: every drug causes harm to someone, somewhere, almost always multiple someones. The question the FDA decides when approving a drug is: "do the chances of doing benefit with the drug outweigh the chances of doing harm?". Different people can have differing opinions on this.
This BTK inhibitor that Pharmacyclics is selling? It's going to cause an infection in someone who has already been weakened by cancer, and that's going to kill them. I can almost guarantee that. But that effect is extremely rare, and in some cases it clears cancer that was resistant to literally every other treatment, in others it boosts the efficacy of current drugs to put people in remission who would otherwise have needed months or years more conventional treatment. It saves many more lives than it takes. That is the calculus that adults use every time they put a pill in their pie hole.
You mean you don't consider the increased chance of getting an ulcer or a heart attack every time you pop an Advil? Read the goddamn package insert for once, and pay especial attention that that black box label that illuminates the most dangerous side effects.
Bold is mine.
OK, what does this have to do with Pharmacyclics?
Well, in order to get to the point where the company and the FDA agree on that package insert, a lot of stuff had to happen first.
A new drug doesn't fall out of the air. Big Pharma doesn't synthesize a bunch of chemicals and stick them in sick rats to see which ones work. That would cost so much they'd all be out of business in a year.
The first step in making a drug actually begins in Academic labs, although Academics are generally totally inept at any of the other steps of making drugs. What a drug maker needs first is a target. Some chemical process in the body that has gone wrong and is causing a disease.
In cancer, cells multiply out of control. That happens all the time. You likely have several forms of cancer cell in your body, right now. However, the immune system picks up on these renegade cells and kills them before they can clump together and form a tumor. Once in a while, one of these cancer strains mutates a defense against the immune system, and evades what we call "immunoediting". Now we have two mutations: out of control cell division (proliferation), and immune regulation. Some tumors develop other mutations. They divide quickly, so they need a lot of oxygen and nutrition. The tumor actually causes new blood vessels to form to feed itself (angiogenesis).
So just think. I've broadly outlined three possible targets for an anti-cancer drug. One, stop the proliferation - kill the fastest dividing cells (or stop the process by which their divide at such a rapid rate), and try to leave as many of the rest as alone as possible. Two, cut down on the mechanism those cells are using to evade the immune system. Three, cut down on the development of new blood vessels that feed certain tumors.
Plaquenil is an example of a drug that kills fast-dividing cells. Low dose (but not high dose) Paclitaxel is an example of a drug that enhances the natural immune response to tumors. And Caprelsa is an example of a drug that inhibits new vessel growth. That last one can also give you a fatal heart arrhythmia, but since 44% of people on it and another cancer drug stopped progressing in their cancer, versus 1% on placebo and the other cancer drug, you bet your ass I'd take it if I needed to.
Be that as it may, we now have a target. The drug designers can get to work and try to make a molecule that hits that target and ONLY that target. Once they have that - well, let's stop there - that is no trivial task - first you have to map out the 3D structure of the target by instrument and by computer simulation, figure out what the sensitive bits are, and synthesize a molecule that can hit that and only that target while also being able to pass the through the gut when you take a pill, not have any nasty side groups that can cause other problems (known as chemotoxicity, rather than mechanistic toxicity) AND doesn't get chewed up by the liver before it even gets to the target - this can take years.
Once you have 2 or 3 compounds that fit the bill, you have to start testing them in animals. Because as good as computer sims are, we are surprised every fucking time we stick a drug in a rat. And usually the surprise is not of the "oh look, our heart drug causes boners" Viagara variety, it's usually of the "well shit, I didn't even know you could measure how much rat testicles shrink - who's the poor fucker who has to weigh the rat balls after we sacrifice the animal?"* variety.
After you've satisfied the FDA that you have done enough experiments to at least know where the likely potential problems are in humans, they let you give just one dose to college kids in need of beer money. If they don't keel over, you can work you way slowly up to a few weeks of dosing in these "healthy normals". That's Phase I.
That's normally where a small biotech goes looking for a partner. You've already spent tens to hundreds of millions by this point, and you haven't even gotten to putting it in patients with the actual disease in Phase II yet. And the really disheartening thing is - Phase II is where most drugs fail. You don't even know if you're going to have a real drug after all the money you've pissed down this hole. And even if you had the money to get all the way to Phase III and approval, you don't have the expertise. You need regulatory specialists who know what the FDA is looking for. You need veterinarians who know how to conduct the long term animal toxicity studies you now have to start (reproductive toxicology and cancer tox). You need skilled doctors who have run many clinical trials and know which sites to trust, how to set up a safety monitoring board and a thousand other details of patient safety. You need formulations chemists to make this stuff into a pill that won't choke someone - and who know how to do the environmental stability testing to determine the shelf life and get the FDA to agree on a printed shelf life for the drug. You might even need (God forbid), a controlled release formulation or some other such nonsense. And you need buy-in from the Academic medical community to publish your papers.
And even if you got through all that, for your first drug, you'll need to hire a sales and marketing team who knows their ass from a hole in the ground, or the FDA is going to Warning Letter your ass into a smoking hole.
Most little firms such as Pharmacyclics just don't have all that expertise, and their patent clock is ticking while they dick around trying to get to proof of concept. So they need a partner.
This is where Johnson and Johnson comes in. They provide the clinical trial expertise to get from Phase IIa to launch, they provide the manufacturing capability, regulatory oversight, all the stuff I mentioned above that Pharmacyclics does not have. Pharmacyclics has some patents, some expertise at the petri dish stage, and a tiny, tiny bit a clinical expertise, just enough to get a little way into Phase II before finding a partner.
Once they have that partner, then they normally conduct a Phase IIa dose ranging study - they give a bunch of different doses to a few patients (dozens) and try to figure out what the top and bottom doses are to have the effect they want. Then they take those good doses (or dose) into some more (hundreds of) patients for 6 months or so in Phase IIb. Then they negotiate with the FDA about what they want their label to look like, and design and execute Phase III in thousands of patients for a year or more. That's assuming that it works as good as you expected (often not) and that some weird side effect didn't kill it (all too often).
Then, if nothing catastrophic showed up side effect-wise in Phase III (usually you know most of the bad stuff after Phase II, but rare side effects take more patient years of exposure to discover), they negotiate for the real label and get approval for the first disease, or "indication" in regulatory-speak. Then the sales and marketing team can get to work.
By the way, for every 30 - 40 drugs that make it out of the petri dish stage, one makes it to market. I stopped doing this kind of work over half a decade ago, after spending nearly a decade doing it. Out of nearly three dozen projects I worked on from an early stage, one made it. I'm right in line with the odds. And those are very, very expensive failures.
If the partner is smart, they pay only a little bit up front for the rights, and spread the rest of the payments out as "milestones". Say $50M up front, another $100M if the drug passes Phsae IIa, another $200M for Phase IIb and $500M for passing Phase III to launch. Then the partner takes the bulk of the profits as a reward for their risk and pays negotiated royalties on the sales back to the biotech.
That's what happened recently for ibrutinib.
And like I said, this drug is bound to cause harm in a few people. But from what I can tell, the Co$ connection extends only to the business side. The drug side went through the same FDA process - a very good process by the way - that everyone else does, and it's on the up and up. J&J would not have touched it with a 10 foot pole if that were not the case. I've never worked at J&J, but I have lots of friends who do, and they are very competent. Shit happens sometimes. If, by some ill fortune, this drug runs into a rare side effect after marketing and gets pulled or restricted, please don't blame that on the $cilons. I'll have to come over and whack you with a clue-by-four if you do.
* An actual example from my own checkered career.
You're like the wog scientist 'John P-wog-capitalist' equivalent of ESMB
it was brain tumor. his name was Demian. He died in 1997, at age 26.
Thank you. This was good reading.
Thanks for typing all of that in. Excellent essay. I knew that bringing a new drug to market was very time consuming and expensive but your explanation is very informative. I laugh (or find it irritating depending on my mood) when some talking head on TV feigns disbelief that a "single pill cost $3000" without even a mention of why.
No drugs of 'any kind' are not completely restricted. Just any drug that affects the mind, or restimulates or turns on 'mental image pictures' or something close to that. That is the theory more or less. Hubbard claimed it was kind of 'interference' with the C/S and auditors ability to produce auditing results and or move a person up the bridge to clear and beyond.
I am trying to remember the details (this was some decades ago) but I was involved in a discussion about someone going to take or having taken a 'medication' and whether or not it was possible to do so per authorization of the C/S. I think the line was that the C/S(case supervisor) had to find out from the Medical Liaison officer' who either had a list to refer to or who had to contact a 'scientology doctor' as regards the 'mind influence' of the drug/medication. Vaguely remember that the DSA was involved also in the discussion.
The above is an aside from the other ideas about drugs/medications and their toxic affect on the body and mind as comes out of the purification program, although the two concepts may have a common subset of interplay.
I much prefer that this 'All scientologist are against ALL drugs at any time and under all conditions' type of statement is not used, as most scientologist know that is too absolute and that some medications although not desired are acceptable under certain circumstances,then they can use the incorrect statement as a reason to throw out the other 'entheta' about the real abuses and bullshit that exists in scientology. Facts are facts so try to stick with them. Opinions are a different game.
If I were the OES in an org I wouldn't mind if a public had to take drugs.
PURF RETHREADS FTW!!!