I work in the industry.
One big pharma has, say 35 compounds in development at any given time, of their own. A drug is an FDA approved compound, you follow. A compound is just a chemical or antibody that is about to undergo FDA approval.
These compounds are aimed at diseases that a) have the greatest number of afflicted people in the key market, which is the United States, and only the United States, and b) has a ‘method of action’ that is patentable, and thus sellable.
Here’s the thing - in order to sell your drug, you have to undergo the four phases of the FDA approval process. To get through that process, it will cost - on average - about $900MM to $1.3BB.
This does not count the introduction of the compound as a therapy or cure in a market that is not governed by such onerous regulation. Central Europe, Mexico, some Asian countries. They will evaluate it there before ever considering putting the compound through the FDA process.
Now, if a big pharma gets one blockbuster drug approved every other year, they will just clean up. The reason why is the chances of passing all four stages of the FDA process is pretty freaking small.
Each of the 35 compounds in this fictional company is its own little company. To determine the annual profitability of the big pharma, the management looks at each compound, evaluates competing compounds with different methods of action under development at rival firms, sizes up the chances of the compound being effective, and if they have doubts, they’ll just whack that drug in mid-development.
They do this because the revenue window for any blockbuster is 10 years, and only 10 years. To make matters worse, the rest of the world operates what is called a monopsony - the revese of a monopoly. Europe pools all of its buyers together and places one big order.
The US is the reverse, all their buyers buy on their own. This makes the US the only, the single, market in which a drug manufacturer, for only 10 years, can recover not just the cost of development, but the cost of the other 34 compounds still under development.
That’s right - typically it is one, or maybe two, drugs that are propping up a big pharma firm.
When the Army handed the blueprint for the anti-Aids therapy AZT to I forget who, they still had to pay the $550MM to go through the FDA ringer.
So, your $500 pill is subsidizing not just the rest of the compounds under development at the company the drug came from. No, you are also SUBSIDIZING the ability for the rest of the world to buy that very same pill for 1000’s of percent less than what you would pay.
Canada, for example, places one giant order for a big blockbuster drug. Every hospital gets their order from the Canadian government. This is why the assholes who live in WA and MI - gigantic bleeding ass liberals that they are - pop over the border to buy their drugs for way less over in Canada.
Now, just to make this a little worse, there are the drugs that are KNOWN TO BE EFFECTIVE AGAINST BROAD SPECTRUM OF CANCERS AND VIRUSES, yet are not available because the drug is ‘public domain’ - as a compound, it can’t be patented. It’s therapeutic usage can be patented, but those patents are very weak, and defeated relatively easily in court.
As such, the drug DCA will NEVER BE AVAILABLE TO YOU, EVEN THOUGH IT KILLS A TON OF DIFFERENT CANCERS. Nobody is going to put up the $500 to $900 to get it through the FDA process when you can’t recover that cost in the open market.
So, consider all the people in your family that were killed by cancer in the last five years, and then look up DCA and find out about which cancers it has been demonstrated to be effective against, and which not.
“Awww, that’s BS. How do they know that this drug is effective against cancers and lots of different viruses, when no FDA studies have been done?”
Well, lots of studies have been done, and because of the ‘method of action’ of this drug, it takes a very simple and radical approach to killing the cancer.
Every cell in your body has the ability to undergo what is called apoptosis, or ‘cell suicide’. When a cell’s RNA is compromised, a chemical signal goes out to the bit in the cell that causes the cell to kill itself. Cancers and viruses like Hemhorragic Fever have developed an ability to cut off that chemical signal prior to the cell killing itself.
This turns the cell into a manufacturing plant for more viruses or cancer cells.
DCA restores the ability of the cell to kill itself, stopping the metastasis of the cancer, or the spreading of the virus, before it can begin.
You will never be able to buy this drug as it stands today. You can go to other countries and obtain the therapy there, but never in the USA.
So, there you go. Any questions?
Cancer’s one thing, a real disease. J&J’s drug, Risperdal, and its Classmate Atypical antipsychotics do not cure Anything, nor can they legally claim to cure anything. and FDA told J&J in Dec ‘93 just before they approved it that FDA would consider it a violation of the FDCA for J&J to advertise of promote it as being safer or more effective than the older typical antipsychotics.
http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf
(pg 23)
“1. One in every 145 patients who entered the trials died, and yet those deaths were never mentioned in the scientific literature.
2. The trials were structured to favor the Atypicals and most of the study reports were discounted by the FDA as being biased.
3. One in every thirty-five patients in Risperdal trials experienced a serious adverse event, defined by the FDA as a life threatening event or one that required hospitalization.
4. Twenty-two percent of patients in Zyprexa trials suffered serious adverse events
5. The Atypicals did not demonstrate superior effectiveness or safety over Typical antipsychotics.
It is important to note that a drug company does not have to prove that a new drug is safer or more effective than an old drug to gain FDA approval. Essentially, the manufacturer has to demonstrate that the drug is proved to yield better results than placebo in a statistically significant number of patients in short-term trials (6-8 weeks). “
1 in 35 patients, back to the ER or the morgue.
Yes, it is expensive ginning up a loser into a blockbuster, no denying it, especially when the product is such a pig that the makers have to hire out of work Star Trek writers to put Lipstick on it.