It claims that there is a 'cost of doing business' gentleman's 'agreement' between the FDA and the Big Pharma on bringing drugs that are 'not quite safe for all' to the market.
The author says that there are 100,000 deaths from drugs annually which is 'murder'.
With all due respect, Sir, people don't always take their pills! In my humble estimate, the number of deaths from noncompliance with blood sugar and blood pressure alone would have higher numbers of 'deaths' than that.
It takes someone from within to truly know the system.
And I do.
Ever with the AIDS crisis, the FDA has allowed 'fast-tracking' of drugs to market to 'save lives'. The usual checks and balances are bypassed through this accelerated route to market.
Once that door opens, it is difficult to close.
Everyone expects it.
Now, Big Pharma has a lot of expense in bringing a drug to market. And that it might never make it to market? Huge, unexplainable loss! So this is the 'motive' for the 'murder', is it not?
I have some tales to tell. Two of them.
This is the first drug, Rapacuronium, or 'Rap'. You see, when I induce anesthesia, I give muscle relaxant to obtain optimal conditions for intubation. The best on the market is succinylcholine, but some are not able to have it due to side effects with their underlying disease and the interaction. Sux works in under one minute. 'Sux' is cheap, old, and readily available in generic form.
Rocuronium, or 'Roc' is the standard I use every day. It has none of the side effects of Sux, and can be reversed after about half hour. But Roc takes about three minutes to work.
Rapacuronium was designed to be as fast as Sux but from the same family as Roc. It was touted as safe, and excellent for use in pediatric anesthesia. I was on my peds rotation at CHLA, and used Rap on an emergency eye case with a full stomach.
What I saw clinically was awful! The worst case of bronchospasm I have ever seen in a child who did not have asthma. The patient almost died. I got him through, but I swore to myself, never to use Rap again! The free pens and stuff were a lie. This drug was crap.
None of my friends and teachers believed me. But I stuck to my guns.
Rap was quickly pulled off the market. Why? Bronchospasm.
Here is the link in Wiki: http://en.wikipedia.org/wiki/Rapacuronium You can see the chemical structure on the right. Here is the text:
Rapacuronium (Raplon) is a rapidly acting, non-depolarizing neuromuscular blocker formerly used in modern anaesthesia, to aid and enable endotracheal intubation, which is often necessary to assist in the controlled ventilation of unconscious patients during surgery and sometimes in intensive care. As a non-depolarizing agent it did not cause initial stimulation of muscles before weakening them.
Due to risk of fatal bronchospasm it was withdrawn from the United States market by Organon on March 27, 2001.
The second drug was widely used in the heart room, Aprotinin, or Trasylol as the brand name.
This is an antifibrinolytic. It saves clot.
Example: you have heart attack. You go to ER. Cath lab gives you fibrinolytics to melt the blockage in your heart, to dissolve that blood clot, right?
In heart surgery, there is bleeding everywhere. So giving an ANTI-fibrinolytic saves clot. It doesn't clot everything, but it blocks the natural pathway in the body to dissolve clot once it is formed.
This man, Dennis Mangano, MD, PhD, formed his own study group (an enormous amount of funding) to pay for the studies to prove that aprotinin was bad news. Increased risk of death, heart attack, stroke, and kidney failure.
I read the studies. And decided to use aminocaproic acid (what we used before aprotinin) instead. But I didn't talk to perfusion. Heart surgeon figured it out on the first case, the father-in-law of the chief of plastic surgery. He yelled at me something awful, because he loved that drug. It made his life easier while he worked in the chest. But since MY drug was in the patient, perfusion had to take down the entire circuit and re-prime a new one with MY drug. Otherwise there would have been catastrophic clotting. I stuck to my guns. I said to the plastic surgeon I stuck my neck out for you. They gave me a nice stack of gifts from Harry and David--he knew the anger of my heart surgeon!
But guess what? After the teasing and the insinuating I was an idiot and the Mangano study was flawed, yada yada yada, guess what? Aprotinin got pulled from the market. Just like that. No apologies, nada.
Mangano is a hero who took the medical cartel by the horns and won.
This was in 2007. Wiki says the ban was 'temporary' and has been lifted in 2012 by a European Committee. Here is the link: http://en.wikipedia.org/wiki/Aprotinin
Here is the NEJM article by Mangano. http://www.nejm.org/doi/full/10.1056/NEJMoa051379
I would follow the money in that European group who is recommending lifting of the ban.