Human mice
From the book: "human guinea pigs in the New Millennium", ed. Medea
More than half of approved drugs have serious adverse reactions not discovered in earlier stages of development and marketing research (1).
The United States alone are more than two million cases of serious adverse reactions each year with over a hundred thousand deaths (2).
These data are almost never broadcast by the media, which usually focus exclusively on the scandals of the single drug, which is withdrawn from the market, or the ruthlessness of the trials in the Third World.
These data lend themselves to a double reading: on the one hand there are those who support the abolition of practices highly insecure and potentially devastating, the other are the proponents of drug discovery, for which the collateral damage inevitable sacrifices on the altar of science.
What matters, however, is that in both cases we are talking about drugs that had passed all safety tests required by national and international laws.
Over a hundred thousand deaths in the United States because of those drugs considered safe enough to be marketed.
Well, consider that in my work I meet often with drugs so devastating that not even receive permission to trade. And forget
animal testing as a method for assessing the safety of a new drug does not work and, later, you'll understand why.
The real rats are men and women so desperate to lend itself to experimentation.
These men and women rely on me, or people like me to be subjected to experiment.
In some cases, these are healthy people who, in exchange for money, take the new molecules developed in laboratories that will be assessed the effectiveness or danger, in other cases they are already sick of people who offer for free food hope.
After an initial phase of animal testing that does not provide useful data but it is only necessary to obtain permits to carry out trials later, they begin to fulfill a legal obligation, the human trials.
The real scandal is not the dead from drugs trade that, compared to a few decades ago, are much lower. They are not the drugs that are withdrawn from the market because more harm than good. Are not individual cases of allergic reactions. The real scandal is
trials before marketing.
The real scandal is the evidence on men and women of new molecules of which we know practically nothing, are the false hopes that are given to sick people who offer themselves as guinea pigs, men are reassured by useless data on animals.
And are the laws that allow this. The laws governing human experimentation are substantially similar to the European Union, from which derives the individual national laws, and the United States. In Switzerland, home to many multinational drug companies, the current law basically ignores the protection of human subjects, so that is being considered a new draft law on human research.
(...) The Investigator's Brochure
At the current exchange rate it comes to about € 700 = $ 1043 = 1200 Swiss francs. Might as well
the life of a human guinea pig.
A beagle dog (breed of dog used in laboratories) costs about 300 €.
now every time I get in the hands of a new Investigator's Brochure I get the cold sweats.
The Investigator's Brochure are among the most secret things that may exist. They are
dossier of the drug industry collect all information about a new molecule is not yet on the market, the physical and chemical properties and pharmaceutical studies performed with the first in vitro screening methods, the results of animal experiments, the results of experiments on humans, the effects side, suspected or verified the validity of the treatment, etc..
Annex to the Investigator's Brochure is a contract of the same company that provides financial coverage of trials.
In other words, the company paying the whole, in the Investigator's Brochure, is defined as "Sponsor".
For example, a typical contract of a major company wishing to find and experience on at least 400-450 diseased mice that already offer free offers in exchange for about 300 000 € divided between payments immediately after the recruitment of a number of guinea pigs and at the end of the study.
So in total, more than 650 € a guinea pig.
The Investigator's Brochure vary over time with increasing information. For example, a
Brochure Version 1 of a new molecule is a documentation of various test results, obtained mainly on animals, and no information for uorno. So here is the most dangerous because the human guinea pigs to test a molecule which will have virtually nothing is known with respect to the reaction of the human organism. E ' the highest risk possible.
(...) The first
Brochure I reveal the contents of which is a version 1, that is one of those magazines that come to us for the first time on a man a new molecule.
are a few pages as there are no results to be considered valid.
Tests on animals show that adverse reactions are read and / or moderately severe in both rats and monkeys especially in the lungs and liver.
Already on page 2 of the introduction is, however, given our task: Find the Maximum Tolerance Dose (MTD), the maximum tolerated dose (3). In
words understandable to the layman, what we do is:
1) find and convincing human guinea pigs to test substances on himself that you do not know practically nothing;
2) start to experiment on them, increasing the dose until you find one that kills or is risking his life.
Before going into specific studies, we have to understand to what we can "push" with the dose, up to what we can punish him. And to do that there 'is another way other than to increase the dose until you reach the point where you show the devastating side effects or significant profits for our statistical records.
Information: None.
Risk: max.
careful, the risk is not up just because there is no information useful, because the risk is greatest, almost going blind, we must continually increase the dose of the experiment until you find the maximum tolerated dose.
If a first experiment does not give large effects neither positive nor negative, we must do it again by increasing the dose and try to "find" the limit.
Note 1) Moore TJ, Psaty BM & Furberg CD Time to act on drug safety. JAMA, 279: 1571-1573, 1998.
2) Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. A meta-analysis ofprospective studies. JAMA, 279:1200-1205, 1998.
3) Anticipated The first-in-patient study will be to ... parallel-arm study designed escalation access to safety and tolerability, and wheter to Determine the maximum tolerated dose (MTD) of ... Is Reached ...
source: http://www.disinformazione.it
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