Comments by "Banana" (@439bananas) on "Real Stories"
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They did not inject cancer. Monoclonal antibodies are made in a complex way. I will try to explain.
Firstly, you identify a unique molecular sequence on the type of cell that you wish to kill.
Secondly, you get the sequence made up in relative bulk.
Thirdly, you mix the sequence with something to make it dirty so that an animals immune system will react to it by producing antibodies to the target sequence, this is called Freund's adjuvant. You inject your animal with this inoculant.
Fourthly, you harvest the animals immune cells.
Fifthly, you take those immune cells and fuse those cells with a myeloma line that does NOT produce any proteins itself, this is done by adding anti freeze. The resulting hybridoma line is immortal as long as you keep feeding it.
You then have to pan out any unfused cells by using selective growth medias and then you have to identify the correct cell line by a combination of repeated passaging and the use of mimotope dot blots and Enzyme Linked Immuno Assay techniques.
Once you have found your clone you then have to expand the numbers for both a seed bank and to use for creating the drug.
When you have decent numbers of cells they are put in a hollow fibre fermenter, where they are kept warm and fed oxygenated nutrients by pumps.
The hybridoma cell lines put out monoclonal antibodies. The nutrient mix is spun at high speed to make the cells and cell fragments drop out, these are then disposed of.
The remaining nutrient soup then contains the valuable monoclonal antibodies. This is passed through a chromatography column packed with a protein A sepharose gel. The antibodies stick to this gel and the crap flows through.
The raw soup is tested by electrophoresis to establish the isoelectric point of the antibody. This the turning point where the arrangement of folding can be changed by the addition of salt.
The drug can then be washed off the separation column by a sterile solution of salt at the appropriate concentration.
The salinity of the drug is then adjusted to that of the human body and its concentration is measured photospectroscopally. Dosimetry is then calculated and any adjustments made.
The drug is then passed through a sterile filter and dispensed.
The dispensed drug is stored frozen and upon thawing it should be dispensed into an IV drip with a sterile filter between the syringe and the needle, just in case any of the protein based drug has either precipitated out or aggregated as proteins are want to do.
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@shielamariehankinson3824 Then you will know that surgery is even more of an unknown than drug trials. Surgery really is flying by the seat of your pants stuff and definitely not for the faint-hearted, however much surgeons earn they sure earn every penny of it.
The reality with clinical trials is that drugs go through a battery of tests mandated by the Geneva Convention before they get anywhere near administering a drug to a human. In general they first go through chemical tests in the lab and then on to tests in the lab in cultured tissues to try establish the action of the drug/ toxicity. The drug then goes into lab animals usually starting with rats or mice to establish the LD20. This is the dose at which 20% of the animals die, this is usually expressed as mg/kg, in other words how many milligrams per kilogram weight of the animals that results in the death of 1 in 5. This is extrapolated to give a safe dose for usually either monkeys or dogs, at this stage it is looked to model the disease as well.
The reality is that frequently there are already similar classes of drug out there, so there is some level of prediction of a drugs action. So for instance monoclonal antibodies, as in this case, your own bodies make a cocktail of antibodies in response to the pathogens that it meets every day. If your body comes up against a big challenge, you get 'flu for instance, then the presence of antibodies will massively ramp up your bodies immune reaction to give you the classic fever/headache combo of 'flu. The same thing happens when you put artificially produced antibodies into people, their bodies ramp up cytokine production and these cytokines can attack your own tissues, if you have got the dose wrong. In general antibody doses are tiny, in the 2-10 mg category once every few weeks, compare that to paracetamol where a typical dose would be 1,000mg up to 8 times a day and you can see that antibody drugs are powerful and there is not much room for error. Nevertheless, the people that ran this trial were extremely negligent in that they did not use the long established protocols for the use of this class of drug.
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@milasuljagic7913 Actually in this case "the could not predict the outcome" get-out clause would be unlikely to hold much water. You see the drug was a monoclonal antibody and at the time of these tests, it was well known that not only do they provoke the immune system, but that the immune system can respond to such provocation with a cytokine storm as seen here.
Back in '93 I was making monoclonal antibodies for clinical trials myself and a number of our lines were further on in the trials process than this drug. The drug itself was added to a saline drip prior to running a very slow infusion. That way if any adverse reactions are observed, then the drip can be stopped before the patient has received the whole dose. Our box insert also said that an anti-inflammatory drug called Prednisolone needed to be on standby in case the patient had a severe reaction.
Given that cytokine storms are a recognised adverse reaction for this class of drugs and that there existed at the time protocols to ameliorate any adverse reaction, the question is likely to be: why did they not follow a suitable protocol. Usually, these trials have to be approved by an ethics committee, did the committee realise the risks of these class of drug and if not were they competent? Or did the drug company put forward a suitable protocol, but the clinical trials company fail to adhere to the protocol because it meant more work and resources? So the legal issues are likely to come down to who is responsible for the outcome, which is likely to be either the drugs company jointly with its ethics committee or a rogue, external clinical trials company that has failed to follow protocol.
Either way despite any waivers that have been signed by the trial participants, the drug company, its ethics committee and the clinical trials company ALL have a duty of care to the test subjects both individually and severally jointly. Under UK law it is extremely likely that given these factors, the test subjects have a case for negligence against at least one of these parties.
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