Comments by "Banana" (@439bananas) on "Real Stories" channel.

  1. Geneva convention sets out the standards to which clinical trials should adhere, but I am aware that some unscrupulous companies do not adhere. They should have looked to existing monoclonal antibody protocols which use slower infusions and have prednisolone on standby.
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  2. There were existing monoclonal antibody protocols at that time that would have advised a) dilution of 1:100 b)slow IV infusion c)that prednisolone and adrenaline is kept on standby. Clinical trial needed to take a more cautious approach and stagger the administration more widely in this first attempt.
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  3. I think the placebo guy would figure it out pretty quickly. But the investigators did not use established monoclonal antibody administration protocols and were therefore negligent
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  4. 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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  5. Cytokine storm same as when people die of flu.
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  6. I am a bit more worried about the woman given the fact that she is covered in bruises and her partner in the main looks totally uninjured. You see if he did this to the dog, it would defend itself and bite back, the arsehole knows this and that is why he will not attack the dog, just a woman that does not fight back.
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  7. They did not follow appropriate protocols and whoever was guilty of that could be done for gross negligence or even manslaughter by gross negligence.
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  8.  @Mofasho  No it looks like a pure Staffie. They start to look real broad and strong across the chest when they reach about 3 years old
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  9. Because when you evaluate a drug, you want to differentiate between the effects of the disease and the side effects of the drug.
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  10. Many people who are desperate will look to drug trials to make extra money, but it is not unusual for research staff to be pressed in to being guinea pigs and some people are simply altruistic.
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  11. OK, I used to work making clinical trials drugs and there are some things that you should know about the law in this area. Just because it is a clinical trial does not exempt the experimenters from a duty of care to their test subjects. Those drugs have to be pretested in animals, that is part of the Geneva convention. Those drugs have to be made to Good Manufacturing Practice industry standards. And the test subjects are still entitled to a degree of care in the way in which the trial is conducted. At the time that this trial was conducted there existed protocols for the administration of monoclonal antibodies. It was already well known at that time that this class of drugs could cause cytokine storms and anaphylaxis and for this reason it was normal procedure to add the drug to a litre of saline and infuse slowly over the period of an hour or so and to have an anti inflammatory drug called Prednisolone on stand by for emergency use. The clinical trials company did not follow these procedures and as such if such a case were to come before a court, then it is very likely that they would be found negligent or their client would be found negligent and compensation would have been awarded. The chances are that any company that did anything like this would offer a substantial compensation package, in return for no court proceedings, because they know that it would not end well for them.
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  12. He may have received the placebo, the dummy dose designed to ensure that any reaction is genuine.
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  13. Actually, administering a steroid called Prednisolone would have been most effective.
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  14. They injected it all in one go instead of slowly infusing it through a drip.
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  15. Would be unlikely to calm he cascade reaction/ cytokine storm. They should have had prednisolone on standby, at the time they did this work, there was already protocols that suggested that this drug be on standby when administering monoclonal antibodies.
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  16. I understand, but in the UK our health service is free to use, it is paid for by our higher tax rates. People are not paid for blood here, but the blood transfusion service is giving it to private companies that fractionate it and sell it back at vast profits. The only blood that should be fractionated is blood that is in excess of that needed for transfusion and this should be provided back to our own healthcare system at no more than cost price, at the most. Any excess could be sold to other countries with the profit from that returning to the health service. People do not give their blood for private individuals to make a profit from it.
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  17. So sorry that you cannot afford dental care. Try a dental training hospital.
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  18. But this is a true story.
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  19. Yes, because that is how they elucidate the effects of the drug from the effects of the disease.
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  20. Because you would not be able to differentiate symptoms due to the drug from those caused by the disease
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  21. It was a class of drug called monoclonal antibody. The contract company that did the testing failed to use the existing protocols for administering this class of drugs and were therefore totally negligent.
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  22. These were monoclonal antibodies and the existing protocols for their administration were not followed, a completely different class of drugs.
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  23. Or hard up or very altruistic.
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  24. I used to make clinical trials drugs.
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  25.  @shielamariehankinson3824  Well, the people we treated were drinking in the last chance saloon and there are many people around today that would not be if it were not for their inclusion in the trial.
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  26.  @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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  27.  @shielamariehankinson3824  I understand that a monoclonal called Ruxolitinib is used when PV fails to respond to the standard treatment regime. The body can eventually form antibodies to many therapeutics as the constant region is often murin in origin.. If this is the case your best next course of action is likely to be a clinical trial, bone marrow transplant increases the risk of AML in this condition.
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  28.  @shielamariehankinson3824  Try Cambridge Uk, beautiful place and plenty to do.
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  29. Unfortunately, they did not use the existing monoclonal antibody protocols that say to infuse slowly.
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  30. Used to work under a DDX license making a clinical trials drug called CAMPATH, so I can say that anyone in charge of these sorts of trials have to be able to demonstrate that they took reasonable measures as they have a duty of care to those taking such drugs.
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  31. I worked making monoclonal antibodies and had a hand in various parts of the production. I spent time: cloning cell lines; epitope mapping; making affinity chromatography purification media; QA testing. All culture ingredients were thoroughly tested and the final product went through a battery of tests including: haemagglutination; chromium 60 cytotoxicity test, endotoxin tests, thin layer chromatography, isoelectric focusing; Enzyme Linked ImmunoSorbent Assay; DNA quantification. Our product was originally meant to treat rheumatoid arthritis, however, it was no better than existing medicines, apart from in cases of psoriatic arthritis. It was then used for bone marrow transplants where the patient had a failed treatment with the standard of the day Fludarabine. It was also used in some rarer cases for vasculitis and Wegener's granularcytoma. It has since been relicensed as a treatment for relapsing-remitting multiple sclerosis and has been remarketed under the name Lemtrada.
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  32. This is a monoclonal antibody. I was involved with the development of CAMPATH in the mid 90s. We always used to add the drug, usually about 5-10ml, to a litre of isotonic saline and then pump into the patient at a slow rate. If there is an adverse reaction, then you can stop before they have received the whole dose and therefore lessen the dose and by extension the adverse effects. We also used to have prednisolone and adrenaline on standby. It would have been better to follow this sort of protocol and as this was the first time in humans they should have staggered the administration across the group by at least 30 minutes. I do wonder what sort of other production precautions that they took, eg did they check all culture materials and separation materials for endotoxins, What sort of separation material did they use, by then there was more effective affinity techniques that could have been used.
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  33. Yes, but at least you know whatever you take for it has been previously tested
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  34. You are completely right. It should have been administered through a drip over the period of about an hour. That way the administration could be stopped once adverse symptoms were noted. They should also have staggered the administration times, then at least they could anticipate problems, rather than be overwhelmed. They should have had a steroid called Prednisolone on standby as well. This is established protocol for the administration of monoclonal antibodies.
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  35.  @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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  36. Absolutely negligent.
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  37. But, he might have only been alive that long because of previous trials. When you are drinking in last chance saloon the options arenm't great
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  38. Neither do British donors.
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  39. I was making CAMPATH in 1993, when it was still a clinical trials drug. We used slow infusions then.
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  40. Unfortunately, the only way out is either death or abandon your life as you know it. For me I had to leave my career and cut contact with all my friends and sell up and move many miles away. I am not on the electoral roll, so I can not vote and even my doctor does not know my real address.
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  41.  @traciemartin3785  Thank you, I have a son with my ex, the violence started with his birth. I am one of the lucky ones, as I escaped with my life.
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  42. The Nazi's tested in humans and as a result part of the Geneva Convention states that any drugs tested in humans must be tested in animals first, it is just the law.
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  43. The drugs are monoclonal antibodies. Your own bodies make them as a flagging response to ramp up an immune system response and this is exactly what they saw in this clinical trial. The drug should have been diluted with about a litre of buffered saline and infused over an hour with prednisolone on standby.
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  44. No, they just want to get a drug onto the market
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  45. It would not have just been tested on monkeys. It would have gone through a number of tests in tissue culture, it would have been tested for haemagglutination, chromium 60 cytotoxicity tests, endotoxin assays and Enzyme Linked ImmunoSorbant Assay and thin layer chromatography. Only then would it be tested in animals and they would not start with monkeys, they would most likely start with smaller mammals to try to establish a measure known as a lethal dose 50.
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  46. Not approved, clinical trial.
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  47. So that they can differentiate the actions of the drug from the course of the disease.
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  48. Drug was infused too quickly and resulted in a cytokine storm.
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  49. Were they testing for CJD.
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  50. Unfortunately, adults who kill children do not always serve life, so the chances of ten year olds doing so were always pretty slim. Robert Thompson appears to be rehabilitated, but not Venables, when people do this sort of thing, if they are guilty of any further serious crimes after release then any remaining sentence should be enacted, but it isn't.
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  51.  @mpono1864  My thoughts exactly.
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  52. Should have given them Prednisolone to knock back the cascade immune reaction that was going on.
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  53.  @samgarlick3082  There are existing protocols for the administration of monoclonal antibodies, which tell you to keep Prednisolone on standby.
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  54. The doctors should have administered the drug in a drip form that could have been stopped and they should have staggered its administration amongst the subjects.
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  55. OK, that statement is simply untrue. This is a class of drugs called monoclonal antibodies. It was well known at that stage that they can cause cytokine storms and to mitigate this they are usually added to saline and infused slowly so that the infusion can be stopped if there is a reaction. In the case of a reaction then it is imperative to administer the steroid prednisolone, immediately, because the situation can escalate extremely quickly into respiratory failure. The trial company or the manufacturer were at fault as they did not follow existing protocols for the administration of that class of drugs.
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  56. She will live with the guilt for the rest of her life for merely a moment's inattention.
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  57. Possibly had an out of court settlement that was in return for signing a non-disclosure agreement or he simply does not want people begging for his money.
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  58. It was a monoclonal antibody class of drug.
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  59.  @angellapoff6136  Caterpillars get eaten all of the time by birds.
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  60. They frequently do. Also, fledgling biotechs often twist their employee's arms into participating
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  61. They do not accept women of child bearing years because ova are formed at birth and can, therefore, be damaged, whereas sperm production is continuous.
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  62. To get animals other than humans to react to any vaccine, scientists have to make it "dirty". They use a solution called Freund's Adjuvunct.
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  63. Don't know about Jon Venables because he has offended twice more since coming out, but Robert Thompson is.
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  64. At least he killed himself
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  65.  @nonamehumandaughterofmosth9808  The funny thing is my cousin's husband was due to test his hearing when West was on remand in Winson Green prison. Anyone on remand gets better healthcare than those convicted, although people are so rarely remanded unless there is evidence that they have committed the crime. West hung himself and saved the guy a job!
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  66. He received the placebo, the saline, drug free injection.
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  67. Well actually, you can expect that: 1] The drug has been trialled on animals and that the dose is correct 2] That the drug has been made to cGMP standards. 3] That any protocol for that class of drugs is followed.
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  68.  @nunomiguel555  The reality of that trial was not that the drug was totally unsafe. The reality was that there are existing protocols for the administration of monoclonal antibodies and none of them were followed. Monoclonal antibodies are well known for causing cytokine storms, so to mitigate this, the usual procedure would be to take the drug [usual volume not more than 10ml] and not inject it directly into the patient, but to inject it through the port of an intravenous saline bag of at least 500ml and infuse it slowly into the test subject. This way if the subject starts to exhibit signs of a bad reaction, then the flow of the drug can be stopped before they have reached the full dose and so less damage is done. Also administering this way seems to lessen bad reactions in itself. Secondly, as cytokine storm is a recognised side effect of monoclonal antibodies, it could be anticipated and the facility should have had prednisolone injections on standby and resus facilities for the number of participants that received the drug. Despite signing any contract the people running the trial still have a duty of care to the participants and that extends to ameliorating any foreseeable consequences of the drug. Because there existed protocols for the administration of monoclonals and these were not followed, it could be argued that the trial company or the manufacturer if they had not revealed the class of drug or given such instruction were negligent.
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  69. Not everyone has the choice, some drug companies enlist their own employees.
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  70. Clinical trials happen for a reason, this was a clinical trial and therefore adverse reactions are more likely to occur. The COVID vaccine will have been through clinical trials to ensure that it is safe before administration.
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  71. It is one thing to be stupid about your own health, quite another when you are stupid about your child's. They rely upon you for a good start in life and to not give them the best start you can afford for them is a gross betrayal.
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  72. Not really. There are protocols for making and administering vaccines that are followed.
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  73.  @aussiegaming8156  You think that there are not protocols?
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  74.  @remoove7231  Exactly, monoclonal antibodies and vaccines are 2 different things. But both are made to well known protocols and both go through considerable clinical trials.
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  75. The type of reaction that was seen is an immune cascade, that you see when the body encounters a substance that provokes an immune response, in this case a foreign antibody. So, no your placebo control idea, although good would not have yielded the result that you expect.
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  76. You can not just give a blood transfusion without tissue matching, even between people that are biologically related, your statement is untrue.
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  77. Because it is mandated by the Geneva Convention.
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  78. They have to elucidate the effects of the drug distinctly from the effects of the disease, that is what is part of what is required for a drug to be licensed for use.
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  79. He is having a cytokine storm that would feel very much like a bad dose of the flu, when your lymph nodes swell and cause pain by pressing against nerves and you have a massive fever.
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  80.  @spork4267  I used to work for Cambridge University making monoclonal antibodies for clinical trials.
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  81. Because you have to differentiate the effects of the drug from the effects of the disease.
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  82. There is treatment, existing protocols at the time should have been used, the correct treatment for this would have been immediate administration of a high dose of an anti-inflammatory steroid called prednisolone.
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  83. Or administer intravenous prednisolone to calm down the cytokine storm and then call 911.
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  84.  @mannmctrash  Intravenous prednisolone is the recognised way to arrest such a rampant cytokine storm and the quicker it is administered, the better.
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  85.  @mannmctrash  That's OK, what this video does not say is that by the time of this clinical trial that it was known that monoclonals could cause these problems and there were well established protocols for their administration that clearly were not followed by the trials company.
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  86. And are in fact mandated by the Geneva Convention.
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  87. With compensation too.
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  88. Should have infused the drug SLOWLY in a drip, staggered the tests and had Prednisolone on standby to treat this with.
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  89. Despite the fact that they were paid volunteers, the clinical trials company had a duty of care to them. At the time this work was done there existed protocols for the administration of monoclonal antibodies, that the trials company did not follow therefore they were negligent.
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  90. Thing is the testing company did not follow the existing protocols for the administration of monoclonals, just because they got people to sign a waiver it does not mean that they do not have a legal duty of care to follow safe and established procedures.
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  91. It still does not absolve the investigators from taking reasonable steps to safeguard their guinea pigs, in UK law they still have a duty of care. The company responsible for this fiasco gave generous out of court settlements. If this had come to court, it would have been made clear that protocols for existing clinical trials monoclonals are that the drug should be diluted in about a litre IV and infused slowly over an hour. Furthermore, prednisolone and adrenaline should be on standby in case of adverse reactions. Also when giving a drug for the first time, a staggered administration means that any problems can be anticipated and addressed. It would have been extremely likely that if this was put before a court, they would have been found guilty of gross negligence.
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  92. The first tests are done on healthy volunteers to establish toxicity, in the absence of symptoms that might be caused by the disease rather than the drug.
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  93. People who are altruistic, people who have lost loved ones to cancer etc, people who are desperate for money
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  94. Lots of people take these risks including a good number of scientists, to improve the lives of the many.
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  95. Drugs start off being tested chemically, they then move on to testing in tissue cultures, the law says that you then have to test in animals and usually they try to establish a dose per kilogram measure using rats or mice before moving on to primates.
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  96. This is a drug trial, which is mandatory, to bring a product to market, not something contagious.
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  97. To get any novel drug ie not a herbal product to market in the UK, USA and Europe it is mandatory to have drug trials not just in animals, but also in humans too.
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  98. To differentiate the effects of the drug on the human body from the effects of the disease that you are hoping to treat. Later in clinical trials, it would have been to treat sufferers.
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  99. This is the UK where it is nigh on impossible to get handguns and difficult to get shotguns even. To be licensed the police interview you and want to know what you want a gun for and whether you have a proper locked gun cabinet and your doctor is also contacted to ensure that you are sane.
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  100. OK, they have to check that the drug does not cause side effects, if you gave the drug straight to cancer patients then it might be difficult to differentiate the side effects of the drug from natural disease progression that would have occurred without the administration of the drug.
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  101.  @R3cuzican  You think that because the people have cancer and are already weakened, that the drug may cause a problem in those patients that it would not cause in a healthy patient? That is a valid point and of course it is entirely the case that, that could happen. This is the reason that we have clinical trials. The next stage in clinical trials is that the drug is often tested in a population that has the disease, but are having problems with the standard treatment. Either the normal treatment is no longer effective against the disease OR the normal treatment is giving potentially life threatening side effects in itself. So the experimental drug has a real potential benefit over and above the standard regime. Or the other circumstance is where the person has been determined to be terminally ill and is drinking in last chance saloon. If the drug is judged to be efficacious in those groups it then passes to a double blind test. In this the patients are randomly assigned the standard treatment or the trial drug. At the half way point in the trial they change drugs to the other drug and at the end of the trial the results are analysed. During the whole period, death rates between the groups are continuously monitored and if there was a problem then the trial would be stopped early and the groups unmasked so that the best treatment could be administered. It typically takes between 8 and 12 years to get a drug from the lab bench and into general use.
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  102. Wow I cloned the cell line that makes that drug from a b7g2b genetic switch back. Hope your arthritis/crohn's disease is responding well?
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  103. People here do not always have a great choice. If you are unemployed and debts build up, you'd most probably do anything. At least it is legal.
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  104. Sorry, but it is extremely difficult to leave someone who is abusive, not because you love them, but because you are terrified what they will do if you leave.
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  105. Hope that was a joke? The drug is a monoclonal antibody not a virus.
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  106. Go back and ask what you were given, if they refuse, start to quote informed consent laws.
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  107. With these drugs they are targetted to a particular epitope associated with the disease, the purpose of what they were doing was to elucidate any side effects of the drug.
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  108. I used to work making clinical trials drugs. The reality is that a lot of things that would have happened in series in a normal drug trial have happened in parallel in this trial. So usually, there are chemical tests in a lab, then a round of meetings with investors and ethics committees and if all is well, then there are tests in tissue culture on isolated cells. If a drug passes this there will be more rounds of meetings with ethics and investors and then the drug goes into rats or mice. These stage have just been run at the same time and the usual round of endless meetings and funding problems have been circumvented. Nothing is 100% safe, that is a fact, there are just degrees of safety with anything.
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  109.  @MsTinkerbelle87  This is the thing, most people understand how vaccines work and will go and have the vaccine because they realise that having the vaccine will produce less side effects than catching COVID. The problem is that vaccines are not 100% effective, some people do not mount a sufficient immune response to the vaccine due to a poor immune system. If you add that to the number of people that are refusing the vaccine, then there is the potential for this to rumble on for a number of years; the problem with that being that the more it is passed around the more opportunity there is for a mutant strain to arise that is so different from the original strain that the vaccine is ineffective against it.
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  110. Usually, blood samples would be taken as part of the investigation of the drug.
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  111. Animal tests before human tests are mandated by the Geneva convention
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  112. No, even in this scenario the experimenters have a duty of care to the volunteers that is enshrined in UK law. If a case like this came to court, because the drug testers did not follow well established protocols for administering monoclonal antibodies, it would be likely that they would be found guilty of gross negligence. I was involved in the development of CAMPATH.
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  113. Clinical trials drugs are initially given to healthy people so that its actions can be differentiated from the disease it is being used to treat.
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  114. Because the Geneva convention forbids it, remember the Nazis?
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  115. There was an out of court settlement for in excess of £2 million, as the testing company still had a duty of care to its guinea pigs. There were established protocols for administering monoclonal antibodies. I was involved with the development of CAMPATH, this drug came in a 5-10ml format which was diluted into a litre of isotonic intravenous drip. It was infused at a fairly slow rate, so if problems arose, you could stop infusing the drug and by extension limit the damage. It was also wise to have prednisolone and adrenaline on standby , in case of serious reactions. Where you are trying out a drug for the first time, it also would have made sense to leave at least 30 minutes between administering doses to individual volunteers. None of these precautions were taken in the trial. Therefore had the matter come before a court of law the victims would have had a good case for negligence.
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  116.  @shielamariehankinson3824  Well to be quiet honest if there are no approved drugs left then all anyone is left with are the experimental ones. There was one young patient called Nicola Coles that we treated, she had extreme vasculitis and she was on the brink of death, the doctors did not think that she would survive. This was '92 or '93, her parents were offered the opportunity of taking one of our experimental drugs, they agreed and the drug kept her alive. It did eventually stop working for her, but it bought her condition under control and bought her time. As a result, she had an extra 25+ years of life. If you put Prof John Isaacs in the youtube search box you will be able to hear some of the story of her treatment from her doctor's viewpoint.
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  117. People who are abusive are incredibly manipulative. To escape my ex, I had to give up my career, move 126 miles away and cut contact with all my friends. I am not on the electoral roll and even my doctor does not have my correct address. When my ex was arrested for attacking wife number 2, the police were so worried that they could not locate me, they contacted my parents. My ex was on remand in prison for 3 weeks, when wife 2 rescinded her statement and we believe that she fled the country.
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  118. No one would have known who received the placebo/saline injection until the others showed an adverse reaction, but the black guy didn't because he got the placebo.
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  119. Others may be too traumatised to speak or may have signed non-disclosure agreements in return for out of court settlements. This is what big business does in response to such worries that nefarious practices might be revealed
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  120. Venables has clearly not changed and should be locked up for life. The other sounds rehabilitated. Should have been given a life sentence and parole should mean that if they are in any more serious trouble like Venables, then the rest of the sentence should be imposed.
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  121. Out of court settlements in excess of £2 million
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  122. For monoclonal antibodies which is the class of drugs that this fell into, there are established protocols that the clinic failed to follow. So they should have diluted the drug in 500ml of IV fluid and infused it slowly over an hour or so. That way if a problem starts to show then you can stop the infusion and treat the symptoms and the person has not received the whole dose. Cytokine storms, such as the ones described here are a known risk for this category of drug and for this reason, you really need to have an anti-inflammatory steroid called Prednisolone on standby to treat this sort of reaction.
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  123. In the UK donors are not paid and a proportion of the blood is fractionated and sold, just the same.
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  124. They don't use women because our lifetime supply of ova is preformed at birth and it would be unethical to damage them, men, however, make sperm continuously, so not such an issue
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  125.  @aftaflash  To elucidate that any side effects are caused by the drug and not disease progression.
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  126. In the UK a protocol is agreed with an ethics committee to keep people safe, I suspect that this was not followed.
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  127. The effect of giving a supposed medicine has to be discounted so that the results can be confirmed as a real effect.
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  128. The problem is that until recently, the courts allowed perpetrators to have unsupervised access to their children and then the abuser would use that as a pretext to continue the abuse. That is what happened in my divorce ten years ago. My ex had been abusive and I called the police after he tried to run me over, I was only slightly injured and the police did not record it as domestic violence, but as a road traffic accident. During a fact-finding hearing, the Judge described my evidence as an exercise in hyperbole and granted my ex unsupervised access. I told my solicitor about what was going on during the handovers and said that I intended to go to the police about it. He told me not to, as he said that the particular judge would take a dim view and see it as trying to frustrate his orders and as such I could be held in contempt of court and lose residency. He told me just to try to sell up and move as quickly as possible. I had no choice but to take the first offer on my house and go. My ex took it back to court, saying that I was frustrating contact by moving. This time I represented myself, as I knew if needs be I could plead ignorance on the finer points of the law and not being a lawyer, I stood a good chance of getting away with it. The defence that I used was that my ex was being abusive at handovers in front of my son and that moving meant that my parents could handle the handovers thereby lessening the chance of our son seeing this sort of conflict and being distressed by it. The opposition claimed that I was lying, so I proffered video evidence, they immediately tried to stop this being shown by saying that my ex had not consented to the handovers being filmed. I came back with the fact that it was filmed on property that solely belonged to me and that they would show whether or not my evidence was true or fictitious. They came back with some legal argument and I managed to counter that in cases involving children that the overriding concern should be the safety and the welfare of the child. That did it, the footage was viewed and contact was bought to an end. Given the amount of damage this relationship has done to my own life, it does not take much imagination to see that when children are bought up with this as their relationship model this is what they take into life as what a relationship should look like.
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  129. Should add ex went on to marry again and was violent in that relationship too. The police contacted me and told me. He spent 3 weeks on remand in prison over one Christmas KARMA
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  130.  @russellbiggs9622  At least you had 8 years without seeing violence. The problem is that it is so difficult to get away from these types. In the end, I moved 126 miles away, gave up my career and cut all contact with all my friends. I am not on the electoral roll and cannot vote or have a credit card and I am not identifiable on social media either, even my own doctor does not know my real address. When my ex attacked wife number 2, the police could not locate me and had to contact my parents, because they thought that something worse had happened to me. The police were not too surprised at the disappearing act and said that they thought he was really dangerous. The problem with a disappearing act is that it takes time and guts to arrange and you have to be prepared to break the law to disappear ie not on the electoral roll and not your real address on driving license etc. Most women are so downtrodden that they lack any sort of plan, whereas I was determined to get away.
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  131. Monoclonal antibodies provoke an immune response which can go nuts and become a cytokine storm. The drug should have been diluted in a litre of buffered saline and infused slowly over an hour with prednisolone on standby to deal with any adverse reaction.
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  132. You have to test new drugs on patients not suffering from the disease to differentiate between symptoms caused by the disease and side effects of the drug.
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  133. By this stage protocols existed for the administration of monoclonal antibodies that were a long way past the stage in trials that this drug was. First mistake, when you first give the drug it needs to be diluted in a drip of half to a litre and you SLOWLY infuse this into the patient. If something goes wrong you can stop the infusion, so the patient receives a minimal dose. Second mistake, they should have had an anti inflammatory steroid called Prednisolone on standby in case of this sort of reaction.
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  134. Not enough testing done? It takes between 8 and 12 years for a new drug to go from lab bench, through all the clinical trials to your doctor's prescribing pad and the vast majority of them do not make it that far.
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  135. First of all, when the heart is no longer beating the blood coagulates really quickly and so it is no good by the time it is removed during embalming. When you take blood for other purposes then either heparin is added to keep it from clotting or the collection is made into a sterile container with sterile glass beads in it, you then swirl the container until a clot forms around the beads.
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  136. Drugs have to be tested on people without the disease first to differentiate the drug's effects from the effects of the disease.
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  137. Sadly the Geneva convention means that all medicines must be tested in animals prior to human trials. It is not the intention to hurt anyone, merely to prove safety as one of the hurdles in getting a new drug to market
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  138. Not the way that monoclonal antibodies work. They only latch on to certain epitopes that are unique to cancer. The problem was caused by the bodies immune reaction to the drug as an unrecognised protein.
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  139. Because you want to elucidate the effects of the drug as opposed to disease progression.
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  140. These drugs are not illegal, they are clinical trials drugs
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  141. The Geneva Convention mandates that experimental drugs are tested in animals before humans, this is not down to the scientists but down to the law. Regardless of the fact that the guys were paid, the clinical trials company had a duty of care to them. They failed in that they failed to follow pre-existing protocols for the administration of monoclonal antibodies. The correct procedure is to dilute the drug in a litre of buffered saline and infuse the dose intravenously over the period of an hour. If someone becomes ill the infusion can be stopped and hopefully the adverse effects are dose dependent. They should also have had prednisolone on standby, as this mitigates the predictable cytokine storm.
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  142.  @juhpeq  No the reality is that monoclonal antibodies are developed to latch on to a molecular combination on the exterior of the cancer cell, the combination that is chosen is UNIQUE to that cancer cell so it provides a targeted response. The problem comes because the drug itself is quite a big protein and the body 'sees' it as being foreign to the body and not 'belonging', this means the body launches its immune system into action, the result is the sort of cytokine storm that was seen in this instance. This is a known side effect of this class of drugs and existing protocols say that you should have an anti-inflammatory steroid called Prednisolone on standby to knock back any reaction to a safe level.
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  143. That it was effective at a lower dosage or that the reaction could be controlled with anti inflammatories?
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  144. There were existing protocols. I worked on CAMPATH and that was diluted in isotonic PBS and infused slowly with prednisolone and adrenaline on stand by in case of serious reactions. The trials were run negligently.
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  145. Yes, it most definitely is.
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  146. Many clinical trials drugs are tried on tissue cell cultures before being tested on first animals and then humans. But you can not replicate the effects on whole organ systems in that way.
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  147. I bet Prednisolone would have done the job.
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  148. It does not matter what religion you are, to beat someone who is weaker than yourself is wrong. If you are unhappy with your spouse then it is time to either get counselling or leave.
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  149. Unlikely that anyone will be jailed, volunteers probably paid off by insurance in exchange for signing a non disclosure agreement.
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  150. These people had a case because the company still has a duty of care to carry out the trial with a degree of care to the participants. In this case, there existed the knowledge that monoclonal antibody drugs can provoke cytokine storms and that to avoid that there were well established procedures, that the clinical trials company failed to follow. For this reason, they could potentially be found negligent in a court of law.
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  151. At least he was doing something good for humanity.
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  152. Robert Thompson appears to have been successfully rehabilitated, but Jon Venables has been in trouble twice more since release.
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  153.  @tammyhuennerkopf9065  Drugs are tested chemically and if they pass, they go on to be tested in human cell cultures, but that is not the same thing as a whole-body system. They are then tested in animals to try and get an indication of toxicity, side effects and effective dose range, this is to try and make it as safe as possible before it goes into humans. To be fair the test company was negligent, they failed to follow existing protocols for the administration of monoclonal antibodies, which would have negated many of the problems that arose with this trial. The reality is: how many times do you hear of a trial going wrong? Almost never, because usually, we have a good idea as to the drugs safety and likely effects due to prior experimentation in animals.
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  154. Not unusual to find that drug researchers do exactly that. This drug was passed from the manufacturer to a contract company that tests drugs. At this time there were established protocols for testing monoclonal antibodies. The usual way to administer this class of drugs is to dilute it into a drip of phosphate buffered saline and to infuse slowly over a period of around an hour. If the patient shows an adverse reaction the infusion can be paused so that the dose that they receive is less. Cytokine storms are a known side effect of this class of drugs and for that reason, the researchers should have had an anti-inflammatory steroid called Prednisolone on standby and resus facilities on hand.
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