French drug trial disaster

[suzieseaside]

Tragic.

http://uk.reuters.com/article/uk-france-health-idUKKCN0UT137

There will always be unknown risks with clinical trials, but thankfully it is extremely rare for side effects to be so severe.

Without volunteers we would not have new effective medicines on the market, but for those individuals damaged it is an extremely high price to pay.

I wonder if we will learn what the cause of the damage was and whether as much as possible was done in terms of research and safety aspects before the initial trial on humans, such as the dose to administer. It seems a bit odd that others had been given the drug previously with no bad side effects, as far as I understand from the short news articles. I’m assuming that the trial on 90 people didn’t all start on January 7th although it’s not very clear. If others were tested earlier I suppose then it was something about this batch that was different, in terms of chemical constituents or dose given?

Although such problems are extremely rare in what must be 1000s of trials that go on there were problems with a trial in London in 2006.

Would you volunteer (paid or not) to take part in a clinical trial?

[cee-dee]

No, I wouldn't but years back I knew a chap who financed his collecting by taking part in such trials.

Side effects are very strange as to how they affect you. Some people take established, well-known prescribed medication without a problem. Some other poor devil suffers most unpleasant side effects.

As chance has it, they could have picked 90 people who suffered no ill effects whatsoever. The next batch of people again, on pure chance might also not suffered any problems and then.......... wallop.

Pick a few drugs at random to research and just scroll down to side effects and see the possibilities and also the warnings about "Do not take this if........"

With a trial, all the possibilities have to be worked out and without knowing the doses given on the trial it'll be difficult to work out what went wrong yet.

There's one drug I know about which is usually given in a small dose to "treat" what it was intended for but is given in a massive dose (comparatively speaking) to transgender males.

How did they find that out?

Bit late at night to get embroiled in the suject? Tomorrow?

[al**bear]

In the States they use a lot of Prisoners for these tests and of course hard up students

[mustard-tree]

Prisoners should be used here, particularly the lifers with no hope of release

The drug in France had been tested on chimps with no adverse effects, so it goes to show how futile animal testing is.

[cee-dee]

http://www.bbc.co.uk/news/world-europe-35337671

[Anonymous]

One of my daughters and her partner took part in a clinical trial last year to finance their trip to Thailand. She knows quite a few students that also do it for the extra money.

I personally wasn't happy with it at all, and was glad when my daughter had to stop half way. It was more to do with the diet she had to stick to. Loads of carbs, which she wasn't used to as she was a very healthy eater, and the carbs blocked her system up. So she had to stop the trial as it could influence the outcome I guess.

She and the other women were actually given the old meds, while the men in the trial were given the new meds. Her partner ended up with a small ulcer in his stomach. The trial was only for a week. It might not have been a problem, and it resolved itself, but still it shows the risks and side effects.

At the end of the day you don't know what the future effects are. Because you don't have any symptoms straight away, doen't mean you might not have caused harm to your body.

If people are offered a lot of money for doing the trials then there will always be takers no matter if they are being made aware of the risks or not. There will be those that will always take that risk.

Forcing people, like prisoners, is in my opinion wrong.

[Anonymous]

At the end of the day it's all about the money......................

http://www.bbc.co.uk/news/world-europe-19711026

[*.*..lola..*.*]

It's a tough one Harry because without these brave volunteers (even if they are doing it purely for the money) there would be no new life-saving drugs  

[mustard-tree]

"Forcing people, like prisoners, is in my opinion wrong."

Did they give their victims a choice?

[jd.linklater]

When my youngest son was at Manchester Uni. he told me lots of his fellow students who couldn't find work financed their living costs by doing clinical trials. I don't think it was anyone's first choice but for many there was no other option. None of them were forced to do it and none of them regarded themselves as victims when they suffered unpleasant side effects from the drugs they were trialing. The risks are explained from the outset. Obviously something has gone badly wrong with these French trials but as others have said without them we would have no drugs, we can't test everything on animals and morally we shouldn't anyway.

[right-then-petal]

One,s Died

[suzieseaside]

Yes, they have to be done and statistically the risks of severe side effects are very low.

In 2012-13, there were 638,000 volunteers in England (no mention of the rest of the UK) and the numbers increased each year from 208,000 in 2007-8.  Although 6 men suffered multi-organ failure in London in 2006 (they recovered although they were left with permanent damage to their immune system and other health problems) clinical trials seem to be viewed as pretty safe and the volunteers are well-monitored. .

However the majority appear to be people with specific illnesses who may benefit themselves from a new drug.   The number of healthy volunteers to test a new drug are, according to the article below, is about 8000-9000 each year. 

http://www.bbc.co.uk/news/health-22594635

I wasn't aware of paid clinical trials when I was a student, but I can see why it could be a good way to earn some money.  I don't think completely novel drugs are tested on women in Phase I, at least not those of child-bearing age, in case of damage to eggs or a foetus if the patient becomes pregnant. 

It seems that many volunteers do not just do it for money but out of altruism and an interest in helping to advance medical research. 

Good for them.  I wonder if the number of volunteers will drop after the disaster in France. I guess it will depend on what the investigation reveals as the cause and whether it was down to human error e.g. wrong dose given, or something about the compound that was completely unpredictable.

[Anonymous]

Did they give their victims a choice?

No most likely they didn't. Although not all who are in prison have hurt others physically.  But I understand your eye for an eye way of thinking. A lot of people would feel that way.

Still forcing someone to take a drug that they do not freely want to take falls to me under the banner of abuse.

[Anonymous]

What about the meds for animals? They will have to be tested on animals.

I'm not sure if there are easy answers to this whole issue.

I do know that many meds are pushed through the system by the pharmaceutical industry without any regard for the side effects it produces. It's all nicely pushed under the carpets so the share holders can make money.

[jd.linklater]

---

@Anonymous wrote:

What about the meds for animals? They will have to be tested on animals.

I'm not sure if there are easy answers to this whole issue.

I do know that many meds are pushed through the system by the pharmaceutical industry without any regard for the side effects it produces. It's all nicely pushed under the carpets so the share holders can make money.

---

Fair enough if animals will be the ultimate beneficiaries, but what I've never agreed with is the use and abuse of animals to test drugs for human benefit. We don't have the right to do that to other species, it's morally reprehensible.

[suzieseaside]

Such as ?  Do you know some examples?

Nearly all medicines will have some side effects for some people and not for others as we all vary in our response to medication.

If they are unpleasant for some, then they can discontinue treatment or try something else, but often the benefits outweigh minor side effects.

Herbal medicines are no better in many cases, unless they have been used by humans for a long time with no problems, because they don't go through such thorough testing. They are still pharmaceutical products.  Many do nothing at all with claims that 'they may help with ...' and some can cause damage.

[Anonymous]

Minor side effects? Sorry Suzie, I'm not talking about a headache or a funny tummy after taking some meds.

Have you not read stuff on anti-depressant for example causing people to commit suicide or even kill others in the process because it has send them loopy? Anti-depressants should do the opposite don't you think?

And what about those same pills causing people to sleep really bad, leaving them exhausted all the time, the sleep they so desperately need, sweating like pigs and not just normal sweat, anxiety sweat ; it really smells different, gaining lots of weight without eating more, making them unable to think straight, among many other things......Not very good for people suffering from depression is it....

I haven't only read about this in articles, my daughter takes them since her baby died, and to be honest I wish she never had. She is cutting down now and supporting her body with supplements and vitamins and feeling better for it......

Or what about the side effects Statins, pushed on anyone who has even only a slight problem with their cholesterol. Enough info about that on the Internet.

I took some meds for Crohn's some years back. I started to have pains in my bones and muscles and my eye sight started to deteriorated quite sudden. I didn't know the side effects at the time, but found out later that arthritis and the rest of what I was experiencing were just one of the side effects. So basically I was swapping one problem for a few more. For some that may be acceptable, but just not for me, so I stopped the meds.

Discontinuing treatment or finding a substitute is not always as easy as you make it sound. You only have to go on a health forum, as I do, and there you might find what people are dealing with and the results of the meds they take.

And indeed some might have little side effects, some don't even connect new ailments with the meds they take and just take some more meds to cover up the side effects of others and so on. Some people are on so many meds that is becomes a nightmare to find in the end what caused what.

My gran was on loads of pills before she went to live with my mum. She was like a zombie, had lost lots of weight, didn't want to eat, could hardly walk, hardly talked, etc. I looked into them all to see what was for what and found that some worked totally against each other, one was even for schizophrenia!!!!  I weaned her off all her meds and gave her vitamins and supplements while doing so to support her system. In the end she only took the occasional Ibuprofen for some back pain and she became totally back to her former self, gaining weight, a healthy appetite, walking unaided, enjoying life again. Her doctor just kept prescribing stuff without even looking at what was really the matter with her.

So maybe my trust in the medical profession isn't very high and I feel I have good reason.

There is no money in Herbal treatments for big Pharma, so research into that area is not getting the funding it might deserve. There is enough good info about if ou care to look for it though.

But I can find as much info against certain meds by the click of my mouse, same as you can find for the good they do. I can find hundreds of articles in support of alternative treatments and you will find hundreds to oppose it.  We all make different choices, as is our right.

We also have the right to be informed properly and that is something that we more often are not. There have been enough whistle blowers regarding the pharmaceutical industry, but it doesn't really hit the headlines in the papers as much as the "bad" effects of an alternative supplement......I have to ask myself "why not?"

[suzieseaside]

I don’t disagree with you. I know that there can be major side effects from some medicines for some people. I didn’t say they were always minor (individuals vary greatly) I'm just saying that IF they are minor, clinical drugs can be beneficial for many illnesses.

I am neither pro medicinal drugs nor anti herbal ones, there are potential problems with both. The danger with both types is that people often trust them too much. They might trust their GP and they may not be interested in finding out about their condition or medication. On the other hand some people (some I know here for example) actually believe that herbal means natural means harmless, which is not always true.

Yes I am aware of the tragic effects that some anti-depressants have on some people, but there are also many that benefit from them. A good doctor will first see if a patient has suicidal feelings and will tell them to come back if the medication affects their mood adversely. At some point patients have to take some responsibility and if they are experiencing worrying symptoms they need to re-visit their doctor or choose not to take the medication and look for other possible solutions, as you have done. I quite agree that it may be difficult to find an alternative treatment. If I made it sound ‘easy’ as you say, then that’s just because it was a short post.

Patients need to read the leaflets that come with medication – clinical or otherwise, and as you say there is a vast amount of information on the internet if people want to look. That doesn’t always help I know because so much is contradictory, and it’s not all reliable.

It’s not just Big Pharma, there’s Big Herba too and it’s big business these days. I’m sure there are some small companies that produce safe supplements but the large manufacturers make a fortune out of their products. Enough profit that they could fund research but no doubt they are also in it for maximum profit and can exploit regulatory loopholes where they don’t have to prove safety or efficacy. Some of them are the same companies that make pharmaceutical drugs .

Some supplements have nothing in them and the public are being swindled. Some supplement companies (probably online) are apparently run by criminals. I suspect the lack of regulation is one reason why alternative treatments make more headlines, if they do.

The bottom line is that, yes, we have a choice. We need to inform ourselves about any kind of supplements or medication, and we need to be responsible and take note of any unwanted side effects. If we don’t, no-one else can.

[cee-dee]

Looking at several medications, a similar "do not take" warning comes up with them and that warning is about taking St John's Wort as well as the medication and other warnings are about over-the-counter "herbal" remedies.

With the criticism about large Pharmaceutical companies, as with everything else it's a shame to generalise. A product may have undergone a lengthy development period along with a lengthy testing period before eventually being granted a licence and a patent. They then have to make enough money during the patent period to cover their costs and actually make a profit. As soon as it comes off patent, the product is then open to generic copies which may or may not be equally effective but cheaper. How so? They didn't have to pay for the lenghty procedures and they can use cheaper materials which go in the the manufacture of the pill/capsule ot whatever along with the actual medication.

A friend was taking a product for some time before her doctor prescribed a generic version. It nearly killed her. The generic version used Wheat flour as a filler. She's allergic to Wheat.

Yes, there are valid criticisms about some companies and their pet product(s) and one of them is Aspartame. We used to have a big "opponent" of it on here, was it Alex? I agree with his criticism because it's often included with things without being noticed being just E951. If you're interested, check out the links between aspartame, Methanol and Formaldehyde.

It's a very complicated subject and different people react differently to the same product. For some conditions there will be a preferred medication which may cause a problem (side effect) with some people. A different product (often having the same "ending" in it's name) will be fine but only slightly less effective.

[*.*..lola..*.*]

A friend was taking a product for some time before her doctor prescribed a generic version. It nearly killed her. The generic version used Wheat flour as a filler. She's allergic to Wheat.

I had a similar experience, CeeDee with Penicillin, Amoxicillin to be precise.

I've taken it for various bacterial infections over the years with no problems whatsoever then suddenly out of the blue a few years ago, I had quite a severe allergic reaction to it.

Now I have to tell doctors/dentists etc that I'm allergic to Penicillin even though I'm pretty sure I'm not, I think it was just a dodgy batch but I daren't take the risk just in case.