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?

[Anonymous]

He was not the only one CD. I have done my research on Aspartame as well. I have done research most of my life and still do to this day into alternatives to what the doctors prescribe. I'm not anti medication, I'm just for less chemicals in my body than really necessary. If you have a robust healthy body it might not be important, but I'm not so blessed, so I have to take care of what I put inside of me.

Sometimes there is no good choice and we just have to take what helps.

Regarding the "do not take if.." warnings on leaflets (whether on supplements or regular meds).

Should our GPs not know what is in the meds they prescribe and not give those that might harm us in the first place, instead waiting till something goes wrong and we end up on their chair again to solve what has gone wrong? Are our doctors not the one responsible for what they give us? Should they not inform us instead leaving it up to us to read the leaflets? They know our medical history. They should know what would work best for us and in combination with what we might already be taking for other ailments. We don't know that do we? We put our trust in them. Like my grand mother did.

And what if you can't read?

Sometimes they say it's better not to read the leaflets to avoid starting imagining the side effects. So we just have to play Russian roulette?

I was given anti-biotics by my dentist for a bad infection. It should have been on record that I have Crohn's as you have to fill in a medical form when you register. I assumed it would be ok to take. There was no leaflet with them.

Well they weren't ok. I got sick as a dog from them. Only on the last day I decided to go on the  internet to have a look, as I felt it could not be right and I was also still in pain with the infection. It said "do not take when you have Crohn's. A bit late for me by then and it took me 4 weeks to recover from it. I phoned my dentist to tell him. Next time I went they had me filling in a new medical history as they said there was no record of me having Crohn's..............Yeah right, something I would not inform them about....

The infection did not go, I could not take any normal painkillers because that would upset my system even more, so I was in agony and my Crohn's had flared big style.

But....Pure Oregano oil (needs to be 75 to 80% pure otherwise useless) did help me to get rid of the infection in my mouth in the end. It takes a bit longer and therefor I had opted for the anti-biotics, wanting a quick fix and it was for free and the oregano isn't that cheap. So you can see I'm not that anti meds.

And Suzie, yes on both sides there will be people who are only interested in profit. There are also a lot of dodgy supplement  product companies out there, I agree. That's why I do a lot of research, so I can find the best alternatives, the best companies available, the purest ingredients, looking up all the research being done on them, etc.

[cee-dee]

If you read all the leaflets before taking something, you'd never take anything.

Would you take this product if you read the following?:-

"Contact your doctor at once if you develop high blood levels of Potassium" (How would you know?)

"Contact your doctor immediately if you experience the following:

•An allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, shock, collapse, skin rask or itching.

•Severe form of skin rash with flushing, fever, blisters or ulcers.

•Severe rash involving reddening, peeling and swelling of the skin that resemble severe burns.

•Severe skin rash involving fever and swelling.

•Blood: increase in blood levels of nitrogen or urea especially in those with impaired kidney function, altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats or infections you should tell your doctor who may want you to have a blood test.

•Metabolism and nutrition: Low blood levels of sodium, changes in the levels of chemicals in the body.

•Nervous system: Lack of muscle control or co-ordination, drowsiness, dizziness, headache, clumsiness.

•Psychiatric: Tiredness, confusion

•Liver: Impaired liver function, a poisonous effect on the liver.

•Stomach and intestines: Stomach upset, inflammation of the stomach lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps, diarrhoea, feeling or being sick.

•Skin. Skin rashes including pale or Red irrecular raised patches with severe itching (hives), hair loss, excessive hair growth, itching, rash.

•Muscle and bone: Bone sorftening due to Vitamin D deficiency, leg cramps.

•Kidneys: Acute kidney failure particularly in those who already have impaired kidney function.

•Reproductive system: Enlarged breasts in men, changes in voice pitch, reduced sexual potency in men, decreased sexual ability/drive, breast tenderness, breast lumps and increased hair growth in females, irregular periods, sweating.

There, wocher think of that lot and that's only one product.

[Anonymous]

I know. And that is very scary to me CD.

And that is why I sometimes get on my soap box.........................

Here is a list of side effects of one of the Crohn's meds, Humera.

More common
Abdominal or stomach fullness
body aches or pain
cough or hoarseness
ear congestion
gas with abdominal or stomach pain
light headedness
loss of voice
lower back or side pain
muscle aches and pains
nasal congestion
pain or tenderness around the eyes or cheekbones
rapid and sometimes shallow breathing
shivering
sunken eyes
thirst
trouble sleeping
warmth on the skin
wrinkled skin

Less common

A sore on the skin of the breast that does not heal
abdominal or stomach pain
abnormal vaginal bleeding or discharge
agitation
arm, back, or jaw pain
black, tarry stools
bleeding from the gums or nose
blindness
bloating or swelling of the face, arms, hands, lower legs, or feet
blood in the stool or change in bowel habits
bloody or cloudy urine
blurred vision
broken bones
change in size, shape, or colour of an existing mole
change in skin colour
chest pain
chest tightness or heaviness
chills
clear or bloody discharge from the nipple
cold hands and feet
confusion
constipation
cough
coughing or spitting up blood
decreased urination
decreased vision
depression
difficult or frequent urination
difficulty with breathing
difficulty, burning, or painful urination
dimpling of the breast skin
dizziness
drowsiness
eye pain
fainting
fast, slow, or irregular heartbeat
fever
forgetfulness
frequent urge to urinate
general feeling of illness
hair loss
hallucinations
headache
increased thirst
inverted nipple
irregular breathing
irregular pulse
irritability
itching or rash
light coloured stools
loss of appetite
lump in the breast or under your arm
lump or swelling in the abdomen or stomach
mole that leaks fluid or bleeds
muscle cramps or spasms
nausea
new mole
night sweats
no blood pressure or pulse
noisy breathing
numbness or tingling in your arms, legs, or face
pain, redness, or swelling in the arms or legs without any injury present
pale skin
persistent non-healing sore on your skin
pink growth
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
raised, firm, or bright red patch
redness or swelling of the breast
seizures
sharp back pain just below your ribs
shiny bump on your skin
slurred speech or problems with swallowing
sneezing
sore throat
sores, ulcers, or white spots on the lips or mouth
spitting up blood
stiff neck
stopping of the heart
sudden high fever or low grade fever for months
sweating
swelling of the face, fingers, feet, or lower legs
swollen glands
swollen neck veins
tightness in the chest
tiredness
trouble breathing with activity
trouble thinking
unconsciousness
unexplained bruising or bleeding
unpleasant breath odour
unusual tiredness or weakness
unusual weight gain or loss
visual disturbances
vomiting
vomiting of blood or material that looks like coffee grounds
yellow skin or eyes

Incidence not known
Blistering, peeling, or loosening of the skin
diarrhoea
joint or muscle pain
pinpoint red spots on the skin
red skin lesions, often with a purple centre
red, irritated eyes
red, scaling, or crusted skin
unusual bleeding or bruising

Do you get it when I'm trying to find some alternatives to eleviated my symptoms? The problem is that some of those side effects are the ones you actually try to cure by taking the stuff. That makes no sense to me. So for me the search is always on for more natural healing.

But for most people needs must and all you can do is popping the pills and hope for the best.

[jd.linklater]

Aspartame has been used  as a sweetener in soft drinks since the early eighties. Its detrimental effects have been known about for many years but it is still used widely in the food and drinks industry today along with a host iof generic equivalents. No surprise that Monsanto is heavily involved in its production. This article is five years old and nothing has changed. It lists not just the side effects induced from prolonged use but also the medical conditions that can be worsened by taking it.

 http://articles.mercola.com/sites/articles/archive/2011/11/06/aspartame-most-dangerous-substance-add...

[Anonymous]

Don't get me started on Monsanto.

I'm trying to get off my soap box.................

[jd.linklater]

I should stay on the soapbox for a while, here's another one from the same company and it's 30 times sweeter than Aspartame and even more toxic.

http://articles.mercola.com/sites/articles/archive/2012/03/28/neotame-more-toxic-than-aspartame.aspx

[Anonymous]

What are you doing to me!!!!

Well people are getting wiser, becoming more aware and fighting back, with at least some results.

http://www.naturalnews.com/049477_diet_pepsi_aspartame_sucralose.html

[jd.linklater]

A glance through their recent history makes terrifying reading. It makes one wonder how such a disreputable company is still allowed to operate.

http://www.naturalnews.com/029325_Monsanto_deception.html

[jd.linklater]

Sucralose has its downside too. This has been marketed as Splenda since 1998 and again it sounds like insufficient research has been done on the effects of long term use. I think we'd all be better to stick to sugar in small amounts.

https://www.downtoearth.org/articles/2009-03/68/sucralose-dangerous-sugar-substitute

[artful_dodgings]

That's an extremely long and extensive list you have provided at post 23. Not even a Russian Roulette scenario, but that a patient is almost guaranteed to suffer at least one of those manifestations.

Mind you, it's possible to contact any one of the symptoms mentioned, through watching TV soaps.

[Anonymous]

Well that's the reason why I don't watch any of those.

[bankhaunter]

Any adverse reactions to a medication should always be reported to a doctor or pharmacist so the information can be passed on through the yellow card scheme.

https://en.wikipedia.org/wiki/Yellow_Card_Scheme

[cee-dee]

Is that for the known about side effects? Isn't it for new side effects?

The thing is, some people are taking a raft of medications and checking the side effects for several will show some similar ones so without stopping them one at a time, how would you know which one is causing the problem? Even doing that may not stop the SE as all the ones with that known SE may be causing your problem.

[bankhaunter]

They all should be reported, a patient may not know if a side effect is common or one is being watched.

The list of side effects with any medication usually gives the likelihood of it occurring, if they are not reported, that likelihood could be wrong.