drug companies could be forced to publish secret research into how medicines are made to reveal...

8/22/2019 Drug Companies Could Be Forced to Publish Secret Research Into How Medicines Are Made to Reveal 'Hidden' Sid

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Drug companies could be forced to publish

secret research to stop them hidingdangerous and unknown side-effects

Under new European laws, firms would have to share results of clinical trials

These could then be analysed by independent scientistsFirms currently only release a small amount of research dataMove could also highlight if patients and customers have been fooled byplacebos or drugs that have not been scientifically proven to work

By Mario Ledwith

PUBLISHED:12:06, 22 July 2013 | UPDATED: 12:07, 22 July 2013

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Pharmaceutical companies could be forced to publish secret research into how drugs are created undernew European laws, potentially revealing information about dangerous and unknown side-effects.

The rules would mean that some of the worlds most powerful drugs companies would have to share theresults of clinical trials which could then be analysed by independent scientists.

Experts said that the move could also highlight if patients and customers have been fooled by placebosor drugs that have not been scientifically proven to work.

Drugs companies currently only release a small amount of their research data from clinical trials, withcritics claiming that negative results are only half as likely to be published.
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The proposed rules w ould mean that some of the w orld's m ost powerful drugs

companies w ould have to share the results of clinical trials w hich could then be

analysed by independent scientists

But the disclosure rules being drawn up by the European Medicines Agency, an EU body, have beenmet with resistance from pharmaceutical companies.

They claim that some of their information might be misinterpreted, potentially sparking a significanthealth scare around the use of a particular the drug.

In the last three years, 26 drugs companies have racked up fines of more than 7billion for actingdishonestly.

Britains largest pharmaceutical company GlaxoSmithKline announced earlier this year that it wouldsupport a move for such legislation by publishing the results of all its clinical trials.

The move followed fierce criticism of the company after it was given a 1.9billion fine in the US in 2012,in part for withholding safety data about Avandria, its best-selling diabetes drug.

News of law comes as a leaked message from the head of a leading pharmaceutical industry body tocompany bosses revealed that patient groups would be used to try to block amendments to the clinicaltrials directive.

The email was sent by European Federation of Pharmaceutical Industries and Associations directorgeneral Richard Bergstrm to the directors and legal departments at companies including Pfizer andGlaxoSmithKline.

In the email, seen by The Guardian, he says that patient groups will be mobilised to express concernsabout the risk to public health by non-scientific re-use of data.


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Drug companies curre ntly only re lease a small amount of their res earch data from

clinical trials, with critics claiming that negative results are only half as likely to be

published

But campaigners said that the groups which are often funded by companies are a front for thepharmaceutical industry.

Tim Reed, from campaign grouop Health Action International, said: Its incredibly ironic that this is atransparency initiative and weve now got clear indications that the pharmaceutical industry is ready touse patient organisations to fight their corner.

He told the Guardian: It underlines the fact that patient groups who are in the pay of the pharmaceuticalindustry will go into battle for them. Theres a hidden agenda here.

Patient groups get traction because they are assumed to represent the voice of the suffering. Butindustry uses them to say were not going to get innovative medicines if the industry is deterred frominvesting by having to be transparent about their clinical trials.

The EFPIA said: Knowing that some people want all data to be made available to everyone, EFPIA isengaging with stakeholders to share concerns with harmful re-use of data.

We will engage not only with patient groups, but also with the scientific community.

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Unknown meaning that they are unknown to the public. They should releas e all information on the drug including ALL

side affects. - canadguy1982 , Windsor, Canada, 23/7/2013 17:13*******That would be "Unpublished or Unreported" side

effects. If something is "unknown" it is exactly that. One person knows about any side effects, then it becomes

"unreported".

- Patrick, Belfast, 23/7/2013 18:33

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You seriously think these firms will publis h data damaging to their wealth prospects? Think again. They'll sign up

publicly and apparently enthusias tically to this, but behind the scenes they'll do anything they can to avoid complying. I

have ins ide knowledge on how they operate.

- peterbj7, Oxford, 23/7/2013 17:23


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Unknown meaning that they are unknown to the public. They should releas e all information on the drug including ALL

side affects.
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- canadguy1982, Windsor, Canada, 23/7/2013 17:13


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To talk about the multiple sclerosis iss ues, as I worked on MS 8 years ago. MS targets the brain and you need to develop

a medicine that passes the blood-brain barrier. As a result of this, and also because sometimes doctors diagnose MS

when it could actually be a virus in the brain, we could not ascertain whether our medicine had altered the blood-brain

barrier to the extent that it permitted viruses to enter, or not. We had to cancel all the phase III clinical trials that we wereperforming and the cases were analysed in detail before decisions were made as to whether we would continue the

trials, as we had to figure out whether it was viable for us to use this medicine in our portfolio. As I said previously, we

don't have 'magic bullets' that just target your one disease, and this is what leads to s ide effects. When more population

numbers are exposed, that is when we see the s ide effects. When we see them, we take immediate, responsible action.

Benefit vs. risk is maintained.

- Mother_of_Diohandi, London, 23/7/2013 16:59

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@Eric_von_Sniff, Yes, Eric, there may be certain drugs that have not had all of their s ide effects publ ished. However,

whenever we submit clinical trial results, by law we have to lis t absolutely everything that is witnessed, from Phase I ti

Phase III trials, and not only that, but we are supposed to perform Phas e IV trials around the time of marketing and pos t-

marketing, to ensure that we can get a bigger population with all of the side effects that can be witness ed. Phase I trials

are controlled and do not have that many patients, likewise for Phase II, which only increases the population by a

relatively sm all amount. Phase III is suppos ed to be designed to get hold of information from as many patients as

possible. There may be patients that are not express ing the s ide effects in that population, and you can only really know

all of the side effects when Phase IV trials are completed and physicians are completing the crucial 'yellow card' for

reporting this to the regulatory bodies.



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In the US they regularly show drug commercials on tv and the s ide effects often outweigh the benefits of taking the drugs

in the first place. They show the benefits of the drug and then at the end of the comm ercial rattle off all of the side effects

and quite hones tly they are scary! Im not sure why this should be any different in Europe mos t the of the drugs are

avaliable world wide so if you have travelled to the US you will have seen these comm ercials

- Colette, Toronto, Canada, 23/7/2013 16:36


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I was once put on pills which made my life an absolute misery. The doctors told me I was imagining these 'side effects'.

Then I took to the internet and found whole webgroups of people with the same problems. I also discovered that my

problems were "a common but unpublicised side-effect" of the medication. I would never have taken them if I'd been told

the truth in advance, but clearly not even my doctors knew.

- Just Dona, Metropolis, Uni ted Kingdom, 23/7/2013 16:26


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Side affects are the affects the use of this word "SIDE" is a method to mis lead.

- Dredd, Hampshire, United Kingdom, 23/7/2013 14:36

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Further information can be obtained at Sense about Science on Twitter, a charity that equips people to make sens e of

science and evidence.

- Blank, Ruthin, United Kingdom, 23/7/2013 14:18


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Yeah right and pigs can fly......no way will those huge corporations ever disclose false trials and hidden data, they will just

threaten to treble their drug prices and that will be the las t you wil l hear of it....too little to late

- GWhizz, Royston, 23/7/2013 13:20


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Well I don't know about you but I'm sure as hell not going to hold my breath!

- J W, Reigate, United Kingdom, 23/7/2013 13:04


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Drug companies concentrate on making drugs that control not cure that way they hook people for li fe. Reading the side

effects currently shown on some drugs is enough to put you off taking them.

- The Master, Gillingham Dorset, 23/7/2013 11:58


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How can you hide an "Unknown" s ide effect? Would you not have to know about it first?

- Patrick, Belfast, 23/7/2013 11:14


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I really wish that I could believe this will actually happen, but the pharmaceutical companies will be fighting this to the

bitter end! It's a real worry when companies that are profiting from our health and well-being are al lowed to withholdcrucial research information with no problems. There really needs to be more independent evaluations and testing by

the medical/pharmaceutical community.

- lulluh, Dorset, United Kingdom, 23/7/2013 10:16


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Independent? Consul tant? Oxymoron?

- Sandyant, Tain, United Kingdom, 23/7/2013 7:11


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How is a s ide effect dangerous, or even a s ide effect, if it is unknown? - Robert , Atlanta ---------------------------------------------

------------------- Why don't you apply for one of those clinical trials for new drugs advertised on TV? I understand they pay

pretty well and you get travel and accommodation paid. The downside is you get to be the first to find out the s ide effects

which the drug companies can then keep secret.

- Grasshopper Farmer, Sandburrville, 23/7/2013 3:36


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How is a side effect dangerous, or even a s ide effect, if it is unknown? - Robert , Atlanta Honestly, some people are s o

dumb I am amazed they ever learned to breath. They are unknown to the public - not to the pharmaceutical companies.

The pharmaceutical companies know about the side effects....so they are not unknown to them. The public do not know

about the side effects because the pharmaceutical companies do not publish them,,,so they are unknown to the public -

hence the term "unknown side effects". GET IT NOW??? - Steve, winchester, United Kingdom, 22/7/2013 18:14------------

Actually your WRONG! Sometimes companies don't know what can happen until the drug goes 'into the wild', AKA the

general population. There are so many genetic variations in the human a drug may be fine for 99.9% but a genetic

variation may make the drug unusable for some individuals. GET IT KNOW?????

- Monicle, Up North, United Kingdom, 23/7/2013 3:30


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What ? How can they publish som ething that was unknown, I agree that they should publish all that is known. About time

the DM edited the headlines before publishing, just to get som e inpact

- Roy Falconer, singapore, 23/7/2013 2:52


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What ? How can they publish som ething that was unknown, I agree that they should publish all that is known. About time

the DM edited the headlines before publishing, just to get som e inpact

- Roy Falconer, singapore, 23/7/2013 2:52


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@Mother_of_Diohandi, I can assure you that not ALL side effects are made public. Vioxx, Propecia, and Accutane are just

three among the many hundreds/thousands of drugs with carefully worded and/or completley omitted warning details.

Therefore, doctors and patients cannot make informed decisions with regards to using such drugs.

- Eric Von Sniff, No mans land, United Kingdom, 23/7/2013 2:51


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There are not many good laws forced upon us by EU, but this one sounds like an exception.

- PeaceToAllGoodPeople , Brighton UK, 23/7/2013 2:50


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I was recently prescribed one of the statins. On the enclosed leaflet the poss ible s ide effects ran to 16 column inches.

That's only the ones they tell you about.
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- BritVic, London, 23/7/2013 2:50


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And who is going to force this publication? Not going to happen is it.

- TicToc, London, 23/7/2013 2:50


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About time too !

- ray g, Nottingham, 23/7/2013 2:50


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There are not many good laws forced upon us by EU, but this one sounds like an exception.

- PeaceToAllGoodPeople , Brighton UK, 23/7/2013 2:50


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It's all about profits and death - our death. I have a doctor who answers my fears about certain side effects of a drug by

offering to prescribe another drug to counter those side effects. The doctors' surgeries I have visited over the las t sixty

years are always full of freebies from Big Pharma. And they take 'incentives' to pres cribe certain drugs over others. I jus t

wish I wasn't diabetic. Oh, by the way, Statins nearly finished me off. I stopped taking them despite the barrage of

protests from the doctor who s till thought the benefits outweighed the s ide effects!!!!!!!!!!!!!!!!!!!! He wasn't lis tening. Noneof them do anymore. He was getting paid for every patient he prescribes them to.

- Big Nige, Up North, United Kingdom, 23/7/2013 2:49


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Having worked in the industry.... yes, i t is for profit. If there is a rare diseas e, they do not develop medicines to tackle it,

e.g. Lorenzo's oil being formulated by individuals . As a rule, we have to report all of the results and hand them into the

regulatory authorities. Unless a drug surpas ses what is al ready on the market, it will not ever reach the market. Side

effects are mentioned in all patient information leaflets. We also focus more on where the disease is prevalent ratherthan less so. As for cancer, all that drugs are managing to do is to improve the quality of life and al low survival for a little

longer. There s imply is no 'magic bul let' yet. But we continue to try and find cures. So you can cast your negative thoughts

about our industry, but when your loved one falls ill, you will appreciate our work. Yes, al l drugs have s ide effects; these

are molecules that are not normal ly in your body. Benefits must outweigh risks, as your doctor well knows.



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Steve is spot on. The profit is to be found in the treatment of illness, not the curing of it.

- danielle, California, United States, 22/7/2013 22:26


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9/14

This is actually VERY important for most ordinary people. Why isn't it the main headline?

- Moomin_mamma, Durham, United Kingdom, 22/7/2013 22:24


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And when they have got Pharma to release the research that they don't want us to see they could then turn thei r attention

to the biotech companies that withhold research on GM crops, even after being dragged through the courts for over 15

years they still won't release the research.

- debbie, leics, United Kingdom, 22/7/2013 22:07


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Omeprazole and lanzoprazole, watch your testosterone go byebye.

- ks, Ippy, 22/7/2013 21:11


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FROM personal experience in the las t year, I will not take any drug now, until i know from people who have used it, what

the side effects are. To put it mildly, I felt like death from the combination of drugs I was given. When I stopped, i was told

you must keep taking them, even though they knew what I was suffering. Suffice to say: I stopped them all and felt much

better after!

- rapier, london, 22/7/2013 21:08


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no one would ever take another pill if we knew what was in them...we are the experiment,,,,,,,

- winstonsmith, somewhere near, United Kingdom, 22/7/2013 20:27


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I grant that they do a lot of research which is costly but once again the profits come before integrity. It's disgusting. I don't

know how the researchers, chemists, biochemists etc can l ive with themselves. - T00ts , glos, United Kingdom

What they are actually doing is typically trying to find the active product of s omething that works in the natural world (like a

plant for example) so they can patent it and make their own. Pharmaceutical companies are in i t for the money - never

forget that. And once you have that fact emblazoned on your mind, remember that there is no profit in curing something,

but there is in treating it. That should explain a lot to you.

- Steve, winchester, United Kingdom, 22/7/2013 20:24


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They sound as irrespons ible than people who manufacture illegal drugs. More so in fact. Apart from the pma people.

- The Right World, Bristol, Uk, 22/7/2013 20:21

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10/14

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MANY MS drugs have killed and caused PML many are involved in and accountable to. 100s of thousands are part of in

the UK. Many of the MS drugs have been prom oted by so many its s ick to the core . This all needs to be scrutinised and

whos part of it all too

- Lynnie, LEICESTER, United Kingdom, 22/7/2013 20:18


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This is a HUGE problem in America! When combined with the secrecy involved regarding the ingredients in our food

products (GMO, etc...) it is no wonder our health is on a steady decline! Governments of the people, for the people?!

LMAO!

- blue bayou, bayou state, 22/7/2013 20:11


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ob its ok its a euro law s o we wont have anything to do with it. That'll please Daves mates

-Adie, Prestatyn, 22/7/2013 20:10


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This should be mandatory?

- Donald Swank, The Isle Of Oh, 22/7/2013 19:49


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I'd rather big pharmaceuticals were forced to publish details of all the potential cancer cures they have rubbished, simply

because they are cheap and/or unable to patent. DCA and THC for example

- Santi-shi, Sarisbury Green, United Kingdom, 22/7/2013 18:38


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What do you mean the 'could be forced'? It is dispicable that these companies have been al lowed, even encouraged, to

put drugs on the market for huge prices without proper trials and without total hones ty about all the s ide effects

discovered and suspected. I grant that they do a lot of research which is costly but once again the profits come before

integrity. It's disgusting. I don't know how the researchers, chemis ts, biochemists etc can live with themselves.

- T00ts, glos, United Kingdom, 22/7/2013 18:35


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its dis gusting that they aren't letting us have all the information so we can make a fully informed decis ion about what weput in our bodies. my dr has failed to tell me about a little known and unpublicised side effect of "harmless" cream for

eczema - just seeing it for myself now.

- rae, Mk, 22/7/2013 18:18

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11/14

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How is a side effect dangerous, or even a side effect, if it is unknown? - Rob ert , Atlanta

Honestly, some people are so dumb I am amazed they ever learned to breath. They are unknown to the public - not to the

pharmaceutical companies . The pharmaceutical companies know about the side effects....so they are not unknown to

them. The public do not know about the side effects because the pharmaceutical companies do not publish them,,,so

they are unknown to the public - hence the term "unknown side effects". GET IT NOW???

- Steve, winchester, United Kingdom, 22/7/2013 18:14


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Too many people are under the impres sion that drugs must be perfect or that a side affects can be completely

unavoidable and anything less is a "scandal", no doubt fanned by a media that loves panic. Sorry, but drugs and the

human body don't work that way. Side affects are inevitable. Its not nice and would be good to avoid them but its a fact. I

would rather take a drug and live with a side affect than wait around for a dream solution that may not come before I die.

- Benny, London, 22/7/2013 18:10


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How can you publish an UNKNOWN side effect??

- Roshea, Devon, 22/7/2013 17:55


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How is a s ide effect dangerous, or even a s ide effect, if it is unknown? - Robert , Atlanta, 22/7/2013 17:34 If it is serious it

can cripple or kill you. Do you not understand the meaning of dangerous? a few months ago a group of human guinea

pigs died of multiple organ failure. The people adminis tering the drug gave all of the volunteers the drug at the same

time, ins tead of waiting to see if there would be a reaction.

- The thinker, Gotham, 22/7/2013 17:52


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COULD -------> SHOULD

- asitis, realworld, United Kingdom, 22/7/2013 17:39


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How is a side effect dangerous, or even a s ide effect, if it is unknown?

- Robert, Atlanta, 22/7/2013 17:34


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This will never happen. Big Pharma holds too much power and political clout. If this were the case no one would go near

statins!
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12/14

- passthebutterplease, Shrewsbury, 22/7/2013 17:29


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How does one know everything has been released for scrutiny if its secret?

- Question, SouthEast, 22/7/2013 16:57


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The pharma companies should update the information available on the poss ible or reported long term side effects of a

particular drug. This way current patients would be able to see i f the long term effects would outweigh the relief they may

get from that drug and allow them to make more informed choices about alternative treatments.

- Jacob Thorke, Westbury, United Kingdom , 22/7/2013 16:48


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n the last three years, 26 drugs companies have racked up fines of more than 7billion for acting dishonestly. Britains

largest pharmaceutical company GlaxoSmithKline announced earlier this year that it would support a move for such

legislation by publishing the results of all its clinical trials.>>>>>>>>>>>>>ONE OF THE BIGGEST ANIMAL

EXPERIMENTAL AGENTS FOR THE WHOLE MEDICAL INDUSTRY..................HOW MUCH DID TONY BLAIR GET FOR

ALLOWING THEM ANOTHER FEW THOUSAND MORE ANIMALS PA?? PLEASE HAVE A LOOK AT HOW CAMORON IS

BEING FUNDED BY THIS EVIL CORPORATION......................WE ALL NEED TO BE SHOCKED TO CHANGE THIS LAW!

- strangerthanfiction, London, 22/7/2013 16:23


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Pharma companies will be fine whatever happens, while people remain deluded that solutions can be found with pills.

Poor Mel Smith and his nurofen habit ... I had an 8-a-day habit with a back injury, but they gave me s tomach cramps

within five minutes of eating after two years. Further, i was never recommended the generic drug ibuprofen - one

charmles s doctor even told me to buy the more expensive nurofen tablets "the pink ones". It all makes leeches look quite

sensible. But it was yoga and cannabis that sorted my health problems out!

- KC, Reading, 22/7/2013 16:21


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the unwanted effects aka side effects are general from either non receptor activity of the drug on other systems or a direct

effect of blocking the complete functioning of the receptors. if an action is blocked in one s ystem then it will be altered in

linked systems or systems that have identical receptor groupings that are run by the same groups of chemicals.

- John Ellis, Egremont, United Kingdom, 22/7/2013 16:14


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Data on File will remain what it is. Hidden. Until NHS Consultant stop taking Retainers from Big Pharma and GP's get ridof their Shares, nothing is likely to change.

- Gordon Webster, Dundee, 22/7/2013 16:02

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13/14

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This should not be a could be but a should be - people before money please!

- Miss Happy, London, 22/7/2013 15:48


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I hate that term 'side effects'... It is just EFFECTS of the drug!!!!

- OricAL, Awake n fresh out of Bubblegum, United Kingdom , 22/7/2013 15:45


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Openness from big pharma? Good luck with that one.

- Mark R, COVENTRY, United Kingdom, 22/7/2013 15:39


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and much do our mps get from pharmaceutical lobbyists, there is your answer.

- chris, southampton, 22/7/2013 15:37


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and on Saturday you were all call ing homeopathy unscientific. Don't you all realise that drug companies just publish the

figures that will give them the profits. This isn't about science and s aving lives it's about making money. That's one

reason they call complementary therapies unscientific, a bit hypocritical under the circumstances.

- Carol, Leeds, 22/7/2013 14:52


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Vote UKIP to keep side effects secret.

- Grasshopper Farmer, Sandburrville, 22/7/2013 14:19


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what do you mean,could be forced,it should be law that people know what is in them not after they take them and maybe

die.money talks as usual.

- cocotkd, glasgow, United Kingdom, 22/7/2013 14:04


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Most s ide effects, including dangerous and potentially fatal ones from drugs/vaccines only become apparent after

licensing and wider use. If these were known before, the drug/vaccine would have to be recalled. This is because i t is not

cost effective to fully evaluate the product due to the length of time involved before profits need to be considered. The
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14/14

population are the guinea pigs for the pharmaceuticals.

- Kenai689, UK, United Kingdom, 22/7/2013 13:43


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Could be?

- Sylvie, London, United Kingdom, 22/7/2013 13:36


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