Drug companies could be forced to publish secret research to stop them hiding dangerous and unknown side-effects

Under new European laws, firms would have to share results of clinical trials These could then be analysed by independent scientists Firms currently only release a small amount of research data Move could also highlight if patients and customers have been fooled by placebos 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

177 shares 64 View comments

Pharmaceutical companies could be forced to publish secret research into how drugs are created under new 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 the results 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 placebos or drugs that have not been scientifically proven to work. Drugs companies currently only release a small amount of their research data from clinical trials, with critics claiming that negative results are only half as likely to be published.

The proposed rules w ould m ean that som e of the w orld's m ost pow erful drugs com panies 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 been met with resistance from pharmaceutical companies. They claim that some of their information might be misinterpreted, potentially sparking a significant health 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 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. 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 to company bosses revealed that patient groups would be used to try to block amendments to the clinical trials directive. The email was sent by European Federation of Pharmaceutical Industries and Associations director general Richard Bergstrm to the directors and legal departments at companies including Pfizer and GlaxoSmithKline. In the email, seen by The Guardian, he says that patient groups will be mobilised to express concerns about the risk to public health by non-scientific re-use of data.

Drug com panies currently only release a sm all am ount of their research data from clinical trials, w ith critics claim ing 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 the pharmaceutical industry. Tim Reed, from campaign grouop Health Action International, said: Its incredibly ironic that this is a transparency initiative and weve now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner. He told the Guardian: It underlines the fact that patient groups who are in the pay of the pharmaceutical industry 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. But industry uses them to say were not going to get innovative medicines if the industry is deterred from investing 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 is engaging 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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Comments (64)
Newest Oldest Best rated Worst rated View newest 10 Unknown meaning that they are unknown to the public. They should release 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 Click to rate Report abuse You seriously think these firms will publish data damaging to their wealth prospects? Think again. They'll sign up publicly and apparently enthusiastically to this, but behind the scenes they'll do anything they can to avoid complying. I have inside knowledge on how they operate. - peterbj7, Oxford, 23/7/2013 17:23 Click to rate Report abuse Unknown meaning that they are unknown to the public. They should release all information on the drug including ALL side affects. Rating 3 Rating 1

- canadguy1982, Windsor, Canada, 23/7/2013 17:13 Click to rate Report abuse To talk about the multiple sclerosis issues, 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 were performing 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 side effects. When more population numbers are exposed, that is when we see the side effects. When we see them, we take immediate, responsible action. Benefit vs. risk is maintained. - Mother_of_Diohandi, London, 23/7/2013 16:59 Click to rate Report abuse @Eric_von_Sniff, Yes, Eric, there may be certain drugs that have not had all of their side effects published. However, whenever we submit clinical trial results, by law we have to list absolutely everything that is witnessed, from Phase I ti Phase III trials, and not only that, but we are supposed to perform Phase IV trials around the time of marketing and postmarketing, to ensure that we can get a bigger population with all of the side effects that can be witnessed. Phase I trials are controlled and do not have that many patients, likewise for Phase II, which only increases the population by a relatively small amount. Phase III is supposed to be designed to get hold of information from as many patients as possible. There may be patients that are not expressing the side 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. - Mother_of_Diohandi, London, 23/7/2013 16:51 Click to rate Report abuse In the US they regularly show drug commercials on tv and the side 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 commercial rattle off all of the side effects and quite honestly they are scary! Im not sure why this should be any different in Europe most the of the drugs are avaliable world wide so if you have travelled to the US you will have seen these commercials - Colette, Toronto, Canada, 23/7/2013 16:36 Click to rate Report abuse 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, United Kingdom, 23/7/2013 16:26 Click to rate Report abuse Side affects are the affects the use of this word "SIDE" is a method to mislead. - Dredd, Hampshire, United Kingdom, 23/7/2013 14:36 Click to rate Rating 4 Rating 7 Rating 2 Rating (0) Rating (0) Rating 3

Report abuse Further information can be obtained at Sense about Science on Twitter, a charity that equips people to make sense of science and evidence. - Blank, Ruthin, United Kingdom, 23/7/2013 14:18 Click to rate Report abuse 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 last you will hear of it....too little to late - GWhizz, Royston, 23/7/2013 13:20 Click to rate Report abuse 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 Click to rate Report abuse Drug companies concentrate on making drugs that control not cure that way they hook people for life. 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 Click to rate Report abuse How can you hide an "Unknown" side effect? Would you not have to know about it first? - Patrick, Belfast, 23/7/2013 11:14 Click to rate Report abuse 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 allowed to withhold crucial 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 Click to rate Report abuse Independent? Consultant? Oxymoron? - Sandyant, Tain, United Kingdom, 23/7/2013 7:11 Click to rate Report abuse Rating 12 Rating 14 Rating 2 Rating 21 Rating 10 Rating 12 Rating (0)

How is a side effect dangerous, or even a side 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 side effects which the drug companies can then keep secret. - Grasshopper Farmer, Sandburrville, 23/7/2013 3:36 Click to rate Report abuse How is a side effect dangerous, or even a side effect, if it is unknown? - Robert , 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-----------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 Click to rate Report abuse What ? How can they publish something 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 some inpact - Roy Falconer, singapore, 23/7/2013 2:52 Click to rate Report abuse What ? How can they publish something 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 some inpact - Roy Falconer, singapore, 23/7/2013 2:52 Click to rate Report abuse @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 Click to rate Report abuse 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 Click to rate Report abuse I was recently prescribed one of the statins. On the enclosed leaflet the possible side effects ran to 16 column inches. That's only the ones they tell you about. Rating 14 Rating 14 Rating 1 Rating (0) Rating 1 Rating 21

- BritVic, London, 23/7/2013 2:50 Click to rate Report abuse And who is going to force this publication? Not going to happen is it. - TicToc, London, 23/7/2013 2:50 Click to rate Report abuse About time too ! - ray g, Nottingham, 23/7/2013 2:50 Click to rate Report abuse 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 Click to rate Report abuse 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 last sixty years are always full of freebies from Big Pharma. And they take 'incentives' to prescribe certain drugs over others. I just 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 still thought the benefits outweighed the side effects!!!!!!!!!!!!!!!!!!!! He wasn't listening. None of 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 Click to rate Report abuse Having worked in the industry.... yes, it is for profit. If there is a rare disease, 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 surpasses what is already 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 rather than less so. As for cancer, all that drugs are managing to do is to improve the quality of life and allow survival for a little longer. There simply is no 'magic bullet' 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, all drugs have side effects; these are molecules that are not normally in your body. Benefits must outweigh risks, as your doctor well knows. - Mother_of_Diohandi, London, 22/7/2013 22:27 Click to rate Report abuse 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 Click to rate Report abuse Rating 20 Rating 2 Rating 6 Rating 6 Rating 6 Rating 4 Rating 10

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 Click to rate Report abuse And when they have got Pharma to release the research that they don't want us to see they could then turn their 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 Click to rate Report abuse Omeprazole and lanzoprazole, watch your testosterone go byebye. - ks, Ippy, 22/7/2013 21:11 Click to rate Report abuse FROM personal experience in the last 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 Click to rate Report abuse 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 Click to rate Report abuse I grant that they do a lot of research which is costly b ut once again the profits come b efore integrity. It's disgusting. I don't know how the researchers, chemists, b iochemists etc can live with themselves. - T00ts , glos, United Kingdom What they are actually doing is typically trying to find the active product of something that works in the natural world (like a plant for example) so they can patent it and make their own. Pharmaceutical companies are in it 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 Click to rate Report abuse They sound as irresponsible 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 Click to rate Rating 7 Rating 39 Rating 40 Rating 28 Rating 8 Rating 23 Rating 16

Report abuse 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 promoted by so many its sick 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 Click to rate Report abuse 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 Click to rate Report abuse ob its ok its a euro law so we wont have anything to do with it. That'll please Daves mates - Adie, Prestatyn, 22/7/2013 20:10 Click to rate Report abuse This should be mandatory? - Donald Swank, The Isle Of Oh, 22/7/2013 19:49 Click to rate Report abuse 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 Click to rate Report abuse What do you mean the 'could be forced'? It is dispicable that these companies have been allowed, even encouraged, to put drugs on the market for huge prices without proper trials and without total honesty about all the side 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, chemists, biochemists etc can live with themselves. - T00ts, glos, United Kingdom, 22/7/2013 18:35 Click to rate Report abuse its disgusting that they aren't letting us have all the information so we can make a fully informed decision about what we put 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 Click to rate Rating 21 Rating 18 Rating 46 Rating 19 Rating 4 Rating 22 Rating 10

Report abuse 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 Click to rate Report abuse Too many people are under the impression 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 Click to rate Report abuse How can you publish an UNKNOWN side effect?? - Roshea, Devon, 22/7/2013 17:55 Click to rate Report abuse How is a side effect dangerous, or even a side 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 administering the drug gave all of the volunteers the drug at the same time, instead of waiting to see if there would be a reaction. - The thinker, Gotham, 22/7/2013 17:52 Click to rate Report abuse COULD -------> SHOULD - asitis, realworld, United Kingdom, 22/7/2013 17:39 Click to rate Report abuse How is a side effect dangerous, or even a side effect, if it is unknown? - Robert, Atlanta, 22/7/2013 17:34 Click to rate Report abuse This will never happen. Big Pharma holds too much power and political clout. If this were the case no one would go near statins! Rating 8 Rating 19 Rating 19 Rating 26 Rating 1 Rating 30

- passthebutterplease, Shrewsbury, 22/7/2013 17:29 Click to rate Report abuse How does one know everything has been released for scrutiny if its secret? - Question, SouthEast, 22/7/2013 16:57 Click to rate Report abuse The pharma companies should update the information available on the possible or reported long term side effects of a particular drug. This way current patients would be able to see if 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 Click to rate Report abuse 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 Click to rate Report abuse 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 stomach cramps within five minutes of eating after two years. Further, i was never recommended the generic drug ibuprofen - one charmless 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 Click to rate Report abuse 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 system 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 Click to rate Report abuse Data on File will remain what it is. Hidden. Until NHS Consultant stop taking Retainers from Big Pharma and GP's get rid of their Shares, nothing is likely to change. - Gordon Webster, Dundee, 22/7/2013 16:02 Click to rate Rating 53 Rating 9 Rating 46 Rating 45 Rating 12 Rating 13 Rating 72

Report abuse This should not be a could be but a should be - people before money please! - Miss Happy, London, 22/7/2013 15:48 Click to rate Report abuse 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 Click to rate Report abuse Openness from big pharma? Good luck with that one. - Mark R, COVENTRY, United Kingdom, 22/7/2013 15:39 Click to rate Report abuse and much do our mps get from pharmaceutical lobbyists, there is your answer. - chris, southampton, 22/7/2013 15:37 Click to rate Report abuse and on Saturday you were all calling 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 saving 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 Click to rate Report abuse Vote UKIP to keep side effects secret. - Grasshopper Farmer, Sandburrville, 22/7/2013 14:19 Click to rate Report abuse 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 Click to rate Report abuse Most side 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 it is not cost effective to fully evaluate the product due to the length of time involved before profits need to be considered. The Rating 98 Rating 39 Rating 79 Rating 48 Rating 101 Rating 31 Rating 36

population are the guinea pigs for the pharmaceuticals. - Kenai689, UK, United Kingdom, 22/7/2013 13:43 Click to rate Report abuse Could be? - Sylvie, London, United Kingdom, 22/7/2013 13:36 Click to rate Report abuse Rating 24 Rating 132

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