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Drug Giants Warned: Tell The Truth on Medicines
The pharmaceutical industry came under assault from senior figures in medical research yesterday over its practice of withholding information to protect profits, exposing patients to drugs which could be useless or harmful.
Experts criticised the stranglehold exerted by multinational companies over clinical trials, which has led to biased results, under-reporting of negative findings and selective publication driven by the market, which was worth £10.1bn in the UK in 2006, amounting to 11 per cent of total NHS costs.
The latest attack was triggered yesterday by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos (dummy pills) in most patients. But doctors said patients on the drugs should not stop taking them without consulting their GPs.
It was the first time researchers - from the UK, Canada and the US - had successfully used freedom of information legislation to obtain all the data presented to regulators when the companies applied to license their drugs. In some cases it had not been made public for 20 years. Over the past two decades the drugs, known as selective serotonin re-uptake inhibitors (SSRIs), have been among the biggest selling of all time, earning billions of pounds for their makers. Yesterday's finding suggests that the money may have been misspent. Drug companies are required by law to provide all data on a drug, published and unpublished, to the regulatory authorities when applying for a licence. But this requirement does not apply to the National Institute for Health and Clinical Excellence (Nice), which assesses cost effectiveness and recommends which drugs should be used by the NHS.
Peter Littlejohns, the clinical and public health director of Nice, said: "The regulatory authorities have access to everything. Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."
Professor Mike Clarke, the director of the UK Cochrane Centre, an international collaboration between researchers in 100 countries which has published more than 3,000 systematic reviews of published trials to establish best medical practice, said lack of co-operation from the drug industry was damaging medical care.
"When we ask for details of a trial the company might tell us nothing. We have even less power than Nice. Researchers trying to make sense of trials for decision-makers need to have access to this data. If we have only got access to half of the data, when we see evidence that a drug works we don't know whether to believe it or not.
"It makes us doubtful - that's the big worry. The companies are in the business of making profits - but they are also in the business of providing safe, effective health care."
Legislation to compel the drug industry to publish its results was included in Labour's manifesto at the 2005 election and last month the Commons Health Select Committee demanded that Nice be given unfettered access to all clinical trial results.
Yesterday, the Government said it had been told that compelling the industry to publish trial data would not be allowed and it was instead pursuing a voluntary approach, developing a "searchable register" of all trials that have taken place in the UK and pressing the EU to make its own confidential register public.
A spokesman for the Department of Health said: "The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law." A World Health Organisation working group is examining how to improve reporting of clinical trials and is expected to announce a consultation shortly.
The pharmaceutical industry was unrepentant about its strategy yesterday. Richard Tiner, the head of medicines at the Association of the British Pharmaceutical Industries, said: "The regulatory authorities have access to all the data - absolutely everything. Nice is not a regulatory authority - it is making decisions on whether medicines should be available on the NHS... There is no reason why the companies would restrict access - it depends what they are asked for. The industry is very much more transparent than it was 10 years ago."
GlaxoSmithKline, maker of Seroxat, said yesterday it "fully endorsed public disclosure of all clinical trial results" and had published all data relating to Seroxat on its website "regardless of study outcome".
The antidepressant debate
Paul Bough, 41: 'You name it, I've tried it: none of them worked'
"The findings of this latest report don't surprise me in the slightest. In fact, they confirm what I already knew.
"I've been a depressive for most of my life, and all of my adult life. After the umpteenth failed suicide attempt seven years ago my doctor said I should try taking antidepressant drugs. You name it, I've tried it. Diazepam, Citalopram, Prozac, Seroxat, Atenolol [a beta-blocker], Efexor: none worked. They turned me into a zombie, totally incapable of motivation or movement and forced to vegetate on a sofa.
"I'd say to anyone on these drugs, you're better off going cold turkey. Talk to people, have therapy, be sociable: but don't rely on these little happy pills. Having tried the lot, I'm coming off - and staying off."
Sylvia Genge, 59: 'Without these drugs I would lose hope altogether'
"The findings go against several decades of experience. I have suffered three major traumas in my life - my father leaving home when I was 11, my husband having an affair, and now an unpleasant divorce - and I'm convinced these drugs helped me survive them. I've been close to suicide myself, but now, in my 60th year, I'm feeling positive and able to survive all the terrifying experiences each day throws at me. I take 20mg of Fluoxetine each day, and it makes me feel I can cope. I simply don't buy the idea that it's just a placebo - but then I suppose the point is even if it were I wouldn't care. These drugs are my crutch and my comfort; without them I would lose hope altogether. I'm staying on."
© 2008 The Independent
10 Comments so far
Show AllInteresting that they focus on clinical trials. Shows that animal research is BS. It is just legal cover, and a way for scientists to get welfare by using a quasi Darwinian myth about the anatomical relation between humans and non humans.
You cant cure elephants by creating medicines for giraffes--the fact that Pfizer has to go to Africa to do research proves this.
Kelmer, they usually try drugs on rats first just so that they can prove that it is safe enough to start human trials. Strangely, it seems that rats can handle a greater relative level of toxicity in certain substances than can humans.
RE: - It was the first time researchers - from the UK, Canada and the US - had successfully used freedom of information legislation to obtain all the data presented to regulators when the companies applied to license their drugs.
Seems that they got together on it.
Heard somewhere that prescriptions for prosaic increased substantially the month of October 2001.
While it is true that "The companies are in the business of making profits", it is not true (at least in the U.S.) that "they are also in the business of providing safe, effective health care". As publicly traded corporations they are legally mandated to maximize profit at any cost. Questions of morality or ethics aren't even relevant.
Tell the truth? Yeah right. . .
Mr. Smith the medicine we worked so hard to bring to market will probably do more harm than good. Side effects? Yes, there are side effects, but they only occur in healthy individuals. Most of the people that take our drugs are to ill to notice the side effects.
Please understand that there is a very good chance that our drug will cause irreparable liver damage and, we will deny any wrong doing long enough to make a sizable profit.
Sorry Mr. Smith, we know the cost is twice as much in the U.S. than in Canada. We hike the prices up for American consumers just because we can.
Of course your health is our number one priority. If we can prolong your illness with our medication then we are guaranteed a sizable return on investment. What's that? A cure? don't be silly Mr. Smith we don't cure illnesses we just attempt to treat the symptoms.
Okay, I'm done. . .
You no longer have to get a presciption for prozac, trace levels are available in your drinking water. We won't talk about hormones and what they do in the environment.
I have been in mental health care since I was 5, and am now 34. I now live on SSI. I have seen the transition from psychoanalysis being the primary treatment to drugs as the primary treatment, and it has been disastrous. Not only for me, but for all thoughs I have met in my travels through the psychiatric industrial complex. Like Paul Bough in the article, none of them worked for me (antidepressants, antipsychotics, stimulants, mood stabilizers, benzodiazepines, etc) and all were extremely painful, each in a different way, and extremely counterproductive and generally destructive to my condition and recovery. Antidepressants are HEAVY DRUGS; it is not like taking an aspirin. Further I have not seen these drugs work for anyone I have met. For a time people, even myself, may think they work because we want them to work sooooo bad, and the psychiatrists are so adept at shaming us into taking them, "How can you question such a mountain of empirical evidence?" Oh yes, they are in collusion with the drug companies, do not forget these drugs are their bread and butter. I remember before Prozac; you did not see a psychiatrist AT ALL unless you were in the hospital or had a severe psychotic condition. Many people say the drugs work for them, yet they continue to end up in the hospital, continue having the same symptoms, or the symptoms are replaced by new zombirific symptoms. Most chronic sufferers I have known are on a cocktail of drugs for instance: 7 daily medications including 2 antipsychotics one of which is Clozeril; when on this medication you must have your blood tested every week because it has the potential to kill all of your white blood cells. Even worse, however, is Electro Convulsive Therapy (ECT). Oh yes it is very much in vogue. Today, unlike the 50's, you are put under and given a muscle relaxant, but that dose not change the loss of memory and brain damage. I never allowed them to use ECT on me, but I've met those who have. A documentary called Shock is coming out trying to give ECT a better face; psychiatrists want to make it the first line treatment against Depression (I am not making this up!), among those who claim to have benefited is Mike Dukakis's wife, but do not buy it for a minute. No one I ever met has been left unscathed by this treatment. I have seen people turned into total zombies robbed of their humanity, one friend forgot about my existence. Some drugs my have some benefit for some people, but the abuse in the prescription and use of these drugs is so strong. ECT has no place in medicine. Therapy has problems too, but unless it's a truly disreputable therapy (like using hypnosis to convince you you were abused by a satanic cult, again not making it up) there is usually a sence of being in a safe place, if you have a real psychologist. Unfortunately, Medicaid does not pay for psychologists; they only pay for social worker therapists (ok for beginners, but useless for chronic problems), Cognitive Behavioral Therapy (CBT), or Dialectical Behavioral Therapy (DBT). CBT and DBT are essentially the same thing, and they are only effective for people with problems like Borderline Personality Disorder, however, they get most government funding because they are supposedly "evidence based" treatments (like antidepressants are) that try to stop bad thoughts and push people back to work. In general in the world of public access, American, mental health care getting a job is seen as "the cure". CBT and DBT practitioners are all too happy to take the money and expand their narrow treatment to try and shame everyone into thinking better thoughts. This way they can win their age old battle with the Psychodynamic Therapists, just like the Psychiatrists rewrote the DSM 3 in 1980 to win the battle against Therapy. Let me tell you, Freud starts to look pretty damn good by comparison. In a sense the chronically mentally ill are the most disenfranchised group that exists. We are totally shunned from most social groups, jobs, and organizations in every culture; We receive endless shame and criticism from individuals in the right and left for our inability to function or for strange behaviors; there are little to no public resources for us (not even a social center like the elderly have in many neighborhoods); Psychiatrists will take total control of your life and brain unless you exercise your legal rights (if able to), and are very vengeful if you do; and when we turn to advocacy groups like NAMI we are told that what we need is More Drugs. There is no movement for us.
Sophistry, Kelmer.
Elephants are treated with largely same medications that are used for dogs, giraffes, and humans. Mammals are mostly the same, much more than they are different. Do you think there is a repertoire of elephant-only medications that were developed using only studies on elephants? Absurd.
TheMan,
If you can consider that we have met, then I would like to say that Effexor worked for me and pulled me out of a deep depression. It has unfortunate side effects, so after I recovered, I tapered off. Suicide, I suppose, would also have been a cure.
There is no way to test antidepressants on animals effectively. The only way to test results is to ask subjects how they feel. You can't ask an animal how it feels.
TheMan,
Perhaps you should read the literature. I know a researcher studying depression in mice, and another studying schizophrenia in rats.
Part of the problem with human studies is the cost of studying human behavior, so they use the screening tools like Beck's Depression Scale Inventory. Unfortunately, those tools have low confidence intervals. The use of animal models allows us to study more aspects of the disease and have better statistical control.