Why are the most popular drugs – the most useless
Each morning begins with Anna Alexandrovna drugs. Nothing special, the usual set for her age : Cerebrolysin, vinpocetine, and tanakan Nootropilum – ” Head ” Wobenzym – ” to cleanse and immunki ” Corvalolum – when the heart aches for trobovazim veins, vitamin D and calcium – ” Bone “. In case of a cold or other infection in her medicine cabinet has an impressive arsenal of immunomodulators, antiviral and homeopathic remedies.
Anna not to self, and all the drugs she was prescribed by doctors. But none of them is sold in Western countries (at least as drugs ), none has stood the test objective methods of evidence-based medicine. Most of them are not subjected to such tests.
Anna – real and not a character, but in its place could be your mother or any other relative, or yourself. The most popular medications that make the lion’s share of the turnover of the Russian pharmaceutical market – at the same time the most useless.
How it does not work in Russia
“The effectiveness of about 90 percent of drugs sold in the world, has not been proved by modern standards, seventy percent of them do not have even slightly significant efficiency,” – says Pavel Vorobyov, deputy chairman of the Formulary Committee. This organization at the Ministry of Health for many years evaluates medical technology and drugs, but soon after Golikova led ministry from services committee refused.
The site Formulary Committee for many years hanging negative list of drugs that are sold in pharmacies and at the same time are absolutely useless. This register 57 generic names. According to Prof. Vorobyov, in fact, unemployed drugs on pharmacy shelves to order more. Pharmaceutical bureaucracy is designed so that new high-tech drugs appear very late or do not appear at all but meaningless legacy of the past and the last century like korvalola or tincture of hawthorn preserved and grows in sales.
In world practice, there are three gold standard of quality that are applied at three stages of life of each drug : preclinical development laboratory (GLP), clinical trials (GCP) and in manufacturing (GMP). In Russia GCP standards adopted since 2005, but are merely recommendations, ie, manufacturers may voluntarily follow them.
“When it comes to large international studies in Russia, they are held by the standards of GCP, just because it is required for registration of medicines in other countries – says Svetlana Zavidova, executive director of the Association of Clinical Research, which nine years ago was engaged in the approved standards GCP in Russia. – But if it is a purely Russian development for the domestic market, is no reason to test the drug on international quality standards, and no one does not do this. ”
In a qualitative study drug compared with placebo ( pacifier ), and even better – with the most effective treatment for the same disease, because in a good new drug must be better than other drugs, and no better sugar pills. Qualitative research should be randomized, that is carried out using a random sample of patients in the test group and the placebo and double-blind, when neither the patient nor the doctor even do not know who in the group gets the medicine, and to whom – a placebo. Qualitative research – it is always tens of thousands of patients, and therefore invest millions. The smaller the magnitude of the effect, the patients need more effect to detect.
There is no point in investing a lot of money and comply with strict conditions in Russia, because the Russian law “On Circulation of Medicines” not established the amount and quality of research – it could be anything.
Number of patients for clinical trials determines the developer himself, his records at registration checks Institute of preclinical and clinical studies with the Ministry of Health. However, the requirements to the protocols can be arbitrary. For example, the popular drug trials involving a total of 62 Trombovazim person. Most of the Russian agents were tested on groups of patients up to 50 people, and not necessarily even compared with placebo, not to mention the comparison with existing analogues.
Effects of drugs have also vary. For example, if a drug eliminates specific symptom – it’s called ” surrogate point ” of effectiveness, and if prolongs life or improves its quality, reduces the number of relapses – it is the “end point “, and it is for them to judge today accepted as a treatment.
British physician and social activist Ben Goldacre in his book “Bad Pharma” leads such a case. In 1980 a group of experienced doctors lorkainid, cure arrhythmia in a hundred patients with myocardial, half of whom received a placebo, the other – the real pills. Arrhythmia this drug really eliminated, ie surrogate point worked perfectly. However, shortly after the study in a group of patients who received lorkainid, nine people died, and in the group that received sugar pacifiers – only one died. It was a failure, and the band ceased study of the potential drug. If the same drug is tested in Russia today, no rules prevented to register it as a business tool from arrhythmia.
Latest revision of the federal law “On Circulation of Medicines” was adopted relatively recently – in April 2010, but it does not appear any quality requirements for clinical and preclinical studies. But there are many vague wording complicating registration and independent study medication. “The law does not allow drug testing of anyone other than the developer – said prof. Vasily Vlasov member of the Cochrane Collaboration – an international organization that provides an independent assessment of the effectiveness of drugs. – I personally appealed to the ministers – and past and current, to change this situation, but was not even awarded answer. Studies claim can only sponsor. Independent examination under this Act is not so independent and subordinated minzdravovskim officials. And research results do not require the publication in scientific journals, and provided directly to officials. This does not exist anywhere in the world. ”
Also, the law not established a mechanism that would allow deny registration ineffective drugs. Article 32 on the abolition of state registration of the drug – one of the shortest – implies that can only be banned hazardous products. Futility is not sufficient reason. Apparently, so long as there was no precedent to certificate of state registration has been canceled due to the futility of the drug.
In general, the law is written as if it is assumed that the drug may experience only the manufacturer or contractor. ” The main innovation of this law was that that the registration of drugs passed from Roszdravnadzor to MOH – said prof. Vlasov. – Ministers are not very willing to share power, especially in the lucrative field of the pharmaceutical market. ”
In 2010, when he was adopted by the current law, in the press detailing the intricacies of family and professional relations minister Golikovoj and management of the company “Pharmstandard”, producer of drugs and arbidol amiksin. Slon wrote that the efficacy of these drugs has not been confirmed, however, as not confirmed the effectiveness of antiviral drugs almost all who love Russian doctors prescribe for the flu and colds.
It seems there is nothing terrible in useless drugs. You can drink it just in case, “suddenly will in any case not be worse.” This, of course, misleading. First, all the useless drugs has not been proved not only efficiency but also security. We do not know really, is fraught than taking these pills. Secondly, any useless drug already known dangerous because it creates the appearance of treatment, and many are content to popular inoperative means exposing yourself to the risk of death. Thus, the two most popular heart medication – and valokordin Corvalolum – really do not have any positive therapeutic effect. They contain a narcotic substance phenobarbital and isovaleric acid, slightly dilates blood vessels, soothe and lull. Rather than go to the hospital and get the real treatment, a person takes a drop, feels relieved and falls asleep. In this attack, if it started developing in a dream.
” As a result, the average Russian patient admitted to the hospital within 20 hours after the onset of heart attack, while intensive therapy only makes sense in the early hours – says Professor Vorobyov. – Same with the symptomatic treatment of colds and flu. Patient takes absolutely useless ” antiviral ” drugs and antipyretics that relieve symptoms. The patient does not pay attention to the disease as long as he did not develop severe pneumonia. A similar problem with renal colic : if you just take painkillers, there is a risk that the symptoms go away and quietly develop severe purulent complication ”
At the beginning of last year, Minister Veronika Skvortsova announced that ” ineffective medication should leave the market.” Then this was a lot of talk and media reports. A year has passed, and my question is, what has been done in this direction came from the Ministry of Health verbose vague answer, the essence of which is to ensure that the amendments to the law are perpetual interagency coordination.
The situation is similar with GMP, international standard of production. Talking about his introduction in Russia conducted fifteen years, however, the legal framework has appeared only in the autumn of 2013, when the Ministry of Justice signed the order Minpromtorga. “But to rebuild production too difficult and costly, so now the players are lobbying special government decree on the grace period for a few years, – says Dmitry Yanin, chairman of the Confederation of Consumer Rights. – We try not to let them spend the ruling. All permits are prudently re-register before the new rules, and audit planned Minpromtorgom, will take at least two to three years. ”
As it is not working in the world
It may seem that ineffective drugs are found only in our country, and in the West drugmakers guided only one love of truth. Not at all. Despite the serious requirements and standards, useless drugs and winding path fall in U.S. and European pharmacies.
Returning to the history of books with lorkainidom Ben Goldacre, the botched investigation was never published. Other groups have in subsequent years have experienced similar anti-arrhythmic drug that has the same side effect, ie increased risk of death, but not so obvious. More than 100,000 Americans have died because of dangerous anti-arrhythmic drugs, says Goldacre. In 1993, the authors of the first study of public apologies. Perhaps if the study was published, it could at least partially prevent the entry of deadly anti-arrhythmic drugs.
To date, no other country has no laws that obliged to publish the results of studies on the effectiveness of all drugs. Scientific journals are more willing to publish research if authors were able to detect an effect than if failed.
In April 2012, in the journal Nature published an article by researchers who attempted to repeat the 53 scientific testing potential drugs for cancer therapy. Repeat managed only six of the 53 works. Authors of the publication suggests that this is due to the fact that scientific journals publish articles with enthusiasm with positive results and do not show sufficient vigilance. As a result, the light goes Unplayable nonsense. And if the study showed that there is no effect, then how would talk about.
And this applies not only to the future development of drugs, but, what is worse, independent research that is already being used by doctors. Eric Turner in 2008 published in the New England Journal of Medicine article about the history of a dozen antidepressants, which were submitted for registration to the U.S. Agency for Drug Control and products in the last fifteen years. Total agency was filed 74 studies, of which 38 works with a positive result ( tablet running ) and 36 negative (tablet does not work ). Turner made a simple thing : he took the seventy four studies from the database and looked FDA, how many of them have been published in peer-reviewed journals. It turned out that the work of the positive results were published, all but one, and negative work – only three of the thirty-six. Doctors who read the scientific press and prescribe drugs to patients receive a monstrous distortion of reality and find effective drugs failing studies that simply were not published.
About half of the scientific work performed in Western countries are not published anywhere, while at work with a positive result likely to be published twice more than work with negative results. Drug trials funded by the manufacturer, are four times more are positive. Not because muhlyuyut authors in the study of ( in terms of design work is just flawless ), but because negative results just do not see the light.
So far, this systemic problem is not solved, but more about her writing, not only in the scientific press. In January in The Lancet, a series of five pieces dealing with incomplete medical information, and the New York Times published a report about the big war waged by a young doctor from the clinic, ” Johns Hopkins ” with farmgigantom GSK for the publication of the results of all studies on the effectiveness of anti-influenza drug Tamiflu.
Gradually, the situation is changing for the better in the last year for the first time GSK has created an online system in which doctors can request the results of clinical trials. To date, such as online services have Roche, Sanofi ViiV and Boehringer Ingelheim. In late January, the company Johnson & Johnson announced that it would publish all of their clinical research data in the public domain.
It would be naive to think that companies are doing so, and in the soul great gusts. Mainly information becomes more accessible, and development – more transparent because it achieve doctors such as Goldacre. Because physicians read peer-reviewed journals, and the laws governing the ” circulation of drugs”, separated quality scientific scrutiny from poor quality, and the latter is not considered during registration. Because officials who write the laws and work in the health care system, are not seen in the obvious conflict of interest and direct communication with manufacturers. Because the success of producers affect their reputation in the eyes of doctors and patients. While in Russia, everything is strictly contrary, useless drugs we will only build momentum.