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The hidden truth you should know about prescription medications
Here is a fact that surprises you: About half of the clinical trials of the drugs we use today have never announced their results.
With only half of the test results, decision makers lack the information needed to make informed choices. In a notorious example, heart medicine known as Locarni was tested in clinical trials in the United States and the United Kingdom in the 1980s. The results showed that patients taking medications were much more likely to die during the trial than patients who did not. However, these results were published more than a decade after the sale. During this period, it was estimated that more than 100,000 people died from taking failed drugs. In another example, the British regulator proposed to the government 10 years ago to purchase Tamiflu, an anti-influenza drug. This proposal is of course based on the results of clinical trials. Due to fear of a pandemic, the government continues to purchase reserves - not once, but twice. It spent a total of 473 million pounds. However, some researchers realize that only a small part of the test results have actually been released. In order to see the missing data, Cochrane, an independent research network, received a comprehensive study and analyzed it. In 2014, scientists released a report that Duffy was ineffective. Five hundred million pounds of government funds have been wasted.
But the problem is not just money - it's about people for me. Remember that clinical trials will never happen in a vacuum; people must participate voluntarily. In large trials, thousands of people may sign up. Most of them suffer from illness or medical conditions because they can help them now or because it can benefit others in the future. There is always a risk of testing new compounds, so participants are taking risks - trial medications may not be as good as other medications, or they may be assigned to a control group and receive a placebo. In addition, test participants need to be constantly monitored, so they will spend hours in hospital and doctor appointments. Finally, volunteers indicated that if they found useful information about their condition or medication during the trial, it would be shared with them and others. Any implied result represents their betrayal of trust. Thousands of clinical trials have never published results, which means millions of volunteers have been betrayed.
You may think: If the information is lost, how do we know how many clinical trials did not publish the results? This is very challenging. Since there is no checklist of each individual test, there is nothing to check. But researchers tried to assess this situation by looking at clinical trial registrations. These are online databases created by the government, the World Health Organization (WHO) and universities to encourage trial sponsors to post details of current and upcoming trials so clinicians, academics and patients can understand and participate. The researchers then track the listed trials to see if the results were published in scientific journals, conference reports or talks, data repositories or other forums.
But finding trial results is not easy. There are hundreds of different places to choose from. When researchers find the data, it may be difficult to determine that it belongs to the test they want. Some researchers have decided to focus on the subset of trials. For example, they may look at all the tests done for a particular drug or situation. Or they narrow down the search by zooming in for a year or a country. Hundreds of such targeted studies have taken place, each studying a small part of the clinical trials puzzle, and they have consistently supported 50% of the numbers.
Some researchers are studying what results are published and which are not. Not surprisingly, it seems that more results are obtained from experiments showing drug works than tests showing that the drugs are not working. In fact, trials that publish positive results are twice as likely to publish results as negative results. In addition to the problem of incomplete information, the information released to us is often biased.
When I tell people this question, they all ask the same thing: "Is there a law that violates this law?" Answer: A bit. Since 2007, a U.S. law has stipulated that some U.S. trials must be registered in the registry. These trials must report their results within one year after their conclusion. However, in 2015, when researchers looked at some of the trials covered by the law, they found that only 13% reported their results within a year. In other words, more than one-tenth of the 10 pilot sponsors followed the law, and nearly 10 of the 10 were illegal. The law allows the FDA to impose a fine of 10,000 U.S. dollars per day on late promoters, but no sponsors have been fined, in part because the code is confusing and difficult to enforce.
People in the EU have a hope of legislation. A comprehensive legal plan, which took effect in 2018, requires that all EU drug trials be registered in public databases before they begin. In addition, the summary of their results must be published on the register within one year of completion of the trial; the abstract must be suitable for laypeople; additional detailed reports, if produced, must be made publicly available; any trials used to support new trial applications must be registered and Results are announced; trial sponsors that do not meet these requirements will be subject to financial penalties. Although the law is very clear and specific, it will be complied with and it remains to be seen whether the regulator will implement it.
The reality is that it is impossible to formulate laws or guidelines for all entities in the world that are suitable for conducting clinical trials. Drug companies are far from the only organizations that run experiments - they are also run by universities, charities and the government. They occur in many different countries and these countries have their own practices and standards. Unfortunately, it seems that there is only one thing in the many groups that run clinical trials: the culture of secrecy.
However, with the increase of consciousness, changes are taking place slowly. This is one of the biggest victories to date. The United Nations issued a report in 2016 stating that clinical trials should be registered and the results published, whether they are positive, negative, neutral or inconclusive. The UN also calls on governments to adopt legislation to achieve this goal. Many people today still do not understand the risk gaps in our clinical trial knowledge. However, if we can all get informed and concerned, then we can work together to eventually bring the hidden information into the light.