The media regularly reports reports of alleged new miracle drugs. We explain what to look for in such news.
What does healing mean?
"A miracle cure for cancer is discovered", "cancer soon healed?": Although such titles look promising, caution is needed. "Cancer occurs and evolves in such a way that a common treatment strategy would not work for all patients," said Michael Arand, professor of toxicology and pharmacology at the University of Zurich. Therefore, a new drug can help only a few patients, but most do not.
On the medical level, a person is considered cured when he is fully recovered, that is, when the initial state has been restored before the onset of his illness. After cancer, doctors use this term only after a long time: cancer patients are considered cured if there are no signs of a new tumor five years after their illness, even if later relapses are not excluded . Of course, a complete cure is not always possible. Doctors therefore speak of successful treatment, even if the life expectancy of a patient is prolonged. For many patients, following a therapy improves their quality of life, it is also a profit.
The media, on the other hand, like superlatives such as "breakthrough" or "miracles". In June 2015, two researchers, Matthew Abola and Vinay Prasad, reviewed information on cancer drugs. the They found that even unhelpful substances were praised. According to the researchers' research, 14% of the acclaimed strong drugs have not even been tested on humans. In most cases it was the journalists themselves who used the superlatives without calling on the experts. Journalists may not have the expertise to assess the kind of progress a superlative is really entitled to, the authors wrote. In addition, the development of new therapies is of course also a commercial activity – and pharmaceutical companies, of course, are more interested in success stories about their shareholders and potential investors than in cautiously worded news.
How is the development of a new drug?
Arand says that it often takes up to ten years to move from initial research to the moment a new drug comes on the market. The first tests are available cell cultures in place. At this point, researchers can already determine if the new drug has undesirable side effects and could damage other cells and cause cardiac arrhythmia. He continues with tests animals. to study the behavior of a drug in a living organism. "The animal experiment is the last filter before humans," says Arand, "unfortunately, biology is so complex that you can not predict everything."
By nature, drug trials must meet strict standards. For example, scientists must register their attempts with drug regulatory authorities and, among other things, clearly define in advance what objectives are expected. The experiments on the man begin in clinical phase I, At this stage, the effectiveness of a substance is not yet in the foreground. The purpose of these experiments is first to discover the behavior of an active substance in the human body. The following questions are in the foreground: Is the active ingredient compatible? How does the metabolism react? What should be the dose? How fast is the drug excreted? These tests are performed on healthy volunteers unless a very potent drug, such as cancer, is tested. In sick patients will be an active ingredient in clinical phase II tested. It is currently being examined whether, in a small group of patients, there are signs of the desired effect of the new substance. The conclusion forms the clinical phase III. in which the new active substance is administered to a large number of patients. It is only now that the effectiveness of a substance can be recorded and evaluated statistically. Then indicate if the drugs are used in practice.
What role do scientific journals play?
New scientific discoveries are published in professional journals and, of course, the more reputable the journal is, the more important individual contributions are. In medicine, the New England Medical Journal on Medicine, Nature, Science, The Lancet, the British Medical Journal and the Journal of the American Medical Association (JAMA) are the most influential journals.
"Peer Review", a quality assurance process for contributions, is one of the key elements of reputable publications. In this case, the editors will send an anonymous manuscript to other independent colleagues for review. It is not uncommon for contributions to be rejected or to be revised. Readers of the magazine can therefore be certain that all authors have been confronted with the critical vote of other experts.
Who decides on the approval of a new drug?
Each country has its own authority, which manages the approval of a new drug, after all studies and all tests have been completed successfully. In Switzerland, Swissmedic, the Swiss Agency for Therapeutic Products, decides, after a thorough examination, whether a drug meets the legal requirements and is approved for sale. For countries in the European Union, the manufacturer of the drug must apply for marketing authorization to the European Medicines Agency (EMA) in London. However, in some cases the authorization also applies to different EU countries and their respective authorities. Even the United States, Japan and many other countries have their own licensing systems.
Basically, the process is relatively similar for the authorities. Pharmaceutical companies must send the competent authorities a request for information on the efficacy, quality, safety, the content of the drug, its purity and its shelf life. In addition, the company must submit all results of preclinical and clinical trials. The authorities then review the data and clarify the outstanding issues with the manufacturers. In the end, a scientific committee of the authority often decides whether the drug receives an admission recommendation ("positive opinion") or a "negative opinion". At EMA, the committee calls the Committee for Medicinal Products for Human Use. According to the recommendation, the actual approval of the drug will be granted by the European Commission. In Switzerland, Swissmedic issues the approval itself.
Authorities sometimes receive high processing fees for the approval process. For example, a new drug containing new active ingredients can cost several hundred thousand francs to the EMA. In addition, the process often lasts more than a year, but there are also expedited procedures when there is a promising treatment for a serious illness.
After the approval of the drugs, the manufacturer can – depending on the legislation – make the medicine available to doctors and patients. In some countries, the contribution to the costs of health insurance has to be clarified before being placed on the market. Often, more than ten years have passed since the start of development when a drug was marketed. This involved high costs for the company, which can now recover it for the first time in the market.