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Over Half of New Cancer Drugs 'Show No Benefits' For Survival Or Wellbeing (theguardian.com)
New research published in the British Medical Journal finds that most cancer drugs that have recently arrived on the market have come with little evidence that they boost the survival or wellbeing of patients. The Guardian reports: Forty-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations. But the study, which looked at the clinical trials associated with the drugs, reveals that at the time the therapies became available there was no conclusive evidence that they improved survival in almost two-thirds of the situations for which they were approved. In only 10% of the uses did the drugs improve quality of life. Overall 57% of uses showed no benefits for either survival or quality of life. The team then looked to see whether the picture improved over time. The team found that after a follow-up period of between three to eight years, 49% of approved uses were linked to no clear sign of improvement in survival or quality of life. Where survival benefits were shown, the team said these were clinically meaningless in almost half of the cases.
Shows great wellbeing to the financial survival of big pharma.
Domestic spying is now "Benign Information Gathering"
There are similarities and differences. Before the EU was formed, each of the 28 countries already had their own approval process. After the formation of the EU, which is principally an economic and trade alliance, a drug approved in ANY EU country could be sold in ALL EU countries. Therefore a pharmaceutical company could choose which of the 28 countries would likely approve the drug most easily / quickly / cheaply. Commonly, a pharmaceutical company will apply in two or three countries at once and see which one approves it first.
Some drugs are now required to go through one of several centralized EU approval processes instead - and there are four for them to choose from. Being run by the EU, the heritage of these agencies is based on promoting commerce between EU countries - the EU is not focused on consumer protection and safety.
In the US, a maker has to get approval from the FDA. They don't get to choose different agencies to seek approval from.
The DA started as a consumer protection agency, trying to make sure drugs were safe. Later, they got mandate to make sure they are effective. The FDA doesn't have the heritage of coming from an organization trying to promote commerce, like the EU does.
Therefore historically it's been easier and cheaper to get drugs approved in Europe than in the US. Europeans got cheaper medicines faster, Americans got better, more expensive medicine. (The difficult and expensive FDA process isn't a total waste).
In the last few years, there has been pressure on both sides of the Atlantic to be more like the other guys. Americans want cheaper drugs, sooner. Europeans want want better, safer drugs. I guess the grass is always greener on the other side of the fence. So each process has become more like the other and the difference isn't as extreme as it once was.
No cancer patient gets just one drug. A typical regime is surgery, radiation, plus a cocktail of multiple drugs.
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