Publicado en Jul 12, 2019, 4 p.m.
It would appear as if one can find a pill for just about anything these days. Watching the television provides ample commercials of big pharma trying to sell off many medications, but are these medications as effective as they claim to be to be worth all of those side effects briefly talked about at the end of the commercial?
A study from the German Institute for Quality and Efficiency in Health Care has concluded that the answer to that question in no; according to the researchers the international drug development processes, standards, and policies are fundamentally broken and must be reformed as more than half of the new drugs entering the German healthcare system show absolutely no added benefits of taking them.
As published in the journal The BMJ, 216 drugs that had passed regulatory approval between 2011-2017 and entered the German market were examined; most of the drugs were also approved by the European Medicines Agency for widespread use throughout greater Europe. Only one quarter of the drugs examined showed any significant medical added benefit based on the available evidence; 16% showed a minor added benefit; and 58% of the drugs studied did not show any added benefit over standard patient care.
Separating the drugs by speciality yielded results that were just as poor: only 6% of psychiatric drugs showed added benefit; and 17% of diabetes drugs showed added benefit of use.
“For the overall patient population, the current output of drug development may thus be resulting in even less progress than our assessments suggest,” the study reads.
There are those within the healthcare industry that will argue limited information on a drug at the time of its approval is how things have always been done, and it is the price to pay in order to provide patients with early access to unprecedented new drugs.
As rebuttal a study on cancer drugs conducted between 2009-2013 was revisited by the researchers to refute this argument; most of the drugs were found to have been approved with little evidence of benefits to patient quality of life or survival chances and after following up on their success rates minimal additional evidence of effectiveness was found.
Most drugs are never studied again after being approved, and even if found to be ineffective the global regulators do very little to punish the offending drug makers, according to the researchers.
“As a consequence, patients’ ability to make informed treatment decisions consonant with their preferences might be compromised, and any healthcare system hoping to call itself ‘patient centred’ is falling short of its ethical obligations,” the study states.
Based on their findings the researchers recommend a more stricter drug approval process that demands stronger evidence from long term studies that are conducted on large, randomized controlled groups; and even after approval the research should continue in order to fill in any remaining information gaps.
The manner in which drugs are priced and incentivized needs to be fully overhauled, as it stands vague and unclear results are being rewarded with monetary gain undeservingly at patient cost; real and tangible results should be the only final outcome to be allowed to produce any profit. Surely the system should be set up so that there is only profit in cures, not the other way around.
“Combined action at EU and national levels is required to define public health goals and to revise the legal and regulatory framework, including introducing new drug development models, to meet these goals and focus on what should be the main priority in healthcare: the needs of patients.”
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