2024-06-25 22:00:00
For six months, medicines agencies in all European countries have known about 400 generic drugs that could cause problems. The manufacturers of these drugs have commissioned India’s “Contract Clinical Research Organizations” (CROs) to produce the data needed to obtain marketing authorization… but they have not yet checked their effectiveness. These questionable data again raise questions about the reliability of clinical assessment…
The old adage may say that you can never be better served than yourself, but companies love to outsource their services. For example, did you know that two-thirds of pharmaceutical companies do not have the structural or human capabilities to conduct clinical studies? They delegate this task to independent laboratories, which are designated as “contract clinical research organizations” (CROs), but this strategy has its limitations, because the manufacturers of approximately 400 drugs have just experienced the process of selling generic versions of their drugs. situation at a cost.
Suspicious CRO
The story begins in Spain in early 2023, during an inspection meeting aimed at authorizing the marketing of generic drugs. Spain’s Medicines and Healthcare Products Regulatory Agency (Aemps) has faced “serious doubts” in its review of the results of bioequivalence studies submitted by about thirty pharmaceutical companies. Bioequivalence studies prove that a (cheaper) generic drug is as effective as the original drug in every way. These are poorly designed bioequivalence studies that were, for example, at the root of the 2019 Merck Laboratories Levothyrox scandal and led to ANSM being sued.
As a result, around 30 laboratories have entrusted their research to Synapse Lab, an Indian CRO. (There are 9 CROs in India, with a market size of approximately US$1 billion, while the market value of hundreds of CROs worldwide exceeds US$80 billion) (1).
As the Spanish regulator noted, “Inspection of good clinical practice finds irregularities, documentation and system failures andMy computer, and data processing programfrom me‘study”. Therefore, Aemps referred the matter to the European Medicines Agency (EMA) in July 2023. Then 1,800 generic drugs were re-examined. Its report, due out at the end of December, contains a list of more than 400 drugs for review…
Also read Prescrire Magazine’s Drugs to Avoid in 2024
silence inAnsim
Five months on… In a letter dated 24 May 2024, the European agency gave all national medicines agencies one month to react and suspend these poorly evaluated generic medicines (2). As of June 24, the date of this writing, our French news agency Ansm has apparently remained silent. In fact, she didn’t even deign to respond to us with a specific timeline for action. Its press department just told us that the discussion didn’t actually “Nothing has happened yet” .
In France, there are at least 72 types of generic drugs involved, including antidiabetic drugs, antiviral drugs, anticancer drugs, antiepileptic drugs, and even painkillers. These Medicare-saving drugs should not all be taken off the market. If laboratories provide new, more conclusive evaluation data, or if no alternative solutions are available, they can remain there (they will then benefit from a two-year “respite”). Furthermore, the EMA insists that none of them have shown the slightest harm so far.
Also read Drug shortages: Regaining industrial sovereignty?
Safety Net…Wide Mesh
However, these bioequivalence studies are not decisive issues, and more broadly, the primary responsibility of laboratories in evaluating their own medicines and the general trend of subcontracting, which also concerns the organization of clinical studies or the handling of pharmacovigilance. data. For example, we have addressed issues with the Pfizer vaccine trial against COVID-19, which was commissioned by Ventavia Research Group Inc., but an investigation by the British Medical Journal revealed that there were irregularities in the trial… From researchers at Synapse Labs, As the company website recalls, various drug clinical trials have been conducted against covid 19, and there was even a vaccination trial on 12,000 patients! But…when wise men show labs…will fools be more willing to show CRO?
Also read Meager compensation for vaccine victims: Justice steps in
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