By: Ozren Podnar |
Shortened drug approval process: gain for patients or pharmacists? |
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The US Food and Drug Administration (FDA) recently issued a decision to speed up the process of approving drugs for cancer.
This, they claim, has made these experimental drugs more easily available to many patients who do not respond to conventional chemotherapy and radiation.
There is no doubt that hundreds of thousands of people are eagerly waiting for more effective therapies against cancer.
In most countries, including the US, the drug approval procedure is time-consuming and sometimes takes up to ten years.
It is also very expensive and costs hundreds of millions of dollars for just one drug.
After a long search for ways to shorten the process and making it cheaper, companies have finally convinced the FDA to expedite the approval process so that new drugs can be placed on the market as soon as possible.
Representatives of the companies claim that the new drugs are much better compared with chemotherapy that destroys healthy cells.
It would be great if it were so.
Possible manipulation
Many media warn that this is just another in the series of concessions to the pharmaceutical industry, which enables it to achieve high earnings in a short time.
New regulations on safety and innovation allow untested, but apparently promising drugs and other treatments to quickly hit the market with the label "innovative therapy".
Such treatments do not have to undergo complete clinical trials, but may be approved based on preliminary clinical evidence that they are superior to the previously available therapies.
Reuters and other media warn that in such a way pharmaceutical companies "skip" certain phases of testing and thus compromise the safety of treatments.
The biggest "sinners" in this regard are the manufacturers of cancer drugs, who are bypassing the usual procedure of testing the effectiveness and safety.
They are motivated by a faster return on investment in the creation of the drug, although both they and the state institutions claim that they have the welfare of patients in mind.
Unfortunately, there is a possibility that an accelerated process fails to determine the harmful side effects that become evident only after a long time.
Pharmaceutical companies may exaggerate the effectiveness of their drugs, just to get their hands on the approval, and an incomplete clinical testing allows them to do just that.
Torrents of money expected
The pharmaceutical industry argues that a new class of immunotherapeutic anti-cancer drugs is so effective that it will bring about a major breakthrough in the treatment of malignant disease.
But is the welfare of patients really what is most important here?
Dr. Alexander Eggermont, Director of the French Institute Gustave-Roussy, revealed to Reuters that this class of drugs could make $ 35 billion in annual revenue.
The pharmaceutical companies are happy that the approval procedure is as fast as possible so that the cash flow can start as soon as possible.
To persuade the patients to accept the new and simplified approval procedures, the pharmaceutical companies have announced a major price reduction of their products.
They claim that soon all of their drugs will become cheaper, because they will no longer have to pay the high costs of long-term testing. But, so far we have not seen any significant price reduction.
"Prices should fall tremendously," said Paul Workman, Director of Cancer Therapeutics at the British Institute of Cancer Research, to Reuters. "But it has not happened yet."
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