To hear Vinay Prasad say, American health care is too ready to intervene unnecessarily, using prescription drugs without sufficient proof of their benefit and put patients at risk of side effects or other negative results.
Food and Drug Administration has, according to Prasad, relys too much on the measures of the effectiveness of cancer drugs which do not help people to live significantly and cost too much for the advantages they offer.
Prasad’s opinions on medicine will be of considerable importance in the future, after the doctor and academic have been named the next head of the FDA biological assessment and research center, which oversees vaccines and blood products as well as gene and cellular therapy.
The medical specialties of Prasad are in hematology and oncology, in which he formed and now practices medicine at the General Hospital of San Francisco. He is also a prolific researcher, writing hundreds of articles evaluated by peers of teachers from Oregon Health and Science University and the University of California in San Francisco.
His philosophy – presented in these articles and in the often impetuous and combative publications of social media – is likely to have a profound influence on the standards by which CBER assesses and approves new drugs.
Already, concerns about how CBR policies could change under Prasads flow the companies of companies whose CBER products are examining. The manufacturer of genique therapy Sarepta Therapeutics, the Moderna mRNM vaccines manufacturer and the Cancer Therapeutics therapy developer are part of a dozen companies that have lost large pieces of their market value since the appointment of Prasad.
The work of Prasad has received funding from Arnold Ventures, a foundation which is pressure for “political solutions based on evidence” which also supported the Institute of Clinical and Economic Review, which developed sometimes controversial profitability of new drugs. Prasad has also received personal costs from the insurer Unitedhealthcare.
Although many Prasad writings relate to cancer drugs regulated by the Center for Drug Evaluation and Research, he examined the file examining some of the types of products that will fall under his authority in CBER. (He also has an appointment of the University of California in San Francisco in epidemiology.)
For example, He argued against Emergency authorization for COVVI-19 vaccines for children And then, after being eliminated, raised concerns about how studies used to support them Measured security risks.
Therapies on CAR-T cells for cancer, which are regulated by CBER, have also drawn the attention of Prasad. In his opinion, Bristol Myers Squibb’s Abecma was Overly expensive For non -prudent treatment for multiple myeloma. “”It is crucial to wonder if unacceptable therapies like (Abecma) are worth it, “he wrote in an article written with two other researchers.
The FDA does not regulate the prices, but as a CBER PRASAD chief would be able to influence the approval of therapy according to their effectiveness as well as to be more important in the drug classes which should be expensive.
The same could also be true for gene therapies, which are intended to be one and fact treatments that can modify or stop the progression of the disease. Prasad was Very critical of the decision by his predecessor, Peter Marks, at Approve the muscular dystrophy of the Duchenne de Sarepta The treatment is due to the limited advantage it has shown in placebo -controlled tests.
“Based on the comments of Dr. Pratad, we fear that his anti-industrial bias can lead to efficiency benchmarks at a level too high to attract capital for new biologicals,” wrote Cantor Fitzgerald, Josh Schimmer, in a note of May 7 to customers.
Prasad’s academic research also reveals strong opinions on the use of “substitution parameters” in clinical trials. As a rule, these are biological signs that may indicate the potential of a drug to provide significant results such as improving survival. They are used to support the accelerated approvals of rare disease drugs that may come under its exam.
A Meta-analysis of cancer studies That it led found a “low or moderate” correlation between substitution parameters and global survival, the gold standard for oncology data. In this analysis, Prasad and its co-authors found that almost all the criteria for assessing the substitution of immunotherapy had a low correlation to survival.
Other research he conducted revealed that cancer trials measuring global survival only took more time that studies using less demanding evaluation criteria such as progression or response survival rates. “Whether this compromise is beneficial or detrimental to patients deserves a more in -depth examination,” wrote him and three colleagues.
Prasad has raised quality of life issues regarding new cancer treatments, saying that people with advanced cancer I spent 16 hours more per month Access and receive treatment for a new drug in relation to support care. “Time is a precious resource for people with cancer, but especially for patients who may have little or no treatment options,” wrote Prasad.
He challenged pharmaceutical societies to move cancer drugs in so -called adjuvant contexts, or those used after surgery or other primary therapies, where the objective is to prevent relapses. A Analysis that he helped to conduct This adjuvant treatment costs $ 1.6 million for each cancer progression event that it avoids.
Analysts that cover biotechnology companies believe that, at CBER, Prasad’s opinions will result in a stricter regulatory environment for the development of drugs and approvals. However, he will work for the FDA commissioner, Martin Makary, who has Support expressed to accelerate opinions In certain circumstances, such as rare diseases.
“Vinay had a well -documented relationship … with Makary,” wrote Schimmer de Cantor. “It is not clear if we have to expect Vinay to shake the boat from the most rationalized approval routes that Makary presented in his plans for the agency.”
