A golden opportunity is frequently being missed due to lack of financial incentives to stu  dy old inexpensive generic drugs for new indications. Imag

Pay for Success Contracts — A New Model to Develop New Therapies from Old Drugs

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2021-09-24 11:00:03

A golden opportunity is frequently being missed due to lack of financial incentives to stu dy old inexpensive generic drugs for new indications. Imagine that you discovered that a combination of off-patent (“generic”) drugs worked to better treat pancreatic cancer, which otherwise kills 95% of sufferers within five years of diagnosis. This may sound like science fiction, but it was the experience of Dr. Steven Biglesen, who was diagnosed with stage 4 pancreatic cancer and used 2 inexpensive generic drugs in addition to his chemotherapy to become a 5-year survivor, now 4 years in complete remission [1]. It was the scientists at the Salk Institute for Biological Studies, not big pharma, that made the discovery that paricalcitol, a form of vitamin D, used by Bigelsen, might be useful to treat pancreatic cancer. Without the ability to perform human trials themselves, and without the ability to profit from their discovery, it has taken well over 20 years since their discovery to finally begin significant clinical trials on this extremely safe and inexpensive drug.

The investment required to develop a new drug is increasing exponentially: estimated to cost USD $1–2 billion and take over 10–15 years from discovery until regulatory approval [2]. By comparison, it can cost less than $10–15 million to obtain regulatory approval for repurposing a generic drug or nutraceutical, because it has already been proven safe in animals and humans [3]. For this reason, generic drug repurposing saw heightened interest during the COVID-19 pandemic [4]. However, easy access combined with a lack of private incentives to conduct large “gold standard” randomized controlled trials (RCTs) has caused significant public harm and ongoing controversies around efficacy, with Hydroxychloroquine (HCQ) [5] and Ivermectin [6] being key examples. Without patent protection, no pharmaceutical company will fund the large and expensive clinical trials required to definitively prove these safe and inexpensive treatments are effective in humans [7].

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