top of page

Expect More from... Clinical Trial Disclosures!

Writer's picture: Kelly PrymiczKelly Prymicz

Doctors Without Borders caught my attention for a surprisingly new call to action. I, like many others, may have expected the storyline to be specific to the healthcare impact of recent devasting conflicts or extreme flooding as these heroes deliver lifesaving care to patients impacted by war, natural disasters, epidemics, and social exclusion. While they are no strangers to adversity, one of their current threats comes from Pharma.


Doctors Without Borders has been raising awareness that a medication needed to treat drug-resistant tuberculosis (TB) is egregiously priced, and therefore out of reach to those in need. The public sector has invested as much as five times that of J&J in the drug’s development. Some believe the pressure from Doctors Without Borders and advocacy groups like the United Nation’s Stop TB Partnership did eventually lower the drug costs by 55%. Opponents to J&J’s reluctant price reduction believe the decision was made after India invalidated a secondary patent allowing the generic manufacturing within their country and numerous others. The decision to lower prices and allow competition has provided some relief, the battle wages on as Doctors Without Borders sets its sights on a broader drug affordability conversation.


At the end of April, Doctors Without Borders presented at the 5th WHO Pharmaceutical Pricing and Reimbursement Policies in Vienna. They provided full cost transparency on the price tag associated with conducting its key clinical trial. The purpose of their disclosure was to debunk a long-standing belief of many experts, government officials and the public - the cost of medication is directly related to the cost of research and development. Many issues surround this established justification. Clinical trial expenses are never fully disclosed (sound familiar to other drug pricing tactics?). Reported costs vary widely without the ability to validate the figures proposed by the manufacturer. Doctors Without Borders has decided to take a stance. They highlight the research, and then open the curtain to their own expenses from a clinical trial 2 years ago was a total cost of $36M. Full detailed dissemination of trial expenses will occur after a medical journal completes its confirmatory review.


We support a competitive market and the ability for Pharma to make a reasonable profit. While we know many drugs in development never make it to the market, those drugs are not without valor. As with many life experiences, we learn more from our failures than successes at times. Keeping detailed, publicly available expenses of all clinical trial expenses, inclusive of drugs that failed to gain approval, builds trust and support. Drugs that do not reap market payoff but contributed to the eventual development of lifesaving medication should be accounted for within the company’s overall expense of that approved therapy’s total expenses. No one is asking these failures to be forgotten. This does not stifle innovation. One must ask themselves the basic question – if R&D is truly one of the leading justifications for high drug costs, why wouldn’t Pharma want to line item this expense?

 

0 comments

Comments


Color Palette and Refreshed Logo_ Foundational Pharmacy Strategies (2).png

We partner with benefit advisors and remove the barriers to effectively navigate the pharmacy benefit for the betterment of employers and patients.

Get Started

Unlock a future where quality healthcare isn't just a dream—it's a reality for every employee, every client, and every business.

bottom of page