TRUST SCIENCE! Dr. Elsie Koch, M.D., Former Clinical Trials Manager at GroßPharma

Excerpt from "COVIDsteria: An Oral History of America's Great Reset" - see https://covidsteria.substack.com/p/covidsteria-table-of-contents

The Great Die-Off wiped out much of the core customer base for big pharma. It also destroyed what little trust surviving American customers had in the industry and its pricey products - leading to a massive industry and product shakeout.

However, there is one silver lining for experienced pharma professionals. Since the end of COVID Spring, the new Administration has forced nearly all outsourced pharma-related work and manufacturing to return home from abroad. 

Nevertheless, Dr. Koch had mentioned in correspondence before our interview that she has not found another full-time job as a clinical trial manager. Instead, she works discreetly behind the scenes as a part-time consultant and Board advisor to surviving pharma companies still doing clinical trials. 

As with Dr. Hodgson and judging by her opulent home, Dr. Koch appears to have been well-compensated during her big pharma career or has done very well with her investments. She also wanted to set the record straight concerning her clinical trial manager role…

When I finished my medical education in the early 1990s, the US pharma industry badly lagged behind Europe when it came to new drug approvals. Most new drugs approved in the USA had been approved in Europe more than a year earlier because American regulators claimed they were overworked and underfunded. ¹ ²

Congress then passed a law that levied charges on every single New Drug Application (NDA) a pharma company filed. The user fees from these applications paid for the hiring of several hundred more regulators to clear the backlog of NDAs needing regulatory approval. These user fees indirectly created more jobs in the private sector for clinical trial professionals. They are the reason I ended up working in and spending most of my career managing clinical trials.  

However and by the late 2010s, it was becoming harder for me to find a full-time non-contractual job as a clinical trials manager in the private sector. The user fees to look at a submitted NDA had ballooned to as much as $2.5 million. Drug development slowed considerably as only the largest big pharma companies could afford to pay such high fees. And they only wanted to come up with drugs for the most financially lucrative diseases.

To make matters worst for clinical trial professionals like me, many American big pharma companies no longer wanted to do clinical drug trials in America. The costs were too high, and there were just too many legal liabilities and regulatory headaches. 

When big pharma did have a drug or something that needed clinical trials done in America, they would hire clinical trial managers on temporary contracts that lasted no longer than the trial itself. When the clinical trials came to their endpoint or the moment it was clear that a drug or therapy would not work, the clinical trial managers would immediately have their contracts terminated and have to look for a new trial to manage.

When COVIDsteria hit, I had heard from friends at GroßPharma that they were developing a COVIDsteria vaccine and needed someone to manage their clinical trials. They also told me the Company had tried to outsource the clinical trials to India or some other third-world country where they could save money and where clinical trial laws and regulations were much looser. 

However, the President had recently issued a series of executive orders. These orders restricted the outsourcing of clinical drug trials, made it harder to bring in clinical trial managers from India on H-1B visas, and required the domestic sourcing of key drug components. These executive orders had turned the whole industry on its head, and American clinical trial managers like me were suddenly in short supply.

So I ended up quickly being hired by GroßPharma as a contract Clinical Trials Manager to manage any animal and human clinical trials for their new nDNA vaccine. 

Who designed the nDNA vaccine clinical trials? 

I thought the Director of Vaccine Research and myself would do the clinical trial designs. Of course, we would have input and approval from GroßPharma’s Scientific Committee and other internal experts. We would then need to get regulatory approval, but that was always a formality. 

However, Dr. Hodgson had given retirement notice and was already busy planning her move to Florida. Then I was handed clinical trial plans that supposedly came from the GroßPharma’s Scientific Committee. But to me, it seemed like these plans were all written by the legal, finance, and regulatory lobbying teams and maybe even Will Doors himself. [She frowns.]

Was it normal for pharma companies to design their own drug and vaccine clinical trials?

[She sighs.] Yes. It was perfectly normal for drug companies to design their own clinical drug trials within very flexible parameters given by the regulators. After all, we were paying the regulators millions of dollars in fees to look at our drug applications. 

The only difference this time around was the pressure to have a COVIDsteria vaccine. The President’s executive orders and new laws passed by Congress had given GroßPharma a blank check to conduct clinical vaccine trials however they saw fit.  

How were the nDNA vaccine clinical trials conducted? 

Not the way I would have wanted to conduct them... [She sighs.]