Chinese Communist Party, Wuhan, Uyghurs, Clinical Trials

The Select Committee On The Chinese Communist Party wants answers from the FDA

A couple of months ago, I happened upon The Select Committee On The Chinese Communist Party website.

Fascinating. For real.

I started researching and realized this bipartisan committee received very little media attention — but it should.

According to its website: “The Select Committee on the Chinese Communist Party is committed to working on a bipartisan basis to build consensus on the threat posed by the Chinese Communist Party and develop a plan of action to defend the American people, our economy, and our values.”

Republican Congressman John Moolenaar of Michigan serves as Chairman of the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party.

Illinois Congressman Raja Krishnamoorthi, a Democrat, is the ranking member. No members of the Arkansas congressional delegation are on the committee.

Why this subcommittee doesn't get more press is perplexing. I signed up for their news releases because I'm very curious how China's business practices influences the United States, and, in turn how the United States works with China especially since the pandemic.

This week, the subcommittee sent a news release about how it was seeking information “from the FDA about the alarming practice of U.S. biopharmaceutical companies conducting clinical trials alongside the People’s Liberation Army (PLA) and in Xinjiang, where the CCP is engaged in genocide of the Uyghur people.

“Reps. Neal Dunn, M.D. (R-FL) and Anna Eshoo (D-CA) joined the inquiry, in which the lawmakers raised serious concerns that the PLA is co-opting sensitive intellectual property through these clinical trials and questioned the ethics of conducting these trials in Xinjiang."

The release stated: “Publicly available information on the FDA’s website, ‘clinicaltrials.gov’, reveals that major U.S. biopharmaceutical companies have conducted hundreds of clinical trials alongside a PLA entity over the last 10 years. In addition to work with the PLA, the lawmakers identified U.S. companies conducting clinical trials in Xinjiang. The CCP forces ethnic minorities in Xinjiang to participate in gruesome medical procedures, which likely overlap with FDA-approved research.”

They continue, “Conversely, there are also concerns with the trustworthiness of clinical trial data produced overseas from PLA institutions. The FDA has previously declined to approve oncology treatments based on clinical trial data solely produced from clinical trial sites in China, suggesting the FDA should also impose similar scrutiny to clinical trial work done in cooperation with the PLA.”

Given the overwhelming amount of FDA-approved coordination between U.S. companies and PLA entities in China, the bipartisan group of lawmakers request answers to the following questions:

1. Has the FDA reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities?

2. Has the FDA ever been denied access to foreign clinical trial sites in the PRC, including but not limited to trial sites located on facilities affiliated with or owned by the PLA?

3. How many PLA-owned, operated, or affiliated facilities has the FDA reviewed for clinical trial work?

4. What is FDA’s estimated average cost for adjudicating a clinical trial conducted in the PRC?

5. What is the earliest date for which the FDA received clinical trial data that included PLA organizations? 

6. Given FDA’s regulations for ensuring that clinical trials are conducted according to ethical and safety standards, has the FDA ever notified any U.S. biopharmaceutical organization that it has conducted studies with the PLA or in the XUAR? If so, please provide the number of notices and time periods when they were issued, and if companies were responsive.

7. What metrics does FDA use when assessing IP and technology transfer risks? Within those metrics, how are the risks calculated when research studies identify collaborations with the PLA or involve PLA-owned facilities as the setting for the research?  

The letter to the FDA was attached.

Where is Xinjiang Uyghur Autonomous Region?

Xinjiang is in northwestern China.

For the last 10 years, the Chinese government has committed a series of ongoing human rights abuses against Uyghurs and other Turkic Muslim minorities in Xinjiang that has often been characterized as persecution or as genocide.

It's also a place where China's “biopharma ecosystem” flourishes.

In 2020 a Chinese news site reported: “Many pharmaceutical companies in Northwest China's Xinjiang Uygur autonomous region are now operating at their full capacity to produce Xinjiang featured medicines to help support Wuhan, the center of the novel coronavirus epidemic in the fight against the disease.

‘The outbreak of pneumonia caused by the novel coronavirus affects the hearts of the people from all over the country, and pharmaceutical manufacturers should spare no effort to help prevent and control the outbreak of the deadly disease,’ said Duan Jiangtao, a senior executive of Xinjiang Yinduolan Uighur Medicine Co Ltd.”

The subcommittee's letter specifically focused on an ongoing trial of Eli Lilly’s Alzheimer’s disease drug donanemab. This drug was recently approved in the U.S. as Kisunla. A former study of Pfizer’s Inlyta in liver cancer also was cited.

Lilly’s trial is being run at the PLA’s General Hospital and Medical School and the military’s Air Force Medical University. Pfizer’s medicine study was conducted with a hospital under the PLA’s Academy of Military Medical Sciences (AMMS), according to the letter.

Last year, the FDA released the following:

Oddly enough, a Google search uncovered a 2006 study by Nickolas Zaller, a professor at University of Arkansas for Medical Sciences (UAMS), concerning blood donors in Xinjiang. Zaller is an internationally known addiction researcher at UAMS and a Fulbright Scholar fluent in Chinese, according to the UAMS website.

That's simply a small-world connection to Little Rock from Xinjiang.

The bigger picture is how the FDA will respond to the The Select Committee On The Chinese Communist Party.

Lawmakers have given the FDA an Oct. 1 deadline to respond.