Key takeaways:

• The U.S. House Select Committee on China has opened investigations into AbbVie, Bristol Myers Squibb, Eli Lilly, Merck and Pfizer.
• The committee chairman questioned whether the drugmakers have aided China’s military biotechnology research.

The U.S. House Select Committee on China has opened investigations into five pharmaceutical companies regarding their clinical trials in China, questioning whether the drugmakers may have aided the country’s military biotechnology research.

Representatives from AbbVie, Bristol Myers Squibb, Eli Lilly & Co., Merck and Pfizer have until July 17 to answer letters sent to each by committee chairman Rep. John Moolenaar, R-Mich., requesting information detailing due diligence and other standards, including intellectual property and data protection, at clinical trial and manufacturing sites in Chinese military hospitals and the Xinjiang Uyghur Autonomous Region.

The U.S. House Select Committee on China has opened investigations into AbbVie, Bristol Myers Squibb, Eli Lilly, Merck and Pfizer.

“Clinical trials held at PRC military hospitals raise significant questions related to how data developed through clinical trials at those hospitals could fuel the CCP’s military biotechnology research, experimentation, and capability development,” Moolenar wrote in the letters to each of the drug companies.

“Clinical trials involve collaborative research activities with doctors, nurses, and other officials at the trial sites and produce sensitive and proprietary data,” Moolenaar continued. “Conducting this research at PRC military hospitals puts the cutting-edge, biotechnology intellectual property (IP) of American companies at potential risk of being transferred to the Chinese military.”

The letters also questioned whether clinical trials in the Xinjiang region were conducted using best practices and without forced labor. Moolenaar referred to Xinjiang as the “epicenter of the CCP’s genocide targeting Uyghurs and other ethnic and religious minorities.” He additionally noted that the 2021 Uyghur Forced Labor Prevention Act prevents goods made with forced labor in the Xinjiang Uyghur Autonomous Region from entering the United States.

“Given what we know about the human rights abuses and oppression in Xinjiang, it is reasonable to question whether clinical trial subjects there are participating voluntarily and with informed consent — indispensable principles of good clinical practice,” Moolenaar wrote.

The letters noted there is no evidence that any of the five drugmakers have engaged in illegal activity or wrongdoing. However, Moolenaar added that conducting clinical trials at Chinese military hospitals and within the Xinjiang region could expose American companies to “ethical and security risks — some of which even the most robust due diligence may not be sufficient to mitigate.”

In response to their letter, Merck issued the following statement to Healio:

“At Merck (known as MSD outside the United States and Canada), patient safety and ethical integrity are the foundational priorities of our clinical research program worldwide. We agree that all clinical trials should be conducted to the same high ethical standards while upholding human rights, regardless of location. That’s why our company follows global standards in accordance with the International Conference on Harmonization - Good Clinical Practices (ICH-GCP), the Council for International Organizations of Medical Sciences International Ethical Guidelines for Health-Related Research Involving Humans (CIOMS, 2016), the Pharmaceutical Research and Manufacturers of America (PhRMA, 2015 Principles on Conduct of Clinical Trials, applicable local regulatory requirements), the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and the ethical principles that have their have their origin in the Declaration of Helsinki.

“We look forward to a collaborative discussion with the committee on advancing U.S. biotechnology innovation and continuing to ensure ethical clinical trials worldwide,” the statement concludes.

Representatives from AbbVie, Bristol Myers Squibb, Eli Lilly and Pfizer did not immediately respond to requests for comment from Healio.

According to Moolenaar, AbbVie has sponsored at least 17 trials at hospitals in Xinjiang, as well as at least 16 trials at Chinese military medical centers and hospitals. These trials reportedly investigated treatments for conditions including several cancers, dermatitis, migraines and systemic lupus erythematosus, the letter states.

Bristol Myers Squibb has sponsored at least eight trials at hospitals in Xinjiang, and at least 17 trials at Chinese military medical centers and hospitals, according to the letters. Trials there investigated treatments for MS, lupus, Sjögren’s disease, multiple myeloma and other cancers, Crohn’s disease and other conditions, according to Moolenaar.

Eli Lilly has sponsored at least 11 trials in Xinjiang hospitals, plus at least 16 trials at Chinese military medical centers and hospitals, according to their letter. These trials examined treatments for type 2 diabetes, heart disease, obesity, Alzheimer’s disease, axial spondyloarthritis, breast cancer, lupus, alopecia, Crohn’s disease and other conditions.

Merck has sponsored at least 31 trials in Xinjiang hospitals, as well as at least 40 trials at Chinese military medical centers and hospitals, according to their letter. Trials there examined treatments for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, prostate and other cancers, bacterial pneumonia and other diseases, Moolenaar wrote.

Pfizer has sponsored at least six trials within Xinjiang hospitals and at least 43 trials at Chinese military medical centers and hospitals, according to Moolenaar. These trials studied treatments for migraines, dermatitis, cervical and other cancers, psoriatic arthritis, plaque psoriasis, fibromyalgia and other diseases, their letter states.

According to the letters, all the trials have been conducted since 2015, with several ongoing.

In the letter to Pfizer, Moolenaar noted that the company has stated it “will no longer sponsor trials in Xinjiang and at PRC military hospitals in the future.”

“I commend this decision, and I would like to learn more about the company’s due diligence efforts that led to it,” Moolenaar wrote to Pfizer. “Furthermore, I would also like to understand how Pfizer’s decision affects its partnerships with Chinese biotechnology companies and associated due diligence efforts.”