Chinese biopharmaceutical company, Changsheng Bio-Technology, is under investigation by Chinese regulators for allegedly falsifying data for a number of products.
Chinese biopharmaceutical company, Changsheng Bio-Technology, is under investigation by Chinese regulators for allegedly falsifying data for a number of products. As the investigation continues, the Shenzhen Stock Exchange has barred the company’s major shareholders and executives from selling stock and may delist the company.
In November 2017, Chinese authorities indicated that two batches of DPT vaccines (diphtheria, whooping cough and tetanus) made by Changsheng and the Wuhan Institute of Biological Products didn’t meet national standards. On July 15, 2018, an unannounced inspection found evidence of forged data related to the company’s manufacture of approximately 113,000 rabies vaccines. At that time the State Drug Administration revoked the company’s license to produce the vaccine, and initiated recalls. Production of the vaccine was suspended the next day, and on July 18, the Jilin Food and Drug Administration fined the company 3.4 million yuan ($502,000 U.S.) over the DPT vaccines from the previous year.
On July 20, the Jilin FDA indicated that the Shandong Disease Prevention and Control Centre had about 252,600 substandard DPT vaccines made by the company. Two days later the People’s Daily, what is described as the “Communist Party mouthpiece” published commentary on the scandal, calling for a thorough investigation. At which time Chinese Premier Li Keqiang ordered an immediate investigation. This was followed a day later—July 23, 2018—by Chinese President Xi Jinping calling the scandal “appalling” and ordering an investigation.
Trading in the company’s stock will be halted on July 25, but restarted on the following day under what it is calling “special treatment” because the company doesn’t expect to resume normal business operations for three months.
Although the scope of the Changsheng Bio-Technology fraud is unusual, occurrences of data fraud are not unheard of.
In 2010, a False Claims Act complaint was filed against Merck & Co. Two virologists who worked at Merck, Stephen Krahling and Joan Wlochowski, filed a suit that was unsealed in 2010 accusing the company of falsifying its mumps vaccine test results to hit an efficacy rate of 95 percent. According to the scientists, Merck added animal antibodies to a blood sample to give the impression of increased antibodies. It spawned several lawsuits.
In 2015, the World Health Organization issued a “notice of concern” (NoC) to India-based contract research organization (CRO) Quest Life Sciences Pvt Ltd over critical lapses from clinical trial standards.
The report stated that the WHO Prequalification Team (PQT) inspected the company’s Chennai, India facility between October 13 and 17, 2014, focusing on Study No. LAZ/032/13, for HA619 Lamivudine, Zidovudine and Nevirapine tablets from Micro Labs Ltd. The three drugs are used to treat HIV.
“The inspection revealed critical and major deviations,” the report stated, “from the WHO Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards as published in WHO publications.”
The team described lack of data integrity in records, problems in subject safety, poor quality assurance, and other issues. Approximately 67 percent of pre-study electrocardiograms (ECGs) in the documents were duplicates. WHO stated, “This means that ECGs may not have been performed or were unreliable and therefore ineligible/unfit subjects could have been used in the study and protocol requirements may not have been met.”
In 2016, the U.S. Food and Drug Administration (FDA) sent a warning letter to India-based Emcure Pharmaceuticals, citing “significant violations” of standard manufacturing practices found during a site inspection between Jan. 27 and Feb. 4.
“We observed multiple examples of incomplete, inaccurate, or falsified laboratory records,” the letter, dated March 3, stated. It was addressed to Satish Mehta, Emcure’s chief executive officer, and was posted on the FDA website on March 15, 2016.
The falsified records were related to appropriate environmental controls testing, which is performed to ensure drugs aren’t contaminated. An employee at the facility told FDA inspectors that faking records was “routine and due to work pressure.”
In January 2016, the FDA sent a report to Mumbai, India-based Wockhardt, indicating the company intentionally hid and deleted data regarding failed tests at its Shendra facility.
And in the U.S., one of the most recent well-known cases of fraud revolves around Theranos. It was reported on July 24, 2018, that the company settled a lawsuit filed by investors alleging they were defrauded by the company. It ends a civil lawsuit brought against the company by Robert Colman and others who “made indirect investments” in Theranos. They sued Theranos saying it made “false and misleading statements about its technology.”
The company’s chief executive officer Elizabeth Holmes and former company president Ramesh “Sunny” Balwani are also facing criminal fraud charges alleging they engaged in a multi-million dollar scheme to defraud investors, as well as a separate plan to defraud doctors and patients. They have both entered not guilty pleas to the criminal charges.
