HPV Vaccines in China: What Constitutes a Trade Secret?

by Chen I-wan, Researcher, Biological Disaster Prevention and Mitigation

[Note from SaneVax: The article below was written by a citizen of China who is concerned about the public having enough information to make a sound decision about the proposed use of HPV vaccines in his country. The SaneVax Team believes he has a valid point.

Why did citizens of China have to petition their government for access to clinical trial data currently available via multiple national and international government sponsored internet sites? Why is information regarding HPV vaccines which is open for public view throughout most of the world deemed a ‘trade secret’ in China?

These questions are particularly relevant when you consider the heated controversy surrounding HPV vaccination programs in so many countries around the world. Is it possible that Director Bi Jing-quan, leader of China’s State Bureau of Food & Drug Administration knows information contained in clinical trial data would reveal substantial safety concerns surrounding HPV vaccines?

Does Director Bi Jing-quan think the citizens of China would be eager to use HPV vaccines if they knew the true rate of adverse events is not known because no inert placebos were used during clinical trials? Is that one of the reasons HPV vaccine clinical trial data is a ‘trade secret’ in China?]

Why does China’s Food & Drug Administration, led by director Bi Jing-quan, refuse to disclose the toxicology report and clinical trial report by GSK on their HPV vaccine?

In July 2016, Beijing food safety volunteers submitted a “government information disclosure application” to the Chinese State Bureau of Food & Drug Supervisory Administration (State Bureau), requesting the release of toxicology test results and data from clinical trials GSK carried out on 6,000 Chinese females prior to their HPV Cervarix® vaccine being approved by the State Bureau.

The “Government Information Disclosure Notifying Document” issued by the State Bureau on Aug. 22, 2016 outrageously argued:

“The information concerning clinical trial data you requested involves enterprise commercial secrets so does not fall under scope of government information disclosure.”

The "Government Information Disclosure Notifying Document" issued on Aug. 22, 2016 by the Chinese State Bureau of Food & Drug Supervisory Administration

The “Government Information Disclosure Notifying Document” issued on Aug. 22, 2016 by the Chinese State Bureau of Food & Drug Supervisory Administration.

When considering the safety and efficacy evaluation of new drugs and vaccines, what constitutes a ‘trade secret’? What information should be kept confidential and not disclosed to the public?

What information is not considered to be a ‘trade secret’ and should be disclosed to the public?

Consider the U.S. FDA definition of “Trade Secrets” below:

fda-trade-secret

According to the U.S. FDA:

“A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process.

Trade secrets include such things as a company’s manufacturing processes and precise product formulations. The Task Force believes that trade secrets have limited value for public disclosure, and that the value for public disclosure of other types of data, such as clinical trial results and adverse event reports, is significantly greater.”

 

The U.S. FDA official website has disclosed and posted:

1) Merck Sharp & Dohme Corp., Toxicology Review of Human Papillomavirus 0-Valient Vaccine, Recombinant (45 pages)

2) VRBPAC Background Document, GardasilTM HPV Quadrivalent Vaccine, May 18, 2006 VRBPAC meeting (30 pages)

3) Clinical Review of Biologics License Application for Human Papillomavirus, manufactured by Merck, Inc. By Nancy B. Miller, M.D. Medical Officer, Vaccines Clinical Trial Branch, Division of Vaccines and Related Products Application, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA (464 pages)

4) Human Papillomavirus (HPV) Registration Study (Gardasil), Last updated: Jan. 7, 2016 (Completed) (Full Text View + Result: 10 pages)

The U.S. NIH (National Institutes of Health) has disclosed and posted:

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Europe’s EMA (European Medicines Agency) has disclosed and posted:

Scientific Discussions (Gardasil – Merck), EMA, 2006 (40 pages)

Why does the Chinese State Bureau of Food & Drug Supervisory Administration led by Party Secretary and Director Bi Jing-quan refuse to disclose GSK’s toxicology reports and clinical trial data on their HPV vaccine?

All those who work to impede the “Healthy China” strategy proposed by chairman Xi Jin-ping, or in any manner harm sustainable safety, health, survival and reproduction of the Chinese nation, are all felony sinners against the Chinese nation, and absolutely cannot escape ruling and punishment by the people’s court!

(Note: The above article was written by Chen I-wan, Researcher, Biological disaster prevention and mitigation, and posted on Advisor Chen I-wan Blog on September 25, 2016)

Read this article on the Chinese site here.

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