Another genetic company was accused of false statements
The US Federal Trade Commission (FTC) announced that GeneLink Biosciences, a company specializing in personal genomics, whose services have already been used by about 30,000 people, made statements that were not confirmed by scientific data, and also did not provide adequate protection of the genetic information of its customers.
The company's statements sounded like a real miracle. It was enough for a person to scratch the inner surface of the cheek with a special brush, place the sample in a special container and send it by mail to GeneLink Biosciences. The company's specialists undertook to analyze the DNA contained in the sample and send the client a complex of dietary supplements selected based on the results of genetic analysis. According to the company's statement, its proposed protocols should reduce the manifestations of aging and help with diseases such as diabetes, heart disease, arthritis, insomnia, etc. However, the US Federal Trade Commission concluded that this statement is unfair advertising and initiated a lawsuit against the company, in which GeneLink Biosciences is accused that its statements were not based on convincing scientific data and misled customers.
This process is the latest in a series of scandals over the services provided by commercial companies for the sequencing of personal genomes. Two months ago, the US Food and Drug Administration (FDA) warned 23andMe about the need to stop selling personal genetic testing kits due to the lack of evidence requested from the company of the effectiveness of these tests, as well as due to concern from the agency that the erroneous results obtained by the company could harm its health. clients.
The lawsuit against GeneLink Biosciences is the first lawsuit brought by the FTC against a company specializing in personal genomics, and a warning signal for other similar companies. According to the resolution announced on January 7, GeneLink Biosciences and its former subsidiary (currently independent) company foru International must stop making unsubstantiated statements according to which the products they offer may in any way affect the course of diseases. In the future, such statements should be supported by the results of two randomized controlled clinical trials conducted by the double-blind method, which is the gold standard of medicine. Violation of this agreement will result in the imposition of a fine.
Another accusation made against GeneLink Biosciences is the lack of an adequate system for protecting customers' personal data, including genetic information, contact details, as well as social security and credit card numbers. According to data collected by the FTC, GeneLink Biosciences and foru International have collected genetic information on almost 30,000 customers since 2008. According to the agreement proposed by the commission, in the future companies should ensure the operation of comprehensive information security programs to protect customer data, as well as hire at least one employee to monitor the implementation of these programs. Companies must also undergo regular external audits to ensure the security of information.
The FTC was unable to comment on the issue regarding the possible initiation of proceedings against other genetic companies in the near future. However, it is known that earlier the commission began investigations of the activities of two other companies and both cases were closed, including due to the fact that the companies stopped offering their products in the United States.
Currently, consumers and regulators alike are not keeping up with the booming industry that provides medical services directly to the consumer. The described case raises new questions about personal genomics. According to James Evans, editor-in-chief of the journal published by the American College of Medical Genetics and Genomics, it will be very good if, thanks to such situations, the average consumer will treat such statements with a certain degree of cynicism. People should be able to trust products and statements, and when these statements become implausible, eventually the ban on the independent use of genetic tests will play a positive role.
Evgenia Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of Scientific American:
After 23andMe, Another Personal Genetics Firm Is Charged with False Advertising.
13.01.2014