Medical triumphs hit privacy
Deliberate or accidental disclosure of personal information could result in discrimination, according to leading authorities. Shan Juan reports.
Increasingly strict government controls on genetic information have resulted in longer, slower registration procedures for new and developing drugs. However, the procedures could pose a threat to the people’s privacy, according to an expert at the Chinese Academy of Sciences.
In an exclusive interview with China Daily, Chen Kaixian, who is also a member of the National Committee of the Chinese People’s Political Consultative Conference, said rather than providing extra safeguards, the precautions are actually making genetic information less secure. He urged greater streamlining of the procedures to ease the bottleneck and shorten the registration process.
In late 2015, the Ministry of Science and Technology issued a statement outlining extra application and approval procedures for clinical drug trials conducted in collaboration with foreign pharmaceutical companies or by research institutions funded by money from overseas. The same strictures apply if projects are overseen by foreign nationals.
The measures require tests to be conducted on a greater number of people, which has resulted in a substantial rise in the amount of personal information being collected and stored.
According to Chen, the stricter procedures have had a negative effect on many potential new treatments in China.
“Many companies have reported six to nine months extra waiting time, which has seriously slowed down the approval process for badlyneeded new drugs,” he said. “Given the concerns related to privacy and security, it’s entirely reasonable for national governments to collect and store people’s genetic information. However, that should be balanced with the research and development of new drugs.”
Although he is in favor of prohibitions on the disclosure of genetic information, especially overseas, Chen said the measures should be amended: “The current procedures can still be improved to make them more efficient.”
In contrast, Zhou Qi, a researcher at the Chinese Academy of Sciences’ Institute of Animal Research, urged even stricter management and regulation. “Genetic information cannot be replicated, and is crucial to life-science research and the development of drugs,” he said.
Scandals
In recent years, there have been a number of scandals involving illegal cross-border projects in the field, largely as a result of the increasing availability, affordability and accuracy of genetic testing. However, these activities are largely underground, so they are difficult to detect, according to Zhou.
Fortunately, the government has recognized the importance of protecting genetic information and has constantly strengthened management of the collection and exportation of human body samples that can be used for genetic testing, particularly when the process involves overseas nationals, he said.
However, industry analysts said the personal genetic-test- ing sector is thriving, especially at nonmedical facilities.
Genetic testing uses a number of techniques, such as analysis of human DNA and a variant called RNA, and proteins, they said.
Zhao Ping, director-general of the Cancer Foundation of China, said medical treatment cannot be given purely on the results of genetic tests, and carrying certain faulty genes doesn’t necessarily result in related medical conditions, because factors such as environment and lifestyle also play major roles.
Personal testing
In recent years, personal genetic-testing kits have become widely available in China via e-commerce platforms and offline facilities that specialize in health checks.
The tests, which cost several hundred to tens of thousands of yuan and are usually conducted via oral swabs or blood taken from the finger, have a number of uses. They range from predicting the risk of developing conditions such as cancer, diabetes, hypertension and Alzheimer’s disease, to assessments of an individual’s potential talents, or even a person’s ability to consume alcohol.
Liang You, a 27-year-old mother in Beijing, has just placed an online order for a genetic-testing kit which the manufacturers claim can identify her 3-year-old son’s potential talents, such as intellectual, sporting or musical ability.
The kit, which cost 1,988 yuan ($288), claims to test for 19 separate indicators, such as memory and attention span, plus linguistic, creative and athletic abilities.
“The kit is affordable, and oral swabs are not dangerous. The results could help me choose the right extracurricular programs for my son,” Liang said.
However, Zhao, from the cancer foundation, said the kits are more about fun than science: “These personal testing products are largely unregulated, so we see a wide range of them offered via the internet.”
Earlier this month, the US Food and Drug Administration allowed marketing of the country’s first direct-to-customer genetic tests, which assess the risks of contracting 10 medical conditions, according to an FDA statement.
Tests manufactured by a US company called 23andMe may help people make lifestyle choices or inform discussions with healthcare professionals about potential intervention, the statement said.
The illnesses include Parkinson’s disease, late-onset Alzheimer’s, celiac disease (an autoimmune disorder), hemophilia C and excessive absorption of iron, which may lead to organ damage.
Jennifer Ho, a physician at the Massachusetts General Hospital, is skeptical of the value of random testing.
“It only makes sense for an individual to be genetically screened if there are prior medical indications,” she said.
Ho urged people to be screened at professional, officially regulated facilities to avoid illegal or accidental disclose of information: “We (people in the United States) worry a lot about privacy of personal genetic information. I’m concerned about what subsequently happens to the details obtained by testing companies.”
In addition to unauthorized disclosure of private information, she identified a number
Would you want information about your genomic sequence to be available to the public or to insurance companies? ... Governments must strictly regulate these practices to protect privacy and avoid potential discrimination.” Jennifer Ho, a physician at the Massachusetts General Hospital
of potential risks, such as accidental contamination or deliberate switching of samples.
“Would you want information about your genomic sequence to be available to the public or to insurance companies?” she said, adding that insurers may reject claims or potential customers whose tests indicate the risk of certain illnesses. “Governments must strictly regulate these practices to protect privacy and avoid potential discrimination.”
Insurance concerns
Luo Yongzhang, a professor of biochemistry at Peking University, said the greater availability of genetic testing and genomic sequencing mean privacy and the threat of discrimination have become important issues in developed countries.
For example, insurance companies may refuse to provide cover for women with defective genes that increase the odds of developing breast cancer. “The general public is still not fully aware of the looming risk,” he said.
In recent years, Chinese insurance companies have enthusiastically embraced genetic testing, mainly as a result of constant reductions in the price of the relevant technology.
Now, many health insurers are partnering with institutions that offer genetic tests by launching insurance packages that offer free tests, either via kits or in designated facilities.
Experts warned that the practice is more about business promotion than health.
“They want to establish a health information pool, specifically focused on the genetic data of clients or potential clients. That information helps with precision targeting of individuals being insured,” said an industry insider, who preferred not to be named.
In addition, inappropriate disclosure of details is a growing concern.
A lack of related laws and regulations in China means unscrupulous companies or individuals may sell a person’s genetic information for profit without permission, the insider warned.
Moreover, leaked information could lead to discrimination, particularly in areas such as marriage or employment, where people with a clean bill of genetic health will be favored, according to experts. They warned that employers could use the information to decide whether to hire or fire workers.
A 2004 survey by the US Genetics and Public Policy Center found that 92 percent of respondents did not think employers should have access to genetic information, while 80 percent were opposed to insurance companies gaining access to private details.
Luo, from Peking University, said public awareness should be further heightened in China, and urged people to pay more attention to the issue.
“The public should be aware of the privacy concerns about genetic information and people should also be wary of genetic-testing products,” he said.