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Author Topic: UK and USA Genetic data Bio Banks - the future?  (Read 4624 times)
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12 December 2013

By Dr Ruth Stirton
Lecturer in law, University of Sheffield
Appeared in BioNews 735

Last week, the US Food and Drug Administration told 23andMe to discontinue some of their personal genetic testing services. They were sent a letter requiring them to stop marketing their 'spit kits' because they were in violation of the Federal Food, Drug, and Cosmetic Act (FD&CA).
The saliva collection kits were being marketed as providing health information to help prevent illnesses including some of the most serious types of cancer. This use makes the tests medical devices under the FD&CA. To obtain the proper marketing authorisation, 23andMe had to submit evidence that the tests had been analytically and clinically validated for the intended uses. None of this evidence had been submitted to the FDA, who state in their letter that many of the necessary trials had not even started.
23andMe continued to market their tests as health reports, adding new indications that could be tested for, and embarking on an extensive television advertising campaign. All this, without having marketing authorisation in place, and without continuing to communicate with the FDA. Matthew Herper suggested that 23andMe were either trying to force a fight with the FDA - which they will almost certainly lose - or they had engaged in the 'single dumbest regulatory strategy' he had seen in his time.
23andMe has accumulated a database of 500,000 genomes since 2007. It underwent no ethical approval process before it started selling DNA testing kits. There are no ethicists on the advisory boards, or on the team as advertised on the website. There is no evidence of 23andMe using independent ethics advisors.
UK Biobank also has a database of at least 500,000 genomes. It is a national population tissue bank that collects genetic information from its participants, as well as detailed health and lifestyle information. Scientists can apply to the bank for access to the data to be used in ethically approved research projects. There is an independent Ethics and Governance Council overseeing compliance with the ethics and governance framework which was subject to an extensive public consultation process. UK Biobank also has approvals in place from the North West Multi-Centre Research Ethics Committee, the Patient Information Advisory Group and the Human Tissue Authority.
These are both large genetic databases. They are big enough to engage in serious population genetic research and to advance genetic research quite significantly. 23andMe have made no provision to open their database to researchers from any other institutions except for their limited call for academic collaborators in 2012, the success of which is not clear from their website. The only people with rights to use the information are those already employed by 23andMe, and those to whom 23andMe choose to sell the information. As I have argued, there are no credible governance arrangements in place. The only restriction on what 23andMe can do with their database is contained within their privacy policy, which they can unilaterally change at any time.
A small change to the privacy policy, and 23andMe could sell the database to the insurance industry, who could use it for underwriting health and life insurance. They could sell it to the pharmaceutical industry who could use it for marketing new products. They could sell it to a supermarket who could combine it with their loyalty card schemes to help target their offers. It was only last year that saw reports of Target using shopping habits to identify pregnant women. Think what they could do with a database linking genetic information to shopping habits. If that information were combined with Google or Facebook, they would be in possession of an extremely powerful resource.
Imagine that you have a genetic predisposition to heart disease, as identified on your entry in 23andMe's database, and you regularly write on your Facebook page about eating junk food while not at the gym, and you use Google to search for the symptoms of angina. If your insurance company could have access to that information before you bought your insurance, your premiums would skyrocket.
Big data of this type is powerful. It has a great deal of promise. That is why we have encouraged UK Biobank and why we support the research that is being done. But UK Biobank's data use is restricted. It cannot be used except in accordance with the ethics and governance framework. It cannot be sold. It cannot be used for commercial ends. The ethical implication of their work is regularly reviewed by an independent Ethics and Governance Council. 23andMe has none of this oversight. They have halted the sale of health-related tests for the moment, but in the event that 23andMe do gain the appropriate marketing authorisations, the collections will begin again, and eventually they will have the million genomes they are seeking. Who knows what could be done with a database that big.
 
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RELATED ARTICLES FROM THE BIONEWS ARCHIVE
23andMe's genetics screening service sold in violation of regulations, says FDA
02 December 2013
By Ruth Saunders
Appeared in BioNews 733
The US Food and Drug Administration (FDA) has ordered 23andMe to 'immediately discontinue' its Personal Genome Service (PGS) after failing to undergo proper agency approval for its marketing claims.
Alberto Gutierrez, director of the FDA's Center for Devices and Radiological Health, stated in a letter dated 22 November, that 23andMe had failed to address the agency's concerns that the tests could dangerously mislead people about their health.
23andMe first introduced the PGS to the market in 2007, and sells access to an array of information on more than 260 genetic conditions and traits, from a person's carrier status, disease risk, drug response and traits.
The warning letter, addressed to 23andMe co-founder Anne Wojcicki, targeted specific marketing claims about the PGS as a 'first step in prevention' that enables users to 'take steps toward mitigating serious diseases', including heart disease, and breast cancer.
Gutierrez wrote that the 'FDA is concerned about the public health consequences of inaccurate results from the PGS device'.
He mentions 'the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these'.
'For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions'.
Relying on the assessments for drug response could lead customers to 'self-manage' their treatment or abandon treatment altogether, resulting in illness, injury or death, according to the FDA.
The Federal Food, Drug and Cosmetics Act regulates products that are intended to diagnose, mitigate, treat or prevent disease.
The company must provide proof about how accurate its tests are as well as supplying information on the rate of false positives and false negatives.
'Most of these uses have not been classified and thus require premarket approval as FDA has explained to you on numerous occasions', said Gutierrez.
The FDA said it has had 'more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications' with 23andMe to discuss compliance with the statute.
'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work'.
'However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions', Gutierrez wrote.
As such, the FDA writes that the applications are considered withdrawn and 23andMe must immediately discontinue marketing until it receives FDA authorisation for its claims.
Failure to take the proper action, the FDA warned, could lead to seizure, injunction, and civil money penalties.
23andMe co-founder Anne Wojcicki responded on the company's blog: 'In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August'.
'We received feedback on those submissions and acknowledge that we are behind schedule with our responses'.
'This is new territory for both 23andMe and the FDA', she wrote.
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