Superdrug criticised by doctors for stocking genetic self-testing kits

http://www.theguardian.com/science/2015/mar/31/superdrug-criticised-doctors-genetic-self-testing-kits

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The leader of Britain’s GPs has warned that doctors are “extremely worried” by the sale of genetic self-testing kits by the Superdrug chain which started on Tuesday.

Maureen Baker, chair of the Royal College of General Practitioners, suggested the move would lead to “unnecessary worry and anxiety” for patients and have huge implications for doctors already struggling to care for those with increasingly complex diseases.

The campaigning group GeneWatch UK accused Superdrug of “acting irresponsibly” as it began selling genetic self-testing kits at £124.99 each in more than 600 of its UK stores.

Related: DNA-screening test 23andMe launches in UK after US ban

The organisation urged shoppers not to buy the products either online, where they have been available since late last year, or from stores.

Superdrug has teamed up with the US company 23andMe to sell products currently banned by US regulators. UK watchdogs have advised consumers to “think carefully” before using them.

The test manufacturers said their products enable “affordable access” to personal genetic information, allowing people to find out more about their ancestry and health.

Spit kits are sent to the Netherlands for processing before testing in the United States. The results take between four and six weeks.

The tests’ manufacturers claim to provide information on genes associated with inherited conditions, including cystic fibrosis and sickle cell anaemia, and enable a greater understanding of the risk factors for blood clotting, Alzheimer’s disease and Parkinson’s disease.

In addition, 23andMe said the tests helped consumers learn more about the genetics behind traits such as whether or not they are frequent smokers, how they metabolise caffeine and how they respond to exercise.

Baker also recognised the “huge potential” for individual testing of patients and the health of the wider population but stressed the role of doctors in the process.

“We estimate that at least one in 10 of our patients in general practice has a genetic disorder and GPs play a key role in identifying families with conditions such as cancer, cardiovascular disease and diabetes, then helping them manage their condition.”

Baker said that taking and considering a genetic family history “is a key skill that is best left to medical professionals, who can also provide the necessary support and advice to patients in a private and confidential environment.

“At a time when we have a severe shortage of GPs and family doctors are already struggling to care for rising numbers of patients with increasingly complex diseases, it is difficult to see how we will be able to deal with the extra volume of people that this initiative will undoubtedly encourage to visit their GP surgery for routine check-ups,” she continued.

“We fear that this scheme will only cause people unnecessary worry and anxiety. We would also discourage patients from paying out significant amounts of money for tests that, if appropriate, are available free on the NHS.”

Helen Wallace, director of GeneWatch UK, said: “23andMe’s gene tests are banned in the United States because the evidence for the health claims they make has not been confirmed. Superdrug is acting irresponsibly by selling unregulated gene tests with no medical involvement.”

Her organisation also said that current UK regulations only covered the safety of the tube used to collect spit and its adherence to laboratory standards, meaning there was no independent check on the claims made by a company about an individual’s genetic risk of developing disease.

23andMe’s president, Andy Page, said: “Our mission is to help people access, understand and benefit from the human genome.” Selling in stores would “improve accessibility” for customers, he insisted.

The company said it had already has 10,000 UK customers through online sales. Its survey had suggested a quarter shared their reports with doctors but only 4% made a special appointment to discuss results. Mostly they were discussed at already scheduled routine appointments .

Users had mainly discussed information with family members and more than seven in 10 “indicated the information they learned from their health and trait reports has been ‘extremely valuable’”, the company said.

23andMe also pointed to an article which genome expert Robert C Green of Harvard Medical School and a colleague published in the science journal Nature last year, suggesting US regulators were wrong to ban such tests’ use.

Steve Gray, healthcare director at Superdrug, said the partnership with 23andMe would “help people actively take steps to look after their health”.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said: “Products used in personal genome services are regulated by the MHRA to meet minimum standards. People who use these products should ensure that they are CE marked and remember that no test is 100% reliable, so think carefully before using personal genome services.

“If after using the service, you have any questions or concerns you should speak to your healthcare professional.”

The US Food and Drug Agency (FDA) banned the 23andMe product along with others in 2013. The company is still working on obtaining FDA approval.

The NHS is currently working on its own initiatives to develop genomics and improve patient care.