The rise of the 21st cen­tury ‘bio­quacks’

Bioin­dus­try chiefs claim so­cial me­dia has given char­la­tans global reach, re­ports Margi Mur­phy

The Sunday Telegraph - Money & Business - - Technology Intelligence -

One un­pleas­ant symp­tom of the web is that “quacks”, once con­fined to trav­el­ling on horse­back to dif­fer­ent vil­lages, have a global plat­form to mar­ket their bo­gus cures. A par­tic­u­larly chill­ing ex­am­ple cul­mi­nated in the death of Aaron Tray­wick, the As­cen­dance start-up founder who was found in a flota­tion tank in Wash­ing­ton, US.

As­cen­dance, a bio­hack­ing com­pany, made head­lines for its plans to bring cheap reme­dies to the gen­eral pub­lic.

Bio­hack­ing is a re­brand­ing of gene ther­apy that aligns it­self with the prin­ci­ples of Tesla’s Elon Musk and Face­book’s Mark Zucker­berg – garage hack­ers who fail fast and break the rules.

The start-up mantra could be per­ceived as a wel­come change. After all, it takes an es­ti­mated seven years, 10,000 pa­tients and more than $1bn (£0.7bn) to de­velop a suc­cess­ful drug.

Reg­u­la­tion and fund­ing for ex­per­i­men­tal gene ther­a­pies are even trick­ier. The emer­gence of cheap gene edit­ing kits that can be bought on­line of­fered hope, but now ap­pear to have the po­ten­tial to risk lives.

“There is a com­mu­nity at the fringes of so­ci­ety that be­lieve they un­der­stand the tech­nol­ogy around to­day and they are pre­pared to take the fastest route to suc­cess,” said Steve Bates, chief ex­ec­u­tive of the Bioin­dus­try As­so­ci­a­tion.

Bates said that “char­la­tans have al­ways mas­quer­aded and mis­rep­re­sented emerg­ing science to fund their fan­tasies”. But he ad­mit­ted that “so­cial me­dia has en­abled the quacks of the 21st cen­tury to be more eas­ily heard”, po­ten­tially cloud­ing the rep­u­ta­tion of se­ri­ous sci­en­tific en­deav­our hap­pen­ing in ex­per­i­men­tal medicine.

Tray­wick, 28, cer­tainly courted so­cial me­dia. He at­tracted global me­dia at­ten­tion when he dropped his suit trousers and in­jected him­self with her­pes while ap­pear­ing on stage dur­ing a bio­hack­ing con­fer­ence in Austin, Texas in Feb­ru­ary.

The stunt raised con­cerns, not only for Tray­wick’s health, but those who had signed up to As­cen­dance’s clin­i­cal tri­als. Tray­wick’s col­league, Tris­tan Roberts, also live-streamed in­ject­ing him­self in an at­tempt to cure his own HIV on Face­book.

Tray­wick was keen to quash any ques­tions over the com­pany’s le­git­i­macy fol­low­ing the stunts. As­cen­dance was a “gene ther­apy ac­cel­er­a­tor and incubator” fo­cused on cre­at­ing cheap treat­ments and de­liv­er­ing them to the gen­eral pub­lic. This was funded, he told The Sun­day

Tele­graph, by sign­ing up pa­tients for fer­til­ity and menopause re­ver­sal tri­als, 135 of whom paid an av­er­age of $5,000 for treat­ment. It is un­clear whether the tri­als were suc­cess­ful.

Tray­wick, speak­ing shortly after his con­tro­ver­sial per­for­mance, told The

Tele­graph that he had 14 dif­fer­ent gene ther­a­pies in ex­per­i­men­tal phases, with plans to even­tu­ally sell each treat­ment to pa­tients for $100. “We do not com­pli­cate to profit from the suf­fer­ing of oth­ers,” he said. Over the course of a num­ber of con­ver­sa­tions over the phone, Tray­wick failed to de­liver ev­i­dence that any of these ther­a­pies would work, but in­sisted that the work would trans­form what he felt was an opaque, im­pen­e­tra­ble and wholly prej­u­diced phar­ma­ceu­ti­cal in­dus­try.

On March 21, the US House of Rep­re­sen­ta­tives passed the “right-totry” bill. There are con­cerns within the in­dus­try that it will make it a lot eas­ier for po­ten­tial treat­ments to be used that have not un­der­gone suf­fi­cient test­ing, and le­git­imise ex­per­i­men­tal treat­ments that avoid reg­u­la­tors.

“It is not help­ful if politi­cians seem sup­port­ive of this, but I guess it is re­flect­ing their frus­tra­tion with the de­lays and ex­pense as­so­ci­ated with proper clin­i­cal tri­als – even though these are con­sid­ered the best way to re­duce chances of ad­verse ef­fects and to pro­vide ev­i­dence of ben­e­fit,” says Robin Lovell-badge, head of stem cell bi­ol­ogy and de­vel­op­men­tal ge­net­ics at the Fran­cis Crick In­sti­tute.

This might give the US a com­pet­i­tive edge, but it al­lows As­cen­dance copy­cats to fes­ter. Tray­wick and Roberts are cer­tainly not alone. En­tre­pre­neur Josiah Zayner is famed for his Youtube videos show­ing him us­ing CRISPR kits for per­sonal mod­i­fi­ca­tion.

Bri­tain’s biotech in­dus­try is overseen by strin­gent reg­u­la­tion but there is an ap­petite for dis­cus­sion around bal­anc­ing risks with in­no­va­tion. Le­git­i­mate, science-based biotech start-ups share lit­tle with the likes of As­cen­dance, but there is scope for chang­ing how aca­demics can ac­cess fund­ing to get treat­ments from plots of data to clin­i­cal trial. Biotech­nol­ogy, that is biotech start-ups, ge­nomics, di­ag­nos­tics and dig­i­tal health, make a sig­nif­i­cant con­tri­bu­tion to the UK econ­omy and to the health and well-be­ing of the pop­u­la­tion. Ac­cord­ing to a re­cent House of Lords re­port in­ves­ti­gat­ing life science’s prof­itabil­ity, it con­trib­uted £30.7bn to the econ­omy in 2015 and sup­ports 482,000 jobs.

Louise Hou­son, UK man­ag­ing di­rec­tor of Us-based MSD, which re­cently an­nounced a new re­search cen­tre based in Lon­don, told the Lords com­mit­tee that this de­ci­sion “was based on our abil­ity to get ac­cess to the best sci­en­tific tal­ent”. The UK “is a re­ally good place at the mo­ment to do early dis­cov­ery-stage science”, she said. As­trazeneca, which has also re­cently moved a large amount of R&D ac­tiv­ity to Cam­bridge, added that the UK should “play to our science strengths by de­vel­op­ing clus­ters of global ex­cel­lence in re­search”, all of which could be bol­stered by ven­ture cap­i­tal and at­tract­ing tal­ent into start-up style en­vi­ron­ments.

Amid the ex­cite­ment of an in­dus­try pre­par­ing to take off, there is a lin­ger­ing un­ease about the un­reg­u­lated play­ers that are emerg­ing. Lovell-badge said: “A lot of us have been fear­ing this might hap­pen for a long time.

“It is so easy to or­der things [CRISPR gene edit­ing kits] on­line. The stem cell field has been blighted by com­pa­nies of­fer­ing treat­ments with no ben­e­fits.”

The UK’S medicine reg­u­la­tor, MHRA, said that it was not aware of gene ther­apy kits on the UK mar­ket. A spokesman said: “While these prod­ucts could be im­ported from out­side the UK for per­sonal use, MHRA ad­vice is to think care­fully be­fore buy­ing prod­ucts such as these. It is not clear where they come from, the in­gre­di­ents are un­known and untested, and they may be harm­ful and dan­ger­ous.”

Dur­ing a phone call, as he walked to his lab, Tray­wick de­scribed how he felt he had suf­fered in­jus­tice at the hands of Amer­ica’s health­care in­dus­try and as a re­sult was op­posed to reg­u­la­tors.

“When I was a child my fam­ily took care of my grand­mother in a very small town in ru­ral Alabama. They had di­a­betes, which was very slowly killing them and it even­tu­ally got to the point where the doc­tors said ‘there is noth­ing we can do for her but if you want to keep her alive pay us this much money ev­ery day’.

“The bot­tom line was, ‘give us this much money or she dies’. I never want to be in the po­si­tion my par­ents were in, I hated them, I hated the doc­tors, I hated the sys­tem of health­care that let this sort of things hap­pen and I didn’t want it to hap­pen to any­one else.”

It is easy to see where the am­bi­tion comes from. Ex­per­i­men­tal gene ther­apy saved the life of 11-month-old Layla, who was treated for leukaemia in Great Or­mond Street Hospi­tal in June 2015, when all other op­tions were ex­hausted. These ex­am­ples are enough to lend hope to those who, with the right fund­ing, could gen­uinely help peo­ple.

“If you look at the case of Layla,” says Lovell-badge, “which was an ex­treme case when medics had tried ev­ery­thing else, you can see why peo­ple like Aaron Tray­wick are latch­ing on to this no­tion of of­fer­ing treat­ments that by­pass clin­i­cal tri­als …. The prob­lem is with rogue stem cell clin­ics it is so easy to prey on pa­tients for them to pay for cures that are to­tally bo­gus”.

Gene edit­ing kits are avail­able on­line, but have the po­ten­tial to risk lives, experts warn

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