ECHO-7
{{Short description|Group of viruses}}
ECHO-7 (trade name Rigvir) is a wild type member of the echovirus group of viruses.{{cite journal|last1=Babiker|first1=HM|last2=Riaz|first2=IB|last3=Husnain|first3=M|last4=Borad|first4=MJ|title=Oncolytic virotherapy including Rigvir and standard therapies in malignant melanoma|journal= Oncolytic Virotherapy|date=2017|volume=6|pages=11–18|doi=10.2147/OV.S100072|pmid=28224120|pmc=5308590 |doi-access=free }} It was formerly approved as a virotherapy medication by the State Agency of Medicines of the Republic of Latvia (2004–19).{{Cite web|url=http://www.zva.gov.lv/zvais/zalu-registrs/?iss=1&lang=en&q=Rigvir|title=Medicinal Product Register of Latvia|website=www.zva.gov.lv|access-date=2018-11-18}} In March 2019, the distribution in Latvia was stopped by the State Agency of Medicines, after laboratory tests found that the amount of ECHO-7 virus was in much smaller amounts than claimed.{{Cite web|url=https://eng.lsm.lv/article/society/health/rigvir-cancer-treatment-at-center-of-fresh-controversy.a313826/|title=Rigvir cancer treatment at center of fresh controversy}} On May 31, 2019, the State Agency of Medicines suspended the registration licence of ECHO-7.{{Cite web|url=https://www.zva.gov.lv/lv/jaunumi-un-publikacijas/jaunumi/aptureta-rigvir-registracija-informacija-esosajiem-pacientiem|title=Apturēta Rigvir reģistrācija; informācija esošajiem pacientiem}}
History
The potential use of echovirus as an oncolytic virus to treat cancer was discovered by Latvian scientist and immunologist Aina Muceniece in the 1960s and 1970s. The virus was obtained from intestinal tract of a healthy children and has not been genetically modified.{{cite journal |last1=Tilgase |first1=Andra |last2=Patetko |first2=Liene |last3=Blāķe |first3=Ilze |last4=Ramata‑Stunda |first4=Anna |last5=Borodušķis |first5=Mārtiņš |last6=Alberts |first6=Pēteris |title=Effect of the oncolytic ECHO-7 virus Rigvir® on the viability of cell lines of human origin in vitro |journal=Journal of Cancer |date=28 February 2018 |volume=9 |issue=6 |pages=1033–1049 |doi=10.7150/jca.23242 |pmid=29581783 |pmc=5868171 |issn=1837-9664|doi-access=free}}{{cite web |title=Aina MUCENIECE - Main invention |url=http://inventions.lza.lv/izg_en.php?id=68 |website=inventions.lza.lv |access-date=2020-09-21 |archive-date=2009-04-06 |archive-url=https://web.archive.org/web/20090406104313/http://inventions.lza.lv/izg_en.php?id=68 |url-status=dead }} She was an honorary member of the Latvian Association of Oncologists and the founder of The Aina Muceniece Virotherapy Foundation.{{Cite web |url=http://www.zz.lv/vietejas-zinas/jelgava/muziba-aizgajusi-medicinas-doktore-un-pretveza-medikamenta-rigivir-izgudrotaja-muceniece-20096 |title=Mūžībā aizgājusi medicīnas doktore un pretvēža medikamenta "Rigivir" izgudrotāja Muceniece |publisher=Zemgales Ziņas |author=LETA |author-link=LETA |language=Latvian |date=15 February 2010 |access-date=20 April 2018 |quote=2002.gadā saņēmusi apbalvojumu kā Latvijas onkologu asociācijas goda locekle |archive-date=21 April 2018 |archive-url=https://web.archive.org/web/20180421031524/http://www.zz.lv/vietejas-zinas/jelgava/muziba-aizgajusi-medicinas-doktore-un-pretveza-medikamenta-rigivir-izgudrotaja-muceniece-20096 |url-status=dead }}{{cite web |title=Prof. Aina Muceniece |url=http://www.virotherapyfoundation.org/en/prof-aina-muceniece-2/ |website=Virotherapy Foundation |access-date=19 September 2020}}
Approval
The data used to register the drug in Latvia is not sufficient to obtain approval to use it in the US, Europe, or Japan.{{cite web |url=https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |title=Feasibility study for registration of medicine RIGVIR with the European Medicine Agency |author= |date=2016-01-08 |website=European Commission |archive-url=https://web.archive.org/web/20161102145626/https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |archive-date=2016-11-02 |url-status=live |access-date=2016-11-02 |quote=However, further use and commercialisation in the EU is prevented as EU regulations require cancer medicines to be registered centrally through the European Medicine Agency (EMA). National registrations are not considered.}} As of 2017 there was no good evidence that ECHO-7 is an effective cancer treatment.{{cite news|last1=Gorski|first1=David|author-link=David Gorski|title=Ty Bollinger's "The Truth About Cancer" and the unethical marketing of the unproven cancer virotherapy Rigvir|url=https://sciencebasedmedicine.org/the-truth-about-cancer-and-the-unethical-marketing-of-the-unproven-cancer-cure-rigvir/|work=Science-Based Medicine|date=25 September 2017}}
Oncologists and other medical experts in Latvia have repeatedly expressed the concern for the lack of clinical trials and evidence of efficacy, as well as unethical advertising.{{Cite web|url=http://skepticisms.lv/enciklopedija/rigvir-when-science-takes-a-back-seat/|title=When science takes a back seat|last=Ritums|first=Eduards|date=October 2016|access-date=2017-08-08|archive-url=https://web.archive.org/web/20180702150742/http://skepticisms.lv/enciklopedija/rigvir-when-science-takes-a-back-seat/|archive-date=2018-07-02|url-status=dead}}{{cite web |title=Rigvir: A cancer "cure" imported from Latvia that cancer patients should avoid {{!}} ScienceBlogs |url=https://scienceblogs.com/insolence/2017/09/25/rigvir-a-cancer-cure-imported-from-latvia-that-cancer-patients-should-avoid |website=scienceblogs.com |access-date=21 September 2020 |language=en}}{{cite web |title=EPA staff report Determining whether Echovirus 7 (Enterovirus B) is a new organism |url=https://www.epa.govt.nz/assets/FileAPI/hsno-ar/APP203537/8753764a8a/APP203537-EPA-Advice-Document-FINAL.pdf |publisher=Environmental Protection Authority New Zealand Government |access-date=21 September 2020}} Oncologist David Gorski has written that "There are many aspects to the RIGVIR story that strongly suggest that RIGVIR is probably cancer quackery" citing the "mysterious creator" aspect, the misleading description of the product as "natural" and the use of testimonials to market it.
In February 2017, the Association of Oncologists, Association of Chemotherapists, Association of Rare Diseases of Latvia, and the Head of Pharmacology Department of Riga Stradiņš University submitted a request to the Ministry of Health of Latvia, State Agency of Medicines, and National Health Service requesting the removal of ECHO-7 from the Register of Medicines of Latvia and from the list of state-compensated medicines.{{cite web |author=David Gorski |author-link=David Gorski|url=https://sciencebasedmedicine.org/rigvir-another-unproven-and-highly-dubious-cancer-therapy-to-be-avoided/ |title=Rigvir: Another unproven and dubious cancer therapy to be avoided |date=18 September 2017 |publisher=Science-Based Medicine}} A revision of clinical treatment guidelines for melanoma was also requested.{{Cite news|url=http://eng.lsm.lv/article/society/society/latvia-to-review-state-compensation-for-rigvir-anti-cancer-drug.a223586/|title=Latvia to review state compensation for Rigvir anti-cancer drug|last=Stirāne|first=Dace|work=Public broadcasting of Latvia}} The request was based on the analysis of available research and suggests that there is no conclusive evidence for the efficacy of RIGVIR as a cancer treatment.{{Cite web|url=http://www.irlv.lv/2017/2/7/rigvir|title=Onkologi prasa izņemt "Rigvir" no Zāļu reģistra|last=Nagle|first=Gunita|website=irlv.lv|date=2017-02-07}} In 2017 the Health Ministry of Latvia responded that RIGVIR would remain on its medicines register, and that in its judgement the risk-benefit ratio for RIGVIR as acceptable.{{Cite web |title= Health Ministry of Latvia statement regarding the registration/approval of medicinal products |url= http://www.vm.gov.lv/lv/aktualitates/preses_relizes/5507_par_zalu_registracijas_kartibu_|language=lv-LV |access-date=16 October 2017}} At the end of 2018, Commission of Social and Labor Affairs of Latvian Parliament started a discussion about possible exclusion of RIGVIR from the list of state-compensated medicines and the Register of Medicines of Latvia.{{Cite web |title= Rigvir may be excluded from the list of state-compensated medicines |url=https://lr4.lsm.lv/lv/raksts/domskaja-ploschad/rigvir-mogut-isklyuchit-iz-spiska-kompensiruemih-lekarstv-zabota.a112620/|language=ru-RU |access-date=18 December 2018}}{{Cite web |title=Validity of Rigvir registration discussed |url=https://www.diena.lv/raksts/latvija/zinas/diskute-par-_rigvir_-registracijas-pamatotibu-tomer-nekadus-lemumus-nepienem-14210643/|language=lv-LV |access-date=18 December 2018}}
On March 19, 2019, the manufacturer of ECHO-7, SIA LATIMA, announced the drug's removal from sale in Latvia, quoting financial and strategic reasons and insufficient profitability.{{Cite web|url=https://bnn-news.com/rigvir-medication-distribution-in-latvia-halted-temporarily-198483|title=Rigvir medication distribution in Latvia halted temporarily|date=2019-03-19}} However, several days later an investigative TV show revealed that State Agency of Medicines had run laboratory tests on the vials, and found that the amount of ECHO-7 virus is of a much smaller amount than claimed by the manufacturer. According to agency's lab director, "It's like buying what you think is lemon juice, but finding that what you have is lemon-flavored water". In March 2019, the distribution of ECHO-7 in Latvia has been stopped.
ECHO-7 has also been removed from the list of state-reimbursed medications.{{Cite web|url=https://www.baltictimes.com/distribution_of_rigvir_anti-cancer_medicine_suspended//|title=Distribution of Rigvir anti-cancer medicine suspended}} On May 31, 2019, the registration licence of ECHO-7 was suspended in Latvia. According to Baltic News Network, "State Agency for Medicines (SAM) has decided to halts registration of Rigvir medication, until all problems have been resolved". It also reported "more than 30 patients, five healthcare institutions and 16 oncologists have turned to the Health Inspectorate with a request to permit them to continue therapy using Rigvir. In response to requests, HI permitted distribution of a single type of Rigvir medication for patients, who are already undergoing melanoma treatment".{{Cite news |title=Baltic News Network – News from Latvia, Lithuania, Estonia » Latvia's State Agency of Medicines halts registration of Rigvir medication |url=https://bnn-news.com/latvia-s-state-agency-of-medicines-halts-registration-of-i-rigvir-i-medication-201694 |access-date=19 September 2020 |work=bnn-news.com}}{{cite web |title=Apturēta Rigvir reģistrācija; informācija esošajiem pacientiem {{!}} Zāļu valsts aģentūra |url=https://www.zva.gov.lv/lv/jaunumi-un-publikacijas/jaunumi/aptureta-rigvir-registracija-informacija-esosajiem-pacientiem |website=www.zva.gov.lv |access-date=11 June 2019}}
According to Solvita Olsena, expert in patient safety at the University of Latvia, people who have used ECHO-7 should contact the police, as facts indicate that a criminal offence has occurred. According to Olsena, police has the duty to protect people; it is a dangerous precedent when people receive medicines that do not contain the substance which should be present.{{Cite web|url=https://skaties.lv/zinas/latvija/zalu-razotajs-rigvir-maldinajis-ne-tikai-valsts-institucijas-bet-ari-pacientus-uzskata-vm///|title=Zāļu ražotājs "Rigvir" maldinājis ne tikai valsts institūcijas, bet arī pacientus, uzskata VM}} A member of Latvian parliament and advisor to the Prime Minister, Renars Putnins, also has called the entire thing an affair and has asked for an official investigation.{{Cite web|url=https://eng.lsm.lv/article/society/health/calls-for-official-probe-over-rigvir-cancer-treatment-scandal.a314845//|title=Calls for official probe over Rigvir cancer treatment scandal}}
Advertising
In Latvia manufacturers of ECHO-7 have a history of receiving fines for off-label marketing this anti-cancer drug directly to general public and cancer patients.{{Cite web | url=http://www.vi.gov.lv/lv/sakums/aktuali/this-just-in/pienemts-lemums-par-naudas-soda-piemerosanu-zalu-rigvir-par-negodigu-komercpraksi | title=Veselības inspekcija | Pieņemts lēmums par naudas soda piemērošanu zāļu Rigvir reģistrācijas apliecības īpašniekam par negodīgu komercpraksi | access-date=2016-11-02 | archive-date=2016-11-04 | archive-url=https://web.archive.org/web/20161104003310/http://www.vi.gov.lv/lv/sakums/aktuali/this-just-in/pienemts-lemums-par-naudas-soda-piemerosanu-zalu-rigvir-par-negodigu-komercpraksi | url-status=dead }}{{Cite news|url=http://www.delfi.lv/news/national/politics/veselibas-inspekcija-par-neatlautu-rigvir-reklamesanu-piemerojusi-naudas-sodu-sia-latima.d?id=47848987|title=Veselības inspekcija par neatļautu 'Rigvir' reklamēšanu piemērojusi naudas sodu SIA 'Latima'|work=Delfi.lv}}{{Cite news|url=http://www.delfi.lv/news/national/politics/neatcel-naudas-sodu-par-neatlautu-rigvir-reklamesanu.d?id=49597417|title=Neatceļ naudas sodu par neatļautu 'Rigvir' reklamēšanu|work=Delfi.lv}}
However, on October 31, 2018 the Regional Administrative Court of Latvia canceled the sanction imposed by the local Health Inspectorate for the unauthorized off-label advertising.{{Cite web|url=http://www.diena.lv/raksts/latvija/zinas/tiesa-atcel-veselibas-inspekcijas-piemeroto-naudas-sodu-par-neatlautu-_rigvir_-reklamesanu-14208021|title=Tiesa atceļ Veselības inspekcijas piemēroto naudas sodu par neatļautu Rigvir reklamēšanu}}