ECHO-7

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ECHO-7 (trade name: RIGVIR) is a virotherapy drug that was approved by the State Agency of Medicines of the Republic of Latvia in 2004.[1] It is wild type ECHO-7, a member of echovirus family.[2]

History[edit]

The potential use of echovirus as an oncolytic virus to treat cancer was discovered by Latvian scientist Aina Muceniece in the 1960s and 1970s.[2]

Clinical approval[edit]

The data used to register the drug in Latvia is not sufficient to obtain approval to use it in the US, Europe, or Japan.[2][3] As of 2017 there was no good evidence that ECHO-7 is an effective cancer treatment.[4][5]

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.[6] 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.[4]

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.[4] A revision of clinical treatment guidelines for melanoma was also requested.[7] 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.[8] 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.[9] 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. [10] [11]


Controversies[edit]

Advertising[edit]

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.[12][13][14][15] 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 of Rigvir.[16]

See also[edit]

References[edit]

  1. ^ "Medicinal Product Register of Latvia". www.zva.gov.lv. Retrieved 2018-11-18.
  2. ^ a b c Babiker, HM; Riaz, IB; Husnain, M; Borad, MJ (2017). "Oncolytic virotherapy including Rigvir and standard therapies in malignant melanoma". Oncolytic virotherapy. 6: 11–18. doi:10.2147/OV.S100072. PMC 5308590. PMID 28224120.
  3. ^ "Feasibility study for registration of medicine RIGVIR with the European Medicine Agency". European Commission. 2016-01-08. Archived from the original on 2016-11-02. Retrieved 2016-11-02. 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.
  4. ^ a b c Gorski D (18 September 2017). "Rigvir: Another unproven and dubious cancer therapy to be avoided". Science-Based Medicine.
  5. ^ Gorski, David (25 September 2017). "Ty Bollinger's "The Truth About Cancer" and the unethical marketing of the unproven cancer virotherapy Rigvir". Science-Based Medicine.
  6. ^ Ritums, Eduards (October 2016). "When science takes a back seat".
  7. ^ Stirāne, Dace. "Latvia to review state compensation for Rigvir anti-cancer drug". Public broadcasting of Latvia.
  8. ^ Nagle, Gunita. "Onkologi prasa izņemt "Rigvir" no Zāļu reģistra". irlv.lv.
  9. ^ "Health Ministry of Latvia statement regarding the registration/approval of medicinal products" (in Latvian). Retrieved 16 October 2017.
  10. ^ "Rigvir may be excluded from the list of state-compensated medicines" (in Russian). Retrieved 18 December 2018.
  11. ^ "Validity of Rigvir registration discussed" (in Latvian). Retrieved 18 December 2018.
  12. ^ Ritums, Eduards (October 2016). "When science takes a back seat".
  13. ^ http://www.vi.gov.lv/lv/sakums/aktuali/this-just-in/pienemts-lemums-par-naudas-soda-piemerosanu-zalu-rigvir-par-negodigu-komercpraksi
  14. ^ "Veselības inspekcija par neatļautu 'Rigvir' reklamēšanu piemērojusi naudas sodu SIA 'Latima'". Delfi.lv.
  15. ^ "Neatceļ naudas sodu par neatļautu 'Rigvir' reklamēšanu". Delfi.lv.
  16. ^ "Tiesa atceļ Veselības inspekcijas piemēroto naudas sodu par neatļautu Rigvir reklamēšanu".