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ECHO-7 (trade name Rigvir) is a
wild type The wild type (WT) is the phenotype of the typical form of a species as it occurs in nature. Originally, the wild type was conceptualized as a product of the standard "normal" allele at a locus, in contrast to that produced by a non-standard, "m ...
member of the
echovirus Echovirus is a polyphyletic group of viruses associated with enteric disease in humans. The name is derived from "enteric cytopathic human orphan virus". These viruses were originally not associated with disease, but many have since been identifie ...
group of viruses. It was formerly approved as a
virotherapy Virotherapy is a treatment using biotechnology to convert viruses into therapeutic agents by reprogramming viruses to treat diseases. There are three main branches of virotherapy: anti-cancer oncolytic viruses, viral vectors for gene therapy and v ...
medication by the State Agency of Medicines of the Republic of Latvia (2004–19). 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. On May 31, 2019, the State Agency of Medicines suspended the registration licence of ECHO-7.


History

The potential use of echovirus as an
oncolytic virus An oncolytic virus is a virus that preferentially infects and kills cancer cells. As the infected cancer cells are destroyed by lysis#Oncolysis, oncolysis, they release new infectious virus particles or virus, virions to help destroy the remaining ...
to treat cancer was discovered by Latvian scientist and immunologist
Aina Muceniece Aina Muceniece (23 March 1924 – 14 February 2010) was a Latvian immunologist and founder of practical cancer virotherapy who discovered that an echovirus might be a useful treatment for melanoma. Life and work Aina Muceniece was born in ...
in the 1960s and 1970s. The virus was obtained from intestinal tract of a healthy children and has not been genetically modified. She was an honorary member of the Latvian Association of Oncologists and the founder of ''The Aina Muceniece Virotherapy Foundation''.


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. As of 2017 there was no good evidence that ECHO-7 is an effective
cancer treatment Cancer can be treated by surgery, chemotherapy, radiation therapy, hormonal therapy, targeted therapy (including immunotherapy such as monoclonal antibody therapy) and synthetic lethality, most commonly as a series of separate treatments (e.g. ...
. 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. Oncologist
David Gorski David Henry Gorski is an American surgical oncologist, professor of surgery at Wayne State University School of Medicine, and a surgical oncologist at the Barbara Ann Karmanos Cancer Institute, specializing in breast cancer surgery. He is an out ...
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 Riga Stradiņš University (RSU) ( lv, Rīgas Stradiņa universitāte, la, Universitas Rigensis Stradina) is a public university located in the city of Riga, Latvia. The Stradiņš (pronounced stradiɲʃ name in the university's title is owed ...
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. A revision of clinical treatment guidelines for melanoma was also requested. 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. 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. 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. 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. 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. On May 31, 2019, the registration licence of ECHO-7 was suspended in Latvia. According to
Baltic News Network Baltic News Network (BNN) is a Baltic news website. It was founded on September 1, 2010, providing online news portals, mainly reporting for and about the Baltic region, Latvia, Lithuania, Estonia. It is published by ''Latvia 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". 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. 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.


Advertising

In Latvia manufacturers of ECHO-7 have a history of receiving fines for
off-label marketing Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although ...
this anti-cancer drug directly to general public and cancer patients. 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.


See also

* List of unproven and disproven cancer treatments


References

{{Reflist Experimental cancer treatments Research in Latvia Immunomodulating drugs Virotherapy Latvian inventions