Sometimes a single image says more than a thousand words.
But is Rigvir really your chance to live, if you have been diagnosed with cancer?
What is Rigvir?
Rigvir is an unproven anti-cancer treatment developed in Latvia. Its proponents claim that it is an oncolytic ECHO-7 enterovirus found in the gastrointestinal tract of young children, that it supposedly destroys cancer cells without harming normal cells, and works in a wide variety of cancers. Importantly, while outside of Latvia Rigvir is only sold by clinics with highly dubious alternative cancer treatments, in Latvia it is an official prescription drug, registered in our State Medicines Agency, reimbursed by the state, and even included in the clinical guidelines for treatment of melanoma. This gives it a veneer of respectability and reassures foreign patients who might normally not choose alternative cancer treatments. Most importantly – this is not an issue that affects only Latvians, as approximately 90% of the income of Rigvir holding comes from foreign cancer patients (USA, UK, Australia, EU countries, etc.), who get this treatment by traveling either to Global Virotherapy Cancer Clinic in Latvia, or to its quack partner clinics.
While in the 1960s initial basic research into Rigvir was a legitimate scientific endeavor by its creator professor Aina Muceniece, to this day, proper clinical trials have not been done. More than 50 years later there is still no reliable, published evidence for its efficacy despite the grandiose claims. In addition, for quite some time the distributors of Rigvir have turned towards alternative medicine and built partnerships with infamous quack clinics in Mexico and elsewhere.
In Latvia, Rigvir was registered in a highly suspect way and only for melanoma, although even for that there is no verifiable evidence of efficacy. However, International Virotherapy Centre (the main distributor) and its partners, local and international, claim Rigvir is effective against many more cancers (including pancreatic, kidney, liver, breast, gastric, colorectal, lung, prostate, bladder cancer, etc., as well as various sarcomas) for which the level of evidence is practically zero.
In which countries is Rigvir currently available?
Partner clinics previously listed on Rigvir websites are based in Germany, Mexico, Thailand, Bahamas, Georgia, and Armenia. Medical tourism agencies provide a far wider list of countries which also includes Canada, USA, Puerto Rico, Spain, the Netherlands, Switzerland, Italy, Poland, the Czech Republic, Russia, Ukraine, Egypt, Cyprus, the UAE, Taiwan, Malaysia, and Thailand. However, Rigvir also provides delivery to other countries and takes pride in having patients from more than 50 countries, so this is truly an international business.
Timeline of Rigvir
Under the management of Professor Aina Muceniece, the study of enteroviruses starts and the virus, now called Rigvir, is discovered. During Soviet times, observations indicate its efficacy in treatment of melanoma. Research continues until production of the substance is discontinued in 1999.
- 29 April, 2004
2 days before Latvia joins European Union, Rigvir is registered in the Latvian Register of Medicines without any evidence from any prospective, randomised, controlled clinical trials. As of 2018, neither the two Latvian oncologist associations, nor patients, nor journalists have received answers about the evidence, based on which Rigvir was registered on this day, other than conflicting statements from various state institutions and a statement from Latvian version of FDA, the State Agency of Medicines: “there is unpublished evidence that is a commercial secret, therefore it cannot be disclosed”.
- 1 May, 2004
Two days after the registration of Rigvir, Latvia joins the European Union and, since then, drug registration in Latvia must be carried out in accordance with EU regulations and stringent criteria to assure that registered drugs are actually effective.
The International Virotherapy Center is opened under management of Professor Muceniece’s relatives Dite Venskus, Jurgis Auzins and others.
Rigvir registration license is renewed by the State Agency of Medicines, despite a completely negative expert conclusion (existence of which is only revealed by journalists in 2017).
Rigvir is included in the Latvian list of state-reimbursed medicines for treatment of skin melanoma (all stages).
- Rigvir is included in national clinical guidelines for melanoma treatment (created under the management of Professor Dace Baltina, who is also an advisor to the Minister of Health of Latvia, and the official “state oncologist”).
- The ultimate cancer quack clinic – Hope4Cancer in Mexico – starts offering Rigvir as one of their core treatments alongside coffee enemas, Laetrile, detox and fruit juice treatments, and becomes the exclusive partner of International Virotherapy Centre in Mexico.
- Representatives of Rigvir Holding participate in an infamous cancer quack propaganda film “Truth About Cancer”. Rigvir is advertised alongside such unproven or disproven treatments as bicarbonate soda, coffee enemas, fruit and vegetable juices, and Laetrile. Representatives of Rigvir claim it is effective against at least 10 different cancers, it should be the first choice of treatment, and has no side effects. This film is likely largely responsible for the recent popularity of Rigvir in various alternative health centers.
- February, 2016
The Global Virotherapy Clinic in Jurmala, Latvia, is opened and attraction of foreign cancer patients increases considerably.
- July, 2016
Professor Dace Baltina, the author of melanoma clinical guidelines and the chief oncologist of the Health Ministry, commences work at the Global Virotherapy Clinic. Later she is presented as the medical director of Rigvir Holding.
- August, 2016
Health Inspectorate (an agency of the Ministry of Health) responds to an official complaint submitted by a local skeptic, referring to illegal advertising of a prescription drug, as well as advertising Rigvir as being effective for various other cancers, not just melanoma (prescription drug advertising to public in Latvia is not legal, off-label advertising even more so). The Inspectorate applies a 6000 EUR fine for dishonest business practice and misleading advertising.The decision is contested by Rigvir (result is not officially known on 04.11.2017). In the next year at least eight other similar complaints are submitted by various activists, however, no notable action follows from the Inspectorate of Health.
- January, 2017
Association of Oncologists of Latvia, Association of Oncologists-Chemotherapists of Latvia, Association of Rare Disease Specialists of Latvia, and the head of Pharmacy Department of Riga Stradins University submit an official request to the Ministry of Health, State Agency of Medicines, National Health Service, and State Audit Office, asking that Rigvir be removed from the register of medicines of Latvia, from the list of state-reimbursed medicines, and clinical guidelines for melanoma due to the “very weak, if not non-existent” evidence of its efficacy. The associations also express doubt about the legality of registration in 2004, as well as re-registration in 2009, since Latvia had already adapted its laws to EU legislation before 2004. The conclusions are based on a detailed, 20 pages long analysis of all available scientific publications about Rigvir, which fail to show evidence of efficacy even in melanoma.
- February, 2017
Ministry of Health does not respond to any of the specific questions mentioned in the letter by oncologists’ associations and claims that the registration of Rigvir in 2004 was legal, essentially avoiding questions, even though publicly it claims that registration will be reviewed. No response is received from the State Audit Office.
- March, 2017
Latvian branch of anti-corruption NGO Transparency International, association “Delna” submits a complaint and requests an explanation from the Ministry of Health regarding the conflict of interest: Dace Baltina is the chief oncologist in Latvian Ministry of Health, while also being the medical director of Rigvir, a pharmaceutical manufacturer. No response is provided.
- March to October, 2017
Newspapers report that the doctors and other medical professionals who criticised Rigvir are being harassed by Rigvir lawyers. At least one court case is in process, and other specialists are receiving letters from lawyers, which is interpreted as an attempt at intimidation and silencing.
- September 2017
A journalist from Latvian National Television show De Facto investigates events regarding Rigvir. The business development manager of Rigvir claims in an interview that “we [Rigvir] don’t need any evidence of efficacy”, and Latvian Health Minister Anda Čakša calls the two associations of oncologists a social group: “A letter by some social group saying they don’t like something – it’s just not helpful. Show us data that this medicine does not work for your patients.” Essentially, she is asking oncologists to prove that Rigvir is ineffective, i.e., to prove a negative. The State Agency of Medicines claims that the publications proving the efficacy of Rigvir are a commercial secret and cannot be revealed. In the meantime, contrary to awkward explanations by the Agency of Medicines, manufacturers of Rigvir themselves admit not having any randomized clinical trials and suggest that such trials may follow in the future.
- October 2017
Investigative magazine IR publishes a critical investigative article, in which it is revealed that during re-registration of Rigvir a completely negative expert conclusion was hidden by the State Agency of Medicines and was never shown to the registration commission. According to the expert conclusion, Rigvir should not be re-registered, as it lacks evidence of efficacy and the unique identity of the virus itself cannot be ascertained, there is no GMP (good manufacturing practice) certificate still in 2009, and that attempts to widen Rigvir indications from melanoma to other cancers border on quackery. In response to the journalist’s questions, a representative of State Agency of Medicine claims that the members of registration commission did not need to see the expert conclusion or its details, only “the big picture”.
- December 2017
Manufacturer of Rigvir loses in an administrative court case against Health Inspectorate of Latvia. Inspectorate’s initial decision in 2016 regarding the applied fine for illegal advertising and dishonest commercial practice of Rigvir is not cancelled.
- May 2018
Health Inspectorate of Slovenia is investigating a physician Kalan Živčec who has prescribed Rigvir to her patients. The private clinic, which this physician represents, has unsuccessfuly tried to request Slovenian state to pay for this treatment. According to the articles (SL/EN), Slovenian oncologists are skeptical about Rigvir, which is not registered in EU, and mention lack of evidence. After an inquiry by the Ministry of Health, Human Rights Ombudsman finds that this physician has caused a breach in the patients’ rights to healthcare, as provided for in the Slovenian Constitution.
- June 2018
Italian Association for Cancer Research (AIRC) publishes an article about virotherapy and Rigvir in the “Disinformation” section of its official website (automated translation here). The evidence behind Rigvir is analysed with the following conclusion:
- So far virotherapy experiments have achieved little controversial results, with important limitations for clinical application, on which scientists are still working.
- Nonetheless, on the Internet a preparation of the ECHO-7 virus, known as Rigvir, is marketed, approved only by the health authorities of Latvia and proposed as a therapy for melanoma and many other types of cancer.
- There are no clinical studies conducted according to the rules of good scientific research that allow to state that the virotherapeutic preparations sold online have therapeutic effects for the treatment of tumors
- There are no publications in good quality international scientific journals that allow physicians and competent scientists to say that Rigvir is able to cure melanoma or other cancers.
- There is no evidence of efficacy obtained through rigorous testing. […] Despite this, the therapy is widely publicized through internet sites and patient groups and, in recent years, even Italian patients have spent large sums to travel to Latvia.
- August 2018
- The court case, in which Rigvir manufacturers SIA Latima had sued Latvian cardiologist Dr. Andris Skride for criticising Rigvir, its lack of evidence, and saying it’s an unproven medication that has turned into a business project, has concluded. Instead of providing evidence contrary to the claims of Dr. Skride, the manufacturers of Rigvir have annulled their lawsuit against him.
SIA Latima, the manufacturer of Rigvir, publishes a public procurement announcement for a toxicology study in rats. Since research in rats is basic preclinical research that any registered drug should already have before running any clinical trials in humans, certain questions arise, as described by Renārs Putniņš, a neurosurgeon from Latvia (LV/EN):
If the toxicity of the medicinal product has been carefully identified and identified, then why is such study needed? Moreover, it is still in rats, not organisms biologically closer to humans. […]
If the published study is an elementary bureaucratic formality aimed at repeating some of the results of previous activities, then it is not clear how the medication could have been approved by the State Agency of Medicines without completing it.
Is it because a completely untested product, whose CV contains white areas, is offered by a local manufacturer, which receives millions of euros from the state budget and then returns some hundred thousand to it? Or is it because the people involved in the distribution of the miracle drug are closely linked to influential people in the political circles of Latvia?
Expert opinions on Rigvir
What do specialists in other countries say? First of all, you won’t find Rigvir registered in any other country in the EU, it is not registered by FDA or in any other large markets with high-level medical care. There is a striking lack of evidence for Rigvir efficacy, and it is obvious to any cancer specialist who evaluates treatments based on scientific evidence. One such specialist is Dr. David Gorski, a well-known surgical oncologist and science-based medicine proponent from the USA, who recently published 3 separate articles examining Rigvir on the website ScienceBasedMedicine.org, which is dedicated to evaluating medical treatments and products of interest to the public in a scientific light, and promoting the highest standards and traditions of science in health care.
In part 1 Dr. Gorski examines the claims behind Rigvir and concludes that it is most likely cancer quackery: https://sciencebasedmedicine.org/rigvir-another-unproven-and-highly-dubious-cancer-therapy-to-be-avoided/
In part 2 Dr. Gorski examines the unethical marketing via the quack film the Truth About Cancer and deconstructs some of the patient testimonials: https://sciencebasedmedicine.org/the-truth-about-cancer-and-the-unethical-marketing-of-the-unproven-cancer-cure-rigvir/
In part 3, communication with Rigvir representatives is revealed: “Rigvir strikes back, or: A conversation with a Rigvir flack” https://sciencebasedmedicine.org/rigvir-strikes-back-or-a-conversation-with-a-rigvir-flack/
Above all, our primary goal is to make sure that anyone who chooses to use Rigvir, makes an informed decision that is fully based on evidence, not on deceptive and dishonest marketing, slick PR, and false claims by the manufacturers of Rigvir. Quite a few of us know from personal experience just how difficult it can be to separate facts from fiction when dealing with cancer and all the emotions it entails – we have experienced it ourselves, within our families or among our friends. We know how precious time and effort is when someone is confronted with cancer.
Therefore in this blog we will attempt to do the following:
- Provide objective information about the actual evidence level for Rigvir (or, more precisely, lack of it).
- Describe the background of Rigvir and its history in more detail.
- Provide updates on events in Latvia regarding its status after the Latvian Oncologists Association requested its removal from the state drug registry due to lack of evidence.
- Translate articles about Rigvir in the Latvian media (investigative reporters’ work, etc.)
- Provide facts that conflict with claims made about Rigvir in materials presented by the manufacturers of Rigvir and their partner clinics
- Collect stories from cancer patients who used Rigvir. Anyone researching this treatment will soon discover Rigvir ads – testimonials from cancer patients who seem to be doing better or think Rigvir has helped them. What they will not find are all the other stories of personal experiences that have been just as public, but never made it into Rigvir websites, because death, lack of improvement, progression of cancer, and lost time and money is not a good marketing tool. However, seeing both types of patients may help those thinking about using Rigvir to see the bigger picture.