This article was originally published in the October 2016 issue of Materia Medica, a Latvian-language journal for healthcare professionals, supported by the Pharmacist Society of Latvia.

The English translation you see below is re-published here with full permission. Click here for the feature in Latvian.


By Eduards Ritums

 

When Science Takes A Back Seat

 

Just a short while ago, Latvians were bursting with pride when they read about the implementation of the melanoma treatment ‘Rigvir’ at the specialized ‘Virotherapy Center.’ The treatment was developed thanks to the singular life-long work of a renowned Latvian scientist, Aina Muceniece.

As the flow of enthusiastic reports and press releases increased, the first complaints emerged as well – concerning unfair practice and deception of oncology patients (in order to increase profits for the new enterprise).

Given that Rigvir was discovered in the middle of the previous century, why is it suddenly being discussed now, and to such great extent? Why is it essential to run trials to demonstrate that new treatments are efficacious? What does the absence of clinical studies indicate in the context of selling a medical service? And what harm can it do?

Read on to find out.

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The story according to patients and their relatives

Antra (name has been changed: Ed.) shared how long and confusing her father’s path had been to getting a diagnosis of having an inoperable, stage three cancer. She and her brother wanted to help, so they looked for options to supplement the treatment provided by oncologists. Their search took them to the Virotherapy Center and to Rigvir.

“My father was not only aware of Aina Muceniece’s legendary personality, but he knew her in person. The scientist’s name certainly convinced me and I immediately called the center,“ Antra recalls. She wanted to make an appointment, but the receptionist replied that there was no need to physically go to the Center, and that Antra should simply forward all the relevant data and laboratory test findings.

That surprised her. “I do have some kind of understanding about patient data protection. Although, when I shared my concerns with our family, my brother thought I was just being petty. As time was running against us, I just placed all my father’s test results and recommendations in a folder and sent them off. The automated response arrived instantly. However, it was only in two languages: Russian and English (Translator’s note: the only official state language in Latvia is Latvian). I didn’t like that. I started to examine the Center’s homepage and compared it to those of other outpatient clinics. It didn’t provide a list of services, a list of physicians, nor any divisions by medical specialties. It was more like a TV-shop advertising page. I soon received a letter reporting that my father’s data was reviewed and that I should come in person to confirm the treatment schedule. This was all done without seeing the patient! However, the expenses and payment procedure were explained extensively and in great detail.”

Antra was not confident that the treatment with Rigvir would be a good option for her father’s tumor and wasn’t sure how this treatment would affect the therapy already initiated at the Oncology Center of Latvia (Translator’s note: the main oncology hospital in Latvia). So, she called again, but it was difficult to get any answers since her initial call was interpreted as if she had already accepted the treatment. A representative of the enterprise explained in detail how and where to obtain the medication, which needed to be placed in an insulated flask she should bring along. Antra had to interrupt the representative to insistently repeat her question about compatibility. The answer was instantaneous: “Yes, yes, it will work just fine, people are using it and they like it!”

“Wait a moment,” Antra continued. “This is a prescription medication that is meant for use in oncology. It is true that a receptionist may not be aware of some specific details, but it is absolutely unacceptable that a medical institution using such a specialized treatment would not even have a page on their website intended for physicians that she could use as a source.” Antra continued trying to find out how they would evaluate “feeling better” and what additional costs the family would have to consider.

She was told no additional costs were to be expected as the improvement would be apparent in blood tests. “Because of the therapy performed at the Oncology Center, my dad already had blood work that showed improvement. Now what?” Antra kept asking. Eventually she understood that it would be more appropriate to seek answers during an appointment, and tried to find out which doctor would see her. The receptionist refused to go into details, just saying that they had been assigned a virotherapy specialist and that should be enough. After thorough questioning, Antra eventually found out that the physician was Linda Brokane. The name of this specialist was present neither on the homepage of the medical center they had an appointment with, nor on the homepage of the Virotherapy Center.

“I contacted my family and brother who had already begun the process of selling some land to be able to pay for treatment with Rigvir. I explained that it made me think of a pyramid scheme and a marketing project, not a treatment. The statement “People are buying, using and liking this medicine” is not usually used with real treatment and real medicine. How can we test this? There is no way! Which physician? We won’t tell you! Is it compatible with other treatment’s currently being used? That does not matter, it’s very compatible! Seriously ill patients should not be treated this way. They need even the smallest bit of strength and confidence. So, we are determined to continue with therapy that uses proven medicines and methods. We have regular appointments at the Oncology Center and see the overloaded, exhausted oncologists trapped on the conveyor belt of our clumsy health care system.

“To this point, my father’s health has remained stable, and lack of further deterioration is already a good sign for a cancer patient. This was a shocking experience. Desperate people might believe in this treatment and may spend their last cent on such a therapy. It is shameless. This treatment is not cheap, it does not come for “5 euros”, the Virotherapy Center asks quite a lot for their ampoules. We would have sold a valuable piece of land, too, just to pay for this therapy. Well, the sale of land is just about the money anyway… The worst would have been the false hope my dad would rely on! Such a deception! Misusing the official recognition of Rigvir as a registered drug in Latvia and the legacy of Aina Muceniece – it is just a trick to lure patients and lead them to legal charlatans. What advice do I give to other cancer patients? ONLY for those with melanoma is it worth giving this therapy a try and hoping that Rigvir will help. The Virotherapy Center is legally PROHIBITED from promising anything else.”

When our editorial staff asked Kristine Juckovica, the CEO of Rigvir Holding, whether this case was characteristic for their business practice, she replied that this case was rather a misunderstanding, and that such procedures were unusual. Her guess was that the misunderstanding may have been caused by the human factor, and that the company has to work more carefully on informing their patients. She explained the lack of information regarding consulting specialists on the homepage by telling us that this page, www.virotherapy.eu, was not a homepage of a medical care facility, but only a website which provides information for treatment options that include virotherapy.

A wonderful beginning and an unfortunate ending

What is the Virotherapy Center and what is its only product - Rigvir?

In the 1960s a young scientist named Aina Muceniece discovered a way to use a virus to assist in identifying and marking melanoma cells. Using this discovery, she was able to create a medicinal substance which could possibly increase the life expectancy of melanoma patients when used alongside other therapeutic methods. The substance underwent preliminary studies and was proven to be harmless. These results made it possible for the scientist to use it in the treatment of melanoma, while recording her observations.

Unfortunately, even the unfailing enthusiasm of Aina Muceniece was unable to successfully turn Rigvir (its name honours Riga, the capital of Latvia), into an approved and widely applied treatment. Efficacy studies would have required much larger resources than were available.

The chain of events should have stopped there. But just a few decades later Rigvir was suddenly  included in the list of state-reimbursed medicines and reappeared under new circumstances and in a completely new light, despite the lack of any further trials and contemporaneous developments in similar fields of medical research.

Although Aina Muceniece has passed away, a group of enterprises was formed using her name as a cover. The profits of these enterprises come from the sales of Rigvir and illegitimate advertising, consequently attracting desperate patients from abroad. This medicine is used as treatment not only for melanoma patients, but for other cancer patients as well, and advertised in a way that discredits other currently approved cancer treatment methods. It is unlikely Aina Muceniece would have supported or wanted something like this to happen.

Our drug must receive global attention!

Local patriotism and the name of Aina Muceniece are the main strongholds of Rigvir. The head of the Latvian Association of Oncologists, Janis Eglitis, starts his interview with the mention of the legendary woman, calling it a unique case and adding that “Muceniece’s discoveries were way ahead of her time”. When talking to physicians, particularly medical professionals from older generation, they gladly and enthusiastically want to share their memories about meeting the professor, even if it was only a one-time encounter; but they avoid evaluating the medication she discovered.

Mirdza Jackevica, a retired doctor who worked at an oncology hospital at the time, says that her task was to be present at surgeries and take tumor samples to be studied in Muceniece’s laboratory. Dr Jackevica was informed about Muceniece’s developments in laboratory research. The studies in melanoma – at a time when cancer was considered a death sentence – yielded such excellent results that all medical staff involved were astonished. Indeed, it was like a miracle: a virus that was able to find melanoma cells and stop the tumor from growing. Still, “it was never assumed that other types of cancer could be treated as well,” Dr Jackevica remembers.

We do not have a clear answer how Rigvir somehow entered the Latvian Drug Register, the list of reimbursed medicines, and, eventually the guidelines for melanoma treatment, since, even then, the lack of proper research should have led to questions of the effectiveness of the treatment. Our interviewees – medical and communication experts – guessed that it may have been the unusual personality of Aina Muceniece which got it into the register. They pointed out that her students may have been involved. Enthusiasm and hope to gather the missing evidence in the future conquered a scientific approach. And it’s likely that patriotism was also a strong driving force. Janis Eglitis agrees with this: “It would be impossible to register a medicinal substance with such data at the moment. I can understand the patriotism was helpful (and still is): this is our drug, and we should do everything to put it on the market. However, we have to carry out a study, and then our invention may receive global appreciation.”

Why is there a lack of global response?

What kind of studies should be performed for a medicinal product? “First, they have to be randomized,“ explains Janis Eglitis. “That means patients are randomly divided into groups (Muceniece’s research did not involve that). Second, several and prospective (planned studies) should be carried out, not only retrospective ones with a small number of patients (“this patient has recovered, let us see what he did”). Most importantly, studies should be controlled: they must have a control group (placebo group or comparative treatment group, as in most oncology trials). Currently, this medicinal product is holding up just on Muceniece’s research into tolerability, side effects and test results from retrospective patient cases. Regarding tolerability: no, this substance does not harm patients (which likely explains the lack of objections and tolerance of colleagues). No, it does not have side effects, but when it comes to efficacy – there is no way to tell if it even exists”.

However, Peteris Alberts, a spokesperson of the Virotherapy Center, referenced many articles in the medical literature (impressing patients who are looking for possible treatment) in an article written by Gunita Nagle titled “Sellers of Hope”, appearing in the Latvian magazine “Ir” [1]: “Are these not studies? We believe they are convincing.” We should mention that doctors obtain information from internationally recognized databases which are compiled by specific search engines, e. g., Medline. These searches return just a few old articles regarding Rigvir. The most recent information the Virotherapy Center can offer are three retrospective case studies. After reading one of the articles, Janis Eglitis asks a rhetorical question: “Did the long-term remission of three patients occur due to Rigvir? No, this story only tells us that three patients used this drug. Unexplained remission in oncology is possible. That can happen either with the use of Rigvir, or anything else – even vitamin C. That does not reflect or prove a trend.” A similar approach is used by authors of self-help books, namely: “I was doing all sorts of things, using anything available, but I believe only this particular something was helpful, so let us all use only this one particular approach!”

Inara Rubene, a pharmaceutical consultant in private practice who has international experience in conducting clinical trials, compares Rigvir’s inclusion in the register of medicinal products with the activities of Ostap Bender (translator’s note: a character from Russian literature, a liar and a boaster, often referred to as ‘the great manipulator’): “The list of clinical trials is absolutely insufficient. Generally recognized phase III trials involving “gold standard” endpoints and overall survival (time to disease progression) are completely absent. Only the great manipulator in his hometown Vasuki would be able to register a medication using such trials.”

“In my opinion, the fact that this medicine was registered in Latvia already in 2004, but has not found a wide application globally by now means the large, rich countries with high levels of oncology care have a hesitant attitude towards this drug. We need a study to address these concerns. It should first include melanoma. The other forms of cancer are completely out of question,” concludes Janis Eglitis.

So, let’s finally organize a study!

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According to Dr. Eglitis, the Oncology Centre offered to carry out a study around the time that the Rigvir registration was initiated, but the Rigvir group did not accept the proposition. Dr. Eglitis suspects the hesitation is intentional and that it’s inappropriate to blame high costs which are also mentioned by Alberts: “We would have difficulties, certainly, because Latvia cannot provide that many eligible patients. Obviously, the study should be performed in several countries with multiple study sites.” The onco-gynecologist and surgeon Ronalds Macuks does not agree with the objections either:

“The Rigvir group should be able to invest money, hire doctors to document results and analyse the data that they acquire - do everything that serious companies do to study their own medications. I believe we could carry out such a study on our own in Latvia because of the inexpensive labor.”

At this point, we are getting closer to the main question: what results could be expected from this study? Eglitis explains that Rigvir was intended as a complete medicinal product (it is based on a virus strain that helps identify and mark cells, but it does not have the so-called carrier: a vehicle to carry it to the identified cells) and that this feature cannot be developed and perfected. It may be possible to prove efficacy for certain melanoma stages. “Even if these studies were performed and positive trends were demonstrated in some patient populations, Rigvir could never be the main therapy,” the oncologist states. “Originally, this medication had potential as an additional therapy. Rigvir cannot achieve a complete recovery. It is unable to ensure that relapse will not happen. It may help somewhat to stabilize a condition of health achieved using conventional therapy. If we can prove this with studies, let’s do just that.”

Yet, research is going on in some other places in the world

Rubene mentions that scientists have encountered numerous problems, even-though oncolytic virotherapy has been studied globally since the 1950s. “Expectations that one virus could be efficient against several types of cancer have not been confirmed. Viruses created in the laboratory for a particular type of cancer have not been effective during clinical trials. New serotypes occur so fast, that viruses which seemed to be promising become outdated before completion of a clinical trial. It must be noted, however, that the first modified oncolytic virus for advanced melanoma was registered in the USA in 2015 and in Europe in 2016.” That means Rigvir now has a competitor which is much more advanced and successfully clinically tested. Unfortunately, in the advertising slogans of the Virotherapy Center there is no mention of that – not even as an option.

Rigvir‘s development and implementation: a timeline

  • 1960s Under the management of Professor Aina Muceniece, the study of enteroviruses is initiated and the virus, now called Rigvir, is discovered. During Soviet occupation, observations indicate its efficacy in the case of melanoma. Research continues until production of the substance is discontinued in 1999.
  • 29 April, 2004 Rigvir is registered in the Drug Register of the Republic of Latvia within national registration procedure.
  • 1 May, 2004 Latvia joins the European Union and, since then, registration must be carried out in accordance with EU regulations.
  • 2008 The International Virotherapy Center is opened under management of Professor Muceniece’s relatives Dite Venskus, Jurgis Auzins and others.
  • 2011 Rigvir is included in the Latvian list of state-reimbursed medicines for treatment of skin melanoma (all stages).
  • 2015 Rigvir is included in the national clinical guidelines for melanoma treatment (elaborated under the management of Professor Dace Baltina).
  • February, 2016 The Global Virotherapy Clinic in Jurmala, Latvia is opened.
  • Summer, 2016 Professor Dace Baltina commences work at the Global Virotherapy Clinic.

Dr. Eglitis says that despite difficulties, immunotherapy has the potential to become a treatment method in the future, but only in close association with current therapies. “Immunomodulating agents can be different, they can stimulate or suppress some processes of the immune system. Colleagues in the USA and Australia are working hard on the development of certain medications, and the Australian researchers can even prove the efficacy of their therapeutic agent with an electron microscope. Still, new drugs seldom appear. Most of them are incapable of passing comparative tests.” R. Macuks agrees that virotherapy may become an industry in the future: “Viruses can increase the body’s immune response as demonstrated by vaccines. That is certainly a future direction in medicine, as demonstrated by the development of immunomodulating chemotherapy in oncology.”

While new pathways in oncology are being explored, we are going to review the objections to the communication methods of Virotherapy Center.

What is wrong with the communication?

Rubene is embarrassed that “manipulative patient testimonials are disseminated, and that magazines and newspapers are flooded with promotional articles where Virotherapy Center representatives without any medical education declare Rigvir to be the the first drug in its group and state there are no similar agents available in the world [2-4]. Rigvir advertising materials also emphasize that this agent was registered in an EU country, thus misleading patients and making them believe that Rigvir was registered according to EU standards, although it is well-known this medication was registered before Latvia joined the European Union. Academic, chemist and Rigvir shareholder Ivars Kalvins (translator’s note: known also as the inventor of meldonium (Mildronate)) [5] keeps asserting without the smallest feeling of guilt that Rigvir is the first-choice agent for the treatment of a “sensitive” tumor [6], even after multiple objections.”

Communications expert (translator’s note: online writer on science and evidence-based medicine) Ksenija Andrijanova emphasizes that the way the Virotherapy Center advertises itself is not typical for a medical facility, even though they are trying very hard to look like one. After exploring fraudulent treatment methods (there are many in oncology), Andrijanova has noticed two common features: “First, conventional treatment approaches are blatantly discredited, especially radiation and chemotherapy since they have side effects (which is true). However, the claim that these therapies do not help and recovery chances are very low is much more dangerous, and it is a false statement. Secondly, there are statements that oncology patients can be treated in a ‘natural way,’ and the real cancer treatment agent is safe, natural and harmless. Both features were present in the Virotherapy Center’s materials.”

There are also reputational problems. Andrijanova objects to the Virotherapy Center’s involvement with an infamous Mexican clinic Hope4Cancer and the issuing of a certificate to a person without medical qualifications, entitling her to administer Rigvir. Andrijanova also points out terminology used by fraudulent institutions and, unfortunately, by the Virotherapy Center in response to criticism. “The opposition is associated with conspirators, huge corporations and Big Pharma.” The use of Aina Muceniece’s name as a cover is also shameless. One of the main slogans of the Virotherapy Center’s communicators is as follows: “By criticising us, you are discrediting her lifelong efforts!” That is a very manipulative defence – like human shields in a war: by shooting the enemy one hits an innocent person.

Signe Mezinska, an expert on medical ethics, suggests that illegal advertising is the primary and most visible problem because advertising of prescription drugs to patients is prohibited. “We may also want to picture how Latvia is presenting itself as a medical tourism destination,” Mezinska says. “This goal of attracting medical tourists is clearly noticeable in the promotional campaigns of the Virotherapy Center. This is a striking case. We have not had such a precedent in Latvia. Up to this point this niche included service advertising, but now it has changed to prescription medications.”

A reasonable question arises: if the entire treatment is based on the use of only one agent, why can it not be used at home and why is there a need to come to Latvia? It all leads back to the absence of studies and research. A medicinal product without clinical evidence cannot be sold anywhere.

Complaints and penalties

  • February, 2016: the Health Inspectorate of Latvia responds to NGO’s Health Projects for Latvia complaint on illegal advertising of prescription medicine, announcing that a decision has been made to prohibit the unfair commercial practice.
  • March, 2016: A representative of the Virotherapy Center gives a lecture to the cancer patient support organisation Tree Of Life (Dzīvības koks), repeating their infringements (confirmed by the Health Inspectorate).
  • August, 2016: the Health Inspectorate of Latvia imposes a 6000 euro fine for the unfair commercial practice of advertising a) prescription medicinal products and b) advertising them for unregistered indications (the company has appealed the penalty).
  • September, 2016: The Community Research and Development Information Service at the European Commission (CORDIS) announces on Twitter that, in cooperation with the EASME and H2020 agencies, it will initiate an investigation to find out if the EU grant to Rigvir manufacturer SIA Latima was issued legitimately. The company received 50,000 euros within the H2020 project framework to evaluate the feasibility of Rigvir‘s registration in the European Union (feasibility study for the registration of the medicine Rigvir with the European Medicine Agency) [7].

Talking about money

Dr. Muceniece’s will states that melanoma patients should receive Rigvir at no cost, which means the state grants (buys from Rigvir representatives) this medication. However, Dr. Eglitis notes: “Initially, the substance was very cheap. The cost has gone up multiple times since then and that is not insignificant!” Rigvir is not indicated for late stage cancer; completely different medications should be used then, explains the oncologist. “However, these products are very expensive and, in addition, one has to prove specific genetic changes to receive them at all. These agents, for financial reasons, are not reimbursed in Latvia (!), and only a few can afford them. They do not promise a miracle recovery and only promise to delay the progression of the disease. It is easier for a patient to go to the Virotherapy Center”. And, certainly, pay. The Medical Director of the Virotherapy Center, Dace Baltina, mentions an excuse in the magazine Ir: “We do not promise to heal”, but “a patient is ready to pay believing the recovery will happen”. This point is completely unacceptable for scientist, physicist, Associate Professor of the University of Latvia and corresponding member of the Latvian Academy of Science Vyacheslavs Kashcheyevs, who has expressed his frustration about the degradation of science: “To assume Rigvir was the agent responsible for recovery without any reason means believing the things we desired have turned into reality. It is like buying a lottery ticket in the belief that you have purchased a car. There are no jokes with cancer. The patient has to know and understand whether he is paying for medication or a hope for a miracle,” the scientist concludes.

Spending money is not the only painful issue

The case of the Virotherapy Center and Rigvir causes not only huge expenses for patients, but demonstrates and even creates a new string of discrepancies. These events show how limited the power of the Health Inspectorate is. They can check on complaints, but they lack any resources for subsequent control, and overseeing misconduct abroad is completely out of the question. These activities discredit scientists in Latvia as well, and it is unclear why the Latvian Academy of Science does not have any objections to the statements from their member Ivars Kalvins.

What can we do?

“The simplest approach would be this – let’s lock up the Virotherapy Center with help from the police!” says Ugis Gruntmanis, Professor at Texas University and Chairman of Latvian Medical and Dental Association. However, the professor thinks in that case then sales would move over to the “black market” where people will be willing to pay large amounts for the treatment. He references a similar case in the USA which was used in the movie Dallas Buyers Club.

“If we can expect Rigvir to become a success story, I would suggest acting pragmatically and in the interests of the state,“ says the professor, suggesting a plan of further action. “First, we should involve global experts to elaborate two or three studies in melanoma patients who have not achieved improvement using other treatment options. Second, we should start a smaller scale study for some other frequently observed cancer type, working out a consent form with the help of an ethics specialist to clearly specify that “this medicinal product has not yet been studied for your type of cancer; it can cause deterioration, etc.”

Gruntmanis continues: “What is absolutely clear? It should be prohibited to advertise Rigvir as a medical treatment, and it can only be allowed as a clinical trial drug and only if such research is commenced. If this doesn’t happen, this institution should be closed. In any case, national and global experts should be involved, and the state should support this by any means necessary, maybe for a share of profits in the future, if feasible.” The Professor assumes, however, that Dace Baltina, who currently manages the Virotherapy Center, would not be able to handle this on her own; but there are oncologists of Latvian origin in the USA and other countries who might be helpful in organizing this complex process.

 

How much does the treatment cost?

Using information from TV reports, the treatment of one patient at the Global Virotherapy clinic costs from 7,000 euros a week, including accommodation, procedures and expenses [8, 9]. Since the treatment regimen for each patient is adjusted individually, it is not known with certainty how much a treatment with Rigvir costs.

How many patients are there and where do they come from?

Currently, 38 requests for donations can be found in public donation portals abroad. They have been created during the last year and they mention treatment with Rigvir in Latvia, at alternative medical treatment clinics in Germany or at the accredited Hope4Cancer clinic in Mexico (Facebook and some other sites have more requests for donations, but they are not included as they are not public).

Only 4 patients out of 38 have melanoma, the others have different types of cancer. The total amount of donations they are trying to collect is: 1,457,972 euros.

According to information submitted by Rigvir representatives to the newspaper Daily Business, during the seven months since the opening of the Global Cancer Virotherapy Clinic in Jurmala, 160 patients have been treated with oncolytic virotherapy medication. 159 patients of them have been from abroad, mainly from the USA, Great Britain, Canada, Australia, etc. [10].

Financial data

According to Lursoft data, the Virotherapy Center or Global Virotherapy Cancer Clinic, Ltd. was registered in 2008. The clinic has been open since February this year. The largest shareholder of the company is Rigvir, Ltd. (95%). Its turnover was € 533 000 with € 160 000 in profit last year. The owner of the largest number of Rigvir shares is Jurgis Auzins (51%), 40% of shares belong to Dite Venskus, 3% to Ivars Kalvins, and 3% to Andrejs Nollendorfs and Katrina Pumpurina each. 5% of Global Virotherapy Cancer Clinic shares are owned by VVMV, Ltd., which is the family enterprise of businessman and sponsor Vilis Vitols.

The previously mentioned company Latima, which belongs completely to Rigvir Holding, had a turnaround of 1.25 million euros and 293 thousand euros in profit last year.

According to statements made by the CEO of Rigvir Holding K. Juckovica in newspaper Daily Business (Dienas Bizness), € 650 000 will be invested in enhanced studies during the next three years, but the total investment in clinical research might be € 25 000 000. The enterprise plans to obtain these means from the European Union grant funds, from loans and their personal funds. The consolidated turnaround for 2016 is planned at 4 million euros.

To obtain a European Commission grant for research, the company has to successfully accomplish Phase 1 of the Horizon 2020 SME grant project, which evaluates the feasibility of the product to be registered in the European Union. Only after that can Rigvir initiate the second phase of this project, which provides them with financial support for clinical research. Phase 1 of Rigvir‘s project will be completed at the end of January, 2017, when project results will become known. It should not be forgotten that clinical research is performed to determine the efficacy of this medicinal product and only a positive outcome would allow planning for further commercialization.

The true will of Aina Muceniece

grave

The protagonist of this story, Aina Muceniece, is buried in one of the smallest cemeteries in Riga, if not in Latvia. Her grave site is located in Kapsila cemetery, Darzini, with just a handful of other resting places. The professor’s grave is marked by a memorial gravestone which has the following words engraved on it: “Science, science unite, promise to save humanity”. It seems the scientist is clearly showing the way to resolve the problems with her discovery.

Science should not take the back seat for the purposes of profit. Instead, the principles of science should be trusted and honored.

[Photo: Grave of Professor Aina Muceniece with epitaph on the gravestone]

References

Editorial footnote: When Materia Medica editorial staff asked the CEO of Rigvir Holding Kristine Juckovica, what steps they were planning to take to clear the accusations about insufficient evidence for Rigvir’s efficacy and to solve product documentation problems in accordance with regulations and ethics requirements, she answered: “This question includes several statements; therefore, I cannot give a precise answer. I can only indicate that safety and efficacy studies have been performed and this medicinal product has been registered with the State Agency of Medicines since 2004. Our goal is to complete the necessary studies within a few years to register the virotherapy medication for treatment of melanoma at first in Europe and then in the USA. We are currently building a new research laboratory, and the total intended investment exceeds 1.5 million euros. The EC grant was issued within the program “Horizon 2020″; its goal is commercialisation of the medicinal product in EU markets. We will invest 650 thousand euros in research within the next three years; we have intended to invest a total of 25 million euros for this purpose. Our main concern is the patient; our goal is to provide patients with the best possible treatment in a timely manner.”