If Rigvir is effective "virotherapy" for cancer, why are quack clinics selling it and quackery promoters like Ty Bollinger promoting it?

Last week, I wrote about Rigvir, a highly dubious cancer therapy developed in Latvia. Rigvir is an oncolytic virus, and its proponents claim that it targets only cancer cells for destruction, leaving normal tissue alone. Its history and how it came to be approved in Latvia in 2004 and added to the Latvian Health Ministry's list of reimbursable medications in 2011 remain rather mysterious, but how it is being marketed does not. For example, Rigvir has become a new favorite treatment at a number of quack clinics, such as the Hope4Cancer Institute in Mexico, where Rigvir is offered along with coffee enemas and a wide variety of quackery. Moreover, as I described last week, there is a striking paucity of evidence supporting the efficacy of Rigvir against any cancer, even melanoma, the cancer for which Rigvir is approved in Latvia and for which there appears to be almost no published evidence at all. Certainly there is nothing resembling well-designed randomized clinical trials supporting the efficacy of Rigvir. Basically, few outside of Latvia and Eastern Europe had heard of Rigvir, as it had flown under the radar, most likely because Latvia is a small country. Then Ty Bollinger featured Rigvir in Episode 3 of his alternative medicine propaganda video series The Truth About Cancer (TTAC), complete with "miracle cure" testimonials, and suddenly Rigvir wasn't so obscure any more.

The Truth About Cancer promotes Rigvir

As I've discovered since last week, the people who run the International Virotherapy Center, where Rigvir is manufactured and sold, are not particularly happy about the increased level of attention directed at them. Indeed, within 15 hours of last week's post going live, I had received an e-mail from someone named Lelde Lapa, whose title was listed as Assistant of Business Development Department at the International Virotherapy Center (IVC). She was quite…unhappy with my post. Personally, I was amazed at how fast I received such a long e-mail after publishing my post. Clearly the IVC has many Google Alerts set for Rigvir and its name and is fast to act.

As of this writing, the exchange is up to four e-mails, two from Ms. Lapa and two responses from me. One thing stood out, and that was how my charge that IVC irresponsibly markets Rigvir using patient testimonials seemed to produce the most defensive response. Based on that, I thought I would look a bit more at how Rigvir is actually marketed, starting with how Ty Bollinger featured it in Episode 3 of TTAC. (After all, Ty Bollinger's video series is where most cancer patients interested in alternative medicine learn about Rigvir.) Although I couldn't force myself to watch more than about the first half hour of the first episode of TTAC when it was first released, fortunately Harriet Hall could and I did download all the episodes off of YouTube when they were briefly available for free. This allowed me to watch the segment on Rigvir, which starts at around the one hour mark and takes up most of the last half hour of the episode.

The segment begins with an interview with Kaspars Losans, MD, IVC's medical director. Dr. Losans claims that Rigvir is a "very good" virus that specifically targets cancer cells and leaves normal cells alone. Next up, we meet Ivars Kalvins, PhD, who is the Director of the Latvian Institute of Organic Synthesis, which is a "state research institute specializing in pharmaceutical research, organic chemistry, molecular biology and bioorganic chemistry." (The appearance of a scientist from a Latvian state research institute made me wonder a bit about collusion between the government and the IVC, for obvious reasons.) In his narration, Bolinger notes that Dr. Kalvins is a member of the European Academy of Sciences and one of three finalists for the European Medicine Award in 2015 and has many publications and patents. In contrast, he does not mention that Dr. Kalvins owns a 3% stake in Rigvir. Googling him, I found that he is best known for developing a heart medication, Mildronate (generic name: meldonium). Interestingly, although Bollinger claims Kalvins has over 650 publications, I could only find ten in PubMed.

In any case, my first thought was: If such a seemingly good "conventional" scientist is behind Rigvir, then why is it that the IVC has not published anything resembling good science supporting its claims for Rigvir? This is not a person who doesn't know how to publish. Oddly enough, he is not co-author of any of the few publications I could find in PubMed about Rigvir. Less oddly, given his support of Rigvir, he is not well-regarded outside of Latvia, basically because he makes claims for meldonium that are equally unsupported. Indeed, meldonium was the alleged performance-enhancing drug that Russian tennis player Maria Sharapova was caught using last year, leading to her suspension. Although it is approved in Latvia and several former Soviet Republics, it is not approved in the U.S. or European Union. Maybe Dr. Losans isn't quite the good conventional science that the first impression gave me.

Be that as it may, Dr. Kalvins goes through the standard "history" of Rigvir, specifically about how Prof. Aina Muceniece discovered it. Interesting to me is Dr. Kalvins's claim that Rigvir is used "very, very successfully" to treat melanoma and "not only melanoma." I also wondered about his claim that Rigvir is a native, non-modified virus. That, of course, is likely true, as Rigvir is an Echovirus, specifically ECHO-7. As I mentioned last time, Echoviruses are RNA viruses that were thought to be orphan viruses (viruses with no known disease associated with them) but in fact do cause mostly (but not always) mild febrile diseases. In any case, Dr. Kalvins claims that Rigvir is a "non-mutating" virus, which, of course, also set my skeptical antennae a'twitching given that there is no such thing as a totally non-mutating virus. I suppose it's possible that he means the ECHO-7 strain used in Rigvir doesn't cause mutations in human cells, but who can tell for sure?

We also meet another physician, Peteris Alberts, MD, PhD, who is IVC's Head of Research & Development. After Bollinger says that Rigvir's activity was first demonstrated in mice, Dr. Alberts says:

Dr. Peteris Alberts: They found that if you take a tumor from a patient, put it into a hamster, then it will start growing, or something like that. If you put [it] on the virus, it will just fade away. Do you know who did that observation first? Ms. Garklava, the lady you saw this morning.

Ty: Really?

Dr. Peteris Alberts: Yeah. She did that.

There is a very brief shot of Bollinger interviewing an old woman, but none of the interview is heard, which I found odd.

Indeed, there are a lot of claims made for Rigvir, none of which seem to be supported by any publications that I've been able to find indexed in PubMed. For example, Dr. Kalvins is shown saying:

There are at least ten different cancers, locations of cancer like renal cancer, like breast cancer, like stomach, lung, many others, also prostate cancer, which is very, very common for men. But, approved officially, it is only for melanoma now, but this is a very, very big success because we see that the people who use this virus for other indications of other types of cancers also can be healed.

If this is true, then the IVC should publish these results. One of the excuses that IVC makes for not having published clinical trials to support Rigvir's efficacy and safety against cancer is lack of finances. However, if the IVC has already done preclinical work that shows all this, there is absolutely nothing preventing it from publishing those results. It hasn't. Why is that? (I think I know the answer.)

Another claim is made by Elita Shapovalova, MD, an oncologist at Riga East Clinical University Hospital:

In melanoma cases, in earlier stages when patients receive Rigvir, the percentage survived is 92 percent. And later stages, for example, if they receive Rigvir it's 60 percent. If they don't receive it, it's only 9 percent. There's no chemotherapy medicine that can treat melanoma, at least not found. In the beginning, we were using radiotherapy. But then, it got rejected. So we could not use it because it kills the immune system and it's very hard to fight. We come back to chemotherapy — the medicine in the chemotherapy field is not found to cure melanoma. And the second negative is that it has side effects, which simply destroys the immune system, which lowers the quality of life of the patient, and simply changes the whole life of the patient by these side effects.

Again, if this is true, then the IVC should publish these results. As I discussed last week, the existing publications indexed in PubMed supporting the efficacy of Rigvir against melanoma are very unconvincing, and there are no randomized clinical trials to speak of, at least none to which I have access. (In actuality, in our e-mail exchanges, Ms. Lapa basically admitted that the IVC has no clinical trial results that meet modern standards.) For other cancers, the paucity of evidence is even more obvious.

None of that stops Dr. Kaspars Losans from claiming:

Then comes the second mechanism of RIGVIR. Whenever those RIGVIRs are attracted to cancer cells, those cancer cells become visible for the human immune system. Until that time, they are invisible, they have the natural ability to be hiding from the immune system. And due to the RIGVIR guidance, because RIGVIR is attached, and attach to cancer, and RIGVIR is inside the cancer cell. So the immune system, due to RIGVIR, recognizes cancer and starts to react against this cancer.

One more time, if this is true, than IVC should publish these results. This is the sort of immunological mechanism that would take a lot of cell culture, animal, and clinical work to demonstrate properly. That's a detailed mechanism that Dr. Losans is claiming. If IVC has the experimental and clinical results to demonstrate such a mechanism, it should publish them. If it doesn't, it has no business making claims like this on a documentary by a well-known proponent of cancer quackery, or anywhere else, for that matter.

Also, Dr. Alberts should stop making the ridiculous claim that prefaced Dr. Losan's description of Rigvir's mechanism of action that Rigvir is "the first real cancer therapy where you have an oncolytic virus which also has immunomodulating activity." There are lots of oncolytic viruses under study with immunomodulatory activity. That's the point! That's the whole idea behind oncolytic viruses, that they "promote anti-tumour responses through a dual mechanism of action that is dependent on selective tumour cell killing and the induction of systemic anti-tumour immunity." Seriously, even if everything the IVC and its minions say about Rigvir is true regarding its mechanism of action, Rigvir is not the only oncolytic virus with a dual mechanism of action!

Finally, having Antonio Jimenez, the director of the Hope4Cancer Institute opining about how Rigvir boosts the immune system doesn't help the credibility of Rigvir:

Often times, in clinical practice, we focus on optimizing the immune system – getting the best immune system possible. And that's great. But still, cancer cells have now developed a way to bypass immune recognition. And the International Virotherapy Center here in Latvia, with the studies on RIGVIR, they have concluded that the RIGVIR is binding to the receptor site on the cancer cell surface, called the CD55. When it binds to this receptor, now the T-cells, the B-cells, the natural killer cells, will recognize the cancer cells and mount a specific immune response.

Again, that's a very specific mechanism that Jimenez is proposing. Where's the evidence to support it?

Again, seriously, any truly scientific institute that had developed a drug would not want a quack like Ty Bollinger or Dr. Jimenez endorsing its discovery. That's the kiss of death as far as scientific credibility goes. Yet IVC embraces these quacks, sells to the Hope4Cancer Institute, and gladly lets its product be featured on a video documentary series designed to attack conventional oncology and promote alternative cancer quackery.

I also can't help but scoff at the claims, made by several IVC boosters, that Rigvir has "no side effects." For one thing, there is no such thing as an effective medicine that has absolutely no side effects. It's clearly just not true. After all, even in the Melanoma Research paper from 2015 that I trashed last week as being so badly done, the authors noted that in previous clinical studies Rigvir had caused subfebrile temperature (37.5°C for a couple of days), pain in the tumour area, sleepiness, and diarrhea. Again, whenever anyone claims that an anti-cancer medication (or any medication, for that matter) is completely without side effects, I start becoming very suspicious.

But what about the testimonials?

A key part of TTAC's segment on Rigvir consists of three testimonials. The first was from a woman named Khrystyna Yakovenko, who in 2012 was diagnosed with melanoma that had metastasized to the liver:

It all started in the end of 2012. When I contacted my doctor, he diagnosed melanoma of the fourth stage, with a metastasize of the liver. They prescribed the plan of chemotherapy and at that time, I even didn't understand what is what. I completely trusted our Ukrainian doctors and I trusted the methods they are using. I trusted this plan of chemotherapy. So I simply didn't realize — I didn't realize the effect of this diagnosis completely, entirely at that moment.

I can't help but note that here Bollinger invokes a typical trope used by quacks, that you have to "believe" in the therapy, saying, "one of the very important parts about a successful cancer treatment is that you believe in it and you're ready to fight to save your life." After that, Yakovenko relates:

I was not feeling afraid. I was not falling into panic. Simply, I understood that I had no right to leave it. I had to fight. When I first came to my therapy center, doctors didn't say, "Yes, we will do it." They said, "We will try." Because the stage was late. I think that sometimes on the earlier stages — on the initial stages people who have this very scary diagnosis, they sometimes are by themselves. They lose hope. They stop the fight. And they simply leave it. But, sometimes there are people who, even at late stages, they continue to fight, and continue to find the out of the situation. In this case, as the disease simply just is overwhelming.

So, basically, Ms. Yakovenko is a woman who was given a "maximum" of a couple of years to live, but was alive in late 2015 or early 2016, when this film was being made. That's about three years, which is very good but not evidence that Rigvir prolonged Ms. Yakovenko's life. Melanoma can have a highly variable course, and there are patients who survive with stage 4 melanoma for years. They are the outliers, of course, but there are too many of them to take someone who survived less than twice as long as predicted as slam dunk evidence that whatever cancer treatment she chose worked. I also can't help but notice that no scans are shown, and no mention is made of whether her cancer shrank, was stable, or progressed. Yes, this is yet another unconvincing cancer cure testimonial.

A more recent interview, dated December 2016, is published on the blog of the Virotherapy Foundation (mentioned last week). Thus, Ms. Yakovenko's story is continuing to be used to promote Rigvir, with her saying, "I have already been alive for 2 years and 7 months thanks to Rigvir," which suggests that this interview occurred in the latter half of 2015, given that she started Rigvir in February 2013.

The next testimonial is a man named Ruslan Isayev, who reports that he was only given seven months to live. In the interview, we are not even informed what kind of cancer Mr. Isayev had, other than that he had surgery for it. I presumed that he had melanoma, which turned out to be correct, as you will see, but it's very sloppy not to have specified the cancer. In any event, Mr. Isayev states that he tried chemotherapy after his surgery but couldn't take it and stopped, living "for one year more without chemotherapy," after which he decided to start Rigvir. Naturally, he credits the Rigvir with saving his life and even holds up a picture of his son, noting that he had been told that it would be very difficult for him to have any more children and that when he learned that his wife had become pregnant he vowed that "if were to be a girl, a daughter, I would name her after Aina Muceniece — after Professor Aina Muceniece, who was the discoverer, the great person, so Aina. And if it were to be a boy, then I would name him after the chairman of virotherapy, Jurgis, who is the grandson of Professor Aina Muceniece." It was a boy, and he named him Jurgis.

A little Googling revealed, though:

In an interview on May 28, 2014, Ruslan Isayev gave a personal account of his experience with stage III skin melanoma. When he was diagnosed in 2010, the Chechen Republic doctors refused to operate on Ruslan. He went to Dagestan for surgery and after two weeks of lying in bed, the doctors gave Ruslan just seven months to live. He went to Grozny for chemotherapy, but after four doses he began to feel worse and worse. A local doctor then prescribed Interferon Alfa, a pharmaceutical drug meant to slow down tumor growth. Ruslan took this drug for one and a half years until a friend mentioned RigVir, an oncolytic virus created by the Latvian Academy of Sciences. After his third injection of RigVir, the doctors said his lymphonodus had shrunk and metastases disappeared. After a year of taking RigVir, Ruslan is alive and healthy.

Stage III melanoma is curable, I note. True, its survival rate is not great, but if the surgery is adequate long term survival is possible. I also note that Isayev received what sounds like considerable conventional therapy, including chemotherapy and a year and a half of interferon-alpha. As is the case with most such testimonials, it's very difficult to ascertain whether the treatment had anywhere near the effect claimed because too little information is given. An account in Spanish reveals a rather convoluted story in which Mr. Isayev had surgery, had a number of complications, briefly underwent chemotherapy, and then underwent treatment with interferon-alpha, during which time he claims that his disease did not progress but that it "didn't help me, either." (Stable disease is actually a desirable outcome.) He then claims that after he switched to Rigvir his lymph nodes shrank, his metastases disappearing. Overall, it's a convoluted story that does not really show that Rigvir is the reason why he's still alive. Again, most likely, it's the variable course of melanoma progression, the surgery, and interferon-alpha that have resulted in his continued survival.

Finally, there is a Russian woman named Zoya Sokolova, who states that she was diagnosed with "third stage cancer." Again, the cancer isn't identified, and I assumed that it was melanoma as well. This time, I was incorrect. It was sarcoma, as you will see. (Google is my friend.) In any case, in TTAC, Ms. Sokolova reports:

It was— the diagnosis was very sudden for me. It was after a very strong stress, and then after a month and a half, I was diagnosed with a third stage cancer. Already after the surgery I had my chemotherapy, then they assigned another six chemotherapy and a full course of radiotherapy. My condition allowed only for chemotherapy to be handles, and after the fourth, I wasn’t able to stand up from the bed. I became a bed patient. Before these courses of chemotherapy I was told about a center, about a treatment, but I believed in our doctors and their treatment methods. So I decided to follow that path.

Then:

It seemed that they wanted it to be so for me, but they couldn’t give a warranty, they couldn’t say for sure that I would [beat] this disease. That moment when I couldn’t stand up from the bed on my own. I was so weak, and my relatives decided to take a van, to make a bed for me, and simply drive me to Riga, to the center. Before coming to Riga I made a blood test and a complete observation for the doctors here to have the full picture of my condition. When the doctor saw my blood test she was really astonished because all the blood tests was lower than for a live person. She was astonished how I managed to get here, staying alive.

Here's what it sounds like to me as a surgeon, based on the account above and the TTAC book that told me she was being treated for sarcoma. Stage III sarcoma means that either the cancer is larger than 5 cm in diameter and grade 3 histology or that it has spread to nearby lymph nodes. I note that stage III sarcomas are still potentially curable. Actually, even some cases of stage IV sarcoma are potentially curable if the distant metastases can be completely resected by surgery. Indeed, surgeons frequently resect lung and liver metastases from sarcoma, when they are few enough and small enough to be completely resected.

My reconstruction of the testimonial is that Ms. Sokolova underwent radical surgery for her cancer, followed by chemotherapy and radiation, both of which are frequently used to treat sarcoma. She obviously had a very bad time of it, suffering multiple complications to the point where she was bedridden. After she began the Rigvir, she slowly recovered from the complications that she had suffered and, of course, attributed her recovery to Rigvir. At no point in this testimonial is any evidence provided that the Rigvir had any effect on her tumor. As far as I could tell from every description of her case, she was tumor-free at the time she chose to use Rigvir, just very ill from complications of surgery, radiation, and chemotherapy. Rigvir almost certainly did not save her, as much as Ms. Sokolava believes that it did, tells the Virotherapy Foundation that it did, and now uses virotherapy to "strengthen her well-being" and prevent recurrence. Again, there is no evidence that Rigvir prevents the recurrence of sarcoma.

Not surprisingly, Bollinger laps up this story as evidence of how great Rigvir is as a cancer treatment.

A previously discussed testimonial revisited

In my post last week, I briefly mentioned a testimonial that is featured on the International Virotherapy Center website:

In brief, Nadine is a British woman who had melanoma in 1999 that recurred in 2009. We know that she's undergone surgery, radiation therapy, and chemotherapy, but that she still has cancer. She is portrayed in the video as doing well after having started Rigvir, even though she is not cancer-free. What I didn't know (but perhaps should have discovered through Googling) last week is that Nadine has a GoFundMe page that paints a much more dire picture of her situation. It was last updated six months ago, which makes me worry about whether she is still alive:

Recently, she has seen huge success from a treatment she had at the Global Virotherapy Cancer Clinic in Latvia. The centre there offers holistic care and a course of virotherapy. Incredibly, just one week after returning from Latvia, Nadine's scan showed that the 2cm tumour on her lung had completely disappeared and all-but-two of her other tumours had shrunk significantly. This is a huge breakthrough and so now Nadine needs to obliterate all the other ones too and go back to Latvia every three months for further treatment at a cost of around £7,000 a time.

Although this treatment isn't available in the UK, it is something that is now being trialled in the USA in combination with immunotherapy, which Nadine is receiving through our amazing NHS.

This treatment is working amazingly well at keeping surface lumps and bumps at bay - a few injections at sites near them sees them shrinking and vanishing - so this must be kept going.

Unfortunately though, the cancer has managed to take up residence in her lower intestine, making it impossible to eat or drink. Nadine, as resilient and incredible as ever, hasn't taken this lying down and has insisted the surgeons try to clear enough of her stomach to allow fluids to pass. As soon as this happens, she will be heading to Hungary for Gerson Therapy. This holistic therapy has been responsible for some fantastic results in other melanoma patients, and Nadine is determined to get out there and get this thing back under control. This therapy will cost around £7,000 too. So, Nadine really needs YOUR help!

Malignant small bowel obstruction due to melanoma is definitely not good. Fortunately, update #2 shows that she did undergo surgery for her bowel obstruction:

Just a little note to say Thank you to everyone who's checked in with me after my operation on Tuesday.

I've been using the cannabis oil instead of morphine and codeine for pain relief, with the added bonus that I can't be bothered to speak or move.... My kids and sister are delighted!!!! Lol

I am soooooo happy too, that with your help I'm almost at my target to help towards my next batch of treatment...I can't thank you enough.xxx
I promise to send each of you a thank you message , bear with me... Xxxxx

So next week once the shoulder starts to heal I have a full on week of getting back on track.

Monday I'm meeting a lady to discuss Biomagnetism therapy, Tuesday follow up at the nutritionists, weds back to hospital for checks, Thursday we get back on the virotherapy injections.....and Saturday I start the spring mindfulness course, this is key in keeping my mind focused and living in the moment.xxxxxxxx

Some times people ask me what I'm doing for work, as you can see, my full time job is trying to stay as well as possible and keep plugging away at trying to find why I've got this disease in the first place.

That was six months ago. It is unclear when the video featured on the IVC website was shot, but it's dated August 11, 2017. However, in it Nadine doesn't mention any surgery for a bowel obstruction; so either that was intentionally not mentioned, with the bowel surgery falling under the rubric of "many operations," or this video was recorded before her bowel obstruction, which, I note, happened while she was undergoing virotherapy, as was made clear to me reading her GoFundMe page. Obviously, the Rigvir didn't stop her tumor from progressing. Yet, the IVC is still using Nadine's testimonial in a deceptive—dare I say irresponsible—manner to sell Rigvir. Yes, I stand by my original assessment, and unfortunately that irresponsible and unethical use of patient testimonials to promote Rigvir is having an effect, particularly now that more and more alternative cancer clinics appear to be offering it.

Meanwhile, Rigvir marketers appear to be using using legal thuggery to try to silence Latvian critics. For example, Riga Stradiņš University recently received a letter from Sorainen, a law firm representing Rigvir Holding, regarding Dr. Santa Purvina, who is faculty there. The letter asked whether Dr. Purviņa's statement that the studies upon which the approval of Rigvir were based were inadequate represented the view of the University. If that isn't an attempt at intimidation, I don't know what is.

The more I learn about Rigvir and the International Virotherapy Center, the more I think the whole operation stinks to high heaven. It should be interesting to see what lands in my e-mail in box this week. Be assured that I do plan on publishing the entire e-mail exchange eventually. I merely held off because I was particularly interested in how the IVC will respond to the e-mail that I sent on Friday. In the meantime, the whole Rigvir operation is starting to remind me of the Burzynski Clinic, only worse given the marketing to alternative cancer clinics and the even more transparent than usual excuses for not doing clinical trials. What I do see is the marketing of Rigvir using the same methods that Stanislaw Burzynski uses to market antineoplastons, patient testimonials and through alternative medicine-promoting hucksters like Ty Bollinger, whose documentary has persuaded cancer patients to eschew effective treatments in favor of quackery.

That's not a good strategy for a company marketing a science-based treatment. It is, however, a good strategy if you're marketing quackery. Which is it, Rigvir?