During the last two Mondays, I have been writing about an unproven most cancers remedy that I hadn’t actually heard a lot about earlier than. The most cancers remedy known as Rigvir; it’s manufactured in Latvia and marketed primarily via a Latvian entity referred to as the Worldwide Virotherapy Middle (IVC). To recap, Rigvir is an unmodified Echovirus, particularly ECHO-7, that, based on the IVC, seeks out most cancers cells, replicates in them, and thus lyses the most cancers cells (causes their membranes to interrupt, spilling out the most cancers cells contents, thus killing the cell), therefore the time period “oncolytic virus.” One way or the other, mysteriously Rigvir was accredited by the Latvian equal of the FDA in 2004 for the remedy of malignant melanoma regardless of what seems to have been grossly insufficient supporting proof after which much more mysteriously positioned on the Latvian Well being Ministry’s listing of reimbursable drugs in 2011. I think that the rationale that I did not look into Rigvir earlier was in all probability as a result of its use had been primarily restricted to Latvia, Georgia, and Armenia. Additionally, there was the language barrier. Almost all the things obtainable on the internet about Rigvir is in Latvian, a state of affairs that has solely lately begun to vary.
It was Antonio Jimenez and Ty Bollinger who plucked Rigvir from obscurity. Dr. Jimenez runs the Hope4Cancer Institute clinics in Baja and Cancun, Mexico, and, for no matter cause (in all probability revenue), these clinics began providing Rigvir comparatively just lately. Then, Jimenez, who’s clearly labored with Bollinger prior to now, should have turned Bollinger on to Rigvir, and Bollinger included it in an extended phase of Episode three of his The Fact About Most cancers (TTAC) propaganda collection of movies. It was this connection and the misleading use of affected person testimonials by each Bollinger and the Worldwide Virotherapy Middle to promote Rigvir that shaped the idea of my second publish on Rigvir final week. As you may think, apparently the administration of the IVC was not comfortable about my posts. Actually, so sad was the administration of the IVC that inside 15 hours of my first publish about Rigvir going reside I acquired an e-mail from somebody named Lelde Lapa, whose title was listed as Assistant of Enterprise Improvement Division on the IVC, protesting and trying to refute my publish. As I famous earlier than, I used to be amazed at how briskly I acquired such an extended e-mail after publishing my publish. Clearly the IVC has many Google Alerts set for Rigvir and its identify and was quick to behave. What adopted was an trade that presently stands at 5 e-mails, three from Ms. Lapa, with two responses from me, with Ms. Lapa’s tone (if it certainly was just one individual writing these) turning into extra strident because the trade went on. As a result of these e-mails are an incredible perception into the considering (comparable to it’s) on the IVC, I made a decision that a most wonderful approach to conclude my collection on Rigvir as a trilogy can be to annotate and publish these e-mails, after which to compose a remaining response to Ms. Lapa’s third e-mail, on the finish of which Ms. Lapa informed me that I did not want to reply. Clearly she do not know me vewy properly, do she? So let’s start. Keep in mind that English just isn’t Ms. Lapa’s native language; so be sort. I wasn’t variety, however not due to any difficulties Ms. Lapa may need had with English.
Rigvir strikes again, spherical 1
So on the afternoon after my first publish about Rigvir went reside, I used to be greeted by this in my e-mail in field:
From: Lelde Lapa To: [redacted] Topic: Weblog about RIGVIR Date: Tue, 19 Sep 2017 00:54:53 +0300 Group: RIGVIR Improvement division Orac: Yesterday we encountered one in every of your blogs (https://sciencebasedmedicine.org/rigvir-another-unproven-and-highly-dub…) On account of the truth that this weblog is now extensively unfold by non-professionals with the title – unbiased conclusion from worldwide skilled, we consider we’ve the rights to tell you that you’re used now as a device in competitors wars. Which we consider was by no means your intention. The drugs RIGVIR has a medical expertise for greater than 50 years and it’s registered for melanoma for greater than 13 years and earlier than the period of recent trials and a lot of the evidences shouldn’t be revealed. Docs and clinics in Latvia use this drugs for majority of melanoma sufferers in Latvia for a few years. In Latvia drugs is prescribed solely in nationwide clinics and by licensed docs they usually have additionally different options, so in all probability they know what they do. 2 years in the past we began EMA (centralised EU) commercialisation course of and even obtained EU fee help from Horizon2020 grant, we additionally obtained EMA regulatory recommendation. There isn’t a doubts concerning the efficacy and security of the drugs, nevertheless we acknowledge that we miss trendy trials for centralised registration and we’re engaged on them. This was by no means a secret to find. However yr in the past a gaggle of very lively, principally nameless individuals appeared that began to assault us, our cooperation companions, even EU fee, spreading bias knowledge and even lies. They’re very aggressive. A part of the sources they use doesn’t exists, a part of supplies are generated by them self and republished in several sources principally social networks, then in blogs after which cross-referenced. A part of materials is made as compilation of various phrases and translated in English with sure pseudo professionals on them (By the best way two such individuals seems additionally in your weblog, these individuals nevertheless has no correct educations, has by no means been concerned in drugs or science). Furthermore on the spring nameless letter (your weblog additionally indicated it ) appeared. It was signed by few skilled organisations of which solely 2 are associated to oncology and actually have been represented by the identical individuals, this letter incorporates ~80 lies and tendentious distortion of data. Sadly there isn’t any writer on the horizon to be liable for aspersion, however there have been instances when TV and portals have withdrawn comparable articles and details about us already. Principally your weblog analyses brazenly out there knowledge, however partially it accommodates false info. It incorporates additionally feedback of pseudo professionals or anti-PR specialists however the producer of RIGVIR was by no means approached for clarification or feedback. Which is gloomy particularly, referring to the assertion from the weblog: “By some means I doubt Rigvir will make it that far. At the least, I sincerely hope that it doesn’t….” We consider that additionally blogs must be goal and respectable professors ought to use solely confirmed knowledge and in addition verified sources. So please think about to right here additionally our place and acquire extra details about virotherapy with RIGVIR, like medical trial knowledge and post-registration expertise. We do present particular trainings for docs and medical scientists. I hope you have an interest, Wanting ahead on your replay. Greatest Regards, Lelde Lapa Assistant of Enterprise Improvement Division www.virotherapy.eu
In fact, I had no concept who this Lelde Lapa was. I could not actually discover something about her. A Google search of the IVC web site for her identify did not reveal something. For my functions, it does not actually matter, however I did discover it odd. I can not assist however word right here that, though I don’t declare to be utterly goal, my bias is relatively well-known: I favor science as the idea of figuring out which medical remedies do and don’t work. I make no bones about that. Furthermore, I could not assist however instantly word that it is fairly arduous to make use of “solely confirmed knowledge” when there’s so little in the best way of confirmed knowledge upon which to guage Rigvir. That was, actually, my key drawback with the drug, that it’s unproven and being marketed with out adequate scientific and medical proof that it does what’s claimed for it. Right here was my response, despatched later that night:
Pricey Ms. Lapa: The Virotherapy Institute have to be very on prime of its social media to have observed my publish and composed such a prolonged e-mail to me inside 15 hours or so after my submit went reside. When you’ve got any particular examples of errors in my submit, be happy to level them out. What I see in your letter just isn’t that; moderately, it’s spin, as nothing you wrote truly casts into doubt any information included in my submit or in any of my interpretations of these details. Sure, I used publicly obtainable info as a result of that’s what many bloggers do once they compose posts. In addition to, I used to be thinking about what I view because the irresponsible advertising of Rigvir for extra than simply melanoma, and there’s loads of that to be discovered on the Web and social media. The 2 movies in your web site that I mentioned fall into that class, unquestionably. In your e-mail, you state that there are “no doubts concerning the efficacy and security of the drugs,” however there are doubts—a number of doubts—a lot in order that my jaw dropped once I learn that. The reason being easy. You your self stated it: “…we miss trendy trials for centralised registration.” Principally, you don’t have something resembling the extent of scientific proof required earlier than we settle for any drug as efficient and protected. You haven’t any randomized double-blind medical trials. All you could have are a handful of case studies, a few very poorly completed retrospective research, and historic proof from many years in the past that can’t be inspected and assessed for scientific rigor. In my nation, our Meals and Drug Administration would snigger at such knowledge. When you’re making well being claims on your product, notably the glowing claims made about Rigvir’s anticancer exercise, then all that issues to me is whether or not there’s strong proof to again up these claims revealed within the peer-reviewed medical literature as listed on PubMed. In fact, this proof have to be within the type of papers reporting improved recurrence-free and general survival in well-designed, randomized double blind medical trials of your product for each most cancers for which a declare of efficacy has been made. I don’t care about unpublished knowledge that I can’t look at myself. I don’t care about claims. I don’t care about “registration,” as clearly the registration course of in Latvia on the time Rigvir was registered left lots to be desired. I don’t care about pilot grants to begin to work on approval by the EU. None of that issues when evaluating a remedy if there isn’t any good medical trial proof supporting its efficacy and security. Until you’ll be able to present me with these knowledge, I’ve no selection however to seek out your complaints about my article to be with out benefit. If Rigvir has been confirmed protected and efficient and isn’t quackery, then why are you promoting it to quack clinics in Mexico and Germany? I’m critical. Hope4Cancer, for example, is a infamous quack most cancers clinic that draws People with most cancers. This isn’t in dispute and might be verified by merely studying the Hope4Cancer web site and analyzing the remedies it provides most cancers sufferers. Additionally, if Rigvir has been confirmed protected and efficient and isn’t quackery, then why was it featured on Ty Bollinger’s “The Fact About Most cancers” video collection and, extra importantly, why is the administration of the Worldwide Virology Middle pleased with being featured in his movies? Bollinger is a infamous promoter of most cancers quackery. (I can present many examples of him selling doubtful, unproven, and quack remedies for most cancers.) No respected firm promoting a most cancers remedy scientifically confirmed to be efficient and protected would ever need to be related in any method with the likes of Hope4Cancer or Ty Bollinger, as a result of it might tarnish its model and convey it into disrepute. In fact, your response makes me extra assured than I used to be initially that I used to be right in my evaluation. Your paranoia, as an example, is makes me very suspicious. You rail towards “nameless individuals” attacking Rigvir and the Virotherapy Middle, however isn’t it true that the complaints to the Latvian Well being Ministry got here from the 2 most important oncology skilled associations in Latvia? That’s hardly “nameless.” They’re revered skilled medical societies! I even have seen fairly a couple of criticisms of Rigvir on blogs and have been capable of determine everybody making the criticisms up to now. Maybe you meant The Mad Virologist, however he isn’t actually nameless both. His identify is in his Fb profile, which I discovered in two minutes. Complaints about “nameless” individuals out to disparage a product all the time make me assume an organization has one thing to cover. Lastly, I perceive that you simply and Latvia are pleased with Prof. Muceniece’s accomplishments, however ask your self this: If she have been alive right now, would she need her identify related to promoting her discovery earlier than it’s truly scientifically demonstrated to delay the lives of most cancers sufferers or remedy particular cancers? Orac
Genuinely, I had no concept whether or not Prof. Muceniece would care what the IVC is doing. I simply needed to see if there was any sense of disgrace over what the IVC was doing together with her invention.
Rigvir strikes again, spherical 2
A few days later, I acquired this. For reference, the weblog by Eduards Ritums was mentioned in my first submit and utilized in half as a foundation for a few of my criticisms. In any case, word the considerably paranoid tone. I additionally confirmed my e-mails to a skeptic from Latvia who has been lively investigating Rigvir, who thought that the fashion modified sufficient that it may need been written by another person. I do not know for positive if that’s the case (you possibly can decide for your self), however I do know that the fallacies and doubtful arguments move freely and with paranoia:
From: Lelde Lapa To: ‘[REDACTED] Topic: RE: Weblog about RIGVIR Date: Thu, 21 Sep 2017 10:03:42 +0300 Group: RIGVIR Improvement division Pricey Orac As we indicated in our final e mail your weblog now’s unfold extensively in Latvia as a proof that our medication isn’t efficient. Was it a aim of your weblog? We acquired impression that the weblog is part of wider marketing campaign that’s at present in place in Latvia and subsequently we simply needed to warn you ASAP and shield your status by offering extra info in case you are prepared to listen to it. A part of your weblog is predicated on the article that’s revealed by writer E.Ritums initially in very particular advertising journal for Pharmacies. This journal is revealed by Drugs Info Centre (http://mic.lv/materia-medica/ ) that isn’t registered within the register of mass media and even present advertising providers (http://mic.lv/materia-medica/). As well as the content material of this journal (based on regulation in Latvia) is taken into account to be specialised publication and should not have public entry. The writer nevertheless (based mostly on google search) is younger graduate from school of Chemistry that along with this specific article has revealed few (~three) extra small articles and hardly is respectable journalist. Specific publication consists of variety of reality errors and uncertain allegations and there’s no respectable or confirmed sources, books or reviewed publications indicated as reference. Furthermore former supervisor (for 12 years) of the identical writer and journal Inara Rubene ( https://www.linkedin.com/in/inara-rubene/) is introduced as unbiased professional right here. The most important situation is, nevertheless, the truth that this text later, bypassing restricted entry information (in line with regulation) to specialists, was translated (with inconsistencies) and unfold extensively with assist of very small, non registered NGO – Skeptiskā Biedrība (https://www.lursoft.lv/lapsaext?act=URCP&ref=LurTop®code=&task=searc…), that operates site – www.skepticisms.lv. Do you contemplate this as reliable supply to construct a part of your story on? Please observe that official web page of the product RIGVIR is rigvir.com and there’s no advertising in any respect. Web page virotherapy.eu is usually devoted to remedy not drugs – there are information, testimonials and trainings. It isn’t a clinic or pharmacy to discuss advertising. Ought to we cover testimonials, if there are such? In Latvia there are very strict laws for advertising of prescription drugs and there’s no official judgment from Latvian Well being Inspection about as you say “irresponsible advertising”. Furthermore the one one declare from Latvian Well being Inspection, that originally was said so, is already modified clearly stating that we can’t be chargeable for third celebration actions. As you understand the medical research are carried out principally for official approval of drugs and in response to Bloomberg no less than one third of research are by no means revealed. So in case you are clearly stating that you simply don’t care about unpublished knowledge, then please modify title of your weblog to one thing like “Evaluation of revealed knowledge of RIGVIR”. As a result of ignoring unpublished medical trials for greater than 30 years, you merely don’t have all of the details to loudly state that our medication is just not efficient or it ought to be prevented. Allow us to make clear that drugs RIGVIR is registered in Latvia in 2004 for Melanoma, earlier than the period of recent necessities for trials, however based mostly on medical trials throughout 30 years interval by which ~700 sufferers was handled with the drugs RIGVIR (there’s additionally registration in Georgia and Armenia). The drugs is used as typical remedy in Latvian, Georgian and Armenian clinics. Along with that, sufferers from everywhere in the world are coming to Latvia or typically are sending kinfolk or trust-persons to Latvia to purchase this drugs in case conventional therapies haven’t succeeded or usually are not nicely tolerated. Sure we do practice medical docs from everywhere in the world and doubtless their sufferers even have acquired drugs from Latvia. We all know that the drugs is efficient, we now have seen it engaged on many thousand instances and we clearly know that it has no uncomfortable side effects. So understanding that, ought to we refuse to assist sufferers of any Physician? We aren’t firm that’s creating progressive answer and in accordance with the heritage of the founder prof. A.Muceniece the drugs ought to be out there to as many sufferers as potential. We aren’t refusing the information and knowledge to any official physician, official clinic or affected person teams. So we don’t see any drawback additionally from showing in The Fact About Most cancers collection. Most of our critics and in addition yours complains are catch-22 logic – “give us evidences earlier than you employ it -> new evidences requires investments -> to offer investments we have to use drugs –> to make use of drugs we must be commercialised -> however with the prevailing evidences you doubt us to be commercialised …” As if solely wealthy pharmaceutical or biotechnological corporations may go within the area… You’re stating that you simply don’t care about present registration, however sadly your evaluation is used to doubt the registration. Which is astray unusual, as a result of nowhere on the earth guidelines and laws (in our case requirements for medical trials) are used with backward date. Sure for brand spanking new registrations – we all know the principles – we’ll present correct RCT knowledge, however as for now, please respect that the drugs is prescription drugs that’s prescribed solely in nationwide clinics and by licensed docs for final 13 years. They’ve options and even reimbursed ones. So clearly these docs have deeper information concerning the remedy with RIGVIR, than simply evaluation of revealed knowledge, since it’s used for greater than 70% of Melanoma sufferers in Latvia. We advise you to study this remedy and check out it your self in your sufferers (that follows entrance standards) as properly. In such case and together with your dedication to make case report and publish it, we would offer all the required help and drugs freed from cost. Greatest Regards, Lelde
Gee, Ms. Lapa makes the remark that my weblog publish has been circulated far and extensive in Latvia as proof that Rigvir does not work as if that have been a nasty factor! In fact I can not assist however really feel a little bit of a heat and fuzzy feeling within the pit of my chilly, black coronary heart that my publish has truly been circulated far and large in Latvia. These behind IVC will in all probability take this as proof that I am out to get them, however I am not. I am out to guard most cancers sufferers. If the IVC had the products, so far as proof, the simplest factor for its administration to do would have been to publish it or by some means present it to me and different skeptics who’re involved that Rigvir is most cancers quackery. We might be persuaded, nevertheless it takes proof. Lastly, discover that final half, during which “Ms. Lapa” tries to co-opt me, considering that if I have been to attempt Rigvir I might conclude that it really works. I’ve observed this sample earlier than, and the place I’ve observed earlier than it is not flattering to Rigvir or the IVC. You see, I’ve found that with regards to most cancers quackery or unproven most cancers remedies I appear to have particular cachet as a result of I’m a most cancers surgeon and researcher. Thus, every now and then, most cancers quacks attempt to persuade me to attempt the remedy they’re promoting alone sufferers. In my response, I made a decision to stomp down exhausting on this supply after giving a little bit of a lecture. See what you assume:
Ms, Lapa, Though I recognize your concern about my popularity, I feel I’m in all probability one of the best decide of what is going to or won’t injury it. In different phrases, I’ll take my possibilities. Relating to Eduards Ritums’ article, which I did cite extensively, I have a tendency to guage an article and its principal arguments much more by high quality when it comes to proof, science, and cause than by who wrote it. Regardless that the article I learn was an English language translation, Mr. Ritums’ central thesis and arguments nonetheless got here throughout as very sound. It doesn’t matter if he’s younger and early in his profession and thus hasn’t revealed very many articles but. In different phrases, who cares if Mr. Ritums revealed his article in a pharmacy journal and is a brand new journalist? I definitely don’t. As for whether or not the journal is “registered” or not, so far as I’m involved that may be a matter of your nation’s particular legal guidelines and methods of doing issues. It means little or no to me as an American studying a translation of the article. In reality, it wouldn’t matter to me if Mr. Ritums wrote for an unregistered weblog beneath a pseudonym if his arguments, science, and proof have been sound. Definitely, you haven’t demonstrated that they don’t seem to be sound; you state that there are a “variety of reality errors and uncertain allegations,” however, oddly sufficient, you haven’t truly specified the errors of reality or “uncertain allegations,” a lot much less used proof and science to point out that they’re factual errors or uncertain allegations. You have got as an alternative engaged in nothing however advert hominem, which is a logical fallacy. To persuade me, you’re going to should get much more particular and supply the proof to again up your criticisms, one thing you haven’t but accomplished after two lengthy e-mails. I discover this very telling. As on your declare that official Rigvir web site is just not about advertising, I urge to vary. The entire web site is clearly all about advertising, as all pharmaceutical firm web sites are. Certainly, it seems to be identical to another pharmaceutical firm webpage selling its merchandise, full with slick movies, just like the one on this web page. Principally, your web site seems like all of quite a few web sites pharmaceutical corporations keep for particular person merchandise, like Herceptin, OncoTypeDX, or numerous new medicine. It’s not fairly as slick, however it is rather comparable in look and content material. True, it doesn’t include affected person testimonials, however that doesn’t make it any much less a advertising web site. Relating to the testimonials on the Virotherapy Middle web site, as a surgical oncologist, I discover them fairly deceptive. Inadequate info is offered to permit me to guage whether or not Rigvir may need had an impact, and one particularly is certainly not proof that Rigvir had a constructive impact. Once more, once I accused you of irresponsible advertising, I did it from my perspective as a most cancers surgeon and researcher. Once more, I actually don’t care what Latvian regulation says with respect to advertising prescription drugs. Clearly, from my perspective, Latvian regulation is way too lax if it permits you to market Rigvir. You say that Rigvir was registered in 2004, “earlier than the period of recent necessities for trials.” I hate to inform you this, however the primary requirements for contemporary medical trials have been codified many years earlier than that. Within the US, it was 55 years in the past in 1962 when the Kefauver-Harris Modification to the regulation creating the FDA mandated that the FDA to require rigorous medical trial proof of efficacy and security earlier than it approves a drug for advertising. Are you truthfully telling me that 42 years after that Latvia nonetheless didn’t require such proof earlier than approving a drug? If true, I discover that surprising. Be that as it might, Latvia’s lax drug regulation 13 years in the past is just not an argument in help of the efficacy and security of Rigvir even for melanoma, a lot much less different cancers. Definitely, it doesn’t excuse you from promoting the drug to a quack clinic in Mexico. And, make no mistake, Hope4Cancer is a quack most cancers clinic, as I’ve documented elsewhere. (It even gives espresso enemas.) I’d recommend that, in case you actually need Rigvir to be accepted outdoors of Latvia, Georgia, and Armenia, promoting it to a quack clinic to market to sufferers it isn’t a profitable technique. It’s going to taint Rigvir with the stench of quackery. I’d extremely recommend that you simply sever all ties with these clinics instantly, however I think that suggestion will fall on deaf ears. You say time and again that you simply “know” that Rigvir is efficient. The very fact is that you don’t, a minimum of not based mostly on science and medical trials, which is how docs are alleged to know which medicine work and which don’t. You declare that I ignored 30 years value of medical trials. Whose fault is that? You haven’t revealed them in a type that may be critically examined. For those who had, I might have critically examined them. You wouldn’t even need to translate them into English. I’m positive I might discover somebody to translate the info for me in case you have been to publish all this knowledge. Why don’t you? No, I can’t change the title of my publish. It’s correct, so far as I’m involved. I stand by my opinions and conclusions, and, sure, I nonetheless strongly consider that it is best to cease advertising Rigvir till such a time as medical trials present it to be protected and efficient. Definitely it shouldn’t be used for any most cancers aside from melanoma, and even for melanoma I don’t assume you’ve proven enough proof that it really works to justify advertising it. Once more, I say this as a result of you’ll be able to’t present me any respectable scientific or medical trial proof to vary my thoughts. Once more, why is that? Does this proof truly exist, or does it truly present Rigvir has such miraculous results towards melanoma? I think that it both doesn’t exist or is just not almost as spectacular as you declare. Certainly, there’s a contradiction right here. You say that 70% of melanoma sufferers in Latvia since 2004 have been handled with Rigvir. Why is it, then, that you would solely discover 52 melanoma sufferers handled with Rigvir in your 2015 Melanoma Analysis paper? Lastly, though I’m intrigued by your supply to offer Rigvir without spending a dime for me to attempt on my sufferers, sadly I don’t see how I can do it. Let me clarify to you ways we do issues within the US. Docs right here can’t simply go round administering unapproved medicine willy-nilly to sufferers if we really feel prefer it. Have been I to manage Rigvir to sufferers with out correct approvals, I might shortly discover myself in deep authorized hassle—and rightly so! Have been I to need to administer Rigvir to sufferers, it must be within the type of a medical trial. I might first should submit an Investigational New Drug (IND) software to the FDA, as a result of Rigvir is just not accredited within the US. The FDA would then should approve it. Subsequent, I must write a protocol for a medical trial. Let’s say I selected to do a part I medical trial, which might not require randomization. That software must be authorised by the FDA and authorised by my establishment, particularly my most cancers middle’s Protocol Evaluation and Monitoring Committee and my college’s Institutional Evaluate Board (IRB). Each would virtually definitely say no, based mostly on lack of proof to justify the trial. They might need preclinical proof in cell tradition and animal fashions, on the very least, or extra compelling human proof. You possibly can present me with neither. In fact, definitely I might be comfortable to evaluate the tutorial supplies you present docs who want to administer Rigvir to sufferers. Perhaps they might begin to change my thoughts, though I’ll be trustworthy with you and inform you that I doubt it. Nevertheless, opposite to what you assume, my thoughts just isn’t closed. What it takes to open it extra is top quality scientific and medical proof. Present it, and maybe it can persuade me. When you proceed to fail to offer it, and also you’ll by no means change my thoughts. The ball is in your courtroom. Sincerely Orac
Rigvir strikes again, spherical three
The IVC did not reply instantly. It took a number of days. Certainly, I used to be starting to marvel if Ms. Lapa was going to reply once more in any respect, notably after nothing arrived instantly after my second submit about Rigvir. Then, simply as I used to be about to ship a fast e-mail to tweak Ms. Lapa and see if I might get a response, this hit my e-mail in field:
From: Lelde Lapa To: [REDACTED] Topic: RE: Weblog about RIGVIR Date: Tue, 26 Sep 2017 18:55:40 +0300 Group: RIGVIR Improvement division Pricey, Dr. Orac …We’re very grateful for each objectively crucial comment that’s addressed to RIGVIR and we all the time try to offer further info to the supply in an effort to enhance objectivity. This time we nevertheless are relay stunned that somebody who requires scepticism and ask for proves, can simply consider to articles with none confirmed references or sources, that incorporates assertion from individuals brazenly in battle of curiosity and that’s revealed in non-official portals as a way to keep away from duty for aspersion. And notably we’re unhappy that you simply was by no means fascinated by our place or in our information that we brazenly provided and that aren’t revealed. Throughout final month we have now seen a lot of false information and lies that was unfold in Latvia with a purpose to neglect RIGVIR, a part of these information is unfold beneath the identify of respectable organisations. However sadly a lot of the tales doesn’t have actual authors. Most of this marketing campaign is completed by way of social networks so we’d like time to answer assaults and we’ll inform you concerning the outcomes. Within the meantime we’re open to organise skilled seminars and conventions to share our info. For instance, final Friday through the eighth Latvian Docs Congress, satellite tv for pc symposium about virotherapy and RIGVIR passed off. Stories on medical trials and post-marketing expertise in medical follow have been introduced to docs. Round 5000 docs have been invited and everyone had probability to ask any query to our main managers. We nevertheless acquired no query from the viewers. Relating to rigorous medical trials, most likely the definition has modified over time. For instance the 1.st RCT ever was run simply after the WWII. What we at the moment name rigorous was outlined solely within the late 1990ies. Whereas for instance the FDA began requiring 5 yr survival knowledge for oncologic medicine, within the early 2000 these type of knowledge have been nonetheless out there just for a portion of NDAs. Nevertheless A really direct consequence of WWII was that Latvia misplaced its independence. As a consequence, Latvia was actually thrown many years again, in addition to held again, in all elements of a complicated society. You could discover that surprising to study in 2017, however we will guarantee you that was a surprising “expertise” already at the moment on website. And it lasted for 50+ years. A slight and minor aspect impact, was that regulatory necessities didn’t adhere to the US framework. They have been the so referred to as Soviet type, which embrace lack of publication as nicely. As we speak, nevertheless, Latvia is a part of EMA territory with probably the most up-to-date regulatory necessities. Subsequently, the mode of displaying efficacy has modified each over time and in area. However, the necessities relating to efficacy have been and are fulfilled. And this once more is accepted by the Ministry of Well being of the Republic of Latvia that on 4th of September 2017 issued official assertion supporting that RIGVIR is registered and included within the listing of reimbursed medicines appropriately (see English translation enclosed) and right here is in latvian supply: http://www.vm.gov.lv/lv/aktualitates/preses_relizes/5507_par_zalu_regis… Relating to using Rigvir in Latvia. It might additionally come as a shock to you that the medical data system in Latvia has not likely modified since WWII. This, in fact shouldn’t be the businesses duty. It might maybe help you in appreciating inclusion standards used and the trouble in managing the evaluation revealed in Melanoma Analysis. If you talk about about our medical trials or reproach us about lack of publications we’re kindly ask you take into accounts additionally the financial variations between USA and Latvia absolutely under consideration, for instance GDP per Capita in Latvia is round 15 thousand Dollars, whereas in USA it’s 52 thousand Dollars or for instance the entire finances for melanoma remedy of Latvia is round zero.7 MUSD. In different phrases you understand how a lot these issues prices and you shouldn’t decide from the stand level of probably the most superior financial system with the very best healthcare and science budgets. We’re founders (Prof. A.Muceniece) household owned firm that’s heritage is to offer this revolutionary remedy to any affected person on the planet who wants it and we won’t discriminate any affected person regardless from which clinic the affected person comes. In your newest weblog you’ve analysed a part of testimonials about virotherapy with RIGVIR (Please word nevertheless that Ty Bolinger’s prompts aren’t associated to us). We now have seen complains that tales of our sufferers was simply coincidence or that there have been different elements behind the survival. However what if we might give you many dozens of such testimonials and instances? Is there one thing in any respect to persuade you? This brings us again to the supply to you – to attempt the drugs on your affected person. For early stage affected person they need to use medical tourism to Latvia, however with late levels or in instances the place there are not any different remedy options, you may contemplate in software of prolonged use of non-registered drugs on-name foundation to make use of the drugs in USA. Astray on a regular basis together with your supervision to watch intently the efficacy. Because of this it will be case evaluation not a medical trial. Because of work with EMA we might not provoke any exercise with FDA but, though we have now preclinical and medical evidences to start out. We discover this dialogue, your weblog and your exercise in twitter actually wired. When you recommend that there are higher drugs for most cancers sufferers, please use it. We now have by no means restricted anybody doing that. RIGVIR is a prescription drugs, sufferers can’t get the drugs by them self with out physician involvement. So to wrap up – if you need to discover virotherapy and use it as a remedy, we’re able to cooperate with you and train you about our evidences. However additional correspondence and the change of opinions isn’t essential any extra. Sincerely, Lelde
Ms. Lapa (or whoever I have been corresponding with) won’t assume that an trade of opinons “shouldn’t be crucial any extra” and that she will flounce off, digitally talking, however I urge to vary. So, as an alternative of responding instantly, I made a decision that a public response can be extra applicable, to be unveiled this morning. So this is my response to Ms. Lapa. I am going to make sure you ship her a hyperlink to this after this publish goes reside. In any case, why hassle if the individual to whom I reply does not see my response? So right here we go. This is my response written over the weekend:
Pricey Ms. Lapa: You clearly do not know me very properly should you thought I might not reply to this. Certainly, given what Rigvir Holding and the IVC are doing, I feel it is a public service to point out what you’ve been telling me to my readers. It is also not true that I’m not eager about your place. If that have been the case, I might by no means have bothered to interact on this prolonged e-mail trade. That is the purpose. I have been looking for out what proof it’s a must to help all of the claims being made for Rigvir’s efficacy in melanoma and different cancers. All that is listed in PubMed could be very skinny gruel certainly in relation to medical proof. It is under no circumstances convincing. But you retain claiming you will have this extremely convincing proof whereas making excuses for not publishing it and whining about individuals criticizing Rigvir on social media. Nicely, I’ve information for you: That is the world. Social media issues. You retain claiming that what’s being stated about Rigvir is fake, however by some means you by no means truly hassle to show it to be false. And have you learnt how you would show that it is false? Present us the info, identical to drug corporations within the US and EU need to do! So that you had a satellite tv for pc symposium on virotherapy on the eighth Latvian Docs Congress. That is nice, however not sufficient. A Google search exhibits that you simply had this convention however nothing about its outcomes. Most satellite tv for pc conferences publish abstracts of the work introduced on the assembly, no less than. Such abstracts are usually not seen as being as convincing as a publication in a peer-reviewed journal listed on PubMed, however they’re a minimum of one thing. After your convention, I’m at present nonetheless left with nothing. It would not even matter to me if the abstracts or convention proceedings have been in Latvian. Present me the info! You declare to have medical trial outcomes and postmarketing outcomes introduced at this convention? Publish them! After my earlier two posts on Rigvir, I am positive that I can discover somebody to translate them if essential. In the long run, I can not assist however marvel in case your symposium was extra of a advertising presentation than an precise scientific convention. Subsequent, I don’t want a discourse on the historical past of medical trials and FDA necessities for approval of medicine, as I’m properly conscious of that historical past and when the primary randomized medical trials (RCTs) just like what we do now have been carried out. I discussed the 1962 Kefauver-Harris Modification to the regulation creating the FDA mandated that the FDA to require rigorous medical trial proof of efficacy and security merely to level out that proof from top quality RCTs has lengthy been a requirement for drug approval within the US and Europe. In oncology at first that meant measuring an endpoint generally known as general (or goal) response charges (ORR), which measures what proportion of the sufferers handled show tumor shrinkage. Sadly, ORR isn’t an ideal surrogate for general survival. So by the early 1980s, the FDA began to require proof of enchancment in OS. Whereas it’s true that lately, in an effort to velocity up the method of drug approval, the FDA has been accepting surrogates for OS, corresponding to pathologic full response (pCR) and granting provisional approval for medicine that produce such surrogate endpoints, I word that Rigvir has no convincing revealed knowledge supporting the conclusion that it will possibly even meet these decrease requirements for provisional approval. I additionally don’t purchase your excuse that Latvia’s medical document system hasn’t modified since World Warfare II. Consider it or not, till very lately, many US hospitals nonetheless used paper charts and comparatively primitive document maintaining. Many personal practices nonetheless do. It took legal guidelines and incentives from the US authorities to prod our medical system into adopting digital well being data, and, even then, I observe that we’ll in all probability by no means have the superb centralized medical report techniques that some nations in Europe do. As on your excuse that Latvia is a poor nation. I counter that the actual fact that Latvia is a poor nation relative to the US and far of Europe is an excellent cause that its authorities should not be losing cash on most cancers remedies whose producer can’t produce robust proof of efficacy! But, since I took an curiosity in Rigvir lately, I’ve seen claims that as much as 70% of melanoma sufferers in Latvia are handled with Rigvir. In a rustic like Latvia, that’s madness if true! Consider what could possibly be accomplished with all that cash if it have been redirected to remedies that work! I additionally see Rigvir being marketed as efficient towards all kinds of cancers when not even you will have claimed to me that it’s efficient towards any most cancers aside from melanoma. You declare that Ty Bollinger’s actions will not be associated, however I do not see it that method. In making the lengthy phase on Rigvir in Episode three of The Fact About Most cancers (TTAC), Bollinger clearly had the complete cooperation of the IVC’s management. He introduced Dr. Antonio Jimenez with him, who runs the quack most cancers clinic Hope4Cancer and is now promoting Rigvir in Mexico. He had entry to your clinic and interviewed luminaries reminiscent of Dr. Ivars Kalvins, your medical director Dr. Kaspars Losans, and your director of analysis and improvement Dr. Peteris Alberts, in addition to three of your sufferers. The ensuing phase was extremely laudatory and introduced Rigvir as a miracle remedy based mostly on doubtful testimonials. Like many most cancers sufferers who came upon about Rigvir from TTAC, I had heard little or no about your virotherapy earlier than TTAC was launched and consider the video collection as the perfect advertising for Rigvir I’ve seen anyplace. By some means, I doubt that you’d have cooperated a lot with Mr. Bollinger for those who thought his phase would do something aside from reward Rigvir and the IVC the best way it did. I conclude by once more addressing your supply. I will probably be blunt. My opinion is that it’s unethical, and I can’t settle for it. Principally, you look like paying for case stories you can publish. My impression of that is backed up by this text in your web site about grants for publications, through which the IVC proclaims that it’s providing €5,00zero “grants” for “publications on medical research of oncolytic virotherapy, observations or medical instances in a publication that may be quoted in PubMed” and that the research “is meant on utilizing oncolytic virotherapy somewhat than utilizing oncolytic virotherapy together with different most cancers therapies, treatment and so forth.” In different phrases, you need case studies or research wanting solely at virotherapy, which, given the doubt about Rigvir’s efficacy, can be extremely unethical. I observe that you simply additionally request that grant candidates “inform IVC on the publication matter and current to IVC the doc draft earlier than commencing the venture and submitting it to the chosen journal.” To me this sounds as if you anticipate the paper to be written, no matter whether or not the research has already been finished or not, however in equity I’ll permit that the anomaly might be as a consequence of a poor grasp of English on the a part of whoever wrote this net web page. Lastly, earlier than you categorical such disappointment with my weblog posts and my exercise on Twitter, I observe that the Enterprise Improvement Supervisor of Rigvir Holding, Kārlis Urbāns, has been attacking me on Twitter utilizing pretend information sources. He is been fairly nasty. Listed here are examples:
Jā ļoti neatkarīgs Onkologs no ASV, kas nez kāpēc perfekti citē Latviešu valodu un jau iepriekš barojies no farmas – https://t.co/ENKPlndHFi
— Karlis Urbans (@kurbans) September 29, 2017
I observe that he cites a submit made by a infamous antivaccine weblog, Age of Autism. I notice that the bloggers at Age of Autism do not like me as a result of I routinely skewer antivaccine pseudoscience. This is one other instance:
Un cik nav pretend itkā-onkologu vēstule?
Ir jau vēl daudz, piemēram, https://t.co/bBX9uS8IPg
— Karlis Urbans (@kurbans) September 29, 2017
TruthWiki is a pretend wiki maintained by Mike Adams, who runs the quack and alt proper (sure, each) web site NaturalNews.com and acquired his begin promoting Y2K scams. The dialog after that’s fairly amusing, despite the fact that I can solely learn it by means of the stilted English from pc translation from Latvian on Twitter. I notice that Mike Adams has been defaming me on his web site for a yr and a half now and is as much as round 40 lie-filled posts about me. You will excuse me if I do not take your lamentations about how imply and nasty I have been to the IVC critically when the BDM and CFO of Rigvir Holding is quoting pretend information sources that routinely lie about me and making an attempt to painting me as a device of massive pharma out to destroy Rigvir. So to wrap up – if you need to offer acceptable scientific and medical proof for the efficacy of Rigvir towards any most cancers, I’m able to cooperate with you and study it. In any other case, additional correspondence and the trade of opinions will not be needed any extra. Sincerely, Orac
After that, there’s just one final thing to do: