Ko Zāļu Valsts aģentūra tev nestāsta par Rigvir, 2. dublis – pilnais onkologu vēstules teksts

Tā kā Zāļu valsts aģentūra turpina izplatīt melus par to, kā onkologi neesot ziņojuši vai atbildējuši par problēmām saistībā ar Rigvir, ievietoju blogā pilno 2017. gadā sūtīto onkologu vēstules tekstu.

Citāts no NRA raksta:

“ZVA tagad norāda, ka onkologi izteica šaubas par sākotnējo pierādījumu bāzi zāļu efektivitātei, bet ne to kvalitātei, un ZVA esot lūgusi Latvijas Onkologu asociācijai sniegt gan informāciju par Rigvir zāļu neefektivitāti, gan informāciju par ārstēšanas praksi, kas var kalpot par pamatu papildu efektivitātes pierādījumu pieprasīšanai no uzņēmuma, kas zāles ir reģistrējis, bet šādus ziņojumus neesot saņēmusi.”

Taču onkologu un ķīmijterapeitu 2017. gadā izsūtītā vēstule nepārprotami apgāž ZVA teikto. Jau vēstules pašā sākumā lūgts uzrādīt SIA Latima aktīvās vielas ražotnes GMP (labas ražošanas prakses) sertifikātu, kas līdz šim brīdim nav izdarīts, jo šāda (likumdošanā noteiktā) sertifikāta ražotnei nav.

Citāts no vēstules:

Lūdzam VM pakļautības iestādes Valsts Zāļu aģentūru un Nacionālo Veselības dienestu izvērtēt zāļu Rigvir reģistrācijas, iekļaušanas kompensējamo zāļu sarakstā un melanomas ārstēšanas vadlīnijās pamatotību un:

  1. Izslēgt Rigvir no Latvijas Valsts zāļu reģistra un Kompensējamo zāļu saraksta, kā arī pārskatīt Melanomas ārstēšanas vadlīnijas atbilstoši starptautiskām vadlīnijām un uz pierādījumiem balstītas medicīnas pamatprincipiem.
  2. ZVA sniegt informāciju, uz kuriem konkrēti pētījumiem balstoties, Rigvir efektivitāte vērtēta kā pietiekama reģistrācijai, kā arī norādīt, kādas tieši reģistrācijas prasības bija spēkā 2004. gadā, kad Rigvir tika reģistrēts, un 2008. gadā, kad tas tika pārreģistrēts, jo LTV7 sižetā izskanējusī informācija, ka Rigvir reģistrācija atbilst “tā laika prasībām”, mūsuprāt, neatbilst patiesībai. Un pat ja tā, 2008. gadā, pārreģistrācijas procesā, Rigvir ieguvuma/riska vērtējums (liekot uzsvaru uz ieguvumu) bija jāveic atbilstoši 2008. gada prasībām.
  3. ZVA sniegt informāciju par reģistrācijas sēdes dalībniekiem un ekspertiem Rigvir reģistrācijas un pārreģistrācijas laikā.
  4. Uzrādīt labas ražošanas prakses sertifikātu Rigvir aktīvās vielas ražotnei – Latima Ltd, Rigvir Laboratory26 (EudraLex Volume 4, Good Manufacturing Practice (GMP) guidelines), jo mums nav pārliecības, ka tā viela, kas šobrīd tiek pārdota ar nosaukumu Rigvir, atbilst tai aktīvajai vielai, ko savulaik pacientiem ordinēja Aina Muceniece.
  5. Izskatīt Daces Baltiņas interešu konfliktu, apvienojot darbību Zāļu valsts aģentūrā un Veselības ministrijā ar darbu Rigvir holdingā, kas ietver vairākus uzņēmumus, bet faktiski ir viena medikamenta ražošanas un izplatīšanas uzņēmums, kas pieder vienām un tām pašām personām.

Vēstules pilnais teksts ar visu Rigvir “pētījumu” analīzi pieejams, noklikšķinot šeit.

 

GMP sertifikātu būtības apraksts pieejams šeit.

Īpaši jauki ir padomāt par to, kā tiek kontrolēts ražošanas process vīrusam, kura patenta aprakstā ir šāda infomācija:

One of the most serious adverse properties of non-modified ECHO type viruses, including ECHO 7, is their ability to cause infections that may have a fatal result (Wreghitt T.G., Gandy G.M., King A., Sutehall G., Fatal neonatal ECHO 7 virus infection, The Lancet, vol. 324, p.465, 1984). These viruses are known to be responsible for hand, foot and mouth disease in Malaysia (http://www.vadscorner.com/echovirus7.html), for myocarditis in leukemic child (Midula M., Marzetti G., Borra G., Sabatino G., Myocarditis associated with ECHO 7 type infection in leukemic child, Acta Paediatrica Volume 65, Issue 4, pp. 649-651, July 1976), aseptic meningitis, paralytic disease and fever (http://virology-online.com/viruses/Enteroviruses6.htm).

Therefore pathogenicity is one of the major limitations that must be overcome in using ECHO 7 type viruses in treating cancer patients.

Tikpat jauki ir arī ņemt vērā V. Baumaņa 2009. gada slēdzienā minēto:

 

 

 

 

Rigvir will no longer rip off cancer patients. What happens next?

 

For a change, this blog has some amazingly good news to share. Latvian version of FDA a.k.a State Agency of Medicines in collaboration with Health Inspectorate has finally halted the distribution of infamous anti-cancer drug “Rigvir”.

If you have followed Rigvir story, you might think it is not humanly possible to sink any lower than registering an anti-cancer drug without any proper evidence, then having it reimbursed by the state, and then, to top it off, selling it in the quackiest and shadiest clinics around the world and attracting countless desperate cancer patients from all over the world, for years. Well, SIA Latima, the producers of Rigvir, State Agency of Medicines and National Health Service of Latvia can now say: “Hold my beer!”

It turns out the vials of this rather expensive drug (around 360 Eur per 1 injection) do not actually contain what they are supposed to. How did this happen?

Earlier in March a strange news report came out, where manufacturer of Rigvir announced halting distribution temporarily due to “financial and strategic reasons”. (After all, what pharmaceutical company would not use such brilliant development strategy that involves stopping the sales of their only product?)

The real reason for the recall became clear soon enough. According to investigative TV show “DeFacto”, State Agency of Medicines had tested one batch of the medicine and discovered that the vial does not contain the active ingredient, i.e., the virus, in the necessary amount and has decided to test other batches. Representative of the State Agency of Medicines had a particularly juicy comment to share:

“It’s like buying what you think is lemon juice, but finding that what you have is lemon-flavored water,” said Guntars Kaspars, ZVA’s deputy laboratory director.

It appears that Rigvir owners tried to be sneaky and get ahead of the avalanche of the negative news and just recalled the product themselves, nervously squeaking an illogical mantra: “But patients were not endangered!” How on earth does insufficient amount of the active ingredient not endanger patients with cancer? It is not clear to anyone with any common sense.

So, for a few days we waited for the final results of the remaining batches, and the news just came in. Insufficient amount of virus was found in all of them! As a result, State Agency of Medicines has halted the distribution of Rigvir in Latvia and also removed it from the list of state-reimbursed drugs.

While this is indeed fantastic news for us, who have invested three years of effort into this story, and for any potential cancer patients who might want to use this miraculous “lemon water”, many questions remain unanswered. We hope to see an actual investigation by police and anti-graft office. There are not too many ways how this could have happened: either State Agency of Medicines and National Health Service employed ridiculously incompetent people who happened to really like Rigvir and be incompetent for approximately 15 years since 2004, or this is a prime example of blatant corruption.

Here are the questions still to be answered:

1)          Who were the political lobbyists in 2004 and 2009 that pushed for registration of Rigvir and then – renewal of licence? (Einars Repse, why are you so silent now?) Will anyone in the State Medicines Agency be brave (and human) enough and become whistle-blowers and tell the real story?

2)     How long have there been problems with the vial contents and who knew about it? Since the very registration in 2004 or only since 2009 when State Agency of Medicines hid an expert report which claimed that not only there is no evidence the drug works, there’s more – the identity of the virus itself is not certain. If a smallish circle of skeptics suspected this several years ago, regulatory institutions would have surely known way earlier. Will state institutions take any responsibility for this situation?

3)      How is it possible that the drug itself is manufactured in a GMP (Good Manufacturing Practice) certified lab Kevelt in Estonia, but the active ingredient, i.e., the legendary cancer-killing virus itself, has no GMP certificate? Why did Estonian lab not report any issues, even if they are “GMP certified”? Why was State Agency of Medicines OK with this situation?

4)      Were any lab tests run on Rigvir vials before? How many, when? If not, why? How is it possible that the state certified LIC lab did not catch these problems before, if drugs have to be tested regularly to ensure quality?

5)      How much money exchanged hands for all this to happen?

 

And finally and most importantly – how can the relatives of patients who died after using Latvian “lemon-infused water” instead of an actual anti-cancer drug, get compensated for the loss of people they loved? Who will be responsible for the homes sold, pension plans exhausted, credit card bills racked up?

 

How will Latvian institutions compensate the patients who are still alive for all the lost time, lost chances to participate in clinical trials with legitimate drugs, for all the false hope? Will anyone end up in prison over this fraud? Somebody from Rigvir, State Medicines Agency, National Health Service? Or perhaps the Ministry of Health itself?

We will be waiting and watching.

 

P.S. Have you used Rigvir? Please get in touch at rigvirfacts@gmail.com. We will gladly collect stories to share. If you are a lawyer, thinking of representing patients harmed by Rigvir and Latvian state institutions, we have documents and information to share.

 

European Cancer Patient Coalition revokes the membership of Virotherapy Foundation a.k.a. Rigvir

As described in previous blog post, Aina Muceniece Virotherapy Foundation pretends to be an organisation that defends the rights of cancer patients. Despite being a front-organisation for Rigvir Ltd., the manufacturer of an unproven cancer cure, it had weaseled  its way into the biggest cancer patient NGO in Europe, European Cancer Patient Coalition, which is involved in the EU legislative health policy process and has access to serious stakeholders, including EU Commision and European Medicines Agency.

After alerting ECPC to this fact yesterday, two things happened. First of all, the reaction of ECPC was immediate and as respectable as the organisation itself: a few minutes after we sent out the e-mail about the blog post, the director of the organisation replied, saying that the issue will be raised with the Board urgently.

In the meantime, Virotherapy Foundation published another conspiracy-style announcement, accusing the authors of the blog of bias and undeclared financial and ideological support (funnily enough, the authors of this blog actually have declared their motivation and funding, contrary to VF). However, the Foundation refuted none of the facts exposed in the previous blog, although it would have been fairly easy to demonstrate that it fulfils the criteria for ECPC membership.

Today, we received the following letter from ECPC: Virotherapy Foundation has been excluded from this organisation, as was expected:

 

This instance clearly illuminates the difference between approach to problematic Rigvir-associated entities in Latvia and in Europe. In Latvia public outcry had to happen before institutions even reacted to unmistakable breaches of law and in many cases official complaints to our regulatory institutions achieve precisely nothing (more on that later). In contrast, European organisations respond to issues that are not even strictly illegal, but are highly unethical and potentially harmful to patients.

Hats off to ECPC and let us hope that regulatory institutions in Latvia learn to follow their example in protecting one of the most vulnerable groups of people – cancer patients.

A wolf in sheep’s clothing: peddlers of unproven cure in European Cancer Patient Coalition

UPDATE: ECPC has revoked the membership of Virotherapy Foundation, please see this blog post.

European Cancer Patient Coalition (ECPC), an organisation that protects the interests of cancer patients at the European level, has accepted as a full member Aina Muceniece Virotherapy Foundation, a front-organisation for a pharmaceutical manufacturer of a virotherapy drug Rigvir. Virotherapy Foundation proudly announced becoming a full member of ECPC in May 2018 and just as proudly displays ECPC logo on their website. Therefore it appears that Rigvir has engaged in astroturfing at European level by creating a fake organisation as a part of attempts to attract more foreign patients and gain more legitimacy to an otherwise obscure treatment. Latvian skeptics suggest caution: the Foundation appears to be a ‘wolf in sheep’s clothing’ and may harm cancer patients and the reputation of ECPC.

 

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