A lesson of politics, corruption, and cowardice: Who is responsible for scamming cancer patients for 15 years? Nobody!

 

The time has come to provide some updates about recent developments in Rigvir saga. In our last blog post we reported some good news – that State Agency of Medicines in collaboration with Health Inspectorate has finally halted the distribution of RIGVIR. The primary reason for this was the fact that finally state institutions decided to actually test the contents of Rigvir vials and, surprise, surprise, they did not contain what they were supposed to:

“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.

While it is indeed fantastic that the march of this completely fraudulent company and threat to cancer patients has finally been stopped, the story cannot end this way. After all, for the last 15 years this drug has been given to cancer patients in Latvia and abroad (actually approximately 90% of Rigvir patients are foreigners from all over the world, not Latvian), and many employees of state institutions knew exactly what was happening. This means that for the most vulnerable members of our society there have been countless deaths, countless lost years of life, lost chances to be treated with legitimate medicines, family members and friends lost, homes sold, pensions spent, debts racked up to purchase this Latvian miracle drug either in Latvia or in one of Rigvir quacky partner clinics in Mexico, Germany, Spain, Georgia, etc.

If you come from a country with a decent legal system, politicians with some level of conscience or perhaps the slightest sense of responsibility, protection of the most vulnerable members of the society would seem to be the obvious route to go and completely self-evident. If due to blatant misgovernance and corruption of state institutions, patients have been harmed for 15 years, if many have died because of inadequate health care, it follows logically that there should be a reaction in the highest levels of government, official investigations, by either police, anti-corruption institutions, parliamentary commissions or whatever other legal route is available.

So, is this happening in Latvia? The answer is one big, fat NO! The official response from the current Minister of Health of Latvia, Ilze Viņķele, is this:

It’s complicated.

Investigative magazine IR published an excellent article (only Google Translate version for now), tracking all the people who pushed for Rigvir registration as politicians, as well as officials in State Agency of Medicines and National Health Service who signed illegal registration, renewal, and state reimbursement documents.

So here are the responsible people in all their glory

First of all, the politicians. According to trustworthy insider information, Rigvir was registered with “a phone call from above” during which an instruction was given to include Rigvir registration in the agenda of the official meeting of State Agency of Medicines Medicines Registration Commission – the last one, a few days before Latvia’s enrollment into EU (when EU-level regulations would come into force).  And yes, we have material to back this up.

Meet Einars Repše

Einars Repše is  a former president of Bank of Latvia, founder of populist anti-corruption party The New Era or Jaunais Laiks in Latvian (the comedy practically writes itself here). Political leftovers from Jaunais Laiks are currently incorporated into the party “Jaunā Vienotība” – the leading coalition party, from which the current Prime Minister, Krišjānis Kariņš, comes.

Also, E. Repše is a former Prime Minister of Latvia, former Minister of Defence. A spectacularly failed politician. Now climbs mountains, makes propaganda films about cancer patients who can also climb mountains because of the magic of Rigvir, and leads the Aina Muceniece Virotherapy Foundation, a poorly masked astroturfing attempt we described earlier. He was the Prime Minister in 2004, when Rigvir was registered.

When asked if in 2004 he was asked to support Rigvir and its registration, Repše says:

This issue was not on my table or on my agenda“.

However, in 2016 Repše becomes the head of above-mentioned Aina Muceniece Virotherapy Foundation, a front organisation for Rigvir.

According to Repše, he became the director of the foundation after talking with Kaspars Urbans, the Financial Director of Rigvir, and discussing “financial issues”. After this meeting, the head of Rigvir Holding, Jurģis Auziņš, asked Einars Repše to take management of foundation in his hands.

Politician No.2 – Ingrīda Circene

Let’s move on and meet Ingrīda Circene, member of the same “anti-corruption” New Era political party as previously mentioned Einars Repše. She was Health Minister under his government, the only other possible person who could have made the “call from above”.

There she is, advertising Rigvir in an e-book about Rigvir, published by an infamous quack clinic in Mexico, called Hope4Cancer. They use such “innovative” cancer treatment methods as coffee enemas, whole body hyperthermia, useless machines that flash colourful lamps to make terminal cancer patients believe their cancers are actually being treated for 50,000 EUR+ per clinic visit and a few smoothies. At the moment Ingrīda Circene leads a tiny, but pompous Latvian Medical Export Association which is basically a pocket-organisation of Rigvir and mostly offers Rigvir in various clinics to foreign patients with slightly different marketing messages.

Any other ties to politics? Hello, current CEO of RIGVIR!

Meet Kristīne Jučkoviča, “Strong business development professional skilled in Lobbying, Governmental Affairs“.  Also, former right hand of both Repše and Circene in the same political party New Era.

Also known for beautiful quotes in public media, such as this:

“The public should not be worried about some sort of problem, and it does not threaten public health,” said Rigvir representative Kristīne Jučkoviča, again insisting that the medication had been pulled from the market as a result of financial restructuring.

And now it’s time for the civil servants!

These are the people who supposedly serve and protect the people of Latvia, tax payers, cancer patients:

Jānis Ozoliņš – deceased

Head of State Agency of Medicines in 2004. Put his signature on the decision to register Rigvir. Not available for comment, since he died in a car crash in 2005.

Inguna Adoviča – with memory problems

Director of State Agency of Medicines in 2009, when Rigvir licence was illegaly renewed. Decision maker, the person who did not stop this scam when it was possible and basically helped Rigvir expand globaly, since from then on it had a veneer of respectability of “being registered somewhere in EU”. Congratulations, we hope I. Adoviča has also counted the victims just as closely as our little skeptic group has. Hopefully, she feels proud.

Now I. Adoviča says the following:

I do not remember a situation where I would have had information about any Rigvir documents missing”.

Brief recap: Already in 2009 there was an expert conclusion about Rigvir, ordered by State Agency of Medicines itself (and then hidden), from which it is absolutely clear that this is a pure scam. A translation of detailed analysis of Rigvir evidence and contents by leading molecular biology expert is available here. Original document leaked to us in Latvian is available here. Hints: there are no proper clinical trials and not a single double-blinded study. There is, however, uncertainty about the actual identity of the active ingredient, i.e, virus, lack of GMP (Good manufacturing practice) certificate, suspicious manipulations with documents, mismatching patient numbers and dates in submitted documents. The document also mentions multiple earlier reports of undetected anti-cancer activity of Rigvir.

According to magazine IR, Inguna Adoviča denies that she has worked for Rigvir holding after leaving her post in State Agency of Medicines. Quote: “I would be crazy to do it“. Interestingly enough, Inguna Adoviča did not sign the renewal of Rigvir licence herself. She was on a vacation or on a work trip.

Dace Ķikute, also with memory problems

While the director of State Agency of Medicines, Inguna Adoviča, was on vacation or a work trip, her deputy director Dace Ķikute signed the decision to renew Rigvir licence. Unfortunately, poor D. Ķikute has no memory of it. She says the following to magazine IR:

Honestly, I don’t remember“.

According to her, the undersigned cannot take any responsibility for the contents of the document.

As is usual in state government, I only signed a document prepared by someone else“.

At the moment Dace Ķikute is the head of Latvian Association of Pharmacists. (Hopefully she now has good access to memory-enhancing drugs and can share some with Inguna Adoviča.)

Daiga Behmane – trusts people. Asks her deputy to sign documents.

Renewal of Rigvir licence lead to another major problem. In 2010, the manufacturer of Rigvir submitted an application to what is now called the National Health Service, lead by Daiga Behmane. Rigvir representatives requested Rigvir inclusion into state-reimbursed medicines list and the request was successful. From 2011 Latvian tax payers have been paying for this scam out of their own pocket.

What does she say now?

“Medicines were included in this list after examining the price and efficacy of each medicine. The fact that the medicine is registered, was proof that it is effective.”

Interestingly, this decision was also signed by a deputy director, not the actual director of the institution. Undersigner was Iveta Gavare, but magazine IR was unable to contact her.

Where is D. Behmane now? Works at Rīga Stradiņš University, Faculty of Medicine. Vice-Dean, Faculty of Public Health and Social Welfare. Deputy Director, Institute of Public Health. Also Head of Study Programme “Management of Health”.

Dace Baltiņa – meet the human orchestra

Dace Baltiņa is indeed a woman of many talents. For 17 years D. Baltiņa has been in positions that can influence decisions about Rigvir. From 2014 she has been the Chief Oncologist of Latvia despite also being the Medical Director of Rigvir. Conflict of interest did not matter, apparently.

From 2002 to 2011 Dace Baltiņa was the head of the Clinical Trial Evaluation Comission in the State Agency of Medicines.  From 2006 to 2016 she was also a member of Medicines Registration Commission in the same agency. However, the agency now claims that she was not present in the commision meetings during registration or renewal of licence. (Must have been on vacation or also has memory problems – we do not really know.)

In 2015 Dace Baltiņa co-authored clinical guidelines for malignant melanoma and included Rigvir in them, despite the lack of evidence. Strangely, in the guidelines another, clinically proven, medicine for melanoma – interferon – became less effective than reported by concurrently published European-level clinical guidelines for melanoma. Baltiņa explains that at the time Rigvir had already been registered for 11 years and included in the list of state-reimbursed medicines.

Quote:

How could I not accept a drug registered by two Latvian institutions?

D. Baltiņa refused to have a conversation with the journalist and promised to answer all questions in writing. She was asked if she has affected the registration and renewal of Rigvir licence, why she did not participate in the meeting and which experts presented reports on Rigvir. No answers were received by IR.

What did other medical specialists say?

In February 2017, the Association of Oncologists, Association of Chemotherapists, Association of Rare Diseases of Latvia, and the Head of Pharmacology Department of Riga Stradiņš University submitted a
request to the Ministry of Health of Latvia, State Agency of Medicines, and National Health Service requesting the removal of Rigvir from the Register of Medicines of Latvia and from the list of state-compensated medicines.
A revision of clinical treatment guidelines for melanoma was also requested. The request was based on the analysis of available research and suggests that there is no conclusive evidence for the efficacy of Rigvir as a cancer treatment.

What was the response of Health Minister Anda Čakša back in 2017? This.

A letter by some social group saying they don’t like something – it’s just not helpful. Show us data that this medicine does not work for your patients. We don’t have anything to react to at the moment,” said Health Minister Anda Čakša.

She also did not find it problematic that Dace Baltiņa, the Chief Oncologist of Latvia, is concurrently working as the Medical Director of Rigvir, technically a pharmaceutical company. Our government is surprisingly tolerant! Luckily, this was exactly the phrase that caught the attention of the surgical oncologist and one of the authors in ScienceBasedMedicine.org website, leading to three separate articles about Rigvir:

Part 1: Rigvir is most likely cancer quackery.

Part 2: Unethical marketing via quack film Truth About Cancer, deconstruction of testimonials.

Part 3: Rigvir strikes back, or: A conversation with a Rigvir flack.

So what about the current Minister of Health, Ilze Viņķele?

Ilze Viņķele, a member of the newly founded party “Latvijas Attīstībai/PAR”, came into politics ages ago, as a fighter for the underrepresented, the vulnerable, the victims. Her current party used such slogans as “accessible public health care for everyone, rule of law standing over power and fair trial standing over corruption”.

Ilze Viņķele is a true fighter, supposedly. Also, the daughter of Soviet time dissidents who fought against the repressive regime. Surely, she should be exactly the person who would finish this saga once and for all?

According to magazine IR, the minister is not planning to evaluate the responsibility of civil servants. She responds to IR by saying

“It’s complicated, because the process of registering Rigvir and renewal of its licence happened in accordance to the legislation of those days. The same applies to inclusion of Rigvir in state-reimbursed medicines list.”

State Agency of Medicines refused to provide other negative conclusions about Rigvir to magazine IR. Acccording to the agency, it is limited-access information and

Revealing it may significantly harm the manufacturer’s competitiveness.

The minister also accepts the decision of State Agency of Medicines to not reveal the names of the experts and their conclusions, if based on law. But Vinkele is ready to evaluate if these legal requirements are in tune with patient safety.

Help needed! Health sector of Latvia in danger.

It is worth pointing out, though, that the very busy minister does have the time and willingness to condescendingly talk to this blog’s writer @Zimbabve (aka Austra Muižniece) on Twitter. Her political minions, including a family friend and former Head of Doctors’ Association of Latvia, Pēteris Apinis, also have the time and motivation to engage in conversations that some may call bashing. There is also sufficient time to invite Austra to public debates about Rigvir (also known as the Gish gallop approach). Some members of the party “Attīstībai/PAR” even go as far as asking Austra for tips on how to go about this entire Rigvir situation legally.

We should be truly worried about the entire healthcare sector in Latvia now, if the Minister of Health, the person with the most power to solve this situation, needs tips from activists and bloggers with zero legal expertise. Please send help to Ilze Viņķele, her administrative and party apparatus is clearly insufficient!

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.

What is Rigvir and what are the claims made about it?

Sometimes a single image says more than a thousand words.

But is Rigvir really your chance to live, if you have been diagnosed with cancer?

What is Rigvir?

Rigvir is an unproven anti-cancer treatment developed in Latvia. Its proponents claim that it is an oncolytic ECHO-7 enterovirus found in the gastrointestinal tract of young children, that it supposedly destroys cancer cells without harming normal cells, and works in a wide variety of cancers. Importantly, while outside of Latvia Rigvir is only sold by clinics with highly dubious alternative cancer treatments, in Latvia it is an official prescription drug, registered in our State Medicines Agency, reimbursed by the state, and even included in the clinical guidelines for treatment of melanoma. This gives it a veneer of respectability and reassures foreign patients who might normally not choose alternative cancer treatments. Most importantly – this is not an issue that affects only Latvians, as approximately 90% of the income of Rigvir holding comes from foreign cancer patients (USA, UK, Australia, EU countries, etc.), who get this treatment by traveling either to Global Virotherapy Cancer Clinic in Latvia, or to its quack partner clinics.

Continue reading “What is Rigvir and what are the claims made about it?”