These suggestions produced howls of protest from people working in Georgia’s healthcare sector. They insisted that the drugs were safe and the point of the programme was to see if Hep C could be totally eradicated in one go, using Georgians as a sample population. Even Georgia’s Health Minister, Dr. David Sergeenko, weighed in by announcing that the new drugs have been approved and “Georgia is not a testing country”.
The trouble is, Georgia’s Health Minister and the others involved with this programme are not telling the truth. If they don’t know this, they should resign. If they do, they should be in jail.
Guilt by omission
The official version runs as follows: Georgia is implementing Phase 1 of a larger project designed for a sample of 5,000 patients suffering from advanced (stage F3 or F4) liver fibrosis and cirrhosis. They will be treated in two ways – one using the drugs Pegylated Interferon Alpha 2A, Sovaldi (otherwise known as Sofisbuvir) and Copegus (otherwise known as Ribavirin) and one using only Sofosbuvir and Ribavirin. Gilead, the American donor, is providing the Sofosbuvir and the Georgian government the Robavirin and Interferon.
This treatment will conducted under European and American guidelines, with the actual treatment being free and the diagnostics part-paid by the patients. Later on, the projected date being Autumn, the combination drug Harvoni will be introduced, and the number of patients treated will increase to 20,000 a year. The drugs being used are the same ones used in Europe, and therefore approved, says the government.
This is the information patients will be given when they are asked for their informed consent. But there is plenty of other information which they are unlikely to be given, which would have a material bearing on their decision if they were given it. Failure to give this information will mean that patients are unable to give INFORMED consent, and the fact that the Georgian government is failing to give this information, highlighting only what it wants people to hear, makes this omission deliberate and criminal.
It was reported on 25 March that nine patients who have taken either Harvoni or Sovaldi, the drugs being introduced to Georgia, in combination with certain other drugs have suffered serious reactions to them. One of these nine had a heart attack and died, and three others had to receive pacemakers. Three of the nine people affected were taking Harvoni, a combination drug which contains Sovaldi, and five were taking a combination of Sovaldi and a drug called Daclatasvir, manufactured by Bristol-Myers Squibb.
The drugs being introduced to Georgia are, in themselves, useless. They only work when combined with others, in preparations like Harvoni and the combination of Sovaldi and Daclatasvir. Therefore the Squibb drug will also probably be used in Georgia. Although it is true this has been approved in Europe, it has not been approved in the US, where Bristol-Myers Squibb is based. The FDA actually responded with a complete response letter asking for more details about how the drug interacts with other viral agents in treating Hepatitis C, as it will be doing in Georgia.
The FDA also issued an important update on the safety aspects of Harvoni and Sovaldi and obliged Gilead to change the warning information on the labels of these products. Gilead has had to issue a letter to healthcare providers pointing out the safety concerns and the problems which have arisen so far. The effect of this will be to change the recommended treatment regimes, which have been found to cause problems, and replaced them with new ones designed to address safety concerns which, as yet, have not been found to work.
It is within this context, and at this time, that these treatments are being introduced to Georgia. We know what happened to some people who took these drugs before the warning letter was sent out. We do not know what will happen to patients who have been given these drugs since the treatment regime was changed, because we have not had enough time to collate and assess the results. Therefore the new treatment regimes are, by definition, experimental, and the experiment is being undertaken because the previous one proved damaging to some patients.
So whatever the Georgian government wishes to say, the introduction of a mass treatment programme using these drugs is nothing more than an experiment, a test, using the Georgian population as guinea pigs. Such an action is highly irresponsible. It is also criminal if the patients are not given the facts about these drugs, because they cannot provide informed consent to take part in this experiment if they are not given the relevant information. But the Georgian government is omitting to tell people about the heart problems the drugs have caused, or the warning letters, or the fact that we don’t know if the new treatment regime has eradicated these problems.
Placebo diseases and real drugs
The vast majority of the estimated 185 million people living with hepatitis C worldwide reside in lower- and middle-income countries like Georgia, where there is virtually no access to treatment and no government response. Georgia has the third highest prevalence of hepatitis C in the world, after Egypt and Mongolia, with officially nearly 7 percent of adults carrying the virus. Furthermore, hepatitis C is a hidden epidemic: most people don’t know they’re infected, due to lack of access to both diagnostics and treatment, so the real figure may be much higher, thus justifying Georgia’s selection for a treatment programme such as this.
But we have all seen this sort of thing before. Discover a disease is widespread, get rich selling and prescribing the drugs used to cure it and everyone is happy. After all, these drugs come from magical West, and win the country important friends, regardless of the consequences for its people. They also win its doctors possible career advancement abroad, regardless of what happens to the patients they leave behind.
Some years ago the mental health services in a certain London borough were under political and funding pressure. They responded to this by inventing a new disease called “acopia”. This was defined as “the inability, whether temporary or permanent, to cope adequately, in the eyes of a mental health professional, with a given situation or task”.
Everyone on earth has had this “acopia” at some point, but they are regarded as mentally ill if they live in that borough. Despite the obvious absurdity of this situation, no one does anything about it because it makes the mental health service in this borough a pioneer in the recognition and treatment of this non-existent mental illness. Professional reputations are enhanced, political reputations are enhanced and money comes in. No one gets over acopia, and such is the definition they never will, but that is irrelevant to those who invented the disease.
Now that Georgia has introduced this Hepatitis C treatment programme the eyes of the world will be upon it. If things do go wrong, it will be praised for sacrificing its own brave citizens to make the rest of the world a better place – it won’t be said in those words, but that is what the words will mean. If nothing goes wrong, it will claim it deserves more special favours from the rest of the world. For the country, it’s win-win. For its citizens, it has all the makings of lose-lose – as if it were otherwise, they would be told the facts about the drugs they are going to be given.
Tourism, not medicine
In researching this article I tried to get hold of the actual contract between the Georgian government and the medical companies involved. The present Georgian government has often said that it has introduced standards of transparency to rival those of the West, so regardless of the commercial secrets which might be involved it should not have been too hard to get hold of at least a redacted version of this.
Unfortunately I have not seen the contract. This new transparency doesn’t extend as far as journalists. But nor does it extends to the doctors who will be involved in this programme apparently. It seems that no one has actually seen this contract, and everyone simply has to take on trust whatever the Health Ministry says.
In fact it is doubtful that the minister himself knows all the details of the contract, as it is unlikely that he personally negotiated it. Most US programmes in Georgia are not standalone projects, they are introduced in the small print, actual or implied, of much broader projects about different matters altogether. For example, USAID has a particular remit, but has been shown to be involved in areas such as weapons procurement which theoretically are nothing to do with it, but are catered for by a very dubious, and not publicly announced, interpretation of the initial agreement.
The US is not only the home of the companies who manufacture these drugs but one of today’s big growth industries – medical tourism. This is a growth industry because the Western insurance companies and hospitals who initially offer treatments for diseases like Hepatitis C then restrict access to them. Patients are led down the garden path by having their hopes of effective treatment raised and then being denied that treatment. This forces them to consider getting that treatment abroad, and a growing number of companies now offer them that option – same treatment, lower cost, providing you pay the tourism company.
Often the companies and hospitals which restrict access to treatment are breaching their initial contracts by doing this. This suggests undue influence is being exerted on them by these medical tourism companies, but they are probably sharing in the proceeds. Who wouldn’t? The patients are off their books but they are still receiving payment for their treatment. Hospitals don’t turn such deals down, neither do countries.
The Georgian government is building a $41 million hospital in the village of Rukhi, near the administrative border with Abkhazia, doubtless with the help of US defence contractors as they are always involved in major civilian construction projects. Prime Minister Gharibashvili has made a point of saying that this is where “our Abkhaz and Ossetuian brothers” can receive Hep C treatment under this programme.
Abkhaz and Ossetians have consistently refused such offers from the Georgian side, and have not indicated they will accept this one. You don’t spend $41 million on a white elephant, or any number of other facilities promised to the Abkhaz before would have been built. So is this hospital designed for Abkhaz, or medical tourists, who will pay for the treatment regardless of the risk simply because they have been denied it back home?
Conclusion
Georgia IS being used as a testing country, regardless of its government’s claims to the contrary. Georgians are not being given the information they need to give their informed consent for this treatment. But it will attract those who are prepared to pay anything to get it, regardless of the risk, because they have been denied it at home after being encouraged to think they would get it.
All this will make a small number of people rich. If you really want to cure Hepatitis C, you won’t begin to do so until this moral sickness is eradicated, and not only in Georgia.
Henry Kamens, columnist, expert on Central Asia and Caucasus, exclusively for the online magazine “New Eastern Outlook”.
