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Controversial medicine
Published in Al-Ahram Weekly on 23 - 10 - 2014

It is not too surprising to see specialists and patients expressing their anger over the cost of the new Hepatitis C virus (HCV) drug Sovaldi, especially after the smuggling of an equivalent Indian drug to the local market at lower prices. According to reports, the Indian version of Sovaldi — which is called “Sovotaj” and cures 90 per cent of HCV — is being sold in the local market for less than $900 for a 12-week course of treatment. The cost of the original American version Sovaldi is $84,000 for a 12-week course.
The Ministry of Health and Population struck a deal with the US producing company Gilead, to buy Sovaldi at a cost of $900 instead of $84,000. However, the smuggled Indian product Sovotaj is being sold at the local market for less still amid expectations that its price could drop to $680. According to press reports, Gilead agreed with Indian manufacturers to produce the drug at a lower price to be sold to 91 developing countries, where more than 100 million people are infected with HCV — more than half the world's infected population.
Gilead intends to provide greater access to Sovaldi for most of the nearly 180 million infected all over the world who do not live in rich countries. More than 350,000 people die every year of HCV-related infections, most of them in middle and low-income nations.
Meanwhile, the Egyptian Centre for the Right to Medicine (ECRM) warned against the Indian drug Sovotaj due to its inefficiency in curing HCV.
A press release issued by the centre noted that the side effects of the Indian product are yet unknown. “The Indian product is being manufactured at unknown manufactories that are utilising the need of millions of HCV patients for the new drug,” Mahmoud Fouad, head of ECRM, pointed out. The Indian product appeared in the local market in mid-September. “Sovotaj is not yet examined. The Ministry of Health has to take the required procedure and conduct inspections where the product is being sold,” said Fouad.
“Patients must be warned by the ministry against buying bottles of the Indian version as it might have fake pills that have no medical effect in curing the deadly virus,” Fouad stated. Any patient who needs the new HCV medicine can get it from the ministry or any of the country's national centres for hepatic viruses, he added.
For his party, Wahid Doss, head of the National Liver Institute, stated that neither the Health Ministry nor the National Committee for Combating Hepatic Viruses (NCCHV) detected Indian smuggled packages.
Doss, who is also a NCCHV member, stated: “It is true the producing company has agreed with Indian and Brazilian companies to produce a generic version of Sovaldi at a lower cost. Gilead agreed with the Indian factories to sell the low cost product to dozens of developing countries, but Egypt is not one of these countries. The ministry does not need to import or use any of their products because it is already taking the original medicine at a 99 per cent discount of its original cost. So we don't need the Indian product,” said Doss.
According to Doss, the Indian product could be useful to patients who don't want to receive their medication at any of the ministry's public hospitals or national liver institutes. HCV patients who take their medication at private clinics or hospitals can benefit from the Indian low price product. “Yet, I have to warn them, the Indian generic product, Sovotaj, is not tested. We don't know whether it has the same effect as Sovaldi or not, or is safe or not. Also, its side effects and components are unknown to us. So whoever wants to take it must understand that he or she is taking it upon his or her own responsibility,” said Doss.
“The American Sovaldi product is the only product approved by the Ministry of Health. Other products are yet unlicensed and are unknown to us,” confirmed Doss.
Mohamed Ezz Al-Arab, of the National Liver Institute, blamed health ministry officials for selling the new HCV treatment at a high price. “The Health Ministry should have considered the health of all patients without differentiating between those who are receiving their treatment at the ministry's hospitals and those who are receiving it in private clinics and hospitals,” said Ezz Al-Arab.
Moufid Moghazi, a member of Doctors Syndicate blamed, the Health Ministry for importing the new HCV treatment at a high price, though it could have imported the cheaper one. “Egypt is a poor country. Most of those who suffer from HCV are the poor people who can't afford the price of the American product. So they have to wait for their turn until it comes — God knows when — or die before taking it because their turn did not come yet. This is ridiculous,” said Moghazi.
“Such vital medicines should be imported under the cabinet's supervision and monitored by the government's different bodies. Egypt can't afford wasting its money or even allow a small group of people to control patients' destiny, utilising and gaining benefit from them,” added Moghazi.
Around 170,000 courses of Sovaldi are currently available and will reach 225,000 by February 2015. HCV patients have started receiving the new medication through eight of the country's 26 national centres for hepatic viruses in the first phase.
The World Health Organisation (WHO) estimates that more than 150 million people worldwide are infected with Hepatitis C, most of them in developing countries, putting them at risk of cirrhosis and liver cancer. Egypt alone has 12 million out of its 90 million population infected with HCV. Each year there are 165,000 new cases in Egypt infected with HCV. The virus kills around 40,000 Egyptians per year.
The Health Ministry announced last week that HCV patients should register online in order to be considered for treatment. According to Mohamed Abdel-Fattah, official ministry spokesman, patients who want to receive the new HCV treatment have to register at www.nccvh.org.eg and then go to the nearest medical centre for their free initial examination. “The ministry has dedicated a hotline — 19153 — for inquiries, but not for registration. The number of patients who registered on the ministry's website exceeded 500,000. Some 50,000 started receiving their first dose of the new medicine last week,” said Abdel-Fattah.
Ahmed Hamdi, 63, expressed his hope at starting treatment at the National Liver Institute. “I heard that the new treatment is magic. I will be cured in just three months after suffering from HCV for long years,” said Hamdi, adding: “Yet I don't know why I have to sign a paper before starting the medication stating I am taking it upon my own responsibility. Isn't it approved by the ministry?”
“It's a routine procedure,” explained Abdel-Fattah.


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