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Category Archives: Hepatitis C

Hepatitis C eradication and profit


Note: This is a guest blog by Helmut Jäger. Dr Jäger’s website and blog provides more information and thoughtful comments on healthcare issues at: http://www.medizinisches-coaching.net/

Good news: hepatitis C can be cured

Since 2016, the World Health Organization recommends treating hepatitis C infection with sofosbuvir (NS5B-Polymerase-inhibitor)The manufacturer (Gilead) demands an extremely high price, and

“.. the public paid twice: for the pharmaceutical research and for the purchase of the product. The enormous profits flow to the Gilead shareholders.”(Roy BMJ 2016, 354: i3718)

The evidence for the effectiveness of direct-acting antivirals (DAA) for chronic hepatitis C comes from short-term trials. Cochrane is unable to determine the effect of long-term treatment with these drugs:

DAAs may reduce the number of people with detectable virus in their blood, but we do not have sufficient evidence from randomised trials that enables us to understand how SVR (sustained virological response: eradication of hepatitis C virus from the blood) affects long-term clinical outcomes. SVR is still an outcome that needs proper validation in randomised clinical trials. (Cochrane 18.09.2017: http://www.cochrane.org/CD012143/LIVER_direct-acting-antivirals-chronic-hepatitis-c.)

Egypt is particularly affected by hepatitis C. Here the government negotiated special discounts with Gilead, so that relatively cheap treatment will be available. It’s the foundation of just another lucrative business based on a man-made disaster.

tourcure

Tour’n Cure: The profitable medical eradication of a problem that would not exist without medicine.

Bad news: Hepatitis C will still be transmitted by skin piercing procedures

About 2-3% of the world’s population is infected with the hepatitis C virus (HCV); 350,000 of these 130-170 million people die per year. HCV causes liver infections, which are chronic in more than 70% of infected persons. That is, they do not completely cure after an infection. After one or maybe two decades, the damaged liver can fail, or develop cancer. The survival rates are low in the late stages of the disease, even under optimal treatment conditions.

Hepatitis C viruses are very sensitive to environmental influences so they are transmitted almost exclusively through blood or blood products or unclean syringes. Unlike hepatitis B or HIV/AIDS, HCV infections through sexual contacts are rare. Hence, the incidence of HCV is an indicator of a dangerous handling of needles, syringes, other medical instruments or products that lead to a direct blood contact. And new cases of HCV are acquired most likely in health care facilities or by intravenous drug use.

Treatment of disease and prevention of new infections 

The World Health Organization (WHO) announced in 2016 that it wants to “combat” hepatitis C and “exterminate” it by 2030. (WHO 2017: http://www.who.int/mediacentre/factsheets/fs164/en/)

unsafe-needles

Hazardous needles somewhere in Africa (image: Jäger, Kinsahsa 1988)

WHO’s optimism is caused by the availability of sofosbuvir. The drug is said to have cured up to 90% of affected patients in clinical trials, and consequently was added to the WHO list of essential medicines. The pharmaceutical company Gilead faces a huge global market with high profit margins (WIPO 2015): The treatment costs in the US are US$84,000 and in the Netherlands €46,000. The production cost of the drug is estimated not to exceed US$140.(‘T Hoen 2016)

Most people affected by hepatitis C are poor. They now learn through the media that their suffering could be cured, and at the same time that this solution seems to be unavailable to them. Consequently, they will demand the necessary funds for humanitarian reasons from their governments. Gilead expects sofosbuvir will not be manufactured and sold without a license (about 100 times cheaper). The Indian authorities already concluded in 2016 a license agreement with Gilead, which will guarantee high profit rates on the subcontinent.(‘T Hoen 2016)

Attractive medical products and markets increase the risk of the production of counterfeit medicines

In India, the requirement to allow the production of the hepatitis C drug in the “national interest” license-free is not only risky for legal reasons. India already is the world’s leading producer of fake medicines. Counterfeit drugs look exactly like real ones, but contain nothing (in the best case) or poison. About 35% of the malaria drugs in the African market are fake or useless, and they are mostly from India or China (see below: fake drugs). In the case of Egypt, medical institutions tried to open up a lucrative international market (“Tour’n cure”). Therefore, it will not be long until the first fake “sofosbuvir preparations” are offered.

The history of the hepatitis C epidemic in Egypt

The disaster of hepatitis C contamination started in Egypt more than sixty years ago. Efforts to regulate the Nile increased the risk of schistosomiasis infections. These parasites cause numerous health problems, mostly in the pelvic organs, and in rare cases, cancer. The worm larvae swim in stagnant water that has been contaminated by human urine or feces, and they enter the blood system of healthy people by piercing the skin.

The frequency of these worm infections increased rapidly after 1964, when the fast-flowing Nile was tamed by the Aswan Dam. In a relatively short time 10% of the Egyptian population was colonized by the parasite. The Ministry of Health then treated large parts of the population with injections containing antimony potassium tartrate. Until 1980 this toxic compound was considered the only effective remedy for this worm-infection. Today it is no longer used, not even in veterinary medicine.

Many years after the start of the campaign an initially unexplained epidemic of hepatitis C  was noticed in Egypt. It turned out that most of the patients with hepatitis C virus received anti-schistosomiasis injections.

Those initially infected with hepatitis C virus had higher risks to be treated in health care facilities, where the virus was then transmitted to other patients. Today (according to different estimates) 3-10% of the Egyptian population is infected with hepatitis C, and 40,000 patients die per year with the disease. Because many patients are infected, today the risk to acquire hepatitis C infection in Egyptian health facilities, even in optimal hygenic conditions, is significantly higher than in countries where hepatitis C is relatively rare.(Strickland 2006, WHO 2014)

Hepatitis C epidemic in industrialized countries

But Egypt is not an isolated case. Hepatitis C affects mostly the residents of developing and emerging countries. But even in Germany more than half a million HCV infections are recorded.

In England, in 2015 the government had to apologize for the infection of nearly 3,000 people who received infected blood products between 1970 and 1990.(Wise 2015)

In the US hepatitis C is called a “hidden epidemic” because 300,000 people were infected each year a few decades ago.(Ward 2013, Warner 2015, CDC 2015, RKI 2015, Pozzetto 2014)

Syringes and blood products are dangerous if handled improperly or if they are used although they are not necessary

blood

Blood Bank in Kinshasa (Congo, 1990, image: Jäger)

Needles (in particular the worldwide introduction of disposable syringes and their inflationary use) contributed to the spread of viruses like HCV, HIV and others.(Jäger 1990-92) The problem of the HCV epidemic is caused by the health care system and its waste products that fall into the wrong hands. The causes of the infections mostly are: bad medicine or intravenous drug addiction. What happened in Egypt is just another example that sometimes (medical) solutions of seemingly controllable health problems can lead to much larger problems: because sometimes “the things bite back.”(Tenner 1997, Dörner 2003)

Therefore WHO’s strategy to eradicate hepatitis C, based only on treatments, cannot succeed as long as the much of the medical sectors in many poor countries remain dangerous-purely-commercial and in large parts uncontrolled. The WHO campaign certainly will enrich Gilead and some health institutions, but a reduction of the hepatitis C incidence will not take place if “bad medicine” and “drug addiction” are not targeted, preferably eradicated, or at least reduced.

Unnecessary medicine is risky and should be avoided

WHO and other international health organizations should strive to avoid unnecessary therapeutic skin piercing procedures, injections, surgery and transfusions, and (if these sometimes life saving procedures are necessary) establish strict quality control. The commerce of medical tourism and beauty-interventions (botox, piercing, tattoo) should be strictly controlled.

unsafe-injection

Hazardous needles anywhere else in Africa (image: Jäger)

And we should invest in training patients: They should be supported to reduce their demand for health-care-products and to increase their knowledge in order to distinguish “good” and “bad” medicine.

 More

Literature

Bad Medicine in economically weak countries (such as “fake drugs”):

Why things bite back

US, Protect Us from All Harm Reduction


Where harm reduction policies went up, hepatitis C (HCV) incidence went down, study finds’. Nothing very surprising about that, is there? Harm reduction strategies, such as free needles and syringes and substitution therapies for injecting drug users (IDU), safe healthcare, etc, reduce harm; sort of tautological, really.

But countries like the US have resisted providing support for harm reduction strategies, refused to put much money into them, and often refused to allow recipients of US donor funding to allocate money to harm reduction.

This refusal to adopt harm reduction strategies has been going on for decades, and could have reduced a lot of HIV transmission as well. The above article is about a study covering harm reduction among IDUs over a period of 25 years.

It finds that HCV infection rates remained high in two US cities and a Canadian city, but dropped in an Australian and a Dutch city. This is because harm reduction strategies were very limited in the US and Canada, but not in The Netherlands and Australia. Should I repeat that for those who continue to resist (till death…etc)?

Decades ago, perhaps even longer, objections to harm reduction strategies were based on the claim that, for example, making clean needles and syringes available would encourage use of injected drugs and even increase use, comprehensive sex education would increase unsafe sex, and the like.

Utterly ridiculous, and shown to be so time and time again. But that’s the sort of argument that conservative people (whether they would identify themselves as conservative or not), professional politicians and many religious people continue to cling to.

Some people were persuaded, perhaps for political rather than rational reasons, to drop their insistence on using these infantile arguments against harm reduction when HIV became the headline health issue, a status it still holds in many countries, but many were not.

Comparing HIV and HCV, hundreds of millions of people are infected with HCV, far more than the few tens of millions of people infected with HIV. Annual deaths from HIV in the US, which has the worst epidemic in the rich world, stand at over 12k; from HCV, the figure in 2014 was close to 20k.

HCV, unlike HIV, is curable. As with any infectious disease, treating people would reduce the number of new infections to the extent that the epidemic could be controlled, and kept at a much more manageable number (although eradication would, of course, be preferable).

But the treatment is so expensive that even most people in rich countries are not able to afford it. This was the case with HIV for a while, but big pharma still manages to make a very large profit, even after negotiating a very lucrative piece of PR about price reduction. So it seems likely that the same could be done for HCV drugs, should there ever be the political will to achieve this goal.

A combined harm reduction and cost reduction strategy would have a massive impact on HCV prevalence. Since HIV is so easily transmitted through IDU, this would at the same time address the second biggest contributor to the US HIV epidemic (the first being anal sex among men who have sex with men).

But another form of harm reduction, safe healthcare, would have an even greater impact on the HIV and the HCV pandemics. Far more people are infected lgobally with HCV through routes other than IDU, especially in high HIV prevalence countries. The highest HCV prevalence in the world is in Egypt, where it was mostly a result of unsafe healthcare.

Although the HIV politbureau of UNAIDS, WHO, CDC and others don’t like to talk about HIV transmission via unsafe healthcare in high HIV prevalence countries, except to bluntly deny it, it is likely that the rate of new infections would mysteriously drop like a stone in countries that adopt a well supported, well funded safe healthcare program.

If harm reduction strategies reduce harm, and this has been known for decades, why is there so much resistance? Skip the dumbass excuses about clean injecting equipment increasing injected drug use and comprehensive sex education increasing unsafe sex, it’s well demonstrated that the opposite is the case. So, what could UNAIDS, WHO and CDC have against HCV and HIV harm reduction strategies? Just the fact that they work?

WHO to Warn About Unsafe Healthcare Transmitted Hepatitis, but not HIV?


UNAIDS, WHO, CDC and other institutions continue their insistence that HIV is almost always transmitted through heterosexual sex in African countries (though nowhere else), and that unsafe healthcare, cosmetic and traditional practices play a vanishingly small and declining role in transmission.

It was suggested to me recently by someone who questions the above views that these well funded institutions will eventually have to change their tune. However, he felt that they would not admit that they are wrong, or that they have known since the 1980s about the risks posed by unsafe healthcare and other non-sexual HIV transmission routes.

Perhaps hepatitis C is the opportunity needed? The WHO is now warning people about the dangers of infection through unsafe blood, medical injections and sharing of injecting equipment. They are also recommending the use of injecting equipment that cannot be reused, rather than equipment that should not be reused, but frequently is.

Unfortunately, the WHO is not very explicit about the problem: there are many health professionals who are unaware about the risks of reusing skin piercing equipment, especially injecting equipment. These health professionals do not warn their patients because they are unaware that they should not reuse syringes, needles, even multi-dose vials that may have become contaminated.

People may be surprised that there are health professionals who are unaware of these risks, or that they take these risks even if they are aware of them. But every year there are cases of infectious, even deadly diseases, being transmitted to patients through careless use of skin piercing equipment. Tens of thousands of people are put at risk, and that’s just in wealthy countries.

As for poor countries, especially sub-Saharan African countries, where the highest rates of HIV are to be found, no one knows how many people have been put at risk, how many have been infected with hepatitis, HIV or other blood borne viruses, or how many are still at risk. People are not being made aware of the risks they face, so they can not take steps to avoid them.

The US National Institute of Allergy and Infectious Diseases (NIAID) still carries the rather limp “HIV cannot survive for very long outside of the body”, instead of warning people that they should not allow the blood of another person enter their bloodstream. It is irrelevant how long these viruses survive; people need to know that contaminated blood may be entering their bloodstream so that they can take steps to avoid this.

Unsafe healthcare, cosmetic and traditional practices carry huge risks, especially in countries where blood borne viruses such as hepatitis, HIV and others are common. People can avoid infection with these blood borne viruses by avoiding potentially unsafe healthcare, unsafe cosmetic practices, such as tattooing or body piercing, and traditional practices, such as circumcision or scarification.