Hepatitis C – The Miracle Drug

Today we will be tackling the topic of hepatitis C drugs to give you an idea of the issues around miracle drugs, rationing and manufacturing.

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Imagine this: you have 10 pounds at hand. Would you give it to 10 hungry and weak children to buy bread that costs 1 pound each? Or would you hand it to a middle-aged beggar who needs 10 pounds to get some antibiotics to cure his nasty bacterial infection?

Some might choose the former based on the utilitarian principle (i.e. achieving the greatest good for the greatest number), whereas others might choose the latter due to the seemingly more severe nature of an infection.

Unfortunately, there is no one right answer.

In healthcare, this situation is no different, except that the hospital budget would have much more than 10 pounds and that the outcome of not allocating resources to a particular group of patients would most likely be death. 

Medical ethics of utilitarianism or deontology would probably be contradictory (opting for the option that maximises patients’ survival vs. the one that good doctors should make as bounded by the duty to do no harm), thus rendering one helpless in the decision-making process.

Drug Rationing

Let’s take a look at drug rationing since medicines take up a large proportion of the healthcare budget. NHS England decided to cap the numbers of hepatitis C patients receiving the new effective treatment, so that:

“only the sickest get the drugs immediately.”

This was not well-received, evident from a charity blaming them for:

“‘abandoning’ thousands of people to a potential death sentence by rationing drugs that can cure hepatitis C.”

This accusation is certainly not an exaggeration, since this blood-borne viral infection can cause liver cirrhosis (i.e. liver scarring) if untreated and could later progress to liver failure or cancer.

Hepatitis C

About 700,000 people die of hepatitis C each year. Researchers are therefore frantically trying to find the miracle cure. They found it recently, or so it seems, as these new direct-acting antiviral drugs (DAAs) can clear the virus from the blood within 12 weeks. The downside, however, is its cost – an eye-watering £30,000 per patient.

But why are they so expensive?

Drug Manufacturing

Whilst the suspicion that big pharma merely wants profit cannot be refuted, one cannot ignore other factors that contribute to the high price, especially the cost of drug development. Drug development is not as simple as discovering the drug and conducting experiments to look at its properties and toxicity. Scientists need to further undergo 4 phases of clinical testing, which takes about 10 to 15 years to complete:

Phases of Drug Manufacturing

Phase 1 – verify the safety and tolerability of the drugs in 20-100 healthy volunteers (6-9 m.o).

Phase 2 – determine the effectiveness of the drug by testing on several hundred patients (up to 2 yrs).

Phase 3 – expanded testing on more patients to look at adverse reactions (1-4 yrs).

4

Phase 4 – is usually done after the drug is shown to work and is given a licence to distribute to investigate long-term effectiveness and side effects.

Pharmaceutical Patents 

Due to the lofty sum of money that went into the development process, companies usually buy a patent that grants them the right to be the only company producing the drug and receiving the profits, thus allowing them to recover the costs. In the UK, the standard patent usually lasts for 20 years.

This may seem like a long period of time, but, in fact, the 20-year duration starts once the drugs are being tested in clinical trials. So what the companies get in reality is only 5 years to make money out of their drug, which explains the need to raise the price as much as they want whilst there is no competition. With all this being said, it still begs the question: is there really the need to raise the hep C drug to £30k per patient? What do you think?

Hepatitis C Drug Effectiveness

We briefly mentioned earlier that despite the fact that researchers may have found the miracle cure for hepatitis C, it is unobtainable due to its costly markup. WHO has even stated that:

“no country in the world could afford to treat all those who needed the drugs.”

As if to comfort those desperate to get their hands on this magic drug, the Cochrane Collaboration published a paper that divulges the drug may not be that effective after all.

Wait… what? So is it effective or not? People’s lives are at risk here!

Before we jump into any conclusion, let’s analyse the evidence before us from two different sides:

Hepatitis C Drug Evidence

Claim

“This hep C drug works.” – drug manufacturer.

Supporting Evidence

Through measuring the amount of virus left in the bloodstream 12 weeks after drug treatment, which has been reduced.

Claim

“The effectiveness of the Hep C drug may be overestimated.” – Cochrane Collaboration (a global independent network of researchers and professionals).

Supporting Evidence

  • The absence of evidence that it can “prevent harm from disease or save lives”.
  • The amount of virus left in the bloodstream does not mean that the virus won’t recur by lingering in other parts of the body. In fact, evidence shows the returning of the virus in very sick patients eventually causes end-stage liver disease.

Cochrane Collaboration further mentions that “all the included trials were with high risk of bias” as they are funded by the drug manufacturer themselves. Essentially, there is a certain probability that the published outcome could be deviating from the true result, be that done intentionally or subconsciously, through systematic errors performed in any phases of research (e.g. in study design, data collection, data analysis, publication). 

Even if you are completely unenthusiastic about whether this hep C drug is effective or not, just remember one take-home message: if you are analysing evidence-based research and wondering what the best treatment for your patient is, remember the difference between disease-oriented evidence (DOE)and patient-oriented evidence (POE).

Disease-Oriented Evidence (DOE)

DOE often looks at the marker of disease, in this case, how much virus left in the bloodstream.

Patient-Oriented Evidence (POE)

POE focuses on outcomes that patients care about, for instance mortality and morbidity.

Unfortunately, many research focuses on the former, but as a good doctor, what we really need is the latter. As one of the reviewers from the Cochrane review, Jakobsen, correctly pointed out, “From a patient perspective, it does not matter if the virus cannot be detected in the blood if DAAs do not improve survival or lead to fewer hepatitis C complications.” 

Hopefully, this has given you an idea of what is going on in the world with drug manufacturing and development. Having an understanding of medical issues is important for interviews where you will likely be asked questions about medicine in the news. We suggest spending a few minutes each week reading articles, like the one above, to get a grasp of what is going on in medicine at the moment. 

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