With his new book, Grave Island, now available to buy, talkhealth caught up with author Andrew Smyth to discuss the research that went in to the book around the operations and activity of pharmaceutical companies, fake drugs and medical legislation. Take a look at the full interview below:
1. What background did you have if any to the pharmaceutical industry?
To tell the truth, like most people, I hadn’t really thought about the source of my medicines and just took them for granted. I have no direct background in the pharmaceutical industry (although my son Chris is Health Editor of The Times and an old friend spent many years with the WHO vaccination programme). But I wanted a “Big Baddie” for my story and “Big Pharma” is so huge that it seemed a good starting point. At the start of my research, I discovered that some of the very largest pharmaceutical companies, such as GlaxoSmithKline (GSK) and Pfizer have been landed with billions of dollars of fines following whistleblowers’ revelations about cover-ups of sub-standard manufacture.
But I realised that a story featuring these companies wouldn’t make sense because none of them would deliberately set out to produce sub-standard medicines. It then occurred to me that counterfeiting drugs is a perfect criminal activity so instead of looking into the pharmaceutical companies, I started research into fakes.
2. What research did you do within the following:
a. Pharma industry?
I tried hard to make the information in Grave Island accurate, and to make it so I had to research a wide range of aspects of the Pharmaceutical Industry. In particular (a) the manufacture and (b) the distribution.
(a) Pharmaceutical manufacturing has changed a great deal over the past couple of decades as it has been moved away from Europe and the United States to places such as India and China. That has reduced costs, but in some cases has reduced quality because it is much more difficult for the main western agencies to monitor. It’s the US Food and Drug Administration Agency that is the main international organisation that looks into fake and substandard medicines and they have opened up a number of overseas offices to help their investigations. But India and China are huge countries with hundreds – probably thousands – of drug manufacturers and controlling them all is impossible
(b) Pharmaceutical distribution is labyrinthine in its complexity because each country has different health systems and different systems of purchasing. Even more importantly, the costs a drug can fetch differs widely from market to market and companies are always trying to get the best price. Hence the term “parallel marketing” (see below) whereby the same drugs are sold to different countries but in different packaging. A large part of the distribution process is packaging – or rather repackaging as consignments meant for one country are repackaged for distribution in another. Once again there are different legislative requirements in each country concerning the information that has to be supplied within each package.
Given that the NHS operates nationwide, its purchases are different from most other countries. They don’t have a complete monopoly, because there are numerous private hospitals throughout the country (indeed health provision is a major export earner) and purchasing is not yet centralised. What can and can’t be prescribed is closely monitored by NICE (The National Institute for Health and Care Excellence) which brings a degree of order into the UK market which is missing in many others. This makes it very difficult for counterfeits to be introduced into the supply chain and fakes in the UK are usually “lifestyle” type of drugs ordered over the internet, such as Viagra. The MHRA (Medicines and Health Regulatory Agency) estimates that of the pharmaceuticals that are bought online, a staggering fifty percent of them are fakes, but since most of them come from abroad, there is little they can do except warn people about it.
c. Parallel markets and distributors
The EU open market regulations have encouraged parallel trading, although it’s something the drug companies themselves strongly disapprove of. Basically it involves intermediary companies – effectively wholesalers – buying product in one country where it’s cheap and repackaging it and selling it in another where it’s expensive. Typically this could involve buying in Greece and selling in Germany and this can result in shortages because the local Greek wholesalers are cleaned out – such is the demand. But it’s not illegal, although it can be considered that it increases the wholesalers’ profits at the expense of the consumer. The EU maintain that whether that happens or not is not their concern, they take the view that, overall, it reduces prices. We experienced this ourselves when stocking up our boat’s medicine cabinet for our trip to the Indian Ocean. We found the drugs in Greece so much cheaper than in the UK, although we did have some problem reading the labels when we needed them!
3. Did you talk with the MHRA and WHO?
I tried to speak to both the MHRA and GSK. The MHRA who directed me to their website where their main concern is online purchases, where fakes are rife. The drugs companies, as noted above, don’t appear to like talking about fake pharmaceuticals.
4. How truthful or near to the truth are the main story lines in terms of:
a. Production of fakes within real laboratories – or certified recognised laboratories
The actual underlying plot of Grave Island (ie how the counterfeits are actually made) is based on several actual cases. I can’t reveal what this is (you will have to read the book) but it is absolutely accurate. As are the analytic processes using Truscan for batch testing. With the AIDS epidemic in Africa, antiretroviral treatment has become increasingly important. In Tanzania, location for the scenes in Zanzibar, the government estimates it has 1.4 million people living with AIDS or HIV, out of a population of 45 million and its free drug programme has had great success in extending lives, but fakes are a huge problem when they are expertly packaged to look exactly like the real thing. But increasingly they have instituted programmes using portable analysis machines and the government estimates that it has reduced fakes by three quarters.
b. Interference with global health roll out programmes
One of the main programmes in sub-Saharan Africa is against AIDs/HIV. Major successes have been achieved with antiretrovirals where the fight against counterfeiting has probably been the most successful. This is perhaps because they have been developed relatively recently and the possibility of counterfeiting is addressed at the outset. To put these successes in context, life expectancy in most of Africa has shown remarkable improvements. In Malawi, for example, it has increased by 42% between 2000, when it was 44.1 years, and 2014 when it was 62.7 years. Zambia and Zimbabwe both show increases of 38%. Artisemisinins – antimalarials – continue to be among the most faked drugs and because of the widespread prevalence of malaria, this remains one of the biggest impediments to vaccination programmes. Once again, providing them cheaply is proving the best way to deter counterfeiters.
Under this heading it should be remembered that fake or substandard drugs don’t just do little or nothing to help the patient but, especially with antibiotics, they can actually be harmful because they build up resistance to the drug, which is an increasing and well-publicised problem throughout the world. This build up in resistance is a danger to all of us.
5. What were the main factors/points that were learned from the pharmaceutical industry?
The most important thing to remember about the industry is its size. It’s vast, but has to cover the entire world. Therefore, at one end of the spectrum there are state of the art research facilities with multi-billion dollar budgets looking into new drugs, while at the other end can be a small African village which has no fridge to store the vaccines which therefore degrade.
As noted above, one of the major factors that drives fake drugs is price – people will buy a cheaper alternative which might contain little or no active ingredients. If the drug companies can reduce their prices for vaccines then that can have a major effect. Charities such as the Bill and Melinda Gates Foundation are working with them to help making genuine vaccines more readily available and drive out the fakes. Similarly, the increasing use of portable analysis machines such as the Truscan is helping the fight against counterfeits.