A testing time in Cambridge now that the European Medicines Agency is no longer based in Britain.
(Spoiler Alert:- This article contains references to later episodes the ‘The Marnow Murders’ , A ‘Walter Presents’ TV Series currently available on the All 4 Website )
There are TV dramas worth watching for the scenery alone, Mystery Road , for example: it was surprising mention of the Australian outback was not more prominent in the credits. The less well known, ‘The Marnow Murders,’ which caught my eye having spent some time in this part of Germany during the 1970s and 80s and more recently when hiking from the Oder to the Elbe in search for someone who died a very long time ago and to see what the countryside looked like without all those Russian tanks. Perhaps not everyone’s choice of a holiday destination, you have to like lakes and trees, lakes and the dark, not for nothing Mecklenburg-Vorpommern is called the land beyond the Milky Way. This is a stargazer’s paradise: smoke on your veranda in the evening and someone from the next village will phone and ask you to put out the light. By episode three it became obvious The Marnow Murders was based on a particularly dark period of East German history.
Anyone expecting the foreign version of Midsommer Murders will be disappointed and Frau Joyce Barnaby and Herr Troy were quickly dispensed with leaving the troubled detective and his equally traumatised female sidekick to solve a series of seemingly unconnected murders on their own. None of Tom Barnaby’s, WTF shrugs or black humour injected by the forensic scientist – in fact very little humour at all: although there was a tongue in the cheek dig at all those wannabe Scandi-noir dramas via a twist on the body chained to the bottom of a lake. Did I mention there was lots of lakes and many square kilometres of trees? Trees the two detective drove through on deserted single-track roads while exchanging long troubled stares: the time wasted doing this ensured they were always one step behind the murderer.
Murderers to be more precise because this story is based on actual events, a scandal involving East German politicians and West German pharmaceutical companies. A decidedly dodgy deal motivated by greed and desperation described in an article Der Spiegel published in 2013. Only when Herr Troy read the name on a gravestone in an abandoned cemetery, and gave one of those knowing looks which in TV dramas usually means you are about to be killed, did I manage to join the dots. It was also at this point I wondered whether Channel 4’s Walter of ‘Walter Presents’, (I’m still not convinced this person actually exists) had indulged in a timely piece of mischief making when selecting this particular drama.
A full week before I identified the culprit, ahead of the detective by the way who, to add to his troubles, had been tricked into accepting as a bribe medication, still in beta stage development, to slow the onset of his mother’s dementia. A touch of symbolism here and an obvious clue for hard of thinking viewers. At this point you need to imagine the theme from the X files playing in the background because the morning after watching this episode the UK government struck a deal with the German pharmaceutical company BioNTech SE. Kemi Badenoch, Steve Barclay and Rishi Sunak jointly announced the signing of an agreement which will provide up to 10,000 patients in Britain with precision cancer immunotherapies as part of a medical trial. Let’s turn up that music because only days after this news an excited Fergus Walsh informed the viewers of the BBC’s Six-o-Clock news there was now a miracle drug shown to slow the progression of Alzheimer’s and this too may be trialled in Britain.
OK, off with the tinfoil hat and time for a little context for which we need to go back several years before the events fictionalised in The Marnow Murders. In the 1960s the Thalidomide scandal shocked the world and temporarily destroyed the public’s faith in the pharmaceutical industry. Thalidomide which caused birth defects when given to pregnant women was marketed by a subsidiary of Mäurer & Wirtz which, it transpired, employed as head the development, Heinrich Mückter who had previously carried out experiments on prisoners in Nazi concentration camps. Its head of pathology Martin Staemmler, had been a leading proponent of the Nazi eugenics program and another employee of the company, Heinz Baumkötter, was former chief medical officer at the Sachsenhausen concentration camp. Perhaps unsurprisingly following this incident, tighter regulation, and a sceptical German public, forced pharmaceutical companies to carry out more of their human testing in China and Africa. However, trials of remedies for age related diseases, such as cancer and dementia, yielded poor results in countries where life expectancy was low.
East Germany dodged the bullet with Thalidomide as it had prohibited its import and the general public remained largely unaware of the problems it had caused in the West. At this time its own health service was struggling, it was both understaffed and under resourced. My one and only visit to an East German GP was during the 1970s. Admittedly, given the circumstances, the doctor went the extra mile but, even so, it was much like stepping onto the set of Dr Finlay’s casebook. This was in a small village, but healthcare in the cities was not much better and Ludwig Mecklinger, the then health minister, felt poor healthcare was in danger of becoming the focus for dissent and disenchantment with life in East Germany.
There were few barriers to an agreement whereby West German pharmaceutical companies supplied medicines which doctors told patients were wonder medicines from West Germany but were in fact drugs still in their beta stage of development. The government was paid approximately 500,000 DM per trial (coincidentally the equivalent of £500,000 today.)
To their credit a handful of doctors, after carrying out some basic research, refused to prescribe previously untested drugs to patients many others, however, were happy to do so. While some medicines helped the patient others either made no difference or actually caused harm. The number of people who died as a result of taking the drugs is probably only known to the pharmaceutical companies who organised the trials. With the fall of the Berlin Wall the trials ended and by 1995 pharmaceutical companies in the united Germany were regulated by the European Medicines Agency EMA which ensured patients taking part in medical trials were not unknowingly put at risk.
The EMA was headquartered in London but moved to Amsterdam in 2017, the year after Britain left the EU. It was feared the loss of this important institution, and EU funding for the Medicines and Healthcare products Regulatory Agency (MHRA), which had a significant input into the EMA, would impact on life sciences research in Cambridge. However, any damage was masked by an increase in private investment in Cambridge University spinouts, especially those working in the field of genomics and AstraZeneca moving its research centre from Macclesfield to Cambridge’s Biomedical Campus. Even so, more recently, the mood music has changed.
The past seven years has seen a flood of groundbreaking discoveries by startups in Cambridge. This has now slowed to a trickle – hardly surprising given investors’ enthusiasm for the life sciences sector has cooled. Even those lucky enough to raise money before venture capitalists turned off the taps (it is claimed up to £1.5 billion had been invested in life sciences in Cambridge each year) are running low on cash. It is also becoming apparent how many of these small companies are trying to solve the same problem with the same tools, predominantly genomics. A lot of companies are overweight and like their US counterparts are neither lean enough nor have the funds to survive long enough to generate revenue in an increasingly crowded market. Now when stories about potentially lifesaving drugs appear in the media it is usually companies and institutions in the EU or US responsible for their development. Despite this, outwardly at least, the Cambridge’s bio-campus appears to be going from strength to strength. It is easy to see why.
Logically, if you were choosing the location for a new hospital focussed on cancer treatment it would be somewhere where survival rates from the disease were low: Liverpool or Sunderland would be prime candidates. So, at first sight, Cambridge seems an unusual choice, although a representative from the board of the bio campus did, when speaking to a local journalist, suggest that the hospital would have a greater economic impact if built in a region with a concentration of highly paid workers – fortunately a comment not picked by the national press.
Building a new cancer hospital next to the existing Cambridge University Trust’s Addenbrooke’s hospital, which has an above average success rate in the treatment of the disease, makes sense in light of BioNTech’s decision to open an R&D hub in Cambridge as well as that deal with the government to test its cancer drugs on patients in Britain. While you could run medical trials in other parts of Britain the infrastructure of neglected parts of the NHS is unable to support the data collection and monitoring required. The same is not true of Addenbrookes which benefits from being home to medical IT companies as well as the Medical Research Council (MRC) unit.
For the residents of Cambridgeshire the new cancer hospital will be a boon. Already spending too long stood over a urinal results in you being whisked into Addenbrooke’s hospital, a machine inserting all manner of sharp objects into your bottom and your prostate ending up under a microscope in one of the MRC’s laboratories. After this you are watched with the intensity of a vulture pursuing someone wandering in the desert. Every six months for the rest of your life (the length of this, rather than your welfare, is what researchers are interested in) you are tested to see if the cancer has returned. The difference between treatment of cancer patients in Cambridge and those living in less affluent parts of England, who struggle to get treated even after the water in the toilet bowl turns pink, is stark. There is a 2% variation in 1 year survival rates for prostate cancer patients across the UK, for lung cancer patients it is 8%. In this respect those of living in Cambridge can count themselves lucky. Or perhaps should say ‘So far, so good.’
When Alzheimer’s Research joined Fergus Walsh in singing the praises of the new drug an alarm bell was ringing in my head, although to be fair the one thing clinicians at Addenbrookes Hospital have not managed to fix is my tinnitus. But both Walsh and Alzheimer’s Research now had my full attention, and I was expecting the miracle drug to have been developed by a Cambridge University spinout given the millions which have been invested in research on the Biomedical campus. So, I was shocked to discover it had been developed by a pharmaceutical company in the US which was merely hoping to test it in the UK. I was also surprised the BBC, usually reticent to mention the names of companies and their products did both, twice. It was obvious someone was lobbying hard to get the drug tested in the UK, either the pharmaceutical company or maybe Alzheimer’s Research who, if permission was granted, may be involved in the trial.
Walsh did make reference to the risks associated with the drug, the sort of warning patients in East Germany never got. As well Britain in 2023 is not 1980s East Germany. We have the Internet and anyone wondering why a company wants to test their drug in Britian, rather than the country where it was developed, can find out by browsing the web. They might be surprised to discover the US Food and Drug Administration (FDA) is less enthusiastic than Alzheimer’s Research or the BBC about the miracle drug and are reluctant to allow a requested ‘accelerated trial’ in the US to go ahead. Given the FDA’s past, and more recent, experience you can understand the reluctance to allow pharmaceutical companies to cut corners.
The US avoided the full impact of the Thalidomide crisis. The FDA was less comfortable than Germany, Spain and Britain with the untested use of a drug whose development had been abandoned by Swiss based CIBA but was now being marketed by a collection of Nazi war criminals. Even so enough drugs made it into the US and were handed out to doctors for use in a trial to cause 17 babies to be born with missing limbs and other deformities. Regulations were tightened but this did not prevent, 50 years on, the opiate scandal which resulted in over 600,000 deaths. Unsurprisingly the FDA is currently at least as risk adverse as the EMA. So what the US pharmaceutical industry needs is a modern-day Ludwig Mecklinger, a health minister in a country with a cash strapped healthcare system and a regulatory body with a light touch when it comes to authorising medical trials. Take a wild guess where some companies believe they have found just the right person.
The good news is NHS patients may be about to get cutting edge medications ahead of anyone else in the world. This as the result of medical testing, post departure of the EMA, having been turned on its head. Where once pharmaceutical companies developed and manufactured drugs in Britain, then tested them in China, these can now be developed in Cambridge University’s labs in Nanjing, or AstraZeneca’s research centre in Shanghai, then tested on patients in one of the hospitals on the BioMed campus in Cambridge. The logic for building even more hospitals on the site is clear and as well as the planned cancer unit there will be a children’s hospital to support research into childhood diseases. The bad news is the possibility of some patients ending up a mere Jacob Rees Mogg style bonfire of regulations away from a bleed on the brain.
As they are instrumental in treating disease, helping us remain healthy and, in some cases, saving our lives our perception of pharmaceutical companies has become distorted. We cannot imagine the people who run these companies ever putting the economic ahead of the moral imperative. This misconception has allowed some of these companies to travel in disguise, portraying themselves as charitable institutions, which is how the Sackler family were able to navigate their company, Purdue, under the FDA’s radar.
It is worth remembering amongst today’s pharmaceutical bemouths are companies which can trace their ancestry back to IG Farben, the company which gave the world its first antibiotic and the first cure for cancer but also developed the gas used to kill millions of people during the Holocaust. Even the employee who developed that first antibiotic was motivated by self-interest, his daughter was in danger of losing an infected arm, rather than any concern for the welfare of mankind. Politicians should not lose sight of the Faustian pact they are signing on behalf of Britain’s citizens. And how dangerous it would be to leave even a microtone width slice difference between the regulatory frameworks of the MHRA and the EMA which the pharmaceutical industry would doubtlessly exploit. The temporary arrangements in place to partially align the MHRA and EMA is set to end in December 2023. By then an under resourced and conflicted MHRA must have a robust regulatory framework in place. The difficultly it faces can be assessed by reading the Human Medicines Regulations Advisory Bodies Annual Report 2022, start at page 124.
Access to untested drugs, and it is worth remembering that is exactly what covid vaccines were, can be a dream. It can also end in a nightmare, their being such a thing as buyers’ remorse. You can explain in detail the risks involved in taking part in a trial and the chance the patient, rather than being cured or the progress of their disease arrested, will die. Should the latter occur, the patient’s relatives will always feel it unjust they were the ones left holding the short straw. Now they would rather have had a parent on a slow journey into the twilight rather than having been left staring at an empty armchair. To usage the feeling of guilt for not preventing their parent’s participation in the trial, these relatives will unburden themselves to anyone who will listen and to a media whose audience finds such stories compelling and overlooks the damage they cause to the public’s faith in its health service.
My aunt died of cancer in an East Berlin hospital just months before the border dividing the city was opened. As sad as it was ironic because she was the one person in the family who would have made the adjustment from communism to capitalism with ease. Was she administered some ‘miracle’ drug from a western pharmaceutical company and if so, did it extend her life or cause her demise, we will never know. As with those Stasi files only those possessing a blind eye possess a clear view of the future.
Back in Marnow our detective tracked down the murderer but discovered the drug he hoped would reverse his mother’s dementia did not work. There was retribution metred out to all those evil East German clinicians responsible for the bodies of children in the graveyard overgrown with trees, next to the lake. Even so one was left wondering whether, had the TV series been made by MDR in Leipzig rather than a production company in Munich, might at least one executive from a West German pharmaceutical company have met a similar end as the bellringers of Midsommer.