Transition in Pharma

What needs to be prescribed to an industry in distress?

by Toby Benham

Recent large scale closures of R&D sites in the UK from pharma giants Pfizer, Merck, GSK and now Novartis has led to the nationwide desolation of the pharmaceutical industry. With cuts extending around the world, and several big challenges ahead, it appears the industry is heading into a time of transition. To emerge through this transition stronger it is important for pharmaceutical companies to collaborate, working together for the collective good of the field.

Difficult times

The dominant business model adopted in recent times by pharmaceutical companies involved investing heavily into promising drug candidates, attempting to create the next big blockbuster. For associated with these iconic blockbusters are fame and fortune. Drugs such as Lipitor and Plavix have allowed their respective companies to thrive previously. However, the industry has been looming over the edge of the “patent cliff” (when many current blockbuster patents expire) for several years and now companies are lining up for the plunge. It means that these drugs can be manufactured and sold by any generics company at the detriment of the inventor company’s profits. This strategy relies on new blockbusters to come through the system but current pipelines appear relatively fruitless. 

Developing new drugs is an expensive business. Forbes estimates that it now costs approximately $5 billion per new drug created; this is not a sustainable figure. Costs spiral during the 15 years that contribute to getting a drug to market. The drug discovery, optimisation, clinical trials, patent protection and marketing involved are all long expensive processes. However, the main reason that the figure is so high is due to the unseen added cost of research into unsuccessful drug projects. Thus, there could not be a worse time for worldwide scandals to be breaking out in the news, smearing the image of pharma. Just last year, both GSK and Novartis were alleged to have bribed doctors and healthcare officials in China. There are also questions over the safety of some drugs already on the market.  GSK’s “Avandia” for diabetes treatment has been under intense scrutiny for several years now with restrictions in the US only lifted recently. With so many hurdles in the development process - ranging from toxicity to manufacturing - high risk, high reward projects may now be considered just that bit too risky. 

The future

Most importantly, big pharma need to ditch their profit alone method and support one another for their collective benefit. In 2013, data analytics company SAS announced the creation of a globally accessible but private bank of data for pharmaceutical companies to pool clinical trial data. GSK have been the first to share. Perry Nisen, the GSK senior vice president for science and innovation, announced that, “in sharing our data with researchers across the world, we hope to further scientific research and increase understanding about our medicines.”  This exemplary collaborative model will allow companies to improve efficiency and enhance the decision making progress which is so crucial in pushing forward drug candidates. Working on projects across companies should also be encouraged with the chance to explore new opportunities, widen portfolios and spread risk. GSK and Novartis recently announced an asset swapping deal, but this could go even further.

In addition, the big pharmaceutical companies can collaborate with the smaller businesses to flourish from symbiotic relationships. Companies such as Aurigene offer cost effective outsourcing of R&D in their respective areas of expertise, creating what Aurigene describe as a “win-win partnership” that accelerates discovery. The opportunities are not limited to industry with many experts in academia to link up with. Sanofi-Aventis and Pfizer have already created strong partnerships for drug development with Harvard University and UCFS respectively. Back in the UK, Astra Zeneca is building a new headquarters located in Cambridge with the intent to partner with Cambridge University and local hospitals.  By sharing scientific talent and resources, the drug development process gains extra quality and creativity from fresh perspectives. Diversity and partnerships lead to innovation which is essential to feeding hungry company pipelines. A wider communication with regulators would also be invaluable. Hopefully this could put an end to public scandals and improve the clinical trial process. 

Change is required to replace the current unsustainable business model in the pharmaceutical industry. With the right partnerships, a new streamlined, cost effective and innovative R&D system is possible. This will reduce the price of creating a drug by increasing productivity whilst simultaneously cutting expenditures. Through sharing scientific talent, resources and knowledge it is possible for the industry to return from the drop of the patent cliff to emerge stronger by optimising the potential of collaboration. Pharmaceutical companies should consider working in unison for the common goal and share the rewards. This is important not just for the companies concerned but for the patients that benefit as a result.

China Lead World in Push for Wind Power

by Toby Benham

China plans to more than double its number of wind turbines in the next 6 years. This bold move involves increasing the nationwide wind power capacity from 75 gigawatts (GW) to 200 GW. To put this into context, all of the countries of the EU combined have a total capacity of around 90 GW. This is an important positive move for a country that is a leading contributor of greenhouse gases. Wind turbine technology is improving due to the massive market potential. Current efforts are innovating the field while simultaneously lowering prices. This is beneficial to other countries worldwide. The opportunity arises to either purchase turbines from the Chinese or further their research. While sustainable energy is the way forward there are still problems to be addressed. 

While China contributes to 26.7% of the worlds installed wind power capacity, this only meets 2% of the country’s power demands. In fact 75% of their power still comes from coal. Clearly more needs to be done in an effort to phase out fossil fuels for renewables. For this to happen, renewable energy technologies need to be improved to be able to provide more power and deliver it to the right places. Excellent research has been carried out to bring us the technology we have today. However there are serious problems when trying to use these technologies to supply countries with large quantities of power. Energy storage is a key issue. Sticking with wind, generally the amount of wind is intermittent. This means that there is either no electricity being generated or too much to cope with. Last year in China around a quarter of turbines were left off during the windiest times because the turbines are vulnerable to damage during high winds. Another problem is that the windiest places are generally far away from the cities that require power from them. New advances may provide answers to these issues, but it is difficult to tell if this will be years or decades away. One thing is for certain; China should be commended for taking a step in the right direction. This is an opportunity for other countries to follow suit and develop more renewables.

Transplanting Memories?

by Rhema Anderews

George Bernard Shaw once said, “All great truths begin as blasphemies.” In the realm of heart transplantation technology, none has posed greater uproar than the controversial concept of cellular memory.

Cellular memory is the notion that the brain is not the only organ capable of storing memories. In fact, all living cells possess “memory”. Evidence for this has been found predominantly in heart transplant patients. Studies on cellular memory from transplant patients are often conducted by scientists with the aid of the hospital system which forbids the recipient to know or communicate with the donor’s family with most cases without the mention of names.

On May 29, 1988, Claire Sylvia received both the heart and lung of an 18-year-old man killed in a motorcycle accident. After the surgery, Sylvia claimed an intense craving for beer, chicken nuggets and green peppers, all of which she never liked before. She began to assume a masculine walk (peculiar for the dancer), started swearing in conversations, and for no apparent reason took up motorcycle riding at dangerous speeds, which was totally out of character. Sylvia even started having recurring dreams of a mysterious man. In her book entitled “A Change of Heart”, she recounted a dream where she kissed a boy thought to be named Tim L. and inhaled him into her. Upon meeting the “family of her heart” as she put it, Sylvia learned the name of her donor was in fact Tim L., and all of the changes she experienced closely mirrored that of Tim L. who strangely at the point of death had chicken nuggets in his pockets. Sylvia’s story quickly captured media attention and soon after, many other transplant recipients came forward with similar testimonies.

The most striking example is that of an eight-year-old girl who received the heart of a ten year-old-girl. Post-surgery, she was consistently plagued with distressing dreams of an attacker and a girl being murdered. Her nightmares proved so vivid that even her psychiatrist believed them to be genuine memories. As it turns out, the donor was a murder victim and as a result of the recipient’s violent recurring dreams, she was able to describe the horrifying incident and the murderer to such great detail that the police eventually apprehended, arrested and convicted the killer.

Ongoing research has shown that neuropeptides and receptors previously known to exist exclusively in the brain have been discovered in places throughout the body, especially in major organs such as the heart. These neuropeptides are a means for the brain to communicate with other organs and for these organs to send feedback to the brain. However, little is known about whether these neuropeptides can store memory; due to the amount of peptides in the heart, there seems to be a strong correlation between the two. But if this were the case, then why don’t all patients go through this experience?

There is no solid evidence that the reports are nothing more than coincidence and fantasy. Even so, the stories are intriguing and we should expect some serious investigation into the matter in the near future. Until then let’s keep an open heart.

The controversy of immortal cells

Louisa Cockbill

Did you know that it is possible for human cells to be removed from the body and survive, even multiply in number? Growing cells outside the body is known as ‘cell culture’. Cells grown in culture are often taken from tumours because tumour cells have the ability to grow infinitely when supplied with nutrients.These immortal cells are incredibly important in medical research, as they allow researchers to study and experiment on cells humanely; that is outside the body.

HeLa cells

But where do these cells originate from? I mentioned that many cells in culture are originally taken from human tumours, from biopsies or from a surgically removed tumour. Nowadays ethical permission is received from the patient to study the tumour; however medical permission forms didn’t always exist and neither did cell culture, so where did the practice of growing cells come from?

The first cells ever to be immortalised in culture were from a biopsy of a cervical mass (a tumour) from an African American woman called Henrietta Lacks from Baltimore in 1951. They were called HeLa cells and their immortalisation in culture changed the face of medical research. HeLa cells were exposed to all forms of bacteria and viruses to study the method of infection, replication etc. in order to block these processes with antibiotics, vaccines etc. Indeed Polio vaccine neutralisation tests were some of the first vaccine trials that used HeLa cells. Today HeLa cells can still be found cultured in every lab and it is estimated that 50 million tons of HeLa cells could have been grown.

I’ve always viewed cell culture from a purely scientific perspective, but since reading ‘The immortal life of Henrietta Lacks’ by Rebecca Skloot I’ve started to look at cell culture from an entirely new perspective. Henrietta Lacks’ family didn’t find out about her immortal cells until 1973; 22 years after HeLa cells were first cultured. Why had no one told the family? Why is it that the Lacks family can’t afford health insurance, when their mother’s cells have driven forward frontiers in understanding disease?

The truth is that Henrietta’s cells were cultured without her knowledge or consent at a time before regulations were set in place to safeguard patient’s rights. Regulations now ensure that informed consent must be received and the patient informed of any commercial benefit that can be made from their medical donation.

Henrietta Lacks

I think what particularly struck me on reading ‘The immortal life of Henrietta Lacks’ is how strange it must have been for Henrietta Lacks’ children to find that cells from their mother were alive! It has made me wonder how I would feel if cells had been taken from my Grandmother’s colorectal tumours and grown; who knows, she died in 1965 before law ensured patient consent, maybe her cells are out there. It’s a disconcerting thought.

On the other hand how amazing would it be if the cells from the cancer that killed my grandmother were used to cure the disease? Especially handy as the cancer appears to be hereditary. Indeed although the Lacks’ family are indignant at not being informed about the culture of HeLa cells for two decades and the lack of explanation given them, they are marvelled by the medical breakthroughs made possible by the cells cultured from their mother.

The story of Henrietta Lacks may have made me question certain scientific precepts but has certainly opened my eyes to better appreciate the invention of cell culture and the lives behind the cells. To read more about Rebecca Skloot’s discovery of the world of Henrietta Lacks and cell culture I’d advise you to read ‘The Immortal life of Henrietta Lacks’ which is available for loan from the University of Bristol Medical Library.

More information:

http://henriettalacksfoundation.org/

http://www.youtube.com/watch?v=_FaQ9Utx--E