Drug development and the conundrum of how we fund a healthier future

His message was that pharmaceutical companies shoulder the staggering cost of research and development of new drugs, against the fact that only the few that prove effective ever generate revenue. On top of that, the revenue depends on the patent period. Once the patent expires, others are free to manufacture generic versions of the drug, so revenue dwindles by 80 per cent, says Dekker, quoting the industry estimate. If the auto industry were subject to the same process, we would still be driving models from the ’60s, he adds.

“It’s a huge dilemma which is not yet solved. And without a solution, I fear there would be no economic motivation and no benefit to healthcare,” he said.

Exactly how much it really costs to develop a new drug remains a mystery. Yet that cost is the focus of all the public scepticism directed at the pharmaceutical industry. Amid the tension, it is the duty of all stakeholders – regulators, pharmaceutical companies and patients/the public – to reach agreement on this, as the future benefits of all patients depend on the answer.

A new study by Tufts University puts the average cost for developing an approved drug between 1995 and 2007 at US$2.6 billion, taking into account R&D spending and the many drugs that never get approved. 

Bayer last week invited journalists from Asia, Europe and Africa to its laboratory in Wuppertal, which has developed several drugs – including aspirin some 100 years ago. The visit offered convincing proof that pharmaceutical companies spend massive amounts on R&D.

At the forefront of the quest to discover new blockbuster drugs is an engineering team responsible for designing and constructing tools used in the labs. The tools and robots that we observed work non-stop to find compounds that may be effective in fighting or preventing disease.

Also working under pressure here are the researchers, part of a 13,000-strong workforce of Bayer scientists spread across Europe, the US and China. Tasked mainly with analysing data, some work in the lab from dawn till dusk. 

And the task has become harder now that Bayer has focused on being a “life science firm”, extending its quest to the discovery of molecules that interfere with harmful biochemical processes in plant and animal species. In layman’s terms, a more effective drug against cancer is the one that kills only the defective cells; today’s drugs tend to kill both the good and the harmful cells.

Once the right compounds are located, the development process starts. It can then take 10-12 years to complete the three clinical test phases and win approval from the regulatory bodies of the countries where the drug is to be distributed.

According to Dekkers, the cost of R&D and commercialisation dwarfs the cost of manufacturing. No doubt that’s true.

 His company flew journalists to Leverkusen to observe R&D activities and also to hear what two patient groups think about new drugs. The focus on that day was Rivaroxaban. Marketed as Xarelto, it is a blockbuster drug for Bayer, used to prevent strokes. About 15 million people suffer a stroke each year, according to the World Heart Federation. 

Needless to say, nobody wants to experience one, given they can be fatal or leave long-term negative effects on patients and relatives.

Melanie True Hills, founder and CEO of StopAfib.org, suffered from an irregular heart rhythm – a condition called atrial fibrillation, which is responsible for about one in five strokes. She lauded Rivaroxaban, convinced it of its effectiveness in protecting her from a stroke. At one point, she asked the reporters to disseminate more information on the relatively new drug, for the sake of patients.

Well, journalists want to help – as long as it doesn’t infringe on reporting ethics. 

We all know that today’s drugs are better than those of decades past and that they will be more effective in the future. Yet journalists are just common people, with limited knowledge to judge which drugs are good or bad. As such, we are told to be extremely careful when writing on this subject, as inadequate knowledge may cause harm.

Complicating our job further is the new drugs arriving on the market. In the US, the Food and Drug Administration approved 39 new drugs in 2012. Without specialist medical knowledge, how many journalists would know what risks or side-effects taking them they carried. Worse, in Thailand, ordinary citizens have no idea how many drugs are approved each year. They depend solely on doctors and pharmacists for information on new medicines.

As such, pharmaceutical companies employ huge sales teams to lobby doctors and pharmacists – their only channel to reach out to consumers. No matter how good new drugs might be, their benefits will be limited if only a few people know about them.

Aside from the high cost of R&D and commercialisation, drug companies also struggle with a fact of life: governments put a cap on public health spending. 

Hence, doctors often refrain from prescribing new drugs, made pricier by development costs.

It all comes back to the cost of R&D. If it is cheap, the drug’s price should be cheap. 

However, it is up to the regulators to judge how much pharmaceutical companies should be allowed to factor in the development costs of the many drugs that never make it to the market. Too much pressure may discourage future R&D activities, which can’t be good for consumers. Leniency, however, would mean exploitation of consumers and exorbitant public health spending.

Consumers too must pay more attention to the quality of healthcare services and new drugs. 

Most of us today will live longer than our forebears and drugs will play an increasing role in our lives.