New Drugs: Less Regulations, Maybe Less Effective

What happens when competition replaces science as the most important reason to develop new medicines?

Regenerative treatments like stem cell therapies have emerged as the frontier of medicine, including neurological medicine and psychiatry. Much promise is held out for these new therapies.

Research on phenotypes, stem cells and genes carried out in mice promises to impact treatment for bipolar disorder in the not too distant future.

But future therapies are incredibly expensive to develop, and companies and governments funding the research seek a return on their investment as soon as possible.  

Political trends against globalization and toward fewer regulations may lead to these therapies entering the market too quickly.

As nationalism flourishes, so does a government’s identification with key, forward looking industries that can set the nation ahead of others.  There’s a very real incentive, in pride and treasure, to be first to market with new technologies.  Especially in a field as influential as medicine.

One of the ways a nation can support its home industry and hasten drugs to market is to reduce regulations that insist a new medicine or therapy definitively prove its efficacy and safety before it is introduced to general medicine.

Countries in Asia like South Korea and China have done just that, and Japan is rolling back regulations in an effort to keep up.

Regulations are tricky.  Most agree some are necessary to protect the people who will use medical products.  But just how much regulation is required is endlessly debated.

In the present political climate many regulations are being rolled back with the argument that they stifle innovation and add too much time and cost to the development of medicines that should be introduced to patients sooner.  Add some anti-globalism to the mix and rigorous international regulations just seem anti-competitive.

But are companies in some countries introducing radical treatments without fully realizing their impact on both individuals and societies?  And what becomes of ethics when the primary motivation for science becomes market return and not pure research?

Yes, bringing a medicine or therapy to market is expensive.  In countries that use public funding to develop medicine there is an incentive to loosen regulations and bring these treatments to market faster.

In the United States and in Europe, where much development is funded with private money, companies complain that the more rigorous regulations they face are hobbling their ability to compete.

The response in the US has been to loosen regulations so that US pharmaceutical and biotech companies can bring therapies to market more quickly in order to compete with developers from countries with fewer regulations.

European companies, still facing tough regulations, lose market share and investment financing daily.

It seems, to some, that competition is more important than rigorous science in the development and testing of new therapies.

There are billions of dollars to be made in fields like regenerative medicine.  Motives to profit on that market do not in themselves endanger the public.  In fact, the promise of profit is a key driver of innovation that goes on to help millions who suffer.

But the scientific method demands certain results and forbids cutting corners in coming to those results.  It’s easy to say something works and does no harm.  It’s harder to prove it.

Science has always benefited from the sharing of research.  But new treatments are proprietary products and the science behind them is closely guarded by companies and countries.  Sensible regulations exist to make sure treatments brought to market are safe and effective.  We must be careful not to eliminate them only in the name of market efficiency.

In the global rush to roll back regulations, are we wrong to demand that companies adhere fully to the scientific method and peer-review as they develop drugs and other therapies for a waiting, needy market?

I don’t want to be skeptical about my medicine.  I want to know it works, and trust those who tell me it does.