By: James Payne
On one of my very first tests in medical school, I was asked which branch of government was responsible for approving new drugs in Canada, and I’m ashamed to say the question gave me pause. One frequently hears about the actions of the FDA in the US; but is there even a comparable body in this country? Of course, I’m being glib. The Health Products and Food Branch of Health Canada (totally didn’t have to look that up) does indeed regulate which drugs are available for patients. So, we can all sleep safe tonight knowing we’re protected from the profit-hungry machinations of Big Pharma; but should we?
Government regulations are designed to keep us safe, and it’s not hard to see why they’re so important. One needs only to recall the failure of the authorities to protect young mothers and their children from thalidomide in the early 1960’s. Even after the drug was withdrawn from markets all around the world due to the terrible effects on fetal development, thalidomide was still legally sold in this country. Ironically, it was a Canadian physician, Dr. Frances Kelsey, who blocked approval of the drug in the United States even while up against enormous pressure; and so spared that country from suffering the same fate of her own. In 1962, Health Minister J.W. Monteith specifically cited the thalidomide tragedy when pushing for a new bill with stricter regulations on drug development in Parliament.
Drugs are among the most important discoveries in the history of science. How many lives have been saved by antibiotics? By chemotherapeutics? By the almighty beta-blocker!? But these drugs can also pose a danger to us all as well. They are designed to change things within our bodies; yet our bodies are so complex that sometimes they may change the wrong things. This is why thorough and extensive drug testing is so important to protect both patients’ safety, and their confidence in the healthcare system. Regulation is essential. But have we recently gone too far?
Big Pharma and Drug Development
People often look with contempt at big pharmaceutical companies. Yet, we should also remember that these companies are responsible for many major drug breakthroughs over the past century. They’re in the business of making money, but saving lives is a happy side effect. I don’t expect you to feel sorry for Pfizer or Novartis or Roche, but I will ask you to consider that when they don’t make money, they don’t make drugs. Their bottom lines can be very much our problem.
Regulations on drug development increase drug costs (okay, fair enough; as we have discussed above, regulations are important!). But the question of the day is: Do we over-regulate? Over the past decades, evidence standards for drug efficacy and safety have steadily risen, and thus so have the costs of development. Yes, this has likely prevented injury and even death from dangerous drugs (which cannot be undervalued); but if there is a steadfast rule of economics, it is that when firms pay more, we pay more. Fifty years ago, the cost of developing a new drug was approximately $250 million USD (adjusting for inflation). Today, it may be as high as $5 billion.
These prices are astonishing, so it’s not hard to imagine some valuable areas of research being dismissed as unprofitable, especially for diseases more prevalent in the developing world. Of course, there is a strong argument to be made that regulations help drug companies to an extent; getting to claim an FDA stamp of approval can be used as justification to charge more per pill, and skyrocketing drug costs are not solely a function of increased regulation. However, stringent regulations may be costing us even more than mere dollars and cents.
Understanding the Process
As standards rise, so does time of development. The time required to take a new drug from discovery to distribution has increased steadily since the 1960’s; currently, the average ‘bench to beside’ period for a new drug is 14 years. Let us consider the implications of this delay: drugs limit mortality and morbidity. Therefore, does increasing the time required to produce a new drug lead, in the interim, to increased death? Basic logic suggests that it does, and some studies have estimated the numbers to be in the hundreds of thousands.
Moving forward, should the drug approval process become a simple matter of guessing whether it will kill or save more people? Of course not. Medicine is more than arithmetic; public confidence and peace of mind depend on the knowledge that what doctors prescribe is safe. But can we reduce those regulations without seriously undermining the efficacy of authorities like the FDA? Several ideas have been proposed, and I encourage you to read some of them here.
To leave some food for thought: are we so preoccupied with making sure our medications don’t kill us, that we allow diseases to do just that? Is one worse than the other? These are difficult questions. But it may be time to ask ourselves: when it comes to regulating drugs, what is the cost, and what is the effect?
Author: James Payne
Photo Credit: Creative Commons, Medications