NCHR Statement on Protecting Patients from Long-Term Risks

When Americans take medication, they don’t expect to have to read the studies that have been conducted on the product. Their physicians don’t expect to read all the studies either. And patients don’t expect to have to carefully scrutinize the fin print and personally weigh the risks and benefits. They expect that the medications that are FDA approved are safe and effective for almost everyone, and therefore safe for them.

Most Americans don’t know about FDA Advisory panels, but even if they don’t know it we are all counting on you. FDA is under fire like never before, and while the public’s concerns will undoubtedly fade, consumer groups and medical researchers know better. So treat your votes as if they are the most important ones you will ever make.

There is plenty to be concerned about regarding the medications you are considering, but since I don’t have access to the data you have, I will focus on the broader issue: the failure of the FDA to scrutinize long-term safety. This is a systemic problem and it will not be fixed by wishful thinking or Advisory Panel instructions.

When the law creating the FDA was passed in 1938, the goal was to prevent people from dying from dangerous concoctions, such as the elixir that killed more than 100 people during a 4-week period in 1937, 34 of them children. In those days, most medications were taken for a short time – for colds, flu, pain, or diseases that would kill you before too long. That made them easy to study in clinical trials.

Now, most blockbuster drugs are taken for chronic conditions – not necessarily illnesses – that are likely to last for the rest of your life. The big money is in drugs that help us manage chronic pain, lower cholesterol or symptoms of chronic diseases, or help prevent us from developing a disease – pills you need to take day after day, year after year. But most of these drugs are approved by the FDA after being studied for just a few weeks or months – just as they always have been.

Unfortunately, drugs that are studied on a few hundred or few thousand people for a few weeks or months are then taken by millions of people for many years. The FDA doesn’t really know what the long-term risks are, especially if the company doesn’t reveal all the information they have.

The FDA should be requiring and carefully monitoring long-term studies of medical products that patients will rely on for a long time. Our government needs to strengthen the FDA an other security check-points designed to protect us from those very real dangers. In the meantime, don’t assume that the companies can be trusted to carefully conduct post-market studies, or that the FDA will enforce requirements to conduct such studies and act on their results in a timely manner. Restrictions on advertisements could help prevent misuse– But those restrictions have been rejected on the grounds of interfering with “free speech”. Don’t rely on unrealistic FDA requirements that the FDA has neither the resources nor the authority to enforce. If you’re not sure that a product is safe or is likely to be used safely, get it off the market.