September 15, 2015

Is It Time for Free Speech in Medicine?

Look out folks; Big Pharma has more power to promote medicines! This is a two-edge sword and I fear that patients will suffer. Others are claiming this as a victory for free speech in medicine. I can see some advantages and disadvantages on both sides.

  • Maybe patients will see a decline in the cost.
  • Maybe patients will have to take less medication.

  • There may be more adverse events on “off-label” medications.
  • Doctors will be under more pressure to prescribe “TV advertised” medications.

The Food and Drug Administration (FDA) regulates both safety and “efficacy.” This causes a drug maker to prove its medicine works to the FDA before marketing it to doctors. However, the cost of clinical trials to prove claims is monumentally high, so drug makers will not always invest in clinical trials for every medical condition where the drug may work.

Once a drug is used, doctors will find that it is effective for more medical conditions than indicated on the label. The new indications are often supported by peer-reviewed, published research. However, the drug makers have not yet invested the time and money to negotiate with the FDA to get the new claims onto the label. The FDA says drug makers cannot talk about these off-label uses. A federal judge just decided they can.

Judges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label.

Oncology is one specialty where off-label prescribing is common. Indeed, off-label prescribing is so common that some states mandate insurers pay for coverage of prescriptions written for off-label use! Surprising how the regulatory bureaucracy is behind the curve on this issue. Nevertheless, the FDA has asserted power to stop pharmaceutical reps from even distributing reprints of peer-reviewed studies supporting off-label uses to doctors.

This does not mean that we are talking about the “snake oil” salesperson. We are talking about high-level discussions with relevant specialists about new evidence-based medicine. This is part of why judges have been ruling for Big Pharma lately.

In this case, a judge recently found – on First Amendment grounds – that representatives of Amarin Pharma can distribute such information to doctors despite the FDA’s disapproval.

Established in 1906, the FDA has consistently increased its power. Not until 1962 did it win the power to adjudicate efficacy. Removing that power, and limiting the FDA to regulating safety, would return authority to doctors and patients. The 21st Century Cures Act, which passed the U.S. House of Representatives in June does not go that far. Nevertheless, it allows more “real world” evidence to be added to a drug’s label, which is a step in the right direction.

No comments: