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