Wednesday, July 26, 2017

Imagine Taking A Cancer Drug That is Fake!

This piece on the issue of deregulating prescription drugs comes from two former attorney generals. That begs the question:  what does Kentucky's Attorney General say about this?

Hat tip to the Sun-Sentinel on an issue that all of us who take prescription meds -- or have friends or family who do -- should watch.

By the way, for anyone who thinks this is not an issue in Kentucky, recall that a few years ago there was an issue in Louisville with fake Botox.

As former state attorneys general, we are keenly aware of how stretched local
law enforcement budgets are and how law enforcement officials already
struggle to contain the flood of illegal drugs flowing into the United States
from other countries. That job could get a lot harder if we have to start
tracking prescription drugs, too.

Bills before Congress would end a longstanding ban on the import of
prescription medicines not previously cleared by the Food and Drug
Administration. The proposals were floated to curb rising drug prices, but the
potential drawbacks are daunting.

Americans have access to safe and effective prescription drugs due in large
measure to the strict safeguards the FDA has established to approve new
treatments and monitor the manufacturing and distribution of existing
medicines. Meanwhile, patients in many other countries are exposed to
substandard medicines produced and sold with less-rigorous oversight by the
local government. Those conditions have spawned an already massive — and
still growing — market for counterfeit drugs all over the world.
Those dangerous knockoffs are starting to infiltrate the U.S. market. The FDA
website lists a number of counterfeit drugs seized in the United States that
were sold as popular biopharmaceutical products. These imitations include
fake Botox, fake Cialis and a number of fake cancer drugs that either lacked
the active ingredients required to be effective or had different compounds
Counterfeit drugs are often sold by unlicensed suppliers who are not
authorized to sell or distribute prescription drugs in the United States. The
FDA has long warned that these products are unsafe and should not be used
because the agency cannot confirm that the makers and distributors of these
drugs adhered to U.S. standards when they manufactured or distributed

Other countries have been inundated with these fake drugs for years. For
example, the World Health Organization estimates as many as 20 percent of
the drugs sold in India are counterfeit. The WHO started warning doctors and
other health care professionals years ago about the dangers of these
counterfeit drugs, and the organization issues frequent reports to spotlight
massive seizures of fake pills and other medicines that were intended for sale
to patients all over the world.

“Health experts believe such operations have only scratched the surface of a
flourishing industry in counterfeit medicines that poses a growing threat to
public health around the world,” the WHO declared in an official bulletin
back in 2009. In 2014, Interpol warned, “Pharmaceutical crime poses a grave
danger to public health.”

Organized-crime syndicates have established sophisticated networks to
produce and sell these counterfeit drugs in other countries. They have already
started working through doctors and medical clinics in the United States, but
U.S. import restrictions are a big reason the FDA, U.S. Customs and Border
Protection and the Drug Enforcement Agency have been able to contain the

The bills before Congress would remove many of the license and oversight
requirements on the drugs imported into the United States by lifting those
barriers, inviting an influx of bogus pharmaceutical products from the same
crime rings that are selling these drugs in other countries around the world
that would love better access to the U.S. market.
Law enforcement would inevitably be tasked with policing the problem, at a
time when most prosecutors and law enforcement officials have their hands
full with the growing opioid crisis. One of the biggest killers is fentanyl, a
potent, synthetic opioid pain medication that is being laced into counterfeit

Just last year, the DEA issued a report sounding alarm bells about these
synthetic opioids. There were more than 700 deaths attributed to fentanyl
between late 2013 and 2014, and the numbers are climbing rapidly. The DEA
report lists a number of specific cases involving counterfeit opioids, including
the seizure last year of 500 pills in Lorain County, Ohio, that included a
synthetic “that caused at least 17 overdoses and several deaths.”

Opening the door to increased prescription drug importation will just make it
easier for smugglers to ship this dangerous opioid into the United States. For
years, we have asked police officers and prosecutors to do more with less.
There are few signs that austerity will end. Changing laws to encourage
importation of drugs would only add to that burden.

Thurbert Baker is a former attorney general of Georgia. Bill McCollum is a
former attorney general of Florida. They wrote this for

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