Wednesday, August 02, 2006

Accountability: Imported vs. Domestic

A few days ago, I posted a PhRMA Intern! Adventure focused on drug importation from Canada. In that post I questioned the Terrorist Card Tactic employed by friends of the drug industry to scare the public (see "PhRMA Intern Tackles Terrorists!").

My friend Harry Sweeney posted this comment to that post:

Maybe it is time to seriously consider allowing the personal importation of drugs from Canada (or India, China, or wherever else they come from) . . . . with one caveat.

All elected officials who vote in favor of this high risk scheme, must submit their resignation in advance, to be triggered by the first confirmed poisoning of Americans by imported prescription drugs.

We can't preach drug safety out of one side of our mouths, and open importation out of the other, without the means to assure the safety of the imported drugs, which it appears is too costly, or politically unfeasible.

The political posturing by the Robin Hoods of Congress should be exposed for what it is: vote buying by demagoguery. Bringing the pharmaceutical industry down will not fix the healthcare financing problem that we have in the U.S.

The liberal democracies of Europe haven't been able to make it work without a two-tier system, and we (the American public) seem unable to reach a consensus on what constitutes "an equitable system" and one in which everyone is treated "equally."
Harry is never one to mince words! (See, for example, "Clash!"). I know he's being sarcastic, but while we're talking about accountability and risk, let's take it a step further.

There are three sources of risk from Rx drugs:

  1. Counterfeit or adulterated imported Rx drugs
  2. Counterfeit or adulterated domestic Rx drugs
  3. Side effects of legitimate Rx drugs
Most pharmaceutical executives would readily agree that every Rx drug on the market has some risk due to side effects -- even a risk of death (eg, Ketek; see "Celsius 3014: Ketek, Drug Safety, & Bioterrorism").

Using Harry's logic against allowing imports, we should demand that pharmaceutical company CEOs or the FDA commissioner (if there ever is one) "submit their resignation in advance," to be triggered by the first confirmed adverse event resulting in the death of an American by an FDA-approved prescription drug bought here in the good old USA.


Ketek, for example, is thought to have caused the deaths of several people (see "
FDA probing death linked to new antibiotic"). Of course, no one can prove that these deaths were caused by Ketek. This uncertainty is certainly played up by Sanofi-Aventis, the company that makes the drug. Merck uses the same defense in its Vioxx trials.

Similarly, as far as I know, there are no confirmed deaths associated with drugs imported from Canada.


I do believe that people who are responsible for protecting us from "bad" drugs -- imported or domestic -- should be held responsible. And those people work at the FDA. Unfortunately, as I noted before, the FDA is not equipped to handle homegrown adverse events let alone imported ones (see "
FDA Paralyzed: Who Will Protect Us?").

Harry claims the FDA does not have the money to assure the safety of imported drugs. This is the standard argument often used to defend the FDA. When a GAO report stated that the FDA "does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings," its critics also said it was an issue of money even though it isn't (see "
Spinning Bad News about FDA & Drug Safety").

BTW, the GAO was talking about the safety of domestic drugs, not imported drugs.


More likely than any terrorist adulterating imported drugs is adulteration occurring within makeshift laboratories run by profit-seeking counterfeiters. These people are much more likely sources of poisoned drugs. And many of them are right here in the US.


If foreign or domestic gangster Rx counterfeiters are sending money to terrorists, which is a claim made as part of the Terrorist Card Tactic, why aren't they shut down? The US government certainly has the authorization, means, and budget to do that. If it's not doing the job, who's accountable? The politicians that passed the Patriot Act? I don't think so.


According to a reader's review on Amazon of the book "Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America's Drug Supply" by Katherine Eban:

While the FDA and drug companies rail about the potential dangers of imported drugs, they ignore or downplay reports about adulterated, counterfeit drugs from within the U.S., and fight efforts to improve the reliability of the system. Meanwhile, law-enforcement efforts to correct the problem are frequently blocked by political intervention for donors, legal threats, a patch-work of varying State laws, fraudulent paperwork, regulators giving drug wholesaling licenses to known criminals, and inter-departmental squabbling over who's in charge or gets the credit.

Sources of problem drugs include theft from warehouses, trucks, and hospitals, diversion from lower-priced markets (eg. foreign sales), purchase from Medicaid recipients, relabeling vials containing weak doses with fraudulent labels claiming much stronger contents, and pills made from worthless ingredients.

The book also summarizes the serious impact in two instances of seriously ill patients receiving adulterated drugs.
Of course, it would not be politically correct for the industry to point out that the FDA has no clothes (only naive bystanders like me can do that). Blaming foreign terrorists, on the other, is politically correct these days.

More than that, playing the terrorist card is certainly a clearcut case of "vote buying by demagoguery" to use Harry's phrase. It clearly fits the definition of demagoguery: "a political strategy for obtaining and gaining political power by appealing to the popular prejudices, fears, and expectations of the public -- typically via impassioned rhetoric and propaganda, and often using nationalistic or populist themes."


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