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Monday, January 16, 2017

Cory Booker And That Big Pharma/Canadian Drug Issue

Cory Booker has been getting a lot of heat for being one of thirteen Democrats to vote against a budget amendment supporting the importation of prescription drugs from Canada. (Overall, 72 percent of Senate Democrats and 23 percent of Senate Republicans supported the amendment.) Since Bernie Sanders cosponsored the amendment, it carries an aura of progressive, anti-establishment virtue, despite the fact that it was also supported by Ted Cruz, Rand Paul and numerous other Republican Senators. It is just obvious to many people that the only possible explanation for Booker's 'nay' vote is that he is in Big Pharma's pocket. They say this for two reasons: first, because of the financial support he has received from the pharmaceutical industry (though it is only two percent of the total financial support he has received, and almost half of that two percent comes from individual supporters who live in his state and work in the pharmaceutical and health care industries); and second, because they don't see any truth in his own explanation, which is that we need to respect the role of the FDA in regulating our drugs.

You may believe that Cory Booker is corrupt because two percent of his financial support comes from people in the pharmaceutical industry. I think that's unfair, especially since many of his constituents work in that industry, but I'm not going to argue the point. Instead of defending the person, I'm going to defend Booker's argument and position.

The main line of attack against Booker's argument is this: What's wrong with Canada's drug regulations? Why can't we trust them? The presumption is that if there was some great danger associated with Canada's drug policies, we would know about it.

There are a number of curious assumptions lurking here. For one thing, since when do Americans get to assume they are so well-informed about what goes on in other countries?  How many of Booker's critics follow the Canadian press? Furthermore, does the American populace hold such a high opinion of Canada that they cannot entertain the possibility that it has drug issues which have failed to gain widespread attention? Would it be absurd to think that Canada might have an under-reported health crisis?

I spent only a few minutes with Google and found some important facts.

Eight years ago, Canada's Parliament failed to adopt an amendment to their thirty-year-old Food and Drugs Act, which is enforced by Health Canada. Among many other crucial measures, the amendment would have made it illegal to sell or import products that have knowingly been adulterated, or to sell counterfeit products. (As we will see, counterfeiting is one of the FDA's greatest concerns.)

Five year ago, Canada's Auditor General concluded that Health Canada "has not adequately fulfilled most . . . key responsibilities [involving timeliness, consistency, transparency, conflict of interest, and risk-based post-market activities] related to clinical trials, submission reviews, and post-market activities for pharmaceutical drugs."

Four years ago, there were reports of serious health concerns related to the lack of transparency in Health Canada's regulatory procedures. According to one of Canada's own specialists (quoted in the linked article), "“No one has any idea what’s happening behind the walls (at Health Canada), . . There are elements of the U.S. and European (drug regulatory) processes that are unclear but no one holds a candle to Health Canada when it comes to the lack of transparency and how byzantine the whole process is.”

Still think Americans should put their health in Canada's hands?

I've only just scratched the surface of relevant facts. Here are several more, based on a recent study of drug reimportation (the process of buying drugs from Canada which were originally exported to Canada):

  • "While international price comparisons of medications show the comparatively higher prices in US, economists argue that international comparisons must be viewed with skepticism" 
  • "Canadians oppose legalization of reimportation in the US as it could exacerbate the problem of medication shortage in Canada." 
  • "Many concerns restrict drug reimportation from being a legal practice in the US. These include safety, efficacy, and therapeutic equivalency of reimported drugs. While these drugs are manufactured in the US, the storage and packaging conditions in countries where drugs were exported cannot be monitored by the US Food and Drug Administration (FDA). In addition, inappropriate storage conditions while reimporting medications back to the US may degrade the quality of drugs." 
  • "The most important issue is distinguishing between drugs that are manufactured in the US from those which were manufactured elsewhere. Although technically ‘reimportation’ involves importing back drugs manufactured in the US, there are no means to check the originality of drugs. Similarly, it is difficult to determine whether the drugs purchased from other countries have the same dosage form, potency, and amount of active ingredient as the prescribed medication. The FDA contends that legalizing reimportation would increase the entry of counterfeit medications in the US drug supply chain." 
  • "The FDA and the Customs and Border Protection carried out a series of “blitz” examinations of 1982 drug packages mailed or shipped to individual recipients from abroad. Approximately 90% of these products were found to be unapproved and to present potentially severe health risks. The examined imports included drugs that had been withdrawn from the US market as unsafe; drugs with restricted distribution programs; drugs requiring initial screening and periodic monitoring of patients to ensure safe use; controlled substances such as codeine; animal drugs sold for human use; and drugs that might cause dangerous drug–drug interactions. . . . The majority of the drugs had unknown quality and originated from Third World countries." 
  • "In another case, FDA officials examined drugs ordered from a supposed Canadian pharmacy. These drugs, (including insulin) arrived in the regular mail and at room temperature (Insulin loses effectiveness at higher temperatures and is supposed to be shipped overnight to ensure it remains chilled)" 
  • "The World Health Organization anticipated that in 2000 about 8% of bulk drugs imported to the US were counterfeit, unapproved, or substandard." 
  • "The FDA claims that the number of counterfeit drugs investigated per year have increased to 20 since 2000 after averaging 5 per year in late 90s."
In short, Canada is already struggling to regulate and supply pharmaceuticals to Canadians. If the door were opened for legal importation from Canadian pharmacies, the demand would skyrocket. On the one hand, we don't know how expensive the drugs would actually be for Americans. On the other, Canada is not prepared to handle the task. Either an enormous investment would have to be made to ensure that all of the drugs were safe and effective, or Americans would be at a much greater risk of harm. The only conscionable option would be to put a greater investment in Canada's regulatory process. And who would pay for that? Canadian tax payers?

I am sure there are even more facets of this issue that I have not considered. However, what seems clear enough is that progressives have been extremely unfair in their out-of-hand dismissal of Cory Booker's argument and position, not to mention their attacks on his character. This is a complicated issue. Bernie Sanders may present it in simple terms, but we would be wise not to follow that lead.

Update: Here's a defense of Booker (and others) at PolitiFact. It highlights the selective reporting that has allowed so many on the Left to smear Democrats who have voted against Bernie Sanders.  It turns out that on the same day Booker and a dozen other Dems voted against that bill that Bernie cosponsored, they also voted in favor of a bill demanding cheaper pharmaceuticals. There's no basis for claiming that Booker is doing Big Pharma's bidding, or that he has been bought by any Big Money interests.