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Thursday, August 19, 2004

Bitter pills...

The U.S. Food and Drug Administration would have us believe that the seizure of pharmaceutical drugs being shipped to the Minnesota Senior Federation is a matter of protecting the American public:
A Toronto pharmacy began sending out new shipments this week to replace prescription drugs seized by U.S. Customs officials in Miami.

CanadaRx, based in Toronto, shipped the drugs valued at $250,000 US about two weeks ago. The drugs seized July 27 came from England, Germany, Switzerland, France, New Zealand and Australia, as well as Canada, and were shipped from Freeport, the Bahamas, in an attempt by CanadaRx to duck Canadian laws prohibiting a pharmacy from importing drugs, then selling them abroad, the Star Tribune reported.

The U.S. Food and Drug Administration, called in after the U.S. Customs Service seized the drugs, said its investigation is continuing, but it has decided there is no ground for prosecution.

"We want to know a little more about these drugs, where they're coming from," said William Hubbard, FDA associate commissioner for policy. "We're very concerned about the potential for harm from mislabelled or counterfeit drugs."
Yes, the FDA works very hard at protecting the American public, according to John M. Taylor (III), the FDA's Associate Commissioner for Regulatory Affairs (in testimony before a U.S. congressional committee):
At FDA, our statutory responsibility is to assure the American public that the drug supply is safe, secure, and reliable. For more than 60 years, the Federal Food, Drug, and Cosmetic (FD&C) Act has ensured that Americans can be confident that, when they use an FDA-approved drug, the medicine will be safe and effective and will work as intended in treating their illness and preventing complications. In carrying out this responsibility, FDA also works to do all we can under the law to make medicines accessible and help doctors and patients to use them as effectively as possible, through such steps as expanding access to generic medicines, reducing the time and cost of showing that new medicines are safe and effective, and providing up-to-date information for health professionals and patients to obtain the benefits and avoid the risks associated with powerful medicines. That is the primary mission of the thousands of dedicated staff, including leading health care experts, doctors, economists and scientists who work tirelessly at FDA in public service for the American people . FDA remains strongly concerned about unapproved, imported pharmaceuticals whose safety and effectiveness cannot be assured because they are outside the legal structure and regulatory resources provided by Congress.
The implication being made in all this is that any prescription drug that is not made in the USofA (or, more importantly, sold in the USofA with FDA approval) is de facto unsafe. More from Mr. Taylor's congessional testimony:
Unfortunately, the drug supply is under unprecedented attack from a variety of increasingly sophisticated threats. This is evident in the recent significant increase in efforts to introduce counterfeit drugs into the U.S. market. FDA has seen its number of counterfeit drug investigations increase four-fold since the late 1990s. Although counterfeiting was once a rare event, we are increasingly seeing large supplies of counterfeit versions of finished drugs being manufactured and distributed by well-funded and elaborately organized networks. At the same time, inadequately regulated foreign Internet sites have also become portals for unsafe and illegal drugs.
And who is posing the biggest threat? Mr. Taylor speaks again:
A second series of import blitz exams, conducted in November 2003, also revealed potentially dangerous, illegally imported drug shipments. Of the 3,375 products examined, 2,256 or 69 percent were violative. FDA found recalled drugs, drugs requiring special storage conditions and controlled substances. These blitz exams were performed at the Buffalo, Dallas, Chicago and Seattle international mail facilities and, for the first time, the private courier hubs at Memphis and Cincinnati. Canadian parcels appeared most frequently (80 percent of the mail parcels), while 16 percent were from Mexico, and the remaining 4 percent came from Japan, the Netherlands, Taiwan, Thailand and the United Kingdom.
I think it's less about safety than it is about protecting the U.S. pharmaceutical industry's profits. And I think there may be just a little bit of complicity between the pharmaceutical industy and the FDA (but only a little....really).

Here's why I think so:

I found this item in the British journal Medical News Today:
If you think all drugs from Canada are cheaper than U.S. drugs, think again. In the United States, generic drugs--roughly half of all prescriptions--are often cheaper than both Canadian brand-name drugs and Canadian generic drugs, according to a study by the Food and Drug Administration.


The FDA study compared the average price of the generic and brand-name versions of seven drugs sold in the United States and Canada by calculating the price per milligram of active ingredients in U.S. dollars. Prices in Canada were converted to prices in U.S. dollars using a 2002 exchange rate. The prices were the costs to retailers, and should predict retail prices to the extent that retail markups are the same in both countries. Pricing information was collected by the pharmaceutical market research company IMS Health of Plymouth Meeting, Pa.
Leaving aside the question of why the FDA is relying on data provided by a pharmaceutical market research company (one might think that the FDA should be using its own investigators, but Mr. Taylor's testimony before the congressional committee implies that the "threats" to US citizens have overtaxed the FDAs resources and the FDA needs more personnel...and funding...but I digress) we would have the appearance of an "official medical stamp of approval" on an FDA study here, wouldn't we? As it turns out, the MNT article is in fact a verbatim reprint of an item which appeared in the July-August 2004 issue of FDA Consumer magazine, although you can't readily tell this from the "attribution" that's buried at the bottom of the MNT article. As for MNT itself? Well, there's precious little info about who actually owns and publishes MNT, but a little pink box at the right of the page tells us that MNT comes to us courtesy of an "educational grant" by AstraZenaca International (and just guess what they make...).

Lest you think that this is mere paranoia on my part, I spent five years reading clinical trial reports and dealing with representatives of several pharmaceutical companies on various AIDS-related issues. I've seen first-hand, admittedly at a lower level, how the game is played. Paranoid about the pharmaceutical industry? No, but I'm very, very wary of it. Onwards...

So if (according to the FDA, at least) cost really isn't the issue here: Why are so many U.S. states and cities looking to buy prescription drugs from Canada?.

A July 23 item in Senior Journal might give us an indication:
The high cost of drugs in America has been causing many to look to Canada for drugs, where they are often 50 percent less than in the U.S. On Wednesday, Boston became the largest U.S. city to offer prescription drugs from Canada, which the city says will save about $1 million in its first year, according to a story by the Boston Globe.
As part of this item Senior Journal also reprints the FDA Consumer magazine article previously referred to (correctly and obviously attributed)...but check out the ad bar to the right of the article.

Although New York is not (so far as I'm aware) seeking to buy drugs from Canada, it may well have good reason to consider it:
The city has sued 44 drug companies for allegedly fraudulent conduct resulting in mililons of dollars in overcharges to its Medicaid budget.

The list of defendants reads like a Who’s Who in pharmaceuticals, and includes companies such as Aventis, Bayer, Eli Lilly. The suit follows similar complaints filed against Purdue and GlaxoSmithKline.

The complaint alleges that the companies inflated wholesale prices, which are used to calculate Medicaid reimbursements for prescription drugs, and reported false pricing information in an effort to underpay Medicaid rebates. Federal criminal and civil actions related to the charges have been taken against some of the defendants named by the city.
[LINK] (item is quoted completely as the link is a bit flakey for access)
Wisconsin, Minnesota, Nevada, and Vermont (among others) are all looking to Canada for cheaper drug pricing. Illinois is the latest state to look our way:
(Illinois Governor) Blagojevich -- appearing with Rep. Rahm Emanuel (D-Ill.), a champion of drug importation -- brimmed with optimism during an afternoon news conference as he touted savings of 25 to 50 percent if consumers take advantage of the program to contact 35 pharmacies and drug wholesalers in Canada, Ireland and the United Kingdom approved by state health inspectors.

They said the program is especially needed by the estimated 23 percent of the state, including 500,000 seniors, who lack prescription drug coverage.

"We've turned our senior citizens into coyotes," Emanuel said. "They're running over to Canada to get drugs."
[LINK] (note the price table accompanying the article)
Whether you wish to believe the safety argument or the cost argument, this is what the U.S. is going through right now. Do we need to see the same arguments played out here in Canada?

With our own politicians making noises about mucking about with Pharmacare, and frequently citing the increasing cost of drugs (a large part of which can be laid at the feet of Brian Mulroney), I'm afraid we may not have much choice...

And that thought, as I contemplate the $2312.40/month cost of my (non-generic) AIDS medications (excluding dispensing fees, if any), has me reaching for the bottle of Ibuprofen...

(2am Update Note: The original link to the article in the National Post started yielding a "story not found" page, so I've posted the Yahoo! News link. If that link fails to work, I've got a copy of the complete text on file - EG)