In this TownHall.com column, Dr. Donald R. May explains more about the pitfalls of prescription drug importation from Canada.
I've been posting this week about how U.S. importation of drugs from Canada can be unsafe for Americans. Dr. May explains how U.S. importation of drugs from Canada can harm, possibly even kill, some Canadians.
Michelle Malkin has responded to my post disagreeing with her December 8 assessment of the drug reimportation safety issue, asking: "The problem of counterfeit drugs surely is worse in Third World countries than in the U.S., but is there any evidence that it is worse in Canada? In other words, is there any reason to believe that a bottle of Lipitor sitting on the shelf of a Canadian Wal-Mart is more likely to be counterfeit than a bottle of Lipitor sitting on the shelf of an American Wal-Mart?"
First, it should be acknowledged that an individual American can buy a prescription drug from a Canadian pharmacy with reasonable assurance of quality. Canada, the U.S., Europe and Japan all have enforced (not perfect, but enforced) drug safety standards in place.
However, the safety of an individual prescription purchased in Canada by an individual American is not the actual issue involved in the drug reimportation policy debate. If Sarah Smith has a prescription for Lipitor and wants to buy it from Canada, she already can. Current U.S. law permits individual Americans to purchase up to a 90-day supply of drugs for personal use from Canadian drugstores.
The policy battle over drug reimportation actually is about legalizing large scale drug importation from Canada and other nations (the drug reimportation bill approved by the U.S. House last year would have allowed importation from 26 nations).
Safety is very much a concern. Here's why:
Under current procedures, the FDA and drug manufacturers guard against the sale of counterfeit, diluted and/or expired drugs by 1) having safety standards for drug manufacturing plants that sell product in the U.S. (even if the plants are located abroad); 2) inspecting those plants, even if located abroad; 3) maintaining a "chain of custody" so that criminals do not have access to the product as it travels from the manufacturing plant to the consumer.
A typical drug sold in the U.S. follows thus follows this chain of custody: manufacturing plant - U.S. drug wholesaler - U.S. drug retailer - consumer.
When the FDA is able to monitor the first three steps, it can make reasonable assurances that the drug is what the consumer expects to buy. If the drug first goes to another nation, however, the chain of custody is broken and an invitation to (very lucrative) criminal mischief is issued.
At this point it might be assumed that I am about to insult the efficiency of Canadian law enforcement and regulatory agencies, but I'm not.
An American consumer would be mistaken to assume Americans can rely on Canadian authorities to monitor the progress of prescription drugs through the Canadian supply chain, not because Canadians don't know how to regulate, but because Canada has already warned the United States that it has no intention of providing expensive drug safety monitoring services for large-scale drug reimportation sales into the United States.
In other words, Canada won't even be trying to stop Canadian-based counterfeiters from selling what appear to be perfectly safe drugs to U.S. retailers.
Given this, how can the FDA possibly be reasonably sure that our drug supply would be safe if we were to permit large-scale reimportation from Canada?
It couldn't be, of course. And if the FDA can't, how could a consumer possibly do so?
Now some might point out that counterfeiting has not been a huge problem in Canada in the past, which is true, although counterfeiting appears to be on the increase. But that's the past. What of the future, in which (if drug reimportation is permitted) the huge American market sits exposed to criminals who inject themselves into the supply chain?
Ed Haislmaier has reminded me that there were many who opposed huge cigarette tax increases who claimed that such increases would dramatically expand the counterfeit cigarette market. Those who issued this warning were ridiculed, but they turned out to be right.
The safety issue, of course, is just part of the overall debate on drug reimportation, which is also very much a debate about economics and foreign policy as well. (For those wanting more, I recommend this efficient overview of the anti-reimportation point of view by Nina Owcharenko of The Heritage Foundation.)
The debate last year leading to a vote in the U.S. House of Representatives was one of the most acrimonious internecine D.C. policy debates among conservatives/free-marketeers I recall in recent years (this press release we issued last year gives a bit of a hint about the heated atmosphere of the debate, though it got a lot more nasty than the press release reveals). I appreciate the fact that Michelle Malkin, unlike several GOP Congressmen, is able to talk rationally about drug reimportation without resorting to unsupportable accusations about reimportation's opponents. Too much of the debate last year was characterized by name-calling, though none of it should have been.
I hate to do it (especially as just last month, I publicly invited Michelle and her family to move from her blue county to our red county next door), but I have to quibble with Michelle Malkin's December 8 post on drug reimportation and what Michelle calls "FDA double standards."
Michelle says, in part: "...If I understand the FDA's argument correctly: it's safe for the federal government to buy 4 million doses of a German-made flu vaccine that hasn't been approved by the FDA, but if a consumer wants to buy a U.S.-manufactured FDA-approved drug from a Wal-Mart in Canada, that's unsafe."
There is more to it than that. The FDA is charged with assuring safety in more than one way.
First, there is the issue of the drug itself being approved as "safe" (a relative term in the pharmaceutical business) when properly manufactured and stored and when dosed correctly to an appropriate patient.
Second, there is the issue of whether the vial or the capsule the consumer is purchasing actually contains what the consumer and his doctor thinks it does.
As Ed Haislmaier wrote in a paper for The National Center last year, counterfeit drugs are a problem:
...three California men pleaded guilty to charges of selling and wholesale distribution of fake Procrit, an anti-anemia drug. The perpetrators of the fraud were passing off vials that "contained only bacteria-tainted water" to unsuspecting pharmacists and patients.Michelle links to a thoughtful piece on reimportation by the Cato Institute's Ed Crane and Roger Pilon. In it, Crane and Pilon argue that legalizing drug reimportation may be the most effective way to stop our "allies" from freeloading on American drug consumers and taxpayers (presently, Americans subsidize the drug purchases of haughty Europeans -- which is an irony we might pause to consider the next time we give Jacques Chirac a richly-deserved headache). Crane and Pilon make a strong case, but they address the economic equation, not the safety concerns.
Other recent cases involved criminals selling fake versions of Lipitor (a cholesterol lowering drug) and Serostim (a growth hormone often used to treat AIDS wasting); passing off sterile water as Neupogen (a drug used to treat cancer patients) and aspirin as Zyprexa (a drug for schizophrenia) and selling tampered vials of Epogen diluted to 1/20th strength (like Procrit, Epogen is used to stimulate red blood cell production in cancer and AIDS patients).
In the Epogen case, an FDA official noted that, unwittingly, "a major wholesale distributor was holding approximately 1,600 cartons of counterfeit product," while the Florida health inspector on the case reported "25,000 patients received a one-month supply of diluted drugs."
The problem is much worse overseas. Counterfeit drug sales are rampant in many Third World countries. Also, both at home and abroad, organized crime is getting into the act. It has discovered that the profits from faking legal drugs are as big as those from selling illegal drugs, while detection by the authorities is less likely and the penalties, if caught, are much lighter. In any country, conviction for selling fake pharmaceuticals will get you a fine and maybe some jail time, while in some countries trafficking in heroin carries the death penalty.
The FDA argues that it just can't guarantee the content and purity of drugs American consumers purchase if those drugs have been in the foreign retail market.
Some may argue for caveat emptor, or simply believe that safety can be assured even if drugs have been at a Canadian -- or Ugandan -- mini-mart before arrival at the U.S. pharmacy. (Remember, you're not just buying drugs from the country you imported them from, but from every country that country has ever imported from.) The caveat emptor position has its adherents, but they definitely don't include the FDA.
The FDA's flu vaccine purchase, in fact, says nothing at all about the safety of drug reimportation. A situation of secure importation of a vaccine from GlaxoSmithKline is a very different scenario than a case of insecure reimportation of a drug that has been on a foreign drugstore shelf, or, perhaps, was created in someone's basement.
Bronson Yake has gifted the blogosphere with a new word, as in "On blause, be back after finals."
Seems a fast and easy way to tell readers you haven't given up on your blog -- you just have to take a break.
Addendum: Jeff at Shape of Days has a quibble. Not me. I have a liking for newly-coined words. I even like the word "blog."
Captain Ed has a good line in an essay about continuing support abroad for U.N. Secretary General Kofi Annan:
Well, now there's a shock: the majority of the world's kleptocracies support the man who presided over the largest swindle in world history.Cynical, but realistic.
It is time to leave the U.N.
Cato Institute President Ed Crane succinctly explains why Social Security must be modernized.
Buried within this essay is this critical core point: "The goal of Social Security reform should be to provide workers with the best possible retirement option, not simply to preserve the current system. If solvency were the only goal, that could be accomplished by raising taxes or cutting benefits, though this would be a bad deal for younger workers."
It goes on: "A successful Social Security reform will result in a solvent, sustainable system. It will improve Social Security's rate of return, provide better retirement benefits, and treat women, minorities, and low-income workers more fairly."
The more you read about Social Security private accounts, the angrier you will become... that America didn't do this years ago.
Unless you already are an expert on Social Security private retirement accounts, I suggest you read the whole thing.
Unless you are dying, this debate will affect your life.
Professor Bainbridge reports that Oliver Stone "plans to explore the possibility of an affair between former British Prime Minister Margaret Thatcher and President Ronald Reagan in his next movie."
The Professor has his own thoughts on this, to which I'll add this: Isn't it ironic that the supposedly P.C. Hollywood left can't imagine a female head of government (Thatcher) without picturing her in bed with somebody?
Zip it up, Oliver. Sometimes men and women get along above the neck.
On a lighter note, if Ronald Reagan and Margaret Thatcher had gotten together, can you imagine what their kids would have been like?
Fellow bloggers, please read this New York Times article about a lawsuit just filed by the Baltimore Sun. The lawsuit asserts that the Governor of Maryland does not have the legal right to decline interviews with several Sun reporters the governor believes are refusing to present facts objectively.
If the Baltimore Sun can convince a court that it has a "First Amendment right" to interview the governor of Maryland and his staff against their will, don't we bloggers have a "First Amendment right" to interview any government official we wish to? You bet we do.
If the Sun suit has merit.
Addendum: Jeff at The Shape of Days has posted some fun comments about this issue.
It is good news that President Bush has asked Defense Secretary Don Rumsfeld to stay.
If you listen quietly, however, you can almost hear the gnashing of teeth in certain quarters.
David Limbaugh has an excellent piece up about this. I agree wholeheartedly with most of it, save David's apparent view that Rumsfeld enjoyed a honeymoon with the press after he first took office. As I recall it, the honeymoon began only after 9/11, coinciding with the birth of "Rumstud," the septuagenarian sex symbol.
To check my memory, I did a quick lookup of articles in the mainstream press between 3/1/2001 and 9/10/01, using only the word "Rumsfeld" as a search term.
The result is not scientific, but I found scant evidence of a pre-9/11 honeymoon:
Rumsfeld: Older but Wiser? The infighter who tried to change the Pentagon has failed so far. Here's why (Time Magazine 8/27/01):
In seven months as Pentagon chief, Rumsfeld has managed to spook the military, alienate defense contractors, mobilize much of Capitol Hill against him -- and even make some in the White House question his toughness.Rumsfeld on High Wire of Defense Reform; Military Brass, Conservative Lawmakers Are Among Secretive Review's Unexpected Critics (Washington Post, May 20, 2001):
In his first four months at the Pentagon, Defense Secretary Donald H. Rumsfeld... [has] rallied an unlikely collection of critics, ranging from conservative members of Congress and his predecessor as defense secretary to some of the generals who work for him. In dozens of interviews, those people expressed deep concern that Rumsfeld has acted imperiously, kept some of the top brass in the dark and failed to maintain adequate communications with Capitol Hill.For Rumsfeld, Many Roadblocks; Miscues -- and Resistance -- Mean Defense Review May Produce Less Than Promised (Washington Post, 8/7/01):
'He's blown off the Hill, he's blown off the senior leaders in the military, and he's blown off the media,' said Thomas Donnelly, a defense expert at the conservative Project for the New American Century. 'Is there a single group he's reached out to?'
... Many of those interviewed said they are worried that the future of the [military] institution to which they have devoted their adult lives is being decided without them. One senior general unfavorably compared Rumsfeld's stewardship of the Pentagon with Colin L. Powell's performance as secretary of state. 'Mr. Powell is very inclusive, and Mr. Rumsfeld is the opposite,' said the general, who knows both men. "We've been kept out of the loop.'
Added another senior officer: 'The fact is, he is disenfranchising people.'
Some noted that the Bush administration came into office vowing to restore the military's trust in its civilian overseers. 'Everyone in the military voted for these guys, and now they feel like they aren't being trusted,' a Pentagon official said.
The Army, which has the reputation of being the most doggedly obedient of all the services, appears to be closest to going into opposition against the new regime. Army generals are especially alarmed...
If anything, Rumsfeld's relations with Capitol Hill have been even more tumultuous...
...six months into an administration that campaigned on a promise to rebuild the military, Rumsfeld's ambitious plans are under fire from all sides....Rumsfeld's Overhaul Struggle (Newsday 5/28/2001):
"There's a strong sense of alienation between the uniformed leadership and the civilians," said retired Marine Gen. Anthony C. Zinni, who supported Bush during the campaign.
Why someone as savvy as Rumsfeld is having such difficulty has become a major topic of conversation at the Pentagon and in national security circles...
'How bad is it? I think it is pretty bad,' said Larry Seaquist, who worked in the Cheney-era Pentagon. Seaquist said that senior career officials at the Pentagon, who had expected to work with professionals, 'now fear they're shackled to incompetence.'
...Others argue... the new administration picked the wrong people for the Pentagon. Some people criticize Rumsfeld personally, saying he was not heavily involved during the campaign in formulating the Bush defense policy he was later asked to carry out. Others point to Rumsfeld's failure to recruit Richard L. Armitage for the No. 2 job at the Defense Department...
Perhaps the most puzzling aspect of Rumsfeld's second tour at the Pentagon has been his sour relationship with Congress -- not just with the Democratic-controlled Senate but also with Republicans in both chambers..."
More and more, Rumsfeld appear[s] to be isolated, and [Sen. Carl Levin (D-MI)] has questioned whether he is in over his head. That image has blunted Rumsfeld's reputation as a decisive corporate executive with personal experience in Congress, the White House and as Pentagon chief during the Ford administration.Why the Hawks Are Carpet-Bombing Rumsfeld (Business Week 8-06-2001):
Levin, who is opposed to defense increases that will jeopardize social programs, seemed to take the wind from Rumsfeld's sails after the committee meeting last Thursday. 'I don't have a good grasp of where the secretary is headed," Levin said. "I don't think the secretary has a good grasp of where the secretary is headed.'
When George W. Bush unveiled his Administration team, three Washington veterans stood out as guaranteed superstars: Vice-President Dick Cheney, Secretary of State Colin L. Powell, and Defense Secretary Donald H. Rumsfeld. Six months in, two of the three have lived up to expectations. Then there's Rumsfeld.But inside a May 25, 2001 Washington Post story containing ample quotes from Rumsfeld's critics was this, three and a half months before 9/11:
To convey his view of the world, and especially of the necessity to change the military to meet the threats of the 21st century, Rumsfeld distributed to [Senators on the Armed Services Committee] a four-page handout. A major theme was the inevitability of strategic surprise -- the notion that threats will come from unexpected directions.Sounds like Rumsfeld hit the nail on the head with that one.
'History should compel planners to humbly acknowledge that 2015 will almost certainly be little like today and certainly notably different from what today's experts are confidently forecasting,' the document said. 'And recent events suggest that [the Department of Defense] at least give some thought to the flexibility of a capability-based strategy, as opposed to simply a threat-based strategy.'
That jargon-laden sentence basically means that the U.S. military needs to move away from a Cold War structure designed to counter one large, clear threat -- from the Soviet Union -- and to develop capabilities to respond to everything from ballistic missiles to terrorist attacks.
David Limbaugh says he admires Rumsfeld -- that it "takes mighty broad shoulders to agree to put up with what promises to be more abuse from these armchair quarterbacking naysayers. But Rumsfeld strikes me as a guy who doesn't require the slightest approval from these lightweight know-nothings whose seeming mission in life is to second guess and ridicule him." On these core points, I could not agree with David more.
Addendum: David Limbaugh has added a note to his post on the media honeymoon point. It appears he and I are now in complete agreement. (Thanks for the note, David.)
Captain Ed at Captain's Quarters explains why Senator Mark Dayton just might be one of the last people one would want to share a foxhole with.
"Paranoid and panicky," Says Captain Ed about Dayton in one of many jabs. "Just the kind of man you want tagging along with you in a tense neighborhood."
And they say ladies have claws? Ouch!
Still, have to admit, it is a fun read.
UPI has a wire story today by Peter Roff providing additional details on the Congressional access to tax returns story. An excerpt:
What actually happened, said one source with knowledge of the back story, is that the amendment was an effort to give appropriators and staff with oversight of the U.S. Internal Revenue Service the ability to make on-site visits to check out how the money they approve each year for the agency is being spent. The problem with making that kind of visit to an IRS facility is that one could potentially encounter one -- a few, dozens, stacks, truckloads -- of tax returns that, to understate things a bit, the federal government takes great pains to protect from public scrutiny and prying eyes.The provision, as has been well-reported, is being struck from the bill in any case. But one can't help but wish that some of the details in this story and the similar AP wire story running today -- which could have been ascertained by making a few phone calls -- had been learned before some politicians in both parties went before microphones and claimed that something far more sinister was afoot.
There are folks over at the House Ways and Means Committee, which has administrative oversight of the IRS as well as the U.S. tax system, who can go visit these sites because of an existing provision in U.S. law -- a provision that Appropriations Committee staff working with the IRS were trying to get for themselves. And that's where it all comes apart.
The committee staff, according to the source, left it to the IRS to draft the language and then inserted the amendment into the bill without too much consideration and without the knowledge of U.S. Rep. Ernest Istook, R-Okla., the chairman of the IRS-overseeing Appropriations Subcommittee on Treasury, Transportation and Independent Agencies.
What the bureaucrats who drafted the measure forgot to do was include language extending to the Appropriations Committee types the same kind of exceptionally tough privacy safeguards -- including rigid consequences like possible jail time for those who do not respect the privacy protections -- under which the Ways and Committee folks have to operate...
The AP, via the Guardian, has a story shedding light on why there was a provision in a recently-approved appropriations bill allowing additional Congressional access to IRS tax returns.
The entire matter, if this report is accurate, looks to be far more benign than one might have thought, given the hullabaloo surrounding it two weeks ago.
Business Week asks: Was meddling in Ukraine's election Putin's biggest blunder?
Is Russian President Vladimir V. Putin losing his touch? Once admired for his steely efficiency, Putin suddenly doesn't seem to be able to get anything right. He has managed to alienate Russian Big Business and many foreign investors by destroying oil company Yukos. September's terrorist attack on Beslan left him looking weak and ineffective and exposed the disorderly state of Russia's security forces. His bureaucratic reforms have led to administrative chaos, while cuts in the social benefit system have sparked Russia's biggest public protests in years. But when future historians come to write the history of Putin's presidency, they may well conclude that his biggest mistake was his disastrous policy in Ukraine, where he has just suffered a failure of epic proportions.Read it all here.
Putin clearly imagined he was promoting the obvious winner when he interfered so heavily in Ukraine's presidential election in favor of Viktor Yanukovych, the candidate backed by outgoing Ukrainian President Leonid Kuchma. Yet the millions of protestors on the streets of Kiev and other Ukrainian cities, and the collapse of the government's authority have made it impossible for the Nov. 21 election result -- which had Yanukovych winning by 49.46% to 46.61% -- to stand. If there is a fair reelection, the candidate demonized by Russia, pro-Western opposition leader Viktor Yushchenko, will almost certainly win, just as he would have won the Nov. 21 runoff but for massive ballot-stuffing, documented in detail by international observers. There's a risk that pro-Yanukovych regions in eastern Ukraine will refuse to accept Yushchenko as President, in which case Ukraine could split apart.
Either alternative will represent a massive blow to Putin... A divided Ukraine would lead to instability in a region where Russia has important economic interests -- 80% of the gas Russia exports to Europe goes through Ukraine -- and would be a permanent point of tension between Russia and the West. If the country remains united, as now seems likely, Putin's goal of linking Russia, Ukraine, and Belarus in a new economic union dominated by Russia looks like a pipe dream. A Yushchenko government is not likely to be great friends with Russia after Putin's blatant interference in the election. And if Kuchma and Yanukovych figure out a way to retain power, a deeply unpopular regime in Kiev would hardly be a stable partner for Russia...
Putin would have been wise to hedge his bets in Ukraine, not least because Yushchenko was always the favorite to win a fair election. Instead, the Russian President made the election in Ukraine a personal priority, pulling out all the stops to secure a Yanukovych victory. Russian advisers and election funds flooded Ukraine, Russian state TV, which is widely received in Ukraine, unleashed a wave of pro-Yanukovych propaganda, and Putin himself appeared on Ukrainian TV to endorse Yanukovych. All these efforts failed to win over proudly independent Ukrainian voters. "Russian political advisers and spin doctors simply don't understand the situation in Ukraine," says Kost Bondarenko, an independent political consultant in Kiev.
The irony is that Russia could quite easily have lived with a Yushchenko victory....
The damage to Russia's interests goes well beyond Ukraine. Putin's interference further alienates opinion in the West, which is increasingly inclined to see the Russian President as a throwback to an earlier, scarier era. Despite its present anti-Western rhetoric, Russia obviously can't afford a new Cold War. As the terrorist attack on Beslan in September showed, Russia's security is already in a perilous state, which is why Russia needs all the cooperation from the West it can get...
Michelle Malkin is asking her blog's readers to send a lump of coal to the mayor of Denver.
Issue at hand: A ban on the singing of Christmas carols.