It would be easy enough to let Senator David Vitter (R, LA) et al. claim victory and go home claiming that we have dodged a public health bullet.

But it would be wrong.

Codifying the “personal exemption rule” comes with a container-full of unintended consequences.

It’s important to get one thing out of the way right away. If you walk into a pharmacy in Windsor, Ontario and have your prescription filled by a real pharmacist — the drugs you receive will be both safe and effective. That being said, there are problems.

A Canadian pharmacy cannot fill a prescription written by an American physician unless it is co-signed by a Canadian doctor. Senator Vitter may see this as an added safe-guard — but he would be mistaken.

Most Canadian provinces (including Ontario and Quebec where most of the cross-border drug trafficking takes place) have a provision called the “Touch Law.” An American prescription cannot be co-signed by a Canadian doctor unless that doctor actually examines (“touches”) the patient. But this rarely happens. Most Canadian pharmacies situated near the American border employ physicians who do nothing more than blithely sign their names without even bothering to see what the prescriptions are for or who they are for.

Bad medicine? You bet — and ripe for abuse. Consider this — last year a doctor in Toronto was indicted for co-signing 24,212 prescriptions for American patients he had never seen — at $10 a pop.

Nice work if you can get it.

Mr. Vitter’s amendment, already passed by both House and Senate, would let Americans carry up to a 90-day supply of medication back to the U.S. from Canada without being stopped by Customs agents — codifying this YOYO (“You’re On Your Own”) policy.

So what’s the problem? It very clearly does not allow importation via the Internet or even tacitly approve any of the failed bone-headed schemes introduced by the likes of Pandering Tim Pawlenty or Wrong-Way Rod Blagojevich.

In fact, the truth of the matter is that the 90-day supply “personal exemption” has been the de facto rule since, well, forever.

So why worry about it? Why not just let Senator Vitter get away with what is really nothing more than a Big Shill? Two reasons.

First — it’s already a proven fact that terrorists are playing in this game and this legislation shines a bright light on how they can further exploit a weakened chain of pharmaceutical custody and, second, it sends the dangerous message that full-blown global importation is okay — and the next logical step.

And that you can take that directly from the horse’s mouth.

According to Senator Vitter, this agreement “proves that we have significant majorities in favor of reimporting.” And, “This really breaks the dam, and it shows that it’s only a matter of time before we pass a full-blown reimportation bill.”

All this at the same time the European Union is moving in the opposite direction, trying to design ways to limit cross-border pharmaceutical shipments because of increased safety concerns and a growing problem of counterfeiting.

Senator Vitter’s amendment is more than just a Big Shill; it’s a dangerous and slippery slope.

The IOM report on drug safety is a pompous and inaccurate reshash developed by people who know nothing about drug development and it shows….It ignores the past 4 years of science and the efforts to integrate it and the panel was stacked with managed care and anti-industry types who believe that one size fits all drugs are all that people need and that companies are capable of producing… Ultimately, it is the report that is the real danger to the public health.

To suggest, as the report does, that when a drug is at the FDA, it’s safety profile is uncertain, is to suggest that it can ever be certain or that by piling on mountains of data post market you can ferret out rare safety events or that even if you can you can thereafter determine which people should get the drugs relative to benefits based on the data. The report and the committeee never provide examples of “how-to”. Rather, it is a knee-jerk reaction to headlines that themselves are based on fear, not science. The identification of ALLHAT as an example is the sort of throwaway and play to the crowd comment that has nothing to do with drug safety evaluation in the first place and secondly reflects a bias towards the findings of ALLHAT which themselves are subject to considerable controversy. What’s more the recommendation that Congress require such large science projects as the model for Phase 4 studies is ominous and troubling. And it contradicts the reports own findings that Bayesian type analysis and observation studies can be used with more sophisticated databases. But then again, the IOM report is more interested in sticking it to drug companies than in getting them to share data and develop measures to make drug safety a continuous part of the drug evaluation and development process.

Restrictions on access to medicines the committee recommends would make getting new drugs onerous and place new burdens on doctors and patients alike. Banning any member with any financial invovlement with companies solves the saftey problem exactly how? And, PS, it drives away the best talent.

The GOP in the House and Senate will bar Customs agents from inspecting packages of prescription drugs purchased in Canada and brought back into the United States. Can you say “drug runner?” Just how will Customs agents be able to stop the flow of fake drugs or narcotics into the US now that our Congress has given criminals a free trade zone for their trafficking operations? We are building a fence down south and opening a hole up north…it makes no sense at all.

Drug imports from Canada set to be eased
By LARA JAKES JORDAN, Associated Press Writer 5 minutes ago
House Republicans tentatively agreed Thursday to prohibit Customs agents from seizing prescription drugs that Americans buy in Canada and bring back into the United States.

The deal would let Americans carry up to a 90-day supply of medication back to the U.S. from Canada without being stopped by Customs agents, House and Senate Republicans said. But it would not let Americans purchase cheaper prescriptions over the Internet or by mail-order, officials said.

“This really breaks the dam, and it shows that it’s only a matter of time before we pass a full-blown reimportation bill,” said Sen. David Vitter, R-La., who led the fight in the Senate to prohibit the Homeland Security Department from seizing prescription drugs being carried over the border. U.S. Customs and Border Protection is an arm of the Homeland Security Department.

Vitter acknowledged that sales of drugs though mail order or through the Internet is significant. But, he added, “I think support for that is going to continue, and going to continue to grow, no matter what this bill says or doesn’t say.”

Both Presidents Bush and Clinton have rejected repeated congressional efforts to lift the ban on prescription imports. Medications are generally cheaper in Canada because of government price controls.

While importing drugs into the United States is illegal, the Food and Drug Administration generally has not stopped small amounts of medicine purchased for personal use. But Customs officials began intercepting imported controlled substances two years ago and prescription drugs since last November. Since then, Customs and Border Protection agents have seized more than 34,000 packages of drugs coming into the country.

The pre-election controversy over the new rule threatened to split House GOP leadership who oppose lifting the import ban and rank-and-file Republican lawmakers who want to help elderly voters buy cheaper drugs.

However, many Customs agents already allow prescription drugs into the U.S. from Canada because they don’t rigorously search people and cars for them.

Democrats who pushed for broader access to imported drugs accused Republicans of trying to “blow smoke to the voters about cheaper prescription prices when it really doesn’t do much of anything,” said Dan McLaughlin, spokesman for Sen. Bill Nelson (news, bio, voting record), D-Fla. Earlier this year, Nelson sponsored legislation to prevent Customs agents from seizing mailed medication after he began getting complaints from seniors in his state.

“I think you could call this agreement in the House a very small advance and certainly we’ll take it, but it’s no place that we can stop and certainly isn’t enough to be satisfied with,” McLaughlin said. “It really doesn’t help very many people.”

Opponents said importing drugs that do not have FDA approval could be unsafe for consumers. The FDA says it cannot guarantee the safety of imported drugs.

Representatives for the pharmaceutical industry said Canadian Internet pharmacies, for example, have been known to sell fake and potentially unsafe medicines to unknowing American consumers through other countries.

“Americans should look at much safer alternatives that already exist and are proving to be incredibly effective here at home,” said Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, or PhRMA.

According to the Congressional Budget Office, brand-name drugs cost, on average, 35 to 55 percent less in other industrialized nations than they do in the United States. Supporters of importing drugs contend that the U.S. is subsidizing the cost of medicine for the rest of the world.

The prescription drug policy shift would be included in a $33.7 billion bill to fund the Homeland Security Department next year. Lawmakers who control the department’s spending levels will meet Monday to debate other last-minute changes to the legislation, which has also been stymied by proposals to give Homeland Security regulatory oversight of security measures at chemical plants.

Lawmakers were negotiating whether to let the department require some high-risk chemical facilities to use nontoxic materials that would be more expensive but safer to the public if there is a release. The chemical industry strongly opposes such a requirement, and environmentalists have been pushing for it just as vociferously.

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JAMA just released a study ahead of print publication on COX-2 drugs entitled Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials. It is accompanied by an editorial from David Graham who cheerfully reminds us that the FDA is there to protect the public not corporate profits….

By now everyone knows the risks associated with taking COX-2 drugs. There is a whole cottage industry of so-called researchers who do nothing but recycle and reprocess earlier studies - good, bad and indifferent — on COX-2s designed to show how likely they are (take your pick, hazard ratio, risk ratio…can anyone tell the damn difference in the media) to have heart problems. And the studies keep on coming despite the mounting evidence that risk is associated with age, illness and genetic variations that metabolize drugs. But you don’t know any of this because the good folks at JAMA are not in the business of publishing such studies. Don’t generate enough media attention which in turn drives demands for reprints which are the bread and butter of JAMA’s business. And JAMA has to compete with NEJM for headlines so they are inclined to run with studies that can show quickly and with data easy to distill into a press release how dangerous drugs are or how dangerous drug advertising is. To call THAT hypocritical is too mild a term since both publications depend on drug ads and reprints for their survival.

In any event, when JAMA weighed with yet another warning about COX-2 drugs I was curious to know if it had published any findings about the products benefits or its risks relative to others NSAIDS or research that sought to put the risks and benefits in perspective.

JAMA published one of the original studies raising red flags about the increase in cardiovasular events back 2001. But since then, it has failed to shed little light on the relative risks and benefits of COX-2s or how they might fit into the pantheon of products.

For example recently

Another meta-analysis showed that high doses of two of the NSAIDs studied, diclofenac and ibuprofen, were associated with a similar increase in the risk of vascular events to COX 2 inhibitors, although the risks of high doses of another NSAID, naproxen, were smaller.

A recent study found that NSAID-associated GI complications and death have been decreasing since 1992, which we believe can be attributed to several factors: use of lower-dose NSAIDs; decreasing prevalence of H. pylori; increasing use of proton-pump inhibitors; and the introduction of NSAIDs with greater GI safety, such as coxibs

Harris and colleagues studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.
studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.

They compared the results with those from a control group of 649 cancer-free women matched for age, race and county of residence.

They discovered that women who used NSAIDs on a regular basis had less breast cancer. Specifically, they found that those who used celecoxib or rofecoxib for at least two years appeared to benefit the most, experiencing a 71 percent reduction in risk of breast cancer. Ibuprofen use over the same period was associated with a 64 percent reduction, while regular aspirin offered a 51 percent reduction in risk of the disease.

On the other hand, acetaminophen, which has a negligible effect upon COX-2 activity, and low-dose aspirin provided no significant change in the risk of breast cancer.

This case control study supports clinical trials which have found that COX-2 drugs work against estrogen receptors.

I could go on, but you get the drift: By now we all know that coxibs have some elevated risk for heart problems for some small percentage of people and while we have an idea who they still often got the drug and in any event their risk for heart problems with other pain killers might be higher or lower. You would think that as one of the flagship medical journals JAMA could take a more responsible position on the risks and benefits of medicines. But in an age where David Graham is a media star and hype sells reprints, that is asking way too much.

Ireland: Medicines Board Halts Web Sales of Prescription Drugs

The Irish Examiner reported that the Irish Medicines Board (IMB) has closed down 4 overseas websites for illegally selling medicines to people in Ireland. According to the article, an investigation found that rogue websites are selling medicines like Viagra, antidepresants and valium to consumers without asking questions about the purchasers, who would be required to provide a prescription. The article included a statement by the IMB on its decision: “We co-operate with the authorities throughout Europe to combat the illegal supply of medicinal products and this strategy has been effective in closing down illegal websites in the past.”

(And, no, the Irish Minister of Health is not Donough Shillelah.)