Latest Drugwonks' Blog

Owing to genuine concerns about pedigree and counterfeiting (courtesy of the FDA’s aggressive use of the Bully Pulpit), together with the successful rollout of the Part D drug benefit, the issue of foreign drug “re-importation” has lost much of its political allure and momentum. Most of the elected officials calling for the “legalization” of foreign drugs have since abandoned their incautious and dotty schemes. Aeternum vale!

But political bloviation abhors a vacuum. Taking the place of drugs are too expensive is the new clarion call of drugs are not safe. A sure-fire political winner. After all, who could be against “safety?” Safe = Good. Unsafe = Bad, right? Well, not exactly. As Dr. Mark Goldberger, director of FDA’s office of antimicrobial products commented, “It’s more complex than it seems at first glance.”

Safety has been hijacked. Safety is the new Re-Importation. But it’s the same old story.

And it sure plays in Peoria or, perhaps more appropriately, in Des Moines. Not surprisingly, the media loves it because; although the pressure point is different the “victim” (the patient) and “the villain” (the pharmaceutical industry) are the same. And, as everyone knows, it’s more than okay to kick the stuffing out of Big Pharma (or, if you prefer, “Big Pinata”). It’s a free hit. Sanctimonious quotes and macho strutting results in terrific headlines for the folks back home.

A little harmless politicking? Hardly. Just ask the people who no longer have access to the medicines they need (like Vioxx), or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result is a dearth of new medicines in the pipeline.

Is it safe? Ask the FDA. Is it politically safe? Ask a Senator. Is it remunerative? Ask an attorney.

What does “safe” mean, anyway? 100% safe? Certainly not. All drugs have risks as well as benefits. And more often than not the more serious the disease the more serious the risks associated with the treatment. Consider advanced non-small cell lung cancer. Then consider Iressa. Are such medicines risky? Indeed they are. Are the diseases they treat serious enough for patients to accept such risks? Decidedly. Consider Multiple Sclerosis. Then consider Tysabri.

But most importantly, consider the Precautionary Principle, the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines. Fatal like in death.

Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.

I should also add that the VA doesn’t pay pharmacy costs. And that’s anywhere between 20%-40% of the purchase price. One more time folks — a half truth is a whole lie.

Here’s an email I received from a producer at ABC about the Families USA “study.” The fact that it gets plastered and picked up as the default position that has to be defended against should tell you all you have to know about coverage bias…but read the entire email and get a load of the stacked questions I am supposed to answer. The full article about FUSA was attached to the email.

” Pasted below is Families USA News release on the cost of drugs under the Medicare prescription drug plan. World News Tonight Weekend is interested in a possible story looking at the issue of whether prescription are in fact now costing LESS for MORE seniors. Below are some questions. We will forward your responses to the ABC News correspondent and producer working on this story.

-What are your views on whether most seniors are or are not saving money on prescription drugs?If they are saving, could they be saving more? And if so, why not?

-Are prices of many of the most popular drugs going up? And if so, why?

-And what is the longterm impact on the plan of those rising prices?

-Are seniors who are saving on some drugs, just losing those savings to other now more expensive ones?

-And are the drug companies making even more money now because of this plan? “

Oy gevalt!

The battle continues apace. Please have a look at this new op-ed (penned by myself and Dr. Bob) that appears in today’s edition of The Washington Times.

And please pass it along.

Here’s the link:

http://www.washingtontimes.com/op-ed/20060621-085649-7788r.htm

I am being cautioned not to regard the two page summary upon which most of the news accounts of the Enzi-Kennedy bill are based as definitive or the final version. Indeed, the two page summary ignores the creation of an agency that would support the creation of tools that would accelerate drug development and promote targeted medicines. The agency would use public and private partnerships such as the Critical Path Institute to fufill the mission and objectives of the Critical Path initiative. This is an imaginative and thoughtful effort to modernize the FDA through scientific collaboration.

In context then, the onerous risk management proposals set forth in the two page summary seem to be totally inconsistent with the effort to improve drug safety post market by increasing the pre-marker ability of the FDA and companies to identify and select populations that would respond significantly to medicines and provide biomarker based screens to reduce the rare liver and heart problems associated with drugs.

Instead, the risk management program is mainly busy work and studies of the sort that will never identify rare events with the certainty hope for by proponents. In particular the risk management effort post market makes the nightmare Scott Gottlieb fears — of physicians too worry of prosecution or lawsuits or too busy to comply with yet another mound of risk management paperwork, tests, followups — controlling clinical decisionmaking of doctors. It is also an example of the agency — not the doctor or patient — deciding what is best for them.

How shameless can a politician be…Chuck Schumer attacking Merck for lowering it’s Zocor prices in response to impeding generic competition..Interestingly, when he introduced changes to the law promoting generic drugs he lauded his proposals as “all about promoting competition in the drug industry…” Except when it comes to creating competition for generic drug firms? Since when did they become a protected class and since when did protecting them become more important than consumers. Since about 15 percent of consumers stick with a generic after a switch, a Zocor price slash will save them money, Schumer rather than later.

June 20, 2006, 2:03PM
Senator Raps Drug Giant Over Zocor Price


By DEVLIN BARRETT Associated Press Writer
© 2006 The Associated Press

WASHINGTON â A New York senator accused the drug giant Merck & Co. on Tuesday of conspiring to undercut a cheaper generic alternative to its cholesterol-lowering drug Zocor just days before it becomes available to patients.

Sen. Charles Schumer, a Democrat, charged that Merck is quietly collaborating with health insurance companies to create lower copays for customers buying Zocor than for those buying the generic equivalent.

Zocor generated $4.4 billion in sales last year, and generic alternatives will be available for the first time on Friday. A company executive scoffed at Schumer’s allegations.

“It appears that Senator Schumer is criticizing us because he says that our prices are too low. That’s a new one,” said Ian Spatz, Merck’s vice president for public policy.

“The truth is that we support generic competition and the generic competition for Zocor is good for patients. It’s good for people who have to pay for medicine, which include health plans. We’re going to continue to price it competitively,” he said.

Both Peter and I were concerned about Gardiner Harris’ article in the NYT which depicted the Enzi-Kennedy FDA bill as a throwback to go slow paper gathering approaches to drug safety without regard to 21st century science orproposals to accelerate a response to the more expensive and prevalent ‘side effects’ of having a disease like Alzheimer’s without effective treatments.

As the Yiddish proverb goes: “A half truth is a whole lie.” The bill does encourage risk management activities and trial disclosures. But Senator Enzi and Kennedy have spent a whole lot of time on Critical Path issues and discussing the science behind it, how to fund it, etc. There is a considerable amount of attention and language devoted to accelerating drug development and using biomarkers and other methods to encourage targeted — and safer — medicines.

Why did Gardiner leave this out? Were his sources selective or was he?

One possible clue: Here’s a guy who has a problem differentiating between suicide and suicidal ideation, ignoring research that demonstrates that suicide has gone down with use of SSRIs and the role that genetic mutations play in causing adverse reactions to SSRIs and other antidepressants one of which is suicidal thinking (which is NOT suicide).

But, to be fair, he is not alone in this, so we’ll give Gardiner the benefit of the doubt.

The take away from all this: those opposed to the Critical Path and faster cures will use the MSM to shape public perception. The reality is more robust and hopeful. And as Anna Mathews mentions in the last line of her story in today’s Wall Street Journal, the bill “would authorize some resources for an FDA effort to spearhead research on drug evaluation.”

Can you say penny-wise and pound foolish? This from Health IT News.. The GOP stalls a bill to encourage the diffusion of health IT because it might — I repeat might — drive up health care spending in the short term as people invest in new hardware and systems to achieve interoperability and patient-centered. Would these Republicans have stalled investment in the highway system or the transcontinental railroad because it drove up costs in the short term?

http://www.healthcareitnews.com/story.cms?id=5109

House Republicans stall healthcare IT bill
Healthcare IT News
By Bernie Monegain, Managing Editor 06/20/06

WASHINGTON â A healthcare IT bill the U.S. House of Representives was expected to vote on this week is expected be put on hold.

Congress Daily reports the move to hold off on the bill came after the Congressional Budget Office forecast the legislation would increase spending and reduce revenue.

The bill bill promotes the adoption of healthcare information technology and calls for national standards for implementing electronic health records.


EU, US To Cooperate Against Counterfeit Goods

BRUSSELS (AP) —The European Union and U.S. plan to tackle together the traffic of fake luxury items, pirated music and counterfeit medicines with a deal set to be signed Tuesday that aims to help improve intellectual property rights protection in countries such as China and Russia.

The 25-nation bloc plans to work with the U.S. to train customs officials, exchange information and send anti-piracy experts to countries where counterfeiting is rife. The E.U. warns that countries that tolerate black market counterfeit goods could lose out on foreign investment and trade.

E.U. Trade Commissioner Peter Mandelson and E.U. industry chief Guenter Verheugen plan to sign the anti-piracy strategy Tuesday and U.S. President George W. Bush and European leaders are to give it their backing Wednesday at an E.U.-U.S. summit in Vienna, Austria.

Initial efforts will focus on working with China and Russia, the E.U. said, but the plan also includes other countries in Asia, Latin America and the Middle East.

Trade in fake medicines is also flourishing, estimated to make up almost 10% of the world trade in medicines in 2004, according to the E.U. executive.

The Journal of the American Medical Association — JAMA — is an island unto itself that seeks to generate revenue and readership by taking politically correct and activist positions that the hit and run media will print. Such an approach comes at the expense of the public health. And the FDA’s commissioner for Medical Affairs Dr. Scott Gottlieb said so in dulcet and diplomatic tones to the AMA: In his speech Gottlieb said JAMA spends too much time and spending too much time politicking and not enough time teaching how to appropriately prescribe the new medicines coming to market. The failure to prescribe drugs according to how they are developed and approved is the single largest source of serious side effects drug that fearmongers like Grassley love to talk about. The simple solution is better communication, between companies and the FDA, and doctors and patients…a low tech solution in a high tech age… And there is another solution too — drugs can be tested to determine how well a person metabolizes them before they are prescribed. That includes drugs like warfarin, antidepressants, ibuprofen and beta blockers…That could avoid costly and serious problems. Where is the JAMA editorial calling on the profession for DNA typing in primary care?

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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