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04.14.2008

Alliance for Patient Access Alternative Health Practice
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Biotech Blog
BrandweekNRX
CA Medicine man
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Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
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CNEhealth.org
Diabetes Mine
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Health Business Blog
Health Care BS
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Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
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Internet Drug News
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Jim Edwards' NRx
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National Review
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Shearlings Got Plowed
StateHouseCall.org
Taking Back America
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The Cycle
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TortsProf
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Washington Monthly
World of DTC Marketing
WSJ Health Blog

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About CMPI

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As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it's important to consider the unintended consequences -- the death of medical innovation.

The global purloiners of patents -- led by Jamie Love -- are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals -- but are far less keen to explain how the fruit tree got there in the first place -- or how they are nurtured. In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all. In other words, the elimination of patent rights doesn’t produce greater access to medicines. There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.

Intellectual property rights are the fertile soil that allowed the tree to grow in the first place -- and to thrive. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. If the IGWG succeeds, pharmaceutical innovation dies. And that's a Silent Spring we cannot afford.

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Heparin Hypocrisy?

04.08.2008

Some people will do anything to shove price controlled drugs from parts unknown down the the throats of unsuspecting Americans...that includes the editors at the San Jose Mercury News (there goes my chances for an oped placement)

From that august body:

"The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.

The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.

This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy."

http://www.hollandsentinel.com/stories/040808/opinion_20080408035.shtml

Some truth is in order by way of Andy von Eschenbach, FDA Commish:

"Our records at FDA indicated that we had inspected that facility in China, but that was incorrect. The inspection records we reviewed were on a facility with a very similar name. But having done the inspection in 2004 probably wouldnâ€™t have prevented this problem, because this chemical contaminant cannot be detected using the standard testing methods for heparin. We have now developed new test methods to screen heparin for this new contaminant and regulators around the world are using those tests to protect their citizens. "

http://www.fda.gov/oc/vonEschenbach/andys_take/lifecycle.html

So much for the canard that the FDA "lied". What do you call a paper that calls someone else a liar when it knows that the very statement is not factual?

Now as to "hypocrisy", why would the FDA allow the importation of drugs from companies that are not producing for the US market when it's first priority is to improve the monitoring of the supply and production chain of products that are approved for US sale and distribution? Why indeed given the fact that counterfeit products are a growing problem worldwide and given the fact that importation will, according to the Congressional Budget Office and the Commerce Department hardly make a dent in health care spending?

Because some people can't understand that there are benefits to having a free and global market for medicines and that such conditions are not inconsistent with a bi-partisan effort to improve the FDA's ability to track and trace the production of such goods.

Now that's hypocrisy for you.

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Democrats Get Tough on ... Drug Importation?

04.08.2008

According to Congressional Quarterly, Chairman Dingell is aggressively pursuing efforts to require the FDA to take a much more aggressive role in monitoring food and drug production and safety abroad, with stiff penalties for companies that import tainted products. The article says: â€œDingellâ€™s plan would also crack down on companies that violate drug import regulations. Manufacturers and importers could be fined as much as $500,000 for bringing contaminated or adulterated food or drugs into the country, and individuals could be subject to fines as high as $100,000 for similar offenses.â€

You may ask, How is that statement compatible with legislatorsâ€™ calls for liberalized prescription drug importation? Good question.

Hopefully Mr. Dingell will point this out when his colleagues raise the subject.

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Sloan Memorial's Saltz: Scare Patients By Posting Prices

04.07.2008

Is Leonard Saltz of Sloan Memorial more interested in attacking drug companies or caring for patients...Rather than pushing insurance companies to cover new cancer drugs, Saltz has devoted time decrying the price of new medications. And now he has taken his ideologically driven campaign to a new low, scaring patients into choosing a treatment based on price. In doing so, Saltz provides an example that even someone with no background in oncology should find shocking and a signal to stay away from Saltz as a treating physician: (From the Pharmamarket Newsletter)

"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."

Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.

Or how about making this information transparent instead of scaring people about prices:

"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "

I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.

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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.