Attention Thoreauvians: Is breaking the law good for you? (Andrew)

First, let me say that it's a pleasure to be involved with the crew of polymaths on this blog.

Secondly, I wanted to get started with a post about prescription drugs.  I often write about music, but lately have been working on a story for Mother Jones about a company that allows Americans to flaunt federal law and fill their prescriptions by buying drugs purchased from the Apollo Hospitals chain's drug purchasing arm, located in Hyderabad. (In fact, if any of the readers of this blog have ever used this American "middleman" company, called ProgressiveRx, or know anyone who has, please email me -- I'd love to hear about your experience, whether positive or negative).

In addition, Americans are ordering a lot of medicine from Canada, also in violation of federal law.  According to the AARP, the Federal government, under the auspices of the Department of Homeland Security, initiated a crackdown against these sick and in many cases elderly lawbreakers in November 2005 and destroyed about 40,000 packages entering the country by mail over the course of the ensuing year.  The outcry was such -- "I ordered my acid reflux medication 6 weeks ago and it still hasn't showed up!" -- that the F.D.A. has dialed back enforcement to a passive stance that looks a lot like "don't ask, don't tell." And a group of states, led by Governor Rod Blagojevich of Illinois, have started their own web site, called isaverx.net, to allow citizens of those states to get heavily discounted medication from pharmacies in Canada, Ireland, and the U.K.  The auditor general of Illinois has found that the program violates federal law, but after 2 1/2 years, I-SaveRx remains in operation.  Once again, the F.D.A. appears to be in a position of "don't ask, don't tell."

Clearly, there are intellectual property rights getting violated here, but when you're dealing with lifesaving medications, the ethics are more complicated.  There's no doubt a drug company needs to profit from its groundbreaking drugs.  The multi-billion dollar question is for how long, before the drug effectively becomes common property of the sick people of the world, through the production of dirt-cheap generics?  As an example, take Pfizer's Lipitor, the anti-cholesterol drug that launched in 1997, and is now the biggest selling drug in the world, with sales reaching $8 billion in 2002, and annual sales of nearly $13 billion in 2006.  Their patent expires in 2010.  Here are the numbers: 90 days worth of 20mg Lipitor pills will run you $321.30 + shipping at the relatively inexpensive American pharmacy drugstore.com -- whereas citizens of Vermont, Kansas, Illinois, Missouri, and Wisconsin can buy it from the U.K. for $124.33 + shipping.  For an un- or underinsured, low-income person  -- or heck, a 57-year-old version of freelance writer like me, buying individual insurance that has a $750 drug annual deductible, the temptation to say "to heck with the drug companies and my so-called insurance" and save nearly $200/month on cholesterol medication is huge!   (The savings from Indian companies are even greater).

But what say you all?  What about what my friend from Microsoft would call "the right to innovate" among the drug companies?  Are my low-income, drug-importing Lipitor poppers merely parasites upon the doughty yeomen and yeo-women of Pfizer, and their many law-abiding customers? And in any case, how should we strike the Solomonic balance between favorable incentives for the drug companies and American people able to afford life-saving medication?

Comments

[Ruchira Paul]

Thank you Andrew for a very informative first post. (I took the liberty of adding your name in the title. This is to ensure that posts by guest bloggers don't get mistaken as my contribution.)

The question you pose is literally a million dollar (billion?) one. I have friends who are retired, quite well off and some are wholly or partially self insured. One of my friends' husband is on seven different prescription medicines. The out of pocket expenditure including supplemental insurance is so ridiculously high that the couple has recently decided to get some of the drugs from Canada. They are breaking the law (a bad law, to begin with) for sure. But are they criminals? Heck, no.

Similarly, on the issue of poorer countries (China and India mainly) flouting patent laws to provide generic drugs to populations in Africa, Asia and Latin America who can ill afford the boutique prices of Pfizer, Glaxo-Smith & Kline, Merck et al. I have mixed feelings on this too. Follow the law which puts life saving drugs out of the reach of poor people or break the law and save lives?

As for expiration of patents, there are innovative ways to milk an already old milch cow. You mention the patent expiration on Lipitor in 2010. Pfizer has already marketed a new drug (with a new patent) called Caduet which combines Lipitor with a blood pressure lowering drug whose patent will last the next twenty years. Merck did the same with Vytorin when the hugely money making Zocor's patent ran out.

Moreover, when big pharma points to recovering R&D costs from drug sales, they avoid telling us that very often they benefit from NIH funded research conducted at universities for which they have to shell out no money at all in the early stages. And in any case, how much profit is too much? Forget about cheap knock offs manufactured in China and India. Why do their own name brands cost less in Europe and Canada? What's the game here? Because those countries have state subsidized health care and the governments negotiate the prices (as does our own VA)? So, in the US open market they can charge several times higher prices because we have no control? We are screwed in the middle of this collusion between Congress, insurance companies and the drug companies.

It's funny isn't it that those who sing the praises of free trade and open markets when it comes to reducing their own manufacturing and labor costs, cry foul if the consumer too wants access to open markets when buying products at a lower price ?

[Sujatha]

Great article, Andrew.

Something I found curious about the ProgressiveRx link you supplied in the post,was that if you happen to click on the link further down the page for the Ebay feedback, it takes you to a page for feedback for userid Medicalrefuge, with thousands of largely positive ratings. The only recent items rated, however are :
Very fast and keep me up to speed EVERY step of the way!!! Great Ebay'er!!!! Buyer:
pcspavers ( 6 )
Jun-07-07 10:14
Dell Latitude D620 Intel Core Duo 1.67GHz, 1GB, 80GB HD (#200112486777)

Great buyer! Would love to do business again! Seller:
everydaysource ( 565813 [Feedback score is 100,000 or higher] )
Apr-30-07 01:27
5 Pack CR2032 3V Lithium Coin Cell Batteries CR-2032 (#180100953834)

Why are they selling computer stuff? Ebay error or something else?

[Star Lawrenece]

Recently the docs decided it's OK to cut cholesterol meds in half...I am just sayin'. But this hardly helps. The whole individual health care situation is a total CF. If you had a sprained ankle in the past or hay fever now, you can't get coverage. My sister was told not to even have her BP taken for a year or the doc visit would not be covered. Oh, that's good medicine. I could go on. Then these clowns like Giuliani say oh, let's own our health care. He means pay for it ourselves, which is fine if you are a millionaire. I guess he hasn't noticed some of us aren't. My formerly state-sponsored ins for uninsurable--uninsurables, so they may be sick, right--is about to go up to $825 a month, with a big deductible, plus tons of things no longer covered. This is getting me too depressed. Have a nice one!

[Andrew Rosenblum]

Hi Sujatha,

Re: the eBay feedback, ProgressiveRx also sells over-the-counter medications through eBay -- and apparently, their own old office equipment!

As for Star and Ruchira's rebuttals of the prohibitive costs of life-saving medication, the taxpayer subsidies for some research, and the manufacture of re-patented "me-too" drugs like Caduet -- they're hard to dispute.

The industry position is something like: "we need these enormous profits, and to spend a lot of our revenue on marketing to boost those profits, in order to continue to attract enormous amounts of capital for potentially risky research. Huge profits and salaries are just part of the costs of doing business in this inherently uncertain and entrepreneurial business."

But it's hard to blame patients for seeing that the law really isn't on their side and going around it -- particularly when the industry is willing to expand the definition of "marketing" to paying doctors hundreds of thousands of dollars in lecturing and clinical trials fees, in an implied quid pro quo to increase prescribing:

http://www.nytimes.com/2007/03/21/us/21drug.html?ex=1182312000&en=d158e3cb0439c1ca&ei=5070.
http://www.nytimes.com/2007/06/03/health/03docs.html?pagewanted=1&ei=5090&en=f6caa5d9c1c929be&ex=1338523200&adxnnl=0&partner=rssuserland&emc=rss

I suspect that many patients feel like "you can't trust the F.D.A. to act in your interests, and you can't trust your own doctor! So why shouldn't I take my own drug therapy into my own hands?"

[Jeffrey Dach MD]

Perhaps you have seen the Direct-to-Consumer TV and print advertisements with Robert Jarvik, the inventor of the Jarvik Heart, speaking on behalf of the Pfizer’s anti-cholesterol drug, Lipitor.

Perhaps Jarvik is not the best choice for the Lipitor campaign which has had mixed reviews. Instead of Jarvik, a more convincing yet unlikely spokesman would be the popular Duane Graveline MD MPH, a former NASA astronaut, and author who was started on Lipitor during an annual astronaut physical at the Johnson Space Center, and 6 weeks later had an episode of transient global amnesia, a sudden form of total memory loss described in his book.

Two more unlikely spokesmen for the Lipitor ad campaign include Mary Enig and Uffe Ravnskov.

Should either one be selected as Lipitor spokesman, I myself would run down to the corner drug store to buy up the drug. It seems unlikey that even Pfizer’s deep pockets could ever induce them to recant their opposing position on the cholesterol theory of heart disease.

Mary G. Enig writes, ”hypercholesterolemia is the health issue of the 21st century. It is actually an invented disease, a problem that emerged when health professionals learned how to measure cholesterol levels in the blood.

Uffe Ravnskov MD PhD is spokesman for Thincs, The International Network of Cholesterol Skeptics, and author of “The Cholesterol Myths, Exposing the Fallacy That Saturated Fat and Cholesterol Cause Heart Disease”. His controversial ideas have angered loyal cholesterol theory supporters in Finland who demonstrated by burning his book on live television.

For more discussion on this, see my newsletter:

http://jeffreydach.com/2007/05/14/lipitor-and-the-dracula-of-modern-technology-by-jeffrey-dach-md.aspx
Lipitor and The Dracula of Modern Technology

http://www.drdach.com/
Jeffrey Dach MD