Tuesday, June 16, 2009

Genzyme's Business Model-You've Got to Read This!

An excellent, thought provoking article by Stephen Heuser, "One girl's hope, a nation's dilemma," appeared in the Boston Globe on June 14. Mr. Heuser details the appalling, rapacious approach Genzyme takes to marketing orphan drugs. A guest response, detailing some of the lesser known implications of Genzyme's predatory practices, follows:

"The Boston Globe article about Genzyme’s business tactics is quite alarming.
Nearly every country in Latin America has incorporat ed a legal guarantee to the "right to the highest attainable standard of health" (a.k.a. right to health) in their constitutions. This judicial language has been enforced in a number of countries.

The right to essential medicines is defined by WHO as “those that satisfy the priority health care needs of the population," with the caveat that they “are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford."

Recent court cases, particularly in Brazil (initially surrounding access to ARVs) have increasing granted the right to access to essential medicines in Latin America, insisting that the government provide the drugs, no matter the cost. In the past this has led to successful cost-lowering mechanisms which both made the drugs available and didn't run the health budget completely dry. For instance, Brazil put significant pressure on international pharmaceutical companies to lower the prices on anti-retrovirals by developing the pharmaceutical capacity to produce their own generic forms as well as fighting heavily in the World Trade Organization. They also focused attention on prevention efforts, as a way to curb the number of people who would eventually need the drugs.

However, the same leverage does not necessarily apply to a small country like Costa Rica. The pharmaceutical capacity is probably not there, and it is too small a population for market interest in many circumstances.

But this particualar case raises a interesting and less discussed issue--- are drugs for rare diseases considered essential medicines, and does the government have the responsibility to provide them to any affected citizens, no matter the cost? In some ways the problem is ultimately about the ability of the pharmaceutical country to charge any amount, unrelated to a reasonable assessment of the costs of production and a marginal profit.

The U.S. has dealt with the issue of rare diseases by creating special incentives for companies to develop drugs for these diseases, on the assumption that there will be no market for profits. This has been moderately successful.

But Genzyme, is breaking the rules (at least in a moral sense). They are using very dirty tactics and enormous resources to engage governments in a questionable manner. While the right to health is open to interpretation, I find it hard to justify such enormous expenditures for so few individuals. That being said, it is not inconceivable for the drug to be viewed as essential.

The problem really lies in the fact that the company is charging such an enormous price, with a huge profit margin, and very little threat of competition in the form of generics, and they stay below the public health activists radar to a great degree.

While pharmaceutical companies have the right to make a profit, just like any other corporation, they should not be allowed to intentionally drain the already strapped resources of the Ministries of Health of developing countries."

Heather Stone
Founder, President of G.A.A.P.E.:
Global Action Against Poverty Everywhere!
Smith College
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Tuesday, May 19, 2009

International Clinical Trials Day

Tomorrow, May 20, is International Clinical Trials Day.

This annual event was established by the European Clinical Research Infrastructures Network, a group formed to help interconnect national networks of clinical research centers across the European Union and to help streamline multi-national studies.

ECRIN launched the International Clinical Trials Day in 2005 to educate the public about clinical trials and to further discussion amongst various interested parties, including clinicians, industry sponsors, ethics committees, regulatory agencies, and patients.

May 20th was selected as the appropriate date for this celebration in honor of James Lind who in 1747 conducted a six-way comparison of cider, elixir of vitriol, vinegar, sea water, oranges and lemons, and a purgative mixture of spices, garlic and mustard seeds on sailors suffering from scurvy. Each treatment group had 2 men. Within 6 days, the two men receiving citrus fruits were well--such a dramatic improvement compared to the other groups that it made the statistical analysis unnecessary. His descriptive treatise was published in 1753 and makes for interesting reading.

When less than 5% of patients with cancer participate in clinical trials, it is clear that a bit more outreach still needs to be done, to educate physicians and patients—and insurance companies, who often have archaic rules that preclude participation. The Public Library of Science (PLOS) is trying to do its part and launched its open access clinical trials journal, also on May 20th.

Some other efforts are not quite as supportive. It probably doesn’t help when a mascot is proposed, “Clint,” the clinical trials guinea pig …nor when a celebration includes discussion of heart-warming topics like “inspections.”

What would you suggest as an enticing celebratory event? How do you encourage participation in, and support of clinical trials?

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Wednesday, May 13, 2009

AccessCR-a Great Source of Infomation

A few months ago I discovered AccessCR, an Australian company with expertise in clinical research. Janelle Bowden, PhD, AccessCR's Managing Director, has a wealth of experience in clinical research and an obvious passion for making research accessible to and more accepted by the public. She also aims to improve communication and partnership between all involved in the clinical research process, from patient to researcher to government to industry. Her website and newsletter reflect that and are a terrific source of frequently updated information.

I’ve been following Dr. Bowden’s site avidly for several months and recently had the pleasure of speaking with her about some of the problems confronting clinical trials both in the US and abroad. I look forward to exploring this with her more in the future.

I highly recommend the AccessCR site and newsletter for interesting updates on clinical trials. Check it out here!

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Sunday, May 10, 2009

A Virtual Personal Assistant for Researchers and Writers

In my never ending quest to be more organized and keep track of little snippets of information that might be useful, well…sometime…I came across a couple of helpful tools worthy of sharing.

First is Zotero. Great application, and easy enough even for determinedly non-techie types to learn. I was attracted to try Zotero by its pedigree—the project is produced by Center for History and New Media at George Mason University, and is funded by the Andrew W. Mellon Foundation, the Institute of Museum and Library Services, and the Alfred P. Sloan Foundation. They provide Zotero as a free program, which is installed onto Firefox. When you see a page you want to save while you are browsing, you can hit the friendly little Z icon. A screen will pop-up in the lower part of your open Firefox page, and you can take a snapshot of the page or just save the link. There are a number of very easy to follow screencast tutorials that illustrate different aspects of saving or searching, but much of Zotero is self-explanatory.

For me (and other OCD researchers, I suspect), one of the best parts of the Zotero program is that it automatically captures citation information from the web pages or papers. This tool is invaluable and would have saved me countless hours and angst when I was trying to verify all of my references for my book, Conducting Clinical Research, just prior to going to press.

Other great features of Zotero are that:
-You can save pretty much any type of article or file—newspaper clippings, images, pdfs, web pages, and word files. You can then link these to files or pdfs and tag them. Zotero’s search feature has jogged my memory accurately, thus far. I don’t know if that will change as I add a zillion more references, or if the program will choke; I suspect it is tougher than I am.

-You can make linked or standalone notes. I like to jot down “factoids” but sometimes have trouble remembering which articles they were associated with. Now I can more easily link the two together in an easily searchable database.

-You can readily mark up or annotate your pdfs for later reference.

-Rumor has it that you can integrate Zotero with word processing programs. I haven’t tried yet. Nor have I tried accessing my files in cyberspace.

-You can also work with Zotero off-line.

-Zotero is open-source, a goal worthy of support.

What’s not to like? Not much, so far.

-I don’t like the way it identifies folders, as you can’t tell what is in them readily.
-When it takes a snapshot of a page, I wish it would discard a lot of the images or advertising on a web page and save space, but it hasn’t learned that skill yet. Zotero stored my files in a peculiar path, which made backing up my files like a scavenger hunt at first.

I’m sure there are other features I’ll learn to love. If a little elf came with Zotero and would go back through all the other folders on my hard drive’s files and import them into Zotero, along with suitable tags, I would commit to Zotero for life.

Zotero is a great little program that should save considerable time and angst by helping to collect, manage, and accurately cite references in writing any type of article. It really is almost like having a personal research assistant, only a lot less expensive. Let me know what you think!

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Wednesday, May 06, 2009

Comic Relief from Swine Flu

Funny Swine flu song from Putnam Pig! Welcome relief. . .but time to go back to work updating the Medpedia site. Care to join me in that task? Medpedia is an exciting new project, but the wiki will work better with input and discussion from others. Come and join the fun.

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Monday, May 04, 2009

Swine Flu on Medpedia

After a hiatus from writing while working and traveling, I’m settling back in, prompted by the H1N1 (swine) flu outbreak. I’m honored to have been asked to work with Medpedia on providing information on this topic. I adapted some from CDC, WHO, CIDRAP, and others. Please check the Medpedia.com/Influenza A H1N1 site, which I will update regularly, trying to provide news and perspective on recommendations in a common sense way. Other physicians will also hopefully contribute to this great new medical wiki project. Please also e-mail me with questions you would like answered or leave a comment. Thanks!

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Monday, February 23, 2009

FDA Approves a New Drug for the Annoyingly Cheerful

In one of the best satires I've seen since "That Was the Week That Was," the Women's Bioethics Blog called my attention to the FDA's approval of Pfizer's new drug, Despondex, to cure the Pollyannas among us.



I wonder how sales will compare to Viagra? Stay tuned...

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