Friday, April 11, 2014

Patents and Vaccines and Ethics

In my last post I reviewed A Patent Lie by Paul Goldstein. The book is a legal thriller involving a court case over the alleged infringement of a patent for an AIDS vaccine.

Within the book was a discussion about the cost that such should be paid for treatments of a vaccine. Hundreds of millions of dollars are spent in the research and testing of the vaccine.

Drug companies could simply work out a worldwide price recouping their costs and make a profit. However, the ability to pay of patients needing the treatment varies immensely by country. Within the book there is debate on how much to charge for the product in wealthy America versus how much to charge in poor southern Africa.

Proposals involved charges of hundreds of dollars for American AIDS patients against $45 in Africa. It was recognized that even $45 is beyond the reach of many Africans.

These 21st Century issues over this AIDS vaccine product reminded me of issues raised in the hearings of the Canadian Royal Commission of Inquiry into the Canadian Blood System during the 1990’s.

The Commission was investigating how and why Canadian hemophiliacs and blood transfused were infected with AIDS and Hepatitis C from tainted blood during the 1980’s. I represented a group of hemophiliacs who did not want representation by the Canadian Hemophilia Society.

There was information on efforts to develop an AIDS vaccine. A difficult issue involved clinical trials. While there was no product being tested at the time there was a challenging ethical question.

Was there a way to ethically run trials in which only half of the people received the vaccine? You would be putting the other half of the cohort at a risk for being infected with AIDS which had no treatment until the mid-1990’s. At the same time, if the potential vaccine, were effective potentially millions around the world were being denied a product that could prevent them from being infected with AIDS.

It was doubtful an appropriate protocol could be drafted for North America. There was discussion on whether trials could be conducted in Third World countries where having the chance of being in the group getting the vaccine was better than any other they would have to avoid infection. Should a protocol be undertaken in a Third World country that could not take place in North America?

A more current discussion can be found on the vaccineethics.org website at http://www.vaccineethics.org/issue_briefs/HIV_clinical_trials.php.

The premise of the book also brought to mind a situation that took place in litigation following the completion of the hearing of evidence in the Inquiry.

In the book Michael Seeley is called from Buffalo to San Francisco to take over as lead counsel this huge patent infringement case but 2 weeks before trial. I might have thought the scenario implausible but for what happened in judicial review proceedings involving the Inquiry.

Several parties to the Inquiry sought to have the Commissioner restrained in his ability to assess responsibility in his report. At the Federal Court Trial Division the application was denied. The decision was appealed to the Court of Appeal.

Approximately 2 weeks before the hearing of the appeal the lead counsel for the Commissioner fell sick and needed surgery. No one wanted an adjournment because of the time involved to re-schedule the appeal. Dozens of lawyers were involved.

A new lawyer stepped in on behalf of the Commissioner to argue the appeal. It was a tremendous challenge. He did his best.

I was one of several lawyers appearing for groups of victims at the appeal. We all had intervener status. All of us supported the Commissioner. We sought to assist the new lawyer by dividing the issues to be argued and adding specific submissions. The appeal was denied as I hoped.

Ultimately the Supreme Court of Canada decided the Commissioner could write his report unhindered. It can be found at http://epe.lac-bac.gc.ca/100/200/301/hcan-scan/commission_blood_final_rep-e/index.html. What happened in the Canadian blood system is a long and sad story.

8 comments:

  1. Bill, you've raised some very relevant issues surrounding the AIDS vaccine and its affordability in different parts of the world, especially Africa. It's been a while since I read about clinical trials for AIDS vaccines in India though I'm aware that they do take place. Indian drug companies supply a lot of life-saving drugs to poor Africans at less than half the rates of those sold by western companies, especially in the areas of TB and AIDS. And I think the powerful pharma lobby in the West resents this as it eats into their profits. Bill, I wonder if you read John le Carré's "The Constant Gardener" about the sinister business operations of pharma companies in Africa. It was made into a nice film.

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    1. Prashant: Thanks for the information. In Canada we hear little about Indian drug companies and their sales in Africa. I have read "The Constant Gardiner". It was my second favourite fiction in 2001. It was a powerful book that left me reflective.

      The book also surprised me as it includes a trip to Saskatchewan.

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  2. A long and sad story indeed Bill. That's a serious and thought-provoking post, raising important issues. Thanks.

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    1. Moira: Since 1991 I have been involved with representing blood transfused and hemophiliacs. Each year I think it will all be over but there are still some cases to be resolved.

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  3. Bill - Thanks for sharing this. It is a very sad stroy with so much that we can and need to learn about this issue. So many complications here and quite a lot of 'food for thought.' And of course, so many ethical issues raised that have far-reaching implications.

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    1. Margot: Thanks for the comment. It seems every issue with AIDS is fraught with politics - sexual, international, religious, community and medical. I am not sure how some of the ethical issues are best dealt with concerning vaccines.

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  4. Bill, I am glad you shared information about this issue. It is a topic I don't know much about. I am also glad that Prashant mentioned The Constant Gardener. That is a Le Carre book I want to read someday. (I did see the movie, but I usually prefer books to their movie adaptations.)

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    1. TracyK: Thanks for the comment. It has been a fascinating journey for me since I started representing hemophiliacs and blood transfused.

      "The Constant Gardener" is a good book. Just do not read it if you are feeling down.

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