patents and informed consent

I recently read two very interesting articles. The first was a column in the Philadelphia Inquirer, “DNA in court” (Faye Flam, Monday, June 21, 2010, Business section). The article was discussing the impending court battle arguing the validity of the Myriad Genetics patent on the DNA sequence of breast cancer genes, BRCA1 and BRCA2 (the name stands for BReast CAncer)*. The second was an article, “Immortal Cells, Enduring Issues”, in the Johns Hopkins Magazine (Dale Keiger, Summer Issue 2010) about the newly published book about the 1st human cells to be grown in a lab, HeLa cells.**

In 1980, Congress enacted the Dole-Bayh Act that provided universities and non-profit organizations with intellectual property rights to inventions developed within their institutions. This has been a boon for scientists, universities and non-profits. It has allowed scientists to patent their ideas and to earn their due rewards. No question, they deserve it! It has also allowed for patents to be issued on DNA sequences. This brings us back to the Myriad Genomics issue. In 2000-2001 Myriad Genomics and the University of Utah Research Foundation obtained a patent on the BRCA1 sequence and a genetic test to detect mutations in the DNA sequence that is associated with increased risk for developing breast and ovarian cancers. Myriad Genomics is not alone; there are greater than 2000 DNA sequences of genes in the body have been patented. This brings up many important ethical issues surrounding ownership of the DNA that exists in every cell of everyone’s body and about donating cells or DNA to studies. The latter topic is the subject of the Hopkins Magazine article.

A recently published book discusses the ethical issues surrounding the methodology used in obtaining cervial cancer cells and in the development of HeLa cells in a Hopkins lab. HeLa cells are named after a woman in Baltimore, Henrietta Lacks, who suffered from cervical cancer. When she went into the hospital, doctors removed the tumor and used part of it to establish an immortalized cell line that is still utilized today. The HeLa cell was the first cells to be maintained outside the body in what is called tissue culture which has revolutionized modern molecular medicine. Using and testing these cells has led to enormous revelations and advancements in science. The importance of this cell line and what has been discovered because of it is truly immeasurable!

The ethical issues raised by the HeLa case are still hotly debated. Probably the most significant surrounds the issue of informed consent. Whenever you volunteer for a scientific experiment or donate tissues/cells/DNA for a scientific endeavor, you provide consent for the scientist to use your material for an expressed purpose. The scientist is required to inform you about how the material will be used in a way that you will understand to which you allow the materials to be used in that way. You are informed and provide consent. The problem arises when laws change over time or technology advances to the point where the scientific questions being asked were not even conceived of at the time of consent. Informed consent was very different in the 1950s when Henrietta Lacks was alive than today. How does a scientist get consent if the idea or technology doesn’t exist or won’t exist for many, many years? Is it ok to use DNA obtained for other purposes?

Obviously, I alone cannot answer these questions, but they point to how much science is so much a part of our lives and how much we need to keep talking about these issues. As an update, recently, the US District court ruled to invalidate the patent held by Myriad and placing the patents for all the other genes in jeopardy as well. Myriad is appealing, which might mean that this case will make it to the Supreme Court. It will be interesting to see where this leads.




* DNA is found in every cell of our bodies and contains the code for the proteins that complete the function of that particular cell (ie. heart cells contain some different proteins than skin cells but all the proteins are encoded by the same DNA sequence that is found in every cell). DNA is made up of 4 units (or bases) that string together in a specific order (or sequence). Mutations in certain genes have been shown to contribute to the development a disease. Mutations in the BRCA1 and 2 sequence are associated with increasing the risk of developing breast or ovarian cancer.

** HeLa cells were the first immortalized human cells to grow in a lab (in culture). Unlike other previous cells, HeLa didn’t die after a few days like other cells.