HeLa’s Immortal Cell Lines

The development of “immortal” cell lines led to major improvements in research and experimentation; unlike most cells, these cells do not die of old age.  Immortal cell lines are significant because of their ability to grow indefinitely and to survive being divided and shared; these traits allow scientists to engage in more productive research.  Scientists created the first immortal cell line, dubbed HeLa, almost 60 years ago, in the 1950s.  Since then, scientists have used HeLa cells to develop the polio vaccine, as well as drugs that treat Parkinson’s disease and leukemia.  Scientists even sent cells from the line into space to aid in research on the effects of zero gravity on human tissue.  Overall, scientists have produced more than two thousand pounds of these cells, the sales of which have generated millions in profits.

The Personal Side to the Story

Recently, renewed interest in this cell line has focused on its origin rather than its results.  In this case, scientists named HeLa cells after the patient in whom they first found them: Henrietta Lacks.  Lacks suffered from a particularly virulent strain of cervical cancer and, after unsuccessful radium treatment, died in 1951 at Johns Hopkins Hospital, Maryland.  Without Lacks’ knowledge or consent, her doctor shared a sample of her tumors with a researcher, Dr. George Gey, intent on developing an immortal cell line.  With Lacks’ tumor cells, the researcher succeeded in making the line that led to medical advancements and high profits.

This behind-the-back cellular research and development story has recently become the subject of controversy.  “Tissue rights” scholars now question whether or not patients should retain any control over cells removed from their body.  Currently, cells be bought and sold without the patients’ permission, but tissue rights advocates suggest that these often-unwitting donors deserve a share in the profits their cells eventually reap.

Complicating the issue is the fact that some believe Henrietta Lacks’ story to primarily be a “case of a black woman whose body had been exploited by white scientists.”  The contrast between her children and grandchildren’s continued poverty and the vast profits made from commercializing the HeLa cell line heightens the feeling that the scientists responsible cheated Lacks and her family.  Also troubling is the fact that researchers continued to collect genetic material for the purposes of HeLa cell development from these family members long after Lacks died, under the guise of routine cancer screening diagnostics.

Legal Complications

Given the current state of the law, the Henrietta Lackses of the world have a hard argument to make if they believe they deserve a share of the profits.  In a similar case in the 1980s, researchers removed the spleen of John Moore as part of his leukemia treatment.  Recognizing the unique scientific and financial potential of Moore’s particular cancerous cells, his doctor promptly developed a cell line from the extracted lymphocytes, patented the line, and licensed it for hundreds of thousands of dollars.  The doctor also gathered samples of Moore’s blood and other tissue on future visits; he told Moore’s that his continued health depended upon such testing but did not reveal that he was keeping the samples to aid in his research.  The resulting cell line, Mo, now has a market value of around $3 billion.

When Moore discovered these lucrative results he sued for his share of the profits. The California Supreme Court, however, rejected his suit, holding that Moore did not have a property interest in the cell line developed by his doctor and that his rights to privacy and dignity were sufficiently protected by the doctrine of informed consent.  The court also pointed out that certain laws seem designed to prevent patients from retaining their organs after their removal.  The court did concede, however, that the doctor’s financial motives should have been disclosed to Moore.

The current regime is one where tissue or cell samples removed from a person’s body are tissues or cell samples in which that person has no property rights.  Today, patients who undergo surgery often sign forms that specify whether any removed tissue may be used for research purposes.

Looking Ahead

The nagging feeling that scientists and doctors treated Henrietta Lacks and John Moore unfairly remains.  It can be unsettling to know that doctors have hundreds of thousands of dollars worth of incentives to operate on or take samples from their patients.  Moreover, as Lacks’ family knows, once tissues have been excised from our bodies, the feeling that they are part of us can remain; the immortal HeLa cell line will always be Henrietta Lacks to her family.

Are Genes Patentable?

Naturally occurring things, even if newly discovered, may not be patented.  The ACLU asserts that the isolated genes in Myriad’s patents are no different from the genes that occur in nature.  The ACLU’s lawsuit seeks to invalidate Myriad’s patents.  They also argue that the patent covers basic human knowledge or thought (more specifically, the process of comparing the mutated gene to the normal one) and is therefore a violation of the First Amendment.  If the court accepts this reasoning, genes will no longer be patentable material under § 101.

Why It Matters: The BRCA Genes and Cancer

The BRCA-1 and BRCA-2 genes are linked to hereditary breast and ovarian cancer.  Women with mutations in these genes have a 40-85% chance of developing breast cancer, and suffer an increased risk for ovarian cancer as well.  Diagnostic tests can reveal these mutations, allowing women to better assess their risk.  Many women who have the mutated genes can undergo screening for the cancers earlier and more frequently than usual; some may even elect to have prophylactic surgeries.  Results can also serve to alert female relatives that they are more likely to have the mutation.  However, since Myriad holds patents on BRCA-1 and BRCA-2, it currently possesses a right to exclude others from performing these diagnostic tests.

The ACLU’s complaint points out that Myriad has failed to license its patent widely, which carries with it important implications.  Given that there are no alternatives, Myriad may freely price their diagnostics; many argue that the current rate ($3000 per test) is too expensive for many of the women who need to be tested.  Additionally, without other laboratories conducting similar tests, women are unable to secure second opinions.

The Big Picture

About 20% of human genes are patented.  Patent holders can prevent a researcher from studying or testing a particular gene.  Many of these genes, like BRCA-1 and BRCA-2, are associated with serious illness, including Alzheimer’s, muscular dystrophy, and colon cancer.  The ability to screen for genetic predispositions to these and similar diseases represents a great advance in personalized and predictive care.  There is concern, however, that allowing gene patents might slow development in this area.  The ACLU claims that, with gene patents, there is no opportunity to invent around the patent or to build upon and improve it.  They argue that this produces a disincentive to innovate.

As the court wrote in its opinion denying Myriad’s motion to dismiss, “the resolution of these issues will have far-reaching implications, not only for gene-based health care . . .  but also for the future course of biomedical research.”

For additional reading: Medical News Today, GEN

The ACLU’s complaint is available here.

By Claire Devine and Kyle de Neve.