Human DNA derived from biological samples is a valuable research commodity in medical research and is high in demand by government and academic centres and drug companies. The value of genetic data has caught the attention of the public and at the same time, drug costs are increasing, leading to a want to be compensated, a guarantee of useful medical information, or control over how their biological samples will be studied.

Some medical start-up companies have seized the opportunity and a research firm has predicted that biological samples will generate USD23 billion in revenue by 2018. Patients argue that innovation and progress will save lives, but they themselves have to be able to afford these new treatments and research teams have overestimated patient altruism.

In fury over how their 'biorights' can be violated, patients are looking for more control over their tissue and cells and its genetic revelations. In May, four people filed a federal complaint against a genetics company in the United States. The group asked for patients to have access to all the genetic data in exchange for the samples given out.

It is no wonder, researchers are getting nervous about the emerging "biorights" movement.

Getting consent from patients


The Health and Human Services and 15 other federal entities in the US have proposed a new requirement for researchers to get patient consent to study biological material that is left over from routine and surgical medical procedures, even if the donor's identity is unknown.

At the moment, consent is not required for these samples. But researchers are outraged at the proposal as they claim it will hinder medical advances and most patients may not consent.

"We may not get enough samples" to study, said Dr. Alexander Lazar, a pathologist at the M.D. Anderson Cancer Centre in Texas. Lazar studies Desmoid tumours, which are rare fibrous masses that have the ability to strangle arteries and compress organs.

He particularly faces a tough situation because as it is, he has trouble finding them. If the proposal is approved, he worries that community hospitals he gets his supplies from, may not have the time or resources to ask for patient consent, leaving him stranded.

Just the medical information


But patients feel taken for granted, as researchers offer nothing in return. Having some form of control on whether their samples can be studied is the least the researchers could do. What patients actually want, is the information from the research that may help them.

"If you study my DNA, just let me know what you find," said Stacey Tinianov, of California, who was diagnosed with breast cancer three years ago. "I don't think that is too much to ask."

For some, the price of some new drugs are rising into the six figure bracket and patients of those clinical trials, want something in return, as they took the time and travel to participate in those clinical trials. Some have even seen that there is an economy surrounding patient data.

After all, many in the reproductive field get paid for a vial of sperm or eggs. But if we were to put a price tag on all biological samples especially samples of rare diseases, the price of drugs will only increase exponentially.

Every disease, a rare disease


In the end, the medical information is what patients really want. And that is what New York-based Regeneron Pharmaceuticals Inc. and Geisenger Health System have collaborated to do. Geisinger patients provide Regeneron with DNA samples, and in return, if any genetic anomaly that is considered "medically actionable", Geisinger will confirm the finding and contact the patient. To date, 140 out of 111,000 patients have had their results returned.

However, research is often prided on exclusivity. If a patient was found to have a rare disease and researchers have provided the patient with the decoded the genetic data upon request, researchers fear that the data will be released publicly to make it available to other researchers.

Moreover, most researchers under a pharmaceutical company are all about positive results and profit. When terminally ill or patients suffering from rare diseases donate biological samples for research, many have no access to the experimental drugs when they undergo clinical trials as researchers are not transparent about who is eligible.

Also, it was found in a survey that only 19% of 100 drug makers publicly post policies about their programs for obtaining these drugs. Only one posted information about the process for making requests and even then, the company did not list any contact information.

For those who are not eligible to obtain an experimental drug, currently they can only apply to the FDA for its expanded access program, also known as compassionate use. While the agency approves over 99% of applications, the final decision still lies within the drug company, denying requests that might affect their chances of getting the drug approved. MIMS

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Sources:
https://www.statnews.com/pharmalot/2016/10/11/experimental-drugs-compassionate-use-policies/
https://www.fastcompany.com/3064518/the-rise-of-biorights-patients-demand-cash-control-for-donating-dna