Clinical trials: Data privacy law needs quick fix

Scientists at work in a clinical laboratory. (Photo: Minerva Studio, via Shutterstock)

I will never forget the appointment. It took place in June of 2012. I had gone to see my oncologist hoping to hear that there was no cancer found in my latest CT scan. I had recently had surgery that was supposed to remove the latest cancer growth. Over the previous 4 years, I had tried every chemotherapy available and was anxious for good news. Unfortunately, my oncologist informed me that my cancer had returned, it was inoperable, unable to be killed by radiation and there were no new chemotherapy options available. That night, I drove home contemplating how I would say goodbye to my precious 8-year old twin daughters.

The next day a miracle happened. I was accepted into a clinical trial at Stanford Cancer Center, which gave me another 3 years of life. I am alive today because of that clinical trial and others in which I have subsequently participated.

Patients who agree to participate in a clinical trial are agreeing to allow researchers to use their data from the trial.

Since beginning this journey, I have had 52 surgeries. I have had every dispensable organ removed. I’ve been given every form of chemotherapy and I’ve had multiple rounds of radiation. Unfortunately, treatment options are limited for most people with advanced colorectal cancer who do not respond to earlier lines of therapy. For many patients at this stage, clinical trials are the only option they have left.

Unfortunately, California’s recently passed data privacy law will have unintended consequences for medical research and clinical trials in California and may inadvertently prevent patients like me from accessing the clinical trials that are keeping us alive.

To avoid a costly ballot initiative, the legislature quickly drafted and passed a sweeping consumer privacy law earlier this session that will change the way companies collect and manage consumer data.

Assembly Bill 375, the California Consumer Privacy Act, will require companies that store large amounts of data, such as Google, Facebook, Twitter, and others, to disclose what kinds of data they collect, and give consumers more control over how that data is shared.

One key provision of the bill allows people to request that a company not use their data. Although this data protection provision makes sense in many situations, it does not make sense for clinical trials.

Patients who agree to participate in a clinical trial are agreeing to allow researchers to use their data from the trial. If even a single patient decided to remove data from the trial, it could be catastrophic for the clinical trial. Biotech companies can spend on the order of a million dollars per patient and may only have a handful of patients in a trial. With so few patients, every patient’s data is extremely valuable. Companies are unlikely to risk this outlay if California residents can pull their data at any time.

As a result, we should all be very concerned that biotech companies will most likely opt not to do clinical trials in California or with California residents because their trial could be substantially impacted or even shut down entirely if one or more patients decide to prohibit use of their data.

A comprehensive federal law (HIPAA) currently has very strong protections for how health care data is used. It can never be shared or sold. This law also applies to third parties – such as research and data analytics organizations – that are critical to the success of clinical trials. If this new law replaced HIPPA, researchers would not be able to share data or work with companies that analyze data.

The authors of AB 375 did not intend for the bill to impact clinical trials. However, the unintended consequences of AB 375 on clinical trials in California need to be fixed now and cannot wait until next year. If there is uncertainty about when and how this problem will be fixed, researchers will simply not begin new research in California.

Clinical trials give many patients living with cancer and other life-threatening diseases hope – hope that if they hold on, a new treatment or cure is around the corner. But for me they have been more than hope.

If I had not had access to that first clinical trial – if AB 375 had become law six years ago – I would not be here and my children would have had to face growing up without a mother. Instead of saying goodbye to my children, I was able to celebrate their graduation from grade school and guide them as they were growing into young adults.

My twin daughters are now 15-years old and they continue to inspire me to fight. I’ve got to stay around to make their lives miserable. After all, what good is being a teenager without a mom around to embarrass you?

Others deserve the same chance.

I urge all members of the California legislature to act quickly to address the unintended consequences of AB 375 in a way that preserves its robust data privacy protections while also ensuring that patients can continue to access innovative, life-saving treatments in clinical trials.

Eve Bukowski is a Davis resident and the vice president of government relations and patient advocacy for the California Life Sciences Association.

  • Paul Gladfelty

    Politics can often be an impersonal business. We often talk about legislative changes in a vacuum and as lobbyists we often talk about the law of unintended consequences.

    Eve Bukowski I have had the the privilege of knowing and working with for a good number of years. She is in a word…INSPIRING! I often have wondered how she does it. A mother, an active industry government affairs representative, and someone who has to face her mortality on a daily basis while having to endure treatments and surgeries to keep her going.

    Assembly bill 375 which passed to address consumer privacy as a result of staving off an expensive initiative fight passed as mostly a “take or leave it” measure. The legislation had many unintended consequences. One of those unintended consequences was its impact on clinical trials, hospitals, physicians, biotechnology innovators and others in the business to cure patients from their illness.

    Current federal law protects patient information at the highest levels. Privacy law affords no greater protection to individuals than a patients medical information! The healthcare community in this case is in unanimous agreement (which rarely happens) to provide language that is a complete solution from AB 375’s unintended consequences of overreaching.

    There is a reason information among providers needs to be shared as protected under federal law! To hamper that in anyway would be a travesty to patients, especially those like Eve and other Californians under similar circumstances who have been given hope with new medicines and treatment where none had previously existed.

    The healthcare industry is often accused of doing things for their own self vested interests. In this case, this is all about helping existing patients and future ones from the effects of a debilitating disease or condition or in the worst case scenario a death sentence that is pending due to no fault of the patient.

    The Legislature needs to act quickly and decisively to do the right thing!

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