Published Nov 26, 2024

Making Way To The White House After Bone Cancer Fight: 33-Year-Old Natalie Harp Stands Firm On ‘Right To Try’ Act Which Led To Lifesaving Treatment

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Understanding The 'Right to Try' Act

Natalie Harp is making her way into the White House as an aide for President-elect Donald Trump, years after urging for support on the federal “Right to Try” Act—something she claims offered her access to life-saving experimental immunotherapy treatment in her fight against stage 2 bone cancer.
The “Right to Try” Act offers “eligible” patients access to “eligible” experimental therapies, not yet approved by the FDA but guidelines remain in place. It’s similar to the “Expanded Access Program” which is FDA-supervised and patients assume all risks for treatments that have not yet been approved for use by the FDA.
Meanwhile, a clinical trial is a research study involving volunteers that looks into using new drugs or therapies. The goal of these studies is to test if new treatments are safe and effective.
“Clinical trials are the first choice for patients seeking experimental therapies,” Dr. Michael Sekeres, Director of the Leukemia Program and Vice-Chair of Clinical Research at Cleveland Clinic Cancer Center told SurvivorNet. “Clinical trials are something I prefer because they are rigorously monitored including for whether or not a drug works and for the toxicities that a patient may experience on that clinical trial.”
SurvivorNet’s guide to clinical trials, explains what clinical trials are, why they’re so important and how to go about taking part in one. These trials can give patients access to incredible new therapies, or what some would call “tomorrow’s medicine,” today. (If you’re looking for a clinical trial, SurvivorNet can help. Check out our SurvivorNet Clinical Trial Finder.)

Political aide and former TV personality Natalie Harp is making her way into the White House after maintaining support for the federal “Right to Try” Act, which was signed into law in May of 2018—something she claims offered her access to life-saving experimental immunotherapy treatment in her fight against stage 2 bone cancer.

The 33-year-old California native, who obtained an MBA from Liberty University and insisted years ago that the Act saves lives despite critics saying it offers false hope, is now working as an aide for President-elect Donald Trump.

While addressing the “Right To Try” Act at the Faith & Freedom Coalitions Road to Majority conference in Washington, D.C. years ago, Harp said, according to Liberty University, which recapped the event, “We all know the story about the Good Samaritan, but what you don’t know is that I was that forgotten person on the side of the road, the victim of medical error — the No. 3 cause of death under the previous administration — and left to die of cancer.

“They wrote me prescriptions for opioids, and they walked on.”

Her health struggles started in 2015 when she was accidentally injected with sterile water by a nurse, followed by two unsuccessful chemotherapies and being denied by clinical trials, Liberty University explains.

Harp said, “When I failed the chemotherapies that were on the market, no one wanted me in their clinical trials. I’d make them look bad. They didn’t give me the right to try experimental treatments. I’d have died waiting for them to be approved.”

Speaking during an interview prior to the conferene, Harp added, “Right to Try empowers the terminally ill to fight with dignity for life-saving experimental treatments and potential cures rather than be forced into pain clinics and ‘Death With Dignity.”

Additionally, in a video interview on Fox News back in 2019, Harp revealed, “I’m not dying of cancer anymore, which is a real miracle.”

Clinical Trials, First, Doctors Say

Clinical trials are the first choice for patients seeking experimental therapies, Dr. Michael Sekeres, Director of the Leukemia Program and Vice-Chair of Clinical Research at Cleveland Clinic Cancer Center told SurvivorNet in an earlier interview.

“Clinical trials are something I prefer because they are rigorously monitored including for whether or not a drug works and for the toxicities that a patient may experience on that clinical trial.”

Dr. Mikkael Sekeres, Director of the Leukemia Program at Cleveland Clinic Cancer Center, points out that, compared to clinical trials, the Right to Try approach makes it difficult to track patient response and side effects of new cancer therapies.

In fact, the Right to Try Act specifies that patients must have exhausted treatment and clinical trial options before they’ll be eligible. So, before exploring untested therapies, always seek clinical trials first.

Another option for obtaining drugs that aren’t yet FDA-approved are called “Single Patient Investigational New Drug Protocols” (or Single Patient INDs).

“We actually submit a very brief protocol through our institutional review board. And a patient signs a consent to receive an investigational drug,” says Dr. Sekeres, who adds that the “FDA approves 99 percent of the applications submitted for single patients INDs.”

“We monitor that patient closely, for side effects and for whether or not that drug works,” he notes.

The Right to Try Act: What Is It?

The Right to Try Act, which was signed into law in May of 2018, offers certain patients access to certain unapproved treatments, according to the Food and Drug Administration (FDA).

It was designed for patients who have been diagnosed with life-threatening diseases or conditions, who have exhausted all treatment options, and who are unable to participate in a clinical trial.

While some have described the Right to Try Act as the medical equivalent of a Hail-Mary pass, the FDA outlines specific criteria for the patients who opt-in as well as for the treatments they hope to try.

For instance, the Act defines “eligible investigational drugs” as those for which a Phase 1 clinical trial has been completed. “We’ve seen so many times, drugs that have failed our patients after early phase studies and that’s when drugs would be available through Right to Try,” says Dr. Sekeres.

“After early phase studies, my preference would be to enroll patients onto clinical trials of investigational drugs or to obtain single patient IND’swhere we can monitor those patients much more closely and educate other patients about the efficacy of these drugs than we would through a Right to Try approach,” he notes.

Dr. Jim Allison, Chair of the Department of Immunology at MD Anderson Cancer Center, and the winner of the 2018 Nobel Prize for Physiology or Medicine tells SurvivorNet that the next big wave of research in cancer treatment involves combining immunotherapy with targeted drugs.

Additionally, The Right To Try Act is similar to the FDA’s “Expanded Access Program” which allows access to investigational medical products when no other options are available.

Under this program, treatment is supervised by the FDAs Institutional Review Board, which reviews and approves all requests.

Understanding Clinical Trials

A clinical trial is a research study involving volunteers that looks into using new drugs or therapies. The goal of these studies is to test if new treatments are safe and effective.

Clinical trials can be an option for people with cancer at many points during the treatment process. Your doctor may have spoken with you about possibly enrolling in a trial if you have advanced disease or if there’s a drug that’s currently considered investigational that may work better than the standard for you.

A lot of patients may feel uncomfortable about the thought of participating in a trial, but the trials can provide amazing opportunities for patients. For one thing, they give patients access to a bevy of new drugs that are currently being developed by pharmaceutical companies.

Things to Consider

In the U.S., all new drugs have to go through clinical trials before the FDA will approve them. In addition to being potentially live-saving for patients, these trials are also necessary to advance science and cancer treatments.

However, participating in a trial comes with risks as well, and it’s important to talk to your doctor about this before getting involved in one. Some risks to consider are:

The risk of harm and/or side effects due to experimental treatments
Researchers may be unaware of some potential side effects for experimental treatments
The treatment may not work for you, even if it has worked for others

Still, joining a clinical trial comes with benefits as well. You will be given access to treatments that could be life-saving, but simply haven’t made it through the approval process yet.

Clinical Trials Can be Life-Saving for Some

If participating in a clinical trial is something you think you may be interested in, the government has a list of trials that are currently ongoing. SurvivorNet also has a tool to help you find trials for your particular disease.

Understanding Informed Consent

The informed consent process for a clinical trial will usually involve the research team presenting you with both standard consent forms as well as any other relevant information you may need about the treatments to know whether you wish to begin a clinical trial or stay in one if you’re already enrolled.

Before you enroll in a trial, you must be given the opportunity to read the consent documents fully and to ask any questions you may have. The documents will likely contain the following:

The purpose of the research
Any risks and benefits expected from the research
Information about procedures that may cause discomfort (like frequent blood tests)
Any alternative procedures the patient might consider instead
How the patient’s information will be kept private
How long the study is expected to take
A form confirming you are participating in research voluntarily
Whether any compensation or additional medical care is available if some sort of injury occurs
The patient’s rights (like the right to stop research in the middle of the trial)
Contacts for any patient questions

Exceptional Responders: Why Do Some People Respond Better to Treatment?

During the time that you are participating in a clinical trial, the researchers may also make new discoveries that could affect you and how you’re being treated. At this point, they may ask you to sign a new consent form or you may decide you no longer want to be a part of the trial. Patients are allowed to walk away at any time during the trial.

Understanding your rights as a voluntary patient is important before you take part in a clinical trial, and understanding that the treatment may not work is crucial as well.

Who Can Sign Up for Clinical Trials?

If you’re interested in taking part in a clinical trial, the first thing to do is to speak to your doctor about the possibility of a trial. Blindly searching trials on the internet might not be the best advice available; using either the government’s clinical trials database or SurvivorNet’s resources specifically for cancer patients is your best option.

However, just because you’re willing to take part in a clinical trial doesn’t necessarily mean you will be able to join. These trials have specific criteria that patients need to meet in order to take part. At the end of the day, even though these trials can have incredible results and provide you with access to cutting-edge therapies, these are controlled experiments.

For each trial, there will be certain inclusion and exclusion criteria.

Why Do People Get Excluded From Clinical Trials?

Sometimes, patients may be excluded from certain trials if their cancer has spread to their brain. If the metastases aren’t under control, the patient may be unable to participate because researchers are concerned that they won’t be able to complete the whole study.

There are options for people who may not be eligible for the clinical trials they wish to participate in, but still want to try the therapies. A few years ago, the U.S. passed something called “Right to Try” legislation. This gives terminally ill people access to highly experimental drugs that are in “phase one” of the clinical trial process.

Your doctor may also request access to a single patient IND (investigational new drug) on your behalf, which can also give access to treatments that the FDA has not yet approved.