Institutionalizing DIY

Image Courtesy of Ben Harris

Image Courtesy of Ben Harris

“I would argue it should be mandatory that the patient’s medical record be public,” said medical physicist and ALS patient Ben Harris. “Privacy kills.”

Thus far, I have focused the story of do-it-yourself medicine on patients working entirely on their own, coordinating their efforts online to test new treatments for an incurable disease. But all of these patients have doctors, many of whom support their DIY efforts. Ben envisions a reformation of existing health-care system and clinical research protocols—supported by patient activism and data sharing.

He envisions physicians of terminally ill patients having the authority “to prescribe any drug to their patient”—even those not yet approved for the disease being treated—“with the agreement that their data is made available publicly,” he told me earlier this month in his home in Bloomington, Indiana. The information generated, he said, could help guide drug development, flagging promising candidates to enter formalized clinical trials, while weeding out the bad eggs. “We should already know if a substance works before we go to a clinical trial,” Ben said. “[To] find out if it works with a clinical trial, it takes too long and is too costly.”

Currently, however, FDA regulations limit patient use of experimental treatments, and even those programs designed to grant early access are often resisted by drug companies and manufacturers concerned that an adverse event could stall or derail the drug’s path to the clinic. Furthermore, even for drugs that are on the market, liability and other legal issues dissuade many physicians from prescribing drugs off-label (for an indication other than the one for which it has been approved).

But Ben thinks that regulations could be put in place to supply patients with experimental drugs and give doctors the freedom to make decisions about the drugs’ use on a patient-to-patient basis, just as they already do for cases in which multiple treatment options are available. “If a trial drug hurts me, I can’t sue anyone. Drug companies are protected,” he said, communicating by typing on the family’s flat-panel television because ALS has completely taken his voice. “Why couldn’t we protect physicians in a similar way?”

Of course, one of the leading criticisms of DIY medicine is safety. Patients may have incomplete information, and physicians may not be qualified to decide whether a patient should take a drug that hasn’t been approved to treat his disease. But when I raised these concerns with Ben, he simply reiterated that he was advocating specifically for terminally ill patients, who need the leeway to go outside of the clinical research system to try new treatments before it’s too late.

“All I am saying is allow those with terminal illness to take big risks,” he said. “I find it fascinating that we as a country were perfectly willing to send 4,000 young men and women to their death overseas but I am forbidden to risk my life with a risky treatment, even though I will die soon anyway.”

Crowd regulation

Among the many safety risks of trying experimental drugs outside the context of a formalized clinical trial is the potential for predatory salesmen to take advantage by peddling unproven or even dangerous remedies for profit. That was the overriding problem that the US Food and Drug administration was founded to resolve, and while the agency has taken great strides toward preventing the deception that was rampant at the turn of the 19th century, such maleficence still exists.

But Ben, who has taken part in both FDA-sanctioned and DIY clinical efforts, argues that the online patient community is “very good at self-regulating.” “I see internet-based sharing is a form of oversight,” he said. “Scams depend on secrecy.” He recalled animated discussions in online patient forums about a stem-cell procedure being offered in China. Some patients were really touting its effectiveness, but when fellow ALS patient Rob Tison took a closer look at the data they were reporting, he found that the treatment was not having any benefit. “It was a bloody fight online, but the truth did prevail,” Ben said—“the procedure was useless.”

He added that the online model he proposes would work most readily for drugs that are already on the market. “Most of the drugs that go through safety testing have been shown to be safe already,” he said. Other treatments, such as sodium chlorite, while not approved as a drug for any medical use, has been tested extensively for safety because it is used to purify drinking water. And besides, he added, there is no reason to believe that the risk is any greater than in an FDA-sanctioned trial. Indeed, several experimental treatments for ALS have actually caused harm, accelerating disease progression in many patients. “The risk is there anyway,” he said.

Furthermore, Ben argued that the risk associated with a formal clinical trial may be more obscure. “When you hand a consent form to an uneducated person, the vast majority do not understand what they are reading.” But in the online model, the ones taking the risk are the ones running the experiment, he said. “If the ‘trial’ is organized by the individuals [partaking], consent takes a different meaning. You don’t have a business entity asking you to swallow a chemical; you are doing it on your own and sharing your experience.”

Ben’s ideas rest on the ability of patients with terminal, incurable diseases to participate in their own risk-benefit assessments and help make decisions about their care—something that many bioethicists will question. But it’s something that Ben has done from the start. “I don’t think you can be overly protective of people,” he said. “It is up to the person what level of risk they are willing to take.”

His thought experiment could be considered radical, but as the Facebook generation ages, he argues, the pressure for such a change is only going to grow. “Twenty years from now, the majority of terminally ill patients will seek outlets for sharing their medical information. If there are a couple success stories with this model, it will probably move the government to formalize it.”

What do you think? Ben welcomes your responses below—the good, the bad, and the ugly! “I love debating so don’t hold back,” he said. “I have an MS in philosophy so I can talk until the cows come home (only limited by my weak hands).”


4 thoughts on “Institutionalizing DIY

  1. This is a remarkable subject, and it’s thrilling that you are looking into it! I hope you can find avenues for reaching a wider audience as it sounds like there is much you have learned — and no doubt will learn — that should benefit the rest of us. Bravo! And whatever you do, keep going!

  2. Whatever happened to the NP001 study. My fathers last dose was Jan. 2012 and it was rumored it would be phase III by mid to late spring 2012. Now we hear nothing about it… It’s as of stem cell took over the media by helping one individual. The Dex trial fought neck and neck for release dates and now the Dex was shut down and I hear nothing about NP001. What on earth is the meaning of Orphan disease and early release. I am baffled by the never ending delays!!!!

  3. Pingback: Rest in Peace, Happy Physicist | DIY Medicine

  4. Every person should be able to control their own life, as long as it doesn’t endanger others. It is simple Human Dignity. Leaving decision to others is wrong, in my view. Take a stand. Stick with it! Or not! Your decision, your life. Gary Hickernell, PhD chemist.

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