Will antidepressant medications ever require informed consent?

That question is at the heart of the new documentary, "Medicating Normal."

man holding various pills and a glass of water
Image by Elisa Riva
  • The directors of the new documentary, "Medicating Normal," want psychiatrists to require informed consent when writing prescriptions.
  • Long-term effects of antidepressant usage do not have to be documented for FDA approval.
  • Big Think talks to producer/director Wendy Ratcliffe and film subject, Angela Peacock.

While humoral theory was finally abandoned with the acceptance of germ theory, Hippocrates offered many important insights into the nature of disease. The humors pointed to bodily causes of disease at a time when many thought divine forces were at play. ("Men think [epilepsy] divine merely because they do not understand it," wrote one Hippocratic student.) Though disease specificity of blood and phlegm took time to understand, important ramifications for the future of medicine were being considered nearly 2,500 years ago.

The most interesting humor was black bile. Black liquid secreted by the spleen, the temperamental correlation resonates: melancholy. Hippocratic students recognized depression as an imbalance and sought methods to cure it. Over the centuries, various tinctures and herbs addressed melancholy. Doctors agreed targeted medicine helped the patient overcome the imbalance leading to depression; they also believed depression was a natural state that everyone experiences from time to time.

Our views on depression changed when twentieth-century pharmacology entered the picture. Doctors had terrible ideas, such as electroshock therapy and lobotomies, but one of the worst might be the chemical imbalance theory of the brain. As former psychiatrist Dean Schuyler wrote in his 1974 book, most depressive episodes "will run their course and terminate with virtually complete recovery without specific intervention."

That's not how the growing pharmaceutical industry treated it. The pathologizing of depression meant that doctors—in this case, psychiatrists—could diagnose and treat what had long been considered a natural part of life. As often happens in drug development, a substance is discovered and only then is a disease needed for it to treat. Mental health seems particularly useful in this process.

Depression wasn't the only mental health condition to be pathologized. Anxiety is a big one. Lack of focus is another. Any minor deviation from a perceived norm has, over the course of the 20th century, become subjected to diagnosis and, thanks to the lobbying power of the pharmaceutical industry, pharmacological treatments with little to no informed consent.

Take Angela Peacock, an Iraq War veteran that was medically retired due to PTSD. Upon her return in 2004, she was put on one drug after another. By 2006, that meant 18 different drugs. "That took away my ability to even know there's anything wrong with that," she recently told me prior to an online screening of "Medicating Normal" a new documentary that challenges the market for increasingly over-prescribed and under-studied prescription drugs.

EarthRise Podcast 93: Medicating Normal (with Angela Peacock & Wendy Ratcliffe)

During our talk, Peacock is seated next to director and producer, Wendy Ratcliffe. Co-director Lynn Cunningham was initially inspired to pursue this topic when a family member's health deteriorated after 15 years of psychiatric medication. A Harvard graduate and star athlete, this family member is now on disability and exhibits poor mental health.

This brings up a question modern psychiatry rarely confronts: Why are prescription drug rates and rates of anxiety and depression increasing? If the former worked, shouldn't the latter be in decline?

That's not what's happened. Ratcliffe decided to produce "Medicating Normal" after reading Robert Whitaker's 2010 book, "Anatomy of an Epidemic." (Whitaker is featured in the film and was recently featured in my column.) For over three years, the crew followed five people (including Peacock) around as they dealt with the terrifying health consequences of medication dependence.

"These medicines are causing an epidemic of disability," Ratcliffe says. When I ask what she learned about the pharmaceutical industry while making the film, her eyes light up. She shakes her head in disbelief.

"I'm totally shocked by the FDA process: medications that are designed to be taken for many years or even a lifetime, to get them approved they only have to be shown to work better than a placebo over three to six weeks. There is no obligation to test these drugs for long-term side effects. I was shocked to discover that pharmaceutical companies pay for most of the research on their own drugs. They design the research to get the result that they want. When they don't like the result of the trial, they throw it out."

Whitaker told me about the original trial for the benzodiazepine, Xanax. At four weeks, it outperformed the placebo. At eight weeks, however, there was no discernible difference between the placebo and Xanax. By 14 weeks, the placebo outperformed Xanax. To get around this inconvenient data, Upjohn only reported the four-week data. The FDA approved the drug.

That was in 1980. In 2017, 25 million Xanax prescriptions were written.

Pharmaceutical companies understand how to get FDA approval. Like oil companies, they're clueless when tragedy strikes. They don't know how to deal with the long-term side effects of their drugs, so they ignore them. Ratcliffe says the doctors she talked with weren't trained in tapering protocols or educated about the negative impact of the drugs they prescribe. The reflexive response is another drug, not an honest investigation of the drugs themselves.

Wendy Ratcliffe and Lynn Cunningham at the premiere of Medicating Normal at the Santa Barbara International Film Festival.

Credit: Wendy Ratcliffe

This is the process that led to Peacock being prescribed 18 drugs at once. The side effects, she confirms, are not minor.

"From a patient standpoint, I thought dizziness meant I had to get up slowly. The dizziness I experienced coming off of antidepressants and benzodiazepines was like, I can't walk. It was like walking on the Grand Canyon in high heels on a tight wire."

Though the final benzodiazepine nearly killed her, Peacock finally abandoned all drugs in 2016. Today, she feels old parts of herself coming back, but she's not yet whole. She's not sure she'll ever be. Currently living in her RV, she travels around the country educating former vets and promoting the documentary. Unlike her time on prescription drugs, she now has a mission.

"The way we bring people home from war and then put them on drugs is not right," she says. She is doing her best to change that fact.

Both women agree on an important point: psychiatry needs informed consent. The problem, Ratcliffe says, is that "psychiatry lobbying groups feel that informed consent impedes their ability to prescribe." She compares the industry to the NRA: any criticism is treated as a potential keystone that, if removed, will take out the entire system. In reality, all patients are asking for is honesty about how these drugs interact in their bodies.

We don't know the long-term effects because pharmaceutical companies don't have to study them. If the industry isn't required to disclose these effects, and psychiatrists remain ignorant of the real damage being done to some of their patients, informed consent remains an intangible dream with no pathway to reality.

As Whitaker writes in "Anatomy of an Epidemic," antidepressants don't treat chemical imbalances—they create them. Over 2,500 years ago, doctors recognized melancholy as a natural part of life—one that, as Schuyler and others realized, goes away with time. Yet for a growing number of Americans, depression will never fade because they weren't informed about the potential consequences of the prescription they were handed. They never know what they're being told to swallow.

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Stay in touch with Derek on Twitter, Facebook and Substack. His next book is "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."

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CRISPR therapy cures first genetic disorder inside the body

It marks a breakthrough in using gene editing to treat diseases.

Credit: National Cancer Institute via Unsplash
Technology & Innovation

This article was originally published by our sister site, Freethink.

For the first time, researchers appear to have effectively treated a genetic disorder by directly injecting a CRISPR therapy into patients' bloodstreams — overcoming one of the biggest hurdles to curing diseases with the gene editing technology.

The therapy appears to be astonishingly effective, editing nearly every cell in the liver to stop a disease-causing mutation.

The challenge: CRISPR gives us the ability to correct genetic mutations, and given that such mutations are responsible for more than 6,000 human diseases, the tech has the potential to dramatically improve human health.

One way to use CRISPR to treat diseases is to remove affected cells from a patient, edit out the mutation in the lab, and place the cells back in the body to replicate — that's how one team functionally cured people with the blood disorder sickle cell anemia, editing and then infusing bone marrow cells.

Bone marrow is a special case, though, and many mutations cause disease in organs that are harder to fix.

Another option is to insert the CRISPR system itself into the body so that it can make edits directly in the affected organs (that's only been attempted once, in an ongoing study in which people had a CRISPR therapy injected into their eyes to treat a rare vision disorder).

Injecting a CRISPR therapy right into the bloodstream has been a problem, though, because the therapy has to find the right cells to edit. An inherited mutation will be in the DNA of every cell of your body, but if it only causes disease in the liver, you don't want your therapy being used up in the pancreas or kidneys.

A new CRISPR therapy: Now, researchers from Intellia Therapeutics and Regeneron Pharmaceuticals have demonstrated for the first time that a CRISPR therapy delivered into the bloodstream can travel to desired tissues to make edits.

We can overcome one of the biggest challenges with applying CRISPR clinically.

—JENNIFER DOUDNA

"This is a major milestone for patients," Jennifer Doudna, co-developer of CRISPR, who wasn't involved in the trial, told NPR.

"While these are early data, they show us that we can overcome one of the biggest challenges with applying CRISPR clinically so far, which is being able to deliver it systemically and get it to the right place," she continued.

What they did: During a phase 1 clinical trial, Intellia researchers injected a CRISPR therapy dubbed NTLA-2001 into the bloodstreams of six people with a rare, potentially fatal genetic disorder called transthyretin amyloidosis.

The livers of people with transthyretin amyloidosis produce a destructive protein, and the CRISPR therapy was designed to target the gene that makes the protein and halt its production. After just one injection of NTLA-2001, the three patients given a higher dose saw their levels of the protein drop by 80% to 96%.

A better option: The CRISPR therapy produced only mild adverse effects and did lower the protein levels, but we don't know yet if the effect will be permanent. It'll also be a few months before we know if the therapy can alleviate the symptoms of transthyretin amyloidosis.

This is a wonderful day for the future of gene-editing as a medicine.

—FYODOR URNOV

If everything goes as hoped, though, NTLA-2001 could one day offer a better treatment option for transthyretin amyloidosis than a currently approved medication, patisiran, which only reduces toxic protein levels by 81% and must be injected regularly.

Looking ahead: Even more exciting than NTLA-2001's potential impact on transthyretin amyloidosis, though, is the knowledge that we may be able to use CRISPR injections to treat other genetic disorders that are difficult to target directly, such as heart or brain diseases.

"This is a wonderful day for the future of gene-editing as a medicine," Fyodor Urnov, a UC Berkeley professor of genetics, who wasn't involved in the trial, told NPR. "We as a species are watching this remarkable new show called: our gene-edited future."

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