Big Pharma Meds Almost Sent Me to an Early Grave, While Pot Helped Ease My Disease

I was diagnosed with Crohn’s disease 10 years ago this August, and looking back those were some pretty horrific days. Within months of being diagnosed I was ready for my first (and hopefully only) surgery to remove over a foot of my diseased colon. At 18 years old I was getting an unintentional crash course on how the American healthcare system works, and the hell of being a human lab rat for corporate pharmaceuticals.

After almost a decade of taking and struggling to pay for Johnson & Johnson’s most profitable drug, Remicade—a drug that brought in $9 billion last year alone—I sought to find out more about this relatively new drug, which was first approved, only for use in treating patients with Crohn’s disease, by the FDA in 1998. Remicade would later be approved to treat seven more conditions, including rheumatoid arthritis, ulcerative colitis and psoriasis. What I found was disappointing, but unfortunately, not all that unexpected in the American healthcare system.

After over a decade and a couple hundred thousand dollars later (scrambled together by me, my family, employers and the insurance companies that fought to throw me off their plans), I have learned that although it worked to an extent, the drug was likely sending me to an early grave while fueling record profits for the drug companies, doctors and hospitals I trusted with my health.

Not only that, likely alternative cures might be right under our noses, but are not being studied in earnest. Cannabis, a federally illegal drug I still risk arrest for purchasing and possessing, is showing signs of putting the disease into complete remission in foreign clinical trials. One-time treatments such as fecal transplants and parasitic worms are also showing promise, but have yet to catch on in favor of expensive pharmaceutical options designed for long-term use.

Because doctors believe Crohn’s disease can only ever be treated, not cured, very little research has been done on these alternative therapies and diet or lifestyle changes that could help treat or cure the illness. Crohn’s disease and conditions like it (both autoimmune and gastrointestinal) have been on the rise and have become really big business. Patients like me seeking alternative treatments are usually left to self-educate and pursue the treatments independent of their healthcare coverage. In the case of cannabis that means risking one's freedom for the sake of one's health.

Crohn’s Disease: A First World Affliction

The cause of Crohn’s disease is unknown, although researchers believe genetics can predispose a person to getting it and environmental triggers may cause the disease to manifest itself. Most diagnoses are made in a person’s late teens or early 20s, although there has been a rise in pediatric diagnoses as well.

I was diagnosed at 18, and because of an adoption in the family, we had no way of knowing to look for it. Doctors told me the problem was my vegetarian diet and sent me to a nutritionist. I was given pills for acid reflux, which I didn’t have. I was given pills for stomach ulcers, which I didn’t have. I reluctantly had my first colonoscopy, and was diagnosed with Crohn’s disease in August 2004.

Crohn’s is an autoimmune condition that causes inflammation primarily in specific parts of the intestines, but can affect any part of the digestive tract. A Crohn’s flareup is characterized by weight loss, fatigue, loss of appetite, chronic diarrhea, severe abdominal pain and inflammation of the joints, eyes, skin and liver. Patients with Crohn’s disease are always at an elevated risk of developing colon cancer.

I had no idea at the time, but I was developing a pretty deadly blockage, which is by far the most horrific thing about having Crohn’s disease. When inflammation is severe and goes on too long, scar tissue develops inside the intestines creating blockages that, if left untreated, can eventually kill the patient. The blockage and surgery to remove it are excruciatingly painful. Even breathing hurts after the surgery.

Once a patient has had surgery to treat the symptoms of inflammation, the risk of needing surgery again increases over time. At some point doctors may decide to remove the colon (we all start with about five feet) entirely and replace it with a colostomy bag outside the body.

Crohn’s disease was first identified and recognized in 1932. Before that it was often misdiagnosed as intestinal tuberculosis. Today 1.4 million Americans have the disease. Worldwide, the highest incidences of diagnosis occur in the United States, Canada, Australia and Western Europe, but beginning recently, other industrialized nations are now experiencing an increase in the rate of diagnosis as well.

The disease seems to manifest itself in more affluent and urbanized populations. While it used to primarily affect white populations (particularly those of Ashkenazi Jewish descent), rates among American blacks and Latinos are increasing. Demographically speaking, I fit the profile to a T. I am white and I grew up near the nation’s second largest city, Los Angeles, which also happens to be one of the wealthiest regions on the planet.

Some researchers believe an increase in the use of antibiotics (eradicating good bacteria in the gut) may play a role in triggering the disease in those with genetic predispositions to developing it, possibly explaining the higher rates of diagnosis in wealthier, first-world populations.

It is fair to say that, generally, the global population of people with Crohn’s have access to health insurance or state-run healthcare programs (which is necessary because the default management of the condition is primarily pharmaceutical and incredibly expensive).

Miracle Drug Makes Miracle Profits

For the first eight months after my diagnosis and leading up to my surgery I followed directions obediently and took a cocktail of pharmaceutical drugs including hydrocodone, 6-Mercaptopurine and Asacol. My doctor was throwing every pill in the book at my colon but none seemed to work. That is, until I was prescribed prednisone.

Prednisone, a powerful steroid, effectively eliminated the inflammation in my colon but gave me raging mood swings, water weight gain and “moon face,” or a swollen, acne-covered face. Finally, after my surgery I was introduced to my "miracle drug," Remicade (infliximab).

Remicade is a tumor necrosis factor (TNF) blocker. Patients with Crohn’s produce excess TNFa, causing inflammation of the lining of the intestines (and all the miserable symptoms that result). Unlike most prescriptions, Remicade is not a chemical drug, but rather a biological one. It is harvested directly from specially bioengineered mice producing a (mostly) human TNFa, to which they create antibodies that block the excess TNF produced. This biological distinction is the determinant factor in the drug’s pricing.

Biological drugs can carry costs of up to 22 times a chemical drug. One major factor in the astronomical pricing is legal. Chemical drugs, regulated via the Hatch-Waxman Act of 1984, cannot be manufactured as generics for a period of five years, allowing the company that invested in the pricey research and development to recoup its expenses and generate a profit before the market can be flooded with low-cost generics. Patents are usually filed for drugs before they win FDA approval, so although the five-year exclusivity period may end, generics are still prevented from entering the market if they violate the name-brand drug’s patent, which usually has a life of 20 years.

Biological drugs like Remicade, which were science fiction at the time of Hatch-Waxman, were not regulated in the legislation and so enjoyed indefinite exclusivity until the passage of the Affordable Care Act (aka Obamacare) in 2009. A 12-year time frame was applied to biologic drug exclusivity retroactive to the date of FDA approval, which would have meant generics could begin to enter the market in 2010. Remicade, however, has a 20-year patent filed in 1998, so no generic will be available domestically until 2018 at the very earliest.

The drug is administered intravenously and before insurance coverage the total cost to the consumer can range anywhere from $15,000 to $20,000 a year to that same price for a single infusion, which is typically administered every eight weeks in a hospital. The price of the drug and its administration fluctuate domestically based on region, insurance plans and individual hospital charges. Everybody gets their cut.

As the drug gets approved for more conditions, more and more patients are being prescribed Remicade. According to Johnson & Johnson, nearly 1.8 million people have been prescribed the drug worldwide. In 2012, estimated worldwide sales were about $6.7 billion. By 2013, total sales rose to $8.7 billion. After sister drug Humira’s $10 billion annual haul, Remicade is the second best-selling drug in the world and the best-selling drug for Johnson & Johnson, which reported net earnings of $13.8 billion in 2013.

Price of A Miracle

While Remicade has proven to be profitable for the healthcare industry and effective for many patients, the treatment comes with serious consequences.

I started taking Remicade in 2005, shortly after my surgery. At first it was fantastic; after two years of pain I felt like I could finally start the next phase of my life. I even enjoyed my time in the infusion center and the interesting conversations I had with people of all walks of life.

Remicade is an immunosuppressant drug. The years I was on Remicade, I was in and out of doctor’s offices with different infections, shingles, swollen inflamed eyeballs, skin rashes, gaping staph wounds and anything else I could possibly come in contact with riding public transportation around San Francisco.

Maintaining health insurance became my number-one priority as I tried to work my way through college (twice) and get a job that meant I could afford my life with Crohn’s. Getting sunk in medical debt alongside my student loan debt continues to be my biggest stressor.

I started gaining weight, which at first was a good thing. At the height of my Crohn’s I had dipped under 120 pounds, an unhealthy weight for my height. At one point I gained so much so fast I became concerned and scheduled a visit to my doctor to talk about it. They told me I needed to eat less and get more exercise. Unfortunately, I chose to believe the doctors that it was my fault and struggled to work it off to no avail.

In 2007, Cristal Brown, a researcher at the University of North Carolina at Chapel Hill, studied unexplained weight gain in patients using Remicade and found that some patients put on up to 75 pounds on the drug. Furthermore, Crohn’s patients were five times more likely to put on extreme amounts of weight, on average between 40 to 60 pounds. I had put on a total of 70 pounds over the course of my Remicade treatment. No such other studies have been conducted or are planned.

Shortly after it was approved by the FDA, the first black box warning for Remicade was issued in 2001 as links were drawn between diagnoses of tuberculosis and its use. The warning was amended in 2004, a year before I began the treatment, to include various cancers, liver failure and hepatitis, among other side-effects. The new warning was in response to a study published in the Journal of the American Medical Association, which concluded that patients taking Remicade had a three-fold increased risk of cancer.

But comparatively, I was lucky: I just got sick, fat and tripled my already elevated risk of getting cancer. In some patients, painful joint freezing takes hold of the body shortly after an infusion. While antibiotics and allergy medications are often administered before an infusion to prevent such reactions, they are not effective in all patients. The treatment has also been known to induce other autoimmune conditions such as lupus.

For Heather Barno of Wayne, New Jersey, Remicade induced lupus “so bad I couldn’t stand, get dressed or walk without help. I couldn’t even pull blankets up in bed.”

Barno was diagnosed with Crohn’s disease over 30 years ago and took Remicade for two periods; the first for three years and the second time only eight months because the treatment induced lupus. While her insurance reimbursed the costs of the treatment, she says paying outright was pretty difficult to manage sometimes.

After my surgery I had refused all other pharmaceutical drug treatments. I reluctantly agreed to the Remicade at first, having just gotten a medical marijuana card and wanting to go that route exclusively. My doctors had convinced me that if I didn’t take it or stopped it my Crohn’s would come back full force.

Then, last year, the insurance premiums started getting really high and I started looking at the option of quitting my miracle drug cold turkey. When faced with the possibility of quitting, I was concerned that my body would react negatively to a complete cessation of the drug and that I would spiral into another painful depressing journey that ended on an operating table again. But then I started doing my research and it became clear to me that my only option was to stop taking the drug, regardless of whether or not I could afford it.

Cost of Alternative Therapies

Today I live part-time between Utah and California. In Utah, possession of even a little bit of cannabis could easily land me behind bars. Despite the legal risk, using cannabis is actually a proven safer route to treating Crohn’s disease and far more effective to treating the symptoms of the disease holistically than any pharmaceutical ever was.

But I don’t own property nor do I have children, so I don’t have much to lose in choosing the safer option. For Greg Terry, a 55-year-old army vet and medical cannabis activist, using cannabis to treat his Crohn’s could potentially cost him his family.

Terry was diagnosed with Crohn’s disease at the age of 17. He was forced to leave the service in 1980 due to complications of the disease and the need for surgery to resect a portion of his small intestines. Since that time, Terry says he has effectively kept his Crohn’s in remission thanks to his cannabis use. For safety and purity, he grew his own medication—that is, before he and his wife Wendy decided to have children. Terry and Wendy live in Missouri, where marijuana possession carries legal punishments of 10 years to life. In all states, getting caught with any amount of cannabis could prompt an investigation by Child Protective Services and potential child removal. Terry made the decision to stop growing and take legal drugs instead, to protect his family.

In 2001 Terry began Remicade infusions. By the fourth infusion, Remicade had given him paralysis. “Every joint in my body was in so much pain. I couldn’t walk,” he says.

Doctors concluded the paralysis was a reaction to the infusion. While he has regained some function, he still uses a cane today. “All I use is cannabis to treat my Crohn’s now, after the Remicade scare I said no more, I will stick with cannabis," he concluded.

Other treatments for Crohn’s are largely experimental and require patients to seek and finance alternatives themselves. Parasitic worms can be ordered from Europe for about $4,700 but a doctor is unlikely to study, approve or monitor a patient’s use with that treatment. Fecal transplants are undergoing clinical trials but are unlikely to be offered to most patients anytime soon.

As for me, I have been off of Remicade for an entire year. At first I got sick, but then I started taking full extract cannabis oil. I have lost almost 40 pounds. Other than a regimen of vitamins, I am completely off all pharmaceutical drugs. I had to stop smoking cigarettes, drinking alcohol and otherwise torturing my body, but all in all I am fine, without paying Johnson & Johnson a dime. While the alternative treatment is not the quick fix Remicade was, it promotes long-term healing and it's safe, even if it isn’t FDA-approved.

Correction 7/30/2014: The original version of this article stated that the author was adopted, but that is not the case. There was an adpotion in the family, which kept the author from knowing her complete family medical history.