The Humira Trials: Judith’s Story

Editorial Note: AbbVie’s current legal action against the European Medicines Agency’s policy on access to clinical trial data led to the idea of an AbbVie – getting people on any drugs at all, especially new drugs and in particular biologicals, to do two things:

1. Report any of the effects they are having on RxISK.org
2. Sign the petition below

AbbVie applied to block access to two clinical study reports that focused on the safety and efficacy of their blockbuster Humira, responsible for 70% of the company’s profits. The reports were on its use for the treatment of Crohn’s disease. Another clinical study report concerned safety risks linked to combinations of Humira and corticosteroids.

Judith’s story below read against this background is fascinating. Is this the kind of thing AbbVie are trying to hide?

Judith’s story

At the age of 65, right after the death of my husband, I developed ulcerative colitis. In the following three years, I ran the gamut of all the drugs and procedures commonly used for this illness; Asacol, Lialda, Pentasa, Colazal, flagyl, prednisone, 6MP, azathioprine/allopurinol, mercaptopurine, hydrocortifoam enemas, Canasa suppositories, Nicotine transdermal patches, Remicaid and others that I cannot recall. Not counting the many colonoscopies and sigmoidosopys I had to endure. I had been seen and treated by three gastroenterologists.

Since nothing was working for me and I had never gone into remission, my last gastroenterologist heard about this clinical trial of Humira and recommended that I had nothing to lose by trying it.

So in November, 2007, I signed up for an Abbot Laboratory clinical trial for people with ulcerative colitis. It was a double blind study of Adalimumab (Humira), which meant I wouldn’t know if I was getting Humira or a placebo.

Before the treatment started, I had to have a physical exam, blood, urine, and stool tests, EKG, tuberculin PPD skin test, chest X-ray, a colonoscopy and flexible sigmoidoscopy. Some of these tests were repeated during specified weeks in the trial. I had to keep a diary and fill out a questionnaire about my health at each visit. I had to learn to inject myself a number of times each week or every other week.

The study stated that after Week 12, the blind would be opened if I had an inadequate response, or the doctor would increase the injections more frequently. If I completed the trial of 52 weeks, I would be compensated, $600.00. If not, $50.00 for each completed visit.

On Week 8, I underwent a flexible sigmoidoscopy according to the protocol. The participating gastroenterologist informed me that I was getting worse and would be removed from the trial. Why?

Nobody was supposed to know if I was getting the placebo or Humira. If I was getting worse, they were supposed to tell me if I was getting the placebo in which case I should get the real Humira. All I was told was that I was no longer in the trial.

I had my regular gastroenterologist call because he was instrumental in having me participate in this trial. He was told that I asked to be taken out of the study! Why would I travel 40 miles to participate in this trial and go through the battery of tests and then after 2 months, ask to be taken out of it? I was immediately sent a check for $200.00.

Over the years, I called to find out if I received the real Humira or the placebo. I was finally, given an answer last year. It seems as if I did receive the real stuff.

I can only conclude that they probably knew this, and since I wasn’t responding favorably, they kicked me out of the trial. This way, the results looked better. Does FDA take this kind of thing into account?

Let us see drug data! Tell AbbVie and InterMune: Drug hazards are not “trade secrets”!

The Petition

For too long, drug companies have sought to maximize their sales by hyping the benefits of new drugs while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in the EU – a development hailed by researchers around the world as a major step towards drug safety.

This process has been temporarily shut down by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, whose pulmonary-fibrosis drug Esbriet has recently been approved in Europe at a cost of over $40,000 per year. AbbVie and InterMune have filed suit to deny access to studies on the benefits and harms of these drugs, claiming these vital facts are “trade secrets” whose release would harm their profits. Their action has led to the shutdown of the entire public-access program, leaving millions of patients worldwide, and their doctors, in the dark.

We call on AbbVie and InterMune to drop their European Union lawsuit and release all the patient level data on Humira, Esbriet and their other products. Vital data on drug safety should never be hidden as a “trade secret.” By copying this petition to President Barack Obama and members of his Cabinet we call on them to ensure that meaningful public access to clinical trial data becomes the policy of the FDA and is written into any international trade agreements governing the sale of prescription drugs and devices.

Click here to read and sign the petition.