Patient expresses concern about lack of data on biological drugs

April 18, 2013
Patient expresses concern about lack of data on biological drugs
A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.

(HealthDay)—A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.

Alex Lomas, a patient with Crohn's disease from London who has been taking for three years with beneficial results discusses the lack of trial data available on biologicals.

Noting that part of the National Institute for Health and Care Excellence's approval for use of adalimumab for Crohn's disease was the recommendation to set up a registry to track long-term outcomes and after treatment withdrawal, Lomas reports that registries are fragmented or are still at pilot stage. He adds that the attempt by AbbVie, the maker of adalimumab, to prevent the European Medicines Agency from disclosing recent trial data submitted during the drug's approval process is cause for concern and is preventing patients and from making informed decisions about the use of this treatment.

"As the drug industry and medical profession as a whole move towards the registration of all trials, and the publication of all trial data—in no small way thanks to the All Trials initiative (www.alltrials.net)—this decision by AbbVie is a backwards step and is offensive to trial participants, patients, and the wider public who ultimately pick up the tab," Lomas writes.

Explore further: Adalimumab is a promising therapy for children with Crohn's disease

More information: Full Text

Related Stories

Adalimumab is a promising therapy for children with Crohn's disease

August 6, 2012
Adalimumab (an anti-tumor necrosis factor [TNF] antibody) is effective in maintaining remission in certain pediatric patients with Crohn's disease, according to a new study in Gastroenterology, the official journal of the ...

Immunogenicity strongly impacts response to adalimumab in RA

December 13, 2012
(HealthDay)—For patients with rheumatoid arthritis (RA), long-term clinical outcomes are good with etanercept and adalimumab; but for adalimumab, treatment response is strongly dependent on the presence or absence of anti-adalimumab ...

Adalimumab relieves hidradenitis suppurativa

December 18, 2012
(HealthDay)—For patients with moderate-to-severe hidradenitis suppurativa (HS), a chronic skin disease characterized by painful abscesses, nodules, and draining fistulas in the axilla and groin, treatment with once-weekly ...

Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

January 18, 2012
Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today.

Adalimumab levels detected in cord blood and infants exposed in utero

May 8, 2011
Adalimumab (ADA), a drug often prescribed for women with Crohn's disease, actively crosses the placenta during the final trimester of pregnancy and remains in a newborn's bloodstream for at least three months, researchers ...

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.