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

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

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.