… and Big Pharma keeps right on selling them
“I still have the unanswered question of how many deaths related to a drug does it take before it is taken off the market?” – Bev Webber, whose mother died after taking a heavily marketed drug
USA TODAY – With her kidneys and liver failing and a 106-degree temperature that had smoldered for days, Helen Tschannen was being kept alive on a ventilator.
Doctors were not certain what was happening, but the family knew this: Tschannen, 77, did not want to be kept alive by machines.
After 21 days in an Illinois hospital, they gathered at her bedside and wrestled with whether they were doing the right thing.
A nurse unhooked the equipment. Tschannen took one breath on her own and died.
It was Oct. 19, 2004.
In the weeks after Tschannen’s death, her family learned she had been suffering from a common fungal infection known as histoplasmosis. For most people, it produces no symptoms or only mild ones.
But Tschannen, it turns out, was at special risk of a bad infection, not because of her age or because she lived in a region where the fungus lurks, but because of a drug she had started taking a few months earlier to tame her rheumatoid arthritis.
The drug, Remicade, had been approved for her condition in 1999.
“The company’s blockbuster rheumatoid arthritis drug Remicade brought in $1.39 billion for the quarter.” BiopharmaDive report on Johnson&Johnson sales of Remicade, first quarter 2018
It was at the forefront of a class of drugs known as biological medicines, or biologics, that treat autoimmune diseases of the skin, joints and gastrointestinal system.
Unlike drugs made chemically, biologics are cultured in the laboratory from animal cells and are given by injection or IV.
In the past 20 years, the drugs — which can cost some $40,000 a year — have flooded the market. Ads for several, including Humira and Cosentyx, are fixtures on television, promising improved gastrointestinal symptoms or clearer skin with “sexy elbows.”
Preliminary numbers for 2018 show that group of biologics was on pace to top 6 million prescriptions last year, a nearly 50% increase from 2013.
The drugs are effective in treating rheumatoid arthritis, psoriasis and other autoimmune disorders. They often lead to significant improvement in symptoms, even remission.
But there is a darker aspect to the drugs that is less known to the public:
They leave patients more susceptible to a growing number of infections and other serious side effects.
Tschannen’s case is one of at least 34,000 reports to the U.S. Food and Drug Administration of people who died while using biologic drugs since 2004 … Read more.
What is Remicade?
SERIOUS INFECTIONS and MALIGNANCY
RXLIST.COM – Patients treated with REMICADE® are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
REMICADE should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy.1,2 Treatment for latent infection should be initiated prior to REMICADE use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with REMICADE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with REMICADE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE [see WARNINGS AND PRECAUTIONS].