Merck & Co., in the middle of $41.1 (US) billion merger talks with Schering-Plough Corp., is facing more troubles as the Food and Drug Administration in the United States demands that warnings of dangerous side effects from its top-selling asthma drug be boosted following growing evidence of problems.
AstraZeneca and Cornerstone Therapeutics are facing similar orders.
After 15 months of investigation, the Food and Drug Administration said Merck & Co. Inc., AstraZeneca and Cornerstone Therapeutics will have to raise label warnings about psychiatric problems reported by a handful of patients taking their drugs.
"Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications," the FDA said in a posting to its Web site.
A spokeswoman for Merck said the language already appears in Singulair's label, but will be raised to the "precautions" section. It's now listed in a section about various side effects reported by patients.
"We've been working with the FDA since Singulair came to market and every time we update the label it's in cooperation with them," said Merck spokeswoman Pamela Eisele. ...
The exact language of the labeling updates has not been released, but the FDA said it could mention a slew of psychiatric problems, including: "agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior — including suicide — and tremors."
The move comes just weeks after a former research subinvestigator at Vivra Asthma & Allergy, an asthma research and treatment centre, went public with allegations that its Singular trails were knowingly skewed and falsified.
Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate, and Xopenex conducted at the Tucson, Ariz., facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications, says Robert Davidson, M.D., a former clinical research subinvestigator (SI) at the facility. ...
Davidson charges that during aggressive recruitment schemes in the late 1990s, patients with abnormal EKGs, multiple risk factors for coronary artery disease, arrhythmias, pulmonary embolisms, rheumatic fever histories, acute illnesses, and even pituitary tumors were enrolled with impunity in trials that earned investigators as much as $10,000 per patient.
Patients were “prescreened” for asthma drug trials with medically unnecessary pulmonary function tests (PFTs) without their knowledge or consent and had medication dosages reduced in apparent efforts to qualify them for the lucrative trials.
Staff could be seen entering rooms where placebos and real drugs were mixed and unblended, invalidating entire studies sent to the FDA as data for new drug applications.
The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials despite risks to their health and early terminations, coercing unwilling patients to participate, and directly falsifying patient study diaries, say documents filed by Davidson in a federal complaint.
Merck stands by its drug.
"For the millions of people suffering from either asthma or allergic rhinitis, SINGULAIR is an important treatment option for appropriate patients," said Scott Korn, M.D., vice president, Clinical Risk Management and Safety Surveillance, Merck Research Laboratories.
Naturally, Merck management scheduled a conference call for drug reps who tout Singulair at 6p.m. on Friday (an hour guaranteed to please reps hoping for a stress-free weekend). Unfortunately, many reps only received the note scheduling the meeting at 7 p.m. — one hour after the call started. From CafePharma:
I found out about a 6PM teleconference after 7PM. Gotta love management.
Other reps had difficulty navigating Merck’s dial in system:
First, they give vague directions about the teleconference (you had to go on to Comm. Central to get the dial-in number). Then they start 15 min late trying to get their s$%t together. Then TC says that this is a great opportunity to show our customers how committed we are to patients. When is the last time these people were in the field? Completely out of touch. Another Monday am to dread.
Those who did dial-in on time were kept on hold, just as they had been at an earlier conference call at 8 a.m. which apparently only got started at 8.20 a.m.:
This morning the the other S teleconference scheduled for 8 AM starts after 8:20 AM. What is going on inside? Half the country is on hold listening to music. I got work to do guys. I have to move and make calls.
I couldn't be more pleased that [insert gratuitous but sincere praise:] outstanding Toronto Star writer Stuart Laidlaw has been rigorously following the Merck/Elsevier scandal. It's practically flattering that he's listening to bioethics' and in particular bioethics' publishing voices, and he's quoted The American Journal of Bioethics Editor's Blog [that'd be the fancy-pants name for blog.bioethics.net] on his own Toronto Star Medical Ethics blog. However...the old adage that "the enemy of my enemy is my friend" may not apply to taking on the admittedly incredible ethical missteps by Merck ... and its publishing mules, comprising a whole fleet of bogus journals made to fool academics and clinicians.
You'd think that Merck would have learned from Vioxx and their New England Journal mistake (oops, forgot to send that data...) where publishing is concerned. You'd think ANY publishing company would learn that presenting the appearance of peer review for sale, then refusing to be transparent about just how much it COSTS to buy a peer reviewed journal. But you'd be wrong.
The thing is ... Stuart ... these guys are not, well, did you see the movie The Insider? [note to pharma lawyers and publishers of all kinds: I live on a small island in the Pacific...really...]
Summer Johnson, PhD
Let's hope she's wrong.