This is an amazing story. It came to Insiders attention via Roy Poses at Health Care Renewal.
The combination of omeperazole and sodium bicarbonate was developed by Jeffrey Phillips, a pharmacologist in the Department of Surgery at the University of Missouri. A comatose patient in the intensive care unit (ICU) had developed a bleeding ulcer despite intravenous therapy with an H2-blocker. Phillips tried to figure out how to administer a PPI to her, but the extended release coating on Prilosec (omeprazole) clogged the patient's nasogastric tube.
But Phillips found that by dissolving the Prilosec in water and adding sodium bicarbonate, he produced a solution he could give through the tube, and the patient's bleeding stopped.
Phillips tried to interest some large drug companies in developing the combination for use in critical care, but without success. Finally, Santarus acquired the rights to it for $1 million, and Zegerid was born.
Phillips' pursuit of a company willing to develop his drug combination to treat critically ill patients produced an important insight into the minds of those who now lead Big Pharma.
Phillips approached AstraZeneca, the maker of Prilosec (omeprazole). But, "the company didn't want to do a study involving ICU patients, fearing that deaths and adverse events would tarnish Prilosec's safety record."
According to Phillips, one "bigwig" said,
"We don't want to do a study in sick people."
Phillips responded,
"Dude, these patients are dying because they are bleeding from these ulcers."
The bigwig replied,
"Well, what if they die while on the drug?"
Phillips' last riposte was,
"What if they die and it's a Friday? No one thinks Friday made them die."
In summary, this showed Big Pharma leadership who seemed utterly uninterested in helping really sick patients, and utterly ignorant of the basic premises of clinical research.
Such leadership, of course, is not likely to produce products that really benefit the patients who need the most help, and hence seems unworthy of the huge compensation that Big Pharma leaders now seem to command.
What sort of health care are we going to have when "bigwigs" don't want to deal with "sick people"?
Insider has the name of the "bigwig" in question...........
Source: Health Care Renewal and
http://www.signonsandiego.com/news/business/20051120-9999-lz1b20meds.html
2 comments:
The doctor is absolutely right when he says if a patient dies on Friday, no one will blame Friday. However, with today's environment, not only would the drug be blamed but, more than likely, the doctor. If the public were more balanced in their way of thinking of pharmaceutical companies, it would be easier for them to conduct reseach and development in all types of populations because it would be okay if patients died in a study, because of their illness, not the drug.
Surely this is the difference between a spontaneously reported adverse event and a medically attributed adverse drug reaction.
The truth probably is that the "market" size (ie sick people in ITU) was thought to be too small to bother with! Which is probably even less moral!
Good luck Zegerid!
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