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Ethics February 23rd
Merck: Background • Most admired company in America for 7 straight years in the 80s • Edward M. Scolnick (Brilliant) in charge of Merck Research Labs • Brought 15 unique new drugs to the market in just 5 years in the 90s • For two decades Merck published more scientific papers and patented more compounds than its competitors
Fast Track FDA approval of new drugs • 13 new drugs approved on average in less than 11 months • Vioxx approved in under 6 months • Pfizer face a review time of over two years • Culture of arrogance?
Fosamax (osteoporosis) • $280 million sales in first year • FDA wanted to withdraw from market after it learned than it caused erosion of the esophagus in some patients • Scolnick used an aggressive letter writing campaign and submitted more info to FDA • Fosamax re-labeled and allowed to remain on the market. (have to sit upright for an hour after taking it) • 2003 sales $2.7 billion
block busters • Cozaar: Hypertension $2.5 billion • Crixivan: HIV • Singulair: $2 billion • Propecia: Baldness • By 1999 the pipeline was empty: Harder to develop new drugs. Merck came into the new millennium facing patent expirations and few miracle drugs in the offing
Vioxx • Last of Scolnick’s blockbusters • Discovered in 1994 • Cox-2 inhibitors • To replace common painkillers like ibuprofen which have the side effects of ulcers and gastrointestinal bleeding. Some estimated that these drugs killed 10,000 people a year due to intestinal bleeding • Direct-to-consumer marketing $500 million $2.5 billion a year
Early warning signs • Even before FDA approval Pennsylvania study: Cox-2 inhibitors interfered with enzymes that play key roles in warding off cardiovascular disease • Merck felt the evidence was inconclusive • 2000 own study showed Vioxx 3x more likely than Aleve (naproxen) • Merck argued that data misleading because naproxen good for heart
Merck Responsible • 60 Minutes • FDA can’t protect • FDA Shares
Pfizer • Celebrex #1 brand of Cox-2 • Also sales Bextra • Initial studies only showed Vioxx • Later studies indicated Celebrex and Bextra had same problems • Chose to not recall • FDA asked them to suspend direct-to-consumers marketing
Outlook for Merck • In 2003 work on potential blockbuster drugs for depression and diabetes didn’t pan out. One didn’t work in clinical trials and the other was linked to cancer • Zocor ($5 billion a year) goes off patent in 2006. • Stock price $95 in 2000 is under $30 in February 2005
VIOXX back • Future?
Questions? • On balance do you think Merck is an ethical and socially responsible company? Pfizer? • How could the disaster with Vioxx been avoided in the first place? • What is your opinion of pharmaceutical advertising? • Should Merck have recalled Vioxx?
How do you respond to the following statements from consumer advocacy groups? • The more than $10 billion Merck has hoarded attests to the obscene profits these drug companies are making at our expense • The FDA is in the pocket of the drug industry: What a travesty this is.
What can be learned • Always be ready for the worst scenario • Be alert to early hints of trouble • Eagerness to sue should be factored into some decisions • The pharmaceuticals industry needs to improve its public image