It is my hope that the American people are starting to find out how the powerful drug manufacturing industry has played fast and loose with the development and marketing of their drugs. A New York Times reporter, Katie Thomas, in a June 2012 article, exposed Pfizer documents that reveal a culture of doubt and deception in the development and marketing of that company’s drugs. Ms. Thomas reported on how Pfizer and its partner, Pharmacia, marketed Celebrex, its arthritis drug, as being a safer alternative to other drugs in lowering risks of perforations, ulcers and stomach bleeds.
After a study came out supporting the effectiveness of Celebrex, a research director at Pfizer wrote in an email to a colleague that “They swallowed our story, hook, line and sinker.” That’s shocking to say the least. But unfortunately it’s an indication of how the drug industry operates. Celebrex was no better at protecting the stomach from serious complications than other drugs and Pfizer knew it. It appeared to be better only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a year-long study rather than the whole thing.
The research chief’s e-mail sent in 2000 is among thousands of pages of internal documents and depositions unsealed by a federal judge in a long-running securities fraud case against Pfizer. Other documents suggest that officials made a strategic decision during the early trial to be less than forthcoming about the drug’s safety. In one email, an associate medical director at Pharmacia (which was later bought by Pfizer) disparaged the way the study was being presented as “data massage,” for “no other reason than it happens to look better.”
In another, a medical director at Pfizer described it as “cherry-picking the data” even as officials were publicly boasting of the study’s success. Dr. M. Michael Wolfe, a gastroenterologist who at the outset had cautiously praised the study in a medical journal, said after reviewing the new documents that he always tries to give “investigators the benefit of the doubt,” but that these “communications make it quite challenging” for him.
The decision by Pfizer and Pharmacia to withhold crucial data became widely known in 2001. The withheld data also led to a lawsuit, filed in 2003, by several pension funds that charged that by handling the results the way they did, Pfizer and Pharmacia had misled investors and were responsible for a drop in Pharmacia’s stock value when the full results were revealed. After describing the decision to use the limited results as “data massage,” Dr. Arbe, a Pharmacia medical director, wrote, “I wouldn’t feel too comfortable presenting a fudged version of the facts.”
Is doubt and deception the way a drug company should conduct business? I believe we all can agree it’s totally unacceptable. But it doesn’t just hurt investors in pension funds. It also affects costs of drugs to consumers. Citizens and governments are concerned about rising healthcare costs. How many billions have been spent on a drug that studies appear to suggest is no more effective than over-the-counter pain medications and may not reduce stomach adverse events as marketed? It’s possible that health insurance carriers have missed out on fraud claims for paying for drugs that were improperly marketed. But it’s highly probable that the consuming public has been badly hurt – because of high costs and also from a safety perspective.
Source: New York Times
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