Big Pharma Prime for Attacks, Thanks to Defective, Ineffective DrugsJan 23, 2008 | Parker Waichman LLP
It’s not easy being a drug company these days. A recent spate of scandals over the safety or effectiveness of medications like Vytorin, Vioxx, Avandia and Ortho Evra, coupled with astronomical drug prices have made Big Pharma an easy target for politicians and consumer advocacy groups. But as many of the drug scandals – especially the most recent one involving Vytorin – illustrate, the drug companies only have themselves to blame.
According to The Wall Street Journal, there is a growing field of investigative research being done by physicians that’s focused on industry influence and the reliability of medical literature – especially as it applies to drug studies and clinical trials. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, told the Wall Street Journal that there are more articles on the drug industry's role in research coming soon. "I want to show how they manipulate the data and why we have to be so cynical about them".
It’s easy to see why the pharmaceutical industry has a target on its back – it put it there all by itself. The list of drug scandals is long and varied. Just last week, Vytorin, a block buster cancer drug was proven to be ineffective. What’s worse, Vytorin makers Merck and Schering-Plough delayed releasing the results of the ENHANCE study that showed it didn’t work for nearly two years. The companies also tried to change the endpoint of ENHANCE after it was completed. The endpoint is the the main medical result a study is meant to measure, and it’s generally accepted that for a clinical trial to be effective, a study’s endpoint must be set at its beginning and remain unchanged. There is much speculation that Merck and Schering-Plough’s maneuvering in regards to ENHANCE was done to protect Vytorin sales, which were an astounding $5 million per year.
Then there’s the case of Avandia. The diabetes drug has been a subject of debate since last May, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. A month later, Congress held hearings to discuss Avandia and the FDA’s handling of its safety issues. At those hearings, it was revealed that in 2005, GlaxoSmithKline, Avandia’s manufacturer, had informed the Food & Drug Administration (FDA) of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. Allegations also surfaced that Glaxo tried to intimidate one Avandia critic in an effort to silence him.
Late last week, the Ortho Evra Birth Control Patch got a second blood clot warning from the FDA. Ortho Evra exposes women to 60% more estrogen than birth control pills, upping the risk of blood clots. More than 2,000 Ortho Evra lawsuits are currently making their way through the courts, and plenty of evidence has emerged that patch maker Johnson & Johnson knew of the increased estrogen exposure long before it made the public or the FDA aware.
According to The Wall Street Journal, many of the current flock of presidential candidates have set their sites on Big Pharma. Democrats want to Medicare to negotiate lower drug prices with the pharmaceutical companies – something forbidden under current law. All the leading Democratic presidential candidates and, on the Republican side, Arizona Sen. John McCain, support importing less-expensive drugs from Canada.
The House Energy and Commerce Committee, led by Michigan Democrat John Dingell, is examining the marketing of drugs including Vytorin, Pfizer Inc.'s Lipitor, Johnson & Johnson's Procrit and Amgen Inc.'s Aranesp. Democratic Rep. Henry Waxman of California, Senate Finance Committee Chairman Max Baucus of Montana and ranking Republican Charles Grassley of Iowa also are investigating the industry. "We see puffing, advertising based on untrue facts or facts that can't be substantiated, medically, ethically or legally,” Michigan Democratic Rep. Bart Stupak told the Wall Street Journal.
Thankfully, that has been the end result of all of the drug scandals -- increased scrutiny of the pharmaceutical industry. And it’s not going to get any better for Big Pharma. In an election year, lawmakers will be looking to hold drug makers accountable for their sins – for a change.