From the wires: The FDA has just completed a fresh set of guidelines that will permit pharmaceutical companies to tell doctors about unapproved uses of their medicines—in effect, giving big pharma carte blanche to hawk unapproved drugs.
Specifically, the new regulations allow drug companies to “distribute copies of medical journal articles that describe unapproved uses” of their drugs to all the doctors they want.
Technically this reg isn’t new; it was in place until 2006, then lapsed until industry lobbyists made sure it was proposed again last year, despite heavy criticism from Democrats and drug industry critics. And now, conveniently one week before the Bush administration draws its final, sputtering breath, the rule has made its way back into the final FDA guidelines.
Big pharma spokespeople pooh pooh the reg as nothing more than a formality: “Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care,” said Alan Bennett, an attorney representing the pharmaceutical industry.
(more…)
Steve Jobs looks terrible. He has for months. After losing a reported 30 pounds last year, the Apple CEO has been the subject of constant scrutiny concerning his health, sparking media coverage that’s bordered on the morbid—including a mistaken obituary and a false report that he’d had a heart attack
The speculation reached a frenzy when Jobs announced he wouldn’t give the keynote speech at this month’s Macworld Expo. While Apple originally denied that the cancellation was due to their CEO’s poor health, they later conceded that Jobs had pulled out because he was ill. Exactly what this illness could be, however, remains the subject of mass conjecture.
In August 2004, Jobs announced he had had surgery to remove an islet cell tumor in his pancreas—a form of cancer that’s far rarer and less deadly than regular pancreatic cancer. It was later reported that he’d delayed the surgery 9 months after his diagnosis in order to pursue holistic treatments—a dangerous move that likely gave his doctors, and Apple’s board members, at least one ulcer apiece.
According to the New York Times, Jobs underwent another surgical procedure in 2008, the “details of which remain unclear.” Off the record, Jobs told Times reporter Joe Nocera that the CEO’s health problems “weren’t life-threatening, and he doesn’t have a recurrence of cancer.”
Still, Jobs’s current illness has reached a point where no one—not even the notoriously secretive Apple and its even more secretive CEO—can deny it.
(more…)
This month in DISCOVER, Mark Anderson has a feature story on the medical controversy surrounding shaken baby syndrome (SBS). The crux of the debate is this:
On one side of the courtroom, representing mainstream medical opinion, are those who believe shaken baby syndrome (SBS) is a valid diagnosis. They say that decades of clinical experience and criminal confessions—in which a parent has admitted to shaking a child with symptoms of SBS—bolster their case to the point of near-certainty. On the other side, a growing number of skeptics are now claiming that the evidence for the syndrome rests on dubious medical ground with questionable biophysical models supporting it.
The confusion centers around the trio of symptoms that lead to an SBS diagnosis: bleeding between the brain and skull, bleeding behind the retinas, and brain swelling. Conventional medical wisdom holds that some or all of these mean a baby is suffering from SBS. But a growing number of skeptics say the symptom list could come from any number of other sources, from infections to diet to a fall.
While the final medical verdict is still up in the air, the issue highlights the tricky—and potentially devastating—fallout when medical uncertainty headbutts the legal system. SBS presents a clear dilemma: If a baby has it, the “fact” that the baby’s death or injuries were caused by SBS is in and of itself evidence that a parent, caretaker, or other handler intentionally committed a crime.
(more…)
• A new administration, a new direction, and maybe—just maybe—a clean divorce between science and political ideology.
• And of course, the debate has already started: Who will Obama pick to head up the EPA?
• Meanwhile, we’re zooming straight into a “health care perfect storm.”
• Which makes it all the more admirable (or crazy, or excessively symbolic) that Wisconsin Democratic Rep. Steve Kagan has elected to go without health insurance as a gesture of solidarity towards his uninsured constituents. Stay healthy, Steve!
• China demands international action on climate change—let’s just hope they practice what they preach.
• And not to judge or anything, but videos like this one certainly don’t inspire confidence.
• The “net energy” debate gets serious. Is the whole thing a load of bull? We’ll leave it to the experts to decide.
Massachusetts Senator and former presidential candidate John Kerry, former Speaker of the House and conservative icon Newt Gingrich, and Oakland A’s manager and minority owner Billy Beane aren’t a trifecta you’d expect co-penning op-eds in the Times. But co-penning they are, on behalf of a common cause: health care.
Specifically, they’re making the argument that just as baseball has profited from a “data-driven approach” to recruiting and payrolls, we need to up our use of “evidence-based” technology—as opposed to the current practice of “informed opinion”—in the U.S. health care system. The crux of the argument is this:
Remarkably, a doctor today can get more data on the starting third baseman on his fantasy baseball team than on the effectiveness of life-and-death medical procedures. Studies have shown that most health care is not based on clinical studies of what works best and what does not —be it a test, treatment, drug or technology. Instead, most care is based on informed opinion, personal observation or tradition.
It is no surprise then that the United States spends more than twice as much per capita on health care compared to almost every other country in the world—and with worse health quality than most industrialized nations. Health premiums for a family of four have nearly doubled since 2001. Starbucks pays more for health care than it does for coffee. Nearly 100,000 Americans are killed every year by preventable medical errors. We can do better if doctors have better access to concise, evidence-based medical information.
Sound points, all—though many doctors might be less than pleased to hear their careers’ worth of experience described as “informed opinion.” Still, as the doctor shortage looms, the need for databases containing accurate records and medical information will likely become more important than ever. After all, somebody/thing’s gotta keep track of all those boomer hip X-rays.
