Category: Pharmaceuticals
Wyeth Vs. Levine: Joe Six Pack Trumps The FDA
The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay...
Comparative Clinical Effectiveness Research: Good News In Shades Of Gray
When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest...
The Anniversary
I received a surprising morning call several weeks ago “Wally?” “This is he.” “This is Judy V…. I just wanted to call and thank you again for what you did for me. It’s the 35th anniversary of my cancer…“ Judy V. is a physician’s widow. Her husband, a surgical specialist died in his 40s, 20plus years ago. She had a Stage II...
Historic College of Pharmacy to Honor Homeopathy Leader
I am a graduate of the institution known formerly as the Philadelphia College of Pharmacy and Science (PCP&S) – the first college of pharmacy in North America, established in 1821. The college, now called University of the Sciences in Philadelphia, counts among its alumni John Wyeth, Silas M. Burroughs, Sir Henry Wellcome, several members of the Eli Lilly and McNeil families, and...
The Debate About Off-Label Prescriptions
So-called off-label uses of prescription drugs is an enduring controversy – probably because it involves a trade-off of competing value judgments.The FDA is considering loosening its monitoring of off-label prescriptions, but critics are charging that, if anything, regulations should be tightened. Many issues of science-based medicine are at the core of this controversy. In the US the FDA (Food and Drug Administration)...
Statins Are Better on JUPITER
Over 26 million Americans are taking statin drugs. Some people think they should be available over-the-counter without a prescription, and it has even been facetiously suggested that they should be added to our drinking water. The protective effect of statins in cardiovascular disease and in high-risk patients with high cholesterol levels is well established. But what about people with no heart disease...
Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?
It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors)...
A natural product of his environment
I’m delighted to have the opportunity to join this outstanding group of medical professional bloggers in adding my natural products angle to the application of science-based medicine. With the exception of Dr. Gorski, who holds MD and PhD degrees, I believe I am the first “only a PhD” to be invited to SBM. However, I have spent much of my career training,...
Cholesterol Skeptics Strike Again
I’m really tired of arguing about cholesterol, but I feel obliged to stand up once more to defend science-based medicine from unfair calumny. Lewis Jones’s article “Cholesterol-shmesterol” in Skeptical Briefs (December 2007) included errors and misconceptions about cholesterol. It was a re-hash of the same kind of misinformation that is being spread by The International Network of Cholesterol Skeptics (THINCS) and that...
Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division
When the marketing division designs clinical trials, scientific medicine loses.