Category: Pharmaceuticals

avastin

Avastin and metastatic breast cancer: When science-based medicine collides with FDA regulation

Not all drugs that prevent progression of cancer prolong the patient's survival. The case of Avastin and metastatic breast cancer reminds us of that simple, unfortunate fact once again.

/ August 30, 2010

Medical Science and Public Opinion: The Avandia Story

The week of 12-16 July saw an FDA Advisory Panel meet to decide the fate of an important drug. Along the way, the FDA charted new territory in using drug comparisons to judge safety, amidst external allegations of corporate malfeasance and patient harm. Avandia, or rosiglitazone, is one of a new class of anti-diabetes drugs approved for marketing by the FDA in...

/ August 19, 2010

Testosterone: Not an Anti-Aging Panacea

On the car radio, I have several times happened upon “infomercial” programs touting the benefits of testosterone replacement therapy for men, broadcast by doctors who specialize in prescribing the drugs. They have lots of wonderful stories about men who feel younger, happier, and more vigorous because of their macho remedies. It’s a tribute to the power of the placebo. I have been...

/ August 17, 2010
sandwich

Bought and Sold: Who Should Pay for CME

There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm...

/ July 16, 2010
Lucas_Cranach_-_Der_Jungbrunnen_(Gemäldegalerie_Berlin) Fountain of Youth

Life Extension: Science or Pipe Dream?

Can a pill keep you young? Many pills, potions, spells, and lifestyles have been promoted as cures for aging, but so far none have worked out.

/ July 13, 2010

Bioidentical Hormones

The Medical Letter recently evaluated “bioidentical” hormones and concluded There is no acceptable evidence that “bioidentical” hormones are safe or effective. Patients should be discouraged from taking them. “Bioidenticals” include progesterone, estrogens (estriol, estradiol, and estrone), and testosterone. They have mainly been promoted as a safer, more natural alternative to menopausal hormone replacement therapy (HRT), but they are also claimed to increase...

/ June 29, 2010

The Great Sunscreen Cover Up

If there’s one thing the media love, it’s a “bungling bureaucrats” story. Yep, the FDA, wrapped up with their science dogma, enslaved to Big Pharma, pushing toxic, unnatural chemicals and ignoring safety data. And that’s the story being told about sunscreens: “Study: Many Sunscreens May Be Accelerating Cancer” “Did The FDA Ignore Proof That Sunscreens May Speed Up Cancer?” “FDA Coverup Of...

/ June 10, 2010

Speaking Skeptically About Vitamins

The scientific understanding of vitamins has evolved over time, from the identification of frank deficiencies, to exploring the value of supplements to prevent chronic diseases. Among health professionals, taking a multivitamin “for insurance” has long been considered to be a reasonable strategy. But as more robust evidence has emerged about the benefits and possible harms of vitamins, even that advice is facing...

/ June 9, 2010

What Do You Expect From Your Pharmacy?

What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input. In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies...

/ June 3, 2010

Rx, OTC, BTC – Wading into Pharmacy’s Alphabet Soup

Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may...

/ May 13, 2010