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Archive for Pharmaceuticals

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

One of the most frustrating aspects of taking care of cancer patients is that in general, with only a few specific exceptions, we do not have good curative therapies for patients with stage IV cancer, particularly solid tumors. Consequently, patients with stage IV disease are viewed as “incurable” because, the vast majority of the time, they are incurable. Over the years, we have thrown everything but the kitchen sink at patients with stage IV disease, largely with dissapointing results. That’s not to say that the few specific exceptions to which I alluded are not a reason for hope. After all, patients with colorectal cancer and liver metastases used to have a median survival of around 6 months, but these days, with newer chemotherapeutic regimens like FOLFOX plus Avastin, median survival has more than tripled. While expecting to live less than two years is cold comfort to cancer patients with this particular clinical situation, the prognosis is far better than it was.

Of course, I specifically mentioned Avastin because it’s been in the news a lot recently with respect to my area of clinical specialty, breast cancer. Specifically, beginning in July there started appearing a spate of stories about the FDA considering revoking the approval of Avastin for advanced breast cancer based on recent studies that demonstrate that it does not prolong survival in these patients. Many lay people and patients find this reconsideration of Avastin to be quite puzzling, given that the drug was granted accelerated approval in 2008 and has since gone on to be used fairly widely. Given that the case of Avastin in breast cancer is rapidly becoming a classic case study of how messy science-based medicine can be when practiced in the public eye and debated among pharmaceutical companies, the government, and patient advocacy groups.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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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 1999. It, and its competitor, Actos (pioglitazone), are thiazolidinediones (TZD’s), a class of drugs that act to decrease insulin resistance. A third TZD, troglitazone, was withdrawn after studies showed a 1:20,000 incidence of hepatitis and potential liver failure.

Avandia was a clear market success, with sales peaking at $2.5B in 2006, the year prior to the first research “shot across the bow” regarding patient safety.

Among scientists, the mid-July review capped a rising level of concern. Among the public, a tide of safety concern had been rising for several years, flowing from the scientific community into the legal and political arena.
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Posted in: Pharmaceuticals, Politics and Regulation

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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 reviewing John Brinkley’s goat gland scam for a presentation on medical frauds. In an era before the isolation of the hormone testosterone, Brinkley transplanted goat testes into human scrotums in an attempt to treat impotence and aging. We are more sophisticated today … but not much. Longevity clinics and individual practitioners are offering testosterone to men as a general pick-me-up and anti-aging treatment. Their practice is not supported by the scientific evidence. (more…)

Posted in: Pharmaceuticals

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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 and truthiness of a late night infomercial.

In the spirit of openness, I will say that I have not talked to a drug rep in 20 years. As far as industry supported gifts and food, I have not taken a pen or eaten pizza from industry in almost 30 years, since I was a fourth year medical student. I have accepted one gift over the years. Years ago, when the Pfizer rep left, he sent me Fleets enema with a Unasyn sticker on it. I still have it in my office, unused. But you never know when it might come in handy.

Being an absolutist about industry gifts does have downsides. It is distracting to sit in an auditorium filled with the smell of pizza and not eat any; somehow the PB&J I bring with me doesn’t smell as sweet. Administration has received one letter complaining about me that was ostensibly from an employee, but curiously was printed from a windows folder that had the same name as the levofloxacin rep. Just a coincidence, I am sure.
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Posted in: Medical Academia, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Life Extension: Science or Pipe Dream?

Wouldn’t it be great if we could find a way to prolong our lives and to keep us healthy right up to the end? Ponce de León never found that Fountain of Youth, but science is still looking. What are the chances science will succeed? How’s it doing so far?

In his new book The Youth Pill: Scientists at the Brink of an Anti-Aging Revolution, David Stipp tries to answer those questions. From the title of the book, I expected hype about resveratrol or some other miracle pill; but instead it is a nuanced, levelheaded, entertaining, informative account of the history and current state of longevity research. It makes that research come alive by telling stories about the people involved, the failures and setbacks, and the agonizingly slow process of teasing out the truth with a series of experiments that often seem to contradict each other.

Anti-aging can mean several things. Extending the average lifespan is not the same as extending the maximum life span. Extending lifespan is not the same as preventing the degenerative changes characteristic of aging. (more…)

Posted in: Book & movie reviews, Herbs & Supplements, Pharmaceuticals

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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 energy, well-being, and quality of life, and to have an anti-aging effect. Suzanne Somers recommends them for all age groups and both sexes. There is no evidence to support any of those claims.

The whole “bioidentical” thing is a pseudoscientific concept: it is a marketing term rather than a scientifically meaningful one. Bioidenticals are promoted by celebrities like Suzanne Somers, a few maverick medical doctors like Kent Holtorf, proponents of “natural” medicine, patients who were frightened by the Women’s Health Initiative study of hormone replacement therapy, and critics of Big Pharma. The mainstream scientific community is in consensus: a number of medical organizations, from the American Cancer Society to the Mayo Clinic, have issued statements similar to that of The Medical Letter.
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Posted in: Pharmaceuticals

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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 Sunscreen Cancer Risk

What’s a consumer to do? If you only read the headlines, you may get the impression that sunscreens do more harm than good. The impetus was the release of the Environmental Working Group’s (EWG) 2010 Sunscreen Guide. EWG is an environmental advocacy organization that focuses on consumer products, and has been conducting annual reviews of sunscreens since 2007. Of the 500 products it reviewed, it only recommends 8%, or 39 products in total. Why were so many products deemed “not recommended”? Reasons for negative ratings included the following:

  • any product containing retinyl palmitate (vitamin A), which is described as a photocarcinogen
  • any product containing oxybenzone, called a “potential hormone disrupter”
  • any sunscreen packaged as a spray or powder, due to inhalation concerns

EWG also raised concerns about nano-sized particles in sunscreens. But before we dive into the report, let’s consider what we’re trying to do with sunscreen.
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Posted in: Pharmaceuticals

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Speaking Skeptically About Vitamins

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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 scrutiny.

This Friday, June 11, I’ll be appearing on the Skeptically Speaking radio show, giving a science-based perspective on vitamins. Call in, listen online, or submit your questions in advance. The show is live at 6pm MST (find your time here).

Posted in: Pharmaceuticals, Science and Medicine

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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 are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.

In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.

How Much Evidence?

The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
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Posted in: Pharmaceuticals, Politics and Regulation

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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 be fatal. In other countries, Drug A is the number one cause of acute liver failure.

Should Drug A be available without a prescription?

Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.

Should Drug B be available without a prescription?
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Posted in: Pharmaceuticals, Politics and Regulation

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