Posts

April 28, 2012

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3:00 AM | Molecules to Medicine: Public Health or Impaired Penises?

Today’s news starkly juxtaposed this countries’ priorities. First was news of the approval of yet another look-alike drug for erectile dysfunction, avanafil (Stendra). Then “From First Cold To Grave: How Two-Month-Old Brady Died Of Pertussis.” Brady was too young to have been protected by receiving immunizations, but there are strategies for protecting newborns from pertussis, [...]

April 25, 2012

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12:44 PM | Molecules to Medicine: Have You Thanked a Clinical Researcher Today?

Seeing a reminder that International Clinical Trials Day will soon occur, I wanted to recognize and thank the clinical research teams and volunteers that make this possible. Clinical research is an enormously complicated endeavor, requiring close cooperation from a number of disparate groups, including sponsors, physicians, nurses, pharmacists, laboratory and radiology staff, regulators, ethics committees, [...]

April 20, 2012

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3:56 PM | A taste of #TEDMED 2012: Main Course

The initial fare at TEDMED 2012 whet my appetite for the sessions that followed. Howard-Yana Shapiro, a plant scientist wizard, focused on how to improve nutrition in crops, rather than just the volume of the yield, and the coming crisis in feeding the world’s population. When he began, my cynical side thought, “Here comes Monsanto [...]

April 17, 2012

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3:59 PM | A taste of #TEDMED 2012: Appetizers

Innovation. Story telling. Discovery. Connections. Beauty. Heartbreak. TEDMED 2012 had it all. What seemed initially like disparate sessions later proved to be a carefully planned series that wove together important themes for making a healthier future. The three days of immersion were, at times, overwhelming, but the careful planning interspersed intense talks with music or [...]

April 02, 2012

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12:08 PM | Molecules to Medicine: When Religion Collides with Medical Care: Who decides what is right for you?

The recent presidential candidate debates, fights over insurance coverage for contraceptives, and the Virginia and Texas legislatures’ imposition of intrusive, unnecessary ultrasounds prior to any abortions are highlighting the fundamental issue of the role of religion in health care and the separation of Church and State. While the emphasis has been on reproductive care, the [...]

March 20, 2012

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12:09 PM | Molecules to Medicine: “Conscience” Clauses versus Refusal: An Historical Perspective

The struggle between conscience and refusal, or individual rights vs. that of the community good, goes far back, and is not limited to reproductive choices. It also forms the foundation of civil rights rulings—prohibiting discrimination and segregation, and discrimination based on race or religion. Unfortunately, there are still ongoing battles regarding discrimination based on sexual [...]

February 03, 2012

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12:39 PM | Molecules to Medicine: Plan B: The Tradition of Politics at the FDA

In my last post, I focused on flaws in the medical device approval process. The Union of Concerned Scientists’ “FDA at a Crossroads” meeting also covered problems with drug approval. This is perhaps no better illustrated than by the disappointing decision by Secretary of Health Kathleen Sebelius’ to deny the emergency contraceptive, Plan B, over-the-counter [...]

December 07, 2011

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3:27 PM | Molecules to Medicine: FDA at a Crossroads—a Tough Place to Be

I took a field trip to the big city last week, to attend the Union of Concerned Scientists’ and George Washington University School of Public Health’s conference, “FDA at a Crossroads.” I have great respect for UCS and their efforts to keep science depoliticized, a topic that I have written and spoken about. They were [...]

November 23, 2011

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7:14 PM | Molecules to Medicine: Should pepper spray be put on (clinical) trial?

Pepper spray is all over the news, following the Occupy Wall Street protests, particularly following the widely disseminated images and videos of protestors being sprayed in NY, Portland, and UCDavis. Before that, I knew and occasionally used its main ingredient, capsaicin, as a treatment for my patients with shingles, an extremely painful Herpes zoster infection. [...]

November 22, 2011

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12:45 PM | Molecules to Medicine: Pharma Trumps HIPAA?

This past week, I was jolted out of my chair by news that a Pfizer-led group plans to buy access to patient data in hospitals. My initial reaction was anger, on a variety of levels: as a researcher, as one who is increasingly wary of the reach of huge corporations, and as an individual. Actually, [...]

November 02, 2011

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6:53 PM | Lilly’s Shocker, or the Post-Marketing Blues

Just last week, I mentioned that Eli Lilly and Company, as a condition of approval for their blockbuster drug, was required to conduct post-marketing studies of Xigris. Yesterday, Lilly unexpectedly announced the withdrawal Xigris from the market. This was not due to adverse events or side effects, but was the result of exactly such a [...]

October 19, 2011

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1:11 PM | Molecules to Medicine: From Test-Tube to Medicine Chest

We looked briefly at why drug studies came into being; now let’s look at how a drug is developed, from test tube to your tissues. Every government approved drug goes through the same sequence of testing anywhere in the world. In the US, this is done under the supervision of the FDA, and is conducted [...]

October 06, 2011

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2:25 PM | Molecules to Medicine: Clinical Trials for Beginners

Have you ever wondered about the medicines you take—how they are developed and produced? We’ll explore that in “Molecules to Medicine.” This new series could be described as “medicine for muggles,” intended to take the mystery out of clinical research and drug development and to provide background information so that both patients and physicians can [...]