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Posts Tagged "FDA"

But Not Simpler

I Hate to Break it to You, but You Already Eat Bugs

Acyrthosiphon_pisum_(pea_aphid)-PLoS

I grabbed a box of cereal out of my cabinet. The flakes smelled stale, but I was hungry enough. I poured a cup or two into a bowl, followed by a splash of milk. Well into my third bite, I knew that stale cereal wasn’t all I was eating. I saw what were likely grain [...]

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Food Matters

Serving size swaps: a research perspective

Nutrition Facts Label iStock_000015829121Small

Last month, the Food and Drug Administration proposed changing Nutrition Facts labels to make serving sizes reflect what people actually eat. Several studies support the changes, though some research suggests it’s going to take more for the public to make healthy choices. Serving sizes have always been intended to represent what people actually eat, not [...]

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Food Matters

Going gluten-free? Things to consider, part 1: Folate

Cereal Flakes

Last spring, I wrote a blog post for Scientific American’s guest blog about gluten sensitivity, a condition in which patients without celiac disease exhibit symptoms, such as bloating or fatigue, that improve with a gluten-free diet. Much controversy still exists in the media over whether non-celiacs should follow a gluten-free diet. Experts often note that [...]

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Guest Blog

How Clinical Guidelines Can Fail Both Doctors and Patients

A physician holds a stethoscope.

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer [...]

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Molecules to Medicine

The s**t hits the fan – FDA, INDs, and fecal microbiota transplants

Bristol Stool Chart

This weekend, the proverbial s**t hit the fan over the Food & Drug Administration’s (FDA) decision to require an Investigational New Drug (IND) application for stool transplants—formally known as “fecal microbiota transplants (FMT)”—for the treatment of C. difficile colitis. “C. diff,” as it is known, is a severe inflammation of the bowel complicating treatment of [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 6: The Run-Around, or Why I Now Call for an Independent Investigation of University of Minnesota

Drink me!

  This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotic drugs at the University of Minnesota, his suicide 2004 while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, I’ve looked at issues of [...]

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Molecules to Medicine

Covering Clinical Trials: a message for journalists and critical readers

Linnea Duff shows off her "famous lungs" at #ahcj13

My message: Ask the hard questions. The Association of Health Care Journalists annual conference (#ahcj13) covered a variety of topics, with lectures and panels followed by question and answer sessions. As with many conferences, it was tough to choose between competing sessions. I learned a great deal about health care, databases, and resources to help [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 5: The Case of the Mysteriously Appearing Documents

This series uses the story of Dan Markingson’s participation in a clinical trial of anti-psychotics at the University of Minnesota, his ultimate suicide while participating on the study, and subsequent events as a case study in which to explore various aspects of clinical trial conduct. In previous posts, we’ve looked at issues of “good clinical [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 4: The University of Minnesota’s Response

Bowl of antidepressants

In earlier posts, we’ve looked at issues of consent, investigator responsibilities, and conflicts of interest on the case of Dan Markingson’s suicide while participating in a clinical trial of anti-psychotics at the University of Minnesota. This time, we turn to the University’s response. Not surprisingly, the University has claimed it has no responsibility for any [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 3: Conflict of Interest

We’ve touched on some of the many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. In my first post, I asked how a psychotic, homicidal patient who was involuntarily hospitalized in a psychiatric hospital could give an informed consent for participation in a clinical trial. There appeared to have [...]

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Molecules to Medicine

A Clinical Trial and Suicide Leave Many Questions: Part 2: Investigator Responsibilities

Dan Markingson and his mom, Mary Weiss

There are many disturbing things that happened during the clinical trial on which Dan Markingson committed suicide. Besides the issue of consent, or lack thereof, which I raised in my last post, one of the most disturbing aspects to me has been the lack of accountability and the apparent violations of clinical practice standards, with [...]

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Molecules to Medicine

Elections Have Consequences: Fungal Meningitis and Compounding Pharmacies

Antikamnia calendar

32 deaths. 461 cases…and counting. Unless you live under a rock, you probably know about the nationwide outbreak of an unusual fungal meningitis caused by Exserohilum rostratum, a plant fungus. The outbreak is now linked to a single pharmacy in Massachusetts, New England Compounding Center (NECC), which compounded a variety of drugs used for injection, [...]

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Molecules to Medicine

Drugs in Search of a Disease—Pharma Targets Women

Dr. Coderre's Pills

Last week I focused on drug advertisement for “Low T” catching up with all the attention given to menopausal women with declining hormones. But women still are the primary targets for pharmaceutical advertising, in part because they can be captured for multiple products—if not quite from the cradle, at least from puberty, through pregnancy, to [...]

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Molecules to Medicine

Diet drugs vs. Healthier lifestyle

BurgerKingQuadStacker-Mychal Stanley-cc-wikimedia

As expected, the FDA recently announced approval of a second drug for obesity within a month, Vivus’ Qnexa, now renamed Qsymia. This approval is less of a surprise, as the data appeared somewhat stronger than that for Arena’s lorcaserin (Belviq). What was rather curious is that USA Today broke news of the drug’s approval before [...]

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Observations

Hey FDA, Poop Is Not a Drug

fecal transplant

Imagine if in the 1960s surgeons like Christiaan Barnard or Norman Shumway had had to use the same rules that govern the development and testing of pharmaceutical medications when they were teaching the rest of the world how to transplant hearts from the recently deceased into their patients. The idea is absurd on the face [...]

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Observations

FDA Was Right to Block 23andMe

A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration’s admittedly user-unfriendly website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes [...]

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Observations

Use of Avastin for Breast Cancer Nixed by FDA

fda logo

The multi-billion-dollar cancer drug Avastin is no longer an approved treatment for breast cancer treatment, per a long-anticipated announcement made Friday by the U.S. Food and Drug Administration (FDA). Avastin (bevacizumab, sold by Genentech/Roche) has been on the market since 2004 as a treatment for colon cancer. Following its lukewarm approval in 2008 for use [...]

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Observations

FDA Starts to Tackle Regulation of Health and Medical Apps

doctors medical health apps fda regulation

On-the-go doctors can already see your latest MRI or CT scan via a smart phone or tablet. But would you want them to be able to download an app that essentially turns an iPad into an EKG to determine if you are having a heart attack? Earlier this year, the U.S. Food and Drug Administration [...]

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Observations

Federal anti-smoking campaign gets graphic with images of blackened lungs and corpses

cigarette, FDA

Good news for those who think that anti-smoking warning labels aren’t prominent enough on cigarette packs and cartons (bad news for the squeamish though)—the U.S. Food and Drug Administration (FDA) will require tobacco companies to include blackened lungs, corpses, crying babies and other disturbing images on their products so that smokers fully understand the risks [...]

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Observations

Regulators consider more rigorous examination of consumer genetic tests for serious diseases

consumer genetic test

Whether you have questions about your ancestry, earwax or Alzheimer’s risk, a recent slew of genetic tests promise to give you highly personal answers. Since this summer, however, the U.S. government has been taking a closer look at establishing standards of availability—and accuracy—for direct-to-consumer (DTC) genetic tests. Some 90 percent of these tests have not [...]

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Observations

Should consumers have the right to buy any genetic test?

should genetic tests be marketed directly to consumers?

Earlier this year, consumers were close to being able to pick up a saliva-based genetic test for disease risk the next time they ran to the drug store for aspirin or sunscreen. But even though the tests are still available for purchase online, consumers, geneticists and other groups quickly started to ask questions about the [...]

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Observations

Diabetes drug investigation yields unclear decision from FDA committee

This week, a federal advisory committee of 33 experts convened to review data on the controversial type 2 diabetes drug, Avandia, and debated whether the drug should remain on the market. The meeting was prompted by recent studies suggesting that patients on the drug have an increased risk of heart attack. The U.S. Food and [...]

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Observations

Hospital error leads to CT scan radiation overdoses in 206 patients

Cedars-Sinai,CT scan,stroke,Häggström

How well do hospital medical technicians know their equipment? Not well enough in the case of some health care workers at Cedars–Sinai Medical Center in Los Angeles, where 206 x-ray computed tomography (CT) scan patients were given eight times the normal dose of radiation during brain scans over an 18-month period. The Los Angeles Times [...]

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Talking back

FDA Enlists Big Data to Track Down Pharma Fraud

Predictive analytics—lumped under the faddish banner of Big Data—is the high-profile set of techniques that tame numeric deluges to deduce that a new epidemic is starting to break or that a last-minute steal of an airfare has just popped up. The best uses for Big D may be yet to come, though. The FDA just [...]

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