FDA

In a long overdue action, the U.S. Food and Drug Administration (FDA) is informing consumers about the hazards of benzocaine-containing over-the-counter (OTC) oral health products which are typically used by parents for infants and young children to manage teething discomfort. The announcement conveys the agency is warning companies if they continue to sell it or market it to this population, then they will be subject to regulatory measures.

FDA Commissioner Scott Gottlieb, M.D. goes on to state:

“The FDA is committed to protecting the American public from products that pose serious safety...

To protect their revenues, and as a result, keep drug prices high, brand-name drug manufacturers have tried several means to stop or slow the entry of comparable generics. They have attempted to extend their patent protection and have even bought the generic for themselves and just not manufacturer it. One of their more insidious approaches has involved Risk Evaluation and Mitigation Strategies (REMS); specific regulatory guidelines that the FDA requires to protect patients who use drugs requiring more supervision than merely providing a prescription. 

Some drugs have pronounced reasons not to be used or severe side effects that are dangerous but can be prevented or at least treated by checking laboratory values. Elements to Assure Safe Use (ETASU) are part of those disclaimers...

The regulatory concerns about genetic modification of animals that I wrote about a while ago have moved towards a Congressional spotlight. Pigs have been genetically modified to resist porcine reproductive and respiratory syndrome virus by deleting a gene. Does deleting a gene make them genetically modified - yes and no, depending on which regulatory agency you ask. 

The virus

The viral disease is carried by pigs and results in an acute phase with increased fetal and peri-natal deaths as well as a more chronic respiratory phase in the piglet survivors and their moms. As with our own experience with viral infections, they are difficult to eradicate. It is highly...

There's no doubt about it. E-cigarettes have the potential to save millions of lives.

What makes smoking so dangerous isn't the nicotine, per se. Nicotine is an addictive alkaloid, just like caffeine. (Believe it or not, plants produce both compounds because they are insecticides.) The addiction makes people want more tobacco, but the molecule itself isn't all that harmful.

Tobacco is lethal because of the smoke. A lit cigarette releases known chemical carcinogens and tiny bits of particulate matter, which are incredibly damaging to the lungs. Setting anything on fire, not just tobacco, and inhaling the fumes is a bad idea. That's why innovative ways to get...

Imagine your wife suffers a cardiac arrest in the middle of the night and remains unconscious. You start CPR and tell your granddaughter to call 911. Paramedics arrive and, unbeknownst to you, automatically enroll her in a clinical trial without her or your consent as they attempt to revive her. You believe they don’t act fast enough to get her to the hospital and give her a shot you can’t decipher because they won’t permit you in the room (in your own home). Then, she dies.

Days later, you receive a letter in the mail alerting you she had

participated in an out-of-hospital study with the county paramedics as part of the...

Let the games begin. With an announcement just made by Intermountain Health, it appears the organization will be leading a multi-system collaborative effort, which controls 450 U.S. hospitals, in making a strategic play in the generic drug market. The stated goal: to reduce drug shortages and lower prices.

Before we delve further into this seemingly disruptive move, a little background is necessary. As of late, the pharmaceutical industry has been much maligned in a very high profile way, in particular throughout the presidential election as a target of blame for rising health care costs and continuing to reach a national stage...

Homeopathic treatments can be bought almost everywhere. They're the ones that are likely labeled as "natural remedies" and have pictures of grass or leaves on them. What they don't have on them is a label that says "FDA approved", which has been the case since 1988.

However, it may be that that is about to change. 

The US Food and Drug Administration (FDA) announced earlier this week that it is going to start to crack down on some homeopathic products. This statement is almost three years in the making since they announced in early 2015 that they were considering changing their stance on homeopathic regulation. Now, a new, risk-based enforcement approach has been announced. 

The plan is not going to concern itself with all homeopathic products. The new policy will...

Recently, I had the pleasure of filming a segment on the top medical, science and technology innovations of 2017 at Reuters TV in Times Square, New York with host of CCTV Bianca Chen (video clip forthcoming).

It was an exciting year in the pursuit of the once impossible when it comes to medical developments. Here are some top picks that genuinely are changing the landscape:

1) Cancer

Immunotherapy takes the top spot as personalized treatments approach cancer cure in a whole new way. This year, there has been success in its use in leukemia and lymphoma, and now solid tumors are being added to the slate. Time will tell if the latter group will yield similar promising results. Though in its relative infancy, the achievements are being...

Nothing elicits a surge in my skeptic meter like the term world-renowned when used in the medical realm. Especially since it is typically self-described by those selling something, routinely an unnecessary product or procedure.

Those who are authentically world-renowned, who are the real deal, rarely boast about it. Shameless self-promotion is a tough thing for the more earnest medical and science professionals. With the ever-increasing competition today, striking the balance so as to garner enough interest in their work so they can pursue what they so incredibly cherish is often an unnatural road.

Being exactly who you say you are, nothing more and nothing less, reflects the best there is in medicine. This way of navigating the profession prioritizes patient...

From CAR-T cancer therapy to the power of CRISPR-Cas9, the recent advancements in gene therapy are astounding. For a particularly impressive example, please read the story of how scientists created a new skin for a dying boy.

The floodgates of gene therapy have opened and the promise of therapies coming down the pike is beyond exciting. New gene-based treatments are being developed that could change the course of cancer and other genetic, infectious, and other diseases.

That said, like most things, there is a time and a place for new developments to be implemented. And, the place to edit genes is not in your living room according to the US Food and...