Naked Medicine

I had no idea that September National Cholesterol Education Month, but it is, and I saw a press release about nonprofit nutrition education organization Weston A. Price Foundation on getting consumers to recognize the importance of cholesterol.

The press release made sense to me, but it seriously will meet lots of antagonism because of the prevalent trend of obese children in the USA these days. I bet these kids have ridiculously high cholesterol levels – and certainly not from eating too much “nutrient dense” foods. So while I as a scientist and also as mother of a toddler who needs lots of “good fats” can sympathize, I don’t think the argument here can stand up to even one voice saying “… then what about all this concern with childhood obesity?”

I sent my query off to the publicist, who got in touch with the Sally Fallon Morell, president of the Weston A. Price Foundation to respond to my challenge above. Sally’s response is here.

I followed the links given as references, including the one from the Foundation itself:
Dietary Recommendations for Children –A Recipe for Future Heart Disease?

“Just Say No!”
When it comes to feeding their children, parents should “just say no!” to the government’s dietary guidelines. Children need a diet rich in traditional fats in order to achieve optimum growth and development, as well as protection from heart disease later in life.

I wished it had addressed additionally the issue of fast foods – because this is the reality of “kids’ diets” these days… if saturated fat plays a role in children’s growth, at what point do parents draw the line in where that source of saturated fat comes from? (this question was answered by another link that Sally’s response included, but I wished the above information would address it immediately rather than me having to look at another (non-related to the foundation) link.

I also found the Swedish study findings interesting, mostly because I’ve been drinking more whole milk (full fat) since that’s what I give to my child, who is almost 2 at this writing. Our pediatrician had told us that at this point, we should cut back milk for him because it doesn’t really do much for him other than the calcium and vitamin D that he can be easily getting from other sources.

I don’t know how much this would convince you as a consumer about the benefits of cholesterol in children. On an objectivity scale, I would have preferred that the links I received were original source citations (i.e. links to the original scientific studies published – such as from PubMed) rather than what appears to be commercial pages or user-contributed pages.

By Jane Chin, Ph.D.

In theory, engaging social media in pharmacovigilance is attractive, if not sensible.

In practice, engaging social media in pharmacovigilance will be fraught with such high noise-to-signal ratio that both pharma companies and regulatory agencies may struggle to embrace it.

Let’s look at how pharmacovigilance has fared from the field perspective. We (used to) have over 100,000 sales reps in the field, who are exposed to adverse events signals every single day, I’d even surmise at least once a day.

All company employees in the U.S. pharmaceutical industry are legally obligated to report an adverse event within 24 hours of receipt from the field or through other communication channels.

Yet today adverse events reporting – sans Web 2.0 – has been bogged down with bureaucracy, and physicians who are willing to spend the time and effort to report AEs directly to the FDA are enormously frustrated with the red tape and hurdles they face. It soon became a lose-lose proposition for doctors whose continuing livelihood has come to depend on patients/day type of clinical practice management.

Will Web 2.0 perhaps simplify the process and reduce red tape? I believe the potential is there.

The question is – HOW? At least, from the regulatory / federal government side.

From the commercial side, the question for pharmaceutical companies becomes – WHY ON EARTH…?

There are so many layers of medical history and patient health context that must be addressed when an adverse event arises – were there confounding factors? was the patient compliant? – that stripping the context away makes the content dangerously misleading when interpreting the safety of a drug.