The FDA Just Lost a Lawsuit That Could Change How Drugs Are Regulated

A small drug company has won an early fight in its case against the FDA, which will allow it to promote its fish-oil pill for treatments not explicitly approved by the agency. The federal case has huge implications for the future of prescription drugs in the US and could weaken the FDA’s power to regulate how drugs are marketed.

Source: The FDA Just Lost a Lawsuit That Could Change How Drugs Are Regulated

The ruling has nothing to do with consumer focused advertising. It has to do with informing and promoting off label uses of the drug to doctors. Pharmaceutical companies are free to share any research with doctors that support uses of the drug not specifically approved by the FDA.

Also, the ruling is incredibly specific to Amarin and outlines exactly what is a truthful and non-misleading in the context of Vascepa only. So in response to the article headline, yes this could change how the FDA regulates drugs but in reality it hasn’t and won’t.

The Dangerous Power of Health Media: 28,000 Quit Statins After Scare Documentary

Unbalanced and poorly researched health reporting is often criticised for the effect it can have on people’s health choices. That effect can be very difficult to quantify, but a paper published this week in the Medical Journal of Australia estimates that an extra 28,000 Australians stopped taking cholesterol-lowering statins after an Australian Broadcasting Corporation (ABC) documentary.

Statins are widely-prescribed drugs that are used to lower the levels of dangerous LDL cholesterol in the blood. According to the Australian government’s most recent estimate, they were the most commonly prescribed drug in Australia in 2011. Any change in the number of people taking statins therefore has a huge impact, affecting thousands of people.

Source: The dangerous power of health media: 28,000 quit statins after scare documentary

Let us not forget the ever-decreasing threshold that doctor’s use to prescribe statins, despite little evidence that the demands for extremely low LDL are actually beneficial.

And that’s all totally ignoring the fundamental issues with the ‘cholesterol hypothesis’ generally — it is possible that elevated LDL is a byproduct of metabolic syndrome or other inflammatory conditions, not vice-versa, and also that total LDL alone is a poor measure of cardiovascular risk. Doctor’s need to consider HDL and triglyceride levels, as well as certain ratios of these lipid levels, and even that is imperfect.

Just remember, folks: researchers and doctors, all too often, inappropriately draw narrow conclusions that are not adequately supported by their data. For example, for decades we’ve been told that dietary cholesterol is bad for our health, and raises LDL — except that it doesn’t, and the data has never adequately supported this conclusion. It was only this year that the FDA finally admitted “oh yea, turns out cholesterol is tightly regulated by the body [which we’ve known for awhile], and dietary cholesterol doesn’t matter” and they removed restrictions on cholesterol in the diet.

Fish Oil Not So Perfect After All

Fish oil is now the third most widely used dietary supplement in the United States, after vitamins and minerals, according to a recent report from the National Institutes of Health. At least 10 percent of Americans take fish oil regularly, most believing that the omega-3 fatty acids in the supplements will protect their cardiovascular health.

But there is one big problem: The vast majority of clinical trials involving fish oil have found no evidence that it lowers the risk of heart attack and stroke.

…Dr. Stein also cautions that fish oil can be hazardous when combined with aspirin or other blood thinners. “Very frequently we find people taking aspirin or a ‘super aspirin’ and they’re taking fish oil, too, and they’re bruising very easily and having nosebleeds,” he said. “And then when we stop the fish oil, it gets better.”

Source: Fish Oil Claims Not Supported by Research

While it’s interesting that so many studies support that there’s no link between the health claims and fish oil extract, there’s only a passing mention of FDA review and support.  Nothing about if the supplement actually contains fish oil.  If other supplements are full of asparagus and lies

My stance remains firmly no-supplement.  Nothing is 100% safe, with farmed salmon getting dyed to resemble wild, or the known fraud in olive oil…  Doing the best you can is all you can hope for, and the field changes without your knowledge.