Are You Marketing a New Drug? FDA Will Do Its Best to See That You Have No Competition from Any Source!

If you thought the FDA was hostile only to supplements, think again. The agency is also unfriendly to drugs no longer under patent.
Aspirin is a very old drug. It is no longer under patent protection, which means there is no longer any financial windfall to be made from it. We have reservations about taking aspirin, which we’ll discuss below. We think there are better and safer natural anti-inflammatories.
But it is an indisputable fact that many studies have found low-dose aspirin to reduce the risk of heart attacks by as much as 40%. Despite such studies, the FDA still won’t let aspirin producers report on their findings. It considers such studies to be “unapproved” health claims and that mentioning them in marketing means you are trying to sell an “unapproved drug.”
In the 1980s, the FDA declared that any company promoting the sale of aspirin to prevent heart attacks would be subject to civil and criminal penalties. In 1998, due to pushback from the industry and further scientific findings, the FDA allowed companies to advertise some cardiovascular benefits of aspirin, but only on a very limited basis.
Studies also show that aspirin can have a preventive effect on cancer, but these claims too remain illegal according to the FDA. The agency seems to have no problem with drug manufacturers investigating and selling pharmacologically similar compounds, like selective COX-2 inhibitors, which show similar anti-cancer properties but have more negative side effects, because these fall under patent protection. The response of the pharmaceutical industry is to take a safe, inexpensive, and readily available compound, manufacture it synthetically, then alter it slightly so that it can become an entirely “new”—and therefore patentable—drug.
Since the FDA receives such a large percentage of its operating budget from Big Pharma’s drug approval fees, it is not surprising that they would promote only substances that can be patented, and squelch competition for anything that won’t help pay their expenses.
Returning to the undesirable side effects of aspirin, these include an increased risk of ulcers and gastric bleeding. Yet it’s a weaker and safer blood thinner than Coumadin (Warfarin), which interferes with vitamin K, weakens bones, and sends calcium into blood vessels and major organswhere it doesn’t belong. Another blood thinning drug, Plavix, also has a scary list of side effects.
What the FDA won’t even discuss is that there are far better, natural alternatives to aspirin for heart health and for reducing the inflammation that seems to be underlying or a part of cancer. Last year we published our comprehensive list of natural treatments for heart health—be sure to check it out! We have also published a list of substances for pain relief. These are also anti-inflammatories which may help quell silent inflammation as well as the more “vocal” kind that produces pain.