FDA allows carcinogens in popular drugs

More evidence that the drug approval process is completely broken.

A pharmacy recently alerted the FDA to the presence of a cancer-causing chemical in the popular blood-pressure drug valsartan, putting millions of patients at risk.

Incredibly, this isn’t even the first time dangerous chemicals have been found in this class of drugs. Generic forms of Valsartan have been recalled since 2018 when three other carcinogenic compounds were found in various versions of the drug.

In this current episode, a solvent called dimethylformamide (DMF) was discovered in valsartan pills still on the market in the US, which the FDA was recommending as an alternative to recalled versions. The World Health Organization classifies DMF as a “probable carcinogen.”

Note that the FDA allows drugs to contain small amounts of DMF. That’s right—the agency charged with protecting public health allows drug manufacturers to put a cancer-causing solvent in their pills.

The contamination of this heart drug highlights, among other things, the pitfalls of the drug manufacturing process. According to one expert, “Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it.” This puts the supposed safety of the medications that millions of Americans take—often more than one—in serious question.

Where is the FDA in all of this? As we know, the FDA doesn’t test the drugs it approves. It reviews the data that drug companies choose to submit, which is why the agency does not (and will not) detect the presence of cancer-causing chemicals in drugs.

Recall, too, the conflict of interest at the FDA. Through drug user fees, pharmaceutical companies pay millions of dollars to the FDA to approve drugs, making the agency financially beholden to the industry. As Dr. David Graham, a former senior drug safety researcher at the FDA, said: “As currently configured, the FDA is not able to adequately protect the American public. It’s more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent.”

There is an irony here. When it comes to dietary supplements, compounded medicine, and other natural health modalities, we’re told by the FDA that more regulations bringing natural products through a drug-like pre-approval system will better protect the public; compounded medicines are viewed skeptically by the FDA because they do not go through the agency’s drug approval process. The example of Valsartan, and the many other examples of dangerous drugs getting approved and subsequently killing thousands of people, should put to rest notions that FDA approval ensures safety. It appears that agency moves to regulate natural products have more to do with eliminating competition for drugs than with safeguarding public health.

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By ANH-USA

What We Believe and What We Do

The Alliance for Natural Health USA (ANH-USA) is committed to sustainable health, the recognition that true health requires a proactive and preventive approach that focuses on a nutrient-rich diet, proper supplementation, and limiting our exposure to toxic substances. A system that is single-mindedly focused on “treating” sick people with expensive drugs, rather than maintaining healthy people, is neither practical nor economically sustainable.

ANH-USA is part of an international organization dedicated to promoting natural and sustainable health—and, in particular, consumer freedom of choice in healthcare—through good science and good law:

  • Since our founding in 1992, we have worked to shift the conventional medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an integrative approach incorporating functional foods, dietary supplements, and lifestyle changes. We believe this is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.
  • Sustainable health also applies the environmental ethic of conservation to our bodies. It urges us to live as nature intended us to live. Diet, nutritional supplements, exercise, and the avoidance of toxins are especially important tools in building and maintaining health.
  • Sustainable health is also about financial sustainability. Ever higher healthcare costs lead directly to higher unemployment and lower standards of living, both of which lead to more illness.
  • Today, preventive medicine is too often defined as taking more and more drugs at an earlier and earlier age, even in childhood. The concept of sustainable health is real preventive medicine and will dramatically reduce healthcare costs.

To this end, ANH-USA actively engages in legal initiatives, standing against forces that would limit your access to safe and effective dietary supplements, complementary therapies, and integrative medicines. We lobby Congress and state legislatures, act as a government watchdog, file comments on proposed rulemakings, and educate the public, the media, and other decision-makers.

Our most important tools:

  • A strong grassroots member base that is ready to act on a minute’s notice. ANH-USA is fortunate to have a dynamic, fast growing member base that collectively presents a unified front and demands their collective voice be heard. Thank you, members!
  • Effective lobbying. ANH-USA monitors legislation and regulatory activity on the state, federal, and international levels daily. Staying apprised of the domestic and global pulse on integrative medicine assists greatly in developing policy to advance integrative medicine.
  • Litigation. The court system has a role in protecting integrative medicine and a consumers’ right to choose. When it is required, ANH intervenes, through legal action, to protect the rights of the public.
  • Strategic coalitions. Collaboration is the most effective means to further a cause. ANH-USA has been highly effective in building long-term relationships with outside groups, members on the Hill, medical societies, and consumers from all walks of life.
  • Timely education campaigns. The timely launch of public educational campaigns is key to increasing support and recognition of key issues while furthering our overall cause.

Working closely with the media. Media can be a friend or a foe and whichever it may be, media is imperative to quickly disseminate a message. ANH-USA works collaboratively with the media to increase coverage of important natural health-related issues.

(Source: anh-usa.org; June 27, 2019; http://tinyurl.com/y2a3pno2)
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