For a long time, homeopathic medicines have not been subject to FDA approval. Now the FDA says homeopathic treatments must follow the same rules as typical drugs. This includes the tens of millions of dollars to run clinical trials to get FDA approval.
The main problem the FDA has is the unproven claims that homeopathic treatments make. They say that claiming without proof that a certain remedy can treat a disease gives someone false hope. They may put their trust and money into something that doesn’t end up helping. Or worse, they might not spend their money on FDA approved drugs!
The FDA approved treatments could never give you false hope or waste your money… right?
What is Homeopathy?
Homeopathic medicines are not the same as natural medicine.
Homeopathy is based on the idea that “like cures like.” That is, if a substance causes a symptom in a healthy person, giving the person a very small amount of the same substance may cure the illness. In theory, a homeopathic dose enhances the body’s normal healing and self-regulatory processes.
While this FDA rule does not itself affect herbal medicine and natural cures, it sets a dangerous precedent. One of my favorite reference books that I mention all the time is The Green Pharmacy. It is an encyclopedia of herbs and foods that can treat common diseases and health issues.
The book presents plenty of evidence. It mentions studies, and laboratory tests to determine the substances in things like garlic and pineapple. But few herbs have gone through double-blind clinical trials to see if they can treat various diseases.
There may be hundreds of years of literature, laboratory tests that confirm the presence of beneficial compounds, and countless anecdotal evidence, but that would not be enough for the FDA.
The FDA applies this strict standard that if it hasn’t gone through FDA approval, it is “unproven.” So the precedent set is that claiming certain herbs and spices treat sickness goes contrary to FDA rules.
This could end up messing with free speech if it goes far enough. How can companies get their natural products out into the market if they can’t tell you what they treat?
Sometimes the timing of the rules is suspicious. Homeopathy has grown to be a $3 billion industry. The FDA says:
Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims.
They go on to explain the uptick in sickness and even death from homeopathic remedies.
To be fair, the FDA does highlight some concerning ingredients in certain homeopathic products. But they don’t provide any statistics, only anecdotes. So there is no clear indication how big of a problem these few products with dangerous chemicals are.
On the other hand, the CDC reports:
Overdose deaths involving prescription opioids were five times higher in 2016 than 1999,1 and sales of these prescription drugs have quadrupled.3 From 1999 to 2016, more than 200,000 people have died in the U.S. from overdoses related to prescription opioids.1,2 …
As many as 1 in 4 people who receive prescription opioids long term for noncancer pain in primary care settings struggles with addiction.7
The prescription opioid industry in the US is close to $18 billion a year. 46 people die every day from opioid overdoes involving prescription drugs.
So to scale that number back to match the $3 billion homeopathy industry, do 7 people per day die from homeopathic remedies?
There are deaths from homeopathic treatments. What started this push to regulate the industry was the deaths of 8 babies attributed to homeopathic teething tablets between 2006 and 2016. That is tragic, and the company should be held accountable.
Most other deaths associated with homeopathy are for lack of conventional treatment for serious illnesses. These are still extremely few. So few that it is hard to find statistics–the cases seem to be isolated.
One of the government’s concerns is that people relying on the promise by these unapproved products won’t seek treatments for opioid addiction that have actually been shown to work…
“Many unproven medications or treatment programs for addiction take advantage of the fact that there are people who are vulnerable and in need of help — and who don’t always have the best ways to evaluate whether something is helpful,” said Dr. Carla Marienfeld, an addiction psychiatrist and an associate professor of psychiatry at the University of California, San Diego…
“These products may not be doing direct harm,” said Marienfeld. “But it can also be very detrimental for companies to promise hope, when a person could instead be using an intervention that actually has a lot of evidence showing it is helpful.” …
Marienfeld said medication-assisted treatments using methadone and buprenorphine have “many years of very good data showing that they help decrease cravings, they help retain people in treatment, and they help dramatically decrease use of illicit opioids.”
Translation: the FDA is concerned that people won’t spend their money on opioids to treat opioid addiction.
So treatments with no side effects, but which might not help, are considered worse than methadone and buprenorphine.
The CDC does not track deaths from Buprenorphine.
The American government-financed clinical trials of Buprenorphine. It cost $28 million to win FDA approval. This is another story of the revolving door of doctors who go in and out of the FDA and private practices pushing and prescribing drugs. The FDA gave the company a seven-year monopoly on Buprenorphine.
Over 10% of doctors authorized to prescribe it were sanctioned for misbehavior, including insurance fraud and excessive opioid prescribing.
Buprenorphine generated $1.55 billion in sales in 2012 and was responsible for at least 420 overdose deaths in 2003, the year it was introduced.
U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks.
Somehow the FDA pushing these drugs–which account for thousands of deaths every year–is not taking advantage of people. But offering over the counter help to people who may otherwise not seek treatment is bad.
Be Smart: There are some real issues with homeopathy. I’m a skeptic, so I likely wouldn’t try homeopathy unless nothing else worked.
Homeopathy seems like the type of thing to use to prevent allergies. It doesn’t seem like the go-to solution for cancer. That being said, the conventional cancer treatments can themselves be very harmful…
Don’t use homeopathy in life or death situations. And look into exactly what chemicals are in homeopathic treatments.
But a handful of deaths should not put an entire industry in jeopardy. Small companies cannot afford clinical trials to get FDA approval. The regulation favors large established pharmaceutical companies, whether or not their products are safe.
The FDA ignores thousands of deaths every year from drugs they approved. But they are concerned about misleading addicts into wasting money and effort on something not proven to treat addiction.
As usual, the money tells a different story.
Note: This article has been updated to remove a comparison between homeopathic cures and vaccinations.