FDA pushes junk science

FDA pushes junk science

The Food and Drug Administration recently released another attack on kratom yet, and in its logic, continues to undermine their own claims. The latest release tallies the deaths attributed to kratom, scientific jargon, and includes an explanation of a 3-D modeling on how kratom attaches itself to the body’s opioid receptors like a addictive drug.

Because of this, according to the FDA, kratom should be considered dangerous and scheduled like heroin, hydrocodone, fentanyl, and methadone.

But after filtering through all mumbo jumbo, all that FDA’s Commissioner Scott Gottlieb is pushing is junk science.

Take for example the number of deaths the FDA claims were caused by kratom. In November, the agency claimed there were 36. Today, it’s up to 40 with nine being in Sweden. In their fake science news, the FDA also distributed selected portions of the medical examiners’ reports of those deaths attempting to confirm the danger of kratom. What those reports clearly show are people dying from anything other than kratom. For examples: one person was shot in the chest and it was ruled a homicide. Another person fell out of a second story window, broke bones, and then refused medical treatment. The following day he was found dead. An obese man with a history of drug abuse and alcoholism was taking medication for his high blood pressure, Xanax, other anti-depressants, marijuana and opioids died from a blood clot. The Swedes took a poisonous illicit synthetic drug. Others were addicts making their own concoction of illicit drugs, synthetics and alcohol. Only one person who ingested kratom by itself died. The results are still inconclusive because the FDA refuses to release the complete report.

This hodgepodge of anecdotal reporting does not bolster the agency’s credibility; rather it makes it suspect at best.

Kratom grows in Southeast Asia and yet, in the 200 years of Western knowledge, not one Asian death can be attributed to the plant. Even a Lexis-Nexis search of thousands of newspaper archives failed to find one story saying a Southeast Asian died from kratom.

According to a 2008 national survey in Thailand, more than a million people reported using kratom. In several southern districts in Thailand, up to 70 percent of the male population use kratom daily. And yet the FDA is not capable of pointing to what should be a staggering number of Asian deaths attributed to the plant. Are Americans and Swedes the only ones susceptible to the deadly plant?

The FDA website discreetly places a caveat of their findings, saying the medical cases don’t imply a “causal relationship” between a product and an event. It also notes the “(medical) reports do not always contain enough detail to properly evaluate an event.” So the FDA is pushing fake science.

The FDA’s smoke and mirror show continues with the claim they did computer modeling showing the compounds found in kratom attaches itself to the mu-receptors in the body. Mu-receptors attract opioids. The agency’s conclusion is “we feel confident in calling compounds found in kratom, opioids.”

Using the FDA’s logic, if a compound sticks to the receptors it must be an opioid. Well then, they are going to have to put coffee, chocolate and dairy products on the dangerous drugs list too, for they all latch onto to the receptors as shown by numerous National of Institute of Health studies.

But this is old science.  Scientists have known this for years.

Andrew Kruegel, an associate research scientist at Columbia University, said the FDA’s computer modeling adds nothing new to the research.

“They said these compounds are predicted to turn on those opioid receptors; that’s already known,” Kruegel said. “I don’t understand what that’s contributing to the field. It’s almost like going back to an earlier stage of scientific discovery.”

Kruegel said the FDA’s claim was akin to “saying that all opioid agonists have the same effect, which is not true based on what we’ve learned about these compounds.”

The fallacy of computer modeling is, that it is done in a vacuum, and the rules are set by programmers. The modeling process doesn’t end when you complete it. You have to compare it to the real world, and that’s done with real-world testing which the FDA and other agencies willingly will not do.

“Molecular modeling is not infallible,” said Josh Bloom, senior director Chemical and Pharmaceutical Sciences at American Council on Science and Health. “When used in drug design it is not uncommon for the model to explain the activity of a molecule rather than predict it.”

Bloom adds, “The magnitude of the effect of any drug is dependent on its dose and binding affinity. Without knowing both, it is impossible to determine the pharmacological effect of a given drug.”

The risk of not having kratom available to those who need it, despite all its liabilities, may be greater than whatever harm the drug may cause, Bloom said.

One has to ask, with all the science that contradicts the FDA’s announcements, why are they so intent in wanting to schedule kratom? What is the real reason for wanting to ban the plant, and yet support pharmaceutical drugs that are more dangerous?

The FDA’s anti-science attacks against kratom fail to recognize that thousands of people using the plant are suffering from intolerable pain, some caused by the very drugs they have approved. By making kratom illegal, Gottlieb’s actions will make law-abiding American citizens criminals by forcing them to seek relief from street drugs. Those have a guaranteed consequence of long-term addiction and death. The FDA is better than that, and should allow real independent science to take place, instead of pushing fake science.

 

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