Executive Summary
- This article describes both critical contexts regarding drug testing and our testing of Ivermectin bioequivalence.
Introduction
- A significant issue with the FDA is that it does not appropriately test manufacturing facilities, and its testing is far worse in foreign manufacturing facilities than in domestic factories in the US. However, the FDA makes claims for testing that it cannot back up and turn out to be false when one looks into this topic in detail.
- There is a dual pricing market, where drugs (including Ivermectin) from higher-quality countries are normally expensive—even though the item is generic. However, inexpensive sources have dubious bioequivalence. Bioequivalence is how much active ingredient (API) is contained in each pill.
- The case of Ivermectin demonstrates why it is not as simple as a drug simply becoming a generic—followed by the price becoming reasonable for a high-quality source.
- The testing of drugs outside of the testing performed during the initial stage when the drug is introduced is rare.
Important Drug Testing Background Topics
Before getting into our testing, I will cover several important topics that explain why we created our own testing program. Understanding why we selected the testing approach that we did is important.
Important Background Topic #1: The Problem With the FDA’s Lack of Testing and Bioequivalence Curves
The FDA does not test drugs’ outcomes in people but instead allows manufacturers to submit bioequivalence tests performed in labs. However, the standards for measuring bioequivalence are very low.
This is explained by the following quote from the book Bottle of Lies.
Patients getting switched from one generic to another might be on the low end one day; the high end the next. The FDA allowed drug companies to use different additional ingredients, known as excipients, that could be of lower quality.
Those differences could affect a drug’s bioavailability, the amount of drug potentially absorbed into the bloodstream.
And there is more to it — because the amount of API or active pharmaceutical ingredient can be reduced to save costs. Furthermore, the other things included in the pill or tablet are also important. That is, the generic copy drug’s ability to replicate the original drug’s pharmaceutical effect is more significant than how much active pharmaceutical ingredient is in the pill or tablet.
The more detailed explanation is more than most people will want to read when finding out about our testing program, so we have moved this detail to the article How the FDA’s Generic Drug Bioequivalence Testing is Fake.
However, this inaccuracy on the part of the FDA perfectly illustrates that even when testing is done, the FDA has deficient standards that make it easy for generic drug manufacturers to game.
The FDA does not prioritize drug quality. Remember, the FDA does not, in a practical sense, work for the public or in the public interest—it works for pharmaceutical companies. This topic is essentially never discussed with the public — and the FDA goes to great lengths to promote the idea that any drug sold is the same as the original drug.
Important Background Topic #2: The Problem and Complications Involved With Lab Testing
Many people have taken drug tests for recreational drug testing and see how quick, easy, and widely available they are and will often assume that the same type of kits are available for testing pharmaceuticals. This assumption is not correct. There is a chasm between the ubiquitousness of illegal recreational drug testing and testing for APIs and impurities. The market for drug testing kits is very much organized around illegal recreational drug testing, and they have very convenient testing. The chemical profiles of recreational drugs are widely published and standardized. Because of the high volume of recreational drug testing, companies have created low-cost kits that are widely used. This is not the case for non-recreational drugs, however.
The Reality of Drug Test Accuracy
The following video explains how the very commonly used recreational drug tests can often provide false positives. That is to say, a person has taken a recreational/illegal drug that they have not taken.
Testing a Pill’s Overall Chemical Composition
To perform labratory testing, one would need to get and be able to use one of a few types of spectrometry machines. This is not only a significant investment in machines, but they also require specialized understanding to operate correctly. Some labs might do this type fo testing, but there are a few problems with this in that the business we would be able to offer them would be low. Recreational drug testing labs are used to low volume “consumer” walk-ins, but labs that test APIs are not set up like that.
Lab testing is the appropriate method for repetitive testing, but it still does not compare to testing the actual drug effect in animals — and thus, it is distinctly inferior to testing in animals or humans.
How We Test Drugs
Due to a deficiency in the market and requests from subscribers, we have stepped in to address this issue for Ivermectin and Fenbendazole by performing our independent testing in the most accurate test for the pill’s ability to replicate the effect of the original drug. This is by doing actual animal testing. Technical lab tests are far less accurate than tests with real subjects. However, the problem is that many things that Ivermectin is helpful for are difficult and expensive to test. So, we needed to find an easily observed and tested outcome. Luckily, this outcome is known and goes back to the origin of these drugs as antiparasitics.
About the Test
Important Background Topic #1: Test Description
Over two months, we purchased and tested several products for their most easily observable and measurable item: Ivermectin’s effectiveness against parasites.
The testing lasted two weeks because Ivermectin effectively quickly pushes parasites out of humans and animals. Therefore, we ranked the best versions of Ivermectin based on their results against ear parasites, in addition to comparing the effects of the original versions of both drugs.
As we cover in detail in articles for subscribers at this site, Ivermectin is effective against many things; however, parasites are the most measurable thing to test. As soon as an Ivermectin version is effective against parasites, its other benefits can be realized. We were not testing Ivermectin against disease (you can see in our articles the references to the studies performed in this regard). Instead, we were trying to determine the real-life effect of the drugs in animals and how well they compared to the original versions of the drugs.
Important Background Topic #2: About The Testing Cycles
Currently, we have repeated this test three times, or we have gone through three testing cycles.
In the first cycle, we tested eight generally well-rated Ivermectin and Fenbendazole versions.
On the second cycle, we dropped the bottom six performing versions of Ivermectin and Fenbendazole, added six replacements, and then did the same on the third cycle.
Important Background Topic #3: Why We Were Able to Test in a Reliable Fashion
The initial tests of Ivermectin were published, and we copied those tests. However, all of our tests were with well-priced generics.
Important Background Topic #4: What the Drugs Were Used Against
Mites will often infect the interior of the large ears of rabbits — and rabbits, which is where we apply the mites, are easy to infect with mites, and it is straightforward to measure when the mites have been cleared from the rabbits. Mites are a common parasitic infection for rabbits in the wild.
The testing is also humane as the mites are not very painful for the rabbits, mainly if the style is cleared quickly and the testing process can clear them.
Rabbits in the wild that have mites will often result in skin damage to the ear as the mites burrow and reproduce. The mites are impacted rapidly by both the Ivermectin and Fenbendazole and will begin to die as their neurological system is negatively affected. Rabbits are treated with Ivermectin, with a 200-400 mcg/kg dosage, SC, two or three treatments 10-21 days apart.
Important Background Topic #5: Where We Obtained the Testing Protocol
We followed this well-established protocol, which we found after reading the research into animal testing. These drugs work the same way in humans as they do in animals.
Important Background Topic #6: Performing Effective Comparison Testing
Because mite infection, growth, and elimination in rabbits are measurable, we were able to test the effectiveness of these drugs between different manufactured items. This test is also “real world” as it is tested in animals with measurable outcomes.
Important Background Topic #7: Covering Testing Costs
Subscribers receive our most up-to-date testing. After weeks of discussions with a supplier to carry the Ivermectin and Fenbendazole that passed our tests, they have just brought their website for those we recommend to them online.
Important Background Topic #8: Our Testing Frequency
So far, we have gone through three rounds of testing. Because we are using animals, we can’t test as frequently as if we used a specialized lab testing machine. However, we consider animal testing far more accurate than using a lab testing machine and comparing curves between the original Merck product and different generic versions of Ivermectin. We are unsure where our testing will go as we have already received several requests from companies to do testing they can use. But as for now, all of our testing has been done with animals. Also, because we don’t use a machine, we don’t have a specific bioequivalence percentage — of, say, this tested Ivermectin is “93%” of the original Merck product. Instead, we record the effect on the rabbits for how quickly the mites drop off. Our testing and the Ivermectin we selected for Summit Products to carry are roughly the same as those of the rabbits who were given Merck Ivermectin. At a certain point, it becomes difficult to distinguish the effect when it is close, as there are also variances between the individual animals and how the drug is processed. Just as with humans, not all rabbits have the same immune system.
One question we have received is whether Summit Products‘ manufacturer of the Ivermectin and Fenbendazole can change something, making the drug less effective. The answer is that it is possible. The only way to stop this would be to run a sample of each batch of the product received by Summit Products through a lab machine and then compare it to the last tested batch and Merck’s original product. We have never stated that we are doing this. Instead, we are performing periodic testing. As per the request I mentioned, we have been asked to get into testing more, but I am not clear that we are interested in running a pharmaceutical testing lab that constantly tests new orders. That is a very different business than the one we are in.
A Question on Which Version of Ivermectin and Fenbendazole to Buy
When one looks at studies on drugs, they typically use the original drug. So, in this case, it would be Merck’s Ivermectin.
They usually don’t state the drug version they use in the study, but that is typically what is done. Those who run the study do this to remove the issue of variance in the active pharmaceutical ingredient, and it is not only the API that is different between the original drug and a generic.
However, to duplicate the effect, buying Merck’s Ivermectin is expensive. The Ivermectin that most people purchase is made in India, which has no bioequivalence or safety regulations. The FDA also does nothing to test drugs, particularly those manufactured outside the US. I cover this topic, which is very little known, in a number of articles on the site, which you can see at the Drug Sourcing Article Index.
We tested a number of Indian versions of Ivermectin to arrive at the one we ended up partnering with Summit Products to carry, the one with the highest bioequivalence to the original Merck product.
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