U.S. Food and Drug Administration

It’s Too Late for Pooled Testing in the United States

I read an exchange on Twitter about pooled testing for COVID-19 and how other countries are using that technique to more quickly identify people who have COVID-19. Unfortunately, we are long past the point where pooled testing would work in the United States.

According to an FDA page on pooled sampling,

Pooling samples involves mixing several samples together in a “batch” or pooled sample, then testing the pooled sample with a diagnostic test. This approach increases the number of individuals that can be tested using the same amount of resources. For example, four samples may be tested together, using only the resources needed for a single test.

Nebraska actually used pooled testing in March, and it was apparently a cost-effective method of quickly testing large numbers of people.

If a pool of 25 samples were to come back negative, all 25 people could be declared infection-free, reducing the overall number of tests by 24. If that pool instead tested positive, a clinic could separate it into smaller pools — five pools of five samples, for instance — and retest. And if, say, two of those smaller pools turned up positive, the clinic could then individually test the remaining 10 samples. Even in the latter scenario, a clinic would save nine of the original 25 tests.

Nebraska eventually gave up on pooled testing for the same reason no one else in the United States is using it–it is only an effective method when the test positivity rate is relatively low.

The person who brought this up on Twitter mentioned its effectiveness in Rwanda, where the test positivity rate is currently at about 1.8 percent.

However, as of December 30, 2020, there is only one state–Hawaii–that has a test positivity rate of under 2 percent. Along with Hawaii, there are only four other states/districts with test positivity rates below 5 percent–Minnesota, Alaska, Washington, DC, and Vermont.

Idaho currently has a test positivity rate of 59.1 percent. California is at 12 percent.

When test positivity rates that high, there’s no point in doing pooled testing because the pooled test is almost always going to come back positive requiring further testing.

This is what happens when your country’s “leaders” count on a virus just disappearing like a miracle rather than make plans and following the science to minimize the impact of a pandemic.

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False Advertising of Hand Sanitizers?

Interesting letter here from the U.S. Food and Drug Administration to Gojo Industries which manufactures Purell brand Healthcare Advanced Hand Sanitizer products.

As currently formulated and labeled, PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). These violations are described in more detail below.
. . .
These statements, made in the context of the Frequently Asked Questions section, clearly indicate your suggestion that PURELL® Healthcare Advanced Hand Sanitizers are intended for reducing or preventing disease from the Ebola virus, norovirus, and influenza. As such, the statements are evidence of your products’ intended uses. However, FDA is currently not aware of any adequate and well-controlled studies demonstrating that killing or decreasing the number of bacteria or viruses on the skin by a certain magnitude produces a corresponding clinical reduction in infection or disease caused by such bacteria or virus.
Based on the above claims, PURELL® Healthcare Advanced Hand Sanitizers are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Further, your PURELL® Healthcare Advanced Hand Sanitizers, which are formulated with ethyl alcohol, are intended for use as both consumer antiseptic rubs and health care antiseptic rubs. Although the individual products claim to be “designed for healthcare environments,” consumers can buy these products from the websites linked to the “Where to Buy” tabs listed on your product website.
Furthermore, PURELL® Healthcare Advanced Hand Sanitizers are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA approved applications pursuant to section 505 of the Act, 21 U.S.C. 355, are in effect for your PURELL® Healthcare Advanced Hand Sanitizers, nor are we aware of any adequate and well controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are generally recognized as safe and effective for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
. . .
Your labeling claims that PURELL® Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Furthermore, the claims on your product websites suggest that PURELL® Healthcare Advanced Hand Sanitizers are effective in reducing illness or disease-related student and teacher absenteeism also go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings. Such claims are not described in any OTC final rule, the above-referenced TFM (see 59 FR 31402, June 17,1994), or any rulemakings being considered under the OTC Drug Review. Additionally, we are unaware of any adequate and well-controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are GRASE for the above-described intended uses. Furthermore, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.

UK Regulatory Agency Warns Against Melanotan Purchased on the Internet

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has warned against using Melanotan purchased on the Internet. I’ve written about Melanotan before — it is a drug that tans the skin, increases the libido, and suppresses appetite. It has been in testing for the better part of a decade, but is still not approved for sale in the United States or Europe.

This hasn’t stopped US-based Melanocorp from selling the drug just the same. In 2007, the U.S. Food and Drug Administration issued a warning letter to Melanocorp to stop selling melanotan in the United States,

Melanocorp, Inc. advertises the product Melanotan II on its Web site as an injectable tanning product, with additional claims that it is effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). These claims cause Melanotan II to be classified as a drug under the Federal Food, Drug and Cosmetic Act, as well as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses. This product does not have an approved new drug application. The product’s introduction and delivery into interstate commerce, therefore, violates federal law. The risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs. The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider.

Issuance of this Warning Letter is consistent with FDA’s focus on fraudulent products marketed on the Internet for serious and life-threatening diseases. Individuals and firms that do not resolve violations of the Federal Food, Drug, and Cosmetic Act risk injunction to halt the illegal activities, seizure of violative products, and other regulatory sanctions.

Melanocorp stopped taking orders for Melanotan in the U.S. shortly afterward, but apparently still sells to consumers in other countries. According to The Guardian, there are at least 18 companies that sell Melanotan on the Internet.