This was highlighted last Friday with the complete split between the FDA and CDC with respect to their public communications and warnings regarding the disease outbreak.
The CDC is undermining the observed connection between black market THC/CBD oils and the majority of the reported cases as well as the finding of high levels of tocopherol acetate in many of the product samples provided by affected patients. The CDC's primary warning is to avoid electronic cigarettes and vaping altogether. This is tantamount to advising ex-smokers who quit by switching to vaping to return to smoking. This irresponsible advice completely ignores the principle of addiction and the lack of a clear and unambiguous warning not to use black market marijuana vape carts is inexcusable and puts youths' lives at risk.
In contrast, the FDA has issued a specific and unequivocal warning not to use THC/CBD oils, especially black market vape carts. The FDA stated that: "consumers are urged to avoid buying vaping products on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores." Although the FDA noted that youth should not vape at all, they did not back down from or undermine the finding of tocopherol acetate in many of the tested samples. Unlike the CDC, the FDA did not issue a recommendation that ex-smokers who vape should return to smoking.
Former FDA commissioner Dr. Scott Gottlieb has also been very clear in his Twitter communications, warning that: "Based on current reports it’s likely to be case most of the vaping injuries are related to illegal products and mostly THC and CBD." He also astutely pointed out that "permissive state laws on recreational THC and our conflicted attitude toward cannabis create a lot of risk. These products and vape pens sold to aerosolize stuff other than nicotine (and thus probably not regulated by FDA) fall into dangerous gap where there’s no proper oversight."
Dr. Gottlieb also noted that: "Legitimate e-liquids are generally based on chemicals that are water soluble, not oils that can cause acute lung injury. High levels of vitamin E acetate were found in nearly all cannabis-containing vapes tested by NYS Department of Health. Nobody should use illegal vape products." I applaud Dr. Gottlieb for stepping in where CDC failed and providing helpful and specific recommendations based on the best available information at the present time.
In contrast to Dr. Gottlieb, the CDC is actually undermining the connection between illicit THC oils and the outbreak. For example, they relentlessly emphasize that many of the patients who reported using THC oils also used "nicotine-containing products": "While many of the patients, but not all, reported recent use of THC-containing products, some reported using both THC- and nicotine-containing products." This completely undermines the previous phrase and downplays the connection between THC oils and the disease, while implying that traditional e-cigarettes are still a likely cause. They also mention that although vitamin E acetate was found in many of the samples, it was not found in every single one of them. Again, this undermines this important finding.
Both of these examples of undermining the role of illegal THC vaping products are completely unnecessary and irrelevant. If THC oils are related to the disease, then it doesn't matter whether the patients also vaped traditional e-cigarettes. If THC oils are causing a large number of cases, then there is no need to invoke the traditional e-cigarettes, even though some patients are using multiple products. In addition, the CDC should know full well that in a disease outbreak investigation, you almost never find a single exposure that ties together every case. The fact that vitamin E acetate was not found in every sample does not eliminate its potential role. Nor does the fact that not every patient reported using THC oils eliminate the possibility that THC oils are responsible for the entirety of the outbreak.
Despite the sharp deviation between CDC and FDA, the most telling sign that the CDC is intentionally protecting illicit marijuana drug dealers in its zeal to go after the legal e-cigarette industry is a glaring omission from its recommendations to clinicians that no one seems to have picked up on.
The Rest of the Story
The CDC issued a Health Alert Network alert which advises clinicians of what they should do with every suspected case.
Here is the entirety of the CDC's recommendations for clinicians:
Recommendations for Clinicians
- Report cases of severe pulmonary disease of unclear etiology and a history of e-cigarette product use within the past 90 days to your state or local health department. Reporting of cases may help CDC and state health departments determine the cause or causes of these pulmonary illnesses.
- Ask all patients who report e-cigarette product use within the last 90 days about signs and symptoms of pulmonary illness.
- If e-cigarette product use is suspected as a possible etiology of a
patient’s severe pulmonary disease, obtain detailed history regarding:
- Substance(s) used: nicotine, cannabinoids (e.g., marijuana, THC, THC concentrates, CBD, CBD oil, synthetic cannabinoids [e.g., K2 or spice], hash oil, Dank vapes), flavors, or other substances
- Substance source(s): commercially available liquids (i.e., bottles, cartridges, or pods), homemade liquids, and re-use of old cartridges or pods with homemade or commercially bought liquids
- Device(s) used: manufacturer; brand name; product name; model; serial number of the product, device, or e-liquid; if the device can be customized by the user; and any product modifications by the user (e.g., exposure of the atomizer or heating coil)
- Where the product(s) were purchased
- Method of substance use: aerosolization, dabbing, or dripping
- Other potential cases: sharing e-cigarette products (devices, liquids, refill pods, or cartridges) with others
- Determine if any remaining product, including devices and liquids, are available for testing. Testing can be coordinated with the local or state health departments.
- Consider all possible causes of illness in patients reporting respiratory and gastrointestinal symptoms and of e-cigarette product use. Evaluate and treat for other possible causes of illness (e.g., infectious, rheumatologic, neoplastic) as clinically indicated. Consider consultation with specialists (pulmonary, infectious disease, critical care, medical toxicology) as appropriate.
- Clinical improvement of patients with severe pulmonary disease associated with e-cigarette use has been reported with the use of corticosteroids. The decision to use corticosteroids should be made on a case-by-case basis based on risks and benefits and the likelihood of other etiologies.
- Lipoid pneumonia associated with inhalation of lipids in aerosols generated by e-cigarettes has been reported based on the detection of lipid-laden alveolar macrophages obtained by bronchoalveolar lavage (BAL) and lipid staining (e.g., oil red O). The decision about whether to perform a BAL should be based on individual clinical circumstances.
- Lung biopsies have been performed on some patients. If a lung biopsy is obtained, lipid staining may be considered during pathologic examination, and is best performed on fresh tissue. Routine pathology tissue processing (including formalin-fixation and paraffin-embedding) can remove lipids. Conducting routine tissue processing and histopathologic evaluation is still important. Consider consultation with specialists in pulmonary medicine and pathology to help inform any evaluation plan.
- Patients who have received treatment for severe pulmonary disease related to e-cigarette product use should undergo follow-up evaluation as clinically indicated to monitor pulmonary function.
The glaring omission in the CDC's recommendations for clinicians is that they failed to recommend that clinicians conduct a sensitive urine drug screen for THC in every patient.
This is the only way to determine with reasonable accuracy whether a patient used a THC-containing product. Simply relying on self-reports is not sensitive enough because many youth will understandably hide the fact that they were using an illicit, black market drug that was essentially obtained from drug dealers. Every patient needs to be tested for THC.
The failure to recommend this testing indicates to me that the CDC is not serious about really wanting to be able to invoke THC oils as a cause of these illnesses if they truly are the cause. By not recommending this testing, the CDC is ensuring that there is no way that THC will be implicated in every case. This, by definition, will leave open the possibility that traditional e-cigarettes are causing some of the cases, allowing the CDC to emphasize that people should not use e-cigarettes!
The rest of the story is that the parameters that the CDC has established for its investigation will ensure that it has the ability to invoke electronic cigarettes as being a possible cause for the outbreak. This tells me that the CDC is more interested in protecting the illicit, underground THC vape cart black market than truly protecting the health of our nation's youth. Apparently, being able to continue to demonize electronic cigarettes is more of a priority.