Earlier this year, the U.S. Food & Drug Administration (FDA) put out a public warning to consumers about possible adverse health effects due to bacterial contamination in a “cancer treatment” known as PNC-27, available through the internet. Laboratory testing by the FDA uncovered that the inhalation solution contained bacteria called Variovorax paradoxus, which can cause serious infections in people with weakened immune systems.
As a result, the agency recommends that anyone who has used this product talk with their physicians about the related health risks, and be on the lookout for symptoms which may require antibiotic treatment. And, of course, they’re recommending that patients seriously consider their treatment options before resorting to unregulated medications.
What Is PNC-27?
PNC-27 is a peptide that has shown some promise in preliminary in-vitro studies as an anti-cancer drug. However, it has not yet been evaluated by the FDA for its safety and efficacy, and has not been approved as a treatment for any sort of cancer.
On the product’s website, the developers of PNC-27 claim that the FDA approval process is so expensive and complex that no pharmaceutical company in America has yet decided to pursue official approval on this medication. Instead, patients can opt to leave the country: For example, they can fly to Mexico to undergo their treatment.
PNC-27 was featured in a popular TEDx talk, giving the drug some momentum online. Patients searching for the drug on the internet will quickly find the drug’s website, which encourages them to sign up to be connected with foreign doctors who can provide the treatment. These treatments can take the form of suppositories, inhaled nebulized solutions, or IV solutions.
However, it is extremely important to understand that PNC-27 clinical trials have not shown the drug to be safe and effective. Given that situation, the question becomes: Is PNC-27 a legitimate cancer drug? Or is it just another in a long line of quack medicines, preying on the hopes and fears of the public?
Miracle Cures and Avoiding Government Regulations
Unapproved miracle cures aren’t new, but regulating them is a relatively new idea. The FDA, which requires premarket review of all new drugs and bans false claims of therapeutic effectiveness, was signed into law in 1938. As a part of this law, no drug can be brought to market and sold to patients in the United States before manufacturers have proven both that it is safe and that it treats the target disease at least as well as currently-available options.
This approval process is accomplished through several rounds of research, animal trials, and human clinical trials. The law exists to protect patients from medications which are insufficiently tested and may come with dangerous side effects. Manufacturers can’t say their drug successfully treats cancer if they haven’t proven that it does, through carefully-constructed randomized trials.
Unfortunately, it’s easy to get around these rules for drug manufacturers unwilling to go through the approval process. PNC-27 gets around the FDA very easily, by making it clear that the treatment is not FDA approved and can’t be administered in the United States. By only selling the drug outside the country, they’re able to avoid FDA rules about safety and efficacy.
Out-of-Country Travel a Red Flag for Safety
This situation should be a red flag to anyone seeking medical treatment. If you have to go to another country for your treatment, then the drug hasn’t been appropriately tested to allow the FDA to decide on approval. It hasn’t been sufficiently vetted for your personal safety, and nobody has evaluated the evidence to determine whether it will effectively treat your disease.
Websites like the one for PNC-27 are loaded with patient testimonials and quotes from physicians who say they have used the drug to cure their terminally ill patients. But you’re not going to see any quotes from the patients who took the medication and got worse, or who spent hundreds of thousands of dollars only to see no improvement in their condition. The evidence is clearly skewed in favor of the drug company.
Talk to your doctors before trying any new drug, especially one which is so untested that it requires you to leave the country for treatment. Yes, it’s entirely possible that PNC-27 will prove to be a legitimate treatment that can help to save some lives. But you have to wonder about why the developers of this important “non-toxic” protein don’t want to bother getting the drug approved by the FDA, while they’re still happily marketing it to American cancer patients over the internet.
Staying Skeptical Is Staying Safe
Safety and efficacy studies exist to protect consumers and patients, so it’s wise to be skeptical of any pharmaceutical company who is unwilling to jump through those hoops when they’re developing a new treatment.
In the meantime, the FDA has issued an update to its warning: Two months after the lab found contaminated PNC-27, another sample of the inhalation solution was tested. This solution, meant for inhalation by an immunocompromised cancer patient, was found to contain another bacteria called Ralstonia insidiosa.
Unfortunately, the FDA can’t demand a recall of the medication. All they can do is warn patients to use their common sense and stick to drugs that have been properly vetted.