False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.

Women urged to get regular cancer screenings, genetic testing options growing

Insurance companies are doing their part to make sure women take care of themselves, but some are calling the tactics into question. Despite some recommendations stating that women should get mammograms starting around ages 45 to 50, insurers and even the Medicaid program are providing incentives, such as cash and gift cards, to get the screenings earlier and more often.

The U.S. Preventive Services Task Force maintains its position that women should have screenings every two years from ages 50 to 74, while the American Cancer Society (ACS) has established guidelines of yearly mammograms between 45 and 54, with screenings every other year after that. The ACS also notes that women at higher than average risk for breast cancer should have both an MRI and a mammogram yearly. This applies to women with an elevated risk based on family history, gene mutations, a first degree relative with a gene mutation, a history of radiation therapy to the chest, or those with certain syndromes. Yet those with a low risk level should not get MRI screening, and the ACS is not yet willing to take a position on the appropriateness of MRI screening for those with a slightly elevated risk level. Still, organizations note that women should pursue screening as early as they are comfortable doing so, especially when they have concerns.

The confusing screening recommendations are compounded by the insurance companies’ incentives. According to the New York Times, there is no reporting requirement for these incentives, which range from $10 to $250. Although additional screening sounds like a great idea, the extra mammograms can result in overdiagnosis, especially for those with some cell abnormalities that are not inherently dangerous. This could lead to women undergoing painful treatments and procedures that are, in fact, unnecessary. Some think that women should be provided better guidance to allow them to make informed decisions, instead of financial inducements.

What’s in the genes?

In 2013, Angelina Jolie revealed that she underwent an elective double mastectomy after genetic testing revealed that she had a BRCA1 gene mutation. This drew more attention to the ability to tell whether a woman is genetically predisposed to having certain types of cancer. The BRCA1 and BRCA2 genes produce tumor suppressor proteins, and mutations that cause the genes to alter the protein formation can lead to further genetic changes, and then cancer. The gene mutations can be inherited from either parent, and together account for up to a quarter of hereditary breast cancers.

Genetic testing allows women, like Jolie, to take preemptive measures and elect to have surgery before cancer strikes. However, insurance companies are not required to cover these prophylactic mastectomies by federal law. Aetna, for example, considers such a procedure medically necessary in several categories of high-risk women, such as those with gene mutations, certain syndromes, or with a high degree of family history. Aetna also considers BRCA testing medically necessary, once per lifetime, for some high-risk adults.

If insurance would not cover testing, however, women were previously forced to pay up to thousands of dollars, depending on the type of testing. But Color Genomics, a startup which launched in April 2015, offers BRCA1 and BRCA2 testing for $250. Founded by former employees of tech and social media companies, Color Genomics focuses on ease of use of its website. Doctors can easily track the progress of the sample’s testing and learn whether the patient has been contacted by a genetic counselor. No patient or family history is required, and many patients can more easily afford the test without hassle from their insurance company. Because it is an e-commerce company, it is exempt from certain regulations for data storage, although Color Genomics says that it is Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191) compliant.

Although the startup seems to be successful, the company is not the only game in town. The growth of affordable opportunities for consumers to take control of their health seems to be a welcome idea, and the company’s founder believes that human genome mapping will be the norm in coming years.