CVS ditches common cold meds after FDA advisers say they’re useless – Ars Technica

Late last week, drugstore giant CVS revealed that it was voluntarily removing some cold and flu medicines from its shelves because they were ineffective, but many other ineffective products were still on the shelves. Remaining.

The move by CVS comes after a Food and Drug Administration advisory panel unanimously resolved last month that phenylephrine, a common nasal decongestant, is not effective in treating nasal congestion. However, this comes before the FDA itself can act on the vote, and it is likely that the agency will ultimately revoke phenylephrine’s approval.

In a statement to Ars, a CVS spokesperson indicated that the FDA advisory committee vote prompted the change, but that the company would “follow FDA guidance.”

“While we are removing a small number of oral decongestant products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores, we are removing many other oral cough and cold products to meet consumer needs,” CVS’s statement said. will continue to be provided.” Details such as which products and how many products will be removed or when the removal will be completed were not disclosed.

Removing phenylephrine products from drugstore shelves is a long-awaited victory for both researchers and consumers. Since at least 2007, researchers have expressed doubts about the effectiveness of phenylephrine, which is included in popular oral medications under brand names such as Sudafed, Mucinex, NyQuil, and Benadryl. The small studies from the 1960s and 1970s that formed the basis for the FDA’s initial approval in 1976 were found to be seriously flawed. And three large clinical trials since 2007 have shown the drug to be ineffective. Pharmacological studies have revealed the reason. Phenylephrine is highly metabolized in the intestine, leaving less than 1 percent of the active drug bioavailable. Consumers, meanwhile, were largely uninformed and would spend nearly $2 billion in 2022 on these products, which researchers have long said are ineffective.

But when these useless drugs eventually disappear from CVS shelves, they leave behind an equally useless group of products: homeopathic products.

“Snake oil” remains

These bogus treatments are based on centuries of pseudoscience and have repeatedly been proven to be no more effective than placebos. In fact, if they prove effective, they would overturn basic scientific understanding.For decades, consumer advocates and watchdogs have blamed against themNevertheless, these products are readily available on the shelves of all major drug stores.

Homeopathy relies on two false beliefs. One is the “law of similars,” also known as “like cures like,” which states that a substance that causes a certain symptom in a healthy person can treat a condition or disease in a sick person with the same symptoms. means. The “law of infinitesimals” states that diluting a substance that is said to have a therapeutic effect will make it even more effective in treating a medical condition. As such, homeopathic products often start out with strange, sometimes toxic substances, and are eventually diluted with ritualistic procedures and forgotten. The result is simply water or an inert filler component. Homeopaths agree that water molecules have “memory“of matter” (they are not).

Sounds silly? that’s right. Nevertheless, homeopathic products are not only available at major drug stores and retail stores nationwide, but they can also be sold on the same shelves alongside evidence-based medicines that have gone through the FDA’s rigorous safety and efficacy evaluations. It happens often.

The FDA has the authority to regulate homeopathic products.However, under the Food, Drug and Cosmetic Act of 1938, homeopathic products are generally Considered exempt from premarket safety and efficacy review by FDA As long as the active ingredient is included in the homeopathic pharmacopoeia (public list of substances approved by homeopathy). As a result, homeopathic products are on the market without FDA review and sit on shelves alongside FDA-approved, evidence-based medicines.

“Most people don’t know what these are,” Nicholas Little, vice president and legal director of the Center for Inquiry, a consumer advocacy group, said in an interview with Ars newspaper about homeopathic products. he said.

double standard

Little and CFI are currently engaged in a long-running legal battle with CVS and Walmart, forcing retailers to at least physically separate homeopathic products from effective FDA-approved medications and discouraging consumers about homeopathic products. They are filing a lawsuit demanding that clear information be provided. What is homeopathy really? In the words of CFI:snake oil. ”

CVS removed medications containing phenylephrine, but not homeopathic products, as ineffective, prompting several questions from advocacy groups right away.

“I would like to ask CVS: Why is it differentiating between over-the-counter cold medicines that the FDA says don’t work and other over-the-counter homeopathic products that the FDA says don’t work? do Do you draw the difference? Is it a business decision? Only they can answer that,” Little said.

CVS declined to answer questions asked by Als why it is not removing homeopathic products as well as some products that contain phenylephrine, saying they are ineffective.

But Little clarified that CFI is not necessarily trying to remove homeopathic products from shelves. They would be happy if retailers simply provided consumers with information about homeopathic products so that consumers would not be fooled into purchasing them by thinking they were similar to effective FDA-approved drugs.

“I know a lot of people…well, I’ve done this myself and I’ve also bought [a homeopathic] When you go to the drugstore when you’re sick, or as an exhausted parent with a seriously ill child, you often accidentally pick up homeopathic products in a hurry or in the fog of an infection. there is. Evidence-based medicines are often accompanied by comforting images and attractive but meaningless labels such as “natural” and may also advertise that they have no side effects. there is.

“Of course there are no side effects and there’s nothing in it,” Little said.

diluted protection

And even consumers who do their due diligence and read labels may still be unsure about what’s in a product. Usually the starting material is written in Latin, and its dilution is written as follows: Obtuse homeopathic nomenclature“200℃” etc.

One of Little’s favorite examples is oscillococcinum, a homeopathic product sold as a cold and flu treatment by Boiron, one of the world’s largest manufacturers of homeopathic products. (You can purchase it at CVS, the goal, walgreensetc.) The “active ingredients” of Oscillococcinum are: Anas Barbariae—For those who don’t know, this is an extract made from Muscovy duck heart and liver.There is insufficient evidence Evidence suggests that duck organ extract may be effective against colds and flu. and, As Mr. Little and Mr. CFI pointed out in a letter to the FDA last month:, Anas Barbariae Not present in Oscillococcinum. It is as follows:

Prepared for homeopathic dilution at 200°C. In plain English, that means one part of a duck’s internal organs. Ten⁴⁰⁰ parts Amount of water in “processing”. Research estimates that the number is between 10.⁷⁸ and 10⁸² [atoms] Even in the entire observable universe, it is physically impossible for a single atom of duck innards to remain in a product. Oscillococcinum is nothing more than a sugar pill.

Mr. Little and CFI’s letter concludes by asking the FDA to remove Oscillococcinum and other Buncum homeopathic products from the market. In an interview with Ars, Little said the organization’s lawsuits against CVS and Walmart are moving faster than the slow pace of FDA bureaucracy, which also struggles with limited resources. He said he was looking forward to it. Still, the litigation is expected to be long. They are currently in the discovery process and Mr Little said he wanted to directly question the pharmacy giant’s decision to remove phenylephrine rather than homeopathic medicines.

For now, Little is happy to see some action from the FDA and CVS regarding phenylephrine. “Congratulations to CVS for taking responsibility on this and taking care of their customers. This is a great, big help for them,” he said. “Now tell them to do the same with homeopathy.”