TIP Talk!

Monday October 31, 2016

What's More Tightly Tested for Safety, Vaccines or Supplements?


The salesperson at the vitamin store recommends a new supplement that says it’s for “immune support.” We all want a healthy immune system that will help us avoid or fight off disease. But what exactly does this mean, immune support? What kinds of research backs up this claim, and what, if anything, does this stuff actually do?

More importantly: Is it even safe to take?

Many supplements are. But at a time when many people are expressing concerns about vaccines, and embracing alternative medicine as a way of staving off illness, it’s worth looking at the differences between how the two make the journey to market, and how their safety and effectiveness are judged. It’s an especially good idea in light of a new study in the journal Pediatrics indicating that parents who seek out alternative medicine appear to be less likely to have their children vaccinated against the flu.

Though the U.S. Food and Drug Administration oversees dietary supplements, just as it does conventional medications, the rules for the two are completely different. That’s because supplements are given special dispensation by the Dietary Supplement Health and Education Act of 1994, which was passed after intense lobbying by the supplements industry.

Most conventional drugs, whether prescription or over-the-counter, cannot be sold until they are approved by the FDA. That approval is granted only after the medications have been rigorously tested for safety, quality and effectiveness. The requirements are even higher for vaccines.

But the FDA isn’t authorized to provide that protection to consumers for these alternative remedies.

“The dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed,” the National Institutes of Health says in an online information site on supplements. “FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.” In other words, the manufacturer is the one who determines whether the supplements are safe enough to sell, even though it stands to make money from those sales.

There is an independent organization, ConsumerLab, that tests many supplements and reports on whether they contain the ingredients — and at the same levels — that they claim, but accessing the results requires a subscription to the ConsumerLab site and not all supplements are assessed. Consumer Lab also isn't responsible for determining overall safety and effectiveness of active ingredients.

The FDA, meanwhile, can intervene only after people have already been sickened.

In late September, the FDA warned parents against using a homeopathic remedy for babies’ teething after reports of seizures and other potentially serious health issues. The remedy has been associated with 10 deaths and perhaps 400 non-fatal adverse reactions, the FDA noted. If parents already bought the product, which is sold in chain drugstores, they should toss it in the trash, the agency said.

“Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels,” the announcement warned.

The warning follows a 2010 safety alert issued by the FDA about the teething remedy, saying that it had found inconsistent levels of belladonna, the active ingredient, which can be dangerous in higher doses. At that time, the manufacturer recalled the product.

Safety concerns aside, does the product even work?

“The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children,” the September announcement reported.

Remember the green coffee bean craze? It was touted on a popular TV show in 2012 as a surefire way to lose weight. It was even backed up by a published study on one brand of green-coffee extract. Hopeful dieters snapped the stuff up, until the Federal Trade Commission went after the company selling it, saying that the study was "so hopelessly flawed that no reliable conclusions could be drawn from it."

The research looked at only 16 subjects, and there was no comparison group—a group that didn’t actually take the extract. Instead, the groups were rotated through a placebo phase, during which they also lost wight. Subjects were supposed to have been told to eat normally, but in fact, according to a report in the Los Angeles Times, they were told to eat less and exercise more. The researchers, based in India, could not get their findings published, so the company paid two Pennsylvania professors to rewrite it and submit it for publication. The professors eventually retracted the study.

The makers of supplements are supposed to be prohibited from making specific health claims for their products unless they can back it up with solid science. That’s part of why shoppers so often find the vague reference to “supports immune health.”

It’s unclear in what way many of them do so. The immune system is complex, involving various components of blood, proteins and so forth.

“And there all the nonspecific parts of immunity that help prevent infection: platelets and cilia that sweep potential pathogens out and iron metabolism that keeps iron away from bacteria and the list goes on and on and on,” says an article on the web site Science Based Medicine. “It is almost like saying you have described the works of Shakespeare by noting it contains the words ‘the’, ‘and’, ‘of’, ‘verily’, and ‘forsooth.’ ”

Proponents of alternative medicine often respond that even if certain supplements don’t work, they don’t hurt anyone.

Not true, Dr. Paul Offit writes in his 2013 book, “Do You Believe in Miracles?” In addition to pointing out potential serious side effects from a long list of herbs and other supplements, including blue cohosh, comfrey, kava, wormwood and many others, he tells about a 24-year-old case in which about 100 people in Belgium experienced kidney failure after taking a weight-loss product that contained aristolochic acid, derived from a plant. At least 70 of them Offit writes, needed dialysis or transplants, and others developed bladder cancer over time. More cases came up in subsequent years, including in the United States, leading to a 2001 warning from the FDA.

“Consumption of products containing aristolochic acid has been associated with permanent kidney damage,” the FDA warning said. “In addition, some patients have developed certain types of cancers, most often occurring in the urinary tract.”

That’s not to say all or most herbal remedies are useless or dangerous; there is evidence that some can be helpful. Manufacturers have a vested interest in producing a safe product in order to avoid lawsuits. And there have been serious issues with some conventional drugs as well. 

But when people consider the relative safety and effectiveness of herbal remedies and vaccines, it’s certainly worth taking into account the wide disparities in testing and standards between the two.

In the first part of this two-part series, we looked at the procedures vaccines must go through to be licensed for human use. Read more about that here. 



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