When presidential candidate Joe Biden began a campaign tour with the slogan, “No Malarkey” (a seeming oxymoron for a politician), the rallying cry was contradicted by his many apologies for past actions and positions. Had he fashioned his expedition as a “No Apologies” tour, he doubtless would have done far more to solidify his position as the most electable Democrat.
But he is not alone in lamenting past positions, actions, or inaction. One could imagine the consternation from Michael Bloomberg’s natural constituency when he felt the need to apologize for his support of “stop, question, and frisk” in New York City. Had Bloomberg simply said he should have made sure the policy was not taken to an extreme, as apparently was the case, he not only could have been truthful, but also avoided alienating those who recognized the positive impact the policy had in his city.
This presidential campaign has raised apologizing to a new art form. Much of it is no more than pandering. A simple explanation that one’s views have “evolved” would, we think, be far more effective. Instead, the pandering has spurred the legions of woke social justice warriors to even greater extremes of political correctness, harassment, and suppression of free speech.
We think it would be more constructive to consider where real apologies for poor governance are due, coupled with plans for improvement. After all, the presidential hopefuls are running to lead the executive branch of government, but they are saying precious little about what federal departments and agencies should be sorry for, and about how they’ll do better.
Let’s start with the Food and Drug Administration, whose overregulation is legendary. The impacts of FDA regulators’ self-serving actions range from the creation of disincentives to research and development (and inflated costs for them) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.
Another egregious example of the impact of excessive risk-aversion is the sorry saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been marketed in Europe, Japan, Canada, and China. During the delay, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.
FDA’s repertoire is wide, and sometimes, it endangers Americans by under-regulating. One of the great hoaxes perpetrated on health-conscious American consumers is the hype and outright fraud of dietary supplements that don’t work and are sometimes dangerous.
How bad are supplements? We have plenty of hard data to answer that question. An article in the New England Journal of Medicine, “ER Visits for Adverse Events Related to Dietary Supplements,” reported the results of a study by the Centers for Disease Control and Prevention and FDA researchers which analyzed representative surveillance data from 63 hospital emergency departments over a 10-year period from 2004 until 2013. The statistical analysis projected about 23,000 emergency room visits annually resulting from ingestion of supplements.
According to the study’s authors, “Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults.”
These findings were confirmed by a 2017 study published in the Journal of Medical Toxicology, which found that U.S. Poison Control Centers receive a call every 24 minutes, on average, due to exposures to dietary supplements. The rate of calls increased by almost 50 percent from 2005 to 2012, with a total of 274,998 incidents reported from 2000 through 2012. About 4.5 percent—more than 12,300 cases—resulted in serious medical complications.
Twenty-five years after politically driven legislation bizarrely defined those products as “food,” during which time the FDA ignored untold numbers of adverse events, including deaths, regulators finally announced last February that they would increase oversight of the dietary supplements industry. After almost a year, we’ve seen little evidence of it.
Another example of the FDA’s not-so-benign neglect is its oversight of the $47-billion-a-year organic industry. Regulators regularly give a pass to outright fraud and, especially, to blatantly false and deceptive advertising claims.
Consider the Whole Foods website, which explicitly claims that organic foods are grown “without toxic or persistent pesticides.” In fact, organic farmers rely on synthetic and natural pesticides to grow their crops, just as conventional farmers do, and organic products can contain numerous synthetic as well as natural chemicals. As observed by UC Berkeley biochemist Bruce Ames and his colleagues in 1990, “99.99% (by weight) of the pesticides in the American diet are chemicals that plants produce to defend themselves.”
Pesticides are by definition toxic, and many organic pesticides pose significant environmental and human health risks. One is copper sulfate, a widely used broad-spectrum organic pesticide that persists in soil and is the most common residue found in organic food. The European Union determined that copper sulfate may cause cancer and intended to ban it, but backed off because organic farmers have no viable alternative.
The FDA also has authority over “absence claims” on food labels. While this isn’t an issue on the same life-or-death scale as drug approvals, it is certainly crucial for continuing innovation in the food supply.
Inexplicably, for decades the FDA has tolerated misleading food manufacturers’ “absence claims”—a label or other assertion that makes a meaningless distinction between their item and another. For example, the Non-GMO Project butterfly label is an absence claim. It’s on tens of thousands of products at the grocery store, even those that could never contain GMOs, such as orange juice (no GMO oranges) or salt (which is a mineral not obtained from organisms).
“A statement may be false or misleading,” says FDA’s guidance for industry, “if it suggests or implies that a food product or ingredient is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered.”
We’d like to see candidates expressing dismay about the ways that government malfeasance or nonfeasance threatens Americans’ health and safety every day. If they don’t, we should make them sorry on Election Day.
Democratic Candidates Are Sorry for All the Wrong Things
Pacific Research Institute
When presidential candidate Joe Biden began a campaign tour with the slogan, “No Malarkey” (a seeming oxymoron for a politician), the rallying cry was contradicted by his many apologies for past actions and positions. Had he fashioned his expedition as a “No Apologies” tour, he doubtless would have done far more to solidify his position as the most electable Democrat.
But he is not alone in lamenting past positions, actions, or inaction. One could imagine the consternation from Michael Bloomberg’s natural constituency when he felt the need to apologize for his support of “stop, question, and frisk” in New York City. Had Bloomberg simply said he should have made sure the policy was not taken to an extreme, as apparently was the case, he not only could have been truthful, but also avoided alienating those who recognized the positive impact the policy had in his city.
This presidential campaign has raised apologizing to a new art form. Much of it is no more than pandering. A simple explanation that one’s views have “evolved” would, we think, be far more effective. Instead, the pandering has spurred the legions of woke social justice warriors to even greater extremes of political correctness, harassment, and suppression of free speech.
We think it would be more constructive to consider where real apologies for poor governance are due, coupled with plans for improvement. After all, the presidential hopefuls are running to lead the executive branch of government, but they are saying precious little about what federal departments and agencies should be sorry for, and about how they’ll do better.
Let’s start with the Food and Drug Administration, whose overregulation is legendary. The impacts of FDA regulators’ self-serving actions range from the creation of disincentives to research and development (and inflated costs for them) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.
Another egregious example of the impact of excessive risk-aversion is the sorry saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been marketed in Europe, Japan, Canada, and China. During the delay, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.
FDA’s repertoire is wide, and sometimes, it endangers Americans by under-regulating. One of the great hoaxes perpetrated on health-conscious American consumers is the hype and outright fraud of dietary supplements that don’t work and are sometimes dangerous.
How bad are supplements? We have plenty of hard data to answer that question. An article in the New England Journal of Medicine, “ER Visits for Adverse Events Related to Dietary Supplements,” reported the results of a study by the Centers for Disease Control and Prevention and FDA researchers which analyzed representative surveillance data from 63 hospital emergency departments over a 10-year period from 2004 until 2013. The statistical analysis projected about 23,000 emergency room visits annually resulting from ingestion of supplements.
According to the study’s authors, “Such visits commonly involve cardiovascular manifestations from weight-loss or energy products among young adults and swallowing problems, often associated with micronutrients, among older adults.”
These findings were confirmed by a 2017 study published in the Journal of Medical Toxicology, which found that U.S. Poison Control Centers receive a call every 24 minutes, on average, due to exposures to dietary supplements. The rate of calls increased by almost 50 percent from 2005 to 2012, with a total of 274,998 incidents reported from 2000 through 2012. About 4.5 percent—more than 12,300 cases—resulted in serious medical complications.
Twenty-five years after politically driven legislation bizarrely defined those products as “food,” during which time the FDA ignored untold numbers of adverse events, including deaths, regulators finally announced last February that they would increase oversight of the dietary supplements industry. After almost a year, we’ve seen little evidence of it.
Another example of the FDA’s not-so-benign neglect is its oversight of the $47-billion-a-year organic industry. Regulators regularly give a pass to outright fraud and, especially, to blatantly false and deceptive advertising claims.
Consider the Whole Foods website, which explicitly claims that organic foods are grown “without toxic or persistent pesticides.” In fact, organic farmers rely on synthetic and natural pesticides to grow their crops, just as conventional farmers do, and organic products can contain numerous synthetic as well as natural chemicals. As observed by UC Berkeley biochemist Bruce Ames and his colleagues in 1990, “99.99% (by weight) of the pesticides in the American diet are chemicals that plants produce to defend themselves.”
Pesticides are by definition toxic, and many organic pesticides pose significant environmental and human health risks. One is copper sulfate, a widely used broad-spectrum organic pesticide that persists in soil and is the most common residue found in organic food. The European Union determined that copper sulfate may cause cancer and intended to ban it, but backed off because organic farmers have no viable alternative.
The FDA also has authority over “absence claims” on food labels. While this isn’t an issue on the same life-or-death scale as drug approvals, it is certainly crucial for continuing innovation in the food supply.
Inexplicably, for decades the FDA has tolerated misleading food manufacturers’ “absence claims”—a label or other assertion that makes a meaningless distinction between their item and another. For example, the Non-GMO Project butterfly label is an absence claim. It’s on tens of thousands of products at the grocery store, even those that could never contain GMOs, such as orange juice (no GMO oranges) or salt (which is a mineral not obtained from organisms).
“A statement may be false or misleading,” says FDA’s guidance for industry, “if it suggests or implies that a food product or ingredient is safer, more nutritious, or otherwise has different attributes than other comparable foods because the food was not genetically engineered.”
We’d like to see candidates expressing dismay about the ways that government malfeasance or nonfeasance threatens Americans’ health and safety every day. If they don’t, we should make them sorry on Election Day.
Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.