Panel: The FDA Desperately Needs to Review its Approach to Opioids

In a report, the National Academy of Sciences, Engineering, and Medicine (NASEM) is calling on the U.S. Food and Drug Administration (FDA) to review the safety and effectiveness of opioid painkillers. The panel of experts says monumental changes are needed to the way in which physicians treat pain, their patients cope with pain, and government and private insurers support individuals’ treatment for chronic pain. [1]

However, the panel says in no uncertain terms that efforts to prevent future opioid addicts will unfortunately drive some current painkiller abusers to seek harder street drugs, including heroin and fentanyl.

The panel wrote that:

“It is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals [already addicted to opioids].

The FDA commissioned the panel in 2016 to shape advice for how the agency should tackle the nation’s opioid epidemic. Many experts, including those on the panel, say the answer to the problem lies in regulating drug companies, as well as prescribers.

As we speak, lawmakers in Washington are debating a healthcare bill that would reduce access to addiction treatment – the polar opposite of what the panel calls for in its comprehensive report. What is needed, panel members say, is for states and the federal government to provide “universal treatment to addiction in hospitals, community-based programs, jails, and prisons.

The topic is a bone of contention for many people who don’t believe taxpayers should have to foot the bill for such treatment. But according to the panel, it is the only way to bring an eventual end to the opioid crisis sweeping America. Make no mistake about it – it is going to take years to gain control over the situation.

Source: U.S. Centers for Disease Control

A member of the report committee, Dr. Aaron Kesselheim of Harvard Medical School said:

“Our recommendation is for a much more systematic approach, integrating public health decision-making into all aspects of opioid review and approval. It would be an ambitious undertaking.” [2]

While the panel stopped short of acknowledging that the war on drugs has not worked, it urged states to reject the current trend of cracking down hard on illicit drug use. This, it said, will reduce harm to opioid users who have turned to the streets to supply their habit.

Instead, the panel said that states should adopt needle exchanges, safe havens for those who inject drugs, and wider access to naloxone – a drug that reverses overdoses from opioids, including heroin. [1]

In deciding how to regulate opioids, the FDA should study how the drug will affect patients’ families, society at-large, and the black market for drugs, the panel continued.

Kesselheim said:

“This is in distinction to the traditional approach that the FDA takes when it evaluates products. But the particular characteristics of opioids, we believe, requires a certain amount of what we term ‘opioid exceptionalism’ from the regulator.

… Overzealous promotional and financial relationships between the pharmaceutical manufacturers of opioids and physicians through the ’80s, ’90s, and 2000s, I think, at this point, has been shown to be a contributor to overprescribing in this area.” [3]

Other recommendations by the panel include:

  • Requiring drug companies to follow stricter rules for marketing opioids than they would for other drugs.
  • Developing campaigns to inform doctors and patients about other was of managing chronic pain. These campaigns should not be run by drug companies, however, even though many drug companies sponsor ongoing pain-management education programs for physicians.
Source: U.S. Centers for Disease Control

In 2016, the CDC released fresh guidelines intended to limit the prescribing of opioids, though there is no legal mandate for physicians to follow them. The agency recommended, among other things, that:

  • Doctors don’t immediately prescribe opioids to treat pain. Instead, physicians should prescribe non-drug interventions first, such as exercise therapy and weight loss.
  • When a doctor does prescribe an opioid, he or she should start the patient on the lowest dose possible, and prescribe immediate-release opioids for short periods of time, rather than for weeks or months at a time.
  • Doctors should urine-test patients to make sure they are following the prescription’s directions.

Read: The DEA Will Slash Opioid Production 25% by 2017

Also in 2016, the FDA published draft guidelines outlining testing standards for harder-to-abuse generic opioids. Under those guidelines, the FDA can only approve a generic painkiller if the maker can prove it is the bioequivalent of a brand-name medication. Prior to that, generic drugs were not individually scrutinized for safety and efficacy the way that brand-name drugs were.

Additionally, the FDA required black-box warnings – the FDA’s most serious drug warning – on all fast-acting opioids concerning the risks for addiction, misuse, overdose, and death.


[1] Los Angeles Times

[2] The Street

[3] Pacific Standard

U.S. Centers for Disease Control

U.S. Centers for Disease Control

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Food Industry Study Slams Recommended Sugar Intake Limits

A study made headlines after stating that there is no way of knowing just how much sugar consumption is too much, and the methods used to create dietary sugar intake limits are flawed.

CNN’s headline reads: “How much sugar is OK? Paper adds to debate.” Hmm, not really. The study was funded by the North American branch of the International Life Sciences Institute (ILSI), a nonprofit with ties to Hershey’s, Coca-Cola, PepsiCo, McDonald’s, Mars, and Kraft Foods. [1]

There’s not much of a debate when the companies funneling money into research make soda, candy, and processed foods.

The Claims

The World Health Organization (WHO) and the U.S. Dietary Guidelines recommend that people consume no more than 10% of their daily calories from sugar. It’s much easier to consume that amount than you might think. Drinking just 1 can of soda can put you over the recommended limit. So it’s not surprising that Coca-Cola – yet again – has its tentacles in a study hinting that you might be able to consume even more of the sweet stuff.

Study author Bradley Johnston, a clinical epidemiologist at the Hospital for Sick Children in Toronto, says those recommendations “are not trustworthy.”

Johnston reviewed the studies and methodology used to create the guidelines. He doesn’t disagree that people should limit their sugar intake, but he says there is no solid answer to the question: “How much is too much?”

Johnston says:

“Sugar should certainly be limited in the diets of children and adults, no question.”

The epidemiologist argues that there is no convincing evidence to support cutting sugar intake to 10%, or even 5%.

He explains:

“There’s a lot of uncertainty about the thresholds that appear in guidelines. What’s happening is that guideline panelists are making strong recommendations based on low-quality evidence.”

Source: McMaster University Daily News – Bradley Johnston

The paper reviewed 9 sugar-intake guidelines from around the world, including the WHO’s guideline and the Dietary Guidelines for Americans, which were updated in 2016.

Furthermore, Johnston argues, current guidelines on dietary sugar do not adhere to standards set by the American non-governmental organization Institute of Medicine in 2011.

He says:

“Although our findings question the specific sugar recommendations from guidelines produced by leading authorities, the findings should not be used to justify high or increased consumption of sugary foods and beverages.

… results from our review should be used to promote improvement in the development of trustworthy guidelines on sugar intake.” [2]

What in the Hell is Going on Here?

Johnston and his colleagues seem to have arrived at some relatively benign conclusions. They don’t recommend that people start eating more sugar. They don’t even really suggest that eating more sugar might be safe.

So what in the hell is going on here?

If there is one thing the 2016 political season taught us, it’s that planting even the smallest doubt in people’s minds can have an overwhelming effect. That is what’s going on here.

The likes of Hershey’s, Coca-Cola, and Kraft are trying to plant doubts in people’s minds. And why wouldn’t they? It’s good for business. Inevitably, at least a few people will have that extra piece of chocolate, that extra glob of mac ‘n’ cheese, or 1 more can of soda because, after all, no one is sure how much sugar is bad for you.

Source: Business Insider

There will be people who get duped, but Johnston’s conclusions haven’t duped many scientists. They see what’s going on here, and they’re calling him out on it.

Read: PepsiCo Sued for Allegedly Misleading Buyers of Sugar-Laden Naked Juice

Marion Nestle, a nutrition professor at New York University who was written extensively about the soda industry, says:

“This is a classic example of industry-funded research aimed at one purpose and one purpose only: to cast doubt on the science linking diets high in sugars to poor health. This paper is shameful.” [1]

Dr. Dean Schillinger, a professor of medicine at the University of California, San Francisco who wrote an editorial accompanying the study in the Annals of Internal Medicine, says:

“In essence, this study suggests that placing limits on ‘junk food’ is based on ‘junk science.’ Studies are more likely to conclude there is no relationship between sugar consumption and health outcomes when scientists receive financial support from food and beverage companies.” [2]

Gosh, y’think? The sugar industry in the 1960’s paid Harvard scientists to downplay the link between sugar consumption and heart disease and promote saturated fat as the cause instead. It worked magically. Fat became the enemy of health, and the market was soon flooded with all sorts of low-fat and non-fat foods. And those foods generally contain about 20% more sugar than full-fat products.

In the study, the researchers wrote that “the rationale and evidence used to make each recommendation were inconsistent.” [2]

Baloney, says Schillinger. For one thing, he explains, the researchers reviewed guidelines published over a 20-year period. It’s no surprise that they found inconsistencies, as “science evolves over time.”

According to Schillinger, Johnston and his crew failed to even use proper research methods in their work. He says:

“In addition, their claims regarding the low quality of guidelines are based on the application of inappropriate metrics.”

He says that one of the methods the “scientists” used in the paper “is the wrong tool for the job and virtually guaranteed that they would falsely conclude that guidelines are of low quality.”

He also cites the sugar industry-fat debacle of the 60’s, calling it a “major limitation.”

In October, the American Journal of Preventative Medicine revealed how Coca-Cola and PepsiCo have sponsored national health and medical organizations. (In that case, even the American Diabetes Association, a government organization, took money from the companies.)

Schillinger says:

“Added sugars not only provide unnecessary and ’empty’ non-nutritious calories but also appear to affect unique and specific unhealthy metabolic pathways that contribute to obesity and diabetes and heart disease, irrespective of calories.

We are in a public health war against diabetes, and we need to create smart strategies to win this war and prevent needless suffering and death. This is serious business.”

There is no doubt that the added sugars pushed on buyers by Coca-Cola, Hershey’s, and Kraft, are causing disease, limb amputations, and deaths, Schillinger says.

“Nearly all experimental studies that examined whether eating added sugars contributes to obesity and [Type 2] diabetes-related outcomes show a cause-and-effect relationship.” [1]

Johnston swears that he, and ILSI, have good intentions:

“We hope that the results from this review can be used to promote improvement in the development of trustworthy guidelines on sugar intake.” [3]

If the spoonfuls of added sugar don’t make you sick, the veiled attempts at making more money off of the poor health of the average buyer just might.


[1] NPR

[2] CNN

[3] Fortune

McMaster University Daily News

Business Insider

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