May 17th, 2023 3-5PM ET
Wednesday on The Robert Scott Bell Show:
The decline of science at the FDA has become unmanageable Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings revealing widespread false advertising of drugs—along with the thalidomide safety disaster—spurred Congress into action. From then on, approval of a New Drug Application (NDA) by the US Food and Drug Administration required proof of “substantial evidence” of effectiveness. This proof was defined as results from “adequate and well-controlled investigations, including clinical investigations,”1 with such evidence also required to advertise claims of safety and effectiveness. A National Academy of Sciences review underscored the need for these mandates, finding over 30% of pre-1962 marketed drugs to be ineffective. The FDA’s legally enforceable regulations detail what “substantial evidence” and “adequate and well-controlled investigations” mean in greater depth, supplemented by guidelines to industry which, although not legally binding, explain the FDA’s current interpretation of drug manufacturers’ legal obligations. However imperfect, the FDA’s enforcement of these provisions assures prescribers, patients, and payers that effectiveness claims are based on science, not science fiction. A published FDA review showed efficacy deficiencies, in whole or in part, underlying initial rejection of 89 of 151 NDAs (59%), highlighting the continuing need for vigilance on this front.
Special Guest Justin Barclay
Justin’s parents will tell you he was born with a microphone in his hand. So, it’s no wonder his radio career started even before he was out of high school. He’s been heard in major markets all across the country, including Philadelphia, Detroit, Tampa, Cincinnati, & Louisville, but fondly calls West Michigan (Grand Rapids) home. Justin’s a frequent guest host for the nationally syndicated Glenn Beck program heard on over 300 radio stations coast to coast. Today, he engages guests and listeners in lively conversations about national and local topics while talking about what matter most in West Michigan. Justin has won multiple ‘Awards for Broadcast Excellence’ from The Michigan Association of Broadcasters and is honored to continue serving the community on and off of the legendary airwaves of WOOD Radio.
Concern grows around US health-care workforce shortage: ‘We don’t have enough doctors’ There is mounting concern among some US lawmakers about the nation’s ongoing shortage of health-care workers, and the leaders of historically Black medical schools are calling for more funding to train a more diverse workforce. As of Monday, in areas where a health workforce shortage has been identified, the United States needs more than 17,000 additional primary care practitioners, 12,000 dental health practitioners and 8,200 mental health practitioners, according to data from the Health Resources & Services Administration. Those numbers are based on data that HRSA receives from state offices and health departments. “We have nowhere near the kind of workforce, health-care workforce, that we need,” Vermont Sen. Bernie Sanders told CNN on Friday. “We don’t have enough doctors. We don’t have enough nurses. We don’t have enough psychologists or counselors for addiction. We don’t have enough pharmacists.” The heads of historically Black medical schools met with Sanders in a roundtable at the Morehouse School of Medicine in Atlanta on Friday to discuss the nation’s health-care workforce shortage. The health-care workforce shortage is “more acute” in Black and brown communities; the Black community constitutes 13% of the US population, but only 5.7% of US physicians are Black, said Sanders, chairman of the Senate Committee on Health, Education, Labor, and Pensions.
How Big Pharma Controls Scientific Research — and Maximizes Profits What many don’t realize is that researchers who do peer review of drug company-sponsored trials do not get access to the raw data. All they get is the drug company’s analysis of that data, which leaves the door wide open for manipulation and obfuscation. As noted by Malhotra, “It’s not scientific, it’s not ethical … and it’s not democratic.” Most doctors, unless they’re involved in the peer review process, are not even aware of this which is why they rarely ever question published science. Yet data analyses by Stanford professor Dr. John Ioannidis show that “the greater the financial interest in a given field, the less likely the research findings are to be true,” Malhotra says. No one protects patients anymore So, is the drug industry all about satisfying shareholders and increasing profits by any means, with no real regard for public health? Rogan wonders. Basically yes. As noted by Malhotra, drug companies have a legal responsibility to provide profits for their shareholders. They do not have a legal responsibility to give patients the best and safest treatment. But the biggest scandal here, Malhotra says, is that “those with the responsibility to uphold scientific integrity — academic institutions, doctors, medical journals — collude with industry for financial gain.” I would add that our regulatory agencies are also “on the take.” They’ve all been captured by industry, which leaves patients with no one to protect them from Big Pharma’s malfeasance.
Chronic pain is substantially more common in the US than diabetes, depression and high blood pressure, study finds There are more new cases of chronic pain among US adults than other common long-term conditions like diabetes, depression and high blood pressure, according to a new study. The researchers say their findings “emphasize the high disease burden of chronic pain in the US adult population and the need for early management of pain.” Research published last month in the US Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report estimated that more than 51 million people – more than 20% of US adults – have chronic pain and 17 million – almost 7% of adults – have high-impact chronic pain. The new study, published Monday in the journal JAMA Network Open, looked at data on more than 10,000 participants in the National Health Interview Survey, which is conducted annually by the CDC’s National Center for Health Statistics. The researchers looked the participants’ reports of chronic pain, defined as pain on most days or every day over the past three months, and high-impact chronic pain, defined as as chronic pain that limits life or work activities on most days or every day over the past three months. Among people who reported being pain-free in 2019, the annual rate of chronic pain the next year was 52.4 per 1,000 people, and there were 12 cases of high-impact chronic pain per 1,000 people. By comparison, the researchers say, there are 7.1 cases of diabetes, 15.9 cases of depression and 45.3 cases of high blood pressure per 1,000 people per year.
Poll: U.S. Depression Hits All-Time High With 29% Of Adults Diagnosed Three in 10 U.S. adults – an all-time high – say they have been diagnosed with depression at some point during their lifetimes, a new Gallup poll shows. The 29% of Americans who say they have been diagnosed with depression is “nearly 10 percentage points higher than in 2015” when 19.6% of U.S. adults say they had been diagnosed with depression, according to data and analysis of the new Gallup poll, which was released Wednesday morning. The survey of more than 5,100 U.S. adults, conducted Feb. 21-28 of this year, asked whether a doctor or nurse ever told them they have depression and whether they have been or are currently being treated for depression. The poll showed 17.8% currently having depression or receiving treatment, which was up from 10.5% in 2015 when Gallup began measuring depression in its current form of data collection, the pollster said. The Gallup survey comes as health insurers, government policy makers including the Biden administration and medical care providers are increasingly look at ways to treat the whole person, integrating behavioral treatment with traditional medical care. Tbe effort to treat depression is taking on more urgency in the wake of the COVID-19 pandemic, the Gallup poll indicates. “Clinical depression had been slowly rising in the U.S. prior to the COVID-19 pandemic but has jumped notably in its wake,” an analysis accompanying the Gallup poll data said. “Social isolation, loneliness, fear of infection, psychological exhaustion (particularly among front-line responders such as healthcare workers), elevated substance abuse and disruptions in mental health services have all likely played a role.”
Eating too much ultra-processed food could induce depression Australian research has for the first time established a link between diets high in ultra-processed foods and an increased risk of depression. The recently published findings in the Journal of Affective Disorders show the risk of depression jumps markedly among people whose daily diet includes more than 30% ultra-processed food. Dr. Melissa Lane, who completed the research as part of her Ph.D. studies at Deakin University’s Food and Mood Center, said the results provide further evidence of the wide-ranging harms of diets loaded with cheap, well-marketed but often nutrient poor convenience foods. “While Australians eat a lot of ultra-processed foods, the link with depression has never been assessed in a group of Australians until now,” Dr. Lane said. Ultra-processed foods are not limited to typical junk and fast foods. They also include mass-produced and highly refined products that might be considered relatively “neutral” or even “healthy” like diet soft drinks, some fruit juices and flavored yogurts, margarine, packet preparations of foods like scrambled egg and mashed potato and many ready-to-heat-and-eat pasta dishes. Working with Dr. Priscila Machado from Deakin’s Institute for Physical Activity and Nutrition (IPAN) and Associate Professor Allison Hodge from the Cancer Council Victoria, Dr. Lane looked at associations between ultra-processed food consumption and depression in more than 23,000 Australians from the Melbourne Collaborative Cohort Study.
New menopause drug for hot flashes gets FDA approval U.S. health regulators on Friday approved a new type of drug for women dealing with uncomfortable hot flashes caused by menopause. The Food and Drug Administration approved the once-a-day pill from Astellas Pharma to treat moderate-to-severe symptoms, which can include sweating, flushing and chills. Astellas’ drug, Veozah, uses a new approach, targeting brain connections that help control body temperature. The FDA said the medication will provide “an additional safe and effective treatment option for women,” in a statement. More than 80% of women experience hot flashes during menopause, the FDA noted, as the body gradually produces lower levels of reproductive hormones between the ages of 45 and 55. The most common treatment consists of hormonal pills aimed at boosting levels of estrogen and progestin. But the treatment isn’t appropriate for some women, including those with a history of stroke, blood clots, heart attack and other health conditions. Large studies have found that the hormones can increase the chances of those problems reoccurring, although the risks vary based on a number of individual factors. The new pill is not a hormone. It carries an FDA warning about potential liver damage. Women will need to be screened for liver damage or infection before getting a prescription, then get a blood test every three months for nine months to monitor for safety problems, according to the FDA label.