Tag: FDA

“Natural” supplements are unregulated for quality, content or safety

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More than two-thirds of Americans take dietary supplements. The vast majority of consumers – 84% – are confident the products are safe and effective.

They should not be so trusting.

The Dietary Supplement Health and Education Act of 1994 allows manufacturers to sell dietary supplements without providing proof of their quality to the FDA. Instead, it’s up to the FDA to prove a product is unsafe and take it off the market. That’s an incredibly tall order, and woefully inadequate. But it’s unlikely to change.

All you have to worry about are heavy metals, bacterial and fungal contamination, undisclosed drugs including not approved for pharmaceuticals, over-and-under-dosing of listed ingredients…and more. Professor White’s article suggests independent labs that monitor supplements. He includes several ways you can assure yourself – to a point about what you’re going to consume.

Please be careful.

Still dumb, still self-destructive

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❝ Dr. John E. Parker was working at a West Virginia hospital in 2015 when a 31-year-old female patient was admitted with acute respiratory problems. A team of doctors ultimately suspected that her mysterious case of lipoid pneumonia might be related to vaping and weren’t sure they had seen anything like it before. They were intrigued enough to present the case report — a type of medical paper on unusual or provocative patient findings. Such reports can serve as a call to the medical community to be on the lookout, though they sometimes raise more questions than they provide answers.

❝ This summer, almost four years later, federal officials began investigating a national outbreak of severe lung illnesses linked to vaping that has struck more than 150 patients in 16 states…

❝ We really felt that it wasn’t going to be a one-off event and that it was what we usually called in public health a “sentinel” health event … that it was an example of a respiratory illness that can be caused by this exposure and that it probably wasn’t the first case ever seen nor would it be the last…

❝ I know we’ve seen a case [of alveolar hemorrhage syndrome] that we published, and in polling some colleagues we think we’ve probably also seen [cases of] cryptogenic organizing pneumonia as well as lipoid pneumonia and acute eosinophilic pneumonia. Yeah, we’ve certainly seen at least probably four forms of lung disease from vaping.

Interesting chronology of medical researchers discovering ailments from recreational, addictive foolishness. The medical community will continue to sort out deaths and impairment — while politicians and the government bodies chartered to preserve health sit around, twiddle their thumbs and do nothing for years.

50,000 reports of malfunctioning heart device hidden by the FDA

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Congressional Quarterly

❝ The Food and Drug Administration allowed the maker of a faulty implantable heart device to secretly log 50,000 malfunction incidents, according to a series of investigations by Kaiser Health News.

The device—the Sprint Fidelis, made by Medtronic—consists of a pair of wires and a defibrillator to jolt the heart into a regular rhythm. But doctors found that it was giving patients random, harmful zaps and sometimes failed during actual cardiac emergencies.

❝ Medtronic recalled the device in 2007 but only after it was implanted in around 268,000 patients. Many of those patients have since faced the ghastly choice of learning to live with the faulty device or undergoing an invasive, risky—sometimes deadly—surgery to remove it. According to the KHN investigation, they’ve been making that choice without information from the 50,000 incident reports.

The FDA accumulated over a million reports they “exempted” from reporting requirements which would have aided patients and doctors…and opened the manufacturers of faulty gear to lawsuits. What’s the likelihood of our 2-party government doing something as radical as that, eh?

So-called church offers miracle cure. Feel like drinking bleach?!

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Industrial Bleach for $20 – what a bargain!

❝ A group calling itself Genesis II Church of Health and Healing plans to convene at a hotel resort in Washington state [last] Saturday to promote a “miracle cure” that claims to cure 95% of all diseases in the world by making adults and children, including infants, drink industrial bleach.

The group is inviting members of the public through Facebook to attend what they call their “effective alternative healing” at the Icicle Village Resort in Leavenworth on Saturday morning. The organizer of the event, Tom Merry, has publicized the event on his personal Facebook page by telling people that learning how to consume the bleach “could save your life, or the life of a loved one sent home to die”.

❝ The “church” is asking attendants of the meeting to “donate” $450 each, or $800 per couple, in exchange for receiving membership to the organization as well as packages of the bleach, which they call “sacraments”. The chemical is referred to as MMS, or “miracle mineral solution or supplement”, and participants are promised they will acquire “the knowledge to help heal many people of this world’s terrible diseases”.

There was a time early on in my life when I spent a significant amount of time in the company of juvenile delinquents. During that period I met a number of “adult” crooks and hustlers. Not as adept as, say, pimps for our fake president; but, still – they loved religious hustles. For the same reasons religious hustlers always do. Built-in cover as some kind of True Believer. Ready and willing to accept every penny they could grab from the gullible.

Feds response to Romaine E. coli deaths is to do nothing!

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❝ A deadly E. coli strain that contaminated romaine lettuce in early 2018, causing five deaths and more than 200 serious infections, most likely infiltrated crops through canal water used to irrigate and apply pesticides in the Yuma, Arizona, growing region, which includes farms in southeastern California.

This finding, from an environmental assessment report released Nov. 1 by the Food and Drug Administration, demands a swift response by the agency, including an accelerated timeline to implement an agricultural water standard for fruits and vegetables that protects public health.

❝ Unfortunately, FDA leaders have given no indication that they will do so. Absent a change, 2022 is the earliest that any produce farm, except those growing sprouts, will be required to meet the agency’s first food safety requirements for agricultural water. Small and midsize operations have been given even longer to comply.

This is unacceptable in the wake of last spring’s outbreak and the deaths and illnesses it caused. Food safety officials should apply in a matter of months—not years—lessons learned from the environmental assessment. Simultaneously, federal and state agencies, working together, should use their authority over canal water quality to require that water be treated to reduce foodborne pathogens before being used in produce fields.

And the time to act is NOW!

AI diagnosis to make medical decisions is just about here

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AP Photo/M. Spencer Green

❝ The US Food and Drug Administration approved this week the first software powered by artificial intelligence that replaces the need for a specialized doctor to interpret medical imagery.

The software is called IDx-DR, made by diagnostic AI startup IDx, and specifically analyzes images of the retina to detect whether a person with diabetes has a complication from the disease called diabetic retinopathy…

❝ Diabetic retinopathy is a complication of diabetes where blood sugar damages the back of the eye, according to the FDA, and is the main cause of the loss of vision for those with diabetes…

By allowing this software to be marketed in the US, the FDA is setting a bar for the accuracy needed in order for AI to take over for human doctors. When validating that the AI system worked, the FDA used images from 900 US patients. The software correctly detected more than mild diabetic retinopathy 87.4% of the time, and identified when patients did not have more than mild retinopathy 89.5% of the time. Accuracy for humans naturally varies from doctor to doctor, but for the FDA to approve the technology it “must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.”

No doubt a predictable percentage of Americans will demonstrate fear of this technology to a greater degree than any other educated nation. Part of that education and, more important, political processes, electoral politics, religious folderol, come together to work harder than anywhere else – to keep citizens from modernizing their lives and thinking. Why – we might even question authority.

Safety risks found in one-third of drugs approved by the FDA

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❝ Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval…

The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.

❝ To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

❝ The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.

❝ Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency’s most serious safety alert, included in the drug’s packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.

The median time for an FDA action was 4.2 years after approval…

You, too, can be a beta tester for the FDA. Betting your life on it.

FDA says no more medically important antibiotics for livestock — Finally!

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A new rule that aims to safeguard essential antibiotics for humans by limiting their use in food animals is now fully in effect.

Under the Food and Drug Administration policy, antibiotics that have been designated “medically important” — in other words, they’re needed to treat people — cannot legally be given to healthy animals to speed their growth. The policy, three years in the making, required producers of agricultural antibiotics to change labeling on the drugs to make clear they should not be used for so-called growth promotion. All manufacturers agreed to abide by the new rule.

The policy also requires that from now on, food animals can only be given medically important drugs under the supervision of a veterinarian — a move designed to restrict their use to the treatment of animal illnesses.

An FDA report on antibiotic use in food-producing animals released just before Christmas revealed that sales of medically important antibiotics rose by 2 percent in 2015, and that from 2009 to 2015 sales of these drugs to the food animal sector increased by 26 percent. The increased sales in 2015 could be the result of a commensurate rise in food animals produced — but critics of the heavy use of these drugs in agriculture note sales haven’t come down…

Scientists and public health professionals have long warned that the increasing use of antibiotics in the rearing of food animals such as chickens, pigs and cattle, and farmed fish and seafood is fueling a rise in so-called superbugs — bacteria capable of evading the drugs.

That puts at risk procedures that have revolutionized modern medicine. Organ transplants, cardiac bypass surgeries, even safe caesarean section births are an accepted part of medical practice but could become much more dangerous to perform if superbugs continue to proliferate…

As things currently stand, antibiotics can be used to prevent illness, which can also lead to prolonged use. Advocates for more judicious use of antibiotics in agriculture argue that this is growth promotion by another name. They insist disease prevention goals should be achieved through better and more humane production practices that reduce the disease risks associated with factory farming.

And, so, the battle is won; but, not the war. Humane, healthy conditions for livestock are important to the health of consumers in more ways than one. Most reasonable, informed people know this. Politicians and their appointees invoke the ever-present American god of sophistry to pretend otherwise.

Another magic bullet is going away — “antibacterial soaps” will disappear

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If you’ve been spending your hard-earned money on fancy antibacterial soaps in the hopes that they’ll keep you clean and healthy, you may want to stop.

The US Food and Drug Administration just released a new, exhaustive report and ruling that there’s actually no good evidence they perform any better than plain old soap and water when it comes to preventing illness or the spread of bacteria and viruses.

What’s more, the agency is banning companies from using 19 common “antibacterial” chemicals — such as triclosan and triclocarban — in products going forward…Manufacturers have a year to reformulate products or remove ones with these chemicals from the market.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term…”

The FDA noted that the ban won’t apply to consumer hand “sanitizers” or wipes, as well as antibacterial products used in health care settings.

Another cash cow created by the “healthiness” industry bites the big one. But, cheer up. Some other health fad will come along. The same old profiteers and maybe a couple new entrepreneurs will “clean up” from consumers who continue to believe there’s always another magic cure ready to be discovered. For just pennies a day.