For more than a decade, patients who need certain controlled substances have suffered from ill-advised and indefensible policies enacted by the U.S. government, purportedly designed to reduce the spiraling number of drug overdose deaths. These policies failed miserably on many fronts: not only did the death toll continue to surge; terrible invasion The Drug Enforcement Administration’s (DEA) intrusion into the practice of medicine has had a chilling effect on patients and their doctors.
As the DEA continues to tighten production quotas painkiller and ADHDhas started tracking Every pills, making doctors increasingly reluctant to prescribe any controlled substances and leaving many patients in limbo. Perhaps worse, the DEA’s production quotas resulted in Back order of many kinds of Medications—an increasingly common burden on patients, even those lucky enough to have doctors who are willing to take risks. DEA Drug Enforcement Operations simply put do their job.
The sick and disabled suffer the most. Almost anyone who suffers from illness or chronic pain will say that the emergency room is the worst place to go for relief from severe pain. Doctors and hospitals are often more concerned with law enforcement surveillance than patient care. Patients desperate for pain relief often turn to street drugs, falling victim to counterfeit pills that contain fentanyl (or worse) instead of legitimate opioids.
In contrast, doctors in Australia, Canada, the UK and throughout Europe have been using fixed-dose inhaled general anesthetics, which are effective at relieving acute pain, but the seemingly unsympathetic US Food and Drug Administration (FDA) has Deny this drug to Americans.
Doctors often use methoxyflurane (Penthrane) as a general anesthesia in the 1960s and 1970s. However, due to its toxic effects on the liver and kidneys, anesthesiologists gradually stopped using it and switched to safer anesthetics. In 2005, the FDA deleted Methoxyflurane was obtained from the market.
However, an Australian company, Medical Developments International, has been marketing a low-dose, self-administered, single-use methoxyflurane nasal inhaler for treatment 30 years. Its brand name is Penthrox, although many people call it “Green Whistle” because pack It comes in. Since 2015a Canadian patient who has been suffering from the disease since 2018.
In 2020, a randomized controlled clinical trial in the UK proved The drug saves emergency room patients an average of 71 minutes in providing pain relief. Likewise, a 2020 Australian Trials A methoxyflurane inhaler found”Clinically significant reduction in pain scores compared to standard treatment. Very few adverse reactionssuch as liver and kidney toxicity, and No cases of addiction or abuse reported.
In 2022, the FDA finally lifted theclinical retention“Regarding the methoxyflurane nasal inhaler and allowing its manufacturer to resume FDA-supervised clinical trials. Unfortunately, this is an unnecessary waste of time.
This isn’t the first time the FDA has fallen behind the times, preventing Americans from accessing drugs that are readily available in other developed countries. Europeans can buy non-sedating antihistamines Like the over-the-counter (OTC) version of Claritin in the 1990s, but the FDA didn’t allow Americans to do that until 2002, instead forcing them to use more dangerous sedating over-the-counter antihistamines like Benadryl.
it took 12 years and 4 months The FDA finally gave women the freedom to purchase emergency contraception Plan B over the counter (beginning in 2001), and in the meantime, women in the United Kingdom, Canada, and European countries have been able to obtain the drug over-the-counter. While women in more than 100 other countries can get birth control without a prescription, U.S. women still must Prescribe for everyone except one.
Australians free to buy opioid overdose antidote naloxone over-the-counter Since 2016Italians can already use it Since 1996. The FDA will not allow Americans to buy the drug without a prescription until 2023, and Only in nasal spray form.
Now, while pain-relieving opioids are becoming increasingly difficult for Americans to obtain, the FDA is forcing them to wait for an alternative to the opioids that people in many developed countries have been using for years.
One way lawmakers can circumvent the FDA’s long and arduous approval process is to pass a law called ” international reciprocity—Allows U.S. doctors and patients to obtain similar drugs and medical devices approved by state regulatory agencies. Labels on such products should clearly state “Not FDA Approved,” but should indicate which country’s agency has approved them.
mutual approval already exists EU countries as well as Iceland, Liechtenstein and Norway. There’s no reason why Americans can’t get products approved by countries like Canada, France, the United Kingdom, Switzerland, Australia, New Zealand, and Israel.
If Congress enacts a reciprocal agreement, Americans in pain will be able to find relief from methoxyflurane while the FDA considers it. This common-sense action has huge potential benefits and very little downside. Congress should take immediate action.
If opioids are killing Americans, why doesn’t the FDA let us try alternatives? appeared first on Reason.com.
