I offer up my own experience here since it may help older/infertile men seeking to be fathers. It’s anecdotal, not statistical, but I did go from zero sperm to 4 to millions in a year. And my first try turned out badly with the eight eggs assigned to me — only two developed, and they were genetically abnormal, which meant more cost and delay to have our egg donor back again. By then more time had passed and presumably the Zymot sorting chip picked out better sperm for ICSI, so it was successful — four good embryos from 20 eggs, which is more than usual.
Disclaimer: this is not medical advice, just what happened to me, so if you are persuaded to follow a similar regimen, there is no guarantee it will work. If you are infertile in middle age and are seeing the clock run out, you would be wise to consult a fertility specialist.
My first try at IVF didn’t result in any viable embryos, presumably because there was SDF (Sperm DNA Fragmentation) — damage to the DNA of the sperm, thought to be the result of oxidative stress on the way from production to delivery and rustiness of the sperm production process in older males. The IVF doctor warned me that such cases can be permanent or take over a year to remedy with medical assistance.
Sperm DNA Fragmentation (SDF):
Men with sperm motility defects often have high levels of sperm DNA fragmentation. The degree of DNA fragmentation in sperm cells can predict outcomes for in vitro fertilization (IVF) and its expansion intracytoplasmic sperm injection (ICSI). The sperm chromatin dispersion test (SCD) and TUNEL assay are both effective in detecting sperm DNA damage. Using bright-field microscopy, the SCD test appears to be more sensitive than the TUNEL assay.
Its main units of measurement is the DNA Fragmentation Index (DFI). A DFI of 20% or more significantly reduces the success rates after ICSI. (more)
I never had an actual test for SDF, but the failure of 8 eggs to produce one viable embryo with my sperm strongly suggested SDF. One of the many causes of SDF is oxidative stress, so it can help (and do little harm) to up your intake of antioxidants.
March 27 2020
We had a great Zoom teleconference with Dr. [Redacted], who’s quite knowledgable (world expert and of course not cheap.) He commended me on my self-help recovery treatment. He also badmouthed compounding pharmacy rHCG and offered to prescribe the regular pharma variety (high-priced, no doubt.)
He’s plugging use of a “Darwinian selection” chip which selects the best by making them compete to swim down a microfluidic channel. This is the culmination of similar ideas in a Petri dish. I may be a good candidate for such since the last test showed 300K sperm, half motile. The more drastic collection from the testicles may not be necessary. The doctor consults for the chip company [Zymot], and he also suggested a line of antioxidant supplements he developed. I checked the ingredients of his branded supplement, and I had already been taking all of them with one exception, so it was less costly to just buy the missing ingredient and add that to my usual vitamins.
Dr. [Redacted] name-dropped [gay Silicon Valley billionaire], who he said “is in the same boat,” not wanting to have his sperm selected by a community-college-educated technician. I appreciate *justified* elitism… but people do come from around the world to our IVF doctor. It costs little extra to use the Zymot or similar sorting chips, so it would be wise for all older men to consider it.
I rarely meet anyone who knows more about much of anything than I do, so that was refreshing. And no one knows when the ASRM will relax the “no procedures unless ongoing” restriction. There’s more data on pregnancy effects (limited) and transfer of the virus to the baby (doesn’t seem to happen), so it’d be nice if they allowed the plans of millions to proceed. Which reminds me of the “no cataract surgery because it’s not critical” ruling. Postponing trans surgery (medically unnecessary, should be discouraged for minors) is no loss, but this is a taste of M4A: some high council will decide on political grounds whether your treatment is necessary or not.
As it turns out, implantation of the first boy was delayed over six months by the ASRM guidelines, which were in turn guidelines of the CMS (Centers for Medicare and Medicaid Services) which decided hospitals and clinics should postpone all non-emergency procedures to keep beds and staffing free for COVID-19 patients. This emptied hospitals and laid off staff, postponing important surgery (cancer biopsies, for one) and causing worse outcomes for millions of people. And how many tens or hundreds of thousands of IVF babies will now never be born?
Repeating the drug regimen from the previous post:
Anastrazole, 1 mg /day – suppresses estrogen production via aromatase inhibition.
hCG, .25 ml / every other day – chemically similar to luteinizing hormone, so shields testosterone and sperm production from negative feedback loops. Restored my levels of FSH (follicle-stimulating hormone) to normal in six months.
Antioxidant Supplements: One commercial supplement (FH Pro for Men) has this ingredient list:
See this study for results with this commercial supplement. Some of these ingredients are questionable. Taking an array of antioxidants is normally not especially beneficial (results of studies are mixed — no effects or even deleterious effects), but in case of SDF, six months of these will probably help.
You can buy this high-priced premixed formula as capsules here (FH Pro for Men) or do it yourself at lower cost (but less convenience.) If you don’t mind taking lots of pills twice a day in hopes it will help with SDF, here’s what I took:
Daily multivitamin for older people (“Spectrum Silver” equivalent)
Vitamin C (500 mg)
Vitamin D (2000 IU)
Vitamin K2
Niacinamide
Methyl Folate
Cal-Mag-Zinc
Acetyl-L-Carnitine
L-Arginine HCl
coQ10 (ubiquinone)
NAC (N-Acetyl-Cysteine)
Amazon links for these (note that if you buy through these Amazon affiliate links, a tiny percentage of your purchase costs comes back to me; it’s always appreciated.):
Acetyl-L-Carnitine bulk powder. This is more cost-effective; add to a protein shake or other strongly-flavored liquid to cover the taste.
L-Arginine Powder
L-Arginine Powder. This tastes so foul it spoils anything liquid. I found it best to dissolve it in warm water to drink quickly, then immediately rinse.
The drugs in the list previously mentioned all require prescriptions. The HCG in particular is used not only by men restoring fertility, but by women doing an IVF cycle; a diet fad (which is now fading) had people injecting themselves with large bootleg quantities to lose weight.
Here’s what a packaged pharmacy bottle looks like — inside the box is a vial of lyophilized (dried and preserved particulate) HCG and a vial of sterile water. Since the FDA no longer allows compounding pharmacies to do this for you, you have to mix it yourself by using a syringe to move water from the water vial to the hCG vial. The result is a water-based, injectable HCG that begins to spoil immediately, so use it in 30-60 days at most.
Packaged HCG
The syringes for these subcutaneous (just beneath the skin) injections are readily available because they are used in the billions for self-administered insulin shots. The procedure is to find an area underlain by fat (often around the naval) and pinch the skin to insert the very fine and short needle before injecting. This is usually nearly painless. The syringes look like this:
Most people experience less than satisfying sleep at least occasionally, but some sufferers go for years without relief. Not being able to fall asleep at the normal hour in a reasonable length of time is known as “sleep onset insomnia.” Older people especially may suffer from waking too soon or not getting enough deep sleep. Sleep is a complex neurochemical phenomenon, and a wide variety of different causes for poor sleep make it hard to diagnose and relieve.
What’s often called sleep hygiene is a collection of good practices and habits that tend to lead to better sleep. Harvard Medical School’s Division of Sleep Medicine has a good list.
If you’re getting exercise and avoiding caffeine or alcohol late in the evening, you might still have problems. Chemical sleep inducers in the form of drugs and supplements can help get you to sleep or keep you asleep, but prescription medications like Ambien and Lunesta can have side-effects, cost a lot, and can be addictive. Many people have been hooked on them (and the drugs of past eras like tranquilizers and sedatives) for years, unable to stop without going through far worse withdrawal symptoms.
If your problem is getting to sleep, your body and mind may be revved up and out of synch with your natural sleep hours. Not engaging in eating, drinking, or stimulating activities for a few hours before normal bedtime can help. Some natural supplements — chemicals already found in your body or food that promote sleep — work for many people. A list:
Melatonin, one of the body’s primary sleep signalling chemicals, is continuously produced by the pineal gland, but destroyed by light hitting the eyes, so it is a driver of the sleep-wake cycle that lags exposure to light; it’s partly because exposure to light synchronizes your sleep cycle that staying up late with bright lighting can disturb it. Taking natural melatonin a few hours before normal bedtime reinforces the natural cycle somewhat, although there’s little evidence of it crossing the blood-brain barrier after absorption by the digestive system. Try sprinkling a bit of melatonin in powdered form under your tongue, perhaps by opening a commercial capsule like these. Melatonin, like some other drugs and vitamins, can be absorbed somewhat by the blood-vessel-rich skin under the tongue — this is called sublingual administration. Melatonin successfully reduces time-to-sleep and insomnia for most people, though it is less effective at keeping you asleep. If you’re already getting up to go to the bathroom at 3 AM, though, you can do another sublingual dose of melatonin and sleep a few more hours successfully.
5-HTP or its precursor L-Tryptophan. Tryptophan is an amino acid component of the proteins in many meats, eggs, and dairy products, and is commonly believed to create the sleepiness after a big Thanksgiving turkey dinner — though turkey meat has no more L-Tryptophan than most other meats. It is also usually credited for the “glass of milk at bedtime” method for assisting sleep. After a Japanese manufacturer of L-Tryptophan produced contaminated batches in 1989, injuring thousands and killing as many as 37 people, L-Tryptophan was banned by the FDA in the US. These restrictions were loosened and finally lifted completely in 2005. As a result of that incident, though, more people still take 5-HTP, which is a metabolite of L-Tryptophan and his similar effects. A few hundred mg of either does tend to produce faster and deeper sleep in most people, and like melatonin thet are both safe and not habit-forming.
Valerian Root is somewhat less harmless. An old herbal standby, this herb in capsule form is used by millions as a sleep aid. While it does work, it can’t be recommended for any but the shortest-term use because it is a mild liver poison — long-term use damages liver function. Other herbal teas like chamomile also have some sedative effects without any obvious toxicities.
GABA is another amino acid and neurotransmitter which doesn’t seem to cross the blood-brain barrier, yet has some obvious effects, producing calm and deeper sleep and perhaps aiding production of growth hormone in older body builders who take it. I take a gram every night before bed and it seems to deepen sleep. It also has some side-effects reminiscent of the niacin flush for some, so be careful and experiment with small doses before trying more. A reliable low-cost provider of GABA powder which can be mixed into any drink is here.Capsules tend to provide less effective dosages.
Doxylamine succinate is an old standby which works fairly well and is cheap and safe as a sleep aid: as an antihistamine, it is obsolete because its side-effect of drowsiness is intolerable during the day. But while it’s unwise to take any drug regularly unless you really need to, it’s at least not addictive and is easy to buy OTC: as this Kirkland-label product from Costco, for example.
Everyone’s sleep problem is different, and with age staying asleep becomes the most common problem. Natural substances can help but good sleep hygiene should be tried first.
I have been researching issues of dysfunctional government and over-regulation for the next book, which won’t be done for months. But now is a good time to discuss some of the results that bear on the new administration’s agenda.
Trump rode a popular wave of anger at being lied to and cheated by the DC pols and bureaucrats who have been in the pockets of special interests — oligopolic corporations, unions, and regulated industries — for several decades now. The fog of disinformation funded by government PR and interlocking media conglomerates obscured how regular people were being shafted to fund ever-increasing costs for medical care, education, housing, and cable TV, special interests that had captured their regulators to increase profits at the expense of middle-class families. Proximate causes of voter anger: the lies of Obamacare and the intentional subversion of the law and welfare systems to support a large population of illegal immigrants intended to tip the electoral balance against citizens who were born in the US or entered legally. The government cheerleaders denigrated blue-collar and less degreed workers, while promising and failing to deliver good jobs. “College for everyone” policies meant college degrees came to be required for all good jobs, and meanwhile failed public schools graduated students unprepared for even low-level college work, then stuck the dropouts with nondischargeable student loan debts. College tuitions rose far faster than inflation while an elite class of academics and administrators took home fat paychecks and enjoyed job security and benefits unavailable to most taxpayers — meanwhile abusing nontenured adjuncts to do the actual teaching for poverty-level pay. Lives have been destroyed by the promises of the social engineers, and the people finally stopped buying the propaganda.
Trump is not beholden to the usual billionaire donors and subsidy-seeking industries. His administration is the first opportunity in decades to seriously overhaul the regulatory structure that has crippled US competitiveness. Real structural reform could unleash a wave of growth and new jobs and lower costs of housing, allowing people to move to where the jobs are and start rebuilding families and lives that have stagnated since 2008’s Great Recession began.
I’m going to propose an agenda of radical reform that not only would create a business boom, but a freedom dividend. The elitists have tried micromanaging normal people by regulating the most trivial details of daily life (for example, incandescent bulb and plastic shopping bag bans) and opposing all new housing, pipelines, and industrial development. They should be told to mind their own business.
Radical reform agendas affecting multiple sectors have a problem getting accepted. One can try to build a coalition to get people to accept the parts they don’t like for the sake of others they do, but you run the risk of notifying the entrenched interests that you’re threatening their monopoly profits. Those special interests will join together to fund propaganda to frighten the population into halting the reforms. This was Arnold Schwarzenegger’s downfall in California; he took on the entrenched power of public employee unions — nurses, prison guards, and civil servants — who funded a massive PR campaign against his reforms and halted them at the ballot box. Schwarzenegger gave up, convinced the interests he had challenged were too powerful to curb. So perhaps the reform agenda should be secret — picking off the interests one by one with as little fanfare as possible, so the people wake up one day to discover they are richer and more free than before. Announcing that you intend to fire millions of paper-pushers so they can go to work in real jobs that actually add value might possibly be a bad idea… even those paper-pushers might be better off in the long run working in more dynamic industries, but it is hard to convince someone to voluntarily undergo wrenching change for some long-term good.
So slow and steady change, with due regard for transitional measures to smooth the way. But smash the system, gently, and let people choose freely how to live and create. The status quo is no longer sustainable, and change rolled out before the inevitable collapse of the debt-based economy will perhaps forestall the worst scenarios.
One of the downfalls of the Democratic-Progressive machine was the failure of the Rube Goldberg ACA / Obamacare health insurance scheme they believed would cement their electoral dominance by creating more dependent citizens. Passed in a hurry when they were about to lose their lock on the Senate, the law was a Frankenstein monster of parts assembled by special interest groups and progressive policy wonks, famously cheered on by MIT Prof. Jonathan Gruber, who admitted the proponents had intentionally obscured its true nature: to greatly raise the cost of insurance for healthy middle-class families so that poorer, sicker people could get subsidies without revealing the huge hidden tax increase involved. Repeated lies were used to pass it, including Politifact’s Lie of the Year for 2013, Obama’s “If you like your health care plan, you can keep it,” plus the promise of $2500 per family yearly savings.
But the current death spiral of the ACA individual insurance market is far worse than the planned hidden tax and subsidy scheme. Through its poorly-designed rules of payment for coverage, the scheme allowed and encouraged gaming — clever consumers discovered they could sign up and pay for one month, then get lots of expensive healthcare services for three months before being cut off for nonpayment. And the loopholes allowing enrollment outside normal time windows were so easy to bypass that many people dropped coverage, returning to pay only when they had a major medical expense upcoming. Because of the high prices — which were barely affordable even with subsidies, and many times the cost of similar pre-ACA policies for those who were not subsidized — many or most of those eligible chose not to buy in, leaving the sickest and poorest to drive up average medical spending for the risk pool.
As a result, the trumpeted increase in coverage was entirely due to expanded Medicaid, which is free and worth every penny. The Oregon study which showed that Medicaid coverage did nothing to increase health or decrease death rates for newly-covered people was ignored, and the claims that new Medicaid coverage would save thousands of lives every year and decrease ER usage among the poor turned out to be false — ER usage rose as poor people continued to prefer no-appointments, no-payment access to ERs over Medicaid clinics with long waits for appointments. Meanwhile, the 20 million people who had paid for their own insurance before the ACA have been soaked, and there are now only 10 million people enrolled in the new individual ACA plans. So while proponents continually claim success in that more people are “insured,” the deteriorating quality of the coverage and the reduced participation by the young and healthy who were supposed to pay the bills mean that it is becoming both a financial and a healthcare disaster.
What happens when a significant number of voters have supposed facts drummed into them by political leaders, but discover they were all lies, and many middle-class voters are being soaked for insurance that covers less and costs much more, reduces choice in providers, and limits travel because they can’t get coverage outside their area of residence? They begin to doubt the word of the “experts” of the government propaganda machine on every other subject, and they yearn for honesty.
Passed to satisfy all major special interest groups, the ACA appeared likely to increase profits for health insurance and drug companies, which is why they supported it. It has not worked out that way, with the companies generally losing $billions on individual health insurance plans. Progressives are now calling for a public option which would somehow undercut the pricing of private insurance companies, many of which are nonprofits, while doing the same work the government way — we can see how well that might work by how patients are treated by the VA.
But the failure of the ACA has created a climate for real reform because the old mostly-functional system is now smashed to pieces and there is less to lose from drastic change. The ACA, ruled constitutional by the Supreme Court, established that the Federal government could regulate and interfere with the healthcare markets of every state. Under the expanded Commerce Clause powers now established as precedent, nothing stops Congress from seizing direct control of medical professional licensing. The balkanized 50-state regulation of care is part of the inefficiency of the system — it should go. In practice there is no evidence that doctors licensed by one state become hazards to care in a different state, and the complex schemes that restrict supply and raise costs for medical certifications need to be streamlined and unified. Irish doctors who go through a four-year program are just as good as doctors trained in the US’s standard eight-year program, which costs hundreds of thousands of dollars more. Services which can be provided by technicians in cheap clinics like those popping up in drugstores nationwide should be expanded; for example, checking for suspicious skin growths to screen for cancer can now be done by AI-based optical scanners at very low cost. Standard tests and treatments for colds, flu, STDs, skin fungus, and impacted earwax don’t require a doctor’s knowledge. State laws requiring doctor supervision of even routine care do little to improve care but a lot to restrict availability and raise prices.
Medicaid is both expensive to taxpayers and provides delayed and substandard care. An expanded system of clinics for the poor is a much better way of spending public money on low-income patients. Hospital ERs need to be free of the requirement to treat non-emergency patients, and free to pass them off to public clinics who can more cost-effectively treat the less urgent problems they bring in.
Requiring prescriptions for drugs raises costs and reduces availability for everyone, even wealthy people — having to see your doctor several times a year to renew routine prescriptions for birth control, blood pressure, cholesterol, and other common medications adds to costs with minimal benefits. Doctors have to waste time jumping through insurance company hoops intentionally imposed to reduce drug costs, and vast amounts of time and money are spent needlessly.
There are some medications which need to be controlled to prevent overuse. Antibiotics, for example, gradually lose their effectiveness as organisms build up resistance, and so having some authority limit their use to cases of real need is cost-effective. But most standard medicines should be free for sale over the counter — only antibiotics and highly addictive drugs need to be controlled. This would cut out layers of cost and reduce prices and the cost in time and trouble to patients and doctors. OTC birth control costs the system much, much less than Obamacare’s “free” birth control pills.
Many newly-approved treatments are startlingly expensive. One reason for this is a hidebound FDA, which requires massive double-blind controlled studies for approval. For each drug that is approved, many more fail, so the billions spent have to come from somewhere, and that means very high list prices for patented treatments. The focus on approvals can make or break billion-dollar companies, and so the FDA deciders are subject to influence-peddling campaigns and barely-hidden bribery, making their decisions less transparent and more political than is decent. Meanwhile, foreign countries control prices and reap the benefits of new treatments while not footing much of the development cost. It’s only because the US government enforces this setup that the market works this way; removing bans on imports and equalizing world prices for medications would force the pharmacy companies to price more rationally and fight the price-controlling developed countries that are free-riding on US research costs.
So setting up a commission to investigate modernizing FDA approvals, freeing up provision of most medical services and licensing, and allowing US sales of any drug approved by reputable agencies abroad would be a good start. Drug companies will fight this since it means they have to find another way to charge the costs of research more broadly to the rest of the developed world while selling at marginal cost to poorer patients wherever located, but the current situation is not sustainable — just as the US no longer dominates the world economy and can no longer afford to pay the lion’s share of defense costs for its allies, medical research and drug approval costs have to be more widely shared. And the paternalistic control of what adult citizens choose to eat, drink, smoke, and take as drugs needs to end. It is vastly wasteful and costly to freedom.
All insurance is a bad deal in that it costs more than the services one might expect on average to get in return; the overhead of the insurance company, claims managers, and payment systems has to be built into the price. Thus insurance for small expenses one could easily afford to pay is a bad deal; extended warranties for appliances, phones, and travel insurance are overpriced. Most people who bought their own insurance pre-ACA had catastrophic coverage, which kept premiums down by having high deductibles. But these policies got them access to the insurance company-negotiated prices, which is important because hospital list prices have been set artificially high in response to the Medicare reimbursement system. Bare-bones policies covered the truly unaffordable costs of serious medical treatments, which is the correct use of insurance. Now many people who had catastrophic coverage can’t get it at the formerly reasonable prices since even unsubsidized policies must conform to ACA rules.
So the first relief for ACA problems is to end regulation of policy benefits so individuals can buy what they actually need in coverage. If medical screening is allowed, setting up a national subsidized high-risk pool for poorer people with pre-existing conditions can help solve that problem, or regulations could require anyone with continuous coverage to be accepted, as they did before the ACA in most states — only a few people would find themselves uncovered and needing a subsidized high-risk pool. Most of the damaging gaming of ACA policies comes from those who stop paying in until they have an expensive need, and requiring continuous coverage limits that problem.
Subsidies for lower-income people are problematic in many ways. One is the benefits cliff, which penalizes someone who increases their income many times the increase, punishing efforts to better their lives. Another is the high cost to taxpayers — the costs have been less in total than expected because ACA policies have been much less popular than expected, but higher per covered person. Getting medical costs down overall through deregulation and heightened interstate competition and economies of scale will help, and making any subsidy required be available through income-tax credits eliminates the need for the costly and mostly failed state and national marketplace web sites, easier dreamed of and promised than executed by government contractors. Those have cost $billions but have proven unsustainable even when they work. Let insurance companies sell directly, let any aggregator compete to sell policies, and get the government out of health insurance provision entirely.
The FDA was once focused on policing the marketplace for food and drugs — its predecessor started under the Pure Food and Drug Act of 1906, and the emphasis was on preventing fraud. Focused on dangerously adulterated food and false claims of efficacy for medical treatments, proper manufacturing and labeling were effective at reducing problems, with the Prohibition-like bans on some drugs and detailed regulation of what chemicals a citizen could buy coming later. Most of the damage caused by quacks and adulterated foods and drugs could be prevented by emphasizing consumer information and labeling instead of prohibition — making sure what is sold is what it is labeled as being and preventing unsupported claims of efficacy are really all that is required, and the growth of FDA regulation beyond that is retarding progress and increasing costs to consumers with very little benefit. Patients with their doctor’s guidance ultimately choose what is needed and useful in medical care, and the FDA has forced them to smuggle in lifesaving medications from abroad and set up a system that prices treatments far above affordable costs. No one who is facing a life-threatening illness to should be kept from trying promising treatments the FDA is too slow to approve. And advanced countries like Britain allow pharmacies to sell, for example, codeine (similar to heroin!!) with acetaminophen tablets for the asking — with little additional risk, though they have been criticized for not warning enough against the dangers of overuse of acetaminophen (Tylenol).
And the FDA is legally prevented from halting the advertisement of and wasted money on homeopathic medicines, which do nothing but can harm people by delaying treatment with real medication. They are also barred from halting supplement sales, and liver toxins like valerian root are still sold freely without appropriate warning labels. Consumers are lead to believe authorities have made the world safe for them, and do not investigate and are not sufficiently skeptical of claims made.
The Hoover Institution’s studies of medical reform are in line with what I’m suggesting, though less radical. I’m particularly bored by HSAs and schemes to jigger tax credits when the underlying problem is that costs are just too damn high, but those incremental improvements would be worthwhile.
[next installment: Sekrit Plan for media conglomerates and cable TV companies, now one and the same]
Corporate HR Scrambles to Halt Publication of “Death by HR”
Nobody gets a job through HR. The purpose of HR is to protect their parent organization against lawsuits for running afoul of the government’s diversity extortion bureaus. HR kills companies by blanketing industry with onerous gender and race labor compliance rules and forcing companies to hire useless HR staff to process the associated paperwork… a tour de force… carefully explains to CEOs how HR poisons their companies and what steps they may take to marginalize this threat… It is time to turn the tide against this madness, and Death by HR is an important research tool… All CEOs should read this book. If you are a mere worker drone but care about your company, you should forward an anonymous copy to him.
The FDA has finally approved Titan Pharmaceutical’s buprenorphine implant after years of unnecessary delay, letting doctors have another useful weapon in treating opioid addiction. The background is here:
— Who Killed Prince? Restrictions on Buprenorphine.
The implant provides a smooth low level of buprenorphine sufficient to relieve opioid cravings, but not enough to degrade mental functions; patients on the implant testify that, unlike opioids or pill forms of buprenorphine, it makes them feel normal so they can function in their daily lives.
The Reuters story mentions the neo-Puritan objections:
The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday. The matchstick-sized implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. Fewer than half of the estimated 2.2 million Americans who need treatment for opioid abuse are receiving help, according to the U.S. Centers for Human and Health Services (HHS).
Currently, two drugs are predominantly used to treat opioid addiction — methadone, which is dispensed only in government-endorsed clinics, and the less-addictive buprenorphine, which exists as a pill or strip of film. While effective, a pill or film may be lost, forgotten or stolen. Evidence suggests that the use of these medicines as part of the overall treatment program are more effective than short-term detoxification programs aimed at abstinence, the FDA said on Thursday….
“I intend to make this the most successful implant that’s ever been marketed … and I think it’s absolutely possible given the unmet need,” Braeburn Chief Executive Behshad Sheldon said in an interview ahead of the FDA decision.
However, some doctors are concerned that the implant may incentivise patients to rely solely on medication, and ignore the lifestyle changes they need to make.
This is the neo-Puritan impulse — if you lack the ability to get off entirely, you should just suffer and die because you don’t deserve a normal life. Addiction is not a “lifestyle choice,” it’s an addiction, and those prone to addiction are generally going to be addicted to something, or many things — the goal of treatment should be to move the addict to habits which don’t interfere with leading a productive and satisfying life. I am, for example, addicted to coffee, working out, eating well, and getting a good night’s sleep…
Since it’s an implant, if it isn’t replaced after six months the patient will taper off the drug fairly slowly, and it might well be easy enough to go off it completely as a result. But even if viewed as permanent maintenance, it is much better for the patient and society than allowing the peaks and valleys of opioid addiction to wreck the patient’s life and possibly kill them.
We are also seeing these perfectionists in the current effort to outlaw vaping, which is one of the best ways to get smokers off the much more damaging cigarette smoking habit — see FDA Wants More Lung Cancer.
The implant has a bright future now. Too bad tens of thousands of people died without treatment in the three years the FDA delayed it. The Reuters story continues:
Braeburn estimated the U.S. market for opioid addiction treatments at about $2 billion, excluding methadone and Vivitrol, Alkermes Plc’s treatment for the prevention of relapse after opioid detoxification.
CEO Sheldon declined to specify a price for the implant on Thursday, but said it would be substantially cheaper than Vivitrol. “We are hoping that our first patient will have received the implant by the first day of summer or June 21,” she added.
The market for long-acting therapies such as Probuphine could be even larger if attempts to raise the limit on the number of opioid addicts a doctor can treat are successful. Under the current law, a doctor can treat only 30 opioid addicts within a year of obtaining a waiver, rising to a maximum 100 after procurement of a second waiver. The Congress and the HHS are working toward increasing this limit. Of particular interest is a proposal that exempts from the patient limit any treatment directly administered by a physician, such as an implant or injection.
UPDATED 2 JUNE 2016:
The preliminary autopsy report has been released showing cause of death as an overdose of Fentanyl, an opioid stronger than morphine or heroin. The report is minimal and gives no hint of what investigators might have found or what legal actions Prince’s doctors may face.
Death by HR: How Affirmative Action Cripples Organizations
The first review is in: by Elmer T. Jones, author of The Employment Game.Here’s the condensed version; view the entire review here.
Corporate HR Scrambles to Halt Publication of “Death by HR”
Nobody gets a job through HR. The purpose of HR is to protect their parent organization against lawsuits for running afoul of the government’s diversity extortion bureaus. HR kills companies by blanketing industry with onerous gender and race labor compliance rules and forcing companies to hire useless HR staff to process the associated paperwork… a tour de force… carefully explains to CEOs how HR poisons their companies and what steps they may take to marginalize this threat… It is time to turn the tide against this madness, and Death by HR is an important research tool… All CEOs should read this book. If you are a mere worker drone but care about your company, you should forward an anonymous copy to him.