FDA issues ‘most serious type of recall’ for insulin pump-related iOS app

FDA issues ‘most serious type of recall’ for insulin pump-related iOS app

https://www.msn.com/en-us/health/other/fda-issues-most-serious-type-of-recall-for-insulin-pump-related-ios-app/ar-BB1mg98J

The U.S. Food and Drug Administration has issued a Class I “most serious type of recall” for an iOS app used in conjunction with an insulin pump.

The “correction” as referred to by the FDA on Wednesday, rather than a product removal, relates to the t:connect Mobile App iOS v2.7. It was confirmed by Tandem Diabetes Care the following day, which stated that Android app users are not included in the recall.

“The t:connect mobile app works with the t:slim X2 insulin pump with Control-IQ technology,” the FDA states. The pump delivers insulin under the skin at set and variable rates for the management of diabetes. 

The app recall is due to a software issue that may cause the app to crash and be automatically relaunched which “may result in pump battery drain and may lead to the pump shutting down sooner than typically expected.”

The FDA says pump shutdown “could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin,” and encourages those with diabetes who use insulin pumps to carry backup supplies in case of pump failure.

“The correction highlighted in the recall notice was addressed in the t:connect app update for the Apple iOS platform (v2.7.1) released on March 18th,” Tandem Diabetes Care said in a press release. “Affected customers were notified by Tandem on March 26th, and more than 98% of affected customers had already updated their devices as of April 15th. We continue to make every effort to contact everyone who has not yet updated their iOS app to the new version.”

Tandem Diabetes Care gives detailed instructions to customers who wish to check their mobile app versions here. 

“Ensuring the safety of our patients is our top priority, and we take any safety concerns with our products very seriously,” Tandem Diabetes Care said in its release. “No deaths have been reported, and we will continue monitoring the new version of the t:connect app released in March to ensure the concerns described in the recent recall notice from the FDA have been addressed.” 

bye-bye so sad

Be careful what you post in titles. I  have a post concerning a chronic pain pt Robert Charles Foster who had lost his pain meds and ended up getting cops to end his pain FOR GOOD.

Apparently, there was a couple of words in the title that did not meet FB’s “community standards” and they deleted them.

They seem to have a problem with intractable chronic pain pts resolving their untreated torturous level of pain via some sort of self-inflicted means.

The hyperlink above points to the one post on FB, they have not found yet.  See how far they go to see if the community standards are met!

PBMs are now often more profitable than the drug manufacturers and insurance companies they work with

Editorial: To save local pharmacies, state must rein in the middlemen

https://www.post-gazette.com/opinion/editorials/2024/05/09/pharmacy-benefit-manager-reform-insurance-reimbursements-express-scripts/stories/202405090037

Pharmacies in Western Pennsylvania are closing at an alarming clip, pushed out of business by a complex, opaque and utterly broken medication reimbursement system. The state legislature, following the recommendation of Gov. Josh Shapiro, must act to bring transparency and accountability to the important, but little-known, health care middlemen called pharmacy benefit managers, or PBMs.

PBMs are corporations — sometimes associated with major pharmacy chains, like CVS subsidiary Caremark, but more often independent — who manage the relationships between the makers of prescription drugs, the insurance companies who pay for them (including Medicaid and Medicare), the pharmacies that distribute them, and the people who need them. In particular, PBMs set terms and pricing.

The original purpose of PBMs was simply to process claims for prescription medicines, but over time they evolved, and now they negotiate prices at every stage of the process. In theory, this give patients and their insurers bargaining power against drug manufacturers. In practice, PBMs cut deals with manufacturers and insurers, including steering patients toward preferred drugs, and have near-total power to set the terms of their contracts with pharmacies.

For many everyday drugs, pharmacists are forced to accept a loss, sometimes in the hundreds of dollars, on each prescription they fill. The result: reimbursement rates that are ruinous for pharmacies, especially independent businesses in underserved areas, leading to closures and reducing vulnerable people’s access to life-enriching, -sustaining and -saving medicines.

Against the spread

PBMs originally made money by charging insurers to process claims and manage prescription benefits. But now they make money from all parts of the process, most notably through a practice known as “spread pricing.” To understand spread pricing, you have to understand how prescriptions are priced. The problem is that PBMs consider this a trade secret.

Even if we can’t know how they do it, we can know what they do: PBMs negotiate the price insurance companies pay for prescriptions, the price pharmacies are reimbursed for prescriptions and the copays charged to patients. The pharmacy has essentially no control over any aspect of the pricing for the products most important to its own bottom line (and in many cases their survival): When the pharmacist plugs prescription information into the computer, the PBM spits out the dollar amounts.

The “spread” in “spread pricing” is the difference between the amount PBMs charge insurers — including Medicaid and Medicare — and the amount they reimburse pharmacies. PBMs pocket the difference without even handling the drugs in question.

Spread pricing is why PBMs are now often more profitable than the drug manufacturers and insurance companies they work with. In 2017, the largest PBM in the nation, Express Scripts, made over $100 billion; the drug manufacturer Pfizer, only $52 billion.

When Ohio investigated the PBMs handling the state’s Medicaid program in 2018, they found that spread pricing was costing taxpayers a cool $223 million per year. When the state banned spread pricing and contracted with a single PBM, it charged only $25 million for its services. The PBMs had been skimming $200 million of pure profit off medications for the state’s poorest patients.

Banning spread pricing in Ohio also resulted in reimbursements for pharmacists rising by $38 million — reflecting better pay for pharmacies and huge net savings for everyday people.

No other choice

PBMs hold all the cards against pharmacies, including chains, because they gatekeep access to major insurers and drug manufacturers in their exclusive networks. It’s even worse in the Pittsburgh region, where healthcare giants UPMC and Highmark both use the same PBM, Express Scripts.

If a Pittsburgh pharmacy doesn’t like the terms Express Scripts offers, it’s free to turn them down — and lose access to about two-thirds of local patients.

This means pharmacies often sign on to unfair pricing structures, controlling everything from reimbursement rates to preferred medications. When pharmacists are forced to accept a loss on so many prescriptions they fill, they must choose between dropping patients whose prescriptions are draining the company and risking the viability of the entire business. In either case, the people they serve lose.

Last month, at least 12 pharmacies closed their doors across Western Pennsylvania alone. There’s no reason to believe we won’t keep losing more. Advocates say that the U.S. loses one pharmacy branch per day. This results in prescription deserts, usually in already underserved urban and rural communities.

No incentive to change

The fact is a shuttered pharmacy isn’t a threat to business for PBMs. Patients will always need their medications. Some PBMs even argue they are providing the remaining pharmacies with a boost in business.

But if a pharmacy closes, it’s likely because the patients it served needed medicines for which PBMs reimbursed unfairly. They’ll have to go somewhere, and the financial contagion will spread. One of the pillars of the health care system — one that seems simple compared to hospitals and other providers — is slowly collapsing.

The state can do something about it. Pennsylvania should follow Ohio’s example and ban spread pricing. Companion bills HB 1993 and SB 1000 would do just that, while forcing PBMs to submit details of their pricing schemes to the state Insurance Department. The bills would also ban PBMs from “patient steering” by creating exclusive networks of contracted pharmacies or charging higher co-pays at pharmacies they don’t contract with.

PBMs claim that their aggressive tactics translate to big savings for their clients, and that spread pricing covers the cost of their services. If that’s true, they should have no issues opening up their books for the public to take a look. The future of access to essential medicines depends on it. People’s health, even their lives, depend upon it.

 

Who are you being referred to for additional care or services

 

you may have to click on graphic to properly enlarge it

Vertical integration visualized

https://ncpa.org/newsroom/qam/2024/05/08/vertical-integration-visualized

We all know what it means, but what does it look like? Each year Drug Channels updates its chart of vertically integrated insurers, PBMs, specialty pharmacies, and providers—all of which, Drug Channels editors point out, face renewed scrutiny from the Federal Trade Commission, the Office of Inspector General, and members of Congress. As the FTC, in particular, takes strides to hold insurer-PBMs accountable, and we’re finding more and more evidence of PBM greed, study this chart so you can help your patients understand the health care world they live in (and one that profoundly affects all of us).

If a practitioner refers you to another healthcare organization or practitioner, this chart may explain why you are being referred!  This chart will show everyone where the referral is to another healthcare organization owned by the same corporation. It is called SELF-REFERRAL and most likely the practitioner that you are seeing is an employee of that same corporation.

Protest Express Scripts May 17th 9AM – 1PM

When a chronic pain pt becomes over verbally abusive not liking my free advice

the 1+ minute audio file below is from a chronic pain pt who reached out to me for assistance. Apparently, a  Wags Pharmacist refused to fill this pt’s controlled Rx.  This pt reached out to me via FB chat. It took me ~ 90 minutes just for the pt to tell me who the pt’s insurance company was.  Finally abt 80 minutes in the back/forth in FB chat, the pt shared a copy of their medication insurance card. The card said Prime Therapeutics, and doing a little research online. I discovered that Walgreens and Prime Therapeutics had jointly created a new company https://www.alliancerxwp.com/ that is a PBM, mail-order pharmacy, and specialty pharmacy. At that point, it seem obvious to me that her PBM was owned by Wags and it was Wags that was refusing to fill her controlled Rx.   I spent another 30-45 minutes talking to this pt on the phone about her issue, and another 30-45 minutes giving her a detailed suggestion that might get her controlled Rx filled.

Maybe I should have just told the pt that the letter could not be changed in any way to get that Wags Pharmacist to fill her controlled med.

This pt’s phone number was from the East Coast, but claimed they were living on the West Coast. The pt was also wants to have someone to find her a new doctor.  I referred to a couple of people within APDF https://americanpaindisabilityfoundation.org/ who could possibly know more about doctors around the country who will possibly properly treat chronic pain pts and are pain refugees.  The advocates were not aware of any prescriber in the pt’s area who the pt could be referred.

Then various verbal abuse started coming. I see ~ 20 emails sent from this pt. The APDF advocate that I referred to, has told me an untold number of calls to his home by this pt. Below is a voicemail that this pt left me. BE WARNED, the language used could be offensive to some.

5 people arrested after surge of suspected drug overdoses in Austin: Police

Here is a example of how our judicial system in VERY INCONSISTENT Pain Management Physician Convicted of Unlawfully Distributing Opioids

The Physician looks at the potential of 480 yrs in prison over prescribing 9 pts three different controlled meds over 6 yrs, BUT NO OVERDOSE DEATHS!

In the below article NINE OD DEATHS, Five people were arrested and charged with possession or delivery of a controlled substanceNO involuntary manslaughter or some degree of MURDER!

5 people arrested after surge of suspected drug overdoses in Austin: Police

Nine people are suspected to have died in connection with the overdoses.

Five people have been arrested after dozens of people overdosed in Austin last week, leading to nine suspected deaths.

The Austin Police Department said Marcellus Barron, 30; Denise Horton, 47; Gary Lewis, 50; Ronnie Mims, 45; and Kanady Rimjo, 32, were arrested and charged with possession or delivery of a controlled substance, according to local ABC News affiliate KVUE.

Police said they located the suspects by investigating the source of the narcotics used in the recent overdoses, KVUE reported. The drugs included marijuana and crack cocaine laced with fentanyl.

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine, according to the Centers for Disease Control and Prevention.

Most cases involving fentanyl-related harm, overdose and death in the U.S. have been associated with illegally made fentanyl, the CDC said. It is often sold through illegal drug markets and mixed with other drugs, such as cocaine or heroin, to increase its effects.

PHOTO: An undated stock photo showing Fentanyl.

STOCK PHOTO/Getty Images

Starting around 9 a.m. ET on Monday, April 29, Austin-Travis County Emergency Medical Services (ATCEMS) said it received a surge of calls concentrated in the downtown area.

ATCEMS said it usually receives two or three overdose calls per day, but the number of calls equated to a 1,000% increase in call volume, Dr. Heidi Abraham, deputy medical director for ATCEMS, said last week during a press conference.

As of Monday, there were 79 reported overdoses and ATCEMS distributed 438 Narcan rescue kits. Narcan is given as a nasal spray and the active ingredient in the medication — naloxone — can quickly restore breathing if someone is experiencing an opioid overdose.

Police say a sixth person, 55-year-old Johnny Lee Wright, was arrested after surveillance video captured him delivering narcotics to Austin residents, KVUE reported. According to the APD, Wright has several previous felony convictions, including some related to narcotics.

APD did not immediately return ABC News’ request for comment.

A record number of Americans have died from drug overdoses. In 2022, there were nearly 108,000 drug overdose deaths, according to provisional data from the CDC.

In Texas, drug poisoning-related deaths for 2022 sit at 15.4 per 100,000 people, which is the highest rate since at least 2011, according to provisional data from the Texas Department of State Health Services.

Medicare Hospital Trust Fund to Stay Solvent Until 2036, Trustees’ Report Says

Medicare Hospital Trust Fund to Stay Solvent Until 2036, Trustees’ Report Says

https://www.medpagetoday.com/publichealthpolicy/medicare/109997

Projection is 5 years longer than last year’s prediction

The Medicare Hospital Insurance Trust Fund is expected to remain solvent until 2036, 5 years longer than projected last year, the Medicare trustees said Monday in their annual report to Congressopens in a new tab or window, but they also expressed concern about low payment rates to physicians.

The longer hospital trust fund solvency is “largely due to greater income and lower expenditures than was projected last year,” a senior administration official said on a call with reporters. “Income was projected to be higher because the number of covered workers and average wages per worker were both projected to be higher than last year’s estimate.”

On the other hand, “expenditures were projected to be lower in the short-range period mainly as a result of a policy change to reduce Medicare Advantage spending,” the official said.

The long range actuarial deficit of the hospital trust fund is 0.35% of taxable payroll, “lower than last year’s estimate of 0.62%,” he said. “Two ways to reduce the deficit are to decrease outlays by 8% or increase the standard payroll tax rate” from 2.9% to 3.25%.

The trustees’ report covers two separate funds. The Medicare Hospital Insurance Trust Fund — also known as the Part A Trust Fund — pays for inpatient hospital care as well as hospice care and skilled nursing facility and home health services following hospital stays. The Supplemental Medical Insurance (SMI) Trust Fund pays for benefits under Medicare Part B — which includes physician services — and Medicare Part D, which is the prescription drug benefit.

The SMI Trust Fund is adequately financed into the indefinite future because it is financed by beneficiary premiums and federal funds that are automatically adjusted each year to cover costs for the upcoming year. In contrast, the Part A Trust Fund is financed by a variety of sources, including payroll taxes, a portion of the taxes on Social Security benefits, Part D state payments, Part B drug fees, and beneficiary premiums.

The Medicare board of trustees has six members: the secretaries of Labor, HHS, and Treasury; the Commissioner of Social Security; and two public trustees, although the public trustee positions have been vacant since 2015. The CMS administrator serves as the board’s secretary.

The Medicare trustees also found that Part B expenditures were $502.9 billion in 2023 and are expected to grow annually at an average of 7.7% for the next 5 years under current law. In 2024, the monthly Part B premium rate is $174.70 and is projected to increase to $185 in 2025, although that amount won’t be finalized until later this fall.

As for the Part D drug program, expenditures there stood at $131.1 billion in 2023 and are projected to grow at an average annual rate of 8.2% over the next 5 years, according to the report.

In comparison to the rosy overall forecast for the Hospital Insurance Trust Fund, the official warned that “uncertainty remains about adherence to current law payment updates, particularly in the long range,” adding that the concern “is more immediate for physician services, for which a negative payment rate update is projected in 2025, and updates are projected to be below the rate of inflation in all future years.”

In particular, the official told MedPage Today on the call, with a negative payment update anticipated for 2025 and 0.25% or 0.75% updates specified after that, which are “considerably lower than projected rates of inflation…, there’s a recognition that those updates are not going to meet up with expectations for provider costs, and that’s the concern that is raised.”

The trustees’ report includes an alternative scenario in which physician payment rates are raised in conjunction with the rate of increase in the Medicare Economic Index (MEI), a measure of healthcare inflation. Under that alternative — which likely would ease concerns about beneficiary access to physicians — “total Medicare expenditures would increase to 8.4% of GDP [gross domestic product] at the end of the long-range [75-year] projection period, as opposed to 6.2%” if current law doesn’t change, the official said. He noted that without changes to current law, “should payment rates prove to be inadequate for any service, beneficiary access to and quality of Medicare benefits would deteriorate over time.”

Raising physician payment rates in line with the MEI was also discussed by the Medicare Payment Advisory Commission (MedPAC) in its March report to Congressopens in a new tab or window. “Given recent high inflation, cost increases could be difficult for clinicians to continue to absorb,” the reportopens in a new tab or window said. “Yet current payments to clinicians appear to be adequate, based on many of our indicators. Given these mixed findings, for calendar year 2025, the commission recommends that the Congress update the 2024 Medicare base payment rate for physician and other health professional services by the amount specified in current law plus 50% of the projected increase in the MEI.”

“Based on CMS’s MEI projections at the time of this publication, the recommended update for 2025 would be equivalent to 1.3% above current law,” the report continued. “Our recommendation would be a permanent update that would be built into subsequent years’ payment rates, in contrast to the temporary updates specified in current law for 2021 through 2024, which have each increased payment rates for one year only and then expired.”

American Medical Association president Jesse Ehrenfeld, MD, MPH, said in a statementopens in a new tab or window Monday that “This report continues the drumbeat of recommendations that all point out that the payment system is failing patients and physicians. When physicians face a set of facts, we respond to improve the situation. It would be political malpractice for Congress to sit on its hands and not respond to this report.”

“Medicare trustees and MedPAC have teed up the issue for members of Congress who, no doubt, have heard from constituents about problems accessing healthcare under Medicare,” he added. “The AMA has plenty of reform ideas to permanently solve the problem and end this annual cycle of payment cuts and patches.”

CDC Admits Its Opioid Prescribing Guidelines Have Hurt Chronic Pain Patients

The CDC guidelines were not created by the CDC but by a dozen or so of “so-called experts” If these people on that committee were “experts” should they not have known that what they created -2016 CDC guidelines -potential to do harm? Could they be financially liable for all the harm that was caused directly & indirectly? I don’t know if the CDC paid those people on the committee – or they just volunteered to have the chance to put “their stamp/beliefs” on the chronic pain community. If they were paid… many were DOCTORS… The CSA states that no one can prescribe a controlled med without doing an in-person exam… While probably none on the committee directly treated pts, they used the perceived creditability of the CDC to convince the DEA, and VA to implement the guidelines as a standard of care and best practices and > 50% of our state legislators to codify these guidelines into law.

CDC Admits Its Opioid Prescribing Guidelines Have Hurt Chronic Pain Patients

https://themighty.com/topic/chronic-pain/cdc-opioid-guidelines-hurt-chronic-pain-patients/

On Wednesday, the Centers for Disease Control and Prevention (CDC) issued a clarification regarding the federal guidelines for opioid prescriptions that were put into place in 2016. The paper, published by CDC researchers in the New England Journal of Medicine, stated that many of the guidelines have been misapplied, causing serious harm to chronic pain patients.

The original prescribing guidelines were intended for primary care physicians treating adults with chronic pain (pain that lasts more than three months) outside of active cancer treatment, palliative care and end-of-life care.

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function, and reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs,” the CDC wrote.

While many medical and health policy communities embraced the guidelines, CDC researchers said some clinicians and policy-makers have misinterpreted them, taking the recommendations too far.

The paper published this week reported that some physicians have encouraged “hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.” The guidelines have also been mistakenly applied to patients with pain associated with cancer, surgical procedures or sickle cell crises – patients who were not included in the original recommendations.

CDC researchers offered several examples of the ways in which their guidelines had been wrongly implemented. They wrote:

For example, the guideline states that ‘Clinicians should…avoid increasing dosage to ≥90 MME [morphine milligram equivalents]/day or carefully justify a decision to titrate dosage to ≥90 MME/day.’ This statement does not address or suggest discontinuation of opioids already prescribed at higher dosages, yet it has been used to justify abruptly stopping opioid prescriptions or coverage.

This misapplication can have major consequences for people with chronic pain. Researchers explained that forcing patients to abruptly taper their dosages can lead to opioid withdrawal, increased pain or other adverse psychological and physical outcomes. Too little is known about the benefits and harms of reducing high dosages of opioids in physically dependent patients for researchers to recommend this strategy to physicians.

Mighty contributor Chris Jolley was one of many people with chronic pain adversely affected by these misimplemented guidelines. In his essay “When a Doctor Forced Me to Taper Off Pain Medication,” he wrote:

I was with my pain doctor on the same medication for 20 years when the medications that control my chronic pain were stopped without my consent. …

I live in unbearable pain 24/7. I’m one of the many people in pain whose doctors have abandoned us and ignored our pleas for help. Many pharmacists profile us based on their perception of our appearance. Some will not even fill prescriptions from cancer patients.

I have disability benefits awarded by my government for intractable pain, yet I suffer discrimination and cannot get treatment for that pain. Until our government admits the epidemic is about street drugs like fentanyl and heroin and stops persecuting people in pain, there will be more and more deaths by overdose from street drugs and more pain patients suffering.

Since the CDC’s guidelines were published in 2016, the number of opioid prescriptions has decreased. In May 2018, SERMO, a social network for physicians, conducted a study of 3,000 physicians and found that seven out of 10 said they cut back on prescribing opioids or stopped prescribing them entirely in the last two years. When SERMO conducted the same study in 2016, six out of 10 doctors said they were cutting back.

Among doctors who had cut back, 22 percent said it was because there were “too many hassles and risks involved,” while 34 percent said chronic pain patients have been hurt by the reduction in opioid prescriptions.

Research has shown that limiting opioid prescriptions does not have an effect on the rates of death and addiction in the U.S. According to reports from the CDC, opioid deaths in the U.S. are rising, with a 9.6 percent increase from 2016 to 2017. But this increase is due to fentanyl, not prescription opioids.

Researchers said the CDC is examining the impact its 2016 guidelines have had on pain patients and will update them when new evidence is available. “Until then, we encourage implementation of recommendations consistent with the guideline’s intent,” they said.

Doc Blows Whistle on Cigna

Doc Blows Whistle on Cigna

https://www.medpagetoday.com/special-reports/features/109910

Cigna increased efforts to speed up claims denials using new software and performance measures that pressured medical directors to close cases without a full review, according to a ProPublica investigationopens in a new tab or window.

The insurance company reportedly pressured medical directors who fell behind in reviewing cases, and even threatened to fire them if they failed to work faster, according to Debby Day, MD, a medical director who worked at Cigna for more than 15 years.

Often, the company encouraged doctors to “cut and paste the denial language that the nurse had prepared and quickly move on to the next case,” according to Day. This practice became so common that Cigna employees took to calling the approach “click and close.”

The company reportedly measured the pace and total number of cases that each medical director closed, which involved a productivity dashboard that tracked performance. Day told ProPublica the only way to keep up with expectations was to “deny, deny, deny.”

But Day told ProPublica that she believed her work was too important to speed through. Medical directors at Cigna were given the responsibility to approve or reject payment requests for critical care such as complex surgeries. And while the insurance company was pressuring doctors to work faster, Day said the work of the nurses “was getting sloppy,” which made reviewing claims harder and more meticulous.

Cigna told ProPublica that medical directors are not permitted to “rubber stamp” nurse denials and the company expects case reviewers to “perform thorough, objective, independent, and accurate reviews in accordance with our coverage policies.”

Longevity Scientist Faces Blowback

A Harvard geneticist who became the face of the longevity movement has drawn increasingly harsh criticism for claiming his products can reverse aging, according to the Wall Street Journalopens in a new tab or window.

Last year, David Sinclair, PhD, faced backlash for posting on social media that a gene therapy invented in his lab and developed by his company, Life Biosciences, had successfully reversed aging in monkeys. He also claimed the therapy had restored vision in the monkeys.

Earlier this year, Sinclair reportedly said another company he co-founded had developed a supplement that had reversed aging in dogs, according to WSJ.

However, other longevity science experts called this an empty promise. There isn’t an accepted standard for measuring aging, let alone a definition of what it means to “reverse” it, they said. The criticism was paired with the resignations of scientists from the Academy for Health and Lifespan Research, a group that Sinclair co-founded and led. Of the roughly 60 members who resigned, one posted on social media that Sinclair was a “snake oil salesman.”

The Academy’s remaining board members called for Sinclair to step down as president, which he eventually agreed to do.

Sinclair made a name for himself by promoting scientific claims about his work that garnered interest from top-tier scientific journals as well as praise in the news and on social media. But he has increasingly drawn criticism for hyping his own research or promoting unproven products, especially when he stood to benefit financially.

“The data is not good, you’re calling it the wrong thing, and then you’re selling it,” Nir Barzilai, MD, the new president of the Academy and the director of the Institute for Aging Research at Albert Einstein College of Medicine in New York, told WSJ. “The selling is a step too far.”

Fertility Clinic Accidents

The growing fertility industry has been plagued by an opaque system that frequently hides major errors and accidents, according to a Washington Post investigationopens in a new tab or window.

Many fertility centers are not required to report errors or accidents, including lost or damaged embryos, to any government or professional oversight organization, the report found. The industry relies largely on self-policing, which means patients are rarely informed immediately after something has gone wrong.

The Post highlighted two accidents that resulted in the loss of thousands of eggs and embryos belonging to hundreds of individuals and couples. One accident in San Francisco involved the implosion of a cryopreservation tank that contained 4,000 eggs and embryos. Another incident in Cleveland resulted in the loss of 4,000 eggs and embryos after a similar storage tank failed.

Both incidents occurred over the same weekend in March 2018, the Post reported.

Industry representatives insisted that error rates are low, and experts told the Post that fertility practitioners are regulated similar to other medical disciplines. Patients are also able to use the courts to address mismanagement of genetic material, experts said.

In fact, the Alabama Supreme Court ruling that frozen embryos are children came during a dispute over the mishandling of human embryos. But experts claim that most lawsuits end in settlements with nondisclosure provisions reinforcing the secrecy around the fertility industry.

Still, Adam Wolf, a prominent attorney for fertility plaintiffs, told the Post that the “vast, vast supermajority of mistakes in fertility clinics, the public doesn’t even know about.”