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A Million Lawsuits Are Coming, And About Time Too !
Posted on May 20, 2019 by Pharmaciststeve
who is going to become a WHISTLE BLOWER ?
Posted on May 19, 2019 by Pharmaciststeve
It is claimed that 10 million Epidural Spinal Injections (ESI) are given every year and 5% of the pts who get these ESI’s end up with Adhesive Arachnoiditis https://en.wikipedia.org/wiki/Arachnoiditis which is a very painful and irreversible condition. Generally caused by the practitioner inserting the needle a “bit to far” and end up injecting fluids into the spinal fluid.
The only medication(s) that can be safely injected into that the spinal fluids must be not only STERILE, but must also be PRESERVATIVE FREE and a SOLUTION – NOT A SUSPENSION.
The class of medications used in ESI’s – Cortisteroids – and particularly Methylprednisolone is ONLY STERILE, contains PRESERVATIVES and is a SUSPENSION.
That same class of medication is discouraged by both the FDA and the company that discovered/produces it – Pfizer – to be used in ESI’s.
These ESI’s at $1000 to $3000 a pop means that Medicare/Medicaid/Insurance is putting out 10’s of billions of dollars EVERY YEAR. Not to mention the untold number of pts that are added to the list of pts suffering with Adhesive Arachnoiditis and how many are not getting proper pain management for a disease caused by a careless healthcare professional ?
Pain clinics that “force” pts to get routine ESI’s with the promise of relief of pain for weeks or months and in reality the pt may only get relief for days or weeks, or requiring pts to get ESI’s at certain intervals because the “insurance will pay again”.. even though the relief of pain has left weeks/months ago.
Often pts are told that they must get ESI’s and/or other procedures that do not provide the promised relief in order for the prescriber to provide the pt with oral pain meds.
Congress is always talking about all the fraudulent billings.. according to this article https://khn.org/news/fraud-and-billing-mistakes-cost-medicare-and-taxpayers-tens-of-billions-last-year/
it was 60 billion in 2016 alone JUST FOR MEDICARE. Billing for medically unnecessary procedures is considered FRAUD.
Is it time for pts of these “needle jockey” pain clinics to start taking notes because some/many of you are going to get dismissed from the practice at some time in the future, often for nebulous or fabricated reasons. This is the time to BLOW THE WHISTLE… don’t call and file a complaint with Medicare, contact your Federal Senators or Representatives.
Successful whistler blower cases the whistle blower gets a percentage of what is recouped. If you have already been tossed out of the practice… why not try to get some revenge ?
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Pete Hegseth adorns a RED BASEBALL CAP after delivering his commencement address
Posted on May 19, 2019 by Pharmaciststeve
Another “mental health” addiction crisis that few are talking about ?
Posted on May 19, 2019 by Pharmaciststeve
Suburban Teen Binge Drinking Rates Outpace Nation
While some parents may think it’s better to allow their kids and friends to drink supervised at home, social hosting, as it’s called, is punishable by jail time in Illinois.
Suburban Chicago teens are getting their hands on alcohol and drinking to excess more often than most of their peers across the country.
NBC 5 Investigates has learned that about 24-27% of suburban Chicago high school seniors admitted to drinking to excess once every two weeks. The information was collected via the Illinois Youth Survey. For comparison, a 2017 Centers for Disease Control study indicated 19% of all high school students binge drink.
Teen Binge Drinking Rates Outpace Nation: Web Extra 1
Binge drinking is defined as 4 drinks for a woman and 5 drinks for a man in a 2-3 hour time frame.
Surveys also show teen binge drinking in some of Chicago’s north suburbs far outpaces the national average.
For example, New Trier Township High School District 203 said 33% of its students answered “yes” to binge drinking at least once in the last 30 days in the CDC’s 2018 Youth Risk Behavior Survey. School district officials announced the findings in a February report and said binge drinking is a significant health concern that may be an issue to which the community is predisposed.
“We have taken significant steps to address this issue within the school and now need to shift our focus to confronting binge drinking as a community issue,” wrote Assistant Superintendent for Student Services Timothy Hayes.
Still, Deputy Chief Brian O’Connell of the Winnetka Police Department said there has not been an increase in teen-related alcohol arrests.
“The New Trier survey results do not reflect what law enforcement is seeing,” said O’Connell .
NBC 5 Investigates talked to North Shore high schoolers who said today’s teens face a lot of real world pressures that could lead some to drink alcohol.
“Everything’s just kind of out in the open now with the influence of the Internet in a way that makes like even the littler things just a lot more high stress,” said one Lake Forest High School junior.
A Lake Forest High School senior said, “There’s kids here that are running businesses, making films, doing these internships that are out-of-this-world and going to these, like, unbelievable colleges. So it’s like they’re living an adult life and so those things kind of come with being an adult.”
Todd Nahigian manages the Committee Representing Our Young Adults (CROYA) after school program in Lake Forest. He said teens often model the behaviors they see from their parents.
“In this area it almost seems that there’s a level of acceptance, that that’s the drug of choice, that that’s a socially acceptable way to have a cocktail at a party or enjoy yourself at the end of a long day,” Nahigian said.
According to Nahigian, parents are the one factor that will have the biggest impact on reducing teen drinking.
“It doesn’t mean that they’re not going to drink if their parents don’t want them to, but they’re more cautious, they’re more safe, they’re more interested in making the right decision knowing that their parents will be awake when they get home, knowing that their parents will be asking where they’ve been,” Nahigian said.
While some parents may think it’s better to allow their kids and friends to drink supervised at home, social hosting, as it’s called, is punishable by jail time in Illinois.
NBC5 Investigates searched through state records and found that state liquor-control officers have cited more than thirteen hundred (1,349) bars, restaurants, groceries and liquor stores for selling alcohol to minors in the greater Chicagoland area — including northwest Indiana – in the past five years.
• We found 161 places that have been cited more than once.
• Another 13 places have been cited three times.
• A liquor store in south-suburban Calumet Park has been cited four separate times.
• And we discovered a convenience store in Crown Point, Indiana that has been cited five separate times – just in the past five years.
But state liquor control officers only focus on certain towns and areas – so this does NOT include all citations and arrests made by local police.
The CDC’s 500 Cities Project also surveyed adults (18 +) about binge drinking and found Arlington Heights, Schaumburg and Palatine ranked among the top ten highest binge drinking cities in the country.
“We’ve wiped out literally most of the prevention money in the state of Illinois. It is important to get prevention education back into schools so that people can learn about drugs and alcohol,” said addiction treatment specialist Dr. Dan Lustig.
Sgt. Doug Hajek of the Arlington Heights Police Department said several northwest suburban police departments are participating in a program to keep alcohol out of the hands of those under 21 years of age, by reminding those over 21 that it is illegal to buy for those who are underage.
Teen binge drinking rates in Portage, Indiana, have been reduced by more than half in the past decade, according to the Porter County Substance Abuse Council. Law enforcement said a combination of proactive policing, students participating in school programs and local business involvement have helped reduce teen binge drinking rates, per youth surveys, from 32.1% in 2009 to 9.1% in 2018.
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$15,000 confiscated .. didn’t cover the cost of the “heroin bust ” ?
Posted on May 19, 2019 by Pharmaciststeve
135 officers arrest 50 people in massive Connecticut heroin bust: 11 suspects on the run
https://www.foxnews.com/us/police-arrest-51-people-in-massive-connecticut-heroin-bust
State and Federal law enforcement arrested 50 people in Connecticut on Friday as part of a massive undercover operation that resulted in the seizure of thousands of bags of heroin, guns and $15,000 in cash.
Police in Waterbury say the arrests were part of an investigation called “Operation Raw Deal” that began in September “in response to an increase in heroin overdoses and heroin-related deaths in the city.”
According to Fox 61, detectives issued 92 warrants for the 52 suspects, with charges ranging from the sale of narcotics, conspiracy at the sale of narcotics, firearm violations and possession in a school zone. Thirteen police teams carried out those warrants in a series of raids across the quiet Connecticut town.
The arrest phase of “Operation: Raw Deal” consisted of 135 detectives, officers, agents and investigators, from the VICE and Intelligence Division, Criminal Investigation Bureau (CID), Gang Task Force (GTF), Street Crime Unit (SCU), Emergency Response Team (ERT), Patrol Division, forensic technicians and investigators from other local and federal law enforcement agencies.
Forty-one suspects from the original list of 52 were arrested for various drug-related offenses, while nine people were arrested for various drug-related offenses and other crimes.
Detectives seized 8 ounces of raw heroin, thousands of bags of heroin packaged for sale, $15,000 in cash, two cars, two handguns, bullets and a rifle.
Waterbury police say most of those arrested in the monthlong operation were mid-level heroin dealers.
Lt. David Silverio says this operation was about saving lives, not just making arrests.
“You have the people that have a medical need and may need treatment and then we have traffickers and suppliers. This kind of operation is targeting the trafficker side of the narcotics problem,” Lt. Silverio of the Waterbury Police Department told Fox 61.
“As of May 4, there’s been 24 deaths in Waterbury this year alone and 99 overdoses. This year, the numbers hopefully will get better, but we have a problem right here in this city,” added Lt. Silverio.
In a nationwide study by the CDC, overdose deaths in 2017 are nearly four times as frequent as they were in 1999. Heroin overdoses have remained stagnant, as other forms of opioid use have increased dramatically.
Fox 61 says there are still 11 people on the run from the operation. The Waterbury Police says if you recognize one of the suspects, do not approach them and contact police immediately.
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Pts die in hospital BECAUSE ….
Posted on May 19, 2019 by Pharmaciststeve
Is the path that the chronic pain community is on … heading for a DEAD END ?
Posted on May 18, 2019 by Pharmaciststeve
Here is a recent article stating that legal opiates filled is down to 34 doses per adult.
Hope in the drug crisis: New data shows prescription opioid use fell at a historic rate last year
If one presumes that the minimum treatment for a intractable chronic pain pt’s treatment would be TWO LONG ACTING DOSES PER DAY… would “take care of” < 50% of the estimated 20-35 million intractable chronic pain pts. Maybe this why many hospitals are giving post surgery pts Tylenol & Motrin because they know that the day is coming when opiates may not be available at all.
I case you haven’t noticed … the DEA has been ABSENT and TOTALLY SILENT in regards to any/all meetings with HHS, FDA, CDC and others..
Oregon recently rescinded their rule that all chronic pain pts on Medicaid has to be off opiates by the end of the year – but if the DEA continues to cut production quota… being prescribed pain meds that there is little/no availability.. does Oregon’s action really mean anything to those seeking pain treatment.
Here is a story that suggests that the DEA is using the state’s PMP database to extract fines out of pharmacies https://www.providencejournal.com/news/20190416/cvs-to-pay-535000-for-filling-forged-prescriptions
39 forged Rxs filled at several CVS stores in Rhode Islands… and how did the DEA find all of these forged Rxs in several stores ? Perhaps one CVS Pharmacist caught one and they turned it over to police or DEA and they went data mining in the State’s PMP database to see what other stores have filled the same C-II from the same doctor and then went to the particular store to look at the Rx.. to see if it is a forged Rx..
If you also notice that the DEA is fabricating cases against prescribers based on GROSS NUMBERS.. here is one in Munster Indiana
Munster doctor sentenced for over-prescribing pain pills
this doc was the 9th largest prescriber of CONTROLLED SUBSTANCES in Indiana and largest in Lake County, but they got him to PLEAD guilty to prescrobing hydrocodone, an opioid, for non-medical purposes. Nothing in the news article which indicated the reason for their original data mining of the state’s PMP (INSPECT).
Maybe the chronic pain community should look at to what is now starting to happen after a couple of states that have passed anti-abortion laws where abortions can’t be preformed after fetal heart beat can be heard – around 6 weeks… normally before the woman even knows that she is pregnant. There is already talk of LAWSUITS being filed, because it is believed that these state laws are in conflict with the Supreme Court decision of Roe v Wade. The outcome of this/these lawsuits will just validate that politicians can create laws that are UNCONSTITUTIONAL and unless they are challenged in our court system… they will be enforced.
Then we have HR 6 – Opioid Crisis Response Act of 2018 – National Key Vote Which throws 8 BILLION toward treating substance abuse and in this Congress that is highly partisan… this bill got ONE NO VOTE in the SENATE and NINE NO VOTES in the House.. That means that 98% of Congress VOTED FOR THIS BILL.
Until the chronic pain community gets the attention of this Administration, Congress and DOJ/DEA and drag them into the conversation… the path that the chronic pain community is on … IS A DEAD END !
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New OU study profiles the ‘changing face’ of suicide
Posted on May 17, 2019 by Pharmaciststeve
New OU study profiles the ‘changing face’ of suicide
Where does suicide live in Ohio? How old is it? What does it look like?
According to a new study released by The Ohio Alliance for Innovation in Population Health (The Alliance), its identity is increasingly comprised of individuals both young and old. In the past 10 years, suicide rates have risen more than 30 percent for those ages 20 to 29 and approximately 57 percent for those aged 60 or older.
The data also revealed a troubling reality unfolding across Appalachian Ohio, which is home to nine of Ohio’s 10 counties with the highest suicide rates per 100,000 population over the past 10 years. Meigs County experienced the highest suicide rate in the state at 21.5, followed by Jackson County (19.9) and Hocking County (19.7).
Such trends are disturbing to mental health organizations across Ohio, including the Ohio Department of Mental Health and Addiction Services.
“The data in this report is very relevant to the work of the Ohio Department of Mental Health and Addiction Services,” said Lori Criss, director of that state department. “Suicide is a serious public health issue. Tackling this issue in Ohio will require collaborative efforts that cross state government, private partners, community mental health and addiction boards and providers, colleges and universities and others.”
The Alliance is a collaborative effort created by Ohio University’s College of Health Sciences and Professions (CHSP), the University of Toledo’s College of Health and Human Services and now including 28 partner organizations. The Alliance recently completed a review of suicide fatalities in Ohio based on data provided by key state partners between January 2008 and December 2017.
Rick Hodges, director of The Alliance, said that 526,501 years of life expectancy was lost in Ohio between 2008-2017 due to suicide. He noted that this sobering figure is largely attributed to the increase in suicide rates of individuals 29 years of age and younger.
“The Alliance’s research indicates that the suicide rate within our state’s younger population (29 and younger) has increased by 33 percent since 2008,” Hodges said. “Our ultimate hope is that this study will help to inform state- and community-level discussions surrounding how the risk of suicide can be reduced in Ohio and beyond.”
Hodges also referenced a June 2018 Alliance study that calculated more than 500,000 years of life were lost in Ohio between 2010 and 2016 due to opioid overdose.
Orman Hall, executive in residence for CHSP and author of the study, said that The Alliance’s research revealed a total of 15,246 suicide fatalities in Ohio between 2008-17, an overall increase of approximately 24 percent per 100,000. White individuals who reside in economically distressed Appalachian communities continue to exhibit the highest suicide rate in Ohio.
Hall emphasized that the intent of The Alliance’s study was not to serve as an exhaustive study of cause and effect, but rather to analyze the scope of suicide fatalities and to identify key demographic characteristics of decedents for this serious and growing problem.
Although the highest suicide rates were experienced in Ohio’s Appalachian region during the 10-year period that was studied, it is important to note that both rural and suburban areas experienced the greatest increase in the rate of suicides per 100,000 population. Cuyahoga (1,461) and Franklin (1,408) counties were home to the highest total number of suicide fatalities in the study.
Tony Coder, director of the Ohio Suicide Prevention Foundation (OSPF), reported that OSPF trains as many community members and healthcare providers as they possibly can across the state. He said collaborative partnerships with various agencies are in effect or are being built to create a state suicide strategy with the goal of reducing suicide attempts and death.
Ohio University College of Health Sciences and Professions Dean Randy Leite shared that the University is doing its part to train the nation’s next generation of mental health professionals.
“Clinicians often encounter mental health clients experiencing crisis; such distress can increase a person’s risk of suicide,” Leite said. “Our college is dedicated to educating the best healthcare professionals in the country and doing everything within our power to help alleviate this serious and growing problem. It is time we recognize suicide as the serious public health issue it is and do all we can to prepare future health and human service professionals to respond to those who may be at risk.”
Joan Englund, executive director of the Ohio Mental Health and Addiction Advocacy Coalition, said that The Alliance’s most recent study shines an important light on a growing need for suicide treatment and prevention services.
“Local, state and federal decisions and actions can reduce the growing number of Ohio suicides. In order to help change the current upward trajectory, all Ohioans must have timely access to appropriate mental health and substance use disorder prevention, treatment and support services,” Englund said. “This report provides public officials and other community leaders with critical data that can be used to inform strategic and impactful policymaking, support the system of care and target this alarming trend.”
Additional key data points within The Alliance’s study include:
- The lowest suicide rates per 100,000 population in the state were reported in Holmes County (6.85), Delaware County (9.87) and Hardin County (10.29).
- Men accounted for an average suicide rate over the 10 years of 21.4 deaths per 100,000, compared to a rate of 5.36 for women.
- Suicide rates for Caucasians were higher (14.6) than African-Americans (7.37).
- Between 2008 and 2017, 161 suicides occurred among those 14 years of age or younger. Senior citizens experienced the highest suicide rate increase by age cohort, climbing from 12.4 deaths per 100,000 in 2008 to 19.5 in 2017 — a 57 percent increase.
- The data show 3,459 people were 60 or older when they died by suicide and nearly 70 percent of those over age 60 used a firearm.
- Firearms accounted for 50.9 percent of all suicide fatalities for the 10-year period, followed by “other” (33.3 percent) and “self-poisoning (overdose)” (15.8 percent).
- “Other” causes of suicidal death included, but were not limited to, cuts or pierces, drowning, falls, machinery and motor vehicle traffic.
“We need to come together as a field to address this problem,” Coder said. “We know that opiates are a big issue, but with suicide being the second-leading cause of death for individuals ages 10-24, this is a public health crisis in which we need to assign the appropriate resources and manpower.”
Additional resources for the study include the Bureau of Vital Statistics, the Ohio Death Certificate File and the Centers for Disease Control.
According to the National Alliance on Mental Illness, warning signs may include threats or comments about suicide, increased alcohol and drug use, aggressive behavior, social withdrawal, dramatic mood swings, talking, writing or thinking about death and impulsive or reckless behavior. If you or someone you know are having thoughts of suicide, contact the National Suicide Prevention Lifeline at 1-800-273-TALK (8255).
The Ohio Department of Mental Health and Addiction Services offers suicide prevention guidance for veterans, school-age youth, faith-based groups, older adults and behavioral health providers.
The Buckeye Firearms Association works to emphasize education that encourages suicide prevention and helps to identify potential suicide warning signs; they often collaborate with county and state partners, including Franklin County LOSS and the Ohio Department of Mental Health and Addiction Services, to help share their message.
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hospital invoked a law allowing it to deny further care to a Texas woman
Posted on May 17, 2019 by Pharmaciststeve
Texas woman taken off life support against family’s wishes – then a pro-life group stepped in
https://www.foxnews.com/health/texas-woman-plug-pulled-life-saving-escape
A Texas woman was taken off life support Monday, against her family’s wishes, after the hospital invoked a law allowing it to deny further care.
But a pro-life group stepped in and helped her “escape” to a place that was willing to provide care. She is now in stable condition.
Donald Jones and his daughter, Kina, were preparing their final goodbyes earlier this week as their wife and mom, Carolyn Jones, 61, who suffered a stroke in 2017 and has been transferred between different rehabilitation facilities, was denied life-saving care by the ethics committee at Memorial Hermann Southwest in Houston.
Texas Right to Life and other pro-life groups in the state rallied together after the plug was pulled and the hospital refused to give Jones dialysis. They were able to get her out Wednesday night using a private ambulance.
“It’s kind of crazy that you try to get someone out of a hospital so their life could be saved,” Mark Dickson, director and vice president of Right to LIfe East Texas, who was with Jones, told Fox News.
Carolyn and Donald Jones have been married for 40 years. Donald had to fight to get his wife out of a hospital that refused her life-saving care. (Texas Right to Life)
The lead pastor of SovereignLOVE church in Longview felt God call him to drive the several hours it took to help rescue Jones. He read her Psalm 71, “about people that are trying to take your life” and encouraged her to keep fighting — that God nor they would abandon her.
“We never thought we’d have to arrange an escape from a hospital,” Dickson recalled. “But we did.”
On Thursday, Jones began receiving dialysis at the new hospital.
Her daughter, Kina, said her mom is in stable condition and looks like herself once again.
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Few prescription medications MADE IN THE USA
Posted on May 17, 2019 by Pharmaciststeve
Heart-Drug Suppliers for Millions Faulted Over Data, Bugs and Dirt
A pair of drugmakers in India that the U.S. is counting on to produce generic blood-pressure pills after a far-reaching recall have been faulted by regulators for quality-control issues.
Cadila Healthcare Ltd. and Alkem Laboratories Ltd. both won approvals in March from the Food and Drug Administration to make generic versions of valsartan for the U.S. market. Neither company made any of the recalled valsartan, but both companies have recently been cited by agency inspectors for quality-control failures that echo problems at other drugmakers — renewing questions about the safety of some of the world’s most widely prescribed medicines.
Workers ignored testing data showing product flaws; destroyed records indicating that drugs were failing key quality measures; and didn’t properly clean equipment, FDA inspection reports stated. Inside one factory, inspectors said they saw swarms of insects.
Millions of Americans take valsartan for high blood pressure and heart failure. Since last year, pharmacies have pulled many formulations of it, as well as other medications in the same class of drugs, after some were found to contain potential cancer-causing contaminants. Some versions of valsartan are now in short supply.
Most of the tainted drugs originated in India and China, which have become popular sources of generic medications and active-drug ingredients as producers and health-care providers try to hold down costs.
Those forces have left regulators scrambling to police an expanding global supply chain. Some of the plants that made the contaminated drugs were flagged by FDA inspectors prior to the valsartan recalls for attempting to cover up manufacturing problems, as reported by Bloomberg News earlier this year.
But the generic drugmakers cleared by the FDA to make versions of valsartan since the recall have many of the same red flags.
No Control
Records obtained through a public-information request show that a year before the FDA cleared Alkem on March 12 to sell generic valsartan in the U.S., agency inspectors noted numerous issues at one of the company’s two main manufacturing plants in India.
At a plant in Daman, India, inspectors found that workers destroyed logbooks or deleted data on quality testing and ignored signs that drugs made there contained impurities. In less than a month, workers deleted 2,000 files that appeared to include failing quality-test results, according to the inspection records. Data issues were so widespread that inspectors wrote that “there is no quality control unit” at the plant.
Inspectors also observed flying insects, including mosquitoes and gnats, that were “too numerous to count,’’ according to the reports.
Despite the array of problems described in the inspection, Alkem’s plant received a clean bill of health. The FDA revisited Daman in January, nine months after its initial, troubling inspection and gave the plant a pass. Two months later, the agency approved Alkem’s valsartan.
Alkem said its version of the drug was made in India but wouldn’t confirm at which plant. The company said the January visit from the FDA didn’t produce a list of any problems at the factory, an indication that the matter is closed.
It’s almost unheard-of for the agency to sign off so quickly on fixes by a plant with extensive problems, according to Massoud Motamed, a former FDA inspector who conducted inspections in China and India and now works in the drug industry.
“That’s not realistic to fix that in nine months,” said Motamed, who left the agency in 2017 and had no role in the Alkem inspection. “Working for industry, I can tell you it’s impossible.’’
An FDA spokesman, Jeremy Kahn, said in an email that the agency can inspect a facility at any time and does so based on risk factors including when the last inspection took place and the prior inspection history. The FDA also considers the need to maintain sufficient supply of a particular drug, he said.
“The agency followed an appropriate timeline given the factors relevant to this firm,” he said. “Generally, FDA can expedite inspection of facilities and assessment of drug applications for drugmakers that want to produce drugs in short supply so they can become operational as soon as possible.”
Quality Concerns
Cadila received approval from the FDA on March 16 to sell valsartan combined with another blood-pressure drug, hydrochlorothiazide. About a month later, records show, FDA inspectors tallied a lengthy list of quality concerns at a plant in Ahmedabad, India, that is making that drug combination.
Inspectors found in April and May that equipment at Cadila’s facility wasn’t cleaned appropriately to prevent contamination and that workers ignored signs of impurities.
A representative for Cadila didn’t respond to a request for comment.
Those issues are similar to problems FDA inspectors flagged at the company in China that’s at the center of the recall. Zhejiang Huahai Pharmaceutical Co. Ltd. was found to have ignored impurity indications in its valsartan. In a November warning letter, the FDA said that if the company had investigated further, it might have been alerted to the presence of the carcinogen NDMA sooner than the original recall, in July 2018.
The NDMA may have been in the valsartan as long as four years, the FDA said at the start of the recall. The agency is looking into whether the manufacturing process may have led to the contamination.
The FDA has estimated that for every 8,000 people who took the highest dose of valsartan, there would be one additional case of cancer.
China Echoes
In 2017, Motamed, the former inspector, discovered that Zhejiang Huahai workers omitted from official records quality-test failures, including ones that flagged impurities in unnamed drugs the company didn’t attempt to identify.
Motamed wanted to impose strict penalties on Zhejiang Huahai but was overruled by senior FDA officials, who allowed the company to attempt to address the problems. A year later, another generic drugmaker that bought valsartan from the manufacturer found an impurity that was determined to be potential carcinogen NDMA — kicking off the wave of recalls, which continues to expand.
The recall has heightened scrutiny of the safety of generic drugs, which are used to fill nine of every 10 prescriptions in the U.S., according to the FDA. Competition from generics has been a key part of the Trump administration’s push to lower drug costs.
Last month, the FDA posted a list of 43 versions of valsartan and similar drugs that don’t contain carcinogens. The FDA hasn’t updated the list, which names another 386 drugs that still need to be evaluated.
Alkem’s valsartan and Cadila’s combination pill aren’t listed in either category. The list will be updated on a periodic basis, said Kahn, the FDA spokesman.
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