This online news website is owned and operated by Becky Watts. If you enjoy reading Pike County Times, consider buying an advertisement for your business or sending a donation to support the only free online newspaper in Pike County. Donations can be sent to: The Pike County Times, PO Box 843, Zebulon, Georgia 30295. Click here to donate through PayPal. Thanks for supporting Pike County's only free online newspaper!
By Editor Becky Watts
ZEBULON - Pike County Times recently wrote on monoclonal antibody infusion that is being given to COVID-19 patients as a way to help people heal and keep them out of local hospitals. The State of Georgia managed to set up over 100 treatment sites before the federal government decided that it was time to regulate the number of infusions that are being given to each state across the nation.
The takeover came without warning on September 3 with a slowing down of orders and a reduction in Georgia’s requests for the infusion medication. The takeover changed again on September 13 and brought orders to a screeching halt through the current system.
According to an update on the Department of Health and Human Services’ (HHS) website, there has been an increase in Delta variant cases that has caused a “substantial surge” in the use of monoclonals, “particularly in areas of the country with low vaccination rates.” It goes on to say that HHS “is committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the country.”
Because of this commitment to “assure consistent availability,” HHS said that it has updated the process for distribution of monoclonals from a direct ordering process back to a state/territory coordinated distribution system that is similar to that used for monoclonals from November of 2020 through February of 2021.
This means that state health departments will now be in charge of distributing where these products go in the future as well as determining how many infusions each site receives. There will be weekly distribution amounts for each state and territory determined by HHS based on weekly reports of new COVID-19 across the nation.
Click here to see distribution amounts: https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Bamlanivimab-etesevimab/Pages/Update-13Sept21.aspx.
For local hospitals and clinics that have been treating patients for months and even some that have come into being lately, this is not welcome news. Pike County Times has been told that many local clinics have already begun running dangerously low of infusion medications, and some are completely out.
Statement from Upson Regional Medical Center
Pike County Times wrote an article entitled “BREAKING NEWS: Upson Regional Medical Center Now Offers REGEN-COV Infusions for COVID Patients” on September 7 that is included here (http://www.pikecountytimes.com/secondary/BREAKINGNEWSinfusions9.7.21.html#.YUJX-X0pDIU), but note that this change in distribution from the federal government has affected the entire process.
URMC CEO Jeff Tarrant advised that “Regeneron is now allocated to each state every week by HHS, and then allocated for distribution to local areas by Georgia DPH. That's a change as of yesterday.”
He also advised that infusions in Pike County can be scheduled at the Zebulon Clinic by calling 770-567-7293, and that all clinics will be continuing to provide the Regeneron monoclonal infusion to patients.
“We received some REGENERON-COV yesterday,” said Jeff said.
Ordering and Receiving Regeneron Undergoes Changes
Jim Totten works at Family Health Clinic as the Operations Director. He wrote a post that went on Facebook last week after the President’s speech about his Covid Plan. Jim said that treatments are being withheld from providers and states.
“Yesterday the President announced his covid plan. While I agree vaccines do help people not get severe illness, I still wish scientist and media talked about natural immunity from having the disease,” he wrote. “He (the President) said his patience was becoming thin by people not being vaccinated, but he spoke very little about the one outpatient treatment that is proven to work!!”
Jim described the situation that HHS has put his clinic in with monoclonals and this new change of ordering because he does the ordering at Family Health Clinic. He said that prior to September 3, he could order these medications from Amerisource and have them within 24 to 48 hours once you set up an account. “It took about 1 minute to order them.”
The clinic found that HHS would have to approve all orders now, and he said that many clinics and hospitals are running low or have run out of monoclonals. “One of my clinics have been approved for an order but because of HHS delay, they may run out before it’s received, it has been ordered since Sept 3rd. My other clinics order is still pending, that clinic may run out by this weekend, that order was also placed Sept 3rd.” [Note from the Editor: More on this in the next section of the article.]
“This is not a state issue, this comes right from the feds per the company that distributes this medication. The emails received from HHS, states they are reviewing data and will let us know the status of our order,” he said. That was on Wednesday.
Jim pointed out that increased testing without being able to treat isn’t good, and that there are treatments besides monoclonals for some people. But he also pointed out that many people don’t have a provider that treats COVID or they don’t have the money for treatment.
Jim stressed that there has to be a way for these people to be treated so they don’t end up in the emergency room, and he pointed out that even some vaccinated and natural immunity people need outpatient treatments.
He said that HHS reduced Georgia allocation of monoclonals to 70% of what it was the week before September 3 and said that the state didn’t know of this before it happened according to the Governor’s office. He went on to say that Georgia has also found out that not all states were reduced in the same manner.
“Vaccines work, masks help, natural immunity is good. Monoclonals save lives and they are being withheld at the federal level.”
“Our state representatives are trying to get monoclonals back to these clinics and hospitals that need them,” Jim said. “For the first time since we started using monoclonals, next week I may not be able to get my friends and family treatment. I know the studies say this treatment is about 70-80% effective. In my experience I see it as 95% effective if given iv.” [Note from the Editor: IV infusion has been proven as much more effective in studies than Sub Q injection (given in a series of shots) which is only about 30% effective and goes against manufacturer recommendations. More on that in the article entitled, “BREAKING NEWS: Small Town Primary Care Office Launches Big Missile in the War Against COVID-19” linked here at http://pikecountytimes.com/secondary/BREAKINGNEWSmonoclonalantibodies9.5.21.html]
He ended his post by asking for prayer for first responders and healthcare workers including public health employees and said that “Many of these public health workers were instrumental in helping our clinics and me during this pandemic with supplies and getting the monoclonals for our community.” He also asked people to call their senators and national representatives and tell them that we need monoclonocals at a local level.
He ended by saying, “I just don’t get pulling back treatments that we know save lives and make people feel better.”
More Changes in Ordering and Receiving Regeneron
Family Health Clinic was willing to talk on the record again with Pike County Times. You can read in depth about monoclonals and how they are helping people in our community through a previous interview with PA Allan Imes from Family Health Clinic by clicking here: http://pikecountytimes.com/secondary/BREAKINGNEWSmonoclonalantibodies9.5.21.html.
Lorrie Imes is the Practice Director for Family Health Clinic’s Zebulon and McDonough locations. She describes the dire situation that distribution centers all over the state are facing at this time.
“We are fighting day in and day out. And a good portion of our time is spent just chasing down monoclonal antibodies and trying to get them,” Lorrie said. She said that she is extremely worried about the supply running out and is waking up every day and saying a prayer, “Lord, please don’t let this be the day. When you serve small communities, most of your patients are family and friends, so this is personal to us.”
She said that these infusions are keeping people alive, and if infusion sites can’t get them, it’s going to impact the communities around Family Health Clinic because they have been giving monoclonals since February of 2021. The McDonough location has been averaging 25 treatments per day of late with some days running more than 30.
“If all of us come to a screeching halt, the hospitalization rate will go way up and deaths are going to go up. And it’s terrible,” Lorrie said. “I expect within the next day to day and a half that we will be out,” she said. “I see no plan in place on how to get more. The ER’s are already overwhelmed. If we go days, or worse weeks without this getting figured out, people will die.”
She explained that their clinic has treated some really sick people and there is no question that lives have been saved. She said most recently other physicians have been referring patients over from long term care facilities where there has been an outbreak. They treated seven patients from there on Monday.
But the source of treatment is drying up. On Tuesday morning, the clinic only had 2 monoclonal treatments on hand. Their shipments for this week were ordered on Friday. Normally, shipments are received next day, but nothing arrived on Monday.
They had ordered 48 monoclonals for the Pike County Clinic and 160 for the McDonough Clinic. They received 24 for Pike County (a reduction of 50%) and that arrived around 10:30 a.m. on Tuesday. When they opened the box for the McDonough Clinic that afternoon, there were only 48 in the box.
“We have very limited supply,” she said. She expects that they may make it through Wednesday and maybe part of Thursday. She points out that they do much more than monoclonal antibody treatments to help patients and wants patients to still seek treatment. “Monoclonals have never been our only treatment and it’s important that people don’t stay home and go at this alone just because there may be no monoclonals. We can and will still treat people.”
She explained before the system was put into place for clinics to order from Amerisource, the state handled the distribution which was only given to hospitals. “It wasn’t until it was handed back from the state to Amerisource that we were able to start getting them. And that was in February of 2021.”
“So I’m praying that the state is more visionary now: that they see what happened when they (the State) did it the first time, and they see what we’ve done since we were allowed to get them, and that there is somebody with some wisdom and foresight to get them to us. We also keep trying to make sure everyone understands that you can’t just give someone a monoclonal antibody shot and send them on their way! Patients need other treatments in combination and they need to be followed through the course of their COVID infection,” Lorrie said.
“I think we could all understand if we were in a national shortage,” she said, “But, in my opinion, there’s not a shortage and this isn’t about shortages. This is political games being played by our Federal government.”
Statement From the U.S. Department of Health & Human Services (HHS)
On September 9, 2021, Pike County Times sent the following email to HHS at media@hhs.gov. It was read that day, but there has been no reply.
To whom it may concern,
I have been investigating monoclonals and have written about this lifesaving treatment that is much needed to keep people out our local hospitals in the rural area of middle Georgia. Our hospitals are full of patients to the point that one hospital about an hour from here shut down for 4 hours because there were 171 people in their ER for various reasons including Covid. This was a couple of weeks ago, but the situation here is dire.
I am reading where HHS has now taken over the shipping of monoclonals and has reduced the number of infusions that the State of Georgia will be receiving. This information came from the state level and is extremely concerning to me since we now have 180 treatment sites throughout the state that mean nothing if there is no medication to administer. [Note from the Editor: 180 was the number given to Pike County Times in a previous article. DPH says 136 today. The error is mine.]
Furthermore, I would like to inquire about the new system of distribution and ask specifically if supplies to both vaxed and unvaxed states are being administered at the same amount or if there is any penalty for states that have lower vax numbers. That's a hard question, but hopefully the answer is that there is no difference. However, if there is a policy in place on this, I would like a quote about it and an explanation of why.
Finally, I welcome a quote on the new system and what HHS is hoping to accomplish by taking over a working system in order to use its own. Surely there was a method to this that the public would like to know.
Thanks for your time.
Becky Watts, Editor, Pike County Times
However, Pike County Times sent the following email to HHS through a different email on Tuesday and received a reply within a short time even after hours.
To whom it may concern,
I was writing an article on the changing system for distribution of monoclonal antibodies and have learned that it has changed once again.
At this point, almost every health care provider in this area--who has had absolutely no problem ordering monoclonals up until the federal takeover--is out or will be out of monoclonals in the next 48 hours.
I have questions, and the families of the people who are dying (both vaxed and unvaxed) because of this new system deserve to have answers from the top level because that is where these decisions are being made.
Apparently there has been a surge in requests for this lifesaving infusion (again for both vaxed and unvaxed) from around the country, but it has been noted that there is a surge from areas in the country with low vaccination rates.
With this in mind, I ask the following for an article that will likely go online tonight or early tomorrow morning as I continue to gather information. If someone would like to send a written statement or speak to me by phone, please let me know and I'll be happy to wait until tomorrow morning.
1) Please advise how the new system works overall.
2) Please advise how the distribution system works with how a low vax state receives its shares of monoclonals as compared to a high vax state. Specifically, is there a separate system for distribution based on vaccination rates? I would hope not, but I have to ask.
3) Why was the system changed?
4) And why was this system changed so quickly without what appears to be a backup plan to ensure that these infusion sites did not run out of medication to keep people (again... both vaxed and unvaxed) out of our hospitals?
I would be more than happy to include any further information that you would like to send. Thank you in advance for your cooperation on this matter.
Becky Watts, Editor, Pike County Times
An HHS Spokesperson answered the following questions by email on Tuesday night as follows:
“At HHS, we are focused on ensuring consistent availability of COVID-19 monoclonal antibody (mAb) therapeutic products for administration sites across the country. We are constantly assessing the environment and our distribution process to determine if and when changes need to be made, and we have adjusted the distribution process several times this year already to optimize our stewardship of these products. The recent increase in the prevalence of the Delta variant coupled with low vaccination rates in certain areas of the country resulted in a substantial (20-fold) increase in the ordering and utilization of mAbs since mid-July. Just seven states accounted for about 70% of our monoclonal antibody ordering. Given this reality, we must work to ensure our supply of these life-saving therapies remains available for all states and territories, not just some. As such, we have updated the distribution process again this week to allow for a more consistent supply of mAbs that is responsive to cases and utilization in all geographic areas of the country. As the President noted last week, we are increasing our distribution of mAbs this month by 50%. In early August, we were distributing an average of 100,000 doses per week. Now, we are shipping an average of 150,000 doses per week. The updated mAb distribution process is a state/territory-coordinated distribution system that allows state and territorial health departments the flexibility of determining where product goes in their jurisdictions. HHS will determine the amount of product each state and territory receives on a weekly basis. State and territorial health departments will subsequently identify sites that will receive product and how much. This system will help maintain equitable distribution, both geographically and temporally, across the country - providing states and territories with consistent, fairly-distributed supply over the coming weeks. HHS has had weekly calls with state health departments, healthcare provider associations, and other stakeholders since the monoclonal antibody therapeutics distribution began last November.”
Pike County Times followed up with two more questions:
Were there complaints that prompted this change? Their reply: This is an effort to ensure that there is continued availability of mAb treatments for those most at risk of severe disease in all jurisdictions.
What happens if a state doesn't use their allotted medication? Their Reply: Weekly distribution amounts will be determined based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and utilization in the data HHSProtect database. States will make the determination as to where the product is distributed in their state.
The follow up answers are pretty much the same as what is in the reply above, but the questions needed to be asked even if no specific answer was given.
Is There a Shortage of Regeneron?
Pike County Times called Regeneron last night and asked whether there are issues with the distribution of Regen and whether there is a shortage of this medication.
The Associate Director of Product & Pipeline Communications advised that my inquiry regarding REGEN-COV was passed along to her as follows: "Are there any issues with distribution of REGEN-COV? Is there a drug shortage? We are being told there is a shortage."
She replied as follows in a response that was received by Pike County Times today:
“Regeneron just announced last night (https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-new-us-government-agreement-purchase) a new agreement for 1.4 million doses of REGEN-COV that is being delivered to the U.S. Government as quickly as possible, starting this month, with the more coming in Q4.” [Note from the Editor: That is Quarter 4.]
“Because the U.S. government currently owns and manages all supply and distribution of REGEN-COV, we understand they are carefully watching the rapidly increasing rate of infections and increased use of monoclonal antibody therapies around the country and have implemented steps in the ordering process to promote optimal and equitable use of available supply. More on those process changes can be found here (https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx) and HHS can answer specific questions regarding those measures.”
The first article entitled “Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail” is dated September 14, 2021, advised that Regeneron “will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022, at a cost of $2,100 per dose. This new agreement follows two earlier agreements with the U.S. government announced in July 2020 and January 2021.” Click on the Investor.regeneron.com link above to read this in its entirety.
The second article entitled, “Regeneron and Roche Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Cocktail for COVID-19” is dated August 19, 2021, and linked from the first article. It advised that “overall capacity of REGN-COV2 is expected to increase by at least three and a half times, substantially increasing the number of doses available to patients in the U.S. and around the world” though it does have a notice at the bottom of the page regarding risks and uncertainties.
Pike County Times followed up inquiring specifically whether there was a shortage of Regen at the company itself that might have lead to rationing of this important weapon in the fight against COVID-19.
Update from Regeneron on September 16, 2021
Pike County Times received an emailed answer to its question on September 16, 2021. The question is verbatim from my email, and their answer is verbatim as well.
Pike County Times asked: "My only follow up question is specifically whether there is a shortage of Regen at the company itself. I understand that the federal government put in a new order, but they are making it seem like your company wasn't prepared for this current Delta wave of sickness, and I'm a little skeptical because this did not happen overnight and should have been expected.
You may not be able to give me a simple yes or no answer to that question, but I have to ask it."
The same representative replied with the following information:
Supply: Although demand was lower in the earlier part of this year, we did have REGEN-COV drug product at various stages in the manufacturing process, which is enabling us to deliver additional doses against this new agreement within the month. And as we’ve all seen the Delta variant lead to a dramatic increase cases, and thus demand for mAbs, we and our collaborator Roche are actively making new product. And in case it isn’t well understood, I think it’s important to note that it takes time and very specialized expertise to produce monoclonal antibody medicines. We have shifted much of our internal manufacturing activities to maximize our REGEN-COV production ability alongside balancing the need to manufacture our other FDA-approved therapies for patients who rely on them.Distribution: Under the REGEN-COV Emergency Use Authorization, the U.S. government is responsible for distribution. Because they own and manage all supply and distribution of REGEN-COV, these systems are under their purvey. We understand the U.S. government was carefully watching the rapidly increasing rate of infections and increased use of mAbs around the country, and are thus the decision-maker to determine if additional measures, including ordering more REGEN-COV, were needed.
That final sentence from Regeneron somewhat answers the question that Pike County Times was asking about whether there is a shortage. Pike County Times has asked for further clarification, but that may not happen. [Note from the Editor: In my opinion, at this point, getting an answer is not worth risking people's lives with a contract for an infusion (that clearly saves lives around the country and around here) that might be in jeopardy depending on what is said.]
End of Update from Regeneron on September 16, 2021
Statement from The Georgia Department of Public Health
The Georgia Department of Public Health (DPH) issued a statement that was received by Pike County Times a little before 5 p.m. today. The statement describes the new distribution process for monoclonal antibody treatments that went into effect on Monday when the federal government took over the distribution of monoclonals.
The statement was issued to Pike County Times through District 4 Public Health which includes Pike, Lamar, Spalding, Upson, Meriwether, Butts, Carroll, Coweta, Fayette, Heard, Henry, and Troup Counties. It is included verbatim. ATLANTA – The federal government has changed the way COVID-19 monoclonal antibody treatments will be distributed in the United States, including Georgia. The decision announced Monday by the U.S. Department of Health and Human Services (HHS) is the result of supply shortages and extraordinary demand for the treatments across the country, particularly due to the rapid spread of the delta variant. Health care providers will no longer be able to order the treatments directly.
HHS will determine each state’s weekly allocation of monoclonal antibody products based on use and the number of new COVID cases. The Georgia Department of Public Health (DPH) will identify which sites in the state will receive the product and the amount each site receives. Healthcare providers must record their administration of the products in order to be eligible to receive additional shipments.
DPH will work to provide monoclonal antibody treatments quickly and equitably to as many Georgia providers as possible. The Department will also address the backlog of requests previously made to HHS, which DPH was not made aware of until yesterday.
Monoclonal antibodies are synthetic, laboratory-created antibodies. They help people at high risk for severe COVID illness, individuals who have recently tested positive (within 10 days) for the virus, or people who are close contacts of persons who have tested positive for COVID. They do not teach a patient’s body how to create its own antibodies.
Monoclonal antibody treatments are not a replacement for COVID-19 vaccination.
“We have safe and highly effective vaccines to protect against COVID-19. It is much easier to get a vaccine than risk becoming seriously ill with life threatening complications,” said Kathleen E. Toomey, M.D., M.P.H., commissioner of the Georgia Department of Public Health. “Monoclonal antibodies are in short supply and high demand and hospital beds are full. What Georgia does have is enough vaccine for all Georgians aged 12 and over to be vaccinated.”
As of today, 53% of Georgians have received at least one dose of COVID vaccine and 46% of Georgians are fully vaccinated. COVID vaccine is available statewide and is our best tool for ending this pandemic and reducing the overwhelming strain on EMS, the healthcare system and healthcare providers. To find a COVID vaccination location, log on to https://dph.georgia.gov/covid-vaccine.
There are currently 136 locations in Georgia where monoclonal antibody treatments are being administered. https://protect-public.hhs.gov/pages/therapeutics-distribution. Patients should talk to their healthcare provider about monoclonal antibody treatments and must have a prescription or physician’s referral to receive the treatments.
For updates on COVID-19, follow @GaDPH and @GovKemp on Twitter and @GaDPH and @GovKemp on Facebook.
Closing
Pike County Times tried to find a definite answer on whether there is a shortage on these lifesaving Regeneron infusion but has been unsuccessful so far. Answers were carefully worded to point back at the federal government and efforts that it is making to ensure that there are enough infusions for all states though an answer of whether all infusions are being used or stockpiled despite current needs was not answered despite direct questions from Pike County Times.
The takeover did happen suddenly and the State seems to be working through a way to distribute monoclonals “as quickly and equitably to as many Georgia providers as possible” while addressing the backlog of monoclonal requests that had been made to HHS that DPH just became aware of yesterday.
The cause of the takeover of monoclonals by the federal government is said to be a shortage of medication based on greater needs by unvaccinated states, but that has yet to be confirmed at this time either. What has been confirmed is that there has been a reduction in infusions for the state of Georgia as well as a backlog of requests that has left providers in our area and possibly around the state without the necessary number of infusions to fulfill patient needs.
At this time, the Georgia Department of Health is putting together a process to ensure that the 136 clinics across the state can have access to monoclonal infusion medication in order to help their patients based on the number of infusions that are allotted to the state through the U.S. Department of Health & Human Services.
Click here (https://protect-public.hhs.gov/pages/therapeutics-distribution) to find an infusion clinic near you and make an appointment.
And please remember that there are a number of treatments that can help patients get over COVID-19 even if the infusion is not available.
Thank you to First Bank of Pike for sponsoring Pike County Times’ Breaking News Alerts! First Bank of Pike has been serving customers in Pike County and the surrounding area since 1901 and offers Personal and Business banking with a personal touch. Services include checking, savings, money market, certificates of deposit, and IRA’s. Mobile Banking and Bill Payment services are also available! Click here for more. Please let First Bank of Pike know that you appreciate their sponsorship of Breaking News Alerts on Pike County's only FREE online newspaper!
If you want to find out about how you can get Breaking News Alerts, click here. Thanks for reading and supporting Pike County Times.com!