Paxlovid for COVID is About to Get Very Expensive

Paxlovid is an antiviral medication in pill form developed by Pfizer pharmaceutical company to treat Sars2Coronavirus or COVID-19. It is designed to prevent severe disease from developing in high-risk patients. There is an alternative, but far less effective, product called molnupiravir (“Lagevrio”) by Merck. Both were developed with a funding package passed by Congress at the start of the COVID pandemic which produced the Pfizer and Moderna vaccines plus a host of monoclonal antibodies to be administered to high-risk patients as well. Those monoclonals can no longer be used because the COVID virus has found a new way to elude or resist them. There are no new monoclonal antibodies in production because the cost of development of each one is about $200 million dollars, and the Federal government has decided not to guarantee purchasing them.

The US government purchased 20 million dosages of Paxlovid from Pfizer for the bulk discount rate of $530 per treatment. Americans who became ill received it for no upfront cost. The funding for that program has run out. The Biden administration submitted a bill to the Senate in early November requesting funding for this project to continue and the Senate replied by voting to end the COVID-19 “Emergency” state. The drug Paxlovid is still being administered to adults infected with COVID and considered high-risk under an Emergency Utilization Authorization designation. Pfizer applied for full approval status to the FDA in June of 2022. So far, the FDA has not taken any action on this request. That process can take months to years.

It is expected that in January 2023 , when Federal funding runs out, pharmacies will be charging patients $2,300 for the five-day course of Paxlovid. It will not be covered by insurance. It will not be covered by Medicare Part D which by law can only cover products which have the full approval of the FDA.

The CEO of Pfizer pharmaceuticals has sent a note out to his shareholders and board anticipating huge profits in 2023 because Paxlovid will be sold at retail price. Public health officials are anticipating that the poor and seniors on fixed income will just not take the medication at that price.

As of last week, with the medication available, there were still almost 400 people in the U.S. dying daily from of COVID. Ninety percent of those deaths occurred in seniors 65 years or older who are already vaccinated.

I URGE YOU TO CONTACT YOUR CONGRESSIONAL REPRESENTATIVES and PROTEST THEIR LACK OF ACTION ON CONTINUING TO FUND THE DEVELOPMENT AND FUNDING FOR MEDICATIONS TO TREAT COVID.

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The End of Monoclonal Antibody Treatment of COVID-19

National Public Radio (NPR) reviewed the end of the outpatient use of monoclonal antibodies to combat SARS 2 Coronavirus (COVID last week. These synthetically produced antibodies were infused into patients infected with COVID and were at high risk to develop severe disease requiring hospitalization or death. It cost about 200 million dollars to invent, develop and then use the drug in trials to gain FDA approval for human usage. Drug manufacturers were willing to take the risk developing these products because the US government financially guaranteed their purchase.

The antibodies were synthetic Y shaped molecules which bound to the viruses spike protein rendering it incapable of invading human cells and alerting our own immune system that the virus was present facilitating the virus’s destruction. Over time, the virus learned to mutate and evade a particular monoclonal antibody rendering it ineffective. When 30% or more of the new COVID variants in a region became able to resist the monoclonal antibody, the CDC and FDA withdrew the product. Drug manufacturers continued to develop new monoclonals due to the Federal guarantee of purchase.

Bebtelivimab was the last product that worked well against COVID and on Monday, November 21, 2022 it was withdrawn as well. The Federal government stopped guaranteeing purchase of these products so drug manufacturers have now discontinued their expensive development.

Let me explain how this impacts my patients locally. Baptist Health BOCA Raton Regional Hospital had a robust outpatient monoclonal antibody program. I phoned or text messaged Lisa, the nurse practitioner program director the patient name , demographics and reason for participation and she scheduled and her team administered the drug within the seven day window required. No one became ill from the infusions. No one had to stop their usual medications due to drug drug interactions. No one progressed to severe disease requiring hospitalization and no one died. I referred at least 100 high risk patients including myself in the last 2.5 years and now that weapon is gone. No one treated cleared the virus and then had a rebound recurrent period of sickness.

So we are now left with Paxlovid and Lagevrio oral pills. One has multiple drug interactions with so many of the common medications the high risk population takes daily for cardiac, renal , diabetic and mental health it requires cessation or a reduction in dosage. The other is just not that effective. Patients taking these drugs also at times clear the virus then several days later have a mild rebound of symptoms and are contagious for a few days more.

We head into winter with an aggressive flu bug, respiratory syncytial virus in epidemic proportions and one less successful weapon against COVID-19. As I reflect on this past Thanksgiving holiday, I am grateful for the BRRH monoclonal antibody team and everyone connected with its development. I wonder what our elected Congressional officials were thinking when they stopped funding the development of these effective and safe, but expensive, products?

COVID-19 Burnout

I was supposed to be visiting the NY Metropolitan area this week to celebrate a family high school graduation. Children and family were traveling from all over the country for this celebration when the parents of the graduate contracted COVID-19. The graduate stayed healthy and attended the ceremony and all post ceremony celebrations. Our family gathering was postponed, and my wife and I stayed home cancelling our flights and hotel reservations. The infected group were all vaccinated months ago and young, healthy and placed on Paxlovid . They are recovering. The fact that all will recover is what is important in a scene played out in homes across the globe all dealing with COVID and family gatherings.

At the same time this was occurring the FDA approved a Pfizer three-shot vaccine and Moderna two-shot vaccine protocol for COVID for children six months to five years old. It provided great joy in my south Miami daughter’s household since her four-year-old son has been attending pre-school and summer camp with no real protection other than a mask. My grandson has been the only child in his class and group wearing a mask indoors and the school psychologist asked my daughter if he could remove it because it was a barrier to playing with the other children.

The vaccine for young kids is not a foolproof shield but at least provided protection against serious illness. The FDA approval was a great comfort to parents hoping to have their kids vaccinated prior to the start of the next school semester in August. Then, the Governor and Florida Surgeon General announced Florida was not ordering the vaccine because they believed healthy kids did not need it despite all the infectious disease, public health and virology experts reviewing the data and approving the vaccine. Morale fell to a new low.

The very next day the Governor announced that doctors and pharmacies could order the vaccine through the Florida Shots website and had that option all along. That is not the way we ordered the vaccine earlier in the pandemic. We ordered it though the Florida Department of Health.

Supporters of the Governor blamed this ordering confusion on “big government bureaucracy”. If that is the case, then why not just announce from the beginning that pharmacies, doctors and health systems can order the vaccine through the Florida Shots website?

In the political gamesmanship of placing barriers in the way of our youngest and most vulnerable children being vaccinated, did the Governor forget that most physician offices do not have freezers capable of storing the vaccine at -90 degrees Centigrade? Also ignored was the plight of those who have relied on their county or city health department to provide the vaccines for their children for years and now those public health facilities will not have the vaccines.

My office was bombarded this week with calls from patient’s testing positive for COVID-19, all with mild symptoms of fatigue and upper respiratory viral symptoms. The current treatment options are to supply supportive care such as fluids, cough medicine, Tylenol and rest or prescribe the Pfizer pill Paxlovid. The Paxlovid must be started within five days of onset of symptoms.

So many patients walk around with cold symptoms for several days before home testing that it’s difficult to start the medicine within the five day window advised by the manufacturer. Paxlovid interacts with so many popular and common prescription medications for seniors which must be discontinued and washed out of your system prior to starting Paxlovid that they can’t start the medication on time.

The best option, in my opinion, remains receiving an infusion of the monoclonal antibody Bebtolivimab within seven days of onset of symptoms. Boca Raton Regional Hospital has a program that gets you in within a few days but several patients have been so anxious and worried that they would not wait for an appointment. Several called private services to come to their homes and treat them with monoclonal antibodies. These companies have popped up out of nowhere and their reputation and reliability are relatively unknown. Are they really administering Bebtolivimab? At least at the hospital I know the product is the real thing and the monitoring staff is well trained and experienced.

Also, several patients have insisted on Paxlovid and stopped their blood pressure, cholesterol and antidepressant medicines. Two of them took the Paxlovid and improved, then rebounded with a positive test and return of all symptoms several days later. They all recovered in a few days, but the potential rebound is another reason I prefer offering the monoclonal antibody infusion.

I have not mentioned the Merck oral medication Lagevrio ( molnupravir) because it used new technology involving disrupting the genetics of the virus. I would like to see the adverse effects of this drug and its efficacy and safety profile after being on the market for twelve or more months prior to considering it.

COVID remains a “bummer”. We are in a much better place to prevent serious illness than we were three years ago but human behavior, the demonizing of science for political gain and the resilience of this virus continue to wreak havoc on my life and those around me.

Ashwagandha Improves Quality and Duration of Sleep

The American Academy of Sleep Medicine and the Sleep Research Society held their 2022 annual meeting earlier this month and researchers presented data on the use of the shrub Ashwagandha on sleep quality and duration.

The researchers found eight studies on the topic including one which showed that after 10 weeks of therapy it took less time to fall asleep than with a placebo. Another study demonstrated “significant improvement in both quality and duration of sleep with patients experiencing an improved mood upon awakening”.

The Ashwagandha plant is native to India but is now grown worldwide and used for “stress resilience”. It is revered in Ayurvedic medicine and felt to reduce stress. The product is used to treat arthritis and treat anemia since it is high in iron. Ashwagandha is also known as Indian Ginseng, winter cherry or poison gooseberry.

Like most alternative and complimentary products, there is limited data on the product in the English research literature. Ashwagandha can cause gastrointestinal upset, nausea, vomiting and diarrhea at higher doses. It should not be ingested by children or pregnant or nursing women. There is data that it interferes with normal thyroid blood tests and should not be taken with sedatives, blood thinners or thyroid medications.

One of the major criticisms of herbal medicines in general is that they are not inspected or regulated by the FDA for purity and safety. The label often does not reflect the contents of the bottle and there are often undesirable contaminants. For this reason, I only recommend products inspected by the independent USP lab.

Ashwagandha, inspected by the USP lab is available in the USA. With insomnia being such a large problem, this product is worth thinking about.

Constipation Treatment with a Vibrating Pill

Constipation is a major quality of life problem. When confronted with it, physicians advise more hydration, more exercise and activity and more fiber in your diet. If that doesn’t work, we try medications.  We start with medications to increase the bulk and fiber in your gut and to soften the stools. Next, we move to different strength laxatives. The problem with laxatives is that often the timing and consistency of the next bowel movement are unpredictable. Getting phone calls about new onset of diarrhea in patients taking a laxative for constipation is common. Chronic use of laxatives can adversely impact the muscles of the colon rendering them less, or completely, ineffective.

Satish Rao, MD, PhD, professor of Medicine at the Medical College of Georgia, presented a paper at the Digestive Disease Week meeting and reported by Medscape about a vibrating pill that reduced constipation. The pill is swallowed at 9:00 p.m. and then is activated remotely to vibrate for three seconds and then rest for 16 seconds. This process continues for two hours twice a day. There were virtually no side effects although some participants said they felt the vibrations. Spontaneous bowel movements per week increased in the treated group. Less straining was required to have a bowel movement and stool consistency was considered improved. Quality of life was felt to be improved. The timing of the vibration cycles enabled participants to have bowel movements at the time of the day they were accustomed  to having bowel movements.

The vibrating pill is now being reviewed by the FDA for approval sometime in 2022.

FDA Approves New Diagnostic Test for Early Alzheimer’s Disease

The Lumipulse G Beta Amyloid Ratio test, made by Fujirebio Diagnostics, detects amyloid plaques found in Alzheimer’s disease in adults 55 and older under investigation for cognitive disorders. Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health said, ”The availability of an invitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis. With the Lumipuls test, there is a new option that can typically be completed the same day and can give doctors the same information regarding amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.”

Currently the PET scan is used to visualize amyloid plaques to diagnose Alzheimer’s disease. The FDA says this test may eliminate the need for a PET scan, “…. a potentially costly and cumbersome option.”

As a physician, I appreciate the innovation and technical expertise required to develop a test that compares the ratio of Beta amyloid 1-42 and Beta amyloid 1-40. To do this, you first must perform a lumbar puncture or spinal tap to access cerebrospinal fluid which is the specimen used in the test.  This requires injecting an anesthetic into one’s back and spine and then inserting a needle to enter the spinal canal and drain the fluid. The needle is then removed, and the patient is required to stay immobile on their back for several hours to prevent a post spinal tap headache. Putting a needle into someone’s spine raises the risk of bleeding, post procedure leak and infection being introduced. Then, add in the cost of the procedure room and the post procedure observation costs and, suddenly, the non-invasive expensive PET scan seems reasonable.

I look forward to the day when a simple blood test based on drawing blood from your arm will be able to provide the information required to support a diagnosis of Alzheimer’s disease. I applaud the scientists and researchers who developed this product but the enthusiasm of the FDA in their statement is probably not shared by anyone who has had to undergo a spinal tap.

New Blood Test Aids in Lung Cancer Screening

The US Preventive Screening Task Force updated its recommendations in 2021 for screening patients with  increased risk for lung cancer. Current guidelines call for providing a low radiation dose CT scan of the lungs annually for patients 50- 80 years old who have a smoking history of twenty pack years (calculated number of packages smoked per day x number of years smoking) and are still smoking or have quit within the last 15 years. These expanded criteria reduced the age to 50 from 55 and pack years from 30 to 20 years.  The recommendation is based on research showing that these criteria reduce deaths due to lung cancer by 20% as seen in the National Lung Screening Trial.

Despite this recommendation, many smokers who meet these criteria never get tested. Access to CT scans is one problem along with financial costs. For this reason, a group of researchers at MD Anderson Medical Center, led by Sam Hanash, MD, PhD, professor of clinical cancer prevention, developed a 4-panel blood test to screen for lung cancer. Their four test blood panel results were published in the Journal of Clinical Oncology on January 7, 2022.

The researchers then combined the results of the blood test with low dose CT scans of the chest and found that the accuracy of this method was far more sensitive than performing lung CT scans alone in the groups recommended for the procedure by the USPTF guidelines. Using the blood test and the low dose CT scan of the lungs, they found 9.2% more lung cancer cases for screening and reduced referrals for further evaluation by almost 14%

The blood test is still in the research phase and not available commercially for screening just yet. It will have to go through the full Food and Drug Administration (FDA) approval and evaluation process first.

The panel included tests for surfactant protein B, cancer antigen 125, CEA and cytokeratin-19 fragment. Currently the Ca125 test and CEA are available through commercial labs but there were no comments or recommendations from the authors or reviewers about whether clinicians should be using those two tests now with low dose lung CT scanning for screening.

Omicron is the Grinch That Stole Christmas

The Center for Disease Control (CDC) is reporting that up to 90% of the infections with COVID-19 Sars 2 Coronavirus are the new Omicron strain. It replicates itself 70 times faster than the Delta strain and contact with an infected person within 12 feet for one or more seconds can result in infection. For those who have been vaccinated against COVID-19 with the Moderna or Pfizer Vaccine, and received a third shot or booster, the expectation is that if they become infected with Omicron, they will either have no symptoms or a mild case. By definition “mild COVID” means your respiratory system is not compromised enough to require hospitalization. Despite this, most of the current deaths in countries which are having a COVID surge are in people older than 65 years of age.

In the past, when patients in this area became infected with COVID-19, we arranged for them to go to the local hospitals to receive an infusion of a monoclonal antibody solution made either by Regeneron or by Eli Lilly. The infusion prevented the infection from becoming severe enough to progress to a severe state requiring inpatient hospital respiratory care. These monoclonal antibodies do not work against Omicron. For this reason, the FDA and CDC have removed the Emergency Use Authorization and ended the administration of these drugs nationwide.

There is a third monoclonal antibody made by Glaxo and Var called Sotrovimab which effectively throttles Omicron, but it is in limited supply. As of today, the State of Florida has received 1050 dosages. Production has been accelerated and hopefully the drug will be available in mid to late January for infusion. There are two new antiviral pills which should work as well. The Pfizer product received FDA approval today and, with production acceleration, some should be available by mid-January. Until these drugs are locally available the medical community has no medications to offer patients who contract the COVID-19 Delta or Omicron variant to limit the severity of the disease.

My advice to my patients and loved ones is to reintroduce distancing and masking. Wear a good N95 mask when you will be around others – especially indoors. If you must be indoors with others, make sure the windows and doors are open and the ventilation is excellent. If there is an air filtration system with HEPA Merv 13 level filters and ultraviolet light that adds protection. Distancing with the aggressive Omicron variant will require 12 feet not six feet.

This is a heartbreaking restrictive change in scheduling and behavior we are asking for at a time of the year when families and friends travel to gather to celebrate. Younger and leaner healthier individuals who are vaccinated will survive this. The real questions are who they will transmit this infection to unknowingly, who is too young to be vaccinated or too old to have a robust immune system?

Our office staff will be reassessing the risk to patients and staff daily. With the local testing positivity rate >10% in Palm Beach County, our contacts will be by phone and telehealth. When the Pfizer anti-viral pill Paxlovid is available, and or Sotrovimab for infusion, we will return to regular in-office patient visits.

I apologize for the inconvenience. Stay safe and call if you have questions.

Quadrapill for Blood Pressure Control

At the beginning of each patient visit I make it a habit to meticulously review with each patient their list of medications, supplements, vitamins, herbs etc. I compare their list with the lists on notes sent to me from consulting specialty physicians and then I access the pharmacy prescribing data base whenever it is available.

I am always amazed by how many chemicals we put into our body for the sake of maintaining health. How patients maintain accurate medication lists and administer daily medications is something I am in awe of. In the best interest of their care, I am always looking for a way to reduce the number of medications taken and to simplify the process if possible.

Clearly researchers in Australia feel the same way. They realize that to control blood pressure, most seniors are taking low doses of 2-3 medications. In previous years we physicians prescribed one medication and pushed its dosage to the limit before adding a second medication to gain control of blood pressure. We soon realized that at the higher dosages, patients experienced adverse effects and just stopped taking their blood pressure lowering medications.

In an intriguing study, Australian researchers created a poly pill consisting of one quarter of the starting dosage of four medications. Irbesartan 37.5 mg, (angiotensin receptor blocker), amlodipine 1.25 mg (a calcium channel blocker), indapamide 0.625 mg (a thiazide diuretic) and bisoprolol 2.5 mg (a beta blocker) were put into one pill. Five hundred ninety-one patients at ten medical centers participated in the study. Their average age was 59 years with a fair mix of men and women. They were randomly selected and blinded from knowing whether they were receiving the Quadrapill or increasing dosages of one pill. If BP stayed up amlodipine was added.

At the end of three months the poly pill group had lowered their BP by 6.9mm Hg more than the single pill group. At a year the figure stools at 7.7. millimeters mercury. There were no significant adverse effects in the poly pill group. The study clearly showed that taking a pill with multiple types of blood pressure medication, at low dosage, controlled blood pressure and was convenient and tolerable. That pill is now in development and should be presented to the FDA and European Union for review in the near future. It’s release to the public will certainly make taking medication simpler and more convenient.

New Device Helps Stroke Victims with Hand Function Difficulties

Stroke victims often lose function of a hand. The road back to recovery involves months of physical therapy and work.

Last month the FDA approved the Neurolutions IpsiHand Upper Extremity Rehabilitation System for survivors of stroke trying to regain hand, wrist or arm function.  The system uses EEG electrodes to record your brain activity and then uses these messages to move an electronic hand brace according to the intended muscle movement. It essentially delivers your brain’s intended electrical message to the brace to retrain your limb to work.

This is a sophisticated device which will need to be fitted by stroke rehab professionals and then tailored for individual patient needs so it can be successfully used.