Monoclonal Antibodies Prevent Severe COVID-19 Disease, Hospitalization and Death

Fast take:

  • Monoclonal antibody therapy is an important but underused treatment for preventing severe disease and death from COVID-19.
  • Monoclonal antibody therapy is the best available therapy for people over 12 years of age who test positive for COVID-19 and who have risk factors for severe disease.
  • It reduces hospitalizations and death by 75% to 85%.
  • It is provided free of charge to any US resident.

Real fast take: Monoclonal antibody therapy is safe; it’s effective and it saves lives: use it!

Monoclonal Antibody Therapy:

Monoclonal antibody therapy is the most effective treatment to date to prevent patients with mild or moderate cases of COVID-19 from developing severe disease, hospitalization, ICU admission, intubation and death. Monoclonal antibody therapy reduces the number of viruses in the patient and lessens symptom severity. It has been demonstrated to reduce COVID-19 hospitalizations and death by 75% to 85%.

When administered within 10 days of onset of COVID-19 symptoms, this one-time treatment is highly effective in killing the virus, preventing symptoms from worsening, and avoiding hospitalization. When administered early, many patients report a rapid and complete resolution of symptoms.

Please remember, monoclonal antibody therapy is not a substitution for vaccination. Vaccination is still the best first line of defense against COVID-19.

What is monoclonal antibody therapy?

This medication consists of antibodies to the virus, quite similar to the antibodies that your own body makes when you are vaccinated or infected with the virus. However, the therapy gives patients an immediate boost in the number of these antibodies. These antibodies are synthesized in a lab. They do not come from other patients.

The monoclonal antibodies kill the virus early before the virus can multiply and make a patient very sick. These antibodies attack the so-called spike protein on the virus, blocking the virus from attaching to a patient’s cells. This slows the growth of the virus within the patient, while the patient’s own body revs up its own natural immunity systems.

The US Food and Drug Administration (FDA) issued emergency use authorization for monoclonal treatments for COVID-19 patients or exposed people, aged 12 and older, who are at moderate or high risk for developing severe COVID-19 disease. This includes many or most adult COVID-19 patients in the US.

Monoclonal antibody therapy involves administering a small amount of medication intravenously (into your vein) over 20 to 30 minutes, or it can be administered subcutaneously (as injections under your skin). The single treatment is followed by an hour of patient monitoring.

This therapy can be administered in an outpatient medical clinic, an emergency room, a long-term care setting such as a nursing home or even in a patient’s home.

For those who would like a more in-depth discussion of the benefits of monoclonal antibody therapy, here is the link to a one hour webinar, with 5 Massachusetts experts, which I moderated for the Massachusetts Health & Hospital Association’s physician leaders on November 22, 2021.

Which patients are eligible to receive monoclonal antibody therapy?

This medication is available for use in patients who are not yet sick enough to be hospitalized and who are at an increased risk for progression to severe disease, hospitalization, and death and who are at least 12 years old.

This therapy can also be given to high-risk patients (for example, nursing home residents) who have simply been exposed to COVID-19, prior to testing positive for COVID-19. We call this prophylactic therapy.

Who is considered at increased risk for severe COVID-19 disease, and therefore an ideal candidate for early treatment with this life-saving disease as an outpatient?

  • Anyone who is
    • Overweight or Body Mass Index (BMI) of greater than 25: use this link to calculate your BMI or
    • Over 65 years old, or
    • Pregnant, or
    • Immunocompromised, or
    • Dependent on a medical technology such as a feeding tube
  • OR any patients who suffer from:
    • Chronic kidney disease, or
    • Diabetes, or
    • Heart disease, or
    • High blood pressure, or
    • Chronic lung disease including COPD, or
    • Sickle cell disease

Please see the complete, regularly updated list of criteria from the Commonwealth of Massachusetts at this link.

If you have tested positive for COVID-19 within the past 10 days, please contact your healthcare professional to discuss monoclonal antibody therapy. The sooner, the better.

Anywhere within the United States, US patients can click here to find a treatment center near you.

Are there side effects to monoclonal antibody treatment?

Allergic reactions can happen with the administration of this medication, like any medication. Patients are therefore evaluated for the development of any signs of allergic reaction for one hour after this one-time treatment.

Most experts believe that these antibodies may limit your own body’s ability to develop an immune response during a subsequent COVID-19 vaccination for a brief period of time. Hence currently, it is recommended that patients delay COVID-19 vaccination for 90 days after receiving monoclonal antibody treatment. Other rare side effects can occur. Feel free to discuss this with your healthcare provider.

Joint MMS – MA DPH announcement:

Just this week, the Commonwealth of Massachusetts’ Department of Public Health and the Massachusetts Medical Society issued this joint statement, strongly urging health care practitioners and providers to consider using monoclonal antibody therapy for their patients who are infected with COVID-19 or have been exposed to COVID-19 when clinically appropriate.

In Summary:

Do yourself a favor; do your family and friends a favor and do me a favor; if you test positive for COVID-19 and qualify for this life saving treatment, seek it out. The life you save may be your own.

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A Dozen Cures For Overpriced Pharmaceuticals

(Part three in a three part series)

 

1. Don’t fall victim to pharmaceutical value-based price anchoring: After Touring pharmaceuticals increased the price for Daraprim from $13.50 to $750 per pill, Stephen Lederer, a spokesman for Turing demurred, the pricing for Daraprim reflected its clinical value.

Imagine if surgeons priced their surgery this way: A surgeon is called to the bed of a 13 year old boy with a burst appendix and says, “Son, you have to ask yourself what is the ‘actual value’ of being alive for another 70 years? 6 million dollars you say?  Well, then you should be happy to pay 5 million dollars for me to remove your appendix.”  If the patient objected, the surgeon might add, “OK, I’ll enter into a value based contract with your insurer, and only collect the money if the surgery works.”

Don’t let the drug companies fool us into anchoring the price negotiation at the value of life, rather than the production cost of the drug.

2. Radical transparency: Sunshine is the ultimate antiseptic. Drug makers should publicly divulge the true cost of research and development for each drug, as well as what they charge for it. This is particularly true as healthcare is increasingly viewed by society as a right, not an option.

Vermont recently passed a law to this effect. Vermont requires drug makers to provide cost data on the 15 most costly drugs the state purchases.

One cannot identify, let alone fix, market breakdown until one views price in conjunction with cost. With fundamental production cost transparency, a miracle cure may still justify a higher price, but only if its development costs support that pricing.

3. Regulate big pharma like a public utility: Currently, their intellectual property rights allow brand name pharmaceutical companies unlimited pricing power for new drugs. This is the definition of a monopoly. Markets are not free if there is only one vendor. In America, if a product is considered essential, (such as electricity) we intervene in the market. Utilities open their books to utility regulators, and based on the cost of production, prices are set.

With pharmaceutical market breakdown, drug prices bear no relationship to the cost of production. A multidisciplinary regulatory commission can price a drug taking into account cost, overhead and reasonable profit, while protecting the public from price gouging.

4. Support the fledgling generic startup, Fair Pharma:  Today, ruthless generic companies can corner the market by purchasing the sole generic manufacturer of a critical life saving drug, and overnight raise its price, 3000%.  According to a recent report, when Valeant Pharmaceuticals purchased the rights to Cuprimine, used to treat a rare genetic disorder, Valeant next increased Cuprimine’s price from from $8.88 to $262 per pill.

Fair Pharma is a new nonprofit generic manufacturer spearheaded by Intermountain Healthcare.  Fair Pharma is essentially a consortium of hospitals and health systems who have decided to band together to produce their own reliable supply of low cost generics. Their mission is not to maximize quarterly profits, but to maximize the free supply of low cost, high quality generic drugs to their patients and their customers’ patients.

5. Support drug reimportation or show me the dead Canadians: Patients in Canada and other countries pay 30% to 50% less than US patients because their governments successfully negotiate with the drug companies for significant discounts.

We could capitalize on these lower prices by allowing US drug stores and patients to re-import these less expensive drugs back into the US. This option is currently illegal. The supposed rationale for banning reimportation is that reimported drugs are somehow counterfeit, of low quality or unsafe. To which we paraphrase former Minnesota Gov. Tim Pawlenty, “show me the dead Canadians.”

Canadians are not dying from low quality pharmaceuticals.  The reimportation ban is in actuality political payback to pharmaceutical firms. It is against the public interest. These medications are safe and purchased from the same manufacturers we buy them from.

Re-importation of drugs from Canada has support from activists on both sides of the political spectrum. Senator Bernie Sanders and President Donald Trump have both called for legalization of drug reimportation recently. 72% of Americans support allowing the reimportation of prescription drugs from Canada. Contrary to some paid alarmists, this can be accomplished safely. Most of these drugs are actually manufactured within the US already.

6. Allow the US government to negotiate drug prices: Canada and European countries successfully negotiate with the drug companies for significant discounts. The US government should likewise negotiate the price of the drugs it purchases. The US government is the largest purchaser of these drugs in North America. Yet US taxpayers pay more than any other consumer in the world for these medications. In any rational market, we would be entitled to a discounted price. This is a grotesque example of the US Congress capitulating to a special interest as opposed to representing the public interest. Congress actually passed a law making it illegal for the government to negotiate the price of the drugs it purchases.

This common sense solution enjoys overwhelming support from the US public; 92%. It also enjoys bipartisan support: Senator Bernie Sanders and President Donald Trump both support this obvious cost savings. Change the law. Enough said.

7. Use generics when appropriate: Hospitals, physician groups and health plans should encourage doctors and other prescribers to use lower cost generics whenever there is a lower cost generic of equivalent effectiveness.

8. Encourage so called “step therapy”: Step Therapy is an approach where inexpensive yet effective medications are tried first, prior to the prescription of more expensive medications.

9. On long term stable medications? Buy them in bulk. Encourage patients who are on chronic, long term, stable medications to buy them in bulk from the most cost effective source, often mail order.

10: Support prescribers with Clinical Decision Support: Encourage Electronic Health Record developers to include effective pharmacy Clinical Decision Support in order to insure prescribers have updated information regarding drug cost and efficacy at the point of order entry (when they are actually prescribing the medication).

11. Payer transparency: Insurers should provide patients and physicians alike with an up to date, fully transparent formulary of covered medications, alternatives, including information on patient co-pays, differing price tiers and generics.

12. Eliminate TV advertising by the drug companies to the consumer:  The American Medical Association supports this solution, as they fear this advertising unnecessarily drives up demand for expensive drugs.

This would remove a large cost from the pharmaceutical industry.  The only other developed country in the world which allows drug company executives to advertise directly to the public is New Zealand. (New Zealand physicians are also lobbying for a ban there too.) Banning ads will result in reduced drug prices, reduced inappropriate demand for drugs by patients and therefore, reduced medical harm from unnecessary side effects.

Perversely, given the complex US tax code, US taxpayers are actually subsidizing the very ads which drug companies utilize to drive up demand and prices for their products. Drug company TV ads are currently considered a legitimate tax deductible business expense.

I ask you to support these cost-effective and life-saving proposals by emailing your elected federal senators and representative to express your support for for this path to the future.

 

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The US Pharmaceutical Market, Merciless and Inefficient: Part Two

Market Breakdown in Need of Repair: part two in a three part series

Previously, in Part One of this series, we discussed what’s good in the US pharmaceutical market.

Today in Part Two: we explore the Bad and the Ugly

  • Generic drug price gouging
  • Market breakdown
  • Deceptive marketing

Later this month, Part Three will develop a path to the future

  • “Show me the dead Canadians”
  • Public private partnerships
  • Market reforms

Why should you care?

Drug prices are higher in America than anywhere else in the world. We pay 34% more than New Zealand and 50% than England. Essentially, patients in the US are subsidizing the cost of pharmaceuticals all over the world.

The systemic weaknesses in our pharmaceutical industrial complex contribute to wasting of billions of dollars each year. This diverts scarce resources away from more pressing needs and is rapidly driving the US healthcare system into insolvency. For example, inexplicably the state of Massachusetts paid $244 for Mylan’s EpiPen in 2012 and subsequently paid $362 for it in 2014.”

A recent Massachusetts Health Policy Commission report indicates that spending on prescription drugs accounted for one third of all Massachusetts healthcare spending growth in 2016. This spending is growing more rapidly than any other healthcare category.

Last year for the first time in history, Massachusetts spent more money on pharmaceuticals than on inpatient hospitalizations. The rate of growth of pharmaceutical spending is too high, and dangerously escalating, squeezing out other priorities at every level of government and in the private sector.

Generic drug price gouging and market breakdown

In an efficient free market, once the patent on a drug has expired, generic manufacturers should be able to compete based on quality, service and cost. This should drive drug prices down. Yet there are examples of oligopolies (only a few manufacturers in the market) or true monopolies (only one manufacturer) in the generic market where US drug price gouging has garnered headlines recently. For example:

CEO who raised price of old pill more than $700 calls journalist a ‘moron’ for asking why

This after Turing Pharmaceuticals unconscionably raised the price of a treatment for a parasitic infection from $13.50 to $700 per pill!

There have been cases where a generic drug is made by one or only a few manufactures, and the firm is bought, with the sole objective of ratcheting up the price of the generic medication.

Another scheme which brand name drug companies use to stifle competition is to pay generic drug manufactures not to produce a lower-cost equivalent generic medication. This effectively delays any competition in the market and has been labeled, “pay-for-delay.” According to a Federal Trade Commission report, it’s estimated that these pay-for-delay schemes cost Americans $3.5 billion per year.

How ridiculous is this? Some have argued that sky high drug prices are a bargain, because these true miracle cures are cheaper than the alternative.  For example, the alternative to the pharmaceutical miracle cure for hepatitis C is for the patient to develop end stage liver disease, hope to get off the liver transplant waiting list and then receive a $100,000.00 liver transplant.  We are told the new drug is, “cost effective,” because it only costs $84,000.00, rather than the $100,000.00 required for a liver transplant.  Really?

Imagine your new car develops a flat tire.  You bring it into the shop and the mechanic tells you a new tire will cost $16,000, and you should consider this “cost effective” because this “miracle cure” to your car’s ailment is cheaper than not repairing the tire and having to purchase a new car for $20,000. You would leave the shop either in fits of laughter, or steaming mad.  Luckily in the real world, you will likely find a new tire for less than $100.

What’s the difference between a new tire and a new pill?  There is an efficient free market for the new tire, and complex market breakdown in the pharmaceutical market.  The patient is not free to walk away from a cure.  The patient is not the one who negotiates the fee and often not the one who pays for the drug. The government gives the drug company years of patent protection, which eliminates competition, and then at the end of that time, the drug companies often use lawsuits or pay-for-delay to prolong their monopoly.

In an efficient market, innovations such as flat screen TVs are expensive at first, but as technology evolves, markets drive prices down.  As an example of how a free market operates, JVC introduced the first VCR in 1977 at a price of $46,000.00 in today’s dollars. The VCR tapes alone cost 72$ (in today’s dollars). But innovation, competition and scale has driven down the price of recording a show to essentially zero today.  Market breakdown, an oligopoly in the generic market, huge barriers to entry and lawsuits, as well as “pay for delay” prevent US patients from reaping the benefits of the free market.

Deceptive marketing:

A key prerequisite for deceptive advertising is severely asymmetric knowledge between the advertiser and the buyer.

Years ago, we banned cigarette advertising to children because kids did not have the sophistication, education and experience to keep from getting hoodwinked into addiction by the tobacco companies. It’s time we do the same for direct drug advertising to the public.

A recent report notes that drug companies spent 19 times as much money on advertising than they did on research.  More than 10% of this advertising ($3 billion) was spent advertising directly to potential patients.  How is it helpful to tell the public to, “ask your doctor if the purple pill is right for you?”

Later this month, in Part Three of this series, we will suggest a path to the future, with specific actionable recommendations to rectify these market imbalances.

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The US Pharmaceutical Market, Merciless and Inefficient: Part One

Market Breakdown in Need of Repair: A three part series

Over the next few weeks, we will be exploring the good, the bad and the ugly of the US pharmaceutical market.

Part one: The Good

  • True miracles

Part two: The Bad and the Ugly

  • Generic drug price gouging
  • Brand name market imbalances
  • Deceptive marketing

Part Three: Path to the future

  • “Show me the dead Canadians”
  • Public private partnerships
  • Market reforms

 

Part one: The Good

As this is the holiday season, we will start with what is good: worldwide, the pharmaceutical industry alleviates suffering, saves lives and on occasion, drives breakthroughs in medicine which can only be described as miracles. No one wants to throw out the baby with the bathwater.

In 2013, a revolutionary new treatment for hepatitis C arrived on the market.  Gilead Sciences Inc.  obtained FDA approval for its new drug Sovaldi. With over a 90% cure rate for this previously incurable and often deadly disease, this was accurately hailed as a medical breakthrough.

In 2016 we learned that Biogen pioneered a miracle cure for a rare disorder of the spinal cord called Spinal Muscular Atrophy.  The disease can affect adults and infants and is particularly deadly in its infantile variety. Infantile Spinal Muscular Atrophy, usually diagnosed in the first weeks of a baby’s life, carries with it a swift death sentence.  Infants diagnosed with this disorder typically have less than two years to live.  Spinraza, sold by Biogen, uses tiny chains of RNA to help repair the nerve cells within the patient’s spinal cord. It is these cells which control voluntary muscles and preserve their function. With repair of these cells, infants with Spinal Muscular Atrophy have been alive for well over four years now.

In 2017 Novartis was the first company in history to receive FDA approval of a human gene therapy to combat cancer, called Chimeric Antigen Receptor (CAR) T-cell therapy.  CAR-T therapy has been shown to have remarkable cure rates for leukemia and lymphoma patients who were previously felt to be incurable. With this therapy, the patient’s own white blood cells are genetically modified in the lab and reinjected back into the patient’s bloodstream to kill their cancer cells. This treatment offers a realistic probability for a cure to many patients previously facing imminent death.

This is all good, and we should be grateful.

The problem: US Pharmaceutical prices are skyrocketing.

In 2013, Sovaldi came with a heavy cost: The drug, Sovaldi was priced at $1000 per pill.  Typically, patients needed 84 of these pills (one per day) in order to be cured.

Collectively, we bought it. We raised spending on insurance premiums and Medicaid expenditures and hoped for the best.

Subsequently we were treated to these headlines:

$1,000 Pill For Hepatitis C Spurs Debate Over Drug Prices

The cost of Biogen’s new drug: $750,000 per patient

$475,000 Too High a Price for Novartis’s ‘Historic’ Cancer Gene Therapy?

In fact, $750,000  is only the first year’s down payment to Biogen. Spinraza was priced at $750,000 for the first year of treatment and a recurring annual price tag of $375,000 per patient.

More recently, in conjunction with CMS, Novartis came up with a performance-based model: Patients will only be charged $475,000 if the drug works in the first month.

We (you and I) have an ownership stake in these products too:

Many or most of today’s miracle drugs were developed with research which was funded or subsidized by the US taxpayer, in academic medical centers.  Shouldn’t the interests of US taxpayers be considered in the pricing of these drugs?

In our next installments, we will look more closely into what is driving these increased costs and what we can do about it.

Wishing you a wonderful 2018,

Happy New year!

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