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Monday, October 3, 2022

Why We Will Never Control Medical Costs

 The purposes of medicine are expanding rapidly beyond treating actual illnesses/injuries and promoting wellness, to also facilitating life fulfillment and making personal dreams come true.

Latest case in point: A gay couple has filed a class-action complaint with the U.S. Equal Employment Opportunity Commission (EEOC) against the City of New York, suing for unlawful workplace discrimination because they were denied coverage for fertility services. If successful, health insurance nationally may eventually be required to pay for IVF/surrogacy services for male gay couples. From the Guardian story:

Corey Briskin and Nicholas Maggipinto met in law school in 2011, were engaged by 2014, and had their 2016 wedding announced in the New York Times. They moved to a waterfront apartment block in Williamsburg, Brooklyn, with a bright playroom for families on the ground floor. “We got married and then we wanted all the trappings: house, children, 401K [retirement saving plan], etc,” Maggipinto, 37, tells me in their building’s shared meeting room, tapping the table in sequence with the progression of each idea.

Briskin, 30, grew up assuming he’d have children. He came out in college. “Once I had come out to myself and others, I don’t think my expectation of what my life would look like changed all that much.” With marriage equality won years ago, they expected to be able to have a conventional married life.

But the couple, both being male, cannot have children together. Hence, the litigation.

Briskin used to work for the City of New York as an assistant district attorney, earning about $60,000 a year. His employment benefits had included generous health insurance. But when they read the policy, they discovered they were the only class of people to be excluded from IVF coverage. Infertility was defined as an inability to have a child through heterosexual sex or intrauterine insemination. That meant straight people and lesbians working for the City of New York would have the costs of IVF covered, but gay male couples could never be eligible.

This isn’t an oversight, it’s discrimination, Briskin says. “The policy is the product of a time when there was a misconception, a stereotype, a prejudice against couples that were made up of two men – that they were not capable of raising children because there was no female figure in that relationship.”

Wait a minute. In the examples given, fertility services were covered because the patients experienced a pathology, i.e., an inability to conceive. Neither of the gentlemen suing, as far as we know, is infertile. They are gay. They cannot conceive together because both are male. That is not a pathology. It’s basic biology. Hence, refusing coverage is not discrimination.

But these days, saying such a truth is often called hateful as political pressure is brought to bear to ensure that insurance pays for services that are about attaining lifestyle desires, not overcoming actual health impairments. For example, California passed a law some time ago requiring group health insurance to cover gay couples as they do infertile heterosexual couples — which actually discriminates against heterosexual couples because they have to demonstrate a medical inability to conceive, while gay couples do not.

But what about this?

Briskin was working alongside colleagues who were happily availing themselves of the benefits he wasn’t entitled to. One of his co-workers – an older, single woman – became a mother using donor sperm, IVF and surrogacy.

The story doesn’t say, but if the woman in question was beyond normal childbearing years, it should not have been covered either because inability to conceive would be caused by biology, not a medical problem.

So, we grind our teeth about the gargantuan cost of health care in this country — as we continually expand the circumstances in which non-health-care services are required to be covered by health insurance. For example, arguments are already being made that transgender women should be eligible for uterus transplants so they can experience gestation.

We need to find the courage at some point to say no to the expansion of medicine’s jurisdiction, or there won’t be enough money in the pot to pay for it all.


WESLEY J. SMITH is an author and a senior fellow at the Discovery Institute’s Center on Human Exceptionalism. 


https://www.nationalreview.com/corner/why-we-will-never-control-medical-costs/



IRA’s Drug Price ‘Negotiation’ Provisions Are the Wrong Answer

 The Inflation Reduction Act (IRA), signed by President Biden on August 16th, includes provisions to address prescription drug prices. While the measure is billed as a step toward stemming the drug pricing crisis, it is a baby step at best. A better approach would be to incentivize innovations that deliver better medicines more cheaply.

The IRA allows Medicare, starting in 2026, to set  prices for 10 drugs, ultimately increasing to 20 per year from 2029. Even after a decade, this will impact only a small proportion of the thousands of drugs covered under Medicare Part D. In total, these provisions amount to an incremental change in drug pricing. According to the Congressional Budget Office, negotiations will save $101.8 billion over ten years, or less than 1.5% of the more than $7 trillion Americans will likely spend on drugs over the same period. This amounts to barely bending the cost curve when our goal should be to break it.

For Washington to be more effective in its efforts to lower drug pricing, it should focus instead on setting the right goals for pharmaceutical innovation and providing incentives to reach them. The government should support moonshot technological breakthroughs that allow for cheaper production and distribution of vital medications, particularly for chronic conditions.

FDA Commissioner Robert Califf, M.D., took a noteworthy step toward setting this goal in an op-ed last month. He argued that the biopharma industry should “review its priorities” and shift focus to developing more new treatments for common chronic diseases. Along with mental health, chronic conditions drive 90 percent of the nation’s $4.1 trillion in annual healthcare expenditures.

Lower cost treatments are well within reach. Revolutionary technologies are currently in development that can treat and prevent chronic conditions such as coronary heart disease and Alzheimer’s for a fraction of the cost of current drugs. Eradicating either of these diseases through broad, cost-effective access to preventive medicine would save over $350 billion per year. Even preventing a portion of annual diagnoses would save Americans far more than the IRA ever could.

If Washington wanted to support these innovations, it could. The U.S. government has proven that when it sets a national priority and dedicates the necessary resources to achieving it, almost anything can be done, and done quickly.

The moon landing, for example, became a reality only eight years after President Kennedy set the initial goal, despite representing one of the most daunting engineering challenges of all time. Operation Warp Speed (OWS) spurred the development of not one, but three vaccines for COVID-19 in less than one year, far faster than most thought possible.

How did the U.S. accomplish these feats? Vision setting, prioritization, and investment. NASA funding accounted for 4.4% of the federal budget in 1966, while OWS allocated $18 billion on COVID-19 drug development in 2020. Today, the entire budget for the National Institutes of Health is $46 billion, or approximately 1% of the federal budget, and it is spread amongst so many different research topics that the largest priority, cancer, gets only $6.35 billion.

Imagine what could happen if we made innovations in lower-cost therapies a true moonshot priority. The playbook could be similar to OWS: federal funding for grants, advanced purchase contracts, and manufacturing investments, combined with development partnerships in the form of FDA regulatory engagement and NIH collaboration on developing research models, cross-sharing of data, and running clinical trials. This full measure of support for innovation would be exponentially better than the half measure of price fixing contained in the IRA.

Solving this crisis is worth it. A 2019 study found that in the previous five years, one in eight Americans lost a loved one because they could not afford the cost of their medication. That figure is double for people of color. In the developing world the situation is far worse.

The IRA represents an evolution in Congress’s approach to drug pricing, but not the revolution that is needed. To spark a real revolution, we must acknowledge that drugs are only a fraction of overall health care costs, and that the best way to lower costs is to prevent the diseases that make expensive care and treatment necessary.

While it may be incomplete, the IRA is nonetheless welcomed by many in the healthcare advocacy space. Patients and their families – those who have lost much more than money to the high price of today’s drugs and treatments – deserve better. Now that Washington has broken the seal on reform, let’s double down and make this the national priority it deserves to be.

Mei Mei Hu is co-founder and CEO of Vaxxinity, a biotech company developing vaccines for chronic diseases such as coronary heart disease and Alzheimer's.

https://www.realclearhealth.com/articles/2022/10/03/iras_drug_price_negotiation_provisions_are_the_wrong_answer_to_the_right_question_111418.html

Y-mAbs: Pivotal Data for Omburtamab

 For 32 patients enrolled in the Company’s ongoing pivotal 101 multicenter study of omburtamab radiolabeled with Iodine-131, the results showed a twelve-month overall survival (“OS”) of 73.5%, with a median follow-up of 25 months. Further, the interim results showed an objective response rate (“ORR”) of 31.3% in the patients with measurable disease after central review based on Response Assessment in Neuro-Oncology (“RANO”) criteria and European Association of Neuro-Oncology (“EANO")/European Society for Medical Oncology (“ESMO”) criteria, and that a total of 75.0% of the patient with measurable disease achieved disease control. Serious Adverse Events (“SAE”) was found in 40.6% of the patients and were mostly related to myelosuppression.

https://www.biospace.com/article/releases/y-mabs-announces-pivotal-data-for-omburtamab/

Heart Failure Treatment Guided by Daxor BVA-100 Lowers Hospital Stay 55%

  Daxor Corporation, the global leader in blood volume measurement technology, today announces new data validating the benefits of the Company’s BVA-100 diagnostic blood test in reducing hospital length of stay (LOS) for heart failure (HF) patients. Data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting (ASM) 2022 – which brought together the world’s leading experts in heart failure from September 30th thru October 3rd, 2022, in Washington, DC.

https://www.biospace.com/article/releases/new-data-shows-heart-failure-treatment-guided-by-daxor-s-bva-100-lowers-hospital-length-of-stay-by-55-percent-/

Enanta Starts Phase 2b Study of EDP-938 in Respiratory Syncytial Virus

  Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the initiation of a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EDP-938, its novel N-protein inhibitor, in adults with acute respiratory syncytial virus (RSV) infection who are at high risk of complications, including the elderly and/or those with congestive heart failure, chronic obstructive pulmonary disease (COPD) or asthma.

https://www.biospace.com/article/releases/enanta-pharmaceuticals-initiates-a-phase-2b-clinical-study-of-edp-938-in-high-risk-adults-with-respiratory-syncytial-virus/

Nevro: Spinal Cord Stimulation for Diabetic Neuropathy in New Treatment Guidelines

  Nevro Corp (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that Nevro's HFX 10 kHz Therapy is the only form of spinal cord stimulation (SCS) therapy to be referenced by the American Association of Clinical Endocrinology (AACE) in its 2022 Diabetes Clinical Practice Guideline to treat painful diabetic neuropathy (PDN).

Based on results from Nevro's landmark SENZA-PDN randomized controlled study, the AACE guideline states that high frequency (e.g., 10 kHz) spinal cord stimulation is a nonpharmacological approach that may be effective in persons with painful diabetic peripheral neuropathy that failed at least one medication.¹,²  The treatment algorithm in the guideline also includes a referral to a pain physician for assessment if medical therapy has failed.   


Soleno STarts Study of DCCR for Treatment of Prader-Willi Syndrome

 Soleno Therapeutics , Inc. (Soleno or the Company) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has initiated a randomized withdrawal period of Study C602, an ongoing open-label extension study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS).

https://www.biospace.com/article/releases/soleno-therapeutics-announces-initiation-of-randomized-withdrawal-study-of-dccr-for-the-treatment-of-prader-willi-syndrome/