PRESCRIPTION DRUGS: ‘WHY THEY REMAIN HIGH-PRICED’

There may be few issues that unite Americans ahead of the 2020 election as do their concerns about the cost of prescription drugs.

A clear majority — 75% — of respondents to a July survey said the cost of prescription medicines would be among the factors likely to influence their votes this year, according to a report from Gallup and the nonprofit West Health. Gallup reported on results from 1,007 interviews conducted with adults between July 1 and July 24.

1. What are the 2020 presidential candidates saying they will do to lower drug prices?

Both President Donald Trump, a Republican, and former Vice President Joe Biden, a Democrat, have highlighted insulin costs in their discussions of the need to lower drug prices.

In a January interview with the New York Times editorial board, Biden noted the widespread discontent among Americans about sticker shock often experienced at pharmacies. He spoke of a need for the federal government to act to make medicines more affordable.

“This is a place where I find, whether you’re Republican or Democrat, you think you’re getting screwed on drug prices. And you are, in terms of everything from insulin to inhalers and a whole range of other things,” Biden said. “So, again, can I guarantee that it gets done? No, but I can tell you what, if anybody can get it done, I can, and I think there’s a consensus for it.”

2. Why doesn’t Medicare, the biggest U.S. purchaser of drugs, directly negotiate on drug prices?

Congress has taken different approaches in designing the terms under which the two largest federal health programs, Medicaid and Medicare, buy drugs.

Medicaid is a program run by states with federal contributions and oversight. It covers people with low incomes and disabilities. Almost 67 million people were enrolled in Medicaid as of May 2020, including about 29 million children. In 1990 Congress decided that drugmakers who want to have their products covered by Medicaid must give rebates to the government. The initial rebate is equal to 23.1% of the average manufacturer price (AMP) for most drugs, or the AMP minus the best price provided to most other private-sector payers, whichever is greater. An additional rebate kicks in when prices rise faster than general inflation.

3. What’s the deal with rebates and discounts?

There’s widespread frustration among lawmakers and policy analysts about the lack of clarity about the role of middlemen in the supply chain for medicines. Known as pharmacy benefit managers (PBMs), these businesses describe the aim of their business as making drugs more affordable for consumers. Insurers like Cigna and UnitedHealth operate some of the nation’s largest PBMs, as does pharmacy giant CVS Health, which also owns insurer Aetna.

“They will tell you their mission is to lower drug costs,” said Rep. Earl L. “Buddy” Carter, a Georgia Republican, a pharmacist and a critic of PBMs, in a speech on the House floor last year. “My question to you would be: How is that working out?”

4. What is the “distinctly American” phenomenon of specialty drugs?

Kesselheim also has written on what he terms “Specialty Drugs — A Distinctly American Phenomenon.” That’s the title of a 2020 paper in the New England Journal of Medicine Kesselheim authored with Huseyin Naci, an associate professor of health policy at the London School of Economics.

In this Perspective article, Kesselheim and Naci look at how the “specialty” designation morphed from its origin in the 1970s. It then referred to a need for extra steps for preparation and delivery of new injectable and infusion products.

5. How much does it cost to bring a new drug to market anyway? 

The median cost for a medicine developed in recent years was $985 million, according to a study published in JAMA in March 2020, “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.”

“Rising drug prices have attracted public debate in the United States and abroad on fairness of drug pricing and revenues,” write the study’s authors: Olivier J. Wouters of the London School of Economics; Martin McKee of the London School of Hygiene and Tropical Medicine; and Jeroen Luyten of Leuven Institute for Healthcare Policy, KU Leuven, Belgium. “Central to this debate is the scale of research and development investment by companies that is required to bring new medicines to market.”

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MEDICINE: ‘THE FUTURE OF NEUROSURGERY’ (VIDEO)

NYU Langone’s Kimmel Pavilion is home to the region’s newest and most technologically sophisticated neurosurgery suite. Designed to optimize patient care, our facilities are just one reason U.S. News & World Report’s “Best Hospitals” ranks NYU Langone among the top 10 hospitals in the country for neurology and neurosurgery.

Learn more about neurosurgery at NYU Langone and meet our renowned surgeons: https://nyulangone.org/locations/neur…

HEALTH VIDEO: ‘SURGEON GENERAL HYPERTENSION REPORT’ (JAMA NETWORK)

The US Surgeon General’s office has released a report emphasizing the importance of making hypertension control a national public health priority. Vice Admiral Jerome Adams, MD, MPH, the 20th US Surgeon General, discusses the report’s background and recommendations.

Recorded October 7, 2020.

THE DOCTORS 101 CHRONIC SYMPTOMS & CONDITIONS #17: ACTINIC KERATOSES

Red hair and freckles are associated with MCR-1 gene variants, and large areas of skin with lowered melanin protection against the adverse effects of the sun. I have red hair and freckles, for which I was teased. My response was that I had a lot of Iron in my blood, and that the freckles were Rust. This is ironic (no pun intended).

Since becoming an Octogenarian, I have had trouble keeping my Iron levels normal. I live in a beach area, where all the young ladies are sunning themselves to promote the socially desirable “bronze goddess” effect, and all of the older ladies hide their leathery skin and wear broad-brimmed hats.

The sun has a good reputation as a health-giver. Being outside does correlate with a lot of beneficial effects, such as enhancing production of Vitamin D. My recommendation, however biased, is to get your Vitamin D in capsule form, and reduce sun exposure.

SUNSHINE, however salutary, is accompanied by invisible, high energy photons capable of breaking DNA strands, and ultimately causing SKIN CANCER. Not accidentally,Visible light has insufficient energy to break bonds, although the rhodopsin in rods and cones do release electrons if stimulated by light.

Actinic Keratoses are the roughened plaques of skin, often on the face, which have a small but definite risk of turning into Cancer. I have a dermatology check every 6 months for precancerous areas to be frozen and destroyed by CO2 spray.

PREVENTION of UV Skin damage is advisable. I wear a broad brimmed hat and UV-blocking sunglasses (UV can promote cataracts and retinal damage as well) when outside in the sun. When swimming I wear a “rashguard” shirt with UV protection in the fabric.

Also, I try to limit my exposure to the Evening and Morning sun, because the light is warmer, and contains less UV. Even with these precautions, I use Sunscreen creams and lotions. I always wondered how a transparent lotion can block UV light.

The explanation lies in the chemicals contained. Such chemicals as Avobenzone and Homosalicylate actually absorb the energy of UV light. Protect yourself now for later health.

–Dr. C.

MEDICAL: ‘JOHNS HOPKINS MUSCULOSKELETAL CENTER’ – FOR MUSCLES, BONES AND CONNECTIVE TISSUES (VIDEO)

The Johns Hopkins Musculoskeletal Center aims to streamline and improve access for diagnosis and treatment of conditions affecting muscles, bones and connective tissues. Each of the center’s locations feature a diverse group of physicians, therapists, and advanced practitioners who work together to bring you the right treatment at the right time.

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VIDEOS: DIAGNOSING AND TREATING COVID-19 (MAYO)

Dr. Stacey Rizza, an Mayo Clinic infectious diseases specialist, discusses the various ways COVID-19 is diagnosed and treated.

COVID-19 can be diagnosed several ways when looking for active infection.

“The most common way that testing is done is with a swab into the nose or into the nasal pharyngeal area,” says Dr. Stacey Rizza, a Mayo Clinic infectious diseases expert.

“This polymerase chain reaction (PCR) test is essentially a test looking for the genetic material of the virus.” If it’s positive, it means that person is infected with SARS-CoV-2, the coronavirus that causes COVID-19.

COMMENTARY:

Dr. Stacey Rizza from Mayo Clinic gave the standard Academic recommendations for Covid Testing and treatment. I will comment on how this differs from the testing recommendations of Dr. Michael Mina from the Chan school at Harvard and the actual treatment given to Donald Trump as we speak.

I agree with the latter recommendations, and route that I would opt for, were I to catch Covid 19. TESTING, if it is to be Epidemiologically effective should offer results that are rapidly available so as to reduce spreading of the virus and treatment delay. One trouble with PCR- based tests is that they are slow. Another trouble, according to Dr. Mina, is that if they run for 40 cycles for maximum sensitivity, they may pick up viral shedding that is too minor to be infective, and may cause unnecessary precautions, such as quarantining. If they run for 35 or even 30 cycles to show only infective, actionable cases, they take several days, and even then labs do not usually report the number of cycles run, but only yes or no, positive or negative.

The RAPID TESTS detect viral protein are available within hours. They are less sensitive, but in Dr. Mina’s view, this can be a virtue, since only definitely infected patients are identified. They are cheaper, and can even be done on site. Frequent testing more than makes up for decreased sensitivity. Most tests currently available use only specimens from nasal swabs, which are uncomfortable.

SALIVA is almost as sensitive, and has one additional virtue, when it comes to testing school children. If school children are organized into learning “pods”, They can all spit into a common collector, and the pod tested preemptively, at least twice weekly. If positive The entire pod is individually tested to find who is positive. Of course if a full 20 kids are in a pod, The sensitivity of the protein test may be insufficient for positive to survive a 20-fold dilution, but this can be empirically worked out. Twice weekly testing vs. every other week is much better for reducing the number of the pod members infected at time of discovery, as the NYT has illustrated.

TREATMENT given to Donald Trump has so far consisted of more than Remdesivir. He is also receiving Corticosteroids, plus an experimental double antibody mixture, derived from both Covid Convalescent serum, and monoclonal antibodies from a “humanized” murine source. The antibodies should theoretically be given early. The corticosteroids are generally not given until a bit later, but with the reported drop in O2 sats, he may be later in the disease than we are led to believe. To my knowledge, he is not receiving his tweeted Hydroxychloroquine- azithromycin combination.

If I were infected, at age 88, I would also like the antibody treatment, but most likely would not be allowed to get it.

–Dr. C.

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