Peter Wehrwein

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Otis Brawley’s reputation precedes him. But he says that what people say isn’t quite true.

“I was sometimes categorized as anti-screening. I am not. I am against 

 screening. And I am for applying science,” Brawley said in a recent video interview with 

® editors Briana Contreras and Peter Wehrwein.

Brawley, M.D., now a professor of oncology and epidemiology at Johns Hopkins, has recently joined the 

’s editorial advisory board. As chief medical and scientific officer for the American Cancer Society from 2007 to 2018, Brawley went against the grain by raising questions cancer screening. 

 interview, “we are still overscreening. But it is not as bad as it once was, especially in prostate cancer.” And Brawley has a high opinion of the United States Preventive Services Task Force (USPSTF) , which issues screening guidelines; he said the task force applies science “very, very well.”

But the USPSTF recommended lung cancer screening for people with a history of heavy smoking in 2013, and it is considering an update that would broaden the recommendation so even more people would be considered candidates for lung cancer screening. Brawley is not shy about expressing his reservations: “Lung cancer screening is a great example of 

Brawley noted that the decisive trial for lung cancer screening was done at 30 of the country’s finest hospitals. Furthermore, he says the recommendations — he was speaking generally not in specific reference to the USPSTF recommendations — come with important qualifications: that the screening be done at a facility where the personnel and equipment can do the low-dose CT screening well and that the people being screened understand risks and benefits well.

“I worry about people (getting screened) in nonacademic settings. I worry about people in rural settings. Is the benefit-to-harm ratio for lung cancer screening going to be the same in the nonacademic setting”

Brawley also sees hospitals as leaping at the chance to provide a new lung cancer screening to the detriment of other programs.

“Unfortunately there are some hospitals that are shutting down navigator programs that would keep women in breast cancer treatment that would ultimately save more lives in order to establish lung cancer screening programs, which are sexy and might bring more prestige to the hospital, and maybe more money.”

Unnecessary care and tests accentuate healthcare disparities, in Brawley’s view. “When we do things in medicine that don’t work,we hurt people. We hurt not just the people who are getting the test or the treatment that should not be sued. We are also hurting other peoplewho need the hospital, who are crowded out of the hospital and can’t get the services they need.”

Videos

“Lung cancer screening is a great example of the problem,” says the former chief medical and scientific officer for the American Cancer Society in this third of four-part video series.

Otis Brawley: It’s Gotten Better but Problems With Cancer Screening Haven’t Gone Away 

 argues that it is time to revisit the retinopathy screening guidelines for people taking hydroxychloroquine
Rather than discontinuing the drug at the first sign of retinopathy, prescribers should put patients on lower doses of hydroxychloroquine and monitored their eyes closely, the commentary argues.

Ophthalmologists have more sensitive tests for retinopathy than they used to, so taking people off hydroxychloroquine because of early retinopathy has become more common than missing the diagnosis, argue 

 of Charlotte (North Carolina) Eye, Ear, Nose and Throat Associates and his colleagues.

“It is a fair question, therefore, whether the emphasis on early detection of HCQR 

(hydroxychloroquine retinopathy) has been pushed too far,” they write. “Ophthalmologists set the guidelines based on a concern for HCQR but the prescribing physicians and their patients are the ones that must live with the ramifications of the guidelines.”

Hydroxychloroquine has been in the news as a possible treatment and preventive of COVID-19 It failed for that purpose. But the drug is a mainstay of the treatment of many autoimmune diseases, especially systemic lupus erythematosus. There are alternatives but, as noted by Browning and his co-authors — Naoto Yokogawa, Paul B. Greenberg and Elliot Perlman — the alternatives have cost and side effect drawbacks. 

Because retinopathy related to hydroxychloroquine can be detected at a subclinical stage these days, Browning and his colleagues say lowering doses and monitoring patients should be considered by guideline writers rather than having people stop taking hydroxychloroquine altogether.

The dosing of hydroxychloroquine is currently based on body weight; Browning and his colleagues suggest that blood levels be considered instead. They also suggest that guideline writers consider the thresholds for diagnosing retinopathy related to hydroxychloroquine and the sensitivity and specificity levels. And they call for inclusive guideline committees that would have the specialists involved hydroxychloroquine prescribing and monitoring.

“By acknowledging the complementary roles of prescribers and ophthalmologists, this approach will lead to wider acceptance of the guidelines and better care for our patients,” concluded Browning, Yokogawa, Greenberg and Perlman.

Articles

Rather than stopping hydroxychloroquine altogether, doses could be reduced and patients monitored if there are signs of retinopathy, say the authors of a commentary in the American Journal of Ophthalmology. 

 Time to Revise Hydroxychloroquine, Retinopathy Guidelines, Say Authors

Doesn’t seem like we're headed for a COVID-19 surprise

 event yesterday that the company get an emergency use authorization in December if there are positive interim results from a clinical trial next month, according to the 

On Friday (October 16), Pfizer CEO Albert Bourla posted an 

 on the company website that said the company expected the vaccine it is developing with BioNtech to pass a safety milestone by the FDA in the third week of November and that assuming “positive data,” it will soon afterward. In August, Bourla was predicting that safety and efficacy data would be in hand in October.

Most touts of the COVID-19 vaccine race have Pfizer and Moderna in the lead, so as of this writing an emergency use authorization before the November 3 seems unlikely.

Many eyes on FDA vaccine meeting this Thursday, October 22

’s Elizabeth Cooney says “nothing extraordinary is expected to happen” but it is a safe bet that a lot of more people will be tuning in the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday. 

Why? Maybe because the committee members will be discussing the small matter of the development, authorization and licensure of vaccines to prevent COVID-19. 

 Editor John Carroll reported this morning that the FDA has invited 

, Ph.D., a professor in the Department of Biostatistics at the University of Arkansas for Medical Sciences and 

, Ph.D., M.D., the president and CEO of Meharry Medical College, to participate in the discussion.

The notice about the meeting on the FDA website says no specific application will be discussed. The start time is 10 a.m. You can watch the webcast

U.K. taking steps toward possible challenge trials

The question of whether to conduct challenge trials to hasten the collection of efficacy and safety data on the various COVID-19 vaccine candidates has been bandied about  for months. Such trials would involve deliberating exposing vaccine trial volunteers to the SARS-CoV-2 virus that causes COVID-19 instead of — more likely, in addition to  — conducting large phase 3 trials that depend on some circumstantial exposure to the virus to assess vaccine efficacy. 

 that the British government has taken a first step toward conducting a challenge study by contracting with 

, a niche contract research organization, for a "characterization study" that would identify the doses of the virus that might be used in a challenge study.

Nir Eyal, Marc Lipsitch and Peter G. Smith wrote about how 

challenge trials could be conducted ethically

 way back in March. Among the ingredients: healthy volunteers and access to top-drawer medical care in case anyone does develop a serious case of COVID-19.

Scientists raise warning about adenovirus 5 vector as COVID-19 vaccine vector

Several COVID-19 vaccine candidates use a presumably harmless variety of adenovirus — adenovirus 5 (Ad5) — as a delivery mechanism for the genetic material that produces the antigen that is stirs up an immune response against SARS-CoV-2 infection.

But the same “vector” was used in HIV vaccine trials, and some evidence suggested that Ad5 itselmight make some men more vulnerable to HIV infection.

“Roll-out of an effective SARS-CoV-2 vaccine globally could be given to populations at risk of HIV infection, which could potentially increase the risk of HIV-1 acquisition,” wrote the authors of a letter published in the 

 yesterday. “This important safety consideration should be thoroughly evaluated before further development of Ad5 vaccines for SARS-Cov-2 and informed consent documents of these potential risks should reflect the considerable literature on HIV-1 acquisition with Ad5 vectors.”

 letter and the checkered background of Ad5 as an AIDS vaccine vector, 

’s Jon Cohen wrote that the results suggestive of a problem with Merck’s Ad5 vector sent AIDS vaccine research into a “tailspin.” Of course there's still no HIV-AIDS vaccine.

The “why” behind Ad5 and a possible link to greater risk of HIV transmission hasn’t been nailed down.

“Precisely how Merck’s Ad5 vaccine increased the risk of HIV transmission in STEP and Phambili [STEP and Phambili are the names of clinical trials] remains murky,” wrote Cohen. “The 

editorial spells out several possibilities, including the dampening of HIV immunity, enhancing replication of the AIDS virus, or setting up more target cells to it.”

State health officials to CDC: 60 cents per person is not enough

Friday, October 16, was the deadline for states and territories to submit their COVID-19 vaccination plans. Coming up with a plan with so many unknowns was difficult, health officials told several news sources. The Association of State and Territorial Health Officials (ASTHO) and the Association of Immunization Managers say the CDC has distributed $200 million to pay for the planning efforts but more money is needed to implement the plans.

“This funding [the $200 million] is a necessary first step but equals approximately 60 cents per person,” Claire Hannan, executive director of the Association of Immunization Managers said in 

. “It is not adequate to vaccinate every American with the expected two dose course at this amount.”

Today, ASTHO and the American Pharmacists Association announced that their representatives are co-chairing a new 

National COVID Vaccine Leadership Council

 to support implementation of the COVID-19 vaccination. The council has an impressive list of 19 member organizations, including the American Medical Association, the American Society of Health-System Pharmacists, the National Governors Association and the National Indian Health Board.

Pfizer, Moderna executives say efficacy, safety data won't be ready till well after 
Election Day. FDA's COVID-19 vaccine meeting on Thursday says sure to draw a big  crowd.

This Week's COVID-19 Vaccine Update: No October Surprise, FDA's Big Meeting on Thursday, and UK Challenge Trials

Drug treatment is entering a dazzling new era of increasingly precise, individualized “bespoke” medications that work in ways that were the stuff of science fiction just a few years ago: T cells modified to home in on cancer cells, antibody drug conjugates that recognize only the disease-causing cells, therapies that intervene in a disease process by cutting DNA and stifling gene expression.

In her keynote address at the 4th Annual 

 reasons these medications are so costly but also offered hope and insight into how those costs will eventually come down. Jung, partner and managing director, 

, Ernst & Young LLP, also said there are good examples from the medical benefit side of healthcare payment that show how payment for high-cost medications can be managed.

A good deal of the high cost of these new medications can be explained by their novelty, complexity, sensitivity and the lack of economies of scale, Jung explained to the attendees of the forum, which was being held virtually like almost every other medical meeting this year because of COVID-19.

The way costs and prices will go down is through higher utilization and repetition.

“Repetition helps us uncover patterns and approaches that can be standardized or shifted to lower-cost resources,” said Jung, whose talk was sponsored by 

But Jung also went through the many factors that ratchet up the cost through the value chain. Hospitals may need to renovate their facilities to accommodate sterile lab requirements and patient infusion rooms. The drug development process needs to be tightly controlled to “zero-defect” standards, partly because the medications are so sensitive and made up of human cells. Conditions need to be more precisely and accurately diagnosed, often at the genetic level, and patients often need to be more closely monitored after they receive a treatment. “When you are putting modified genes into a human being, you have to monitor the person very carefully to ensure that you haven’t done something to alter gene expression in another part of the body,” said Jung, who also mentioned labor costs.“You have highly specialized labor that isn’t your typical provider, nurse or nurse assistant. You are talking about specialists who make hundreds of thousands of dollar a year who know how to manage these products.”

Regardless of the cost issues, and because of the promise of a potential cure, Jung said she expected high demand for these therapies from affected patients and that providers and payers will have to adapt.

Providers, she said, “can’t just write a prescription for a bunch of pills in a bottle going forward because patients are going to demand something a little bit more potent if they know there is a potential cure for them, especially if they have a high mortality or morbidity profile. They are going to have an opportunity to seek cures. So those of those of us who work in the payer community are going to have to figure out how to pay for these therapies because many of these drugs are expensive to produce, distribute and administer.”

Jung returned to her message about repetition and economies of scale when discussing what payers might do.

“Right now is there is a lot of hostility and animosity between payers and the drug companies around these therapies because the argument is always about the price. The argument here shouldn’t be about the price. The argument should be about the process. If we can get everyone to agree on a process that is consistent, agile and scalable — as I said before — we can start to see patterns and approaches that we can standardize to improve the value proposition then we can eventually bring the prices down.”

But that shift to process requires a “culture of innovation,” in Jung’s view, which she said is present in the drug companies because that is the nature of their business.

Jung gives PBMs a “needs improvement” grade in innovation.

“I have to honest. I have worked in PBMs my entire career. There is not a lot of innovation in the culture in a lot of these organizations that isn’t administrative in nature. I would love PBMs to have a culture of innovation when it comes to therapy and the solutions they bring to market around patient therapies.”

That’s the long game. In the near term, Jung said payers who managed pharmacy benefits need to look at high-cost medical events, such as treatment of severe trauma or caring for pre-mature infants, as models for how the cost of these new-priced therapies might be managed.

“That is a lot more work than that we are used to do doing when paying for a drug, but it is only the way for us to be able to pay for them in the long run” Jung said.

Alex Jung of EY-Parthenon, Ernst & Young LLP, explains why therapies in new era of drug treatment are so expensive and what can be done about it.

Author | Peter Wehrwein

Articles

Otis Brawley: It’s Gotten Better but Problems With Cancer Screening Haven’t Gone Away

Time to Revise Hydroxychloroquine, Retinopathy Guidelines, Say Authors

This Week's COVID-19 Vaccine Update: No October Surprise, FDA's Big Meeting on Thursday, and UK Challenge Trials

PBMI Specialty Pharmacy Keynote Speaker: How to Bring Sky-High Costs Down to Earth