Category Archives: News Stories & Editorials

Biden’s ‘end cancer’ pledge begs for environmental oversight

Ariel Wittenberg, E&E News: May 4, 2021


President Biden pledged last week to “end cancer as we know it,” a bold promise focused on boosting funding to the National Institutes of Health for a special Advanced Research Projects Agency-Health.

ARPA-H would be similar to the Department of Energy’s Advanced Research Projects Agency-Energy, or ARPA-E, acting as a technology incubator by funding high-potential, high-impact projects that are too early for private-sector investment, but with the “singular purpose to develop breakthroughs to prevent, detect and treat” diseases.

“I can think of no more worthy investment. I know of nothing that is more bipartisan,” Biden told Congress last week. “So let’s end cancer as we know it. It’s within our power. It’s within our power to do it.”

But public health experts who have spent their careers examining environmental causes of cancer say it may not be possible to truly stop cancer without EPA stepping in.

The agency has been infamously slow to stop the use of known carcinogens for decades. Those include benzene, arsenic and asbestos, which is responsible for 40,000 deaths per year alone.

“We know that several chemicals are known to cause cancer in humans and others are highly suspect,” said Bob Sussman, an attorney and former EPA official now representing multiple groups in asbestos litigation against the agency. “There are many causes of cancer, but if we don’t address chemicals, we won’t get the job done.”

EPA could help Biden on his mission if it were faster to regulate not just asbestos but also PFOA, phthalates and bisphenol A, said Linda Birnbaum, who formerly led the National Institute of Environmental Health Sciences.

Listening to Biden’s address to Congress, she said, she was happy to hear the president “talking about major changes in how society functions.”

“But the focus was on treatment and cures,” she said. “I’m not opposed to treatment and cures, but I think it’s better to prevent if you can.”

Diana Zuckerman, president of the National Center for Health Research, agreed that the nation needs a “two-pronged attack” to end cancer.

“You can’t talk about even reducing cancer without talking about environmental toxins,” she said.

She noted that while Biden did mention a need to research cancer “prevention” during his speech, the medical community often refers to cancer screenings as prevention.

“Screening isn’t prevention; it’s early detection. You’ve already got the cancer; we just found it early,” she said. “If you want to prevent it, you have to deal with what causes it in the environment.”

Asked whether EPA sees a role in Biden’s quest to “end cancer as we know it,” the agency responded only, “EPA is fully on board with President Biden’s agenda.”

It’s not exactly clear what that means. Biden did not mention a role for the agency during the cancer portion of his speech to Congress. But the president’s quest to end cancer is famously motivated by his late son, Beau Biden, who died of glioblastoma in 2015.

[….]

Margaret Kripke, a professor of immunology at the University of Texas’ MD Anderson Cancer Center who has been studying the environmental causes of cancer for years, served on the President’s Cancer Panel in the early 2000s. The culmination of her work on the panel was a report on environmental causes of cancer that said “the true burden of environmentally-induced cancer has been grossly underestimated.”

The paper also took aim at EPA, complaining that “ubiquitous chemicals,” like bisphenol A, were still found in many consumer goods despite growing evidence of links to cancer.

“Not a whole lot has changed since then,” Kripke told E&E News last week, “except that we do know more about cancer and how it works, and how chemical exposures work.”

Unfortunately, she and Birnbaum concur, not everyone agrees about what type of evidence is needed to prove a given chemical causes cancer.

[….]

Kripke said EPA might be empowered to regulate more carcinogens if there were more research, either in the lab or in epidemiological studies.

“I do think it’s on the regulatory agencies, because there are a lot of things that are clearly carcinogenic that are regulated in other countries that are not regulated here,” she said. “But at the end of the day, the agencies can only act on the basis of information, and that information ultimately comes from the research efforts.”

That’s where she hopes Biden’s new mission can help. She said cancer funding is often determined by panels of researchers, who themselves can be biased toward funding research similar to their own. If the purpose of an ARPA-H organization is to fund research that would have difficulty obtaining funding otherwise, she said, studies on the health impacts of chemicals could fit that bill.

“If they are going to have a little broader thinking about what is appropriate for funding than traditional panels made up of people doing current cancer research, then maybe there might be a better opportunity to propose studies on cancer-causing agents or chemicals,” she said.

The Department of Health and Human Services did not respond to a request for comment on whether, if approved by Congress, a new ARPA-H would emphasize environmental causes of cancer.

But Zuckerman said she is skeptical that an ARPA-H would mean more funding for research on environmental carcinogens. While ARPA-E, at the Department of Energy, does fund applied and demonstration research for new technologies — the kinds of work private companies don’t find economical — Zuckerman noted that the research is often then picked up and used by companies looking to make money.

“You may get a huge infusion of cash, and yay for that, but it is still within a system where, at the end, there are people who want to earn money off this research,” she said. “You can earn a lot more money off a cancer treatment than you can off reducing pollution.”

You can read the entire article here https://www.eenews.net/stories/1063731675

To Stay: Two More Cancer Indications With ‘Dangling Approvals’

Kerry Dooley Young, Medscape News: April 29, 2021


Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one.

Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indications for a number of immunotherapy checkpoint inhibitors, despite poor results in studies that were meant to confirm the benefit of these medicines for certain patients.

On the second day (April 28) of the 3-day FDA meeting, the Oncologic Drugs Advisory Committee (ODAC) supported the views of pharmaceutical companies in two more cases of what top agency staff call “dangling accelerated approvals.”

ODAC voted 10-1 in favor of maintaining the indication for atezolizumab (Tecentriq) for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

ODAC also voted 5-3 that day in favor of maintaining accelerated approval for pembrolizumab (Keytruda) for first-line cisplatin- and carboplatin-ineligible patients with advanced/metastatic urothelial carcinoma.

The FDA often follows the advice of its panels, but it is not bound to do so. If the FDA were to decide to strip the indications in question from these PD-1 medicines, such decisions would not remove these drugs from the market. The three drugs have already been approved for a number of other cancer indications.

Off-label prescribing is not uncommon in oncology, but a loss of an approved indication would affect reimbursement for these medicines, Scot Ebbinghaus, MD, vice president of oncology clinical research at Merck & Co (the manufacturer of pembrolizumab), told ODAC members during a discussion.

[….]

Another participant at the meeting asked the panel and the FDA to consider the burden on patients in paying for medicines that have not yet been proven to be beneficial.

Diana Zuckerman, PhD, of the nonprofit National Center for Health Research, noted that the ODAC panel included physicians who see cancer patients.

“You’re used to trying different types of treatments in hopes that something will work,” she said. “Shouldn’t cancer patients be eligible for free treatment in clinical trials instead of paying for treatment that isn’t proven to work?”

[….]

To read the entire article, see https://www.medscape.com/viewarticle/950165

FDA Scrutinizes Pricey Cancer Drugs

Politico Pulse: April 28, 2021


What should be done about expensive cancer drugs on the market that might not work? That could be the first thorny question to confront Woodcock, who is acting FDA commissioner while Biden weighs whether to nominate her for the full-time role.

The FDA is convening an expert panel this week to discuss whether the agency should revoke approved uses of three therapies that, despite positive signs from early research, failed to help patients with certain cancers live longer. All three medicines were approved under Woodcock’s tenure as drug chief and after increasingly speedy reviews.

Drug regulators “wanted to get these drugs to market as quickly as possible,” said Diana Zuckerman, a drug safety expert and president of the National Center for Health Research, who is presenting several times at this week’s meeting. “That was clearly their goal and they succeeded in doing it. But now there is a reckoning.”

What the companies say: Genentech, Merck and Bristol-Myers Squibb, the companies at the center of the debate, say their drugs still have value against the cancers in question, they just need to do more research. And Genentech on Tuesday applauded the advisory panel’s vote to keep its drug on the market for triple-negative breast cancer, one of the approvals in question.

To see the entire Politico Pulse, read https://www.politico.com/politicopulse/.

Can California’s public universities mandate COVID-19 vaccines?

Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021


Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall.  Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused.  The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?

With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated.  Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.

Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions.  Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions.  Further, 45 states permit religious exemptions and 15 recognize philosophical objections.  Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.

Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization.  Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks.  That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.

To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.”  For the EUA’s,  FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.

With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.

What do we know about safety?  137 million Americans have had at least one dose of the vaccine.  Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it.  The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines.   As with V-SAFE, reporting is not enforced and therefore reactions are under-reported.  The current systems are limited because they were not designed to accurately determine how many people experience adverse events.

UC/CSU should be commended for proposing a bold strategy to address a serious problem.  A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.

Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here

Conflicts Galore: Upcoming Accelerated Approval Cancer Panel May Be Tainted By Industry Relationships

Sarah Karlin-Smith, Pink Sheet: April 21, 2021


Six members of the FDA Oncologic Drugs Advisory Committee received conflict of interest waivers to participate in the agency’s upcoming three-day meeting to review the accelerated approval of six checkpoint inhibitor indications after the three cancer immunotherapies at issue failed to confirm clinical benefit in post-market trials raising questions about whether industry influence may heavily factor in the committee’s decision making.

The high number of waivers could mean that a majority or close to a majority of the panelists will have conflicts based on the typical number of advisors on FDA panels. The agency used to be subject to waiver limits but the 2012 FDA Safety and Innovation Act removed these restrictions.

ODAC’s 27-29 April meeting, part of the agency’s broader industry-wide effort to evaluate accelerated approvals for oncology drugs, is unprecedented in the number of drugs and indications up for accelerated approval withdrawal. The committee will discuss two indications for Tecentriq (atezolizumab); three for Keytruda (pembrolizumab); and one for Opdivo (nivolumab).

[….]

Vinay Prasad, a hematologist-oncologist at the University of California San Francisco acknowledged that it may not always be easy to find unconflicted experts but, he said they do exist. He also argued that in this case you might be able to look at other professionals like internists who study research methods and FDA approvals, for example for panel members.

[….]

Diana Zuckerman, president of the National Center for Health Research said that while FDA needs some people with clinical expertise who understand the illness and issues with the treatment, it doesn’t need an entire panel of these people. She said that one way FDA can find more qualified experts is by looking at schools of public health where academics rarely get money from industry and they have expertise in understanding clinical trials as well as biostatics.

Even if the academic’s salary isn’t directly funded by their work with industry, there are multiple reasons to be concerned that work on industry trials with the same drugs creates conflicts.

“There’s research showing that researchers feel more positively about drugs that they’ve studied. That’s normal human behavior. You feel proprietary towards something that you’ve studied. You also have a relationship with the company,” said Adrian Fugh-Berman a professor Pharmacology and Physiology at Georgetown where she directs PharmedOut, a project that focuses on evidence-based prescribing and studying industry marketing practices.

The person may also be thinking about how their behavior on the committee may impact other research opportunities the university or they in particular have with the company, she explained.

“Are you going to get more research grants for the company if you kill their drug?” Fugh-Berman said.

[….]

Over the past 12 months ODAC has had two other committee meetings where four waivers were granted but that is far from typical. Most agency advisory committees don’t have any waivers or at most have one or two, per data from FDA from 2018 onward.

FDA is supposed to publish an annual report to Congress on advisory committees that include information on waivers but the latest report available online was from fiscal year 2016. FDA did respond to questions about whether more updated data exists and where it can be found.

To read the entire article, see https://pink.pharmaintelligence.informa.com/PS144196/Conflicts-Galore-Upcoming-Accelerated-Approval-Cancer-Panel-Includes-Many-Industry-Relationships

4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor

Steven Reinberg, HealthDay: April 14, 2021


Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds.

In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor, the new research found.

“Doctors and policymakers should know that many older adults are viewing and valuing online ratings and reviews when choosing physicians,” said researcher Dr. Jeffrey Kullgren. He’s an associate professor of internal medicine at the University of Michigan in Ann Arbor.

[….]

Diana Zuckerman is president of the National Center for Health Research, a nonprofit think tank that conducts research on a range of health issues. She said that choosing a doctor is a complex undertaking.

“The trouble with these ratings is they’re not based on how good the physician is,” said Zuckerman, who wasn’t involved in the new study. “They’re usually based on convenience issues, like how long do you have to wait in the waiting room, how nice is the doctor, and does the doctor listen to you. These are all nice things, but they’re not really the important things.”

[….]

In all, the survey found that 40% of adults aged 50 to 80 have used online doctor rating sites and trust them almost as much as recommendations from family or friends for choosing a doctor. Also, online ratings were seen as more important than where a doctor went to medical school or trained.

[….]

Women, people with more education and those with chronic conditions were the most likely to turn to online rating sites, the investigators found.

[….]

Zuckerman said that most people don’t have the expertise to rate a doctor in ways that are meaningful in terms of how good a physician is or how good the medical care that they’re going to get is.

Often, online ratings should be taken with a grain of salt, she said, because you don’t know exactly what the ratings are based on.

The recommendation of friends or family members can be helpful, but in the end, it’s going to be how your experience with a doctor measures up to your needs and expectations that are important. And you shouldn’t be afraid to change doctors if you’re dissatisfied with your care, she adonvised.

Zuckerman agreed with the researchers that it’s up to policymakers and clinicians to set standards and criteria for online reviews. Patients, too, need to understand the pros and cons of online ratings.

You can read the entire article here.

What Genentech is doing to fix biotech’s diversity problem

Fortune Editors, Fortune: April 7, 2021


There’s a big problem with clinical trials: a lack of diversity. And that issue is ultimately detrimental to countless people’s lives and health.

Take, for example, breast cancer research. For a long time, the thinking in the health care world was that Black women didn’t develop breast cancer as often as white women, but when they did, they were more likely to die because of it.

“There was this assumption that it was an issue of access to care, the quality of care,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes the latest research and helps consumers and organizations put that information to work. But “if you looked at the research, you saw that the original major studies of breast cancer treatment were done on white women.”

That meant the research featured fewer women with triple-negative breast cancer, which Black women develop more often than white women. “Because [women with triple-negative breast cancer] weren’t studied,” Zuckerman continues, “[the researchers] didn’t realize that the treatments that they were studying would not work on those types of cancer.”

Zuckerman talks with Fortune’s Ellen McGirt on this week’s episode of Leadership Next, a podcast about the changing rules of business leadership. Also on the episode with McGirt and cohost Alan Murray is Alexander Hardy, who became CEO of biotech company Genentech two years ago.

Hardy has made it clear that he’s committed to boosting diversity within the biotech world and in clinical trials, and he was already doing so before the pandemic. But COVID-19 crystallized some of the issues in the U.S.

[….]

During the show, Hardy also discusses the ways the COVID-19 pandemic has changed the biotech industry, and how those changes could spill over into research on diseases such as Alzheimer’s, ALS, and cancer.

To read the entire article and listen to the podcast, click here.

The FDA Cut Off COVID Vaccine Testing. That Was a Really Bad Idea.

Shannon Brownlee and Jeanne Lenzer, Washington Monthly: March 26, 2021


Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. After a year of isolation, fear, and death, most of us can hardly wait to get vaccinated against Covid-19.

[….]

From everything we know about the various Covid-19 vaccines, normal life, or some semblance of it, could return as early as late summer or fall in the United States. The first two vaccines, made by Pfizer and Moderna, appear to be more than 90 percent effective. The Johnson & Johnson vaccine also looks to be quite effective. Thus far, the side effects seem tolerable. If there’s a problem with the vaccines, it’s that production has not kept up with demand and rich countries are scooping up the majority of available doses, leaving poorer countries to fend for themselves.

But behind the scenes, there’s a lot we don’t know, especially about the vaccines made by Pfizer and Moderna, which employ a completely novel technology involving mRNA, a type of genetic material. The reason we don’t know it is because of a decision made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will. That might sound like the kind of hairsplitting that hardly matters when a pandemic is raging and people’s lives are at stake, but it does matter for future vaccination campaigns. It’s worth considering why the FDA did it and whether or not that’s how vaccines and other medical products should be regulated in the future.

[….]

Even before the first vaccine came out, there were worries the FDA would not hold the companies’ feet to the fire and make them finish the trials. In an editorial published on September 10, Howard Bauchner, the editor in chief of the Journal of the American Medical Association and colleagues wrote, “prematurely approving a vaccine could undermine Covid-19 vaccine efforts and erode confidence in vaccines more generally.”

Bauchner and others also predicted that once the shots were available to the public, study volunteers would leave the vaccine trials in droves in order to find out if they had gotten the real vaccine or a placebo (dummy shot) – so they could get the vaccine as soon as possible if they were on placebo. That would undermine the studies, effectively stopping them after just a median of two months of data had been collected. Once the studies were stopped and the vaccines were released to the general population, it would be very hard to track side effects and efficacy.

[….]

Back in September, Anthony Fauci, who was then head of President Trump’s Covid-19 task force and remains the chief of the National Institute of Allergy and Infectious Diseases, had already proposed a clever plan. He recommended a “blinded crossover design.” Volunteers who had been in the placebo group would be given the real vaccine, while vaccine recipients would receive placebo—without anybody being told which they had gotten first. In this way, all volunteers would receive the vaccine while allowing ongoing surveillance regarding long term safety and efficacy. When the FDA called in Steven Goodman, an expert in clinical trial design from Stanford, he too endorsed the blinded crossover design, which is commonly used in medical research.

The manufacturers were less than enthusiastic. They told the FDA that executing crossover studies would be “onerous.” In this case, that word translates to “expensive,” and there’s no doubt that continuing the trials would cost more money. Not to mention the fact that the longer the trials went, the more likely it would have been that the vaccines would look a little worse than they did at first, at least in some populations, like people with immune disorders. That’s precisely the kind of data the FDA needs to protect the public health. Nevertheless, with a solution offered by top experts on the one hand, and industry opposition on the other, FDA higher ups made their decision. Instead of insisting on the trials continuing, they asked the companies to “inform the agency” of their plans. Was it pressure from the Trump White House, members of Congress, or some other reason the FDA caved to industry, as often happens? We can’t be sure, but the testing design Fauci and Goodman endorsed would have let the wider public get the vaccine just as quickly.

This decision to cut the trials short could come back to haunt the FDA. For one thing, getting more data could have reassured millions of Americans who are currently “vaccine hesitant” that the agency is looking out for them.

[….]

Another reason longer trials would have been good policy: Public health officials and individual patients would probably like to know who is least likely to be protected by the vaccines and who is most vulnerable to their side effects. Diana Zuckerman, president of the non-profit National Center for Health Research, says, “I’m especially concerned that Pfizer’s vaccine trials included only five people aged 75 and older who were diagnosed with Covid-19.” She adds: “That makes it impossible to determine how effective the vaccine is for frail elderly patients.”

[….]

This episode in the annals of potentially wrongheaded FDA decisions bears directly on the Biden administration’s decision about who to nominate as FDA commissioner. The two top picks are Janet Woodcock, current acting commissioner and 35-year veteran at the agency versus Joshua Sharfstein, vice dean for public health practice at Johns Hopkins. Both are physicians and both have experience at the agency, and that’s pretty much where the similarity between them ends. Woodcock has presided over many of the most questionable drug approvals the FDA has made in recent memory. She sees industry as a “partner,” and she’s the preferred candidate of Pharma, device makers, and several patient groups, most of which receive industry funding – precisely because she has weakened the FDA’s oversight.

Sharfstein comes with a public health perspective and an acute awareness of the need to rebuild the agency’s reputation as independent from both politics and industry. As deputy commissioner of the FDA during the Obama presidency, he proved his mettle when he headed an internal investigation into the approval of an ineffective and harmful medical device.

[….]

Whoever the Biden administration chooses, whether it’s Sharfstein, Woodcock or someone else, Americans need to know the agency charged with protecting their health from dangerous medical products is, as the president often says, “following the science,” rather than the pleas of industry. We should be thankful that we have Covid-19 jabs that can help free us from this plague year. But we may never have the full story on them. The FDA can do a better job in the future.

To read the entire article, click here.

The Differences Between the Vaccines Matter

Hilda Bastian, The Atlantic: March 7, 2021


Public-health officials are enthusiastic about the new, single-shot COVID-19 vaccine from Johnson & Johnson, despite its having a somewhat lower efficacy at preventing symptomatic illness than other available options. Although clinical-trial data peg that rate at 72 percent in the United States, compared with 94 and 95 percent for the Moderna and Pfizer-BioNTech vaccines, many experts say we shouldn’t fixate on those numbers. Much more germane, they say, is the fact that the Johnson & Johnson shot, like the other two, is essentially perfect when it comes to preventing the gravest outcomes. “I’m super-pumped about this,” Virginia’s vaccine coordinator told The New York Times last weekend. “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.”

The same glowing message—that the COVID-19 vaccines are all equivalent, at least where it really counts—has been getting public-health officials and pundits super-pumped for weeks now. Its potential value for promoting vaccination couldn’t be more clear: We’ll all be better off, and this nightmare will be over sooner, if people know that the best vaccine of all is whichever one they can get the soonest. With that in mind, Vox has urged its readers to attend to “the most important vaccine statistic”—the fact that “there have been zero cases of hospitalization or death in clinical trials for all of these vaccines.” The physician and CNN medical analyst Leana Wen also made a point of noting that “all of the vaccines are essentially a hundred percent” in this regard. And half a dozen former members of President Joe Biden’s COVID-19 Advisory Board wrote in USA Today, “Varying ‘effectiveness’ rates miss the most important point: The vaccines were all 100% effective in the vaccine trials in stopping hospitalizations and death.”

There’s a problem here. It’s certainly true that all three of the FDA-authorized vaccines are very good—amazing, even—at protecting people’s health. No one should refrain from seeking vaccination on the theory that any might be second-rate. But it’s also true that the COVID-19 vaccines aren’t all the same: Some are more effective than others at preventing illness, for example; some cause fewer adverse reactions; some are more convenient; some were made using more familiar methods and technologies. As for the claim that the vaccines have proved perfectly and equally effective at preventing hospitalization and death? It’s just not right.

[….]

The data were indeed suggestive of an encouraging idea. Based on the numbers so far, we can expect the vaccines to provide extremely high levels of protection against the most dire outcomes. Still, we don’t know how high—and it’s clear they won’t uniformly cause hospitalizations and deaths from COVID-19 to disappear in vaccinated people.

The experts understand this, of course. Gandhi has been updating her table as more data come in, and now pegs Moderna’s efficacy on that front at 97 percent; Jha has since tweeted that “nothing is 100 percent … But these vaccines sure are close”; and Topol told The Atlantic that the numbers in his tweet are not a sufficient basis from which to draw “any determination of magnitude of effect,” though the fact that they all point in the same direction is “very encouraging.” Still, the message of perfection that their initial tables and tweets spawned—the gist, for many readers, of all those 100s and zeros—has since been picked up far and wide, and misinterpreted along the way.

For the AstraZeneca vaccine, one person in the control group had severe COVID-19, but eight people were hospitalized; for Johnson & Johnson, 34 people in the placebo group had severe COVID-19, but only five people were hospitalized. It’s true that zero vaccinated people were hospitalized in either study after the vaccines took effect. But with numbers that small, you can’t draw a reliable conclusion about how high efficacy may be for these outcomes. As Diana Zuckerman of the National Center for Health Research pointed out about the Johnson & Johnson trial, “It’s misleading to tell the public that nobody who was vaccinated was hospitalized unless you also tell them that only 5 people in the placebo group were hospitalized.” She’s right. And you can’t be confident about predicting effectiveness precisely in a wider population outside the trial, either. For example, some of the vaccine trials included relatively few people older than 60 as participants.

You can see how fragile these numbers are by looking at those compiled for severe disease. In the Pfizer trial, for example, just one vaccinated person developed severe COVID-19 versus three in the placebo group—which meant that a single bout of disease made the difference between a calculated efficacy rate of 66 percent and one of 100 percent. For the Novavax and Oxford-AstraZeneca trials, there were zero people with severe disease in the vaccinated group versus only one in the control group, so adding or subtracting one would have been even more dramatic. The problem is even greater for deaths. For that efficacy analysis, only two of the vaccine trials—for Moderna’s and Johnson & Johnson’s—reported any COVID-19 deaths at all in the control groups.

It’s also important to remember that these are early results: Some people who enrolled very late in the trials aren’t yet included in reported data, and analysis is still under way. Indeed, the FDA pointed out in December that one vaccinated person in the Moderna trial had been hospitalized with apparently severe COVID-19 two months after receiving a second dose. That person was in a group still awaiting final assessment by the researchers, and was not mentioned in Moderna’s formal readout of results.

[….]

 

“The idea that people can’t handle nuance,” Jha tweeted at the end of February, “it’s paternalistic. And untrue.” I couldn’t agree more. The principle of treating people like adults is fundamental. We don’t need to exaggerate. Talking about the trade-offs between different medicines and vaccines is often complicated, but we do it all the time—and we can do it with COVID-19 vaccines too.

To read the entire article, click here

Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors

Nicholas Florko, STAT News: March 1, 2021


In 2000, the Food and Drug Administration approved just three cancer drugs. Last year, even with the agency laser-focused on the coronavirus pandemic, much of its staff teleworking, the agency still approved a record-breaking 17 different cancer therapies — more than in any other category. That’s the legacy of FDA drug center chief Janet Woodcock. Woodcock, a 36-year veteran of the agency, is infamous for pushing the FDA to loosen its standards for drugs for rare conditions like Duchenne muscular dystrophy. But Woodcock’s most lasting impact at the FDA is her transformation of the way the agency approaches cancer drug approvals….. Now the nation’s top cancer doctors are emerging as Woodcock’s most vocal backers in her campaign to become President Biden’s FDA commissioner.

Critics say Woodcock’s cancer crusade has come at a cost. With the speed has come an erosion of the agency’s high standards and an increasing willingness to greenlight drugs that haven’t actually been proven to extend a patient’s life. … Their complaint mostly revolves around Woodcock’s willingness to accept studies testing drugs based on so-called surrogate endpoints, measures like the shrinkage of a tumor, rather testing a drug based on how long it keeps a patient alive. ….It’s a view that even some former FDA officials hold; one described Woodcock as pushing “flexibility even at the expense of science.”

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“For many cancers there is an improvement in survival, the question is which drugs are responsible for that and which ones aren’t, that’s the big unknown and that’s what’s so frustrating,” said Diana Zuckerman, the president of the National Center for Health Research. The end result of this confusion, critics argue, is that doctors and patients are left guessing whether a drug is truly effective, or worth the money.

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