FDA approves LIKMEZ as the brand name for Metronidazole Oral Suspension (LIKMEZ is a Trademark of Saptalis Pharmaceuticals, LLC)
Currently LIKMEZ is the only liquid oral suspension of metronidazole approved in the U.S.
Patent coverage provides drug market exclusivity through at least 2039
For patients with acute myeloid leukemia (AML), especially those who are older or have relapsed/refractory disease, standard chemotherapy treatments often fail to change their poor clinical trajectories. These days, however, a new era of targeted therapy is improving prognoses somewhat — and raising hopes that even bigger advancements are on the horizon.
"We went almost 3 decades with nothing, then all of a sudden we've had nine approvals in 5 or 6 years," said Harvard Medical School, Boston, leukemia specialist Amir Fathi, MD, in an interview. "We've had a lot of advancement and a number of good options emerge."
However, Dr. Fathi and other hematologists cautioned that the treatment landscape is becoming more complex to navigate. And they noted that prognoses for many older patients with AML remain grim. The expensive new treatments may only extend their lifespans by a matter of months, although some are surviving for years.
As the specialists explained, there are a variety of reasons why AML is especially difficult to treat.
"AML is one of the fastest growing human cancers, with tumor cell doubling times measured in mere hours in some patients. Therefore patients can present critically ill with white blood cell counts in the hundreds of cells/mcl compared to the normal range of 4-11 cells/mcl," said leukemia specialist Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. "Because blood cells are found in every organ of the body, the sheer volume of rapidly growing cancer cells can overwhelm multiple organ systems in a very short amount of time. These rapid growing cells and the fact that the median age of diagnosis with AML is 67-70 years old makes this a clinically challenging cancer to treat. Chemotherapy strong enough to kill cancer cells run the risk of also harming the patient as well."
Also, older patients often have comorbidities, and they face risks of infection from both the disease and its treatments, said AML specialist Nicole R. Grieselhuber, MD, PhD, of the Ohio State University, Columbus, in an interview.
Enter targeted therapy, which "has allowed individuals who previously were not candidates for cytotoxic chemotherapy because of their age or possible toxicities to receive effective therapy for AML," Dr. Wang said. "Therapy directed at specific biological features of AML cells such as mutations (FLT3, IDH1, IDH2) or surface proteins (CD33) can augment the efficacy of conventional chemotherapy or in some cases (i.e., FLT3 inhibitors) be more effective than chemotherapy in controlling AML."
Targeted therapy drugs "are expected to more selectively kill cancer cells and spare normal counterparts," she added.
The FDA has approved nine targeted therapy drugs for AML in the last few years.
Retinoic acid and arsenic trioxide therapy for acute promyelocytic leukemia "has transformed this AML subtype into one of the most curable AML diseases," Dr. Wang said. A 2017 long-term analysis of the drug combination found that complete remission was reached in 96% of 54 high-risk patients and 133 low-risk patients; the 5-year survival rate was 88%. (Some patients also received gemtuzumab ozogamicin, a CD33 antibody-drug conjugate.)
According to Dr. Wang, three FLT3 inhibitors have been approved for AML with the FLT3 mutation: midostaurin and quizartinib in the frontline setting in conjunction with intensive chemotherapy and gilteritinib for relapsed/refractory FLT3-mutant AML.
A 2017 study linked midostaurin plus chemotherapy to longer survival (hazard ratio for death = 0.78; P = .009), versus placebo plus chemotherapy, in patients aged 18-59. This year, a phase 3 randomized trial of quizartinib versus placebo linked the drug to longer survival median overall (31.9 months versus 15.1 months; P = .032) In a 2019 trial, patients who took gilteritinib had longer median overall survival (9.3 months versus 5.6 months; HR for death = 0.64; P < .001).
The success of these treatments "has led FLT3 mutant AML to be reclassified from a poor risk AML subtype to intermediate risk AML," Dr. Wang said.
A 2022 report about FLT3 inhibitors cautioned, however, that "several drug resistance mechanisms have been identified" and added that "the benefit of FLT3 inhibitor maintenance therapy, either post-chemotherapy or post-transplant, remains controversial, although several studies are ongoing."
Gemtuzumab ozogamicin is a monoclonal antibody connected to a chemotherapy drug, according to the American Cancer Society. "The addition of gemtuzumab ozogamicin to intensive chemotherapy has enhanced outcomes of favorable and intermediate risk disease," Dr. Wang said.
Ivosidenib, olutasidenib, and enasidenib target the IDH1 or IDH2 genes in ADL. "These drugs seem to work by helping the leukemia cells mature (differentiate) into more normal cells," according to the American Cancer Society. "Because of this, they are sometimes referred to as differentiation agents."
In older adults, a combination treatment with venetoclax, a BCL-2 inhibitor, and a hypomethylating agent has become standard, Ohio State's Dr. Grieselhuber said. The treatment is FDA approved.
There are caveats to targeted therapy in AML. The treatments can be enormously expensive, "and even patients with insurance are often shocked by the copay," Dr. Grieselhuber said. It helps to work with pharmacists, social workers, or nurse navigators to help patients afford the treatments, she said.
Side effects vary by therapy and can include QT elongation and differentiation syndrome.
Most challenging of all, many AML patients still face shortened lifespans even if new treatments are available for them.
"Typically for older patients with AML, the lifespan of patients with therapy was 5-7 months and without therapy was 2-3 months," Dr. Wang said. "Now, with regimens specifically designed for elderly and/or unfit subjects, many individuals are now routinely living more than a year: 14-18 months to 3-4 years."
But "the vast majority of AML patients will still die of their disease with overall 5-year outcomes still less than 30% in all age categories," she said. In addition, "fewer than 50% of AML patients are eligible for treatment with FDA-approved targeted therapies, as their disease biology does not express the mutation or protein needed for efficacy."
Still, she said, "this represents a vast improvement." And, she added, "in younger individuals, the combination of chemotherapy followed by allogeneic transplant has now permitted more of these individuals to be cured of their disease." Dr. Grieselhuber noted that transplants are now considered appropriate even for patients in their 60s or early 70s, and they can be combined with targeted therapy.
Dr. Grieselhuber urged colleagues to keep in mind that quality-of-life preferences will play a role in some patient choices. For example, a elderly patient may reject burdensome infusion therapy and choose a pill instead, even if it has less efficacy. "There's really no one-size-fits-all," she said.
And, she added, it can be difficult to make choices about treatment because of the lack of randomized, head-to-head data regarding new therapies.
What's on the horizon? Dr. Wang highlighted a novel class of targeted therapies called menin inhibitors for patients with NPM1-mutated AML, which she said accounts for one-third of patients with the disease. A treatment targeting disease in the 5%-10% patients with the KMT2A gene is also in the works, she said.
For now, Dr. Wang said it's essential for clinicians "to perform timely comprehensive molecular and genomic tests on all AML patients at diagnosis and relapse to determine which individuals would benefit from targeted therapy versus cytotoxic chemotherapy. And participation in clinical trials at every stage of AML therapy can help accelerate clinical development of new agents for this disease."
Dr. Fathi discloses relationships with Daiichi Sankyo, Pfizer, Rigel, Autolus, Amgen, Servier, Takeda, Orum, Menarini, Remix, AbbVie, Astellas, BMS, Ibsen, Gilead, Genentech, and AstraZeneca. Dr. Wang discloses ties with AbbVie, Astellas, BMS, CTI Biopharma, Daiichi Sankyo, Gilead, GSK, Johnson & Johnson, Kite, Kura, Novartis, Pfizer, Rigel, Sellas, and Sumitomo Pharma. Dr. Grieselhuber has no disclosures.
https://www.medscape.com/s/viewarticle/996821
President Biden’s dog, Commander, bit another Secret Service agent at the White House on Monday, the Secret Service confirmed.
“Yesterday around 8pm, a Secret Service Uniformed Division police officer came in contact with a First Family pet and was bitten. The officer was treated by medical personnel on complex,” spokesperson Anthony Guglielmi said in a statement Tuesday.
A record 1,889 physicians applied to take the 2023 American Board of Obesity Medicine (ABOM) certification exam, which tests doctors for their competency in treating obesity. Physician candidates will take the test between October 2-14, 2023 at Pearson VUE computer-based testing centers throughout the United States and Canada.
The 1,889 exam candidates represent more than a dozen fields of medicine including internal medicine (38%), family medicine (30%), pediatrics (6%), endocrinology (5%), surgery (4%), gastroenterology (3%) and obstetrics/gynecology (3%). They come from all 50 states, the District of Columbia, Puerto Rico, and include 57 physicians from Canada.
The exam candidates will look to join the more than 6,700 physicians who are already certified ABOM Diplomates. Since 2020, ABOM has added more than 2,500 new Diplomates.
“We hear from our Diplomates that they seek certification to demonstrate their knowledge and skill in treating obesity—an area that many have learned little about during their prior medical training,” said ABOM Board Chair Judith Korner, MD, PhD. “With recognition of obesity as a complex chronic disease and continuing advancements in effective treatment options, we believe the desire to provide the best possible care for patients with obesity will continue to attract physicians to this rapidly growing field.”
Long COVID patients had specific differences in immune and hormone function than other people, blood tests showed.
Compared with matched controls, people with long COVID had marked differences in circulating myeloid and lymphocyte populations, reported Akiko Iwasaki, PhD, of Yale University in New Haven, Connecticut, and co-authors in Nature.
Long COVID patients had exaggerated humoral responses directed against SARS-CoV-2. In addition, their antibody responses were higher against other pathogens that weren't SARS-CoV-2, especially Epstein-Barr virus (EBV).
An algorithm that incorporated blood test and self-reported survey data showed diagnostic potential with an area under the curve (AUC) of 0.94, Iwasaki and co-authors found.
"We found a number of immunological and hormonal factors that collectively are able to distinguish people with versus without long COVID at 94% accuracy," Iwasaki told MedPage Today. "This study speaks to the underlying biological causes of long COVID and provides a basis for future studies that interrogate various therapies that target the root causes of this disease."
"The reduced cortisol levels found in the long COVID patients suggest hypothalamus-pituitary-adrenal imbalance," she pointed out. "The elevated activated B cells and exhausted T cells suggest persistent antigen and potentially persistent virus infection. The EBV reactivation, which was demonstrated by others also, inform about a subset of patients who may benefit from EBV-targeting therapies."
This work is "a crucial first step towards identifying a set of biological differences between people with and without long COVID" and may lead to novel blood biomarkers for an objective diagnosis of long COVID, co-author David Putrino, PhD, of Icahn Mount Sinai in New York City, told MedPage Today.
The study "provides physicians with important insights by highlighting the fact that people with long COVID show measurable signs of hormonal and immunological dysfunction, which should serve as further irrefutable evidence that long COVID is not a functional or psychosomatic diagnosis," Putrino said.
Long COVID symptoms -- ones that lasted more than 3 months after acute infection -- affected 7.5% of U.S. adults according to 2022 CDC data. By June 2023, that percentage fell to 6%.
Symptoms of long COVID can include postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements.
In their analysis, Iwasaki and colleagues evaluated data from about 273 people with and without long COVID from Yale and two Mount Sinai locations.
The researchers looked at several groups, including people with no previous SARS-CoV-2 infection, those who had fully recovered after COVID, and those with active long COVID symptoms for 4 months or longer after COVID. The median length of symptoms in the last group was 12 months after acute infection.
Participants completed questionnaires about symptoms, medical history, and health-related quality of life, and provided blood samples. Most acute infections in the long COVID group occurred early in 2020, when parental SARS-CoV-2 strains drove most new cases.
Long COVID participants had a mean age of 46 and convalescent controls had a mean age of 38, but the two groups did not differ in sex or hospitalization for acute COVID. The aggregated medical history of the two groups did not differ in baseline prevalence of anxiety or depression.
Fatigue (87%), brain fog (78%), memory difficulty (62%), and confusion (55%) were the most common self-reported symptoms in the long COVID group. Postural orthostatic tachycardia syndrome (POTS) also was prevalent; 38% of people with long COVID in the study had formal diagnostic testing and clinical evaluation. Half of participants with long COVID reported negative effects on employment status.
Serum cortisol was the most significant predictor of long COVID status. Other biomarkers indicated abnormal T cell activity and reactivation of multiple latent viruses, including EBV and other herpesviruses.
The findings on EBV, herpesviruses, and low cortisol are especially important, observed Ziyad Al-Aly, MD, of Washington University in St. Louis and chief of research and development at the VA St. Louis Healthcare System, who wasn't involved with the research.
"They may help inform treatment trials," he told MedPage Today. "For example, whether treating EBV or cortisol replacement would ameliorate symptoms and improve outcomes would need to be considered in the light of these findings."
People with long COVID often are told the disease is "all in your head," Al-Aly noted.
"This study provides objective evidence of significant differences in the immune profiles of people with long COVID versus matched controls." he said. "I hope this puts the 'it's all in your head' idea to rest."
Disclosures
This work was supported by the National Institute of Allergy and Infectious Diseases, FDA Office of Women's Health Research Centers of Excellence in Regulatory Science and Innovation, Emergent Ventures at the Mercatus Center, the Howard Hughes Medical Institute Collaborative COVID-19 Initiative, and the Howard Hughes Medical Institute.
Researchers reported relationships with UnitedHealth, Element Science, Identifeye, F-Prime, Refactor Health, Hugo Health, CMS, FDA, Johnson & Johnson, Google, Pfizer, Thyron, Boehringer Ingelheim, Pliant, AstraZeneca, RoBar, Veracyte, Galapagos, FibroGen, BMS, RIGImmune, Xanadu Bio, PanV, Paratus Sciences, InvisiShield Technologies, Roche, and Seranova Bio, and are inventors of a patent describing REAP technology.
Primary Source
Nature
Source Reference: Klein J, et al "Distinguishing features of long COVID identified through immune profiling" Nature 2023; DOI: 10.1038/s41586-023-06651-y.
Signaling what may be an emerging national trend, two influential medical groups with San Diego-based Scripps Health are cancelling their Medicare Advantage contracts for 2024 because of low reimbursement and prior authorization hassles, leaving 30,000 enrolled seniors to look for new doctors, or different coverage.
"Negotiations with the payers for MA with our medical foundation groups and Scripps Health were unsuccessful and we have been forced to withdraw from those plans due to annual losses that exceeded $75 million," Scripps CEO Chris Van Gorder told MedPage Today in an early morning email.
He said the losses are due to "low reimbursement, denials, and administrative costs to manage high utilization and out of network care."
Van Gorder emphasized that about 30,000 enrollees will have to make a change in their coverage or pick another doctor. About 1,000 physicians and advanced practitioners such as physician assistants are members of the two groups.
"We certainly regret any inconvenience to them," he said, but "that kind and size of loss is unsustainable by Scripps. We will remain in MA with our IPAs [independent physician associations] as those contracts are structured differently and of course, traditional Medicare."
The two medical groups affected are Scripps Coastal and Scripps Clinic Medical Group. Five other Scripps medical groups will continue to take MA plans, he said. Affected beneficiaries should receive a notice directly from the plans.
Enrollees "can continue to see Scripps through traditional Medicare at all our hospitals and affiliated medical groups or can switch to an independent medical group (IPA) that still maintains a MA contract at Scripps Mercy, Scripps La Jolla, and Scripps Encinitas hospitals," he added.
Patients can also switch to Kaiser Medicare Advantage during re-enrollment starting Oct. 15, or to another hospital system whose physicians still take MA plans.
However, switching to traditional Medicare without a supplemental plan -- also called a Medigap plan -- means patients incur 20% of all physician, lab, imaging, and emergency room costs, along with a $1,600 deductible per hospitalization episode this year. In California and in 44 other states, supplemental plans can reject applicants with common health conditions such as cancer, high blood pressure, a prior hospitalization, or joint replacement. In addition, these plans are expensive, with increasing monthly premiums as one gets older.
But Van Gorder said he had no choice. "We are a patient care organization and not a patient denial organization and, in many ways, the model of managed care has always been about denying or delaying care – at least economically. That is why denials, [prior] authorizations and administrative processes have become a very big issue for physicians and hospitals – not to mention that the reimbursement is insufficient in most government programs as we all know."
"Now with intermediaries taking their profit and offering insurance to beneficiaries for free in many cases [the extra benefits like trips to the doctor], the end of the economic food chain is once again the hospitals and physicians."
Van Gorder said patients should ask themselves, "'Am I receiving the care I need if my hospital and physician are not even covering their costs? How long is that sustainable?'"
Where these patients will go is an open question.
More than half of all Medicare beneficiaries are now enrolled in MA plans nationally. In San Diego County, the fifth largest in the country, that percentage is 54% of those eligible.
Nate Kaufman, a San Diego-based health system consultant, wasn't surprised at Scripps' news.
"I advise all hospitals to terminate their Medicare Advantage plans with anybody unless they're getting over 115% of Medicare," Kaufman told MedPage Today.
The problem is complicated, but in a nutshell the issue is a lack of funds to go around to pay hospitals and doctors the cost of care.
Medicare's contracts with Medicare Advantage plans pay less than what Medicare pays for traditional Medicare enrollees on the expectation that the plans will save money," Kaufman said. "Then, the MA plan takes a piece off the top. The remaining funds go into two buckets. One for MA plan pharmacy benefits and the other for hospital and physicians. And that requires a major reduction in utilization to maintain profitability."
Kaufman said all of this is made worse by the issue of prior authorization, which is now under Congressional scrutiny.
"It creates hassles for everybody and cost," he said. "The foundation upon which Medicare Advantage was built, which was that there's excess money somewhere, has disappeared after the insurance company takes their cut off the top and captures the pharmacy rebates."
Additionally, providers are seeing delays in getting paid, which carries its own cost. And because enrollees pay very low or no premiums, there are less funds for most of the providers, he said.
The issue is likely to keep many independent insurance agents busy. Christopher Westfall of Senior Savings Network, who is licensed to write Medicare contracts in 47 states, also sees providers ending their MA relationships as a national trend.
He said it can be extremely frustrating for his agents when seniors either don't check their plan or choose the wrong plan thinking their provider is in network, only to find out after Jan. 1 that their doctors are in different plans, or have dropped out.
Many health systems have announced that they're terminating their MA contracts, or are strongly considering it.
The Mayo Clinic in Jacksonville, Florida, and Scottsdale, Arizona, told beneficiaries last October that it would no longer take most MA plans. If those patients sought care, it would be considered out-of-network, leaving them with a higher share of the costs.
Samaritan Health Services in Corvallis, Oregon, ended its MA contracts with UnitedHealthcare, one of the largest Medicare Advantage contractors in the country.
Regional Medical Center in Cameron, Missouri terminated contracts with Cigna's MA plans in 2023, and planned to drop Aetna and Humana MA contracts in 2024. Cameron's Regional CEO Joe Abrutz blamed the plans' practice of "delaying any action on reimbursement."
Stillwater Medical Center, a 117-bed hospital in Oklahoma, called it quits last year with all of its in-network MA plans, blaming rising operating costs and a 22% prior authorization denial rate, compared with a 1% denial rate for traditional Medicare.
Brookings Health System, a 49-bed hospital in South Dakota, won't be in network with any MA plan starting in January to preserve its financial sustainability.
St. Charles Health System in Oregon encouraged its seniors not to enroll in MA this year as it re-evaluates its participation in Medicare Advantage contracts.
And Baptist Health Medical Group in Louisville, Kentucky failed to agree on terms by its deadline with Humana's Medicare Advantage plan and alerted their patients to seek other options.
Officials for the Medicare Advantage industry had not returned requests for comment as of press time.
https://www.medpagetoday.com/special-reports/exclusives/106483
The White House Cancer Moonshot
recently announced new efforts to "End Cancer as We Know It." Yet, the announcement includes no mention of the FDA, which is not only directed at protecting and promoting the public health but also has existing powers that could reduce cancer deaths and harms more rapidly than any existing or planned Cancer Moonshot initiatives.
The Moonshot announcement stresses the fact that smoking is the "biggest single driver of cancer deaths in this country." But its newly announced anti-smoking measures are remarkably weak and indirect, focusing largely on increasing cessation services and related smoker awareness. In particular, one new initiative would provide $15 million over 5 years to help increase implementation and enforcement of policies to increase awareness of smoking cessation services among disadvantaged smokers or prohibit the sale of menthol or other flavored tobacco products. But $15 million over 5 years is a drop in the bucket compared to the tobacco industry's expenditures of more than $7.5 billion per year to promote cigarettes.
Moreover, any new efforts to support state and local policies to prohibit flavored tobacco products would be largely unnecessary if FDA implemented its long-overdue final rules to ban menthol cigarettes (the only added-flavor cigarettes currently allowed under federal law) and prohibit cigars with added flavors. By reducing youth initiation of smoking and prompting many existing smokers to quit, those two rules could sharply reduce cancer and cancer deaths. A recent University of Michigan study, for example, estimated that banning menthol cigarettes, by itself, would prevent 650,000 people from dying from smoking over the next 40 years -- and roughly one-third of those prevented deaths would have been caused by smoking-caused cancers. But FDA has not received the support it needs from the White House, either through the Cancer Moonshot or otherwise, to get those final rules issued.
The absence of any mention of FDA or any support for the FDA rules to ban menthol cigarettes and prohibit added-flavor cigars in the new Moonshot announcement is odd given that FDA has otherwise been mentioned as a participant since the Cancer Moonshot was reignited in February 2022. A March 2022 fact sheet even mentioned the planned FDA rules to ban menthol cigarettes and added-flavor cigars as a major part of the Moonshot. In addition, the federal Unified Agenda of upcoming government regulatory action has included references to the two rules for years, and the most recent Unified Agenda said that the menthol cigarette and flavored cigar final rules would be issued by August 2023.
However, FDA missed that August deadline and has subsequently stated only that it expects to issue the final rules "in the coming months." The Cancer Moonshot says nothing about this inexplicable delay in effective federal anti-cancer measures. Nor has the White House, FDA, or the Office of Management and Budget (which oversees federal regulatory efforts) provided any new deadlines or other assurances that the final rules will actually be implemented soon or at all.
If the White House and its Cancer Moonshot were truly serious about preventing and reducing cancer, they would have not only ensured that these two FDA rules were already fully implemented but would have also supported additional FDA anti-smoking rule-making that would reduce cancer deaths and harms even more quickly and sharply. Most notably, an FDA-coordinated study found that a new rule to reduce nicotine levels to non-addictive levels in cigarettes would, at a minimum, save millions of lives through reducing smoking initiation and increasing quitting. In addition, since fall 2017 the Unified Agenda has repeatedly said that FDA planned to issue a nicotine-reduction rule. But its announced date for issuing just the preliminary proposed rule has been repeatedly postponed, with the nicotine rule falling completely off the Agenda between spring 2019 and spring 2022; and implementing such a rule has never been part of the Cancer Moonshot. The most recent Unified Agenda says the proposed nicotine reduction rule will be issued before the end of this year. But if that were a real deadline that FDA was actually going to meet -- or if FDA were actually going to issue its final rules on menthol cigarettes and flavored cigars soon -- one would think the Cancer Moonshot would have at least mentioned that as a major upcoming success in federal efforts to reduce cancer deaths and harms.
Unfortunately, the White House Cancer Moonshot's failure to support these FDA anti-smoking rules is nothing new. Since 2009, when the Tobacco Control Act first provided FDA with extensive powers and resources to regulate cigarettes and other tobacco products and their labeling, marketing, distribution, and sale, no U.S. president, vice president, or major White House official has publicly expressed any support for any FDA rulemaking to prevent or reduce smoking or overall tobacco use deaths and harms.
Thanks in large part to this absence of White House support, FDA has not yet been able to implement any substantive rule that would significantly reduce smoking or overall tobacco-caused deaths and harms. Without such support (or a statutory or court-ordered deadline), it is extremely difficult for FDA to get a draft proposed or final rule successfully through the federal bureaucracy's behind-the-scenes prior review and clearance process. The Unified Agenda listings stating that FDA would issue final rules to ban menthol cigarettes and added-flavor cigars in August 2023 suggested that FDA was finally getting the White House support it needs to take effective action. But those missed deadlines and the absence of any reference to those or any other FDA anti-smoking rules in the subsequent Cancer Moonshot announcement suggests otherwise. It is also especially troubling that the White House Moonshot highlights a new initiative to support state and local policies to ban flavored tobacco products when the White House could simply ensure that FDA quickly did that nationwide instead.
This 14-year and counting absence of any major FDA tobacco control rule is a national tragedy. It is difficult to imagine any public health or policy justification for FDA not using (or not being allowed to use) its extensive tobacco control powers and resources, not only to reduce cancer deaths and harms more sharply and quickly than any other Moonshot initiative but also to prevent and reduce enormous amounts of other unnecessary smoking-caused death, disability, disease, and other harms and costs.
Eric N. Lindblom, JD, is a former official at FDA's Center for Tobacco Products and a long-time tobacco control policy analyst. He currently serves as an independent consultant to researchers, lawyers, and investors on tobacco-related issues and is a senior scholar at Georgetown Law's O'Neill Institute for National and Global Health Law.
