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83 hot topic(s) found with the query "Pcsk9"

First trial of 'base editing' in humans lowers cholesterol - but raises safety concerns.
Miryam Naddaf et al. Nature 2023 11 (Posted: Nov 14, 2023 9AM)

From the paper: "The first trial in humans of the precise gene-editing technique known as base editing has shown promising results for keeping cholesterol levels in check in patients with familial hypercholesterolemia. The approach injects into people a treatment called VERVE-101, which permanently deactivates a gene in the liver called PCSK9. That gene controls the level of low-density lipoprotein (LDL), or ‘bad’ cholesterol — a key contributor to heart disease. But the findings have also drawn criticism. Two serious adverse events in the trial, including a death, have raised safety concerns. "

Novel and future lipid-modulating therapies for the prevention of cardiovascular disease.
Julia Brandts et al. Nat Rev Cardiol 2023 4 (Posted: Apr 15, 2023 8AM)

Key proteins involved in lipoprotein metabolism, such as PCSK9, angiopoietin-related protein 3, cholesteryl ester transfer protein and apolipoprotein(a), have been identified as viable targets for therapeutic intervention through observational and genetic studies. These proteins can be targeted using a variety of approaches, such as protein inhibition or interference, inhibition of translation at the mRNA level. These novel and upcoming strategies are complementary to and could work synergistically with existing therapies, or in some cases could potentially replace therapies, offering unprecedented opportunities to prevent ASCVD.

Association of Rare Protein-Truncating DNA Variants in APOB or PCSK9 With Low-density Lipoprotein Cholesterol Level and Risk of Coronary Heart Disease.
Jacqueline S Dron et al. JAMA cardiology 2023 2 (Posted: Feb 02, 2023 6AM)

What is the prevalence of protein-truncating variants (PTVs) in the apolipoprotein B (APOB) or proprotein convertase subtilisin/kexin type 9 (PCSK9) genes and their association with low-density lipoprotein (LDL) cholesterol levels and coronary heart disease (CHD)? In this genetic association study including 19?073 US participants and 190?464 UK participants, a PTV was identified in 0.4% of individuals. Estimated untreated LDL cholesterol concentrations were 32% to 37% lower in PTV carriers vs noncarriers, and PTVs were associated with a 49% reduction in CHD risk.

Association between genetically proxied PCSK9 inhibition and prostate cancer risk: A Mendelian randomisation study.
Fang Si et al. PLoS medicine 2023 1 (1) e1003988 (Posted: Jan 04, 2023 6AM)

Using genetic variants associated with LDL cholesterol, liver-derived gene expression, and plasma protein levels, the researchers applied drug target Mendelian randomization (MR) and colocalization to examine the association between lipid-lowering drug targets and the risk of overall, early-onset, and advanced prostate cancer. Additional MR analyses were conducted to explore putative mediators of drug effects. This study provided evidence of an association between genetically proxied PCSK9 inhibition and lower risk of overall and early-onset prostate cancer supported by both MR and colocalization approaches.

Association of PCSK9 Loss-of-Function Variants With Risk of Heart Failure.
Trudsø Linea C et al. JAMA cardiology 2022 12 (Posted: Dec 23, 2022 6PM)

A pragmatic clinical trial of cascade testing for familial hypercholesterolemia.
Miller Alexandra A et al. Genetics in medicine : official journal of the American College of Medical Genetics 2022 9 (Posted: Sep 30, 2022 7AM)

We compared new cases detected per index case in familial hypercholesterolemia (FH) families with or without an identifiable monogenic etiology. We enrolled 52 FH probands with a pathogenic variant (FHg+) in LDLR, APOB, or PCSK9 and 73 probands without such a variant (FHg–). New case detection rate was significantly higher in FH families with a monogenic etiology than in those without such an etiology owing to greater uptake and yield of cascade testing.

Joint Genetic Inhibition of PCSK9 and CETP and the Association With Coronary Artery Disease: A Factorial Mendelian Randomization Study.
Cupido Arjen J et al. JAMA cardiology 2022 8 (Posted: Aug 05, 2022 8AM)

In this cohort study, a 2?×?2 factorial Mendelian randomization study including 425?354 participants from the UK Biobank, an additive association of a genetically reduced combined concentration of CETP and PCSK9 was found for lipid levels and risk of coronary artery disease, while the association of CETP with age-related macular degeneration was not mitigated. Our findings suggest that joint inhibition of CETP and PCSK9 has additive effects on lipid concentrations and clinical outcomes.

PCSK9 inhibitors and ezetimibe for the reduction of cardiovascular events: a clinical practice guideline with risk-stratified recommendations.
Hao Qiukui et al. BMJ (Clinical research ed.) 2022 5 e069066 (Posted: May 11, 2022 8AM)

For adults already using statins, the panel suggests adding a second lipid-lowering drug in people at very high and high cardiovascular risk but recommends against adding it in people at low cardiovascular risk. For adults who are intolerant to statins, the panel recommends using a lipid-lowering drug in people at very high and high cardiovascular risk but against adding it in those at low cardiovascular risk. When choosing to add another lipid-lowering drug, the panel suggests ezetimibe in preference to PCSK9 inhibitors. The panel suggests further adding a PCSK9 inhibitor to ezetimibe for adults already taking statins at very high risk and those at very high and high risk who are intolerant to statins.

Expanding Discovery in Cardiovascular Genome-Wide Association Studies
P Natarajan et al, JAMA Cardiology, June 9, 2021 (Posted: Jun 10, 2021 7AM)

Genome-wide association studies of individuals of African ancestry typically living in the US are uncommon, yet they have yielded high-impact observations, including the discovery that PCSK9 loss-of-function mutations protect against coronary artery disease. Genome-wide association studies of individuals living in Africa are even rarer, representing approximately 0.4% of GWAS participants.

Cholesterol-lowering oligonucleotides pass preclinical milestone
K O'Leary, Nature Medicine, May 20, 2021 (Posted: May 21, 2021 0PM)

PCKS9 is a protein that regulates low-density lipoprotein (LDL) cholesterol in the liver and is a promising therapeutic target for the treatment of dyslipidemia and atherosclerosis. Monoclonal antibodies directed against PCSK9 are available for clinical use, but these must be administered by injection. To overcome this limitation, a recent study developed a potent antisense oligonucleotide–based PCSK9 inhibitor (known as AZD8233) suitable for oral delivery.

Genetic Inhibition of PCSK9 and Liver Function.
Rimbert Antoine et al. JAMA cardiology 2020 Nov (Posted: Nov 05, 2020 6AM)

A ‘Cure for Heart Disease’? A Single Shot Succeeds in Monkeys
G Kolata, NY Times, June 27, 2020 (Posted: Jun 29, 2020 8AM)

In the first gene-editing experiment of its kind, scientists have disabled two genes in monkeys that raise the risk for heart disease (PCSK9 and LDL). Humans carry the genes as well, and the experiment has raised hopes that a leading killer may one day be tamed.

A Genetic Approach to the Association Between PCSK9 and Sepsis.
Feng QiPing et al. JAMA network open 2019 Sep (9) e1911130 (Posted: Sep 12, 2019 7AM)

Editorial: PCSK9 Inhibitors Prior Authorization- Redundant Process Due for a Redesign
K Nasir et al, Circulation, Cardiovascular Quality and Outcomes, July 23, 2019 (Posted: Jul 24, 2019 8AM)

In 2015, the cardiovascular community enthusiastically welcomed FDA approval of PCSK9i (proprotein convertase subtilisin/kexin type 9 inhibitors) as an additional add-on therapeutic option for managing cholesterol-related cardiovascular disease risk. However, the celebrations were short-lived.

Individuals Had More Heart Attacks and Strokes if Cardiovascular Prescription Rejected or Unfilled
The FH Foundation, July 23, 2019 (Posted: Jul 23, 2019 3PM)

Individuals with familial hypercholesterolemia, established heart disease, or extremely high risk of heart disease were found to have more cardiovascular events when PCSK9 inhibitor prescriptions were rejected or unfilled. The study analyzed almost 140,000 adults from 2015 to 2017.

Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes
D Myers et al, Cardiovasc Quality and Outcomes, July 2019 (Posted: Jul 23, 2019 8AM)

The study measured the impact on cardiovascular outcomes of high rates of prescription denials and abandonment using a comprehensive electronic healthcare dataset with over 221 million patients. Using propensity score?matched patient cohorts, we demonstrate that individuals in PCSK9i rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort.

Enhancing the value of PCSK9 monoclonal antibodies by identifying patients most likely to benefit
JG Robinson et al, JLA, June 2019 (Posted: Jun 29, 2019 5PM)

Initial pricing limited uptake of highly effective proprotein convertase subtilisin/kexin type 9 monoclonal antibodies. ?Recent price reductions call for new guidance in this National Lipid Association statement. ?Value assessment may improve access to proprotein convertase subtilisin/kexin type 9 monoclonal antibodies for appropriate patient groups such as familial hypercholesterolemia

Genetics, Dyslipidemia, and Cardiovascular Disease: New Insights.
Stein Ricardo et al. Current cardiology reports 2019 Jun (8) 68 (Posted: Jun 27, 2019 8AM)

In the last two decades, significant advances have been made in understanding the genetic basis of dyslipidemias. This review discusses current knowledge of the genetics and pathophysiology of disorders that predispose to dyslipidemia. The authors also discuss new cholesterol-lowering medications, including PCSK9 inhibitors.

Low LDL Cholesterol by PCSK9 Variation Reduces Cardiovascular Mortality.
Benn Marianne et al. Journal of the American College of Cardiology 2019 Jun (24) 3102-3114 (Posted: Jun 25, 2019 8AM)

Genetically low LDL cholesterol due to PCSK9 variation was causally associated with low risk of cardiovascular mortality in 109,566 individuals from the Copenhagen General Population Study and the Copenhagen City Heart Study

Potential utility of the SAFEHEART risk equation for rationalising the use of PCSK9 monoclonal antibodies in adults with heterozygous familial hypercholesterolemia.
Pérez de Isla Leopoldo et al. Atherosclerosis 2019 May 28640-45 (Posted: May 22, 2019 8AM)

Getting the Lower List Price for PCSK9 inhibitors
The FH Foundation, March 18, 2019 (Posted: Mar 18, 2019 5PM)

Sanofi and Regeneron lower list price for PCSK9 inhibitor
The FH Foundation, February 2019 (Posted: Feb 14, 2019 8AM)

What have we learned about lipids and cardiovascular risk from PCSK9 inhibitor outcomes trials?
Banach Maciej et al. Cardiovascular research 2019 Jan (Posted: Jan 04, 2019 9AM)

Role of PCSK9 inhibitors in high risk patients with dyslipidemia: Focus on familial hypercholesterolemia.
Papademetriou Vasilios et al. Current pharmaceutical design 2018 Oct (Posted: Oct 17, 2018 10AM)

Whole-gene duplication of PCSK9 as a novel genetic mechanism for severe familial hypercholesterolemia
MA Iacocca et al, CJC, August 2018 (Posted: Aug 09, 2018 8AM)

Large-Scale Phenome-Wide Association Study of PCSK9 Variants Demonstrates Protection Against Ischemic Stroke.
Rao Abhiram S et al. Circulation. Genomic and precision medicine 2018 Jul (7) e002162 (Posted: Jul 16, 2018 2PM)

Balancing Affordability And Access: Lessons From New Cholesterol-Lowering Drugs
JA Doshi et al, Health Affairs, June 5, 2018 (Posted: Jun 06, 2018 8AM)

PCSK9 genetic variants, life-long lowering of LDL-cholesterol and cognition: a large-scale Mendelian randomization study
D Lyall et al, BioRxIV preprints, May 31, 2018 (Posted: Jun 02, 2018 11AM)

The Pharmacologic Role and Clinical Utility of PCSK9 Inhibitors for the Treatment of Hypercholesterolemia.
White C Michael et al. Journal of cardiovascular pharmacology and therapeutics 2018 Jan 1074248418769040 (Posted: Apr 18, 2018 10AM)

Cardiovascular Event Reduction with PCSK9 Inhibition Among 1,578 Patients with Familial Hypercholesterolemia: Results from the SPIRE Randomized Trials of Bococizumab
PM Ridker et al, J CLin Lipid, Ape 2018 (Posted: Apr 07, 2018 0PM)

PCSK9 inhibitor valuation: A science-based review of the two recent models
SJ Baum et al, Clinical Cardiology, Mar 7, 2018 (Posted: Mar 07, 2018 10AM)

PCSK9 inhibitors in clinical practice: Delivering on the promise?
Atherosclerosis, Mar 2018 (Posted: Mar 01, 2018 3PM)

Proprotein Convertase Subtilisin-Kexin type-9 (PCSK9) and triglyceride-rich lipoprotein metabolism: Facts and gaps.
Baragetti Andrea et al. Pharmacological research 2018 Feb 1-11 (Posted: Feb 18, 2018 8AM)

Prescribing Patterns of Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors in Eligible Patients with Clinical Atherosclerotic Cardiovascular Disease or Heterozygous Familial Hypercholesterolemia
DG Karalis et al, Am J Cardio, Feb 2018 (Posted: Feb 18, 2018 8AM)

Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers
JA Doshi et al, Circulation Cardiovascular Disease, Jan 2018 (Posted: Jan 21, 2018 9AM)

Analysis of publicly available LDLR, APOB, and PCSK9 variants associated with familial hypercholesterolemia: application of ACMG guidelines and implications for familial hypercholesterolemia diagnosis.
Chora Joana Rita et al. Genetics in medicine : official journal of the American College of Medical Genetics 2017 Oct (Posted: Jan 03, 2018 10AM)

PCSK9 Mutations in Familial Hypercholesterolemia: from a Groundbreaking Discovery to Anti-PCSK9 Therapies.
El Khoury Petra et al. Current atherosclerosis reports 2017 Oct (12) 49 (Posted: Dec 08, 2017 10AM)

Large-scale phenome-wide association study of PCSK9 loss-of-function variants demonstrates protection against ischemic stroke
AC Rao et al, BioRXiv preprints, Oct 2017 (Posted: Oct 29, 2017 10AM)

Effect of intensive LDL cholesterol lowering with PCSK9 monoclonal antibodies on tendon xanthoma regression in familial hypercholesterolemia.
Bea Ana M et al. Atherosclerosis 2017 Aug 92-96 (Posted: Aug 22, 2017 10AM)

Cholesterol Management in the Era of PCSK9 Inhibitors.
Svatikova Anna et al. Current cardiology reports 2017 Sep (9) 83 (Posted: Aug 18, 2017 9AM)

PCSK9 inhibition in the management of familial hypercholesterolemia.
Ogura Masatsune et al. Journal of cardiology 2017 Aug (Posted: Aug 18, 2017 8AM)

PCSK9 Inhibitors, Statins, Low-Density Lipoprotein Cholesterol, Mevalonate Pathway, and Toxicity-Reply.
Koren Michael J et al. JAMA cardiology 2017 Aug (Posted: Aug 18, 2017 8AM)

PCSK9 Inhibitors, Statins, Low-Density Lipoprotein Cholesterol, Mevalonate Pathway, and Toxicity.
Guijarro Carlos et al. JAMA cardiology 2017 Aug (Posted: Aug 18, 2017 8AM)

Inconsistent Guideline Recommendations for Cardiovascular Prevention and the Debate About Zeroing in on and Zeroing LDL-C Levels With PCSK9 Inhibitors
JP Ioannidis, JAMA, July 2017 (Posted: Jul 26, 2017 3PM)

Prevention of cardiovascular disease in patients with familial hypercholesterolaemia: The role of PCSK9 inhibitors.
Pecin Ivan et al. European journal of preventive cardiology 2017 Jan 2047487317717346 (Posted: Jun 28, 2017 10AM)

PCSK9 inhibitor access barriers-issues and recommendations: Improving the access process for patients, clinicians and payers.
Baum Seth J et al. Clinical cardiology 2017 Apr 40(4) 243-254 (Posted: Jun 28, 2017 9AM)

Therapies That Target PCSK9 Effective at Reducing LDL Cholesterol.
Slomski Anita et al. JAMA 2017 May (20) 2054 (Posted: May 29, 2017 7AM)

How many familial hypercholesterolemia patients are eligible for PCSK9 inhibition?
Masana Luis et al. Atherosclerosis 2017 May 262107-112 (Posted: May 24, 2017 9AM)

Update on the use of PCSK9 inhibitors in adults: Recommendations from an Expert Panel of the National Lipid Association
CE Orringer et al, J Clin Lipidology, May 2017 (Posted: May 20, 2017 10AM)

PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease.
Schmidt Amand F et al. The Cochrane database of systematic reviews 2017 Apr CD011748 (Posted: May 20, 2017 10AM)

PCSK9 Inhibition to Reduce Cardiovascular Risk: Tempering Expectations.
Waters David D et al. Circulation research 2017 May (10) 1537-1539 (Posted: May 20, 2017 10AM)

National Lipid Association Releases Updated Recommendations on the Use of PCSK9 Inhibitors at the 15th Annual Scientific Session
National Lipid Association, May 2017 (Posted: May 20, 2017 10AM)

NLA Expert Panel on Treatment with PCSK9 Inhibitors: 2017 recommendations
National Lipid Association, May 2017 (Posted: May 20, 2017 10AM)

New data on familial hypercholesterolaemia and acute coronary syndromes: The promise of PCSK9 monoclonal antibodies in the light of recent clinical trials.
Ellis Katrina L et al. European journal of preventive cardiology 2017 Jan 2047487317708890 (Posted: May 17, 2017 9AM)

Nine paths to PCSK9 inhibition
A Mullard, Nature Rev Drug Discovery, April 2017 (Posted: Apr 28, 2017 10AM)

PCSK9 Inhibition to Reduce Cardiovascular Events.
Dullaart Robin P F et al. The New England journal of medicine 2017 Mar (Posted: Apr 02, 2017 6PM)

PCSK9 Inhibition to Reduce Cardiovascular Events
Robin P.F. Dullaart, NEJM, March 17, 2017 (Posted: Mar 17, 2017 1PM)

Old challenges and new opportunities in the clinical management of heterozygous familial hypercholesterolemia (HeFH): The promises of PCSK9 inhibitors.
Arca Marcello et al. Atherosclerosis 2016 Sep (Posted: Jan 04, 2017 11AM)

Eligibility for PCSK9 treatment in 734 Hypercholesterolemic patients referred to a regional cholesterol treatment center with LDL cholesterol ≥ 70 mg/dl despite maximal tolerated cholesterol lowering therapy.
Glueck Charles J et al. Lipids in health and disease 2016 Mar 1555 (Posted: Jan 04, 2017 11AM)

Variation in PCSK9 and HMGCR and Risk of Cardiovascular Disease and Diabetes
BA Ference et al, NEJM, November 30, 2016 (Posted: Dec 01, 2016 7AM)

Cholesterol, Cardiovascular Risk, Statins, PCSK9 Inhibitors, and the Future of LDL-C Lowering
Fatima Rodriguez, et al, JAMA, November 15, 2016 (Posted: Nov 14, 2016 6PM)

Expert consensus on the rational clinical use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
Achimastos Apostolos et al. Hormones (Athens, Greece) 2016 Jan 15(1) 8-14 (Posted: Apr 20, 2016 10AM)

Initiation of PCSK9 inhibition in patients with heterozygous familial hypercholesterolaemia entering adulthood: a new design for living with a high-risk condition?
Vuorio Alpo et al. European heart journal 2016 Feb (Posted: Feb 11, 2016 1PM)

PCSK9 Inhibitors: Good Early Responses With Pricey Drugs, but Doctors Still Waiting on Real Data
M O'Riordan. tctmd, January 27, 2016 (Posted: Jan 27, 2016 10AM)

Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors for Treatment of High Cholesterol Levels Effectiveness and Value
JA Tice, JAMA Internal Medicine, December 14, 2015 (Posted: Dec 14, 2015 11AM)

Evolocumab (Repatha)—A Second PCSK9 Inhibitor to Lower LDL-Cholesterol
JAMA, December 1, 2015 (Posted: Dec 01, 2015 5PM)

PCSK9 Inhibitors for Treating High Cholesterol
J Jin. JAMA Patient Page, December 1, 2015 (Posted: Dec 01, 2015 5PM)

PCSK9 inhibitor dramatically reduces cholesterol in patients with familial hypercholesterolemia,
European Society of Cardiology 2015 Conference Coverage, Sep 1 (Posted: Sep 02, 2015 1PM)

PCSK9 inhibitors - past, present and future.
Reiner Zeljko et al. Expert Opin Drug Metab Toxicol 2015 Aug 3. 1-5 (Posted: Aug 17, 2015 2PM)

PCSK9 Inhibitors, A Historic Change in Cardiovascular Care
Seth Baum, Preventive Cardiology, July 27, 2015 (Posted: Jul 27, 2015 10AM)

News of the Week for Many, News of a Lifetime for Those With FH: FDA PCSK9 Hearing
The FH Foundation, June 19, 2015 (Posted: Jun 22, 2015 11AM)

PCSK9 Inhibitors in the Cardiovascular Field | Ten Points to Remember
M Rubenfire, American College of Cardiology, June 15, 2015 (Posted: Jun 17, 2015 5AM)

PCSK9 Inhibition: Discovery, Current Evidence, and Potential Effects on LDL-C and Lp(a).
Ferdinand Keith C et al. Cardiovasc Drugs Ther 2015 Jun 12. (Posted: Jun 17, 2015 5AM)

VIDEO: PCSK9 inhibitors generate excitement in field of lipidology
(Posted: Jun 17, 2015 4AM)

PCSK9 variation and association with blood pressure in African Americans: preliminary findings from the HyperGEN and REGARDS studies.
Tran Ngan T et al. Front Genet 2015 136 (Posted: May 06, 2015 0PM)

PCSK9 inhibition in patients with hypercholesterolemia.
Desai Nihar R et al. Trends Cardiovasc. Med. 2015 Feb 11. (Posted: Apr 29, 2015 7PM)

PCSK9 inhibitors.
Gencer Baris et al. Swiss Med Wkly 2015 w14094 (Posted: Apr 29, 2015 7PM)

Emerging PCSK9 inhibitors for treating dyslipidaemia: buttressing the gaps in coronary prevention.
Page Michael M et al. Expert Opin Emerg Drugs 2015 Apr 10. 1-14 (Posted: Apr 29, 2015 7PM)

Mutations in PCSK9 cause autosomal dominant hypercholesterolemia.
Abifadel Marianne et al. Nat. Genet. 2003 Jun (2) 154-6 (Posted: Apr 29, 2015 7PM)

PCSK9 Inhibitors: A New Era in Lipid-Lowering Treatment?
Cainzos-Achirica Miguel et al. Ann. Intern. Med. 2015 Apr 28. (Posted: Apr 29, 2015 7PM)

Genotypic and phenotypic features in homozygous familial hypercholesterolemia caused by proprotein convertase subtilisin/kexin type 9 (PCSK9) gain-of-function mutation.
Mabuchi Hiroshi et al. Atherosclerosis 2014 Sep (1) 54-61 (Posted: Feb 28, 2015 0PM)

Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial.
Raal Frederick J et al. Lancet 2015 Jan 24. (9965) 341-50 (Posted: Feb 28, 2015 0PM)

Normalization of low-density lipoprotein receptor expression in receptor defective homozygous familial hypercholesterolemia by inhibition of PCSK9 with alirocumab.
Lambert Gilles et al. J. Am. Coll. Cardiol. 2014 Dec 2. (21) 2299-300 (Posted: Feb 28, 2015 0PM)


Disclaimer: Articles listed in Hot Topics of the Day are selected by Public Health Genomics Branch to provide current awareness of the scientific literature and news. Inclusion in the update does not necessarily represent the views of the Centers for Disease Control and Prevention nor does it imply endorsement of the article's methods or findings. CDC and DHHS assume no responsibility for the factual accuracy of the items presented. The selection, omission, or content of items does not imply any endorsement or other position taken by CDC or DHHS. Opinion, findings and conclusions expressed by the original authors of items included in the Clips, or persons quoted therein, are strictly their own and are in no way meant to represent the opinion or views of CDC or DHHS. References to publications, news sources, and non-CDC Websites are provided solely for informational purposes and do not imply endorsement by CDC or DHHS.
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