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NEWS

“ Health Equity Tourism ” Does More Harm Than Good for Racial Disparities in Medicine

Following the National Institutes of Health ( NIH ) announcement that it would provide $ 100 million in health equity research funding after the COVID-19 pandemic and the murder of George Floyd placed a spotlight on severe racial and ethnic disparities in the
IMBRUVICA ® ( ibrutinib )
Reduce the recommended dose when administering IMBRUVICA to patients with mild or moderate hepatic impairment ( Child-Pugh class A and B ). Monitor patients more frequently for adverse reactions of IMBRUVICA [ see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 ) in Full Prescribing Information ]. Plasmapheresis : Management of hyperviscosity in WM patients may include plasmapheresis before and during treatment with IMBRUVICA . Modifications to IMBRUVICA dosing are not required .
PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ).
• Hemorrhage : Inform patients of the possibility of bleeding , and to report any signs or symptoms ( severe headache , blood in stools or urine , prolonged or uncontrolled bleeding ). Inform the patient that IMBRUVICA may need to be interrupted for medical or dental procedures [ see Warnings and Precautions ].
• Infections : Inform patients of the possibility of serious infection , and to report any signs or symptoms ( fever , chills , weakness , confusion ) suggestive of infection [ see Warnings and Precautions ].
• Cardiac arrhythmias and cardiac failure : Counsel patients to report any signs of palpitations , lightheadedness , dizziness , fainting , shortness of breath , chest discomfort , or edema [ see Warnings and Precautions ].
• Hypertension : Inform patients that high blood pressure has occurred in patients taking IMBRUVICA , which may require treatment with antihypertensive therapy [ see Warnings and Precautions ].
• Second primary malignancies : Inform patients that other malignancies have occurred in patients who have been treated with IMBRUVICA , including skin cancers and other carcinomas [ see Warnings and Precautions ].
• Tumor lysis syndrome : Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [ see Warnings and Precautions ].
• Embryo-fetal toxicity : Advise women of the potential risk to a fetus . Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions , Use in Specific Populations ]. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [ see Use in Specific Populations ]. Advise males with female partners of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose [ see Use in Specific Populations , Nonclinical Toxicology ( 13.1 ) in Full Prescribing Information ].
• Lactation : Advise women not to breastfeed during treatment with IMBRUVICA and for 1 week after the last dose [ see Use in Specific Populations ].
• Inform patients to take IMBRUVICA orally once daily according to their physician ’ s instructions and that the oral dosage ( capsules or tablets ) should be swallowed whole with a glass of water without opening , breaking or chewing the capsules or cutting , crushing or chewing the tablets approximately the same time each day [ see Dosage and Administration ( 2.1 ) in Full Prescribing Information ].
• Advise patients that in the event of a missed daily dose of IMBRUVICA , it should be taken as soon as possible on the same day with a return to the normal schedule the following day . Patients should not take extra doses to make up the missed dose [ see Dosage and Administration ( 2.1 ) in Full Prescribing Information ].
• Advise patients of the common side effects associated with IMBRUVICA [ see Adverse Reactions ]. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION .
• Advise patients to inform their health care providers of all concomitant medications , including prescription medicines , over-the-counter drugs , vitamins , and herbal products [ see Drug Interactions ].
• Advise patients that they may experience loose stools or diarrhea and should contact their doctor if their diarrhea persists . Advise patients to maintain adequate hydration [ see Adverse Reactions ].
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Distributed and Marketed by : Pharmacyclics LLC Sunnyvale , CA USA 94085 and Marketed by : Janssen Biotech , Inc . Horsham , PA USA 19044
Patent http :// www . imbruvica . com IMBRUVICA ® is a registered trademark owned by Pharmacyclics LLC
© Pharmacyclics LLC 2020 © Janssen Biotech , Inc . 2020 PRC-07288
U . S ., researchers are clamoring for grants to publish papers on the topic . However , a STAT investigation found that many of these researchers have little to no background or training in health equity research – and are often white and already well-funded . In dozens of cases , white researchers were found to be building on the work of Black and brown researchers without citing them or offering to include them as coauthors or on grants .
For instance , in August , the Journal of the American Medical Association ( JAMA ) published a special themed issue on racial and ethnic disparities in medicine . Of the five research papers published in the issue , none had a Black lead or corresponding author , and only one had a Hispanic lead author .
The gold rush for health equity research funding presents a threat to Black researchers ’ careers . Newcomers to health equity research may be taking opportunities away from scientists of color in one of the few areas of academic medicine where they have historically worked and led by taking cuts of the still limited funding directed toward health equity research . “ It all comes down to the tenure system . If we ’ re not getting funded , we ’ re not going to get promoted ,” said Whitney Sewell , PhD , MSW , a lecturer in population medicine at Harvard Medical School who studies HIV prevention in Black women .
Additionally , scientists who are new and unskilled in the field of health equity may be producing low quality work that could underestimate or inaccurately report disparities . One such study , published by JAMA Network Open in June , indicated that COVID-19 death rates were higher in Black patients than white patients because they were more likely to be treated at poorerperforming hospitals .
Jorge A . Caballero , MD , a San Francisco Bay Area anesthesiologist and cofounder of Coders Against COVID , told STAT that the study contained major data gaps that may have minimized true disparities . The paper did not consider ethnicity and grouped Hispanic patients with white patients , most likely shrinking the disparity in mortality between white and Black patients . Patients who did not have six months of continuous insurance coverage in 2019 were excluded , meaning the paper was more likely to exclude Black people , who tend to be less likely to have stable health coverage .
“ These are just glaring deficiencies that are obvious to BIPOC subject matter experts ,” said Dr . Caballero . “ On the one hand , you don ’ t want to discourage the work , but this particular paper could do more harm than good ,” he said . “ It makes it seem like the disparities aren ’ t as pronounced as they really are .”
Source : STAT , September 23 , 2021 .
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