当前位置： SCI文献检索 > BRITISH JOURNAL OF CLINICAL PHARMACOLOGY期刊下所有文献 > Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

Abstract：

AIMS:This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. METHODS:Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. RESULTS:There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. CONCLUSIONS:Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators.

journal_name

Br J Clin Pharmacol

journal_title

British journal of clinical pharmacology

authors

Habibi R,Lexchin J,Mintzes B,Holbrook A

doi

10.1111/bcp.13360

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

2549-2556

issue

11

eissn

0306-5251

issn

1365-2125

journal_volume

83

pub_type

杂志文章

相关文献

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY文献大全
  • Effects of the nitric oxide synthase inhibitor ronopterin (VAS203) on renal function in healthy volunteers.

    abstract：AIMS:Reduced nitric oxide (NO) availability may adversely affect renal perfusion and glomerular filtration. The aim of the present study was to characterize in detail the pharmacological effects of VAS203, an inhibitor of NO synthase, on renal haemodynamics in humans. METHODS:This double-blind, randomized, placebo-con...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章,随机对照试验

    doi：10.1111/bcp.13870

    authors： Ott C,Bosch A,Winzer N,Friedrich S,Schinzel R,Tegtmeier F,Schmieder RE

    更新日期：2019-05-01 00:00:00

  • Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.

    abstract：AIMS:Generic products can be regarded as therapeutically equivalent and switchable with the reference product. However, switchability between generics is unknown, as direct comparisons between generics are not performed. The aim of this study was to investigate the bioequivalence between generic clopidogrel products by...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/bcp.13997

    authors： Pejčić Z,Vučićević K,García-Arieta A,Miljković B

    更新日期：2019-09-01 00:00:00

  • Do statins protect against upper gastrointestinal bleeding?

    abstract：AIMS:Recently, an apparent protective effect of statins against upper gastrointestinal bleeding (UGB) was postulated in a post hoc analysis of a randomized trial. We aimed to evaluate the effect of statin use on acute nonvariceal UGB alone or in combinations with low-dose aspirin and other antithrombotic drugs. METHOD...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.2009.03362.x

    authors： Gulmez SE,Lassen AT,Aalykke C,Dall M,Andries A,Andersen BS,Hansen JM,Andersen M,Hallas J

    更新日期：2009-04-01 00:00:00

  • Nonlinear protein binding of phenytoin in clinical practice: Development and validation of a mechanistic prediction model.

    abstract：AIMS:To individualize treatment, phenytoin doses are adjusted based on free concentrations, either measured or calculated from total concentrations. As a mechanistic protein binding model may more accurately reflect the protein binding of phenytoin than the empirical Winter-Tozer equation that is routinely used for cal...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/bcp.14053

    authors： Ter Heine R,Kane SP,Huitema ADR,Krasowski MD,van Maarseveen EM

    更新日期：2019-10-01 00:00:00

  • Lack of a relationship between the polymorphism of debrisoquine oxidation and lung cancer.

    abstract：:1. Determination of debrisoquine oxidation phenotype was carried out in 119 healthy subjects, 135 patients with chronic bronchitis and 153 patients with lung cancer, all of Caucasian origin. 2. A non-Gaussian distribution of the log D/HD ratio was observed in the three groups. 3. Assuming an antimode of 1.12, the prop...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1991.tb05575.x

    authors： Duche JC,Joanne C,Barre J,de Cremoux H,Dalphin JC,Depierre A,Brochard P,Tillement JP,Bechtel P

    更新日期：1991-05-01 00:00:00

  • Evidence for the changing regimens of acetylcysteine.

    abstract：:Paracetamol overdose prior to the introduction of acetylcysteine was associated with significant morbidity. Acetylcysteine is now the mainstay of treatment for paracetamol poisoning and has effectively reduced rates of hepatotoxicity and death. The current three-bag intravenous regimen with an initial high loading dos...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1111/bcp.12789

    authors： Chiew AL,Isbister GK,Duffull SB,Buckley NA

    更新日期：2016-03-01 00:00:00

  • Bopindolol in chronic stable angina pectoris: duration and extent of antianginal action.

    abstract：:The effects of bopindolol, a new beta-adrenoceptor blocker, on the exercise tolerance of 12 in-patients, mean age 57 (5 years), with stable angina pectoris and documented coronary artery disease were evaluated. All patients received on 4 different days a single oral dose of bopindolol 0.5 mg, bopindolol 1.0 mg, bopind...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：

    authors： Carboni GP,Scardovi AB,D'Ermo M,Prati PL

    更新日期：1991-12-01 00:00:00

  • Management of hypertension in the elderly: attitudes of general practitioners and hospital physicians.

    abstract：:1. The attitudes of general practitioners and hospital physicians to the management of hypertension in the elderly, were examined by responses to a postal questionnaire distributed within the Northern Region, concerning the management of a healthy 75 year old male non-smoker with sustained diastolic or isolated systol...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1995.tb04481.x

    authors： Ford GA,Asghar MN

    更新日期：1995-05-01 00:00:00

  • Cimetidine, but not oxmetidine, penetrates into the cerebrospinal fluid after a single intravenous dose.

    abstract：:1 Thirty-six patients with various neurological diseases or symptoms received single intravenous doses of either cimetidine 400 mg (n = 19) or oxmetidine 200 mg (n = 17), 15 or 60 min before a diagnostic lumbar puncture. 2 In the 15 min CSF samples concentrations of cimetidine were detectable but not measurable in 5 a...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1111/j.1365-2125.1982.tb02042.x

    authors： Jönsson KA,Eriksson SE,Kagevi I,Norlander B,Bodemar G,Walan A

    更新日期：1982-12-01 00:00:00

  • Incidence and risk factors of major bleeding following major orthopaedic surgery with fondaparinux thromboprophylaxis. A time-to-event analysis.

    abstract：AIMS:Increased exposure to fondaparinux, as observed in patients with renal impairment, may increase bleeding risk. This study aims to determine the time course of major bleeding after major orthopaedic surgery, identify predictors of bleeding and simulate the effect of a reduced dose of fondaparinux on bleeding for pa...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章,多中心研究

    doi：10.1111/bcp.13663

    authors： Zufferey PJ,Ollier E,Delavenne X,Laporte S,Mismetti P,Duffull SB

    更新日期：2018-10-01 00:00:00

  • Pharmacokinetics, pharmacodynamics, long-term efficacy and safety of oral 1-deamino-8-D-arginine vasopressin in adult patients with central diabetes insipidus.

    abstract：:1. The pharmacokinetics and pharmacodynamics of intranasal (IN) and oral 1-deamino-8-D-arginine vasopressin (DDAVP) were compared in 10 Chinese adults with central diabetes insipidus previously controlled on IN DDAVP. This was followed by comparison of the acute pharmacodynamics of commonly used oral preparations (con...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1046/j.1365-2125.1996.39914.x

    authors： Lam KS,Wat MS,Choi KL,Ip TP,Pang RW,Kumana CR

    更新日期：1996-09-01 00:00:00

  • Effect of P-glycoprotein inhibition at the blood-brain barrier on brain distribution of (R)-[11 C]verapamil in elderly vs. young subjects.

    abstract：AIMS:The efflux transporter P-glycoprotein (ABCB1) acts at the blood-brain barrier (BBB) to restrict the distribution of many different drugs from blood to the brain. Previous data suggest an age-associated decrease in the expression and function of ABCB1 at the BBB. In the present study, we investigated the influence ...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1111/bcp.13301

    authors： Bauer M,Wulkersdorfer B,Karch R,Philippe C,Jäger W,Stanek J,Wadsak W,Hacker M,Zeitlinger M,Langer O

    更新日期：2017-09-01 00:00:00

  • Evaluation of long-term treatment of essential hypertension with guanfacine.

    abstract：:1. Twenty-two patients with moderately severe essential hypertension were treated for a period of 12 months with guanfacine (BS 100-141), a new centrally-acting antihypertensive agent. A twice daily schedule was followed and the dose range of guanfacine was 1-8 mg daily. 2. In twenty patients satisfactory blood pressu...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1111/j.1365-2125.1980.tb04906.x

    authors： Higuchi M,Overlack A,Stumpe KO

    更新日期：1980-01-01 00:00:00

  • Sulphate conjugation of beta 2-adrenoceptor stimulating drugs by platelet and placental phenol sulphotransferase.

    abstract：:A possible route of metabolism of beta-adrenoceptor stimulating drugs used in obstetrics consists of conjugation by the enzyme phenol sulphotransferase. The substrate specificities of the platelet and the placental enzymes towards these drugs were tested. The specific activities of the beta-adrenoceptor agonists were ...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1984.tb05009.x

    authors： Sodha RJ,Schneider H

    更新日期：1984-01-01 00:00:00

  • The pharmacokinetics of recombinant human erythropoietin after intravenous and subcutaneous administration to healthy subjects.

    abstract：:1. The pharmacokinetics of recombinant erythropoietin, r-Epo, were evaluated after intravenous and subcutaneous administration of 50 u kg-1 to six healthy male volunteers. 2. The calculated mean values (+/- s.d.) for volume of distribution at steady state and clearance after an i.v. dose were 76 (+/- 33) ml kg-1 and 1...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1990.tb03692.x

    authors： Salmonson T,Danielson BG,Wikström B

    更新日期：1990-06-01 00:00:00

  • The rates of common adverse events reported during treatment with proton pump inhibitors used in general practice in England: cohort studies.

    abstract：AIMS:To estimate the rates of common adverse events in patients treated with the proton pump inhibitors omeprazole, lansoprazole and pantoprazole in general practice in England. METHODS:In prescription-event monitoring cohort studies, data on dispensed prescriptions prescribed by general practitioners in England soon ...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1046/j.1365-2125.2000.00262.x

    authors： Martin RM,Dunn NR,Freemantle S,Shakir S

    更新日期：2000-10-01 00:00:00

  • Use of labetalol and methyldopa in pregnancy-induced hypertension.

    abstract：:1 Nineteen pregnant patients whose mean arterial pressure (MAP) was persistently greater than or equal to 103.3 mmHg were given labetalol or methyldopa. 2 Singificant falls (P less than 0.001) in BP only occurred in the group treated with labetalol, and daily BP control was better in this group. 3 Two severely hyperte...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1979.tb04784.x

    authors： Lamming GD,Symonds EB

    更新日期：1979-04-01 00:00:00

  • Excretion of chloroquine, dapsone and pyrimethamine in human milk.

    abstract：:The concentration of chloroquine (CQ), dapsone (DDS) and pyrimethamine (PYR) in plasma and milk were measured following the coadministration of a single dose of chloroquine and Maloprim to lactating women. The milk to plasma area under the concentration-time curve (AUC) ratio ranged from 1.96 to 4.26 for CQ, 0.22 to 0...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1986.tb02967.x

    authors： Edstein MD,Veenendaal JR,Newman K,Hyslop R

    更新日期：1986-12-01 00:00:00

  • Initial therapy, persistence and regimen change in a cohort of newly treated type 2 diabetes patients.

    abstract：AIMS:The aim was to describe the utilization of antidiabetic agents, in terms of persistence and regimen change, in the management of a cohort of newly treated type 2 diabetes patients and to investigate associated socio-demographic and treatment factors. METHODS:A population-based retrospective cohort study was condu...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/bcp.12573

    authors： Grimes RT,Bennett K,Tilson L,Usher C,Smith SM,Henman MC

    更新日期：2015-06-01 00:00:00

  • Social media and pharmacovigilance: A review of the opportunities and challenges.

    abstract：:Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges rem...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章,评审

    doi：10.1111/bcp.12717

    authors： Sloane R,Osanlou O,Lewis D,Bollegala D,Maskell S,Pirmohamed M

    更新日期：2015-10-01 00:00:00

  • Dose-dependent effect and side-effect of prostaglandin E1 in erectile dysfunction.

    abstract：:1. Recent work has demonstrated artificial penile erection after intracavernous injection of prostaglandin E1 (PGE1). A possible dose-response relationship between PGE1 and its erectile action was examined in a double-blind, cross-over designed, placebo-controlled study. 2. Twenty patients aged (mean +/- s.d.) 45 +/- ...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1111/j.1365-2125.1989.tb03543.x

    authors： Schramek P,Waldhauser M

    更新日期：1989-11-01 00:00:00

  • Haem arginate improves hepatic oxidative metabolism in variegate porphyria.

    abstract：:1. The elimination of antipyrine was investigated before and after intravenous administration of haem arginate (3 mg haem kg-1 day-1 on three or four successive days) to six patients with variegate porphyria in remission. 2. Haem arginate decreased the faecal content of protoporphyrin from 557 +/- 91 to 118 +/- 32 (me...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1988.tb05315.x

    authors： Tokola O,Mustajoki P,Himberg JJ

    更新日期：1988-12-01 00:00:00

  • Chenodeoxycholic acid therapy for hypertriglyceridaemia in men.

    abstract：:1 Ten consecutive patients with hypertriglyceridaemia who adhered to a low carbohydrate diet without complete control of serum triglycerides were started on chenodeoxycholic acid 750 mg daily and followed monthly for 6 months. Nine of these patients were then followed for a further month on placebo capsules and therea...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章

    doi：10.1111/j.1365-2125.1978.tb01632.x

    authors： Bateson MC,Maclean D,Evans JR,Bouchier IA

    更新日期：1978-03-01 00:00:00

  • Perturbation of paracetamol urinary metabolic ratios by urine flow rate.

    abstract：:The effects of high and low urine flow rates on the urinary metabolic ratios for paracetamol glucuronidation, sulphation and oxidation were determined at steady-state in seven healthy young adult volunteers. Metabolic partial clearances were unaffected by urine flow rate, but individual paracetamol metabolic ratios va...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.1992.tb05643.x

    authors： Miners JO,Osborne NJ,Tonkin AL,Birkett DJ

    更新日期：1992-10-01 00:00:00

  • Cato Guldberg and Peter Waage, the history of the Law of Mass Action, and its relevance to clinical pharmacology.

    abstract：:We have traced the historical link between the Law of Mass Action and clinical pharmacology. The Law evolved from the work of the French chemist Claude Louis Berthollet, was first formulated by Cato Guldberg and Peter Waage in 1864 and later clarified by the Dutch chemist Jacobus van 't Hoff in 1877. It has profoundly...

    journal_title：British journal of clinical pharmacology

    pub_type： 传,历史文章,杂志文章,评审

    doi：10.1111/bcp.12721

    authors： Ferner RE,Aronson JK

    更新日期：2016-01-01 00:00:00

  • Regulatory challenges for new drugs to treat obesity and comorbid metabolic disorders.

    abstract：:Obesity is a major cause of morbidity and mortality through cardio- and cerebrovascular diseases and cancer. The metabolic consequences of obesity include dyslipidaemia, hypertension, proinflammatory atherogenesis, pre-diabetes and Type 2 diabetes. For a significant proportion of patients, pharmacotherapy to tackle ob...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.2009.03549.x

    authors： Heal DJ,Gosden J,Smith SL

    更新日期：2009-12-01 00:00:00

  • Absence of large intragenic rearrangements in the DPYD gene in a large cohort of colorectal cancer patients treated with 5-FU-based chemotherapy.

    abstract：:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Dihydropyrimidine dehydrogenase (DPD) is the enzyme responsible for the elimination of approximately 80% of the administered dose of 5-fluorouracil (5-FU). * Mutations in the DPD-coding gene have been shown to increase the risk of severe toxicity in 5-FU treated patients. * T...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/j.1365-2125.2010.03683.x

    authors： Paré L,Paez D,Salazar J,Del Rio E,Tizzano E,Marcuello E,Baiget M

    更新日期：2010-08-01 00:00:00

  • Long-term trajectories of medicine use among older adults experiencing polypharmacy in Australia.

    abstract：AIMS:To explore longitudinal changes in the number and type of medicines used among older people who experience polypharmacy. METHODS:We used pharmaceutical claims for a 10% sample of Australian Pharmaceutical Benefits Scheme beneficiaries to identify people aged 70 years and older who were exposed to 5 or more medici...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1111/bcp.14504

    authors： Falster MO,Charrier R,Pearson SA,Buckley NA,Daniels B

    更新日期：2020-07-31 00:00:00

  • Genetic polymorphisms in human CYP2A6 gene causing impaired nicotine metabolism.

    abstract：AIMS:Previously, we determined the phenotyping of in vivo nicotine metabolism and the genotyping of the CYP2A6 gene (CYP2A6*1 A, CYP2A6*1B, CYP2A6*2, CYP2A6*3, CYP2A6*4 and CYP2A6*5 ) in 92 Japanese and 209 Koreans. In the study, we found one Korean and four Japanese subjects genotyped as CYP2A6*1B/CYP2A6*4 who reveale...

    journal_title：British journal of clinical pharmacology

    pub_type： 杂志文章

    doi：10.1046/j.1365-2125.2002.01667.x

    authors： Yoshida R,Nakajima M,Watanabe Y,Kwon JT,Yokoi T

    更新日期：2002-11-01 00:00:00

  • Intestinal first pass metabolism of midazolam in liver cirrhosis --effect of grapefruit juice.

    abstract：AIMS:Grapefruit juice inhibits CYP3A4 in the intestinal wall leading to a reduced intestinal first pass metabolism and thereby an increased oral bioavailability of certain drugs. For example, it has been shown that the oral bioavailability of midazolam, a CYP3A4 substrate, increased by 52% in healthy subjects after ing...

    journal_title：British journal of clinical pharmacology

    pub_type： 临床试验,杂志文章,随机对照试验

    doi：10.1046/j.1365-2125.2002.01615.x

    authors： Andersen V,Pedersen N,Larsen NE,Sonne J,Larsen S

    更新日期：2002-08-01 00:00:00