Exposing drug industry funding of UK patient organisations

Drug firms ‘could shape the profiles of patient organisations through heavy investment’ even if they don’t have a say in their content of campaigns or research

Big pharma poured £57m into UK patient charities which could influence NHS drug decision makers, Bath University researchers’ analysis finds, the independent reports Read University of Bath blog.

Key messages

  • From 2012 to 2016 the drug industry donated over £57m (€65m; $73m) to UK patient organisations, with the annual sum more than doubling over the period
  • The funding benefited a small number of organisations and activities related to research and public involvement
  • The industry gave priority to commercially high profile conditions
  • Industry payment disclosures had limited transparency

We’ve been banging the drum about transparency of payment to doctors for years – we’ve even put a moratorium on financial conflicts of interest in the authors of any of our education articles. Not because we think that all doctors who receive money from industry are being influenced to push their agenda – but because we have no way of telling when that’s happening…

At the same time, and rightly, patient groups are becoming more involved in setting things like research priorities, and in guideline development – and we’re campaigning to increase that involvement. but as that involvement increases, it’s also important to make sure that potential industry influence is made transparent.

Piotr Ozieranski, is an assistant professor at the Department of Social and Policy Sciences at the University of Bath and one of the authors of a new analysis which attempts to build a picture of industry funding of UK patient groups.

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Corruption in the pharmaceutical sector

Diagnosing the challenges, Transparency International UK, 2016

Summary

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes. Whether it is a pharmaceutical company bribing a doctor for prescribing its medicines irrespective of a health need or a government employee facilitating the infiltration of substandard medicines into the distribution system, public resources can be wasted and patient health put at risk.

For policy makers to implement successful anti-corruption measures there is a need to identify and understand corruption vulnerabilities in the pharmaceutical sector. To support this task this paper identifies key policy and structural issues in selected activities of the pharmaceutical value chain, along with relevant anti-corruption policies. This analysis showed that anti-corruption policies are needed throughout the pharmaceutical value chain to increase transparency around key decision points and strengthen the accountability of actors.

Four overarching challenges derived from structural issues and anti-corruption policies across the selected activities of the value chain have been identified. These are:

  • A lack of objective data and understanding of corruption inhibited by environmental context, the complexity of issues in the sector and policy makers not viewing corruption as an issue.
  • A weak legislative and regulatory framework because of poor investment, a lack of oversight and national regulatory frameworks that are often decentralised and reliant on self-regulation for key decision-point.
  • The potential for undue influence from companies due to a high degree of autonomy over key decision points and unparalleled resources, on policy and regulation so profit maximisation goes beyond ethical norms and negatively impacts health outcomes and public health objectives.
  • A lack of leadership committed to anti-corruption efforts from all actors. National leaders often only implement reforms after a crisis, with their inaction regularly hindering other actors.

Similarly, three key action areas to mitigate corruption vulnerabilities in the pharmaceutical sector are examined. These include establishing leadership committed to addressing corruption, adopting technology throughout the value chain and ensuring accountability through increased monitoring, enforcement and sanctions.

These overarching challenges and action areas are neither novel nor resource-intensive, stressing the lack of effective action in the past; as well as the difficulty of dealing with corruption in a sector that is extremely complex, has a high level of government intervention and often has regulatory systems in place that are inadequate to properly govern the value chain. Only by overcoming these challenges and focusing on these action areas will the global health community be better able to meet the health Sustainable Development Goals.

Angell on Big Pharma

Some more truth about the pharmaceutical companies

Do pharmaceutical companies corrupt academic research and the clinical trial process ? You bet.

Dr Marcia Angell of Harvard Medical School and the author of The Truth About the Drug Companies talks with EconTalk host Russ Roberts about the impact of pharmaceutical companies on academic research, clinical trials and the political process. Angell argues that the large pharmaceutical companies produce little or no innovation and use their political power to exploit consumers and taxpayers. Reference.

Comment un géant pharmaceutique a saboté le combat pour un traitement anti-cancéreux abordable

Novartis contre la Colombie ; la guerre du prix du Glivec – 2015-2019

En Colombie, le prix d’un médicament anti-leucémique est devenu trop élevé pour le budget de la santé publique. En 2015, le gouvernement décide donc d’émettre une déclaration d’intérêt public pour le Glivec, privant ainsi le géant pharmaceutique Novartis de son monopole de production, dans un espoir de faire baisser le prix du médicament en faisant jouer la concurrence. Mais Novartis, craignant de voir sa poule aux œufs d’or lui échapper, menace d’attaquer la Colombie devant un tribunal d’arbitrage international. Si le prix du Glivec finit par baisser, les tactiques d’intimidation de Novartis ont aussi raison des velléités du gouvernement de mettre fin au monopole de Novartis. Le géant suisse parvient à éviter un fâcheux précédent, qui en faisant des émules, aurait pu entamer ses énormes bénéfices dans le monde.

Référence. Téléchargez l’affaire.

Pharma sales rep paid physicians to participate in hundreds of sham “speaker programs” in order to prescribe med drugs

Subsys : Drug Company Sales Rep Sentenced for Role in Kickback Scheme Related to Fentanyl Spray Prescriptions

John H. Durham, United States Attorney for the District of Connecticut, announced that NATALIE LEVINE, 35, of Scottsdale, Arizona, was sentenced today by U.S. District Judge Janet Bond Arterton in New Haven to five years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. Judge Arterton also ordered Levine to spend the first six months of probation in home confinement, and to perform 150 hours of community service.

According to court documents and statements made in court, from approximately March 2013 to October 2014, Levine was employed by Insys Therapeutics, an Arizona-based pharmaceutical company that manufactured and sold Subsys, a fentanyl-based sublingual spray that was approved by the Food and Drug Administration solely for the management of breakthrough pain in cancer patients. Levine was a sales representative for the company and was responsible for covering the territories that included Connecticut, New Hampshire and Rhode Island.

Levine induced certain medical practitioners, including an advanced practice registered nurse (APRN) in Connecticut, a physician’s assistant (PA) in New Hampshire, and a physician in Rhode Island, to prescribe Subsys by paying them to participate in hundreds of sham “Speaker Programs.” The Speaker Programs, which were typically held at high-end restaurants, were ostensibly designed to gather licensed healthcare professionals who had the capacity to prescribe Subsys and educate them about the drug. In truth, the events were usually just a gathering of friends and co-workers, most of whom did not have the ability to prescribe Subsys, and no educational component took place. “Speakers” were paid a fee that ranged from $1,000 to several thousand dollars for attending these dinners. At times, the sign-in sheets for the Speaker Programs were forged so as to make it appear that the programs had an appropriate audience of healthcare professionals.

The medical practitioners were paid thousands of dollars in illegal kickbacks in order to prescribe Subsys, and induce others to prescribe Subsys, over similar medications. Medicare Part D plans authorized payment for hundreds of Subsys prescriptions written by the three medical practitioners, resulting in a loss of approximately $4.5 million.

Levine’s restitution figure will be determined after additional court proceedings.

On July 11, 2017, Levine pleaded guilty to one count of conspiracy to violate the anti-kickback law.

Several other individuals affiliated with Insys Therapeutics, and medical practitioners involved in this kickback scheme, have been charged and convicted in the District of Connecticut and in other Districts across the United States. In sentencing Levine, Judge Arterton credited Levine’s significant cooperation and assistance to the government’s prosecution of defendants in Connecticut, Massachusetts, New Hampshire and Rhode Island.

On January 3, 2019, Levine’s husband, Michael Babich, who was the CEO and President of Insys Therapeutics, pleaded guilty in the District of Massachusetts to conspiracy and fraud charges stemming from the scheme. He awaits sentencing.

On May 2, 2019, a federal jury in Boston found John N. Kapoor, the founder and former Executive Chairman of Insys Therapeutics, and four other former Insys executives guilty of racketeering conspiracy.

Earlier this month, Insys Therapeutics agreed to pay a total of $225 million to resolve criminal and civil investigations of the company.

The investigation in the District of Connecticut is being conducted by the U.S. Department of Health and Human Services Office of the Inspector General and the Federal Bureau of Investigation, with the assistance of the Drug Enforcement Administration’s Tactical Diversion Squad. The case is being prosecuted by Assistant U.S. Attorneys Douglas P. Morabito, Sarah P. Karwan and Richard M. Molot.

U.S. Attorney Durham encouraged individuals who suspect health care fraud to report it by calling the Health Care Fraud Task Force (203) 785-9270 or 1-800-HHS-TIPS.

Department of Justice
U.S. Attorney’s Office, District of Connecticut, News And Press Releases, Monday June 24, 2019

Les laboratoires pharmaceutiques font-ils la course au profit, au mépris de la santé des citoyens ?

Les labos sont-ils aux mains de “Big Pharma” ?

Questions à Boris Hauray, chargé de recherche Inserm à l’Institut de recherche interdisciplinaire sur les enjeux sociaux, juin 2019.

  • Les laboratoires sont-ils aux mains du Big Pharma ?
  • Est-ce qu’il existe une entente secrète entre les laboratoires ?
  • D’où vient cette idée de la toute-puissance de cette industrie ?
  • Entre professionnels de santé et industrie, y a-t-il forcément conflits d’intérêts ?
  • Le monde médical est-il plus transparent aujourd’hui ?
  • L’industrie cache-t-elle des remèdes pour vendre de nouveaux traitements ?
  • Cette industrie fait-elle du lobbying contre les médecins douces ?

Référence : questions au cœur des Idées Claires, programme hebdomadaire produit par France Culture et Franceinfo destiné à lutter contre les désordres de l’information, des fake news aux idées reçues.

Clinical Trials on Vaccines : the Revelations of a Doctor

Meehan MD on the poor science of the recent Danish MMR Autism Study

Published on 6 March 2019, by Jim Meehan, MD

 

Undisclosed financial ties between guideline writers and pharmaceutical companies

One in five Australian clinical guideline writers have potentially relevant undisclosed links to drug companies

Abstract

Objectives
To investigate the proportion of potentially relevant undisclosed financial ties between clinical practice guideline writers and pharmaceutical companies.

Design
Cross-sectional study of a stratified random sample of Australian guidelines and writers.

Setting
Guidelines available from Australia’s National Health and Medical Research Council guideline database, 2012–2014, stratified across 10 health priority areas.

Population
402 authors of 33 guidelines, including up to four from each area, dependent on availability: arthritis/musculoskeletal (3); asthma (4); cancer (4); cardiovascular (4); diabetes (4); injury (3); kidney/urogenital (4); mental health (4); neurological (1); obesity (1). For guideline writers with no disclosures, or who disclosed no ties, a search of disclosures in the medical literature in the 5 years prior to guideline publication identified potentially relevant ties, undisclosed in guidelines. Guidelines were included if they contained recommendations of medicines, and writers included if developing or writing guidelines.

Main outcome measures
Proportions of guideline writers with potentially relevant undisclosed financial ties to pharmaceutical companies active in the therapeutic area; proportion of guidelines including at least one writer with a potentially relevant undisclosed tie.

Results
344 of 402 writers (86%; 95% CI 82% to 89%) either had no published disclosures (228) or disclosed they had no ties (116). Of the 344 with no disclosed ties, 83 (24%; 95% CI 20% to 29%) had potentially relevant undisclosed ties. Of 33 guidelines, 23 (70%; 95% CI 51% to 84%) included at least one writer with a potentially relevant undisclosed tie. Writers of guidelines developed and funded by governments were less likely to have undisclosed financial ties (8.1%vs30.6%; risk ratio 0.26; 95% CI 0.13 to 0.53; p<0.001).

Conclusions
Almost one in four guideline writers with no disclosed ties may have potentially relevant undisclosed ties to pharmaceutical companies. These data confirm the need for strategies to ensure greater transparency and more independence in relationships between guidelines and industry.

Reference. Image credit sciencemag.

Doctors’ unconscious instinct to reciprocate med reps’ gifts

What Big Pharma knows about people’s hardwired instinct to return the favor when given a gift

Abstract

… “You might reasonably ask whether a modest meal with a pharmaceutical sales rep matters all that much. You might also be surprised by what a small gift can buy. In recent years, social psychologists and marketers have demonstrated that the pull of reciprocity is exceedingly powerful in human beings, often acting on us in ways we may not consciously appreciate. Perhaps it’s too much to suggest that free pens were responsible for the opioid epidemic. But it’s become more and more clear that a gift, even from a salesperson, can make the receiver feel obliged to give something in return.” …

Read Did Free Pens Cause the Opioid Crisis? on the atlantic, about the role of medical representatives in the promotion of pharmaceuticals in general, and the opioid crisis in particular.