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.

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.

Does a prediabetic condition increase the risk of developing (type 2) diabetes ?

Development of type 2 diabetes mellitus in people with intermediate hyperglycaemia (‘prediabetes’)

A war on “prediabetes” has created millions of new patients and a tempting opportunity for pharma. But how real is the condition, and is it good medicine?

2018 Study Abstract

Review question
We wanted to find out whether raised blood sugar (‘prediabetes’) increases the risk of developing type 2 diabetes and how many of these people return to having normal blood sugar levels (normoglycaemia). We also investigated the difference in type 2 diabetes development in people with prediabetes compared to people with normoglycaemia.

Background
Type 2 diabetes is often diagnosed by blood sugar measurements like fasting blood glucose or glucose measurements after an oral glucose tolerance test (drinking 75 g of glucose on an empty stomach) or by measuring glycosylated haemoglobin A1c (HbA1c), a long-term marker of blood glucose levels. Type 2 diabetes can have bad effects on health in the long term (diabetic complications), like severe eye or kidney disease or diabetic feet, eventually resulting in foot ulcers.

Raised blood glucose levels (hyperglycaemia), which are above normal ranges but below the limit of diagnosing type 2 diabetes, indicate prediabetes, or intermediate hyperglycaemia. The way prediabetes is defined has important effects on public health because some physicians treat people with prediabetes with medications that can be harmful. For example, reducing the threshold for defining impaired fasting glucose (after an overnight fast) from 6.1 mmol/L or 110 mg/dL to 5.6 mmol/L or 100 mg/dL, as done by the American Diabetes Association (ADA), dramatically increased the number of people diagnosed with prediabetes worldwide.

Study characteristics
We searched for observational studies (studies where no intervention takes place but people are observed over prolonged periods of time) that investigated how many people with prediabetes at the beginning of the study developed type 2 diabetes. We also evaluated studies comparing people with prediabetes to people with normoglycaemia. Prediabetes was defined by different blood glucose measurements.

We found 103 studies, monitoring people over 1 to 24 years. More than 250,000 participants began the studies. In 41 studies the participants were of Australian, European or North American origin, in 7 studies participants were primarily of Latin American origin and in 50 studies participants were of Asian or Middle Eastern origin. Three studies had American Indians as participants, and one study each invited people from Mauritius and Nauru. Six studies included children, adolescents or both as participants.

This evidence is up to date as of 26 February 2018.

Key results
Generally, the development of new type 2 diabetes (diabetes incidence) in people with prediabetes increased over time. However, many participants also reverted from prediabetes back to normal blood glucose levels. Compared to people with normoglycaemia, those with prediabetes (any definition) showed an increased risk of developing type 2 diabetes, but results showed wide differences and depended on how prediabetes was measured. There were no clear differences with regard to several regions in the world or different populations. Because people with prediabetes may develop diabetes but may also change back to normoglycaemia almost any time, doctors should be careful about treating prediabetes because we are not sure whether this will result in more benefit than harm, especially when done on a global scale affecting many people worldwide.

Certainty of the evidence
The certainty of the evidence for overall prognosis was moderate because results varied widely. The certainty of evidence for studies comparing prediabetic with normoglycaemic people was low because the results were not precise and varied widely. In our included observational studies the researchers often did not investigate well enough whether factors like physical inactivity, age or increased body weight also influenced the development of type 2 diabetes, thus making the relationship between prediabetes and the development of type 2 diabetes less clear.

Authors’ conclusions:
Overall prognosis of people with IH worsened over time. T2DM cumulative incidence generally increased over the course of follow-up but varied with IH definition. Regression from IH to normoglycaemia decreased over time but was observed even after 11 years of follow-up. The risk of developing T2DM when comparing IH with normoglycaemia at baseline varied by IH definition. Taking into consideration the uncertainty of the available evidence, as well as the fluctuating stages of normoglycaemia, IH and T2DM, which may transition from one stage to another in both directions even after years of follow-up, practitioners should be careful about the potential implications of any active intervention for people ‘diagnosed’ with IH.

To be prediabetic : a (very) questionable condition

A third of Americans are considered prediabetic – but many may be better off without treatment

A war on “prediabetes” has created millions of new patients and a tempting opportunity for pharma. But how real is the condition, and is it good medicine?

“Practitioners should be careful about the potential implications of any active intervention for people ‘diagnosed’ with intermediate hyperglycaemia (‘prediabetes’)” cochrane.

Attacking the Devil

Harold Evans and the Last Nazi War Crime

Intrepid newspaper editor Harold Evans wages an ongoing battle to expose the truth about a dangerous drug and obtain compensation for its victims.

More info and Videos

  • Xan Brooks, Peter Bradshaw and Henry Barnes review a documentary on the Thalidomide scandal that digs into the drug’s history as an experimental compound developed by the Nazis and pays tribute to the heroic efforts of the Sunday Times, lead by Harold Evans, which persisted in an investigation into Thalidomide-affected children in the face of cover ups and lawsuits. Released in the UK on Friday 22 January 2016.
  • Watch on Netflix. Read The Guardian press release.

Prescribed Drug Spending in Canada, 2018

Canada’s love affair with prescription meds…

Drug spending is increasing more than the other major areas of health spending — with a large proportion of drug spending going toward high-cost drugs for a small number of individuals.

Key findings

  • In 2018, $14.4 billion (42.7%) of prescribed drug spending will be financed by the public sector.
  • About 1 in 4 Canadians received a benefit from a public drug program in 2017. Individuals living in low-income and rural/remote neighbourhoods were more likely to receive a benefit.
  • Canadians with drug costs of $10,000 or more represented 2% of beneficiaries but accounted for more than one-third of public drug spending in 2017.

More Information

In 2017 : $40 Billion

Take an in-depth look at prescribed drug spending in Canada and learn more about how different drug classes contribute to current trends in total public drug spending.

In 2013 : $29.3 Billion

Prescribed Drug Spending in Canada 2012 cover image
Canada’s love affair with prescription meds…

Millions of Canadians buy prescription drugs; we spent a record $30 billion in 2013. But the annual rate of growth that year —2.3%— was one of the lowest in more than two decades. This is due in part to an increase in the use of less-expensive generic drugs as well as government policies that help keep prices low. ”

Key findings
  • More than 40% of prescribed drug spending was paid for by the public sector, totalling more than $12 billion. In the public sector, payers include provincial and federal drug programs and social security funds (such as workers’ compensation boards).
  • Generic drugs account for almost three-quarters of use but less than half of spending in public drug programs.
  • The number of Canadians who are taking more than $10,000 worth of prescription drugs every year is on the rise, because public drug programs are spending more on high-cost drugs.
  • In 2012, high-cost beneficiaries accounted for about 25% of public drug spending, compared with only 15% in 2007.
  • Almost half of these people were taking a high-cost drug used to treat conditions such as rheumatoid arthritis, Crohn’s disease and macular degeneration.
Sources

Evaluating the Strength of the Association Between Industry Payments and Prescribing Practices in Oncology

Doctor payments drove scripts for cancer drugs from Pfizer, Novartis and more: study

New study showed that physicians who received payments over three consecutive years and tied to a specific drug boosted their prescriptions of that product.

Abstract

Background
Financial relationships between physicians and the pharmaceutical industry are common, but factors that may determine whether such relationships result in physician practice changes are unknown.

Materials and Methods
We evaluated physician use of orally administered cancer drugs for four cancers: prostate (abiraterone, enzalutamide), renal cell (axitinib, everolimus, pazopanib, sorafenib, sunitinib), lung (afatinib, erlotinib), and chronic myeloid leukemia (CML; dasatinib, imatinib, nilotinib). Separate physician cohorts were defined for each cancer type by prescribing history. The primary exposure was the number of calendar years during 2013–2015 in which a physician received payments from the manufacturer of one of the studied drugs; the outcome was relative prescribing of that drug in 2015, compared with the other drugs for that cancer. We evaluated whether practice setting at a National Cancer Institute (NCI)‐designated Comprehensive Cancer Center, receipt of payments for purposes other than education or research (compensation payments), maximum annual dollar value received, and institutional conflict‐of‐interest policies were associated with the strength of the payment‐prescribing association. We used modified Poisson regression to control confounding by other physician characteristics.

Results
Physicians who received payments for a drug in all 3 years had increased prescribing of that drug (compared with 0 years), for renal cell (relative risk [RR] 1.81, 95% confidence interval [CI] 1.58–2.07), CML (RR 1.22, 95% CI 1.08–1.39), and lung (RR 1.69, 95% CI 1.58–1.82), but not prostate (RR 0.97, 95% CI 0.93–1.02). Physicians who received compensation payments or >$100 annually had increased prescribing compared with those who did not, but NCI setting and institutional conflict‐of‐interest policies were not consistently associated with the direction of prescribing change.

Conclusion
The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year). Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing.

Implications for Practice
Financial payments from pharmaceutical companies are common among oncologists. It is known from prior work that oncologists tend to prescribe more of the drugs made by companies that have given them money. By combining records of industry gifts with prescribing records, this study identifies the consistency of payments over time, the dollar value of payments, and payments for compensation as factors that may strengthen the association between receiving payments and increased prescribing of that company’s drug.

Press release.