Tag: Big Pharma

How big data’s big bias is bringing noise and conflicts to US drug regulation

Jeanne Lenzer investigates, The BMJ, July 2017

A little known private foundation to support FDA’s “regulatory science” takes money out of the FDA’s coffers to support analyses using levels of evidence recommended by industry; many of the foundation’s directors have financial links to the drug and device makers that the FDA regulates.

Overview
  • No drug risks identified
  • Reagan-Udall Foundation
  • Directors’ ties to industry
  • Panel stacking
  • Funding the foundation
  • Funding the Medical Evidence Development and Surveillance (IMEDS)
  • Light touch FDA

“Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety. For example, it has been used to identify overuse of some interventions and can show drug and device complications in real world settings rather than idealized controlled trials.

However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).” …

…continue reading Jeanne Lenzer investigation Big data’s big bias: bringing noise and conflicts to US drug regulation on The BMJ, 18 July 2017.

Pharmaceutical industry payments and oncologist drug selection

Payments linked to higher odds of doctors prescribing certain cancer drugs

In preliminary findings that will be presented at the American Society of Clinical Oncology Annual Meeting 2017 in Chicago on Saturday, June 3, researchers show that when physicians had to choose between multiple, on-patent drugs for metastatic kidney cancer and chronic myeloid leukemia, they were more likely to prescribe drugs from companies they had received general payments – for meals, talks, travel, etc. – from.

2017 Study Abstract

Background
Financial relationships between physicians and the pharmaceutical industry are common, and have the potential to influence clinical practice in potentially inappropriate ways. Oncology may be an ideal setting to study the influence of industry payments on physician drug choice given the high levels of competition for market share and high prices commanded by orally administered oncologic drugs.

Methods
We linked the Open Payments database of industry-physician financial transactions with the Medicare Part D Prescriber file by physician name and practice location. We used McFadden’s conditional logit model to determine whether receipt of industry payments was associated with higher odds of using a drug manufactured by the same company. We applied this model to clinical scenarios in which oncologists may choose between multiple, on-patent drugs: metastatic renal cell cancer (mRCC) (sunitinib, sorafenib, and pazopanib) and chronic myeloid leukemia (CML) (imatinib, dasatinib, and nilotinib). The primary, binary independent variable was receipt of payments from a manufacturer of one of these drugs in 2013; the primary dependent variable was choosing that manufacturer’s drug in 2014. We divided industry payments into two categories, research payments and non-research “general” payments (including meals, travel, lodging, and speaking/consulting fees), and analyzed each payment type separately.

Results

More evidence that drug companies are able to influence prescribing practices through gifts to physicians.

Physicians who received general payments from a manufacturer had increased odds of prescribing that manufacturer’s drug for both mRCC (OR: 1.78, 95%CI 1.23-2.57, mean payments $566) and CML (OR: 1.29, 95%CI 1.13-1.48, mean payments $166). Research payments were associated with an increased odds of manufacturer drug use for mRCC (OR: 2.13, 95%CI 1.13-4.00, mean payments $33,391) but not CML (OR: 1.10, 95%CI 0.83-1.45, mean payments $185,763).

Conclusions
Receipt of general payments from pharmaceutical companies is associated with increased prescribing of those companies’ drugs. An association between research payments and prescribing was less consistent. This study suggests that conflicts of interest with the pharmaceutical industry may influence oncologists in high-stakes treatment decisions for patients with cancer.

Sources and Press Release

Comment garder son indépendance face à l’industrie pharmaceutique?

Téléchargez le livret du collectif d’étudiants en médecine de La Troupe du Rire

Téléchargez le livret du collectif d’étudiants en médecine de La Troupe du Rire.

Les liens d’intérêts et l’influence de l’industrie pharmaceutique constituent un risque sanitaire non négligeable.

  • Où se cache cette influence dans notre parcours de soignant ?
  • Comment se manifeste-t-elle ?
  • Pour quelles conséquences ?

C’est à ces interrogations que ce petit livret tente de répondre..

En savoir plus

More than 80 Percent of Patient-Advocacy Organizations are Pharma funded

Conflicts of Interest for Patient Groups

More than 80 percent of patient-advocacy organizations accept funding from drug and medical-device companies. For some patient groups, the donations from industry accounted for more than half of their annual income, and in nearly 40 percent of cases, industry executives sit on governing boards.

2017 Study Abstract

In this examination of 104 large patient-advocacy organizations, 83% receive financial support from drug, device, and biotechnology companies, and industry executives often serve on governing boards. The authors recommend more transparency about industry involvement.

More Information

  • Conflicts of Interest for Patient-Advocacy Organizations, The New England Journal of Medicine, DOI: 10.1056/NEJMsr1610625, March 2, 2017.
  • More Than 80 Percent of Patient Groups Accept Drug Industry Funds, Study Shows, nytimes, MARCH 1, 2017.
  • Pharma Funded “Patient” Groups Keep Drug Prices Astronomical, counterpunch, MARCH 6, 2017.
  • Image credit brewlife, March 13, 2013.

How to eliminate the risk of the third leading cause of death

Dr Peter Gøtzsche’s views on prescription drugs

Video published on 1 April 2015 by John McDougall.

Peter C. Gøtzsche, MD is a Danish medical researcher, and leader of the Nordic Cochrane Center at Rigshospitalet in Copenhagen, Denmark. He has written numerous reviews within the Cochrane collaboration.

Dr.Gøtzsche has been critical of screening for breast cancer using mammography, arguing that it cannot be justified; His critique stems from a meta-analysis he did on mammography screening studies and published as Is screening for breast cancer with mammography justifiable? in The Lancet in 2000. In it he discarded 6 out of 8 studies arguing their randomization was inadequate.

In 2006 a paper by Gøtzsche on mammography screening was electronically published in the European Journal of Cancer ahead of print. The journal later removed the paper completely from the journal website without any formal retraction. The paper was later published in Danish Medical Bulletin with a short note from the editor, and Gøtzsche and his coauthors commented on the unilateral retraction that the authors were not involved in.

In 2012 his book Mammography Screening: Truth, Lies and Controversy was published. In 2013 his book Deadly Medicines and Organized Crime: How Big Pharma has Corrupted Healthcare was published.

There is no such thing as “free” vaccines…

Why Médecins Sans Frontières (MSF) rejected Pfizer’s donation offer of pneumonia vaccine (PCV) doses for the children they serve

Abstract

… “Free is not always better.

Donations often involve numerous conditions and strings attached, including restrictions on which patient populations and what geographic areas are allowed to receive the benefits. This process can delay starting vaccination campaigns, which would be an untenable situation in emergency settings, or grossly limit who you’re able to reach with the vaccine.

Donations can also undermine long-term efforts to increase access to affordable vaccines and medicines. They remove incentives for new manufacturers to enter a market when it’s absorbed through a donation arrangement. We need competition from new companies to bring down prices overall — something we don’t have currently for the pneumonia vaccine.

Donations are often used as a way to make others ‘pay up.’ By giving the pneumonia vaccine away for free, pharmaceutical corporations can use this as justification for why prices remain high for others, including other humanitarian organizations and developing countries that also can’t afford the vaccine. Countries, which continue to voice their frustration at being unable to afford new and costly vaccines such as PCV, need lower prices as well to protect children’s health.

Critically, donation offers can disappear as quickly as they come. The donor has ultimate control over when and how they choose to give their products away, risking interruption of programs should the company decide it’s no longer to their advantage. For example, Uganda is now facing a nationwide shortage of Diflucan, an essential crytpococcal meningitis drug, in spite of Pfizer’s commitment to donate the drugs to the government. There are other similar examples of companies’ donation programs leaving governments and health organizations in a lurch without the medical tools they need to treat patients.” …

… Read the full paper – There is no such thing as “free” vaccines: Why we rejected Pfizer’s donation offer of pneumonia vaccines, by Jason Cone, Executive Director of Doctors Without Borders in the United States, on medium.

  • More about the MSF Access Campaign, “pushing for access to & the development of life-saving and life prolonging medicines, diagnostic tests & vaccines for patients in MSF programmes and beyond“.
  • The Needle image by ps_sahana.

Big Pharma’s Manipulation and Influence

Truth in Media, 4 Part Series, on Big Pharma Manipulation of Healthcare

Ben Swann Truth in Media – Original Air Date: June-July, 2016.

All 4 parts of Ben Swann’s Truth in Media series about Big Pharma.

More Information

  • When it comes to providing transparency and following proper procedure in protecting the health of the American people:
    • where does the FDA stand?
    • has the FDA maintained its integrity in maintaining oversight of drug companies?
    • is the FDA doing its job to the best of its ability in assuring that our medicines have been rigorously tested?
    • is the FDA making sure that drugs found to be dangerous are assigned proper warnings or removed from the market?
  • New Truth In Media Episodes: Confronting Big Pharma’s Manipulation, Influenc, Truth In Media, Jun 7,, 2016.
More Videos

How Big Pharma rakes in Profits from Deadly Drugs

How the pharmaceutical industry avoids accountability with ‘off label’ drugs

Ben Swann‘s channel, 6 July 2016.

Episode 4 of 4 in Truth in Media series on Big Pharma manipulation of healthcare.

More Information

  • The fourth episode of this serie, How Big Pharma Uses Off-Label Drugs, illustrates how pharmaceutical companies have made massive profits in spite of being ordered to pay enormous settlements related to harmful side effects of certain drugs.
  • How Big Pharma Avoids Accountability With ‘Off Label’ Drugs, Truth In Media, July 8, 2016.
More Videos

Fausses maladies… vrais médicaments !

Le “disease mongering” expliqué par Prescrire et le professeur Even

Vidéo publiée le 22 mai 2014 par On n’est plus des pigeons!.

Peut-on faire confiance aux pharmacies et à tous les médicaments prescrits?

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