89% of clinical trials run by European universities violate EU regulations, study shows

Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

Data released today via the BMJ show that thousands of clinical trials conducted in Europe violate EU rules that require results to be published within 12 months. Failure to publish trial results endangers patients, contributes to exploding drug costs, and slows down the discovery of new treatments and cures, transparimed reports.

Abstract

Objectives
To ascertain compliance rates with the European Commission’s requirement that all trials on the EU Clinical Trials Register (EUCTR) post results to the registry within 12 months of completion (final compliance date 21 December 2016); to identify features associated with non-compliance; to rank sponsors by compliance; and to build a tool for live ongoing audit of compliance.

Design
Retrospective cohort study.

Setting
EUCTR.

Participants
7274 of 11 531 trials listed as completed on EUCTR and where results could be established as due.

Main outcome measure
Publication of results on EUCTR.

Results
Of 7274 trials where results were due, 49.5% (95% confidence interval 48.4% to 50.7%) reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% v 11.0%, adjusted odds ratio 23.2, 95% confidence interval 19.2 to 28.2); as were trials by a sponsor who conducted a large number of trials (77.9% v 18.4%, adjusted odds ratio 18.4, 15.3 to 22.1). More recent trials were more likely to report results (per year odds ratio 1.05, 95% confidence interval 1.03 to 1.07). Extensive evidence was found of errors, omissions, and contradictory entries in EUCTR data that prevented ascertainment of compliance for some trials.

Conclusions
Compliance with the European Commission requirement for all trials to post results on to the EUCTR within 12 months of completion has been poor, with half of all trials non-compliant. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. Accessible and timely information on the compliance status of each individual trial and sponsor may help to improve reporting rates.

Industry Payments to Physician Specialists Who Prescribe Repository Corticotropin

Medicare spent $2 billion for one drug as the manufacturer paid doctors millions

2018 Study Key Points

Question
What is the association of industry payments to physicians and prescriptions for repository corticotropin (H. P. Acthar Gel; Mallinckrodt Pharmaceuticals)?

Findings
In this cross-sectional study of 235 specialist physicians who frequently prescribe corticotropin to Medicare beneficiaries, 207 (88%) received a monetary payment from the drug’s maker, with more than 20% of frequent prescribers receiving more than $10 000. There was a significant association between higher dollar amounts paid to these prescribers and greater Medicare spending on their corticotropin prescriptions.

Meaning
Financial conflicts of interest among physicians may be driving corticotropin expenditures for the Medicare program.

Abstract

Importance
Despite great expense and little evidence supporting use over corticosteroids, prescriptions for repository corticotropin (H. P. Acthar Gel; Mallinckrodt Pharmaceuticals) have increased markedly. Aggressive sales tactics and payments from the manufacturer may influence prescribing behavior for this expensive medication.

Objective
To characterize industry payments to physician specialists who prescribe corticotropin in the Medicare program.

Design, Setting, and Participants
This study was a cross-sectional analysis of Centers for Medicare & Medicaid Services 2015 Part D prescribing data linked to 2015 Open Payments data. Nephrologists, neurologists, and rheumatologists with more than 10 corticotropin prescriptions (frequent prescribers) in 2015 were included.

Exposures
Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt recorded in the Open Payments database.

Main Outcomes and Measures
Frequency, category, and magnitude of corticotropin-related payments from Mallinckrodt, as well as corticotropin prescriptions and expenditures for Medicare beneficiaries.

Results
Of the 235 included physicians, 65 were nephrologists; 59, neurologists; and 111, rheumatologists. A majority of frequent corticotropin prescribers (207 [88%]) received corticotropin-related payments from Mallinckrodt. The median (range) total payment for 2015 was $189 ($11-$138 321), with the highest payments ranging from $56 549 to $138 321 across the specialties. More than 20% of frequent prescribers received more than $10 000 and the top quartile of recipients received a median (range) of $33 190 ($9934-$138 321) in total payments per prescriber. Payments for compensation for services other than consulting contributed the most to the total amount. Mallinckrodt payments were positively associated with greater Medicare spending on corticotropin (β = 1.079; 95% CI, 1.044-1.115; P < .001), with every $10 000 in payments associated with a 7.9% increase (approximately $53 000) in Medicare spending on corticotropin. There was no association between corticotropin-related payments and spending on prescriptions for synthetic corticosteroids.

Conclusions and Relevance
In this study, most nephrologists, neurologists, and rheumatologists who frequently prescribe corticotropin received corticotropin-related payments from Mallinckrodt. These findings suggest that financial conflicts of interest may be driving use of corticotropin in the Medicare program.

Medicare spent $2 billion for one drug as the manufacturer paid doctors millions

CNN reports on Acthar : doctor payments, paid prescribers, drug sales and pricing

“More than 80% of doctors who filed Medicare claims in 2016 for H.P. Acthar Gel — a drug best known for treating a rare infant seizure disorder — received money or other perks from the drugmakers, according to a CNN analysis of publicly identified prescribers.

The analysis, which looked at doctors who filed more than 10 Part D claims, found that the drugmakers — Mallinckrodt and Questcor — paid 288 prescribers more than $6.5 million for consulting, promotional speaking and other Acthar-related services between 2013 and 2016. Mallinckrodt purchased Questcor in 2014.

At about the same time, Medicare spending on Acthar rose dramatically — more than tenfold over six years.”

continue reading about Acthar and doctor payments, paid prescribers, drug sales and pricing on CNN.

Financer la science, récolter l’ignorance

Voyage en “agnotologie”, pays de la science et de l’ignorance (4/4)

Combien coûte l’ignorance à ceux qui la subissent et combien rapporte-t-elle à ceux qui la propagent ?

Produire de l’ignorance scientifique, est-ce un bon placement ? Qu’espèrent les philanthropes toujours plus nombreux en retour de leurs investissements toujours plus massifs dans la science d’aujourd’hui ? Quant à notre psychisme, garde-t-il toute sa raison dès qu’il est question d’argent, de pari, de gain ? Et le monde financier lui-même, ses agents, ses théoriciens, ne sont-ils pas tantôt victimes tantôt responsables d’aveuglements, de croyances, de falsification des risques, bref, d’ignorance économique ? Argent et ignorance font-ils bon ménage ?

Par Perrine Kervran , sur France Culture LSD, La série documentaire.

Le Distilbène DES, en savoir plus

Can pharmaceutical companies hold States hostage ?

Roche decided to withdraw an innovative oncology medicine from the Greek market, claiming that its price has fallen more than 50% because of the government’s regulatory interventions in the pharma area…

Roche decision to remove the drug from the prescribed medicines list means that its cost can no longer be covered by the state…

“There is a need to develop strong and systematic synergies in the policy area of pharmaceuticals, particularly on bargaining power in order to prevent unfair trading practices that are especially inappropriate in this very sensitive area,”

the Greek Council delegation said, adding that the case goes beyond narrow national interests.

More Information – Press Releases

  • Drug pricing debate to take place in heated atmosphere, euractiv, December 8, 2017.
  • Athens brings its dispute with pharma industry to the EU Council, euractiv, November 24, 2017.
  • Pharmaceutical company gives free access to drug after clash with Greek government, euractiv, Nov 2, 2017.
  • Greek health minister fumes at pharmaceutical company after drug withdrawal, euractiv, October 31, 2017.
  • Pharmaceutical company withdraws oncology drug from Greek market, euractiv, Oct 30, 2017.
  • Greek government on collision course with pharmaceutical companies over innovative drugs, euractiv, Oct 25, 2017.
  • New Commission study fuels generic drugs industry ‘manufacturing dispute’, euractiv, Oct 13, 2017.
  • Special Report – Protecting innovation in the pharmaceuticals market, euractiv, Oct 13, 2017.
  • Southern EU states present unified front in drug talks, euractiv, May 10, 2017.

Subsys, Fentanyl Spray Nationwide Bribery Scam : Opioid Manufacturer Insys Therapeutics ex-CEO Arrested

Dangerously Addictive Painkiller Prescribed for Patients Who Shouldn’t Have Received It

Opioid crisis in the USA : D. Trump declares a state of emergency health for this scourge that causes 100 deaths / days, while the ex-CEO of Insys Therapeutics, producing Subsys, Fentanyl Spray, is arrested for corruption.

“the company looked to bribe doctors into prescribing Subsys, a fentanyl spray, outside the usual course of their professional practice”

“the company started misleading insurers and agents into authorizing payment for the Fentanyl Spray”

Press Releases

  • Drug company’s billionaire ex-CEO arrested in nationwide bribery scam, abcnews, Oct 26, 2017.
  • Insys Founder Arrested Over Subsys Fentanyl Spray Marketing, Resigns from Company Board, rxinjuryhelp, October 30, 2017.
  • Dangerously Addictive Painkiller Prescribed for Patients Who Shouldn’t Have Received It, Says Whistleblower, nbcnews, JUN 5 2017.

Industry gifts to doctors linked to their branded and costly prescriptions, and should be banned

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia

Health care professionals who received gifts from the pharmaceutical industry not only wrote more prescriptions, but also more costly ones (including more brand name medications), than colleagues who did not receive such gifts.

2017 Study Abstract

Importance
Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs. Even less research addresses the effect of gifts on the prescribing behavior of nurse practitioners (NPs), physician assistants (PAs), and podiatrists.

Objective
To analyze the association between gifts provided by pharmaceutical companies to individual prescribers in Washington DC and the number of prescriptions, cost of prescriptions, and proportion of branded prescriptions for each prescriber.

Design
Gifts data from the District of Columbia’s (DC) AccessRx program and the federal Center for Medicare and Medicaid Services (CMS) Open Payments program were analyzed with claims data from the CMS 2013 Medicare Provider Utilization and Payment Data.

Setting
Washington DC, 2013

Participants
Physicians, nurse practitioners, physician assistants, podiatrists, and other licensed Medicare Part D prescribers who participated in Medicare Part D (a Federal prescription drug program that covers patients over age 65 or who are disabled).

Exposure(s)
Gifts to healthcare prescribers (including cash, meals, and ownership interests) from pharmaceutical companies.

Main outcomes and measures
Average number of Medicare Part D claims per prescriber, number of claims per patient, cost per claim, and proportion of branded claims.

Results
In 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with more branded claims. Gift acceptance was associated with increased average cost per claim for PAs and NPs. Gift acceptance was also associated with higher proportion of branded claims for PAs but not NPs. Physicians who received small gifts (less than $500 annually) had more expensive claims ($114 vs. $85) and more branded claims (30.3% vs. 25.7%) than physicians who received no gifts. Those receiving large gifts (greater than $500 annually) had the highest average costs per claim ($189) and branded claims (39.9%) than other groups. All differences were statistically significant (p<0.05).

Conclusions and relevance
Gifts from pharmaceutical companies are associated with more prescriptions per patient, more costly prescriptions, and a higher proportion of branded prescriptions with variation across specialties. Gifts of any size had an effect and larger gifts elicited a larger impact on prescribing behaviors. Our study confirms and expands on previous work showing that industry gifts are associated with more expensive prescriptions and more branded prescriptions. Industry gifts influence prescribing behavior, may have adverse public health implications, and should be banned.

More Information

The Real Reason Hospitals Are So Expensive

Adam Ruins The Hospital – Season 2 | Ep 203, 2017

American healthcare might not be the best in the world, but it is the most expensive. Adam Conover explains that inflated hospital costs have created a system that’s unaffordable and unfair.