Financial toxicity: cancer treatment’s side effect

The shock and anxiety of a cancer diagnosis can be followed by a second jolt: the astronomical price of cancer drugs

Presented by Arjun Rajagopalan,
uploaded on SlideShare. Watch it full screen.

The mechanism by which a drug’s market price is fixed is opaque and mostly arbitrary. Medical research, particularly new drug discovery, is a very expensive endeavour; the drug industry uses this argument to price new drugs at levels that are breathtakingly high. With the backing of currently enforced patent protection laws, drug companies can insulate themselves against market forces that are operational in most other consumer markets where competition assures reasonable prices. The Indian drug industry which used to pride itself on its ability to reverse engineer and deliver generics substitutes at low prices, can no longer indulge in this tactic.

Cancer treatment is a large area of interest for drug research. Unlike other noncommunicable diseases like hypertension, diabetes and the like, patients with a diagnosis of cancer are usually keen to seek the best available treatments. Newer generations of cancer drugs are priced at astounding figures. Treatment costs can exceed 100,000 US dollars a year. Even for those in wealthy, developed nations, the burden can lead to far reaching domains: a complication that has been labeled as “financial toxicity”.

Quand le prix élevé et insupportable des médicaments devient un effet secondaire du cancer

Très chères minutes de vie, Luc Perino, 2018

Publié par Luc Perino, médecin généraliste, humeur du 22/10/2018

En cancérologie de l’adulte, la chirurgie et la radiothérapie ont permis de prolonger la vie de certains patients. On a longtemps et honnêtement pensé que la pharmacologie pourrait encore améliorer les choses. Mais depuis une vingtaine d’années, les études indépendantes montrent l’inefficacité globale des anticancéreux anciens ou modernes.

Pour évaluer l’action des anticancéreux lors des essais cliniques, on utilise principalement trois critères :

  1. les biomarqueurs (analyses biologiques),
  2. l’amélioration clinique
  3. et la survie sans progression tumorale.

Il s’agit de critères dits « intermédiaires ». Le seul critère important pour le patient et ses proches étant celui de la survie globale assortie ou non d’une qualité de vie acceptable. Les critères intermédiaires ne sont que des leurres. Certes la baisse d’un biomarqueur ou la diminution du volume tumoral à l’imagerie sont une grande source de satisfaction pour les patients et les médecins, mais elles ne sont pas corrélées à une augmentation de la quantité-qualité de vie.

Il peut paraître cruel de dire les choses aussi brutalement, mais peut-on vraiment faire progresser la médecine sans admettre les faits cliniques ?

Par rapport aux anciens antimitotiques, les nouvelles thérapies ciblées, et plus récemment, les immunothérapies, ont trois caractéristiques nouvelles :

  1. un support théorique séduisant,
  2. des tests de surveillance auto-satisfaisants
  3. et un coût faramineux.

Hélas, à une ou deux fragiles exceptions près, elles ne prolongent la vie que de quelques mois ou semaines.

Ces coûts exorbitants et injustifiés ont deux effets pervers inattendus.

  1. D’une part, ils deviennent la plus importante part de l’effet placebo,
  2. d’autre part, en politisant le sujet, ils majorent les revendications des associations de patients.

« Le cancer est un fléau » et « la vie n’a pas de prix » sont devenus des arguments indirects bougrement efficaces qui détournent l’attention hors de l’examen objectif des résultats. Les lobbyistes de l’industrie ont bien compris la puissance de ces arguments indirects et ils misent diaboliquement sur la détresse des patients en utilisant leurs associations pour faire pression sur les ministères. Ils savent aussi que les élus sont piégés par l’électoralisme et la démagogie et que les médias sont à l’affut de leurs moindres ambiguïtés.

Enfin, la validation de ces supercheries par les agences du médicament soulève inévitablement la question de la corruption.

Quand bien même certaines thérapies feraient gagner quelques minutes de vie, aucune société, quel que soit son niveau de richesse, de compassion ou de solidarité, ne peut supporter les coûts indécents de chacune de ces minutes, sans se mettre toute entière en péril.

Il est difficile d’expliquer ceci à des patients en détresse et à leurs proches, mais ce n’est pas une raison pour laisser de séduisantes théories renouer avec l’obscurantisme médical des siècles d’antan.

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Vaxxed: From Cover-Up to Catastrophe

Doctor behind film that links autism to vaccines speaks out featuring Dr. Andrew Wakefield & Polly Tommey

A 2016 American film alleging a cover-up by the Centers for Disease Control and Prevention (CDC) of a purported link between the MMR vaccine and autism.

Official site.

It’s a moral requirement to make money when you can to sell the product for the highest price, Pharma CEO says

Pharmaceutical executive defends 400 percent price hike

“I think it is a moral requirement to make money when you can . . . to sell the product for the highest price.”

“The point here is the only other choice is the brand at the higher price. It is still a saving regardless of whether it is a big one or not,”

“I agree with Martin Shkreli that when he raised the price of his drug he was within his rights because he had to reward his shareholders,”

“If he’s the only one selling it then he can make as much money as he can,”
“This is a capitalist economy and if you can’t make money you can’t stay in business.”

said Nirmal Mulye. Nostrum chief executive, in an interview…
read Pharma chief defends 400% drug price rise as a ‘moral requirement’ in the Financial Times September 11, 2018

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.

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