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Showing posts with label Big Pharma. Show all posts
Showing posts with label Big Pharma. Show all posts

12 March, 2016

Changing oral vaccine to inactivated polio vaccine might increase mortality

None - This image is in the public domain and ...None - This image is in the public domain and thus free of any copyright restrictions. As a matter of courtesy we request that the content provider be credited and notified in any public or private usage of this image. (Photo credit: Wikipedia)
We, the undersigned, write as physicians and scientists committed to optimising the beneficial effects of vaccines to reduce infant mortality worldwide. In settings with high childhood mortality, live vaccines such as oral polio vaccine (OPV), BCG vaccine, and measles vaccine might have heterologous (non-specific) effects that reduce mortality from diseases other than poliomyelitis, tuberculosis, and measles, respectively, whereas inactivated vaccines might increase all-cause mortality.1 The importance of these effects is controversial.
See full Article here.

23 June, 2015

Hepatitis C: no habia almuerzo gratis

Mientras estamos trabajando con un grupo sobre uno de los nuevos medicamentos para Hepatitis C, nos encontramos con dos noticias, no tan vieja una pero si relevante, aparecida en el diario El País de España, dónde la India rechaza la patente de Sovaldi, tal cual lo habia echo en 2013 con Novartis con el medicamento Glivec (Imatinib). Por si esto no alcanzara, hoy y por iguales razones: no constituyen ninguna novedad terapéutica, el BMJ publica exactamente lo mismo para China.
Mal momento para Gilead, que en pocos meses acaba de perder dos mercados que suman en conjunto tan sólo 2.500 millones de personas.
Y mal momento para el resto de las empresas farmacéuticas, que han tomado como "novia" a este medicamento, prometiendo una cura en 12 o 24 semanas de la hepatitis C.
A nadie le importaria esto, si no fuera por que el mayor escándalo no es sólo éste, sino las políticas de fijación de precios, que varian de 55 mil Euros en Francia, 25 mil en España, a 900 dolares en Egipto.
Demostrando de esta manera que no existe ninguna correlación entre el costo de producción, y el precio de venta. Nada nuevo, si se piensa que medicamentos como el diazepam (Valium, su marca más conocida), no sólo sigue siendo consumido, y es adictivo, sino que el precio de su producción se multiplica hasta mil veces en la farmacia de cualquier lugar de la tierra.

Los enlaces se pueden leer aqui:
http://elpais.com/elpais/2015/01/15/ciencia/1421340220_413035.html
http://www.bmj.com/content/350/bmj.h3429

29 December, 2014

Mala Farma




Sinopsis
Subtítulo: Cómo las empresas farmacéuticas engañan a los médicos y perjudican a los pacientes

La medicina está en quiebra. Mientras los pacientes creen que los fármacos que toman son seguros y están aprobados, y los médicos intentan prescribir los medicamentos más efectivos, en la industria farmacéutica global, que mueve cada año casi 5 billones de euros, reina la corrupción y la avaricia.
Los médicos y los pacientes necesitan estudios científicos solventes para poder tomar decisiones informadas. Pero las empresas proporcionan una información sesgada de sus medicamentos, distorsionando y exagerando los resultados y eliminando aquellos aspectos que no les favorecen. Las agencias reguladoras de los gobiernos ocultan información de vital importancia. Y médicos y asociaciones de pacientes aparentemente independientes están financiados por la industria. El conjunto de estos factores hace que, inevitablemente, un gran número de pacientes se vea perjudicado por las malas prácticas de la industria farmacéutica.
Mala Farma es un ataque claro e inteligente a este estado de cosas, y nos demuestra con toda exactitud las distorsiones a las que se ve sometida la ciencia, cómo ello contribuye a la destrucción de nuestros servicios de salud, y qué fácil sería arreglar esta situación.

04 February, 2014

Reforming big pharma

Deadly Medicines and Organized Crime
Deadly Medicines and Organized Crime (Photo credit: DES Daughter)

Reforming big pharma

Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare
Peter C Gøtzsche
Drugs kill. After heart disease and cancer, drugs are the third leading cause of deaths in Europe and the USA, states Peter Gøtzsche in Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. He estimates that in the USA, every year, about 100 000 deaths are due to drugs, despite people taking the drugs correctly, and another 100 000 people die because of errors. According to Gøtzsche, “we now suffer from two man-made epidemics, tobacco and prescription drugs, both of which are hugely lethal” and the norm for both industries is a “morally repugnant disregard for human lives”. Furthermore, Gøtzsche claims, the business model of the drug industry is “organised crime”. He told The Lancet that he has written his latest book because he wants to “influence policy towards much more transparency”.
Throughout Deadly Medicines and Organised Crime Gøtzsche uses many anecdotes, provides countless facts and comments based on facts, and cites more than 900 references to draw attention to the allegedly shocking crimes committed by the drug industry (including manufacturers of medical devices). Gøtzsche understands pharmaceutical companies only too well because of his long and varied career in health care, with roles that have included drug representative for big pharma, researcher in clinical trials, physician, lecturer, and author of papers and books. He cofounded the Cochrane Collaboration and is the Director of the Nordic Cochrane Centre in Copenhagen. With his expertise and uncompromising attitude, Gøtzsche is outraged and outspoken in his book about pharmaceutical companies being “just like street drug pushers”.
Some pharmaceutical companies have been caught and fined for their activities. For example, Gøtzsche details how during 2007—12, in the USA, Abbott, AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, and Sanofi-Aventis were fined from $95 million to $3 billion for illegal marketing of drugs, misrepresentation of research findings, hiding data about the harms of the drugs, Medicaid fraud, or Medicare fraud. However, some companies seem not to be deterred and apparently regard fines as marketing expenses.
According to the pharmaceutical industry, high prices of drugs are attributable to the high costs of discovery and development. Gøtzsche argues that the price of a drug is determined by its value in the prevention and treatment of a disease, and in warding off competition. Novartis, he states, developed imatinib for chronic myeloid leukaemia at minimum cost (not reported in the book), but charged $25 000 for 1 year's treatment in 2002. Another myth, according to Gøtzsche, is that breakthroughs arise from research funded by the industry. But many breakthroughs take place in the non-profit sector—universities, research institutes, and government laboratories. Some of the most important drug discoveries in the 20th century Gøtzsche notes—including insulin, penicillin, and polio vaccine—occurred in publicly funded laboratories.
“Fundamentally, I think capitalism and health care go very poorly together”, Gøtzsche told The Lancet. In his book, he recommends several reforms to address this issue. He claims that, like tobacco marketing, drug marketing is harmful and should be banned. Gøtzsche also stresses the need to remove the for-profit model and to radically reform the currently impotent or too-permissive drug regulation. His unequivocal opinion is that the pharmaceutical industry should not be allowed to do trials of its own drugs because being both the judge and defendant is a conflict of interest. Ideally, non-profit enterprises should invent, develop, and bring new drugs to market. Removal of the link between the costs of research plus development and the price of drugs would, Gøtzsche believes, address the unaffordability and unsuitability of the current medical innovation model, and reduce the incentives for the development of me-too products (ie, variations of known substances) and marketing and promotion of drugs that might not be used rationally or are no better than the existing alternatives.
Another of Gøtzsche's recommendations is that drug regulatory agencies should be funded publicly to avoid the competition created by user fees between agencies to become the fastest and hence the least critical in approving new medicines. Also, he suggests the agencies should have separate divisions and authorities for dealing with approvals and the safety of drugs. Although Gøtzsche vehemently criticises the pharmaceutical industry, the reforms he proposes to address some of the issues raised in his compelling book could perhaps help improve the current state of health care.

20 December, 2013

Tinsel or transparency? GlaxoSmithKline’s marketing overhaul

 Source:  The Conversation. By Bruce Baer Arnold

GlaxoSmithKline, one of the Big Five global pharmaceutical companies, this week gave the world an overdue Christmas present. Glaxo will stop paying doctors to promote its drugs and will no longer pay its sales representatives on the basis of the number of prescriptions written by those practitioners.
But before we say thanks – and ask Glaxo’s peers to follow its lead – we need to ask: is this tinsel or transparency?
Pharmaceuticals are big business. We like to believe that drug development and marketing “just happens”, but drug companies vigorously seek to influence government policy at home and abroad.
We have seen this in lobbying about free trade agreements, which typically privilege the interests of overseas drug companies over Australian consumers and taxpayers. The taxpayer is important because we subsidise prescription medications through the Pharmaceutical Benefit Scheme.
The secret Trans Pacific Partnership Agreement, for example, has rightly been condemned for threatening to increase the price Australians pay for pharmaceuticals.
Drug companies also influence medical practitioners and medical practices. One way is through pharmaceutical payola: practitioners get financial incentives for prescribing a particular company’s medications.
Some lucky practitioners, managers and partners have been getting presents in the form of free trips to professional conferences or, more egregiously, to educational opportunities at plush overseas resorts. There’s nothing like a week of golf in Hawaii interspersed with promo about drug x or drug y.
Glaxo’s new policy will see doctors having to pay their own way at conferences. Image from shutterstock.com
Given the money at stake, leading companies have gone further. They’ve influenced perceptions of their products through ghostwriting research papers in professional publications and through consulting arrangements for gatekeepers or “opinion leaders”.
Some companies simply haven’t reported problems with medications. And some have actively promoted products for unapproved uses, potentially with a tangible risk of serious injury or death. Dementia patients, for example, were at increased risk of stroke after being prescribed Johnson & Johnson medications that were only approved for the treatment of schizophrenia.
The Australian Competition & Consumer Commission (ACCC), informed by industry critics, has slowly started to address the lack of pharmaceutical transparency in Australia. In signing off on the industry self-regulatory scheme, it encouraged Medicines Australia – representing major non-generic drug companies – to move towards greater transparency about payments. Medicines Australia has agreed to aggregate disclosure but resisted transparency about benefits to individuals.
Regrettably, there is still no requirement for disclosure at the researcher or practitioner level and no expectation that gift-giving stop altogether.
Action by the ACCC followed news that the US government has imposed billion-dollar penalties on leading drug companies over a range of marketing abuses. Johnson & Johnson, for example, paid US$2.2 billion. The US Justice Department stated that a Johnson & Johnson arm knew patients taking Risperdal had an increased risk of developing diabetes but nonetheless promoted the drug as “uncompromised by safety concerns (does not cause diabetes)“.
Glaxo paid US$3 billion after the government found it unlawfully promoted Paxil for treating depression in young patients even though the drug was unapproved for paediatric use. Glaxo’s Wellbutrin was promoted for weight loss, treatment of sexual dysfunction, substance addictions and ADHD despite legally only being prescribed for severe depression.
Glaxo, along with its peers, concurrently indicated it would behave as a good citizen. Leading drug companies acknowledged that there had been misbehaviour, in some instances direct illegality. Their excuses? Some claimed over-zealous agents were primarily responsible, that such behaviour was standard practice across the industry and had been tacitly accepted by a range of regulators, or that market realities meant that they were at the mercy of practitioners.
The new Glaxo move to stop paying doctors for speaking engagements or to attend conferences and abolish sales targets for drug reps will come into effect in Australia and other nations during the next two years. We can expect Glaxo’s peers to follow. That emulation will reflect marketing – no-one wants to be left behind. It’s also a way of pre-empting government regulation.
But we still need to question the gift-wrapping. Glaxo’s announcement coincides with investigation in China of what would conventionally be described as bribes (claims doctors were paid handsomely for conferences that did not take place).
We still don’t know how much doctors receive in grants and consultancy fees. Image from shutterstock.com
It also anticipates disclosure under the Physician Payments Sunshine Act, as part of Obama’s controversial health plan.
But Glaxo has not revealed how much it has been paying to individual researchers, reviewers, ghost writers and practitioners. And it will continue to make “unsolicited, independent educational grants” to doctors.
A truly beneficial Christmas present – one with more substance than tinsel – would be a commitment by drug companies to publicly reveal where the money is going on such “grants”, “consultancies” and ghostwriting. Public health specialists advocate disaggregated disclosure – and it is possible.
Next Christmas let’s see how much is going to individuals. If there is nothing wrong with the payment, there is nothing to hide and everyone can enjoy the festivities.

02 December, 2013

More Than a Billion People Taking Statins?

 Source JAMA Network

Potential Implications of the New Cardiovascular Guidelines

The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on assessment of cardiovascular risk1 and on treatment of blood cholesterol, which included recommendations for primary prevention with statins,2 came under intense criticism immediately with their release. Main concerns focused on flawed methods (problems with the risk calculation),3 ethics (conflicts of interest),4 and inferences (too many people offered treatment).
The ACC and the AHA are among the most experienced organizations in medicine that develop guidelines. Their processes are meticulous, including transparent reporting of conflicts. The work behind the guidelines’ development was monumental. References to randomized trials and systematic reviews were continuous (the word “evidence” appears 346 times in the cardiovascular risk assessment report and 522 times in the treatment report alone). Panelists were highly qualified. Statins have been extensively evaluated in numerous randomized clinical trials. The guidelines focused on hard clinical outcomes such as myocardial infarction and stroke. Remaining caveats were explicitly acknowledged in documents covering hundreds of pages. However, this apparently seasoned integration of data and opinion eventually would lead to massive use of statins at the population level; ie, “statinization.” It is uncertain whether this would be one of the greatest achievements or one of the worst disasters of medical history.
According to the ACC/AHA guidelines1,2 of the 101 million people in the US population without cardiovascular disease and aged 40 to 79 years, 33 million are expected to have a 10-year predicted risk of cardiovascular disease of 7.5% or higher (ie, high-intensity statins are recommended) and another 13 million are expected to have a predicted risk between 5% and 7.4% (ie, statins should be considered). The US population is approximately one-twentieth of the global population in this age range. If crude distributions of risk profiles were similar, on average, around the globe, a rough estimate would suggest that (33 + 13) × 20 = 920 million people would be classified in the same risk categories. This is probably an underestimate. Accounting for population growth, an increasingly aging population in developed countries, and increasing prevalence of cardiovascular risk factors in developing countries resulting in risk profiles worse than that of the United States,5 these risk categories may already exceed or could soon exceed 1 billion people. These projections do not even count the hundreds of millions of patients who already have cardiovascular disease or extremely high low-density lipoprotein cholesterol levels and for whom statins demonstrate even better effectiveness.
Risk profiles and the importance of risk factors may well differ in other populations, and the ACC/AHA guidelines are very careful in avoiding such extrapolations.1 However, unavoidably, extrapolations will happen. Prior experience shows that previous efforts such as the Framingham risk score and the Third Adult Treatment Panel (ATP III) guidelines were adapted and adopted widely around the world. Authoritative guidelines of this sort carry such prestige that they influence global treatment and marketing. Moreover, several statins are available as generic products and are relatively inexpensive, contributing to further pressure to “statinize” the planet even in countries with modest health care budgets.
The core of the ACC/AHA guidelines depends on a new risk score that was explicitly developed for the sake of informing US-oriented recommendations. Problems with this score have been noted,3 and even its developers largely acknowledged them up front.1 Based on the evidence of overprediction derived even in the original validation of the risk calculator and subsequent independent validations, perhaps about half of statin candidates may actually have a true 10-year risk of less than 7.5%.1,3 However, there is large uncertainty about the extent of any overprediction, and the cohorts in which the model was developed and validated may differ compared with current populations. Here, several important factors must be considered. First, after 30 years of work and hundreds of cardiovascular predictors and models,6 when the time came, the expert panel considered (probably correctly) that none of the models previously developed was good enough and had to develop a new one. Second, despite a plethora of candidate emerging predictors of cardiovascular risk, the model ended up selecting risk factors known since the 1960s: age, sex, race, lipids, diabetes, smoking, and blood pressure. Third, when looking at the granularity of the predictors (eg, how lipids should be represented), high-density lipoprotein cholesterol was selected even though it is clearly noncausally related to coronary artery disease,7 an example of how highly significant predictors may have little to do with how treatment works. Fourth, even the new model was acknowledged by its developers as having major limitations.1 Performance in external validation cohorts is clearly disappointing. Areas under the curve range from 0.56 to 0.71 (except for African American women) and calibration metrics (χ2 of 15 to 67) are worse than almost any previously published cardiovascular model.6 The development of the new model most likely was rigorous, and these disappointing numbers are an accurate reflection of its performance. But what does this say about the credibility of all the other previous models that seemingly have superior (published) performance? It is concerning that after thousands of articles on cardiovascular prediction, this is the best that can be expected. Fifth, even though many randomized trials on statins have been published, there is no randomized evidence that this particular risk model, rather than any of its predecessors built with the same, similar, or other predictors, would identify the patients who benefit most from statin therapy and that the optimal treatment threshold is 5%, 7.5%, or even 2.5% or 15%. Information on potential statin harms (myopathy, diabetes, and more) is accumulating and concerning but also less systematically collected and thus carries more uncertainty than the benefits. The exact incidence of harms could markedly affect the optimal risk threshold for treatment.
Eventually, a leap of trust is needed to interpret clinically this excellent but convoluted and problematic modeling effort and its management implications—this was left to the otherwise excellent content experts who made the influential treatment recommendations. So, here, critics point out that 8 of the 15 panelists had industry ties.4 Perhaps this is an improvement because almost all panelists who participated in the prior ATP III guidelines had industry ties. Moreover, the new guidelines often recommend more inexpensive therapies. However, should the very best content experts be the ones writing recommendations, making that delicate leap from the often fragmented or uncertain evidence to the actual dicta? Can the very best content experts ever be conflict free?8 Critics have justifiably pointed out4 that severing ties with the industry while working on the guidelines and promising not to have any industry ties for at least 2 years after the guidelines are published does not abolish conflicts. Even if all expert panelists have no financial industry ties, the decisions they make may affect how many patients will visit preventive cardiology clinics and influence patient activity in these divisions. The debate over the ACC/AHA guidelines offers an opportunity to rethink the membership of these influential panels. As articulated by the American Cancer Society and as recommended by the Institute of Medicine, the American Cancer Society will separate the processes of specialty input and evidence synthesis from writing of the actual guideline.9 Perhaps these panels should include knowledgeable patients who are well versed in understanding the scientific background (eg, predictive models), many methodologists (ideally working in different applied fields), and excellent clinicians/scientists from other specialties whose practice volume is not at stake. Content experts could serve as nonvoting members or advisors to such panels.
The ACC/AHA guidelines demonstrate that even in a topic area with extensive amounts of data and published clinical trials, crucial evidence is still missing. The definitive way to test the recommendations is to subject them to randomized experimentation. The new proposed model could be compared against other models or approaches in its ability not only to predict risk accurately but also affect patient outcomes.8 The proposed strategy could also be compared against different strategies where treatment is recommended at different thresholds. With potentially more than 1 billion people caught in the statin dilemma, there should be hundreds of thousands of interested participants for such trials. With expanded target populations and more affordable generic prices, the cumulative global sales of statins may approach $1 trillion by 2020. Lipitor sales alone exceeded $120 billion between 1996 and 2011. Therefore, funding for trials to demonstrate the best predictive model and treatment threshold should be negligible compared with the accumulated profit from statins and the millions of lives and deaths at stake.

ARTICLE INFORMATION

Corresponding Author: John P. A. Ioannidis, MD, DSc, Stanford Prevention Research Center, 1265 Welch Rd, Medical School Office Building, Room X306, Stanford, CA 94305 (jioannid@stanford.edu).
Published Online: December 2, 2013. doi:10.1001/jama.2013.284657.
Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

REFERENCES

Goff  DC  Jr, Lloyd-Jones  DM, Bennett  G,  et al.  2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online November 12, 2013]. Circulation. doi:10.1161/01.cir.0000437741.48606.98.
PubMed
Stone  NJ, Robinson  J, Lichtenstein  AH,  et al.  2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online November 12, 2013]. Circulation. doi:10.1161/01.cir.0000437738.63853.7a.
PubMed
Ridker  PM, Cook  NR.  Statins: new American guidelines for prevention of cardiovascular disease [published online November 20, 2013]. Lancet. doi:10.1016/S0140-6736(13)62388-0.
PubMed
Lenzer  J.  Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers. BMJ. 2013;347:f6989.
PubMed   |  Link to Article
Ajay  VS, Prabhakaran  D.  Coronary heart disease in Indians: implications of the INTERHEART study. Indian J Med Res. 2010;132(5):561-566.
PubMed
Siontis  GC, Tzoulaki  I, Siontis  KC, Ioannidis  JP.  Comparisons of established risk prediction models for cardiovascular disease: systematic review. BMJ. 2012;344:e3318.
PubMed   |  Link to Article
Voight  BF, Peloso  GM, Orho-Melander  M,  et al.  Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study. Lancet. 2012;380(9841):572-580.
PubMed   |  Link to Article
Lenzer  J, Hoffman  JR, Furberg  CD, Ioannidis  JP; Guideline Panel Review Working Group.  Ensuring the integrity of clinical practice guidelines: a tool for protecting patients. BMJ. 2013;347:f5535.
PubMed   |  Link to Article
Brawley  O, Byers  T, Chen  A,  et al.  New American Cancer Society process for creating trustworthy cancer screening guidelines. JAMA. 2011;306(22):2495-2499.
PubMed   |  Link to Article

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