De staat van de farmaceutische industrie in 2013

Transcriptie

1 Corporate crime in the pharmaceutical industry is common, serious and repetitive. De staat van de farmaceutische industrie in was een topjaar voor de farmaceutische industrie. D r is weer een hoop geld binnen gehaald en meer dan ooit medicijnen verkocht. De vooruitzichten zijn ook goed: over 2 a 3 jaar wordt een omzet verwacht van 1 triljard US-dollars was ook een topjaar qua schandalen en onthullingen rondom Big Pharma. The dark side of pharma is dit jaar zichtbaarder en manifester geworden dan ooit. Hierna volgt een bloemlezing van conclusies en citaten uit studies, boeken en artikelen, welke dit jaar zijn gepubliceerd over het duistere opereren van de farmaceutische industrie. Elke conclusie en citaat kunt u terugvinden op Ongetwijfeld gaat u na lezing hiervan denken dat het wel een erg eenzijdig en negatief beeld is van de farmaceutische industrie. Dat klopt : ongetwijfeld zijn er farmaceutische bedrijven welke zich niet schuldig maken aan allerlei wanpraktijken. Maar het globale beeld van deze bedrijfstak is absoluut niet positief. Hierna volgt een overzicht van alle mogelijke wanpraktijken welke geconstateerd worden:

2

3 De internationaal bekende medische onderzoeker Peter C. Gøtzsche, verbonden aan het Cochrane Centre, is ronduit vernietigend negatief. Hij stelt dat It is scary how many similarities there are between this industry and the mob en Corporate crime in the pharmaceutical industry is common, serious and repetitive. Let s face the brutal facts Rolf Mulder December 2013

4 "It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry... The difference is, all these people in the drug industry look upon themselves - well, I d say 99 percent, anyway - look upon themselves as lawabiding citizens, not as citizens who would ever rob a bank... However, when they get together as a group and manage these corporations, something seems to happen... So there s something that happens to otherwise good citizens when they are part of a corporation. It s almost like when you have war atrocities; people do things they don t think they re capable of. When you re in a group, people can do things they otherwise wouldn t, because the group can validate what you re doing as okay." Het ministerie van Volksgezondheid (VWS) heeft de afgelopen vier jaar bijna een ton geschonken aan een door medicijnfabrikanten opgerichte praatclub. About 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs. All of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. Every week, about 53,000 excess hospitalizations and about 2400 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier. One in every five drugs approved ends up causing serious harm. There has been a 42% increase in the number of reported cases of ADHD since % of news items reporting on medical trials specifically on randomised controlled trials (RCTs), which are seen as the gold standard in judging whether a treatment is effective or safe were subject to spin by drugs companies With drug pipelines yielding fewer blockbusters and profits from branded drugs being increasingly eroded by generic incursion, pharmaceutical companies are looking to maximize the return on investment of their drugs that do make it to market. Consequently, reformulation has become a common defense by drug makers to prolong the lifecycle of their top sellers From , 39% of

5 the total product launches from the 50 top manufacturers were reformulations Almost half of the established medical practices that are tested are found to be no better than a less expensive, simpler, or easier therapy or approach. New research published in the BMJ has suggested that academics with links to the pharmaceutical industry were more likely to give increased risk assessments of the swine flu pandemic of 2009/10 when talking to the media, compared with academics who were not linked to the pharmaceutical industry. Diclofenac, een veelgebruikte pijnstiller en ontstekingsremmer, verhoogt de kans op hart- en herseninfarcten. Dat is al jaren bekend, maar met die kennis gebeurt verrassend weinig, zeker in Nederland. Honderden vermijdbare sterfgevallen zijn blijkbaar geen reden voor urgentie.

6 Big Pharma: no. 1 Lobby in 2013 Half of the doctors on the panel that recommended a whopping increase in statin drug use have ties to Big Pharma. This past Tuesday, the American Heart Association and American College of Cardiology issued the first new guidelines in a decade for preventing heart attacks and strokes - guidelines which called for

7 one-third of all adults to consider taking cholesterol-lowering statin drugs. JAMA study raises red flag on big-selling testosterone drugs. Big Pharma has turned testosterone-boosting drugs into a tidy little business--if we can call a $2 billion market "little." But as more and more baby boomers signed on for testosterone testing--and, in turn, therapy--worries about its safety have grown. Now, a new study in the Journal of the American Medical Association puts some numbers to that concern. Pharmaceutical companies are using stealth marketing tactics by eavesdropping on patients discussions on social networks and tracking patients digital footprints online to target them for advertising. Big Pharma suffers from institutional corruption according to Harvard University researchers. They came to this conclusion after examining Pharma s practices and policies in 5 different categories: systemic problems, medical research, medical knowledge and practice, marketing, and patient advocacy organizations. Where did the medical community get the idea that Vioxx, Trovan and Baycol were safe and the benefits of Prempro, Neurontin and bisphosphonates outweighed their risks? From research published in medical journals written by drug companies or drug-company funded authors. Some of the bestselling drugs for Big Pharma have gone off patent. These include Lipitor, Seroquel, Zyprexa, Singular, and Concerta. Even though these drugs have gone off patent, it isn't going to stop the company from earning a profit. Pharma has designed six new marketing strategies that recycle old drugs and market diseases to ensure sales of their new drugs. Patents and copyrights are both explicit government policies to promote innovation and creative work. They reward inventors, musicians, writers and other creative workers with government-enforced monopolies for set periods of time, and these monopolies allow the holders to charge prices far above the freemarket price. For example, the nation will spend close to $300 billion in 2011 on prescription drugs.2 In the absence of government- enforced patent monopolies, the same drugs would cost around $30 billion, an amount that implies a transfer to the pharmaceutical industry of close to $270 billion a year, or about 1.8 percent of gross domestic product. According to Zack Cooper from the London School of Economics:

8 Every shred of evidence suggests that price competition in healthcare makes things worse, not better. Marketing campaigns for pharmaceuticals are putting in place a new understanding of the nature of illness and health. Whereas bodies once were understood as normatively healthy and only sometimes ill, they are now understood as inherently ill, and only able to be brought towards health. The treatment of risk factors for illness, and not just illness, is a development linked to prospects of dramatically increased sales of drugs. Nearly 20 percent of corporate crime is being committed by companies that make products for your health. Crimes committed by some of the top pharmaceutical companies include fabricated studies and hiding damaging research A number of recent articles and books have delved into the practices of the drug industry, concluding it operates like an organized crime ring Corruption of science is one of the most dangerous forms of corruption. Doctors rely on published studies to make treatment recommendations, and large numbers of patients can be harmed when false findings are published A recent study concluded that a majority of American drug commercials 60 percent of prescription drug ads, and 80 percent of ads for over-the-counter (OTC) drugs are either misleading or outright false. Het gezaghebbende British Medical Journal heeft een onderzoek laten uitvoeren naar 2500 van de meest voorgeschreven reguliere medische behandelingen en medicijnen. De uitkomsten zijn gepubliceerd in Clinical Evidance Handbook. En deze uitkomsten, gedaan door de reguliere medische wereld zelf, zijn zeer verontrustend. De geneeskunde blijkt al jarenlang gebruik te maken van medicatie waarvan slechts 12% een positief effect zou kunnen hebben. De rest is kwakzalverij of zelfs levensgevaarlijk.

9 Vaccine Injuries:

10 A study published in the Journal of General Internal Medicine asked 1,620 medical students and 739 residents doctors-in-training across the U.S. about their contacts with pharmaceutical companies, finding that roughly half of all students received gifts of some kind. More than half of senior medical students and residents received gifts, which ranged from pens, donuts and pizza to offcampus meals. Nearly 15 percent of seniors had received free drug samples, despite medical students lack of a license to prescribe medications. There is overwhelming evidence" that any conflict of interest in the scientific review progress is a threat to patient health, the European Medicines Agency has been told. Summary of a study: 1. Influenza vaccines provide no benefit. 2. Influenza vaccines cause a hugely increased number of respiratory illnesses. 3. Influenza vaccines and very likely other vaccines harm the innate cell mediated immune response, which results in a significant increase in infectious disease incidents.

11 Conclusions: a majority of panels proposed changes to disease definitions that increased the number of individuals considered to have the disease, none reported rigorous assessment of potential harms of that widening, most had a majority of members disclosing financial ties to pharmaceutical companies. Seventeen of 18 scientists who wrote a controversial editorial critical of the European Commission's plan to regulate endocrine-disrupting chemicals have past or current ties to industries. Drug manufacturers have developed various evergreening strategies that contribute to increased overall healthcare costs. The study provides further evidence that cost-saving policies encour- aging generic medicine prescriptions,

12 which can have substantial savings for healthcare expenditures, may be offset by increased costs from follow-on drugs. A hospital s attempts to minimise its own medication costs can, as an unintended consequence, lead to increased overall community healthcare expenditure through spillover effects. Amid claims that Indian citizens are being used as guinea pigs in an industry worth an estimated 310m a year, the Supreme Court told the government that no trials for new drugs should go ahead until a mechanism is put in place to monitor them. It said the health ministry should meet with regional officials within four weeks to discuss strengthening the regulation of clinical trials. In recent years, India has emerged as one of the main locations for clinical trials by British, American and European pharmaceutical companies, looking for places to test new drugs and medicines. Hundreds of trials may be taking place at any one time. If vaccins are safe, why get patients compensation for vaccine injuries? The statin industry, with all of its spin-off(s), is a multi-billion-a-year industry. We are observing the revealing of the utmost medical tragedy of all times. It is unprecedented that the healthcare industry has inadvertently induced lifethreatening nutrient deficiency in millions of otherwise healthy people. "Many of the trials taking place today are unregistered and unpublished,

13 meaning the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk," said Andrew Miller, chair of the Commons science and technology committee. Het CBG, het College ter Beoordeling van Geneesmiddelen, is het orgaan dat beslist welke medicijnen veilig genoeg zijn om de Nederlandse markt op te mogen. In dat College zitten deskundigen van wie je mag verwachten dat ze dat onafhankelijk opereren, zonder inmenging van de farmaceutische industrie. Maar hoe onafhankelijk ben je als je grotendeels gefinancierd wordt door de bedrijven die je moet keuren? En hoe goed kun je je werk doen als je niet voldoende mankracht hebt om de medicijnen zelf te onderzoeken? We show that there has been an almost fourfold increase in prescription rates of ADHD medications, specifically for children and adolescents with ASD, in Denmark over the past decade. Thousands of desperate Kenyan patients are being used as guinea pigs in a thriving multibillion-drug industry with some trials contravening the country s laws and the international drugs-trial protocols. So, (1) the reality is that the death rate for cancer hasn't improved very much in the past 50 years, and (2) pharma's little "pills" haven't contributed much to that statistic.

14 Last week The Lancet published a meta-analysis of 27 statin trials, an attempt to determine whether patients with no history of heart problems benefit from the drugs true story. The topic is controversial, and no less than six conflicting meta-analyses have been performed also a true story. But last week s study claims to show, once and for all, that for these very low risk patients, statins save lives true story. Actual true story: the conclusions of this study are neither novel nor valid.

15 'The main reason we take so many drugs is that drug companies don't sell drugs, they sell lies about drugs. This is what makes drugs so different from anything else in life...virtually everything we know about drugs is what the companies have chosen to tell us and our doctors...the reason patients trust their medicine is that they extrapolate the trust they have in their doctors into the medicines they prescribe. The patients don't realise that, although their doctors may know a lot about diseases and human physiology and psychology, they know very, very little about drugs that hasn't been carefully concocted and dressed up by the drug industry If you don't think the system is out of control, then please me and explain why drugs are the third leading cause of death If such a hugely lethal epidemic had been caused by a new bacterium or a virus, or even one hundredth of it, we would have done everything we could to get it under control.' We estimate that as many as around persons in US can have been poisoned to death due to the painkilling substance Propoxyphene during the years (29 years).the best known trademarks have been Darvon and Darvocet fatalities in India between (27) as a result of DXP use. 4,503 people died in Sweden as a result of DXP use during the 24 years An algorithm designed by US scientists to trawl through a plethora of drug interactions has yielded thousands of previously unknown side effects caused by taking drugs in combination.

16

17 Three-quarters of the members on guideline panels that proposed changes in disease definitions and diagnostic criteria had ties to drug companies. 'We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear'. (George Merck, President Merck Chemical Manufacturing Company, 1950) Pharmaceutical Companies Spent 19 Times More On Self- Promotion Than Basic Research De grenzen tussen gezondheid en ziekte vervagen. Leefstijlgerelateerde aandoeningen, psychisch (on)welbevinden, preventieve geneeskunde en steeds striktere parameters voor lichamelijke gezondheid maken dat de populatie te behandelen Nederlanders steeds groter wordt. Dit is niet alleen een cultureel verschijnsel, maar ook een commercieel fenomeen dat actief bevorderd wordt door disease-mongering, gericht op zowel huis artsen als potenti ele pati enten. In dit artikel leggen wij aan de hand van voorbeelden uit hoe dat werkt. Disease-mongering, een combinatie van de begrippen disease awareness (ziektebewustzijn en fear mongering bangmakerij, heeft onnodige en vaak onverantwoorde medicalisering tot gevolg. m die medicalisering terug te dringen is het belangrijk dat zorgverleners begrijpen hoe de be nvloeding door disease-mongers werkt. "The pharmaceutical industry is the most lucrative, the most cynical and the least ethical of all the industries. It is like an octopus with tentacles that has infiltrated all the decision making bodies, world health organisations, governments, parliaments, high administrations in health and hospitals and the medical profession". De farmaceutische industrie houdt negatieve uitkomsten van medicijnonderzoek nog steeds buiten beeld. Driekwart van de negatieve resultaten wordt niet in vakbladen gepubliceerd, maar op weinig gelezen websites. Zo omzeilt de industrie de publicatieplicht. Dat concludeert Jarno Hoekman in zijn proefschrift waarop hij vandaag aan de Technische Universiteit Eindhoven promoveert. Volgens Hoekman stoppen farmaceuten onwelgevallige resultaten uit strategisch oogpunt in 'een digitale la'. 'Zij hebben belang bij positieve studies over hun product.'

18 The idea of a better ordered world is one in which medical discoveries will be free of patents and there will be no profiteering from life and death. (Indira Gandhi, 1982 World Health Assembly) Slaapproblemen zijn big business. Voor miljoenen gaan er over de toonbank (zo'n 26 miljoen euri's in 2010). Helaas, uit een meta-analyse van allerlei onderzoek blijkt dat ze nauwelijks werken en dat er ook nog de nodige gezondheidsrisico's aan kleven. Het einde van een patent, betekent het einde van een melkkoe voor Big Pharma. Dus dat moet zo lang mogelijk uitgesteld worden via vormen van 'evergreening' en 'pay for delay'. Pfizer, de maker van de bestseller (Lipitor) voegt daar nog wat extra maatregelen aan toe. Gezien de naderende einde van het patent, heeft Pfizer afgelopen 5 jaar de prijzen nog even met 50% verhoogd. Toen het patent verlopen was, bood/biedt dit bedrijf allerlei kortingen en extraatjes aan om gebruikers van Lipitor vast te houden. Niets is Big Pharma vreemd. Sterker nog: Big Pharma vertoont business-praktijken die zelden in andere branches vertoont worden Hoe komt het dat we biljoenen spenderen aan R&D terwijl slechts 1 op de 10 nieuwe medicijnen meer voordelen opleveren voor de patient? Hoe komt het dat we biljoenen spenderen aan R&D terwijl 9 van de 10 nieuwe medicijnen geen verbetering of zelfs een verslechtering betekenen? Antwoord: het business model van Big Pharma. Je hebt met een griepprik 5.1 % minder kans op griep. En dat klinkt heel wat anders dan de 50-90% minder kans op griep, zoals verkondigd wordt in het Nationaal Kompas Volksgezondheid!

19 Onlangs lekte een geheim rapport van Glaxo Smith Kline (GSK) uit, wat eigenlijk uitsluitend bedoeld was voor overheden, waar, in een veiligheidsstudie naar het veel gebruikte Infanrix Hexa vaccin voor babies/kinderen, ondanks de opmerkelijk vele doden die daarbij vielen, dit toch als veilig werd beoordeeld! A class of diabetes drug taken by millions of patients around the world may be considerably more dangerous than originally though, owing to the reticence of pharmaceutical companies to share data and make public the results of some of their studies, claim investigators with the British Medical Journal. De relatie dokters-pharma is soms behoorlijk controversioneel. Wat blijkt is dat studenten al heel vroeg in aanraking komen met farmaceutische marketing en dat ze hier positief tegen aan kijken en dat ze weinig oog hebben over de eventuele negatieve implicaties van de wisselwerking met farmaceutische bedrijven. Zo worden al snel innige en langdurige relaties gemaakt. Als ' evergreening' niet meer kan, dan schakelt Big Pharma over naar de volgende tactiek om hun markt te behouden: pay for delay. Medicijnfabrikanten betalen dan concurrenten om goedkopere medicijnen nog niet op de markt te zetten. Daarmee behouden zij hun marktaandeel en kunnen een hogere prijs handhaven.

20 Uit recent (2012) vrijgegeven documenten van Britse overheidsorganen, blijkt dat men al 30 jaar stelselmatig vaccinatie-risico s doelbewust ontkent en systematisch verhult. Een recente studie laat zien dat artsen de bijwerkingen van medicijnen vaak niet kennen en dat farmaceutische bedrijven dit ook vaak 'vergeten' te vertellen. De helft van de huisartsen en een onbekend deel van de praktijkondersteuners in Nederland blijkt artsenbezoekers te ontvangen. Daarnaast volgt een groot deel van hen gesponsorde nascholing en nemen zij relatiegeschenken aan. Sommigen ontvangen via farmaceutische bedrijven gratis ondersteuning, al dan niet via zorggroepen. Desondanks zijn deze huisartsen van mening dat er geen sprake is van beïnvloeding: hoe bijzonder! Het imago van de farmaceutische industrie is belabberd. En dat wordt o.a. veroorzaakt doordat ze voortdurend de wet overschrijden. In drie jaar tijd hebben ze alleen al in de Verenigde Staten ' 11 billion US dollars' aan

21 boetes voor 'unethical and illegal practices' moeten dokken. De kans dat een patiënt een statistisch bewezen doeltreffende medische behandeling ( therapie of medicijn) krijgt voorgeschreven in de reguliere geneeskunde, is 1 op 120. A senior executive with Britain's biggest drugs company has admitted that most prescription medicines do not work on most people who take them. Farmaceutisch bedrijf Wyeth heeft tientallen door ghostwriters geschreven artikelen gebruikt om onbewezen baten van hormoontherapie voor vrouwen in en na de overgang op te blazen en ernstige bijwerkingen te verdoezelen. Onder de vermeende voordelen: minder kans op hartziekten, zichtproblemen, Parkinson, dementie en, niet te vergeten, rimpels. Onder de verdoezelde bijwerkingen: een hogere kans op borstkanker. Farmabedrijven oefenen steeds meer invloed uit op psychologen en psychiaters. Van de experts die bepalen wat er in het wereldwijde handboek voor psychische stoornissen komt te staan, heeft ruim twee derde banden met een geneesmiddelenfabrikant. Geschat wordt dat Big Pharma jaarlijks zo n 91 miljoen euro investeert in lobby binnen het Europese Parlement. Zo n 220 pharma-lobbyisten zijn achter de schermen actief in het beinvloeden van onze europarlementariërs. Er zijn 750 europarlementariers. Er van uitgaande dat maximaal 10 procent van die parlementariers zich actief bezig houden met medicijnen en gezondheid, is de verhouding lobby-ist versus parlementarier 3 op 1! Een op de 12 medische wetenschappers in Vlaanderen geeft toe data te verzinnen of te ' masseren' om een hypothese te laten kloppen. En bijna de helft ziet zulke frauduleuze praktijken om zich heen gebeuren. Een onthutsende blik in de keuken van medisch onderzoek.

22 Een Japanse professor heeft in een onderzoek aangetoond dat Diovan van Novartis, beter werkt dan andere vergelijkbare medicijnen. Nu blijkt dat hij gefraudeerd heeft. De universiteit merkt op dat 'it does not question the drug s effectiveness':-) Een medewerker van Novartis, bleek betrokken te zijn bij deze studie:hij deed de statistische analyse:-) Deze medewerker was ook betrokken bij research aan 4 andere universiteiten. :-) Eindconclusie van een recente studie naar vaccinaties: ''It seems that it would be worthwhile to apply the precautionary principle - the ethical principle, according to which if there is a probable, although poorly known, risk of adverse effects of new technology, it is better not to implement it rather than risk uncertain but potentially very harmful consequences''. About half -- 48% -- of researchers with conflicts related to the trial sponsor or manufacturer failed to disclose some or all of them. That number rose to 88% when the authors looked at conflicts related to competing manufacturers, and 89% for any drugmaker at all. Of the 100 reports, 49 were funded by industry, 30 had mixed sponsorship, 19 were not funded by industry, and two did not specify. Every government in the world has some sort of committee established to provide advice on vaccines and vaccination practices to those who establish vaccination policies. Since the recommendations made by these committees are the first step toward making any vaccine part of public health policy, it is time to take a serious look at the quality of advice being offered by these committees. Just how valuable is it?

23 There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.

24 Verschijnt in 2014:

25