Legal judgements against big pharma aren’t enough. Friday 30th August 2019
On Monday, Johnson & Johnson got hit with a $572-
Anticholinergic meds linked to an almost 50 per cent higher risk of dementia. Tuesday, 25th June 2019
Scientists at the University of Nottingham looked at decades' worth of prescribing and diagnosis data for 284,343 over fifty fives registered with GPs in the UK. Nearly 59,000 of the people studied were diagnosed with dementia at some point. Within the 11 years leading up to their dementia diagnosis, 56.6 per cent of the patients (33,253) had been prescribed anticholinergic medications.
Anticholinergic medications include Anaspaz generic name: hyoscyamine.
Levsin SL (Pro) generic name: hyoscyamine.
Donnatal (Pro) generic name: atropine / hyoscyamine / phenobarbital / s.
Levbid generic name: hyoscyamine.
Millions taking antidepressants must be warned of dangerous side effects. Thursday 30 th May 2019
Patients seeking treatment for depression should be informed of the potential for "severe and long-
US Right to Know: Wednesday 3rd April 2019
More than 11,000 people have filed suit against Monsanto Company (now Bayer) alleging that exposure to Roundup herbicide caused them or their loved ones to develop non-
The New York Times: Saturday 8th September 2018
One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet. The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-
According to an analysis by The New York Times and ProPublica, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief. At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-
News of the World: Friday 24th August 2018
Even an occasional glass of wine or beer increases the risk of health problems and dying, according to a major study on drinking in 195 nations that attributes 2.8 million premature deaths worldwide each year to booze. An average of two drinks per day, for example, translated into a 7.0 percent hike in disease and injury compared to those who opt for abstinence. In the 15-
The Independent: Tuesday 21 August 2018
There are now more than 70,000 children (preadolescent) on antidepressant drugs in the UK. The drugs are prescribed for one in ten adults in most developed nations, and prescription rates for young depressed people are climbing in the US and UK. Many people getting the drugs don’t have severe depression, and the drugs barely work better than placebos for mild or moderate depression. On a standard depression scale, which rates depression from zero (not depressed) to 52 (most severely depressed), the drugs improve things by an average of about two points, compared with placebos in adults.
Worryingly, the drugs are often not being prescribed in an evidence-
Significant side effects
Trials show that antidepressant drugs increase the risk of suicide, compared with placebos in young people. Other side effects include nausea, sexual dysfunction and sleepiness.
Mail Online: Saturday 11th August 2018
The NHS spends more than £500 million a year on statins. The drugs are commonly prescribed to cut the level of so-
When brain cells are deprived of cholesterol, they are five times less effective at releasing chemical messengers, says the research, published in the highly respected journal Proceedings Of The National Academy Of Sciences. 'If you deprive cholesterol from the brain, then you directly affect how smart you are and how well you remember things,' says Yeon-
The Guardian: Tuesday 24th July 2018
The death of 11 babies born to women who were given sildenafil during a drug trial has led to the termination of the experiment – and an anxious wait for other mothers involved. Sildenafil is sold by Pfizer as Viagra, but the pills used in the study were not ones produced by the pharmaceutical giant. The trial was designed to test whether the medication could help boost babies’ growth in the womb. Previous trials had determined that there was no benefit to giving Viagra in cases where babies were underdeveloped in the womb. All the children that died had lung complications and died after birth.
A warning about Hydrochlorothiazide.
New research from Denmark has found that use of hydrochlorothiazide, a drug widely prescribed for high blood pressure, substantially increases the risk of developing skin cancer. Based on the analysis of 80,000 Danish cases of this disease and 1.5 million healthy people, the research shows that patients taking hydrochlorothiazide had up to seven times the risk of developing squamous cell carcinoma, one of the most common forms of skin cancer. This is not the first study to link this drug with skin cancer and it is now classified as 'possibly carcinogenic to humans'. On top of this, one of the particularly critical nutrients inhibited by this drug is coenzyme Q10. Significantly, a deficiency of coenzyme Q10 is well known to be associated with high blood pressure, coronary artery disease, heart failure, and other cardiovascular problems. Remember, this drug is being prescribed to alleviate high blood pressure. You couldn't make this up.
The Telegraph: Wednesday, 25th April 2018
A major new study, published in the British Medical Journal, found a “robust link” between the degenerative disease and the medication, even when taken up to 20 years before a diagnosis. It suggests some patients with long-
The antidepressant medications most implicated by the study include Amitriptyline, Dosulepin and Paroxetine. A dementia risk was also associated with the bladder drugs Tolterodine, Oxybutynin and Solifenacin, as well as the Parkinson’s drug Procyclidine. It is believed nearly 2,000,000 people in England are taking these and other similar drugs.
The following article was brought to our attention by Claire Baker
Mail Online: Thursday, Jan 4th 2018
A woman who battled blood cancer for years without success finally halted the disease with turmeric, it has been reported.
Dieneke Ferguson is now leading a normal life after giving up on gruelling treatments that failed to stop it.
Doctors say her case is the first recorded instance in which a patient has recovered by using the spice after stopping conventional medical treatments.
With her myeloma spreading rapidly after three rounds of chemotherapy and four stem cell transplants, the 67-
The cancer, which has an average survival of just over five years, was causing increasing back pain and she had already had a second relapse. But it stabilised after Mrs Ferguson, from north London, came across the remedy on the internet in 2011 and decided to try it as a last resort. The tablets are expensive – £50 for ten days – but as kitchen turmeric contains just 2 per cent curcumin it would be impossible to eat enough to get the same dose. Mrs Ferguson, who was first diagnosed in 2007, continues to take curcumin without further treatment and her cancer cell count is negligible. Her doctors, from Barts Health NHS Trust in London, wrote in the British Medical Journal Case Reports: ‘To the best of our knowledge, this is the first report in which curcumin has demonstrated an objective response in progressive disease in the absence of conventional treatment.’ The experts, led by Dr Abbas Zaidi, said some myeloma patients took dietary supplements alongside conventional treatment but ‘few, if any, use dietary supplementation as an alternative to standard antimyeloma therapy’.
N.B. Mrs Ferguson is not using turmeric but curcumin in very high doses. Curcumin is used all the time, in conjunction with other nutrients, to treat cardiovascular disease and is a powerful anti-
The Guardian: Wednesday 22 November 2017
The Competition and Markets Authority (CMA) has discovered a rich seam for inquiries – pharmaceutical companies allegedly gouging the National Health Service. Pfizer, together with a small UK company called Flynn Pharma, was fined £90m last December for “excessive and unfair” pricing of an anti-
Now comes an accusation that the Canadian firm Concordia Healthcare abused its dominant position to overcharge the NHS on a thyroid treatment. The price of the drug rose by almost 6,000% while production costs remained “broadly stable,” says the CMA.
The Concordia case is similar to the Pfizer one in that the price hikes followed the de-
The government has tried to address the problem by creating powers to control prices of generic medicines. But the open question is how severely the system has been abused. The CMA says its investigators are pursuing another seven cases involving several companies, which may suggest a pricing loophole has been quietly exploited for years. The CMA is doing its bit, but there is a strong case for a wider investigation that looks beyond the narrow application of competition and consumer-
The Guardian: Tuesday 31 October 2017 23.30
There are more than 50 million prescriptions for proton pump inhibitors in the UK, though they have previously been linked to side-
Proton pump inhibitors (PPIs) reduce the amount of acid made by the stomach and are used to treat acid reflux and stomach ulcers. A study published in the journal Gut identified an association between long-
While H2 blockers were found to have no link to a higher risk of stomach cancer, PPIs was found connected to an increased risk of more than double. Daily use of PPIs was associated with a risk of developing the illness that was more than four times higher (4.55) than those who used it weekly. Similarly, when the drug was used for more than a year, the risk of developing stomach cancer rose five-
CBS News: Oct 27, 2017 12:47 AM
Drug company founder John Kapoor arrested for alleged opioid scheme.
Federal agents arrested the founder of a major drug company in an early-
John Kapoor, founder and former CEO of Insys Therapeutics, is the most significant pharmaceutical executive to be criminally charged in response to the nationwide opioid crisis. Brian Kelly, an attorney for Kapoor, said his client "is innocent of these charges and intends to fight the charges vigorously." Kapoor stepped down as CEO of Insys in January but still serves on its board. The company makes a spray version of fentanyl, a highly addictive opioid intended only for cancer patients. Authorities allege Insys marketed the drug as part of a scheme to get non-
CBS News correspondent Jim Axelrod reports Insys made 18,000 payments to doctors in 2016 that totaled more than $2 million. CBS News has identified headache doctors, back pain specialists and even a psychiatrist who received thousands of dollars to promote the drug last year. A federal judge on Thursday set bail for Kapoor at $1 million and ordered him to wear a electronic monitoring bracelet and to surrender his passport, CBS News' Pat Milton and Laura Strickler report. Last December, six other Insys executives were indicted on federal charges in Boston in connection with the alleged scheme to bribe doctors to unnecessarily prescribe the painkilling drug.
The Telegraph: Sunday 25 October 2017
The Serious Fraud Office is considering an inquiry into allegations that some drug companies are secretly colluding with pharmacists to overcharge the NHS millions of pounds, following an undercover investigation by The Telegraph.
In a letter to the shadow attorney general, Emily Thornberry, the SFO said it was in discussions with the NHS about launching a criminal inquiry into the questionable relationship between some drug companies and high-
This newspaper found that representatives of some companies agreed to invoice chemists for drugs at up to double their actual cost. Chemists would then send inflated invoices to the NHS, allowing them to pocket the difference. Mrs Thornberry, the Labour MP, wrote to the SFO asking them to investigate. Last week, David Green, the director of the organisation, responded. "The SFO are working closely with NHS Protect and the allegations that have been made are the subject of careful consideration”, wrote Mr Green.
The disclosure comes as the Office of Fair Trading have confirmed that they are also considering an investigation into another drug company that has hiked the price of a prescription medicine for menopausal women from £26 a pack to £395.
N.B. The price of £26 a pack is already double what you should be paying.
Guardian Today: Tuesday 24 October 2017 06.00 BST
Statins are being overprescribed to low-
The report also found there could be “significant overtreatment” of statin therapy among patients who have less than a 10% chance of developing CVD within 10 years. The risk assessment tool – which predicts a person’s risk of CVD within 10 years – was introduced in 2012 and is recommended by the National Institute for Health and Care Excellence (Nice). Only 27.1% of patients prescribed a statin after 2012 – when the tool was introduced – were considered at risk. Nice recommends that patients with a 10% or higher chance of developing CVD should be offered statins. One in six patients who had the risk assessment and went on to start statin therapy were in the low-
N.B. We have to bear in mind here that there is no evidence that statins reduce CVD and, contrary to general advice from the medical profession, a high level of cholesterol does not cause arteriosclerosis or CVD. Cholesterol is manufactured in the liver and high levels of cholesterol can be the result of either a hereditary condition or an indicator of damaged arteries. The body uses LDL (wrongly termed “bad cholesterol”) like a sticking plaster to cover the damage inside the arteries and so, reducing the amount of cholesterol doesn’t help the damaged arteries. It would make more sense to treat the cause rather than the symptom although, this wouldn’t be anything like as profitable for the pharmaceutical companies.
BBC News: Sunday 22 October 2017
A new report, seen by 5 live Investigates, claims that UK taxpayers and patients worldwide are being denied the medicines they need, despite the public sector playing a pivotal role in the discovery of new medicines. The report, published by campaign groups Global Justice Now and Stop Aids, says that even when the government has part-
It says: "In many cases, the UK taxpayer effectively pays twice for medicines: first through investing in R&D, and then by paying high prices for the resulting medicine once ownership has been transferred to a private company." It claims the high prices of new medicines are "unsustainable for an already underfunded NHS".
The Telegraph: Sunday 22 October 2017
The NHS is spending more than £750m on drugs to treat conditions brought on by unhealthy lifestyles, official figures show. Prescriptions for drugs to combat obesity, diabetes, alcoholism and smoking have all increased. For the first time ever, more money is being spent on treating diabetes than any other single disease. It is now one of the biggest health problems facing the UK as increasing obesity levels have caused an explosion in the type 2 form of the disease. Figures showed more than than 1.23m prescriptions were written for obesity drugs last year (Antiobesity Medications) at a cost of £51.83m, a rise of 8.5 per cent on the amount spent in 2006.
And drug treatments used to combat alcohol addiction, drug misuse and to help people quit smoking also rose to more than 5.7m prescriptions at a cost of £111.2m last year. On top of this millions of people are receiving medicines to control cholesterol levels and high blood pressure which can also be helped to a certain extent by exercise and diet. The figures raised concern that the NHS is spending ever increasing amounts of money on conditions that could be prevented if people adopted a healthier lifestyle.
N.B. Many of these medications have limited benefits to the patient.
CBS News: 17 October 2017
In the midst of the worst drug epidemic in American history, the U.S. Drug Enforcement Administration's ability to keep addictive opioids off U.S. streets was derailed -
Joe Rannazzisi is a tough, blunt former DEA deputy assistant administrator with a law degree, a pharmacy degree and a smoldering rage at the unrelenting death toll from opioids. His greatest ire is reserved for the distributors -
The Washington Post: 15 October 2017
In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets. By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.
A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-
The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch (R-
“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-
The Gardian:Thursday 5 October 2017 06.01 BST
Most cancer drugs that have recently arrived on the market have come with little evidence that they boost the survival or wellbeing of patients, research reveals. Forty-
In only 10% of the uses did the drugs improve quality of life. Overall 57% of uses showed no benefits for either survival or quality of life. The team then looked to see whether the picture improved over time. Huseyin Naci, assistant professor of health policy at the London School of Economics, and a co-
“What we find very surprising is that not very many studies are looking at overall survival or quality of life as their [primary] objective,” said Naci. He said that instead most of the studies examined indirect measures, such as x-
The Guardian: Thursday 21 September 2017 05.00 BST
There is no magic pill to cure alcoholism, according to a scientific review of the evidence of five drugs being prescribed by doctors. None of the five drugs has a body of reliable evidence behind it, say the scientists, even though one of the drugs, nalmefene, has been approved for use in the NHS by Nice, the National Institute for Health and Care Excellence. Another, baclofen, has generated huge excitement, especially in France, but has been linked to deaths.
The pills have been developed for people who have not stopped drinking completely and are intended to help them cut down, with a view to reducing the harm they are doing to their bodies. But at best, says the study in the journal Addiction, the pills had a low-
The researchers looked at the trials carried out on nalmefene, naltrexone, acamprosate, baclofen and topimarate against placebos. So many people dropped out of the trials that 26 of the 32 studies – 81% of them – had unclear or incomplete outcome data. Lead author Dr Clément Palpacuer from Inserm, the French National Institute of Health and Medical Research, said: “Although our report is based on all available data in the public domain, we did not find clear evidence of benefit of using these drugs to control drinking. That doesn’t mean the drugs aren’t effective; it means we don’t yet know if they are effective. To know that, we need better studies. Researchers urgently need to provide policymakers with evidence as to which of these drugs can be effectively translated into a real harm-
Concerns have already been voiced about the drugs. The first to be licensed in Europe was nalmefene, an opioid antagonist that acts on the urge to consume alcohol. But critics pointed out that the trials had not proved it reduced the harm alcoholics were doing to themselves. That drug was later endorsed for use in the NHS by Nice, but against protests. In August last year, a review of the trial evidence led by the University of Stirling also in Addiction said that “evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients”. This created a dilemma for GPs and commissioners, it said, “where nalmefene has been heavily promoted”.
The Telegraph: 10 September 2017
With NHS budgets under pressure and medicine prices inexorably going up, something had to give. Nevertheless, the decision by some of the world’s largest pharmaceutical firms this summer to challenge public sector powers to limit drug bills in the High Court still raised eyebrows. The action brought by trade body the Association of the British Pharmaceutical Industry (ABPI) divided the sector, with Britain’s two largest drug makers, FTSE 100 giants GlaxoSmithKline and AstraZeneca, distancing themselves from a move driven by overseas conglomerates.
At a time when the Government has been working to boost the £63bn life sciences sector, legal action was seen by some in the industry as reckless. For them, the backdrop of Brexit and the sector’s special pleading for continued close integration between the UK’s medicines regulation and the EU’s compounded the miscalculation.
However, the bitterness between industry and the NHS became all too apparent yesterday, as court papers seen by The Sunday Telegraph revealed the NHS had attacked the drug makers’ claims as “unarguable” and “makeweight”. The dispute surrounds powers given to the NHS that allow it to ration medicines that are expected to cost more than £20m in any of their first three years of use. Previously they would have been automatically funded if approved by health costs agency Nice. Drug firms argue cutting-
As medicines become ever more complex and costly to develop, the tensions exposed by the judicial review are only likely to increase. In the United States, a separate development illustrates why some multinational drug firms feel strongly enough to take the significant reputational risk of taking the NHS to court. Swiss giant Novartis, working with British biotech group Oxford BioMedica, won US approval a fortnight ago for Kymriah, a landmark gene therapy for a form of leukaemia. The blood cancer most commonly affects children and teenagers.
It was the first so-
Novartis priced Kymriah at $475,000 (£356,000), making it one of the world’s most expensive medicines. The drugs giant says its expense is justified due to its dramatic clinical benefit, one-
Dr Nick Crabb, Nice’s programme director for scientific affairs, points out it ran the first of a series of workshops on pricing and access to regenerative medicine, the catch-
The Cancer Drugs Fund, a £1bn-
There is some evidence the NHS already pays too much for medicines. A study by health economists at the University of York two years ago concluded Nice’s existing thresholds for gauging the cost-
Mick Cooper of Trinity Delta agrees: “The big issue is that many of these new treatments will need a large upfront payment, with the benefits to the country felt over the subsequent years or decades. So it would make sense for a number of these treatments to be funded from a purely economic perspective. However, it would put greater pressure on healthcare budgets.” Analysts expect Nice to be comfortable with a high price for Novartis’s Kymriah for ALL, given the likely long-
N.B. Big Pharma has not produced any drugs in recent years that will offer the patient a cure. In order to be acceptable for distribution in the NHS a new drug is supposed to demonstrate significant benefits to the patient. In only one instance has this been demonstrated in recent years. In some cases drugs actually shorten patients lives. When it says that the government is eager to promote life sciences this can include cellular medicine which has shown significant benefits in both heart disease and cancer at a fraction of the cost.
Natural News: Monday, July 31, 2017
The extremely aggressive therapy, which kills both cancerous and healthy cells, has been found to increase the chance of cancer cells migrating to other parts of the body. When this happens, the disease is called metastatic cancer, which is the most lethal form. Chemotherapy gives people the false impression of “curing” the disease. Unfortunately, this is only half of the story. While shrinking primary tumours for some patients in the short term, chemotherapy drugs trigger a mechanism in the body which allows cancer cells to grow back faster and stronger. Most patients receiving chemotherapy are basically trading one cancer for another deadlier form of the disease. Yet, chemotherapy remains the go-
For their study, researchers at the Albert Einstein College of Medicine in New York analysed the effect of common chemotherapy drugs on breast cancer patients. Dr. George Karagiannis and colleagues discovered that two common chemo drugs increased the number of “doorways” on blood vessels. Via these little entry points, cancer cells can easily migrate to the bloodstream and other organs in the body. Also, additional testing in mice showed more circulating cancer cells in the body and lungs after the drugs were administered. Lead author Dr. George Karagiannis told The Telegraph that given these results, every cancer patient receiving chemotherapy should be closely monitored to check if the disease is spreading.
The Pharmaceutical Journal : 14 July 2017
The cholesterol and calorie hypotheses are both dead — it is time to focus on the real culprit: insulin resistance.
Over the years, medical guidelines have continually expanded the number of individuals for whom statin therapy is recommended. Proponents argue that statins are ‘life-
However, the true benefit of statins in altering risk of CVD is increasingly being questioned by respected members of the medical community, creating bitter divisions within the ranks. Several cardiologists have countered that the benefits of statins have been grossly exaggerated (especially as primary prevention), while their risks have been consistently underemphasised. In some quarters, the scepticism about statins has reached fever pitch. Some say that the preponderance of statin trials has been tainted by ‘industry sponsorship’, influenced by ‘statistical deception’, and riddled with ‘flawed methodology’.
Those who challenge the cholesterol hypothesis are accused of ‘cherry-
The Guardian: Friday 28 April 2017 06.30
The Cancer Drugs Fund, set up by the government to pay for expensive medicines that the NHS would not normally finance, failed to benefit patients and may have resulted in some of them suffering unnecessarily from toxic side-
But the medicine it paid for was not worth the money, the report concluded. The analysis in the Annals of Oncology journal looked at 29 cancer drugs approved for 47 different types of treatment (known as indications), some of which were approved to treat more than one cancer. They found that only 18 of the 47 treatments prolonged the patient’s life, and then only by an average of three months. Many of the drugs were approved by the fund on the basis of clinical trials that aimed only for what is called “progression-
N.B. Statistically, 3 months isn’t enough to say that the drug has been beneficial as the placebo effect will make more of a difference than this. There is no evidence that any of the drugs had any benefit at all. People who change their way of life i.e. stop drinking and smoking, take regular exercise and change their eating habits will fare much better than this and will often survive completely. Work that has been carried out over the past 20 years suggests that the survival rate can be improved even further by taking certain supplements to boost the bodies repair mechanism.
The Telegraph: 16 December 2016 • 10:56am
The Competition and Markets Authority issued a statement of objections after it found Actavis UK put up the price of generic 10mg hydrocortisone tablets from 70p a pack in April 2008 to £88 per pack by March 2016. The company also raised the price of 20mg hydrocortisone tablets by nearly 9,500pc. The NHS went from paying £1.07 a pack to £102.74 a pack by March 2016. "This is a life-
The CMA's action marks its second intervention in the space of a week after it hit US giant Pfizer with a record £84m fine for raising prices on an anti-
The Telegraph: 16 September 2016
This sentence appeared in an article in the Telegraph and is telling when it comes to expensive treatments for cancer. “Earlier this week a major study found that prostate cancer survival rates are equally high if [the] disease is monitored rather than treated.”
Independent: Wednesday 1 June 2016 23:12 BST
Corrupt tactics highlighted in the campaign group’s report include paying doctors to participate in surveys of medicines they have never actually prescribed, and companies secretly ghostwriting clinical trials research before passing it off as the work of impartial academics. Bribery and corruption, the report says, also allow some companies to get round manufacturing regulations, helping to create a situation where about a quarter of medicines consumed in low and middle-
Part of the problem, the report said, was the huge power of the pharmaceutical industry in a world where global spend on medicines is expected to grow to $1.3tn by 2018. Big Pharma’s financial muscle, the report claimed, allowed it to spend millions every year on political lobbying: “Pharmaceutical companies can unduly influence national political systems through their large spending power. [They] often fund candidates that support their position on key issues.” Although some industry associations, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) have previously insisted they are “educating” not advocating, the Transparency International report insisted: “Such funding can shape policy debates to favour a pharmaceutical company’s profit maximisation and negatively impact public health objectives.”
Pharmaceutical companies, it was claimed, could also buy a positive but misleading gloss on trials of a drug’s safety and effectiveness. The report said one study found that 94 per cent of industry-
The corruption could even extend to disguising who had actually written the research. The report claimed that having the pharmaceutical industry ghostwrite clinical trial articles and pass them off as the work of eminent researchers was “a common practice, particularly in industry-
The Express: Sunday 27 September, 2015
Scientists have found the heart disease drug, known as statins, badly affects our stem cells, the internal medical system which repairs damage to our bodies and protects us from muscle and joint pain as well as memory loss. Last night experts warned patients to “think very carefully” before taking statins as a preventative medicine. A GP expert in the field said: “They just make many patients feel years older. Side effects mimic the ageing process.”
The new research by scientists at Tulane University in New Orleans has reignited the debate about statin side effects which many doctors say have been played down. They include memory loss, muscle pain, diabetes, cataracts, liver dysfunction, diabetes, fatigue and memory loss. Professor Reza Izadpanah, a stem cell biologist and lead author of the research published in the American Journal of Physiology, said: “Our study shows statins may speed up the ageing process. People who use statins as a preventative medicine for heath should think again as our research shows they may have general unwanted effects on the body which could include muscle pain, nerve problems and joint problems.”
The scientists who treated stem cells with statins under laboratory conditions found that after a few weeks the cholesterol-
N.B. Statins reduce the body’s ability to utilize and produce co-
PubMed: 6 February 2015
In contrast to the current belief that cholesterol reduction with statins decreases atherosclerosis, we present a perspective that statins may be causative in coronary artery calcification and can function as mitochondrial toxins that impair muscle function in the heart and blood vessels through the depletion of coenzyme Q10 and 'heme A', and thereby ATP generation. Statins inhibit the synthesis of vitamin K2, the cofactor for matrix Gla-
Liberty Voice: March 27, 2014
AminoSweet and Aspartame are one of the same. Some health advocates are saying the name was changed to trick the public. Aspartame consists of three separate chemicals. Aspartic acid, phenylalanine and methanol. Some advocates such as Phyllis Balch, author of Prescription for Nutritional Healing, put aspartame in the “chemical poison” category. First introduced into Europe, aspartame is an everyday product now. It is found in most diet beverages, chewing gum and sugar-
Gardian Today: Friday 13 June 2014 15.33 BST
Draft guidance from the National Institute for Health and Care Excellence (Nice) has recommended that everybody with a risk as low as 10% over 10 years (rather than 20% as now) should be eligible for statins from their GP. About 7 million middle-
This week, one British Medical Journal (BMJ) author and seven other doctors, including the president of the Royal College of Physicians, Sir Richard Thompson, and a former chair of the Royal College of GPs, Dr Clare Gerada, wrote to Nice and the health secretary, Jeremy Hunt, asking for the guidance to be delayed. The letter questioned the benefits and side-
Thompson has declined to comment, but the British Cardiovascular Society, which represents physicians treating heart disease, said the letter he signed did not represent the views of its members. Nice rejected the call for delay. "Cardiovascular disease maims and kills people through coronary heart disease, peripheral arterial disease and stroke. Together, these kill one in three of us. Our proposals are intended to prevent many lives being destroyed," said Prof Mark Baker, director of its centre for clinical practice. At the heart of the furore is a deep-
The two papers published by the BMJ last year are part of a long-
Dr Clare Gerada said this was the main reason she had signed the letter, rather than any suspicion of the drug companies. The statins story, she said, was "a metaphor for what is going on today – the medicalisation of humans". We have, she said, "paradoxical and conflicting agendas. One is patient empowerment, putting the public and patients in charge of their health, trying to get them to self-
But on the other side was a different agenda, she said, committed to "if it can be measured, it shall be and this idea that fit, healthy people who are middle-
N.B. You have to read to the end of this report as the first part seems to support the use of statins. Even if statins had a proven beneficial effect, putting people on them who don’t need them is just plain wasteful. It opens the question of who is paying whom when the National Institute for Health and Care Excellence and the Health Secretary refuse to address concerns regarding the benefits of statins and insist on increasing their use.
Financial Tmes: 4th July, 2012
GlaxoSmithKline broke a shameful record this week with a $3bn fine from US regulators for marketing medicines beyond their authorised uses. It would be comforting to believe the action was an exception by a few individuals in a single company, in one country, and in a past era. The evidence is not so reassuring. The punishment is the latest levied on a series of large pharmaceutical companies employing aggressive tactics in the US. Pfizer was fined $2.3bn in 2010, and Abbott $1.5bn in May this year. Several other cases have already been concluded, and still more are pending.
Many of the events took place a decade ago, and the US seems to have had a particularly aggressive commercial culture that put sales before patient safety or value to healthcare systems. Yet some of the accusations against GSK date as recently as 2010. Furthermore, legal actions elsewhere, including against Servier in France, suggest overly cosy links between drug companies and doctors are not simply an American problem. While the drug industry has introduced tougher ethical codes in recent years, almost every reform companies have taken has been a response to litigation and regulatory action, notably in the US. It is these threats which bring the greatest chance of an improvement in ethical conduct. There may yet be a case for a tougher threat of criminal action against the individuals responsible for abuse.
Greater transparency is necessary, with more disclosure on clinical trial design and results, as well as side effects, payments and entertainment from industry to all those with influence over prescribing decisions. Medical education in particular should be more firmly separated from corporate funding. Marketing can have a place in medicine, but it should be evidence based. It would be dangerous to entirely isolate doctors from drug companies. The best researchers and clinicians need to engage with industry to develop and assess new treatments. But doctors have sometimes appeared as willing to take money as companies have to give it. They should be subject to more scrutiny and controls on financial support they receive.
Prescription medicine producers like to describe themselves as the ethical pharmaceutical industry. To deserve that label – particularly at a time of growing pressure on margins – they will have to redouble their efforts to recognise that drugs are not simply a commercial product.
The New York Times: 15th January 2008
A clinical trial of a widely used cholesterol drug has raised questions both about the medicine’s effectiveness and about the behavior of the pharmaceutical companies that conducted the study, cardiologists said Monday. Merck and Schering-
In a press release, Merck and Schering said that not only did Zetia fail to slow the accumulation of fatty plaque in the arteries, it actually seemed to contribute to plaque formation — although by such a small amount that the finding could have been a result of chance. Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.” “This is as bad a result for the drug as anybody could have feared,” said Dr. Nissen, a widely published researcher and senior consulting editor to the Journal of the American College of Cardiology. Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects, he said. Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed, he said. Both companies’ shares fell Monday. Sales of the two drugs were $5 billion in 2007, and they are important contributors to Merck’s and Schering’s profits. The House Energy and Commerce Committee, which is investigating the delay, said in a statement Monday that the negative results added to suspicions that the companies had deliberately sat on their findings from the study, which was known as Enhance.
“In light of today’s results, which were released nearly two years after the Enhance trial ended, it is easy to conclude that Merck and Schering-
Lee Davies, a spokesman for Schering, said the delay was unrelated to the negative findings and that the companies had not known the results until two weeks ago. Dr. John Kastelein, a Dutch cardiologist who had conducted the Enhance trial for Merck and Schering, did not return calls or reply to an e-
Worldwide, about one million prescriptions are written for Zetia and Vytorin each week, and about five million people are now taking the drugs worldwide.
World Health Organisation (WHO): February 2006
Dr Jerome Kassirer, a former editor of the New England Journal of Medicine (NEJM), contributed an article to the report documenting his own experiences with the long financial tentacles of the pharmaceutical industry. “Throughout my time at NEJM, we saw a steadily increasing number of submitted articles that couldn’t be published because of authors’ conflicts of interest,” he told the Bulletin.
In the United States, 90 000 pharmaceutical representatives ply doctors with gifts and junkets. The US$ 2 billion spent annually just on free meals and other hospitality events would dwarf many health budgets in African countries. “Yet the doctors receiving all these gifts are unanimous in insisting it has no effect on their practice,” said Kassirer, a professor at Tufts University School of Medicine in the United States.
The available research suggests otherwise, he argues in his contribution to the report. In one study, doctors who requested additions to their hospital’s drug formularies were found to be 9–21 times more likely than their colleagues to have accepted hospitality or funding from the drugs’ manufacturers. Kassirer also points to a famous decision by the US Food and Drug Administration (FDA) to keep the drugs Vioxx and Bextra on the market after concerns were raised over cardiovascular risks. Most of the panellists on the FDA committee, it later emerged, had financial ties to the manufacturers. If these panellists had declared a conflict of interest and refrained from voting, the decisions would have gone the other way.
N.B. Pharmaceutical giant Merck & Co. has agreed to a massive $950 million settlement with the U.S. government and 43 states over the way it marketed the painkiller Vioxx. The arthritis drug was withdrawn from the market in 2004 after it was linked to increased risk of heart attack and stroke among those who took it. The U.S. Department of Justice said Merck will also plead guilty to misdemeanour charges that it marketed Vioxx as a treatment for arthritis before it gained approval to do so from the Food and Drug Administration (FDA). The criminal component of the agreement centres on the illegal marketing and promotion of Vioxx for the treatment of rheumatoid arthritis. The FDA estimated in 2004 that Vioxx was responsible for more than 27,000 deaths.
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