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Legal judgements against big pharma aren’t enough. Friday 30th August 2019

On Monday, Johnson & Johnson got hit with a $572-million fine in Oklahoma for misrepresenting the dangers of its opioid medications, Nucynta and Duragesic, thereby causing a “public nuisance.”  The company has been hit with numerous multimillion-dollar jury verdicts in recent years for serious health issues related to its talcum powder, hip implants, pelvic mesh, the anti-psychotic drug Risperdal and other products. The judgments are simply part of the company’s cost of doing business.  Neither the opioid cases nor the myriad other pharmaceutical lawsuits will make a real difference until consumers wake up to the fact that drugs and medical devices aren’t panaceas: They can have tremendous costs and consequences.


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-lasting withdrawal symptoms"  A total of 70.9 million items to treat conditions including depression and anxiety were given out in 2018 in England, according to data published by NHS Digital.  What this article doesn’t talk about is that contrary to the pro-drug propaganda that is commonly spread through the mainstream media, the fact is that antidepressant drug treatments are far from safe. Illustrating this, an analysis of hundreds of thousands of patients published in 2017 found these medications to be associated with a significantly elevated risk of death. Overall, people using the drugs had a 33 percent higher risk of death than those not using them. They also had an increased risk of suffering cardiovascular problems such as heart attacks and strokes.


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-Hodgkin lymphoma, and that Monsanto covered up the risks. As part of the discovery process, Monsanto has had to turn over millions of pages of its internal records. We are posting these Monsanto Papers as they become available here.


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-Myers Squibb, among other corporations, has had a stake in start-ups testing cancer therapies, and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

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-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.


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 15-49 age bracket, alcohol emerged as the most lethal factor, responsible for more than 12 percent of deaths among men.


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-based way for young people. Whereas guidelines in the UK state that antidepressants should only be prescribed within child and adolescent mental health services (CAMHS), many GPs prescribe them. This means that children are unlikely to be getting the supervision needed to avoid unnecessary harm. And the harms can be serious.

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-called 'bad' LDL cholesterol that our livers create.  In patients vulnerable to heart attacks and strokes, the drugs reduce the risk of fatty deposits gathering in their bloodstream and causing life-threatening blood clots.  But cholesterol is also produced by the brain, where it is used to release vital chemicals called neurotransmitters that carry messages between brain cells. Now a study by Iowa State University suggests that statins inhibit this vital process.

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-Kyun Shin, the biophysics professor behind the study. 'This may lead to depression and irrational acts.' He believes this is directly caused by disruption in the neurotransmitter release in the brain.


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-term exposure to the drugs could face a 30 per cent increased chance of dementia.

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-year-old began taking 8g of curcumin a day – one of the main compounds in turmeric.


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-oxidant. Other powerful anti-oxidents already used in the successfully treatment of cancer are NAC (N-Acetyl-Cysteine) and EGCG (green tea extract) both of which induce cell death in cancer cells and have other effects also. Mrs Ferguson could get a more effective treatment at half the price at the Rath Foundation, however, if it works, don’t knock it. This treatment may have only a minimal effect on other types of cancer.



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-epilepsy drug. GlaxoSmithKline and two small firms were later hit for £45m for conspiring to delay competition on an antidepressant.

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-branding of a medicine. De-branding takes a drug into an unregulated pricing regime where competition from generic manufacturers is supposed to act as a brake on prices. In practice, competition doesn’t always arrive – thus a pack of Concordia’s liothyronine tablets rose from £4.46 before de-branding in 2007 to £258 by July this year.

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-protection laws. As it is, NHS England’s response felt limp – the CMA’s action “sends an important enforcement signal … that taxpayers and the NHS will not tolerate market abuses,” it said. Well, yes, signals are important. But taxpayers and patients also want to know if the NHS has been taken for a ride on generics, whether officials are wiser to pricing games and whether the new law is up to the job. There is scope for a parliamentary inquiry. And, since the companies all shout about their ethical codes of conduct, they would surely be happy to be questioned in detail about how they deal with the NHS.


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-effects and increased risk of death. A drug commonly used to treat acid reflux is linked to a more than doubled risk of developing stomach cancer, researchers have claimed.

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-term use of the drug and a 2.4 times higher risk of developing stomach cancer. In the UK, there are more than 50m prescriptions for PPIs every year but they have been linked to side-effects and an increased risk of death. A link between PPIs and a higher stomach cancer risk has previously been identified by academics – but never in a study that first eliminates a bacteria suspected of fuelling the illness’s development. Research by the University of Hong Kong and University College London found that after the Helicobacter pylori was removed, the risk of developing the disease still rose in line with the dose and duration of PPI treatment. They compared the use of PPI against another drug which limits acid production known as H2 blockers in 63,397 adults. The participants selected had been treated with triple therapy, which combines PPI and antibiotics to kill off the H pylori bacteria over a week, between 2003 and 2012. Scientists then monitored them until they either developed stomach cancer, died or reached the end of the study at the end of 2015. During this period, 3,271 people took PPIs for an average of almost three years, while 21,729 participants took H2 blockers. A total of 153 people developed stomach cancer, none of whom tested positive for H plyori but all had long-standing problems with stomach inflammation, the study found.

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-fold, and as high as eight-fold after three or more years, the findings showed.


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-morning raid Thursday on charges stemming from an alleged scheme to get doctors to illegally prescribe a powerful opioid to patients who don't need it. John Kapoor, 74, was taken into custody in Phoenix, Arizona. Kapoor is the billionaire founder and former CEO of the pharmaceutical company Insys Therapeutics. He faces charges including racketeering, conspiracy, bribery and fraud.

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-cancer doctors to prescribe it. Numerous physicians were allegedly paid bribes by the company to push the painkilling drug.

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-street chemists. Last month, the Telegraph exposed how the prices of more than 20,000 drugs could have been artificially inflated, with backhanders paid to chemists who agreed to sell them. The taxpayer is thought to have lost millions of pounds.

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-risk groups and underprescribed to high-risk groups, research by the British Journal of General Practice (BJGP) has shown. The report found potential “undertreatment” among people who have at least a 20% chance of Cardiovascular Disease (CVD) within a decade, who are considered high-risk patients. Slightly over a third (35%) of this group were prescribed statins, meaning that after risk assessments were undertaken the majority were not offered the drugs, which are prescribed to reduce cholesterol levels to help prevent heart attacks and strokes.

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-risk category, the researchers found.

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-funded the research and development, there is no guarantee that patients will be able to access the medicines at an affordable price.

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 -- that according to Joe Rannazzisi, one of the most important whistleblowers ever interviewed by 60 Minutes. Rannazzisi ran the DEA's Office of Diversion Control, the division that regulates and investigates the pharmaceutical industry. Now in a joint investigation by 60 Minutes and The Washington Post, Rannazzisi tells the inside story of how, he says, the opioid crisis was allowed to spread -- aided by Congress, lobbyists, and a drug distribution industry that shipped, almost unchecked, hundreds of millions of pills to rogue pharmacies and pain clinics providing the rocket fuel for a crisis that, over the last two decades, has claimed 200,000 lives.   

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 -- some of them multibillion dollar, Fortune 500 companies. They are the middlemen that ship the pain pills from manufacturers, like Purdue Pharma and Johnson & Johnson to drug stores all over the country. Rannazzisi accuses the distributors of fueling the opioid epidemic by turning a blind eye to pain pills being diverted to illicit use.  


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-friendly law, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” The DEA had opposed the effort for years. The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.

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-Utah) negotiated a final version with the DEA.

“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-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”


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-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations. But the study, which looked at the clinical trials associated with the drugs, reveals that at the time the therapies became available there was no conclusive evidence that they improved survival in almost two-thirds of the situations for which they were approved.

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-author of the study, published in the British Medical Journal, said: “We wanted to see once [the drugs] were already on the market did they actually generate some evidence to show that they improved or extended life?” The team found that after a follow-up period of between three to eight years, 49% of approved uses were linked to no clear sign of improvement in survival or quality of life. Where survival benefits were shown, the team said these were clinically meaningless in almost half of the cases.

“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-rays or laboratory tests that were assumed to offer clues as to a drug’s survival benefits. He added: “Unfortunately the expectation is that once the drugs are on the market then companies will be investing in [longer term] trials to then demonstrate overall survival benefits. But unfortunately these trials are not necessarily taken up and conducted.”


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- or medium-level effect on the amount people were drinking. The scientists looked at 32 double-blind randomised controlled trials representing 6,036 patients, published between 1994 and 2015. None of them showed any improvement in the health of those taking the pills, because they measured only the reduction in the amount of alcohol drunk each day.

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-reduction strategy.”

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-edge treatments, including gene and immune system boosting therapies, justify high prices.

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-called “CAR-T” treatment to get the green light. Such therapies work by modifying a patient’s cells to detect and attack cancer, and it was hailed as ushering in a new era of cancer treatments. It will be prescribed to patients with relapsed acute lymphoblastic leukaemia (ALL), who would otherwise have a poor chance of survival. In clinical trials patients that received Kymriah had a 79pc chance of surviving at least a year.

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-time use and $1bn-plus development costs. Its price also undershot expectations, as analysts had forecast the price could be as high as $700,000. The Swiss firm has not yet submitted Kymriah for approval in the UK. But it is perhaps no coincidence Novartis is the only ABPI member so far to publicly back the court action. Novartis has said the NHS’s new drug pricing powers could delay “game changer” medicines, including several it plans to launch in Britain for cancer and cardiovascular diseases over the next five years. The ABPI argues the changes will limit patients’ access to cutting-edge therapies, particularly for rare diseases – the NHS and Nice counter this won’t happen providing they have sufficient proven health benefits. The new powers proved divisive among patient groups in a consultation prior to their implementation, with some such as Prostate UK saying they were “very concerned” about their potential impact. The ABPI said the claim was “the right thing to do” given the “exceptional circumstances”. NHS England and Nice have so far declined to comment on the judicial review. On the general issue of giving patients access to next-generation medicines, however, Nice is adamant it is being “proactive” in engaging with drug makers.

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-all term for the new wave of treatments, this summer. Yet he does not downplay the challenge. “Where you have products with a high price and high uncertainty of patient benefits long-term, but the evidence suggests quite substantial benefits, it is quite a challenge for organisations that allocate public resources,” he says. The agency is considering extending the use of long-term and outcomes-based payments, for instance where the high cost of a medicine is split into annual payments and made only if the patient is seeing maintained health benefits. Dr Crabb, despite the evident tensions between industry and public health bodies, is “optimistic” solutions can be found. “Sustainable healthcare is a really massive issue not just for the NHS but for most healthcare systems globally,” he says.

The Cancer Drugs Fund, a £1bn-plus pot of money first announced by David Cameron for accelerating patient access to new treatments, offers a cautionary tale when it comes to rushing through medicines. A major analysis by King’s College London and the London School of Hygiene and Tropical Medicine earlier this year found just one in five of the treatments offered through the fund over a six-year period were capable of benefiting patients, and more than half had not undergone adequate clinical trials before being used. Last summer the fund was pared back and placed under Nice control.

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-effectiveness of new drugs were already too high and it needed to get better value. Analysts believe that Nice and the NHS are likely to continue to drive a hard bargain from drug makers. “It will be difficult to get expensive drugs approved if they don’t have a health-economic rational – and Nice is particularly strict on this,” Julie Simmonds of Panmure says. “It’s all about being able to justify prices on the basis of future NHS cost savings.”

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-term benefits for young patients. But negotiations could be harder for expensive drugs for older patients given the way Nice does its cost-benefit calculations, which favour longer-term benefits. Anyone hoping the coming High Court battle between the drugs industry and the NHS and Nice might put an end to the matter is likely to be disappointed.

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-to treatment.

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-savers’ and that ‘people will die’ if they discontinue their medicine. Prominent researchers from reputable universities have declared that ‘everyone over 50’ should be on a statin to reduce their risk of CVD and that even children with high LDL-C as young as 8 years should be afforded statin therapy.

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-picking’ the data. Ironically, pro-statin researchers themselves are the ones who are guilty of cherry-picking. A recent article in The Lancet, published in 2016, purported to end the statin debate, ostensibly to silence dissenting views. Yet, despite billions invested in developing medicines to reduce LDL-C drastically, there remains no consistent evidence for clinical benefit with respect to either events or mortality. For instance, there are 44 randomised controlled trials (RCTs) of drug or dietary interventions to lower LDL-C in the primary and secondary prevention literature, which show no benefit on mortality. Most of these trials did not reduce CVD events and several reported substantial harm. Yet, these studies have not received much publicity. Furthermore, the ACCELERATE trial, a recent well-conducted double-blind randomised controlled trial, demonstrated no discernible reduction in CVD events or mortality, despite a 130% increase in high-density lipoprotein cholesterol (HDL-C) and a 37% drop in LDL-C. The result dumbfounded many experts, sparking renewed scepticism about the veracity of the cholesterol hypothesis.


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-effects, experts say. An analysis in a leading cancer journal has found that the fund paid out £1.27bn from 2010 to 2016 – an amount that would have paid for an entire year of mainstream cancer drugs for the NHS.

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-free survival”, where there is no sign in a scan or test that the cancer is growing. But patients often did not live any longer because the cancer would come back suddenly with lethal force.

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-saving drug relied on by thousands of patients, which the NHS has no choice but to continue purchasing,” said Andrew Groves, CMA senior responsible officer.  The CMA said that prior to April 2008, the NHS spent approximately £522,000 a year on hydrocortisone tablets. This had risen to £70 million a year by 2015.

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-epilepsy drug by 2,600pc overnight after it went off-brand. It comes amid concerns that drugmakers are using the absence of price controls on generic drugs and their market dominance to push through price hikes that the NHS is often forced to swallow, because it is either risky or impossible for doctors to switch patients to alternative treatments.


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-income countries are falsified or sub-standard.

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-funded clinical trials of antidepressants was written up to suggest positive results, but when the US Food and Drug Administration re-examined the same studies, it found only 51 per cent had genuinely positive outcomes.

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-led trials. Ghostwriting [can] increase the prestige of the findings, while researchers improve their reputation, which can lead to promotions.


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-busting treatment had a dramatic effect. Statins prevented stem cells from performing their main functions, to reproduce and replicate other cells in the body to carry out repairs. The researchers found the statins prevented stem cells from generating new bone and cartilage. They also found that statins increased ageing.

N.B. Statins reduce the body’s ability to utilize and produce co-enzyme Q10. As co-Q10 is needed in the production of energy it is important for cells with a high energy demand, which include cardiac cells (such as those in your heart) which are known to be extremely sensitive to CoQ10 deficiency. As Co-Q10 (ubiquinol) is a powerful antioxidant it can prevent oxidative damage occurring to the cells in the cardiovascular system which will again protect against cardiovascular disease.


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-protein activation, which in turn protects arteries from calcification. Statins inhibit the biosynthesis of selenium containing proteins, one of which is glutathione peroxidase serving to suppress peroxidative stress. An impairment of selenoprotein biosynthesis may be a factor in congestive heart failure, reminiscent of the dilated cardiomyopathies seen with selenium deficiency. Thus, the epidemic of heart failure and atherosclerosis that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically reevaluated.


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-free deserts. As the public has been learning about the potential dangers that go with artificial sweeteners, manufacturers have been scrambling to find a replacement. The latest aspartame marketing idea was the decision to change its name to AminoSweet. Whichever name GD Searle & Company use, both should be avoided as, when absorbed, it forms the deadly neurotoxin formaldehyde which has been shown to cause cancer, eye damage and causes birth defects.


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-aged people are now taking a daily statin and the regulator's proposed guidance could extend that to 5 million more.

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-effects in low-risk people and claimed the true picture was distorted because drug companies had not put trial data into the public domain.

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-seated concern on the part of some GPs and the public about putting people on pills when they are not ill. While childhood vaccination has been widely accepted, the idea of a daily drug dose to ward off illness in adulthood disturbs many people.

The two papers published by the BMJ last year are part of a long-running campaign against this "medicalisation" of life by the journal. People who turn up in GP surgeries with raised cholesterol are often unfit rather than unwell. They have lifestyle issues, including inactivity and being overweight. Nice's guidance says doctors should support patients in changing their lifestyle first and offer statins only if they and the patient think it appropriate, but some GPs fear there will be pressure to put more people on pills.

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-manage, trying to get them to try to understand the consequences of what they do and trying to get them to self-care."

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-aged or elderly shouldn't be congratulated for that. Instead we should pull them in and give them medicines, just in case."

A middle-aged woman, for instance, could be on a statin, aspirin, hormone-replacement therapy and possibly vitamin D. "A whole bucketload of medicines are being promoted to people and yet this is juxtaposed against the self-care agenda. And at the same time we have the fattest people, the most unhealthy people, who are taking less exercise and drinking more. So are we then being hoodwinked into thinking if we take this pill, we can abdicate responsibility for all our health needs because we've taken a pill?"

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-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006. Merck and Schering repeatedly missed their own deadlines for reporting the results, leading cardiologists around the world to wonder what the study would show. At the same time, millions of patients have continued taking Zetia and Vytorin. The drug companies blamed the complexity of the data for the delay. Now, barely a month after news articles noted the delay and Congress pressured the companies to disclose the study’s findings, the results are out.

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-Plough intentionally sought to delay the release of this data,” Representative Bart Stupak, Democrat of Michigan, said in the statement. Mr. Stupak is chairman of the committee’s Subcommittee on Oversight and Investigations. Dr. Harlan M. Krumholz, a cardiologist at Yale, said drug companies had a responsibility to release all their trial findings, positive or negative, as quickly as possible — even if the results might hurt sales. “People may have been on this drug without the ability to know that there was additional data that may have thrown into question its effectiveness,” Dr. Krumholz said. “That’s extremely unfortunate, and that’s an understatement.”

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-mail message seeking comment. Mr. Davies said that Dr. Kastelein would not comment until he formally presented the results at a cardiology conference in March. In the trial, patients received either Zocor — an older cholesterol drug — or a combination of Zocor and Zetia, in the pill form known as Vytorin. About 60 percent of patients who take Zetia do so in the Vytorin form, which like Zetia is jointly marketed by Merck and Schering.

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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