250. Big Pharm. The Great Big Drugs Rip-off (Part 3)

GlaxoSmithKline (GSK)

In 2012, GSK agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. This blog is based on the press release issued by the USA Department of Justice on 2 July 2012, updated on 22 May 2015 (1). The drugs involved were Paxil, Wellbutrin and Avandia.

CRIMINAL PLEAS

Paxil

The government alleged that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for paediatric use. The United States alleged that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, GSK did not make available data from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.

Wellbutrin

The United States alleged that, from January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. The United States contends that GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wllbutrin for these unapproved uses. GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not bear adequate directions for these off-label uses. For the Paxil and Wellbutrin misbranding offenses, GSK has agreed to pay a criminal fine and forfeiture of $757,387,200.

Avandia

The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of:

  • congestive heart failure, and
  • myocardial infarction (heart attack).

GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.

CIVIL SETTLEMENTS

Off-Label Promotion and Kickbacks

The civil settlement resolves claims set forth in a complaint filed by the United States alleging that, in addition to promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.

GSK has agreed to pay $1.043 billion relating to false claims arising from this alleged conduct. The federal share of this settlement is $832 million and the state share is $210 million.

Avandia

In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia.

Price Reporting

GSK is also resolving allegations that, between 1994 and 2003, GSK and its corporate predecessors reported false drug prices, which resulted in GSK’s underpaying rebates owed under the Medicaid Drug Rebate Program. As a result, GSK underpaid rebates due to Medicaid and overcharged certain Public Health Service entities for its drugs, the United States contends. GSK has agreed to pay $300 million to resolve these allegations, including $160,972,069 to the federal government, $118,792,931 to the states, and $20,235,000 to certain Public Health Service entities who paid inflated prices for the drugs at issue.

Conclusion

These revelations are absolutely staggering. They demonstrate a company culture that is dominated by profiteering on a scale that is quite exceptional. There is no pretence to be acting in the best interests of those who are suffering ill-health and in need of treatment. Rather the reverse, these unfortunate individuals are being exploited at a time when they are most vulnerable. It is only right and proper that the authorities should seek to apply draconian measures. However it is crucial to appreciate that this requires extensive resources and there may well be other drug company activities that have not been subject to this type of scrutiny. All the indications are that the strategies which have been exposed here are endemic and probably are being applied to many of the other drugs promoted and marketed by the company.

Although the fines and payments are substantial, there is no guarantee that they are sufficient to act as a brake on these activities. I accept that certain measures have been introduced in an attempt to curb further similar activities but it remains to be seen how effective these will be. It is regrettable that no individuals have been charged with offences. The penalties levied on those who fiddle their expenses are usually very severe and may result in termination of employment yet company executives appear to avoid any sanction. It would not be unreasonable for the company to be suspended as a supplier to the state but this does not seem to have been considered. Is this because the company is too big and there are no alternative suppliers or is it that most of those companies supplying the public sector are all operating in the same way?

As these large pharmaceutical companies have global operations it is fair to assume that exactly the same strategies are used in other countries. The USA is out in front with respect to efforts to tackle these issues. In this sense it is exceptional and so it follows that in most other countries there will be relatively control so the drug companies are given a fairly easy ride.

Reference

  1. https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

 

 

249. Big Pharm. The Great Big Drugs Rip-off (Part 2)

Johnson & Johnson

In November the USA Department of Justice announced that Johnson & Johnson (J&J) would pay more than $2.2 billion as a result of criminal and civil offences in the way certain drugs were promoted and marketed. This blog has been prepared using material from the official press release issued on 4 November 2013 and updated on 22 October 2014 (1).

Risperdal

Risperdal is an antipsychotic drug that was approved for the treatment of schizophrenia. However the sales representatives of Janssen Pharmaceuticals, a J&J subsidiary promoted the drug to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. It was alleged that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia.  The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.  

In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to healthcare providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.  Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million.

In a related complaint it was alleged that Janssen marketed Risperdal to control the behaviours and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  Further allegations were that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.

NOTE: Off-label refers to the use of the drug for a treatment, which has not been approved by the regulatory authorities.

The U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger said that:

“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities. This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”

It was also alleged that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks.  For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleged that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events.  A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that:

“[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”

The complaint alleged Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as:

“uncompromised by safety concerns (does not cause diabetes).” 

When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.

The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. 

In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities.  The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production.  Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients.  Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.  Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.

The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal.  Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.

One example of the documents involved in this investigation is a letter written by a regulatory official to the company, which makes specific allegations (2).

Kickbacks to Nursing Homes Pharmacies

The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients.  In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.”  These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes.  Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients.  Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”

J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs.  The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million.  In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.

 

Off-Label Promotion of the Heart Failure Drug Natrecor

The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor.  In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity.  This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.

In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. 

The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these treatments and misleadingly used a small pilot study to encourage the serial outpatient use of the drug.  Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor.  Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.

As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor.

Conclusion

It certainly does not get any better. This is another example of absolutely unethical and illegal activities, which most people would regard as totally unacceptable. Despite the penalties levied, it appears that these are not enough to stop these practices.

References

1.       https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations/

2.       https://www.justice.gov/sites/default/files/opa/legacy/2013/11/04/civ-exhibit4.pdf

 

 

248. Big Pharm. The Great Big Drugs Rip-off (Part 1)

The major international drug companies have an appalling record with respect to compliance with the law. On many occasions they have been called to account and required to pay massive sums as a result. This record is convincing evidence that these companies cannot be trusted to operate ethically. This blog and the next two will summarise some examples of the actions by the regulatory authorities in the UK and the USA. In view of the huge expectations many people have about the drugs they are using, I believe this information should be widely disseminated.

Action against Pfizer in the UK

The Competition and Markets Authority (CMA) in the UK has imposed a record fine of £84.2 million on the pharmaceutical manufacturer Pfizer, and a £5.2 million fine on the distributor Flynn Pharma for charging excessive and unfair prices for phenytoin sodium capsules in breach of the competition law. This drug is used to treat epilepsy (1).

The CMA has also ordered the companies to reduce their prices.

The original price was that paid when the product was sold under the brand name Epanutin. The price of branded products are controlled by regulation. What happened was that in September 2012, Pfizer sold the UK distribution rights for Epanutin to Flynn Pharma, which de-branded (or ‘genericised’) the drug, meaning that it was no longer subject to price regulation.

Since September 2012, Pfizer has continued to manufacture phenytoin sodium capsules and has supplied them to Flynn Pharma at prices that were significantly higher than those at which it previously sold Epanutin in the UK – between 780% and 1,600% higher than Pfizer’s previous prices. Flynn Pharma then sells on the products to UK wholesalers and pharmacies charging them prices which have been between 2,300% and 2,600% higher than those they had previously paid for the drug.

Hugh increase in the price charged to the NHS

The impact of this can be demonstrated by the fact that the charge to the NHS for 100 mg packs of the drug was bumped up from £2.83 to £67.50 overnight. Subsequently it was reduced to £54.00 from May 2014, which is still an enormous increase. This meant that NHS expenditure on phenytoin sodium capsules increased from about £2 million a year in 2012 to about £50 million in 2013. The CMA noted that these prices were very much higher than those charges for the same drug in other European countries.

The drug is considered to be important for the treatment of epilepsy for about 48,000 patients in the UK. Epilepsy patients who are already taking phenytoin sodium capsules should not usually be switched to other products, including another manufacturer’s version of the product, due to the risk of loss of seizure control which can have serious health consequences. As a result, the NHS had no alternative to paying the increased prices for the drug.

Dominant market position

The CMA has found that both companies have held a dominant position in their respective markets for the manufacture and supply of phenytoin sodium capsules and each has abused that dominant position by charging excessive and unfair prices.

The fines follow prices increasing by up to 2,600% overnight after the drug was deliberately de-branded in September 2012. For example, the amount the NHS was charged for 100mg packs of the drug rocketed from £2.83 to £67.50, before reducing to £54.00 from May 2014. As a result of the price increases, NHS expenditure on phenytoin sodium capsules increased from about £2 million a year in 2012 to about £50 million in 2013. The prices of the drug in the UK have also been many times higher than Pfizer’s prices for the same drug in any other European country.

Phenytoin sodium capsules are used in the treatment of epilepsy to prevent and control seizures, and are an important drug for an estimated 48,000 patients in the UK. Epilepsy patients who are already taking phenytoin sodium capsules should not usually be switched to other products, including another manufacturer’s version of the product, due to the risk of loss of seizure control which can have serious health consequences. As a result, the NHS had no alternative to paying the increased prices for the drug.

The CMA has found that both companies have held a dominant position in their respective markets for the manufacture and supply of phenytoin sodium capsules and each has abused that dominant position by charging excessive and unfair prices.

Pfizer rejected the findings of the CMA’s three-year investigation and said it would be appealing “all aspects of the decision”. The group has previously said it had been making the drug at a loss, but was unable to stop making it because so many patients relied on it. But the CMA said Pfizer could have recouped the previous losses within just two months.

Philip Marsden, Chairman of the Case Decision Group for the CMA’s investigation, said:

  • “The companies deliberately exploited the opportunity offered by de-branding to hike up the price for a drug which is relied upon by many thousands of patients. These extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds.
  • Businesses are generally free to set prices as they see fit but those holding a dominant position should not abuse this situation and set prices that are excessive and unfair. There is no justification for such rises when phenytoin sodium capsules are a very old drug for which there has been no recent innovation or significant investment.
  • This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour and to protect customers, including the NHS, and taxpayers from being exploited.”

Conclusion

The CMA is to be congratulated on this initiative and on the fines it has imposed. Although the companies have protested, I suspect this is a case of “They would say that wouldn’t they?” As far as I can see, the CMA has conducted a thorough a detailed, thorough investigation. There appears to be no satisfactory explanation for the much higher prices being charged in the UK compared with those in other European countries. Drugs are responsible for a substantial slice of the expenditure by the NHS. It is imperative that the drug companies and other suppliers to the NHS provide very good value for money. As the NHS has huge purchasing power, we would expect that organisation to ensure that it is not being ripped off. Why should it have to rely on the CMA to do this on its behalf? I am quite sure that the major supermarkets would never allow their suppliers to act in this way.

The CMA has a number of other investigations under way but we still left with the strong suspicions that there may well be other examples of overcharging which have not been tackled by the CMA. One thing is certain, most of the major drug companies have “previous” as shown by the much larger fines which have been levied by the authorities in the USA. This example cannot be brushed aside as a “one off”. In the next blog I will highlight some of the actions that have been taken in the USA, which will help to understand the bigger picture.

Reference

  1. https://www.gov.uk/government/news/cma-fines-pfizer-and-flynn-90-million-for-drug-price-hike-to-nhs

247. Jorge Luis Garcia Provides more Evidence in Support of Low Carb High Fat (LCHF) Diets

I am very grateful to Jorge for the information that I have used to prepare this blog. He is another individual who has had to discover this insight from his own efforts, which have only been possible because of the access to a wide range of resources available on the internet. It is a sad commentary on the mainstream professionals that so many are unaware of this knowledge or even worse actually dismiss it.

Mother develops cancer

Jorge is a specialist in dental prosthetics originally from Venezuela who moved to Florida in 2007. However in 2011 he returned home to look after his mother who was seriously and unable to cope on her own. She had suffered from hypertension for many years but her blood sugar was high and Jorge was convinced she was insulin resistant. She was on a long list of different medications, including statins. In July-August 2012, she noticed that the tonsil on her right side was swollen. Shortly after this she started coughing continually. As Jorge says:

 “Everytime that I listen to her coughing I felt like somebody was punching me in the stomach.”

Then in November of that year a biopsy showed that it was Stage III Cancer. The tumour grew very rapidly and his mother was eating almost nothing because it was so difficult to swallow. Jorge would prepare soups using a blender based on green vegetables and meats such as chicken or salmon. Surgery was not suggested by any of her medical advisers and so in January 2013, chemotherapy was initiated.

Doing the research

However just before the chemo started, Jorge started to do research to discover if there was any alternative way of treating the cancer. Using the internet opened up a whole new world for him. He came across articles, books and podcasts, which explained and advocated the benefits of diets low in carbohydrates and high in healthy fats (LCHF). He watched television programmes such as

“The men that made us fat”

by the BBC and

“The heart of the matter, Dietary villains”

made by Maryanne Demasi for ABC TV in Australia.

The cancer is cured

All of this convinced him that the rationale used to justify the LCHF approach was perfectly sound. It just so happened that the food Jorge was preparing complied with these principles. Although his mother was losing weight and becoming quite thin, the nasty coughing stopped shortly after the chemo commenced. Then she noticed that it became easier for her to swallow. When she went for her third chemo session, the doctor could not find any lesion and the tonsil was no longer swollen: in fact it appeared to be normal. It was not possible to obtain a sample to do a biopsy. A PET/CT scan could not find any cancerous cells. There was no doubt she was cured. Not only that, her blood pressure and blood sugar were both normal. Her body weight had dropped from 75 to 52 kg. Her triglycerides were also satisfactory so the advice to go on statins was rejected.

Here is how Jorge describes and explains what had happened:

“She was radiant, she no longer had back pain even though she has a severe scoliosis, she was using pants she didn’t use for a very long time, she was active again, she started to call her students (she is a painter and she teaches painting) and started giving classes again; I was very happy for her, and I told her my theory about how she was cured, because she went on a VLCHF or KETO, not on purpose but because she could eat almost nothing, she started a “forced fasting” and was feeding herself with her own fat; by not eating carbs, her cancerous cells starve and when the chemo came in, those glucose hungry cells took it and finish themselves quickly and the healthy cells feeding on fat, had a stronger membrane and that helped them to resist the strong chemo effect; that was my theory of what happened.”

LCHF works for Jorge himself and for his son

But this is not the end of the story. Jorge himself also tried the LCHF approach. He is 56 years old and weighed 104 kg before he started but he lost 35 kg and his waist has reduced from 91 to 76 cm.

His 18-year old son also had severe health problems. For most of his life he has had allergies, which cause constant sneezing and so he was prescribed antihistamines. In his case they decided to try gluten-free as well as LCHF. This was based on the book “Wheat Belly” by Dr. William Davis as well as interviews with Dr. Tom O’Bryan and Dr. Alessio Fasano. Within 2 weeks, his sneezing and watery eyes has stopped and he no longer needs antihistamines.

Conclusion

Regular readers of this blog will not be in the least surprised by this story. Nevertheless it is another piece of evidence that supports the case for a diet based on LCHF principles. Many conventional scientists dismiss these stories on the grounds that they are “anecdotal”. There are no proper controls and so we cannot rely on the information. While that might be reasonable if this was an isolated example, it certainly does not apply when there are thousands of stories like this. In any case, there is a growing body of sound research that implicates a diet that is high in carbohydrates as a cause of cancer. The ground-breaking research of Otto Warburg, which showed that cancer cells can only survive on glucose all fits together neatly with the rationale that justifies the use of LCHF.

However the real scandal is that this knowledge and information is not being used to any extent by the mainstream medical profession. It still being left to individuals to do their own investigations in order to discover how best to cope with any kind of cancer.

The reality is that there is a huge cancer industry, which is heavily dependent on the concept that it is possible to find a magic cure that will work for each different cancer. This suits the pharmaceutical companies and the research community very nicely. It is conveniently ignored that this is not working and that, despite all the hype, the success with cancer is almost non-existent. In fact the incidence continues to increase.

Genuine progress will only be made once there is recognition that it is essential to understand the causes and take steps to eliminate them. There are three main treatments for cancer, namely surgery, chemotherapy and radiotherapy. All of these focus on removing tumours, which are of course symptoms. So even if the treatment is apparently successful in the short term, the likelihood is that another one will develop if the cause is not identified and addressed.

Diet, exposure to toxins and stress may all be causes. In this case it is evident that diet was the cause. Hence altering the diet has proved to be effective. It is also worth mentioning that one of the few cancers where there has been success is lung cancer with tobacco smoking identified as one of the primary causes. It has clearly been demonstrated that stopping smoking is the most effective means of reducing the risks.

It is hoped that people will take inspiration from the experience of Jorge and have the confidence to do their own research and if necessary challenge the views of orthodox medicine.

246. Vitamin D: the evidence just gets stronger

There is no doubt that a low Vitamin D status is associated with a range of diseases and conditions of ill-health. If it can be confirmed that an inadequate intake of Vitamin D is a contributory factor then it follows that supplementation would have enormous benefits. However there is some debate on the level in the blood that has to be maintained in order to achieve optimum health.

One of the big problems is that there have been few randomised controlled trials (RCTs), which can provide conclusive proof that supplementation is effective. Furthermore it is essential to ensure that the Vitamin D dose is sufficiently high to obtain a substantial increase in the blood concentration as estimated by the content of 25 (OH) Vitamin D.

Vitamin D and cancer

Much progress has been made on this topic by GrassrootsHealth. An investigation reported in 2007 produced very promising results on cancer incidence (1). 1180 women from rural areas in Nebraska were recruited and allocated to one of three different treatments, which consisted of:

  • Controls who took a placebo (n=288);
  • A supplement of calcium (n=445);
  • A supplement of calcium plus Vitamin D (1,100 IU of Vitamin D3/day)(n=446).

The study continued for 4 years, when the information was collated for the incidence of all cancers. Excluding those who developed cancer during the first year, to eliminate any that might have been initiated before the start of the trial, it was found that in the calcium plus Vitamin D group, the cancer rate was reduced by over 75%, compared with the controls. In this group the blood levels of Vitamin D increased from 71.1 nmol/L at the outset to 96.0 nmol/L after 12 months but it was unchanged in the other groups. It was estimated an increase of 25 nmol/L would reduce the risk of cancer development by 35%.

The monitoring of this group of women was maintained after the completion of the above project in order to compare them with another cohort of Volunteers in the GrassrootsHealth programme (GRH) (3). This consisted of 1,135 women who were recruited to match those in the Nebraska-based study. However they were taking Vitamin D supplements and so their Vitamin D status would have been much higher than in the other group. The information obtained enabled the researchers to compare the incidence of cancer over a wide range of values for the concentration of 25(OH)D (a measure of the Vitamin D concentration) in the blood. It was found that if the concentration was >100 nmol/L the risk of cancer was reduced by 67% compared with those with a concentration of <50 nmol/L.

Vitamin D and Alzheimer’s Disease (AD)

In a similar study, 1,658 adults, who were free of dementia, cardiovascular disease and stroke at the beginning, were followed for 5.6 years (3).

171 participants developed all-cause dementia and 102 developed AD. It was found that those with blood 25(OH)D of <25 nmol/L had more than twice the incidence of dementia and AD compared with those whose values were >50 nmol/L.

Once again these results are consistent with the hypothesis that insufficient Vitamin D is a critical factor in the development of a serious chronic disease.

Vitamin D and type 2 diabetes (T2D)

In this study, a comparison was made between the GRH and data obtained from the US National Health and Nutrition Examination Survey (NHANES) (4). When adjustments were made for differences in characteristics of the 2 groups, it was found that the incidence of T2D in the NHANES group was three times that of the GRH. The 25(OH)D concentration was 102 nmol/L in the GRH but only 55 nmol/L in the NHANES. Obviously this is not conclusive proof that increasing the intake of Vitamin D would reduce the incidence of T2D but it is one more piece of evidence that fits the picture.

Vitamin D and Multiple Sclerosis (MS)

There is good evidence that a low blood level of 25(OH)D is one of the important risk factors for MS. It has certainly been established by epidemiological studies that exposure to sunshine can make a big difference to the incidence. Professor George Ebers of Oxford University has noted that if people move from the UK to Australia the risk is substantially reduced (5). Within Australia, there is a much higher rate in Tasmania than in Queensland, which is sub-tropical and therefore has lots more sunshine. He has also found that the incidence of MS is much lower in Norway than in Scotland, even though the exposure to sunshine is roughly the same. He believes this is because the Norwegians have a high intake of fish contains high quantities of Vitamin D. He is a strong advocate of supplementation, although there is still not possible to guarantee that this will be successful. His view is:

“When looking at the risks, costs and benefit equation, the risks seem tiny, and the benefits are yet to be established but indirect studies are supportive. The cost of vitamin D is dirt cheap but the costs of MS are staggering and are increasing.”

He contends that the vast majority of us don’t spend much time in sunshine. This means we are Vitamin D deficient and therefore supplementation makes sense. With respect to toxicity and specifically that supplementation may cause renal failure he has no concerns. He says the margin of safety is greater than for water and that there is no problem with taking 4,000 IU/day.

Conclusion

On the basis, of the accumulated evidence there is a strong case for taking supplements up to about 4,000 IU /day as Professor Ebers advocates. Bear in mind that his main interest is MS and when all the other factors are taken into consideration this would seem to be sound advice. There is little doubt that the recommendation by the Scientific Advisory Committee on Nutrition in the UK is far too cautious (6).  It suggests a that blood level of >25nmol/day is sufficient and that the recommended intake should be 400 IU/day, which is only 10% of the figure advocated by professor Ebers. All the indications are that it should be at least double that value and possibly even higher. GrassrootsHealth propose that the blood level should be >100nmol/L.

References

  1. J M Lappe et al (2007). http://ajcn.nutrition.org/content/85/6/1586.long
  2. S L McDonnell et al (2016). http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0152441#pone.0152441.ref014
  3. T J Littlejohns (2014). http://www.neurology.org/content/83/10/920.full
  4. S L McDonnell et al (2014). http://www.sciencedirect.com/science/article/pii/S0960076015300091
  5. http://www.medscape.com/viewarticle/812045#vp_2
  6. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/537616/SACN_Vitamin_D_and_Health_report.pdf
  7. http://www.grassrootshealth.net/

 

 

245. Weight Loss for Treatment of Type 2 Diabetes (T2D)

Weight loss is an important aspect of the official policy for treating T2D. The recommendations are to increase the amount of fibre and to reduce fat, especially saturated fat. Specific advice includes:

  • Increase consumption of foods such as wholegrain bread and cereals
  • Choose foods that are low in fat – replace butter, ghee and coconut oil with low fat spreads and vegetable oil
  • Choose skimmed and semi-skimmed milk, and low fat yoghurts

If you have a BMI of 30kg/m2 or over you should lose weight by gradually by reducing your calorie intake and becoming more physically active. Losing 5-10% of your total body weight over the course of a year is considered to be a realistic initial target.

Doubts about the guidance on weight loss

There are two fundamental assumptions which underpin the recommendation to lose weight, namely:

  • Excess weight is a direct cause of T2D (and other disease).
  • Elimination of that excess will help to overcome T2D and improve health generally.

It is an article of faith that the BMI should be in the normal range of 20-25kg/m2. Hence anyone with a higher value is advised to reduce their weight in order to achieve “normality”. However this has been questioned by various researchers. In particular Katherine Flegal and her team at the US Center for Disease Control (CDC) have found that with respect to life expectancy, the optimum BMI range is 25-30 kg/m2 which according to the official approach in many countries is “overweight”. Her original report, published in 2005 (1) was based on information from the US National Health and Nutrition Examination Surveys (NHANES) with 36,859 participants, of whom 8,849 died. It was found that the lowest mortality was observed for those in the overweight BMI category. The highest death rates were in those who were underweight (BMI <18.5kg/m2) and with severe obesity (BMI >35 kg/m2). These conclusions have been confirmed by studies in Canada (2) and Norway (3). More recently the CDC team has conducted a meta-analysis based on almost 100 studies from the US, Canada, Europe, Australia, China, Taiwan, Japan, Israel, India and Mexico (4). There was data from 2.88 million participants and over 270,000 deaths. The results confirmed that the lowest death rates were in those who were overweight but also found that the death rates for those with obesity category I (BMI 30-35 kg/m2) were lower than for those with normal BMI.

It has to be recognized that these finding were not accepted with equanimity by everyone (5).

One of the prime concerns is that reports are likely to confuse the public and therefore undermine public policies to curb rising obesity rates. Some of the criticisms are related to decisions on which data should be excluded about individuals who may have lost weight because they smoke tobacco and/or suffer from illnesses and would therefore confound the results. However it has been shown that provided those with obvious weight loss have been excluded, any other any other limitations on the data used in the analyses have little impact on the final result (6, 7).

Relationship between BMI and death rates

As long ago as 1985, Reubin Andres used actuarial data to find out how the relationship between BMI and death rates changed with age. His findings indicated the weight for minimal mortality increased by about 2.5 kg per decade from the age of 40 years for both men and women (8).

Clearly there are serious doubts about the validity of the use of BMI to assess the optimum weight of an individual. It may well be that many people are being advised to lose weight when there is no reliable evidence that there will be a worthwhile benefit. The reality is that those who adopt the conventional approach to weight loss are rarely successful. In fact, they may actually do more harm than good. In a comprehensive review of the effectiveness of various strategies it was concluded that the efforts so far have been disappointing and that essential information is missing (9). Although some promising results have been achieved in clinical trials with carefully controlled conditions, attempts to replicate these in the wider community have not been successful. It is claimed that weight loss in the short term may be effective. Based on an evaluation of studies which continued for more than 12 months, the following points were noted:

  • After one year, any weight lost starts to be regained.
  • The weight loss achieved in the first year in most of the community programmes was less than that achieved in the prevention trials at the equivalent period. In other words it was probably too small to have much impact.

The conventional approach to weight loss is to reduce the input of calories by eating less and increasing the output by taking exercise. The reality is that:

  • It is extremely difficult to achieve weight loss by restricting calorie intake.
  • Of those who do succeed most regain the weight subsequently.
  • Paradoxically there are strong indications that weight loss in this way may actually be associated with an increase in all-cause mortality.

Further doubts about the benefits of weight reduction emerge from the Louisiana State University Hospital-Based Longitudinal Study (LSUHLS) which was a prospective study with diabetics which related death rates to BMI (10). A total of 34,832 (15,354 white and 19,478 black) patients with T2D who were between 30 and 94 years of age participated in the study. During a mean follow-up period of 8.7 years, 4042 subjects (1946 black and 2096 white) died. All-cause mortality (ACM) among blacks (11.5 per 1000 person-years) was lower than among whites (16.4 per 1000 person-years). It was found that among blacks, there was a significantly increased risk of ACM with baseline BMI <30 and ?35 kg/m2. This means that the lowest death rates were with those who were considered obese (category 1). For whites the highest death rates were reported for those with BMI <25 and ?40 kg/m2.while the lowest were also found in those who had a BMI of 30 to 34.9 kg/m2. This relationship did not change when patients with cardiovascular disease and cancer were eliminated from the analysis. Similarly removing those who died within 2 years of the start of the study there was no change. This relationship between BMI and mortality was found irrespective of age, sex, smoking status or type of diabetic medication. These results can be regarded as robust because there was a large sample size with a long follow-up time, and use of administrative databases to avoid differential recall bias.  If this study is accepted as reliable then it would be counter-productive to encourage diabetics to lose weight. There is certainly no convincing evidence that it would be beneficial but there are now strong indications that this may well be harmful.

This is consistent with a study involving 4786 men aged between 40 and 59 years who participated in the British Regional Heart Study (11). BMI was recorded in 1992 and 1996. During the follow-up period of 7 years there were 858 deaths from all causes (381 CVD and 477 non-CVD causes). It was found that weight loss as a result of ill-health or physician’s advice was associated with a small increase in mortality, largely owing to death from non-CVD causes. Furthermore these men tended to have a greater prevalence of disease and tended to be heavier than those who lost weight intentionally as a result of personal choice. It is likely that these men had been prompted to lose weight as a result of having already developed disease. It was also found that when weight had been lost intentionally, irrespective of underlying reason, there was no benefit in terms of CVD mortality. This is in agreement with many other studies which suggest that in these older men who are aged 56 to 75 years, once atherosclerotic vascular disease is established, it is not easily reversed.

In California, an increase in ACM was observed in both men and women, including some with T2D, who lost 4kg or more over a 12-year period (12). In the men with T2D the death rate was over twice that in those who did not lose weight.

We simply have to face the reality that the relationship between weight/BMI and good health is much more complex than was recognised by those who devised the current the guidelines. Despite the emphasis on weight loss as a therapy for diabetics, there is no evidence to demonstrate that it has been successful. Further doubt about the credibility of this approach is that many diabetics have a BMI which is <25 kg/m2.

The conventional method of losing weight is based on reducing the consumption of calories and increasing the output by taking more exercise. With respect to diet, invariably this means lowering the amount of fat and increasing that of the complex carbohydrates as indicated in the advice cited above. The fundamental problem is that this only adds fuel to the fire because it is likely to INCREASE the glucose level in the blood. Hence MORE insulin has to be produced which of course only makes things worse. Since one of the key functions of insulin is to direct the glucose to the liver, where it is converted into fat, and then stored, it follows that it is virtually impossible to lose weight with this type of diet. In practice, the only way to lose weight is to starve, which explains why so few are successful. Not surprisingly, most of these re-gain the weight lost within a relatively short time and probably finish up heavier than they were initially. One of the major weaknesses in in these studies on weight loss by means of calorie reduction has been the failure to take hunger into account. In an article in the New York Times, Gary Taubes comments on a study which compares a diet which is low in fat with one which is low in carbohydrates (13) and notes that no attempt was made to allow for the possibility that the subjects might be hungrier on one diet than the other. In fact, it has been established that one of the benefits of a diet which is restricted in carbohydrates and high in fat is that satiety is readily achieved. Weight can be lost without having to count calories.

Conclusion

The advice to reduce weight by calorie reduction just does not work as shown by many different studies and, of course, the experience of so many individuals. It simply does not make sense to continue a strategy which has been such an abject failure. On top of all this, it reinforces the view that T2D is restricted to those who are overweight/obese. The hard reality is that many with T2D have a BMI that is regarded as “normal” and even if the approach did work it would not be applicable to these patients.

Essentially, the development of policies for coping with T2D has been a total disaster that is confirmed by this examination, which has identified a number of fundamental flaws in the thinking behind them.

References

  1. K L Flegal (2013). Journal of the American Medical Association 293 (15) pp1861-1867
  2. Heather M Orpana et al(2010). Obesity18 (1) pp214-218
  3. H T Waaler (1984). Acta Medica Scandinavica supplement 679 pp 1-56
  4. K L Flegal (2013). Journal of the American Medical Association 293 (15) pp1861-1867
  5. V Hughes (2013). http://www.nature.com/news/the-big-fat-truth-1.13039#/b2
  6. R Andres (1999). Obesity Research 7 (4) pp 417-419
  7. D B Allison et al (1999). Obesity Research 7 (4) pp 342-352
  8. R Andres et al (1985). Annals of Internal Medicine 103 (6, part 2) pp 1030-1033
  9. R Kahn and M B Davidson (2014). Diabetes Care 37 (4) pp 943-949
  10. W Zhao et al (2014). Circulation 130 (24) pp 2143-2151
  11. S G Wannamethee et al (2005). JAMA Internal Medicine 165 (9) pp 1035-1040
  12. N M Wedick (2002). Journal of the American Geriatric Society 50 (11) pp 1810-1815
  13. Gary Taubes (2015). New York Times 29 August

 

 

244. Is it any Wonder the Diabetes Prevention Programme in the UK is a Disaster?

It is quite obvious that the strategies for dealing with Type 2 Diabetes (T2D) in the UK (and in most other countries) are a complete failure. There is no indication that the disease is under control. In fact, all the projections expect the current rates of increase to be maintained for the foreseeable future.

Latest initiative

In March 2015, NHS England announced the Diabetes Prevention Programme (DPP) which is a joint initiative with Public Health England (PHE) and Diabetes UK (1).The object is to achieve a significant reduction in the number of people with T2D which is expected to be about 4 million if no action is taken. It is claimed that there have been well-designed trials conducted in Finland, the USA, Japan, China and India which show that reductions of up to 60% can be obtained in adults at high risk by means of intervention programmes to encourage changes in lifestyle.

The justification has been developed by NICE. The initial proposals were subject to severe criticisms by specialists in the treatment of T2D (2). For example great emphasis was placed on the importance of weight loss and exercise in spite of limited evidence in support of this strategy. Furthermore this approach was not logical because many of the drugs recommended actually promote weight gain.

As a consequence substantial amendments were made and a revised consultation document was issued. The guidelines are set out in a document entitled “Type 2 diabetes in adults” (3). In addition there is whole raft of appendices.

In view of the importance of developing a policy which will successfully control this key public health issue, it is worth analyzing the DPP carefully.

The Rationale

T2D is defined as a:

 “condition of insufficient insulin production often exacerbated by insulin resistance, the primary treatment for which is weight loss and exercise. Pharmacological measures to increase insulin sensitivity or to increase insulin release can be added to lifestyle interventions, but insulin therapy may eventually be needed by the majority of people as their insulin secretion declines” (4).

Subsequently it goes on to explain that:

“The underlying disorder of type 2 diabetes is usually that of a background of insulin insensitivity where the body is unable to respond to normal levels of insulin, and insulin deficiency where the pancreas is unable to secrete enough insulin to compensate for this resistance. Insulin insensitivity is usually evidenced by excess body weight or obesity, and is exacerbated by overeating and inactivity. It is commonly associated with raised blood pressure, a disturbance of blood lipid levels, and a tendency to develop thrombosis. This combination is often recognised as ‘metabolic syndrome’, and is associated with fatty liver and abdominal adiposity (increased waist circumference). Insulin deficiency is progressive over time, such that the high glucose levels usually worsen relentlessly over a period of 30 years, requiring continued escalation of blood glucose lowering therapy” (3).

These statements are quite remarkable because they are a gross distortion of the science which can only be interpreted as an attempt to provide a justification for using insulin and other drugs as a form of treatment for T2D. As this is the rationale for a massive programme designed to address one of the most pressing public health issues, it must be subjected to detailed scrutiny. In particular, there is a need to understand the role of insulin not only in relation to diabetes (both Type 1 (T1D) and T2D) but also to the other diseases linked to it.

While it is true that T1D is the result of insufficient insulin production because of damage to the pancreas, there seems to be a failure to appreciate that T2D is a totally different disease. The fundamental issue with T2D is excessive levels of glucose in the blood. This in turn stimulates the production of extra insulin which is needed to cope with the large amounts of glucose. While this may be perceived as a requirement for more insulin, it is inevitable that additional insulin will exacerbate the insulin resistance (IR) and cause further ill-health. It really does not take a genius to work out that if there is a reduction in the blood glucose (BG) then there should be a corresponding reduction in the requirement for insulin to be produced. The level of BG is determined by the diet and therefore it follows that alteration to the diet is the obvious solution to the problem.

The Proposed Strategy

Although the main emphasis in the DPP was on the use of drugs to treat T2D there is one chapter which is devoted to “Lifestyle and non-pharmacological management”. This concludes that:

there was little new evidence to warrant any change to previous views in this field. The major consensus-based recommendations from the UK and USA emphasise sensible practical implementation of nutritional advice for people with type 2 diabetes. Management otherwise will concentrate on principles of healthy eating (essentially those for optimal cardiovascular risk protection), and reduction of high levels of free carbohydrate in foods that may cause hyperglycaemia in the presence of defective insulin secretory reserve”.

Here again, note the term “defective insulin secretory reserve” where the underlying assumption seems to be that the body should be able to cope with whatever is thrown at it. Would it not be much more sensible to regard a diet which produced excessive glucose in the blood as toxic? Obviously this question never arose because it is certainly not addressed in the current official recommendations which are to:

“Emphasise advice on healthy balanced eating that is applicable to the general population when providing advice to adults with type 2 diabetes. Encourage high-fibre, low-glycaemic-index sources of carbohydrate in the diet, such as fruit, vegetables, wholegrains and pulses; include low-fat dairy products and oily fish;  and control the intake of foods containing saturated and trans fatty acids”.

It goes on to state that:

“If people are currently gaining weight, weight maintenance is advantageous”.

Finally some suggestions for future research are presented on the grounds that:

“Type 2 diabetes is associated with obesity, and lifestyle interventions including diet and physical activity are thought to be useful in helping to control the condition and improve patient outcomes such as reducing the risk of long-term complications and increasing quality of life. Low carbohydrate diets have been a source of discussion over the past two decades and there is much debate regarding its effectiveness and safety in controlling blood glucose levels, particularly in the longer-term. Specifically, there is little consensus on the optimal intake of daily carbohydrates, where the risk of adverse effects such as hypoglycaemia is minimised. A randomised controlled trial addressing this clinical question would help to provide a better understanding of the effects of low carbohydrate diets on diabetes control and maintenance to inform appropriate management strategies”.

Conclusion

The reasoning here is bizarre. It seems pretty obvious that there has not been any real effort to consider the science and the related issues objectively. IR is a symptom. This is caused by excessive consumption of sugar and carbohydrates. It follows that the way to address the disease is to alter the diet so that the consumption of these constituents is reduced. It is disingenuous to conclude that there is a need for more studies to address this question. In reality there has been more than enough to demonstrate that this approach is effective (6). Why should there be any adverse effects since there are plenty of populations that have consumed low carb diets for generations without any indication of problems? As experience with T1D has shown, hypos are much more likely to occur with high insulin doses, which are necessary with a high carb diet. By contrast, hypos are less frequent on a low carb diet, which incidentally also requires lower doses of insulin, thereby reducing the risks of developing IR.

When it comes to the dietary recommendations, the official government strategy appears to be accepted without debate, which advocates reduced fat and increased carbs. It is no great surprise to discover that those with T2D who follow this advice do not improve and almost certainly deteriorate even further.

This approach also advocates weight loss by calorie reduction. Again this does not work and this topic will be considered in the next blog.

References

  1. http://www.england.nhs.uk/2015/03/12/diabetes-prevention/
  2. http://www.pulsetoday.co.uk/clinical/diabetes/nice-risks-making-itself-a-laughing-stock-over-guidance-on-metformin-alternatives-say-experts/20009139.article#.VdhZxnlRHIU
  3. https://www.nice.org.uk/guidance/gid-cgwave0612/documents/type-2-diabetes-final-scope2
  4. http://www.nice.org.uk/guidance/gid-cgwave0612/resources/type-2-diabetes-full-guideline2
  1. http://www.nhs.uk/Conditions/Diabetes-type2/Pages/Treatment.aspx
  2. http://www.nutritionjrnl.com/article/S0899-9007(14)00332-3/pdf

 

243. Even more Skulduggery in Nutrition

Nina Teicholz made a very significant contribution to the arguments about a healthy diet with publication of her book entitled The Big Fat Surprise (1), which was extremely well received. The Economist named it as the Number One science book of 2014. Several US publications, including the Wall Street Journal, identified it as the “Best Bookof the year.

Significantly, a review in the American Journal of Clinical Nutrition said:

“This book should be read by every nutritional science professional.”

A former editor of The BMJ, Dr. Richard Smith, was even more complimentary. He concluded that Teicholz had done a remarkable job analysing the weak science, strong personalities, vested interests, and political expediency of nutrition science.

A year later, she wrote an article published in The BMJ (2). In it, she criticised the expert report (3) that formed the basis for the revision of the US Dietary Guidelines for Americans. In particular, because the report omitted reference to many reviews of crucial topics, it did not reflect accurately the current state of play in human nutrition. This indicated a reluctance to consider any evidence that contradicted the official dietary advice promoted over the last 35 years.

Call for retraction

This resulted in an extraordinary response from doctors and scientists, initiated by Bonnie Liebman, director of nutrition in a Washington-based pressure group, The Centre for Science in the Public Interest (4). In an email, she claimed that the article was “full of errors” and asked respondents to sign a letter to The BMJ demanding retraction of the Teicholz article.

As a result, Dr. Frank Hu, a prominent professor and researcher at the Harvard School of Public Health, emailed Professor Miguel A. Martinez-Gonzalez at the University of Navarra, Spain in which he said:

“I would greatly appreciate if you can ask your colleagues in Spain and other European countries to sign the letter. I think it is extremely important to retract the terrible BMJ article for the sake of science and public health.”

Martinez-Gonzalez forwarded the email to colleagues in Europe and asked them to sign the following:

“I have read the full version of the attached letter and I agree to include my signature on it. I endorse its full content and the request to the BMJ to retract the journalist’s article.”

As a consequence, more than 180 experts signed this letter. These included all the members of the 2015 Dietary Guidelines Advisory Committee, all the living authors of Ancel Keys’ Seven Countries Study, scientists involved in the American Heart Association, and others, including environmental scientists, management consultants, and graduate students (5).

Commenting on the retraction demand, Ian Leslie in a Guardian article commented that:

“Publishing a rejoinder to an article is one thing; requesting its erasure is another, conventionally reserved for cases involving fraudulent data.

As a consultant oncologist for the NHS, Santhanam Sundar, pointed out in a response to the letter on The BMJ website:

“Scientific discussion helps to advance science. Calls for retraction, particularly from those in eminent positions, are unscientific and frankly disturbing.”

The letter lists “11 errors” that on close reading turn out to range from the trivial to the entirely specious. I spoke to several of the scientists who signed the letter. They were happy to condemn the article but when I asked them to name just one of the supposed errors in it, not one of them was able to.

One admitted he had not even read it. Another told me that she had signed the letter because The BMJ should not have published an article that was not peer reviewed (it was peer reviewed). Meir Stampfer, a Harvard epidemiologist, asserted that Teicholz’s work was “riddled with errors”, while declining to discuss them”(6).

The BMJ stands firm

In September 2016, The BMJ announced that it would not retract the article. The details of the investigation were reported in December 2016 (7). In an article, the editor-in-chief, Dr. Fiona Godlee stated that:

“We stand by Teicholz’s article and its critique of this highly influential advisory committee’s processes for reviewing the evidence, and we echo her conclusion: “Given the ever increasing toll of obesity, diabetes, and heart disease, and the failure of existing strategies to make inroads in fighting these diseases, there is an urgent need to provide nutritional advice based on sound science.” “

She continued:

“Neither Teicholz nor The BMJ are new to criticism. Healthcare is rife with controversy, and the field of nutrition more so than many, characterised as it is by much weak science, polarised opinion, and powerful commercial interests. But nutrition is perhaps one of the most important and neglected of all health disciplines, traditionally relegated to non-medical nutritionists rather than being, as we believe it deserves to be, a central part of medical training and practice. The current state of nutrition research should be a matter of grave concern to those attempting to develop evidence based health and economic policies that truly serves the public interests.”

Richard Smith commented:

“I congratulate The BMJ on withstanding pressure to retract this article…. There is an ugly tendency these days for powerful groups to call for retraction of any article they don’t like. The BMJ has stood up for science on a crucial subject that affects everybody (8).”

Conclusion

It is gratifying that Fiona Godlee and her employers at The BMJ have had the good sense and sheer guts to stand up to this bullying. It is extremely nasty and disturbing. Essentially it is powerful vested interests and arrogance on the part of the researchers to misuse their positions. In effect it means that they do not have the confidence in the quality of their own results to stand up to scrutiny and have to resort to tactics that are totally unacceptable. The tragedy is that millions of people have complied with the advice promulgated by the authorities because it is regarded as reliable but has been responsible for human suffering on an enormous scale.

This is certainly not the first time this has happened and probably will not be the last. Let us hope that more and more people will resist this type of intimidation and take inspiration from the courageous action of Fiona Godlee and the The BMJ.

References

  1. Nina Teicholz (2014). “The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet”. Simon & Shuster New York
  2. N. Teicholz (2015). The BMJ http://www.bmj.com/content/351/bmj.h4962/
  3. Dietary Guidelines Advisory Committee (2015). Advisory Report to the Secretary of Health and Human Services and to the Secretary of Agriculture. https://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf
  4. D. S. Jones (2016). Silencing Science: The War on Nina Teicholz. https://shootingthemessenger.wordpress.com/2016/05/05/silencing-science-the-war-on-nina-teicholz/
  5. N. Teicholz (2016). Overview of BMJ Retraction Request. http://thebigfatsurprise.com/overview-bmj-retraction-request-including-response-11-allegations/
  6. I. Leslie (2016). Guardian https://www.theguardian.com/society/2016/apr/07/the-sugar-conspiracy-robert-lustig-john-yudkin?CMP=share_btn_tw
  7. F. Godlee (2016) The BMJ http://www.bmj.com/content/351/bmj.h4962/rr-48
  8. http://thebigfatsurprise.com/press-release-bmj-decision-not-retract/

 

 

242. Sugar: the Number One Threat

If I am asked

“What is the first step to take to improve the nutritional quality of my diet?”

my answer is that you should reduce sugar intake as much as possible. But this may prove to be very difficult.

Lots of sugar

First of all, there is an awful lot of sugar out there. Every time I go to a supermarket I am appalled at sheer quantity of products that contain loads of sugar. There are soft drinks in abundance. A standard can of soda may contain as much as 60 gm of sugar. Some people drink several cans in a day. WHO recommends that the intake should be about 10% of Calories, which is about 50 gm per day, although a value of 5% would be preferable. Back to the supermarket shelves again and there are huge bottles of pop, which contain two or three litres that have to be transported into the store on pallets. I often see shopping trollies with many of these bottles and I just hate to think what the effect will be on the members of the household. Then we have all the sweets, chocolates and biscuits. All this before we get to the foods. Unfortunately, many of the processed foods such as ready meals, sauces and baked goods have sugar added during their manufacture. On top of all this, there are the “healthy” “low-fat” foods, many of which have replaced the fat with sugar.

Secondly, sugar is relatively inexpensive, which explains why it is used so widely as a “filler”.

Thirdly, many consumers have a “sweet” tooth and therefore find foods that contain sugar are attractive. Even worse, for some people sugar is addictive and may lead to other nastier drugs.

One of the major hurdles in trying to convince friends that sugar is dangerous to health is that people cannot perceive that such a widely used item of food could possibly be bad for health. A classic case of “familiarity breeding contempt”.

The case against sugar

There is now a very good understanding of what happens inside the body when sugar is consumed.

However the concerns about the dangers to health of consuming sugar have been around for many years.

USA science writer Gary Taubes in his excellent book, The Diet Delusion, provides the following examples of evidence that sugar contributes to the development of various diseases (1):

  • In 1924, Haven Emerson, director of the Institute of Public Health at Columbia University in New York, concluded that:

“Rises and falls in sugar consumption are followed with fair regularity within a few months by similar rises and falls in death rates from diabetes.”

  • In 1975, Richard Doll and Bruce Armstrong commented that:

“The higher the sugar intake, the higher the incidence of any mortality from cancer of the colon, rectum, breast, ovary, prostate, kidney, nervous system and testicles.”

    • In Israel, diabetes specialist Aharon Cohen found that in 5000 immigrants from the Yemen in 1949 there were only 3 cases of diabetes. By contrast, the incidence of diabetes in Yemenis who arrived about 20 years earlier was almost 50 times greater. Cohen concluded that the much greater consumption of sugar amongst those who had already settled in Israel was the critical factor responsible for difference in disease levels.

 

  • In South Africa, Dr. George Campbell, who was in charge of the diabetic clinic in Durban, observed that diabetes, coronary heart disease (CHD), hypertension and gall bladder disease were common in the local white population but virtually non-existent in the Zulus living in rural areas. Furthermore, as sugar consumption by the rural population increased, there was an increase in heart disease. In 1956, Campbell spent a year in Philadelphia, and discovered that the pattern of disease in the local black population was virtually the same as in the whites in South Africa. When he returned to Durban, he noted that Indian people working in the sugar industry had a high incidence of diabetes which he described as

 

“…almost certainly the highest in the world”.

  • In the UK, physiologist and nutritionists Dr. John Yudkin noted that the rise in sugar consumption preceded very closely the rise in deaths from heart disease.
  • Cancer: until recently, the 1920s work of German physiologist Otto Warburg, which concludes that glucose is essential for cancer cells to function effectively, has largely been ignored. Warburg showed that cutting off the supply of glucose was an effective way of tackling cancer. Today, researchers, such as USA biology professor Thomas Seyfried, are conducting investigations that provide convincing support for this concept.
  • Alzheimer’s Disease (AD): here again there are strong indications that excessive sugar is an important risk factor.  People who suffer from type 2 diabetes (T2D) may be up to five times more likely to develop AD compared to those who do not have the disease.

Incidentally, Gary Taubes has written another book, which is specifically about “The Case Against Sugar” that has just been published (2). I have yet to read it but the reviews indicate that it is another tour de force that is a comprehensive explanation of why sugar consumption should be limited.

T2D may be regarded as the tip of the iceberg because those who suffer from this disease have a much higher risk of developing the common chronic diseases than those who do not. The crucial factor is the build-up of glucose in the blood, which in turn triggers the secretion of insulin by the pancreas. When sucrose is digested it breaks down to glucose and fructose (fruit sugar). Robert Lustig, one of the leading campaigners for tighter controls on sugar explains that the glucose and fructose are metabolised in different ways, and therefore have totally different effects in the body. The glucose can be utilised by every cell in the body, whereas the fructose must be metabolised by the liver that converts it into fat. Essentially, the body metabolises fructose using the same biochemical pathways it uses to metabolise alcohol. Excessive amounts of fructose (and alcohol) causes the condition known as “fatty liver”, or non-alcoholic fatty liver disease (NAFLD).

As Taubes puts it:

“Because sucrose and high fructose corn syrup (HFCS-55) are both effectively half glucose, half fructose, they offer the worst of both sugars. The fructose will stimulate the liver to produce triglycerides (fat), while the glucose will stimulate insulin secretion. And the glucose-induced insulin response will prompt the liver to secrete even more TG than it would from the fructose alone, while the insulin will also elevate blood pressure (BP) apart from the effect of fructose.”

Conclusion

It is important to appreciate that sugar is not an essential nutrient. It is often presented as such by dietitians who argue that it is required in order to supply the body with energy. However, energy can be sourced from fat and protein. We know that there are populations, which consume little or no sugar (or any carbohydrates for that matter) that are perfectly healthy.

So while there may still be debate about the desirability and dangers of the starchy foods such as bread, flour, pasta and rice, we have now reached a point where we have a very powerful case for excluding sugar from the diet. In fact it is somewhat surprising that the UK Government has accepted that there is a case for introducing a tax to discourage the consumption of sugar. Anyone who would like some support in attempting to reduce sugar consumption might find it useful look at The SugarFree Revolution established by Karen Thomson in South Africa (3).

References

  1. G Taubes (2007). “The Diet Delusion” Vermillion London
  2. G Taubes (2016). https://www.amazon.co.uk/Case-Against-Sugar-Gary-Taubes/dp/1846276373/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=&sr=
  3. http://www.thesugarfreerevolution.com/

 

 

241. New Training Course. How to Control Type 2 Diabetes (T2D) by Diet

There is now overwhelming evidence that T2D is caused by the habitual consumption of diets that have a high content of sugar and foods that contain starch such as rice, pasta, potatoes and pasta. While there is growing acceptance that sugar is bad news, there is disagreement about the role of the starchy foods.

The official advice promoted by the mainstream healthcare professionals is summarized in this extract from the NHS Choices website:

The important thing in managing diabetes through your diet is to eat regularly and include starchy carbohydrates, such as pasta, as well as plenty of fruit and vegetables. If your diet is well balanced, you should be able to achieve a good level of health and maintain a healthy weight.”

In addition, patients are also advised to reduce the amount of fat consumed, with special emphasis on the saturated fat.

The big problem is that this is simply not working. Patients who follow this advice do not get better. The vast majority continue to deteriorate and may well become very seriously ill.

However there is lots of good news. Many individuals have discovered for themselves that they can overcome T2D and some are convinced that they are completely cured. What comes through loud and clear is that the diets, which produce this success are in direct conflict with the conventional advice. The fundamental approach is to restrict the consumption of not only sugar but also all other sources of carbohydrates such as starch. In addition these carbohydrates are replaced by healthy fats. Such diets are described as low carb high fat (LCHF).

This should be no great surprise because we know that the sugar and other carbohydrates are broken down to release glucose. The higher the glucose in the blood, the harder the pancreas has to work to produce the insulin to control the glucose. Ultimately the pancreas packs up and the blood glucose can no longer be controlled and causes havoc inside the body. For example it sticks to the haemoglobin, which explains why the circulation deteriorates possibly resulting in the amputation of limbs. This is all well-established and in no way controversial. In addition, there is reliable research, which provides conclusive proof that LCHF is a very effective way of controlling T2D.

Convincing confirmation is provided by the success of Dr. David Unwin, who is a GP based in Southport. At an event in Skipton held at the beginning of September, he described his amazing results with patients, who suffer from obesity and diabetes. The vast majority discover how to control T2D and avoid the need to use drugs. The impact can be measured by the fact that he has reduced the cost of drugs prescribed by the practice by £45,000 per annum.

Dr. Unwin has been advising a group of his patients to reduce sugar and foods with a high starch content such as bread, pasta and rice. These can be replaced by increasing consumption of green vegetables, whole-fruits, such as blueberries, strawberries, raspberries and the “healthy fats” found in olive oil, butter, eggs, nuts and full-fat plain yoghurt. Calorie counting was not needed.

All the participants reported that they felt healthier and more energetic on this type of diet. They also appreciated that the diet did not involve any weighing of food or calorie counting.

However, the most significant result was that the markers for blood sugar improved to such an extent that they reached “normality”, which is absolutely tremendous news. To cap it all, the average weight loss was 9 kg.

New training course for diabetics

There is now an opportunity for follow-up our event in September by means of a training course here in Skipton. This will be presented by Keith Rathbone, who used his skills as a Design Engineer to work out how to control his own T2D by making changes to his personal diet. He is very enthusiastic about sharing this knowledge with others and is a Patron of the Public Health Collaboration. Keith is particularly keen to attract people who have recently been diagnosed with T2D and wish to avoid the use of drugs. He will explain the rationale which underpins the strategy and provide detailed guidance on how to make the appropriate changes to the diet. It is proposed that the programme will commence on Monday 23rd January with an introductory session, which will be followed by one session per week for another six weeks (on Mondays). The venue is The Rendezvous in Skipton. Sessions will commence at 6.30pm.

Here is an outline of the topics which will be covered.

Session 1 What is pre-diabetes and diabetes?

Explains the effects of how digestion of carbs effects BG control.

Also includes 7 lifestyle factors for optimal heath.

Health results- what they mean.

Medications used in diabetes.

Setting Goals.

 

Session 2 Weight Management

Eating for good health – food groups/portions

Addressing the myths and misconceptions.

Physical activity – when what and how?

Options for weight loss.

How to assess what I am eating.

Setting goals: eating and activity.

 

Section 3 Carbohydrate Awareness

Carbohydrate and blood glucose levels

Assessing the amount of carbohydrate

Practice at estimating carb content.

Daily intake of carbs

Setting Goals: the right carbohydrate for me.

 

Section 4 Understanding Food labels

Nutrition information on food packaging

Traffic light system

Reference intakes

Nutritional claims – what do they mean?

Setting Goals: the foods I buy

 

Section 5 Health Check

Low and High BG levels

How could diabetes effect my long term health?

Prevention of complications

Importance of regular check ups

Work, driving insurance, travel and sick days

Setting goals: to reduce risk

 

Section 6 Leave the Best to Last

Recapping with the X-PERT Game

What resources are available to help me?

Revisiting my health profile

Have my needs been addressed?

More confidence to self-manage my health?

Setting goals: self-management in the future…

It will especially valuable to anyone who has just been diagnosed with Type 2 Diabetes or is at risk of developing the disease. If interested please contact Verner Wheelock at:

verner.wheelock@vwa.co.uk

Binns Lane Farm

Glusburn

Keighley

West Yorkshire

BD20 8JJ