120. Revelations about Aspartame

Aspartame is a low-calorie sweetener which is produced by G D Searle a company owned by Monsanto. It is approximately 200 times sweeter than sucrose. According to the official website the benefits include:

  • Aspartame Tastes Like Sugar
  • Aspartame Enhances and Extends Flavors
  • Aspartame Does Not Promote Tooth Decay
  • Aspartame is Helpful for Individuals with Diabetes
  • Scientific Studies Show Aspartame is Beneficial in Weight Control
  • Aspartame Can Be Part of a Healthful Diet (1).

The Food Standards Agency (FSA) takes the view that aspartame is perfectly OK as shown by this extract from the website:

Aspartame was first approved in the UK in 1982 following the review of its safety by the UK’s Committee on Toxicity, Consumer Products and the Environment (COT), a committee of independent experts that advises the Government on the safety of food chemicals. This was reaffirmed in 1988 by the European Commission’s former Scientific Committee on Food (SCF).

Following the publication of a number of anecdotal reports, which cast doubt on the safety of this sweetener, the SCF reviewed more than 500 papers published in the scientific literature between 1988 and 2001 on the safety of aspartame, including studies supporting the safety of aspartame and others pointing to potential adverse effects, which concluded, in 2002, that there was no evidence to suggest a need to revise the outcome of their earlier risk assessment or the Acceptable Daily Intake (ADI) previously established for aspartame of 40 milligrams per kilogram of body weight per day (40 mg/kg bw/day).

A study published by the Ramazzini Foundation in Bologna, Italy, in July 2005 claimed to have shown that rats given dosages of aspartame equivalent to the Acceptable Daily Intake (ADI) may develop tumours. EFSA assessed the study and raised a number of concerns regarding it. They concluded, that ‘there is no need to further review the safety of aspartame nor to revise the previously established ADI’.

The FSA supported the conclusions of EFSA’s review but reiterated that all approvals of food additives should be kept under review as and when new scientific information becomes available. Indeed, as part of its systematic re-evaluation of all food additives, EFSA has re-evaluated the safety of aspartame (see External sites box). As a result, it concluded in December 2013 that ‘aspartame and its breakdown products are safe for human consumption at current levels of exposure’ ” (2).

However not everyone would agree with this position. In particular, Devra Davis has delved into the background and she would certainly dispute the rather complacent line taken by the FSA (3). Devra  has impeccable credentials. She is an epidemiologist who spent 10 years employed by the National Academy of Sciences. During her time as Senior Advisor to the Assistant Secretary for Health in the Department of Health and Human Services, she advised leading officials in the United States, United Nations, European Environment Agency, Pan American Health Organization, World Health Organization, and World Bank. Between 1983 and 1986 she served as a member of the Board of Scientific Counselors of the U.S. National Toxicology Program. She founded the Center for Environmental Oncology of the University of Pittsburgh Cancer Institute where she was director from 2004 to 2010.

In an interview in the late 1990s, the author discovered some interesting history about aspartame from James Olney, a research neurologist and psychiatrist at Washington University in St Louis. In 1969 a study conducted by researcher Harry Waisman with 7 infant monkeys found that after drinking milk flavoured with aspartame for a year. One was dead and 5 had suffered epileptic seizures. In 1971 Waisman died and the work was never completed. However Olney’s own studies showed that aspartame paired with MSG to produce brain tumours in rats. Two years later, FDA scientist Martha Freeman decided the information submitted by the manufacturers on safety was inadequate.

In July 1976, the FDA decided to investigate the 15 key aspartame studies submitted by G D Searle and set up a Task Force under the chairmanship of Jerome Bressler. The sequence of events following the publication of the report is described in a document prepared by the Aspartame Toxicity Information Center (4). This provides a mine of information which should be consulted by anyone who is interested in the background to the approval of aspartame by the FDA. The references have been removed but many relate to official US Government documents. In August 1977, the Bressler report was released and it contained major criticisms of the procedures relating to the material presented by Searle, namely:

  • In one study, 98 of the 196 animals died but were not autopsied until as much as one year later. Because of the delay, much of the animal tissue could not be usedand at least 20 animals had to be excluded from postmortem examinations
  • The original pathology sheets and the pathology sheets submitted to the FDA showed differences for 30 animals
  • One animal was reported alive at week 88, dead from week 92 through week 104, alive at week 108, and finally dead at week 112
  • An outbreak of an infectious disease was not reported to the FDA
  • Tissue from some animals were noted to be unavailable for analysis on the pathology sheets, yet results from an analysis of this “unavailable” tissue was submitted to the FDA
  • There was evidence that the diet mix was not homogeneous allowing the animals to eat around the test substance. This evidence included a picture and statements by a lab technician
  • Fifteen foetuses from animals in one experiment were missing
  • Sections from the animals were too thick for examination
  • There was no documentation on the age or source of the test animals
  • There was no protocol until one of the studies was well underway
  • Animals were not permanently tagged to prevent mix ups
  • Some laboratory methods were changed during the study, but not documented

A G.D. Searle pathologist referring one of the studies was quoted by investigators as saying:

You should have seen things when this study was run — there were five studies being run at one

     time — things were a mess!”

Bressler himself commented

The question you have got to ask yourself is: Because of the importance of this study, why

     wasn’t greater care taken? The study is highly questionable because of our findings. Why didn’t

     Searle, with their scientists, closely evaluate this, knowing fully well that the whole society,

     from the youngest to the elderly, from the sick to the unsick . . . will have access to this

     product.”

At this point it should be noted that Donald Rumsfeld who had just left office as Defense Secretary had been appointed as the CEO of Searle. It was evident that he had been hired early in 1977 because of his connections with government and with the Republican Party, although at that time the Democrat Jimmy Carter was president.

In September 1997, the Director of the FDA’s Bureau of Foods received a report from another Task Force which claimed that the Searle studies appeared to be authentic (meaning that they had

actually conducted).

For each of the major discrepancies found by the Bressler-led Task Force — those listed above and many others – there was a comment in the FDA Bureau of Foods Report minimizing the problem. It seemed that no matter how serious the mistakes were, the FDA Bureau of Foods was determined to

accept the studies by G.D. Searle.

The experimental errors as described above were so bad that it proved difficult to minimize all of the major errors in these key studies. In some cases, the best that they could do was to say that “The Task Force could find no evidence that this was a deliberate attempt to influence the study.” or “It could not be determined if the results would have been altered….”

In other words it was evident that moves were being made to downplay the serious criticisms in order to pave the way for approval. This was confirmed by Jacqueline Verrett, a senior investigator at the FDA, who earlier had conducted an examination of the procedures and protocols which applied to the Searle studies. After she left the Agency, she was interviewed by a journalist who reported as follows:

Jacqueline Verrett, the senior scientist on the review team, said members were barred from stating opinions about the research quality. ‘It seemed pretty obvious that somewhere along that line they

(bureau officials) were working up to a  whitewash,’ she said. ‘I seriously thought of just walking off of that task force.’ Verrett, now a private consultant, said that she and other members wanted to ‘just come out and say that this whole experiment was a disaster and should be disregarded.”

In her testimony before the U.S. Senate during 1987, Dr. Verrett stated the following:

This authentication was hence intended to verify that the submitted data had not been altered;

that it reflected the actual outcome of the study and that it did not change substantially,       particularly in a statistical sense, the various parameters from which the conclusion of safety had been derived.

Our analysis of the data in this manner reveal that in these three studies, there were really no

substantial changes that resulted, although in numerous instances, a definitive answer could not

be arrived at because of the basic inadequacies and improper procedures used in the execution of these studies.

I would like to emphasize the point that we were specifically instructed not to be concerned with, or to comment upon, the overall validity of the study. This was to be done in a subsequent review, carried out at a higher level.

It would appear that the safety of aspartame and its breakdown products has still not been

satisfactorily determined, since many of the flaws cited in these three studies were also present in

all of the other studies submitted by Searle.

 

Well, they told us in no uncertain terms that we were not to comment on the validity of it. And I

hoped, although having been there at that point for 19 years, I should have known better, that

there really would be an objective evaluation o this beyond the evaluation that we did.

I do not feel that that was done, based on what I have read in the GAO report that I have looked at and so forth. They definitely did not objectively evaluate these studies, and I really think it should have been thrown out from day one.”

 

“We were looking at a lot of little details and easy parameters in this study, when the foundationof the study, the diet and all of these other things, were worthless. We were talking about the jockey when we should have been talking about the horse, that he had weak legs. It is built on foundation of sand.”

  • In March of 1979, the FDA somehow concluded that G.D.Searle’s aspartame studies could be accepted. They decide to convene the Public Board of Inquiry (PBOI).
  • The PBOI voted unanimously to reject the use of aspartame until additional studies on aspartame’s potential to cause brain tumours could be done. The PBOI was particularly concerned about experiment E33/34 where 320 rats received aspartame and a much higher percentage of animals in the aspartame group developed tumours than in the control group (Brannigan 1983, page 196). In addition, the PBOI was concerned about experiment E70 where 80 rats received aspartame. Both the aspartame group and the control group had an unusually high number of tumours, leading one to suspect that both groups were actually given aspartame.”
  • “On January 21, 1981, the day after Ronald Reagan takes office as U.S. President, G.D. Searle reapplied for the approval of aspartame. G.D. Searle submits several new studies along with their application. It was believed that Reagan would certainly replace Jere Goyan, the FDA Comissioner. G.D. Searle president, Donald Rumsfeld’s connections to the Republican party were also thought to play a part in Searle’s decision to reapply for aspartame’s approval on the day after Ronald Reagan was inaugurated.”
  • “In March of 1981, a 5-member panel of scientists was established by the FDA Commissioner Jere Goyan to review the issues raised by the PBOI.”
  • “In April 1981, Arthur Hull Hayes, Jr. was appointed FDA Commissioner by Ronald Reagan.”
  • “On July 18, 1981 aspartame was approved for use dry foods by FDA Commissioner Arthur Hull Hayes, Jr. overruling the Public Board of Inquiry and ignoring the law, Section 409(c)(3) of the Food Drug and Cosmetic Act (21 U.S.C. 348), which says that a food additive should not be approved if tests are inconclusive (Federal Register 1981, Farber 1989,page 38). In an article in Common Cause Magazine, Florence Graves states that two FDA officials said that Arthur Hull Hayes, Jr. wanted to push aspartame approval through in order to signal reforms of the Reagan Administration.”
  • “On October 15, 1982, G.D. Searle petitioned the FDA for approval to use aspartame in soft drinks and children’s vitamins.”
  • “On October 1, 1982 an amendment was attached to the Orphan Drug Act (an act which encourages the development of drugs for rare diseases) which modified the U.S. Patent law

The amendment extended the patent on only one product — aspartame — by 5 years, 10months and 17 days. The amendment did not mention aspartame or G.D.Searle by name and there was no debate or discussion on the amendment.”

  • “In 1983 acting FDA Commissioner, Mark Novitch approved aspartame for use in carbonated beverages and carbonated beverage syrupbases . FDA Commissioner, Arthur Hull Hayes was out of town the day that the approval was signed, but he worked closely with Mark Novitch on this issue. Ignoring the FDA’s own safety standards, they more than doubled the Acceptable Daily Intake (ADI) of aspartame from 20 mg/kg to 50 mg/kg.”
  • “Shortly after the FDA approval for aspartame in carbonated beverages, FDA Commissioner, Arthur Hull Hayes left the FDA under charges of improprieties, took a position as the Dean of New York Medical College and was hired as an a consultant ($1,000 per day) with G.D. Searle’s public relations firm, Burston Marsteller.”

CONCLUSION

There really is no need for much comment. The information speaks for itself. There is a lot more for anyone who wishes to follow the link to reference (4). The case for approving aspartame is built on a foundation of sand. With this background it is difficult to understand how and why the FSA and other regulatory bodies appear to be so complacent. One wonders if they have even bothered to review the information presented here. No doubt further testing has been done but how much can this be trusted in view of the appalling record of the company? If this information could be disseminated widely, then consumers could make up their own minds. As aspartame is extensively used in low calorie products, those especially at risk will be people who are attempting the follow the official dietary guidelines.

REFERENCES

  1. http://www.aspartame.org/
  2. http://www.food.gov.uk/science/additives/aspartame
  3. Devra Davis (2009) “The Secret History of the War on Cancer” pp 419-426. Basic Books New York ISBN 978-0-465-01568-9
  4. http://www.fda.gov/ohrms/dockets/dailys/03/Jan03/012203/02P-0317_emc-000202.txt

 

119. The Medical-Industrial Complex

As long ago as 1960, President Eisenhower warned about the dangers of the Military-Industrial Complex. Here is a quote from the famous speech:

“In the councils of government, we must guard against the acquisition of unwarranted influence, whether sought or unsought, by the militaryindustrial complex. The potential for the disastrous rise of misplaced power exists and will persist.

We must never let the weight of this combination endanger our liberties or democratic processes. We should take nothing for granted. Only an alert and knowledgeable citizenry can compel the proper meshing of the huge industrial and military machinery of defense with our peaceful methods and goals, so that security and liberty may prosper together” (1).

There are compelling reasons for concluding that these features are characteristic of the current relationships between the pharmaceutical industry, the medical profession and governments. In other words we now have a Medical-Industrial Complex. My thoughts have been triggered by my recent blog (2) which highlighted evidence showing that there are serious deficiencies in the regulation of drugs leading to suggestions that the process has been corrupted.

It is essential to face up to the fact that the standards of public health are deteriorating as demonstrated by the increased incidence of diabetes, which has doubled in the past 15 years. While it is true life expectancy has been extended it is highly doubtful if the quality of life has shown a corresponding improvement. The increased incidence of dementia and related conditions such as Alzheimer’s Disease means that many people are unable to care for themselves in later years. On the other hand, expenditure by the NHS in the UK continues to increase. Much of this is to meet the extra costs incurred by expenditure on the latest development in drugs and other tests/procedures.

A detailed analysis has been conducted at the Safra Institute in Harvard University entitled:

“Institutional Corruption of Pharmaceuticals and the Myth of safe and Effective Drugs” (3)

The authors contend that institutional corruption has occurred at three levels. First, large-scale lobbying and political contributions by the pharmaceu­tical industry has influenced Congress to such an extent that legis­lation has been passed which compromised the role of the Food and Drug Administration (FDA). Second, because of industry pressure, Congress has underfunded FDA enforcement capacities since 1906 so that it is incapable of thoroughly evaluating drugs submitted to it for approval. Since 1992 it has had to depend on industry-paid “user fees” which has effectively limited the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages. Finally, industry has commer­cialized the role of physicians and undermined their position as independent, trusted advisers to patients.

Many of the drugs submitted in recent years have few if any advantages over those already on the market. In fact the FDA can actually approve drugs even if they are inferior to those which have previously approved. An evaluation conducted in France concluded that of all the new drugs approved between 1981 and 2001, about 12% offered therapeutic advantages. However between 2002 and 2011, only 8% were assessed as genuinely better than existing ones. However almost 16% were judged to be more harmful than beneficial. As few as 1.6% were considered to be substantially better. Assessments by the Canadian advisory panel to the Patented Medicine Prices Review Board and by a Dutch general practice drug bulletin have come to similar conclusions.

The reality is that most of the expenditure on research and development (R&D) is focused on developing drugs which differ slightly in chemical make-up but have a therapeutic function similar to existing drugs. This approach is adopted because it has a high chance of success and therefore less risk commercially.

Despite the failure to develop many drugs that will make a valuable contribution towards improving health, sales and profits have soared. This is because the marketing arms of the drug companies have successfully persuaded physicians to prescribe the much more costly new products that are at best therapeuti­cally equivalent to established drugs.

Two studies have found that 80% of the increase in drug expenditures was to pay for these minor-variation new drugs, rather than for important advances.  Companies claim that R&D costs are “unsustainable.” But the reality is that revenues have increased six times faster than has investment in R&D over the past 15 years.

Between 1964 and 1995, a systematic review of patients who were hospitalised in the US because of adverse drug reactions (ADR) or experienced an ADR while in hospital found some disturbing results. In all 6.8% had serious ADRs which means that 2.7 million people were affected. Of those 0.32 died, which represents 128,000 deaths every year. On this basis, ADRs are the 4th leading cause of death. These figures do not include ADRs which occurred outside hospitals.

1. Because politicians are dependent on drug companies for financial support to get elected as public representative, there has been a reluctance on their part to ensure that the regulatory process is completely thorough and effective. This can be demonstrated as follows:

  • New drugs are often tested against placebos rather than against established effec­tive treatments.
  • Surrogate or substi­tute end-points instead of the actual effects on patients’ health are often used to assess the effectiveness of new drugs.
  • Noninferiority trials which show that the product is not worse than another drug used to treat the same condition by more than a specified margin are accepted. Ideally there should be a requirement to show that the new drug is significantly better than one already on the market. These criteria do not conform to international ethical standards because they provide no useful information for prescribing.

2.  Companies are allowed to test their own products. Hence the trials are designed in such ways that they minimise the detection and reporting of harms and maximise evidence of benefits. They are permitted to exclude patients who are most likely to have ADRs, while including those most likely to experience benefit. Therefore drugs can be marketed as safer and more effective than they are in the real world.

3. In a submission to the House of Commons Health Committee, Richard Horton, editor of the Lancet, spelled out the problems which have arisen as a result of the heavy involvement of the drug companies in medical research as follows:

the extent of the commercial sponsorship of medical research and its intrusion into the academic sphere is one of the gravest threats to the independent evaluation of new medicines—indeed to the notion of an independent science base. Without greater scrutiny of the interaction between private and public sectors, the health of our population will continue to be put at risk by biased, over-interpreted, and misreported research findings. At present, our population is part of a largely unregulated experiment involving poorly investigated new medicines that have been licensed on the basis of insufficient data” (4).

He went on to describe how the entire process of publication of scientific research has been debased by the activities of the drug companies, whose over-riding consideration is the promotion of their products to the exclusion of all other factors. Examples include:

  • Manipulation of research findings. A drug which had “no effect” according to the researchers but the marketing actually claimed “primary endpoints significant in hypertensive patients”, which was a total distortion of the actual result.
  • Bias in sponsored studies: research has demonstrated clearly that sponsored studies are more likely to produce a positive result for a company than an independent study of their product.
  • Hiding negative data: the classic recent example concerned Paxil (GlaxoSmithKline). The results of trials which were not disclosed showed a pattern suggesting limited efficacy of the drug and risks of potentially fatal adverse effects. The available published evidence indicated a very different story. Under pressure, GSK was forced to reveal these hidden results—leading to a $2.5 million US legal settlement and an unequivocal FDA warning about the risks of the drug.
  • Undisclosed conflicts of interest: the escalating problem of industry payments to scientists—stock options, consultancy fees, research grants, staff costs, entertainment, conference fees, hospitality—has been recognised for several years.
  • Editorial kick-backs: The Lancet has been offered substantial sums of money in exchange for publishing certain research studies.

This is all sordid, unethical and totally unacceptable. A Medical-Industrial Complex definitely does exist. There is absolutely no doubt that industry, governments and the professionals interact and collaborate to exploit people when they are most vulnerable. Because all the players are very powerful, it will not be easy to achieve reform in order to ensure that the drug companies are subject to stringent regulatory control. Probably the best hope is transparency with the assistance of the internet. The recent incident involving Rory Collins and the BMJ is at least an encouraging sign that the drug companies and their acolytes are no longer getting their own way (5,6). The one thing we can all do is to be very, very careful before agreeing to take any drug.

REFERENCES

  1. http://coursesa.matrix.msu.edu/~hst306/documents/indust.html
  2. http://vernerwheelock.com/?p=575
  3. D W Light, J Lexchin & J J Darrow (2013) Journal of Law, Medicine and Ethics 14 (3) pp590-610
  4. http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4121604.htm
  5. http://vernerwheelock.com/?p=432
  6. http://vernerwheelock.com/?p=528

 

118. Crony Capitalism. The Pharmaceutical Industry.

The use of drugs is an integral component of the conventional approach to modern medicine. Invariably a visit to your GP results in a prescription for at least one pill or potion. A similar treatment is often associated with a stay in hospital. The fundamental principle which underpins this strategy is that these medicines will be beneficial to the patient’s health. Furthermore while it is accepted that there may be side-effects, these can be tolerated if the benefits are genuinely worthwhile. The entire basis of the approach is dependent on regulatory processes that are rigorous in their assessments of the effects the drugs have on people who are treated.

Unfortunately a huge amount of evidence has emerged in recent years, which shows that there are serious deficiencies in the regulation of drugs and there are even suggestions that the process has been corrupted.

A recent book published in the US entitled “Crony Capitalism in America 2008-2012” (1) has a whole chapter devoted to the relationship between the pharmaceutical industry and the Food and drugs Administration (FDA). This has been reproduced on the Alliance for Natural Health website (2). This blog will focus on some of the key points. Although the book refers to the US many of the companies operate in the UK and it would not be in the least surprising if the relationship between the companies and the UK/EU regulatory authorities is essentially the same. Here are some of the hard realities of this business:

  1. Drug companies do not usually use natural compounds because it is impossible to patent them. As it costs somewhere around $billion to obtain approval, patenting is essential in order to recoup the costs involved.
  2. To facilitate approval process, the companies regularly hire staff with experience of working for the FDA. Many of the experts in the field who may be employed by universities and research organisations act as both advisers to the FDA and consultants to the industry.
  3. This engenders a cosy relationship between the both sides who participate in the regulation of the drugs
  4. According to a quote from the “Economist”:

Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.”

The “Economist” continues:

“Medical journals frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice goes uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs.”

5.       Knowledge of what is happening with respect to the progress of individual applications for approval can have major financial implications. An FDA chemist charged with criminal offences has pleaded guilty to leaking information about drug approvals or company mergers. Over a 5-year period the chemist had been involved with 25 companies and benefited to the tune of almost $4 million dollars.

6.       Once a drug has been approved it may be prescribed on a large scale, especially by official bodies such as the US government’s Medicare. Annual treatment costs for these approved drugs may be as high as $500,000 per patient. On the other hand, drugs which have not been approved are effectively banned in the US and doctors who prescribe them risk being stuck off and may even be prosecuted

7.       Although there may be compelling anecdotal evidence, including numerous case studies which indicate that naturally-occurring substances can be used successfully to treat a variety of diseases and conditions, the FDA insists that they can only be approved if the complete testing programme is implemented. Since there is no organization or company prepared to spend the money needed, there is no way that these substances will ever be approved. The position is re-inforced by the stance of the American Medical Association (AMA) which as a general rule is opposed to the use Complementary therapy but is also dependent on the pharmaceutical industry for much of its funding

8.       The use of generic drugs ought to be an effective means of reducing the costs of many drugs but this approach is to some extent stymied because the FDA insists that bioequivalence is demonstrated which adds to the costs. More significantly the FDA has a huge backlog of about 1900 applications for generics and the average time for a decision on approval is 26 months,

9.       In the US the government is very careful to avoid charging any leading pharmaceutical company with criminal misconduct. This is because conviction under the current law would mean that the government would no longer be able to purchase any products from that company. The government is too closely integrated with the drug/vaccine industry to allow that to happen. Thus, when Merck was found to have misled about its painkiller Vioxx, alleged to have caused at least 55,000 deaths (some estimates are much higher), the settlement with plaintiffs reached $4.9 billion. But Merck continued partnering with and selling to government without any interruption or even question.

This is just one example of crony capitalism in which government and industry become so interdependent on each other that there is really no effective control and the only beneficiaries are those individuals who have their “snout in the trough”. In essence the normal rules of competition are suspended and inefficiencies are rampant. It is of course the ordinary citizens who suffer because it is their taxes which are used to fund these excesses. They also miss out from the continued improvement in the quality of products coupled with a steady reduction in prices. As an example, compare the pharmaceutical industry with the mobile phone industry which advances in leaps and bounds. By contrast there is reliable evidence that there are very few new drugs which actually perform significantly better than those already on the market and some which are worse, but no doubt are promoted as “wonderful”.

REFERENCES

  1. Hunter Lewis (2013) “Crony Capitalism in America 2008-2012” ISBN 978-09887627-2-7
  2. http://www.anh-usa.org/big-pharma-and-fda-a-marriage-not-made-in-heaven/

 

 

117. Statins: Email to Julian Smith MP

Good Morning Julian,

I have just posted this article on my blog at

http://vernerwheelock.com/?p=569   More details of the damaging effects of statins will be found at http://www.spacedoc.com/statin_side_effects

My primary concern is the fact that such a large number of perfectly healthy people are suffering serious ill-health even though NICE accepts that it will not improve their health in any way. I contend that this is totally unjustified and unacceptable.

The reality is that 100s of thousands (maybe even millions) of people are being damaged by statins when the vast majority  of them do not benefit in any way. There is no doubt that there is manipulation of the results conducted by the drug companies to play up the advantages and play down the undesirable side-effects of statins. (See http://vernerwheelock.com/?p=545  and http://vernerwheelock.com/?p=528)

This issue has all the hallmarks of other scandals which have come to light recently such as Rotherham, Stafford Hospital or Hillsborough. The only difference is that much larger numbers of people are involved. There is no doubt that NICE is a major part of the problem. I believe that for a start some of the parliamentary committees should conduct a detailed investigation into the role of NICE and its relationship with the drug companies. This email is a formal request to you to place this information with the Parliamentary Committees for Public Accounts, Science and Technology and Health in the hope that they will take appropriate action. Please take any other measure you think would be effective.

All the factual information is based on thoroughly reliable sources and I believe that this issue must be addressed sooner rather than later. Let us hope that this will not be another scandal that drags on and on for years because nobody in a position to act would listen !!!

A copy of this email is being sent to the Craven Herald and I will also be placing the information on my blog at http://vernerwheelock.com/

I look forward to hearing your response.

Very Best Wishes

Verner

 

116. Microchip to beat Obesity

According to The Guardian (8september 2014) Professor Sir Stephen Bloom is developing an “intelligent microchip” which will send signals to the brain that will stop the urge to eat. Bloom is head of the diabetes, endocrinology and metabolism at Imperial College London in Hammersmith Hospital. He believes that this will reduce appetite and therefore act as a means of overcoming obesity. In the interview Bloom says that obesity increases blood pressure and therefore increases the risk of having a stroke. He mentions that higher cholesterol means a person is more likely to have a heart attack, presumably also linked to obesity. Furthermore the incidence of Alzheimer’s Disease is one third higher in people who are obese. He goes on to state that most diabetes is caused by people being slightly overweight. So he concludes that if:

“….you could get rid of obesity, diabetes would fall to about a third or maybe a quarter”.

In my opinion Professor Bloom has made a number of assumptions in developing his strategy, which do not stand up to rigorous examination. As a consequence it is extremely doubtful if he can achieve his objectives.

First of all, if we consider those who are “overweight” as determined by BMI, we find that they actually have a greater life expectancy than those with a “normal” BMI, which is regarded as the ideal    (Table 1) (1). Although there is a small increase in the number of deaths due to kidney diseases and diabetes, this is more than offset by the reductions in deaths attributed to other causes.While it is true that those who are in the “obese” category have higher death rates, this only applies to those who are severely obese with a BMI >35 (2). Even then it is crucial to recognise this does not allow us to conclude that the cause is the excess weight.

TABLE 1 RELATIONSHIP BETWEEN BMI AND EXCESS DEATHS (1000s)

                                                                 BMI
Cause of death <18.5 18.5-25 25-30 >30
Coronary heart disease +3 0 -12 +6
Other   cardiovascular +8 0 -5 +36
Lung   cancer 0 0 -10 -7
Obesity   related cancer 0 0 -3 +20
All   other cancers +3 0 +3 +2
Diabetes/kidney   disease 0 0 +15 +34
Chronic   respiratory +16 0 -30 -6
Acute   respiratory/infectious +8 0 -8 -3
Injury +2 0 -32 -13
Other   causes +6 0 -52 +13
ALL +46 0 -134 +82

 

The nutrition literature is littered with examples of confusing cause and effect, which can be simply illustrated by this example. In an area of high crime it is likely that there will be frequent observations of police cars, while low crime localities will rarely have a visit from a police car. This does not mean that the police cars are the cause of the crime rate and it certainly does not follow that crime will be reduced if police cars are kept away!

We really do need to be much more critical in our thinking. It could well be that diabetes is one cause of obesity. However the most likely explanation is that there is a common cause for both. Our main concern is diabetes Type2 (T2D). This is raised blood glucose which stimulates the production of insulin by the pancreas. The insulin directs the glucose to the liver where it is converted into fat and then stored, which can ultimately result in obesity. The high levels of insulin in the body damage many of the organs, which can lead to heart disease and cancers. The obvious answer is to reduce the amount of glucose coming into the blood by cutting back on the consumption of sugar and refined carbohydrates.

There is a growing volume of evidence that this approach can overcome T2D (3,4,5). Invariably those who successfully reduce their blood glucose also find that they lose weight and the risk factors for heart disease are also lowered.

By contrast, the results for those who focus on weight loss alone are not encouraging. For example, in the Honolulu Heart Study, 6537 Japanese-American men aged 45 to 68 in 1965 and living in Hawaii, were monitored from 1973 to 1988 during which time there were 1217 deaths. The results are shown in Table 2. It is quite clear that there has been a notable increase in the death rate of those who lost weight. On the other hand, those who gained up to 4.5kg had a reduced death rate while those who gained more than that did not experience any increase in mortality rate when compared with those whose weight did not vary (6). Similar results have been observed in other investigations (7).

TABLE 2 RELATIVE DEATHS AND CHANGE IN BODY WEIGHT

  ALL-CAUSE MORTALITY  RELATIVE   RISK
Weight loss >4.5 kg 1.21
Weight loss 2.6-4.5 kg 1.29
No change 1.00
Weight gain 2.5-4.5 kg 0.83
Weight gain >4.5 kg 0.99

 

The hard reality is that T2D is not confined to those who are overweight or obese. A recent study conducted in the USA compared the death rates between those with T2D who were normal weight (BMI 18.5-25) and those who were overweight and obese (BMI>25). It was found that the death rates for those with normal weight was more than double that of those who were in the heavier categories (8). This paper also noted that overweight and obese patients with end-stage renal disease have better health outcomes than those who are lean. Furthermore, lean people with raised blood pressure and those with heart failure have worse health outcomes than their heavier counterparts.

So any strategy which focuses on weight loss per se is unlikely to be effective and may well do more harm than good. In addition, many diabetics are not overweight so weight loss is clearly not the solution.

CONCLUSION

It is virtually certain that this project is doomed to failure. There is ample evidence to demonstrate that weight loss by calorie control is very difficult to achieve and even when successful is rarely maintained. Even then, the chances are that there will not be any benefit to health. The real danger is that it diverts attention from the methods that are effective, especially making changes to food consumption patterns by limiting sugar and refined carbohydrates.

REFERENCES

  1. http://jama.jamanetwork.com/article.aspx?articleid=209359
  2. http://vernerwheelock.com/?p=132
  3. http://vernerwheelock.com/?p=226
  4. http://vernerwheelock.com/?p=405
  5. http://vernerwheelock.com/?p=422
  6. http://www.nejm.org/doi/full/10.1056/NEJM199509143331102
  7. http://vernerwheelock.com/?p=221
  8. http://jama.jamanetwork.com/article.aspx?articleid=1309174

 

 

 

 

 

115.Statins: Another Scandal in the Making

The latest edict from the National Institute for Clinical and Health Excellence (NICE) means that virtually everyone over 50 will be recommended to go on statins. NICE recognises that 77 people will have to be treated with these drugs over a 3-year period for one person to derive any benefit (1). It is crucial to understand that most of these are individuals who are perfectly healthy: the rationale for extending the scope of those being treated is prevention rather than cure. NICE also rejects claims that there are adverse side-effects when statins are used.

It really is unbelievable that NICE should be taking this stance when the benefits are so absolutely minimal. The organisation must be living in cloud cuckoo land if it considers this decision to be reasonable and logical. If people were informed there was only one chance in 77 that they would benefit I have no doubt that that the vast majority would not agree to the treatment and that is before any consideration of side-effects. In answer to a question, a spokesman justified statin use on the grounds that with blood pressure lowering drugs, only one in 104 would benefit!

A much more realistic picture was painted by a group of medical professionals led by Sir Richard Thompson, President of the Royal College of Physicians and Dr Clare Gerada, a former chair of the Royal College of GPs (2). In a letter to NICE, copied to Jeremy Hunt, they pointed out that:

  • There is  a lack of reliable evidence to demonstrate that when statins are used for primary prevention( ie. for people who have not had heart disease) there is any reduction in all-cause mortality
  • There is sound evidence that statins do cause adverse side-effects, which include muscle pain, cognitive impairment and erectile dysfunction. A study conducted in the USA with over 150,000 middle-aged women found that those on statins had a 48% increased risk of developing diabetes compared with those on a placebo
  • As 8 out of the 12 members of the NICE committee which made the recommendation on statins have financial links with the pharmaceutical companies producing the statins, there are genuine concerns about conflicts of interest
  • In a recent survey of 511 GPs conducted by the magazine Pulse, it was found that 57% oppose the plan to lower the current 10-year risk threshold for primary prevention from 20% to 10. Only 25% would support the proposals. It was also highly significant that 55% would not personally take a statin or recommend a family member to do so, based on a 10% risk.

An analysis of the results of trials to evaluate statins, shows that most of these studies have been conducted on men. Although there are fundamental differences between men and women in the way they respond to drugs, there is no convincing evidence that statins have any beneficial effect in women.

There is evidence that pressure has been applied by drug company interests to influence the results of a Cochrane Collaboration report in order to favour the use of statins (3).

It is clear that there is a very convincing prime face case that NICE is “not fit for purpose”. In particular, there is genuine concern that it is dominated by the interests of the pharmaceutical industry. Hence drugs are being recommended which have minimal benefit and therefore public money is being wasted on drugs that are ineffective. Even worse, some patients experience side effects which are not only unpleasant but can also cause serious damage to their health.

All the indications are that this is a major scandal which ought to be tackled sooner rather than later. Recent issues including Stafford Hospital, Hillsborough and Rotherham demonstrate the inertia of the authorities to take action despite numerous warning signs. There is not the slightest doubt that there is a pressing need to examine the role of NICE and its relationship with the drug industry simply because of the evidence that I have cited here. Ideally the Ministerial team at the Department of Health should act but they are probably incapable of dealing with the modern day Sir Humphreys. However these issues could well be tackled by Parliamentary Committees, which have the power to summon witnesses and cross-examine them. I would envisage that these topics would be ideal for the Public Accounts Committee, the Health Committee and the Science and Technology Committee. It would be fascinating to watch any attempt to justify the use of stains when the number to benefit is so small. Up to now these committees have been quick to jump into action once an issue has hit the headlines. However it would certainly be preferable if they did not have to wait to be prompted from outside sources.

Recently the Parliamentary Committee on Science and Technology expressed concern about the lack of transparency of the detailed results of clinical trials conducted by pharmaceutical companies to determine the effectiveness of drugs (4). In the absence of all the available original data it is not possible to make an accurate assessment of the effectiveness of any particular drug. The full implications of this have been spelled out in a recent book by Peter Gøtzsche (5). In this he describes how Pfizer had been fined $2.3 billion in the United States for promoting off label use of four drugs, while Merck had been responsible for the deaths of thousands of patients with its deceptive behaviour around a drug for arthritis.

I will be making this information available to the various Committees in the hope that this issue will be placed on their agendas. I also intend to forward this to my MP with a request that he presses for action and I hope that other readers in the UK will also pass on to their own MP.

At the very least I would expect that all information on the odds of success and the risks of adverse side-effects should be accessible to each and every patient before agreeing to treatment with any drug. If this episode is anything to go by, I suspect that most people would be very surprised at what they learn!

REFERENCES

  1. http://www.bmj.com/content/349/bmj.g4694
  2. http://www.nice.org.uk/media/877/AC/NICE_statin_letter.pdf
  3. http://vernerwheelock.com/?p=545
  4. http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/writev/clinicaltrials/clinicaltrials.pdf
  5. Peter Gøtzsche(2013). “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare Radcliffe Publishing London

114. Potential Breakthrough in South Africa

There is now overwhelming evidence that the decision to advise consumers to reduce the amount of fat and saturated fat (SFA) in the diet has turned out to be one of the most disastrous mistakes in the history of public health policy. As people implemented the recommendations it was inevitable that there was a corresponding increase in the intake of sugar and carbohydrates. This was driven by the promotion of “low fat” products, many of which were formulated by replacing the fat with sugar. In addition, there has been a phenomenal growth in the sales of soft drinks, which usually have a very high content of sugar. The changes in food consumption patterns have been accompanied by increases in the incidence of obesity, although this has tailed off a bit recently in the UK. Even more seriously, diabetes is now a major problem. Here in the UK the incidence has doubled in the past 15 years and it is expected to continue increasing. Diabetes is especially worrying because it is associate with increased risk of heart disease, cancer and Alzheimer’s Disease. The NHS in England currently spends almost £1Billion on drugs to treat diabetics, while the cost of all treatment is about £10 Billion. It is reaching the point where it is becoming unsustainable.

The solution is blindingly obvious. The cause has to be removed. Diabetes is caused by excessive levels of glucose in the blood. If the amount of sugar and starch, which is broken down to glucose, is restricted in the diet then it follows that there will be less available for absorption from the gut into the blood. The logic is irrefutable. This is fully supported by reliable scientific research and a huge number of personal case histories from individuals who have reduced their intake of sugar and refined carbohydrates. It should also be appreciated that most of this can be replaced by fats, especially the SFAs, which are valuable nutrients in their own right (1). For more details of current thinking on nutrition I can recommend “the Diet Delusion” (2) by Gary Taubes and “Big Fat Surprise” by Nina Teicholz (3).

The big hurdle is that the majority of those in the medical and public health professions are not prepared to accept this relatively “new” understanding and interpretation. The fundamental issue is that most of those in a position to initiate a U-turn have been active proponents of the existing policies which have failed so miserably. There are probably several reasons for this.

  • They have closed minds and simply cannot adjust their thinking. As a result they perform all sorts of contortions in rather pathetic attempts to justify the status quo
  • They choose to ignore the new information and the consequences
  • They just cannot face up to the fact that they have been wrong in the past and therefore presented patients and governments with advice that was faulty.

There are also very powerful business interests, including food, pharmaceuticals and weight loss which would be adversely affected if there was a big shift in policy.

At present there is little doubt that the reactionary forces hold the upper hand simply because virtually all politicians are not prepared to challenge the relevant “experts”. This may seem bizarre but it does appear they lack the ability and the confidence to do so.

However the hard reality is that we are largely dependent on the politicians to initiate action. This is why we need to watch developments in South Africa very carefully indeed.

The story starts with Professor Tim Noakes, Professor of Sports Medicine at the University of Cape Town (UCT). For most of his life he had followed the conventional dietary guidelines. He was also very active as he went running most days and had competed in over 70 marathons and ultramarathons. About 4 years ago he started to question the rationale behind the dietary he was following and promulgating to others. As a consequence he decided that the advice was fundamentally flawed and so he went through the painful process of changing his mind. His current position is explained in an interview (4). He explains the rationale in a lecture given in 2012 (5).

Within the last few weeks Tim Noakes was invited to address members of the South African Parliament , where he obviously made a significant impact(6). As a result there is already an initiative to implement some of the proposals suggested. This really is a very big step forward and it is to be hoped that sooner rather than later, there will be moves to re-formulate the public health policies in order to alter the national patterns of food consumption.

However it will not be plain sailing because there has been a backlash from other academics in UCT, who wrote a letter which condemning the stance taken by Noakes. It was signed by Prof Wim de Villiers Dean of Faculty of Health Sciences, Prof Bongani Mayosi, Head of Department of Medicine, and emeritus professor, cardiologist Dr Lionel Opie, and Dr Marjanne Senekal, associate professor and Head of Division of Human Nutrition.

Here is the letter in full:

“The apparent endorsement by Members of Parliament of South Africa of the latest fashionable diet, ‘Banting’ (‘SA’s Ticking Time-bomb’, Cape Times, 19 August 2014) and the message it sends out to the public about healthy eating, is cause for deep concern – not only regarding Parliament’s support for it as an evidenced-based ‘diet revolution’, but sadly, the long-term impact this may have on the health of the very people they have been elected to serve.

“Any diet for weight loss and maintenance should be safe and promote health in the long-term. Currently the long term safety and health benefits of low carbohydrate, high fat diets – such as Atkins, Paleo and South Beach, and in which Banting falls – are unproven, and in particular whether it is safe in pregnancy and childhood.

“Importantly, while the consumption of a low carbohydrate, high fat diet may lead to initial weight loss and associated health benefits – as indeed would a balanced weight loss diet – there is good reason for concern that this diet may rather result in nutritional deficiencies, increased risk for heart disease, diabetes mellitus, kidney problems, constipation, certain cancers and excessive iron stores in some individuals in the long term. Research leaves no doubt that healthy balanced eating is very important in reducing disease risk (see web page below dedicated to this debate).

“It is therefore a serious concern that Professor Timothy Noakes, a colleague respected for his research in sports science, is aggressively promoting this diet as a ‘revolution’, making outrageous unproven claims about disease prevention, and maligning the integrity and credibility of peers who criticise his diet for being evidence-deficient and not conforming to the tenets of good and responsible science. This goes against the University of Cape Town’s commitment to academic freedom as the prerequisite to fostering responsible and respectful intellectual debate and free enquiry.

” This is not the forum to debate details of diets, but to draw attention to the need for us to be pragmatic. Research in this field has proven time and again that the quest for lean and healthy bodies cannot be a quick-fix , ‘one- size-fits-all’ solution. The major challenge lies in establishing sustainable and healthy dietary and physical activity patterns to promote long term weight maintenance and health after weight loss, and includes addressing psychosocial, environmental and physiological factors.

“Our bodies need a range of nutrients sourced from a variety of food groups to survive. Diets like the Banting are, however, typically ‘one dimensional’ in focus. They promote increased intake of protein and fat containing foods at the expense of healthy carbohydrate containing foods, and focus on adherence to a limited food plan. Ignored are the other important factors impacting on health – like physical activity (the important of which we cannot emphasise enough), environmental factors, and individual health profiles.

“UCT’s Faculty of Health Sciences, a leading research institution in Africa, has a reputation for research excellence to uphold. Above all, our research must be socially responsible. We have therefore taken the unusual step of distancing ourselves from the proponents of this diet. To foster informed engagement of the issues related to the Diet debate, the Faculty has established a (page on its website) with material on this.”

And this is the reply:

For whatever reasons, the Faculty of Health Sciences of the University of Cape Town manages consistently to misrepresent my public message which is simply the following: a high carbohydrate diet is detrimental to the health of persons with insulin resistance whereas carbohydrate restriction in this group can be profoundly beneficial as it can reverse obesity and in some cases Type 2 diabetes mellitus, the two conditions that will ultimately bankrupt South African medical services unless we take appropriate preventive actions. This message first presented publicly in my book Challenging Beliefs in 2011, has never changed.

“It is also the message I presented to members of staff at Parliament a week ago.

“If that message is without scientific support, then the Faculty of Health Sciences has every right to cross the civil divide as it has now chosen; an action which, I suspect, is unprecedented in the history of the Faculty of Health Sciences and perhaps the history of the University of Cape Town. But if there is evidence for my position, then the Faculty is guilty of failing fully to inform its past and present science, medical and dietetics graduates in a manner appropriate for a Faculty that considers itself to be a world-leader.

” An outline of the scientific evidence for my position is presented in about 20 000 words in our book Real Meal Revolution. That work includes references to the most important scientific works (of an abundant literature) supporting my interpretation. For the Faculty of Health Sciences of the University of Cape Town consistently to deny that peer-reviewed evidence is a classic example of cognitive dissonance.”

CONCLUSION

In my opinion, the letter from the academics is totally unacceptable. To claim that that the ideas advocated by Noakes may:

“result in nutritional deficiencies, increased risk for heart disease, diabetes mellitus, kidney problems, constipation, certain cancers”

simply beggars belief. There is not a shred of evidence to support the statement. Similarly it is totally unjustified to accuse Noakes of

“outrageous unproven claims about disease prevention”.

If the authors of the report had bothered to examine the evidence, there is plenty. Wild unsubstantiated statements are the hallmarks of desperation.

There is a very little doubt that obesity, diabetes and related diseases have been caused by precisely the type of diet which the UCT academics support. The writers of the letter appear to be so committed to theories which have been totally discredited that are not prepared to consider any alternative. The fact is that they are advocating strategies which have been largely responsible for the current disaster in public health. They would do well to note the conclusion of Albert Einstein who defined insanity as doing the same thing over and over again and expecting a different result!

It is to be hoped that the South African politicians stick to their guns and adopt the Noakes approach to construct a completely new public health policy. This would undoubtedly produce enormous benefits for the country with huge improvements in the health of the population, which must pay off in the economy. There would also be savings in health expenditure.

Finally South Africa would establish itself as the world leader in health policy innovation, which ought to trigger similar initiatives in many other countries.

REFERENCES

  1. http://vernerwheelock.com/?p=155
  2. Gary Taubes (2007) “The Diet Delusion” Vermillion: London
  3. Nina Teicholz (2014) “The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet” Simon & Shuster New York
  4. http://www.biznews.com/health-biznews-com/2014/07/tim-noakes-makes-real-meal-critics-say-diet-dangerous/
  5. https://www.youtube.com/watch?v=5IYVIdztWWs#t=31
  6. http://www.iol.co.za/news/politics/sa-s-ticking-time-bomb-1.1737511

 

 

113. Can We Trust the Drug Companies?

The banking industry quite rightly suffers from public opprobrium because of its role in the financial crisis, manipulation of the bank rate and mis-selling of various products. By contrast the pharmaceutical industry is somewhat more highly regarded. Nevertheless recent examples of unethical behaviour indicate that the approach to business in this sector does not exactly embrace the highest principles of corporate social responsibility.

I have just discovered a website which provides reliable evidence on how this industry operates (1). In this blog I will refer to a number of issues which have arisen in recent years.

  • In an undercover investigation, initiated by a tip-off from a whistleblower, The Daily Telegraph discovered that pharmaceutical firms appear to have rigged the market in so-called “specials”. These are prescription drugs that are largely not covered by national NHS price regulations. Secret recordings by Telegraph reporters showed that sales representatives for drug firms offered to provide apparently falsified invoices allowing chemists to bill the NHS for sums far greater than they would spend. Hence the retailers would be able to send inflated invoices to the NHS, allowing them to pocket the difference. As a consequence it was estimated that hundreds of millions of pounds of public money has probably been wasted in recent years due to the practice (2).
  • In a Newsweek investigation, reporter Sharon Begley concludes that the framework of medical research is fundamentally flawed so that the wrong answers are being produced time and time again (3). According to John Ioannidis, who is in charge of the Prevention Research Center at Stanford University people are being hurt and dying because of false medical claims which are based faulty research.
  • In a recent blog I have described in detail how pressure was applied to the respected Cochrane Collaboration to influence the conclusions of an evaluation of statins (4). Two professors from the University of Oxford persuaded the compilers of the report to reach a conclusion favourable to statins, based on data produced by pharmaceutical companies, which was not open to independent scrutiny. Other evaluations have concluded that there is no net benefit from statins when used for primary prevention. Despite this NICE has made recommendations which effectively mean that everyone over 50 will be offered statins. Even NICE accepts that 77 people will have to treated in order that one will benefit! In the USA alone the expenditure on statins is more than $20 billion per year, much of which is probably unnecessary.
  • There are many examples of “breakthroughs” which turn out to worthless when subjected to further examination. Various studies which concluded that popular antidepressants work by altering brain chemistry have now been contradicted. A study done in 1996 which concluded that estrogen therapy reduces older women’s risk of Alzheimer’s was overturned in 2004.
  • Richard Smith, a former editor of the British Medical Journal (BMJ) is convinced that fraudulent research regularly appears in the 30,000 scientific journals currently published throughout the world. Furthermore even when fabricated or falsified research is discovered, journals rarely publish a retraction. Dr Smith is critical of the failure of scientific institutions, including universities, to discipline dodgy researchers even when alerted to problems by journals. Most cases are not publicised. Few countries have measures in place to ensure research is carried out ethically. In practice such incidents are simply not recognised, covered up altogether or the guilty researcher is urged to retrain, move to another institution or retire from research (5).
  • Ben Goldacre trained as a medical doctor and is the author of the “Bad Science” column in The Guardian. In his book “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” he describes how he ended up prescribing the antidepressant reboxetine to his patients based on insufficient data. Despite the fact that there is overwhelming research which shows that the drug is ineffective, it was still approved in the U.K. In order to get approval of the drug in Europe, the manufacturer had simply kept quiet about its negative data. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had shown a positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. Goldacre had no idea they existed. It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this showed that patients on reboxetine did worse than those on other drugs. He goes on to describe how drug companies hide data about medication risks that affect children, how they attempt to intimidate the employers of researchers who produce results they don’t like, and how they routinely withhold safety data in various other ways that do harm to patients (5).The fundamental problem is that the regulatory bodies, which we would reasonably expect to stamp out such practices have failed us. Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. There is good evidence to demonstrate that the results of research funded by drug companies are highly likely to favour the manufacturer. On the other hand if the results are not favourable then there is absolutely no obligation to make these public. Consequently doctors and patients, only ever see a distorted picture of true effects of any particular drug. In view of the fact that the drug companies are the main source of information to the medical profession this is the picture which becomes widely disseminated. This is reinforced by the fact that the same messages are promulgated through the scientific journals. Although these are usually regarded as objective the reality is that are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by a single drug company (6).

REFERENCES

  1. http://www.wanttoknow.info/pharmaceuticalcorruptionmediaarticles-0-20
  2. http://www.telegraph.co.uk/health/healthnews/10133557/Pharmaceutical-scandal
  3. http://www.thedailybeast.com/newsweek/2011/01/23/why-almost-everything-you-hear-about-medicine-is-wrong.html
  4. http://vernerwheelock.com/?p=545
  5. http://www.theguardian.com/society/2006/may/03/health.medicineandhealth
  6. http://healthland.time.com/2012/09/24/a-doctors-dilemma-when-crucial-new-drug-data-is-hidden/

 

 

 

112. Diabetes can be Cured: Change the Diet and Ditch the Drugs

As a society we seem to have been conditioned to expect that treatment with drugs and other medical procedures are the answer to every form of ill-health. Many of us feel short-changed if we come away from a visit to the GP without a subscription for one or more medicines. However the hard reality is that the NHS expenditure on drugs continues to increase. During 2013-2014 there were 45.1 million items prescribed for diabetes, with a net ingredient cost of £803.1million (1). This represents an increase of 66.5% in the number of items and 56.3% in the net ingredient cost since 2005-2006. In England it is estimated that 6% of the population has diabetes and the total cost is currently about £10billion, which is 10% of the NHS budget (2). It is estimated that by 2025 there will be 5 million people with diabetes in England (3). Those with diabetes have a reduced life expectancy and an increased risk of retinopathy, stroke, kidney failure, heart disease and amputation of limbs.

A man diagnosed with diabetes at age 40 will lose almost 12 years of life and 19 Quality Adjusted Life Years (QALYs) compared with a person without diabetes. A woman of the same age will lose about 14 years of life and 22 QALYs (4).

Unfortunately at present there is little success in controlling the disease. In the light of the current projections, it would seem that there is little confidence that there will be any improvement in the immediate future. Screening for diabetes does not seem to be effective. In a large study conducted in the East of England it was found that screening of patients with increased risk of diabetes was not associated with any reduction in all-cause, cardiovascular, or diabetes-related mortality over a 10-year period (5). There are also serious questions about the effectiveness of treatments of diabetes to lower the blood glucose. In a meta-analysis of data from 13 randomized controlled trials there was no benefit from intensive glucose lowering in terms of all-cause mortality or deaths from cardiovascular disease. in adults with diabetes (6). Furthermore, an increase in all-cause mortality of 19% cannot be ruled out. Only one study showed a protective effect on myocardial infarction but this was counterbalanced by an increase in total mortality. The authors pointed out that drugs for the treatment of diabetes are being approved on the basis of their effectiveness in lowering blood glucose, despite the fact that there is no evidence based on clinically relevant criteria.

The fundamental problem is that the key to overcoming any disease is to identify the root cause and take appropriate steps to eliminate it. In practice, this is rarely done and most of us blithely accept that even though we continue doing whatever caused the disease, it can be overcome by treatment with drugs. The reality is that the best that be achieved with drugs is some alleviation of the symptoms. Even if a “cure” is achieved, the likelihood is that the disease will recur unless the cause is removed. This is very aptly illustrated by the experience of David Servan-Schreiber, who was clinical professor of psychiatry at the University of Pittsburgh School of Medicine (7,8). At the age of 31 he was diagnosed with a brain cancer. A tumour was successfully removed by surgery. He persistently asked the cancer specialists what advice they could give him to prevent the development of another tumour. Much to his surprise they had absolutely no suggestions to offer and even worse they seemed to have no interest. This encouraged him to do his own investigations and in his book (7) he describes what he found out. Much of this related to his lifestyle. As a consequence he made a series of changes, including a complete transformation to his diet. With brain cancer the life expectancy is 2-3 years but Servan-Schreiber managed to survive for another 20 years. Had he just accepted the advice of the medical profession, it is highly unlikely he would have lived for so long.

I cannot over-emphasise the crucial importance of this episode. There must be literally millions of people here in the UK who would benefit from advice on how to avoid diseases and how cures could be achieved by making changes to lifestyle.

Type 2 diabetes (T2D) is responsible for the increased incidence referred to above. There is ample evidence that it can be controlled, possibly even cured completely by making changes to the diet. The condition is directly due to the increased level of glucose in the blood. As a result the pancreas has to produce insulin to keep prevent excess glucose in the body. Excess insulin damages many of the organs, which can eventually lead to a range of diseases. If there is excessive glucose over a prolonged period the pancreas is unable to cope and the glucose becomes rampant, causing all sorts of damage. The solution is obvious. Reduce the amount of glucose which enters the body by altering the diet. Sugar is one of the main culprits, so it should be avoided like the plague. In addition starch is broken down to produce glucose. This means that foods such as refined flour, rice or pasta should be limited because the starch is released quickly giving rise to big increases in the blood glucose.

Essentially this means a diet which is low in carbohydrates (LC). The big problem is that the official advice is to increase carbohydrates. There is a strong possibility that those diagnosed with T2D will be advised to replace fat with carbohydrates. This is fundamentally wrong! The recommendation to reduce fat and especially saturated fat (SFA) does not stand up to rigorous examination. In fact, many of the individual SFAs are important nutrients (9). So what we should be doing is limiting the carbohydrates and consuming plenty of fats. Obviously avoid the trans fats which may be present in manufactured products and are being eliminated by the industry anyway. Despite the marketing claims that polyunsaturates (PUFAs) are good for you because they ”lower cholesterol” I certainly do not recommend them (see 9).

There is now a very convincing case that diets which are low in carbohydrates and high in fat (LCHF) can overcome many of the common chronic diseases. With respect to T2D, there is growing body of scientific research showing that this type of diet is extremely effective in lowering blood glucose and effectively curing T2D provided the LC intake is maintained (10). There are also numerous case studies of individuals who have successfully overcome T2D by making these changes to their diets 11,12).

CONCLUSION

First of all it is essential that all those diagnosed with T2D should be advised to make changes to their diets so that they are LCHF. It is an absolute disgrace that at present they will probably advised to eat more carbohydrates. In any event, the use of drugs should only be used as a last resort or better still not used at all, as there is a lack of evidence that they will be effective.

Even more important is that the official dietary guidelines must be revamped. It is a matter of great concern that we are still being advised to reduce the fat/SFA.

It just does not make sense to carry on as we are at present. The incidence of the disease is getting worse and the costs are increasing. It is becoming unsustainable. We have the answers, all that is needed is that we apply our existing knowledge and the benefits would be enormous.

REFERENCES

  1. http://www.hscic.gov.uk/catalogue/PUB14681/pres-diab-eng-200506-201314-rep.pdf
  2. http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf
  3. http://www.diabetes.org.uk/Documents/Reports/State-of-the-Nation-2012.pdf      
  4. http://jama.jamanetwork.com/article.aspx?articleid=197439
  5. Rebecca K Simmons et al (2012) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61422-6/fulltext
  6. Remy Boussageon et al (2011) http://www.bmj.com/content/343/bmj.d4169.pdf%2Bhtml
  7. D Servan-Schreiber(2011) “Anticancer: a new way of life” Penguin Health ISBN 978-0-718-15684-8
  8.  http://vernerwheelock.com/?p=279
  9. http://vernerwheelock.com/?p=153
  10.    http://vernerwheelock.com/?p=226
  11.  http://vernerwheelock.com/?p=229
  12.   http://vernerwheelock.com/?p=405

 

 

 

111. The Institute of Economic Affairs (IEA) Report on Obesity

The IEA has just published a report which concludes that:

“The rise in obesity has been primarily caused by a decline in physical activity at home and in the workplace, not an increase in sugar, fat or calorie consumption” (1).

The report relies mainly on official statistics but is also heavily dependent on the conventional view that obesity is the result of consuming more calories than are expended. Despite the fact that this concept is the basis of official policies in the UK and in many other countries and organisations there are compelling reasons why it is fundamentally flawed. In this blog I will explain why it is not calories per se but sugar/refined carbohydrates, which is the fundamental cause of obesity. In addition I will assess the quality of the information presented on how the consumption of sugar has changed over the past 30-40 years.

The author Christopher Snowdon concludes that the evidence shows that in Britain the per capita consumption of sugar, salt, fat and calories has been falling for decades. In particular, sugar consumption has fallen by 16 per cent since 1992 while calorie consumption has fallen by 21 per cent since 1974.

QUALITY OF THE DATA

The main sources of information are the National Food Survey (NFS) up to 2000, when it was replaced by the Family Food survey. Because these 2 surveys each have different basis, it is not possible to obtain a continuous tracking of the changes. It was not until 1993 that obesity statistics were commenced. Although there has been a steady increase in the incidence of obesity in adults since then the pattern in children is rather different. The information was first collected in 1995 and then there was a peak about 2004 and the decline in recent years has reduced the incidence in 2012 to almost the same level as in 1993.

Although the NFS has limitations it is probably fair to conclude that it does provide a reasonably reliable indicator of trends. This certainly applies to total calories which declined from 2210 in 1980 to 1750 in 2000. The NFS also showed declines in total fat from 106g in1980 to74 in 2000. The corresponding values for total carbohydrate, which of course includes sugar were 264 and 218. The author of the IEA report presents a graph which shows that “sugar” has declined between 1992 and 2012. Presumably the data for the period up to 2000 is from the NFS. I have gone back to the original, which makes it clear that the calculations for the intake of nutrients does not include information on soft drinks and alcoholic drinks and confectionery. All of these contain sugar and if an accurate assessment of the trend is to be determined it is essential that allowance is made for the contribution from these sources. I have also been in touch with the team which is responsible for the food statistics, which has confirmed that there is no reliable information available on the intake of sugars prior to 2000

The difficulties of estimating the intake of sugar are exacerbated by the fact that it is present as an ingredient of many different processed foods, because it is inexpensive and makes foods attractive to the palate. Many of the “low fat” variations of foods are actually formulated by removing the fat and replacing it with sugar. Yoghurts are a typical example. In order to calculate the total intake for the population it is necessary to know the volume of sales and the exact nutrient composition of each particular food. It is a huge and difficult task to do this properly. In Australia the bureau of Statistics simply decided to abandon attempts to produce a reliable value because it was too difficult (and expensive!). Although the UK attempts to deal with this problem, the complexity of the food market and the rapid rate of change mean that it is virtually impossible to obtain reliable information

To sum up, in all probability there has been a substantial drop in the consumption of calories and possibly also in fat. However when it comes to sugar, reliable information is hard to obtain but we can be confident that there is absolutely no credible evidence that there has been a decline in the consumption of sugar. In the light of the substantial increase in the amounts of soft drinks sold, coupled with the growth of sugar-containing processed foods, there are strong indications that total sugar consumption has increased steadily in the period up to 2000.

In recent years, some people are actively cutting down on their sugar consumption, which could mean that for a sector of the population sugar consumption could continue to increase even though the amount for the population as a whole remained constant.

Finally we have to place this in the context of what we know about nutrition. Although many still hold to the view that obesity is caused by consuming more calories than are expended, this has been subject to severe criticism. An excellent example is the work of Zoe Harcombe in her book  “The Oesity Epidemic”(2). For example it has been shown that weight loss by calorie reduction simply does not work (3).Invariably this involves a reduction in fat, which can actually result in an increase in the amount of carbohydrates consumed. Furthermore there is convincing evidence that it is sugar and the refined carbohydrates which are the fundamental cause of obesity (4).In particular, there are compelling studies showing that it is the composition of the diet, which is crucial for obesity to occur. Specifically diets which are high in sugar/refined carbohydrates predispose not only to obesity but also to diabetes, heart disease, various cancers and Alzheimer’s Disease. Conversely, there is now a body of knowledge which demonstrates that diets which are low in carbohydrates and high in fat (LCHF) can be beneficial with respect to a range of diseases/conditions(5). These include heart disease, blood pressure, cancers, body weight and overcoming Type 2 Diabetes.

It follows from this that the crucial issue is the intake of sugar and refined carbohydrates. As I have explained above the Information on sugar is not reliable. The case presented by Christopher Snowdon does not stand up to scrutiny. There is no “English Paradox”. In any event, it is not obesity per se that should be a matter of concern with respect to public health. Much more critical is the growing incidence of diabetes, which has doubled in the past 15 years or so (4). There is absolutely no doubt that this is caused by excessive consumption of sugar and refined carbohydrates.

This report has rather uncanny parallels with what has been happening in Australia, where 2 academics from the University of Sydney have claimed that there is an “Australian Paradox “(6). This was based on a conclusion that the consumption of sugar had declined over the same period that obesity had been increasing. This was disputed by an economist Rory Robertson, who showed convincingly that there was no credible data to demonstrate how the consumption of sugar had changed over the relevant period. He concluded that:

All in all, we are left with a clear sense that there is no “Australian Paradox”, just an idiosyncratic and unreasonable assessment – and avoidance – of the available sugar data by those who coined the phrase” (7).

Because of this he forced the university to set up an inquiry into the activities of the academics with respect to manipulation of the data. The results of the inquiry have recently been announced. Although Christopher Snowdon has claimed that the academics were exonerated, the reality is that the findings were somewhat unequivocal.

Although the adjudicator dismissed the allegations about “research misconduct” it was clear that he was not impressed by the quality of the original “Australian Paradox” paper. He concluded that the paper was not tightly written and contained a number of arithmetic errors. He expressed the view that important new findings would usually be published in a high-impact, rigorously peer-reviewed journal. Subsequently the results would be considered in special edition publications of conference journal format. Clearly this had not been done as the original was published in what was regarded as a ‘soft’ journal, where the quality controls are less stringent. As a consequence it was recommended that a new one be prepared which specifically addresses the key factual issues raised in the inquiry. Furthermore this paper should be written in a constructive manner which respects the issues relating to the quality and reliability of data, raised by Rory Robertson (8).

However, from a close reading of the report it is obvious that there really has been no attempt to deal with many of the serious allegations made by Rory and that effectively it is a rather poor attempt at a “whitewash” (9). A further detailed submission has been prepared by Rory and it is to be hoped that ultimately the issue will be addressed properly (10).

CONCLUSION

So it is evident that this report by IEA does not make any useful contribution to our understanding of the causes of obesity and should be ignored. The fact remains that sugar and refined carbohydrates lie at the root of many of the public health problems not only in the UK but right across the globe.

REFERENCES

  1. http://www.iea.org.uk/sites/default/files/in-the-media/files/Briefing_The%20Fat%20Lie.pdf
  2. Zoe Harcombe (2010) “The Obesity Epidemic” Columbus
  3. http://vernerwheelock.com/?p=221
  4. http://vernerwheelock.com/?p=158
  5. http://www.nutritionjrnl.com/article/S0899-9007(14)00332-3/fulltext
  6. http://vernerwheelock.com/?p=510
  7. http://www.australianparadox.com/pdf/DitchingSugar27032012.pdf
  8. http://vernerwheelock.com/?p=513
  9. http://vernerwheelock.com/?p=517
  10. http://www.australianparadox.com/pdf/RR-response-to-inquiry-report.pdf