Prescription Drugs: How safe are they?

Many of us take less trouble researching prescription drugs than we would buying a new TV. When it comes to your health doing some research will help you know if you are taking the right drugs and if they really work for your ailments.

Doctors can answer differently too. Following concerns about one drug in the States, the number of prescriptions halved within a year. Here in the UK, however, where far less coverage was given to the problem, prescription numbers actually went up. Because Americans do have to pay for their drugs, the amount of information available over there from sources like Congressional hearings and court cases is much greater. So here are some recent findings about five commonly prescribed types of drugs that you probably won’t be told about and you might want to consider when weighing up whether to go down the drugs or the nutritional route.

Diabetes drugs – Avandia (rosiglitazone) Avandia is one of a class known as thiazolidinediones that has a history of problems, including weight gain, heart problems and liver failure. The other is Actos (pioglitazone). About 2 million prescriptions are made out for these drugs in England every year. Doctors are keen on them because they are effective at controlling blood sugar, but at what cost?

Eighteen months ago a study found that Avandia raised the risk of heart disease. [1] A few months later, another found it increased heart attacks but not the chances of dying from one. [2] In the States, as a result, Avandia prescriptions dived sharply. In the UK, however, the drugs watchdog – the Medicines and Healthcare products Regulatory Agency (MHRA) – asserted that all was well and prescriptions have actually risen. Further studies didn’t always find the risk. However, some local bodies have come out against Avandia, including the UK Midlands Therapeutics Review and Advisory Committee (MTRAC) who don’t recommend either Avandia or Actos,[3] consultants in the Greater Glasgow and Clyde area are not giving Avandia to any new patients,[4] and the National Institute for Health and Clinical Excellence (NICE), which offers guidance to healthcare professionals, has warned about the increased heart attack risk. [5] And in the last few months, two more serious problems with Avandia have been identified – liver failure and bone fracture.

The excellent American consumer watchdog Public Citizen has called for the drug’s withdrawal after identifying 14 cases of liver failure on the official FDA Adverse Events Reporting System (AERS) database.[6] Then a study found that use of thiazolidinediones for more than one year can double the risk of bone fractures in women – that’s on top of the raised risk of fractures that comes with diabetes anyway.[7] Despite all this, the most recent advice available on the DiabetesUK website dates from July 2007 and says that thiazolidinediones “are a safe and effective treatment for Type 2 diabetes”. If you’d like to find out more about the nutritional approach see the Special Report ‘Preventing and Reversing Diabetes’ on my website (log on to the Advice section to access).

Cholesterol-lowering drugs – Statins
The official line is that virtually everyone over 50 should be on these drugs to lower their cholesterol and protect against heart attacks. However, what you are rarely told is just how tiny their benefit is, if you haven’t had a heart attack already. Take the latest big trial known as Jupiter, which was reported as if it was a great success. It found that the statin Crestor reduced the risk of heart attack and strokes by 50% over two years. However, the actual figures are less impressive: 37 people out of 10,000 on a placebo had a heart attack or stroke versus 17 out of 10,000 on a statin. Twenty fewer attacks among 10,000 people means that 500 people (10,000/20) need to take a statin daily for two years to prevent one event.[8]

The most favourable other studies report benefits of 1/100. Then there are the side-effects. Muscle weakness is a well known one, although there is a big disagreement about how many are affected. A recent paper suggests as many as 9% experience it;[9] supporters claim it is a few as 1/1000. But the Jupiter trial threw up a risk that is much less commonly mentioned – diabetes. While 216 people on a placebo developed diabetes, 270 did in the statin group – an increased risk of 61 in 10,000. That is indeed small but it is greater than your chance of avoiding a heart attack! So perhaps not such a good bet.[10] And there are other reasons for caution with statins. Makers of the best-selling statin Lipitor are currently being sued on the grounds there is no evidence it prevents heart attacks in women.[11] The special feature of the Jupiter trial was that it wasn’t testing for cholesterol-lowering – what statins are known to do – but for reducing a marker for inflammation known as CRP (C-reactive protein) which has been linked with heart disease risk. But if reducing inflammatory markers is your aim, then many nutritional supplements can do the same, without the risk of harmful side effects such as diabetes or muscle pains. For instance, a randomised trial involving 160 healthy men and women who were smokers found a 25% reduction in CRP levels with 515mg a day of vitamin C. [12] Another study comparing 602 people who took high levels of a number of supplements had greatly improved CRP levels compared to those who took a single supplement or none.[13] If you’d like to find out more about the nutritional approach to reducing cholesterol, read the Special Report ‘What To Do If You Have High Cholesterol’ on my website.

Painkillers – aspirin and the NSAIDS Almost everyone takes an aspirin or some other NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen occasionally with little chance of harm. But used chronically for such conditions as arthritis and joint pain they are famously linked with an increased risk of bleeding and damage to the small intestine.[14] American figures estimate this causes 103,000 hospitalisations and 16,500 deaths.[15] Even so NSAIDS are widely used long term – 70% of people over the age of 65 take them at least once a week and nearly half of those take seven doses or more per week.[16] But for reducing arthritic knee pain for longer than a few weeks they are little better than a placebo.[17]

The gastrointestinal damage from NSAIDS led to the development of a new version – cox-2 inhibitors – the most infamous of which was Vioxx. This was withdrawn in 2004 because it doubled the risk of heart attack; it caused between 88,000 and 160,000 in the US alone.[18] Two other painkillers of the same type – Arcoxia (etoricoxib) and Celebrex (Celecoxib) – are both still on the market in the UK. The continued used of Arcoxia here (NHS spend is £11 million and rising) is remarkable in light of the FDA decision in 2007 not to license it. By a vote of 20-1, a committee rejected it because it could cause as many as 30,000 heart attacks a year, and caused nearly three times as many heart attacks, strokes and deaths as a cheap NSAID called Naproxen.[19]

In fact, apart from Naproxen, the risk of heart disease turns out to be about the same for cox-2 inhibitors and NSAIDS.[20] If you’d like to find out about the nutritional approach, read the Special Report ‘Natural Painkillers’ on my website. Excess stomach acidity – proton pump inhibitors The regular medical solution to the gut damage caused by long-term use of NSAIDS is to prescribe PPI drugs (proton pump inhibitors) which reduce the amount of acid in the stomach.[21] These drugs are also widely used for stomach ulcers, indigestion and heartburn; the NHS spends about half a billion pounds on them annually. Unfortunately, much of that is a waste of money because these drugs are heavily over-prescribed. In fact between 25% and 70% of those prescriptions have no medical basis.[22] This isn’t just a waste; it also exposes patients to the inevitable serious side effects which include pneumonia, osteoporosis and kidney disease.

Using a PPI for more than 12 months increases your risk of a fractured hip by 44%; taking a high dose more than doubles the risk.[23] The reason is probably because lower acid interferes with calcium absorption. These drugs may also increase your risk of being infected by the superbug C.difficult if you go into hospital because a normal amount of stomach acid kills it off.[24] Instead of using PPIs, patients should avoid alcohol, smoking, wearing tight clothing around the abdomen and eating certain foods (eg fatty foods, onions, caffeine, peppermint and chocolate) that trigger the condition. In addition, it is best to avoid food, and particularly alcohol, two or three hours before bedtime. When sleeping, elevate the head of the bed about six inches or sleep with extra pillows. For more on PPI, see this reference.[25]

To find out more about how to improve your digestion, see the November 2008 issue of 100%health. Tranquillising drugs – Antipyschotics Antipyschotic drugs are powerful tranquillisers with a nasty range of side effects including dramatic weight gain, involuntary or repetitive movements, very low blood pressure, lethargy, seizures, and intense dreams or nightmares. Patients are also at raised risk for diabetes and premature death. They are only licensed for treatment of psychosis and serious psychiatric disorders such as schizophrenia. Despite this they are among the most commonly prescribed drugs because in recent years, they have been increasingly given to elderly patients with dementia and children with behavioural disorders. The manufacturers are also pushing for them to be given as antidepressants. Over 60% of their use is what’s called ‘off-label’ prescribing, meaning the use isn’t backed up by proper evidence.[26] They are not specialist drugs; if you or a relative is at risk for Alzheimer’s or you have a child with psychological problems, you could be offered them by your GP. They are prescribed to around 200,000 elderly people in England every year. So there are a few points that it is worth knowing about them.

In January 2009, the company making one of the best-selling antipsychotic drugs – Zyprexa (olanzepine) – was fined a record $1.4 billion in America for illegally promoting the drug for uses it didn’t have a licence for, ie for the likes of children and old people.[27] This came on top of a payment of $1.7 billion two years earlier to settle 46,500 American lawsuits brought by people whose health was damaged by Zyprexa. Internal company documents revealed in court show that Eli Lilly had known of the health risks but had waited ten years before putting a strong warning on the label.[28] The number of side-effects ‘officially’ reported for Zyprexa in the UK is tiny. What makes this mis-selling and distorting of the evidence base much worse is that there is no evidence that these drugs actually help the elderly demented patients but they do make them die sooner.[29] For years psychiatrists claimed that the newer version of these drugs, known as ‘atypicals’, were safer and had fewer side effects. But Zyprexa is an atypical, and several large studies have found little difference between the two.[30] Despite this litany of failures and dangers, the NHS spends over £250 million a year on antipsychotics – more than £100 million of that on Zyprexa alone.

If you’d like to find out more about the nutritional approach to alleviating anxiety and treating mental health problems, read The New Optimum Nutrition for the Mind or visit the Brain Bio Centre.

References

1. SE Nissen & K Wolski, Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, New England Journal of Medicine (2007), vol 356(24), pp 2457-71.

2. S Singh, YK Loke, CD Furberg, Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis, Journal of the American Medical Association (2007), vol 298(10), pp1189-95.

3. www.keele.ac.uk/schools/pharm/MTRAC/Latest/documents/newsletterDec08.doc

4. Lyndsay Moss and Marisa de Andrade, Doctors demand freeze on use of diabetes drug for heart patients, The Scotsman, 7 April 2008.

5. Lilian Anekwe, Rosiglitazone risk highlighted in new NICE guidance, Pulse 10 Oct 08 (www.pulsetoday.co.uk)

6. www.worstpills.org/results.cfm?drug_id=797

7. YK Loke, S Singh, CD Furberg, Long-term use of thiazolidinediones and fractures in type 2 diabetes: systematic review and meta-analysis, Canadian Medical Association Journal (2009), vol 180, pp 32-39.

8. www.orthomolecular.org/resources/omns/v04n22.shtml

9. A Thalacker-Mercer et al, Simvastatin Reduces Human Primary Satellite Cell Proliferation in Culture, presented at the American Physiological Society (www.The-APS.org) conference, The Integrative Biology of Exercise, September 24-27, 2008.

10. For the full version of the trial and 400 plus comments, many critical, see www.nejm.org 9 November 2008 (10.1056/ NEJMe0808320) This site requires a subscription or pay-per-view.

11. R Dobson, Atorvastatin advertising misled over benefits for women, study claims, British Medical Journal (2008), vol 337, pp a2209.

12. G Block, C Jensen et al, Plasma C-reactive protein concentrations in active and passive smokers: influence of antioxidant supplementation, Journal of the American College of Nutrition (2004), vol 23(2), pp 141-7.

13. G Block, et al, Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study, The Nutrition Journal (2007), vol 6, pp 30. Open access available at www.nutritionj.com/content/pdf/1475-2891-6-30.pdf

14. DY Graham, AR Opekun et al, Visible small-intestinal mucosal injury in chronic NSAID users, Clinical Gastroenterology and Hepatology (2005), vol 3(1), pp 55-9.

15. Press release: Study shows long-term use of NSAIDs causes severe intestinal damage, American Gastroenterological Association, 3 January 2005.

16. Press release issued by Annual Digestive Disease Week, 16 May 2005, referring to a study later published as JL Goldstein, JF Johanson et al, Healing of gastric ulcers with esomeprazole versus ranitidine in patients who continued to receive NSAID therapy: a randomized trial, American Journal of Gastroenterology (2005), vol 100(12), pp 2650-7.

17. N Jan Magnus Bjordal et al, Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials, British Medical Journal (2004), vol 329, pp 1317

18. DJ Graham, Testimony to the Senate Finance Committee, 18 November 2004, www.senate.gov/~finance/sitepages/ hearing111804.htm

19. Gardiner Harris, FDA Panel Rejects Merck Pain Pill in 20-1 Vote, New York Times, 12 April 2007.

20. S Schneeweiss, DH Solomon et al, Simultaneous assessment of short-term gastrointestinal benefits and cardiovascular risks of selective cyclooxygenase 2 inhibitors and non-selective non-steroidal anti-inflammatory drugs: an instrumental variable analysis, Arthritis & Rheumatism (2006), vol 54(11), pp 3390-8.

21. F Ka Leung Chan, V Wai Sun Wong, Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial, The Lancet (2007), vol 369 (9573), pp 1621-1626.

22. Editorial: Overprescribing proton pump inhibitors, British Medical Journal (2008), vol 336, pp 2-3.

23. MD Yu-Xiao Yang, JD Lewis et al, Long-term proton pump inhibitor therapy and risk of hip fracture, Journal of the American Medical Association (2006), vol 296, pp 2947-2953.

24. R Cunningham, Is over-use of proton pump inhibitors fuelling the current epidemic of Clostridium difficile-associated diarrhoea? Journal of Hospital Infection (2008), vol 70 (1), pp 1-6.

25. For more information see ‘Avoiding Overuse of Proton Pump Inhibitors (PPIs)’, Worst Pills Best Pills Newsletter, March 2008 available at www.worstpills.org. This is a subscription site linked to Public Citizen.

26. DC Radley, SN Finkelstein RS Stafford, Off-label prescribing among office-based physicians, Archives of Internal Medicine (2006), vol 66, pp 1021-1026.

27. Z Kmietowicz, Eli Lilly pays record $1.4bn for promoting off-label use of olanzapine, British Medical Journal (2009), vol 338, pp b217.

28. A Berenson, Lilly waited too long to warn about schizophrenia drug, doctor testifies, New York Times, 8 March 2008.

29. SS Gill, SE Bronskill, SL Normand et al, Antipsychotic drug use and mortality in older adults with dementia, Annals of Internal Medicine (2007), vol 146 (11), pp 775-86.

30. PB Jones, T Barnes et al, Randomized controlled trial of the effect on quality of life of second – vs first-generation antipsychotic drugs in schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1), Archives of General Psychiatry (2006), vol 63, pp 1079-1087.

I trust this helps you towards better health. Don’t forget, as a 100%health member you can have FREE access to an extensive range of Special Reports online at www.patrickholford.com Books To learn more about drug safety and nutritional alternatives, read Food is Better Medicine Than Drugs. Supplements and Tests To find out about high-quality supplements, tests and health products to support you on your journey to 100% health, call freephone 0800 085 7749 or visit www.totallynourish.com