SuperBowser
Smash Lord
This topic is inspired by the debate in current events. This is a topic everybody can probably learn something new because it is so vast.
I wrote a related essay a while ago and figured it could form a good grounding for this topic. I wrote this whole essay during an all-nighter (the best way to work!) so please forgive any glaring errors. I don't actually have strong opinions on this subject. The object of the essay was to produce a newspaper article; I chose to take a cynical stance because it was more interesting to write. Depending on responses I could argue either way.
While I speak of the NHS, I think many of these problems are applicable to other healthcare systems. I left some issues out due to a strict word count. You guys may mention them so I won't speak further for now. Feel free to scroll to the bottom if you are lazy.
Does the National Healthcare System need new drugs? The natural response to such a question may be a resounding “yes”. After all, the United Kingdom has one of greatest healthcare systems in the world; it is only natural we seek the best medicines for our population. However, when we explore a little deeper than the surface, the waters become murky. In this article I put forward opposing viewpoints and challenge the current system.
The pharmaceutical industry maintains a strong advertising presence. We associate this industry and newly developed drugs with words like “innovative”, “research and development” and “essential”. We are reassured the premium costs the NHS pay are justified by these drugs’ ability to lengthen life, enhance quality of life or prevent more expensive medical procedures. Simply put, the pharmaceutical industry would have us believe we get what we pay for. How true is any of this?
Well the pharmaceutical industry certainly is expensive, accounting for over 20% of the NHS budget.1 In 2008 the National Audit Office found we spend an astounding £8.2 billion a year on prescriptions compared to £4 billion a decade ago. Expenditure on primary care drugs has increased by 60 per cent in real terms. Further growth is expected due to an ageing population, continued development of new drugs and identification of new applications for existing drugs.2 Such alarming rises in costs are unsustainable and restrictions in drugs funding will be inevitable.3
The pharmaceutical industry may attribute rising prices to increasing research and development (R&D) costs and the associated risks they so benevolently shoulder upon themselves. Yet this industry has consistently been one of the most profitable sectors in the U.S. for two decades, questioning how much ‘risk’ really exists.4 R&D budgets are dwarfed by the vast marketing and administration expenditures within companies and even more so by profits.5 When studies observe little relationship between the costs of making a drug and the prices paid we should be wary of why expenditure on new drugs continue rising.5 Within the current economic climate, it is difficult to justify the NHS paying ever exorbitant prices to an industry posting record-breaking profits each year – unless these drugs are actually worth it.
Despite a belief we receive cutting-edge drugs, the pharmaceutical industry does not appear “innovative” at all. Influential new drugs are usually based on taxpayer-funded research through academic institutions, small biotechnology companies or the National Institute of Health (NIH);6 45 of the top 50 selling drugs in the U.S. from 1992-1997 received government funding at some phase of their development. It is therefore not rare for pharmaceutical companies to be spared financial risk.6 When left to themselves, pharmaceutical companies inundate the market with “me-too” drugs instead. These medications are mere minor molecular variations of already existing drugs. Over the period of 1998-2003, 68% of new drugs approved by the U.S. Food and Drugs Administration (FDA) were not even new compounds, they were simply formulations or combinations of old ones.7 A huge portion of R&D costs lie here rather than in genuine innovation. Dr Sharon Levine, associate executive director of the Kaiser Permanente Medical Group succinctly summarised the situation:
Copycat drugs are produced for two primary reasons, neither of which benefit the NHS: for a company to hold on to a market where their original patent expires or for a new company to enter the same market. Some retort the pharmaceutical industry is unfairly demonised. They argue such competition in the free market drives prices down and options are valuable because when drug A does not work for a patient, drug B might. However, evidence does not support such claims. When a “me-too” drug enters the market the original rarely drops in price, nor is it marketed as a cheaper alternative.9 There are countless documented examples where copycat drugs were more expensive, be it the case of statins or cancer therapy drugs; yet we purchase these very drugs.10 Secondly, companies rarely produce scientific evidence that near-identical drugs will prove effective when another fails. Angell goes so far as to claim pharmaceutical companies do not produce such research precisely because they do not want to know such results.10 David Kessler, the former commissioner of the U.S. FDA famously asserted that only a small minority of “me-too” drugs actually offer a clear clinical advantage to existing treatments.11
This begs the question, why would the NHS need such drugs? Despite there often being no practical clinical benefit, strong marketing campaigns lead consumers to falsely believe these “new” medications are superior.12 Companies are therefore enabled to charge greater prices for their newly patented “brand” me-too drug instead of a generic non-patented drug. Ultimately, costs of healthcare needlessly increase.10 The NHS patient sees no benefit when he is prescribed the statin, Lescol instead of Lipitor. Having said this, some “me-too” drugs have proved considerably better than their counterparts. One recent example is the oral hypoglycaemic drug, Troglitazone. It was shortly removed after introduction in 1997 due to unacceptable hepatotoxicity. However, follow-up drugs such as Rosiglitazone did not cause these adverse events; these glitazones now play an important role in diabetic therapy.13 While some “me-too” drugs deserve their place in modern medicine we must thoroughly examine the evidence presented on an individual, careful basis. Few confer a cost advantage or practical clinical benefit to the NHS.
One famous blunder is the case of COX-2 inhibitors. Released in 1999, celecoxib and rofecoxib propelled to success on the back of strong marketing pushes from their parent companies, Merck and Pharmacia. They took a huge portion of the NSAID market, garnering over US $3 billion by October 2000 in U.S. alone.14 Unfortunately this success was based on faulty studies; data showing a long-term association with cardiac thrombotic events had been purposefully neglected from the VIGOR trial.15 It was soon apparent why – all 13 authors of the VIGOR trial had strong associations with the parent company Merck.16 Wilful presentation of misleading statistics is not new in the medical world.10 In this case thousands of people likely died. This debacle seriously damaged public and physician trust alike. Can the NHS trust the way drugs are created in the current system? When outcome measures and comparison groups are selectively used for aggressive marketing purposes (and others ignored), it is difficult to truly assess new medications;10 sometimes with disastrous consequences.
Of course, there is a flipside. As long as illness exists, we will always have demand for better treatments. The United Kingdom should be able to provide its population with the cutting-edge of medicine. The case of Anne Marie Rogers with breast cancer who fought for herceptin comes to mind.17 One can argue it is wrong to withhold acknowledged effective treatments for such serious diseases because we must then question the aim of the NHS and our role as medical professionals. New drugs are currently assessed by NICE* through the QALY** score, accounting for cost effectiveness and ability to lengthen/enhance life.18 A simple equation is not always enough though – not for the patient anyway. A current example is monoclonal antibodies. These drugs (which include herceptin) have the potential to revolutionize management of conditions such as cancer and autoimmune diseases. It is difficult to argue the NHS does not need such medications.
Finally, we must accept the global impact of the system we implicitly advocate. While the pharmaceutical industry seemingly cater to our needs, the same cannot be said for developing nations.19 It is odd witnessing companies scramble to spend more on advertising and marketing than on research, to research more on lifestyle drugs than on life-saving drugs and that most of these great medical advancements never reach developing countries’ citizens.20 Daily, people die of preventable, curable illnesses such as tuberculosis, malaria and acute lower-respiratory tract infections; 6.1 million people in 1998 alone.19 The drugs to treat these illnesses are either non-existent or no longer effective. This is not because nothing can be done, but because the current system does not reward such action.19, 20 We can argue the NHS needs new drugs, but perhaps other nations need new drugs more.
So does the NHS need new drugs? Absolutely, one cannot deny the great triumphs of medical research. Over the past two decades, the immeasurable impact medications such as statins, long acting beta-2 agonists and atypical antipsychotics have had is undeniable; the health of our nation has continually improved. However, I do not believe this paints the whole picture. Many of the drugs we receive bring nothing more than what they mimic, many of the drugs we receive are more expensive than the last and many of the drugs we receive are questionably marketed.12 I believe the NHS requires far fewer new drugs than most would claim.
References
1. National Audit Office (2007). Prescribing costs in primary care. National Audit Office, pp. 4-15.
2. National Health Service (2009). About the NHS [online]. Available from: http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx [accessed 7/11/2010].
3. Mayor, S. (2007). NHS pays £500m too much for prescription drugs. British Medical Journal, vol. 334, p. 383.
4. CNN Money (2009). Top industries: Most profitable [online]. Available from: http://money.cnn.com/magazines/fortune/fortune500/2009/performers/industries/profits/ [accessed 7/11/2010].
5. Huff, B. (2001). What Does R&D Really Cost? [online]. Available from: http://www.thebody.com/content/art13514.html [accessed 7/11/2010].
6. Public Citizen (2001). Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Caard”. Public Citizen Congress Watch July 2001, pp. 1-43.
7. Kumar, V. and Singh, B. (2008). Me-Too Drugs - A Tiny Revolutionize. Pharmainfo, vol. 6, no. 3, pp. 15-20.
8. On ABC Special with Peter Jennings, "Bitter Medicine: Pills, Profit, and the Public Health," May 29, 2002.
9. Angell, M. (2005). The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York, America : Random House Trade.
10. Gardiner, H. (2004) 2 Cancer Drugs, No Comparative Data, New York Times, 26 February [Online]. Available at http://query.nytimes.com/gst/fullpage.html?sec=health&res=9505E2DA133CF935A15751C0A9629C8B63&fta=y [accessed 7/11/2010].
11. Kessler, D., Rose, J.L., Temple, R.J. et al (1994). Therapeutic-Class Wars -- Drug Promotion in a Competitive Marketplace. New England Journal of Medicine, vol. 331, pp. 1350-3.
12. Radowitz, J. (2004) 85% of New Drugs ‘Offer Few Benefits’, The Independent, 17 August [Online]. Available at http://www.independent.co.uk/life-s...-of-new-drugs-offer-few-benefits-2054972.html [accessed 7/11/2010].
13. Henney, A. (2000). Withdrawal of Troglitazone and Cisapride. Journal of the American Medical Association, vol. 283, no. 17, pp. 2228.
14. Pharmacia (2002). Pharmacia earnings releases [online]. Available from: http://www.pharmacia.com/investor/earnings.asp [accessed 13/10/2010].
15. U.S. Food and Drug Administration (2004). Statistical Reviewer Briefing Document for the Advisory Committee [online]. Available from: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1.htm. [accessed 13/10/2010].
16. Mukherjee D., Nissen S.E., Topol E.J. (2000). Risk of cardiovascular events associated with selective COX-2 inhibitors. Journal of the American Medical Association, vol. 343, no. 21, pp 1520-28.
17. BBC News (2006). Woman loses Herceptin court bid [online]. Available from: http://news.bbc.co.uk/1/hi/health/4715430.stm [accessed 7/11/2010].
18. National Institute of Clinical Excellence (2010). Measuring effectiveness and cost effectiveness: the QALY [online]. Available from: http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp [accessed 7/11/2010].
19. Silverstein, K. (2000). Millions for Viagra, Pennies for Diseases of the Poor [online]. Available from: http://www.thenation.com/article/millions-viagra-pennies-diseases-poor [accessed 7/11/2010].
20. Shah, A. (2010). Pharmaceutical Corporations and Medical Research [online]. Available from: http://www.globalissues.org/article/52/pharmaceutical-corporations-and-medical-research [accessed 7/11/2010].
For the lazy
tl;dr version:
- drugs are too expensive nowadays.
- drug companies consistently post huge profits while crying about high R&D costs.
- drug companies often make governments fund "difficult" research and rarely take risks themselves. drug companies like to make copycat drugs if governments do not fund their research.
- studies show copycat drugs do not even necessarily reduce market prices. they are useless!!!
- drug companies are clever. they set up studies to prove what they want. trust issues exist.
- drug companies only make drugs for the highest bidder. this has left developing nations with seriously lacking healthcare. this can be argued unethical.
- illness exists. it is wrong to not seek the best healthcare we can provide.
- it is wrong to not provide effective treatments if they exist.
I wrote a related essay a while ago and figured it could form a good grounding for this topic. I wrote this whole essay during an all-nighter (the best way to work!) so please forgive any glaring errors. I don't actually have strong opinions on this subject. The object of the essay was to produce a newspaper article; I chose to take a cynical stance because it was more interesting to write. Depending on responses I could argue either way.
While I speak of the NHS, I think many of these problems are applicable to other healthcare systems. I left some issues out due to a strict word count. You guys may mention them so I won't speak further for now. Feel free to scroll to the bottom if you are lazy.
New Drugs – Does the NHS need them?
Does the National Healthcare System need new drugs? The natural response to such a question may be a resounding “yes”. After all, the United Kingdom has one of greatest healthcare systems in the world; it is only natural we seek the best medicines for our population. However, when we explore a little deeper than the surface, the waters become murky. In this article I put forward opposing viewpoints and challenge the current system.
The pharmaceutical industry maintains a strong advertising presence. We associate this industry and newly developed drugs with words like “innovative”, “research and development” and “essential”. We are reassured the premium costs the NHS pay are justified by these drugs’ ability to lengthen life, enhance quality of life or prevent more expensive medical procedures. Simply put, the pharmaceutical industry would have us believe we get what we pay for. How true is any of this?
Well the pharmaceutical industry certainly is expensive, accounting for over 20% of the NHS budget.1 In 2008 the National Audit Office found we spend an astounding £8.2 billion a year on prescriptions compared to £4 billion a decade ago. Expenditure on primary care drugs has increased by 60 per cent in real terms. Further growth is expected due to an ageing population, continued development of new drugs and identification of new applications for existing drugs.2 Such alarming rises in costs are unsustainable and restrictions in drugs funding will be inevitable.3
The pharmaceutical industry may attribute rising prices to increasing research and development (R&D) costs and the associated risks they so benevolently shoulder upon themselves. Yet this industry has consistently been one of the most profitable sectors in the U.S. for two decades, questioning how much ‘risk’ really exists.4 R&D budgets are dwarfed by the vast marketing and administration expenditures within companies and even more so by profits.5 When studies observe little relationship between the costs of making a drug and the prices paid we should be wary of why expenditure on new drugs continue rising.5 Within the current economic climate, it is difficult to justify the NHS paying ever exorbitant prices to an industry posting record-breaking profits each year – unless these drugs are actually worth it.
Despite a belief we receive cutting-edge drugs, the pharmaceutical industry does not appear “innovative” at all. Influential new drugs are usually based on taxpayer-funded research through academic institutions, small biotechnology companies or the National Institute of Health (NIH);6 45 of the top 50 selling drugs in the U.S. from 1992-1997 received government funding at some phase of their development. It is therefore not rare for pharmaceutical companies to be spared financial risk.6 When left to themselves, pharmaceutical companies inundate the market with “me-too” drugs instead. These medications are mere minor molecular variations of already existing drugs. Over the period of 1998-2003, 68% of new drugs approved by the U.S. Food and Drugs Administration (FDA) were not even new compounds, they were simply formulations or combinations of old ones.7 A huge portion of R&D costs lie here rather than in genuine innovation. Dr Sharon Levine, associate executive director of the Kaiser Permanente Medical Group succinctly summarised the situation:
“If… I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavour, which is looking for brand-new drugs?”8
Copycat drugs are produced for two primary reasons, neither of which benefit the NHS: for a company to hold on to a market where their original patent expires or for a new company to enter the same market. Some retort the pharmaceutical industry is unfairly demonised. They argue such competition in the free market drives prices down and options are valuable because when drug A does not work for a patient, drug B might. However, evidence does not support such claims. When a “me-too” drug enters the market the original rarely drops in price, nor is it marketed as a cheaper alternative.9 There are countless documented examples where copycat drugs were more expensive, be it the case of statins or cancer therapy drugs; yet we purchase these very drugs.10 Secondly, companies rarely produce scientific evidence that near-identical drugs will prove effective when another fails. Angell goes so far as to claim pharmaceutical companies do not produce such research precisely because they do not want to know such results.10 David Kessler, the former commissioner of the U.S. FDA famously asserted that only a small minority of “me-too” drugs actually offer a clear clinical advantage to existing treatments.11
This begs the question, why would the NHS need such drugs? Despite there often being no practical clinical benefit, strong marketing campaigns lead consumers to falsely believe these “new” medications are superior.12 Companies are therefore enabled to charge greater prices for their newly patented “brand” me-too drug instead of a generic non-patented drug. Ultimately, costs of healthcare needlessly increase.10 The NHS patient sees no benefit when he is prescribed the statin, Lescol instead of Lipitor. Having said this, some “me-too” drugs have proved considerably better than their counterparts. One recent example is the oral hypoglycaemic drug, Troglitazone. It was shortly removed after introduction in 1997 due to unacceptable hepatotoxicity. However, follow-up drugs such as Rosiglitazone did not cause these adverse events; these glitazones now play an important role in diabetic therapy.13 While some “me-too” drugs deserve their place in modern medicine we must thoroughly examine the evidence presented on an individual, careful basis. Few confer a cost advantage or practical clinical benefit to the NHS.
One famous blunder is the case of COX-2 inhibitors. Released in 1999, celecoxib and rofecoxib propelled to success on the back of strong marketing pushes from their parent companies, Merck and Pharmacia. They took a huge portion of the NSAID market, garnering over US $3 billion by October 2000 in U.S. alone.14 Unfortunately this success was based on faulty studies; data showing a long-term association with cardiac thrombotic events had been purposefully neglected from the VIGOR trial.15 It was soon apparent why – all 13 authors of the VIGOR trial had strong associations with the parent company Merck.16 Wilful presentation of misleading statistics is not new in the medical world.10 In this case thousands of people likely died. This debacle seriously damaged public and physician trust alike. Can the NHS trust the way drugs are created in the current system? When outcome measures and comparison groups are selectively used for aggressive marketing purposes (and others ignored), it is difficult to truly assess new medications;10 sometimes with disastrous consequences.
Of course, there is a flipside. As long as illness exists, we will always have demand for better treatments. The United Kingdom should be able to provide its population with the cutting-edge of medicine. The case of Anne Marie Rogers with breast cancer who fought for herceptin comes to mind.17 One can argue it is wrong to withhold acknowledged effective treatments for such serious diseases because we must then question the aim of the NHS and our role as medical professionals. New drugs are currently assessed by NICE* through the QALY** score, accounting for cost effectiveness and ability to lengthen/enhance life.18 A simple equation is not always enough though – not for the patient anyway. A current example is monoclonal antibodies. These drugs (which include herceptin) have the potential to revolutionize management of conditions such as cancer and autoimmune diseases. It is difficult to argue the NHS does not need such medications.
Finally, we must accept the global impact of the system we implicitly advocate. While the pharmaceutical industry seemingly cater to our needs, the same cannot be said for developing nations.19 It is odd witnessing companies scramble to spend more on advertising and marketing than on research, to research more on lifestyle drugs than on life-saving drugs and that most of these great medical advancements never reach developing countries’ citizens.20 Daily, people die of preventable, curable illnesses such as tuberculosis, malaria and acute lower-respiratory tract infections; 6.1 million people in 1998 alone.19 The drugs to treat these illnesses are either non-existent or no longer effective. This is not because nothing can be done, but because the current system does not reward such action.19, 20 We can argue the NHS needs new drugs, but perhaps other nations need new drugs more.
So does the NHS need new drugs? Absolutely, one cannot deny the great triumphs of medical research. Over the past two decades, the immeasurable impact medications such as statins, long acting beta-2 agonists and atypical antipsychotics have had is undeniable; the health of our nation has continually improved. However, I do not believe this paints the whole picture. Many of the drugs we receive bring nothing more than what they mimic, many of the drugs we receive are more expensive than the last and many of the drugs we receive are questionably marketed.12 I believe the NHS requires far fewer new drugs than most would claim.
References
1. National Audit Office (2007). Prescribing costs in primary care. National Audit Office, pp. 4-15.
2. National Health Service (2009). About the NHS [online]. Available from: http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx [accessed 7/11/2010].
3. Mayor, S. (2007). NHS pays £500m too much for prescription drugs. British Medical Journal, vol. 334, p. 383.
4. CNN Money (2009). Top industries: Most profitable [online]. Available from: http://money.cnn.com/magazines/fortune/fortune500/2009/performers/industries/profits/ [accessed 7/11/2010].
5. Huff, B. (2001). What Does R&D Really Cost? [online]. Available from: http://www.thebody.com/content/art13514.html [accessed 7/11/2010].
6. Public Citizen (2001). Rx R&D Myths: The Case Against the Drug Industry’s R&D “Scare Caard”. Public Citizen Congress Watch July 2001, pp. 1-43.
7. Kumar, V. and Singh, B. (2008). Me-Too Drugs - A Tiny Revolutionize. Pharmainfo, vol. 6, no. 3, pp. 15-20.
8. On ABC Special with Peter Jennings, "Bitter Medicine: Pills, Profit, and the Public Health," May 29, 2002.
9. Angell, M. (2005). The Truth About the Drug Companies: How They Deceive Us and What to Do About It. New York, America : Random House Trade.
10. Gardiner, H. (2004) 2 Cancer Drugs, No Comparative Data, New York Times, 26 February [Online]. Available at http://query.nytimes.com/gst/fullpage.html?sec=health&res=9505E2DA133CF935A15751C0A9629C8B63&fta=y [accessed 7/11/2010].
11. Kessler, D., Rose, J.L., Temple, R.J. et al (1994). Therapeutic-Class Wars -- Drug Promotion in a Competitive Marketplace. New England Journal of Medicine, vol. 331, pp. 1350-3.
12. Radowitz, J. (2004) 85% of New Drugs ‘Offer Few Benefits’, The Independent, 17 August [Online]. Available at http://www.independent.co.uk/life-s...-of-new-drugs-offer-few-benefits-2054972.html [accessed 7/11/2010].
13. Henney, A. (2000). Withdrawal of Troglitazone and Cisapride. Journal of the American Medical Association, vol. 283, no. 17, pp. 2228.
14. Pharmacia (2002). Pharmacia earnings releases [online]. Available from: http://www.pharmacia.com/investor/earnings.asp [accessed 13/10/2010].
15. U.S. Food and Drug Administration (2004). Statistical Reviewer Briefing Document for the Advisory Committee [online]. Available from: http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1.htm. [accessed 13/10/2010].
16. Mukherjee D., Nissen S.E., Topol E.J. (2000). Risk of cardiovascular events associated with selective COX-2 inhibitors. Journal of the American Medical Association, vol. 343, no. 21, pp 1520-28.
17. BBC News (2006). Woman loses Herceptin court bid [online]. Available from: http://news.bbc.co.uk/1/hi/health/4715430.stm [accessed 7/11/2010].
18. National Institute of Clinical Excellence (2010). Measuring effectiveness and cost effectiveness: the QALY [online]. Available from: http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheqaly.jsp [accessed 7/11/2010].
19. Silverstein, K. (2000). Millions for Viagra, Pennies for Diseases of the Poor [online]. Available from: http://www.thenation.com/article/millions-viagra-pennies-diseases-poor [accessed 7/11/2010].
20. Shah, A. (2010). Pharmaceutical Corporations and Medical Research [online]. Available from: http://www.globalissues.org/article/52/pharmaceutical-corporations-and-medical-research [accessed 7/11/2010].
For the lazy
tl;dr version:
- drugs are too expensive nowadays.
- drug companies consistently post huge profits while crying about high R&D costs.
- drug companies often make governments fund "difficult" research and rarely take risks themselves. drug companies like to make copycat drugs if governments do not fund their research.
- studies show copycat drugs do not even necessarily reduce market prices. they are useless!!!
- drug companies are clever. they set up studies to prove what they want. trust issues exist.
- drug companies only make drugs for the highest bidder. this has left developing nations with seriously lacking healthcare. this can be argued unethical.
- illness exists. it is wrong to not seek the best healthcare we can provide.
- it is wrong to not provide effective treatments if they exist.
