I am proud to present my Bachelor Research Paper!
I wrote it to show how messed up the pharmaceutical process is from the government, to the drug companies to the doctors. The system is loaded with problems that threaten our safety.
Are you ready? Here we go!
Legal Drugs Considered ‘Safe’ Are Killing Americans
While modern medicine intends to fight disease, the quest to treat illness by prescription drugs comes with a price. It is generally accepted that prescription drugs carry unwanted side effects. Hidden in the well-known category of annoying side effects are events known as ‘adverse drug reactions’. Less is understood about the frequency and severity of adverse drug reactions. “Unintended, harmful reactions to medicines (known as adverse drug reactions) are among the leading causes of death in many countries,” according to the World Health Organization.[1]
In the United States, the most quoted and best estimate of the incidence of adverse drug reactions comes from a meta-analysis published in the Journal of American Medicine in 1989.[2] Searching a database of 39 different studies, the research team’s stated goal was to estimate the injuries incurred by drugs that were properly prescribed and administered. Especially since the study excluded therapeutic failures, errors in prescribing and administering, noncompliance, overdose and drug abuse, the numbers are astounding. In the year they focused on they found that 2,216,000 hospitalized patients had serious adverse drug reactions and 106,000 patients had fatal adverse drug reactions. This article claimed adverse drug reactions from properly prescribed and administered drugs appeared to be the fourth leading cause of death behind heart disease, cancer and stroke. While the numbers are impossible to adequately verify, the fact is, legal drugs that are considered ‘safe’ are killing Americans in large numbers. We are not fully aware of the extent of adverse drug reactions because there are many flaws in the system.
To avoid the risks of adverse drug reactions and sudden cardiac death, patients can guard themselves with knowledge about flaws in the system and the nature of drugs to make informed and better decisions to avoid regret. If we look to the system to offer protection from adverse drugs reactions, we will focus on the main characters: the government, the drug companies, and the medical doctors who prescribe drugs.
Government- The original Federal Food and Drug Act of 1906 brought drug regulation under federal law and the Food and Drug Administration (FDA) began evaluating new drugs. Following the 1962 amendment, the FDA requires manufacturers to show that their new drug products are safe and effective before entering the market. The FDA approves on average, 22 new drugs a year, known as New Molecular Entities (NMEs).[3] Of the 941 new drug approvals between 1995 and 2004, over six hundred were not NMEs, but slight variations of already existing drugs.[4] Because the FDA requires drug manufacturers to provide research prior to approval, it is generally assumed that drugs on the market are safe and effective. Further investigation shows that ensuring drug safety and effectiveness is an astronomical task for the FDA.
It may seem like 2,889 employees[5] in the drug department of the FDA is sufficient to regulate all prescription drugs on the market. But there are 17,143 drugs listed in the Orange Book, the FDA’s publication formally called Approved Drug Products with Therapeutic Equivalence Evaluations.[6] The Orange Book has 16,609 drugs in the prescription category and 534 drugs in the over-the-counter (OTC) category.[7] The FDA drug department also supervises OTC drugs, like pain relievers and cold medicines. The website gives examples of other products it regulates that are not normally considered to be OTC drugs, such as fluoride toothpaste, antipersperspirants, dandruff shampoo and sunscreens. The FDA drug department monitors a large amount of different products when OTC drugs are included.
Not only do the 2,889 employees perform drug evaluation and research on 17,143 drugs, they regulate marketing claims in all magazines, TV, pamphlets, physician seminars and luncheons sponsored by drug companies. If a company claims a drug is effective for a condition it was not approved for, the drug company is in violation and receives a carefully detailed warning letter and follow-up from the FDA.[8] The FDA also monitors all drug-warning labels to ensure the right information is given to consumers. Consumers have a right to know if their medication has a risk for liver toxicity or gastrointestinal bleeding.
Not only evaluating pre- and post market drug surveillance, regulating all marketing claims and warning labels, the FDA hosts the Adverse Event Reporting System, a database that contains information submitted about adverse drug events in the population. Anyone can submit drug information to the AERS; statistics and files are made public on the website. Data collected through the AERS has limitations, the FDA warns, “First, there is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event…Therefore AERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.”[9] The AERS is a step in the right direction for cataloging adverse drug events; but is under-utilized by those who are affected most. We can’t expect the FDA to protect us from adverse drug events. Of the 758,890 reports received in 2010, only 28,952 came from consumers or healthcare professionals.[10] The majority of adverse drug reporting came from drug companies themselves, manifesting a conflict of interest.
Drug Companies- ‘Conflict of interest’ seems to be synonymous with pharmaceutical companies. They market drugs to improve public health, but also to make money. The healthier the public is, the less profit the drug companies make. Reliable financial data about the earnings and spending of drug companies is scarce. The U.S. General Accounting Office refers to IMS,[11] a firm that provides pharmaceutical market research and is largely backed by the pharmaceutical industry. According to IMS, in 2011, Americans spent $319 billion dollars on prescription drugs.[12]
Public concern over the cost of prescription drugs, the slower pace of new-drug development and suspicions that the ‘pharmaceutical industry is highly profitable’ led to a 65-page study by the federal Congressional Budget Office, called Research and Development in the Pharmaceutical Industry.[13] It was an attempt to explain the mystery of why prescription drugs cost so much. The average cost for the average brand-name drug in 2010 was $198,[14] which would be about $2300 a year if a person was only taking one drug. Many senior citizens have more than one prescription, commonly five or more. The FDA and the drug companies blame high prices on the expensive and tedious research and development process.
Forbes magazine estimates that it costs between 4 and 11 billion dollars to bring the average new drug to market.[15] It explains that included in high cost of development, are drugs that fail; fewer than 1 in 10 medicines that start research in human clinical trials succeed to market. According to the FDA, the proportion of all new drugs that begin testing in human clinical trials on healthy volunteers (phase 1) and make it through the next two phases of trial to approval is 8%.[16] It usually takes about 11 years to complete all testing phases and gain FDA approval.[17]
Critics claim that most of the drug research is not being done by the drug companies, but in universities for little cost to the drug companies. “As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on tax-payer-funded research at academic institutions, small biotechnological companies, or the National Institutes of Health. The majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative, market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first.”[18] These six lipid regulating cholesterol-lowering drugs, by themselves brought in 20.1 billion U.S. dollars to the drug companies in 2011. In the last five years, 95 billion U.S. dollars were spent by Americans on these six drugs alone, according to IMS.[19] This estimate does not include sales in Europe or any other countries rich enough to afford a cholesterol-lowering drug.
Drug companies are not required to divulge how much money they spend in research and development or on marketing. Finding reliable numbers is difficult. To keep their prices high and their practices hidden and protected, drug companies spend 855 million dollars[20] a year on lobbying in Washington D.C.
Drug companies might underestimate the amount they spend on promotion to enhance their public image. One independent figure based on numbers from two different pharma-backed market research companies, estimates that 57.5 billion dollars are spent each year on various marketing venues, twice as much as on research and development.[21] It is more lucrative to promote existing drugs than it is to create new ones. It is cheaper to find off-label uses for existing drugs. It is cheaper to promote research that shows existing drugs should be taken by more people for life. It is cheaper to lead the public into believing that the existing drugs will prolong their life and enhance the quality of their life through clever marketing. Direct to consumer marketing has increased dramatically, but the biggest portion of marketing dollars is spent on physicians.
Physicians- In the U.S. alone, 3,703,594,389 prescriptions were filled in retail pharmacies [22] in 2010, managed by an estimate of 691,000 physicians.[23] There are only 314 million people in the U.S.[24] who are filling 3.7 billion prescriptions and only about a half a million doctors to manage those prescriptions.
The time limit a physician has to spend with each patient has decreased as managed healthcare began ‘restricting doctors to an average seven-minute “encounter” with each customer. This apparently kept shareholders happy. But it reduced the doctor-patient relationship to a financial concept…’[25]
Dr. Victoria McEvoy describes seeing patients as trying to look for one face in the window on a train as it goes by. As the train picks up speed, all the faces start to blur. If you look away, you might miss the one you are seeking. The faces start to look the same. Looking becomes monotonous. Doctoring becomes habitual. As a pediatrician, she sees an endless number of cranky children with a fever. The diagnosis is almost always a virus or strep throat. But if she becomes complacent, she might miss the one child who has meningitis.[26]
Physicians are human just like anybody else. Doctors make mistakes. Misdiagnosis could occur anywhere from 8% - 42% of the time, according to the best estimates of a few studies.[27] Doctors need sleep to perform at the optimal level. Pilots are required to log at least 10 hours in between flights. Doctors are often required to work 24 hours shifts, or take on-call duty that wakes them up throughout the night, impairing judgment.
Physicians have biases that affect their judgment and the ability to make the right diagnosis. ‘All new mothers are overprotective and nervous about the health of their babies.’ ‘Kids and a full-time job will cause this kind of fatigue, of course.’ ‘It’s all in your head.’ ‘You need an anti-depressant.’ In seven minutes, it is difficult to get past biases to examine the real issues.
One study in California monitored 45 doctors caring for more than 900 patients.[28] Almost half failed to specify the dose of the drug and how often it should be taken.
Two thirds of the doctors did not tell their patients either how long to take a new medication or what its side effects could be. Many drugs have so many side effects, doctors cannot keep track of them, especially the little known side effects.
Physicians rely on drug companies to learn about prescription drugs. The American Medical Association requires physicians to complete continuing education. In Washington D.C. thirteen pharmaceutical companies are approved to provide continuing education to doctors.[29]
No Free Lunch is a website sponsored by healthcare professionals dedicated to stopping the unethical behavior of drug company-to-physician marketing and promotion. They claim that doctors are influenced by promotion, even the pen or mug given by drug reps. Gifts, even small ones create relationships, obligations and the need to reciprocate. There have been observational studies that show that doctor’s prescribing behavior is influenced by promotions and interactions from drug reps. No Free Lunch claims, “Doctors who practice on the basis of promotion, meet with reps, and use information provided by them are more likely to prescribe more expensive, inappropriate medication.”[30] Drug companies know this. That is why they spend 80% [31]of their 57.5 billion[32] dollars a year on marketing to physicians. Strapped by insurance companies, health maintenance organizations, the overbearing legal system, and other forces, many doctors feel there is nothing they can do to change the system. Those who fight the system risk losing their licenses to practice.
Solution- So far, this prescription drug system paints a dismal picture for modern medicine. As one desperate arthritic blogger commented, “So all the drugs are bad. What the heck are we supposed to do?! Rot in our wheelchairs and die?” No, luckily there is good news. The good news lies in the statistics. While 106,000 deaths a year seems like a large number, it is insignificant compared to the 3.7 billion prescriptions filled a year. Compared to 3.7 billion prescriptions, even 2.2 million serious adverse drug reactions are only about 16% of the total number.
There is more good news from the World Health Organization, “At least 60% of ADRs are preventable, and can be due to: wrong diagnosis of the patient’s condition; prescription of the wrong drug or wrong dosage of the right drug; an undetected medical, genetic or allergic condition that might cause a patient reaction; self-medication with prescription medicines; not following the instructions for taking the medication; and reactions with other drugs (including traditional medicines) and certain foods… Vigilant assessment of the risks and benefits of medicines promotes patient safety”
To avoid ADRs, become familiar with prescription drugs before taking them. You should know that Ibuprophen, aspirin and most arthritis medications are so highly linked to severe gastrointestinal bleeding that these NSAIDS have their own disease name: NSAID Gastropathy. Oral contraceptives and Hormone Replacement Therapy are highly linked to blood clots, strokes and heart attacks. Statins are highly linked to liver problems, severe muscle degeneration and early dementia. You should know that if 150 people have a cholesterol level of 280, and all are taking a statin drug, only one of them would be ‘saved’ from a heart attack. The other 149 would not have suffered the heart attack even with a cholesterol level of 280.[33] It’s called the ‘number needed to treat’ and it is very different than the statistics doctors usually give to patients when suggesting medications. You should know that Erythromycin, an antibiotic is linked to hepatitis (liver disorder) and it is part of a group of antibiotics called macrolides that cause long QT. Long QTs are highly linked to torsades de pointe, an unsustainable heart rhythm. Pepcid, Effexor, Zoloft, Paxil, and others are also linked with long QT under certain conditions.[34] That means in a small way, these medications can be linked to sudden death. Our own due diligence can save us from regret. To avoid the risks of adverse drug reactions and sudden cardiac death, patients can guard themselves with knowledge about the flaws in the system and the nature of drugs to make informed and better decisions.
Health reporter Kristin Dold suggests, “Before taking any prescription drug, ask your doctor the following three questions: Are there nondrug options I can try first? Why did you pick this medication over others? And what are the pros and cons of taking this? If he or she brushes off your queries, it’s time to find a new MD.”[35]
As Dr. Peter Salgo suggests, “This leaves the solution to the problem in the hands of our patients. You, the patient, are the system’s best hope. In the age of seven-minute health care, you need to realize that you employ doctors. That is, your doctor works for you…Evaluate what it is you expect from your doctor, then ask for it. If you are unhappy with your doctor, fire him…the true power in the health care economy rests not with the doctors and certainly not with the backroom business staff [and not with drug companies] it rests with you. If you insist on being treated with care and respect, you will be. And the system will improve as a result.” [36]
The highest health goal to hope for is in the words of Thomas Edison, “The doctor of the future will give no medicine but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease.”[37]
Footnotes:
[1] World Health Organization. (2008) http://www.who.int/mediacentre/factsheets/fs293/en/ Fact Sheet No 293, Page Last Updated Oct 2008
[2]Lazarou.J. (1989). The Journal of the American Medical Association, JAMA. 1998;279(15):1200-1205. doi:10.1001/jama.279.15.1200
[3]FDA www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf includes 2010 information
[4] FDA “CDER 2004 Report to the Nation: Improving Public Health Through Human Drugs” www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/ucm078941.pdf
[5] FDA www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm Page last updated 8/19/2010
[6] FDA www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm Orange Book Preface 32nd Edition, FDA Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations
[7] FDA www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/sld008.htm
[8] www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm Page Last Updated January 25, 2012
[9]www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm Page Last Updated April 27, 2012
[10]www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm Page Last Updated July 15, 2011
[11] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[12]IMS www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/POTop-line%20Market%20Data/Top_Therapy_Classes_by_Sales.pdf
[13] Congressional Budget Office www.cbo.gov/sites/default/files/cbofiles/ftpdocs/76xx/doc7615/10-02-drugr-d.pdf October 2006, Research and Development in the Pharmaceutical Industry
[14] Johnson, L, A. (2011) Prescription-drug prices to plunge as patents expire. The Seattle Times, July 24, 2011
[15] Herper, M, (2012) The Truly Staggering Cost Of Inventing New Drugs. Forbes www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/
[16] Congressional Budget Office (2006) Research and Development in the Pharmaceutical Industry, p. 23
[17] Congressional. p. 20
[18] Angell, M.D. M. (2004) The Truth About Drug Companies. New York: Random House. p. 15.
[19] IMS www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/POTop-line%20Market%20Data/Top_Therapy_Classes_by_Sales.pdf
[20] Dilanian, K. (2007, March 10). Senators Who Weakened Drug Bill Got Millions From Industry. USA Today. www.usatoday.com/news/washington/2007-05-10-senators-drug-bill_N.htm
[21] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[22] The Kaiser Family Foundation. www.statehealthfacts.org/profileind.jsp?sub=66&rgn=1&cat=5
[23] Bureau of Labor Statistics. Occupational Outlook Handbook 2012-2013 edition. www.blsgov/ooh/Healthcare/Physicians-and-surgeons.htm
[24] U.S. Department of Commerce. www.census.gov/main/www/popclock.html
[25] Salgo, P, MD. (2006, March 22). The Doctor Will See You for Exactly Seven Minutes. The New York Times. www.nytimes.com/2006/03/22/opinion/22salgo.html
[26] Groopman, J. (2007). How Doctors Think. Boston, Houghton Mifflin. p.77
[27] www.rightdiagnosis.com/intro/common.htm
[28] Groopman, J. (2007). How Doctors Think. Boston, Houghton Mifflin. p. 266
[29] Health Professional Licensing Administration. List of Pharmaceutical Companies Approved for Continuing Education. Hpla.doh.doc.gov/hpla/cwp/view,a,1195,q,501203.asp
[30] www.nofreelunch.org/faqs.htm
[31] Rosenthal, M. (2002, February 14) Promotion of Prescription Drugs to Consumers. The New England Journal of Medicine. 346:498-505
[32] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[33] Groopman, J. (2011). Your Medical Mind, How to Decide What Is Right for You. New York, The Penguin Press. pp. 17, 24.
[34] The Critical Path Institute. Drugs with Conditional Risk of Torsades http://www.azcert.org/medical-pros/drug-lists/list-04.cfm
[35] Dold, K. (2012, June 3). Doctors Behaving Badly: 7 Types to Watch Out For. MSNBC.MSN www.todayhealth.today.msnbc.com/_news/2012/06/03/12034113-doctors-behaving-badly-7-types-to-watch-out-for?lite
[36] Salgo, P, MD. (2006, March 22). The Doctor Will See You for Exactly Seven Minutes. The New York Times. www.nytimes.com/2006/03/22/opinion/22salgo.html
[37] www.snopes.com/quotes/edison.asp
I wrote it to show how messed up the pharmaceutical process is from the government, to the drug companies to the doctors. The system is loaded with problems that threaten our safety.
Are you ready? Here we go!
Legal Drugs Considered ‘Safe’ Are Killing Americans
While modern medicine intends to fight disease, the quest to treat illness by prescription drugs comes with a price. It is generally accepted that prescription drugs carry unwanted side effects. Hidden in the well-known category of annoying side effects are events known as ‘adverse drug reactions’. Less is understood about the frequency and severity of adverse drug reactions. “Unintended, harmful reactions to medicines (known as adverse drug reactions) are among the leading causes of death in many countries,” according to the World Health Organization.[1]
In the United States, the most quoted and best estimate of the incidence of adverse drug reactions comes from a meta-analysis published in the Journal of American Medicine in 1989.[2] Searching a database of 39 different studies, the research team’s stated goal was to estimate the injuries incurred by drugs that were properly prescribed and administered. Especially since the study excluded therapeutic failures, errors in prescribing and administering, noncompliance, overdose and drug abuse, the numbers are astounding. In the year they focused on they found that 2,216,000 hospitalized patients had serious adverse drug reactions and 106,000 patients had fatal adverse drug reactions. This article claimed adverse drug reactions from properly prescribed and administered drugs appeared to be the fourth leading cause of death behind heart disease, cancer and stroke. While the numbers are impossible to adequately verify, the fact is, legal drugs that are considered ‘safe’ are killing Americans in large numbers. We are not fully aware of the extent of adverse drug reactions because there are many flaws in the system.
To avoid the risks of adverse drug reactions and sudden cardiac death, patients can guard themselves with knowledge about flaws in the system and the nature of drugs to make informed and better decisions to avoid regret. If we look to the system to offer protection from adverse drugs reactions, we will focus on the main characters: the government, the drug companies, and the medical doctors who prescribe drugs.
Government- The original Federal Food and Drug Act of 1906 brought drug regulation under federal law and the Food and Drug Administration (FDA) began evaluating new drugs. Following the 1962 amendment, the FDA requires manufacturers to show that their new drug products are safe and effective before entering the market. The FDA approves on average, 22 new drugs a year, known as New Molecular Entities (NMEs).[3] Of the 941 new drug approvals between 1995 and 2004, over six hundred were not NMEs, but slight variations of already existing drugs.[4] Because the FDA requires drug manufacturers to provide research prior to approval, it is generally assumed that drugs on the market are safe and effective. Further investigation shows that ensuring drug safety and effectiveness is an astronomical task for the FDA.
It may seem like 2,889 employees[5] in the drug department of the FDA is sufficient to regulate all prescription drugs on the market. But there are 17,143 drugs listed in the Orange Book, the FDA’s publication formally called Approved Drug Products with Therapeutic Equivalence Evaluations.[6] The Orange Book has 16,609 drugs in the prescription category and 534 drugs in the over-the-counter (OTC) category.[7] The FDA drug department also supervises OTC drugs, like pain relievers and cold medicines. The website gives examples of other products it regulates that are not normally considered to be OTC drugs, such as fluoride toothpaste, antipersperspirants, dandruff shampoo and sunscreens. The FDA drug department monitors a large amount of different products when OTC drugs are included.
Not only do the 2,889 employees perform drug evaluation and research on 17,143 drugs, they regulate marketing claims in all magazines, TV, pamphlets, physician seminars and luncheons sponsored by drug companies. If a company claims a drug is effective for a condition it was not approved for, the drug company is in violation and receives a carefully detailed warning letter and follow-up from the FDA.[8] The FDA also monitors all drug-warning labels to ensure the right information is given to consumers. Consumers have a right to know if their medication has a risk for liver toxicity or gastrointestinal bleeding.
Not only evaluating pre- and post market drug surveillance, regulating all marketing claims and warning labels, the FDA hosts the Adverse Event Reporting System, a database that contains information submitted about adverse drug events in the population. Anyone can submit drug information to the AERS; statistics and files are made public on the website. Data collected through the AERS has limitations, the FDA warns, “First, there is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event…Therefore AERS data cannot be used to calculate the incidence of an adverse event or medication error in the U.S. population.”[9] The AERS is a step in the right direction for cataloging adverse drug events; but is under-utilized by those who are affected most. We can’t expect the FDA to protect us from adverse drug events. Of the 758,890 reports received in 2010, only 28,952 came from consumers or healthcare professionals.[10] The majority of adverse drug reporting came from drug companies themselves, manifesting a conflict of interest.
Drug Companies- ‘Conflict of interest’ seems to be synonymous with pharmaceutical companies. They market drugs to improve public health, but also to make money. The healthier the public is, the less profit the drug companies make. Reliable financial data about the earnings and spending of drug companies is scarce. The U.S. General Accounting Office refers to IMS,[11] a firm that provides pharmaceutical market research and is largely backed by the pharmaceutical industry. According to IMS, in 2011, Americans spent $319 billion dollars on prescription drugs.[12]
Public concern over the cost of prescription drugs, the slower pace of new-drug development and suspicions that the ‘pharmaceutical industry is highly profitable’ led to a 65-page study by the federal Congressional Budget Office, called Research and Development in the Pharmaceutical Industry.[13] It was an attempt to explain the mystery of why prescription drugs cost so much. The average cost for the average brand-name drug in 2010 was $198,[14] which would be about $2300 a year if a person was only taking one drug. Many senior citizens have more than one prescription, commonly five or more. The FDA and the drug companies blame high prices on the expensive and tedious research and development process.
Forbes magazine estimates that it costs between 4 and 11 billion dollars to bring the average new drug to market.[15] It explains that included in high cost of development, are drugs that fail; fewer than 1 in 10 medicines that start research in human clinical trials succeed to market. According to the FDA, the proportion of all new drugs that begin testing in human clinical trials on healthy volunteers (phase 1) and make it through the next two phases of trial to approval is 8%.[16] It usually takes about 11 years to complete all testing phases and gain FDA approval.[17]
Critics claim that most of the drug research is not being done by the drug companies, but in universities for little cost to the drug companies. “As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on tax-payer-funded research at academic institutions, small biotechnological companies, or the National Institutes of Health. The majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative, market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first.”[18] These six lipid regulating cholesterol-lowering drugs, by themselves brought in 20.1 billion U.S. dollars to the drug companies in 2011. In the last five years, 95 billion U.S. dollars were spent by Americans on these six drugs alone, according to IMS.[19] This estimate does not include sales in Europe or any other countries rich enough to afford a cholesterol-lowering drug.
Drug companies are not required to divulge how much money they spend in research and development or on marketing. Finding reliable numbers is difficult. To keep their prices high and their practices hidden and protected, drug companies spend 855 million dollars[20] a year on lobbying in Washington D.C.
Drug companies might underestimate the amount they spend on promotion to enhance their public image. One independent figure based on numbers from two different pharma-backed market research companies, estimates that 57.5 billion dollars are spent each year on various marketing venues, twice as much as on research and development.[21] It is more lucrative to promote existing drugs than it is to create new ones. It is cheaper to find off-label uses for existing drugs. It is cheaper to promote research that shows existing drugs should be taken by more people for life. It is cheaper to lead the public into believing that the existing drugs will prolong their life and enhance the quality of their life through clever marketing. Direct to consumer marketing has increased dramatically, but the biggest portion of marketing dollars is spent on physicians.
Physicians- In the U.S. alone, 3,703,594,389 prescriptions were filled in retail pharmacies [22] in 2010, managed by an estimate of 691,000 physicians.[23] There are only 314 million people in the U.S.[24] who are filling 3.7 billion prescriptions and only about a half a million doctors to manage those prescriptions.
The time limit a physician has to spend with each patient has decreased as managed healthcare began ‘restricting doctors to an average seven-minute “encounter” with each customer. This apparently kept shareholders happy. But it reduced the doctor-patient relationship to a financial concept…’[25]
Dr. Victoria McEvoy describes seeing patients as trying to look for one face in the window on a train as it goes by. As the train picks up speed, all the faces start to blur. If you look away, you might miss the one you are seeking. The faces start to look the same. Looking becomes monotonous. Doctoring becomes habitual. As a pediatrician, she sees an endless number of cranky children with a fever. The diagnosis is almost always a virus or strep throat. But if she becomes complacent, she might miss the one child who has meningitis.[26]
Physicians are human just like anybody else. Doctors make mistakes. Misdiagnosis could occur anywhere from 8% - 42% of the time, according to the best estimates of a few studies.[27] Doctors need sleep to perform at the optimal level. Pilots are required to log at least 10 hours in between flights. Doctors are often required to work 24 hours shifts, or take on-call duty that wakes them up throughout the night, impairing judgment.
Physicians have biases that affect their judgment and the ability to make the right diagnosis. ‘All new mothers are overprotective and nervous about the health of their babies.’ ‘Kids and a full-time job will cause this kind of fatigue, of course.’ ‘It’s all in your head.’ ‘You need an anti-depressant.’ In seven minutes, it is difficult to get past biases to examine the real issues.
One study in California monitored 45 doctors caring for more than 900 patients.[28] Almost half failed to specify the dose of the drug and how often it should be taken.
Two thirds of the doctors did not tell their patients either how long to take a new medication or what its side effects could be. Many drugs have so many side effects, doctors cannot keep track of them, especially the little known side effects.
Physicians rely on drug companies to learn about prescription drugs. The American Medical Association requires physicians to complete continuing education. In Washington D.C. thirteen pharmaceutical companies are approved to provide continuing education to doctors.[29]
No Free Lunch is a website sponsored by healthcare professionals dedicated to stopping the unethical behavior of drug company-to-physician marketing and promotion. They claim that doctors are influenced by promotion, even the pen or mug given by drug reps. Gifts, even small ones create relationships, obligations and the need to reciprocate. There have been observational studies that show that doctor’s prescribing behavior is influenced by promotions and interactions from drug reps. No Free Lunch claims, “Doctors who practice on the basis of promotion, meet with reps, and use information provided by them are more likely to prescribe more expensive, inappropriate medication.”[30] Drug companies know this. That is why they spend 80% [31]of their 57.5 billion[32] dollars a year on marketing to physicians. Strapped by insurance companies, health maintenance organizations, the overbearing legal system, and other forces, many doctors feel there is nothing they can do to change the system. Those who fight the system risk losing their licenses to practice.
Solution- So far, this prescription drug system paints a dismal picture for modern medicine. As one desperate arthritic blogger commented, “So all the drugs are bad. What the heck are we supposed to do?! Rot in our wheelchairs and die?” No, luckily there is good news. The good news lies in the statistics. While 106,000 deaths a year seems like a large number, it is insignificant compared to the 3.7 billion prescriptions filled a year. Compared to 3.7 billion prescriptions, even 2.2 million serious adverse drug reactions are only about 16% of the total number.
There is more good news from the World Health Organization, “At least 60% of ADRs are preventable, and can be due to: wrong diagnosis of the patient’s condition; prescription of the wrong drug or wrong dosage of the right drug; an undetected medical, genetic or allergic condition that might cause a patient reaction; self-medication with prescription medicines; not following the instructions for taking the medication; and reactions with other drugs (including traditional medicines) and certain foods… Vigilant assessment of the risks and benefits of medicines promotes patient safety”
To avoid ADRs, become familiar with prescription drugs before taking them. You should know that Ibuprophen, aspirin and most arthritis medications are so highly linked to severe gastrointestinal bleeding that these NSAIDS have their own disease name: NSAID Gastropathy. Oral contraceptives and Hormone Replacement Therapy are highly linked to blood clots, strokes and heart attacks. Statins are highly linked to liver problems, severe muscle degeneration and early dementia. You should know that if 150 people have a cholesterol level of 280, and all are taking a statin drug, only one of them would be ‘saved’ from a heart attack. The other 149 would not have suffered the heart attack even with a cholesterol level of 280.[33] It’s called the ‘number needed to treat’ and it is very different than the statistics doctors usually give to patients when suggesting medications. You should know that Erythromycin, an antibiotic is linked to hepatitis (liver disorder) and it is part of a group of antibiotics called macrolides that cause long QT. Long QTs are highly linked to torsades de pointe, an unsustainable heart rhythm. Pepcid, Effexor, Zoloft, Paxil, and others are also linked with long QT under certain conditions.[34] That means in a small way, these medications can be linked to sudden death. Our own due diligence can save us from regret. To avoid the risks of adverse drug reactions and sudden cardiac death, patients can guard themselves with knowledge about the flaws in the system and the nature of drugs to make informed and better decisions.
Health reporter Kristin Dold suggests, “Before taking any prescription drug, ask your doctor the following three questions: Are there nondrug options I can try first? Why did you pick this medication over others? And what are the pros and cons of taking this? If he or she brushes off your queries, it’s time to find a new MD.”[35]
As Dr. Peter Salgo suggests, “This leaves the solution to the problem in the hands of our patients. You, the patient, are the system’s best hope. In the age of seven-minute health care, you need to realize that you employ doctors. That is, your doctor works for you…Evaluate what it is you expect from your doctor, then ask for it. If you are unhappy with your doctor, fire him…the true power in the health care economy rests not with the doctors and certainly not with the backroom business staff [and not with drug companies] it rests with you. If you insist on being treated with care and respect, you will be. And the system will improve as a result.” [36]
The highest health goal to hope for is in the words of Thomas Edison, “The doctor of the future will give no medicine but will interest his patients in the care of the human frame, in diet and in the cause and prevention of disease.”[37]
Footnotes:
[1] World Health Organization. (2008) http://www.who.int/mediacentre/factsheets/fs293/en/ Fact Sheet No 293, Page Last Updated Oct 2008
[2]Lazarou.J. (1989). The Journal of the American Medical Association, JAMA. 1998;279(15):1200-1205. doi:10.1001/jama.279.15.1200
[3]FDA www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf includes 2010 information
[4] FDA “CDER 2004 Report to the Nation: Improving Public Health Through Human Drugs” www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/WhatWeDo/ucm078941.pdf
[5] FDA www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm Page last updated 8/19/2010
[6] FDA www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm Orange Book Preface 32nd Edition, FDA Center for Drug Evaluation and Research Approved Drug Products with Therapeutic Equivalence Evaluations
[7] FDA www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/sld008.htm
[8] www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm Page Last Updated January 25, 2012
[9]www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm Page Last Updated April 27, 2012
[10]www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm Page Last Updated July 15, 2011
[11] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[12]IMS www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/POTop-line%20Market%20Data/Top_Therapy_Classes_by_Sales.pdf
[13] Congressional Budget Office www.cbo.gov/sites/default/files/cbofiles/ftpdocs/76xx/doc7615/10-02-drugr-d.pdf October 2006, Research and Development in the Pharmaceutical Industry
[14] Johnson, L, A. (2011) Prescription-drug prices to plunge as patents expire. The Seattle Times, July 24, 2011
[15] Herper, M, (2012) The Truly Staggering Cost Of Inventing New Drugs. Forbes www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/
[16] Congressional Budget Office (2006) Research and Development in the Pharmaceutical Industry, p. 23
[17] Congressional. p. 20
[18] Angell, M.D. M. (2004) The Truth About Drug Companies. New York: Random House. p. 15.
[19] IMS www.imshealth.com/deployedfiles/ims/Global/Content/Corporate/POTop-line%20Market%20Data/Top_Therapy_Classes_by_Sales.pdf
[20] Dilanian, K. (2007, March 10). Senators Who Weakened Drug Bill Got Millions From Industry. USA Today. www.usatoday.com/news/washington/2007-05-10-senators-drug-bill_N.htm
[21] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[22] The Kaiser Family Foundation. www.statehealthfacts.org/profileind.jsp?sub=66&rgn=1&cat=5
[23] Bureau of Labor Statistics. Occupational Outlook Handbook 2012-2013 edition. www.blsgov/ooh/Healthcare/Physicians-and-surgeons.htm
[24] U.S. Department of Commerce. www.census.gov/main/www/popclock.html
[25] Salgo, P, MD. (2006, March 22). The Doctor Will See You for Exactly Seven Minutes. The New York Times. www.nytimes.com/2006/03/22/opinion/22salgo.html
[26] Groopman, J. (2007). How Doctors Think. Boston, Houghton Mifflin. p.77
[27] www.rightdiagnosis.com/intro/common.htm
[28] Groopman, J. (2007). How Doctors Think. Boston, Houghton Mifflin. p. 266
[29] Health Professional Licensing Administration. List of Pharmaceutical Companies Approved for Continuing Education. Hpla.doh.doc.gov/hpla/cwp/view,a,1195,q,501203.asp
[30] www.nofreelunch.org/faqs.htm
[31] Rosenthal, M. (2002, February 14) Promotion of Prescription Drugs to Consumers. The New England Journal of Medicine. 346:498-505
[32] Gagnon, M-A; Lexichin, J (2008) The Cost of Publishing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PloS Med 5(1): el. Doi:10:1371/journal.pmed.0050001
[33] Groopman, J. (2011). Your Medical Mind, How to Decide What Is Right for You. New York, The Penguin Press. pp. 17, 24.
[34] The Critical Path Institute. Drugs with Conditional Risk of Torsades http://www.azcert.org/medical-pros/drug-lists/list-04.cfm
[35] Dold, K. (2012, June 3). Doctors Behaving Badly: 7 Types to Watch Out For. MSNBC.MSN www.todayhealth.today.msnbc.com/_news/2012/06/03/12034113-doctors-behaving-badly-7-types-to-watch-out-for?lite
[36] Salgo, P, MD. (2006, March 22). The Doctor Will See You for Exactly Seven Minutes. The New York Times. www.nytimes.com/2006/03/22/opinion/22salgo.html
[37] www.snopes.com/quotes/edison.asp
RSS Feed