IS CHEMO SCIENCE BASED?
Do you think your Oncologist prescribes drugs based on “scientific evidence”?
Journal of Clinical Oncology, 2013, Mar 20; 31(9): 1134–1139
Prevalence of Off-Label Use and Spending in 2010 Among Patent-Protected Chemotherapies in a Population-Based Cohort of Medical Oncologists. By: Conti et al
“The extent of inappropriate chemotherapy use is a public policy concern because of the cost and potential harms to patients from the use of toxic agents with little likelihood of clinical benefit.” [1-4 ]
1. Shrank WH, Asch SM, Adams J, et al: The quality of pharmacologic care for adults in the United States. Med Care 44:936-945, 2006
2. Chassin MR, Galvin RW: The urgent need to improve health care quality: Institute of Medicine National Roundtable on Health Care Quality. JAMA 280:1000-1005, 1998
3. Laetz T, Silberman G: Reimbursement policies constrain the practice of oncology. JAMA 266: 2996-2999, 1991 [Erratum: 267: 3287, 1992]
4. Giordano SH, Lin YL, Kuo YF, et al: Decline in the use of anthracyclines for breast cancer. J Clin Oncol 30:2232-2239, 2012
A 2008 study found that 81% of oncologists had used chemotherapy drugs “*off-label”.
Journal of Clinical Oncology, 2008, December 20, vol. 26, no. 36, pages; 5994-6000
Self-Reported Practices and Attitudes of US Oncologists Regarding Off-Protocol Therapy
By: Jeffrey Peppercorn, Harold Burstein, Franklin G. Miller, Eric Winer, and Steve Joffe
“…Ninety-three percent reported ever discussing and 81% ever prescribing…”
*off-la·bel, adjective- relating to the prescription of a drug for a condition for which it has NOT been officially approved.
Oncologists promote chemotherapy as “evidence-based medicine” because it’s approved by the FDA. But when 30-80% of chemotherapies are prescribed off-label, outside of their intended use, on cancers they have never been approved to treat, where is the evidence?!
American Cancer Society, 2015, March 17 Bulletin titled; Off-label Drug Use
“Studies have reported that about half of the chemotherapy drugs used are given for conditions not listed on the FDA-approved drug label.”
The National Cancer Institute has stated, “Frequently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs.” From; Off-Label Drug Use in Cancer Treatment, Posted: January 1, 2014
Journal of The American Medical Association, 2007;297(2):205-208
A new era of unapproved drugs: The case of Abigail Alliance v. Von Eschenbach. By: Jacobson & Parmet
“The idea that the way to save lives is through unapproved drugs offers the illusion of choice and the reality of false hope—not an acceptable basis for public policy.”
Archives of Internal Medicine, 2006,166(9):1021-1026
Off-label Prescribing Among Office-Based Physicians, By: Radley et al
A total of approximately 150 million audited prescriptions were prescribed “*off label”.
“Using data from a nationally representative survey of office based physicians, we found that about 21% of all estimated uses for commonly prescribed medications were off label, and that 15% of all estimated uses lacked scientific evidence of therapeutic efficacy…Among off-label mentions, most (73%) lacked evidence of clinical efficacy, and less than one third (27%) were supported by strong scientific evidence.
*off-la·bel, adjective- relating to the prescription of a drug for a condition for which it has NOT been officially approved.
New South Wales Department of Health, September 2003
Off-Label Use of Registered Medicines and Use of Medicines under the Personal Importation Scheme in NSW Public Hospitals
A Discussion Paper
“In a survey of 130 patients conducted at the Peter MacCallum Cancer Institute in Melbourne in January 2001, there were 1351 medication orders of which 17.9% were for off-label uses. Of these, 8.7% were used for off-label indications, 10.3% for off-label dose and 2.8% for off-label route. Ninety two per cent of patients received at least one medicine that was prescribed off-label or that was unlicensed.”
Annals of Oncology, 2007, 18: 1923–1925
The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO), By: P. G. Casali
“All drugs need to be given a marketing authorization by a relevant regulatory body in order for patients to receive them… In fact, by prescribing a drug off-label, the physician is asked to take a special responsibility. Formally, he is prescribing something which the regulatory body has not stated is safe and effective…off-label uses of drugs might be viewed as illegal…”
Journal of Oncology Practice, September 2005, vol. 1, no. 3: pages 102-105
“Off-Label” Indications for Oncology Drug Use and Drug Compendia: History and Current Status
“Today 50% to 75% of all uses of drugs and biologics in cancer care in the United States are off-label…”
Journal of Clinical Oncology, 2013, vol. 31, no. 9: pages 1125-1127
Off-Label Use of Cancer Drugs: A Benchmark Is Established, By: Monika K. Krzyzanowska
“…the main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk-benefit ratio is often not completely understood in circumstances where off-label prescribing occurs.”
Medical Journal of Australia, 2006; 185: 544–548
Off-label use of medicines: consensus recommendations for evaluating appropriateness, By: Gazarian et al.
“…only a small proportion of off-label prescribing may be justified by scientific evidence…In addition, the legal and ethical ramifications of such prescribing appear to be a source of confusion, with variability in opinions and practice among prescribers and professional organisations.”
Canadian Standing Senate Committee on Social Affairs, Science and Technology, January 2014
Prescription Pharmaceuticals in Canada Off-Label Use
“…a recent study that found 11%, or one in nine, prescriptions were for an off-label indication… the researchers reported that 79% of the off-label prescriptions were not supported by strong scientific evidence. Strong scientific evidence was defined as including at least one randomized, controlled clinical trial (RCT)…Of particular concern, this study measured a 43% increase in ADRs [Adverse Drug Reactions] for off-label use over on-label use of prescription drugs.”
United States General Accounting Office, September 1991, Report to the Chairman, Committee on Labor and Human Resources, U.S. Senate
GAO/PEMD-91-14 Reimbursement Policies for Off-Label Drugs
Page 3- “GAO found that off-label use of anticancer drugs is widespread. A third of all drug administrations to cancer patients were off-label, and more than half of the patients received at least one off-label drug. The extent of off-label use varied by therapeutic intent, stage of disease, and type of cancer. In general, off-label use was higher where there was no consensus on the best therapy for a specific cancer.”
New England Journal of Medicine, 2008; 358: 1727-1732
Pharmaceutical Promotion to Physicians and First Amendment Rights, By: Aaron S. Kesselheim, M.D., J.D., and Jerry Avorn, M.D.
“…recent research indicates that nearly half of all prescriptions in some drug classes may be off-label, and more than 70% of off-label uses may have insufficient scientific support.”
Supportive Care in Cancer, May 2004, Volume 12, Issue 5, pp 302-305
Off-label prescribing in oncology, By: Susan G. Poole, & Michael J. Dooley
“In our experience, the frequent practice of off-label prescribing in oncology poses added difficulties to an already complex medication regimen. There are limited published data on off-label prescribing in oncology..[and yet]..up to one-half of all chemotherapy is used for an off-label indication.”
Journal of the American Medical Association, 2008;300(9): pages 1069-1071
Industry-Sponsored Clinical Research A Broken System
By: Dr. Marcia Angell, M.D., Harvard Medical School, former editor-in-chief of the New England Journal of Medicine.
“…physicians learn to use drugs for off-label uses without good evidence of effectiveness. Although it is illegal for companies to market drugs for off-label uses, faculty “thought leaders” on company speakers’ bureaus regularly promote off-label uses in the guise of education or research.”
United States Congress. Advertising, marketing and promotional practices of the pharmaceutical industry: Hearing before the committee on labor and human resources. 101st Congress, 2nd Session. Washington, DC: U.S. Government Printing Office; 1991. Senator Edward M. Kennedy on p-154 “…why did Abbott sponsor an all-expenses-paid symposium at Disneyworld for doctors and spouses, devoted entirely to unapproved uses of Lupron?”
The practice of off-label drug prescribing violates the very foundation of “evidence-based medicine.” It makes a mockery of the claim that all medications are based on “good science”.
So how many off-label prescriptions are actually happening?
ACS Chemical Neuroscience, 2012, 3, 630−631
The Top Prescription Drugs of 2011 in the United States: Antipsychotics and Antidepressants Once Again Lead CNS Therapeutics
By: Dr. Craig W. Lindsley, Ph.D., Editor-in-Chief
“Total prescription drug sales in the United States increased from $308.6 billion in 2010 to $319.9 billion in 2011 (an∼3.5% increase despite pressure from generics), with a concomitant increase in prescriptions dispensed (3.99 billion in 2010 compared to 4.02 billion in 2011).”
So 4.02 billion total prescriptions were written in 2011 alone in the U.S.
Consumer Reports, Shopper’s guide to prescription drugs- number 6 “Off-Label” drug use. Produced by Consumers Union and Consumer Reports Best Buy Drugs, a public information project supported by grants from the Engelberg Foundation and the National Library of Medicine of the National Institutes of Health. “One in five prescriptions in the U.S. is for a use not approved by the FDA. And most of those (about 75 percent) are for a use that lacks any evidence or rigorous studies to back it up.”
Dr. Allen Roses, Glaxo-SmithKline’s worldwide vice-president of genetics-
“The vast majority of drugs – more than 90 per cent – only work in 30 or 50 per cent of the people.”
Therapeutic area: drug efficacy rate in per cent
- Alzheimer’s: 30
- Analgesics (Cox-2): 80
- Asthma: 60
- Cardiac Arrythmias: 60
- Depression (SSRI): 62
- Diabetes: 57
- Hepatits C (HCV): 47
- Incontinence: 40
- Migraine (acute): 52
- Migraine (prophylaxis)50
- Oncology: 25
- Rheumatoid arthritis50
- Schizophrenia: 60
The Independent 2
New Zealand Herald
Royal Pharmaceutical Journal
So out of more than 4 billion prescriptions written each year in the United States, over 600 million are “off-label” prescriptions that utterly lack FDA-approved efficacy and scientific proof. In addition, most drugs are admitted not to work at all most of the time. Science based medicine is really not so “scientific” after all…
Shouldn’t the medical technology we use be rooted in a foundation of good and tested science? The answer is yes, but this just doesn’t happen most of the time. Is Modern Medicine Really Scientific?
The United States Congressional Office of Technology Assessment reviewed current medical practice in the United States in 1978 to determine how much day to day practice was tested by the scientific method. Its report, Assessing the Efficacy and Safety of Medical Technologies, astonished those who believe in the myth of modern scentific medicine. It concluded that “only 10 to 20 percent of all procedures currently used in medical practice have been shown to be efficacious [effective] by controlled trial.” In other words, 80 to 90 percent of what doctors do is scientifically unproven guesswork. By this government-supported definition, most of modern medicine is quackery.
As time goes by, the song remains the same…
British Medical Journal, 1991 Oct 5; 303(6806):798-9
Where is the wisdom. ..? The poverty of medical evidence
By: Dr. Richard Smith, former editor of the British Medical Journal and chief executive of the BMJ publishing Group for 13 years.
“Only about 15% of medical interventions are supported by solid evidence…This is partly because only 1% of the articles in medical journals are scientifically sound, and partly because many treatments have never been assessed at all.”
In 1995, the United States Congressional Office of Technology Assessment compared medical technology in eight countries (Australia, Canada, France, Germany, Netherlands, Sweden, United Kingdom, and the United States) and again noted that few medical procedures in the U.S. had been subjected to clinical trial. The same study also reported that infant mortality was high and life expectancy was low, compared to other developed countries.
Journal of Evaluation in Clinical Practice, (2007), 13, 481–503
Medicine and evidence: knowledge and action in clinical practice, By: A. Miles et al.
“A fundamental assumption of EBM (Evidence Based Medicine)… is that doctors who practise it provide superior clinical care compared to those who do not…so far no convincing direct evidence exists that shows that this assumption is correct…It is noteworthy that the advocates of EBM (Evidence Based Medicine) have consistently avoided the organisation of, or involvement in, this most fundamental of scientific processes – the testing of an hypothesis…its advocates do not cite this one, single fundamental and serious deficiency – the complete lack of an evidentiary basis of EBM (Evidence Based Medicine).”
BMJ Clinical Evidence comprises a database of high-quality, rigorously developed systematic overviews assessing the benefits and harms of treatments”, and has proceeded to categorise the effectiveness of 3000 treatments with an astonishing and in fact shocking outcome. The data exhibited reflects to what extent treatments are evidence-based. The outcome of this categorisation has shown that a mere 11% of trials and studies show beneficial outcome, 24% are considered likely to be beneficial with the remaining 65% ranging from questionable, of unknown effectiveness, to ineffective or harmful. Accessed February 2016
Pseudo-Evidence Based Medicine: When Biomedical Research Becomes an Adjunct of Pharmaceutical Marketing.
In Free Knowledge¸ editors: Patricia W. Elliott and Daryl Hepting, University of Regina Press, 2015, pp. 26-42
By: Professor Arthur Schafer, University of Manitoba
“When the evidence on which evidence-based medicine relies has been massaged or otherwise tainted, then it scarcely provides a reliable tool for medical decision making. In the interests of truth-in-advertising, perhaps the medicine practised in this era of corporate-university partnerships should be referred to as ‘pseudo-evidence-based medicine’.”