Show Me the Evidence!. Identifying the Truth about Rx Drugs Enter event/location May 19, 2008. Faculty Disclosure. Your Name Here, MD Dr. Your Name Here reports that he has No Conflict of Interest with this presentation.
Identifying the Truth about Rx Drugs
May 19, 2008
Your Name Here, MD
Dr. Your Name Here reports that he has No Conflict of Interest with this presentation.
In accordance with the requirements of the Standards for Commercial Support of the Accreditation Council for continuing Medical Education adopted by the AMA and the Oregon Medical Association, each instructor is asked to disclose any affiliations with, or financial interests in, companies whose products are discussed in his/her presentation.
Event/Location of Lecture CME Presentation
May 19, 2008
$2.1 trillion or $7,026 per person
Health care inflation generally outpaces increase in GDP.
When health care costs rise faster than the overall economy, affordability and range/quality of benefits decrease.
Health Affairs 2008;27(1):14-29
Medical Expenses: 22 Developed Countries
Per Person Annual Medical Expenses
2007 DMAP class 07/11 expenditures (total fund, excludes rebates)
http://www.oregon.gov/DHS/aboutdhs/budget/07-09budget/index.shtml (accessed 6/10/08)
http://www.oregon.gov/DAS/BAM/GRB0709.shtml (accessed 6/10/08)
Increased at a faster rate than any other area of health care over the last 15 years
Major contributor to rising health care costs
Responsible for a large portion of insurance cost increases
Costs increased because of
Increased utilization (prescribing rate)
Increased price per prescription
Increase in prescription drug coverage
More chronic conditions
Impact of Medicare Coverage
Price increases for existing drugs exceed inflation
Largest driver of increased Rx spending
Newer drugs replace older less expensive agents
Shorter approval time
Marketing of newer agents drives market share
Source: Kaiser/HRET Survey of Employer-Sponsored Health Benefits
Health care affordability continues to deteriorate
Health costs, including Rxs, expected to rise faster than economy
Increased consumer out-of-pocket costs increased premium share, deductibles, co-insurance, and co-payments
State & Federal budget deficits
Increased rate of uninsured/underinsured
Currently, the US spends more per capita on health care than any other developed country, yet is ranked near the bottom in terms of quality.
Continuing on the current path has huge societal implications. How much more can we spend?
The alternative is to spend more wisely.
Payers are looking at all options to contain health care and pharmaceutical costs, and to get better value.
This creates a great opportunity for prescribing physicians.
US has 5% of the worlds population but 50% of drug consumption
Strategies to expand markets
Promotional campaigns change the way people think about common ailments
Menopause becomes hormone deficiency
Shyness becomes social anxiety disorder
Acid indigestion becomes gastroesophageal reflux disease
Lowering thresholds for treating common conditions
Selling Sickness by Moynihan and Cassels
Does not assess cost vs benefit for a drug or device.
Does not determine whether one drug is better than another.
Does not approve every use to which a product may be put.
Does not require large trials that will identify all potentially rare complications.
and Advertising, 2005
Total spending: $29 billion
(Source: IMS Health, in Donohue, NEJM 2007)
Socolar D, Sager A. Pharmaceutical marketing and research spending: the evidence does not support PhRMA’s Claims.
http://dcc2.bumc.bu.edu/hs/sager/pdfs/120601/DrugIndustryMarketingStaffSoarswhileReserchStaffingStagnates5Dec01.pdf; Accessed 3/6/08
*Med Ad News 2004;23(3):1
*Sigworth SK et al. JAMA. 2001;286(9):1024-5.McKinney WP et al. JAMA 1990;264(13):1693-7
**Chren MM et al. JAMA 1994 Mar 2;271(9):684-9; Lurie N et al. J Gen Int Med 1990;5:240-243; Wazana A. JAMA 2000 Jan 19;283(3):373-80.
(Wazana A, JAMA 2000)
*Shuchman, NEJM, 2007
**Donohue et al. NEJM, 2007
***Eaton, Stanford University Press, 2004
****Gellad et al. Amer J Med, 2007
*Eaton, Stanford University Press, 2004
**Rosenthal, NEJM, 2002
1999 review of pharm ads from 10 US journals:
Ann Intern Med 2007;146:742-48
Source: ACCME, Annual Report Data 2006
(Wazana A, JAMA 2000)
(Bowman MA, Mobius1986)
J Gen Int Med 2007;22:184-90
“The best defense the physician can muster against (misleading) advertising is a healthy skepticism... cultivate a flair for spotting the logical loophole, the invalid clinical trial . . . and the unlikely claim. Above all, develop greater resistance to the lure of the fashionable and the new.”
P.R. Garai, 1964
“First of all, do no harm” (Hippocratic Oath)
2008 version: Never offer treatment to a patient without convincing evidence that it will provide more help than harm.
Shouldn’t we also consider help/harm to the patient’s family & overall community in this equation?
Decision making in clinical practice
What is EBM?
What EBM is not
Unfortunately, many decisions are made based on unreliable “evidence”
Expert opinion plays a heavy role in medical decision making
Personal observation or anecdotal experience can frequently overcome clear evidence to the contrary
Mulrow: Ann Intern Med, Vol 126(5) 3/1/97, pp 389-91
EBM is "the conscientious, explicit and judicious use of best current evidence in making decisions about the care of individual patients.”
Evidence based medicine requires the integration of the best research evidence with our clinical expertise and our patient’s unique values and circumstances.
Sharon E. Straus: Evidence Based Medicine 3rd Edition
A process in which we:
Ask – to precisely define a patient problem
Acquire – figure out what’s needed to answer the question, conduct an efficient search of the literature.
Appraise – Select the best of the relevant studies and apply rules of evidence to determine their validity
Apply – Extract the clinical message and apply it to the patient problem
Assess – Determine if the action was helpful
Adjust – Use the outcomes of intervention to modify the treatment
The same old thing we’ve always done
Something that can only be done from ivory towers
A “cookbook” method of practice
A method for administrators to save costs
Restricted to randomized trials
Case Control Studies
Editorials and Opinions
Lab studies and Animal Research
This work was made possible by a grant from the state Attorney General Consumer and Prescriber Education Program which is funded by the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.