Lessons from the 4th Century BC:“First Do No Harm”

Wendy J. Wolf, MD, MPHPresident & CEO

Maine Health Access Foundation

www.mehaf.org

The Maine Health Access Foundation (MeHAF)

Maine’s largest private non-profit health care foundation created in April 2000 from the sale of Blue Cross & Blue Shield to Anthem Charged with increasing access to care state-wide for Maine’s uninsured and underservedCurrent Assets: $110 millionAnnual grants & program spending: $ 5 million

The MeHAF mission is to promote affordable The MeHAF mission is to promote affordable

and timely access to comprehensive quality and timely access to comprehensive quality

health care, and improve the health of every health care, and improve the health of every

Maine resident. Maine resident.

MeHAF supports strategic solutions for Maine’s health

care needs through grants and other programs,

particularly for projects that serve the uninsured and

medically underserved.

MeHAF has awarded millions to advance its mission and serve Maine people

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Since 2002, MeHAF has awarded over $30 million in cumulative grant and program support to nonprofits across Maine

MeHAF’s role in advancing access to medications for people who are uninsured, and promoting better

patient and family-centered care Grant Programs:

Medication Assistance Programs: Pharmacy benefit enrollment & medication management

Integration Initiative: Grants to advance integrated care between primary care, mental & behavioral health, and oral health

Special Grants: Medicare D outreach & enrollment with GOHPF, DHHS, Legal Services for the Elderly and Area Agencies on Aging

Advocacy: ME Citizen Leadership Fund grant for Rx drug education for Maine’s seniors and people with disabilities

Convening: Medication Management stakeholder group meetings

Policy studies: Adverse drug event analysis Education support: Academic detailing meeting

and this conference

Prescription Drugs: The good news

The development of effective pharmaceuticals has revolutionized medical care, offering treatments for a vast array of acute and chronic illnesses:

Some pharmaceuticals prevent or cure illnesses, especially those that historically resulted in premature death and disability (antibiotics, vaccines)

Most pharmaceuticals focus on alleviating the symptoms or side effects of chronic disease

The US has been a leader in the development of new pharmaceuticals and the industry is one of the nation’s most successful private sectors in the US economy.

Prescription Drugs:The not-so-good news

The growth of prescription drugs has resulted in an explosion of polypharmacy that often causes negative health outcomes

The rise of prescription drug costs is a significant factor in the rise of overall health care costs in Maine and the USA, and the retail prices of Rx drugs have more than doubled over the past decade

The growth of pharmaceutical industry profits has driven a greater focus on “copy-cat” drugs that target “profitable” illnesses.

Direct to consumer advertising has fueled consumer demand for drug therapy for many conditions that can be improved by life-style modification

Prescription Drugs:The concerning news

The growing use of pharmaceuticals in humans and animals has driven new issues for concern:

Growth of pro-industry bias that has eroded the objectivity of scientists, physicians and regulators

Promotion of off-label use to expand market share

Rx overuse and resistance

“Medicalization” of non-illness

Unintended consequences of newer technologies (genetic engineering)

Cross-species effects

Environmental impact

Prescription Drugs:The not-so-good news

Growth of Rx drug use

Dangers of polypharmacy

The role of medications in rising health care costs

Growth of Rx Drugs

Prescription drug use is the highest ever among insured Americans*

More than half of al insured Americans (51%) are taking Rx meds regularly for chronic health problems

Americans buy much more medicine per person than another country

Most widely used drugs: Anti-hypertensives

Lipid-lowering

Among seniors, 28% of women

and 22% of men take > 5 meds

Largest increase in 20–44 year olds

primarily due to more drugs for

depression, diabetes, asthma

ADD, seizures*Data from Medco Health Solutions Inc, May 2008

Rise of Polypharmacy

Average # of prescriptions filled by each person in the US increased from 8.9 per year in 1997 to 12.6 per year in 2007

Polypharmacy increases the risk of drug-drug interactions and adverse drug events (ADEs)

ADEs account for a significant number of hospitalizations in Maine (based on primary or secondary discharge diagnosis)

Quality medication management needs to focus on managing ALL medications – and DISCONTINUING medications that are ineffective or no longer needed

Prescription drugs account for a significant proportion of National Health Expenditures

Levit et al. Health Affairs, Jan/Feb 2003 and 2005 CMS Services Data

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Why are prescription drugs so costly?

Drug research & development is costlyPhRMA estimates the average cost of bringing one new drug to the market is $500 millionThe industry estimates this process takes an average of 12-15 years

However, the largest portion of the pharmaceutical industry’s budget goes toward advertising and marketing rather than research and development

Pharmaceutical companies spend 2 ½ times more on marketing and administration than on research and development.Academic researchers in public and private institutions frequently spearhead the development of new drugs with funding from the federal National Institutes of Health. Although tax dollars support this research, these discoveries are increasingly sold to private industry for development and profit.

Direct to consumer advertising is a significant factor driving up the cost of Rx drugs – but does it result in better quality and health outcomes?

The drug industry spends $3 billion/year in DTC ads

The industry argues:Educates patients about medical conditions, treatment options, side effects, etcPrompts dialogue between providers and patientsImproves appropriateness of prescribingImproves compliance

Others say:Increases cost by prompting requests for brand name drugsPromotes newer more expensive Rx,often with higher profit margin

Prescription Drugs:Opportunities for advocacy

The growing use of pharmaceuticals in humans and animals has prompted new issues for advocacy:

Growth of pro-industry bias that has eroded the objectivity and trust by scientists, physicians and regulators Promotion of off label use to expand market share“Medicalization” of non-illnessRx overuse and resistanceUnintended consequences of newer technologies (genetic engineering) Cross-species effectsEnvironmental impact

Prescription Drugs: Pro-Industry Bias

Erosion of Firewalls between Science and Industry The pharmaceutical industry has transformed the culture of medical school and scientists conducting basic research, instilling a pro-industry bias*

Example: Dr. Charles Nemeroff of Emory University—the principal investigator on a government-financed study of antidepressant drugs made by GlaxoSmithKline—failed to report almost a half a million dollars he was paid in fees and expenses from the drug company while he led the study (NY Times, 10/11/2008)

Researchers were 5 times more likely to recommend a drug when a study was funded by the industry rather than by a non-profit

Drug companies pay for postgraduate accreditation courses for doctors. Under the guise of offering educational opportunities for doctors, drug companies use the lectures and conferences they sponsor to push their products

Schools and medical centers often hold equity in the start-up companies that sponsor their research

*Angell, JAMA Sept 2008

Prescription Drugs:Opportunities for advocacy

Special issues for children

Promotion of off label use

Applying adult models to

childhood conditions

“Medicalization” of non-illness

Rx overuse and resistance

Unintended consequences

Prescription Drugs: Opportunities for advocacy Insure access – and advocate for standardization of pharmacy benefit programsPromote quality medication management that insure that unneeded or ineffective medications are eliminated (and returned to drug disposal sites).Advocate for comprehensive health information through better health IT and HealthInfoNet Support policies that insure scientific rigor, strict attention to conflict of interest and insure firewalls between industry, scientists, and providers to insure science and evidence is unbiased (Ex: Grassley/Kohl bill that would require drug companies to publicly disclose payments to physicians > $500/yr) Broad program to support academic detailing to combat promotion of brand name drugs and off label use Advance public policies that balance medication costs with quality and effectiveness Consider regulation to limit “medicalization” of non-illness so insurers are protected from mandates to cover non-evidence based treatmentsProactive hospital and insurer policies, and consumer education to prevent Rx overuse and resistanceSurveillance/examination of unintended consequences of newer technologies (genetic engineering) Convening of key leaders/researchers to examine cross-species effectsPolicies and public education to mitigate environmental impact

These issues touch every person in Maine – and we all have a stake in addressing these

health care challenges