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Involving consumers in the surveillance of medicines use and quality

and drug promotion

Margaret EwenCoordinator, Global Projects (Pricing)

Health Action International (HAI) GlobalAmsterdam

Email: marg@haiweb.org

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Why this issue?

• Increased focus on access – needs equal focus on rational use of medicines

• Those who are directly affected by policy decisions must be engaged in debates

• Clearly civil society needs to be involved in medicine policy debates as it directly affects their lives

• Civil society engagement: - democratic accountability- lobbying for change (individuals/groups)- providing independent evidence (surveillance)

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Expectations and accountability

• Expectation that legislators and regulators will put public health needs before any other priorities

• Expectation that regulators will be competent and enforce legislation and policies

• Expectation that health professionals will work in the best interest of patients

• Expectation that medicines are effective, good quality and of therapeutic value

• Expectation that medicines will do no harm

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Civil society understanding of medicines

CS’s understanding of medicines is weak - pill for every ill- new better than old- injection better than tablets- low cost = poor quality!- brands better than generics- generics = counterfeits!

Why? Because of competing interestsPharmaceutical promotion, media manipulation, capture by industry of regulators, MoH, doctors, pharmacists, patients groups. Governments also have interests.

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I DON’T TAKE CHANCES I DON’T TAKE CHANCES I ONLY USE ORIGINALSI ONLY USE ORIGINALS

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Civil society engagement

• CS organises as an interest group around specific issues

• But so does the government, industry, healthcare professionals etc.

• Despite CS’s mandate, it is not enough to influence the public-health agenda

• Power is unequally distributed and the CS voice is marginalised

• Governments should ensure that interest relations are equalised

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How to engage with CS

• CS is not a token partner• Appropriate selection of expertise• Facilitate CS engagement so they can actively

participate• Long term perspective• Provide an environment that equalises power

Remember, CS and governments actually often want the same thing!

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CS surveillance of medicine use

Reporting adverse medicine reactionseg. Netherlands (CSO & govt), UK (govt), Denmark (govt), Sweden

(CSO)

European Commission is now encouraging consumer AMR reporting in proposed changes to EU pharmacovigilance legislation

Canada: - consumer reporting mechanism but no public access to database- PharmaWatch & Canadian Broadcasting Corp lobbied for a copy of

database. Five years latter – on CBC website in searchable format with appropriate controls

- Health Canada issued ‘nasal’ safety advisory – nose severely out of joint!

- Within a year Health Canada put the database on their website

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Irrational medicine useTwo examples of research in India by CSO’s:• Antimicrobial use in Delhi – Anita Kotwani:

interviews consumers & health professionals, focus group discussions

• Marketing and annual turnover of irrational medicines in India – Community Development Medicinal Unit

Many examples of CSOs in North and South informing consumers &/or health professionals on rational use issues

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CS surveillance of medicine quality

• Difficult for CS to identify poor quality product. Easier to identify poor packaging.

• CS often unaware of mechanism for reporting suspect packs/product to the regulatory authority, and get no feedback when they do report

• CSO’s can identify poor quality eg. HAI Bolivia uses minilabs to test medicines

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Drug Promotion

• Is a global concern

• Contributes to the irrational use of medicines

• However…– Less than half of countries report that they

regulate promotion (46%)– Most countries rely on industry self-regulation

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Advertisement from Taiwan promotes unnecessary antibiotic use. Problematic for society (resistance) and individual patients (unnecessary exposure to potentially fatal risks).

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Pakistan 2005: 1-2 day relief claim

Excellent safety, side effect profile similar to placebo?

USA 2003: illegal ad (below) no risks, unsubstantiated 3-day relief claim

USA 2004: warning of serious risks USA 2007: safety withdrawal

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Peru 2006

Canada 2005

Same drug, same company, same unethical promotional campaign

Unapproved use Illegal direct-to-consumer advertising Costly and not very effective

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Funding of physician ‘opinion leaders’

Physicians who attended sponsored presentations on Vioxx by another physician wrote an additional $624 worth of prescriptions in the next year versus non-attendees. Sales visits only led to $127/physician/year.

Caplovitz A. NJPIRG Law & Policy Center, 2006

Marketed 1999 – 2004:

- Prescribed to 80 million people

- US spending on advertising $550 million (more than Pepsi-Cola 2000)

- VIGOR trial: 4-5 times risk of heart attack

- No more effective than other anti-inflammatory medicines for arthritis

- Estimated 88,000-140,000 extra heart attacks in US, 40% fatal

16Prescriptions for gabapentin by diagnostic category

Steinman, M. A. et. al. Ann Intern Med 2006;145:284-293

“Gabapentin [Neurontin] was promoted by using education and research, activities not typically

recognized as promotional. “independent” continuing medical education, “peer-to-peer” selling by physician

speakers, and publications…”

Approved use

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Influence on clinical practice guidelines

Survey of 192 authors of 44 chronic disease clinical practice guidelines JAMA 2002; 287:612-617

59% of authors had financial relationship with manufacturers of medicines in guideline

Do financial links matter ?• Eight of the nine authors of the US cholesterol treatment

guidelines released in 2004 had financial links to statin manufacturers

• These guidelines extend treatment to patient groups in which a morbidity and mortality advantage has not been established

• From a previous 13 million, now 40 million Americans are defined as needing treatment

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2007 CI Report Drugs, Doctors and DinnersPakistan: write 200 prescriptions of a particular new

medicine and company pays the deposit on a new car

Oct 2005, Vancouver: Bayer invites “15 local pain specialist practitioners with

knowledge and expertise in treating multiple sclerosis” to participate in the “Sativex Pain Specialist Regional Advisory Board”, Hyatt Regency“In appreciation of your participation and feedback, we are pleased to extend an honorarium of $1250… Dinner will be provided following the program.”

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Barriers to effective regulation

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weak information standards

• no active monitoring

• non-transparent complaints procedures

• little correction of misinformation

• burden of proof on complainant, ads run during adjudication

• sanctions ineffective, “the price of doing business”

• no systematic evaluation of what does and does not work to prevent misleading messages & the promotion of inappropriate use

• published evaluations and exposés of promotion that distorts science (academic, NGO, courts) have had little effect on regulatory procedure

• the sheer volume of promotional activity!

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WHA 2007 Resolution

Members governments are urged to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion on medicines, to monitor drug promotion, and to develop and implement programmes that will provide independent, non-promotional information on medicines

The key question is one of political will…..

taking the link between promotion and

public health seriously