23 May 2006

Web-Kusuri-no-Check International No9

Call for Ban on Direct-to-Consumer Advertisement (DTCA) in New Zealand

On 28 April 2006, the following letter, written by the Executive Group of NPOJIP, was submitted to the Ministry of Health in New Zealand, in support of ban on DTCA.

Kusuri-no-Check Rokuro Hama M.D.

DTCA Consultation
 Sector Policy Directorate
 Ministry of Health
 PO Box 5013
 WELLINGTON, New Zealand

Dear Sir or Madam,

Non-profit organization Japan Institute of Pharmacovigilance (NPOJIP) publishes "Kusuri-no-Check (Check-up your Medicine in Japanese)," an independent drug bulletin aimed at both public and professionals in Japan. It has been a full-membership drug bulletin belonging to ISDB (International Society of Drug Bulletin) since 2000.

Kusuri-no-Check supports ban on DTCA and stands against retaining DTCA in New Zealand. Therefore, we support Option 3: Ban DTCA and regulate disease-state advertising (Therapeutic Products Advertising Code + harmonisation with Australia's policy on DTCA and disease-state advertising).

We are very much concerned about DTCA in New Zealand because the state of DTCA in New Zealand might influence that in Japan very much. It might become a major issue also in Japan in the near future.

Our concern about DTCA is related to rational use of medicines.

Innovative drugs with truly therapeutic advance have been developed in 1970s and 1980s. Only few good drugs have been developed since 1990 worldwide, though many new agents with strong biological actions such as agonists or antagonists of many receptors have been developed, utilizing high technology.

Pharmaceutical industries do not want to sell better but rather older drugs. They want to sell new drugs with less proved efficacy and with less proved safety because new drugs are expensive and produce more profit for the industries.

Methods for evaluating drugs such as RCTs, systematic reviews with meta-analysis and pharmaco-epidemiological methods have been well developed, and EBM has been better recognized as essential for daily medical practices among health care professionals especially since around 1990.

To overcome this critical and unfavorable situation for pharmaceutical industries and regulatory agencies especially of US, EU and Japan, they facilitated the development of deregulation strategies against what pharmaceutical industries consider as "over-regulation" after the thalidomide disaster in 1961.

Deregulation methods against may be as follows:

  1. Data manipulation without actually Lying to Overcome the Truth (so called HARLOT by Sacket et al in BMJ 2004),
  2. Medicalization or disease mongering,
  3. Closure of scientific data of evidence,
  4. Funding by pharmaceutical companies of key organizations and/or persons including drug regulatory agencies, academies, the media and patients groups and
  5. DTCA.

Pressure of medicalization or disease mongering is becoming bigger and bigger recently even without DTCA, for example, guidelines for treatment of hypertension forces doctors to treat otherwise healthy people as patients (see the attached power point slides). The other examples are statins for lipidemia, SSRIs for depression, anti-cancer agents such as gefitinib (Iressa) in Japan and so on.

If DTCA is banned in New Zealand, it will contribute to prevent introduction of DTCA in other countries such as Japan and European countries.

To encourage rational use of drugs, it may be very important to restrict overuse of new and less qualified prescription medicines, to restrict medicalization or disease mongering to prevent public from being harmed by medication and maximise public health and safety.

This submission is written by the Executive Group of our organization according to the fundamental policy of the organization: independent drug bulletin "Kusuri-no-Check" for evidence-based rational use of drugs.

Yours Sincerely,

Rokuro Hama MD
 Chairman of Non-profit organization
 Japan Institute of Pharmacovigilance publishing
 ISDB-full-membership Drug Bulletin "Kusuri-no-Check"

Deputy Editor of The Informed Prescriber
 Invited professor of Osaka University of Pharmaceutical Sciences

#402 Ohsaka 2-3-2, Tennouji-ku, Osaka, Japan 543-0062
 TEL +81-6-6771-6345 Fax +81-6-6771-6347
 URL http://www.npojip.org/