The pharmaceutical industry is facing substantial criticism from many
directions, including financial barriers to access to drugs in both developed
and developing countries, high profits, spending on advertising and marketing,
and other issues. Underlying these criticisms are fundamental questions about
the value of the current patent-based drug development system. Six major problems
with the patent system are (1) recovery of research costs by patent monopoly
reduces access to drugs; (2) market demand rather than health needs determines
research priorities; (3) resources between research and marketing are misallocated;
(4) the market for drugs has inherent market failures; (5) overall investment
in drug research and development is too low, compared with profits; and (6)
the existing system discriminates against US patients. Potential solutions
fall into 3 categories: change in drug pricing through either price controls
or tiered pricing; change in drug industry structure through a “buy-out”
pricing system or with the public sector acting as exclusive research funder;
and change in development incentives through a disease burden incentive system,
orphan drug approaches, or requiring new drugs to demonstrate improvement
over existing products prior to US Food and Drug Administration approval.
We recommend 4 complementary reforms: (1) having no requirement to test new
drug products against existing products prior to approval but requiring rigorous
comparative postapproval testing; (2) international tiered pricing and systematic
safeguards to prevent flow-back; (3) increased government-funded research
and buy-out for select conditions; and (4) targeted experiments using other
approaches for health conditions in which there has been little progress and
innovation over the last few decades.
Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more
Subscribe for full-text access to content from 1998 forward and a host of useful features
Activate your current subscription (AMA members and current subscribers)
Purchase Online Access to this article for 24 hours
Data from Centers for Medicare and Medicaid Services.6
Data from Pharmaceutical Industry Profile 2005 .9
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and
Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early
dhildhood mortality and growth failure data and their association with maternal
Thank you for submitting a comment on this article. It will be reviewed by JAMA editors. You will be notified when your comment has been published. Comments should not exceed 500 words of text and 10 references.
Do not submit personal medical questions or information that could identify a specific patient, questions about a particular case, or general inquiries to an author. Only content that has not been published, posted, or submitted elsewhere should be submitted. By submitting this Comment, you and any coauthors transfer copyright to the journal if your Comment is posted.
* = Required Field
Disclosure of Any Conflicts of Interest*
Indicate all relevant conflicts of interest of each author below, including all relevant financial interests, activities, and relationships within the past 3 years including, but not limited to, employment, affiliation, grants or funding, consultancies, honoraria or payment, speakers’ bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued. If all authors have none, check "No potential conflicts or relevant financial interests" in the box below. Please also indicate any funding received in support of this work. The information will be posted with your response.
Some tools below are only available to our subscribers or users with an online account.
Download citation file:
Web of Science® Times Cited: 36
Customize your page view by dragging & repositioning the boxes below.
More Listings atJAMACareerCenter.com >
and access these and other features:
Enter your username and email address. We'll send you a link to reset your password.
Enter your username and email address. We'll send instructions on how to reset your password to the email address we have on record.
Athens and Shibboleth are access management services that provide single sign-on to protected resources. They replace the multiple user names and passwords necessary to access subscription-based content with a single user name and password that can be entered once per session. It operates independently of a user's location or IP address. If your institution uses Athens or Shibboleth authentication, please contact your site administrator to receive your user name and password.