Pharmaceutical companies sponsors

Fundamental healthcare issues may also be involved in the situation of policy-driven therapeutic research. The future investment of society in health may require a large-scale national clinical trial to answer questions relating to the prevention of disease or premature death. This type of clinical trial will not simply relate to one manufacturer s product. As such, it is preferable that the trial is organised on a national level, not necessarily with the exclusion of the company(s) involved. An independent data-monitoring committee (IDMC) should oversee the clinical trial with as much support from the pharmaceutical company(s) as possible. The clinical data collected belongs to the state and should be treated with the same quality standards as any pharmaceutical company sponsored study. 

Globally, there is concern that biased results could be produced from studies conducted by investigators who own shares or other financial benefits in the pharmaceutical company sponsoring their trials. The Declaration of Helsinki (2000) requires that sources of fimding, institutional affiliations and possible conflicts of interest should be declared in any publication. All studies conducted on products that are likely to be part of a submission to the US FDA require the sponsor to make a disclosure of financial holdings of the investigators that participate in all studies. Any significant pa)unents (US 25000)... 

Applications for listing a product on the PBS are generally submitted by the pharmaceutical company sponsor, which has the data required to support the application, to the Pharmaceutical Benefits section of the Department of Health. However, submissions from medical bodies, health professionals or members of the public may also be considered. 

The Commonwealth Government negotiates an agreed wholesale price with the pharmaceutical company sponsor, through a senior officer in the pharmaceutical benefits branch. This process applies to all products subsidised as PBS-listed items under Section 85 of the National Health Act, including products that are priced below the general patient co-payment. 

Alsante et al. (262) recently reported the results a survey of American pharmaceutical companies, sponsored by Eli Lilly Company and Pfizer Inc., U.S. 

When a pharmaceutical company sponsors or secures in any other way, or regulates the publication of, promotional material in a scientific journal, the said promotional material must not be presented as an independent article. 

Market research material, which need not reveal the company name, must state nevertheless that a pharmaceutical company sponsors it. 

Tn order to ensure transparency when employees of medical institutions are invited to pharmaceutical company sponsored events the employer must consent in writing that the employee can attend and that the pharmaceutical company can bear the costs. ... 

The name of the pharmaceutical company sponsor should be stated clearly on the home page of every website or on a sponsored web page. 

Medication Assistance Programs, Pharmaceutical Company-Sponsored... 

Two ethical issues concerning pharmaceutical company-sponsored medication assistance programs include drug diversion and the reporting of false information to obtain medications. Drug diversion and the reporting of false... 

Many patients cannot afford to purchase needed prescription medication. Approximately 16% of the U.S. population docs not have any health insurance, and a greater percentage has health insurance without prescription medication benefits. Pharmaceutical company-sponsored medication assistance programs provide valuable options to both patients and healthcare providers by providing drugs to patients who have limited means of purchasing their medications. 

One fundamental idea in the development of new pharmaceutical products is that pharmaceutical companies (sponsors) would like to demonstrate that participants who receive a test treatment tend to fare better than those who receive some alternate therapy. This alternate therapy could be an inactive control (a placebo) or some other approved therapy (an active control). We said "tend to fare better" because participants will not all respond in the same way to the same test treatment. It is also true that, if and when the drug is approved for marketing and prescribed for patients, some patients will do better on the drug than others, but it is still very useful to clinicians to know how patients will tend to respond. 

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