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Alert Number 128

The Big Business of Clinical Trials

Date: September 24, 2005

The following press release from the pharmaceutical industry is a telling one. I am but a novice in this area with my interest focused on CLL clinical trials only. But even here I am struck by the amount of money and business incentives that ride on these clinical trials. Where there is big money, there is big business with its own drivers, and their agendas may not always fit our own priorities. I will recommend a recently released movie called "The Constant Gardener" based on a novel of the same name by John LeCarre that you might enjoy, especially if you are not a fan of big pharma, big healthcare machinery and love a good conspiracy yarn in any case.

The level of non-transparency and secrecy that surrounds drug clinical trials in this country is appalling. Getting a look-see at the trial protocols is like pulling teeth. I would like to review the important CLL clinical trials as they come along. It would help a great deal if you folks pitched in as well. Please bring new trials to my attention, send me consent forms and trial protocols and any other information that you can get your hands on. One thing we can guarantee with no caveats is complete patient confidentiality. Your name and identity will not be revealed to any one, in any way. We all benefit when we pool our resources and information and work together as a patient community. If you have something to send me and need a fax number, just write and ask.

Our recent reviews of the FRC + mitoxantrone clinical trial is a case in point (see links below). Would you have known about the need for prior screening for potential heart complications with this combination, something that was missing in the clinical trial protocol, prior to CLL Topics raising a fuss about it? Public scrutiny is the best way of shining a spotlight on such omissions. Hopefully the good doctors are now more sensitized to our concerns in this area. (The distributor of mitoxantrone, OSI Pharmaceuticals, has dodged our queries thus far. Why am I not surprised.) On the positive side of the equation, we hear a good review in the patient press also helps researchers in getting the recruitment process off to a good start and patient-friendly trial designs get justly rewarded. Did you know that roughly 40% or the cost of clinical trials is recruitment costs?

Mitoxantrone plus FCR;
Mitoxantrone plus FCR Part B;
FMC plus R - Brit. Version.

Be well,

Chaya
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Press Report

Drug Firms Launch Web Site to Disclose Trials Data

By Ben Hirschler LONDON (Reuters)
Sept 21 2005

The global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines in a bid to allay patient fears over drug safety.

The move follows criticism that companies manipulate or suppress results of clinical studies in order to come up with favourable conclusions.

The new portal (www.ifpma.org/clinicaltrials), established by the International Federation of Pharmaceutical Manufacturers and Associations, links available online information about clinical trials worldwide.

Plans for the portal were first announced earlier this year.

Drugmakers - some of which have already voluntarily launched their own databases - hope the project will head off legislation from governments in the wake of scandals over pain drug Vioxx and the use of antidepressants in adolescents.

The site will carry detailed information about most new clinical trials, but companies have the option to withhold some information.

Early-stage phase I studies on healthy volunteers -- often the first sign a company has a good hunch about a new drug approach - are exempt, and there is no obligation to reveal the results of studies before a drug is approved.

The voluntary scheme says that results should be published within one year of a medicine's approval or, for trials on drugs that have already been approved, within one year of the trial being completed.

Nonetheless, industry leaders said the new site was a significant step forward in transparency, allowing doctors and patients to carry out searches in particular areas quickly and easily.

Daniel Vasella, chairman and chief executive of Novartis AG and president of the federation, acknowledged that finding this data had been difficult in the past and said the site might give patients more options.

"It will allow patients, for example, to apply to enter into clinical trials or to wait for relevant data," he told reporters in a Webcast.

The new Web site, which was developed in conjunction with IBM, has the backing of other major pharmaceutical groups such as GlaxoSmithKline Plc , Pfizer Inc. , AstraZeneca Plc , Merck & Co. Inc. and Sanofi-Aventis SA.

Controversy that drug companies conceal research, either to prevent rivals from learning too much or because negative results would hit product sales, has been simmering for years.

But the issue came to a head last year with the worldwide withdrawal of Merck's Vioxx and accusations by New York Attorney General Eliot Spitzer that Glaxo fraudulently suppressed information about the use of its antidepressant Paxil, or Seroxat, in children. Glaxo settled the case for $2.5 million.

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