Saturday, April 4, 2009

The Unscientific Method

Pharmaceutical corporations, since the 1990s, have utilized what are called contract research organization s (CROs) to conduct their clinical trials for the drug company's existing and pending medications. These CROs are supposed to be assessed and monitored by what are called institutional review boards (IRBs).

These clinical trials and their monitors, by the way, are often if not entirely created with the business models being of marketing rather than science. They cater and sell themselves to companies within the pharmaceutical industry as the apex of what is known as the pharmaceutical company’s publication planning.

Components of such plans consisting of clinical trial research design by such drug companies involve the formulation of what are seeding trials. Seeding trials are those designed by drug companies to give the impression of a desire to acquire knowledge, but in actuality are implemented as a significant marketing element of the drug company that becomes the sole sponsor of these trials.

The drug company chooses the investigators of these clinical trials involving the drug company’s promoted products, as well as the locations where these trials will be conducted as well. Often, the investigators are simply family practice doctors with little if any research experience, and are selected by the trial sponsors, the pharmaceutical companies.

The drug company creates clinical trials involving human subjects to acquire if not create favorable results from these trials illustrating the incredible benefits of their drugs which are involved in the clinical trials. Afterwards, these results are shared with those relevant to the drug involved with these clinical trial results, which include targeted prescribers and medical journals.

CROs are outsourced companies that provide research services for those in the pharmaceutical industry. Their relationship with their clients, the drug companies, is that of independent contractors. Because of the nature of this relationship, the drug company is exonerated from any potential liability involving the research they are paying for and controlling.

The CROs are either owned by, or are in fact advertising agencies that have a medical communications element. They above all else execute the publication plan of the sponsor with a team that is responsible for manipulating the media, and the public, as well as the medical community. Familiar names of CROs include Quintiles and Covance.

Most clinical trials conducted by pharmaceutical companies at this time are done so by CROs presently. Maybe two or more decades ago, the same clinical trials were performed by various academic institutions. CROs are progressively increasing in both size and number today. It is believed that the CRO industry is now a 20 billion dollar a year industry.

CROs and their sites that they, upon the wishes of their clients, include for the clinical trials are supposed to be evaluated and monitored by IRBs to, most importantly, assure the safety and protection of the human subjects in these trials. The IRBs, which are often for profit companies as well, are registered with the Department of Health And Human Services (DHHS) before it may conduct business.

The DHHS often if not entirely registers IRB applicants without apparently any evaluation of these for profit regulators- the IRBs.

The IRBs market themselves to pharmaceutical companies as being the IRB of choice for them due to their guarantee for fast approvals of research protocols designed by these drug companies. A for profit IRB can make 10 million dollars a year presently due to their aggressive marketing to pharmaceutical clients in collusion with CROs.

The IRB may charge around 1500 dollars for a clinical trial protocol review.

Because the IRB is for profit in many cases involving clinical trials, they, as with CROs, are primarily concerned with pleasing their sponsors, which are the drug companies. As such, the IRB in the past has failed to discontinue a flawed clinical trial, or intervene in a sponsored clinical trial if it is suspected of participating in wrongdoing, nor is any action taken by the sponsor of such a clinical trial.

So what exists with this corrupted research which fails to utilize the scientific method appears to be works of fiction as the clinical trials are conducted and planned. The profit element of all involved with these clinical trials leaves a welcome sign for these organizations to perform unethical manipulation of the clinical trials that again involve human beings. One could safely conclude the research being conducted today in this manner is both dangerous and flawed to unbelievable degrees with great concern.

Regulation is largely absent as this activity you have read is conducted more often than most realize. It is my hope that this activity will stop as it is implemented today for the safety and health of others,

Dan Abshear

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