More Re-Definition of Terminology

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Missouri, Sanctity of Life, Stem Cells

First, they tried to re-define "embryonic" as "early". Next, they tried to re-define "cloning" as "implantation". Now, they're trying to re-define "cure".

Adult stem cells have thus far produced at least 72 human treatments. It appears that one of the latest tactics of the pro-Amendment 2 Coalition is to refute that fact (emphasis added):

Winship says there have been no proven cures found with embryonic stem cell research and said adult stem cells are a proven - and ethical - alternative.

"The reality is, it’s still zero" cures "for embryonic stem cells," she said.

Farrow said embryonic stem cell opponents would do anything to derail the initiative, including overstating the potency of adult stem cells.

"You’ll hear our opponents say that there are between 65 to 100 adult stem cell cures. That’s simply not true," Farrow said.

"The truth is there are only nine adult stem cell cures, and we believe that research needs to go forward," she said. "But adult stem cells have been researched for over 50 years. The first earlier embryonic stem cell research didn’t start until 1998. We haven’t even had a full decade of research with embryonic stem cells."

What on earth could possibly explain such disparity? Apparently, the Coalition, in an attempt to level the playing field in their favor, have begun applying a "FDA-approved" qualification (emphasis added):

Dr. William Neaves is with the Stowers Institute Medical Research. "This is a contest between society and disease, not between adult stem cells and early stem cells," says Neaves.

Researchers say embryonic stem cells hold infinitely more potential than adult stem cells for curing disease. They say the claim about dozens of treatments already developed from adult stem cells is not true. "At best, only nine of those diseases have, after 50 years of research with adult stems cells, FDA-approved therapies that are available to patients," says Neaves.

The Coalition is obviously hedging on the belief that the general public have no real understanding of what FDA approval is, what it means, or how it happens. I will try to give a brief overview.

FDA is divided into various "centers". I work for a pharmaceutical company that manufactures, packages, and sells drugs. We are under the direction of FDA's CDER: the Center for Drug Evaluation and Research. Medical devices - pacemakers or defibrilators, for example - are under the direction of CDRH: the Center for Devices and Radiological Health. Stem cell treatments are under yet another center - CBER: the Center for Biologics Evaluation and Research.

In order for a drug, device, vaccine, or other treatment (hereafter, treatment) to get FDA approval, a rigorous and intensive process is required. The sponsor (company requesting approval) must complete a submission application including all the data supporting the approval request. For a new treatment, the submission would include data from three phases (Phase I, Phase II, Phase III) of clinical studies. These clinicals are the heart of the company's justification for requesting approval. Phase I clinicals are very small (less than 100 participants) studies, generally using healthy humans, to determine physiological interaction of a treatment with humans. Phase II clinicals follow successful of Phase I, and are controlled, small-scale (a few hundred participants) studies using people who have the condition for which the treatment is indicated, used to determine preliminary data with respect to the effectiveness of the treatment, and any side effects associated with the treatment. Phase III clinicals follow successful completion of Phase II, and are controlled (or uncontrolled), large-scale (a few hundred to thousands of participants) studies used to determine the effectiveness of the treatment for the general population, and to ascertain the overall risk-benefit relationship of the treatment.

Based on these data, in addition to other aspects of the submission (stability data for a drug, for example), FDA will approve or reject the application. Once FDA has approved an application, the sponsor can legally market and sell the treatment in the US.

As with many other treatments, due to the nature of the conditions for which stem cell treatments are intended, such treatments are not always well-suited for typical clinical trials. FDA is aware of and working to reconcile the difficulty of translating stem-cell treatments into clinical trials.

Note, however, that other mechanisms exist, prior to or in lieu of FDA final approval, for treatments to be used (legally and effectively). Two such mechanisms are the Treatment Investigational New Drug (Treatment IND) approval, in which "FDA will permit an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population", and the parallel track policy, in which "patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising."

Some treatments - such as prenatal drugs - may never proceed through all clinical phases and final approval, but may be given to patients as investigational treatments for non-approved indications as long as the patient gives informed consent (which is also required for participation in clinical studies). Such is the case for Treatment INDs discussed above.

The bottom line is this: all treatments administered in the US must have FDA approval, whether in the form of a final New Drug Approval (NDA), or as an Investiational New Drug approval (IND). So, of the more than 72 treatments currently in use, every single one in use in the US has FDA approval of one form or another.

That said, much stem cell research and advancement takes place outside the borders of the US and outside the control of FDA. Any treatments derived from such research would not be subject to FDA approval; therefore, any implication regarding such approval is

This argument is not unique to the Missouri Amendment battle. In this 07/06 letter to Science, Do No Harm refutes the argument for the straw man that it is, and also points out that some 1170 clinical trials involving stem cells currently exist, including some 565 trials currently active and seeking participants - while not one single clinical trial is underway for embryonic stem cell treatments. Moreover, the letter points out that there are currently no peer-reviewed references to embryonic stem cell-derived human treatments. The above-referenced list of 72 human treatments derived from adult stem cells, which Do No Harm maintains, includes only those treatments for which peer-reviewed scientific publication of their effectiveness exists.

Yet again, the Coalition can only offer mistruths and deception.