From the feature article in the August 2010 Townhall Magazine,
“A Right-Wing War on Science? Really?”:
The War That Wasn’t
Read the entire in-depth report in the August issue of Townhall Magazine.
During George W. Bush’s presidency, the popular perception was that Republicans were trying, as Hillary Clinton put it, “to turn Washington into an evidence-free zone.” Bush and his congressional allies were regularly rebuked for allowing religious faith and political ideology to trump the prevailing science.
But it was a weak argument. President Bush funded scientific research proportionate to past administrations, and science funding increased steadily through his two terms.
And on many of the issues raised by liberals as proof of a Republican war on science, the evidence now vindicates the conservative position. For instance, Bush’s 2001 executive order limiting federal funding of embryonic stem-cell research (ESCR) was decried by the Left as “anti-science.” But not only does ESCR destroy nascent human life, it also has failed to produce any medical cures or treatments. Dr. Bernadine Healy, a former National Institutes of Health director, wrote last year, “Embryonic stem cells, once thought to hold the cure for Alzheimer’s, Parkinson’s and diabetes, are obsolete.”
Meanwhile, ethical adult stem-cell research, which President Bush funded, is thriving. Dr. David Prentice, a leading expert on stem-cell research and a senior fellow at the Family Research Council, recently told me that adult stem cells treat more than 70 conditions in more than 50,000 people a year.
The 2006 successful “re-programming” of human skin cells to behave like embryonic stem cells was lauded by the science community. It won Science magazine’s 2008 “Breakthrough of the Year.” ESCR pioneer Dr. James Thomson predicted, “A decade from now, [ESCR] will be just a funny historical footnote.” The conservative position on stem cells, it turns out, is not only the ethical position but also the “pro-science” position.
“That gives adult stem cells really a very interesting and potent quality that embryonic stem cells don’t have,” says Rocky Tuan of the University of Pittsburgh.
And yesterday, CBS had this report that adult stem-cell research is, as conservatives have long noted, leaving embryonic stem-cell research in the dust.
For all the emotional debate that began about a decade ago on allowing the use of embryonic stem cells, it’s adult stem cells that are in human testing today. An extensive review of stem cell projects and interviews with two dozen experts reveal a wide range of potential treatments.
Adult stem cells are being studied in people who suffer from multiple sclerosis, heart attacks and diabetes. Some early results suggest stem cells can help some patients avoid leg amputation. Recently, researchers reported that they restored vision to patients whose eyes were damaged by chemicals.
Apart from these efforts, transplants of adult stem cells have become a standard lifesaving therapy for perhaps hundreds of thousands of people with leukemia, lymphoma and other blood diseases. “That’s really one of the great success stories of stem cell biology that gives us all hope,” says Dr. David Scadden of Harvard, who notes stem cells are also used to grow skin grafts.
“If we can recreate that success in other tissues, what can we possibly imagine for other people?”
Adult cells have been transplanted routinely for decades, first in bone marrow transplants and then in procedures that transfer just the cells. Doctors recover the cells from the marrow or bloodstream of a patient or a donor, and infuse them as part of the treatment for leukemia, lymphoma and other blood diseases. Tens of thousands of people are saved each year by such procedures, experts say.
But it is harnessing these cells for other diseases that has encouraged many scientists lately. In June, for example, researchers reported they had restored vision to people whose eyes were damaged from caustic chemicals. Stem cells from each patient’s healthy eye were grown and multiplied in the lab and transplanted into the damaged eye, where they grew into healthy corneal tissue. … And on Friday, Italian doctors said they’d transplanted two windpipes injected with the recipients’ own stem cells.
Some of the new approaches, like the long-proven treatments, are based on the idea that stem cells can turn into other cells. … [ESCR]cientists say they’re harnessing the apparent abilities of adult stem cells to stimulate tissue repair, or to suppress the immune system.
Having worked in Clinical Research for the past 14 years I consider myself not an expert by any means, but someone with a great deal of experience in the area of Clinical Drug Development and Clinical Trials. I can tell you that the costs heaped upon the developers of prescription medications are so severe that many promising treatments are passed by simply based upon cost. Simply put the costs of Prescription drugs are caused by discovery costs, testing, government regulations, the length of time involved, the quality of personnel required, patent protection limitations and lastly marketing. IMHO extending patent protections and reforming government regulation would bring drug costs into a more reasonable cost bracket.
One such example from my knowledge is a molecule being developed for the treatment of cancer . At one of the first management discussions to plan the testing of the drug’s efficacy the discussion came to types of cancer this molecule would be tested to treat. One of the cancers eliminated was ovarian cancer, due to cost of testing and development versus cost return (size of potential patient base). After four years of Clinical Trials it was discovered that the one cancer that this molecule was very effective treating was ovarian cancer, but it was too late to pursue that treatment since the patent would expire before the trial could be completed, no sense throwing precious resources into a molecule that can not bring a profit. A very efficacious treatment for ovarian cancer was laid aside and will not be brought to market.
Now you may conclude that this was a purely financial decision and anti-humanitarian. Well, the cost of bringing a molecule from discovery to market is estimated to be $800,000,000. Where is that money to come from? If a pharmaceutical company is to stay in business, there has to be a profit, a return on their investment. They have costs just like any other manufacturing facility that makes cars or any product. Imagine if there were people clambering for cars to be sold for $5000 each when the cost of development and manufacture is $30,000 per vehicle. How long will the automaker stay in business? Or if the auto maker was allowed to make Jeeps for 6 years and then New Delhi manufacturers could start making Jeep knockoffs and sell them for 1/3 of the price GM charges? Why is this practice allowed only in pharmaceutical drugs? (hint: liberals invented generic drug laws when “universal healthcare” failed).
The question then becomes why are the costs so high? Who is ripping off the sick people? Well let me try to explain. First the scientists must go to school for about 10 years to obtain a masters or phd. These people then are hired by the pharma company to begin “discovery”. They will work on existing compounds and hopefully make discoveries of their own, but this work is complex and difficult. Often a scientist working their whole career may not make one original discovery. The pharma company will have many, many scientists working at all times to make new discoveries, , that’s an extensive cost. when a discovery is made it will be thoroughly tested chemically before it is tested on animals to determine toxicity and side effects. Once it is determined that the molecule is safe for human testing, many many management meetings are held to verify the findings of the preclinical testing. A plan is developed and the first human dose trials are begun, this is called a Phase I Trial. These are very limited usually one or two sites are chosen and 20 people are involved. The subjects are given very limited amounts and are carefully watched for adverse events (reaction of side effects). If these tests are positive the molecule will progress to Phase II trials where more subjects are enrolled, but the trial is still very cautious. If the results of the trial are still showing efficacy the molecule will progress to Phase III Clinical Trials which involve many subjects. The molecule will even be named at this point .
“All these tests and analysis took time and cost money. Recobs estimated the entire process of naming a drug costs a pharmaceutical company about $250,000.”
Once the Clinical Trial is completed, the data and statistics analyzed and a Clinical Study Trial Report has been prepared the drug is now ready for submission to the FDA for approval to market it for use. If the drug is approved there is still the requirement to conduct a Phase IV after market trials in order to discover any additional side effects or adverse events which occur in the wider population. All of this activity has consumed an average of 8 years and a patent holder is only given protection for 14 years. That means that the Pharmaceutical company which has invested $800million in this product has only 6 years to market the drug before a generic drug company in India or China can reformulate the drug for a fraction of the cost market it at half the cost.. without any of the development or Clinical Trial cost… and make a fortune. (See More)
Back to the beginning premise: are Conservatives anti-science? Well, considering that development of new drugs is a very expensive and time consuming process and most business owners are capitalists meaning they expect to make a profit. Leaving aside moral considerations; doesn’t good science take into account that some theories are merely bad ideas and pipe dreams (ie embryonic stem cell research) which should be rejected in favor of more effective therapies and sources (ie adult stem cell research)?
Which brings us to the second matter, must we leave aside the moral considerations in order to be “scientific”? Must we overlook the fact that the major scientific discoveries were made by Christians who were seeking to understand the world the Creator had provided for us? a Newton, Galileo, Kepler, ad infinitum all credited their faith for their curiosity and discoveries. Is it wrong to refrain from experimentation which one deems immoral or to cleave to a worldview which values human kind above animal life? The accusations of the left in this area are no different from their accusations in any other and amount to a cry of “there is no God because I say so and anyone who doesn’t agree with me is just stupid”. Well,I’m sorry, but that isn’t scientific thinking that is opinionated, arrogant and backward thinking. Science without morals is Megelian experimentation and will not lead to good health or progress.
For Further reference:
Most importantly, the study highlights the point that regardless of the exact cost figure
estimated, if we are not cognizant of the complex, risky and costly process of drug development,
public policy can damage an industry that has over the past generation bestowed enormous benefits on society by improving the effectiveness of health care.
My question is: why on earth would anyone even go to all this trouble and expense? I have only recounted the steps which a company goes through to develop and test a new drug. The major expense is compliance with Federal Regulations which hamstring the Industry and stifle development and discovery. Take a look at the Regulations for application for a new molecule below and realize this is just the first step. (See More)