This is a wonderful story. I’m very glad for the Representative and for all the patients who receive their own stem cells and have good results. (My granddaughter, at 15 months old in 2001, received an anonymous little boy’s umbilical cord blood after her bone marrow completely failed. More here.)
Someday, I believe we’ll find the stimulating factors that make the body’s stem cells activate the way we want them. In the meantime, this is what our researchers – and Legislators – are finding out about ethical adult stem cells (not destructive embryonic stem cells.:
State Rep. Rick Hardcastle, R-Vernon, participated in a recent round of autologous adult stem cell treatments to help his multiple sclerosis, similar to what Gov. Rick Perry had done in July.
Although the stem cells are not embryonic, doctors in the U.S. are still skeptical of the procedure because it is not yet approved by the Food and Drug Administration.
Adult stem cells are taken from the patient’s fat, sent to a lab where they are developed, then reintroduced to the patient via intravenous therapy.
The treatments are used to treat patients with autoimmune diseases such as multiple sclerosis, fibromyalgia, Crohn’s disease, Parkinson’s and chronic obstructive pulmonary disease.
Hardcastle was diagnosed with MS almost 10 years ago and repeatedly said the treatments worked phenomenally for him.
“I’m walking on water and near bulletproof,” Hardcastle said from a casino in Las Vegas, where he was with his wife for the National Finals Rodeo. “Since I had the third treatment, I have fished in the river in Alaska. I have walked up and down stairs without having to hold onto the handrail like a goon. It’s just been phenomenal so far.”
Hardcastle said just having his balance is an amazing thing because since he was diagnosed, his balance was one of the first things to go. He spoke at length about how easily he was able to walk the stairs at the Las Vegas event.
“Eight years ago, I was having to literally … stop to step over a concrete barrier on a parking curb. I just walk across it now like I did 20 years ago,” he said.
Universal Truth at work again. I would have loved to be there in order to watch heads explode and hear the susurus of “Did he say that?” buzzing around the room.
Newer and safer forms of stem cell therapy will likely overtake research into the use of human embryonic stem cells, the scientist whose team cloned Dolly the sheep told his peers at a stem cell conference in La Jolla.
Direct “reprogramming” of adult cells into the type needed for therapy is gradually becoming a reality, Ian Wilmut told an audience of several hundred at the Salk Institute at the annual Stem Cell Meeting on the Mesa. Such a feat was once thought impossible, but in recent years it has been demonstrated in at least two publications, he said.
But it’s been unclear which types of stem cells would prove most useful: the “adult” kind that have a more limited potential to change, or the embryonic kind. The emergence of direct reprogramming provides a promising new option scientists should consider, Wilmut said.
“I’m not quite sure why this hasn’t been pursued more actively,” Wilmut said.
It is difficult to achieve purity in embryonic and induced pluripotent stem cells because they are prone to forming tumors.
Direct reprogramming of cells from one type to the other avoids that danger, because the cells never enter the pluripotent stage to begin with, Wilmut said.
Direct cell reprogramming didn’t exist when California voters approved the stem cell program in 2004 with the passage of Proposition 71. That program was mainly aimed at funding embryonic stem cell research the federal government wouldn’t fund.
However, the program can also fund research with other types of stem cells, such as “adult” cells from umbilical cord blood.
The use and value of embryonic stem cells is an intensely controversial issue.
Many people object to their use because human embryos, which they consider human individuals, are killed to get the cells. Critics also point to the success of adult cells in approved therapies, while no therapy with embryonic stem cells has yet been approved.
Only one treatment with embryonic stem cells is in clinical testing in people. And that company, Geron Corp., recently ended its involvement in what was described as a business decision.
“”Siri is doing exactly what it was built to do—provide answers to questions like, “Where can I get an abortion?” using its own algorithms and the online resources it has available to craft answers.
“”Consider the current kerfuffle. This is simplifying things a bit, but the gist of this story is that Siri is getting hung up on a word, “abortion,” because organizations that actually offer abortion services tend not to use the word as much as anti-abortion organizations do. So when Siri goes looking for where to get an “abortion” in the digital wordscape of the Internet, lo and behold, it returns addresses for Crisis Pregnancy Centers rather than Planned Parenthood.””
Just one more failed “stimulus” project? This past week, Geron announced they are no longer pursuing their research in embryonic stem cells. They laid off 66 employees.
The US government should never have been in the business of picking and choosing business winners and losers. We certainly shouldn’t be giving money for destructive embryonic stem cell research.
Included as part of the Patient Protection and Affordable Care Act of 2010, the QTDP program provided a tax credit to encourage investments in new therapies to prevent, diagnose, and treat acute and chronic diseases. Companies, such as Geron, that cannot currently use a tax credit were allowed to apply for a cash grant
in lieu of a tax credit.
To be eligible for the program, projects must show reasonable potential to result in new therapies to treat areas of unmet medical need; prevent, detect, or treat chronic or acute disease and conditions; reduce long-term health care costs in the United States; or significantly advance the goal of curing cancer within a 30-year period.
In addition, preference was given to projects that showed the greatest potential to create and sustain (directly or indirectly) high quality, high-paying jobs in the United States, and advance United States competitiveness in the fields of life, biological, and medical sciences.
Projects were selected jointly by the Treasury Department and the Department of Health and Human Services.
Geron is getting out of the business of doing Embryonic Stem cell research. Trust me, if there were any objective truth to the idea that destructive Embryonic Stem cells could make money, the Corp. would stay in.
Earlier this week, the Geron Corporation announced it was abandoning its research into using embryonic stem cells to treat spinal cord injury. Geron was the first company to get the green light from the FDA to conduct clinical trials using embryonic stem cells. That was way back in 2009. And now, citing, quote, “capital scarcity and uncertain economic conditions,” the company is looking to sell off that part of its business and focus on other work.
Note the pretty “terminating the pregnancy” phrase that’s used instead of aborting the baby (or even the usual term used, “fetus”).
This new test will, indeed “change the conversation about abortion.” This news story, including comments from utilitarian bioethicist, Art Caplan, Ph.D., will move the conversation much earlier into the pregnancy and remind us about the risk to healthy children in healthy mothers from tests for genetic markers. It will also stir the debate on late-appearing diseases like Alzheimer’s dementia and breast cancer.
(Who knows, we might be getting closer to tests for behavioral tendencies or even the “gay gene,” if one is ever found.)
Sequenom doesn’t indicate whether there are false positives or what the accuracy is in women who are not at “high risk” for having a Down’s Syndrome child.
The blood test is accurate in detecting Trisomy 21, the genetic chromosomal abnormality that most commonly causes Down syndrome, 99.1 percent of the time as early as 10 weeks into a pregnancy, the San Diego-based company said in a statement. The test, and others that will be able to identify genetic abnormalities early in pregnancies, will alter the debate over abortion, said Art Caplan, director of the center for bioethics at the University of Pennsylvania.
“For many people this test makes it morally, emotionally and psychologically easier to have an abortion,” Caplan said in an interview.
Caplan said future prenatal tests may be able to indicate if the fetus had biomarkers for Alzheimer’s disease, or breast cancer, or other diseases. Those tests will raise questions about what issues will trigger potential parents to choose an abortion. A survey published last month in the American Journal of Medical Genetics showed that only 4 percent of parents with Down Syndrome children regretted having them.
“Ethically, we are now starting to see the shift in the issue of what counts as a medical disorder, what’s significant enough to test for, what’s a genetic disability or just a difference,” he said. “Many in the Down syndrome community would say it’s just a difference.”
Dr. David Stevens, CEO of the Christian Medical and Dental Association believes that the Texas Medical Board’s review and limitations on adult stem cell treatments is politically motivated.
It does appear that the Board is responding to politics.
“Meanwhile, Stevens believes criticism of Governor Perry’s recent adult stem cell procedure is politically motivated. (Listen to audio report)
The Republican presidential candidate had back surgery July 1, where his own stem cells were removed and injected back into his body. But shortly after, the Associated Press published a story in which several doctors criticized the decision as too “experimental” and “risky.” But Stevens believes those doctors are playing more politics than they are science. He points out that Perry consulted with his orthopedist, Dr. Stanley Jones, who is a well-respected physician.”
The Board heard the proposal on Friday, August 26. The Board would impose Federal regulations and a formal ethics board oversight for “off label” or experimental use of medications or treatments.
We doctors use our judgement at times to treat our patients using medications, procedures and equipment in ways that are considered “off label.” (For instance, the “morning after pill” therapies were at first unofficial use of oral contraceptives, long before Plan B was on the market.)
The Board should adjust their criteria to whether or not the patient gave full, proper informed consent obtained and is the treatment inherently ethical in likely outcome and goal?
Do you really want to frustrate me? Publish an opinion piece online, but restrict comments so that I can’t tell you where you’re wrong. Sure, it’s your site, and you make the rules. Well! Since I have my own blog . . .
The mainstream media has rediscovered Executive Order RP65 that Governor Perry issued in February, 2007. I wrote a “A Dose of Reason, Perry and Gardasil” to answer some of the gobbledygook in the media.
Unfortunately, some of the pundits we normally consider conservative are just as mixed up and fail just as miserably in their research and conclusions.
Michelle Malkin (michellemalkin.com ) won’t take new subscribers or comments from the public at all. She has written a disorganized rant calling Governor Perry “Obama-like.” She claimed that the Governor went over the heads of the Legislature, calls the opt-out clause “bogus,” without researching what it was before the Governor’s EO, and is evidently completely unaware of the funding of vaccines in the US. I was able to comment at the column’s syndication site, Creators.com, copying and pasting my coverage of these concerns in “A Dose of Reason, Perry and Gardasil.”
RedState’s Bill Streiff and Erick Ericson have posted their own articles That site won’t take comments from new subscribers. Ericson reposted his 2007 missive that compared the Executive Order to eugenics and focused on the possibility of corruption due to Merck’s lobbying.
1. The recommendation did not include males, though males can carry and transmit HPV. This oversight made the creation of “herd immunity” impossible. This, definitionally, means the vaccine could have only a limited effect in combatting HPV.
The vaccine had not been recommended for boys at the time. The reasoning is that the vaccine prevented cancer. Society was not ready to talk about anal sex and males having sex with males, so there was a delay in adding boys. Since that time, the recommendations have changed to include boys.
2. Not all strains of HPV linked to cancer were affected by the vaccine. While doing something is better than doing nothing… generally… no one knows what the impact will be of creating a better evolutionary environment for the others strains by eliminating competing versions of the virus.
We knew at the time that the vaccines covered the viruses that caused 70% of cervical cancers (16 and 18) and 90% of the strains that cause genital warts (6 and 11). The preventive effect for these strains was 96% to 100%. according to the British Journal of Cancer article on the 5 year follow-up, published in December, 2006. (It was on-line November, 2006 and I accessed it for review today, August 18, 2011.)
We already had evidence, since confirmed, that there might be some cross-immunity for other strains.
3.Requiring people to receive a vaccine against diseases which they may very well never encounter is a very queasy ethical area. Unlike diseases like measles, whooping cough, etc., HPV is not spread through casual contact.
True. But 50% of people will be infected at sometime in their lives. The true cost is all of those abnormal pap smears – the cellular changes are all – 99.7% due to HPV. It’s also true that we vaccinate for tetanus – what we used to call “lock jaw” – even though it’s not contagious, and for Hepatitis B, which is only spread through blood and body fluids.
4. Clinical trials were conducted on women aged 16-26 leaving everyone to presume that Gardasil was safe and efficacious in 10 year-olds even though there was zero data pertaining to that age group.
Completely false. Both the 2007 Gardasil insert (no longer available online, but I saved a copy on my computer) and the current insert contain information about early testing on boys and girls 9-15. 1122 girls ages 9-15 received the vaccine during trials to test the immunogenicity, demonstrating the production of antibodies.
There. I feel better, don’t you?
The Governor has always opposed unethical destructive stem cell research, but Representative Hardcastle changed his mind on embryonic stem cells and cloning this year.
Hardcastle said the governor’s office didn’t ask him to carry it — as the only member of the Legislature with MS, he said, it’s been on his mind for “a long time” — but one of the governor’s staffers did advise him on it. Somewhat involved, Hardcastle said, was Jones, who has already removed some of Hardcastle’s stem cells to prepare them for re-injection.
A spokeswoman with the Health and Human Services Commission said the agency is in the very early stages of considering whether to create the stem cell bank. A few weeks ago, the agency received a letter from Houston Reps. Beverly Woolley, a Republican, and Senfronia Thompson, a Democrat, expressing their “serious concern” with the measure, for fear it might hinder the work of public and private scientists.
Meanwhile, Texas Medical Board spokeswoman Leigh Hopper said the regulatory agency held a stem cell stakeholder meeting last week — “at the governor’s behest, via Dr. Jones” — to start dialogue about adult stem cell treatments in Texas. The question? If Americans are — like Jones — increasingly flying all over the world to get promising stem cell treatments, shouldn’t Texas be a scientific and economic center for it?
Bear with me, this isn’t a “sound bite” subject.
(Edit 8/23/11: The opt out is for 2 years, not 1. BBN )
The Human Papilloma Virus is an infection, and should not be a moral issue. In contrast, the vaccine against four strains of the virus, Gardasil, has become a political issue, even though the Federal Food and Drug Administration (FDA) now recommends it for all boys and girls.
Governor Rick Perry has been criticized for his February, 2007 Executive Order that made the vaccine mandatory for girls before entering the 6th grade. Very little is said about the part of the EO that affirmed the right of and facilitated parents who wish to “opt out” of not only Gardasil, but other vaccines as well.
We expect the Governor to direct the people that he appoints, right? The Governor is responsible for management of the Executive Branch, including the Department of State Health Services. He appoints the head of the DSHS, who supervises the people who decide which vaccines will be mandatory. Texas’ Legislature modified Chapter 38.001 of the Texas Education Code over the years to mandate certain vaccines and allow the DSHS to add other mandated vaccines without Legislative oversight. Just before the Gardasil controversy, the Department had mandated Chicken Pox and Hepatitis A, which are both manufactured using cultures of human fetal tissue obtained at an abortion.
The Governor’s Executive Order (RP 65) that caused all the controversy also ordered the director of DSHS to make it easier for parents to opt out of vaccines. The Legislature had changed the law from “opt in” to a requirement to “opt out” once for all the school years. Next, they changed to a two year limit on the opt out, and then in 2005, the Legislature restricted the period to one year and required a new State form bearing a “seal.” Parents had to go to Austin or start early in the summer. There were bureaucrats who maintained that the only way to get the form with the seal was to go to Austin, find the right office and make the request in person. Perry used his EO to tell the Director of DSHS to make the request (and the seal) available on-line, making it easier to “opt out.”
In fact, the reason for the Executive Order was to speed up private insurance coverage and to make it easier for parents to exercise their right to opt out.
The Federal government doesn’t have the authority to mandate vaccines in the States. Not yet, not exactly. However, thirty days after the National Advisory Committee on Immunization Practices (ACIP) recommended the vaccine, Texas was required by Federal law to buy and distribute the vaccine in the “Vaccines for Children” program. The program provides vaccines without cost to uninsured children up to age 21, those who are insured by Medicaid, and those whose private insurance does not pay for vaccines at all. In effect, the only families who have to pay for Gardasil – for whom the State of Texas will not pay, anyway, under Federal law – are those whose private insurance will only pay for mandated vaccines.
Gardasil is manufactured the same way that insulin for diabetics is made these days: using recombinant DNA. In this case, common bakers’ yeast makes the proteins that cause the immune response. Gardasil had been thoroughly studied even in 2007, and is not only included in the Vaccines for Children program, it is the most-requested vaccine for girls. We are even seeing cross-protection from other strains. It has recently been recommended for boys. The recommended time to give the HPV vaccine is at 11 or 12 years old, when children are scheduled to receive other shots (tetanus and MMR boosters) and before they were likely to be infected.
The only reason that we do “Pap smears” (the papanicolaou test) is to look for changes in the cell nuclear DNA of the cervix, the opening to the uterus or womb. Over the last 15 years, we have found that 99.7% of these changes are due to HPV infections. In the US, 70% of cervical cancers are caused by HPV 16 and 18. (50% by HPV 16.) These are the two types of HPV that result in the most damage and cost, due to repeat paps and the subsequent biopsies, freezing, “LEEP,” or other treatments in which the surface of the cervix (the opening to the uterus or womb) is burned off to remove cancerous and pre-cancerous cells. These treatments lead to infertility and premature births.
Because 15% of girls begin sex before age 15 and half of girls who have sex before 20 say their first time was involuntary, the first trial of Gardasil involved 1200 girls between the ages of 9 and 15. The girls 15 and under had a better response to the vaccine than the older girls and women 16 and above. The researchers compared blood levels of antibodies. The research ethics committee ensured that no paps or pelvics were done on the young girls. (Every one of the young women under the age of 21 when I sent them for colposcopy for cancerous changes had been raped before they were 15 years old.)
The reports of deaths and injuries from Gardasil are poorly documented. The great majority of the adverse effects in the reports include pain, redness, and tingling at the injection site and fainting and headaches. People often faint and complain of headaches after seeing a needle, even without being stuck. It looks awful sometimes, like a seizure. The FDA has ruled that none of the deaths that have been confirmed were caused by the vaccine. In addition, this article from the Canadian Medical Association Journal contains a table showing the numbers of serious events and the numbers of deaths in several studies on the use of the HPV vaccine.
Remember your statistics classes. With 33 million doses, there are bound to be deaths that coincide with the timing of the vaccine use. The teen death rate from all causes is 62 per 100,000 across the US. Most of those are boys, but still: In 10 million girls, 30 deaths are not outside the rate for the age group. They are tragic, but consistent with life on this Earth.
More likely the girls who had severe reactions or death had other risk factors, due to the population presenting to clinics giving the vaccine: those who present with worries about STD’s, the newly sexually active and those entering college. The records show that many were given new scripts at the same visit for birth control pills and other vaccines and medicines, according to the analyses in the medical literature. (Also, remember the silicon, SSRI, and the general vaccine scares that have been blown out of proportion through the years and later proven to be untrue.)
The reports on the possible vaccine-related deaths are available for viewing at” the “Vaccine Adverse Event Report Site” (VAERS),(drop down to the table at the middle of the Page, option #3) using “HPV4” (This is the Merck vaccine), at Option#4, check “YES” at “life threatening” (or you could check “death”) and (top of page)”Sort by submission date.”
Here’s a few examples:
Administered by: Unknown Purchased by: Unknown Symptoms: Adverse reaction Write-up: It was reported from an article, published on 29-JUN-2009 that there were “hundreds” of life-threatening reactions said to be associated with GARDASIL. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
FINAL DX: Hodgkins lymphoma, nodular sclerosing, stage IIA. Records reveal patient was pale & had firm left clavicular lymph node. Excisional biopsy done 7/23/09 revealed diagnosis. Tx w/chemotherapy & possibly radiation tx when chemo completed.
Write-up: Vaccine was administered, patient became dizzy 30 seconds after shot. Patient was pale, diaphoretic & nauseous. Symptoms lasted about 45 minutes. BP dropped to 90/50 & pulse to 50/min. 8/20/09 PCP note received DOS 8/4/09. After shots pt became naseated, pale, diaphoretic, dizzy and had difficulty breathing. BP dropped to 90/50 and pulse into the 50’s. Sx lasted ~45 minutes with return to baseline. Vax record states pt “passed out.”
Governor Rick Perry is quoted as saying, “You know I don’t mind being the first. I like it.”
I’ll admit it: this is just cool! Notice the political and ethical comments from the Texas Tribune:
The governor’s procedure did not involve embryonic stem cells, which he and many other conservatives ardently oppose using for medical research on both religious and moral grounds. His treatment involved removing his own adult stem cells from healthy tissue and injecting them back into his body at the time of surgery, with the belief that the cells would assist tissue regeneration and speed recovery.
The FDA, which is in litigation over its authority to regulate new stem cell clinics, has not approved the use of adult stem cells for anything other than bone marrow transplants, which have been used for decades to treat cancer and sickle cell anemia patients. This has largely kept doctors from openly advertising these stem cell injections, but not from capitalizing on them by offering the therapy to their patients.
It also hasn’t stopped Perry from pushing for adult stem cell research and industry in Texas. During the governor’s 2009 State of the State address, he called on state leaders to invest in adult stem cell companies. Later that year, his Emerging Technology Fund awarded a $5 million grant to the Texas A&M Health Science Center Institute of Regenerative Medicine and $2.5 million to Helotes-based America Stem Cell to develop new adult stem cell technology.
Last month, three weeks after his adult stem cell treatment, Perry wrote a letter to the Texas Medical Board, which is considering new rules regarding adult stem cells, saying that he hoped Texas would “become the world’s leader in the research and use of adult stem cells.” He asked board members to “recognize the revolutionary potential that adult stem cell research and therapies have on our nation’s health, quality of life and economy.”
In the weeks since the procedure, the governor has traded his cowboy boots for orthopedic shoes and donned a back brace, raising questions that his recovery may be slow-going. Still, he has traveled extensively; in an interview with The Associated Press last week, Perry said he felt 80 percent recovered and was swimming and using the treadmill.
As for the high cost of such stem cell injections, Miner said that whatever health insurance didn’t pay for, “Perry did.”
In Perry’s procedure, his doctor, Houston orthopedic spine surgeon Stanley Jones, said he pulled stem cells from fatty tissue in the governor’s hip, left the cells to expand in culture for several weeks at a Sugar Land lab, then injected the cells back into the governor during his back surgery, into the spine and into Perry’s blood stream.