Technology

Politics at Texas Medical Board

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?

The Facts on Gardasil and Perry: Right Wing vs. WingRight

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.

Streiff’s two pieces, here , and  here,  cover the de-bunked corruption charges and provide a succinct list of ethical objections that are less subjective and a bit more organized. Here’s my reply:

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?

Rick Perry is against embryonic stem cell research, but he wants Texas to be center of stem cell advances | Texas on the Potomac | a Chron.com blog

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?

via Rick Perry is against embryonic stem cell research, but he wants Texas to be center of stem cell advances | Texas on the Potomac | a Chron.com blog.

Dose of Reason: Perry and Gardasil

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 6^th 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.

Another:

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.

And another:

    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.”

The moon or bust

Funny, as I was writing this, David Letterman discussed the future of the US in space with Chris Ferguson, the commander of the last flight of the space shuttle Atlantis.

This afternoon, I got a reminder that Tweets sometimes play time-warp games – I suppose when someone signs up for the first time.

A tweet on the TMA member’s only daily newspaper sent me to an old 2006 post on the Residency Notes blog,with their beautiful theme and graphics (why didn’t I think of that?).  The post concerned Slate.com’s complaints (yes, they’re still around, even today) about NASA and President Bush’s former proposal to put a permanent base on the moon. Why not a little time travel to a time when the US was still considering out of this world research?

It looks like NASA’s cuts may have limited the progress on the base.The recession/depression is reality. Wonder whether there’s any private money out there working on the idea?

NASA is working on a new lunar landing, though, called Morpheus.   You can even follow them on facebook.

I’d donate my own money to a permanent base. Great boon to research in low gravity, some place for kids to reach for and part of that horizon we’re always looking over. (Heinlein, Asimov,and Wall-E fan)

The Brief: Top Texas News for Aug. 4, 2011 — Texas News | The Texas Tribune

Governor Rick Perry is quoted as saying, “You know I don’t mind being the first. I like it.”

The Brief: Top Texas News for Aug. 4, 2011 — Texas News | The Texas Tribune.

Perry’s Surgery Included Experimental Stem Cell Therapy — Rick Perry | The Texas Tribune

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.

via Perry’s Surgery Included Experimental Stem Cell Therapy — Rick Perry | The Texas Tribune.

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.

DPS caught up (for me, anyway)

The DPS website let me know that my State permit to prescribe has been renewed for another year.Yeayy!

The story is that DPS brought in extra people and have been working nights to put about 3000 delayed permits through their new software before Midnight, August 1.

I’m glad they’re catching up, but I still believe that it was irresponsible for them to install the new software program during what is probably their busiest time of the year, when they knew they’d have less personnel, because of budget cuts and because of vacations, etc.

Woman Seated Near Beck at Movie Claims Innocence…But What Does Twitter Tell Us…(With UPDATES!) | Breaking news and opinion on The Blaze

If you tweet it, it exists. I often think that if more people had learned to live under – and write under – the threat of something like medical malpractice, the ‘Net would be a kinder, gentler place.

Woman Seated Near Beck at Movie Claims Innocence…But What Does Twitter Tell Us…(With UPDATES!) | Breaking news and opinion on The Blaze.