"Homework" (fallacies about Gardasil)

Last week I posted on research that shows that Gardasil, the Merck vaccine against four strains of the Human Papilloma Virus, may actually give partial protection against 8 more strains.

There's a comment today on that post from someone who warns us to do our "homework" and gives a link to a video on "You Tube" that appears to be made in a radio station, during an interview between a host called "Alex" and Cathie Adams of the Texas Eagle Forum.

(Mrs. Adams and I agree on 98% of things. I admire the work that she does and am thrilled when we can work together. But, we've disagreed before and we probably will in the future.)

I believe that "Alex" is Alex Jones, of "InfoWars" radio network and something called "Prison Planet." Alex screams and cusses (Texas slang for cursing and bad language) while spreading falsehoods that he could so easily check. First, the vaccine is not a live virus. Alex Jones got that one completely wrong. It's certainly not the first vaccine of its kind, other than having antigens against four strains of HPV.

In fact, Gardasil is made the same way as most of the commercially available insulin that diabetics inject into themselves several times a day, like Humulin N, and Lantus.

We've used "recombinant DNA vaccines" for well over 20 years to make vaccines like the Hepatitis B vaccine and proteins like insulin. Strains of yeast or bacteria - in Gardasil its Saccharomyces cerevisiae, common bakers' yeast and for insulin, it's E. coli- are induced to make the proteins.

This vaccine uses alumininum. But so do many other vaccines that we've been using for years.

There is a mention of the thimerosal that has been used in some vaccines as a preservative. Thimerosal contains mercury, and there has been concern about the cumulative doses that babies were exposed to due to the 20 to 30 vaccinations that they get the first two years of their lives.

The biggest fear was that the mercury caused autism. A couple of years ago, lawsuits caused the removal of thimerosal from most vaccines, but the number of cases of autism have not gone down. This week, the New England Journal of Medicine reported a new study - and published it with free access - that gives us more evidence that there is probably no connection.

Results Among the 42 neuropsychological outcomes, we detected only a few significant associations with exposure to mercury from thimerosal. The detected associations were small and almost equally divided between positive and negative effects. Higher prenatal mercury exposure was associated with better performance on one measure of language and poorer performance on one measure of attention and executive functioning. Increasing levels of mercury exposure from birth to 7 months were associated with better performance on one measure of fine motor coordination and on one measure of attention and executive functioning. Increasing mercury exposure from birth to 28 days was associated with poorer performance on one measure of speech articulation and better performance on one measure of fine motor coordination.

Finally, there's a call from a woman whose daughter developed vasculitis after receiving her first dose of the vaccine. Vaculitis is the inflammation of the blood vessels. Except for some known infectious causes - like scarlet fever caused by certain strains of the strep throat bacteria - it is a rare autoimmune condition. Most of the time we can't find the cause and some times we find that it is caused by diseases, including Rheumatoid arthritis, lupus, and an over reaction of the immune system after an infection such as Hepatitis B and Hepatitis C. Antibiotics and many medicines can cause it. It can also happen after a vaccination that stimulates the immune system. We have seen vasculitis after the flu vaccine, for instance.

A certain number of people will develop vasculitis each year. We cannot know whether the vaccination caused this girl's vasculitis.

I'm one of those doctors who prefers to wait a while before adopting new medicines. However, it's not true that we don't have much information on Gardasil. The vaccine has been tested for nearly eight years now, in the US, Canada, and Europe.

We should do our homework, especially before we spread information that will frighten others. Beware of shouters and conspiracy theories. Bad things happen and people do bad things, but most of the time it's not so hard to check up on them. Check the sources, or better yet read several sources, and learn which ones are reviewed and reliable.

Embryonic stem cells for chemical weapons detectors?

First, I want to say admit that this whole subject gives me the creeps. As an avid science fiction reader, I was surprised to find that I am not ready for disembodied human neural cells sitting around - functioning - in machines. I'm certainly not willing for anymore human embryos to be destroyed for such a utilitarian purpose.

I'm sure that you've heard that the stock of embryonic stem cells that President Bush will allow to qualify is insufficient, not functional, and definitely useless in light of all the people with diseases, right? And you've probably read that alternative methods that don't depend on destruction of embryos is a red herring, a waste of funds, too.

Well, it seems that one lab has been able to use 3 of the embryonic stem cell lines okay'd by President Bush and some that are derived from embryos that were considered "naturally dead embryos." because they appear to be unable to divide and develop.

Steve Stice, Ph.D., a University of Georgia animal science professor and Georgia Research Alliance eminent scholar in the UGA College of Agricultural and Environmental Sciences, is already renowned for cloning cows and pigs - including cloning a calf from a cow that had been dead for 48 hours. He also made news by reporting the ability to make cultures of motor neuron cells from human embryonic stem cells. At one time, he worked for Advanced Cell Technologies.


Dr, Stice has been working with the Navy to build a prototype for a monitor that can detect chemical weapons. Currently, there are non-cell monitors that can not only detect some chemicals, but identify them. There are also monitors that use mouse neural cells. But those cells are short lived while human motor neurons derived from embryonic stem cells will live at least 6 months.

From the University of Georgia:

"It's like a canary-in-a-coal-mine scenario," said Stice, a University of Georgia animal science professor and Georgia Research Alliance eminent scholar in the UGA College of Agricultural and Environmental Sciences.

In collaboration with the U.S. Naval Research Laboratory, Stice hopes to use his recently developed neural cell kits to detect chemical threats.

"They have a device that looks like a small tool box that contains neural cells and can detect changes in their electrical activity," Stice said. "When these cells’ activity is altered, you know there's something present that shouldn't be and they don't like it."

Cell monitors
The system now being used in the monitoring device uses mouse neural cells. "The problem is," Stice said, "mouse neural cells die out pretty fast on their own. So if you tried sending this device out with the troops, somebody has to change out the cells every couple of weeks. Plus, mice aren't humans. They react very differently to chemicals than we do."

Stice's neural cell kits created from human embryonic stem cell lines last up to six months. "We've never tested to see how far beyond that they're viable," he said. "It could be much longer."

Stice believes the project has "huge implications for Homeland Security and the Department of Defense." He came on the idea when he was searching for immediate uses for his neural cell kits.

"I contacted researchers at NRL who had published a paper on the detection system. We met in Washington to see what we could do together," he said. "They've developed the recording device, and we have the cells they need. So working together, we can vastly improve that project."

Measuring activity
Stice explained the device. "The monitoring system records electrical activity in the neural cells, which are usually in a set, rhythmic pattern," he said, drawing a chart that looks like a pattern on a heart monitor.

"When faced with a chemical agent," he said, "the electrical activity is reduced quite a bit, and the signals are erratic." He shows the effect by shortening the length and frequency of the upward lines in the pattern.

"The computer interprets the neural cell signals and indicates a problem," he said.

The researchers got support for the project from several congressmen, including Georgia Sen. Johnny Isakson and Rep. Jack Kingston.

Other implications
Stice has already begun to think of implications beyond the obvious.

"We think that working with these human neural cells can lead to other collaborative projects in treating posttraumatic stress syndrome and head injuries from war," he said. "Those are just two of the many possible spinoffs I foresee."

The current system can detect an agent but it can't identify it. "We may be able to further develop the system so that for some chemicals there are signatures that will lead to a future way to rapidly identify exactly what the chemical is," Stice said.

"Noncell systems available now can detect specified chemicals," he said. "But this is a broader detection system that will be more valuable because we don't know what terrorists will hit us with."

The idea is planted and the materials assembled. Now the waiting for funding begins.

"We can start as soon as the money comes," Stice said. “We've already done the preliminary work. We know our cells will work with their system. How well they'll work is the question we'll have to answer."

Stice feels this detection system is important to troops and civilians. "There's always a concern for nerve agents and unintentional effects of warfare where troops are in the way of chemical agents," he said.

"The beauty of this system is that it will detect a wide range of chemical agents," he said. "And the speed that they're detected is the beauty of these cells."

To simplify the system and make it more mobile, Stice's team can preset each kit.

"We'll be able to preload the cells in the detection devices, and they're good to go for at least six months," he said. "These systems will be useful in national defense, whether it's in a subway, an airport or on the front line of the war in Iraq."

While I'm not concerned about these cells becoming "aware," I am uncomfortable with using cells that resulted from the destruction of human embryos as a disposable machine part.

Catholic Bishops to Allow Plan B in Emergencies

Can anyone be forced to act against his conscience? Do religious convictions have any weight in the law? How far can the courts go to make a person do an act that he believes is unethical or immoral?

I hope these questions are not ignored due to the sensationalism that surrounds emergency contraception.

The Catholic Bishops of Connecticut have decided to allow the doctors in Emergency Rooms at the Catholic hospitals in their State to prescribe Plan B for rape victims. (More here.) The courts had ruled that the hospitals would be required to follow state law mandating that all emergency rooms prescribe the pills, even those belonging to religious organizations which object to contraception and abortion.

The law requiring all hospitals to prescribe Plan B to rape victims, which passed in June and takes effect Monday, does not allow for an ovulation test. Instead, it requires a pregnancy test.

Barry Feldman, a spokesman for the Connecticut Catholic Conference, said that since the bill passed, the bishops have questioned the feasibility of the original policy because of "further revelation by them about the state of existing science and the lack of definitive teaching by the church and the fact that there are many who are affiliated with the church that believe the ovulation test isn't necessary."

Feldman said the bishops' decision to allow Plan B to be used for all rape victims in the hospitals does not mean that the bishops' personal beliefs have changed. Also, they still believe the law is seriously flawed and should be changed to allow an ovulation test.

In June, Bridgeport Bishop William E. Lori said the new law violated religious liberties and suggested that politicians might force Catholic hospitals to perform abortions or euthanasia.

Sen. Jonathan Harris, D-West Hartford, who worked to negotiate a compromise bill with the church, said lawmakers have no interest in taking such steps.

"Our efforts had only one goal, to protect the victims of rape," he said. "There was no other agenda. It was started to just do that."

Rape crisis counselors in Connecticut said there have been unclear and inconsistent policies for supplying Plan B to victims who seek treatment in emergency rooms across the state, including some in nonreligious hospitals.

According to Connecticut Sexual Assault Crisis Services Inc., 40 percent of rape victims were not offered or did not receive the full dose of emergency contraception at the hospitals where they were treated during the first half of 2006.

Plan B, a package of pills containing levonorgestril, a progesterone, is also called "the morning after pill."

My review, "Plan B, How It Works and Doesn't Work," with links to reliable information and research papers, is here.

It appears that the bishops aren't just caving in to legal pressure, but were convinced that the pill works, when it works, by delaying ovulation or keeping the sperm from getting to the oocyte. There is quite a bit of evidence that this is true and none (from some pretty good studies in animals and ovulating women) that the Plan B formulation prevents implantation or causes an implanted embryo to be aborted.

The biggest problem now is that the courts in Connecticut dared to over-rule a religious principle and conscience issue in the first place. At what point can the state force men and women to act against their consciences?

Courts force 14 States to pay for elective abortions

Here's an interesting fact: of the 17 states that use their own Medicaid funds to cover elective abortions, 14 of them were forced to do so by the courts. (Georgia may be the next one.)

The "Hyde Amendment" has been added to Federal health care funding bills since 1976. Those who support abortion on demand (such as the ACLU, the Center for American Progress, and, of course, the National Abortion Federation and Planned Parenthood) are constantly calling for its "repeal," although in fact, the language would just be dropped from that year's appropriations bill.

Reminds me of the comment of one of the judges in a "right to die" case: The founding fathers did not intend for the important matters to be decided by the courts and only the trivial matters determined by the legislators.

Buzz on SCHIP - crisis interrupted or delayed

Do we want health insurance for everyone or do we want government health insurance for everyone? The current system increases the chances that employee coverage for children will decrease, that more gaps will occur because of changes in jobs and the delays inherent in qualifying for government assistance. A simple flat tax deduction for health insurance would cure these ills for everyone.


Where's the fun in taking away the deadline? The House has passed a "stop gap" bill to allow the current program and current funding to continue to November.

Bloggers and pundits are waiting breathlessly to see whether the President vetoes the House's $35 Billion SCHIP expansion. Many of them, like the Wired and Bioethics.net posts are thinly veiled political hits against the current administration, ignoring the fact that President Bush proposed an instant "coverage" solution. (Some are in-your-face attacks)

On the other hand, the Wall Street Journal (subscription) notes that the House version is much more of a compromise than expected:

In some ways, after difficult negotiations, the bill turned out to be an unusual example of cooperation. In talks with two Senate Republicans, House Democrats compromised. They cut new spending from $50 billion to $35 billion, gave up an effort to cover legal immigrants and young adults, and dropped cuts to private health insurers operating in Medicare.

The final deal includes many nods to Republicans -- though most Republicans in the House and Senate oppose it as an irresponsible expansion of government spending. It reduces federal funding for states that enroll children from families with incomes above about $60,000 a year for a family of four; it bars the federal government from allowing any more states to use CHIP funds to cover parents; and it phases out coverage of childless adults that some states include in CHIP.

To tilt the program toward poorer children, the bill calls for states not meeting enrollment benchmarks for the lowest income children by October 2010 to give up CHIP funds for enrollees above 300% of the poverty level.(emphasis mine)

Medical Ethics and the Holocaust Lecture Series

The Holocaust Museum of Houston and the University of Texas at Houston are sponsoring a lecture series, "Medical Ethics and the Holocaust."

I'm not sure of the procedure, but there is information at the website on watching the lectures, live, on the Internet.

More on Clinton Health Plan

After my review about some of the news coverage of Hillary Clinton's proposed government healthcare plan, I did some more digging. The Kaisernetwork.org review is here. A Wall Street Journal editorial is here.

The proposed Clinton plan mandates coverage and depends on 1/3 of its revenue from "$35 billion in savings to the government through a more efficient health system." (I wonder who will be considered less "efficient" - doctors or very sick patients?) And mandates that insurance premiums remain below a certain percentage of household income and that tax rates increase in households above $250,000.

All of which, the history of HMO's, capitated plans, and most especially government funding tells us, will result in restrictions in services, long waiting times, and less convenience combined with loud demands for more.

I know it seems a cliché, but how does government "efficiency" work at the Post Office? Fed-ex, UPS and DHL don't have nearly the restrictions medical care does: They charge according to weight, size and distance, but the customer and the recipient decide the contents of the package and the destination. I've never heard of Fed-Ex telling a customer that their package wasn't necessary or couldn't be moved because some Ph.D. (Doctor of Packing handling) had set a formulary - or that they'll take the package 100 miles and no farther. The biggest difference is convenience and the variety of options offered. Although they are able to compete financially and functionally with the US Postal Service, the lines aren't as long and the system is built to handle the unusual. The unusual is a large part of our business in Family Medicine.

The US First Class stamp is great for letters that don't need to be delivered for a day or two. Maybe the government should cover preventive health and let insurance cover sick people.

Mandates don't guarantee coverage. In Texas, we have to show our insurance card when we register the car, get our license renewed and each year when we have the car inspected. The uninsured rate is estimated to be around 24% (anywhere from 20 to 60%, according to the numbers of tickets issued in the big cities). In Colorado, it may be as high as 35%. (More here.) To compensate, Texas will soon begin correlating driver's licenses, car registration and insurance by a data bank accessible to the police car behind you in traffic. Wait 'till Bubba catches wind of this.


A little bit for everyone from the first dollar that cuts off above a certain level is dangerous. I know Medicare eligible patients who had great drug benefits through their retirement plans. They were forced to go to one of the "donut hole" plans, and now pay more out of pocket than before. We now have a good indication that the "donut hole" in the Medicare Part D drug plan leads to an increase in hospitalizations.

However, while researching all this, I did read about one plan that seemed to make sense to me. I've copied, pasted, and changed the name to "the Plan."

The Plan Gives All Americans The Same Tax Breaks For Health Insurance And Helps States Make Affordable Private Health Insurance Available To Their Citizens.

1. The Plan Will Help More Americans Afford Health Insurance By Reforming The Tax Code With A Standard Deduction For Health Insurance – Like The Standard Deduction For Dependents. The primary goal is to make health insurance more affordable, allowing more Americans to purchase coverage. The Plan levels the playing field for Americans who purchase health insurance on their own rather than through their employers, providing a substantial tax benefit for all those who now have health insurance purchased on the individual market. It also lowers taxes for all currently uninsured Americans who decide to purchase health insurance – making insurance more affordable and providing a significant incentive to all working Americans to purchase coverage, thereby reducing the number of uninsured Americans.

* Under the Plan, Families With Health Insurance Will Not Pay Income Or Payroll Taxes On The First $15,000 In Compensation And Singles Will Not Pay Income Or Payroll Taxes On The First $7,500.
o At the same time, health insurance would be considered taxable income. This is a change for those who now have health insurance through their jobs.
o The Plan will result in lower taxes for about 80 percent of employer-provided policies.
o Those with more generous policies (20 percent) will have the option to adjust their compensation to have lower premiums and higher wages to offset the tax change.

2. The Affordable Choices Initiative Will Help States Make Basic Private Health Insurance Available And Will Provide Additional Help To Americans Who Cannot Afford Insurance Or Who Have Persistently High Medical Expenses. For States that provide their citizens with access to basic, affordable private health insurance, the Plan's Affordable Choices Initiative will direct Federal funding to assist States in helping their poor and hard-to-insure citizens afford private insurance. By allocating current Federal health care funding more effectively, the Plan accomplishes this goal without creating a new Federal entitlement or new Federal spending.

There's no list of covered benefits, no mandates. However, each family would choose how much and what kind of coverage to buy. The current system of larger tax breaks to employers for more expensive health insurance and smaller breaks for less expensive coverage would disappear. Tax breaks for insurance would no longer be tied exclusively to a given job. Government subsidies would only be necessary for the indigent and those "hard-to-insure."

The plan was proposed by President Bush in his 2007 State of the Union address and is outlined here.

Rao: Adult Stem Cells "soon to be on the market"

The journal Stem Cells has published an Open-Access review by the former NIH director, Mahendra Rao, MD, PhD, covering last month's "Adult Mesenchymal Stem Cells in Regenerative Medicine Conference" at the National Center for Regenerative Medicine in Ohio.

Another review with summaries of some of the individual talks as well as the history of the National Institute for Regenerative Medicine and Dr. Arnold Caplan's part in founding both the NIRM and Osiris, can be found at Medscape.

Mesenchymal stem cells (MSCs) can be found in bone marrow and other organs. MSCs are proving to be multipotent, meaning that they can be induced to give rise to different types of cells.


Speakers at the conference included virtually every "big" name in stem cell research, including Dr. Rao, Caplan, Anthony Atala, Catherine Verfaille, and Paul Simmons. The program covered the history, basic science and techniques involved in harvesting and culturing mesenchymal stem cells. There were reports covering the multipotent nature of MSC's and some of the treatments and commercial applications that are in use or will soon be available. One company, Osiris, has been in phase III of some clinical trials of stem cells for treatment of heart disease, graft vs. host disease, Crohn's, and cartilage and tendon repair. Veterinarians are already using MSC's to treat horses and other animals.

Take a look at the last page of the review which contains a graphic covering the wide range of topics.

Gardisil protects against other HPV strains

Medscape Medical News reports that Gardisil, the vaccine against 4 strains of Human Papilloma Virus that cause cervical cancer and warts, also causes the body to make antibodies against other strains of the virus. The information comes from data obtained in the last 7 years of research on the vaccine:

The first evidence of this cross-protection comes from the original and ongoing Merck trials of the vaccine, which protects against HPV types 6, 11, 16, and 18. These new data were presented here at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

The dominant HPV 16/18 strains account for about 70% of all cervical cancers; the vaccine protects against approximately 99% of infections and almost 100% against the development of lesions by those strains. Ten other strains of HPV (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) account for approximately an additional 20% of cervical cancers worldwide.

Combining analysis of all 10 strains showed cross-protection that reduced incidence of precursor lesions by about 38%. The effect was most dramatic with strains 31 and 45, where protection reached about 45%.

Lead investigator Darron Brown, MD, PhD, professor of medicine, microbiology, and immunology at the Indiana University School of Medicine, Indianapolis, said this analysis had been built into the initial study design. The foundation for the work "came from in vitro cross-neutralization studies that showed some suggestion that antibodies to closely related types may be able to cross-neutralize other close types.

"But I think that we all are pleasantly surprised with the high degree of cross-protection that was shown to occur, both in terms of resisting infection and, more importantly, disease," he told Medscape Infectious Diseases.

Dr. Brown suspects that the different degrees of cross-protection the researchers observed are probably related to the level of antibody generated, and perhaps to memory B cells, both of which are likely have an individual genetic component to them.

Dr. Brown mentions a point that I believe is important: the different types of immunity to viruses. When we contact HPV through the skin or mucus membranes, our bodies fight the disease with T-cell immunity. Gardisil induces B-cell immunity. The latter lasts much longer, because of so-called "memory cells" that lie dormant in the body for many years. That is why infection with one virus may not give immunity to other strains or even that strain with future exposure.


There is more on-line at KaiserNetwork.org the AP/Philadelphia Daily News.

There are more than 60 strains of the HPV virus. About 15 are thought to cause cervical cancer; Gardasil protects against 12 of those, plus two more that cause genital warts but not cancer.

Two strains cause 70 percent of cervical cancer. Merck studies following 17,600 young women for three years found the vaccine to be 99 percent effective in blocking those strains.

New analysis of that data shows that the vaccine reduced incidence of HPV-caused precancerous lesions by nearly two-thirds for the three next most common HPV strains in North America. While those three strains are less common elsewhere, together they cause about 11 percent of cervical cancer worldwide.

Government mandated healthcare is government-controlled healthcare

According to this article from the Associated Press, Hillary Clinton envisions a day when you will have to show proof of insurance to your employer prior to being hired for a job.

By BETH FOUHY, Associated Press Writer Tue Sep 18, 12:59 PM ET

WASHINGTON - Democrat Hillary Rodham Clinton said Tuesday that a mandate requiring every American to purchase health insurance was the only way to achieve universal health care but she rejected the notion of punitive measures to force individuals into the health care system.
ADVERTISEMENT

"At this point, we don't have anything punitive that we have proposed," the presidential candidate said in an interview with The Associated Press. "We're providing incentives and tax credits which we think will be very attractive to the vast majority of Americans."

She said she could envision a day when "you have to show proof to your employer that you're insured as a part of the job interview — like when your kid goes to school and has to show proof of vaccination," but said such details would be worked out through negotiations with Congress.

Coincidentally this month, we read about a man in the UK who is being refused surgery by National Health Service docs because he won't quit smoking - although he did cut back to 10 cigarettes a week. And there's the woman who was required to cover her hair or risk being turned away by an NHS dentist.

Here in the US, beginning in 1996, there was a push to punish Medicare recipients who went to docs who charged more that the Medicare allowable. As it is, docs have to "opt out" officially if they want to do a cash-only practice - cheaper or higher - and are not allowed to charge Medicare, Medicaid, or any Government insurance for at least 24 months. This pretty much locked all Medicare eligible patients into the system - they must see a doc who plays the ICD, CPT game or all procedures, hospitalizations will mean going to another physician who has not opted out.

However, back in 1997 and 1998, there were some opinions given by the Clinton administration that Medicare eligible patients were themselves breaking the law if they chose to go out side the system.

Of course, that was just at the time that the E&M codes and all the Uber-reporting rules came into force due to the Balanced Budget Act of 1997. Here's a page full of stories covering that period.


It was also about the time that the Office of the Inspector General started making armed raids on hospitals and Reno, Shalala, and Freeh held rallies in football stadiums to teach Medicare recipients to turn their docs and hospitals in for fraud and abuse and $1000 reward.

More on Liberal Conservative Nature Neuroscience article

Dr. Amodio, the corresponding author of the report I mentioned Thursday, "Neurocognitive correlates of liberalism and conservatism," was kind enough to send me the article and the supporting material. The picture above is the figure that accompanies the 2 page report.

I believe that the paper may demonstrate some evidence concerning the part of the brain which deals with reacting to visual stimuli by making a choice between the correct and incorrect choices. The experiment involved a questionnaire, self description as to "Liberal" vs. "Conservative" along a gradient of "very liberal" to neutral to very conservative, and then participating in a "Go/No Go" experiment while a latex cap placed on the head measured the participant's brain wave paterns or EEG.

The 43 participants were college students and 63% of them were female. The figure 1a indicates that 7 of them identified as conservative, although none called themselves "very conservative."

There is no mention of correlation of any of the other variables (age, gender, visual acuity) involved in hand to eye coordination.

I'm afraid that, as I feared, the problem with the experimental method is that these participants predominantly identified as liberal and that there is some sort of blind spot at work at Nature Neuroscience.

Stem Cells in Tendons (Plus some education)

The National Institutes of Health (NIH) reported last week that scientists have isolated stem cells from tendons which help in the growth and repair of those structures. The abstract of the peer-reviewed report, "Identification of tendon stem/progenitor cells and the role of the extracellular matrix in their niche," is curently available at Nature Medicine at Advance Online Publication. (Later readers of this post will need to search at Nature Medicine for updated location.)

Once again, we have confirmation that tissues that grow, remodel and repair themselves after birth have stem cells that are available for research and which may soon be harvested from injured patients and utilized in medical treatments.

From "Monsters and Critics,"

Songtao Shi identified unique cells within the adult tendon that have stem-cell characteristics -- including the ability to proliferate and self-renew.

The researchers were able to isolate the cells and regenerate tendon-like tissue in an animal model.

'Clinically, tendon injury is a difficult one to treat, not only for athletes, but for patients who suffer from tendinopathy such as tendon rupture or ectopic ossification,' Shi said. 'This research demonstrates that we can use stem cells to repair tendons. We now know how to collect them from tissue and how to control their formation into tendon cells.'

The NIH press release is the most interesting to me (probably because I haven't had a sprained ankle in a while), because of the discussion of "niches" and the conclusion of one of the authors to "follow the phenotype." (More on this phrase, later.)

From the NIH press release:

Marian Young, Ph.D., an NIDCR scientist and the senior author on the study, said the findings also bring to light an unexpected biochemical habitat, or niche, that harbors stem cells. The cells are embedded between layers of extracellular matrix (ECM), the chain-like coils of protein that give tendon its elasticity and contain relatively few cells or blood vessels. To date, most known adult stem cells occupy cell-rich environments with a ready source of nutrients.

"We read a lot about the promise of stem cells, but sometimes overlooked is the importance of the niches that surround them," said Young. "Each individual niche in the body helps to carefully regulate the activities of a given stem cell. What�s nice is we have begun to characterize both in tandem, and that gives the field a head start in learning to meld an understanding of both and hopefully one day to re-engineer damaged tendon."

According to Young, the stem cells, which her group named tendon stem/progenitor cells, or TSPCs, would have never been discovered had it not been for their studies with mice — and good fortune. Young�s laboratory for several years had been knocking out, or inactivating, specific genes in developing mice that likely were involved in forming skeleton and its associated tissues. Among these genes were those that encoded the structural proteins biglycan and fibromodulin, major components of the ECM.

Having knocked out the genes for biglycan and fibromodulin in a new litter of mouse pups, they noticed the mice developed an unusual gait and had difficulty flexing their limbs at two months old. Subsequent X-rays provided the reason: Without biglycan and fibromodulin, the mice were abnormally forming bones within their tendons.

Young and her colleagues theorized that the tendons in these mice might contain stem cells that normally form tendon and, when their niche is altered, misguidedly create bone. If so, they theorized the ECM might house the stem cells, and biglycan and fibromodulin likely played a key role in regulating their normal activity.

The article goes on to quote Dr. Young as saying, "The lesson here is: Follow the phenotype."

If I understand correctly, Dr. Young is confirming that in order to produce stem cells and progenitor cells that will be useful and therapeutic in human patients, we will need to understand and/or be able to reproduce or influence the actual environment where the stem cells develop. Rather than focusing so much of our research efforts and money on embryos, we should be looking at the normal and abnormal local conditions that we want to treat: the "extracellular matix," the local chemical, hormonal, and physical conditions which surround the body's own stem cells and which may be tweaked to induce healing in place, in the patient.

Confirmation: Adult Cells Reprogrammed to Embryonic Stem Cells

Last year, we read, and blogged about experiments by Drs. Kazutoshi Takahashi and Shinya Yamanaka of Kyoto University in Japan demonstrating that (adult) mouse fibroblasts could be reprogrammed to become embryonic stem cells in hopes of being able to one day develop truly "patient specific" stem cells made from the person's own adult stem cells.

This summer four labs, including Yamanaka's Kyoto University, a collaboration between Harvard and the University of California at Los Angeles, and a group at MIT, confirmed the technique as well as reporting on refined methods.

Now, Cell Stem Cell has published a free report from stem cell researchers Robert Blelloch, Monica Venere, Jonathan Yen, and Miguel Ramalho-Santos at the University of California at San Francisco, describing a simplified and improved technique to turn mouse fibroblasts into mouse embryonic stem cells.

Here's an explanation of the significance of the new process, from ScienceDaily:

The UCSF team said their new finding should accelerate research aimed at improving the original strategy, as well as increasing its potential use for studying disease development and creating patient-specific stem-cell based therapies.

"The new technique removes a major technical hurdle that has likely discouraged many labs around the world from carrying out studies on the strategy," said the study's senior author Ramalho-Santos.

There are hurdles to overcome before human adult cells are reprogrammed and useful in the treatment of the donor's diseases. From a news report in Nature, June 2007:

If it works, researchers could produce iPS ["induced pluripotent stem" LifeEthics] cells from patients with conditions such as Parkinson's disease or diabetes and observe the molecular changes in the cells as they develop. This 'disease in a dish' would offer the chance to see how different environmental factors contribute to the condition, and to test the ability of drugs to check disease progression.

But the iPS cells aren't perfect, and could not be used safely to make genetically matched cells for transplant in, for example, spinal-cord injuries. Yamanaka found that one of the factors seems to contribute to cancer in 20% of his chimaeric mice. He thinks this can be fixed, but the retroviruses used may themselves also cause mutations and cancer. "This is really dangerous. We would never transplant these into a patient," says Jaenisch. In his view, research into embryonic stem cells made by cloning remains "absolutely essential".

If the past year is anything to judge by, change will come quickly. "I'm not sure if it will be us, or Jaenisch, or someone else, but I expect some big success with humans in the next year," says Yamanaka.

However, the very same hurdles face researchers who utilize human embryonic stem cells harvested from human embryos. The worries about tumors are inherent in research with embryonic stem cells. The reports from Texas researchers last March on lung cells derived from human embryonic stem cells described a method that was also dependent on infection with viruses in order to induce the desired cell type.

The difference is that reprogrammed adult cells from patients who ar to be treated would truly be "patient specific," without the further hurdle of as-yet-unachieved human cloning. More importantly, they would not depend on the unethical creation and destruction of human embryos.

Parental Notification for Abortion Decreases STD risk

Instinctively, I believe that many of us knew this. However, now we have documentation to point to.

The Journal of Law, Economics, and Organization Advance Access published an article online by Jonathan Klick and Thomas Stratmann on September 4, 2007 , entitled, Abortion Access and Risky Sex Among Teens: Parental Involvement Laws and Sexually Transmitted Diseases

Laws requiring minors to seek parental consent or to notify a parent prior to obtaining an abortion raise the cost of risky sex for teenagers. Assuming choices to engage in risky sex are made rationally, parental involvement laws should lead to less risky sex among teens, either because of a reduction of sexual activity altogether or because teens will be more fastidious in the use of birth control ex ante. Using gonorrhea rates among older women to control for unobserved heterogeneity across states, our results indicate that the enactment of parental involvement laws significantly reduces risky sexual activity among teenage girls. We estimate reductions in gonorrhea rates of 20% for Hispanics and 12% for whites. Although we find a relatively small reduction in rates for black girls, it is not statistically significant. We speculate that the racial heterogeneity has to do with differences in family structure across races.

The authors use CDC data, correlated with the time that State laws went into effect, and cross-referenced with gonorrhea diagnosed in the States among adult women.

The gonorrhea rates decrease in both boys and girls in those states that have parental notification laws.

Liberal/conservative neuro-experiments?

Nature Neuroscience has reported on an experiment that is being touted as proving that "liberals" are smarter than "conservatives." Or, as the LATimes' Denise Gallene states, "that liberals tolerate ambiguity and conflict better than conservatives because of how their brains work."

I wonder whether these findings mean that all those visual field tests we've been doing could be affected? Which group would be more likely to have a skewed "blind spot"? For that matter, did the researchers have one of their own?

From a review in the LA Times:

Participants were college students whose politics ranged from "very liberal" to "very conservative." They were instructed to tap a keyboard when an M appeared on a computer monitor and to refrain from tapping when they saw a W.

M appeared four times more frequently than W, conditioning participants to press a key in knee-jerk fashion whenever they saw a letter.

Each participant was wired to an electroencephalograph that recorded activity in the anterior cingulate cortex, the part of the brain that detects conflicts between a habitual tendency (pressing a key) and a more appropriate response (not pressing the key). Liberals had more brain activity and made fewer mistakes than conservatives when they saw a W, researchers said. Liberals and conservatives were equally accurate in recognizing M.

Researchers got the same results when they repeated the experiment in reverse, asking another set of participants to tap when a W appeared.

Frank J. Sulloway, a researcher at UC Berkeley's Institute of Personality and Social Research who was not connected to the study, said the results "provided an elegant demonstration that individual differences on a conservative-liberal dimension are strongly related to brain activity."

Analyzing the data, Sulloway said liberals were 4.9 times as likely as conservatives to show activity in the brain circuits that deal with conflicts, and 2.2 times as likely to score in the top half of the distribution for accuracy.

Sulloway said the results could explain why President Bush demonstrated a single-minded commitment to the Iraq war and why some people perceived Sen. John F. Kerry, the liberal Massachusetts Democrat who opposed Bush in the 2004 presidential race, as a "flip-flopper" for changing his mind about the conflict.

Based on the results, he said, liberals could be expected to more readily accept new social, scientific or religious ideas.

The article is "currently unavailable online," but the website instructs us to contact subscriptions at subscriptions@nature.com. Hopefully this is some sort of elaborate practical joke. The potential weaknesses at the least include drawing conclusions from hand to eye coordination to poorly defined political affiliations among the self-described college students. I wonder about the "n" of the college students who call themselves "conservative." How many could there be? Would libertarians call themselves liberal or conservative?


In the meantime, here's the abstract:

Neurocognitive correlates of liberalism and conservatism

David M Amodio (1), John T Jost (1), Sarah L Master (2) & Cindy M Yee (2)
1.Department of Psychology, New York University, 6 Washington Place, New York, New York 10003, USA. 2. Department of Psychology, 1285 Franz Hall, University of California, Los Angeles, Los Angeles, California 90095, USA.

Political scientists and psychologists have noted that, on average, conservatives show more structured and persistent cognitive styles, whereas liberals are more responsive to informational complexity, ambiguity and novelty. We tested the hypothesis that these profiles relate to differences in general neurocognitive functioning using event-related potentials, and found that greater liberalism was associated with stronger conflict-related anterior cingulate activity, suggesting greater neurocognitive sensitivity to cues for altering a habitual response pattern.

Hat Tip to BioEdge, an email newsletter.

States demand Feds subsidize middle class insurance

$82,000 for a family of four is not "poor," or even the "working poor," except perhaps in Manhattan. Could it be that the State and local taxes make these families the "working poor" and are more responsible than the "high cost of insurance" for the families' perception that they can not afford health insurance?

Remember, CHIP was not designed to subsidize families whose children have special needs or catastrophic health costs.

The effect of expanding chip to cover more children (and their families, in some cases), is that other States will subsidize the States whose legislatures pass bills to expand CHIP coverage. I've heard many times that Texas is "losing Federal dollars." Some of that money that we send to Washington in form of Federal Income Taxes goes to New York. See the Table from the first year of redistribution, 2000, here.

Here's the AMA morning newsletter coverage of the movement to force the rest of us to subsidize the health insurance of people who make 4 times the poverty level:

Leading the news
Bush administration rejects New York's request to rescind SCHIP limitations. In continuing coverage from previous briefings, the New York Times (9/8, B2, Pear) reported, "The Bush administration on Friday rejected a request from New York State to expand its [state] children's health insurance program (SCHIP) to cover 70,000 more uninsured youngsters, including some from middle-income families." The Times continued, "New York wanted to expand its program to cover children in families with incomes up to four times as much as the federal poverty level, or $82,600 for a family of four. The state's current limit is 250 percent of the poverty level." The Bush administration has argued that plans like New York's "would divert resources from lower-income children and 'crowd out' private health insurance."
The AP (9/8) added, "Kerry Weems, acting administrator for the Centers for Medicare and Medicaid Services, said that New York did not meet the 95% threshold, and noted that the new guidelines require New York to make sure that middle-income children have been uninsured for at least a year before allowing them into SCHIP." New York wanted to decrease the waiting period to six months. The AP continued, "Democratic lawmakers will attempt to overturn the administration's new guidelines in coming months as Congress considers renewing the children's program for an additional five years."
Pointing out that this decision could have implications for other states and future congressional action, the Los Angeles Times (9/8) noted, "The ruling by the Health and Human Services Department sent a clear signal that the administration intends to enforce a new policy aimed at refocusing the State Children's Health Insurance Program on the children of the working poor." Certainly, California would be affected because the state plans to "cover uninsured children in families that earn up to about $60,000 for a family of four," which exceeds the administrations threshold of $50,000 for a family of four. The Times continued, "The children's health insurance program covers about 6 million youths whose parents make too much to qualify for Medicaid but too little to afford private coverage. It will expire Sept. 30 unless Congress and the president renew it or approve a temporary extension." Should the administration prevail, several states "could be forced to drop hundreds of thousands from the rolls."
According to Long Island's Newsday (9/8, Evans), "Gov. Eliot Spitzer (D-N.Y.) Friday threatened to sue the Bush administration to reverse its rejection of his proposed SCHIP health insurance program expansion, saying the rejection would leave too many children uncovered." He added, "Today's federal decision is a cruel blow to New York's uninsured children, and to uninsured families across the country." In addition, "The state's top Republican, state senate Majority Leader Joseph Bruno (R-Brunswick) called the rejection 'an error in judgment,' and vowed to put aside his ongoing feud with New York's Democratic governor in an effort to reverse the federal decision."
And, the Buffalo News (9/8, Zremski) added, "State officials had hoped to start enrolling those children in the program this month." Now, that no longer seems possible. In an attempt to combat this decision, Governor Spitzer "plans to meet Monday with New York's congressional delegation, where he will likely find plenty of support. On Friday, some 25 members of the delegation -- all Democrats -- sent a letter to federal officials asking them to rescind the strict limits they are putting on the child health program."
Governor Schwarzenegger's plan for uninsured Californians stymied. The New York Times (9/9, Sack) reported, "After losing much of August to a budget impasse, state lawmakers and Gov. Arnold Schwarzenegger (R-Calif.) have been unable to reach agreement on a proposal to extend health coverage to all uninsured Californians." Earlier this year, "Mr. Schwarzenegger proposed coverage for all 6.7 million uninsured Californians. Vowing that his state would lead the nation, the moderate Republican made his plan the centerpiece of a new 'postpartisan' politics." However, while "polls indicate that Californians are fed up with the health care system," they also seem concerned that taxes would have to be increased in order to pay for universal health coverage. If the various interest groups do not settle their differences regarding health coverage for the uninsured, the issue may have to be resolved by a special ballot.

Texas Researchers: Prostate Pluripotential Stem Cells

Researchers Dr. Liping Tang from the Bioengineering Department at University of Texas at Arlington, and Dr. Victor K. Lin of the Department of Urology at UT Southwestern (Dallas, Texas) have published a paper describing pluripotent adult stem cells from prostate tissue. Tissue cultures as well as biochemical markers show that the cells harvested from men undergoing surgery to remove the prostate contained mesenchymal adult stem cells that could be induced to grow the smooth muscle cells that they become in the prostate. In addition, they were induced, in the laboratory, to become stem cells that gave rise to fat cell lines ("adipogenic") and bone cell lines ("osteogenic" cells).

The men did not have prostate cancer. They had BPH, "Benign Prostatic Hypertrophy," (or "Hyperplasia")which is an overgrowth of the prostate tissue, a donut of tissue that surrounds the urethra of men, blocking or restricting the passage of urine from the bladder to the outside.

It's exciting for researchers to not only report research that may help in the treatment or prevention of a disease that affects many older men, but to also find stem cells that are easy to grow and which give rise to several different lineages of adult cells from a common precursor cell.

From the (free) abstract in The Prostate:

Our study on primary stromal cells from BPH patients have yielded many interesting findings that these prostate stroma cells possess: (1) mesenchymal stem cell (MSC) markers; (2) strong proliferative potential; and (3) ability to differentiate or transdifferentiate to myogenic, adipogenic, and osteogenic lineages. These cell preparations may serve as a potential tool for studies in prostate adult stem cell research and the regulation of benign prostatic hyperplasia. (Emphasis mine.)

For an easier to read explanation, read the Press Release from the University of Texas at Arlington School of Engineering:

The research team was particularly interested in human pluripotent stem (hPS) cells, which are the primary cultured BPH stromal cells and have two unique characteristics; they do not exhibit markers typical to epithelial cells (covering the lining of body tissue) and have few markers for disease-causing smooth muscle cells.

This study on primary stromal cells from BPH patients resulted in findings that prostate stroma cells possess multipotent stem cell markers, strong proliferative potential and the ability to differentiate or transdifferentiate to muscle-forming, fat-forming and bone-forming lineages. These cell preparations may serve as a potential tool for prostate stem cell research and its role on regulation of prostatic hyperplasia.

(Hat Tip to DT of daily transformation.)

The all or nothing dilemma (SCHIP)

The advocates of government-funded health care are (repeatedly, pleadingly, as though they are in some weakened, minority status) urging doctors and everyone with an eye to see or ear to hear to let our legislators know that we, too, want government to grow, to own medical care, and to tax us and regulate us out of business, please.

I don't feel that it's a bad thing for SCHIP to stay the same size or even to shrink. Somehow that thought never occurred to the AMA, the Kaiser Foundation, or the New England Journal of Medicine, who published a free editorial and audio clip entitled "No Child Left Uncovered."

The problem is that the bills and regulations have become so cumbersome that no one really knows what is in them, and there are so many interdependencies that we are told the whole house of cards will fall if the big budget is not passed.

From the American Academy of Family Physician's news service, "This Just In,"

House and Senate members are committed to providing positive physician payment updates in 2008 and 2009 but the question is how that will be accomplished.

"The House negotiators are adamant they are not going to have another opportunity to address the SGR in any real way before the end of the (fiscal) year -- that (SCHIP) is the only opportunity," said Burke. "The Senate seems to feel it can get a payment provision together by the end of the fiscal year when they are passing their appropriations bills or tax bills."

Without congressional reauthorization, SCHIP will expire on Sept. 30. Congress, for its part, will have a hard time reauthorizing the program by the Sept. 30 deadline, and as a result, congressional members are likely to extend the deadline for the program's reauthorization.

As you can see from the images at the top of this post, SCHIP hasn't changed the coverage of children over the 200% of poverty level and the current House bill will allow decreases in physician payments (edit - and the proposed expansion by the House bill would increase payments).

Patients' own adult stem cells in the news

There's hope in the news for future adult stem cell therapies using patients' own stem cells within the next ten years.

The (UK) Times Online reports on the rapid progress in research on tissue regeneration using patients' own adult stem cells to produce heart valves and muscles. The researcher predicts the technology will be available in three to five years for use in humans.

To support this hope, Nature Biotechnology will publish a report on adult stem cells that make muscles in immune deficient mice. The abstract is available here and the UPI report is available here.

Gambling with CHIP (Pork, Perks and Politics, not Poker)

We've been hearing and reading about how desperately Congress needs to pass the bill to fund - and expand - SCHIP, the Children's Health Insurance Program. However, you may not have heard about the pork, perks and politics that are included in the current versions of the House and Senate bills, which led President Bush to threaten to use his veto.

When Congress returns from their August break, the House and Senate versions will be the subject of conference committees charged with ironing out the differences, in order to send a bill to the President by the deadline of September 30.

(For the amounts currently spent on Medicaid and SCHIP, see total Medicaid funding and total SCHIP funding for fiscal year 2006.)

This week's American Medical Association News (available free for 90 days) pleads for expansion:

In terms of patient access, the stakes can't be overestimated. In an AMA poll of nearly 9,000 physicians, 60% said next year's 10% cut would force them to limit the number of new Medicare patients they treat or stop seeing beneficiaries altogether. Doctors simply cannot absorb a financial hit of that magnitude.

The House bill would preserve seniors' and disabled patients' access to doctors by replacing the next two years of physician pay cuts with 0.5% increases each year. The measure is not without problems, however. The AMA is working to remove Medicare provisions dealing with physician-owned hospitals and imaging services.

As for SCHIP, a congressional failure to reauthorize the program would devastate children's health care access. About 6 million children (and about 600,000 adults) rely on this program.

Reauthorizing SCHIP at $25 billion -- its level for the past five years -- is not an option. That amount would not be enough to cover the children who are currently enrolled, let alone the roughly 2 million uninsured kids who are eligible for the program, but not enrolled.

Fortunately, the House and Senate bills would increase funding by $50 billion and $35 billion over five years, respectively. This would provide enough money to extend coverage to all eligible, uninsured children.

The House measure would not change states' existing family income limits. About half of the states cover children from families up to 200% of poverty, and the other half cover kids from families above that limit. The most generous level, in New Jersey, is 350% of poverty. The Senate legislation would allow states to cover children in families earning up to 300% of the federal poverty level.

Some Republicans, including President Bush, have said the SCHIP expansions envisioned in the House and Senate bills go too far. Bush's budget proposed a $5 billion increase in funding over five years and an eligibility limit of 200% of the federal poverty level. On Aug. 17, the Bush administration issued new standards that make it more difficult for states to cover children from families above the 250% mark. Republican critics argue that the House and Senate measures are a step away from private coverage toward nationalized health care.

But this argument ignores the statistic that 70% of children on SCHIP are enrolled in private health plans that contract with the states. The remainder are in public plans operated by the counties or in fee-for-service SCHIP.

With about 9 million U.S. children lacking insurance, Congress should make sure the funding level it settles on is enough to enroll uninsured children who are eligible for SCHIP.

Congress already has found two sensible ways to pay for Medicare payment relief and the SCHIP expansion. To help prevent the Medicare physician payment cut, the House bill would end overpayments to private health plans operating in the program. It is only fair that Medicare Advantage be on equal footing with the program's traditional component.

The House and Senate measures would pay for the children's insurance expansion by increasing the federal tobacco tax (currently 39 cents) by 45 cents and 61 cents, respectively.

However, there are other opinions about the cuts to Medicare in order to fund the SCHIP expansion, the hidden pork that favors some hospitals over others, and the language and focus change from covering prenatal care to covering a wide range of "reproductive health services" for women who are pregnant, rather than covering prenatal care and delivery of their unborn children.


"Don't pit children against seniors" Washington Post Letter to the Editor describes the effects of cutting Medicare programs in order to increase funds for SCHIP.

"Select Hospitals Reap a Windfall Under Child Bill," a New York Times piece on the custom of building in increased reimbursement for certain hospitals, without actually naming those hospitals or noting which legislator put the perk in the Bill:

The two hospitals in Kingston, N.Y., that are beneficiaries of the bill, Benedictine Hospital and the nearby Kingston Hospital, recently announced an agreement that would bring them together under a single parent corporation.

Neither hospital is named in the bill, but they are the only ones that could qualify. The bill guarantees higher Medicare payments for New York hospitals with a “single unified governance structure,” located less than three-fourths of a mile apart in a city with a population of 20,000 to 30,000.

and

Lawmakers did not identify St. Vincent by name, but referred to a hospital with Medicare provider number 360112. That is the identification number for St. Vincent.

There's also the change in language from care for unborn children to pregnant women - which leads to fears that abortion services will be required, and changes the focus from "Child" toward universal government health care.

From the Left: "Bush and SCHIP: It’s Also About Fetuses"

And from the Right: "Protect Life: Tell the House to vote NO on H.R. 3162"