FDA goes after fraudulent cancer cures

We were just talking about this.

The Washington Post reports

Neil Baker, a retired maker of truck canopies in Helena, Mont., fills about two orders a month for E-Mune through his company, Herbal Remission. It is made from bloodroot, a plant that contains sanguinarine, which has been studied for possible anti-tumor activity. He says one customer's melanoma was cured.

"I really don't know a whole lot about it. All I know is it works," said Baker, 63. "As far as I'm concerned, humanity should have it. But if the FDA doesn't like it, that's okay with me, too."

The FDA's list of "fake cancer cures" is at http://www.fda.gov/bbs/topics/factsheets/fakecancercures.html.

Wait 'Till Next Week! (More iPS good news)

Dr. Yamanaka of Japan, the MD who made history last week by announcing that he had been able to obtain embryo-like stem cells fom adult skin cells called fibrobalsts. On Friday, November 30, has published a new report in Nature Biotechnology telling us how he was able to skip inserting the potential cancer causing gene, c-Myc.

At this rate, who knows what we'll have next week?

From The Scientist (online here):

In the current study, the researchers showed that pluripotent cells can be made from both mouse and human adult cells without introducing the c-Myc gene, by transducing just the other three. It's not that Myc isn't needed in the process, the authors noted in the paper; rather, they suggest that the other three genes may be spurring endogenous Myc activity. None of the 26 chimeras made from cells generated without c-Myc developed tumors within 100 days, compared to six out of 36 chimeras made from cells using all four genes.
*************
So far, too, efficiency with this triple-gene method is much lower than with the original four genes; half of the experiments without c-Myc did not produce pluripotent cells at all, while experiments using the four genes almost always yielded pluripotent colonies. "Does this mean that it now only works with a rare cell type?" Lovell-Badge wrote. "As always, many more questions are posed than answered."

The question is whether all fibroblasts are alike, or whether there is a smaller group of fibroblasts that are easier to induce to become "induced Pluripotent Stem" Cells.

If there are specialized cells in the skin that are easier to manipulate than others, this is good news for researchers and the patients who are looking toward stem cell research for treatments and cures.

UTexas: Modified virus fights stem cell cancer

Viral gene therapy (similar to techniques used in the stem cell breakthrough last week) has been used by University of Texas MD Anderson Cancer Center researchers in animal models and reported in the September 19, 2007 issue of the Journal of the National Cancer Institute. From MD Anderson:

Since 2004 scientists have found that brain tumors are driven by haywire stem cells that replicate themselves, differentiate into other types of cells, and bear protein markers like normal stem cells.

"Research has shown that these cancer stem cells are the origin of the tumor, that they resist the chemotherapy and radiation that we give to our patients, and that they drive the renewed growth of the tumor after surgery," Fueyo said. "So we decided to test Delta-24-RGD against glioma stem cells and tumors grown from them."

Researchers used a virus to infect the cells of aggressive tumors of the cells that support brain cells, glioblastoma multiforme. Gliomablastomas are 60% of brain cancers and patients have a survival rate as short as 2 to 3 months, with less than 10%-25% survival after 2 years even with current aggressive therapy. The virus is modified so that it is "selective" for cancer: it only infects the cancer tumors and cannot infect others.

The team first developed mice with transplanted human brain cells derived from stem cells found in four samples of glioblastoma multiforme. The researchers then developed a customized virus, Delta-24-RGD, to fight the cancer. According to a 2003 MD Anderson press release on the trials, the virus infection inserts copies of a certain gene, retinoblastoma protein (Rb), that acts as a "brake" on the cell duplication system of the cell. In order to make the therapy more efficient and safer, the virus also insert a gene to for a cell surface receptor, a sort of "docking" area on the outside of the cell.

The cell surface receptor for viruses is one of the ways that we are studying to fight both cancers (see this free article from this month's JNCI) and viral infections, themselves. The goal is vaccinations to affect genetic causes of cancer (as in these two reports) or to prevent viruses from binding to the cells and infecting them in the first place.

Liver cell regeneration and adult stem cells

Wesley Smith posted to his own blog and to Bioethics.com about the research out of Germany showing that patients' own bone marrow stem cells can be stimulated to regenerate (normal) liver stem cells and then liver tissue, allowing the regrowth of enough new liver that surgeons can remove the cancer. (UK Telegraph article here, the abstract at Radiology online here.)

The next day, we learned that White House Press spokesman, Tony Snow, has metastatic colon cancer in his liver. This post was prompted by a not-so-nice comment on one of the non-prolife, pro-embryonic-stem-cell-research blogs that we should promote embryonic stem cell research. There's a much kinder and informative post at the Cheerful Oncologist.

Mr. Snow's illness may help educate and save many lives, both embryonic and non-embryonic.

I hope that the hope of stem cell research will be spread including the good news that multiple studies concerning the fine-tuning of knowledge about the precise population of stem cells that are functioning to regenerate the liver, and I believe that there will soon be treatments using adult, but not embryonic stem cell treatements. The patients' own stem cells will be much easier to get past any Ethics Committee than any embryonic stem cells.

For more information try a "Pub Med" search on "liver regeneration." at "Entrez Pub Med." There are 20 or so promising articles on non-embryonic stem cell liver regeneration in the last month, including this one from the authoritative journal, Stem Cells, that appears to have identified the specific population of cells from the liver that serve to become liver stem cells and then functioning liver.

Relapsing breast cancer

The Cheerful Oncologist has a post about the recurrence of Elizabeth (Mrs. John) Edwards' breast cancer. The comments from readers are wrenching -- with repeated remarks that, now, the survivors are afraid that their own cancer will return.

Having just gone through my mother's cancer and death - not due to the cancer, but from the effects of "para-neoplastic syndromes," due to the antibodies her body made against the cancer - I strongly urge the the Edwards family focus on their lives together.

Cord Blood Cells: Godsend or Gimmick?

"There are people who are alive now who otherwise would've been dead if there hadn't been a mother who donated their cord blood."

If you know me and my granddaughter Roni, you know that my answer is "Godsend."

ABC News has a video news report from Good Morning America on the current status of cord blood use. Note that one of the cases discussed is for an "immune problem." This could be a lack of immune cells or one the treatments for Rheumatoid Arthritis, lupus, and other autoimmune problems that are in Phase I and Phase II trials.

I thought about editing out the negative remarks, but I've left the article intact. Be sure and read the last section, "Public Banking Could Save Many Lives."

ABC News
Umbilical Cord Cells: Godsend or Gimmick?
Stem Cells Offer Life-Saving Treatment, but Private Storage Remains Expensive

March 22, 2007— - For most of us, our connection to an umbilical cord lasts only during our first few seconds of life.

However, for a growing number of people, umbilical cords represent a crucial lifeline even in adulthood.

Take Rhonda Kottke, for instance. On Dec. 28, 2001, at the age of 29, her doctor diagnosed the Chicago woman with leukemia.

Her treatments ravaged her immune system to the extent that if it were not replaced, she would die.

Kottke's siblings were tested, but their bone marrow was not a close enough match to hers. It was then that her doctors suggested a different course of treatment altogether -- an infusion of stem cells obtained from an umbilical cord.

The transplant came six months after her diagnosis. Today, doctors say the graft likely saved Kottke's life.

"I'm doing great, knock on wood," she told ABC's "Good Morning America." "I have no signs of leukemia in my blood. I have no sign of cancer at all. I'm as healthy as anyone else."

Kottke received her transplant from a public cord cell bank. However, many private companies offer new parents the chance to freeze their child's cord cells for personal use -- that is, if the child or a family member needs them.

But as the trend of banking cord blood continues to grow, critics say those who bank umbilical cord cells at private banks will most likely never use it.

And with an initial price tag of more than $1,000 to store the cord blood -- and yearly storage fees in the hundreds of dollars -- the cost of this biological insurance policy may outweigh the actual benefits for most.

Cord Blood a Versatile Tool

At birth, the umbilical cord is normally thrown away. But in the past few years, doctors have discovered that it is chock full of stem cells, which can be used to treat as many as 70 different diseases.

Treatments using cord blood cells are still relatively new; so far, only about 6,000 Americans have received cord blood transplants. Most commonly, the cells are used to regenerate the immune systems of patients who have received treatment for leukemia.

"Cord blood is an increasingly valuable alternative to bone marrow transplant," says Dr. Curt Freed, head of clinical pharmacology and toxicology at the University of Colorado School of Medicine.

However, researchers say that future applications could be far broader. But, though cord blood treatments appear promising, much of the science surrounding these treatments is still speculative.

"There may be technology developed in the future that allow patients and parents to find it useful in a clinical setting, but there is a lot of science needing to be performed before any of this stem cell hype becomes reality," says Bryon Petersen, associate professor of pathology at the University of Florida.

A Wise Investment?

Joshua D'Eramo's parents privately stored his umbilical cord blood when he was born. It was an expensive decision -- they paid their company $1,200 up front and $100 each year to store it.

"It's like an insurance policy," says his mother, Rena. "We get insurance for our cars, for a car accident and we may never need it, but it is comforting to know it is there if you do need it."

Today there are 25 private companies that will store a baby's cord blood for a fee. Like a bank account, it will be available exclusively to the family of the donor.

But the chances that anyone will ever need to make a withdrawal from such an "account" may be slim.

"There's nothing particularly wrong with doing that, but it's not very useful," says Dr. Cladd Stevens, medical director for the New York Blood Center's National Cord Blood Program.

"I think most of the professional organizations, the pediatric society and obstetric society, recognize that it's not very useful."

"A single individual has about a one-in-one-thousand chance of needing a bone marrow transplant in his or her lifetime, so banking does not make much sense as an insurance policy," Freed says. But, he adds, "In individual cases, such as a family member's illness that might be treated with cord blood, retaining cord blood could make sense."

Critics go one step further, saying that advertisements used by such private banks prey on the fears of new parents.

"I'm sure there are a certain amount of businesses and people with less than admirable scruples who take advantage of the public fears," Petersen says. "Those companies would blacken the eye of the business as a whole."

Public Banking Could Save Many Lives

Parents who choose not to seek the services of a private bank have another option as well -- they can donate the cord cells to a public bank, which will, in turn, donate them to those in need.

"We initially thought about private banking, and I think most parents that think about it probably do, because your first thought is 'oh, my God, what happens if something happens to my baby?'" says 35-year-old new mother Angie Bongaarts of Chicago.

But Bongaarts and her husband discussed the matter, and together they agreed that since they had no family history of leukemia, they would, instead, send their daughter's umbilical cord to a public bank.

"We figured that there was probably a better chance for the blood going for use for someone who did have a problem right now," she says.

Two-and-a-half months after they donated their baby's cord blood to a public bank, Bongaarts and her husband were notified that the cells were used to help a young man with an immune problem.

Bongaarts says the prospect that her daughter's cells may have saved someone's life was a special gift.

"I was euphoric," she says. "It's been nice to think back on for the past couple weeks, to know that we were able to do that for someone."

According to Stevens, Bongaarts' story is not unique.

"We estimate there are probably 10,000 patients around the world who have benefited from the fact that a mother donated her baby's cord blood for anybody who needed it," she says.

"There are people who are alive now who otherwise would've been dead if there hadn't been a mother who donated their cord blood."

Largely due to the success stories seen thus far with public cord cell banking, many experts say a fully stocked national registry of 150,000 samples -- a project currently in development -- could save many lives.

"With medical research progressing -- and if everyone donates cord blood to public banks -- then an excellent cell match should be available for those that need cell transplantation in the future," Freed says.

Public banking saved Kottke's life. And she says the impacts of the lifeline she received are overwhelming.

"It's absolutely the most amazing thing anyone has ever done for me," Kottke says. "I'm thankful every day."

For more information about donations, visit www.nationalcordbloodprogram.org

Copyright © 2007 ABC News Internet Ventures

HT: Bioethics.com

More on HPV, mandates, and tax money

All State Medicaid programs must offer the vaccines recommended by the (Federal) Advisory Committee on Immunization Practices, under the Vaccines for Children program. The States don't have to mandate the vaccine, however.

Some of the docs I've talked to are convinced that Medicaid and uninsured patients will have an easier time accessing and affording Gardasil than insured patients - unless the insurance companies are forced to cover it somehow.

I predict that within just 2 or 3 years, the private insurers will see that the girls who receive the vaccine don't have to have nearly as many repeat paps, fewer colposcopies and biopsies. Eventually, in 5 or 6 years, there will be fewer freezing and laser therapy treatments. Somewhere in there, they will begin to cover and strongly encourage the vaccine, without being forced.

It turns out that the transition from infection with the more virulent strains to a precancerous or even carcinoma intraepithelial neoplasm (cancerous cells in the surface layer - the kind that leads to repeat pap smears, colposcopy and biopsies and then freezing or laser ablation or removal of the surface layer of the cervix. The pathology-reported names given to these spots on the cervix include "Low Grade Squamous Intraepithelial Lesions, High Grade SIL, Carcinoma in Situ ) can occur within 2 to 3 years, although most take 10 years or so.

From an article available here, free on line,

The traditional view has been that this process takes years, if not decades, to occur after initial HPV infection. Recent studies suggest that these changes may develop more quickly than previously thought. Winer et al followed women after initial HPV infection for the development of CIN 2/3.

As shown in Figure 3, approximately 27% of women with an initial HPV 16 or 18 infection progressed to CIN 2/3 within 36 months [20]. A second study of a large health maintenance cohort found that approximately 20% of women 30 years of age or older who were initially infected with HPV 16 developed CIN 3 or cervical cancer within 120 months.

Women who had an initial HPV 18 infection had approximately a 15% risk of developing CIN 3 or cervical cancer at 120 months [21].

The strong correlation between infection with high-risk types of HPV and LSIL, HSIL, and cervical cancer suggests that HPV DNA testing would be a useful tool for the management of women with abnormal Pap test results, especially in the case of those with equivocal test results. In the case of an equivocal Pap test result, HPV DNA testing can help determine whether the individual should be referred for colposcopic assessment [22].

(Ault, Kevin. "Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract." Infect Dis Obstet Gynecol. 2006; 2006: 40470. Published online 2006 January 30. doi: 10.1155/IDOG/2006/40470. Copyright © 2006 Kevin A. Ault.)


The biggest financial gain to the Medicaid program and then the insureres - as well as the biggest gain in decreased worry and actual pain and suffering of women - will not be from a decrease in diagnoses of the cancer, itself. It will be from the decrease in the visible warts, as well as precancerous changes from the occult infections that can't be seen with the naked eye and the repeat testing and biopsies, along with the cervical damage from excisions, lasers and freezing which can lead to infertility and premature births.

More information at this summary of another research paper. And this paper reports on 2 year risk of developing CIN.

Texas HPV Vaccine

One of my goals is to translate between the pro-life and pro-family community that has a religious background and those who do not necessarily count themselves as religious. Sometimes, it seems that's all I do.

Governor Rick Perry evidently surprised most of the world with his brave move concerning a vaccination against Human Papilloma Virus, a group of sexually transmitted viruses that cause abnormal pap smears and cervical cancer. While he follows a 2003 law, he has been criticized by the Family Policy Center, the American Association of Physicians and Surgeons and many Texas conservatives. Even the Republican Party of Texas issued a statement calling on him to rescind his Executive Order.

Although I normally agree with these groups, I think they are wrong in this case. The Christian Medical and Dental Association agrees with me. And Governor Perry, since he went so far in his EO to protect the right of parents to "opt out."


The vaccine will not interfere with our efforts to teach and encourage our children to abstain from sex outside of marriage. In fact, I hope that by giving the vaccination before 6th grade, younger children will be less likely to connect the vaccine with sexual activity and will be protected when they do have sex for the first time. The fact that the vaccine is so necessary could also be used to teach the fallacy of "safer sex."

The research showed that younger girls show stronger immune responses to the vaccine than older girls and women. And logically, vaccines only work before contracting the disease.

Studies of teen girls have shown that over 2 years, 40% to 80% of them will become positive for HPV, and over 10% of them will have the high risk virus, HPV 16, that is associated with over 50% of cervical cancers. Admittedly, the infected girls must be exposed. However, contrary to popular opinion, the viruses can be spread by the hands during heavy petting.

Besides the pain and cost of the cancers and the 400 deaths per year in Texas from cervical cancer, however, there is the cost of the early precancerous changes from the viruses. There are the every three to six month repeat paps and HPV tests, the freezing and lasers, and the weakened cervices that can result in premature labor.

Gardasil, while new, is produced the same way most insulin for diabetics is manufactured these days: by recombinant DNA. It’s not a weakened or killed virus, isn’t grown in human tissues and doesn’t contain mercury. The vaccine contains copies of antigens that are part of the outside covering of the virus, not the DNA that causes infection and cancer. Vaccinated patients make antibodies against four strains that cause the most harm.

In contrast, the last two vaccines mandated for schoolchildren in Texas are manufactured using human tissue cultures that resulted from abortions. Many parents object to the “Chicken Pox” Varicella and Hepatitis A vaccines – although the children were not aborted in order to obtain the vaccine, and there is some ethical support for accepting the vaccines because the unethical act is isolated from the intention and act of the vaccine.

(Edit: The Hepatitis B vaccine is also made by recombinant DNA, and not one of the un-ethical methods. This was added to strengthen the case for the safety of the recombinant technique, similar to the evidence due to the wide spread use of insulin from recombinant DNA. I could have added that Hepatitis B is another virus that is unlikely to be spread by casual contact in school. That fact is also true of another mandated vaccine for Tetanus - what we used to call "lock jaw.")

The vaccine against Hepatitis B, which is spread by blood and bodily fluids, has been mandated for school children in Texas since 1998.

The Texas Legislature gave the Governor the power that he exercised as the head of the Executive Branch: the power to regulate the Medical Board and the Department of State Health Services. The Legislature has passed law as recently as 2003 that allows the Department and Board to add vaccines as they deem them necessary.

The Governor's language strongly promotes the parental right to "opt out" and orders the Department to make the “opt out” provision available on the Internet. Currently, parents have to make a request in writing for an affidavit, which has to be notarized and then delivered to the Department - eventually the Department mails the exemption to the parent. (Can you imagine? There's no way we could have ever managed to get parental consent forms this complicated or the process so convoluted for abortions.) The Governor's language would make the opt out process easier.

Governor Perry’s Executive Order: here.

The Texas Education Code: here.

Gardasil prescribing information: here.

Statement from the Christian Medical And Dental Association: here.

Texas Governor pulls a fast one (HPV shot)

In all the excitement about Texas becoming the first State to mandate the vaccination against a Sexually Transmitted Disesase, no one seems to have noticed that Governor Rick Perry ordered the Health Department to make it easier on parents who wish to opt out on vaccinations for their children.

Parents' Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children's health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.

The current relevant law is all over the website containing Texas Statutes. I'm not at all sure that I tracked it all down, but most of it is in The Education Code, especially Chapter 38 and some is in the Health and Safety Code. The "opt out" provision is in 38.001, which was passed in 2003. I believe that this law was the first time in Texas that there was a formal way for parents to object for philosophical reasons, without having to claim health risks.


However, the law concerning the paperwork is in 161.0041 of the Health and Safety Code, and has higher requirements than the parental consent for abortion rulings!

Sec.A161.0041. IMMUNIZATION EXEMPTION AFFIDAVIT FORM.
a) A person claiming an exemption from a required immunization based on reasons of conscience, including a religious belief, under Section 161.004 of this code, Section 38.001 or 51.933, Education Code, or Section 42.043, Human Resources Code, must complete an affidavit on a form provided by the department stating the reason for the exemption.
(b)The affidavit must be signed by the person claiming the exemption or, if the person is a minor, the person ’s parent, managing conservator, or guardian, and the affidavit must be notarized.
(c)A person claiming an exemption from a required immunization under this section may only obtain the affidavit form by submitting a written request for the affidavit form to the department.
(d)The department shall develop a blank affidavit form that contains a seal or other security device to prevent reproduction of
the form. The affidavit form shall contain a statement indicating that the person or, if a minor, the person ’s parent, managing conservator, or guardian understands the benefits and risks of immunizations and the benefits and risks of not being immunized.
(e)The department shall maintain a record of the total number of affidavit forms sent out each year and shall report that information to the legislature each year. The department may not maintain a record of the names of individuals who request an affidavit under this section.

Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.163, eff. Sept. 1,
2003.

In order to opt-out, the parent has to send a "written request" for the paperwork to the Department. The law actually states that the legal affadavit has to have "a seal or other security device" to prevent copying. Can this be done online?

Texas: First to Mandate STD Vaccine

That'll shock 'em on the coasts, won't it? Not to mention France and England, since the story has gone global.

Governor Rick Perry reportedly (free registration required) has signed an order mandating that teen girls in the State of Texas receive the vaccine against four strains of the Human Papilloma Virus by 12 years old and that the State pay for the vaccines that are not covered by health insurance. Two of these strains cause most cases of cervical cancer, and the other two cause most of the big, ugly genital warts that, while they don't cause cancer, can obstruct the urine or bowels and definitely cause bleeding and pain.

We all hope that our daughters and sons will meet their perfect mate, get married while they are both virgins. Then, we wouldn't have to worry about 99.7% of all cervical cancer. However, as Dr. Gene Rudd of the Christian and Dental Medical Association has said, no matter how well we raise our daughters and sons, their future husbands and wives may not have benefitted from the same background. A virginal wife can catch the virus from her husband on their wedding night(and vice versa - although he has vastly less risk of cancer of the penis in the US).

Another shock will probably come when (what the Houston Chronicle and the Austin American Statesman are calling) "the Governor's base" does not rise up in revolt and rants.

There is a strong lobby in the State against mandated vaccines (largely driven by objection to mercury preservatives, the vaccinations that are grown in human cell cultures and the troubles with the pertussis [whooping cough] vaccine from the '70's and '80's.) However, while good people who probably agree with the Governor's pro-life, pro-family views on other issues, these are not quite large enough to be called the Governor's "base."

In my opinion, the Governor decided that the vaccine is too important to leave to politics - especially in a State still healing from the redistricting fight of 2003, that ended up with first the Democratic Representatives and then the Democratic Senators running away from Austin and leaving the State to stall legislation.

I wish he would go ahead and let both the boys and girls get the shot -- Take a look at this video on "herd immunity." If we're going to do this thing, we might as well eradicate as much of the virus as possible.

I am concerned that no one knows how long the vaccine's effects will last.

On the other hand, this is Texas.

We don't like the government mandating anything. We can be convinced that some things are for the good - at least for other people - if you sell it right(grin).

The Governor must make a huge effort to convince the parents of Texas that this is good for the boys and girls in Texas, and that the money spent on the vaccine ($360 per girl, for 3 shots over 6 months) will save lives and money by preventing cervical cancer, genital warts and even anal cancer in both men and women.

Documentation of stem cell cancer link

From Science Daily, January 22:

U.S. scientists have clarified how normal stem cells become cancer stem cells, as well as how cancer stem cells can cause the formation of tumors.

Dr. Xi He and associate investigator Linheng Li, both with the Stowers Institute for Medical Research, studied the intestinal system in mice in which one of the human tumor suppressor genes, PTEN, had been deleted.

"We found that a loss of PTEN in intestinal epithelial cells accompanied by a loss of PTEN in stromal cells can lead to changes that may increase the number of stem cells and change their position or location," said Li. "These changes result in crypt fission and budding and can lead to intestinal polyposis and uncontrolled tumor growth."

"What we learned," added He, is that "cancer stem cells are a rare population in the tumor mass; that they are slow cycling, but more active than normal stem cells; and that cancer stem cells and stromal insertions initiate the process of primary tumorigenesis ..."

The study appears on the Nature Genetics journal's Web site.