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.

Coffee drinkers live longer

If true, I may live forever.

According to the Washington Post,

The researchers found that women who drank two or three cups of caffeinated coffee daily had a 25 percent lower risk of death from heart disease during the follow-up (from 1980 to 2004) than non-drinkers. Women also had an 18 percent lower death risk from a cause other than cancer or heart disease compared with non-coffee drinkers.

For men, drinking two to three cups of caffeinated coffee daily was a "wash" -- not associated with either an increased or a decreased risk of death during the follow up, from 1986 to 2004.

The lower death rate was mainly due to a lower risk for heart disease deaths, the researchers found, while no link was discovered for coffee drinking and cancer deaths. The relationship did not seem to be directly related to caffeine, according to the researchers, since those who drank decaf also had a lower death rate than those who didn't drink either kind of coffee.

Meningitis damage repaired with adult stem cells

A 20 year old young man from Bedford, Texas was about to lose his arms and legs due to the clotting of blood in his vessels caused by meningitis but no longer.

The treatment involved doctors and technicians at Parkland Hospital in Dallas, Florida, Israel and the Dominican Republic, and one aunt with a computer search.

(While it's wonderful that this young man was rescued, I can't help but wonder how many other experiments are going on in other countries, led by US doctors. Remember that Dr. Wilkerson of Houston did his first experiments using adult stem cells in Brazil.)

From the Fort Worth Star Telegram (Free subscription required):

Lampkin's medical odyssey has taken him from his home in Bedford to a hospital in an island country for a treatment the U.S. Food and Drug Administration has not approved.

Sudden onset
It began when Lampkin, a freshman attending Cisco Junior College on an athletic scholarship, returned home for spring break.

That Friday he was fine. But on Saturday while visiting friends, he complained of having a headache and went to bed early, said Michelle Gideon, Lampkin's godmother.

The next morning -- Easter Sunday -- she found him lying on a bedroom floor.

"One side of his face looked totally normal, but the other side was swollen and looked like he had chickenpox," she recalled.

Lampkin was rushed to Harris Methodist H.E.B. Hospital, where he was treated for bacterial meningitis. Those chickenpoxlike spots were signs of clots cutting off blood flow.

Antibiotics helped stabilize Lampkin, who was transferred to Parkland Memorial Hospital in Dallas.

There doctors planned to amputate his legs at the knees and his arms at the elbows.

But an aunt searched the Internet for other treatments and found Grekos, who was using adult stem cells to stimulate tissue regrowth, improve circulation and reduce diabetic amputation rates. Grekos, director of cardiology and vascular disease at Regenocyte Therapeutic in Florida, flew to Dallas to escort Lampkin and his mother to the facility.

"If there was any hope of helping this young man we wanted to offer it," he said.

Once Lampkin was in Florida, his blood was drawn and sent to a lab in Israel.

Although it was Passover and the lab staffers were on vacation, they agreed to process the blood, Grekos said. The cells were then replicated into millions of super cells that Grekos' company has branded "Renocytes." The cells can become almost any type of new cell or tissue, he said.

Oklahoma abortion Bill survives Governor's veto

The Oklahoma State Legislature has overturned Governor Henry's veto of an "omnibus" bill containing abortion regulations. (The veto is explained at the United Kingdom site of Medical News Today. Besides gives the best definition of human embryo that I've seen in legislation:

“Human embryo” means a human organism that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Pro-abortion groups are concerned that the bill requires the facility doctor to perform an ultrasound before every abortion, that the girl or woman be allowed to see it, and that the results be explained to her. Not only is there a requirement to post a notice in the facility informing the women and girls that it is "against the law for anyone, regardless of his or her relationship to you, to force you to have an abortion" and the abortionist evidently must actually speak the words out loud before each abortion!

Called the "Freedom of Conscience Act," (The text is here, in a Word document) the bill offers protection to any medical professional who refuses to act in a way that goes against his or her conscience.


The best news article that I've found is here, at the "Daily Women's Health Policy Report" of the National Partnership for Women and Families, a group I'd never heard of before. It appears that the main focus has been legislation to protect women in the workplace.
Robert Cole, an Oklahoma native, writing for Associated Content, has explained the bill in this article. Here's an article from The Feminist Majority, with good links.

Ironically, Democratic Presidential Candidate, Barack Obama, used the objection to abortion by the Senator from Oklahoma, Senator and Obstetrician Tom Coburn, to justify his relationship with the Weatherman bomb-building conspirator and now-college professor, William Ayers. (Ayers is the man who was quoted in the New York Times on September 11, 2001 as regretting that he did not do enough bombing and fighting the US government in the early '70's.)

Secretary of Health Supports Conscience

Secretary of Health Michael O. Leavitt has stepped up to protect the right of conscience and conscientious refusal, specifically in the right not to be forced to commit or be complicit in abortion and other forms of killing. The Secretary has sent a letter to the President of the American College of Obstetrics and Gynecology warning about a possible conflict with Federal anti-discrimination rulings secondary to ACOG's Ethics Statement #385. (that's a pdf)

See the LifeEthics post explaining the origin of the conflict, here.

The American Association of Pro-Life Obstetrics and Gynecology, alerted us to the Press Release sent out by the HHS, most likely due to the fact that the ACOG Ethics Committee is meeting Monday and Tuesday, March 17 and 18.

Here's the news item:

FOR IMMEDIATE RELEASE Contact: HHS Press Office
Friday, March 14, 2008 (202) 690-6343

HHS SECRETARY CALLS ON CERTIFICATION GROUP TO PROTECT CONSCIENCE RIGHTS

Unless changes are made, physicians could be forced to refer patients for abortions even if it violates their conscience

Health and Human Services Secretary Mike Leavitt today expressed disappointment in a new policy put forth by the American College of Obstetricians and Gynecologists (ACOG).He also called on the American Board of Obstetrics and Gynecology (ABOG) to reject this policy and protect the conscience rights of physicians.

In a letter sent to ABOG Executive Director Dr. Norman Grant today asking for clarification, Secretary Leavitt notes, "It appears that the interaction of the [ABOG Bulletin for 2008 Maintenance of Certification] with the ACOG ethics report would force physicians to violate their conscience by referring patients for abortions or taking other objectionable actions, or risk losing their board certification."

In particular, the Secretary expressed concern that enforcement of this ACOG policy by certain federally-funded entities would violate federal laws against discrimination.

Secretary Leavitt continues, "As you know, Congress has protected the rights of physicians and other health care professionals by passing two non-discrimination laws and annually renewing an appropriations rider that protect the rights, including conscience rights, of health care professionals in programs or facilities conducted or supported by federal funds."

The full text of Secretary Leavitt's letter appears below:

Norman F. Gant, M.D.,
Executive Director
The American Board of Obstetrics and Gynecology
2915 Vine Street
Dallas, TX 75204

Dear Dr. Gant:

I am writing to express my strong concern over recent actions that undermine the conscience and other individual rights of health care providers. Specifically, I bring to your attention the potential interaction of the American Board of Obstetrics and Gynecology's (ABOG) Bulletin for 2008 Maintenance of Certification (Bulletin with a recent report (Opinion Number 385) issued by the American College of Obstetricians and Gynecologists (ACOG) Ethics Committee on November 7, 2007 entitled "The Limits of Conscience Refusal in Reproductive Medicine".

The ACOG Ethics Committee report recommends that in the context of providing abortions, "Physicians and other health care professionals have the duty to refer patients in a timely manner to other providers if they do not feel that they can in conscience provide the standard reproductive service that patients request." It appears that the interaction of the ABOG Bulletin with the ACOG ethics report would force physicians to violate their conscience by referring patients for abortions or taking other objectionable actions, or risk losing their board certification.

As you know, Congress has protected the rights of physicians and other health care professionals by passing two non-discrimination laws and annually renewing an appropriations rider that protect the rights, including conscience rights, of health care professionals in programs or facilities conducted or supported by federal funds. (See 42 U.S.C. § 238n, 42 U.S.C. § 300a-7, and the Consolidated Appropriations Act, 2008, Pub. L. No. 110-161, 121 Stat. 1844, § 508). Additionally, threats to withhold or revoke board certification can cause serious economic harm to good practitioners.

I am concerned that the actions taken by ACOG and ABOG could result in the denial or revocation of Board certification of a physician who -- but for his or her refusal, for example, to refer a patient for an abortion -- would be certified. These actions, in turn, could result in certain HHS-funded State and local governments, institutions, or other entities that require Board certification taking action against the physician based just on the Board's denial or revocation of certification. In particular, I am concerned that such actions by these entities would violate federal laws against discrimination.

In the hope that compliance of entities with the obligations that accompany certain federal funds will not be jeopardized, it would be helpful if you could clarify that ABOG will not rely on the ACOG Ethics Committee Report, "The Limits of Conscience Refusal in Reproductive Medicine" when making determinations of whether to grant or revoke board certifications.

Thank you very much for your assistance in this matter.

Sincerely,

Michael O. Leavitt
cc:
Kenneth Noller, M.D.

The American College of Obstetricians and Gynecologists

Nature Reviews Stem Cell Heart Treatments

The journal, Nature, has published a review article, "Stem-cell therapy for cardiac disease,"
about treatment of heart disease with stem cells, focusing on the many types of cells that are being used in research, including bone marrow derived stem cells and progenitors and "resident" cardiomyocyte stem cells. The latter are actually found in the heart and can be harvested from the patient who needs them and used to repair damaged heart disease.

The abstract promises more than I ever thought I'd read in a "First tier" journal.

Heart failure is the leading cause of death worldwide, and current therapies only delay progression of the disease. Laboratory experiments and recent clinical trials suggest that cell-based therapies can improve cardiac function, and the implications of this for cardiac regeneration are causing great excitement. Bone-marrow-derived progenitor cells and other progenitor cells can differentiate into vascular cell types, restoring blood flow. More recently, resident cardiac stem cells have been shown to differentiate into multiple cell types present in the heart, including cardiac muscle cells, indicating that the heart is not terminally differentiated. These new findings have stimulated optimism that the progression of heart failure can be prevented or even reversed with cell-based therapy.

Doctors, Abortion and Conscience

The debate on medical ethics has definitely moved from "Our Bodies, Our Choice," to "My Choice, You Don’t Have a Choice." Autonomy, the "I want" ethics, trumps the right to life, the right to liberty and the physician's duty to do no harm. Where once laws were written to punish doctors who harmed patients, doctors are now threatened with lawsuits and the loss of our licenses for refusing medications or procedures demanded by patients and their surrogates.

The American College of Obstetricians and Gynecologists ethics statement, "The Limits of Conscientious Refusal in Reproductive Medicine" is a case in point. Abortion is so important to the ACOG Ethics Committee that they deny the right not to be killed and threaten the right not to be enslaved by calling abortion the “standard reproductive care that patients request” and demands that doctors who “deviate from standard practices” (object to abortion) “practice in proximity to individuals who do not share their views or ensure that referral processes are in place” (with a willing abortionist). The President of ACOG then wrote letters asking Congress for laws to force these limits on our consciences: doctors who object to abortion should either change their practice so that they don't take care of women and girls or move close to a willing abortionist.

The Christian Medical Association and 28 other pro-life, pro-family organizations have written a letter criticizing ACOG’s Statement as “a profound misunderstanding of the nature and exercise of conscience, an underlying bias against persons of faith and an apparent attempt to disenfranchise physicians who oppose ACOG's political activism on abortion.”

GrannyGrump posted several reasons conscientious doctors should consider elective intentional abortion bad for the mother. I agree with her that abortion is wrong because it is bad for women. I also believe that she begins from the same viewpoint that I do: Even if abortion weren't bad for women, it would still be wrong.

Elective intentional abortion is immoral because it takes the life of a human being. If the mother's life is in danger, she has the right to self preservation and it is moral to help her save her life. Even then, the child's life should also be protected if at all possible. The intent can never be to produce a dead child.

State officials have mandated that all medical students learn to perform abortions in New York and that all pharmacies stock and dispense contraceptives in Illinois and Washington. ER doctors are forced to dispense Emergency Contraception in Connecticut, California, Massachusetts, New Jersey, New Mexico, New York, Ohio and Washington. How long before autonomy supersedes the physician's right to conscience at the end of life since the American Medical Association has condoned the use of Oregon's "Physician Assisted Suicide" law (now renamed and redefined as "Aid in Dying")?

Laws against the conscience are a poor substitute for medical ethics and will result in the death of those same ethics. The end result of limiting the physician’s conscience is cook book health care written in court rooms by lawyers and judges. The practice of medicine will no longer be a profession, much less a calling, practiced by men and women of conscience. It will become a job done by people capable of following orders, doing what they believe is wrong.

Cutting Edge Juvenile Diabetes Adult Stem Cell Research

Interrupting our discussion on State force and conscience, but this news is just too cool to postpone:

Regenetech, the company that has the license agreement with NASA for the "Intrafuge" that processes cord blood cells and bone marrow cells for the production of embryonic-like and select stem cell treatments, has announced a two year agreement for research with Johns Hopkins, on Type 1, insulin-dependent or Juvenile Diabetes:

Regenetech®, Inc. announces that it has signed a Sponsored Research Agreement (SRA) with Johns Hopkins University in order to work toward a treatment for type 1 diabetes. This is in addition to the research agreements which the Company currently has in place with Texas A&M University and the University of Texas Medical Branch at Galveston. Regenetech is pioneering the development and commercialization of technology which the company believes will enable regenerative therapy with adult stem cells for widespread use.

Regenetech’s agreement with Johns Hopkins University will span over two years, and involves significant funding from the Company. The goal of the research project is to develop a treatment for type 1 diabetes using a patient’s own adult stem cells expanded in Regenetech’s IntrifugeTM Bioreactor. Dr. Mehboob Hussain, Assistant Professor of Pediatrics and Medicine at Johns Hopkins University, has considerable experience in the treatment of diabetes with stem cells, and is overseeing the research which will use Regenetech’s technology.

University of Texas Medical Branch at Galveston (UTMB) supplies blood and cord blood stem cells to Regenetech’s laboratories and uses them for their own research purposes as well. In addition, the Company has signed a sub-license agreement with UTMB to use Regenetech’s NASA licensed IntrifugeTM Bioreactor system to expand the stem cells found in the blood. The ultimate goal is to provide low cost, safe doses of adult stem cells for a broad range of diseases and known therapies. The principal investigator from UTMB is Professor Larry A. Denner, who has significant expertise in the identification, expansion and differentiation of primitive cord blood stem cells for pre-clinical studies.

Regenetech also has a SRA with Texas A&M University for the treatment of bone fractures in animals. The research is to demonstrate the clinical efficacy of NASA’s patented time-varying electromagnetic field (TVEMF) technology, which is exclusively licensed to Regenetech. This technology holds rapid healing potential for animals, such as high value race horses and pets, which offer highly significant markets for Regenetech. Once the veterinary treatment protocols have been finalized successfully, it is expected that they will lead the way to human clinical trials.

Regenetech also has a good stem cell "primer," as well as more information on their ongoing research and patents. They do make a case for embryonic stem cells, saying that adult stem cells haven't been found for all tissues and organs and that it might take too long in emergency situations to grow the needed tissues, but do not acknowledge that these limitations also exist for embryonic stem cells.

Oh well, no one's perfect.

Previous review Texas Cancer and stem cell research

Here's a link to a post from last January on HB 14, and House Joint Resolution 90, the Bills which became Proposition 15, the Legislation for $3 billion in cancer research bonds and the Texas Cancer Prevention and Research Institute of Texas.

The original article is no longer available on the Austin American Statesman site, but here's another article on the debate:

From the San Antonio Express-News, November 3, 2007,

Unlike the California initiative, which was enmeshed in controversy — and litigation — over potential conflicts in its governing board, Proposition 15 would create a new entity — the Cancer Prevention and Research Institute of Texas — that would operate with two advisory boards. A scientific group would decide which research ideas merit funding, while a panel of 11 political appointees would provide oversight.

Political appointees would be restricted from decisions about institutions to which they have ties. And they could overrule the scientists on individual grants only with a two-thirds majority vote. The governor, lieutenant governor and speaker of the House each would appoint threepanel members. The other two would be the governor and state comptroller, or their delegates.

Local communities have been moving to put together lists of local candidates in the event the measure passes, believing the panel would make sure the money is distributed fairly across the state, rather than simply handing most of it over to the University of Texas MD Anderson Cancer Center — Texas' 600-pound gorilla of cancer research. The Greater San Antonio Chamber of Commerce's health care and bioscience committee would recommend John Kerr, president of the Southwest Foundation for Biomedical Research; and Phyllis Browning, CEO of Phyllis Browning Co.; as well as a slate of top local cancer experts for the scientific panel, said Ron Tefteller, who chairs the committee.

Local cancer researchers acknowledge that even with all that, they'll be at a competitive disadvantage with their neighbors to the east — as well as other Texas research institutions with a richer pool of benefactors. The law would require that researchers find matching funds equal to half the amount of the grant they're seeking under the program — "skin in the game," Nelson calls it.

Small Town Hospital Collects Cord Blood for Texas Public Banks

I was so happy to hear that my local hospital is now one of the hospitals that collects cord blood for the public banks.

The cells from cord blood are rich in adult stem cells that can be used to replace the bone marrow of children with blood disorders and for treatment of all sorts of diseases. How about that: a small hospital in a small town can join in adult stem cell therapy!

See my grand daughter's story, here.

Summary of Forensics Reports from New Orleans Hospital

The link to the experts’ reports in the case against Dr. Pou has been published by CNN.


I was worried that I was just reacting in defense of a fellow doctor, so I spent quite a bit of time reviewing and typing up a summary, in order to get as much of the case as clear as I could. The reports by Baden and Brescia convinced me that I was right to defend Pou.

A February, 2006 “All Things Considered” (National Public Radio) article that describes the conditions that led up to the charges. (The photograph above is from that article.) 2000 people were in the hospital after the hurricane. Some were patients and their families, some were from the surrounding area and trying to get to high ground. All had to be evacuated.

A Ms. McManus, the daughter of one of the patients described the attempted evacuation of one lady who died due to the efforts:

According to McManus, attempts were made to evacuate other patients from the seventh floor. She recalls seeing workers desperately trying to get one woman out of the hospital, only to see that the woman died in the process.

That article also describes Ms. McManus' evacuation at gun point by the local police.


I used Baden’s report for the order, with correlation from Brescia’s notes added (in italics) where he seemed to give additional information. These were incredibly sick patients, and there is at least some indication and documentation of pain, anxiety, worsening condition in each case. No one should be surprised that the patients died that last day. The worst thing that could be proven from the pathologist’s notes is that the documentation wasn't done by a lot of people, over several days. (Not surprising considering the conditions.)


1. Paraplegic admitted 7/13/05 to Chalmette hospital for fecal impaction and pitting edema of LE. Surgery was being considered before evacuation to New Orleans. There were no Physician’s notes in the charts after transfer to Life Care in NO. The nurse’s note 8/31 documented the evacuation order by verbal order from a Dr Thien. Someone called wife 8/31 to check on her safety (I can’t tell whether the patient made or received the call. BBN) Positive morphine and versed in tissues at autopsy. Body removed from hosp. 9/11, Autopsy 9/17.

Dr. Brescia noted that patient had a “mega colon,” "chronic ileus" and cirrhotic. It looks as though this patient was prescribed Ativan for anxiety before the last day, and there’s documentation about the patient being or complainig about being “hot” and “too big to move.”

2. Admitted to NO hospital for decubitis ulcers. CVA, Dementia, pernicious anemia, contractures, bed bound total care. Alert/Awake, but no verbalizing. Bilateral Above the Knee Amputation due to ulcers planned but not done. Dr. LaCorte made notes. 8/31 code blue, F 105, sinus tachycardia at 123. Aspiration pneumonia afterwards. “No c/o pain.” Body recovered 9/11. Autopsy showed gangrene of toes Rt. Foot. Cerebral atrophy, “prominent post mortem changes.” + Morphine and versed.

3. Transferred from Chalmet 8/22 with acute bronchitis, hyperkalemia, renal insufficiency. 8/25 notes improved function. Darvocet 8/24. Fentanyl 8/28. (Shows pain, BBN.) Recovery 9/11, Autopsy 9/18. moderate to advanced decomposition. Morphine in liver.

4. Nursing home resident admitted to NO Memorial from NO Methodist Hospital 7/1, 2005 with coffee ground emesis, sepsis and hypotension. 8/7 surgical treatment of cellulitis. 8/30 Dr. Cashman ordered evacuation. 8/31 Dr. Joubert ordered “prn MSO4 1-4 mgm ivp/im q 1 hr prn restlessness/agitation.” Joubert hadn’t seen patient. Body recovered 9/11 Autopsy 9/19, extensive decomposition. “Bronchopneumonic changes limited to the lower lung lobes and pyelonephritic changes were present in both kidneys.” (bilateral lower lobe pneumonia and bilateral kidney infection) + Morphine and versed.

Brescia’s notes on his patient # 1: Sepsis GI bleeds, DNR. Orders 8/5 Restraints, PEG, debridemet (sic). 8/7 penile cellulitis, Ativan prn agitation 104.8 temp. 8/26 “Outlook poor . . . hospice not unreasonable.” 8/27 last entry by MD “quiet vs. stable Antibiotics” 8/21 MS for agitation, “last seen alive.” “9/1 No lights, water toilet air, electricity. T 102 (squared) sponge bath.” (I’m not sure whether this last was from the records or Dr. Brescia’s opinions. BBN)

5. Admitted to NO with multiple infected decubitus ulcers and malnutrition 7/19. Lt Leg debridement 7/26, rt leg debridement 8/19, Rt. Below the knee amputation 8/26. Evac order 8/31. Body recovered 9/11, Autopsy 9/17. Moderate decomposition and bronchopneumonia rt lung. + Vicodan (sic), morphine, versed.

6. Nursing Home resident admitted to Chalmette 8/12 for treatment of decubitus ulcers. Evac to NO 8/27. History of Congestive Heart Failure, organic brain syndrome, Chronic Obstructive Pulmonary Disease. 8/30 evac order. 8/31 fever 100.8. Body recovered 9/11, autopsy 9/21. + Morphine and versed.

7. Admitted to NO Memorial 8/2 and LifeCare 8/10 severe decubitus ulcers, H/o Arteriosclerotic heart disease, CVA hypertension and rectal surgery for cancer with a permanent colostomy. 8/22 inferior vena cava filter inserted Bilateral deep venous thrombosis. CT 8/25 showed osteomyelitis and abcess in pubic bone. Temp 104 9/29. Note 8/39 “no acute distress.” 8/31 signed order to evac. Unsigned order for morphine 1-4 mg every hour for restlessness/agitation Ativan 1-2 mg every hour for restlessness/agitation. Nurses note 8/31 Vicodan (sic) given for c/o of pain. Autopsy moderate to advance degree of decomposition and heart disease. No pulmonary embolism or other acute pathology. +morphine and versed. (note, no dates for recovery, autopsy)

Dr. Brescia’s notes have dates apparently crossed out, but documents temperatures, “uncomfortable,” “daughter refuses surgery,” “thick secretions,” ” yelling out,” “Doctor gave something to make ‘feel better’ x3 doses”

8. Admitted to Chalmette for treatment of pneumonia and sepsis. 8/25 transferred to Life Care Chalmette and 8/27 evac to LC NO. Treated for Arteriosclerotic heart diseas, congestive heart failure, hypertension and acute renal failure with last dialysis 8/26. 8/30 vital signs normal no note of pain. Autopsy moderate decomposition severe arteriosclerotic heart disease. +morphine and versed. (No dates for recovery, autopsy. BBN)

Dr. Brescia’s notes:
Oxygen, PEG, foley Coded during dialysis. Dialysis m/w/f Last note, “quiet vs. stable” Last nursing note 8/30/05 BP 128/56, 69, 22 awake, no distress.
“nl breathing no pain”per Dr. B(my question: ? With a respiratory rate of 22?BBN)
Autopsy – rt coronary 100% thrombosis.

9. Admitted to LC NO from Memorial NO 8/8 for decubitus ulcers, dehydration and malnutrition. Morphine 8/22. Order for morphine d/c’d 8/24, with Fentanyl patch and as needed Demerol. 8/30: vital signs normal, Demerol for pain. At 8 PM, temp 106.4 breathing agonal. Evac ordered. Autopsy severe arteriosclerotic heart disease. +fentanyl, demorol, morphine. “The presence of morphine in liver, brain, muscle and purge fluids demonstrate that the heart was beating and __ was alive with that injection was given.

Great news from the mom of a child with diabetes (cord blood)

There's a great comment today from the mom of a boy whose Type 1 or Juvenile Diabetes is being treated with cord blood:

Darla Lindenmayer said...

My son so far has been the oldest to participate in the cord blood trial. We are excited how well it is working. My son has gone from 5 shots a day to only one and that one is being weaned down. It also has cured him of his thyroid disease which he also was diagnosed with a few months after he was diagnosed with juvenile diabetes. We know the cord blood we collected is working somehow to change the molecular structure and increase his beta cell production. We hope and pray that this continues on. Dr. Haller is doing great research!!

Diabetes and thyroid disease tends to go together - more evidence for an autoimmune risk factor for Diabetes.

Thanks, Ms. Lindenmayer for giving us the update!

Angina treatment from patients' own adult stem cells

Patients were given shots to stimulate the production of blood stem cells, the cells were removed from their blood - not from a bone marrow biopsy - and then injected in areas of their hearts that were alive, but not functioning.
There's more information at ScienceDaily online.
While the researchers remind us that this is a "small pilot study," I'll bet the patients who went from having chest pain when walking across the room to being able to climb stairs don't feel that it was so small!

Austin Texas Patients In Adult Stem Cell Research

The Austin, Texas TV station, KEYE, has a report on the research trial using donated adult stem cells from bone marrow in patients within 10 days of a heart attack. (I've highlighted the part about the bone marrow.)

Seema Mathur
Reporting

(CBS 42) AUSTIN

A clinical stem cell trial involving Austin patients has some doctors saying it may change medicine forever.

The trial involves heart attack patients using adult stem cells. The stem cells are from the donated bone marrow of healthy adults.

The trial is in its first phase, with just 10 sites around the nation. Doctors are already saying the results hold the promise of doing what has never been done before, rebuilding heart muscle of heart attack patients.

Ben Calvo, a math teacher, was willing to take what he considers a calculated risk. He's one of 53 heart attack patients in the nation taking part in an adult stem cell clinical trial.

“I don't feel like a guinea pig,” Calvo said. “I don't want to say I feel super human, but I feel just great.”

Dr. Roger Gammon is director of research at Austin Heart, cardiologist providers in Central Texas. He says that in the double blind study, within 10 days of a heart attack, some patients received adult stem cells from donated bone marrow and other patients received a placebo.

“We hang a bag that has millions of stem cells in it,” Gammon said. “They infuse through the vein and travel to where there is an injury. It's just a simple intravenous infusion over 30 minutes.”

Calvo thinks he received the real thing. According to recent images of his heart, so does Gammon.

“Now, his whole heart is moving well,” Gammon said.

The image of Calvo’s heart is amazing because, up until this study, nothing could repair damaged heart muscle.

“They don’t just patch the problem, they actually become heart tissue that starts beating,” Gammon said.

“I feel that I can breathe better,” Calvo said.

Gammon says there was no rejection. He says some patients also had unexpected improved lung function and less irregular heartbeats.

“There seems to be an amazing homing mechanism with these cells to where they can figure out where there is an injury in your body and they go there and start to heal it,” Gammon said.

Calvo believes healing heart muscle is exactly what he experienced. Calvo also had some stents put in after his surgery.

Before this can become an approved treatment, many more people need to be studied to see if the results continue to be promising. But if they do, Gammon suspects this treatment may also help other inflammatory conditions like Alzheimer’s.

(© MMVII, CBS Broadcasting Inc. All Rights Reserved.

Vaginal approach to gallbladder removal

Or removal of the appendix through the mouth?


I finished my residency training in 1993, and was privileged to witness some of the first "laparoscopic" gallbladder removals on one of my rotations with some private surgeons. After 5 years or so of observing and assisting with the old technique that required a 7 to 10 inch incision at the right upper abdomen and months of recovery, I was used to patients lying very still and needing encouragement to breathe after the surgery. I nearly fell apart myself when, just an hour after we removed her gallbladder, one of my patients sat up in bed. I've never moved faster than I did that time, trying to catch her before she tore her wound or fell out of bed when the pain hit!

My first reaction to this story was one of alarm about possible harm due to trying a new, risky maneuver, just because it's surgically possible.

I wasn't sure how much of my distaste was a woman's reaction to invasion through the vagina. After I read the description of the appendectomy through the mouth, I decided that it's a true caution about the risk of such a route.


The biggest problem with recovery from surgery is the trauma to the tissues surrounding the surgical site, especially the muscles that are cut and sewn.

I finished my residency training in 1993, and was privileged to witness some of the first "laparoscopic" gallbladder removals on one of my rotations with some private surgeons. After 5 years or so of observing and assisting with the old technique that required a 7 to 10 inch incision at the right upper abdomen and months of recovery, I was used to patients lying very still and needing encouragement to breathe after the surgery. I nearly fell apart myself when, just an hour after we removed her gallbladder, one of my patients sat up in bed. I've never moved faster than I did that time, trying to catch her before she tore her wound!

The new technique allowed for us to remove the gallbladder - and later, the appendix (and other stuff) - by making 3 or 4 cuts, all less than an inch and using instruments and a camera that allowed remote or video-guided surgery. Without all that cut skin and all those layers of muscle, patients got better, faster.

It's almost routine to perform hysterectomies through the vagina these days. But let's face it, in this case, everything's right there. The surgeon just has to watch for the blood vessels, the bladder and the rectum, and virtually no muscles have to be cut, at all.

Either of these operations would require muscles and "surface" tissues to be cut, and each require that the surgeons' instruments pass other organs. There's also the problem of making the surgical field sterile and maintaining infection control.

With removal of the gallbladder, there is also the risk to the liver, and especially, the common bile duct from the liver to the intestines. For that matter, an oral approach to the appendix would require reaching past the lungs, the diaphragm, the liver and the intestines, unless the instruments can be passed through the esophagus and stomach. (How would you intubate this patient, protect her lungs, or handle the leaks of acid from the stomach into the abdominal cavity?

The surgeons quoted in the New York Times article are proponents of "no scar" surgery.

I'm a little concerned about the way they "read":

Dr. Bessler said his patient agreed to the procedure (two others had declined) because he told her he thought it would have advantages for her, and she accepted his judgment. She was the first in a study that is to include 100 women who need gallbladder surgery, appendectomies or biopsies taken from inside the abdomen. All the procedures will be done through the vagina.

Dr. Dennis Fowler, another surgeon who participated in the operation, said the team began experimenting on women because “incisions in the vagina have been used for a variety of procedures for decades, and proved safe with no long-term consequences.”
. . .
The operation took about three hours, twice as long as the usual laparoscopic surgery, but it was the team’s first operation on a human, and the time should decrease with practice, Dr. Bessler said. Also because it was the first time, to be on the safe side, the doctors did make three small openings in the abdomen for surgical tools. But their ultimate goal is to perform the operation entirely through the vagina.

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.

Umbilical Cord Blood Saves Lives

Today, the Texas House State Affairs Committee heard from a young man who was born with sickle cell disease. Young Joseph, Jr. told the Representatives that his baby brother saved his life. And now, he doesn't have to take medicine or get shots any more. (The oblivious hero slept through the hearing.)

And of course, I told about my granddaughter who received cord blood stem cells at 15 months old from an unrelated, anonymous little boy to cure her Kostmann's nutripenia. That's her with me, last August when we testified to the Senate State Affairs Committee.

You can watch the video at the Texas Legislature Online website archived files from 3/12/07, here, beginning around 25 minutes in. (Don't miss the earlier testimony in favor of legislation to protect embryos and embryo adoption. Joseph and his family testify at 45 to 47 minutes.)

Representative Robert Puente (D- 119) presented his House Bill 709 was before the Committee and is a perfect example of the "common ground" that is possible for those of us looking for ethical ways to further (ethical, non-embryonic) stem cell research.

The Bill would require the State Department of Health Services to develop and distribute a brochure to educate expectant parents about donating and banking cord blood. We heard that there are free opportunities for all mothers and fathers to donate their child's cord blood, if they have time to make the arrangements.

We also were privileged to hear from David Harris, Ph.D., of The University of Arizona. (His testimony begins at 30 minutes on that video) Dr. Davis began the first cord blood bank, and he told us that his children were the first to have their cord blood banked at birth.

I learned quite a bit, including that there are out of State public banks that will accept cord blood stem cells from Texas, and that there is a procedure to donate blood from a private, "family" bank to the public bank.


Here's a few sites with more information:

The Texas Cord Blood Bank

The MD Anderson Cord Blood Bank

HealthBanks (a commercial health information site)

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.

Debate On Ethics

After several days of discussion about a baby that Texas lawyer Jerri Ward asked Wesley Smith to blog about on Secondhand Smoke, I have been asked "How can you be a doctor and not know this about what passes for ethics nowadays?"

Because I have a different understanding "about what passes for ethics nowadays."

I do not agree that euthanasia is practiced in Texas medicine or that utilitarian arguments prevail in medical ethics, especially in Texas. I am a pro-life family doctor who has been studying and practicing medicine, and now, bioethics in Texas. My activism and biggest motivator has been focused on the manipulation and dehumanizing of humans at the beginning of life, because of the advocacy for abortion and destructive embryonic research. I am repeatedly reassured that our Texas physicians do not support euthanasia at the end of life by what I know of them and by what I witness at our medical association meetings and at the meetings where we have been debating the amendment of the Texas Advance Directive Act.

I know what is said in the literature, in the media, in the blogs, and what is said between doctors. I've experienced being the patient, the daughter, wife and mother of a patient, and the doctor in some tough ethical situations.

The elite "ethicists" across the world voice and publish all sorts of utilitarian ideas, including the feminist bioethicists at the American Society of Bioethics and Humanities who discounted conscience as a legitimate guide for physician's actions. I oppose this sort of "ethics" every chance I get.

However, the doctors in Texas do not advocate or encourage such drivel. The very rare doc who is unwise enough to voice the opinion that some lives are not worth living is immediately countered and out-numbered and out-reasoned by his or her professional and compassionate colleagues.

In contrast to my own experiences and education, in the one-sided reports on the blogs and in the media, I hear a story that never quite fits what I know about medical facts, much less about the way I see practical clinical ethics being practiced and taught in Texas. Unlike the other posters at Secondhand Smoke, it is not at all "obvious" to me what happened in this case.

Concerning the bit we know about the case in question, it's not at all "obvious" to me that any pediatrician would have argued to an ethics committee that there are not enough resources to go around or that a child would be better off dead than to have a safe tracheostomy and feeding tube placement in order to continue the current level of technology and in anticipation of transfer to the proper step down care.

On the other hand, if, as I suspected, there had been concerns about imminent death or about a crisis due to the mitochondrial defect flaring after stress of surgery, then it would have been appropriate to object to treatment that could hasten death while causing pain and (surgically) separating the child from her/his mother.

I spent several hours over the last two days watching and listening to the hearings last August 9 on the TADA. I couldn't attend them because my mother was in the hospital - she died August 14. I was reassured by the testimony of the doctors and hospital representatives.

As I said, part of what the lawyer who reported this case experiences is most likely ("obviously") the result of her previously publicized comments in the media that doctors and hospitals kill patients and bury their mistakes.

Healing wounds and regrowing tissue

Doctors at the Brooks Army Medical Center in San Antonio, Texas take care of soldiers (and sometimes civilians) who have been severely wounded or burned. I did 3 or 4 rotations at the old BAMC during medical school and residency and I was always impressed with the enthusiasm and care for the patients that all the staff and doctors displayed. The Burn Center at that hospital has always been on the cutting edge. And, now the BAMC docs are leading, again.

We've used special powders and cloths or tissues to speed wound healing or to give wounds more strength while the tissues grow back. There's a wound treatment that seems to encourage the growth of healthy tissue rather than scar tissue.

First, a little about the healing process. Think of the repairing cells as a crew that works best under water. The body first covers the wound to keep out infection and to provide a scaffold for the new tissues to grow on. The immediate repair is replaced over a couple months' time after the first healing. The workers that build the scaffold that the new skin will grow on need to swim into place. The new skin cells themselves - actually the stem cells that divide and develop into the new skins - must swim in. That's probably one reason that wounds which are dressed with wet coverings or an ointment that holds in the body's tissues heal so much faster.

The powder or tissue, ACell Powder Wound Dressing, is approved for use in wounds as a scaffold or matrix for the new skin to grow on. It appears that in some cases, the wounds grow back better, with more normal tissue and less scarring than in wounds without the powder.
The plan is to try the substance on men who have had their fingers amputated, leaving no tissue appendages that allow us all to grasp a pencil or a fork, to close buttons or a zipper. The hope is that even the smallest improvement will allow grasping.

Med Associations Announce Position Statements on HPV Vaccine

Washington State is planning to offer the Human Papilloma Virus vaccine free to girls. New Hampshire has made the vaccine available on an "opt in" basis. Florida's Legislators are considering following Texas Governor Rick Perry in making the vaccine mandatory, with an "opt out" option, similar to the way that Hepatitis B and other mandated vaccines are regulated. (The vaccine would also have been mandatory under the bills that had been introduced in the Texas Legislature before the Governor's Executive Order.)

Two letters (via email) concerning the HPV arrived since yesterday, one from the Christian Medical and Dental Association and the other from the American Academy of Family Physicians. There is also a newspaper article that covers the Statement of the Texas Medical Association. (I'm a member of each.) Another group forwarded the statement from the Catholic Medical Association.

All encourage the voluntary use of the HPV, because of the safety and efficacy of the vaccine and the ethical practice of preventing disease. And all discourage making the vaccine mandatory.

The Catholic Medical Association (CMA) statement is available online, but in "Macromedia FlashPaper" form, which I've never seen before. The statement is well thought out, with excellent ethics and medical basis. The short statement explained by the 5 page document is:

Does the CMA Support Use of the HPV Vaccine?
The CMA supports widespread use of Gardasil for girls and women in the age range for which the vaccine has been recommended by the ACIP, because it is effective, safe and ethical to use, provided certain conditions are met.

Those conditions include continued teaching concerning abstinence outside of marriage and allowing parents to give informed consent.


The Christian Medical and Dental Association gives the following analogies:

The condom, safe-sex message is like telling your teen not to speed and then giving them a radar detector. HPV vaccination is like telling your teen not to speed, while reminding them to wear their seat belt. You want them to have protection from harm if they are in an accident – whether their fault or not.

and for the Christian philosophical basis for the vaccine:

As Jesus taught us in the story of the woman caught in adultery, Scripture teaches that we can/should show compassion by protecting others from the consequences of sin (while not endorsing sin or promoting continued sin). Facing death by stoning, Jesus protected her and offered forgiveness before calling her to a path of righteousness. He showed grace and compassion, not requiring her to commit to some standard prior to offering protection.

The American Academy of Family Physicians' (AAFP) email contained concerns about the ability to fund the vaccine and to obtain enough vaccine to administer it to all the eligible girls. The AAFP already had a provisional statement, but the move in several states, including Texas, to make the vaccine mandatory prompted the following:

"The AAFP feels it is premature to consider school entry mandates for HPV vaccine until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified."

Recently, there has been increasing state level action considering mandating HPV vaccination with proof of vaccination required for school attendance among other mandates. Upon review of the situation, the Commission on Science felt that this usage does not fit the classic public health model for infectious diseases such as measles. Several issues arise when considering a mandated school entry requirement. These include:



HPV does not adhere to the public health model for control of infectious disease in a school setting. (e.g. measles, chicken pox)

Universal school entry requirement would come at a cost of approximately $900 million per year to provide coverage for the female birth cohort (2 million girls: $120 per dose plus $25 administration fee; 3 doses). This would be a significant burden on state public health budgets.

There would have to be an assurance of supply of 6 million HPV doses per year to meet the school entry cohort. Given the recent experience with shortages of new vaccines such as the MCV4 for meningitis and Thimerosal-free influenza vaccine for three year olds, it is not clear that this new vaccine could be produced in adequate amounts to meet such demand at this time.

As with the costs for public health departments, there is concern that physician practices may not be able to afford such a large scale requirement at this time.

The Texas Medical Association leaders gave interviews to reporters concerning their reaction to the Governor's Executive order.

"We support physicians being able to provide the vaccine, but we don't support a state mandate at this time," said Dr. Bill Hinchey, a San Antonio pathologist and president-elect of the TMA, which represents 41,000 physicians. "There are issues, such as liability and cost, that need to be vetted first."

Other reasons cited by doctors in Texas and across the country include the vaccine's newness; supply and distribution considerations; the possibility opposition could snowball and lead to a reduction in other immunizations; the possibility it could lull women into not going for still-necessary cervical cancer screenings; gender-equity issues; and the tradition of vaccines starting as voluntary and becoming mandatory after a need is demonstrated.

Hinchey said that TMA leadership expressed their concerns to Perry on Tuesday. He said the TMA arrived at its position after debating the issue in committees in recent days.

A spokeswoman for Perry reiterated Tuesday that the governor stands by the order. She said he is listening to the discussion but thinks the vaccine is safe and effective.

Bad, Bad Doctors (Religious, with Consciences)

The NEJM has a free on line article evaluating the results of a survey of doctors, "Religion, Conscience and Controversial Clinical Practices," which is a perfect example that far too much of the effort of "medical ethics" or "bioethics," goes into deciding who can be killed.

"In recent years, several states have passed laws that shield physicians and other health care providers from adverse consequences for refusing to participate in medical services that would violate their consciences. For example, the Illinois Health Care Right of Conscience Act protects a health care provider from all liability or discrimination that might result as a consequence of "his or her refusal to perform, assist, counsel, suggest, recommend, refer or participate in any way in any particular form of health care service which is contrary to the conscience of such physician or health care personnel." In the wake of recent controversies over emergency contraception, editorials in leading clinical journals have criticized these "conscience clauses" and challenged the idea that physicians may deny legally and medically permitted medical interventions, particularly if their objections are personal and religious. Charo, for example, suggests that the conflict about conscience clauses "represents the latest struggle with regard to religion in America," and she criticizes those medical professionals who would claim "an unfettered right to personal autonomy while holding monopolistic control over a public good." Savulescu takes a stronger stance, arguing that "a doctor's conscience has little place in the delivery of modern medical care" and that "if people are not prepared to offer legally permitted, efficient, and beneficial care to a patient because it conflicts with their values, they should not be doctors.""

"If physicians' ideas translate into their practices, then 14% of patients — more than 40 million Americans — may be cared for by physicians who do not believe they are obligated to disclose information about medically available treatments they consider objectionable. In addition, 29% of patients — or nearly 100 million Americans — may be cared for by physicians who do not believe they have an obligation to refer the patient to another provider for such treatments. The proportion of physicians who object to certain treatments is substantial. For example, 52% of the physicians in this study reported objections to abortion for failed contraception, and 42% reported objections to contraception for adolescents without parental consent."

Not surprisingly, these "controversial" "legal" practices are abortion "for failed contraception," giving "birth control to teenagers between the age of 14 and 16 if their parents do not approve," and "sedation to unconsciousness in dying patients." For some reason, the authors do not give results or even discuss the other "Controversial Issues in Medicine": Physician assisted suicide, withdrawal of artificial life support or abortion for congenital anomalies.



First, "elective" abortion is neither mandatory nor beneficial.

Second, I guess that the first discussion must be whether or not "legal" implies that a practice is necessarily "beneficial," moral, or required.

Third, the legality of providing contraceptives to minors under the age of consent, against their parents' wishes, is questionable, except in Federally funded clinics, where it is mandated under Title X funding for Family Planning clinics.

Fourth, it is illegal in most states to participate in "Physician Assisted Suicide."

And fifth, the "monopolistic control" is distraction. Are all professionals who are licensed by the government required to do w