The recommendation *not* to teach exams throws the whole report into question for me. If we are changing the frequency of mammograms, should we also change the recommendation to do self exams? Won't the first change the effectiveness of the second?
In the news, the report by the Agency for Health Care Research and Quality. The "conventional wisdom" about breast cancer screening was turned on its head - or, at least tweaked, this week.
I think we might have been over doing the mammograms ("MMG"), but the old recommendation to do a "baseline" MMG between 35 and 40, with self exams each month and MMG each 2 years from 40 to 55 and then one a year or each 2 years according to risk, made sense to me.
What I absolutely don't get is the recommendation to stop teaching self exams. Teaching self breast exams received a "Grade D" recommendation - meaning there's no empirical evidence that the procedure is "effective." In other words, it has "moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits." The practice would be "discouraged" -- considered bad medicine, and actually put the doctor at risk for criticism. It most certainly won't be paid for.
There's a reason to find masses: it will change what we do, we have treatment that we can and should do for positive changes. Any mass that's fast growing and lasts over a month is highly suspicious and any mass we can feel should be biopsied. Even though the sensitivity may be low (compared to MMG), patients who do regular exams have been proven to be more likely to find masses earlier and smaller than the doc would at an annual exam, and it's non-invasive, cheap, and accessible. Teaching the self exam gives me something to talk about while I'm doing my own exam of the patient and is an opportunity to explain what I've written, above.
It looks like the fuss over the recommendation will be the first test of the realities of "Comparative Effectiveness Panels" which was funded by $1 Billion allocated in the 2009 "Stimulus Package." Emotions and reactions are high, with Health and Human Services Secretary Sebelius, Medicare and most insurance companies already reporting that their policies (paying for annual MMG and recommending teaching at doctors' exams) won't change. The Mayo Clinic has absolutely renounced the recommendations.
For more information on the policies of other nations, see this article.
Thursday, November 19, 2009
?No self breast exams?
Posted by
LifeEthics.org
at
12:54 AM
1 comments
Labels: bioethics, cancer, government medicine, health care funding, Medicare, medicine, public health, public policy, regulations
Friday, September 25, 2009
Don't laugh: Nanoparticle rub for impotence
What about the man's sperm? And what about the female partner? How much of a dose will she and her DNA receive.
What are nano particles, anyway? (Don't answer that, I know the text-book answer.)
There is a report of a new topical cream that delivers medication by using nanoparticles to deliver the drug - such as nitrous oxide, in the case of impotence - through the skin.
Just think about the marketing technology: beauty, sex and the latest nanomedicine. And it doesn't hurt (that we know of).
Get ready to mute your TV if the kids are in the room. The jokes will be risque,' to say the least.
Posted by
LifeEthics.org
at
3:00 AM
1 comments
Labels: bioethics, medicine, nanotechnology
Friday, April 17, 2009
Study of iPS cells draws nearer to finding cures
Research in stem cells and the origin and treatment of disease is definitely moving away from destructive embryonic stem cell research toward induced pluripotent stem cells (iPS).
A fantastic review that connects Japan's Dr. Yamanaka, San Francisco's Srivastava, the University of Texas Southwestern Medical Center in Dallas, and the Burnetts of Sulphur Springs, Texas, is published in the Japan Times. (Written by Rob Waters for Bloomberg news.)
Yamanaka, a professor at Kyoto University, developed a technology that may make the argument moot. Yamanaka, who has two daughters, started his effort 10 years ago, after peering at a tiny embryo through a microscope and reflecting that it might form a child if it wasn't used to make stem cells, he said in an interview.
"That's the moment I thought about this project," he said. "I saw that if we could make pluripotent stem cells without using human embryos, that would be ideal."
In 2006, he scored his first success. Using a virus to insert four genes into the skin cells of mice, he started a process that returned the cells to a primordial state able to form any other cell in the body. Yamanaka named them induced pluripotent stem, or iPS, cells. The next year, he repeated the feat with human cells.
Yamanaka and researchers elsewhere are now racing to find better ways to achieve the same effect. They would like to get rid of the virus, which can cause the genes to lodge permanently in the structure of the cell and may trigger the growth of tumors.
Yamanaka's technique exploits a basic fact of human biology — that every cell in a person contains the genetic instructions that set that person's traits, from hair color to inherited disease. By taking skin cells from a person with a disease and turning them into cells in the heart, brain or pancreas that are affected by a genetic disease, researchers can experiment with disorders at their earliest stages, Harvard's Melton said.
Labs are now creating iPS cells because making them is far simpler than getting cells from embryos, said Jeanne Loring, founding director of the Center for Regenerative Medicine, part of the Scripps Research Institute in La Jolla, Calif.
"Every stem-cell researcher I know has made about a dozen," Loring said.
She estimates that researchers have made 300 different so-called lines of iPS cells, a number that may double this year. Each line is a colony of cells descended from the first ones made. Scientists keep them alive in culture and the cells keep replicating.
Grants of $23 million awarded last June by the California Institute for Regenerative Medicine, the state's stem-cell funding agency, show that researchers are embracing iPS cells. Of 16 grants awarded, eight went to teams developing new iPS cells and five to groups comparing iPS and embryonic cell types. Just three went to scientists proposing to work solely with embryonic cells, according to the San Francisco-based agency.(Emphasis mine.)
And actual treatments are coming soon:
In 2004, Srivastava, then working at the University of Texas Southwestern Medical Center in Dallas, went with colleagues to Sulphur Springs, Texas, to collect blood samples and perform ultrasound scans on members of the Burnett family.
The researchers analyzed the genes of family members and found that 11 had heart-valve defects linked to mutations in a gene called Notch1, which plays a role in the formation of many organs, including the heart.
People with this mutation make half as much of the Notch1 protein as they should and their heart valves develop abnormally. The protein shortage primes their valves to take on extra calcium, which, over time, makes them stiffen, malfunction and require replacement.
Four years after his Notch1 discovery, Srivastava, now the director of the J. David Gladstone Institute of Cardiovascular Disease, supervised as the Burnetts had a pencil-shaped skin punch pushed into their calves to extract a bit of skin. When the boy's turn came, his 12-year-old brother, Ryan, laid a comforting hand on his back.
The iPS cells made from the Burnett's skin will be coaxed to become heart cells that carry the Notch1 mutation, Srivastava said. He plans to use the cells to test for drugs that boost levels of the Notch1 protein. This, he reasons, should make the hearts of people like the Burnetts more resistant to the entry of calcium and reduce the mineral's buildup on the valves.
A drug that could do this may essentially prevent the disease, Srivastava said. That is because the condition is present at birth, yet symptoms usually take decades to develop, giving a medicine ample time to work.
Within five years, Srivastava predicts, he will have found the right drug and be ready to start human clinical tests. A closely held company named iZumi Bio Inc., in California, will collaborate with Srivastava on this and other research involving iPS cells, Seidenberg of Kleiner Perkins said.
Posted by
LifeEthics.org
at
7:38 AM
1 comments
Labels: bioethics, embryonic stem cells, induced Pluripotent Stem Cells, iPS, medicine, Yamanaka
Monday, March 02, 2009
AMA: "People aren't going to waste time on Embryonic Stem Cells, anymore"
A member of the "lobby group Comment on Reproductive Ethics" maintains that there are "some scientists who like to hold on to what they've got, but" she doesn't "think people are going to waste time on embryonic stem cells any more."(Josephine Quintanelle, quoted in the Guardian, 3/1/09)
The American Medical Association sends its members a "Morning Rounds" email with the latest headlines on science and medicine. The articles have more links than my posts and the editors seem to choose that days' big story.
Today's big story is that the Washington Post (free registration required) reports on a from a Letter to the journal, Nature. Two groups of scientists, one from Toronto (Andras Nagy, from the University of Toronto) and another from Edinburgh (Dr Keisuke Kaji, at the Medical Research Council Centre for Regenerative Medicine at the University of Edinburgh) have found a way to make skin cells transform into embryonic-like stem cells without using viruses.
This should lead to a cheaper way for people to have their own cells transformed into therapies. Farther down the line, it could help us treat disease and injury -and aging - in place, by inducing repair where it's needed and without transplants. On the other hand, if we use embryonic stem cells, it would be necessary to make a clone of each person or find some sort of universal donor cell that would not be rejected. The previous way of reprogramming cells to an embryonic stage used viruses that could not be removed and which have the potential to cause cancer if left in the DNA of the cells.
The scientists used human fibroblasts - a type of skin cell - which were treated with a "jumping gene" from a cabbage looper moth, that inserts itself into chromosomes along with the genes that "reprogram" the fibroblast -- then, the extra gene can be removed.
From the Post, a very clear description.
The alternative cells, known as induced pluripotent stem cells, or iPS cells, appear to have many of the same characteristics as embryonic stem cells but are produced by activating genes in adult cells to "reprogram" them into a more primitive state, bypassing the moral, political and ethical issues surrounding embryonic cells. Until now, however, their use has been limited because the genetic manipulation required the use of viruses, raising concerns the cells could cause cancer if placed in a patient. That has triggered a race to develop alternative approaches.
"These viral insertions are quite dangerous," Nagy said.
In the new work, Nagy and his colleagues in Toronto and at the University of Edinburgh in Scotland instead used a sequence of DNA known as a transposon, which can insert itself into the genetic machinery of a cell. In this case, the researchers used a transposon called "piggyBac" to carry four genes that can transform mouse and human embryonic skin cells into iPS cells. After the conversion took place, the moth gene, called "piggybac" lost its ability to insert itself into the chromosomes of the cells and "disappear" or can be removed.
"PiggyBac carries the four genes into the cells and reprograms the cells into stem cells. After they have reprogrammed the cells, they are no longer required, and in fact they are dangerous," Nagy said. "After they do their job they can be removed seamlessly, with no trace left behind. The ability for seamless removal opens up a huge possibility."
Unfortunately, for some reason the scientists used (non-stem) fibroblast cells from embyros as the cells that are reprogrammed, so the research is being repeated in cells from non-embryonic sources.
Other news articles on the breakthrough are at BBC News, Nature News,
AFP, Financial Times, the Candian Press, the Guardian and the Globe and Mail.
Posted by
LifeEthics.org
at
4:12 AM
1 comments
Labels: adult stem cells, bioethics, embryonic stem cells, iPS, medicine, morals, research ethics
Wednesday, December 17, 2008
Top 50 Medical Blogs list
We made number 12, under Bioethics. The list appears to be a good resource - just come back here when you're done surfing the others!
Spelling corrected 1/6/09
Posted by
LifeEthics.org
at
4:57 AM
2
comments
Health care reform conversation
There's a comment from a proponent of single payor health care payments on one of my November posts. A few points need to be clarified:
The numbers about infant mortality are skewed in the US because we count more infants as "live births" than other countries.
We use Medicaid money to finance special education and Medicare to finance medical education -- are those included in those numbers?
Also, that $7000 is an average - that includes all the expensive care for very ill patients. It would be more interesting to note per-capita bone marrow or other organ transplant.
I would like to see how much of our medical spending is actually elective - Botox and plastic surgery as well as contraceptives and abortions.
The majority of Family Physicians are against or conflicted about about single payer. We don't have a great history of changing policy to the benefit of our practices. Medicare, medicaid, and Workman's Comp pays better for procedures like surgery and invasive tests than they do for cognitive and preventive skills.The Family Doctor could do more if we weren't under pressure to see 4 to 5 patients per hour.
Health care outcomes are strengthened where primary care is strongest, according to research.
What I want to see is a public policy that allows patients to own their own health insurance and for doctors to work for the patient. Medicare still won't pay for tetanus shots when a covered patient needs one.
I just worry that what we have is not working because of regulations and laws. I don't want more of those.
Posted by
LifeEthics.org
at
4:37 AM
0
comments
Labels: bioethics, Medicare, medicine, public health, public policy
Wednesday, December 03, 2008
"Tea-bag" Adult Stem Cell Treatment for Stroke
British researchers report an amazing recovery for a 49 year old man who suffered a hemorrhagic stroke on October 15, 2008. The researchers at the company, "Biocompatibles," used adult stem cells from a healthy donor. The cells had been engineered to cause them to produce a protein that helps prevent "programmed" cell death (even after the bleeding stops and the pressure is removed) and embedded in tiny beads that had been sewn up in a cloth "tea-bag."
From the press release, published on the Medical News Today Neurology and Neuroscience website:
Stroke is one of the leading causes of death in the elderly population in the developed world. The incidence rate has been reported as 145 per 100,000. Hemorrhagic stroke is responsible for ~15 to 20% of all stroke and it is the least treatable form of stroke. It is associated with the highest morbidity and mortality rate of all stroke with only 44% of affected patients surviving the first 30 days. Only 20% of these survivors regain functional independence. The cascade of events starts with the sudden rupture of a blood vessel in the brain, causing haemorrhage and pressure inside the skull. Surgery may be used to relieve the pressure; but the haemorrhage causes a longer-term process of programmed cell death, or apoptosis, and it is this that causes the lasting neurological damage.
The CellBeads™ are delivered directly to the injury site during the surgery. They are programmed to deliver CM1, a proprietary version of a naturally occurring protein, GLP-1, which has been shown to have powerful anti-apoptotic effects. The delivery mechanism is a cluster of human adult mesenchymal stem cells obtained from a healthy donor and encapsulated in alginate beads. The cells are genetically engineered to produce the protein, which is delivered continuously, directly to the injury site. The alginate beads protect the stem cells from the body's immune system, which would otherwise destroy the foreign cells. CellBeads™ are transplanted within a retrievable mesh device and are removed completely after a treatment period of 14 days. Retrieval of the implant prevents possible long-term side effects from the transplanted cells.
The research is a "Phase I/II" trial, which means that the doctors and scientists are actually testing the safety of the treatment, and not the actual effectiveness of the treatment, itself. In other words, "does the treatment do more harm than good."
The CEO of Biocompatibles, Crispin Simon (that name is as British as tea bags), spoke to a Reuters reporter for a story published at Forbes online, stressing that the patient is young and other wise healthy, and had the standard of care for hemorrhagic strokes, surgery to relieve the pressure from the blood on the cells around the stroke. 10% to 20% of patients have similar recovery, without the Biocompatible beads.
Still, the report is a welcome source of hope for anyone who has watched and waited helplessly after a patient or a loved one had a hemorrhagic stroke.
Posted by
LifeEthics.org
at
2:37 AM
2
comments
Labels: adult stem cells, bioethics, cellular medicine, medical technology, medicine, neuroscience, regenerative medicine, reprogrammed cells, research, stem cell research, stem cells
Wednesday, November 19, 2008
"A return to power"
That's the sub-heading from Science Magazine's "Obama takes the reigns." The story was yesterday's little "ScienceNOW" report on the (newly created) Office of the President Elect's selection of Mario Molina, who will be co-lead for the review of the White House Office of Science and Technology Policy. Molina has received the Nobel Prize for his discovery of the nature of the "hole" in the atmospheric ozone layer. He worked in the Clinton OSTP.
That's the sub-heading from Science Magazine's "Obama takes the reigns." The story was yesterday's little "ScienceNOW" report on the (newly created) Office of the President Elect's selection of Mario Molina, who will be co-lead for the "review" of the White House Office of Science and Technology Policy (OSTP) Molina received the Nobel Prize for Chemistry for his discovery of the effects of chlorofluorocarbon gases of the "hole" in the atmospheric ozone layer. He worked in the Clinton OSTP. You can watch him talk about global warming, here.
The (newly created) Office of the President Elect also announced that Robin Alta Charo would join the group "reviewing" the Department of Human Health and Services, especially the issues of bioethics, health care and science policy. Charo is a lawyer, one of the founding members of the Center for American Progress and their Bioethics Initiative (a pdf transcript) and Science Progress, formerly on the "medical advisory" boards of the Alan Guttmacher Institute and Planned Parenthood and on Clinton's National Bioethics Advisory Committee that made the recommendations on human cloning (continue with cloning for research, but have a 5 year moratorium on cloning for reproduction). She's notable for coining the term the "endarkenment" as description for President Bush's Bioethics Council (more, here) and for her comments that there shouldn't be any problem with abortion for sex selection and that cloning might prove that there isn't a God and we humans are just a step in evolution.
Posted by
LifeEthics.org
at
12:08 PM
0
comments
Labels: bioethics, ethics for sale, medicine, politics, public policy, science
Wednesday, October 08, 2008
Healthcare lottery
When you buy a lottery ticket, do you choose the cash option with its immediate payout of half the winnings or do you choose the payment of the full amount, doled out over 20 years?
I've found this question to be a good way to help other people understand the difference between conservativism and those who think that someone else can take care of them or the "totalitarian mamas" who believe that they can take better care of us than we could ourselves and for our own good. (Of course, some Conservatives tell me don't gamble, so they never buy lottery tickets.)
It's amazing how many people tell me that they always buy the "cash option." Some say they worry that their families wouldn't get anything if they die before the 20 years is up. Some tell me that they believe they can manage and invest the money to earn more than they would if they wait out the smaller payments. A few tell me that they would rather not have all the money at one time, preferring the guaranteed income over the years or fearing blowing the money.
The latter group never understands why I suggest that their health insurance should be something that they own and control, rather than something doled out by government and their employers.
A "right" is something that we each have without conditions and which we can call on society and government to enforce or punish if someone infringes that right. The right to life is actually the right not to be killed. We expect our fellow citizens to protect us through providing armies and law enforcement, a militia and by allowing self-defense. If another person infringes our right not to be killed, we expect society to punish him.
Last night, Democratic Presidential Candidate Barack Obama stated that health care is a right. I strongly disagree.
"Health" and "health care" are difficult terms to define. Instead of people and their actions, health is threatened by disease, age and injury. If I'm not well, how will society protect my health - and who or what will be held responsible as I inevitably age? If I have a "right" to health care, then I want everything possible to maximize my health. Rights can't be rationed.
What we're really talking about is health care funding. Funding certainly can be rationed. Take a look at Medicare, Medicaid, and the Veteran's Administration.
These systems work fairly well most of the time. However, they rely on limiting the costs of health care. The limitations fail when demand for cutting edge, expensive treatments or emotional arguments override them. That's why Medicare won't pay for a tetanus shot after a dirty wound, but will pay for annual physicals, screening mammograms and prostate specific antigen tests, although there's no evidence that these prolong life.
Or why Oregon Health sends notes telling patients that they won't pay for cancer treatments, but they will pay for assisted suicide.
For more on this subject, here's another opinion.
Posted by
LifeEthics.org
at
6:28 PM
0
comments
Labels: bioethics, government medicine, health care funding, insurance, medical economics, medical finance, Medicare, medicine, politics, public policy
Wednesday, June 18, 2008
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.
Posted by
LifeEthics.org
at
6:16 AM
1 comments
Labels: bioethics, cancer, government medicine, medical ethics, medicine
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.
Posted by
LifeEthics.org
at
12:20 AM
0
comments
Sunday, May 18, 2008
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.
Posted by
LifeEthics.org
at
7:40 PM
0
comments
Labels: adult stem cells, bioethics, infectious disease, medicine, research ethics, wound healing
Tuesday, April 22, 2008
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.)
Posted by
LifeEthics.org
at
5:55 AM
1 comments
Labels: abstinence, bioethics, conscience, legislation, medicine, politics, public policy
Saturday, March 15, 2008
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
Posted by
LifeEthics.org
at
1:50 AM
0
comments
Labels: abortion, bioethics, conscience, government medicine, medical ethics, medical finance, medicine
Friday, February 22, 2008
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.
Posted by
LifeEthics.org
at
12:13 AM
1 comments
Labels: adult stem cells, embryonic stem cells, medicine, stem cell research, stem cells
Wednesday, December 12, 2007
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.
Posted by
LifeEthics.org
at
7:10 AM
4
comments
Labels: abortion, bioethics, conscience, Free Stuff, medical ethics, medicine, morals, politics, professionalism, public policy
Saturday, November 17, 2007
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.
Posted by
LifeEthics.org
at
8:29 AM
0
comments
Labels: adult stem cells, bioethics, cord blood, diabetes, medicine, Texas research
Wednesday, November 07, 2007
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.
Posted by
LifeEthics.org
at
8:28 AM
2
comments
Labels: adult stem cells, bioethics, medical ethics, medicine, politics, public policy, research ethics, research finance, taxpayer funds, Texas research
Wednesday, October 24, 2007
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.
Posted by
LifeEthics.org
at
9:20 PM
0
comments
Labels: adult stem cells, bioethics, cord blood, medicine, umbilical cord stem cells
Tuesday, August 28, 2007
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.
Posted by
LifeEthics.org
at
10:31 AM
1 comments
Labels: bioethics, euthanasia, medical ethics, medicine