China Breaks Promise to Halt Unethical Biotech

By Wesley J. Smith, J.D., Special Consultant to the CBC

The other day, I opposed Texas’ plan to allow doctors to charge for conducting human experiments with unapproved and still uncertain adult stem cell therapies. No matter how well “regulated” I don’t see how it would be that much different from what is happening in China — where clinics use the media-touted promises of CURES! to prey on the desperately ill for big bucks. The government promised a crackdown — and considering it is a tyranny, that shouldn’t be too hard — but despite the “promises, promises,” Surprise! It hasn’t happened. From the Nature story:

Three months after the Chinese health ministry ramped up its efforts to enforce a ban on the clinical use of unapproved stem-cell treatments, a Nature investigation reveals that businesses around the country are still charging patients thousands of dollars for these unproven therapies.

The clinics operate openly, with websites promoting the treatments for serious disorders such as Parkinson’s disease, diabetes and autism, and attract thousands of medical tourists from overseas. They advertise case studies of individual patients who they say have benefited from the treatments, and some have clinics in major hospital complexes, giving them an air of mainstream acceptance. Stem-cell experts contacted by Nature insist that such therapies are not ready for the clinic and say that some may even endanger patients’ health. But the Chinese government is struggling to enforce its ban.

These kind of rogue clinics are a form of quackery. They cost a lot of money for “treatments” that have not been proven. That hurts people, sometimes by hurting people directly or by preventing them from getting treatments from which they might actually benefit, and/or seducing desperate people to chase shadows. One clinic is even claiming success in treating autism and Alzheimer’s with stem cells:

Shanghai WA Optimum Health Care, for example, which has plush headquarters in a gated estate in one of the wealthiest areas of central Shanghai, claims success in using stem cells derived from umbilical cord or adipose tissue to treat a range of disorders, from autism to multiple sclerosis. Tony Lu, a member of the company’s science and technology board, says that four to eight injections of such cells can treat Alzheimer’s disease, at a cost of 30,000–50,000 renminbi (US$4,750–7,900) per injection. According to the company’s senior patient-liaison officer, Karina Grishina, autism can be treated with an adipose-tissue-derived cell injection for 200,000 renminbi, followed a few days later by a 50,000-renminbi injection of umbilical cord cells.

There is little reason to believe that stem cells will treat Alzheimer’s or autism. The MS treatment that does show clinical promise, requires first that the patient’s immune system be destroyed and then rebuilt. That is a potentially dangerous approach that requires great care and protection from infection.

Promises. Promises. Promises. It is worth noting that is the same China that has promised to crackdown on organ buying from murdered prisoners. That ain’t going to happen either, methinks. Talk is cheap. Abiding by what is right even if it means one doesn’t personally profit — whether in health or pocketbook — is difficult. Falling prey to exploiters of false hopes is tragic.

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Deadly Potential of Live Organ Donation Should Preclude Market Approach

By Wesley J. Smith, J.D., Special Consultant to the CBC

Some people believe that all of us have an obligation to participate in live organ donation, that is, giving one of our two kidneys or a lobe of liver. While I certainly admire those who risk their lives and health to help others, I don’t think anyone is ethically obliged to give a piece of their body when the risks could be severe. One case came to light recently in which a donor of a liver lobe tragically died during the surgery. From the CNN story:

As Lorraine sat in the waiting room with Susie that May morning two years ago, she prayed her husband’s liver lobe would cure her brother-in-law. She prayed for her husband, too, but she was less worried about him, since she says the surgeons had reassured them while liver donation wasn’t without risks, it was safe for Paul, a 56-year-old man in good health . . . Her husband died that very day on the operating room table. “We walked into the hospital a married couple, and I left the hospital at the end of the day as they loaded my husband onto the coroner’s truck,” says Lorraine, who has hired a lawyer and plans to file a lawsuit against the hospital. Paul Hawks, an electrician for the Florida Department of Transportation, was one of more than 4,500 people in the United States in the past 25 years who have donated a section of their liver while still alive. Death is rare: Besides Paul, three other donors have died since 1999.

I bring this up because there is a great push being made to allow organ selling, including from live donors. But the sellers would generally be poor. If we are going to permit live organ donation, fine. But we should not permit financial inducements to tempt people to risk their lives and health.

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Countering Brave New World Thinking

Thank you for your personal interest in the Center for Bioethics and Culture (CBC). I deeply appreciate your commitment to helping make a difference in a world where Brave New World thinking is threatening human dignity. So much is at stake as we are watching many seek to redefine even life itself.

The last few weeks have been filled with a whirlwind of activity for the Center for Bioethics and Culture. So much is going on that it is sometimes difficult to catch my breath. Pacing is everything. There is far more to do than the small, dedicated team of CBC can undertake.

Here is a sampling of a few of the highpoints of the last couple of weeks:

Continue reading at CBC-Network.org

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Texas Should Not Let Doctors Charge for Adult Stem Cell Research

By Wesley J. Smith, J.D., Special Consultant to the CBC

I oppose off-label prescribing. I oppose states legalizing medical marijuana when it should be done by changing the Controlled Substances Act. I oppose novel interventions upon the disabled, such as “Ashley’s Treatment,” without proper regulatory studies and approval. I would certainly oppose a state allowing embryonic stem cell researchers to circumvent the FDA approval processes. And the same should be true for adult stem cell research.

But Texas is apparently on the verge of permitting doctors to use non-approved approaches to adult stem cell therapies, which would basically circumvent the Common Rule for human subject studies — and charge patients for the privilege. From the Houston Chronicle story:

Texas’ proposed adult stem-cell regulations, up for approval this week, are under fire for circumventing the Food and Drug Administration and making the experimental therapy commercially available before it’s been proven safe and effective. The criticism of the Texas Medical Board draft policy, developed in the aftermath of Gov. Rick Perry receiving stem-cell treatment for his back problems, is coming from a host of pre-eminent scientists and institutions, including the influential scientific journal Nature and the International Society for Stem Cell Research . . .

The policy, thought to be the first of its kind, would allow Texas doctors to provide the unlicensed therapy as long as they have approval from a review panel that assesses the cells’ use for patient safety, as is customary in clinical trials. But unlike most clinical trials, in which experimental therapy is provided free, the policy would allow Texas doctors to charge for it, typically tens of thousands of dollars.

If the FDA is dragging their feet in approving adult therapies, we should light a match. But states should not seek to circumvent crucial ethical rules that exist for the protection of human research subjects. That road leads to biotech anarchy. It could be dangerous. But beyond that, it just isn’t right.

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“Anonymous” Sperm Donor Fathers Hundreds

By Wesley J. Smith, J.D., Special Consultant to the CBC

The Center for Bioethics and Culture has a good film out called Anonymous Father’s Day, which deals with the emotional impact on children of sperm donors from not knowing anything about their biological fathers. This too is a form of reproductive commodification and the consequences in the lives of the people created are more intense than I certainly would have thought. Of course, that isn’t the only way of being an “anonymous father,” but the film brings up issues I had not considered before seeing it. It is well worth your while.

I bring this up because, relevant to that film, a story is out in which the owner of a UK sperm bank may have used his own sperm, biologically fathering perhaps 600 children. From The Sun story:

A BRITISH scientist may have fathered 600 children after making donations to a fertility programme he ran with his wife. And one of his biological children has suggested the number may even be as high as ONE THOUSAND. Bertold Wiesner — who was born in Austria — ran the Barton Clinic in London which helped more than 1,500 women conceive. Barry Stevens, a film-maker from Canada, was conceived using Wiesner’s donated sperm and said the number could be much higher. He said last night: “He was the one that found the donors so it’s possible he didn’t tell his wife and she believed the donations were coming from a lot of different men.”

Wiesner ran the controversial clinic with his wife Mary — until he died in 1972. Research shows he regularly made donations from the early 1940s until the mid-1960s. David Gollancz, a London-based barrister also conceived at the clinic, said last night: “A conservative estimate is that he would have been making 20 donations a year. “Using standard figures of live births which result, including allowances for twins and miscarriages, I estimate that he is responsible for between 300 and 600 children,” he added.

Talk about egomania. And if the half siblings mate not knowning they are related, there are significant moral and health issues that arise.

This story, albeit from actions taken decades ago, illustrates the potential harm that one unscrupulous person can inflict on the innocent, illustrating once again the need for strong regulations and oversight over the businesses that help infertile couples become parents.

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Eggs Made From Stem Cells Will Lead to Mass Human Cloning

By Wesley J. Smith, J.D., Special Consultant to the CBC

Scientists have announced that they have made mature eggs from ovarian stem cells. They want to fertilize said eggs and experiment on the embryos before destroying them after 14 days. From the Independent story:

The first human egg cells that have been grown entirely in the laboratory from stem cells could be fertilised later this year in a development that will revolutionise fertility treatment and might even lead to a reversal of the menopause in older women. Scientists are about to request a licence from the UK fertility watchdog to fertilise the eggs as part of a series of tests to generate an unlimited supply of human eggs, a breakthrough that could help infertile women to have babies as well as making women as fertile in later life as men. Producing human eggs from stem cells would also open up the possibility of replenishing the ovaries of older women so that they do not suffer the age-related health problems associated with the menopause, from osteoporosis to heart disease. Some scientists are even suggesting the possibility of producing an “elixir of youth” for women, where the menopause is eradicated and older women will retain the health they enjoyed when younger.

Please. Helping older women have babies, whatever one might think of its propriety, is not what this technology is primarily about. Rather, mass egg production would open the door to assembly line human cloning experimentation. But they won’t say that because it could jeopardize public support.

Cloning is the dream technology for those who intend to completely deconstruct the definition of family, and more broadly, to open up Brave New World technologies from the theoretical to the implementable. But it has been thwarted so far by what I call the egg dearth. Each cloning attempt requires an egg, you see. UK scientists tried cow eggs without success. But if a virtually unlimited egg supply can be derived, that would permit mass cloning experiments, leading eventually to overcoming the complexities that have so far thwarted perfecting the technique in humans.

These experiments will be unethical in my view, because nascent human beings will be created for the purpose of using them as a mere resource. That, alas, is nothing new. However, if the eggs prove usable, the next step will be manufacturing human life via cloning. That, in turn, will eventually lead to reproductive cloning, fetal farming for organs, experiments in genetic engineering, etc. Huxley warned us it would come to this.

Don’t think those things can’t be done. Never bet against the ingenuity and imagination of scientists. But we can prevent them from happening through law, regulation, and strangling the money supply. Leaders of states and nations, the time has come: Follow the UN General Assembly’s lead and outlaw all human cloning as ”incompatable with human dignity and the protection of human life.” If that can’t be done, at least outlaw taxpayer funding to pay for human cloning experiments.

Will we control science or will science control us? The jury is definitely out.

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German Judge Opens Assisted Suicide Door

By Wesley J. Smith, J.D., Special Consultant to the CBC

I am not a German lawyer, and so I don’t know if this is dispositive or merely the first step in a longer legal process. But a German administrative court has apparently ruled that the ban on physician-assisted suicide is too “general,” whatever that means. From the UPI story:

An administrative court in Berlin has given German doctors the power to use their own judgment in cases involving terminally ill patients who want to die. The court lifted a physician’s association ban on assisted suicide that included fines of up to $65,722 on doctors who provided their patients with enough drugs to kill themselves, The Local reported Wednesday. Court spokesman Stephan Groscurth said the judges found the ban “too general.” Euthanasia is currently illegal in Germany. However, if a doctor is certain a dying patient wishes to end his or her life, a physician can provide that patient with the means to commit suicide.

Apparently, this is viewed as an answer to Swiss “suicide tourism:”

Observers said the court’s action means terminally ill patients will no longer have to travel to countries where assisted suicide is legal. “This is a step towards stopping ‘suicide-tourism’ that is happening in Germany right now,” said Dieter Graefe, a judge who is an expert on assisted suicide.

Surrender to it, actually. Don’t make them go to Switzerland to kill themselves, let them do it at home!

That last bit really has my teeth grinding. Not only will that mean more suicides potentially — common sense tells us that suicidal patients are more likely to do so at home rather than travel to die — but the Swiss suicide clinics are not limited to the terminally ill. There have even been joint suicides of married couples! Under the court’s reasoning, doctors should be thus be allowed to assist these suicides as well. Once the door is opened, the door is open!

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“Perform Fewer Medical Screenings” Recommendations Breeds Cynicism

By Wesley J. Smith, J.D., Special Consultant to the CBC

Back when the ICU was the big profit center, people complained that they were often “hooked up to machines” until death, even when they just wanted to stop or go home to die. Then, when the ICU became a potential big money loser due to capitation, we began to hear more complaints about patients being pushed to refuse expensive treatments and even being denied efficacious life-extending interventions they wanted under Futile Care Theory.

We have also been told for many years about how important preventative and screening tests are in catching disease early when it is more treatable. But now, we are about to be told to refuse many of such tests, and doctors are being urged not to offer them. From the NYT story:

In a move likely to alter treatment standards in hospitals and doctors’ offices nationwide, a group of nine medical specialty boards plans to recommend on Wednesday that doctors perform 45 common tests and procedures less often, and to urge patients to question these services if they are offered. Eight other specialty boards are preparing to follow suit with additional lists of procedures their members should perform far less often.

The list of tests and procedures they advise against includes EKGs done routinely during a physical, even when there is no sign of heart trouble, M.R.I.’s ordered whenever a patient complains of back pain, and antibiotics prescribed for mild sinusitis — all quite common. The American College of Cardiology is urging heart specialists not to perform routine stress cardiac imaging in asymptomatic patients, and the American College of Radiology is telling radiologists not to run imaging scans on patients suffering from simple headaches. The American Gastroenterological Association is urging its physicians to prescribe the lowest doses of medication needed to control acid reflux disease. Even oncologists are being urged to cut back on scans for patients with early stage breast and prostate cancers that are not likely to spread, and kidney disease doctors are urged not to start chronic dialysis before having a serious discussion with the patient and family.

I’m sorry, but color me cynical. If these recommendations had been made before cost-cutting under Obamacare had become all the rage, before the Medical Establishment began to embrace health care rationing, before we were told that screenings were good, the more the better, I might be less distrusting. Bingo:

Some experts estimate that up to one-third of the $2 trillion of annual health care costs in the United States each year is spent on unnecessary hospitalizations and tests, unproven treatments, ineffective new drugs and medical devices, and futile care at the end of life.

As we know, “futile care at the end of life” is often treatment that works, when the patient is the one really deemed “futile.”

I am not saying that these recommendations are wrong. Perhaps the original standards of care were erroneous, which in itself would beg several questions. I am saying that these reversals of course — which just coincidentally happen to match the current medical economic zeitgeist — does not exactly boost credibility. Or to put it another way, my trust level is definitely not what I would prefer.

P.S. Doctors are really being put between a rock and a hard place these days. Their general compensation is being strained. If not giving these tests results in a patient’s cancer not being caught when it was treatable, or someone dying sooner of kidney disease, they will be sued to Timbuktu. But under the Obamacare cost/benefit boards — which I believe these changes are being teed up for to allow a declaration of general non coverage — there will be no payment permitted if they are ordered. Yikes.

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Murder Not the Answer to Alzheimer’s

By Wesley J. Smith, J.D., Special Consultant to the CBC

David Brooks rarely gets it right, I find. But he mostly did in his last column about a man named Charles Darwin Snelling. Brooks had earlier extolled Snelling’s essay about how caring for his Alzheimer’s-stricken wife had “humanized” him. But then, Snelling murdered her and killed himself. Brooks is clearly agahast. From “Respect the Future:”

Everyone approaches this case with sadness and trepidation. But I can come to only one conclusion: Either Snelling was so overcome that he lost control of his faculties, or he made a lamentable mistake. I won’t rehearse the religious arguments against murder and suicide, many of which are based on the supposition that a life is a gift from God. Our job is not to determine who is worthy of life, but how to make the most of the life we have been given.

I would just refer you to the essay Snelling himself wrote. Only a few months ago, Snelling wrote that his life as his wife’s caretaker was rich and humanizing. By last week, he apparently no longer believed that. But who is to say how Snelling would have felt four months from now? The fact is, we are all terrible at imagining how we will feel in the future. We exaggerate how much the future will be like the present. We underestimate the power of temperament to gradually pull us up from the lowest lows. And if our capacities for imagining the future are bad in normal times, they are horrible in moments of stress and suffering.

My uncle died of Alzheimer’s. I know the terrible toll the disease takes and the tremendous strain it puts on families, and in particular, on spouses. My aunt endangered her own health caring for him and hiding the extent of his disability from the rest of the family. She would never have dreamed of killing him. She would have cared for him into her own grave first.

But with the assisted suicide movement telling us that lethal injections and/or suicide is “dignified” and at least implying that life with serious afflictions isn’t, should we wonder that some take their deadly message farther than might be intended?

There is also a sense in our current moment that we shouldn’t have to be burdened. That abandoning meme is catching hold in various ways. Pat Robertson, for example, disgraced himself when he assured a viewer that it was fine for someone to divorce a wife with dementia, since, as he so crassly put it, “She’s gone! She is gone!” No, she’s very ill. She’s still her.

Losing control is very hard. Seeing a beloved spouse so ill is utterly devastating. With that, we can all sympathize. But many of the comments to Brooks’ column are very disheartening and dangerous: So many are excusing, even supporting, what Snelling did. He may well have had a breakdown, but if not, it was far worse than merely a “lamentable mistake.”

How ridiculous in a column involving murder that Brooks felt the need to assure readers his opposition wasn’t based on religion. Are we really to the place that only the religious are perceived as opposing the murder of the seriously ill? We had better not be. Otherwise, no one who is seriously ill, dependent, or disabled is safe.

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Anonymous International

By Matthew Eppinette, CBC New Media Manager

I am happy to report that three months after its release, Anonymous Father’s Day has now sold in nearly a dozen countries. I suppose this isn’t surprising given the international scope of anonymous sperm donation.

For example, in the Australian state of Victoria, a parliamentary committee has recommended that donor-conceived persons should be told the identity of their biological parent, even if the sperm donor was originally promised anonymity.

Continue Reading at CBC-Network.org

 

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