Vol. 15, No. 4 November/December 2004
The Great California Boondoggle
In November, "values voters" returned President Bush to the White House and increased pro-life votes in both the Senate and House.
All in all, those allied against unborn life had little to cheer about on election night. Their one bright spot was the passage of California's Proposition 71, which established a state "constitutional right" to engage in human embryonic stem cell research and human cloning – and funded that "right" at a cost of $6 billion ($3 billion for research and $3 billion interest on the bonds). But already the luster of "Prop 71" is gone, and it's beginning to look more like a black hole into which California taxpayers' money will disappear without returns or accountability.
How were voters in financially-strapped California hoodwinked into approving the measure? The simple answer is that over $25 million from venture capitalists, highly politicized patient advocacy groups, and wealthy individuals flooded the media with promises of cures and appeals to compassion. Those on the side of morality, fiscal responsibility, and fact-based science raised barely $400,000 to inject a little reality into the debate.
Cures! Compassion! Future business school marketing classes can use "Prop 71" as a case study in how to create demand for a lousy product by extravagant promises and appeals to consumers' vanity: "I'm a caring person. I voted to cure people!" We heard Ron Reagan make these same appeals in his prime-time speech at the Democratic Convention last summer. Commentator Charles Krauthammer, MD sums up Reagan's sales pitch this way: "On the one side are the forces of good, on the verge of curing such terrible afflictions as Parkinson's, diabetes and spinal-cord injury. On the other are the forces of reaction and superstition who, slaves to a primitive religiosity, would condemn millions to suffer and die. Or as Reagan subtly put it, the choice is 'between reason and ignorance, between true compassion and mere ideology'" (Krauthammer, "Why Lines Must Be Drawn," TIME, Aug.16, 2004).
Do Californians get anything in return for their $6 billion, apart from feeling good about themselves? They get an "Independent Citizens Oversight Board" comprised of 29 people who are anything but independent. Most have vested interests in biotechnology – California-based university researchers, for-profit biotech companies, and patient advocacy groups. They alone will decide where all the money goes, with priority given to those ethically-objectionable areas of research NOT funded by the federal government, notably human cloning and research on stem cell lines created by destroying human embryos after August 9, 2001. This means that the most clinically promising research, using stem cells from adult tissues and umbilical cord blood, will be neglected.
Only a super-majority of the California legislature can overrule funding decisions by the Oversight Board. The chief "safeguard" against self-dealing is that an individual member cannot vote funds to the institution with which he or she is affiliated. Not to worry, there's enough pork in that $3 billion barrel to be divvied up among all California universities and private biotech companies represented on the Board. The affiliated member's recusal will not deprive his/her employer of a slice of the pie.
Will Californians get cures for their money? Not likely. After over twenty years of research using animal embryonic stem cells, scientists have not solved two of the major obstacles to clinical use in humans – tissue rejection and tumor formation. All the astonishing cures and breakthroughs of recent years have occurred through adult stem cell therapies, including stem cells derived from umbilical cord blood.
Real People, Real Cures
Here's a sampling of real people who have greatly benefited from or been cured by adult stem cell therapies:
Spinal cord injuries
Laura Dominguez and Susan Fajt, both paralyzed in automobile accidents, can now walk with the aid of braces or a "walker" frame. Dr. Carlos Lima of Portugal has successfully treated them and dozens of other patients by transplanting stem cells from their own olfactory mucosa to the site of the spinal cord injury. Their rehabilitation continues, with the goal of being able to walk unassisted.
Melissa Holley, whose spinal cord was severed in an auto accident, was treated in Israel with macrophages from her own blood, and has regained muscle movement and bladder control.
Hwang Mi-soon of South Korea now walks with a frame after being paralyzed for 20 years. She received transplanted umbilical cord blood stem cells at the site of her spinal injury.
Heart attack damage
Dmitri Bonnville and perhaps 100 other patients in the U.S., Germany, Brazil, and France have been treated with their own stem cells to regenerate heart muscle tissue that "died" during a heart attack or injury. The heart's pumping ability was greatly improved in most cases.
Michael May (blind 43 years), Jon Newton (blind 30 years), and Shawn Smith (blind 10 years) have had their vision restored, as have 16 other patients in the U.S. and Taiwan following limbal stem cell transplantation.
Over 200 Type I Diabetes patients no longer have to take insulin, after receiving pancreatic islet cells from cadavers under the "Edmonton Protocol" developed in Canada.
Kathy Duffey and at least 3 other patients have been cured of this life-impairing disease after treatment with stem cells from their own blood.
An 18-year-old girl was cured, and 90% of 18 other patients are in remission or improved following treatment with their own blood stem cells.
David Hassenpflug's condition improved after being treated with stem cells from his own blood; he has no more pain in his legs and hips.
Dennis Turner's symptoms improved over 80% after receiving a transplant of his own neuronal stem cells from Dr. Michel Levesque of Cedars-Sinai Medical Center in Los Angeles. He was virtually symptom-free for 4 years; now his symptoms have begun to recur on the side of his brain left untreated, and he is urging support for broader clinical trials.
Savannah Jantsch, Makenzie Brawner, Patrizia Duarte and hundreds of other leukemia patients are free of leukemia after treatment with umbilical cord stem cells or stem cells taken from their own, or a donor's, blood or bone marrow.
In 1998, then 12-year-old Keone Penn was expected to live only five more years due to an extreme form of sickle cell anemia. Doctors at the University of Pittsburgh cured him by replacing his blood with stem cells from umbilical cord blood which grew new blood cells for him. More than 200 patients have undergone similar therapy with an 80-85% success rate.
Adult stem cell therapies also have cured or substantially improved the condition of patients with the following conditions: ovarian cancer, breast cancer, multiple myeloma, non-Hodgkin's lymphoma, SCIDS ("Bubble Boy" Syndrome), Hurler's Syndrome, scleromyxedema, and brittle bone disease (including babies cured by therapies in utero!).
Broader Impact of Proposition 71
If Proposition 71 did nothing more than enrich biotech researchers at the expense of gullible taxpayers, it would be bad enough. Unfortunately, its consequences are far-reaching. Creating human embryos by cloning for destructive research was legal in California before Prop-osition 71, but it's not the type of activity private investors are eager to fund. Now that a constitutional provision promises funding, the only remaining impedi-ment to the mass exploitation of embryonic humans is the conscience of biotech researchers. Enough said.
What's worse, the California initiative has prompted officials in other states to propose additional funding for human embryonic stem cell research. Wisconsin Governor Jim Doyle announced a new $750 million initiative in human embryonic stem cell research in mid-November. New Jersey's acting Governor Richard Codey has promised to expand that state's human embryo research funding plans to better compete with California. Speakers of both the Massachusetts House and Senate now favor legislation endorsing human embryonic stem cell research. They are considering tax credits and other incentives to attract more biotech companies to Massachusetts. A measure to endorse and fund human embryonic stem cell research in Illinois, however, was narrowly defeated on November 18.
An important step toward halting this mad rush into a brave new world would be for Congress to ban all human cloning. In February 2003, the House of Representatives voted 241-155 (38 not voting) to do just that, but Senators have not brought cloning legislation to the floor. The consequences of their failure to act grow more serious daily.
RU-486 claims lives of more young women
The death of a young person produces a terrible void. Who can be indifferent to the loss of a unique human being and her capacity to love, to create and do good? Who could be insensitive to the raw grief of family members, and count the death as nothing more than a statistical blip?
Apparently the folks at Danco Laboratories can.
Danco, the U.S. distributor of RU-486 (Mifeprex), seems quite willing to overlook another death – or three (in the U.S.) or seven (including Canada, the U.K. and Sweden) – so long as it can keep selling the "magic pill" to make pregnancy disappear. And if the pregnant mothers disappear too, well that's just "a rare complication."
The Food and Drug Administration (FDA) is acting no better. On November 15, the FDA decided not to suspend distribution of RU-486 even after the 7th reported death in recent years associated with an RU-486 abortion, after 676 "adverse event" reports including 17 ectopic pregnancies, 72 cases where blood transfusions were needed, and 7 serious infections.
Instead, the FDA is content to beef up the warning labels and belatedly include Emergency Room Directors in their mass mailing because – go figure – lots of teens and young women who take RU-486 end up in emergency rooms.
Responsible medical associations and the pro-life community have warned the FDA for nearly a decade about the dangers inherent in the RU-486/misoprostol combination. Citizens' Petitions were filed with the FDA both during and after its dubious fast-tracked approval of this regimen in the waning months of the Clinton presidency.
RU-486 is potentially lethal to women in at least three ways: lethal blood loss, infection, and ruptured ectopic pregnancy. Why? Because the pills always cause bleeding and pain which can mask potentially fatal problems.
We can now put names to these risks.
Lethal blood loss
In June 2003 Rebecca Tell Berg, a Swedish teen, bled to death after taking RU-486. She didn't go to the hospital because she was told to expect to bleed for two weeks. Other RU-486 users survived near-fatal hemorrhaging. A woman in Waterloo, Iowa, for example, nearly died after losing one-half to two-thirds her blood volume following an RU-486 abortion. Her life was saved by emergency room physician Mark Louviere, MD, who later testified about the drug's risks before the FDA. The patient was so close to death that Dr. Louviere did not even stop to "scrub up."
Dr. Lesley Rothwell, who monitors abortion for the New Zealand government, revealed this month that a New Zealand woman nearly bled to death from RU-486 pills purchased on-line. This was the fourth such purchase in 18 months to come to Dr. Rothwell's attention, presumably when the women sought emergency care.
Eighteen-year-old Holly Patterson of Livermore, California died in September 2003 from an infection following an RU-486 abortion.
An unnamed Canadian woman died in September 2001 from infection, her death suspending the Canadian RU-486 drug trials being conducted by Dr. Ellen Wiebe.
According to the FDA, the most recent U.S. victim also died from an RU-486-related infection.
And in May 2002, "Californian Danlin Tang took RU-486 ...and later landed in the intensive-care unit with a massive infection and bleeding so intense she needed blood transfusions. 'I almost died from this pill,' she said ..." (D. Rosenberg, "Her accidental legacy," MSNBC.com, Oct. 5, 2003 (available at http://msnbc.com/id/3129988/ ).
Ruptured ectopic pregnancy
Brenda Vise of Hamilton County, Tennessee died in September 2001 from a ruptured ectopic pregnancy after undergoing an RU-486 abortion. Because RU-486 is ineffective in ending tubal pregnancies, they should be ruled out in advance, but the FDA eliminated the proposed requirement of an ultrasound examination for this purpose.
Dana Powell of Cuyahoga Falls, Ohio was luckier. After she took RU-486 in October 2002, a ruptured ectopic pregnancy destroyed one fallopian tube, but she survived.
There are many such stories among the 676 adverse event reports filed with the FDA.
The utterly galling aspect of these deaths and "adverse events" is that none had to happen. To be sure, adverse side effects and complications can arise with any drug. Doctors and patients have to carefully weigh the therapeutic benefits of any drug against the risk of complications. But the "therapeutic benefit" of RU-486 is ZERO. Its only goal is to destroy a healthy, developing unborn child. It is not even claimed to be "safer" than other abortion methods, which are readily available. And it costs more than surgical abortion, because of the time-consuming counseling and monitor-ing. It also has a long list of contraindications.
RU-486 has one hoped-for "benefit": if widely available in doctors' offices across the country, it would "mainstream" abortion. Carolyn Westhoff, an Ob-Gyn at Columbia University medical school, explains: "One of my real, and I think realistic, hopes for this method is that it will help get abortion back [sic] into the medical mainstream and out of this ghettoized place it's been in" (M. Talbot, "The Little White Bombshell," New York Times Magazine (July 11, 1999), at 39-43).
Carole Joffe, a U.C.-Davis sociologist, puts it this way: "Abortion in the U.S. is this degraded, shameful, violence-surrounded thing" and RU-486 "is the only solution I see to being targeted by terrorists [read: pro-lifers]. It's what I think of as the King of Denmark model. If everyone in Denmark puts on a yellow star, how do you know who the Jews are? If all kinds of practitioners – OB-GYNS, nurse-midwives, family doctors – are all doing abortions, how do you single out your targets?" The dream of Dr. Westhoff and Professor Joffe has not materialized. For the most part, doctors who don't regularly perform abortions have shunned the drug.
In November 2003, Congressmen Jim DeMint and Roscoe Bartlett and Senator Rick Santorum introduced bills (nicknamed "Holly's Law" with the approval of Holly Patterson's father) to suspend FDA approval of RU-486 pending review of its safety. They plan to reintroduce the legislation when Congress reconvenes in January. The bills authorize the Government Accounting Office (GAO), an investigative arm of Congress, to conduct a 6-month review of the drug, its safety and the approval process (which deviated from regulatory law and precedent in numerous, serious ways).
An honest review by the GAO would expose the FDA's many regulatory lapses. The FDA, for example, abandoned its vaunted "gold standard" for drug approval (that is, requiring two randomized, controlled clinical trials), and settled instead for one highly suspect French trial and one uncontrolled U.S. trial.
In addition, the FDA used its "fast track" regulatory scheme known as "Subpart H" to approve RU-486. Yet Subpart H is limited to evaluating drugs used to treat serious or life-threatening conditions, such as AIDS, where the outcome under current treatments (such as certain death) outweighs the drug's risks. Possibly, the FDA needs to be reminded that pregnancy is not a disease, much less a fatal one. And the outcome of the patient's pregnancy in the absence of RU-486 is not the mother's death, but the baby's survival.
Moreover, in approving the distribution of RU-486, the FDA mandated the unapproved use of a second drug, misoprostol, to be used in conjunction with RU-486. The manufacturer who held the patent on misoprostol (sold as Cytotec) repeatedly and consistently warned against its use as an abortifacient. It was only after the Cytotec patent expired in mid-2000, and generic versions of Cytotec could be produced, that the FDA was able to thwart the original manufacturer's intentions. The agency approved a new use for misoprostol – to cause uterine contractions to expel dead embryos, increasing the effectiveness of dangerously ineffective RU-486 – although no new drug application had been filed for such use!
And under pressure from Danco and the abortion lobby, the FDA-prescribed regimen for using RU-486/misoprostol did not contain the safeguards present in the clinical trials. For example, ultrasonography to pinpoint gestational age and rule out ectopic pregnancy was not required, although it could have saved the life of Brenda Vise and the reproductive health of Dana Powell and many others.
The trials on which FDA approval was based excluded women younger than 18 and those over 35, although Danco intended that RU-486 would be available to all girls and women of child-bearing age. Despite mounting adverse event reports, Danco is not even forcing doctors to comply with the relaxed FDA regime. For example, some doctors and clinics advertise that misoprostol can be taken at home, although it is supposed to be administered under medical supervision. Other countries allowing RU-486 abortions typically require that patients be monitored by medical personnel for at least four hours after misoprostol administration.
A GAO investigation could reveal all this, if the bill becomes law. But one obvious drawback in the proposal is the GAO's lack of expertise in the pharmaceutical field. Also, if investigators have a pro-abortion agenda like Dr. Westhoff and Professor Joffe, they may be willing to whitewash the glaring defects in the approval process, the deaths and other adverse events in the name of mainstreaming abortion. Still, if the FDA cannot be relied upon to protect women from this dangerous and unnecessary drug, Congress should step in and do so.
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