June 20, 2008
Genetic Testing Regulation and Inspection
Earlier this week, California started inspecting genetic testing companies. The LATimes reported,
California health regulators have dealt a blow to direct-to-consumer genetic testing start-ups by demanding that 13 companies halt sales in the state until they prove they have met quality and reliability standards.
The Department of Public Health sent the cease-and-desist letters last week, after an investigation spurred by consumer complaints about the tests' accuracy and costs, a department spokeswoman said Monday. The department said it would not identify the companies involved until it confirmed they had received the letters. It said they all advertised on the Internet. Two of the best-known companies to offer consumer genetic tests, Navigenics Inc. and 23andMe Inc., both confirmed receiving the letters.
All the companies have two weeks to demonstrate to regulators that their laboratories are certified by the state and federal governments, said department spokeswoman Lea Brooks.
They must also show that the tests currently being sold to California residents have been ordered by a doctor, as required by state law. Companies face fines of as much as $3,000 a day if they don't comply. The New York State Department of Health issued similar notices to nearly two dozen testing companies in April. . . .
The Food and Drug Administration does not evaluate the tests for accuracy, though a federal panel recently recommended stepped-up oversight to ensure their validity.
Many individuals have responded to the new genetic testing companies and the required inspections and certifications California requires. The LATimes has collected some of the results and writes,
. . . . Should a doctor's authorization be required for someone to obtain personal genetic testing? So far, California and New York state authorities say yes. But this debate is just beginning. The controversy is being played out this week on the many genetic medicine blogs. Daniel at Genetic Future writes:
"To a large extent what's going on here is a turf war between proponents of the old-school medical regulation model and upstart advocates of the free information paradigm of the Google generation."
Jason at TechCrunch suggests the lack of professional medical advice accompanying personal gene testing is troublesome, too:
"The problem with this kind of casual DNA testing is that it almost trivializes the importance of genetic information." . . .
Happy Friday and Longest Day of the Year. Just for fun - Take the Superhero Quiz to find out your inner superhero personality.
Thanks to Shakespeare's Sister for the quiz.
June 19, 2008
AMA - Home Births Resolution
The AMA passed a resolution to introduce legislation to regulate home births. Women's Health News provides some background on the resolution and states,
The AMA did recommend for adoption an amended resolution (205) on home birth, as follows:
“That our AMA support state legislation that helps ensure safe deliveries and healthy babies by acknowledging of the concept that the safest setting for labor, delivery and the immediate post-partum period is in the hospital, or a birthing center within a hospital complex, that meets standards jointly outlined by the AAP and ACOG, or in a freestanding birthing center that meets the standards of the Accreditation Association for Ambulatory Health Care, The Joint Commission, or the American Association of Birth Centers.”
Aren’t they just saying that certain types of trained professionals should be the only ones to attend home births?
Not exactly. There were also two resolutions on the table (204 & 239) that were combined and adopted as amended. They stated that the AMA should “support state legislation regarding appropriate physician and regulatory oversight of midwifery practice, under the jurisdiction of either state nursing and/or medical boards.” . .
The resolution also asks that the “American Medical Association only advocate in legislative and regulatory arenas for the for the licensing of midwives who are certified by the American College of Nurse-Midwives.” In other words, the AMA is formalizing in the form of a resolution the notion that CNMs and CMs recognized by the ACNM should be the only legally practicing midwives, and that “lay” midwives (there is a lot of term confusion here, but CPMs, direct-entry, that type of thing) who are not regulated by a nursing/medical board (because they are not doctors or nurses by training/certification) should not be allowed to be licensed to practice under state regulations. . . .
In effect, encouraging states to explicitly make non-ACNM-certified midwives illegal would probably reduce the pool of available homebirth providers in a given state considerably, even though this particular resolution doesn’t specifically address home births. . . .
Midwives and some lay health care providers groups are quite concerned by the resolution as seen in this article at RH Reality Check. Amie Newman writes,
In an unmistakably insecure and aggressive move, the American Medical Association (AMA) adopted a resolution at its annual meeting last weekend to introduce legislation outlawing home birth - according to The Big Push for Midwives. . . .
"It's unclear what penalties the AMA will seek to impose on women who choose to give birth at home, either for religious, cultural or financial reasons-or just because they didn't make it to the hospital in time," said Susan Jenkins, Legal Counsel for The Big Push for Midwives 2008 campaign. "What we do know, however, is that any state that enacts such a law will immediately find itself in court, since a law dictating where a woman must give birth would be a clear violation of fundamental rights to privacy and other freedoms currently protected by the U.S. Constitution." . . . .
What the AMA's resolution and these other kinds of potential and actual legislation do is to open the door to penalizing motherhood, in effect. Because most of these legislative attempts do not directly address the issue, they leave the door dangerously open to criminalizing women for making the decisions they feel are best for themselves, their fetuses and their families.
Proposing this kind of legislation would also force women to birth in government-approved settings, a scenario that seems almost unbelievable. According to the Big Push for MIdwives:
Until the AMA proposed ‘Resolution 205 on Home Deliveries,' no state had considered legislation forcing women to deliver their babies in the hospital or limiting the choice of birth setting. Instead, states have regulated the types of midwives that may legally provide care. Currently, 22 states already license and regulate CPMs, who specialize in out-of-hospital maternity care and have received extensive training to qualify as experts in the types of risk assessment and preventive care necessary for safe and high-quality care for women who choose give birth at home. Certified Nurse Midwives (CNMs), who are trained primarily as hospital-based providers, are licensed in all 50 states and the District of Columbia.
The resolution did not offer any science-based information for the AMA's anti-midwife or anti-home birth position. Steff Hedenkamp, Communications Coordinator for The Big Push for Midwives says, "Maternity care is a multi-billion dollar industry in the United States. So it's no surprise to see the AMA join the American College of Obstetricians and Gynecologists in its ongoing fight to corner the market and ensure that the only midwives able to practice legally are hospital-based midwives forced to practice under physician control. I will say, though, that I'm shocked to learn that the AMA is taking this turf battle to the next level by setting the stage for outlawing home birth itself-a direct attack on those families who choose home birth, who could be subject to criminal prosecution if the AMA has its way." . . . .
Health Reform and the Senate Finance Committee
Ezra Klein continues his praise for Prepare to Launch and Senator Max Baucus' efforts to raise awareness of health reform and what type of support such reform needs from the Senate Finance Committee. He writes,
Whether anyone is actually more prepared today than they were two days ago is debatable. The various sessions of the Senate Finance Committee's "Prepare for Launch" Health Summit were informative enough but offered nothing the senators hadn't heard in previous testimony or read in memos from staff. No legislation was proposed, and no votes were taken. None of the senators set forth their reform plans or laid out the considerations that would drive their decisions.
Even so, it was arguably the most promising day for health reformers in a decade. The Finance Committee asserted its jurisdiction over crafting and passing a health-reform bill. And the committee's centrist chair, Max Baucus, asserted his commitment to the effort. If health reform is to pass, both of those things will need to be more than assertions; they will need to be proven true. . . .
So health-care reform requires a Finance Committee -- and a Finance Committee chairman -- interested and invested in passing a bill. In 1993, there was no such chairman. Many think that the original sin of the Clinton health-reform effort was Clinton's decision to choose Lloyd Bentsen, the canny chair of the Finance Committee, as his secretary of the Treasury, thus depriving the committee of his leadership. In his place came the mercurial, touchy Daniel Patrick Moynihan. Moynihan had many virtues, but he did not like the Clintons and did not want to do health reform. His intransigence and general lack of enthusiasm was crucial to emboldening the opposition and killing the bill. When Moynihan appeared on "Meet the Press" on September 19, 1993, three days before President Clinton was to give his speech calling for universal health care, and flatly stated that "there is no health-care crisis" and Clinton was using "fantasy numbers," it was an early sign that the effort was doomed. . . .
This time around, however, Baucus has given health reformers reason for optimism. He has staffed up, hiring Liz Fowler, a well-regarded health-policy staffer with immense Hill experience. He's held a series of hearings on the need to reform the system, inviting experts to testify on everything from the explosion in costs to the failures of the insurance market. More importantly, his statements at these hearings have been invariably action-oriented. He opened a recent session by saying, "Today let us talk again about health-care reform. Let us hear from the experts about how to do it right. And let us plan, next year, to actually do something about it."
Yesterday's "Prepare to Launch" event was his initiative and served as another opportunity for him to signal that he wanted to pass health reform through his committee. "Congress must prepare for the work of reforming the health-care system," he said in his opening statement. "We must develop common understandings of our system, the good and the bad, so we're ready to work towards reform." Questioning Federal Reserve Chairman Ben Bernanke after Bernanke's bloodless presentation, Baucus asked him to "drill down" on what would happen if the Senate didn't get health costs under control, prompting Bernanke to offer a dark vision of fiscal meltdown. Where most of the panel sessions featured two senators presiding over a panel of experts, Baucus hosted a viewing of the PBS Frontline documentary, Sick, which looks at other nations' health care systems and declares "When it comes to providing health care for people our nation is a fourth-rate power." Introducing the film, Baucus mused, "We Americans can be a bit smug. We figure we can't learn from everyone else because we're the biggest and the best. But I think the time has come for America to learn a bit from these other countries."
The final event of the day was a roundtable discussion among the members that was, by turns, hopeful, tetchy, and constructive. The content, however, was secondary to the optics. This was the whole of the relevant committee, sitting in a single room, talking through health reform. It was a photo op, yes, but a promising one. By publicly asserting jurisdiction on health reform, the Finance Committee is also taking responsibility for it. If the effort fails, it will be on their heads. And none will receive more blame then Baucus. Summing it up, Baucus said, "I don't know of anything more daunting than trying to solve health care. But hey, we're masochists! It's why we signed up for this job." . . .
June 18, 2008
ADHD as a Beneficial Adaptive Trait?
Slate.com's WIlliam Saletan has a brief article discussing ADHD and its evolutionary origins. He writes that an understand of its potential usefulness in the past may help our society to adopt to ADHD rather than forcing individuals with ADHD to adopt to our societal standards. He says,
. . . . A new study suggests that this ADHD-friendly world may actually be part of our past.
The study, led by Dan Eisenberg of Northwestern University and published in BMC Evolutionary Biology, examined a Kenyan tribe called the Ariaal. Part of the tribe has recently settled into an agricultural community. Another part remains nomadic. The tribesmen were tested for DRD4 7R, a genetic variant that, Eisenberg notes, "has been linked to greater food and drug cravings, novelty-seeking, and ADHD symptoms." He and his colleagues report:
DRD4 7R+ genotypes were associated with indices of better nutritional status among nomads, particularly higher fat free mass, but worse indices in the settled individuals. This suggests that the 7R allele confers additional adaptive benefits in the nomadic compared to sedentary context. . . . .
But how would the gene help nomads? The authors speculate:
Increased impulsivity, ADHD-like traits, novelty-seeking like traits, aggression, violence and/or activity levels may help nomads obtain food resources, or exhibit a degree of behavioral unpredictability that is protective against interpersonal violence or robberies. …
I don't know whether the speculated reasons for the gene's benefits will pan out. But the benefits do seem real. And that finding suggests two things. First, we should be careful about designating diseases and disease genes. Traits that are harmful in one setting can be helpful in another. Advantages or "defects" that we think of as natural may actually be products of our cultural decisions. As Eisenberg puts it, we might "begin to view ADHD as not just a disease but something with adaptive components."
Second, our society may be the wrong place to assess a gene's evolutionary harm or benefit. As the authors note, "[N]on-industrialized or subsistence environments … may be more similar to the environments where much of human genetic evolution took place." . . . .
The lesson of the Ariaal study is simply that society can adapt to genes instead of the other way around. Maybe we don't have to screen and chuck embryos for every "disease" gene, or drug the kids once they're born. Maybe we can put ADHD kids in educational settings more like the dynamic environment of our nomad forebears. And maybe we can raise kids with fat-storage genes in settings less full of food. . . .
Searching for a New Surgeon General
McClatchy News reports that Dr. James W. Holsinger is unlikely to be the next Surgeon General. Halimah Abdullah writes,
Sen. Jim Bunning, one of Dr. James W. Holsinger Jr.'s staunchest supporters in his bid to become U.S. surgeon general, suggested Tuesday that the physician's quest for the nation's top medical post is at an end. During a telephone press conference Tuesday, Bunning said he doubts Holsinger's nomination will move forward. Bunning cited the Democratic leadership's blockage of several Bush administration-backed judicial appointments -- a move that has rankled both of Kentucky's senators. . . . Meanwhile, both the White House and Senate Minority Leader Mitch McConnell said Holsinger's nomination is still alive. . . .
Holsinger served as Gov. Ernie Fletcher's secretary for health and family services from 2003 through 2005, was a professor and chancellor of the University of Kentucky's medical center for nine years in addition to other academic and administrative medical school posts across the country, and served for 26 years in the Department of Veterans Affairs. He also served for more than 30 years in the U.S. Army Reserve. He has a master's degree in biblical studies from Asbury Theological Seminary in Wilmore. He obtained his medical degree in 1964 and a doctorate in anatomy in 1968, both from Duke University. . . .
From the moment his name emerged as a potential U.S. surgeon general, Holsinger's nomination was rife with controversy. Last year, Holsinger faced a firestorm of criticism from gay rights groups, the National Organization for Women, the American Public Health Association and some public health experts for a Methodist church paper he wrote in 1991 titled "Pathophysiology of Male Homosexuality," which described same-sex intercourse as incompatible with Christian teaching.
Holsinger distanced himself from the paper during a July Senate hearing, saying the comments don't reflect his current views. However, Senate Democrats refused to move forward with a confirmation until Holsinger completed written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee. Democrats stayed in session over December's holiday break to prevent President Bush from naming the physician to the post in a recess appointment.
Dr. Steven Galson, a rear admiral in the U.S. Public Health Service, was named acting surgeon general last fall. . . .
June 17, 2008
Medicare Fraud - Too Easy
The Washington Post reported on last Friday some rather shocking facts about Medicare Fraud - and how easy it appears to be. Carrie Johnson writes,
All it took to bilk the federal government out of $105 million was a laptop computer. From her Mediterranean-style townhouse, a high school dropout named Rita Campos Ramirez orchestrated what prosecutors call the largest health-care fraud by one person. Over nearly four years, she electronically submitted more than 140,000 Medicare claims for unnecessary equipment and services. She used the proceeds to finance big-ticket purchases, including two condominiums and a Mercedes-Benz.
Health-care experts say the simplicity of Campos Ramirez's scheme underscores the scope of the growing fraud problem and the need to devote more resources to theft prevention. Law enforcement authorities estimate that health-care fraud costs taxpayers more than $60 billion each year.
A critical aspect of the problem is that Medicare, the health program for the elderly and the disabled, automatically pays the vast majority of the bills it receives from companies that possess federally issued supplier numbers. Computer and audit systems now in place to detect problems generally focus on overbilling and unorthodox medical treatment rather than fraud, scholars say.
"You should be able to spot emerging problems quickly and address them before they do much harm," said Malcolm Sparrow, a Harvard professor and author of "License to Steal," a book about health-care fraud that advocates for greater federal vigilance. "It's a miserable pattern, a cycle of neglect followed by a painful and dramatic intervention."
Fallout from the Campos Ramirez case continues. After pleading guilty to filing false claims, she has helped authorities win indictments against more than half a dozen doctors and patients who allegedly accepted kickbacks for pretending to receive costly HIV drug therapy. With cooperation from Campos Ramirez, FBI agents this week arrested three Miami-area men who, the government alleges, financed sham clinics that billed the government more than $100 million.
Daniel R. Levinson, the inspector general of the Department of Health and Human Services, has warned repeatedly that the Medicare program is "highly vulnerable" to fraud, particularly in South Florida, where schemes center on expensive, infusion-based HIV medications and on equipment such as wheelchairs, walkers, canes and hospital beds.
Officials from the Centers for Medicare and Medicaid Services (CMS), which oversees federally funded health programs, say they have stepped up their efforts to combat fraud over the past year by working closely with investigators, removing the requisite billing numbers of nearly 900 companies and imposing new standards in high-fraud areas that would prevent people convicted of felonies from ever receiving a Medicare number. . . . .
Officials who oversee the Medicare program say they are vigilant despite time pressure and limited resources. Employees review fewer than 5 percent of the nearly 1 billion claims filed each year. The vast majority of claims shuttle through computer systems that are tweaked when authorities notice fraud patterns. This year, CMS is working to finalize a rule that would prevent convicted felons from obtaining Medicare billing numbers. At present, that regulation applies only in a few high-fraud regions. "It's a big volume," Brandt said. "No matter how hard we try to get people trained, there's always going to be a margin of error."
Sentenced to 10 years, Campos Ramirez, 60, may yet reduce her prison term by helping authorities unwind "the large web of medical clinics, doctors, nurses, money laundering companies and HIV clinic financiers who participated in this massive fraud," prosecutors wrote earlier this year in court papers. Her lawyer did not return calls seeking comment. . . .
Harriet McBryde Johnson
A little over a week ago, disability rights activist, Harriet McBryde Johnson passed away at age 50. The New York Times reports,
Harriet McBryde Johnson, a feisty champion of the rights of the disabled who came to prominence after she challenged a Princeton professor’s contention that severely disabled newborns could ethically be euthanized, died on Wednesday at her home in Charleston, S.C. She was 50.
No cause has been determined, her sister, Beth Johnson, said, while pointing out that her sister had been born with a degenerative neuromuscular disease. “She never wanted to know exactly what the diagnosis was,” Beth Johnson said. The condition did not stop Harriet Johnson from earning a law degree, representing the disabled in court, lobbying legislators and writing books and articles that argued, as she did in The New York Times Magazine in February 2003, “The presence or absence of a disability doesn’t predict quality of life.” . . .
“Her impact came mostly from her writing,” said Laura Hershey, a disability rights activist with several organizations, including Not Dead Yet. “Millions of people by now have read that article, and it was reprinted in her book. Dozens of people who read the article told me, ‘Wow, I never thought about it that way.’ ” Ms. Johnson’s memoir, “Too Late to Die Young,” was published in 2005. Her novel, “Accidents of Nature,” about a girl with cerebral palsy who had never known another disabled person until she went to camp, was published in 2006.
Born in Laurinburg, N.C., on July 8, 1957, Ms. Johnson was one of five children of David and Ada Johnson. Her parents taught foreign languages at colleges. Besides her parents and her sister, Ms. Johnson is survived by three brothers, Eric, McBryde and Ross.
The fact that her parents could afford hired help was a salient point in another Times Magazine article Ms. Johnson wrote in November 2003, “The Disability Gulag.” Describing institutions where “wheelchair people are lined up, obviously stuck where they’re placed” while “a TV blares, watched by no one,” she called for a major shift from institutionalizing people to publicly financing home care provided by family, friends or neighbors.
“I sometimes dare to dream that the gulag will be gone in a generation or two,” she wrote. “But meanwhile, the lost languish in the gulag.”
Early on, Ms. Johnson was a troublemaker. At 14, at a school for the disabled, her sister said, “Harriet tried to get an abusive teacher fired; the start of her hell raising.” In her memoir, Ms. Johnson describes how, after watching a Jerry Lewis muscular dystrophy telethon while in her teens, she turned against “the charity mentality” and “pity-based tactics.”
Ms. Johnson graduated from Charleston Southern University in 1978, then earned a master’s degree in public administration from the College of Charleston. She graduated from the University of South Carolina School of Law in 1985 and soon went into private practice. . . .
More on Ms. Johnson's life can be found here.
June 16, 2008
Health Summit: Learning About Future Fiscal Problems
Ezra Klein reports on how Congress is getting ready for health reform. He writes,
. . . . Today, the Senate Finance Committee is hosting the "Prepare for Launch" health reform summit. Baucus, Grassley, and the rest of the committee are holding panels, giving talks, listening to speeches, and generally putting on a public show of their seriousness about health reform. What does it mean? It's unclear. Baucus says it's about "learning." Grassley says it's about "listening." . . .
The morning plenary was given by Federal Reserve Chairman Ben Bernanke, and was basically a bloodless recitation of what readers of this blog already knew. Towards the end, though, Baucus asked him to be a bit clearer on what would happen if Congress doesn't act to arrest the growth of health costs. "Well," said Bernanke, "as a matter of simple arithmetic, if you don't cut costs, one of three things will have to happen. You can shrink everything else, cutting military spending, national parks, and so forth. That's an unpleasant option. You can raise taxes tremendously, which has various costs on efficiency and growth. Or you can have huge deficits." . . .
Pro-Life Pharmacies . . .
The Washington Post reports today on the opening in Virginia of a new pharmacy that will not carry contraceptive devices. Rob Stein writes,
When DMC Pharmacy opens this summer on Route 50 in Chantilly, the shelves will be stocked with allergy remedies, pain relievers, antiseptic ointments and almost everything else sold in any drugstore. But anyone who wants condoms, birth control pills or the Plan B emergency contraceptive will be turned away. That's because the drugstore, located in a typical shopping plaza featuring a Ruby Tuesday, a Papa John's and a Kmart, will be a "pro-life pharmacy" -- meaning, among other things, that it will eschew all contraceptives. The pharmacy is one of a small but growing number of drugstores around the country that have become the latest front in a conflict pitting patients' rights against those of health-care workers who assert a "right of conscience" to refuse to provide care or products that they find objectionable.
"The United States was founded on the idea that people act on their conscience -- that they have a sense of right and wrong and do what they think is right and moral," said Tom Brejcha, president and chief counsel at the Thomas More Society, a Chicago public-interest law firm that is defending a pharmacist who was fined and reprimanded for refusing to fill prescriptions for birth control pills. "Every pharmacist has the right to do the same thing," Brejcha said.
But critics say the stores could create dangerous obstacles for women seeking legal, safe and widely used birth control methods. "I'm very, very troubled by this," said Marcia Greenberger of the National Women's Law Center, a Washington advocacy group. "Contraception is essential for women's health. A pharmacy like this is walling off an essential part of health care. That could endanger women's health.". . . .
Some pro-life pharmacies are identical to typical drugstores except that they do not stock some or all forms of contraception. Others also refuse to sell tobacco, rolling papers or pornography. Many offer "alternative" products, including individually compounded prescription drugs, as well as vitamins and homeopathic and herbal remedies. "We try to practice pharmacy in a way that we feel is best to help our community and promote healthy lifestyles," said Lloyd Duplantis, who owns Lloyd's Remedies in Gray, La., and is a deacon in his Catholic church. "After researching the science behind steroidal contraceptives, I decided they could hurt the woman and possibly hurt her unborn child. I decided to opt out."
Some critics question how such pharmacies justify carrying drugs, such as Viagra, for male reproductive issues, but not those for women. "Why do you care about the sexual health of men but not women?" asked Anita L. Nelson, a professor of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. "If he gets his Viagra, why can't she get her contraception?" . . .
Bioethicists disagree about the pharmacies. Some argue that they are consistent with national values that accommodate a spectrum of beliefs. "In general, I think product differentiation expressive of differing values is a very good thing for a free, pluralistic society," said Loren E. Lomasky, a bioethicist at the University of Virginia in Charlottesville. "If we can have 20 different brands of toothpaste, why not a few different conceptions of how pharmacies ought to operate?"
Others maintain that pharmacists, like other professionals, have a responsibility to put their patients' needs ahead of their personal beliefs. "If you are a health-care professional, you are bound by professional obligations," said Nancy Berlinger, deputy director of the Hastings Center, a bioethics think tank in Garrison, N.Y. "You can't say you won't do part of that profession." . . .
Pharmacists at eight pro-life drugstores contacted by The Washington Post said they would not actively interfere with a woman trying to fill a prescription elsewhere, but none posts signs announcing restrictions or offers to help women get what they need elsewhere. "If I don't believe something is right, the last thing I want to do is refer to someone else," said Michael G. Koelzer, who owns Kay Pharmacy in Grand Rapids, Mich. "It's up to that person to be able to find it." . . .
But others worry about what will happen if such pharmacies proliferate, especially in rural areas. "We may find ourselves with whole regions of the country where virtually every pharmacy follows these limiting, discriminatory policies and women are unable to access legal, physician-prescribed medications," said R. Alta Charo, a University of Wisconsin lawyer and bioethicist. "We're talking about creating a separate universe of pharmacies that puts women at a disadvantage."