When is discrimination against women not considered discrimination?

When the Federal Appeals Court is involved. In a brilliantly circuitous line of reasoning, the majority Republican panel decided that the exclusion of contraceptives from Union Pacific’s insurance plans was not discriminatory, as it also excluded condoms and vasectomies.

However, the Democratic appointee, to the panel, Judge Bye, dissented, perceptively noting that there is an inequality in terms of the medical effect of the lack of coverage since “This failure only medically affects females, as they bear all of the health consequences of unplanned pregnancies.”

According to the NYTimes, “The appellate panel explicitly rejected a 2000 decision by the Equal Employment Opportunity Commission that the Pregnancy Discrimination Act required employers to cover prescription contraception for women if they covered prescription drugs and devices used to prevent other medical conditions.” and that “Union Pacific’s health plans did not violate the Pregnancy Discrimination Act because contraception is not related to pregnancy.”

They brilliantly concluded, “Contraception is a treatment that is only indicated prior to pregnancy …Contraception is not a medical treatment that occurs when or if a woman becomes pregnant; instead contraception prevents pregnancy from even occurring.”

It is reassuring to know that Rogaine, for men’s baldness, and Viagra will still be covered as medically necessary drugs.

More Partisan Politics Plays at the FDA

First we had that embarrassment, veterinarian and religious zealot Dr. Lester Crawford, appointed as head to the FDA. Later in 2005, we had the FDA ignoring its own advisory board’s recommendations regarding Plan B, the emergency contraceptive that, were it readily available over the counter, would avoid unplanned and unwanted pregnancies and subsequent abortions.

Susan Wood, the head of the FDA’s Office of Women’s Health (OWH), resigned in protest over this turn of events and then was initially replaced by appointment of another veterinarian, Edwin Foulke, by President Bush. Shows how highly women are regarded by this administration. (See the late and sorely missed Molly Ivins’ column for an astute review . So that plan failed and instead, Dr. Andrew von Eschenbach was appointed head of the FDA after a pointed confirmation battle.

Dr. Wood made some insightful recommendations regarding getting the FDA back on track as a trusted, scientifically based agency.

Unfortunately, the feds don’t appear to have read her thoughtful comments. In apparent retaliation for the Plan B dispute, the OWH “just had more than one-quarter of this year's $4 million operating budget quietly removed,” according to Rick Weiss in the Washington Post. This would effectively incapacitate the office for the remainder of the fiscal year.

Recognizing the important work the Office of Women’s Health achieves, a broad coalition, including the American College of Obstetricians and Gynecologists, American Public Health Association and women’s groups are petitioning congress to restore this funding, critical to women’s health. Please urge your congressional representatives to support this move to reinstate funding, as proposed by Congresswoman Rosa DeLauro, and hope that reason will prevail for once over vindictiveness and petty partisan politics.

Government Misplaces Priorities Again

Business beats people’s needs in battle over bugs

At least the Feds are consistent—supporting business rather than the public. In this case the FDA is prepared to allow the use of an antibiotic called Cefquinome in animals—this, despite the strong warnings and opposition from its own advisory board, from infectious disease experts, and from other highly respected groups, such as the Union of Concerned Scientists.

The Infectious Diseases Society has previously called attention to growing problem of antibiotic resistant organisms in “Bad Bugs, No Drugs.” At the same time as there is increasing resistance, most pharmaceutical companies have withdrawn from the antibiotic development business, and there are very few new antibiotics in the pipeline. Cefquinome, like the already-marketed cefepime, is in the “4^th generation cephalosporin” class of antibiotics, a class generally reserved for use in serious infections with resistant bacteria.

The FDA’s guidance #152 is quite narrow and allows use of antibiotics in animals unless it can be shown to be harmful only to patients with food-borne diseases. In contrast, the World Health Organization recommends against such approval if there is likely to be resistance for any serious human disease.

If history repeats itself, the use of cefquinome in animals will rapidly result in bacteria resistant to cefquinome infecting people, as has happened with other antibiotics.

With there being so few antibiotics available, it is foolish to squander our limited resources, putting the public at risk. This is yet another demonstration of this government’s pattern of listening to money rather than reason, ignoring its own expert advisors, and wasting dwindling resources.

Disparities: Global Health and Clean Water

An idealistic and hard-working group of young women are sponsoring the Disparities: Global Health and Clean Water conference on March 2-3, 2007 @ Smith College. Check it out at www.gaape.org or at Smith College's news.

I’ll be moderating as well as giving a talk on Ethical Aspects of Global Care & Drug Development. Being somewhat OCD, I googled moderating panels and came up with some great sites.

Perhaps the best suggestions are from Barry Eisler’s “The Moderator’s Manifesto.” Great info and visually stunning website.

Check it out for useful tips on marketing as well.

More coming about ethics and global care soon.

How to Survive Your Hospitalization

Health care isn't what it used to be. Having just spent a week guarding my mother during her hospitalization, I have a few suggestions for the less medically experienced:
a) You have to have an advocate. Really sick patients can't do it alone.
b) Have a family member* stay as close to 24-7 as possible.
*This should not just be any family member. You need someone with common sense, who can stay relatively calm and pleasant, rational and assertive. Tall order, I know. But if you are angry and abrasive, you will drive staff away or anger them, resulting in worse care. Human nature.
c) The biggest problem we encountered was lack of communication between shifts, and the lack of continuity of the staffing. You can provide that vital link of continuity, alerting staff to something that appears new or alarming.
d) You or your advocate need to ask what each medicine being administered is. If it is something new or unexpected, insist on understanding what it is for before taking it.
e) Ask about blood draws, too--especially those that are painful, like blood gases. Request that the blood draws be coordinated and, if possible, be limited to one or 2 times per day.
g) Remember-you can refuse labs or treatments. You want to be sure that the reasons for your refusal are rational and are recorded accurately in the progress notes, so that you are not perceived as just being difficult.
f) If you know your loved one is not normally confused or agitated and anxious, and there is a change in behavior, insist that there be an attempt to find a "physical" or metabolic reason.
I heard repeatedly that mom was "anxious" and that this made her short of breath. In fact, her blood oxygen was very low and she felt like she was drowning, making her understandably anxious. Understanding the source of the problem is critically important.
More to follow as I recover from being a guard dog. . .

Patients take research into their own hands

Patients with multiple sclerosis are joining together to fund research that they find promising.
Naltrexone is a drug, an opioid receptor antagonist, which is sometimes used for treating addictions. Naltrexone was discovered 20+ years ago, so is off-patent, and therefore no longer highly profitable nor of interest to large drug companies. Low Dose Naltrexone (LDN) was anecdotally found to be helpful for treating multiple sclerosis. A number of MS patients banded together, forming their own research group to review current knowledge and direct studies. They held a fund raising benefit; the $25,000 proceeds were awarded to UCSF to conduct a small, double-blind, cross-over trial this spring, according to LDNers. Sounds like a carefully designed study. Way to go!

The folks at "accelerated cure" also have a terrific brochure on working with MS. This handy booklet gives lots of suggestions for dealing with workplace issues that are applicable to those with any chronic disease.




http://www.acceleratedcure.org/downloads/acp-workingwithms.pdf

Lost in Limboland

Ever since the hellish conditions created by Hurricane Katrina in 2005, Drs. Anna Maria Pou and two nurse co-workers, Cheri Landry and Lori Budo, have been in limbo. In July, 2006, they were accused of murder by Louisiana Attorney General Charles Foti, arrested and charged with homicide, but they have yet to be formally charged. They have had their careers needlessly destroyed and endured incredible and unnecessary stress, when they should have been regaled as heroes for staying and caring for their patients.

New this week is that toxicology reports from Orleans parish coroner, Frank Minyard, failed to show lethal amounts of medication in the patients' bodies. Despite this lack of evidence, the theater of the absurd continues, with a grand jury being called to weigh the murder charges against the healthcare workers. According to CNN, Assistant District Attorney Michael Morales said, "There is no legal bar in going forward with a homicide prosecution just because a coroner has not classified it as a homicide."

No doubt our taxes and energies would be better spent investigating the botched response of the government to Hurricane Katrina, or the suspicious motives of Mr. Foti and the District Attorney's office in pursuing this witch hunt, than in continuing this travesty of justice.

Please support Dr. Pou, Ms. Landry and Ms. Budo. If you would like to help or receive more updates, please check Dr. Pou's new website.

Another physician punished for her good work

Dr. Anna Pou and 2 nurses who stayed to help care for patients during Hurricane Katrina have been charged with homicide for the deaths of some patients under their care.

The charges against Dr. Pou and the nurses caring for patients during Katrina appear little more than grandstanding and scapegoating, as has been done with Dr. Thomas Butler and Michael/Terry Schiavo.

I applaud these health care workers for their dedication to their patients and their tough decision to stay with the patients. The drugs found are commonly used to help patients be more comfortable. It is unfortunate if occasionally patients die—perhaps in larger part due to the appalling and stressful conditions they were under, including the extreme heat.

In a related, timely article, Dr. Daniel Sokol discusses the ethics of healthcare workers “duty of care” in responding to virulent epidemics. While no clear conclusion can be made, I appreciate Dr. Sokol’s discussing the multiple roles that physicians have that may be in conflict. For while a doctor has an obligation to patients, they also have

“a duty to care for their own children by protecting them (and hence themselves) from infection. So a further problem with the duty to care, aside from its vagueness, is that it fails to consider the holder of the duty as a multiple agent belonging to a broader community. Doctors, in such situations, play several incompatible roles—doctor, spouse, parent, for example—and they must deal with them as best they can. The limits of the duty of care are thus also defined by the strengths of competing "rights and duties.”

The irresponsible charges brought against Dr. Pou and her colleagues will have a chilling effect on other health care workers in the future, who will be loathe to respond to disasters. First, there is the risk of malpractice for caring for patients outside our specialties or beyond our experience. Now there is the risk of prison and reputation/career destroying attacks from Monday morning quarterbacks.

Dr. Pou and her nurse colleagues should be hailed for their heroism and devotion to their patients.

Who will care for you during the next disaster or epidemic?

Patriot Act warning to researchers

In January, Dr. Thomas Butler lost his appeal of his felony conviction.

Why should you care?

Dr. Butler was a leading researcher who, most recently, was studying treatments for plague, bearer of the "Black Death," a bacteria that might be weaponized and used for bioterrorism. When he reported vials missing from his lab, federal agents descended on his Lubbock, Texas lab, and he was charged--and ultimately acquitted--of 69 felony counts related to bioterrorism. He ultimately served 2 years on minor unrelated charges.

Dr. Butler is also the leading researcher responsible for developing "oral rehydration solution," an inexpensive powder that has saved millions of lives in developing countries. This treatment, which replaces intravenous therapy for severe dehydration "is credited by the World Health Organization for saving between 2 and 3 million lives of under-4-year-olds each year around the planet," according to Dr. William Greenough, professor of medicine at Johns Hopkins University.

Dr. Butler's trial was apparently intended to serve as a warning to researchers that the Patriot Act concerns extended to them.

It has done that. It has also resulted in many researchers losing their willingness to study agents of concern, lest their lives be similarly destroyed.

I would recommend John Mangel's recent thoughtful series in the Cleveland Plain Dealer for an excellent review of this tragic story.

"Destroying the Life and Career of a Valued Physician-Scientist (pdf) Who Tried to Protect Us from Plague: Was It Really Necessary?" reflects the analysis by many of Dr. Butler's colleagues, including:

"Reactions in favor of Butler and expressions of concern about the handling and impact of the case have been strong, including comments from the Human Rights Committee of the National Academy of Sciences (NAS), the Institute of Medicine (IOM), the National Academy of Engineering, and the New York Academy of Sciences. The presidents of the NAS, the IOM, and the European Society of Clinical Microbiology and Infectious Diseases, as well as many prominent scientists and physicians, wrote to then Attorney General John Ashcroft to express their concern about the impact of the prosecution of Dr. Butler (the presidents of the NAS and the IOM had written only once before to an attorney general, Janet Reno, and their letter was concerned with the prosecution of Los Alamos National Laboratory scientist Wen Ho Lee).

Four academy members who are Nobel Laureates wrote, on behalf of themselves, that "this respected colleague has been subjected to unfair and disproportionate treatment." . . .many other news sources have run stories suggesting that Butler may have been a victim of the widespread fear about (bio)terrorism and may have been singled out, presumably to serve as an example, as part of a flawed strategy to fight bioterrorism.

We think it makes very little sense to have removed from action such a knowledgeable and active clinician and clinical investigator who was working to protect us from plague--such removal is akin to shooting ourselves in the foot…

Dr. Tom Butler, a physician-scientist and member of the IDSA, respected by all colleagues who know him and his work, has been stripped of his professorship, tenure, salary, and medical license and has spent his life savings and retirement to defend himself. . . He and his family have no sources of income. His situation is a cautionary tale to all of us, especially those who work with biological agents with potential for use in bioterrorism, even if in collaboration with governmental laboratories and scientists."

Dr. Butler's colleagues have gotten the fed's message.

Dr. Peter Agre, was a co-recipient of the 2003 Nobel Prize in chemistry, and is a member of Duke University's faculty, recently said, "many scientists are reluctant to study these organisms because their best attempts to know and to obey applicable regulations still might land them in prison, might cost them their faculty positions, their licenses to practice medicine, or their right to vote."

Dr. Stanley Falkow, an expert microbiologist from Stanford University, echoed Dr. Agre's concerns, noting, "In my letter to Ashcroft, I said I couldn't imagine why I would let my students work in this area when a simple mistake can lead to incarceration," and "they took one of the only experts on plague in the U.S. and totally muzzled and incapacitated him."

Dr. Butler is currently working in a Lubbock warehouse, instead of continuing his valuable research or developing other life-saving therapies, as he had in the past.

Do you feel safer now?