While refreshing the Red Sox scores . . . .

I’m a Red Sox fan living in New York City with a Yankees fan spouse. This means that these days/evenings I spend a lot of time hitting the F5 refresh button on the computer to update the log of the game. So the Sox just tied the score against Toronto, 4-4 going into the 9th. It’s hard to focus on work during a close game at this time of year with the Red Sox and Yankees going into their final weekend, a deciding series in Fenway Park.

All this is preface to how I started checking out some of the medical blogs between "refreshes" and came to “Grand Rounds #53,” a posting on Family Medicine Notes. Check it out for a review of a selection of doctor blogs, some new and some not so new. Jacob Reider (MD) says he has been writing Family Medicine Notes since 1999, and considered 50 doc blogs before selecting about half to briefly (very) review. Anyway, I don’t have time now to check out all these blogs, but it looks like a good list to explore—if the Red Sox stay in the race and I am still hitting F5 after this weekend.

“a place none of us know until we reach it”

Susan Sontag wrote,

Everyone who is born holds dual citizenship, in the kingdom of the well and in the kingdom of the sick. Although we all prefer to use only the good passport, sooner or later each of us is obliged, at least for a spell, to identify ourselves as citizens of that other place.

Sontag went to that “other place” when she was first diagnosed with breast cancer in 1977 and she wrote about it in her now classic essay, “Illness as Metaphor.” She returned to that kingdom of the sick in 1998 and before she died in December 2004.

In last weekend’s New York Times Magazine, Joan Didion shared with readers a selection from her forthcoming book, The Year of Magical Thinking in which she describes her entrance into the kingdom of grief.

Grief, Didion tells us, is different from the sadness she felt when each of her elderly parents died.

What I felt in each instance was sadness, loneliness (the loneliness of the abandoned child of whatever age), regret for time gone by, for things unsaid, for my inability to share or even in any real way to acknowledge, at the end, the pain and helplessness and physical humiliation they each endured. I understood the inevitability of each of their deaths. I had been expecting (fearing, dreading, anticipating) those deaths all my life. They remained, when they did occur, distanced, at a remove from the ongoing dailiness of my life.

There is no distance from grief, from the immediacy of a partner’s sudden death.

Grief comes in waves, paroxysms, sudden apprehensions that weaken the knees and blind the eyes and obliterate the dailiness of life. . . . [Grief is] a place none of us know until we reach it.

Didion’s book is reviewed in January Magazine by our Health Advocacy Program assistant, Emily Macel, a student in the graduate writing program at Sarah Lawrence. Emily contextualizes this memoir within illness narrative writing, and describes its impact on the reader, drawn into the “vortex” by Didion’s compelling prose.

Weeds break through the surface

As a strange follow-up to my blog of September 16 about the resignation of Dr. Susan F. Wood as the director of the FDA's Office of Women's Health, Lester M. Crawford, FDA Commissioner resigned suddenly on Friday (although this news is not posted on the FDA website as of today, Saturday, September 24, 2005). Apparently this resignation, only two months after his confirmation, had nothing to do with the Plan B stonewalling, which, after all, was what the administration wanted, and everything to do with financial improprieties Crawford had not disclosed to the Senate during his confirmation hearings. The FDA has been severely criticized in recent years for putting politics before science, and for shielding drug companies by withholding information from the public.

FYI, the postponement of the emergency contraception decision was the subject of a recent New England Journal of Medicine commentary, "A Sad Day for Science at the F.D.A."

Meanwhile, as a sequel to drug companies influencing physician prescription practices, we have this week a report by Reed Abelson of the New York Times on device manufacturers who have consulting contracts with doctors who use their products. (See related editorial in the Saturday, September 24, New York Times and report by CNN News.) So now that there is public disclosure, by the media, if not by medicine, of the ways many doctors are influenced to make treatment decisions based on their financial interest instead of on the best interest of the patient, what are patients to do? The Times editorial suggests that full disclosure by doctors to their patients would be a good start, “That would alert patients and institutions to look hard at whether the devices recommended by a doctor-consultant were really the best to use.” But realistically, should patients be expected to do their own research (even if sources were available), on which drugs or devices are best? Surely we can agree that professional ethics requires not only disclosure, but complete separation of practice decisions about drugs and devices from financial self-interest.

For a really good review of evidence and issues related to physician ties with pharma, read this piece by Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine. (“Physicians' Ties With The Pharmaceutical Industry: A Critical Element Of A Wildly Successful Marketing Network,”) Kassirer hits hardest at the medical elite, those academic physicians who should be professional leaders, who should set ethical standards, who are the educators of the next generations of physicians.

[W]e should not lose sight of the fact that patients do not order the industry’s products, physicians do. And physicians represent the audience for the pharmaceutical industry’s marketing efforts. The physician network that the pharmaceutical industry has engaged in these marketing efforts is truly impressive. With minor exceptions, most of academic medicine seems to be involved in one way or another in industry’s marketing efforts: carrying out research that shed a good light on a drug, testifying about a drug’s good qualities, writing papers and pamphlets and developing clinical practice guidelines and registries that that promote products, working behind the scenes to help avoid litigation. And all the time, in the pay of industry. It is an impressive network of people who have been assembled either intentionally or inadvertently by industry to do its bidding. Because the doctors order the drugs, the companies depend on their passive acquiescence or active participation in their marketing efforts. Many physicians are not just being compliant, but also complicit.

Kassirer ends with this admonition: “'Conflicts of interest are institutional weeds. They take root below the surface and become pervasive problems often long before they show their ugliness.'” Unfortunately, the weeds have long since broken through the surface."

"The Constant Gardner"

A few weeks ago the Alliance for Human Research Protection posted two rave reviews of the movie, “The Constant Gardner,” one from The New Republic and the other from The Chicago Tribune. And I went to see it. The movie proved just as compelling as the reviews promised, particularly its focus on the collusion of government and pharma in testing, without consent, and, indeed with coercion, new products on poor African populations. It is a beautifully filmed and exceptionally well acted movie. I immediately told my students and colleagues in the Health Advocacy Program to go.

This week the New York Review of Books includes a review of John le Carré’s book as well as the movie by Marcia Angell, former editor of the New England Journal of Medicine, Senior Lecturer in Social Medicine at Harvard Medical School and author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It, an exceptionally clear and well researched book about pharmaceutical companies and the public.

Read this excellent review for yourself. Angell, who knows a great deal about drug company activities, confirms le Carré’s author’s note at the end of the book, "As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with reality, my story was as tame as a holiday postcard."

According to Angell, the real fiction in the story is that drug companies would actually be threatened by knowledge of its unethical drug trials becoming public. “In fact, many of the practices that so horrified le Carré's heroine are fairly standard and generally well known and accepted,” writes Angell. “They seldom provoke outrage, let alone murder.”

Advocates and ethicists should pay particular attention to Angell’s review:

This system makes a mockery of the notion of informed consent—the requirement that subjects be given full information about the nature of the research and have the right to refuse to participate, without penalty or consequences for their usual health care. That requirement is enforced in the US and other well-to-do countries, and partly for that reason, drug companies are having a hard time getting enough volunteers for the growing number of clinical trials. Not so in the third world, where authoritarian regimes and corrupt local government officials and health authorities are eager to be paid off by first-world organizations and to have good relations with them. They "encourage" entire villages or provinces to enroll in research programs, while local doctors enrich themselves by providing human subjects.

Perhaps the most important reason for conducting human research in Africa and other poor regions outside the US is that it is a way of circumventing FDA regulations. . . .

Before a study is exported to the third world, two important questions should be asked. First, would it be possible to do the research in the first world? And second, why is it being diverted to poor countries? It is sometimes claimed that research should be done where health needs are greatest—and that is certainly the case in the third world. But this view confuses research with treatment. There is a great need to apply the results of research, wherever it is conducted, to the treatment of people in the third world. Unfortunately, that is not what happens. Research findings are applied predominantly in well-to-do countries even when the research is done in poor ones. The only clinical research that clearly needs to be conducted in the third world is research on third-world diseases. Such work is amply justified, and far more of it is needed. Unfortunately, it is not a high priority either for the pharmaceutical industry or the National Institutes of Health.

While we are on the subject of emergencies . . .

Harvard’s World Health News arrived by email yesterday (9-15-05) with an article about how the health ministry in India has made emergency contraceptive pills available to women in India without a prescription. According to The Times of India (September 9, 2005), Health Minister Ramadoss noted that “More than 100 countries have made ECPs an OTC drug. China is making it available through vending machines. This is our way to help empower women in India.'"

This caused me to refocus on the fact that American women have been once again denied such empowerment. And I am not alone. As Amy Goodman says today in the Boston Globe,

NOW that we have waved "Bye, Bye, Brownie" to Michael Brown, the hapless head of FEMA, could we turn our sights back to another agency on the skids: the Food and Drug Administration? If FEMA is an example of a government run on cronyism, the FDA has become a portrait of a government run on ideology. After its blunders over Vioxx and defective heart devices, it has now deliberately tanked the homeland emergency contraceptives.

On August 26 the FDA deferred ruling on over-the-counter sales of Barr Pharmaceuticals Inc.'s "morning-after" contraceptive on the grounds that approving the contraceptive for women over 17 would risk enabling girls under 17 access the contraceptive. When FDA denied approval in 2004 it was because of objections related to access by young teens.

Meanwhile Republican politicians are scoring points with the national Republican party and conservative voters by vetoing emergency contraception legislation with wide state support. In July Governor Mitt Romney (MA) vetoed state legislation to expand access to emergency contraception. This week the Massachusetts Senate overrode his veto 37-0. The House had already overridden the veto 139-16. In his 2002 campaign, Romney said he supported wider access to emergency contraception. I guess things change the closer he gets to thinking about national office. (New York Times, September 16, 2005)

In early August, Pataki did the same thing in New York State, vetoing the emergency contraception bill on the grounds that it would allow minors access to contraception without seeing a doctor.

Democracy Now notes that vetoing emergency contraception legislation is a trend among presidential hopefuls.

Meanwhile, overshadowed by Katrina and the recognition, finally, by millions of Americans that this administration will not—cannot—keep them safe from disaster of any kind, was the rare principled action of Susan Woods, Director of FDA’s Office of Women’s Health, who resigned over the FDA decision to delay yet again approval of Plan B emergency contraceptive. A group of women’s health advocacy organizations wrote this powerful statement in response to Woods’ resignation.

August 31, 2005

Washington, DC - The national effort to improve the health of women suffered a serious blow today with the resignation of Dr. Susan F. Wood as the director of the FDA's Office of Women's Health. Dr. Wood resigned in protest over the agency's handling of Plan B. She announced her resignation earlier today.

The women's health community applauds Dr. Wood for her personal commitment to the FDA's mission of making science-based decisions to improve the health of the public and we are very sorry to lose her. Dr. Wood was one of the champions of a decade-long effort to improve women's health through increased federal research and support.

Dr. Wood's impact on women's health was felt in many ways during her nearly 5 years at the FDA. She led the agency's effort to ensure that women were included in trials of new drugs and medical devices, and put into place reporting and recordkeeping systems that enabled researchers to quickly determine whether women were affected differently than men by specific products.

Dr. Wood was also a key player in the FDA's efforts to increase our shared knowledge about the effects of medications used in pregnancy on the health of the fetus and the pregnant woman.

Dr. Wood also demonstrated her leadership in women's health by creating new programs to communicate important health information to average women, such as the FDA's Take Time to Care campaign. She was awarded the Commissioner's Certificate of Excellence for her work on the agency's education campaign on menopause hormone therapy.

Dr. Wood encouraged dialogue with the FDA on a broad range of women's health issues, from many avenues. She welcomed input from consumers as well as industry, health professionals and biomedical researchers.

The resignation of Dr. Wood is just one example of the damaging implications of the FDA's willingness to ignore clear scientific evidence and clear scientific shortcomings in their approval decisions for prescription drugs, medical devices, and other medical products. American women will be harmed directly by FDA's inappropriate decisions, as well as indirectly harmed when outstanding public servants decide to resign from this ailing agency.

Lorraine Cole, President
Black Women's Health Imperative
(202) 548-4000

Barbara Brenner, Executive Director
Breast Cancer Action
(415) 243-9301

Cindy Pearson, Executive Director
National Women's Health Network
(202) 347-1140

Judy Norsigian, Executive Director
Our Bodies, Ourselves
(617) 233-0062

Diana Zuckerman, President
National Research Center for Women &
Families
(202) 223-4000

The Human Connection and the Government Disconnnect

According to Alan Manevitz, a psychiatrist at NewYork-Presbyterian/Weill Cornell hospital and an expert on post-traumatic stress disorder, during the aftermath of disaster, a doctor’s role evolves: "At first, you act like just a fellow human being," he said. "Then as a physician." Manevitz was at Ground Zero after the World Trade Center attacks and he is now in in Gulfport Mississippi at the Health Department Command Center (New York Times, September 11, 2005) .

Last night I was given a copy of On the Ground After September 11, a collection of accounts by people in the mental health field who responded to the September 11, 2001 crisis. About 65 authors have contributed their stories, their responses and their own emotional reactions to bring us as readers into the web of connectedness that characterizes the response to 9/11. The book has over 100 chapters, and is more than 600 pages long, so I have barely dipped into its contents, but already I am engaged, mainly because the mental health workers tell their stories as connected people. First they are human beings. Their humanness connects them to the people they help, and to each other. And then they are able to provide service. I have two running partners who have contributed to this book, Ellen Stoller and Louise Klaber. Look for their stories.

Obviously and sadly the release of this book is timely. Yesterday a Health Advocacy student sent me a link to Adele Stan’s blog. Stan posted an article written by an anonymous and very experienced psychologist who volunteered her services in Dallas at the Convention Center and Reunion Arena. She is angry and frustrated by the lack of coordination, of official response, of real help. “No one is in charge, she shouts.” And then she makes the link between 9/11 and Katrina we are all afraid to think about:

The government has failed!!! We are more vulnerable now than before 9/11 because faith in the system is gone. No system can sustain itself as a viable entity when the citizenry are the walking wounded. Victims implode a system from within and expose its decay. This is the beginning of the end unless we can get a drastic change of philosophy and restore the government to a system "by the people for the people." Right now nobody down here believes we have that.

Yes, “Shame.” Now let’s face it.

Yesterday (September 6) Nicholas Kristof in the New York Times pointed out “The Larger Shame” that Katrina has exposed, “the children and families trapped in a never-ending cyclone of poverty.“ He sites the recently released report by the U.S. Census Bureau,"Income, Poverty and Health Insurance Coverage in the United States, 2004” (US Census Bureau) reporting that the official poverty rate in the US actually rose last year (from 12.5 percent in 2003 to 12.7 percent in 2004). Accompanying that rise was an increase in the number without health insurance, now 45.8 million people (15.7 percent). It is a horrible irony of a tragedy like Katrina that, as Kristof says, “in some ways the poor children evacuated from New Orleans are the lucky ones because they may now get checkups and vaccinations.”

Infant mortality rates are often used as a shorthand to get a sense of how well a country is doing providing basic health care to its population. “Under Mr. Bush, the national infant mortality rate has risen for the first time since 1958. The U.S. ranks 43rd in the world in infant mortality, according to the C.I.A.'s World Factbook; if we could reach the level of Singapore, ranked No. 1, we would save 18,900 children's lives each year,” writes Kristof. In January 2002 when a group of Health Advocacy students, alums and faculty went to Cuba to learn about the Cuban health care system , the official Cuban press headlined the fact that the infant mortality rate in Cuba was lower than in the US.

It seems as if we have been inured to such facts. Our shame should be deep. Let’s hope this time it leads to action.