The November/December issue of the Journal of Midwifery & Women’s Health has an article on nitrous oxide by Judith Rooks, a nurse-midwife and epidemiologist who has long advocated for making nitrous oxide available as a pain relief option for U.S. women in labor.

Nitrous oxide (N2O) is a gas that a laboring woman can breathe in through a mask.  It works very quickly, taking effect in about a minute, and wears off quickly.  Because it is administered by the laboring woman herself, it allows her to obtain a short burst of relief only when needed, as an alternative to an epidural. It is the most commonly used form of analgesia in the United Kingdom.

However nitrous oxide is not widely available in the U.S., despite the endorsement of various childbirth advocacy organizations, including the American College of Nurse Midwives.

In her article, Rooks reviews the research and literature on the safety and risks of nitrous use. She discusses questions around high and low doses of the gas, labor progress, maternal and fetal/newborn effects, and occupational hazards.  She notes that:

Because N2O/O2 labor analgesia does not have adverse effects that could threaten the safety of the mother or fetus, laboring women who use it do not need routine intravenous access, continuous electronic fetal monitoring, or other procedures that are intrusive and restrict the mother’s freedom of movement during labor. Nitrous oxide labor analgesia is safe for the mother, fetus, and neonate and can be made safe for caregivers.

The review points out several health concerns,  including that women who have had recent ear surgery (because of potential vomiting and inner ear pressure issues) and women who at increased risk of vitamin B12 deficiency may need special review before using nitrous, and that workplaces should take care to make sure the appropriate safety measures are taken to limit birth workers’ exposure. She also points to the need for additional research on issues like brain effects and occupational exposure in birth settings.

Although it’s only available to members, the American College of Nurse-Midwives also covered nitrous oxide in their recent Quickening newsletter. In it, they speak to Michelle Collins, CNM at Vanderbilt, who was instrumental in pushing for nitrous to be an option there. Collins explains several reasons women might choose nitrous: to take the edge off contractions, reduce anxiety, relieve discomfort while waiting on an epidural or during other procedures, or simply to delay epidural and keep more time available when the woman can be mobile.

Collins shares that in one month this summer, “35 women used the nitrous during labor at Vanderbilt, and of those, 22 used it as their sole analgesia. The remain­ing 13 used it and later had an epidural.”

For more on this topic, see this previous post with further discussion from Judith Rooks.

Escrito por Rachel; traducido del orginial en inglés Sept. 20, 2011.

OBOS has received funding to make blog entries available in Spanish. We hope to expand outreach efforts in the coming year.

Los bisfosfonatos (p.e. Fosamax, Boniva, etc.) son medicamentos para el tratamiento y la prevención de la osteoporosis en mujeres postmenopáusicas, pero hay preocupación por los posibles efectos secundarios causados por el uso de estos medicamentos por periodos largos.  Entre los posibles efectos secundarios se incluyen: fracturas atípicas de fémur (muslo), osteonecrosis (muerte de la mandíbula), y cáncer de esófago.

El otoño pasado, la FDA pidió cambios en las etiquetas de los bisfosfonatos para incluir advertencias sobre riesgos de fracturas, para explicar que no se sabe exactamente el tiempo que se debe consumir el medicamento, y recomendar que pacientes y doctores reevalúen periódicamente el uso del medicamento.

Recientemente, algunos comités de la FDA encargados de los medicamentos para la salud reproductiva y del manejo de la seguridad/riesgo de las medicinas, se reunieron para discutir el consumo extendido (>3-5 años) de bisfosfonatos, y sus posibles complicaciones.

En un documento informativo preparado para la reunión, la FDA revisó evidencias sobre estos relativamente raros pero preocupantes efectos, y concluyó: “La seguridad para el consumo prolongado de  bisfosfonatos aún no es clara, por cuanto los resultados de los estudios sobre la posible relación entre la osteonecrosis de la mandíbula, las fracturas atípicas de fémur, o el cáncer del esófago, y el uso de bisfosfonatos para la prevención y el tratamiento de la osteoporosis son conflictivos.”

La agencia concluyó que la evidencia sugiere un aumento en la incidencia de osteonecrosis de la mandíbula con un uso prolongado, especialmente de 4 años o más, pero que se necesitan estudios más profundos.  También dice, “Las fracturas atípicas….parecen tener una asociación importante con los bisfosfonatos, pero no hay actualmente consenso en cuanto a la manera como el uso acumulado de bisfosfonatos aumenta los riesgos de este tipo de fractura poco común.  Finalmente, no hay evidencia definitiva para apoyar la relación entre el cáncer de esófago y el uso prolongado de bisfosfonatos.”

En cuanto a los posibles beneficios resultantes del uso prolongado de bisfosfonatos para reducir fracturas relacionadas con la osteoporosis, la agencia no encontró beneficios evidentes.  “Los resultados sugieren que no hay ventajas de importancia en continuar usando esta medicina por más de 5 años.”

El New York Times también informa acerca de las recientes reuniones de la FDA, y destaca: “El comité convocó a más estudios para establecer la eficacia del medicamento en la meta deseada de prevenir fracturas.  Así mismo, los asesores recomendaron que la FDA examine la razón por la que el medicamento es recetado como medicina preventiva a mujeres que nunca han tenido osteoporosis.”

Para más información sobre este tema, vea nuestras previas entradas de blog, y la Red Nacional de la Salud de la Mujer (the National Women’s Health Network), la cual también pregunta si este producto debe ser comercializado y recetado como medicina preventiva para mujeres con buena salud.

Bisphosphonates (e.g. Fosamax, Boniva, and the like) are drugs prescribed for treatment and prevention of osteoporosis in postmenopausal women, but concerns have been raised about possible adverse effects of using the drugs for long periods of time, such as “atypical” femur (thigh) fractures, osteonecrosis (death of the jaw bone), and esophageal cancer.

Last fall, the FDA requested changes to bisphosphonate labels to warn of the fracture risk, explain that the optimal amount of time to take the drug is not known, and recommend that patients and their doctors periodically reevaluate whether the drug should be continued.

Recently, FDA committees on reproductive health drugs and drug safety/risk management met to discuss long-term (>3-5 years) use of bisphosphonates and these potential complications.

In a briefing document prepared for the meeting, the FDA reviewed evidence on these relatively rare but concerning effects, and concluded, “The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting as to whether or not ONJ [jaw osteonecrosis], atypical femoral fractures or esophageal cancer are associated with use of bisphosphonates for the prevention and treatment of osteoporosis.”

The agency further concluded that the evidence suggests an increased prevalence of jaw osteonecrosis with longer use, especially of 4 or more years, but that larger studies are needed. It also writes that “Atypical fractures…appear to have a strong association with bisphosphonates but there is no current consensus on the extent to which cumulative use of bisphosphonates increases the risk of this rare type of fracture. Finally, no definitive evidence is available to support an association between esophageal cancer and long-term use of bisphosphonates.”

In discussing whether long-term use of bisphosphonates would have a benefit of reducing osteoporosis-related fractures, the agency found no clear benefit of continuing, stating, “These results suggest no significant advantage of continuing drug therapy beyond 5 years.”

The New York Times also has coverage of the recent FDA meeting, and notes: “The committee also called for more study of the overall effectiveness of the drugs in their desired goal of preventing fractures. And the advisers recommended that the F.D.A. take a close look at why the drugs are prescribed as preventive medicine for women who do not even have osteoporosis.”

For more on this topic, see our previous posts, and the National Women’s Health Network, which also raises the issue of whether these drugs should be marketed and prescribed for prevention to healthy women.

Many U.S. users of cosmetics may not realize that they do not require FDA testing or approval and the federal agency is not authorized to require a manufacturer to recall unsafe products from the market. Because cosmetics are not regulated in the same way drugs are, it’s more difficult for consumers to make informed decisions, and the FDA has less power to regulate the cosmetics industry and respond to problems.

The Safe Cosmetics Act of 2011, introduced by Janice Schakowsky (IL-D), is intended to help close some of these gaps in cosmetics regulation.

The Act would give the government the power to recall unsafe cosmetics, require better disclosure of ingredients, establish additional safety standards and require manufacturers to submit data on the safety of their products, mandate reporting of adverse health effects, allow the banning of ingredients found to have reproductive or cancer-causing effects, encourage alternatives to animal testing, address worker safety, along with other measures.

The Campaign for Safe Cosmetics, which promotes the legislation and greater consumer awareness of cosmetic safety concerns, has more information at http://www.safecosmetics.org/section.php?id=74.

More info:

• More information on the FDA’s current role in regulating cosmetics
• Rep. Schakowsky’s press release on the Act
• Additional coverage at Good and Forbes

An upcoming webinar may be of interest to readers:

Patients Before Profits: What You Should Know About the FDA, Big Pharma, and Breast Cancer
June 21, 2011 10:00AM – 11:00 AM Pacific (1:00 pm – 2:00 PM Eastern)

Featuring Miriam Hidalgo, BCAction Volunteer Program Coordinator and Jane Zones, Medical Sociologist and Former BCAction Board Member

We will focus on how the competing interests of pharmaceutical companies and regulatory governmental bodies can fail to deliver safe and effective drugs that patients need. If you sign up, you will learn about power players at the FDA, the origins of the accelerated approval process, and more.

You will need to register online for this webinar and then will receive an email with instructions on how to join in on the 21st.

by Susan  Bell

Forty years ago, the New England Journal of Medicine published an article about the synthetic estrogen DES that is now recognized as a watershed in the annals of medicine.

The authors of the study, physicians at Massachusetts General Hospital, reported an association between DES – a prescription “wonder drug” intended to prevent miscarriages – and vaginal cancer in women who were just 15 to 22 years old. From the 1940s to the 1970s, between 5 and 10 million pregnant women and their sons and daughters were exposed to DES during pregnancy. When the daughters became teenagers and some of them developed reproductive tract cancer, the MGH physicians identified DES as the first transplacental carcinogen, and the daughters took on the new identity of “DES daughters.”

When DES daughters had trouble becoming pregnant and giving birth to healthy babies, DES was connected with miscarriage and other problems during pregnancy. These characteristics – crossing the placenta, disrupting the developing fetus, and affecting the bodies of DES daughters in multiple ways that often do not appear for many years – are those that identify DES as the first endocrine disruptor.

Much has been written in the past few weeks about DES. There have been reports of current research about damaging effects of DES: of its possible effects on the children of DES daughters, of its significance for understanding how human reproductive organs develop, and of the dangers of too much haste and too little prudence in adopting medical technologies.

Physicians writing in the New England Journal of Medicine use the words “humble” and “trauma” and “unanswered questions” in looking back and looking ahead to the future of DES. All of this is wise and good. Yet there is more that must be said in this time of remembering.

The DES story is about more than a tragedy that occurred to a population in the mid-20th century and more than a humbling experience for medicine. It is also about a women’s health movement that questioned whether doctors always know best. These women were among the first to judge science based on their intimate, firsthand knowledge of their own bodies, and joined together in collective action for social change.

Thank goodness for one “DES mother” whose daughter developed vaginal cancer during the 1960s and for her doctor who worried too. This mother asked her daughter’s physician—who was also puzzled about the cause of her daughter’s very rare cancer and was searching for answers—whether it could have been caused by the DES she took during the pregnancy.

Her physician was Dr. Howard Ulfelder, who listened to her, took her question seriously and researched the possibilities. We should celebrate this mother for voicing her hunch and this physician for listening to her. Ulfelder became one of the authors of the NEJM article; the mother remains anonymous.

DES mothers and DES daughters began the grassroots organizations DES Action (in 1975) and the DES Cancer Network (in 1982). Among other things, we should be grateful to these organizations for their efforts in bringing about an interdisciplinary, international “workshop” about DES in 1992 – a watershed in DES research, legislation and funding. Lines of research and practice initiated at that 1992 workshop have transformed the doing of science by incorporating activists in the conceptualization and conduct of DES science.

Thirty years ago, I began a research project to understand DES daughters’ experiences. I interviewed DES daughters, read their letters to the editor of these grassroots organizations, and traced their participation in the DES workshop. The results, published in my book, trace story by story their individual and collective efforts that galvanized the watershed DES research, legislation and funding.

One DES daughter who had vaginal cancer in her early 20s was devastated when her surgeon told her she would need a complete hysterectomy. Years later, after she had returned to see him many times for examinations she told me, “I was one of the wonders of medical science,” a woman whose surgeon had saved her life and rebuilt her body. For her surgeon – one of the pioneers in surgery for DES cancer – her body was “the most wonderful thing in the world.”

By the time she told me her story, “it was nothing abnormal to have five or six guys standing around” watching and learning as her surgeon examined her during follow-ups. They learned both from him and from her. As she put it, during those exams, “I used to tease him a lot you know, ‘Oh yeah, I know what to do now.’” The repeated examinations and displays of her body had educated her as well as doctors. She too, became a bearer of knowledge about the clinical contours of DES.

In taking care of themselves these patients and their mothers created new pathways, transformed relations of power and knowledge, and contributed to making new spaces and bringing world wide attention to DES. So on this 40th anniversary of that publication, let us celebrate the courage and the unique contribution of women’s health activism to the DES story.

Susan E. Bell is Professor of Sociology and A. Myrick Freeman Professor of Social Sciences at Bowdoin College in Brunswick, Maine. She is the author of “DES Daughters: Embodied Knowledge and the Transformation of Women’s Health Politics” (Temple University Press, 2009).

An increasing number of women are prescribed medications while they are pregnant, and unfortunately, far too often, too little is known about the safety of the medicines during pregnancy. A new article in the American Journal of Obstetrics and Gynecology looks at what medicines pregnant women are taking, and how that has changed over time, with a goal of showing the need for further research on the risks of medication use during pregnancy.

Researchers used data on women and their children from the Slone Epidemiology Center Birth Defects Study and the CDC’s National Birth Defects Prevention Study. For these studies, mothers of children with and without birth defects reported what prescription and over-the-counter medicines they remembered taking while pregnant. They excluded vitamins, blood, oxygen, and topical and IV medicines.

Among the findings:

• In 2008, 93.9% of pregnant women took at least one medicine; 82.3% used at least one medicine during their first trimester.
• The average number of medicines used at any time during pregnancy increased from 2.5 medicines in 1976-1978 to 4.2 in 2006-2008.
• The percentage of women taking 4 or more medicines during pregnancy increased from 23.3% in the early years to 50.1% in the most recent years.
• Antidepressant use increased the most, with less than 1% women taking any antidepressant during pregnancy through 1988-1990, climbing to 7.5% of women in the most recent years.
• The top 20 mostly commonly used medicines (in the first trimester) were identified, an include examples of antibiotics, the flu vaccine, allergy and asthma drugs, thyroid drugs, antidepressants, hormones, and a diabetes drug.

The researchers note that of course women’s recall of medication use may be imperfect. However, they conclude that the most commonly used medicines should have their risks and safety in pregnancy evaluated, and ongoing monitoring should be done to better inform women and their providers of potential risks of the medicines they use.

On April 28, the FDA is hosting a webinar to explain the “Bad Ads” program, which asks healthcare providers to report examples of inappropriate pharmaceutical promotions to the agency.

We’ve discussed concerns about direct-to-consumer pharmaceutical advertising previously, but this program is intended more to monitor inappropriate claims about drugs made directly to providers (rather than directly to consumers).

According to the webinar website, “The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.” Problematic examples of these promotions to healthcare providers include presentations that describe a drug’s benefits while omitting the risks, sales reps pushing a drug for a non-FDA-approved purpose, misrepresentation of study data and outcomes, or other incomplete or misleading claims.

The FDA has asked that healthcare providers “monitor drug companies’ promotional messages for fair balance and truthfulness.” To learn more about the “Bad Ads” program, see the webinar information page. It will take place at noon (presumably Eastern time) on Thursday April 28.

For more information, see “Direct to Consumer Advertising” on the Our Bodies Ourselves website.

[hat tip to Siobhan]

We wrote earlier this week about growing objections to the new, drastically increased price for a drug to prevent preterm birth, now branded as Makena.

One concern has been that cheaper versions of the drug compounded by pharmacies would no longer be available to patients. The company making Makena, KV Pharmaceuticals, previously sent letters to compounding pharmacies instructing them to stop compounding the drug lest they run afowl of FDA regulations. The FDA has now issued a statement in response indicating that the agency:

does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products.

The FDA also says the letters send out by KV Pharmaceuticals to pharmacies are “not correct” when they suggest that the agency plans to take action against compounding pharmacies.

Earlier this year, the FDA approved Makena (a progesterone injection from KV Pharmaceuticals, generically known as 17-Hydroxyprogesterone or 17OHP) for use to reduce the risk of preterm delivery in pregnant women with singleton pregnancies and a history of at least one spontaneous preterm birth.

17-Hydroxyprogesterone has been in use for preventing preterm birth for decades, but had not specifically been approved by the FDA – it was usually compounded by pharmacists. It is now the only drug on the market with FDA approval for preventing preterm birth.

Following this new FDA approval for an old intervention, what was once a $10 per dose drug has become a $1,500 per dose drug. This has raised some hackles. Nicholas Fogelson of Academic Ob/Gyn urged readers to “Boycott Makena,” stating that he will try to keeping getting compounded (and cheaper) injections for his patients.

Others have expressed outrage that the March of Dimes, which works in part to reduce premature birth, supported KV Pharmaceutical’s application to the FDA and “has received hundreds of thousands of dollars in donations from KV’s subsidiary Ther-RX, which will market Makena,” according to a Time health blog.

A blogger at The Preemie Primer expresses dismay that the March of Dimes didn’t anticipate such a price hike when they supported the pharmaceutical company’s application, and also notes that Rep. Henry Waxman and colleagues have sent a letter to the drug company with a list of pointed questions about the pricing. Objections also include the steep costs to Medicaid programs and the lack of affordability for low-income women. The Preemie Primer has several additional posts on this issue for further reading.

Time also indicates that KV Pharmaceuticals “has warned compounding pharmacies that they face FDA action if they continue to sell nonbranded versions of the drug.” This aspect of the controversy is still being disputed, as the drug company does not hold a patent on Makena and so it is questionable as to whether they can prevent compounding.

The New England Journal of Medicine included a perspective piece on the issue, which concluded:

Rather than representing a good investment of increasingly scarce health care resources, Makena will force patients, physicians, and those responsible for financing care to make hard choices. K-V Pharmaceutical has announced a copayment-assistance program, but no program providing short-term financial assistance to some patients will mitigate the harm that this new cost will cause to publicly funded programs, including Medicaid, and the women who rely on them. Nor will it mitigate the cost to employers and individuals who purchase insurance coverage and therefore directly bear all increases in health care costs. This tremendous cost increase and the likely decrease in access to an effective medicine are sizable unintended consequences of the FDA approval of 17OHP. They demand reconsideration and corrective action.

Call for Interviewees:
Reporter Molly M. McGinty is interviewing patients who were denied reproductive care at Catholic hospitals for a piece for Ms. magazine. Please contact her at mollymaureen@juno.com or 212-531-1679 by Wednesday, March 9. Patients are welcome to use pseduonyms if needed.

Interventions to Reduce Early Inductions:
My local (Nashville, TN) newspaper has an article today on early inductions without medical indication. The paper reports that local hospitals implemented a pilot program that asked doctors to check a form if they were inducing labor for nonmedical reasons; rates of babies delivered at 37 to 39 weeks’ gestation with no medical reason subsequently dropped from 9.8% to 4.8%.

The Health Beat Blog also explored issues of inductions (including early inductions) and cesareans in a blog post last month.

Save the Date: Orgasm, Inc:
I expect we’ll have more on this soon, but readers are invited to attend a preview screening of the film Orgasm, Inc. at the Coolidge Corner Theatre in Brookline, MA on March 24. More event info is available on Facebook. The film focuses on the pharmaceutical industry’s attempts to produce and market Viagra-type drugs to women.

OBOS Stories: Submit Your Own!
Just a reminder that we are collecting readers’ stories of how OBOS has touched their lives, in conjunction with our 40th anniversary celebration. You can read the submitted stories on our blog, and submit your own here.

We have previously written about the apparently small risk of a rare bone fracture associated with drugs meant to prevent bone fractures in people with osteoporosis. These drugs are called bisphosphonates, known under trade names such as Fosamax and Boniva.

Today, NPR’s Morning Edition has a good overview of this topic, noting the dilemma for women weighing whether to take such drugs. Bisphosphonates can help some women prevent serious hip fractures, but they may be associated with a increased risk of other atypical fractures in some women, especially those who use the drugs long-term.

There’s a new study on this topic in the Journal of the American Medical Association as well. The study found that treatment with a bisphosphonate for more than five years was associated with an increased risk of subtrochanteric or femoral shaft fractures, though the risk of these fractures is low.

The FDA announced a labeling change to the drugs in October 2010 to note the possible risk of thigh bone fractures.

On Friday, Christine posted, FDA Moves to Revoke Approval of Popular Breast Cancer Drug, with the news of and reactions to the FDA’s recent decision that Avastin (bevacizumab) should no longer be approved for use for breast cancer because “the agency has determined that the risks of the drug outweigh the benefits for this use.”

The FDA has posted a site with additional details about the recommendation, including their decision memo explaining the agency’s rationale, press release, questions and answers, and letter to the breast cancer community.

The FDA has begun the extraordinary process to revoke approval of the use of the popular drug Avastin to treat advanced breast cancer.

Avastin had received accelerated approval in 2008, but further studies have not shown that the drug improves either overall survival rate or quality of life.

Andrew Pollack of The New York Times notes that the approval is not without some controvery — as “various breast cancer patients and some patient advocacy groups have urged the F.D.A. to keep the drug approved and not deny patients a chance at what they say could be a life-saving therapy.”

Pollack also notes the financial stake the drugmaker Roche has in the drug: “Avastin is the world’s best-selling cancer drug, with annual sales of about $6 billion. Analysts have estimated that revocation of the breast cancer approval could cost Roche $500 million a year or more in lost sales.”

Some Republicans in Congress, moreover, have tried to portray the potential revocation as “an attempt at cost control, the beginning of rationing under the new health care law,” even though the FDA’s actions are part of the system set up in the 1990s to evaluate drugs that have received accelerated approval.

Breast Cancer Action, whose opinion we trust more than Republicans’ when it comes to advocating for the best interests of women, opposed Avastin’s original approval of the drug and sent a letter to the FDA this past July recommending approval be revoked. As BCA Program Manager Kimberly Irish noted in an e-mail concerning the latest news, the FDA’s decision is a matter of medical justice:

In 2007, BCA was the only breast cancer organization to actively oppose the use of Avastin for metastatic breast cancer patients because of its failure to improve overall survival or quality of life, its side effects and its high price tag. We applaud the FDA for recommending that Roche’s request for full approval of Avastin for advanced breast cancer treatment be denied.

The interests of patients must come before the profits of companies manufacturing the treatments. We need to continue to demand better drugs for people with metastatic disease. We have a long way to go to end this epidemic but the FDA’s decision to put patient needs before drug company profits is at least a step in the right direction.

Boston Review recently produced a special issue entitled “Big Pharma, Bad Medicine” — and it is well worth reading.

Marcia Angell, former editor of the New England Journal of Medicine (NEJM) and author of “The Truth About Drug Companies,” wrote the lead article — to which many other academics, health writers and industry representatives responded.

Angell’s opening critique of the cozy relationship between the pharmaceutical industry and medical research institutions is devastating. Summarinzing an argument she made in her book — and in many prominent op-eds, interviews and in a NEJM editorial, “Is Academic Medicine for Sale?” — Angell outlines the steps through which big pharma influences, and in many cases controls, the entire process of medical research — from clinical trials of new drugs to continuing education of doctors.

By putting profit before public good, big pharma’s power distorts the medical mission of many universities:

Academic medical centers are charged with educating the next generation of doctors, conducting scientifically important research, and taking care of the sickest and neediest patients. That’s what justifies their tax-exempt status. In contrast, drug companies — like other investor-owned businesses — are charged with increasing the value of their shareholders’ stock. That is their fiduciary responsibility, and they would be remiss if they didn’t uphold it. All their other activities are means to that end. The companies are supposed to develop profitable drugs, not necessarily important or innovative ones, and paradoxically enough, the most profitable drugs are the least innovative. Nor do drug companies aim to educate doctors, except as a means to the primary end of selling drugs. Drug companies don’t have education budgets; they have marketing budgets from which their ostensibly educational activities are funded.

This profound difference in missions is often deliberately obscured — by drug companies because it’s good public relations to portray themselves as research and educational institutions, and by academics because it means they don’t have to face up to what’s really going on.

Angell’s most pointed criticism is not at the drug companies, however, who, apologists could argue, are just trying to do right by their investors. Rather, she is most bothered by the complicity of the academic institutions. Angell ultimately recommends three specific reforms:

First, members of medical school faculties who conduct clinical trials should not accept any payments from drug companies except research support, and that support should have no strings attached. In particular, drug companies should have no control over the design, interpretation, and publication of research results. Medical schools and teaching hospitals should rigorously enforce this rule and should not themselves enter into deals with companies whose products are being studied by members of their faculty.

Second, doctors should not accept gifts from drug companies, even small ones, and they should pay for their own meetings and continuing education. Other professions pay their own way, and there is no reason for the medical profession to be different in this regard.

Finally, academic medical centers that patent discoveries should put them in the public domain or license them inexpensively and non-exclusively.

Several of the respondents in the Boston Review pick up on one of Angell’s points and pursue it with more depth. In  ”The Case of H1N1,” Howard Brody, director of the Institute for the Medical Humanities at University of Texas and author of “Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry,” explains how the pharmaceutical company Roche was able to obscure negative or neutral research on the drug Tamiflu while public health agencies around the world stockpiled large supplies. Later, the research in support of Tamiflu was found to be unconvincing.

David Bollier, author of “Viral Spiral: How the Commoners Built a Digital Republic of Their Own” and co-editor of Onthecommons.org, takes Angell’s recommendations a step further with his call to “Restore Medicine to the Commons“:

Understanding academic medicine as a commons helps us appreciate more clearly why it is so important to protect the non-market paradigm of research, education, and clinical care. In this mode, medicine harnesses the power of the scientific method through a transparent, ethical, merit-based process. It mobilizes community judgment and ethical scrutiny. It is insulated from the corrupting influences and self-dealing associated with an unregulated market economy.

Unfortunately, we have not been attentive to the value of academic medicine as a commons. We are suffering mightily as a result.

Suzanne Gordon, author of “When Chicken Soup Isn’t Enough: Stories of Nurses Standing Up for Themselves, Their Patients and Their Profession,” reminds us: “Don’t Forget Nurses.” She notes that nurse-practioners, who prescribe a great deal of medicine, have not been overlooked by the pharmaceutical industry, even if they are often forgotten in this type of discussion:

Today nurses no longer have to beg to get noticed. Like medical conferences, nursing conferences are now heavily supported by pharmaceutical and medical-equipment companies, which, like the corporations advertising on public television and radio, demand more and more of the spotlight. Nurses, like physicians, are flown to exotic spots and showered with so-called educational presentations. When I mentioned this phenomenon to a very respected nurse-academic, I expected her to share my concern. Her response: “It’s about time we got ours.”

Perhaps the most poignant — and funny — response comes from Adriane Fugh-Berman, associate professor of physiology and family medicine at Georgetown University Medical Center and director of Pharmedout.org. To show how continuing medical education (CME) is, in Angell’s words, “marketing masquerading as education,” Fugh-Berman creates a fictional scenario:

The gurgles and rumbles of an empty stomach are called, in medical-speak, borborygmi (it is one of the few onomatopoeic medical words). Let’s imagine that a company is developing a drug that prevents borborygmi. The first step would be to encourage people to take the disease state seriously. Marketing messages developed while the drug is still undergoing testing might include:

• While the occasional growling stomach is not a cause for concern, regular episodes could indicate the presence of CLASS (Chronic Loud Atypical Stomach Sounds).

• CLASS is not always benign. The distinction between normal stomach rumbling and a symptom of a serious disease can only be made by a physician.

• CLASS sufferers may limit their travel, work, and recreational activities out of embarrassment; some may become reclusive, fearing social stigmatization.

• CLASS can lead to overeating and obesity because sufferers may eat constantly to prevent audible stomach rumbling.

A pharmaceutical company may then begin to recruit physicians to act as mouthpieces for specific marketing messages …

Fugh-Berman continues the story all the way to the point where other companies are attempting to create “me-too” drugs that piggy-back on the original company’s success.

Angell, in her response to the responders, notes that Fugh Berman’s scenario “would be hilarious if it were an exaggeration, but it’s not. Drug companies frequently engage in such campaigns to prepare the way for a new drug or a new use for an old one. One example was the creation of an epidemic of ‘social anxiety disorder,’ formerly known as shyness, and the marketing of Paxil to treat it.”

*In related news, Harvard Medical School just last week announced new restrictions on relationships between its 11,000 faculty members and pharmaceutical and medical device makers. Here’s a summary of the changes.

_ _ _ _ _ _ _ _ _ _

Plus: Drugs, of course, can’t solve everything. Writing in The New Yorker, Atul Gawande explores (in a very humanizing and moving way) how our healthcare system, which can do a great job of prolonging life, is often at a loss when it comes to care for the dying.

“People have concerns besides simply prolonging their lives. Surveys of patients with terminal illness find that their top priorities include, in addition to avoiding suffering, being with family, having the touch of others, being mentally aware, and not becoming a burden to others,” writes Gawande. “Our system of technological medical care has utterly failed to meet these needs, and the cost of this failure is measured in far more than dollars.”