Archive for the ‘Drugs & Pharmaceutical Companies’ Category

November 15, 2008

Double Dose: Obama’s Pre-Inauguration Boom for Women’s Health; Baby in the Home (and Garden); Changing the Culture of Rape Prevention; Prescription Drugs Deliver Phthalates …

Obama Does More for Women’s Health Pre-Inauguration Than Bush in 8 Years: “President-Elect Obama has not been inaugurated yet and, already, he’s taken some critical steps towards restoring the United States as a leader in global women’s health,” writes Amie Newman at RH Reality Check. Newman goes on to identify global reproductive and sexual health mandates that Obama has prioritized since he won the election way back on, oh, Nov. 4.

Plus: NARAL Pro-Choice America Foundation has unveiled a new initiative, Free.Will.Power. Check out the t-shirt design contest.

Baby, You’re in the Home (and Garden): The New York Times published a cool story on the increasing number of women opting for home births (still a very small percentage of all births) that took a very New-York perspective: How does one give birth in a small apartment — especially if the room is filled with family and the walls between neighbors are thin?

If the story had left it there, it’s placement in the Home & Garden section might have been more justified. But as it reads — complete with condemnation of home births from the American Medical Association — it’s better suited for Health.

Plus: Don’t miss the related slide show of home births. And here’s a great trivia question: Who was the first American president to be born in a hospital? Answer: Jimmy Carter.

Sexual Assault on Campus - Changing the Culture: Terrific story in the Star Tribune about rape prevention programs on college campuses that focus on men. Check out the intro below, and be sure to read the rest:

Tyler Jones was tipping back a couple of beers with friends at a Dinkytown bar when he suddenly had to take a stand.

“Hey, see that girl over there?” Jones recalled an acquaintance asking, nodding toward a woman he wanted to take home. “She’s almost drunk. Not quite drunk enough. … What shot should I buy her?”

There was a time, Jones says, when he might have laughed off the remark. Not anymore.

“You want to buy her something really strong to like, basically knock her out?” Jones, a University of Minnesota senior, recalled saying. “Man, that’s not right. That’s rape. That’s sexual assault.”

The acquaintance looked stunned. “Whatever,” he mumbled, and walked away.

It was one moment at one bar. But it’s also a sign of a big shift in strategy on campuses trying to tackle a culture that some say tolerates sexual assault. Instead of teaching women not to walk alone at night or to carry Mace, some colleges are trying something much harder — changing college men. Jones, fresh from sex assault prevention training, is in the vanguard of the movement.

Hat-tip: Kay Steiger

Women Gain Some Access, but Not Political Power: “Women still lag far behind men in top political and decision-making roles, though their access to education and health care is nearly equal, the World Economic Forum said Wednesday,” reports Reuters. “In its 2008 Global Gender Gap report, the forum, a Swiss research organization, ranked Norway, Finland and Sweden as the countries that have the most equality of the sexes, and Saudi Arabia, Chad and Yemen as having the least.”

Where does the United States rank? A measly 27th — below Germany (11th), Britain (13th), France (15th), Lesotho (16th), Trinidad and Tobago (19th), South Africa (22nd), Argentina (24th) and Cuba (25th). Here’s the full report (PDF).

The EPA’s Stalin Era: Yes, it really has been that bad, reports Rebecca Claren at Salon. To wit: “[T]he story of the hundreds of sick people who live near the former Kelly Air Force Base illuminates an entirely new manner in which the Bush administration has diluted science and put public health at risk. This year, largely in obeisance to the Pentagon, the nation’s biggest polluter, the White House diminished a little-known but critical process at the Environmental Protection Agency for assessing toxic chemicals that impacts thousands of Americans.”

Prescription Drugs May Deliver Phthalates: We’ve written before about the potential dangers of phthalates — chemical compounds commonly found in plastics, perfumes and lotions that are linked to reproductive abnormalities. But this one is news to me: Environmental Health News reports that prescription drugs can deliver high doses of phthalates.

“At least 47 prescription medications — including the colitis drug Asacol, an antacid and an HIV drug — contain phthalates, according to scientists at the Harvard School of Public Health and U.S. Centers for Disease Control and Prevention,” writes Marla Cone.

Victoria’s Toxic Secret: Feminist Peace Network picks up the story concerning allegations that Victoria’s Secret’s bras are causing skin irritations. The suspect irritant? Formaldehyde.

Racial Barriers Between Doctors and Patients: “In politics, the racial barriers might have fallen, I thought, but what about in health care?” asks Pauline Chen, MD, in her latest doctor/patient column in The New York Times. Chen looks not only at the striking health care disparities and racial inequality, but also at the experiences of minority physicians:

Of all the surgical residents I trained with, “Eric” was easily one of the smartest. He possessed a great bedside manner, brilliant clinical skills and plenty of that Obama cool. Eric was African-American, and one night, when we were both on call together, he told me something I have never forgotten.

“You know, Pauline,” he said, “there are a lot of times when I go to a patient’s room for the first time and they ask me, ‘Are you transport? Are you here to wheel me to radiology?’” I can remember Eric shaking his head as he spoke. “They never assume I’m one of the doctors.”

Supreme Court Hears Gun Rights Case: Allison Stevens of Women’s eNews explains a gun-control case heard before the Supreme Court this week that could effect abusers’ access to guns in some states.

If the justices side with the U.S. government’s challenge — which argues the law should not be restricted to just a portion of the states — batterers in every state and territory would be subject to the gun control ban.

If the court rejects the government’s reading of the law and limits the application of the law to those states with specific anti-domestic violence laws, safety advocates are apprehensive that thousands of abusers across the country will be erased from criminal lists, giving them new access to guns, said Peter Hamm, a spokesperson for the Brady Campaign to Prevent Gun Violence, a group in Washington, D.C., that lobbies for gun control.


November 13, 2008

Stephen Colbert on Women’s Health, With a Special OBOS Appearance

“Our Bodies, Ourselves” was featured in the beginning of Dr. Stephen Colbert’s “Cheating Death” segment — a biting look at the overuse of costly pharmaceuticals and the medical relevance of the Bee Gees. Oh yes, Colbert covers it all. 

Just look at what the skeleton is holding up when Colbert mentions “women health” (without air quotes!).

This is as good (or better?) as when OBOS was featured in an episode of the first seaon of “Friday Night Lights.” Predictions on whose show we’ll end up on next? 


October 15, 2008

CDC Denies Intent to Force HPV Vaccination of Immigrants

A number of bloggers have written over the past month about a new requirement that immigrants seeking permanent legal status in the United States must receive the HPV vaccine. The requirement is troublesome for a number of reasons, including the lack of an opt-out provision (in contrast to requirements for U.S. citizens), the expense of the series, the lack of significant public health risk posed by omitting this vaccine, and the vulnerability of the affected population.

This requirement originates in the CDC’s vaccination recommendations, which become mandatory for those seeking legal residency. These vaccines are typically for readily infectious diseases such as meningitis, polio, hepatitis, and measles. When the CDC adopted the HPV vaccine (currently only the Gardasil brand shot is available) into its recommendations, that triggered their requirement for immigrants.

Recently, the Wall Street Journal ran a piece on the controversy generated by this requirement, and noted that the CDC claims it never really intended the effect on immigrant populations. According to the piece:

“A CDC spokesman said the experts on the immunization committee didn’t realize their decision would affect tens of thousands of immigrants. However, a government official said the cervical vaccine’s inclusion on the list might be reviewed.”

I would have expected that considerations about the meaning of vaccine recommendations - of what actually happens as a result - might have been part of the decision-making process. Perhaps the CDC will be more alert in the future as to the actual implementation effects of their recommendations. A U.S. Citizenship and Immigration Services spokesperson interviewed by WSJ explained that the mandate is “a statutory requirement. It’s based on CDC recommendations.”

Read additional perspectives on this topic via:


October 4, 2008

Double Dose: Palin Condoms; Dispute Over Vaccines Reframed as Catfight; Chicago’s Toxic Air; Black Midwives Conference Oct. 10-12; Pregnant Women & Medical Research; Questioning the “War on Fat”

Always Carry Protection: Lucinda Marshall has the goods on the Palin condom.

And did you know that as of Sept. 26, Planned Parenthood took in more $802,678 in donations from 31,313 people made in Sarah Palin’s name?

Donations poured in after an anonymous email was circulated urging donations in any amount and recommending that the personalized thank-you card from Planned Parenthood be sent to Palin at the McCain-Palin campaign headquarters in Virginia.

L.A. Times columnist Patt Morrison took credit for the fundraising, recalling how she first made a similar suggestion after President Bush took office in January 2001.

Every donation generated a “thank you card.” I envisioned a scene out of “Miracle on 34th Street,” sacks and sacks of thank-you cards from Planned Parenthood, delivered to Bush in the Oval Office.

It worked. Boy, did it. Ultimately, more than a million dollars, I was told, was generated for Planned Parenthood in Bush’s name. George Bush became one of the biggest money-generators in Planned Parenthood’s history. The idea won me an award from Planned Parenthood, and a splash in Ms. Magazine. So I am delighted that my ”Mother of All Ironic Donations” notion has been revived for Palin.

Jenny McCarthy v. Amanda Peet: Nothing like turning a disagreement over the safety of vaccines into a male fantasy. Seriously, why/how did this get published?

Chicago’s Toxic Air: Proving real journalism still happens at the Tribune, here’s the intro to a special report on toxic air pollution:

People living in Chicago and nearby suburbs face some of the highest risks in the nation for cancer, lung disease and other health problems linked to toxic chemicals pouring from industry smokestacks, according to a Tribune analysis of federal data.

The U.S. Environmental Protection Agency spent millions of dollars to assess the dangers that air pollution poses but has failed to fulfill promises to make the research more accessible to the public. So the Tribune is posting the information on its Web site, where users can easily find nearby polluters and the chemicals going into their air.

Those who look up Cook County will see it ranked worst in the nation for dangerous air pollution, based on 2005 data. The Tribune also found Chicago was among the 10 worst cities in the U.S.

Plus: The Trib also published a searchable database of health-risk information (based on the EPA’s Risk-Screening Environmental Indicators (RSEI) database) and the health effects of long-term exposure to various industry-produced chemicals.

Bioethicists Challenge Reticence to Include Pregnant Women in Medical Research: A paper to be posted online and later in print in the November edition of the International Journal of Feminist Approaches to Bioethics (IJFAB) argues why more pregnant women must be included in medical research.

“As a society we are ethically obliged to confront the complex challenges of pregnant women in research, otherwise we relegate all expectant mothers to second-class medical citizens,” said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, in this press release about the journal article.

“One of the key messages of this paper is that progress will not happen until we shift the burden of justification from inclusion to exclusion and to an explicit commitment to studying the effects of drugs in pregnancy,” Faden added.

Midwives Fight AMA to Provide Black Maternal Care: “Shafia Monroe’s sixth annual International Black Midwives and Healers Conference, taking place in New York’s Harlem neighborhood Oct. 10-12, comes in the middle of a showdown between home-birth midwives and the American Medical Association,” writes Malena Amusa at Women’s eNews.

The AMA wants to bar licensing to certified professional midwives, who specialize in out-of-hospital births (births at home and in birthing centers) and is backing state legislation that restricts licensing to nurse midwives who have additional nursing training and certification required to work in hospitals.

“Certified professional midwives are a critical component to meet the growing maternal health needs in the black community,” said Monroe, noting that every sort of midwife is needed to reduce maternal morality rates among African American women.

Read more about the history of black midwives at the International Center for Traditional Childbirth. Here’s the description of the conference (PDF), which takes place in Harlem.

Top Psychiatrist Didn’t Report Drug Makers’ Pay:  “One of the nation’s most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules, according to documents provided to Congressional investigators,” reports Gardiner Harris in The New York Times. “The psychiatrist, Dr. Charles B. Nemeroff of Emory University, is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.”

Cancer Research Briefing: Bloggers recently had a chance to discuss the current state of cancer research and biotechnology with Dr. Gil G. Mor, an associate professor at Yale Medical School and director of Reproductive Immunology and Translational Research in Gynecologic Oncology, and Lori Lober, who was diagnosed with stage IV breast cancer in 2000 and has maintained a diagnosis of “no evidence of disease” for five years.

Treating Vascular Disease in Women: Arterial vascular disease is underdiagnosed and undertreated in older women, according to studies. Earlier this year, medical experts met to discuss the differences between men and women when it comes to the prevention, diagnosis and treatment of vascular diseases such as heart attacks and strokes. Out of that symposium came newly released recommendations for improving research on sex differences.

Losing the Weight Stigma: The Idea Lab section of The New York Times Sunday Magazine questions the “war on fat” and offers examples of how academics and activists are emphasizing health over weight. Robin Marantz Henig writes:

This is a core argument of fat acceptance: that it’s possible to be healthy no matter how fat you are and that weight loss as a goal is futile, unnecessary and counterproductive — and that fatness is nobody’s business but your own.

Many fat-acceptance activists prefer a new approach to dieting that focuses on nutrition, exercise and body image. A new book out this fall, “Health at Every Size,” by Linda Bacon, a nutritionist and physiologist at the University of California at Davis, outlines this approach, which is less about dieting than a lifestyle change that emphasizes “intuitive eating”: listening to hunger signals, eating when you’re hungry, choosing nutritious food over junk. It encourages exercise, but for its emotional and physical benefits, not as a way to lose weight. It advocates tossing out the bathroom scale and loving your body no matter what it weighs.

The philosophy is migrating slowly into mainstream programs, like a spa in Vermont that focuses on “acceptance of ourselves and our wonderful sizes.” But the spas and other programs have trouble with the bottom line of fat acceptance — rejection of weight loss as a goal. Weight Watchers, for instance, uses some of the same slogans, and while it promotes its program as “not a diet,” it still tracks weight loss down to the decimal point.


September 2, 2008

Re-Framing Empowerment: Allergan, Breast Implants and a New, Improved You

What’s the most empowering action you’ve taken recently? Did you ask for a raise? Stand up for a cause? Run for president?

If you answered “Got breast implants!” well, Allergan’s marketing is working.

Allergan is a global pharmaceutical company perhaps best known for producing Botox. In late 2005, Allergan merged with Inamed, maker of silicone breast implants — just before silicone breast implants received FDA approval.

Earlier this summer, Orange County Register columnist Colin Stewart, who is admittedly no fan of elective cosmetic surgery but who remains “dazzled by the ways Allergan makes the idea” of “injecting, slicing and rearranging body parts” seem appealing, devoted a column to Allergan’s marketing scheme, which is all about empowering you:

In its new breast-implant campaign, for example, Allergan’s marketers imply that implants are artful, like designer clothing. Even though implants are basically plastic bags filled with silicone or saline solution, Allergan portrays them as sources of power, freedom, individuality and self-confidence.

That’s a big change from last year, when Allergan bought Santa Barbara-based Inamed and its breast implants for $3.2 billion. Then, the implants were labeled “Style 68,” “Style 101,” etc.

The old labels were cold and clinical, so Allergan is giving them a new identity that sounds natural, feminine and artful. In a new marketing campaign, they’re the “Natrelle collection of breast implants.”

Breast implants can seem crudely sexual, but Allergan combats that impression too, ingeniously presenting them almost as a feminist issue. The company says it’s “empowering” women with information about their options.

The tag line for the Natrelle collection: “To each her own.”

Studies of breast-implant users reveal that women “aren’t getting them to attract men, but to feel greater confidence in their femininity,” says Robert Grant, president of the Allergan Medical division.

Presumably, women whose natural attributes have Natrelle enhancements will gain self-confidence from each masculine head that turns when they walk past.

“Nearly 400,000 women did something fabulous for themselves last year,” is Allergan’s message about Inamed’s breast implants. But to Grant that number isn’t fabulous enough.

“The $3.2 billion price for Inamed isn’t worth it for us” at that rate, Grant says. “We can grow (the rate of annual implants) to in excess of one million procedures.”

How else is Allergan making a show of empowering women? Let’s consider the research. Last November, a review of studies on the safety of breast implants appeared in the journal Annals of Plastic Surgery. The authors concluded that “the weight of the epidemiologic evidence does not support a causal association between breast implants and breast or any other type of cancer, definite or atypical connective tissue disease, adverse offspring effects, or neurologic disease. Women with breast implants do not present with more advanced stages of breast cancer or suffer impaired survival after breast cancer diagnosis.”

In fact, the only caution the authors registered concerned the observed higher incidence of suicide among with women with implants. On this point, they recommended future studies “to determine whether the consistently observed excess of suicide among women with implants reflects underlying psychiatric illness prior to breast augmentation surgery or other factors.”

But if that sounds, well, mostly reassuring, there’s more.

After the study was published, Diane Zuckerman, president of the National Research Center for Women & Families notified health activists that the journal article’s four authors all have financial ties to the breast implant industry. The lead author, Joseph McLaughlin, has been a consultant to Inamed/Allergan.

“In fact, McLaughlin is an author of almost every study on breast implants of the last 10 years, all funded by Dow, all concluding that implants are safe,” wrote Zuckerman. “With a couple of exceptions, the only studies he hasn’t co-authored are ones by NCI and FDA, which found significant increases in several illnesses among women with implants.”

“This isn’t a new study, it’s a review of all the old studies that McLaughlin co-authored. So, he’s summarizing his own work (without admitting it is his) and once again concluding that implants are safe.”

Makes you want to replace the guards at the hen house, no?

Despite the increasing popularity of breast implants — breast augmentation was the most popular plastic surgery procedure in 2007, with close to 350,000 procedures done — the safety debate rarely breaks through the marketing noise.

But thoughtful and personal critiques are carried out each day in blogs like Beauty and the Breast, which covers the impact of breast implants, and in documentaries such as “Absolutely Safe,” which has a terrific website filled with resources, including a section on the data debate.

Another documentary, “America the Beautiful,” which opened (or will be opening) in some theaters this summer, looks at the obsession with plastic surgery in general — and how surgeries can go horribly wrong.

And who knows — perhaps “empowerment” will be reclaimed in the future to mean making choices and taking risks that truly improve, not harm, our well-being. Then again, the FDA could approve the lip implants


August 22, 2008

Double Dose: Concerns Over HPV Vaccines; HHS’ Latest Contraception/Conscience Proposal; The Future of Personalized Medicine; Spinach With a Side of Radiation; WALL*E, a Lesbian Love Story …

Flesh-Eating Fish Perform “Pedicures”: See what shows up in my in-box from NPR?

Drug Makers’ Push Leads to Cancer Vaccines’ Rise: “In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment,” begins this lengthy New York Times story by Elisabeth Rosenthal about concerns over the rapid rollout of vaccines against HPV, which have now been used by tens of millions of girls and young women in the United States and Europe.

Some of the issues raised:

Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. Some data from the clinical trials indicate immune molecules may wane after three to five years. If a 12-year-old is vaccinated, will she still be protected in college, when her risk of infection is higher? Or will a booster vaccine be necessary?

Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer, some experts ask. A major killer in the developing world, particularly Africa, where the vaccines are too expensive for use, cervical cancer is classified as very rare in the West because it is almost always preventable through regular Pap smears, which detect precancerous cells early enough for effective treatment. Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway.

“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School. Dr. Harper was a principal investigator on the clinical trials of both Gardasil and Cervarix, and she spent 2006-7 on sabbatical at the World Health Organization developing plans for cervical cancer vaccine programs around the world.

“Because Merck was so aggressive, it went too fast,” Dr. Harper said. “I would have liked to see it go much slower.”

Plus: In a separate story, Rosenthal refers to two articles published in New England Journal of Medicine that conclude the vaccines are being used without knowing for sure that they are worth the high cost or if they are effective in preventing cervical cancer. Read the articles here and here.

HHS Fails to Deliver on Contraception/Conscience Proposal: “The Department of Health and Human Services today formally released proposed regulations that Secretary Michael Leavitt claims are necessary to protect health care providers and institutions who decline to provide certain medical services because those services offend their ‘consciences,’” writes Emily Douglas at RH Reality Check.

“After intense criticism in the mainstream media and from millions of Americans, HHS has removed an explicit redefinition of contraception as abortion from the regulation. In so doing, the agency may have created a much larger problem.”

Plus: Here’s the official version of the regulation, and Rachel’s previous writings on this topic.

Birth of a Movement: “Last month, a seven-judge appellate panel in Pennsylvania ruled that delivering babies is not the practice of medicine. It’s always comforting when the law catches up to history; midwifery is, after all, the second-oldest profession,” writes Roberta Devers-Scott, a Vermont midwife and psychologist who has written an op-ed about the prosecution of midwives, including her own case.

Health Care is the Issue:  Judy Waxman, vice president and director of health and reproductive rights at the National Women’s Law Center, identifies seven questions to ask when looking at health reform proposals to determine whether the proposals help to ensure that all women have access to health care that meets their needs.

The Future of Personalized Medicine: View a webcast of the Kaiser Family Foundation’s series Today’s Topics In Health Disparities, which discusses the potential of race-based medical solutions for improving healthcare and reducing racial/ethnic health disparities. The webcast takes a closer look at efforts to study the interaction between race, genetics and health.

Spinach With a Side of Radiation: “Consumers worried about salad safety may soon be able to buy fresh spinach and iceberg lettuce zapped with just enough radiation to kill E. coli and a few other germs,” reports the AP. “The Food and Drug Administration on Friday will issue a regulation allowing spinach and lettuce sellers to take that extra step, a long-awaited move amid increasing outbreaks from raw produce.”

A leading food safety expert said irradiation indeed can kill certain bacteria safely — but it doesn’t kill viruses that also increasingly contaminate produce, and it isn’t as effective as tightening steps to prevent contamination starting at the farm.

“It won’t control all hazards on these products,” cautioned Caroline Smith DeWaal of the Center for Science in the Public Interest.

She questioned why the FDA hasn’t addressed her agency’s 2006 call to require growers to document such things as how they use manure and ensure the safety of irrigation water. Irrigation is one suspect in this summer’s nationwide salmonella outbreak attributed first to tomatoes and then to Mexican hot peppers.

“We are not opposed to the use of irradiation,” DeWaal said. But, “it’s expensive and it doesn’t really address the problem at the source.”

The Claim: Morning Sickness Means a Girl Is More Likely: “The notion that morning sickness can sometimes indicate that a girl is on the way may be an exception,” to a number of old wives tales about pregnancy that are based more on fantasy than fact, reports The New York Times. “A number of large studies in various countries have examined the claim, and almost all have found it to be true, with caveats. Specifically, studies have found that it applies to women with morning sickness in the first trimester, and with symptoms so severe that it leads to hospitalization, a condition known as hyperemesis gravidarum.”

A True Love Story: “I’m completely smitten with WALL•E, this summer’s Pixar/Disney offering. But the last thing I expected to see in my friendly, heterosexual upper east side Manhattan neighborhood movie theater was a feature length cartoon about a pair of lesbian robots who fall madly in love with each other,” writes Kate Bornstein. “WALL•E is nothing short of hot, dyke Sci Fi action romance, some seven hundred years in the future! Woo-hoo! Isn’t that what you saw? No? What movie were you watching?” Hee. via en|Gender.


August 22, 2008

Doctors, Drugs and Data Mining

We all know that our personal data is generally less personal than we think. But did you ever consider that the prescription you hand over to a pharmacist is being used to track what drugs your doctor is prescribing?

The AP’s Matthew Parone wrote a good story explaining how the data is obtained and used. He also explains how state and federal lawmakers are seeking to protect doctors from this sort of data mining. Here’s how it works:

Companies like IMS Health Inc. have built an industry around gathering prescription data and selling the information to pharmaceutical companies for millions of dollars each year. Pfizer Inc., Merck & Co. Inc. and nearly every other drugmaker uses the data to identify which doctors are prescribing their drugs and which are prescribing the competition. When freebie-wielding salespeople show up at their offices, most doctors don’t know they’re being targeted based on their own prescribing habits.

But the political tide may be turning against IMS Health and competitors like Verispan, a unit of Surveillance Data Inc. After years of steady growth, they are fighting against laws in three New England states to keep prescribing information out of their hands.

Judges in Maine and New Hampshire have handed the companies early victories, declaring laws aimed at stopping the commercial use of prescription data unconstitutional. But an impending decision by a federal appeals court could overturn those actions and open the door to more restrictions nationwide.

As many as 18 states considered data restrictions this year, though analysts said they held off to see if New Hampshire’s law survives legal scrutiny.

The challenges to so-called data-mining companies are part of a larger backlash against pharmaceutical marketing efforts, which involve courting doctors with gifts, meals and other perks.

State advocates say the sales push drives up the cost of health care by convincing doctors to prescribe the latest, most expensive medications — instead of cheaper, sometimes better, options.

Amazingly, the American Medical Association is compliant in all this. Once the prescription data is bought from pharmacies, the companies turn to AMA’s databases to match the data with individual doctors. The information doesn’t come cheap — the AMA made $46 million on the sale of its database information last year. Doctors can choose to opt out of the lists shared with drugs salespeople, but apparently that option is not well publicized.

Sen. Herb Kohl, who chairs the Senate Committee on Aging, is trying to get the AMA to improve its protections for doctors who’d rather keep their prescriptions private.

“By selling data that allows pharmaceutical sales representatives to see which doctors are prescribing which drugs, the AMA is giving drugmakers what they need to exert more influence,” Kohl told the AP.


July 17, 2008

Bone-Building Drugs May Cause an Uncommon Fracture

A story making headlines this past week raises questions about what we know/don’t know about a class of drugs commonly used to treat osteoporosis.

The New York Times looks at a rare type of leg fracture in the upper thighbone — a fracture that typically affects people in car accidents or very frail older people — which is showing up in women who have used a class of bone-building drugs called bisphosphonates for five years or more. Tara Parker-Pope writes:

Some patients have reported that after weeks or months of unexplained aching, their thighbones simply snapped while they were walking or standing.

“Many of these women will tell you they thought the bone broke before they hit the ground,” said Dr. Dean G. Lorich, associate director of orthopedic trauma surgery at NewYork-Presbyterian/Weill Cornell and the Hospital for Special Surgery. Dr. Lorich and his colleagues published a study in The Journal of Orthopaedic Trauma last month reporting on 20 patients with the fracture. Nineteen had been using the bone drug Fosamax for an average of 6.9 years.

To be sure, the problem appears to be rare, notes Parker-Pope, and the drugs have proved useful for women with severe osteoporosis. But it’s enough of a concern that Merck, the drug company that makes Fosamax, said it will study whether the fracture is occurring more in bone-drug users.

Up to this point, “the fracture pattern did not emerge in placebo-controlled studies of bone drugs. But those studies have lasted only three to five years, although follow-up studies of the drug users have lasted longer. Now that the fracture pattern has been identified, researchers expect more doctors to publish reports,” writes Parker-Pope.

Meanwhile, studies show that there’s there’s not much to be gained by taking bisphosphonates for more than five years, and some doctors recommend that long-term users take a break from the drugs.

The story also notes another rare side effect associated with the drugs: osteonecrosis of the jaw, which destroys a patient’s jawbone. Though it mostly affects cancer patients taking an intravenous form of the drug, ordinary users have also reported the side effect.


July 1, 2008

Side Effects Revealed: Women Share Their Experiences with Breast Cancer Drugs

Our Bodies Our Blog has invited the folks at Breast Cancer Action to write monthly guest posts on breast cancer and related issues.

by Pauli Ojea

Women facing a life-threatening illness like breast cancer often have very difficult decisions to make about whether they can live with the side effects of what could be a helpful drug. Deciding whether the benefits outweigh the risks can happen only if all the information on side effects is available. All too often it’s not.

In an effort to remedy this situation, Breast Cancer Action (BCA) just released a report on women’s experiences with side effects of aromatase inhibitors (AIs), a common class of drugs for breast cancer treatment. In doing so, we hope to encourage additional research on how AIs affect women.

For women living with estrogen-receptor-positive breast cancer, AIs are a relatively new class of drugs that have quickly become the standard of care. Limited information about AI side effects is available, but there’s still a lot we don’t know.

Arimidex, the first AI, was approved by the FDA in 1996 for breast cancer treatment. Soon after, BCA started hearing from women whose doctors were recommending Arimidex, asking what the known side effects were and how long they should stay on the drug.

Knowing that the FDA couldn’t — and the drug industry wouldn’t — collect this information in a way that’s helpful to patients, we decided to do it ourselves. We wanted to make sure that this information was being captured somewhere. So, with an online survey we launched in 2005, we began collecting information from women about their experience on the three AIs approved for use in breast cancer: anastrozole (Arimidex), letrozole (Femara) and exemestane (Aromasin).

In 2007, we released a preliminary report based on the first 612 responses to the survey. Our new release, “Side Effects Revisited: Women’s Experiences with Aromatase Inhibitors,” is based on nearly 1,200 responses. The most common side effects reported continue to be hot flashes, bone pain, tiredness, muscle pain and insomnia. We also found that more than 25 percent of respondents experienced side effects so severe they decided to stop taking their AI. This is particularly troubling, because it means that the side effects were so bad that women felt they would rather risk a breast cancer recurrence than experience such poor quality of life.

The report also found that the women who took our survey (which is not necessarily a representative sample of all women taking an AI) are on average much younger than the women who have been studied in clinical trials of these drugs. These younger women — and by younger we mean under 60 — are experiencing more and worse side effects than older women on AIs. This is particularly true for younger women whose menopause was induced.

As a result, they’re experiencing very real quality-of-life issues that aren’t reflected in clinical trial data thus far. These results tell us that it will be crucial for future studies to look at how AIs are affecting younger women.

Here at BCA, we understand that patients almost always know before the medical community does what side effects they are experiencing. Through these reports on AI side effects, we hope to encourage additional research on the long-term side effects for all women taking these drugs. After all, this information is what allows people to make informed decisions about their health care — a value that’s critically important to all of us.

Pauli Ojea is the community organizer at Breast Cancer Action, where she mobilizes people to do something besides worry. Read BCA’s full report on women’s experiences with side effects of aromatase inhibitors, including quotes from the women themselves. Visit http://community.breastcancer.org to join online discussions on the topic.


June 28, 2008

Double Dose: Planned Parenthood Expands Reach; Pack Journalism in Search of a Pregnancy “Pact” in Gloucester; Teen Pregnancies at 30-Year Low; Mandating Insurance Coverage for Anorexia; Will Women Give Hormone Maker a Second Chance? …

Planned Parenthood Expands its Reach: “Flush with cash, Planned Parenthood affiliates nationwide are aggressively expanding their reach, seeking to woo more affluent patients with a network of suburban clinics and huge new health centers that project a decidedly upscale image,” reports the Wall Street Journal.

Unfortunately the full story is available to subscribers only, but the WSJ health blog has a summary that includes these remarks:

Despite some critiques to the contrary, Planned Parenthood insists it’s not compromising is long-held focus on serving the poor with birth control, sexual-health care and abortions. Officials there say they take a loss of nearly $1 on each packet of birth-control pills distributed to poor women under a federal program that funds reproductive care. But they make a profit of nearly $22 on each month of pills sold to an adult who can afford to pay full price. That money helps subsidize other operations, including care for the poor as well as pursuing Planned Parenthood’s political agenda.

“It is high time we follow the population,” said Sarah Stoesz, who heads Planned Parenthood operations in three Midwest states. She recently opened three express centers in wealthy Minnesota suburbs, “in shopping centers and malls, places where women are already doing their grocery shopping, picking up their Starbucks, living their daily lives,” she said.

Pregnant in Gloucester: Concerning the 18 high school students pregnant in Gloucester, Mass, that have received national news coverage for supposedly choosing to get pregnant and raise their children together, Kelly McBride, who covers media ethics for Poynter Institute, has an excellent piece on pack journalism in search of a “pact..” Meanwhile, the high school principal who first said their was evidence of a pact defends his comments and his memory.

Plus: Courtney Macavinta of Respect RX discusses her own sex “pact” at age 15 and the cycle of disrespect that leads girls who don’t value themselves to make choices “in which the fine print (that life is about to get even harder) is written in invisible ink.”

Teen Pregnancies at 30-Year Low: Writing in the Chicago Tribune, Lisa Anderson reports on the latest pregnancy statistics released by the Guttmacher Institute.

Pregnancies — whether they end in birth, miscarriage or abortion — among women age 15 to 19 dropped to 72.2 per 1,000 women in 2004, down from a peak of 117 per 1,000 women in 1990 [...]

While some 700,000 women age 15 to 19 become pregnant every year, the rate has declined 36 percent since it peaked in 1990. The rate of abortions among teens also plummeted, to 19.8 per 1,000 women in 2004 from a high of 43.5 per 1,000 in 1988.

But researchers are keeping a close eye on the numbers, as there are some signs that the drop may be reversing:

Despite decades of improvement and for reasons yet unknown, there is statistical evidence that the drop in pregnancy rates, the age of first sexual activity and contraceptive use among teens stalled after 2001.

The exception may be in the teen birthrate. After a 14-year decline, the birthrate, meaning the number of live births, among women age 15 to 19 rose 3 percent in 2006 to 41.9 per 1,000 women from 40.5 per 1,000 women in 2005, according to the U.S. Centers for Disease Control and Prevention. Until more data are compiled, it is unclear whether the 2006 uptick in births was an isolated blip or the harbinger of a more significant and negative change on the teen reproductive landscape, according to David Landry, a senior research associate at the Guttmacher Institute.

Mandating Insurance Coverage for Psychiatric Ailments: Illinois will become the 17th state to mandate insurance coverage for treatment of anorexia and bulimia, assuming the governor signs a bill recently approved by the state Legislature.

Bonnie Miller Rubin and Ashley Wiehle of the Chicago Tribune write:

The measure is part of a larger national debate about addressing inequities in insurance coverage between psychiatric and physical ailments.

More than 12 million Americans, mostly young women, have eating disorders in their lifetime, according to the National Association of Anorexia Nervosa and Associated Disorders. The organization ranked risk of death as higher with anorexia than with any other mental illness. Among patients with anorexia, almost half of all deaths are suicides, according to ANAD. Yet many insurers balk at covering the tab, which can run as high as $2,500 a day.

“I’ve met so many parents who have had to refinance their homes,” said Rep. Fred Crespo (D-Hoffman Estates), one of the bill’s sponsors.

But others cite the financial cost of such a law. Richard Cauchi, health program director for the National Conference of State Legislatures, said Illinois has taken “an unusual action” for 2008, when the trend is to move away from mandates on business and governments.

“There’s more pressure now to repeal and restrict mandates than to enact new ones,” he said..

“Neglected Infections of Poverty”: “Despite plummeting mortality rates for most infectious diseases over the last century, a group of largely overlooked bacterial, viral and parasitic infections is still plaguing the nation’s poor, according to a report released this week,” writes Wendy Hansen in the L.A. Times.

“Many of the diseases are typically associated with tropical developing countries but are surprisingly common in poor regions of the United States, according to the analysis, published in the Public Library of Science journal PLoS Neglected Tropical Diseases.”

The study’s author, Dr. Peter Hotez, chairman of George Washington University’s department of microbiology, immunology and tropical disease, says there are 24 diseases affecting at least 300,000 Americans, and possibly millions. Poverty-stricken regions, including Appalachia, inner cities, the Mississippi Delta and the border with Mexico, are the areas most severely affected.

Will Women Give Hormone Maker a Second Chance?: “Can Wyeth win back the 40 million Premarin and Prempro users it’s lost since 2002 — along with $1 billion a year in profits — with a new menopause drug? Or will the once-bitten women who have filed more than 5,000 lawsuits claiming the hormones gave them cancer feel fooled twice?” asks Martha Rosenberg at AlterNet.org, in this look at Wyeth’s hope of marketing Pristiq as the first nonhormonal treatment for menopause symptoms.

Don’t Ask, Don’t Tell Affects Women More: “The Army and Air Force discharged a disproportionate number of women in 2007 under the “don’t ask, don’t tell” policy that prohibits openly gay people from serving in the military, according to Pentagon statistics gathered by an advocacy group,” reports The New York Times.

While women make up 14 percent of Army personnel, 46 percent of those discharged under the policy last year were women. And while 20 percent of Air Force personnel are women, 49 percent of its discharges under the policy last year were women. By comparison for 2006, about 35 percent of the Army’s discharges and 36 percent of the Air Force’s were women, according to the statistics.

The information was gathered under a Freedom of Information Act request by the Servicemembers Legal Defense Network, a policy advocacy organization.

Gardasil Not Approved for Older Women: “U.S. regulators have told Merck & Co they cannot yet approve Merck’s application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women, the drugmaker said on Wednesday,” reports Reuters.

“Merck had applied for the use of Gardasil in women ages 27 through 45. The U.S. Food and Drug Administration said in a letter regarding the application that it has completed its review and there are ‘issues’ that preclude approval within the expected review time frame, Merck said.”

Exercise as a Tonic for Aging: The New York Times reports on an updated series of physical activity recommendations for older adults from the American Heart Association and the American College of Sports Medicine, which are expected to match new federal activity guidelines due in October from the United States Health and Human Services Department.

“Contrary to what many active adults seem to believe, physical fitness does not end with aerobics,” writes Jane Brody. “Strength training has long been advocated by the National Institute on Aging, and the heart association has finally recognized the added value of muscle strength to reduce stress on joints, bones and soft tissues; enhance stability and reduce the risk of falls; and increase the ability to meet the demands of daily life, like rising from a chair, climbing stairs and opening jars.”


June 9, 2008

Physicians Fail to Disclose Drug Industry Payments

Yesterday’s New York Times included the piece, Researchers Fail to Reveal Full Drug Pay, which explained that renowned Harvard child psychiatrist Dr. Joseph Biederman had failed to report money accepted from the makers of antipsychotic drugs.

The National Institutes of Health, which is the major U.S. funder of medical research, requires researchers to disclose of earnings over $10,000 per year to their universities, such as when they receive payments from the makers of drugs they are studying. Senator Charles Grassley has been investigating the financial relationships between drug companies and researchers, and explains in his report to the Senate Finance Committee that what initially looked like “a couple hundred thousand dollars” received by two psychiatrists was eventually found to be much more:

Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies. And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies. The question you might ask is: Why weren’t Harvard and Mass General watching over these doctors? The answer is simple: They trusted these physicians to honestly report this money.”

The document also notes that in some cases researchers have received federal grant money to study a drug while also accepting money from the pharmaceutical company that makes the drug under investigation.

Sen. Grassley previously introduced the Physician Payments Sunshine Act [S 2029] last fall to require more transparency in payments made to physicians by manufacturers of drugs, devices, and medical supplies, and to make the resulting information available to the public through an online registry. The bill was referred to the Senate finance committee; companion bill HR 5605 has been referred to the House subcommittee on health.


May 28, 2008

FDA Provides List of Pregnancy Exposure Registries

Determining the safety of medications during pregnancy can be difficult, with pregnant women needing to weigh the benefits of a potential medicine to themselves with the potential risks to the fetus. The Organization of Teratology Information Specialists has compiled numerous fact sheets on specific medicines in pregnancy and breastfeeding, and the LactMed database focuses on possible effects of substances (including over-the-counter products) while breastfeeding.

Pregnancy exposure registries collect data from women who have been exposed to a specific drug during pregnancy in order to study possible effects on fetal health. In some cases, the FDA requires that a drug company set up a registry - you may remember the FDA requiring women taking Accutane to register and assert that they would use contraception.

The FDA’s Office of Women’s Health is now maintaining a list of such registries, including some for HIV/AIDS medications, the HPV and hepatitis B vaccines, and drugs for depression, migraines, diabetes, and other conditions. ClinicalTrials.gov is another searchable source of fetal exposure studies and registries for women interested in participating.

Some registries require women to sign up through their health care providers, and it’s important to remember that these are research studies - participants may be required to complete multiple interviews and should be fully informed prior to agreeing to enroll. The registries also are not generally designed to determine whether the drugs have any unusual effects on women during pregnancy, but typically focus on fetal effects. Additionally, the registries typically focus on branded drugs, but registries for other exposures (such as environmental concerns) are very limited. Because clinical drug trials typically exclude pregnant women, however, these registries are one way to collect information on whether a drug is safe for pregnant women and their fetuses.

Update: This week the FDA proposed a new rule for prescription drug labeling with the intent of providing clearer information on drug effects on pregnancy and breastfeeding. The new system would remove the mysterious letter categories for describing pregnancy-related risks and would add new sections to labels to describe fetal risk and other considerations. Public comments on the proposed rule are being accepted through August 27, 2008.


May 27, 2008

FDA’s Mommy’s Bliss Nipple Cream Warning Disappears (and Reappears) Without Explanation

On Friday, the FDA issued a warning about Mommy’s Bliss Nipple Cream (as Christine noted), “because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.” The FDA warned consumers not to use the product (intended for nursing mothers), explaining:

Potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

At last check, more than 1,000 blog posts have appeared warning about the FDA’s advisory and cautioning mothers not to use the cream, and the story has been broadly spread through outlets such as CNN.

Strangely, though, the FDA’s warning vanished from their website. Following the original link for much of the day on Sunday turned up a message with a Mommy’s Bliss headline and the explanation, “This document has been removed from the web site. Please update your bookmarks.” The original had also been removed from the FDA’s list of news items, although both this and the warning still turned up in a search of the FDA’s website (leading to blank pages).

What could not be found in a search of the FDA site is information about the document’s removal. The Mommy’s Bliss people had responded by suspending sales of the product, but also noting that, “Apparently the FDA had conducted an assessment of the product in early October but only contacted the company about two weeks ago. This is extremely troubling since it has taken the FDA over 6 months to inform us of the results of this assessment.” They, and the FDA, also point out that no consumer complaints had been received about the product.

Thus, for the entire time the warning was missing, consumers were left wondering whether the FDA erred in issuing the warning, if the product is or is not safe to continue using, and whether Mommy’s Bliss’s statement about the FDA’s process created pressure to remove the warning (whether or not it was correct). The FDA had not issued an updated or corrected statement, but simply removed the original document. Because a corrective statement has not been issued, it was impossible for the average consumer to know whether there are legitimate concerns about the product.

The warning and link to the warning from the news page reappeared later on Sunday, although no explanation as to the previous disappearance has been added. In this case, I think it would be appropriate for the agency to point out whether the previous removal was a simple technical or web administrator error, given the wide attention this type of warning was sure to get and uncertainty about the product - the FDA’s own warning states, “the FDA has not received any reports of injury to infants.”


May 22, 2008

Reducing Breast Cancer Risk: From the Personal to the Political

Our Bodies Our Blog has invited the folks at Breast Cancer Action to write monthly guest posts on breast cancer and related issues.

by Pauli Ojea

Last week, as part of a special section on health and the human body, The New York Times published a story on reducing breast cancer risk. The piece included the usual tips: exercise, maintain a healthy weight, limit alcohol consumption, breast-feed and avoid hormone therapy.

While these tips are generally good guidelines to follow by anyone who wants to stay healthy, keep in mind that they all pertain to personal lifestyle habits. By only addressing individual lifestyle choices, The New York Times missed an opportunity to bring up another important breast cancer factor: the environment.

More than half the women who get breast cancer don’t have a family history of the disease or lifestyle factors like the ones described in the article. If we’re really going to reduce the high rate of breast cancer, we have to do better at addressing the root causes.

Over the last decade, increased attention has been given to the relationship between the environment and breast cancer, and we’re slowly starting to see more information and resources on reducing individual exposure to suspect chemicals or activities. But what about the things people can’t control for themselves?

For example, a woman can make the individual choice to eat fruits and vegetables and to buy organic food in order to reduce her breast cancer risk. However, if her drinking water contains pesticides, she’s involuntarily exposed to toxins. On her own, there’s not much she can do about pesticides showing up in her drinking water. But working with others in her community, she may be able to influence policy decisions around pesticide use.

The example above is not a hypothetical one, as pesticides and other hazardous chemicals often make their way into our drinking water. A chemical that is of particular concern to Breast Cancer Action is an herbicide called atrazine.

Quick science lesson: Aromatase is an enzyme that helps convert testosterone to estrogen in the body. Atrazine acts as an aromatase promoter. Breast cancer is largely an estrogen-driven disease, so you don’t want anything that unnecessarily and artificially increases its production. In fact, one of the ways doctors are treating breast cancer patients is with drugs called aromatase inhibitors (AIs). AIs work by inhibiting the production of aromatase, which in turn, limits the production of estrogen.

So, there is a drug that cuts off aromatase, and there is an herbicide that makes more of it. This means that it’s possible that a woman could be taking an aromatase inhibitor for breast cancer treatment, while at the same time consuming small amounts of atrazine, an aromatase promoter in her drinking water.

What’s even more baffling is that two of the pharmaceutical companies that make aromatase inhibitors (Novartis and AstraZeneca) own the agricultural company (Syngenta) that makes atrazine. The pharmaceutical companies say that inhibiting aromatase is good for breast cancer, while the agricultural company says there is nothing wrong with some aromatase promoter in our drinking water. Frustrated? You can read more about these conflicting stories in the latest issue of