Archive for the ‘Drugs & Pharmaceutical Companies’ Category

August 18, 2009

Debate on Banning Prescription Drug Ads

Last week, the New York Times hosted a “Room for Debate” discussion on prescription drug ads that focused on whether these ads harm consumers or serve as educational resource. Participants included medicine/public health and advertising/marketing experts, science/medicine authors, and drug company critics.

For context, check out this ad for a drug for restless leg syndrome:

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Notice the warning about how the medication can cause “new or increased gambling, sexual, or other increased urges”? Really makes you want to try the drug, huh?

Also check out this ad for “Latisse,” a prescription drug for “eyelash hypotrichosis,” which is… get this… when you think your eyelashes are too thin and light.  The product, advertised in medical-sounding language, attempts to convince women that this is a real defect that requires prescription therapy.
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A recent Times piece on these ads calls this “inadequacy mongering.”

The “Room for Debate” article notes that some lawmakers would like to further regulate direct-to-consumer pharmaceutical ads, especially when drugs have been newly released. According to a follow-up article on the initial debate, many NY Times readers agree: “Of the more than 300 comments the forum generated … the overwhelming majority would like to see these ads altered or banned altogether.” The article includes excerpts of the relevant reader comments.

For further reading, check out this earlier post on the topic of direct-to-consumer pharmaceutical advertising.


August 17, 2009

Double Dose, Part 1: Poll – Pro-Life Majority a Fluke?; Drug Prescriptions, Personal Data for Sale; Individual Insurance Market Full of Loopholes …

A bit of catching up to do …

About That Pro-Life Majority …: Amy Sullivan always thought the Gallup poll released in May that showed, for the first time, a majority of Americans describing themselves as “pro-life” rather than “pro-choice,” was a fluke. And she was right:

My skeptical interpretation of the poll didn’t turn out to be terribly popular. The idea that just a few months after the election of a pro-choice president, Americans were racing to embrace the pro-life cause was too tempting a storyline. The poll made headlines everywhere, and we ran an essay on it anyway.

Now along comes a follow-up poll from Gallup and whaddya know, the much ballyhooed pro-life majority seems to have disappeared. The percentages of Americans calling themselves “pro-life” and “pro-choice” are essentially the same (47% for pro-life; 46% for pro-choice). Meanwhile, the positions they hold — a more useful indicator than the labels people choose for themselves — haven’t budged. A solid 78% think abortion should be legal in some or all circumstances.

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Think Prescriptions Are Private? Think Again: After buying fertility drugs at a pharmacy in San Diego, a woman started receiving coupons and samples in the mail — for everything from diapers and baby formula to gifts for an elementary school graduate — for a child she did not have. Milt Freudenheim writes that your prescription information — including your and Social Security number — is “a commodity bought and sold in a murky marketplace, often without the patients’ knowledge or permission.”

But protections might be strengthened under federal law:

The federal stimulus law enacted in February prohibits in most cases the sale of personal health information, with a few exceptions for research and public health measures like tracking flu epidemics. It also tightens rules for telling patients when hackers or health care workers have stolen their Social Security numbers or medical information, as happened to Britney Spears, Maria Shriver and Farrah Fawcett before she died in June.

“The new rules will plug some gaping holes in our federal health privacy laws,” said Deven McGraw, a health privacy expert at the nonprofit Center for Democracy and Technology in Washington. “For the first time, pharmacy benefit managers that handle most prescriptions and banks and contractors that process millions of medical claims will be held accountable for complying with federal privacy and security rules.”

The law won’t shut down the medical data mining industry, but there will be more restrictions on using private information without patients’ consent and penalties for civil violations will be increased. Government agencies are still writing new regulations called for in the law.

New Blog: The Global Fund for Women has a new blog: http://globalfundforwomen.wordpress.com. Read about reflections on gender and power; a feminist look at the financial crisis; and tips from Dolores Huerta on keeping activism alive.

Egg-As-Person Crusade Draws Big Money: “In just five short years, the primary movers and shakers in the absolutist anti-abortion/anti-choice movement seeking to promote the ‘personhood’ of zygotes (the single cell that forms after a sperm fertilizes an egg) have amassed nearly $58 million in tax-deductible contributions for their cause,” writes Wendy Norris at RH Reality Check. Norris profiles five organizations that have raised the most money.

Plus: “A Vermont woman whose 6-month-old twin fetuses died after a car crashed into the family van wants them to be legally recognized as children, which is not the case under current state law,” reports the AP.

Why LeRoy Carhart Won’t Stop Doing Abortions: Newsweek profiles Omaha physician LeRoy Carhart, one of three abortion doctors who took turns assisting at the clinic of George Tiller, the Kansas doctor who was murdered in May. Sarah Kliff writes:

Carhart knows there are people who want him dead, too. A few days after Tiller’s murder, Carhart’s daughter received a late-night phone call saying her parents too had been killed. His clinic got suspicious letters, one with white powder. It’s been like this since Carhart started performing abortions in the late 1980s. On the same day Nebraska passed a parental-notification law in 1991, his farm burned down, killing 17 horses, a cat, and a dog (the local fire department was unable to determine the fire’s cause). The next day his clinic received a letter justifying the murder of abortion providers. His clinic’s sidewalks have been smeared with manure. Protesters sometimes stalk him in airports. The threats, the violence, now the assassination of his close friend — all of it has left Carhart undaunted, and the billboard-size sign over his parking garage still reads, in foot-high block letters, ABORTION & CONTRACEPTION CLINIC OF NEBRASKA. “They’re at war with us,” says Carhart of the anti-abortion activist who killed Tiller. “We have to realize this isn’t a difference of opinions. We need to fight back.”

Health Insurance Fail: Sarah Wildman’s daughter cost more than $22,000. Not because of fertility treatments, or adoption. And yes, she and her partner have insurance, which they obtained on the individual market:

Our insurer, CareFirst BlueCross BlueShield, sold us exactly the type of flawed policy— riddled with holes and exceptions — that the health care reform bills in Congress should try to do away with. The “maternity” coverage we purchased didn’t cover my labor, delivery, or hospital stay. It was a sham. And so we spent the first months of her life getting the kind of hospital bills and increasingly aggressive calls from hospital administrators that I once believed were only possible without insurance.

Wildman continues:

Last fall, the National Women’s Law Center issued a report detailing exactly how women who want to bear children are derailed when searching for out-of-pocket health care. Only 14 states require maternity coverage to be included in insurance sold on the individual market, according to the Kaiser Family Foundation. In contrast, the Pregnancy Discrimination Act of 1978 requires employers with more than 15 employees to include maternity benefits in their health insurance packages. “We looked at 3,500 individual insurance policies and only 12 percent included comprehensive maternity coverage,” said Lisa Codispoti, Senior Advisor at the National Women’s Law Center. Another 20 percent offered a rider that was astronomically expensive or skimpy or both. One charged $1,100 a month; others required a two-year waiting period.

Continue reading at Double X.

Gene Mutation That Affects Hair Color Linked to Greater Pain Sensitivity: “A growing body of research shows that people with red hair need larger doses of anesthesia and often are resistant to local pain blockers like Novocaine,” reports The New York Times. The story goes on to note that the mutation in the MC1R gene also occurs in people with brown hair, though it is less common. I think I’m one of ‘em.


August 14, 2009

Stephen Colbert on Wyeth Pharmaceuticals Pushing Hormone Replacement Therapy

More swooning over Stephen Colbert ensued last night when “Our Bodies Ourselves” popped up on the screen during a feature on women’s health.

The topic? How Wyeth pharmaceutical company hired ghostwriters to write scientific papers that emphasized the benefits of taking hormone replacement therapy and de-emphasized the risks. More than 8,000 lawsuits have been filed against Wyeth by women who claim that the company’s hormone drugs caused them to develop illnesses.

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The New York Times broke the news earlier this month. Natasha Singer writes:

That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients.

The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

The articles did not disclose Wyeth’s role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.

Here’s the video of last night’s “The Colbert Report” segment “Cheating Death With Dr. Stephen T. Colbert, DFA.” The women’s health feature starts around 4:50.

Colbert offers this hilarious disclaimer about his credentials: He’s a doctor of fine arts, not a MD — “When I deliver a baby, it comes out through a Georgia O’Keefe painting” (must see). Then he launches into the Wyeth story:

Recently the scientific community was shocked to learn that Wyeth Pharmaceuticals hired ghostwriters to author 26 papers downplaying the risks of taking hormones for menopausal women.

This is shameful. Menopausal women?

What about pre and post menopausal women? We need to fabricate studies to make them take hormones, too, so every woman can enjoy the increased risks of heart disease, stroke and dementia. It’s what connects them as sisters. They can call it “The Sisterhood of the Traveling Hospital Gown.”

The story of these ghostwriters alerted ["Cheating Death" sponsor Prescott Pharmaceuticals] to one group of women that hasn’t yet been offered the benefits of hormone therapy: dead women.

Which is why Prescott pharmaceuticals is proud to present Vaxa-Geist — the first hormone replacement therapy for lady ghosts.

Why do you think they’re haunting us? They’re moody.

This hormone works great for ghosts of all ages, from little girl ghosts to old librarian ghosts to 3,000-year-old biblical ghosts. Talk about a hot flash.

Side effects of Vaxa-Geist may include hair blood, internal coolating and barry manilobes.

That’s it for cheating death …

OK, so maybe a little forced for Colbert. But still. It’s very cool to see the preeminent political satirist take on the exploitative manipulation of women’s health — and the fact he shows “Our Bodies Ourselves” while doing it makes me giddy.


July 14, 2009

FDA Approves Generic and One-Step Plan B, OTC Access for 17-Year-Olds

If you’re somewhat confused about who can get what forms of emergency contraception and how, you’re not alone. Recent decisions and approvals related to age, dose, and a generic version make the availability details somewhat baffling, but I hope the following will shed some light on the matter.

Earlier this year, a judge ordered that Plan B be made available over-the-counter (OTC) to women 17 and older, rather than the previously set age limit of 18. At that time, the FDA explained that they would not appeal the decision because it was consistent with the scientific findings on the drug, stating that: “…the FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”

However, it wasn’t immediately clear whether the manufacturer had asked for such approval or when it might be issued. The FDA website now indicates a label change meaning that “both Plan B One-Step (see below) and Plan B will be available without a prescription to women 17 years of age and older.”

Last month, a generic version of Plan B (levonorgestrel, to be marketed under the name “Next Choice” according to a company press release) was approved by the FDA, “by prescription only for women ages 17 and under.” While you may assume that the “by prescription only” line is meant to remind us that Plan B has only been available OTC for women 18 and older, that’s not the case. As the FDA’s release notes, “No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.”

Will the generic version be available to women 18 and older on Aug. 24? We don’t quite know yet. It has been suggested that women older than 17 could get the generic version prescribed as an off-label use, but that would of course require a visit to a clinician.

Finally, a 1.5 mg one-pill version of the drug (Plan B One-Step) also has just been approved by the FDA. The older Plan B requires users to take  one 0.75 mg pill within 72 hours after intercourse and a second 0.75 mg pill 12 hours later. The new Plan B One-Step means a woman will only need to take one pill. It will follow the same (but new!) rules as regular Plan B, with OTC access for women 17 and older, and prescription access for younger women.

In summary, and as best I can tell, here’s the availability breakdown right now:

17 and up Younger than 17 years
Plan B OTC (new OTC access for 17-year-olds) Prescription Only
Single Dose Plan B (Plan B One-Step) OTC Prescription Only
Generic Plan B (NextStep) Not until after 8/24/09 (actual date uncertain); 17-year-olds may get via prescription Prescription Only


July 6, 2009

Double Dose: Fat is Not a Death Sentence; Google AdWords Prohibits Abortion Ads; Survey: Sex After Kids; What Would Buffy Do?

Excess Pounds, Longer Life?: It wasn’t so long ago that we heard calorie restriction was linked to longevity. Now it seems the scales have shifted: A new report, published online in the journal Obesity, found that people who are moderately overweight live longer.

“[W]hy is it so hard to believe, even in the face of such evidence, that being fat’s not exactly a death sentence?” asks Washington Post columnist Jennifer LaRue Huget.

On another note, looking at the journal’s website, I wish access wasn’t restricted to an article touted on the homepage as an “important review” of weight discrimination and the stigma of obesity.  The “comprehensive update” features “sections on stigma-reduction research and legal initiatives to combat weight discrimination”; alas, only the citation is available without charge.

Plus: Also see Huget’s column on locally grown food. Miriam at Feministing has more on food politics.

Google AdWords Won’t Advertise Abortion: Lori Adelman of the International Women’s Health Coalition writes that as a result of policy changes, Google AdWords, the search engines’s advertising network, now prohibits ads for abortion services in more than a dozen countries, including Brazil, France, Mexico, Poland, and Taiwan.

“Google’s rationale behind disallowing ads in these particular countries, whose abortion laws range from conservative (Argentina, Brazil ) to more liberal by comparison (France, Italy), is shrouded in mystery: the spokeswoman deftly avoided answering my question about how the countries were chosen,” writes Adelman at Feministing. She includes an email exchange she had with a Google representative.

IWHC has an action alert over at its blog that encourages emailing Google.

Plus: Frances Kissling, a visiting scholar at the Center for Bioethics at the University of Pennsylvania and the former president of Catholics for a Free Choice, wrote a provocative piece at Salon last month that asks whether it’s ever appropriate to say “no” to a woman seeking an abortion.

Nurse Stereotypes Are Bad for Health: Theresa Brown, an oncology nurse, writes about how popular culture misrepresents nurses and the work that they do. She recommends a new book — “Saving Lives: Why the Media’s Portrayal of Nurses Puts Us All at Risk,” by Sandy Summers and Harry Jacobs Summers.

“Saving Lives” is an important book because it so clearly delineates how ubiquitous negative portrayals of nursing are in today’s media, particularly three common stereotypes of nurses — the “Naughty Nurse,” the “Angel” and the “Battle Axe.” They argue that these images of nursing degrade the profession by portraying nurses as either vixens, saints or harridans, not college-educated health care workers with life and death responsibilities.

There’s a media advocacy website connected with the book: TruthAboutNursing.org.

Sex, Kids & Reality: Amy Richards and Jennifer Baumgardner’s new book-in-progress — “The Family Bed: Is There Sex After Kids?” — focuses on the sex lives of parents after having children. As research for the book, they’re looking for folks to complete this survey on sex and parenthood.

When Wives Don’t Know: The New York Times Room for Debate Club brought together an all-female panel to discuss modern marriage. The central issue? Political wives who said they didn’t know about their spouses’ infidelities and Ruth Madoff, who said she didn’t know her husband of 50 years was practicing massive fraud.

Sales Outpace Data in Rush for Natural Remedies: “In 2002, when the initial findings of a National Institutes of Health study — known as the Women’s Health Initiative project — suggested that women on conventional hormone therapy were at greater risk for heart disease, cancer, stroke and blood clotting, the market for alternative treatments soared,” writes Camille Sweeney at The New York Times.

“There are now more than 500 products that purport to relieve symptoms associated with menopause, including capsules, tablets, teas, gels and creams. In the United States, the dietary supplement market associated with menopause has grown to $337 million in 2007 (the last year tabulated) from $211 million in 1999, according to the Nutrition Business Journal, a trade publication.”

“Beauty” Aces Talent at Wimbledon: Anyone else watch women’s tennis at Wimbledon last week? Read how looks came under consideration in determining which matches were played in the premiere Centre Court. Slender white women with long hair clearly had the advantage.

What Would Buffy Do?: See what happens when our favorite heroine takes on Edward from “Twilight” in a mash-up not to be missed.

“My re-imagined story was specifically constructed as a response to Edward, and what his behavior represents in our larger social context for both men and women,” creator Jonathan McIntosh explains in a blog post at Women in Media & News. He continues:

More than just a showdown between The Slayer and the Sparkly Vampire, it’s also a humorous visualization of the metaphorical battle between two opposing visions of gender roles in the 21ist century. [...]

In the end the only reasonable response was to have Buffy stake Edward — not because she didn’t find him sexy, not because he was too sensitive or too eager to share his feelings — but simply because he was possessive, manipulative, and stalkery.


May 24, 2009

Double Dose: Prop 8 Decision Due Tuesday; Ruling Against Tobacco Companies; Vermont Moves to Publicize Payments to Doctors; Violence Against Women Ignored and More …

Prop 8 Decision Due Tuesday: The California Supreme Court will announce its decision on Proposition 8 on Tuesday, May 26. The court’s decision will be posted online at 10 a.m.: www.courtinfo.ca.gov/courts/supreme

Check www.marriageequalityusa.org or www.equalityactionnow.org for info about where and how to organize a response.

“If we must reverse Prop. 8 at the ballot, we will do so,” Kate Kendell, executive director of the National Center for Lesbian Rights and a lawyer for couples in the case. “We will win – if not on Tuesday, then one day soon.”

A post-decision event is scheduled for Saturday, May 30. Marriage equality supporters from across California will “Meet in the Middle for Equality” at Fresno City Hall to celebrate or protest the Supreme Court’s ruling.

Standing Up For Her Own: Vogue’s Anna Wintour does her best to fulfill every dreaded stereotype of how fashion magazine editors regard the rest the word.

Ruling Against Tobacco Companies: A federal appeals court on Friday upheld a 2006 court ruling that found cigarette companies deceived consumers for decades about the dangers of smoking (view the decision [pdf]). From the Washington Post:

In a 93-page opinion, a three-judge panel cleared the way for new restrictions on how cigarette companies market and sell their products. Under the decision, the manufacturers will no longer be allowed to label brands “light” or “low tar” and will have to purchase ads on television and in major newspapers that explain the health dangers and addictiveness of their products.

Tobacco companies indicated that they will appeal the decision to the Supreme Court, a process that would probably put compliance with the ruling on hold for at least several months.

Vermont Shines Light on Payments to Doctors: The Vermont Legislature has passed the nation’s strictest law (pdf) concerning the relationship between the medical industry and doctors. Under the law, which will take effect July 1 (assuming the governor signs it, as expected), pharmaceutical companies and medical device makers would be required to disclose all money given to physicians and other health care providers. Natasha Singer of The New York Times writes:

The Vermont law promises to provide a window into the considerable efforts and spending by device and drug makers to woo doctors even in a small state.

Makers of medical products spent about $2.9 million in fiscal year 2008 on marketing to health care professionals in Vermont, according to a report last month from the state’s attorney general. Of Vermont’s 4,573 licensed health practitioners, almost half received remuneration, including payments for lectures, meals or lodging from pharmaceutical companies in the 2008 fiscal year, the report said.

“If the drug industry gives $3 million on average for three years now to physicians in a small state like Vermont, what is happening in California and New York?” said Ken Libertoff, director of the Vermont Association for Mental Health, an advocacy group that supported the law.

Plus: Richard A. Friedman, MD, a professor of psychiatry at Weill Cornell Medical College, writes about the popularity of “sexy blockbuster drugs” that are newer, but not necessarily better, and the effect that drug company marketing has on both patients and physicians.

Midwife Shortage in Mexico: IPS reports on the shortage of professional midwives in Mexico and the training at the only officially accredited Mexican school of midwifery, run by the non-profit Centre for Adolescents of San Miguel de Allende (CASA). Since the school was founded in 1997, 38 professional midwives have graduated; currently, 32 women are being trained.

Violence Against Women – Yawn: “We are so used to violence against women we don’t even notice how used to it we are,” writes Katha Pollitt, in a column on the shooting death of Johanna Justin-Jinich, a Wesleyan University student.

“When we’re not persuading ourselves that women are just as violent toward men as vice versa if you forget about who ends up seriously injured or dead, or pointing out that most murders are of men by men, we persuade ourselves that violence against women just comes up out of nowhere. Murder is serious, especially if the victim is young, white, middle-class, pretty; harassment, abuse, domestic violence, even rape, not so much.” Do go and read the rest.

Student Activists: In her first column as The Plain Dealer’s philanthropy writer, Margaret Bernstein writes about a group of high school girls who are taking on relationship violence. “These girls may not sound like philanthropists, but I think they are. They’re grass-roots philanthropists, using their actions instead of money to spark change.”

Rape Escalates in Eastern Congo: Dominique Soguel reports for Women’s eNews on the worsening sexual violence in the Eastern Congo. “Last week,” she writes, “the Congolese army came under scrutiny from the United Nations and human rights groups for its role in raping, killing and looting sprees during military operations in the two eastern provinces of North Kivu and South Kivu.

“Human Rights Watch called on the army to hold accountable soldiers involved in the rape of 143 women and girls, more than half of the 250 rape cases the organization documented in North Kivu.”

Plus: Eve Ensler, writing about the war on women in the Congo, asks: “I was in Bosnia during the war in 1994 when it was discovered there were rape camps where white women were being raped. Within two years there was adequate intervention. Yet, in Congo, femicide has continued for 12 years. Why? [...]

“What is happening in Congo is the most brutal and rampant violence toward women in the world. If it continues to go unchecked, if there continues to be complete impunity, it sets a precedent, it expands the boundaries of what is permissible to do to women’s bodies in the name of exploitation and greed everywhere. It’s cheap warfare.”


April 20, 2009

Double Dose: Bed Commercial Draws Praise from Home Birth Activists; Meet Disney’s New Princess; $10 million if You Can Transform Health Care; Quiverfull Movement Takes Root …

You Know You’re Not in the U.S. Anymore When …: BirthActivist.com posted an incredible video of a Barcelona couple’s at-home birth — a video made all the more amazing because it’s a commercial for a Spanish mattress company. The tagline: “Your bed, the most important place in the world.” Swoon.

Snow White, She’s Not: Almost three quarters of a century after the debut of Snow White, Disney is about to release a film starring its first black princess, Tiana. Neely Tucker writes in the Washington Post:

Her appearance this holiday season, coming on the heels of Michelle Obama’s emergence as the nation’s first lady, the Obama girls in the White House and the first line of Barbie dolls modeled on black women (“So in Style” debuts this summer), will crown an extraordinary year of visibility for African American women.

But fairy tales and folklore are the stories that cultures tell their children about the world around them, and considering Disney’s pervasive influence with (and marketing to) young girls, Princess Tiana might well become the symbol of a culture-changing standard of feminine beauty.

“If this figure takes off, you’re looking at 30 or 40 years of repetition and resonance,” says Tricia Rose, a Brown University professor who teaches both popular culture and African American studies, citing the enduring popularity of Disney princesses at the company’s theme parks, on Web sites and in videos.

Not only that, but Tiana learns that she needs love and a career to find happiness. Finally, my wish has come true.

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Fan Club for Non First Lady Fans: “A first lady whose entire bearing says, “Here I am!” and who by all appearances is living comfortably in her own body is a compelling symbol of female agency,” writes Rhea Hirshman in the New Haven Register. “Even as she is being made into a fashion icon, Michelle Obama is subverting the status quo, thus pulling off the neatest trick of all.”

Plus: More on Michelle Obama from Patricia Williams.

Deadly Silicone: A 43-year-old woman died a day after receiving silicone injections from an unlicensed practitioner. The New York City Health Department is concerned that illegal use of silicone as an alternative to cosmetic surgery is on the rise, reports The New York Times.

Drugmakers Spend Less on Advertising in 2008: “Drug makers cut their spending on consumer advertising of prescription drugs by 8% in 2008 to $4.4 billion, the first pullback since at least the late 1990s,” reports the Wall Street Journal.

Pharmaceutical-ad experts blame last year’s spendng decline on fewer new-drug introductions and heightened congressional scrutiny of drug marketing. Critics say the ads, which are permitted in few other countries, inflate health-care costs by prompting patients to request brand-name medicines, rather than cheaper generic alternatives. The industry’s trade group, however, cites a 2003 statement from the Federal Trade Commission that argues that the ads educate consumers about drug options and haven’t been shown to lead to higher prices.

In the U.S., ads aimed at consumers typically account for only about 40% of the total marketing budget for prescription drugs, according to the pharmaceutical industry. The majority of manufacturers’ promotional efforts are directed at doctors.

Spending on drug ads peaked in 2007 at $4.8 billion, according to IMS Health. The market researcher last month reported that annual U.S. prescription sales grew 1.3 percent in 2008, to $291 billion.

Plus: FDA rules designed to clarify pharmaceutical companies’ online ads — such as paid Google ads — and provide more consumer information are causing more confusion than before, say industry officials. How do you list side effects in 95 words or less?

Plus 2: The AP reports that drug makers “spent more than $2.9 million on Vermont’s doctors, hospitals and universities to market their products in the last fiscal year, according to a report issued Wednesday by the state attorney general’s office.” The reports’ findings note that 25 doctors and nurses each got more than $20,000 in cash or benefits from the companies; 10 got more than $50,000; and one psychiatrist received $112,000.

$10 Million if You CanTransform Health Care: The X Prize Foundation is offering $10 million to the winner of a contest that aims to transform healthcare in a small U.S. community:

The Grand Challenge for the Healthcare X PRIZE is to create an optimal health paradigm that empowers and engages individuals and communities in a way that dramatically improves health value. The proposed prize is designed to improve health value by more than 50 percent in a 10,000 person community during a three year trial. In order to effectively compete for this prize, teams will need to fundamentally change health financing, care delivery, and create new incentives that will result in achieving the required improvements in health value for both individuals and communities.

Reuters has more.

“Be Fruitful and Multiply”: NPR’s “Morning Edition” reports on the small but growing Quiverfull movement. These conservative Christians shun birth control and advocate for large families. The agenda is political as well as religious.

“They speak about, ‘If everyone starts having eight children or 12 children, imagine in three generations what we’ll be able to do,’” said Kathryn Joyce, author of the new book “Quiverfull: Inside The Christian Patriarchy Movement. “”We’ll be able to take over both halls of Congress, we’ll be able to reclaim sinful cities like San Francisco for the faithful, and we’ll be able to wage very effective massive boycotts against companies that are going against God’s will.’”

Eight-Year-Old Denied Divorce: From Akimbo: “Earlier this week, a judge in Saudi Arabia refused for the second time to annul the marriage between an eight year-old girl and a 47 year-old man. The girl’s father promised her hand in marriage to a friend as payment for financial debts. The girl’s mother brought the case in an attempt to free her daughter from the forced marriage. While this disturbing case has made headlines, it is not uncommon.”

Read the full post for steps advocates and governments should take to eliminate early and forced marriage.


April 15, 2009

Critique of Osteoporosis as a Disease and Related Drug Concerns

Osteoporosis, a loss of bone mass that can precede serious and costly breaks or fractures, is of particular concern to women – current estimates suggest that “osteoporosis is a major public health threat for 44 million Americans, 68 percent of whom are women… One out of every two women and one in four men age 50 and older will have an osteoporosis-related fracture in their lifetime.”

Often overlooked in discussions of the condition, however, are questions related to the efficacy and potential harms of the tests and treatments used to measure and prevent bone loss.  In particular, women’s health advocates have concerns about the overuse of medications in women who have risk factors for osteoporosis, but do not actually have the disease itself.

The April issue of the American Journal of Nursing (AJN) includes a piece, “The Marketing of Osteoporosis,” which comments on the promotion of drugs to symptom-free women for bone fracture prevention.

Author Maryann Napoli (of the Center for Medical Consumers) writes:

“In the name of prevention, millions of Americans have accepted the idea that it’s reasonable to treat a risk factor such as bone loss or high cholesterol as if it were a disease…More people should question the wisdom of starting long-term drug therapy. Often the magnitude of the risk factor has been overestimated, or the danger of the disease itself exaggerated, by people trying to sell you something-like a drug you must take for the rest of your life.”

She describes how what was once a risk factor (bone loss) came to be thought of as a disease (osteoporosis), and notes the role of pharmaceutical companies such as Merck in shaping this thinking, as well as in encouraging women to have bone density scans and take drugs as a “preventive” measure.

Napoli notes that as drugs such as alendronate came on the market, middle-aged rather than elderly women became the targets of osteoporosis-related advertising and drugs. She explains:

“A multipage glossy ad campaign that ran frequently in the Annals of Internal Medicine, for example, featured a thin, 40-something white woman with a crumbling ancient stone column in the background. “Don’t wait for a fracture…. No matter what her degree of osteoporotic bone loss.” I wrote to the editor-in-chief of Annals, pointing out that alendronate had no proven benefit in women in early middle age or in those without a history of fracture. I never received a reply, but the journal stopped running the ad about six months later….

Today, women in the osteoporosis drug ads are usually in their early 60s. The 2002 guidelines for osteoporosis screening from the Agency for Healthcare Research and Quality recommend that bone-density scanning not begin until age 65 (or 60 in some high-risk cases).”

Christine has previously written about the potentially serious side effects medications for postmenopausal osteoporosis and non-drug prevention options, and OBOS’s Judy Norsigian and Heather Stephenson addressed the issue in a commentary for Women’s eNews, “Let’s Make May the Month to Tame Osteoporosis Hype.”

Side note: The current cover of the AJN features a piece of art called Nursing Bra, part of the Artfull Bras Project, a collection of 50 bras created by the Quilters of South Carolina to raise breast cancer awareness.


April 12, 2009

Double Dose: New Book on Drugs Used to Control Height; America Rejoins Global Reproductive Policy Discussion; Film Critics Write off Rape; The Peeps Factor …

A “Too-Tall” Medical Tale: Christine Cosgrove, co-author with Susan Cohen of the new book “Normal at Any Cost: Tall Girls, Short Boys, and the Medical Industry’s Quest to Manipulate Height,” wrote a great piece in the L.A. Times about the history of doctors prescribing DES, a synthetic drug that acts like estrogen, to girls to stunt their growth.

Why? Because decades ago, “if a girl were heading toward 5 feet 8 inches, or, horrors, 5 feet 10 inches, not only would she have trouble finding clothes that fit, she’d have a hard time finding a husband. And in the days when there were few options besides marriage and children for women, well, that left an old maid.”

Thousands of girls, including Cosgrove, took the pills. Some have experienced myriad health problems, and an Australian study found a significant decrease in fertility among those who were treated.

Check out more about the book. Here’s an interview with the authors.

America’s Back — Now What?: Linda Hirshman and Gloria Feldt wrote a commentary on the significance of the U.N Cairo + 15 meeting:

On March 31, State Department Acting Assistant Secretary for Population, Refugees, and Migration, Margaret Pollack, told delegates to the United Nations Commission on Population and Development, meeting in New York, that America was back.

Marking a 180 degree turnaround from Bush administration policies that fought international efforts to enable people to control their own reproductive fate, the U.S. will once again defend the “human rights and fundamental freedoms of women” and support “universal access to sexual and reproductive health.” [...]

The global sigh of relief was palpable. For with all its money and diplomatic resources, the U.S. is the 10,000 gorilla in international reproductive policy. Now the question is, while this is certainly change we can believe in, is it all the change we need?

Film Critics Write Off Rape: Tiger Beatdown has a great analysis of the new Seth Rogen film, “Observe & Report,” and the reviews that give a pass to the rape scene. At least New York Times film critic Manohla Dargis will restore your faith. Rachel points to more links.

Why Women Stay: Hilzoy at Obsidian Wings has written the must-read post of all must-read posts about why women stay in abusive relationships. As one commenter put it, “If I always had a hilzoy around to explain it, I think I could understand every human phenomenon in the world.”

Johns Hopkins Bans Free Drug Samples, Gifts to Doctors: “Johns Hopkins is the latest big name in health care to try to restrict doctors’ ties to the drug and device industries,” reports the Wall Street Journal. “Its new policy ‘on interaction with industry’ bans free drug samples and says doctors can’t participate in consulting gigs in which they’re essentially paid for not doing anything.”

Plus: Iowa Republican Sen. Charles Grassley asked a nonprofit mental health organization about its funding as part of his investigation into drug company influence, reports Bloomberg.

Everybody Hurts Sometimes: “Long lines come up frequently in the American healthcare discussion, the symbol of all that is to be feared about a government-run system,” writes Ezra Klein on the L.A. Times op-ed page.

And it’s true that in Canada and Britain, the two countries most often cited in discussions of what nationalized healthcare might mean, some patients report having to wait months for some elective treatments. Sometimes.

But we’ve got waiting lines too — along with 50 million uninsured and a system that costs more than twice as much per person as that of any other country. We’ve just managed to hide our lines through clever statistical gimmickry.

Debate Over Digital Health Records: The Obama administration maintains health information technology is as an essential, cost-savings component of health care reform and has set a goal for every American to have an electronic health record by 2014. But critics fear the money to implement the system will be wasted if doctors and hospitals can’t share information, reports USA Today.

“We could head for a techno-Katrina,” said Sen. Barbara Mikulski, D-Md. “I do not want to do that, where we do a dollar dump, and at the end of the day, we have a lot of microchips floating around.”

Plus: Writing in the New England Journal of Medicine, National Coordinator for Health Information Technology David Blumenthal discusses the health IT provisions of the federal economic stimulus package — collectively called HITECH in the law. Read “Stimulating the Adoption of Health Information Technology.”

Vitamin Sales Up as Economy Falters: “Sales of vitamins and nutritional supplements, which have grown consistently for years, have surged in recent months, rising as the stock market has fallen,” writes Alex Williams in The New York Times. “People are clearly cutting back on many items, from bread and milk to designer jeans and flat-screen televisions, but they are stocking up on pills that they think can spare them expensive doctor visits.”

thelma_and_louise_peepsMy Peeps: We end on a colorful note — Tis the season of the peeps. The Washington Post displays its 40 finalists here; don’t miss Peep/Tuck and Thelma and Louise: Peeps on the Run.

Here, first place winner Melissa Harvey discusses her gorgeous interpretation of Edward Hopper’s “Nighthawks” painting.

The winner of the Chicago Tribune contest created an imaginative Wizard of Peeps. And for political junkies, check out this portrayal, at TwinCities.com, of the Minnesota U.S. Senate Trial between Al Franken and Norm Coleman.


April 6, 2009

Op-Ed Offers Directives for New FDA Leadership

Today’s Boston Globe has a great op-ed piece from Marcia Angell on the direction FDA Commissioner nominees Margaret Hamburg and Joshua Sharfstein should take the FDA under their leadership.

Angell offers the following directives:

  • “Congress should repeal the Prescription Drug User Fee Act
  • Consultants for drug companies should no longer be permitted to serve on FDA advisory panels
  • The agency should see that the post-marketing studies it mandates are actually carried out
  • The FDA should review generic drugs as fast as brand-name drugs
  • Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type
  • The FDA should stop approving me-too drugs on the basis of surrogate endpoints
  • The FDA should prohibit direct-to-consumer advertising for three years after drugs are approved”

All of these are important issues, and you should read the whole piece for Angell’s rationale. For example, she notes that the Prescription Drug User Fee Act:

“…authorizes drug companies to pay ‘user fees’ to the FDA for every drug the agency considers for approval. That puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably – a bargain for drug companies. Drug companies should not be considered ‘users’ of the FDA; the public is the user, and it alone should support the agency.”

I would add to the list ensuring that decisions about drug approvals be made based on sound science free of political ideologies – see Christine’s recent post on the FDA’s approach to Plan B emergency contraception access for an example of why attention to this issue is needed.

Relatedly, Angell, a Senior Lecturer on Social Medicine at Harvard Medical School and former editor of The New England Journal of Medicine, is the author of a book I’m going to have to add to my to-read list: The Truth About the Drug Companies: How They Deceive Us and What to Do About It.

An in-depth article on the same topic, published in The New York Review of Books in January, provides more on Angell’s perspective: see “Drug Companies & Doctors: A Story of Corruption.”

And finally, The Boston Globe looks at what the FDA could do to improve the information consumers are given about prescription drugs. The article quotes OBOS’s own Judy Norsigian.


March 27, 2009

Real Problems with RealAge

I’ve been assuring myself lately that I’m not really as old as my driver’s license insists. My true age — a number determined by health and lifestyle habits — must be lower. All these years without red meat has to count for something.

To confirm my wishful thinking, I planned on taking an online quiz called RealAge that promises to help you find … your real age. Despite an intimidating 150 or so questions, I was courting the payoff: Every time I look in the mirror I would see a member of Generation Y, not X.

But even the virtual fountain of youth comes with a catch. While I was counting on re-setting my internal clock (assuming the test did not inquire about Grateful Dead concert attendance), RealAge has banked on its users turning over their health information to pharmaceutical companies. These companies would of course find something that would make them feel better — and younger.

Along with offering nutrition information, advice on de-stressing and organic gardening books, RealAge “makes its money by selling better living through drugs,” writes Stephanie Clifford in this front-page New York Times story.

“Pharmaceutical companies pay RealAge to compile test results of RealAge members and send them marketing messages by e-mail,” explains Clifford. “The drug companies can even use RealAge answers to find people who show symptoms of a disease — and begin sending them messages about it even before the people have received a diagnosis from their doctors.”

More than 27 million people have taken the test; one-third, or 9 million, have signed up to be members — encouraged by RealAge spokesman and adviser Dr. Mehmet Oz, a frequent guest on “The Oprah Winfrey Show” (oh, Oprah). RealAge only collects and shares medical information from members, and it does not reveal their names, but the privacy policy does not clearly state RealAge’s close relationship with drug companies. And it’s this point that concerns consumer health advocates.

“Literally millions of people have unknowingly signed up,” Peter Lurie, the deputy director of the Health Research Group at Public Citizen, told The Times. The company, he said, “can create a group of people, and hit them up and create anxiety even though the person does not have a diagnosis.”

Members receive emails from RealAge, and advertisements are labeled as such. Yet the super-precise targeting is designed to convince any semi-worried person that the perfect solution is just one click away.

Consider this scenario:

Steve Williamson, an executive at the medical company Hologic, uses RealAge to sell a treatment called NovaSure, which removes the endometrial lining in post-childbearing, premenopausal women who have heavy periods.

With RealAge, he buys lists of women who have answered a test question by saying they have heavy menstrual bleeding, among other criteria. He chooses the ones in the 37- to 49-year-old age range, then sends them a series of e-mail messages. Several of the messages do not mention NovaSure, they just identify heavy bleeding as a problem — then, he said, the messages suggest NovaSure as a solution.

“We’re trying to get out to those customers right now and let them know that it is an option for them,” said Mr. Williamson, the vice president for sales and marketing for the gynecologic surgical products division of Hologic. “A lot of women don’t know it’s a problem, and that’s the thing. It’s not something they necessarily talk about.”

A 31-year-old former pharmaceuticals saleswoman quoted at the end of the story said she isn’t bothered knowing that drug companies have access to her answers. Patients, she said, rely too much on their doctors for answers. “As a patient and a person, you have to take your health into your own hands,” she said.

Right. But in this case, your health isn’t in your own hands. The diagnosis doesn’t come from an unbiased source, but from a company that thinks it has just what you need — whether you really do or not.

Plus: The American Psychiatric Association announced on Wednesday that it would no longer allow drug company-financed medical seminars at its annual meeting and it would discontinue meals paid for by industry money, reports The New York Times.

And here’s a topical New York Review of Books article from January: Marcia Angell discusses three books that look at the relationship between drug companies and doctors. Two of the books are on the topic of fear-mongering — convincing patients (and their doctors) that they have medical conditions that can be helped by long-term drug treatment.


March 9, 2009

Double Dose: Where’s the Media Coverage of Breast Cancer and Environmental Causes?; New Report on Sex Education in Florida; Gender Neutral Prounouns; Domestic Violence and Technology …

Overlooking Evidence: “When it comes to breast cancer, why is it so hard to get the most influential media to pay attention to the possibility that, in addition to better-understood risks, unnatural substances entering women’s bodies might also be a factor?” That’s the million-dollar question in this Fair! analysis on the surprising dearth of news coverage on environmental hazards and breast cancer. An excellent report by Miranda Spencer.

Skimping on Care: More than a third of people surveyed have skipped medical check-ups or dental visits over the past year due to concern over health care costs, and 27 percent have put off getting needed health care, according to the Kaiser Family Foundation’s first health care tracking poll of 2009.

Supreme Court: No Legal Shield in Drug Labeling: The Supreme Court on Wednesday ruled that people injured by drugs can sue the drug manufacturer in state courts, even if the drugs were approved by the Food and Drug Administration.

“The ruling could have significant implications beyond drug manufacturing,” writes Adam Liptak at The New York Times. “Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.”

The case involved a Vermont woman, a musician, whose arm had to be amputated following an injection of the anti-nausea drug Phenergan. Levine sued the drug maker Wyeth because Wyeth had not changed the label indicating that one method of administering the drug had a small risk of error which caused irreversible gangrene. Nina Totenberg did a good report on the ruling. The NPR link also includes excerpts from the oral arguments heard last November.

Sunshine State Keeps Teens in the Dark: The Healthy Teens Campaign of Florida and the Sexuality Information and Education Council of the United States (SIECUS) have released a report on failed abstinence-only sex education programs in Florida’s public schools: “Sex Education in the Sunshine State: How Abstinence-Only-Until-Marriage Programs Are Keeping Florida’s Youth in the Dark” (pdf).

“[O]ur research has exposed both the state’s appalling indicators of poor outcomes for young people and the equally appalling nature of how abstinence-only-until-marriage programs have become pervasive throughout the state,” writes Adrienne Kimmell at RH Reality Check.

Him/Her/They: Elizabeth Landau at CNN reports on the history of the search for gender-neutral pronouns, an issue that has recently been taken up on Twitter. An interesting story.

On the Issues: Good reads in the On the Issues Magazine cafe, including Diana Whitten’s look at Women on Waves, a Dutch organization that provides on-ship abortions in international waters for women from countries where it is illegal. Women on Waves recently won an important victory in the European Court of Human Rights. And don’t forget to check out the winter issue, which features stories on topics from ratifying CEDAW to Second Life.

Moving Reproductive Services Off-Site (Six Feet Away): From Women’s eNews: For more than a decade, a hospital merger in New York state was held up by abortion politics. Last week, community activists gathered for a ribbon-cutting ceremony marking their hard-fought compromise. Rebecca Harshbarger reports.

Plus: Emily Douglas points to this Albany Times Union op-ed on the implications of a possible merger between two secular hospitals and one religious hospital in Rensselaer County, New York. The merger raises questions about reproductive health care for patients and employee health insurance benefits, since Catholic directives prohibit coverage for contraception.

In Translation: Over at Sociological Images, a blog sponsored by the American Sociological Association, there’s been some debate over the English and Spanish versions of a pamphlet for pregnant women offered by Kaiser Permanente. Kaiser provides a response.

The Economic Future and Women’s Roles: The Chicago Foundation for Women looks at how the stimulus package affects women’s economic security.

Teaching Domestic Violence Victims Safe Use of Technology: Via this press release, I learned about a Washington state program designed to help victims of domestic violence by increasing their knowledge of how to use technology safely.

“Domestic violence is built around control, not anger, and an abusive partner often limits a woman’s access to information and support. Monitoring computer activity is one of many ways to control a spouse,” said Jerry Finn, a University of Washington Tacoma professor of social work who also evaluates the effectiveness of human services programs.

The training covers how to prevent such things as identity theft; concealing browser history; how to be safe in a chat room; how to set up an e-mail account without using a real name; and how to prevent being followed with a GPS device. What a smart idea.

Welcome Particle, Wave, Astarte and …: To apologize for the late Double Dose, I offer some cute overload, via feminist poet and performance artist Diana Tigerlily, who also raises goats.

Meet the newest ones — five in all, if my counting is correct. Makes me think two dogs and two cats may not be enough : )


March 4, 2009

Examining Drug Industry Influence on Medical Education

We have written a fair bit here in the past about direct-to-consumer drug advertising and drug industry payments to physicians, but a recent New York Times article points to another area in which drug industry dollars may have an unexpected influence – medical education.

The article offers this example:

In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching online that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

Zerden wasn’t the only concerned Harvard medical student – more than 200 of them, along with some faculty, are apparently riled up and working to expose these types of connections and payments. From other students:

“Harvard needs to live up to its name,” said Kirsten Austad, 24, a first-year Harvard Medical student who is one of the movement’s leaders. “We are really being indoctrinated into a field of medicine that is becoming more and more commercialized.”

David Tian, 24, a first-year Harvard Medical student, said: “Before coming here, I had no idea how much influence companies had on medical education. And it’s something that’s purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.”

Students such as these are also alarmed that Harvard Medical School received an “F” grade on the American Medical Students Association’s 2008 PharmaFree Scorecard, a rating of conflict of interest policies at academic medical centers in the United States.

The students’ efforts have apparently generated results, such that there is now “a requirement that all professors and lecturers disclose their industry ties in class — a blanket policy that has been adopted by no other leading medical school.” A committee has also been established to re-examine the institution’s conflict-of-interest policies, and includes student members.

Relatedly, the Times also reports that last fall a Pfizer employee turned up on Harvard’s campus to photograph students who were protesting pharmaceutical industry influence on campus.

The AMSA scorecard mentioned in the article is freely accessible online, allowing users to browse and compare institutions and view policy information on gifts and samples, disclosure, site access, curriculum, and other factors.


February 23, 2009

A Discussion of Menstrual Activism with Chris Bobel

Following up on our recent post on Chris Bobel’s article on menstrual activism, I discussed the topic further with the author. Bobel’s new book is due out in Spring 2010 from Rutgers University Press. Its working title is “New Blood: Third Wave Feminism and the Politics of Menstruation.”

Our Bodies, Our Blog: Can you tell me a bit about what is covered in the book, in addition to the menstrual activism history covered in your recent article?

Chris Bobel: The book is written for an undergrad/general public audience with lots of lively examples of the very cool activism I encountered — and pictures, too. In short, the book is at once a history and sociological study of menstrual activism using this little-known activism to track changes in feminist thinking and doing over time. There’s a lot of debate right now about the future of feminism: Is the movement dead? Is there something new going on? Is it really new or just recycled?

The newest iteration of feminism (in the West) is called third wave and I wanted to find a concrete way to tease out what third wave is and how it both reflects the past of feminism and takes off in new directions. We talk about feminism in the abstract a lot and we lose people. I wanted to show what third wave feminism looks like on the ground.
Read the rest of this entry »


February 18, 2009

Debating Direct-to-Consumer Pharmaceutical Advertising

This month’s issue of the journal Canadian Family Physician features a debate on direct-to-consumer advertising (DTCA) of prescription drugs, with arguments for and against allowing DTCA in Canada (where it is currently prohibited).

In putting forth her case for DTCA, Durhane Wong-Rieger says that such ads “contribute to public health by increasing appropriate consultation for undiagnosed or untreated health conditions.” This is a fairly common selling point from the drug companies themselves, who argue that prescription drug advertising is a form of education and a service for the public.

Dr. Barbara Mintzes, however, argues that “Any benefits could be better achieved through public health campaigns,” and expresses concern about increased prescribing of potentially dangerous drugs before the harmful effects are fully understood. Mintzes offers the following example, of a drug campaign targeted at women:

“The 2006 tegaserod ad for irritable bowel syndrome is emblematic of the hazards of prescription drug advertising. The eye-catching ad featured women baring their bellies to reveal slogans. Closing shots panned women of many different ages and races, suggesting widespread use. Relief of vague symptoms along with a comparison to fibre and laxatives implied use for mild problems. But key information on safety concerns, limited effectiveness, and the limited appropriate patient population was lacking. In 2007, the drug was withdrawn from the market because of cardiovascular risks. The first Food and Drug Administration safety warning, on risks of ischemic colitis, dated back to 2004. Tegaserod prescriptions rose by 56% in a US Medicaid population and 42% in English speaking Canada following exposure to US DTCA campaigns.”

Minztes also argues that advertisements may exaggerate benefits and target people with mild problems who are unlikely to benefit (perhaps such as in the YAZ example we discussed recently), and could lead to higher health care costs through “substitution of new, expensive drugs without treatment advantages.”

For related discussion, see this OBOS companion content. Time magazine also recently covered this topic, including whether a two-year moratorium on advertising new drugs may be achieved in the new administration, and Consumer Reports Health has critiqued the “stealth advertising” of Pfizer’s Chantix.