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Nov. 15, 2004 — Food and Drug Administration officials announced Monday that they are relaxing some regulations in an effort to make it easier for companies to use anticounterfeit microchips on prescription drug packages.
Agency officials say they believe that the microchips — basically tiny radio antennas similar to those used in automatic toll booth payment cards — can help reduce what they see as a growing problem of fake and adulterated drugs in the U.S. supply.
Officials maintain that counterfeiting is rare in the U.S. and that the prescription drug supply here is safe. But they also point to what they say are a growing number of incidents involving fakes or misdirected drugs.
Meanwhile, several manufacturers announced that they would soon place microchips on packages of popular or often abused drugs, such as Viagra and OxyContin.
The microchips, known as radio frequency identification tags, can store information about a package’s point of origin and its trip through the network of wholesalers and distributors that make up the U.S. drug supply chain. Repeated reading by electronic scanners can create a detailed record of where the drug has been on its trip from the pharmaceutical factory to the pharmacy.
A February 2004, FDA report recommended widespread but voluntary use of the chips by drug makers by the end of 2007. But companies were apparently slow to react for fear that implanting microchips on their bottles or packages could violate strict FDA rules governing drug labels.
The agency issued guidance to companies Monday informing them that regulators would not enforce label rules on companies that run experiments or full-scale use of the microchips before December 2007.
“In some technical fashion they may have been concerned,” says William K. Hubbard, the FDA’s associate commissioner for policy and planning. “We’re essentially saying don’t worry about that.”
Florida is set to begin implementing a new law in January requiring detailed paper records for all pharmaceutical shipments. Many safety experts like the idea of computerized microchips because they can potentially accomplish the same record keeping more cheaply and efficiently.
Officials say they have no plans to require the use of radiofrequency microchips or readers. The decision Monday also applies only to drugs intended for the domestic market and not those that come into the country via overseas Internet sales or by other means.
Increasingly popular overseas shipments of drugs are thought to be the main source of fake or adulterated drugs, says Michael Cohen, a pharmacist who is president of the Institute for Safe Medication Practices.
“This would be something for the pharmacists to assure that they got a U.S. product,” Cohen says. “I don’t see where it’s a direct help to consumers.”
Cohen notes that the proposal is a step in the right direction for keeping counterfeit drugs off the American market. “I am all for this as long as it doesn’t add tremendous cost to already costly medications,” he says.
Purdue Pharma, announced Monday that it would begin placing tracking chips on 100-tablet bottles of the narcotic pain killer OxyContin destined for Wal-Mart stores and drug distributor H.D. Smith. OxyContin, widely sought after for illicit street sales, is among the fastest rising drugs of abuse in the U.S., according to federal drug surveys.
“Our objective in implementing these security features is to deter counterfeiting, reduce diversion, and help ensure the authenticity, safety, and integrity of our products,” Aaron Graham, the company’s vice president and chief security officer, said in a statement.
Pfizer, Inc. announced that it would begin using microchips on U.S. shipments of its popular drug Viagra, the industry’s most frequently counterfeited drug. British drug maker GlaxoSmithKline also announced it would experiment with electronic tags on one of its range of anti-HIV drugs within the next year and a half.
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Sept. 4, 2000 — When Seattle pharmacist Jennifer Erickson returned to work
in late July one day after filing a headline-grabbing lawsuit against her
employer, the Bartell Drug Co., her female co-workers were ecstatic. “It
was all high fives and ‘You go, girl!’ ” Erickson says with a laugh. Her
customers thanked her. Strangers who recognized her from interviews in the
local and national media stopped her on the street.
So why is this 26-year old suing her own employer — and getting so much
attention and support from her co-workers and customers? Erickson is
challenging one of the longest-standing disparities in medicine. She thinks
it’s wrong that the health insurance plans offered by so many companies across
the country provide coverage for drugs like Viagra for men but don’t cover
birth control pills and other contraceptives. And she thinks changes are long
overdue.
To try to close this gender gap, Erickson volunteered to be the lead
plaintiff in a class action lawsuit filed last month by Planned Parenthood –
the first case ever seeking to force an employer to include contraceptives in
its health plan. While the lawsuit targets only Bartell, it could pave the way
for similar suits against every company in the United States that provides
similar prescription coverage to its employees but fails to cover
contraceptives.
“This problem affects millions of women all over the country,” says
Sylvia A. Law, a law professor at New York University. “Yet it’s the first
time the issue has ever been addressed in a court — and it’s high time.”
Law was the first to argue in a 1998 Washington Law Review article that
excluding contraceptives from prescription coverage illegally discriminates
against women under Title VII of the federal Civil Rights Act.
Three-quarters of American women of childbearing age rely on
employer-sponsored plans for their health coverage, according to the Alan
Guttmacher Institute, a research group that works to broaden access to family
planning services. Yet half of all large group-insurance plans do not cover any
form of prescription contraception, and only a third cover the Pill. While most
HMOs do cover oral contraception, only about 40% cover all five of the
FDA-approved prescription birth control methods available in this country.
Erickson’s lawsuit aims to assist working women like herself — those who
are neither rich enough to easily pay for contraceptives themselves nor poor
enough to qualify for help from the government. And while the young newlywed is
new to activism, the role of crusader for women’s rights seems to be coming
quite naturally. “I’m very outgoing and outspoken,” Erickson says.
“It’s easy for me to say, ‘This is wrong, fix it.’”
Bartell has yet to file a response to the suit, but in a press statement the
company defended its policy as “lawful and nondiscriminatory,” noting
that “no medical benefits program covers every possible cost.” Company
officials have not spoken with Erickson about the lawsuit. She says her working
environment has remained friendly.
Erickson, who grew up in Lafayette, Ind., moved to Seattle in 1999. She has
worked for Bartell for 18 months and was recently promoted to pharmacy manager.
She says she loves her job and considers Bartell — which operates a chain of
45 drugstores in Washington — a progressive workplace. But she hates telling
customers that their health plans don’t cover the contraceptives they need.
Even more, she hates watching them turn away angrily.
“One woman recently said to me, ‘I have to make rent this month, I have
five kids to feed, I can’t afford to pay for birth control pills,’ ”
Erickson says. “I want to say to her, ‘Don’t leave without these!’ I feel
so bad.”
But Erickson’s efforts aren’t simply aimed at helping others. The fact that
her own company’s insurance plan doesn’t cover contraceptives forces Erickson
– who says she’s not ready to have children — to pay $360 a year
out-of-pocket for birth control pills.
While she can afford this expense, she thinks it’s unfair that she has to.
And there were times in the past when she couldn’t. Like many women, she turned
to Planned Parenthood, where she was a regular client and a strong supporter.
So when representatives from the local chapter said they would help her file a
complaint against Bartell with the Equal Employment Opportunity Commission last
December, she didn’t hesitate.
The resulting lawsuit has made waves for its landmark legal strategy. It
charges that a company whose insurance plan covers most prescription drugs but
excludes contraceptives violates federal discrimination laws because only women
use prescription contraceptives.
Family planning advocates argue that excluding birth control from
prescription coverage is not only discriminatory, it’s also economically
short-sighted. Contraception is far cheaper than the cost of either a pregnancy
or an abortion. In 1996, the Health Insurance Association of America estimated
it would cost about $16 per person to provide birth control coverage for
members of group plans. Compare that to the average cost of an abortion:
$316.
“Services for men get covered much quicker than services for women,”
says Judith DeSarno, president and CEO of the National Family Planning and
Reproductive Health Association. It was only 25 years ago that insurance
companies agreed to cover the cost of prenatal care. “There’s a very clear
pattern here,” she says. “It’s the nickel-and-diming of women’s
health.”
A recent nationwide survey found that two-thirds of Americans want insurers
to cover contraception. Currently 13 states have passed laws requiring health
plans to pay for contraceptives if they cover prescription drugs to include
contraceptives, and 21 states are considering such legislation. Federal
legislation has been stalled in Congress since 1997.
The big problem with the state laws, says Roberta Riley, the Planned
Parenthood attorney who filed the lawsuit, is that they generally don’t apply
to self-insured companies like Bartell, which put together their own medical
coverage for their workers. Because self-insured companies account for half of
all employer-sponsored health insurance, that leaves a large gap. And that,
Riley says, was one reason Planned Parenthood decided it was time to go to
court.
But before any lawsuit could be filed, the advocates needed a plaintiff who
was willing to risk taking on her employer. They found one in Jennifer
Erickson.
“Jennifer is a Rosa Parks; she has a sense of idealism and
altruism,” says Riley. “She’s a very intelligent young woman, a
thinking person. No doubt her experiences turning down women raised her
awareness and motivated her to stand up and do something about it.”
What also made her an ideal plaintiff is that “she’s not disgruntled,
she has no ax to grind with her employer about any other issue,” says
Riley. “She wants to pursue her career at Bartell Drugs, but she also wants
this company to cover contraception and wants to change the law so all
companies do so as well.”
“It’s hard to find a woman who will stand up to her boss for $30 a month
– the cost of birth control pills — and risk her job for a principle,”
says Law.
Jennifer Erickson simply shrugs off the deluge of praise. “Stepping
forward is not as hard as I thought it would be,” she says. “When you
really believe in something, it’s easy to do.”
Loren Stein, a journalist based
in Palo Alto, Calif., specializes in health and legal issues. Her work has
appeared in California Lawyer,Hippocrates,L.A. Weekly,
and The Christian Science Monitor, among other publications.
Read More »
(CBS) As Uprima, an alternative to Viagra that helps men with erectile disfunction, inches closer towards Food and Drug Administration approval, there is a growing chorus of opposition that says the drug is too dangerous.
On its Web page, the maker of Uprima says the drug will offer men “a promising new option.”
But it may inspire more sickness than romance, according to some medical experts.
CBS News Correspondent Sharyl Attkisson reports a full 20 percent of the men in one study were nauseated by Uprima. That’s not surprising, perhaps, since it’s made with the same medicine doctors once used to induce vomiting in children who swallowed poison.
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(CBS/AP) A prominent consumer advocacy group is calling for the government to add the most serious of warnings to the labels of Viagra and other impotence drugs, noting that some users have gone blind.
Public Citizen petitioned the Food and Drug Administration Thursday to add black-box warnings to the labels of Viagra, Cialis and Levitra, as well as the hypertension drug Revatio, which is similar to Viagra.
CBS News correspondent Sharyl Attkisson reports that two reasons fueled Public Citizen’s FDA request. First, studies show that people don’t pay much attention to the type of warning that was added in July. They do pay attention to a Black Box warning, which is what Public Citizen is pushing for.
Read More »
Oct. 29, 2004 — Move over, Viagra. Soon women may have a treatment for sexual dysfunction that is all their own.
Though Viagra and a few other drugs are approved for erectile dysfunction, there are no approved medications to specifically treat lack of arousal in women, called female sexual arousal disorder. But a new study shows that a topical gel called Alista may be just what the doctor ordered.
The preliminary study included 51 premenopausal women with female sexual arousal disorder. The women were treated with both Alista and placebo. Each treatment period lasted two months, and the treatments were administered in random order. Women kept diaries recording their sexual experiences including arousal and orgasm.
Those who used Alista had 48% more successful and satisfactory sexual encounters than they did when they used a placebo gel.
The study was presented at the annual meeting of the International Society for the Study of Women’s Sexual Health in Atlanta.
“Female sexual arousal disorder is a common yet largely undertreated condition,” says researcher Stephanie Kuffel, PhD, an instructor in the department of psychiatry and behavioral sciences at University of Washington School of Medicine in Seattle. Though further research is needed, “these results with Alista appear encouraging for the treatment of premenopausal women with female sexual arousal disorder,” she says.
About 20% of American women have female sexual arousal disorder, according to the study, making it one of the most common sexual dysfunction disorders in women.
Alista is believed to work by increasing blood flow to the genitals, which occurs when a women is sexually aroused.
Women in the study reported some minor burning when applying both topical treatments. Read More »
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The chaste older person. The dirty old geezer. The horny old
broad. Stereotypes all.
“The stereotype is grim,” says Walter M. Bortz II, MD,
author of We Love Too Short and Die Too Long. “The reality is that
older people are a lot sexier than younger people think. The common notion is
that when you are old you don’t — and maybe shouldn’t — have sex. Our
studies have shown that older people are sexier in attitude and performance
than they have been credited for.”
And that performance has some interesting documentation.
“You must realize that in the U.S. the biggest use of
prostitutes is on the day Social Security checks come out,” says John
Morley, MD, director of the division of geriatric medicine at St. Louis
University.
So who’s responsible for the myth that sex becomes unimportant
as one ages?
“People who are older get very little support from the
younger generation about sex,” says Joani Blank, MPH, author of Still
Doing It: Women and Men Over 60 Write About Their Sexuality. “Young
people identify everyone in the next generation with their parents, and of
course they don’t have sex.”
The danger is that people come to accept these stereotypes as
true. They then risk losing one of the most important parts of their lives –
and their health.
“Sex is good for you,” says the 63-year-old Blank, a
sex educator for more than 25 years. “You should continue to have good sex
for the same reason you should continue to get good exercise: It’s taking care
of yourself. Wake up your body again if it has been shut down. Do it whether
you feel like it or not.”
Bortz, a specialist in internal medicine at the Palo Alto
Medical Clinic in California and a clinical associate professor of medicine at
Stanford University School of Medicine, goes even further:
“We should as a moral responsibility continue to be
sexually active,” he says. “Is it OK for a 75-year-old widow to say,
‘Sex is not on my agenda any more?’ I would challenge that and say, ‘Maybe you
should make an overt effort to make the rest of your life as full as you can.’
And that includes being daring, flaunting the stereotype.
“Not infrequently an older woman will tell me, ‘I just
don’t give a damn about sex any more,’” Bortz continues. “I say, ‘You
should, because it is important for your life quality.’ She will say,
“Well, is it OK to stop making love if you feel like it?” And I say,
‘No.’ We agree it is not OK not to exercise. If we agree sex is good for you,
you shouldn’t stop — regardless of apathy.” Read More »
(AP) The first loud crackle tastes and feels like popcorn, but by the time the juices spray wildly in your mouth and the filament-like legs slide down your throat, there’s no mistaking this toasted ant queen.
The people of sun-soaked northern Colombia have been eating ants for centuries. They believe the accurately named “hormiga culona” or big-butt queen ant is everything from a natural form of Viagra to a protein-rich defense against cancer.
Now the invertebrates are going global: A businessman in Santander province exported more than 880 pounds of the inch-long queen ants last year, many of them to be hand-dipped in Belgian chocolate and sold in fancy packaging at $8 for a half dozen at upscale London department stores like Harrods and Fortnum & Mason.
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WASHINGTON (AFP) - Injections of botulinum toxin A, or Botox, into the prostate gland eased the symptoms of enlarged prostate in men for up to a year, according to the results of a small study published Wednesday.
Researchers at the Chang Gung University Medical College, Taiwan, and the University of Pittsburgh School of Medicine, Pennsylvania, based their study on 37 men with benign prostatic hyperplasia (BHP), or enlarged prostate.
All patients received a single injection of Botox into their prostate, the researchers said in their paper published in a summary ahead of this week&39;s annual conference, in Annaheim, California.
A year into the treatment 27 patients - 73 percent of the group - experienced a 30 percent improvement in urinary tract symptoms and quality of life, said Dr Yao-Chi Chuang, chief investigator for the Taiwanese university.
Chuang said Botox - a popular, surgery-free cosmetic treatment for wrinkles - reduces the size of the prostate gland through a cellular process called apoptosis, in which the prostate cells die in a programmed manner.
The treatment posed no significant side effects, such as stress urinary incontinence or erectile dysfunction, said Pittsburgh's Michael Chancellor, senior author of the study.
The reduction in size of the prostate can improve urine flow and decrease residual urine left in the bladder, he said.
“Our results are encouraging because they indicate that Botox could represent a simple, safe and effective treatment for enlarged prostate that has long-term benefits,” Chancellor added.
BHP is one of the most common diseases affecting men as they age. More than half of all men over the age of 60 and by age 80 develop enlarged prostates, the researchers said.
Forty to 50 percent will develop symptoms of BHP, including more frequent urination, urinary tract infections, the inability to completely empty the bladder and, in severe cases, eventual damage to the bladder and kidneys, they added.
Botox is a powerful neurotoxin introduced nearly two decades ago. It is used to cure some facial problems but is best known for its cosmetic qualities in paralysing facial muscles and thus giving foreheads a wrinkle-free appearance. Read More »
, and more another.
June 8, 2001 — Walking down a street in Honolulu, Mark Moyad, MPH, an expert in nutritional supplements for sexual disorders, was stopped by a merchant who asked him if he’d like to buy some “Viagra.”
Intrigued, Moyad followed the man into the store. As it turns out, the merchant was not selling Viagra, but an herbal supplement called “Vigra” with an asking price of $75. Upon inspection, the product was found to contain a host of compounds touted — but never proven — to improve sexual functioning: ginseng, zinc, L-arginine, and saw palmetto, among others.
Moyad and others at a meeting of the Sexual Medicine Society of North America say this episode on the streets of Honolulu illustrates the enormous and lucrative market for herbal supplements to treat erectile dysfunction and other sexual disorders. The Society met this week in Anaheim, Calif., in conjunction with the American Urological Association.
“In my opinion, this is the largest profit area of the [herbal supplements] industry,” Moyad says. “They may not be the hottest selling supplements out there, but the average cost runs $50-100 per bottle.”
Moyad, who is completing his medical degree at the University of Michigan School of Medicine, is affiliated with the complementary/preventive medicine in urology and oncology there.
And most of these products have a long way to go before they are proven to live up to their claims. “Most erectile dysfunction supplements have a very slow response, if any,” Moyad says. “This area begs for more research and objectivity.”
The compounds found in Moyad’s bottle of Vigra are among the usual suspects in compounds sold over the counter to promote sexual health. Another popular one is the steroid dehydroepiandrosterone, or DHEA, Moyad says.
Yet scientific studies to test the claims of these compounds are invariably weak. In almost every case, the claims are based on studies that did not compare the supplement against another drug or a placebo, were not long enough to determine long-term effects, or showed significant side effects, Moyad says.
Despite this, supplements for sexual disorders, including erectile dysfunction, abound, and the Internet is a popular, confidential venue to advertise and sell them.
“The web is probably a good place for some men to seek information about erectile dysfunction,” said James H. Barada, MD. “Erectile dysfunction is an intensely personal issue, and many men feel more comfortable pursuing information in utmost confidentiality. Unfortunately, the Internet can be a very dark place because it provides confidentiality without control of content.”
Barada says that more than 50,000 web sites specialize in herbal medications, and “a significant number of these sites also provide products for sexual dysfunction.” Barada is with the Center for Male Sexual Health in Albany, N.Y.
In an informal study at his clinic, Barada asked six men with sexual disorders, including erectile dysfunction, to spend two hours on the web searching for products to treat the disorders. The men were able to find 16-39 different nonprescription medications, claiming to treat erectile dysfunction or premature ejaculation or to increase libido and general sexual stamina, Barada says.
Independently, Barada says he was able to find nearly 175 different sites and 75 products using the following search words: “better than Viagra,” “safer than Viagra,” or “faster than Viagra.”
“When we looked at some of the specific products, they were multiple compounds of undetermined efficacy for treatment of erectile dysfunction,” Barada says.
And many sites claim their products are “FDA approved,” but a reading of the fine print reveals the approval has been for purity only, not for treatment of a disorder, Barada says.
David Schardt, PhD, of the Center for Science in the Public Interest, says the marketing of supplements was boosted by the passage of the Dietary Supplement Health and Education Act of 1994. That legislation gives manufacturers the freedom to market products with little proof that they live up to their claims, he says.
“You don’t have to have any evidence that the substance you are marketing has any efficacy or even any biological effect,” Schardt says. “It could be totally inert, or you could have evidence that it doesn’t work and still sell it as a dietary supplement.”
Schardt explains that the 1994 law provides two tiers for regulating claims made on supplement packages. One tier regulates claims made about a product’s ability to prevent, treat, or cure disease. The criteria for making those claims are extraordinarily strict, and no herbal product is likely to pass the grade any time soon, Schardt says,
“None of the dietary supplements being sold for sexual dysfunction have anywhere near the evidence required by the FDA for the approval of a health claim,” Schardt says. “It is unlikely you will see any dietary supplement being able to make a claim that it has any effect on prevention, treatment, or cure of any sexual dysfunction.”
But the second tier of the law’s regulation addresses “structure-function” claims. These are claims that a product affects the structure or function of the body — and these criteria, much less stringent, are where herbal product manufacturers have considerable leeway. For instance, ginseng can be touted as “improving sexual well-being” under the regulation, Schardt says.
Moyad will be chairing a committee of the Society for Sexual Medicine to look at all the data on herbal supplements and to make recommendations to physicians for their patients. “It is time for researchers and physicians to get involved and look at the data objectively,” Moyad says. Read More »
To: MEDICAL EDITORS
Contact: Lori Yeghiayan, Associate Director of Communications, +1-323-860-5227, mobile: +1-323-377-4312, lori.yeghiayan@aidshealth.org, or Ged Kenslea, Communications Director, +1-323-860-5225, mobile: +1-323-791-5526, gedk@aidshealth.org
LOS ANGELES, Aug. 15 /PRNewswire-USNewswire/ — AIDS Healthcare Foundation
(AHF), the US’ largest HIV/AIDS healthcare provider, once again denounced
direct-to-consumer (DTC) advertising by the pharmaceutical industry after an
article published in the New England Journal of Medicine revealed not only an
astronomical 330% increase in spending on drug ads over the past ten years
($11.4B up to $29.9B), but also the fact that — despite the industry’s own
recommendation to delay ads for new drugs — most drug company ad campaigns
for the most heavily promoted drugs begin within a year after FDA approval.
“A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” (NEJM,
August 16, 2007, Julia M. Donohue, Ph.D., Marisa Cevasco, B.A., and Meredith
B. Rosenthal, Ph.D.) also concludes that despite the more than tripling of DTC
ad spending, regulation of the industry by the U.S. Food and Drug
Administration (FDA) has grown weaker, instead of stronger. This, despite the
fact that the drug industry and the FDA have come under fire over major
missteps such as the Vioxx debacle and others in which heavily advertised
drugs have turned out to have serious, unknown health risks. Read More »
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