The food and drug administration does not consider
At this time, FDA is not aware of any child being harmed by taking one of the recalled products, said the staff report, dated May 24. FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines.
Since the April 30 recall, several hundred more cases of complications, including seven deaths, have been reported to the FDA, the report said.
When the recall was announced, FDA officials said the chance of getting sick from the products was remote.
On Thursday, the committee will hold a hearing with officials from both the FDA and JampJ over manufacturing lapses that led to contamination and a nationwide recall of liquid childrens versions of Tylenol pain reliever and other medications.
Infant and childrens versions of pain medicine Motrin and allergy drugs Benadryl and Zyrtec were also recalled. In total, about 70 percent of the market for over-the-counter pediatric liquid medicines were involved, the staff said.
It is the largest recall of childrens medicine in the history of the FDA, they wrote in the memo to committee lawmakers.
In a separate document from committee Republicans, staff questioned the corporate culture at JampJ, a diversified consumer healthcare company, and increased autonomy at its subsidiaries.
Minority staff believes that there have been ongoing, systemic failures at McNeil facilities which have put childrens health at risk, the Republican staff wrote.
JampJ has shut down manufacturing of the liquid nonprescription medicines made at its Fort Washington, Pennsylvania, plant until it can win clearance from the FDA to resume production.
Agency inspectors found multiple problems, including bacterial contamination of ingredients and filthy equipment, among other quality lapses. They also found that the products made by JampJs McNeil Consumer Healthcare unit had the potential to be superpotent, the report said.
The head of the U.S. Senate health committee is also investigating the recall, but so far no hearing is planned, a spokeswoman for Committee Chairman Senator Tom Harkin has said.
Reporting by Susan Heavey editing by John Wallace source
The fda also needs more help consumers navigate maze food
A series of food safety scares has shaken consumer confidence in the food supply, the GAO said. Just last week California-based Caldwell Fresh Foods recalled alfalfa sprouts after salmonella sickened 20 people.
We found that FDA was hampered in its ability to carry out some food safety responsibilitiesoversight of food labels, fresh produce, and dietary supplements — because it lacked certain scientific information, Lisa Shames, director of Natural Resources and Environment for GAO, wrote in a letter accompanying the report.
The GAO, the investigative arm of Congress, said the FDA had tried to meet some of its recommendations but needed to do more.
These needs are becoming more important as the U.S. food supply changes, the report said.
First, imported food makes up a substantial and growing portion of the U.S. food supply, with 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from across our borders, it said.
The FDA can inspect just 1 percent of this food.
Second, we are increasingly eating foods that are consumed raw and that have often been associated with foodborne illness outbreaks, including leafy greens such as spinach.
The FDA regulates 80 percent of the food supply, except for meat and processed egg products, which the U.S. Department of Agriculture regulates.
MORE AUTHORITY
The FDA has met some recommendations, GAO said. For example, FDA reported in May 2008 that it created the Office of Chief Scientist, it said.
And it is working on a computer system that will predict which food imports are most likely to be contaminated. But GAO said Customs and Border Patrol was not alerting FDA when imports of food arrive.
The FDA should ask for more authority to regulate nutritional supplements, as well, the GAO said. The Dietary Supplement and Health Education Act, or DSHEA, covers most supplements and does not allow the FDA much intervention.
An Institute of Medicine report this month said the FDA needs new standards to measure the benefits of food, drugs and supplements. Committee members noted that consumers often wrongly assume the FDA regulates food and supplements in the same way it does drugs.
The GAO also said the FDA does not have the enforcement tools it needs.
FDA does not have empirical research on consumer perceptions to support enforcement against misleading food labels, the report reads.
For example, stakeholders from health, medical, and consumer organizations reported that whole grain labels can be misleading because the product may contain little whole grain, transfat free products may still be high in saturated fat, and natural products may be highly processed.
Separately on Monday, the FDA and National Institutes of Health launched a new website to help report pre- and post-market safety data on food and drugs at www.safetyreporting.hhs.gov.
We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public, FDA Commissioner Dr. Margaret Hamburg said in a statement.
Editing by Xavier Briand source
Study on cell phone link to cancer inconclusive
But with its meteoric rise came concerns about safety and whether it can cause brain tumors.
The frustratingly unresolved debate erupted again this week with the release of a 24 million U.N. study covering 13 nations that suggests frequent cell phone use may increase – albeit marginally – the chances of developing a rare but deadly form of brain cancer.
What is more, since cancers takes years, even decades to develop – longer than cell phones have been in widespread use – even the studys authors say there is no way yet to tell how big the risk is, if there is one.
Experts were nearly unanimous in saying the results of the study are inconclusive. But the fact that it turned up even some evidence of an increased cancer risk may cause some disquiet among people who have become accustomed to seeing the device as extensions of themselves.
From farmers in Africa who rely on cell phones to check crop reports to hedge fund traders obsessively checking BlackBerrys at trendy restaurants to suburban American kids spending hours calling their friends – people around the world have come to rely on mobile phones as never before.
Cell phones send out radio waves in a form thats similar to the one used in microwave ovens, but at very low levels. There is no accepted theory to explain how or if these weak radio waves can affect the body, beyond heating it to a very small degree.
All the same, U.S. and European regulators already limit the energy cell phones can project into the body and todays digital phones radiate less power than the analog phones that dominated in the early 90s. Common advice for those concerned about the radiation is to use a headset, since these emit even less power.
The survey of almost 13,000 participants – the biggest ever of its kind – found up to 40 percent higher incidence of glioma, a cancerous brain tumor, among the top 10 percent of people who used their mobile phone most.
No increased risk was observed for meningioma, a more common and frequently benign tumor.
Researchers ignored the time spent using handsfree devices, keeping the phone in a pocket or beside the bed at night because even a distance of 4 inches 10 centimeters reduces the amount of radiation to the brain to almost zero.
But because cell phone use has boomed since the study started, the researchers definition of heavy use as 30 minutes of calls or more a day is now common.
The users in the study were light users compared to today, said Prof. Elisabeth Cardis of the World Health Organizations International Agency for Research on Cancer, or IARC, which organized the study.
The highest risk found was for tumors on the same side of the head as users held their phone, particularly for tumors in the temporal lobe closest to the ear, Cardis told reporters in Geneva on Monday. This is the region of the head which receives the most exposure.
The 21 researchers involved in the study disagreed on the conclusion, in part because participants were asked to remember how much and on which ear they used their mobiles over the past decade – leading to what scientists call recall error.
For example, the study appeared to show that casual users had a lower risk of getting cancer than people who didnt use cell phones at all, a result the researchers described as implausible and blamed on these methodological problems.
The message The researchers refused to rule out that cell phone use causes brain cancer but wouldnt say it does either.
We cant establish without any doubt that there is no link, said Prof. Anthony Swerdlow of Britains Institute of Cancer Research, another of the studys authors. But he added that it seems unlikely that there are large risks that happen soon.
Handset manufacturers and network providers, who paid for about a quarter of the study, have seized on such conclusions as evidence their products were safe.
The overall conclusion of no increased risk is in accordance with the large body of existing research and many expert reviews that consistently conclude that there is no established health risk from radio signals that comply with international safety recommendations, said Jack Rowley, director of research for the telecoms companies association GSMA.
The Mobile Manufacturers Forum likewise welcomed the study and insisted their industry takes all questions regarding the safety of mobile phones seriously and has a strong commitment to supporting ongoing scientific research.
But Christopher Wild, director of IARC, cautioned that the results related to a time when cell phones were much less common than they are now. This investigation is a victim of the changing patterns of mobile phone use over the years, he said.
Critics contend the study also ignored several important factors such as the slow growth rate of most brain tumors, which can take up to 25 years to develop.
It is simply too early to detect anything, said Graham Philips of the Britain-based anti-radiation campaign group Power Watch.
Prof. Bernard Stewart, a scientific adviser to Cancer Council Australia, said the study tells us little about any risk associated with mobile phone use over decades.
In particular, he said, insufficient time has passed since mobile phones were introduced to determine whether there is a risk in children.
Cardis acknowledged that with X-rays and atomic explosions the spike in tumors could take up to 30 years to show up, but said it was unclear whether cell phones have the same effect on the body as those forms of radiation.
Most of the estimated 4.6 billion cell phone subscribers around the world today appear prepared to take the risk even without firm assurances that its safe.
In Copenhagen, student Michaela Vinter, 27, said she wasnt worried.
I have heard about this for all the years that I have had a cell phone and I have never heard anything firm about the risk, she said.
The scientists involved in the study plan to publish a comprehensive overview of available research within two years. Separately, researchers are also examining whether cell phone use increases the risk of tumors in the ears acoustic nerve and the parotid gland, where saliva is produced. Another study will look into the effects of cell phone use on children, who are believed to be more susceptible to the effects of radiation.
Until stronger conclusions can be drawn one way or another it may be reasonable to reduce ones exposure, said Cardis. One way to do this would be to make calls using a handsfree device.
It cant hurt, she said.
The IARC study, which was published in the International Journal of Epidemiology, was compiled by researchers in Australia, Britain, Canada, Denmark, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway and Sweden. Scientists interviewed 12,848 participants, of which 5,150 had either meningioma or glioma tumors.
There is no similar, large-scale study going on in the U.S., though here have been smaller studies which failed to show links between cell phone use and cancer. The federal government mandates that states collect data on benign brain tumors, at least partly in response to concerns about radiation.
Online
International Journal of Epidemiology http//ije.oxfordjournals.org/
International Agency for Research on Cancer http//www.iarc.fr/ source
Easing bone marrow transplants to widen their use
The old way High doses of radiation and chemotherapy wipe out a patients own bone marrow before someone elses is infused to replace it, hopefully before infection strikes.
The new way Rather than destroying the patients bone marrow, just tamp it down enough to make space for the donated marrow to squeeze in alongside and a sort of twin immune system takes root. Its what doctors taking a page from mythology call mixed-cell chimerism – patient and donor blood and immune cells living together to improve health.
To find the best methods for these less intense transplants, different mixes of low-dose radiation and immune-suppressing drugs are under study at hospitals around the country.
But the ultimate quest is to allow transplants even when donors arent a good genetic match, says Dr. Suzanne Ildstad of the University of Louisville – whose technique involves an experimental tweaking of donated cells to help them grow better.
It makes it possible for anyone who has a mom or dad willing to donate marrow to them to have a transplant, says Ildstad, who has families with sickle cell and other childhood genetic illnesses lining up to try.
Separately, several hospitals are testing how to combine kidney transplants with bone marrow transplants from the same donor, in hopes that a hybrid immune system lessens the need for lifelong anti-rejection drugs.
People are watching with eager expectation, says Dr. Lakshmanan Krishnamurti of Childrens Hospital of Pittsburgh, who is helping to plan a multi-hospital study of some of the new methods for hard-to-treat adults with sickle cell disease.
Doctors have long known that a traditional bone marrow transplant can cure young children of sickle cell – if they have a well-matched donor. New marrow produces healthy red blood cells to replace the sickle-shaped ones that cant squeeze through small blood vessels, the cause of the diseases pain, infections and life-threatening organ damage.
But only about 17 percent of children have a suitable donor, usually a healthy sibling. Attempts to transplant adults have failed, their bodies too ravaged from years of the disease. Another hurdle Certain immune cells in donated marrow sometimes become too aggressive and attack the recipient, called graft-versus-host disease or GVHD.
Enter the new research.
First came a tantalizing success in severely ill adults. Nine of 10 patients who underwent a less intense transplant – using low-dose radiation and two drugs to inhibit problem immune reactions – had their sickle cell apparently eliminated, Dr. John Tisdale and colleagues at the National Institutes of Health reported in December. They developed a hybrid immunity that produces normal red blood cells with no GVHD.
But those people had perfectly matched donor cells provided by healthy siblings. Few patients do.
Back in Louisville, Ildstad gives donated marrow a boost to try to overcome that problem while avoiding GVHD, a risk that worsens with mismatched donors. She removes troublesome immune cells from the donated infusion, leaving concentrated amounts of the blood-producing stem cells patients need plus facilitating cells that she discovered seem to help them take root.
In an NIH-funded experiment at Louisville and Duke University, the method so far worked in two children with sickle cell who had well-matched donors and one of four with a half-match.
Dr. Joseph Leventhal of Northwestern University gave an Ildstad-treated stem cell infusion to a handful of kidney transplant recipients who developed hybrid immune systems that seem to be holding nearly a year later. The first three treated are using one anti-rejection drug instead of the usual cocktail, and one soon will attempt full weaning.
Were doing this in patients where it could have potentially the biggest impact, those with unrelated donors, says Leventhal, who anticipates giving one patient a month the dual transplant as the study continues at Northwestern Memorial Hospital.
The attraction to families You dont die from the new way, is how Bob Evanosky of Aurora, Ill., puts it.
His three sons have a devastating metabolic disease called metachromatic leukodystrophy, or MLD. Last summer, son John got an experimental outpatient transplant at Duke – a far cry from the months his brother Jack had to spend in intensive care after a well-matched transplant the old-fashioned way.
Dad was Johns donor even though hes only a half-match – and the new cells are making the enzyme his body had lacked, too late to reverse the brain damage that has paralyzed the 8-year-old but perhaps able to ease some complications, says Evanosky, who plans to donate to his Johns twin Christopher this fall. source
Us cancer costs double in nearly 20 years
The study confounds conventional wisdom in several respects. The soaring price of new cancer treatments has received widespread attention, but the researchers conclude that rising costs were mainly driven by the growing number of cancer patients.
The study also finds cancer accounts for only 5 percent of total U.S. medical costs, and that has not changed in the last few decades.
I will say Im a bit surprised, said Dr. Len Lichtenfeld of the American Cancer Society, who said he would have expected the proportion of cancer costs to rise.
The researchers also found that private insurers now cover a greater share of cancer treatment costs – about 50 percent – while patients out-of-pocket costs have fallen over the past two decades.
Though taken aback by some of the findings, Lichtenfeld and other experts did not dispute the study, which compared medical cost data from the late 1980s to that of the early 2000s. But they said the picture surely has changed in the last several years.
The study is being called the first to combine national cancer costs for all types of payers and see how theyve changed over time. The figures are reported in 2007 dollars.
It found that cancer treatment costs rose from nearly 25 billion in 1987 to more than 48 billion by the end of 2005.
The rise in costs is mainly due to an increase over 20 years in how many cancer patients there are, said the studys lead author, Florence Tangka of the U.S. Centers for Disease Control and Prevention.
The researchers used data from national telephone surveys done in 1987 and from 2001 through 2005, which gathered information on medical conditions as well as who paid the bills. More than 164,000 people were surveyed.
The study did not offer precise estimates of how the number of people treated for cancer changed from the late 1980s to the early 2000s. But it showed dramatic increases in the number of cancer cases covered by the governments Medicare and Medicaid programs. Medicare, which covers the elderly and disabled, has consistently covered about a third of the nations cancer costs. Medicaid accounts for only 3 percent.
The U.S. population is aging, and older people tend to get cancer at higher rates, Tangka noted.
Better and more advanced treatments mean more people with cancer are remaining alive, so the spending increases represent money well spent, said Kenneth Thorpe, a health policy researcher at Emory University who has focused on the cost of health care.
It seems like were buying increases in survival, Thorpe said.
The study is being published in Cancer, a medical journal of the American Cancer Society.
The researchers also found
-The percentage of cancer costs from inpatient hospital care fell from 64 percent to about 27 percent. A shift to less expensive outpatient care, along with cost containment efforts by large health insurers, helped keep down increases in the costs per patient, the authors said.
-The proportion of cancer costs paid by private insurance rose from 42 to 50 percent.
-The proportion of costs paid out of pocket by patients – including copayments and deductibles – dropped from 17 percent to 8 percent.
Those last two findings surprised some experts.
Recent government reports have found that the percentage of Americans with private health insurance has been shrinking and recently hit its lowest mark in 50 years. Yet the study found that the proportion of cancer treatment costs paid by private insurance rose.
And companies have been tightening or cutting employee benefits, causing out-of-pocket costs to go up for many patients. Yet the study found that the proportion of bills paid by patients declined.
That last finding in particular was striking, said Lichtenfeld, the cancer societys deputy chief medical officer.
He alluded to widely reported increases in personal bankruptcies prompted by medical bills. Theres no question that the out-of-pocket costs for some patients have risen dramatically, Lichtenfeld said.
The rising price of certain treatments also should be acknowledged, he said.
The challenge of rising prices was recognized by American Society of Clinical Oncology ASCO, which last year released its first guidelines counseling cancer doctors on how to talk to patients about deciding between less expensive chemotherapy drugs made more sense than newer, more expensive products.
The study did not add in the cost of diagnostic tests and scans, which are cost drivers. And the data does not include the last five years, which saw some extremely pricey cancer drugs come on the market.
The picture may have changed since the studys data was collected and the U.S. economy deteriorated, said Dr. Neal Meropol, a Case Western Reserve University cancer expert who worked on the ASCO guidelines.
Newer treatments along with wider testing are driving up the overall cost of cancer care, Meropol said. source
Fda inspectors found lax testing for contamination at j&js tylenol production site
Agency officials said Tuesday none of the companys finished products tested positive for the contaminants, though such testing is not definitive.
We think the risk to consumers at this point is remote, said Deborah Autor, director of FDAs drug compliance office, on a call with reporters.
The FDA report, which was posted online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort Washington, Pa., where the formulas were made. The recalled products include children and infant formulations of Tylenol, Motrin, Zyrtec and Benadryl.
FDA inspectors visited the plant in mid-April and wrapped up their inspection Friday. JJ issued its voluntary recall later that night.
Among other problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and failed to follow up on customer complaints.
JJ did not investigate more than 46 complaints received in the last year about black or dark specks in Tylenol products, according to the FDAs report.
Additionally, inspectors found some pieces of equipment covered with thick layers of dust, while others were held together with duct tape.
In a statement Tuesday, JJ called the problems cited by the FDA unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. The health conglomerate, which is based in New Brunswick, N.J., said production at the plant wont resume until the problems have been fixed.
The FDA reiterated that serious medical problems with the products are unlikely, but advised consumers to stop using the medicine as a precaution. Parents are instructed to use generic alternatives instead.
JJs McNeil Consumer Healthcare unit has said some of the recalled medicines may have a higher concentration of the active ingredient than listed on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet testing requirements.
FDA leadership told reporters Tuesday that they first met with JJ in February to discuss manufacturing problems identified in a warning letter about another JJ plant. The agency decided to step up inspections of the companys facilities based on those problems.
That warning letter brought us to the point where we thought it was necessary to sit down with management and discuss our concerns, Autor said.
FDA officials said they are considering taking additional action against JJ, ranging from issuing more warning letters to pursuing criminal action. source
Us stomach cancers rates take puzzling rise in young, white adults decline in others
Chances for developing stomach cancer are still very low in young adults but the incidence among 25 to 39 year old whites nonetheless climbed by almost 70 percent in the past three decades, a study found.
National Cancer Institute researchers and colleagues examined new cases from 1977 to 2006 of cancer in the lower stomach, which can be caused by chronic infection with a common bacteria called H. pylori. It also causes stomach ulcers.
Overall, there were 39,003 cases detected in a surveillance program that covers about one-fourth of the U.S. population.
These included only 734 white young adults, but their incidence rate climbed from .54 per 200,000 to about 1 per 200,000.
Among white adults aged 25 to age 84, the rate declined from almost 12 per 200,000 to 8 per 200,000 among black adults it declined from about 27 per 200,000 to 19 per 200,000.
Rates also declined for other races, which werent specified.
Dr. Jaffer Ajani, a digestive cancer specialist at the University of Texas M.D. Anderson Cancer Center in Houston, said the increase in young white adults is surprising but not alarming. Ajani, who was not involved in the research, said it could be a statistical blip but that it needs to be investigated.
The study appears in Wednesdays Journal of the American Medical Association. It focused on lower stomach cancer, not cancer of the upper stomach, which has been linked with gastric reflux. Together, these cancers are the fourth most common type of cancer worldwide.
In U.S. men, stomach cancer is among the top 10 most common cancers in blacks, Asian-Americans, Hispanics and American Indians. Its also among the most common cancers in Asian-American women.
Lower stomach cancer has been linked with diets high in salt and salt-preserved foods, and low in fresh fruits and vegetables its incidence historically has been higher in Asia and other countries where this type of food preservation is more common.
But stomach cancer rates have been declining in many countries because of improved food preservation and better hygiene, which decreases risks for H. pylori infection, so the overall U.S. decline was expected, said Dr. Charles Rabkin of the National Cancer Institute, the studys lead author.
However, the researchers noted that salt intake has increased among Americans of all ages, and said they will be investigating whether changes in eating habits explain the rise in young adults.
H. pylori prevalence might have increased in young adults, or there may be some other unknown bacteria that could play a role, although those theories remain unproven, Rabkin said.
On the Net
JAMA http//jama.ama-assn.org source
Healthbeat: radical treatment for asthma melts off tissue to alter spasm-prone airways
Bronchial thermoplasty isnt for everyone, just a subset who wheeze despite todays best medications. Its neither a cure nor without risk.
But the Alair system, rolling out this month, offers the first method of physically altering spasm-prone airways.
It does seem to improve your ability to live with your asthma, says Dr. Michael Silver of Chicagos Rush University Medical Center, who isnt involved with Alairs manufacturer but has monitored its development. I certainly have moved from skeptical to, it has a niche.
Its a very novel, very innovative treatment – but only for the right patient, agrees Dr. William Calhoun of the University of Texas Medical Branch at Galveston, a spokesman for the American Academy of Allergy, Asthma Immunology.
About 22 million Americans have asthma, and medications offer good control for many patients. Still, asthma kills about 4,000 people a year and hospitalizes at least half a million. Up to 15 percent of patients have severe disease, experiencing frequent attacks despite daily medication – and too often needing emergency-room care to end the gasping.
Its like slow suffocation, says John Rapp, 59, of Arlington, Va., who wound up in the ER four or five times a year before participating in a study of bronchial thermoplasty.
California-based Asthmatx Inc. estimates its Alair system, which the Food and Drug Administration approved last week, could target up to 2 million adults like Rapp.
Asthma is a two-pronged disease. First, inflammation inside the lungs branch-like airways narrows those channels to make breathing difficult. The airways also contain a layer of muscle tissue that spasms when something irritates the lungs. That so-called smooth muscle can double in thickness with repeated attacks, making airways increasingly twitchy.
Bronchial thermoplasty beams radiofrequency waves to heat up and shrink that muscle layer so that airways cant constrict as badly during an asthma attack.
In a half-hour outpatient procedure, doctors thread a flexible tube called a bronchoscope through the nose or throat and down into the airways. An electrode at the tip beams those RF waves through the airway wall to reach the muscle underneath without causing a burn.
A company-funded study tested 288 adults at 30 medical centers. About two-thirds received bronchial thermoplasty. The rest got a sham treatment, a bronchoscope that reached into their airways but didnt fire – to be sure that if people felt better, it was due to the thermoplasty and not a placebo effect. Indeed, sham-treated patients reported feeling better. Both groups stayed on their daily medications.
It takes three treatments a few weeks apart to reach different parts of the lungs. But a year later, thermoplasty-treated patients reported better improvements in quality of life, fewer severe asthma attacks – 26 percent of thermoplasty patients had one compared with 40 percent of the sham patients – and, importantly, a major drop in ER visits.
The drawback Thermoplasty irritates airways, meaning risks right after treatment that include temporarily worse asthma, a partially collapsed lung and coughing up blood. Some 8.4 percent of thermoplasty patients required hospitalization, mostly on the day of treatment, compared with 2 percent of the sham group.
If youre willing to take that short-term risk, the long-term benefits are substantial in quality-of-life, concludes Dr. Mario Castro of Washington University in St. Louis, who led the study. Weve maximized everything we currently have available for these patients … and theyre still not controlled.
The big caution, says Rushs Silver What are the long-term effects RF is used safely in other health conditions, and animal studies and some patients tracked for several years dont suggest problems. But Silver asks if scarring might show up years later and how long thermoplastys benefits last. The FDA is requiring Asthmatx to conduct a five-year study to find out.
Thermoplasty isnt for patients currently experiencing worsening asthma or who have an infection or a bleeding disorder, FDA warns.
And candidates must have realistic expectations, adds Texas Calhoun. Thermoplasty doesnt reach smaller airways, or treat asthmas inflammatory side.
Typical bronchoscopes range from 2,000 to 4,000, he says, and its not how much an Alair-aided one will cost. Asthmatx says the disposable catheter for each procedure costs 1,500 doctors also will need the wire-heating machine, which costs about 30,000, similar to other radiofrequency generators.
Back in Virginia, Rapp hasnt made an ER visit in the three years since his thermoplasty, and says the shortness of breath he experienced from a partially collapsed lung after one trial treatment cleared up quickly.
I can run around like a wild idiot, have fun with the dog, with my daughter, he says. Im always going to have asthma symptoms but this greatly reduces them. source
Americas Favorite Birth Control Method Turns 50
“Our own ideas of morality had nothing to do with the case,” said John Harvey of the Food and Drug Administration in 1960.
The pill was safe, in other words. Dont blame us if you think its wicked.
Sunday, Mothers Day, is the 50th anniversary of that provocative announcement that introduced to the world what is now widely acknowledged as one of the most important inventions of the last century.
The world has changed, but its debatable what part the birth control pill played. Some experts think it gets too much credit or blame for the sexual revolution. After all, sex outside of marriage wasnt new in 1960.
The pill definitely changed sex though, giving women more control over their fertility than theyd ever had before and permanently putting doctors – who previously didnt see contraceptives as part of their job – in the birth control picture.
But some things havent changed. Now as then, a male birth control pill is still on the drawing board.
“Theres a joke in this field that a male pill is always five to seven years away from the market, and thats what people have been saying since 1960,” said Andrea Tone, a history professor at Montreals McGill University and author of “Devices and Desires: A History of Contraception in America.”
The pill is Americas favorite form of reversible birth control. (Sterilization is the leader overall.) Nearly a third of women who want to prevent unwanted pregnancies use it. “In 2008, Americans spent more than $3.5 billion on birth control pills,” Tone said, “and weve gone from the one pill to 40 different brands.”
There are Yaz, Yasmin, Seasonale, Seasonique and Lybrel – all with slightly different packaging, formulations and selling points. Lybrel is the first pill designed to eliminate menstrual periods entirely, although gynecologists say any generic can do the same thing if you skip the placebo and take the active pill every day.
In the 1960s, anthropologist Ashley Montagu thought the birth control pill was as important as the discovery of fire. Turns out it wasnt the answer to overpopulation, war and poverty, as some of its early advocates had hoped. Nor did it universally save marriages.
“Married couples could have happier sex with more freedom and less fear. The divorce rate might go down and there would be no more unwanted pregnancies,” said Elaine Tyler May, 62, a University of Minnesota history professor who wrote “America and the Pill.
“None of those things happened, not the optimistic hopes or the pessimistic fears of sexual anarchy,” she said.
The pill is often associated with the womens movement of the 1970s. But the two feminists behind the pill, the ones who provided the intellectual spark and the financial backing, were born a century earlier, in the 1870s.
As suffragists worked for the vote, renowned birth control pioneer Margaret Sanger distributed pamphlets with contraceptive advice and dreamed of a magic pill to prevent pregnancy.
Her grandson, Alex Sanger, 62, now chair of the International Planned Parenthood Council, remembers playing catch as a boy with his famous grandmother and eating her firehouse-spicy food.
“My grandmother had the idea for the pill back in 1912 when she was working on the lower East Side of New York,” Alex Sanger said. “She saw women resorting to back alley, illegal abortions. One too many of these women died in her arms and she said Enough.
Katharine McCormick, a philanthropist with a science degree from the Massachusetts Institute of Technology, bankrolled the work of Gregory Pincus, the man Sanger convinced to develop the pill. “It was my grandmothers idea and Katharine McCormicks money,” Alex Sanger said.
Mammograms Before 40: Few Cancers, Several Callbacks
When to start routine mammograms, at 40 or 50, is debated. But health guidelines dont recommend them before age 40 unless women are at particularly high risk, such as those who carry the BRCA1 and BRCA2 breast cancer-causing genes.
Still, about 29 percent of women in their 30s report having had a mammogram.
So researchers tracked the records of more than 117,000 women who had their first mammogram before 40, and the results support todays guidelines for average-risk women.
If 10,000 35- to 39-year-olds had a routine screening mammogram, 1,266 would be called back for further testing to find 16 with cancer, reported Dr. Bonnie Yankaskas of the University of North Carolina, Chapel Hill. Thats less accurate than in older women, and she said those considering a young exam should know the drawbacks: Earlier radiation exposure and extra testings anxiety and cost.
Her teams study is in Mondays online edition of the Journal of the National Cancer Institute.
The vast majority of these women had no family history of breast cancer, but researchers found no better detection rates in those who did. But the study couldnt track BRCA carriers, an important gap.
Overall accuracy was much better for so-called diagnostic mammograms, done when a woman feels a lump or experiences another symptom that needs checking out.
The study shows better ways to detect breast cancer are needed, plus better evidence to advise BRCA carriers about screening, Dr. Ned Calonge of the Colorado Department of Public Health wrote in an accompanying editorial.
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On the Net:
National Cancer Institute: http://www.cancer.gov/