FDA will ask about Medtronic spinal disc
Fri, 13 Jul 2007 17:22:02 GMTBy MATTHEW PERRONE, AP Business Writer
WASHINGTON - Federal regulators will ask outside medical experts next week whether implanting an artificial spinal disc made by Medtronic is more effective than surgery at treating certain neck injuries.
The Food and Drug Administration said in documents posted online that Medtronic's Bryan implant is just as effective as the current surgical procedure for treating worn out spinal discs. But agency reviewers said it is unclear whether the titanium-coated plastic disc is superior to the spinal fusion procedure, in which a surgeon removes the damaged disc and brings together the surrounding vertebrae.
Roughly 200,000 people in the U.S. undergo spinal fusion surgery each year, at an average cost of about $34,000, according to an article in the New England Journal of Medicine. Medtronic said the total cost of implanting its device would be comparable.
FDA will ask a panel of outside experts on Tuesday whether the device should be approved, and whether Medtronic should be able to claim it represents an improvement over currently available options.
The Minneapolis-based company states the device is superior because it maintains patients' ability to turn their heads from side to side, something not possible after spinal fusion.
While company studies showed the disc to be 10 percent more effective than surgery, FDA reviewers say further analyses of the data show the device may not be that effective. About 15,000 people outside the U.S. have already been implanted with the device, according to Medtronic.
The Bryan disc is the second spinal device from Medtronic to go before FDA's panel of orthopedic experts in the last year.
In September, the panel voted unanimously for approval of a similar device from Medtronic made from stainless steel, though the agency has yet to issue a final decision. The panel said that the Prestige disc should not be labeled as superior to surgery. If FDA ultimately agrees with that assessment, some analysts say it will probably limit sales of the device.
Both the Prestige and Bryan discs are approved for use in Europe.
Medtronic, the largest medical device maker in the world, had revenues of $12.3 billion last year, with roughly 20 percent coming from sales of spinal devices.
Shares of Medtronic Inc. fell 64 cents, or 1.20 percent, Friday to $52.56.
Diabetes drug side effect reports triple
Fri, 13 Jul 2007 12:00:38 GMTBy MARILYNN MARCHIONE, AP Medical Writer
In the month after a surprising analysis revealed possible heart risks from the blockbuster diabetes drug Avandia, reports of side effects to federal regulators tripled.
The sudden spike is a sign that doctors probably were unaware of the drug's possible role in their patients' heart problems and therefore may not have reported many such cases in the past, several experts said.
It also shows the flaws of the safety tracking system and suggests that a better one might have detected a potential problem before the drug had been on the market for eight years.
Avandia is used to control blood sugar, helping more than 6 million people worldwide manage Type 2 diabetes, the kind that is linked to obesity. These people already are at higher risk for heart attacks, so news that the drug might raise this risk by 43 percent was especially disturbing.
In the 35 days after May 21, when the New England Journal of Medicine published the analysis on the Internet, reports of heart attacks, deaths and hospitalizations leaped. The sharp rise in reports of heart problems appears in data obtained by The Associated Press through a Freedom of Information Act request to the federal Food and Drug Administration.
Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet.
Reporting a drug's side effects is voluntary, and only a crude indication rather than a scientific measure of how many problems patients are actually having. The FDA relies on this unenforced system once a drug is on the market. Critics say it leads to haphazard oversight in which problems can be missed because doctors don't connect the dots between a drug and symptoms they see in an individual patient.
With Avandia, the published analysis likely led to more cases being reported, said Vanderbilt University diabetes specialist Dr. Alvin C. Powers.
"Now, patients and their doctors are much more aware of the possible link between Avandia and cardiovascular disease. This is good — this is going to help us going forward to determine whether or not this drug is safe," he said.
The drug's manufacturer, British-based GlaxoSmithKline PLC, insists that the drug is safe and effective.
"This is a very well-known phenomenon," where news reports lead to increased reporting, said company spokeswoman Mary Anne Rhyne. "It's good that there's awareness of the reporting system, but drawing conclusions on such data is inappropriate."
The FDA plans hearings on safety concerns about the drug on July 30. In the meantime, diabetes experts have advised users of the medication to talk to their doctors and not to immediately discontinue it.
The side effects reported range from as minor as a blister to as serious as sudden cardiac death. Most of the reports the AP reviewed seemed to involve serious side effects, and rosiglitazone was listed by the FDA as the "primary suspect" rather than other medicines the patient may have been taking.
There was a total of only 50 adverse event reports in January and 73 in February. From April 16 to May 21, when the study was published, 121 events were reported, including 11 deaths. In the 35 days after the study, 357 events were reported, including 38 deaths.
"You really can't infer anything about incidence rates from that," because the spike in reports is likely due to the "publicity effect" of the study, said Dr. David Graham, an FDA drug safety expert.
Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital, agreed, saying it was "not conceivable" that only five people among the 1 million Americans taking Avandia had heart attacks in the month preceding the May 21 study, as the FDA reports suggest.
"It just heightens the concern about the poor reporting we have," said Nathan, who has received speaker fees from Glaxo and other drug companies. Powers and Graham have no financial ties to any diabetes drug makers.
The issue has roiled the medical community and sparked congressional probes into whether the FDA is properly investigating safety issues. The FDA issued a "safety alert" about the drug only after the May 21 study came out, even though Glaxo had informed the agency of its own analysis of heart risks nearly a year beforehand and possibly as early as 2005.
Avandia's label warns about possible heart failure and other heart problems when taken with insulin. The drug also raises LDL, or bad cholesterol, and can cause fluid retention and weight gain.
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On the Net:
GlaxoSmithKline: http://www.gsk.com
Food and Drug Administration: http:http://www.fda.gov
Avandia's label: http://www.diabetes.org
and http://diabetes.niddk.nih.gov/
Report Teen birth rate hits record low
Fri, 13 Jul 2007 11:17:18 GMTBy JENNIFER C. KERR, Associated Press Writer
WASHINGTON - Fewer high school students are having sex these days, and more are using condoms. The teen birth rate has hit a record low.
More young people are finishing high school, too, and more little kids are being read to, according to the latest government snapshot on the well-being of the nation's children. It's good news on a number of key wellness indicators, experts said of the report being released Friday.
"The implications for the population are quite positive in terms of their health and their well-being," said Edward Sondik, director of the National Center for Health Statistics. "The lower figure on teens having sex means the risk of sexually transmitted diseases is lower."
In 2005, 47 percent of high school students — 6.7 million — reported having had sexual intercourse, down from 54 percent in 1991. The rate of those who reported having had sex has remained the same since 2003.
Of those who had sex during a three-month period in 2005, 63 percent — about 9 million — used condoms. That's up from 46 percent in 1991.
The teen birth rate, the report said, was 21 per 1,000 young women ages 15-17 in 2005 — an all-time low. It was down from 39 births per 1,000 teens in 1991.
"This is very good news," said Sondik. "Young teen mothers and their babies are at a greater risk of both immediate and long-term difficulties."
The birth rate in the 15-19 age group was 40 per 1,000 in 2005, also down sharply from the previous decade.
Education campaigns that started years ago are having a significant effect, said James Wagoner, president of Advocates for Youth, a Washington-based nonprofit group that focuses on prevention of teen pregnancy and sexually transmitted diseases.
"I think the HIV/AIDS epidemic and the efforts in the '80s and '90s had a lot to do with that," Wagoner said of the improved numbers on teen sex, condoms and adolescent births.
"We need to encourage young teens to delay sexual initiation and we need to make sure they get all the information they need about condoms and birth control," he said.
The report was compiled from statistics and studies at 22 federal agencies, and covered 38 key indicators, including infant mortality, academic achievement rates and the number of children living in poverty.
Other highlights:
_The percentage of children covered by health insurance decreased slightly. In 2005, 89 percent of children had health insurance coverage at some point during the year, down from 90 percent the previous year.
_The percentage of low birthweight infants increased. It was 8.2 percent in 2005, up from 8.1 percent in 2004.
_More youngsters are getting reading time. Sixty percent of children ages 3-5 were read to daily by a family member in 2005, up from 53 percent in 1993.
_The percentage of children who had at least one parent working year round and full-time increased to 78.3 percent in 2005, up from 77.6 percent the previous year.
_More young people are completing high school. In 2005, 88 percent of young adults had finished high school — up from 84 percent in 1980.
The report was released by the Federal Interagency Forum on Child and Family Statistics — a consortium of federal agencies that includes the National Institute of Child Health and Human Development, the Census Bureau and the Administration for Children and Families.
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On the Net:
Report available after midnight: http://childstats.gov
Atty Guilty plea coming in steroid case
Fri, 13 Jul 2007 03:25:25 GMTBy ERIN CONROY, Associated Press Writer
PROVIDENCE, R.I. - A pharmaceutical company owner accused of illegally marketing and distributing steroids then paying doctors to write medically unnecessary prescriptions will plead guilty, his attorney said Thursday.
Daniel McGlone, who owns New Jersey-based American Pharmaceutical Group, agreed to plead guilty to 50 counts, including conspiracy, health care fraud and money laundering, according to court documents and his attorney Bob Mann.
McGlone is accused of illegally distributing human growth hormone and steroids to body builders in several states, and allegedly got some of the drugs from a Florida-based pharmaceutical company charged by New York authorities in a larger steroid case.
Prosecutors say McGlone advertised in bodybuilder publications and recommended the drugs for anti-aging and weight-loss purposes. Federal law restricts the use or distribution of human growth hormone to specified medical uses, such as wasting disease associated with AIDS.
McGlone took orders over the phone and paid two New York doctors to write prescriptions for the drugs even though they never met or examined the patients, according to prosecutors.
He made more than $860,000 through the scheme between April 2004 and August 2006, prosecutors said. Authorities seized more than $125,000 and two Dodge Vipers from McGlone, according to federal court documents.
McGlone sent the prescriptions to pharmacies, including Orlando, Fla.-based Signature Pharmacy, according to prosecutors. The company is not charged in the Rhode Island case.
One doctor pleaded guilty in March to conspiracy and illegal drug distribution charges. The other doctor had initially agreed to plead guilty, then declined to do so at a court hearing last month.
