On 2/16/08, while at KTOL, I was informed that we have the new IO drill. It’s called EZ-IO. The following link will take you to the instructional material concerning its placement both in adults and kids. I would suggest you review this material at your leisure.
ProMEDmail, 2/15/08: The nation’s 1st known cases of antibiotic-resistant meningococcal
disease surfaced in northwest Minnesota and eastern North Dakota over
the past year [2007], according to the Minnesota Department of Health.
Health authorities on Friday [8 Feb 2008] asked doctors in the Fargo
[North Dakota]/Moorhead [Minnesota] area to stop using ciprofloxacin
for preventive treatment of people in close contact with
meningococcal patients and to use antibiotics outside the quinolone family.
The drug-resistant strains are the latest evidence of antibiotic
overuse, particularly in patients whose colds are viral and not
bacterial. “Even though there are other drugs that can be used to
prevent meningococcal disease, having one less weapon in our arsenal
reminds us of the importance of appropriate antibiotic use,” said
Dr. Ruth Lynfield, state epidemiologist.
The 2 Minnesota cases turned up last month [January 2008], one
involving a 53-year-old from Marshall County [Minnesota] who died and
a 2nd involving a 22-year-old student at Minnesota State
University-Moorhead. The North Dakota case in January 2007 involved a
child at a Fargo daycare facility. The bacterial strains in all 3
cases are similar, but the patients had no known connections. Health
officials believe these strains are simply circulating in the region.
As many as 15 percent of people can have a meningococcal bacteria in
their throats or noses at any given time, but only a few suffer
severe infections.
Federal officials have been anticipating such a case. An official
from the U.S. Centers for Disease Control and Prevention (CDC)
traveled to the region Thursday [7 Feb 2008] and was taking random
throat swabs in an attempt to find someone carrying the
drug-resistant bacteria.
Close friends of the patients have been treated as a precaution, so
the CDC official will go to college campuses, bars and other
high-traffic locations. The infected student took music lessons, so
other music students might be tested, said Richard Danila, assistant
state epidemiologist. Danila stressed that these 1st cases are
significant but shouldn’t worry the general public or cause people to
demand preventive treatment.
That the strain in the 53-year-old who died was drug-resistant didn’t
factor into the fatality, Danila said, as patients with the infection
aren’t treated with ciprofloxacin. All 3 patients developed
meningitis, a swelling of the brain and spinal cord, and required
hospital care. Minnesota is one of a dozen or so states that test
meningococcal strains for antibiotic resistance. That partly explains
why the 1st case was discovered here.
[Vaccination for meningococcal meningitis is] recommended for the
11-18 age group and for college freshmen [age 18-20. - Mod.JW]. While
a vaccine protects against two-thirds of these bacterial infections,
it wouldn’t have worked against this particular strain. The vaccine is
recommended for children ages 11 to 18 and college freshmen.
Meningitis cases are somewhat rare, with an average of 24 per year
since 2000 in Minnesota. A total of 22 deaths have been linked to the
bacterial infection from 2000 through 2006 in the state, 10 of them
involving people 23 or younger.
NY Times, 2/16/08: When federal drug regulators approve a medicine for sale, they limit how drug makers sell it. A drug approved to treat only breast cancer cannot be marketed for lung cancer even if some studies suggest that the medicine may save lung patients.But the Food and Drug Administration proposed guidelines Friday that would change this, and advocates on both sides of the issue say that lives are at stake.
The rules would allow drug and device makers to provide doctors with copies of medical journal articles that discuss product uses that have not been vetted or approved by the F.D.A. The rules also say that drug companies do not have to promise to adequately test the unapproved use discussed in the article.
Advocates of the rule say the F.D.A. is so slow in assessing drug and device benefits that companies need to be able to hand out medical journal articles so that doctors can learn immediately about life-saving uses.
“The consequence of rapid disclosure of these benefits could be measured in lives,” said Dr. Scott Gottlieb, a former F.D.A. deputy commissioner.
Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, said that “journal articles can offer physicians valuable insight that helps them make informed decisions regarding appropriate medical treatments for their patients.”
But critics of the proposal say that drug and device companies have a long history of promoting unapproved drug and device uses that later proved dangerous and that allowing companies to talk about such unapproved uses removes incentives for companies to research adequately whether the new use is actually beneficial.
“People will die if they are getting drugs that don’t have clear evidence that the benefits outweigh the risks,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group.
Representative Henry Waxman, Democrat of California, said the proposed rule “caters to the industry’s desire to market their products without adequate testing or review.”
The F.D.A. will accept comments from the public on the proposal and take it up for final consideration in 60 days.
The reason for this debate is that doctors are not overseen by the F.D.A. Medicine is regulated by state medical boards, which generally let doctors prescribe drugs and devices as they see fit regardless of F.D.A. judgments.
In some cases, this is beneficial. Pediatricians for years had very few drugs approved for their use because drug makers often failed to test new medicines in children. So they prescribed drugs for children anyway, and, sometimes, saved lives.
A 2006 study estimated that more than 20 percent of all prescriptions written by doctors were for unapproved uses.
But drug makers have in the past abused doctors’ discretion by telling them that some medicines were appropriate for patients in whom the drugs may have caused more harm than good. In 2004, Pfizer paid a $430 million fine to resolve criminal and civil charges that it marketed its epilepsy drug Neurontin for conditions in which the company’s own studies suggested that the drug was ineffective.
The F.D.A. has for years struggled to find the appropriate balance between the need to inform doctors of experimental but hopeful drug and device uses and the need to guard against hucksters promoting dangerous products as cure-alls.
To complicate the issue, the drug agency’s power to prevent companies from providing truthful, albeit uncertain, information to doctors has been questioned by federal courts as a possible infringement of commercial free-speech rights.
Congress stepped in to resolve the issue in 1997, passing a law that let drug makers hand out studies from medical journals as long as reprints were given to the F.D.A. beforehand and they promised to seek approval from the agency of the use discussed.
That law lapsed in 2006 and “questions have been raised since then about what our policy is,” said Rita Chappelle, an F.D.A. spokeswoman.
Under the proposed rule, the agency would let drug and device companies pass out articles to doctors if the articles were peer-reviewed and came from a journal with an expert editorial board. The article must be accompanied by a prominent warning that the use described is not approved or cleared by the F.D.A.
The agency abandoned the requirement that drug and device makers must provide the studies to the F.D.A. beforehand or promise to seek approval of the discussed use. An F.D.A. official said the agency did not really enforce those requirements anyway.
Diane Edquist Dorman, vice president of the National Organization for Rare Disorders, said she supported the F.D.A. position because patients with rare diseases are generally treated with unapproved drug uses about which doctors must be informed.
“And these companies are just never going to do the confirmatory trials when only a couple of hundred people have the disease,” she said.
But Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said the rule would stop companies from underwriting expensive trials to confirm new drug uses. “Companies could openly promote products for unapproved indications without testing these drugs,” he said. “I’m astonished that this rule would even be considered.”
NY Times, 2/16/08: A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews.
Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it. The United States Food and Drug Administration said this week that it had not inspected the plant either — a violation of its own policy — before allowing the company to become a major supplier of the blood thinner, heparin, to Baxter International in the United States.
Baxter announced Monday that it was suspending sales of its multidose vials of heparin after 4 patients died and 350 suffered complications. Why the heparin caused these problems — and whether the active ingredient in the drug, derived from pig intestines, was responsible — has not been determined.
The plant in Changzhou, west of Shanghai, appears to fall into the type of regulatory void that American and Chinese health officials are trying to close — in which chemical companies export pharmaceutical ingredients without a Chinese drug license.
China provides a growing proportion of the active pharmaceutical ingredients used in drugs sold in the United States. And Chinese drug regulators have said that all producers of those ingredients are required to obtain certification by the State Food and Drug Administration. However, some of the active ingredients that China exports are made by chemical companies, which do not fall under the Chinese drug agency’s jurisdiction.
In December, American and Chinese regulators signed an agreement under which China promised to begin registering at least some of the thousands of chemical companies that sell drug ingredients. Some of these companies are the source of counterfeit or diluted drugs, including those used to treat malaria.
Discussions that led to the accord began after an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115.
The heparin plant in China has not been accused of providing a harmful product. The American majority owner of that plant, Scientific Protein Laboratories, also owns a plant in Wisconsin that produces the active ingredient in heparin for Baxter.
In response to questions, Scientific Protein issued a statement confirming that its Chinese plant had no license from the Chinese agency, but said that its raw ingredients come from a licensed supplier.
The statement added that an “independent private U.S. validation company” had found the plant to be in compliance with good manufacturing practices. And a spokeswoman for Baxter, which buys heparin’s active ingredient from Scientific Protein, said it had inspected the China plant less than six months ago.
A spokesman for China’s State Food and Drug Administration, Shen Chen, said Friday that “as far as we know, it is not a drug manufacturer — it is a producer of chemical ingredients.”
Eric S. Langer, managing partner of BioPlan Associates, which prepares and publishes reports on the biopharmaceutical and biotechnology industry, said he found it hard to believe that a company exporting the heparin ingredient would not be licensed by Chinese drug regulators.
“Being able to produce a pharmaceutical or a biologic in the U.S. or anywhere without having regulatory oversight really doesn’t happen,” Mr. Langer said, adding, “I find it surprising from a regulatory perspective, and I find it surprising from a business perspective.”
Karen Riley, a spokeswoman for the United States Food and Drug Administration, said inspectors from that agency would be visiting the Changzhou plant soon. Ms. Riley said she could not be more specific. Earlier in the week she described her agency’s failure to inspect the plant as a “glitch.”
Congress has criticized the oversight by the Food and Drug Administration of bulk pharmaceutical ingredients made by foreign manufacturers and sold in the United States. A growing number of those ingredients now come from China. Of the 700 approved Chinese drug plants, the United States agency has inspected only 10 to 20 each year.
Baxter makes roughly half of the United States supply of heparin, which is used widely for surgical and dialysis patients. Problems with Baxter’s heparin were first noticed late last year when four children undergoing dialysis in Missouri had severe allergic reactions minutes after being injected with the drug.
The F.D.A. then allowed Baxter to deliver heparin that it was in the midst of shipping, for fear that a total recall would lead to a shortage of the drug, but cautioned doctors to use as little of it as possible and to administer it very slowly.
The agency also suggested that doctors give steroids or antihistamines with the Baxter heparin to help prevent allergic reactions.
Erin Gardiner, a spokeswoman for Baxter, defended Scientific Protein, saying it had been making the heparin ingredient for more than 30 years. “They have been a good supplier,” she said.
Although the cause of the adverse reactions has yet to be determined, she said tests performed by her company had detected unspecified differences between some lots of the ingredient. She did not say whether the lots had come from China or from the Wisconsin plant, which Scientific Protein also owns.
Those differences had not turned up in routine testing that the company does on active ingredients, Ms. Gardiner said, but she said Baxter had used “advanced testing techniques” to find the differences. She added that it was unclear whether the finding was significant.
Two Congressional committees have asked the Food and Drug Administration for more information about inspections of plants making the active ingredient of heparin.
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