Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Sunday, December 30, 2012
Year in Review: Meningitis Outbreak Still a Challenge
By MICHAEL SMITH, MedPage Today North American Correspondent
Dec. 30, 2012
The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.
What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.
The outbreak was unprecedented for its size, for the spectrum of disease, for the clinical challenges that faced doctors, and for the way the pattern of illness has changed since the outbreak began, Chiller told MedPage Today.
It also has enormous implications for patients, their families, hospitals, and insurers, said Carol Kauffman, MD, a fungal infections expert at the University of Michigan in Ann Arbor, Mich.
"The extent and repercussions of this outbreak, in comparison to other smaller outbreaks, are really amazing," Kauffman told MedPage Today. "The huge morbidity and, for some, mortality, is enormous."The outbreak, which has been linked to an injectable drug widely used to control chronic pain, has also seen the FDA under attack for not doing more to monitor so-called "compounding pharmacies."
And the FDA has responded by saying it did not have clear authority to intervene, even though worries about the pharmacy in question, the New England Compounding Center (NECC) of Framingham, Mass., date back to at least 2002.
The agency is now asking for its authority to be clarified, although an organization representing compounding pharmacies has told lawmakers the FDA had all the power it needed, but just dropped the ball.
The bottom line from a public health standpoint is that as of Dec. 17, the CDC had recorded 620 cases of disease and 39 deaths. And more are likely, according to Chiller: "We're still in the middle of this thing."
Compounding Out of Bounds
The outbreak can be said to have started in the summer, when NECC made 17,675 vials of preservative-free methylprednisolone acetate, an injectable steroid, and shipped them to 76 healthcare facilities in 23 states.
That was problematic in itself: The company was licensed as a compounding pharmacy, meaning in principle it was allowed only to make up small quantities of specialized drugs, after getting a prescription from a doctor for an individual patient.
Instead, it was acting more like a large-scale drug manufacturer, and had been for some years, according to Massachusetts officials, which should have placed it under the FDA's authority.
The manufacturing scale played a key role in what ensued: more than 13,000 people were exposed to the drug when they got injections – mainly into the spine – to control chronic pain.
They were also exposed to a fungal contaminant in the steroid vials, later found to be a black mold called Exserohilum rostratum, which only rarely causes human disease.
Oddly, the index case for the outbreak, reported to health authorities on Sept. 18, was a 56-year-old man in Nashville who had a case of meningitis apparently associated with the fungus Aspergillus fumigatus.
Source found and video found here
Readers: Talking Up Off-Label Drugs Won’t Impact Practice
Posted by Chris Dalrymple D.C., F.I.C.C. on
December 16th, 2012
A plurality of MedPage Today readers said that classifying off-label drug
promotion as free speech would not have any bearing on clinical practice.” Are
there any competent clinicians out there who don’t or have never [prescribed]
off-label? Would any willingly give up the right to do so? Then why should there
not be the ability to interact regarding such use with those who represent the
products?” asked one reader. Several readers noted that the very intelligence of
physicians and their professional judgment is called into question if they can’t
be trusted to listen with unbiased ears to pharmaceutical company
representatives.
Readers, however, sounded a jaded note to”record-breaking fines to pharmaceutical companies” because they are “actually dwarfed by the record-breaking profits made by promoting drugs for many uses.”
It might help, suggested a reader, if patients “sign releases that they realize it is an off-label use and that they accept the consequences of that.” But she added: “I’m sure a clever lawyer will try to sue us anyway.”
Source found here
Several readers noted there is a
difference between docs going off-label and pharma reps promoting off-label
use. “When a doctor goes off-label, it’s most likely for the benefit of the
patient. When pharma pushes off-label use, it’s for the benefit of the company
pocketbook. Big difference. It’s hard to know what world that court panel is
living in to call this free speech.”
Other problems detailed by those against sales reps having such “free speech”
include more patients experiencing adverse side effects from drugs prescribed
off-label. Nearly 9% of our readers said the court’s ruling will result in an
increase in drug-related adverse events.nterestingly, shortly after the ruling,
Wyeth, a subsidiary of Pfizer, agreed to pay $55 million plus interest to settle
allegations it promoted off-label use of its acid reflux drug pantoprazole
(Protonix).Readers, however, sounded a jaded note to”record-breaking fines to pharmaceutical companies” because they are “actually dwarfed by the record-breaking profits made by promoting drugs for many uses.”
It might help, suggested a reader, if patients “sign releases that they realize it is an off-label use and that they accept the consequences of that.” But she added: “I’m sure a clever lawyer will try to sue us anyway.”
Source found here
Ruling Is Victory for Drug Companies in Promoting Medicine for Other Uses
By KATIE THOMAS
Published: December 3, 2012
- Google+
- Save
- Share
- Reprints
In a case that could have broad ramifications for the
pharmaceutical industry, a federal appeals court on Monday threw out the
conviction of a sales representative who sold a drug for uses not approved by
the Food
and Drug Administration. The judges said that the ban on so-called off-label
marketing violated the representative’s freedom of speech.
The 2-to-1 decision by a three-judge panel of the
Court of Appeals for the Second Circuit in Manhattan addresses a long-running
and costly issue for the industry, which has paid billions of dollars in
penalties to the federal government in recent years after being accused of
marketing blockbuster drugs for off-label uses.
In July, for example, the British drug maker
GlaxoSmithKline agreed
to pay $3 billion in fines, in part for promoting antidepressants and other
drugs for unapproved uses; a month later, Johnson
& Johnson announced that its pharmaceutical unit had reached a $181
million consumer fraud settlement with 36 states and the District of Columbia
over its marketing of Risperdal, an antipsychotic drug.
“Most if not all of these cases have been based on a
central premise: that it is unlawful for a company and one of its employees to
be promoting a drug or a medical device off-label,” said John R. Fleder, a
director at the law firm Hyman, Phelps & McNamara who represented the F.D.A.
while working at the Justice Department. “And this decision hits at the heart of
the government’s theory.”
The ruling, in United
States v. Caronia, involved the conviction of Alfred Caronia, a former sales
representative for Orphan Medical, which was later acquired by Jazz
Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive
daytime sleepiness, known as narcolepsy. He was accused of promoting it to
doctors as a treatment for insomnia, fibromyalgia and other conditions. He
became the target of a federal investigation in 2005 and was caught on an
audiotape discussing the unapproved uses of the drug with a doctor who was a
government informant. He was convicted by a jury in 2008.
Mr. Caronia appealed the conviction, arguing that his
right to free speech under the First Amendment was being illegally restricted.
The appellate court decision applies only to the Second Circuit, which comprises
New York, Connecticut and Vermont, but some lawyers said that the government was
likely to appeal and that the case could find its way to the Supreme Court.
Under the Food, Drug and Cosmetic Act, which gives the
F.D.A. the authority to regulate drugs, selling a “misbranded drug,” or one that
is intended to be used for purposes not listed in the label, is illegal.
Doctors, on the other hand, are free to prescribe a drug for any use. The agency
has argued that off-label promotion of drugs is evidence that a sales
representative or company intended to sell misbranded drugs.
In its decision, the court said this view violated the
First Amendment and cited as precedent a 2011 Supreme Court decision, Sorrell
vs. IMS Health. In that case, the high court, citing freedom of speech,
overturned a Vermont law restricting pharmaceutical companies from using
prescription data for marketing purposes.
“The government clearly prosecuted Caronia for his
words — for his speech,” the majority wrote, concluding later “the government
cannot prosecute pharmaceutical manufacturers and their representatives under
the F.D.C.A. for speech promoting the lawful, off-label use of an
F.D.A.-approved drug.”
The lone dissenting judge, Judge Debra Ann Livingston,
vigorously disagreed, arguing that by throwing out Mr. Caronia’s conviction “the
majority calls into question the very foundations of our century-old system of
drug regulation.” She argued that if drug companies “were allowed to promote
F.D.A.-approved drugs for nonapproved uses, they would have little incentive to
seek F.D.A. approval for those uses.”
Gerald Masoudi, a former chief counsel of the F.D.A.,
said the ruling made a distinction between truthful discussion of off-label uses
of drugs, many of which are considered legitimate by the medical community, and
those that are misleading or false. He noted that “anyone on the planet” could
discuss off-label uses of drugs, except for pharmaceutical companies.
“It’s very significant,” he said, “because it’s going
to make F.D.A., in its promotion cases, focus on the kinds of speech that are
more likely to harm consumers, such as false or misleading marketing versus
something that is not approved.”
In a statement, the trade group for the pharmaceutical
industry, Pharmaceutical Research and Manufacturers of America, said it was
pleased with the ruling.
“PhRMA believes that truthful and nonmisleading
communication between biopharmaceutical companies and health care professionals
is good for patients, because it facilitates the exchange of up-to-date and
scientifically accurate information about new treatments,” the statement said.
A spokeswoman for the F.D.A. said the agency did not
comment on active litigation.
Lawyers said the government would most likely ask for
a rehearing before the circuit court’s full panel of judges and after that, it
could be taken up by the Supreme Court.
Because pharmaceutical companies market their drugs
nationally and the ruling applies only within the Second Circuit, the ruling is
not likely to lead drug makers to change their marketing policies. Rather, some
said, the F.D.A. will be unlikely to pursue convictions in similar cases until
the legal issues are resolved.
A version of this article appeared in print on December 4, 2012, on page B1 of the New York edition with the headline: Ruling Is Victory for Drug Companies In Promoting Medicine for Other Uses.
Source found here
Michigan hospital blazes trail in fight against fungal meningitis
By Julie Steenhuysen | Reuters – 5 hrs ago
CHICAGO (Reuters) - After his first day working at St Joseph Mercy Ann Arbor hospital's newly created Fungal Outbreak Clinic, Dr David Vandenberg struggled to describe to his boss the enormity of what lay ahead. He settled on a line from the movie Jaws.
"We're going to need a bigger boat," Vandenberg told Dr Lakshmi Halasyamani, chief medical officer of the Michiganhospital, echoing the film's local police chief after he first eyes a 25-foot (7.5-metre) killer shark.
The St Joseph Mercy clinic has been at the front line of the fight against one of the biggest ever U.S. outbreaks of fungal meningitis, a killer infection that has been traced to tainted steroid shots from a Massachusetts pharmacy.
So far, 620 Americans have developed serious infectionsrelated to the outbreak, including 367 cases of deadlymeningitis, and 39 people have died. Of the 19 U.S. states affected, Michigan has been worst hit, handling more than one third of the total cases in the outbreak.
St Joseph Mercy - a 537-bed Catholic hospital located in Ypsilanti, on the doorstep of the University of Michigan - has treated 169 of the state's 223 cases of infections that can cause meningitis, including 7 people who died.
At one point it was so overrun that 87 of its 537 beds, which are usually occupied by patients with cancer or heart ailments and the like, were occupied by patients with fungal meningitis and related infections.
Dr Tom Chiller, the fungal disease expert at the U.S. Centers for Disease Control and Prevention, who has been overseeing the outbreak, praised the work of the hospital in helping to limit deaths from the outbreak.
"They have been incredibly creative in dealing with these complicated patients," he said.
In all, almost 14,000 people seeking relief from back and joint pain received injections from moldy steroid shots made at the now-bankrupt New England Compounding Center in Massachusetts before they were recalled in late September.
CDC experts initially feared death rates in the 40 to 50 percent range; instead, only about 6 percent of those infected have died, and the CDC credits the creative and dogged efforts of state and local health officials for keeping the death rates so low.
The first wave of the outbreak involved the most severe cases of meningitis - an inflammation of the membranes that cover the brain and spinal cord. But starting in mid-October, patients who had been recovering from meningitis were developing potentially fatal localized infections near the site where contaminated drug was injected to treat back or neck pain.
As they started seeing more cases of these local, secondary infections, the staff at St Joseph's devised a bold plan to screen all patients in their database looking for potential new infections that might have been missed in the first wave.
On December 20, the CDC issued an alert to doctors incorporating some of lessons learned by the efforts of doctors at St Joseph's and other hospitals, calling for increased screening of patients who may be harboring localized infections.
A BEWILDERING FUNGI
Among the patients who developed secondary infections was Bonita Robbins, a 72-year-old retired nurse from Pinckney, Michigan, who received doses of the tainted drug at the Michigan Pain Specialists clinic in the nearby town of Brighton while seeking relief for lower-back pain.
The first shot brought some relief, the second did little to ease her aches, and the third was contaminated. In October, Robbins went to St Joseph's with a severe headache, back pain and pain in her thighs.
She spent 37 days in the hospital taking two kinds of antifungal drugs.
continue reading here
Subscribe to:
Posts (Atom)