tagged w/ Pharmaceutical Research and Manufacturers of America
Patients, hospitals face shortages of some medications.
Periodic shortages of pain relief medications have caused problems in recent months for some area hospitals and the patients who rely on them.
On its Web site, the Food and Drug Administration reported the shortage of oxycodone immediate release tablets in 5, 15 and 30mg.
Erica Abbett, a spokeswoman for drugmaker Covidien, explained the shortage this way: "Currently there is an industrywide supply issue with oxycodone-related products. The situation is due to multiple factors, including two competitors' products being removed from the market because of recalls.
"Covidien has significantly increased our product output as a result of the supply issue, however we alone cannot meet the total demand for these products. We are working diligently to ensure that interruption of patient access to vital pain management products, like oxycodone, is minimized," Abbett said.
The medicines affected are grouped mostly among the narcotics, said Andrew Lowe, Director of Pharmacy at Arrowhead Regional Medical Center. Among those he cited are morphine-related Oxycontin, Percocet and Vicodin, all derivatives of oxycodone.
"There is nothing specific (to cause the shortages) that they have told us about," Lowe said. "It's usually a manufacturing problem.
"There has been no action by the FDA" that could have caused it, he said.
Oxycontin is oxycodone in a time-released formula, and its generic cousin oxycodone releases the drug without
delay. Percocet is a combination of oxycodone and Tylenol, Lowe said.
The shortages at Arrowhead have occurred in oxycodone and Percocet. Last month, Vicodin was in short supply. Supplies of morphine, a well-known and widely used generic, have not been affected, Lowe said. Supplies of Norco, a combination of acetaminophen and hydrocodone, have been unaffected. Lowe described Norco as the most widely used legal narcotic in the Inland Empire.
Brian Kawahara, chief of pharmacy at Jerry L. Pettis Veterans Administration Medical Center in Loma Linda, said the supply there has been in flux. "It varies from day to day. It has a kind of domino effect.
"It is taking a while for the supply lines to get back to normal" from an earlier shortage, Kawahara said.
The shortage has been "mainly narcotics," he said. "That's why I am being cautious.
"I don't want to say what I have and what I don't," the pharmacy chief said, "because those are drugs that are highly abuseable.
"We are getting supplies," he confirmed.
When asked if his caution was from fear of theft, Kawahara said, "You could say that."
Do you know when supplies will be normal again, he was asked.
"If I could predict like that," Kawahara said, "I'd be sitting on a yacht."
Lowe at Arrowhead didn't seem particularly worried about the situation. "Shortages occur periodically," he said. "We just find an alternative."Patients, hospitals face shortages of some medications.
Periodic shortages of pain... more
Why is it so easy for pharmaceutical companies to screw us?
One Survey suggests U.S. research misconduct is common....
By Will DunhamPosted 2008/06/18 at 2:04 pm EDT
WASHINGTON, June 18, 2008 (Reuters) — Research misconduct at U.S. institutions may be more common than previously suspected, with 9 percent of scientists saying in a new survey that they personally had seen fabrication, falsification or plagiarism.
The survey of 2,212 mainly biomedical scientists at 605 universities and other research institutions, published in the journal Nature on Wednesday, also showed that researchers are very reluctant to report bad conduct.
Thirty-seven percent of cases of suspected misconduct were never reported to the institution involved for investigation, perhaps due to fear of reprisals for turning in a colleague or a desire to protect the flow of research money.
"There's more misconduct, or potential for misconduct, out there than probably anyone has appreciated before. And a good part of that goes unreported," James Wells, director of the Office of Research Policy at the University of Wisconsin who helped conduct the survey, said in a telephone interview.
"Usually what happens is that somebody very close to the research has to observe this going on. And they have to step forward and report it to their institution in order for something to happen. And they can very often be jeopardizing themselves," added Wells.
Wells did the survey with two experts from the U.S. Health and Human Services Department's Office of Research Integrity.
Examples of misconduct reported by the survey respondents include changing data to "improve" findings, submitting false data to win a grant and misrepresenting findings.
Wells and his colleagues wrote that the HHS research integrity office receives only about two dozen reports of research misconduct a year, a mere "tip of the iceberg."
Merrill Goozner, who heads the Integrity in Science Project at the activist group Center for Science in the Public Interest, said, "It's really the universities' responsibility to police this. And as we've seen in the (financial) conflict-of-interest field, they do a very poor job."
Its individual people, such as the scientists who have to make the decision to stop this corruption. It starts with them. These scientists should feel motivated to turn over information to help protect the public interest. Instead they are harming the public.
Why is it so easy for pharmaceutical companies to screw us?
One Survey suggests... more
4 years ago
A new law being considered in the U.S. Congress would attempt to prevent postpartum depression in new moms by allowing doctors to prescribe SSRI antidepressant drugs while they're still pregnant.
SSRI drugs have never been approved for use on newborns, yet this new MOTHERS Act will effectively drug unborn babies and newborns with drugs like Prozac. This will certainly have an impact on their developing brains, and the bulk of the research available today shows that the impact will be negative. Will these children be more prone to violent thoughts and behavior? Will they contemplate suicide at younger ages? And what will be the impact of the drugs on the mother?
This legislation is being aggressively pushed by pro-pharma front groups in an effort to expand the customer base for SSRI drugs by targeting pregnant women as new "customers" for the chemicals.A new law being considered in the U.S. Congress would attempt to prevent postpartum... more
Drug companies are struggling because their products don´t work for preventive health and they can´t make money just using them for appropriate uses. Their main trade group spent $22 million in 2007 to buy favors from Congress.
Partly this money was spent trying to maintain a legal monopoly – such as blocking less expensive drug re-importation, preventing fair-price drug negotiations for Medicare, manipulating patent laws to extend drug profits, and ensuring direct to consumer ads continue.
Most of the increase in spending was to get Congress to reauthorize the State Children´s Health Insurance Program, a program to get and keep low-income kids on mind altering drugs – a cash cow worth billions for Big Pharma. These drugs cause permanent adverse alterations in the developing nervous system of children. There is a reason every school-related mass murder involves shooters that have been on psych drugs.
Proposals aimed at lowering drug prices and restricting industry advertising fell by the wayside in Congress.Drug companies are struggling because their products don´t work for preventive... more
The most prestigious universities have let themselves become prime candidates for doing the bidding of the pharmaceutical industry.
The dependence of Universities on biomedical research funding from big business is leading to a disastrous decline in scientific ethics and on the public perception of science.The most prestigious universities have let themselves become prime candidates for... more
The FDA seeks to broaden the range of use for drugs
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.
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 FDA seeks to broaden the range of use for drugs
The rules would allow drug and... more
A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows.
Even users of bottled water and home filtration systems don't necessarily avoid exposure. Bottlers, some of which simply repackage tap water, do not typically treat or test for pharmaceuticals, according to the industry's main trade group. The same goes for the makers of home filtration systems.
The federal government doesn't require any testing and hasn't set safety limits for drugs in water. Of the 62 major water providers contacted, the drinking water for only 28 was tested.
Contamination is not confined to the United States. More than 100 different pharmaceuticals have been detected in lakes, rivers, reservoirs and streams throughout the world. Studies have detected pharmaceuticals in waters throughout Asia, Australia, Canada and Europe — even in Swiss lakes and the North Sea.
Pharmaceuticals also permeate aquifers deep underground, source of 40 percent of the nation's water supply. Federal scientists who drew water in 24 states from aquifers near contaminant sources such as landfills and animal feed lots found minuscule levels of hormones, antibiotics and other drugs.
Perhaps it's because Americans have been taking drugs — and flushing them unmetabolized or unused — in growing amounts. Over the past five years, the number of U.S. prescriptions rose 12 percent to a record 3.7 billion, while nonprescription drug purchases held steady around 3.3 billion, according to IMS Health and The Nielsen Co.
Also, pharmaceuticals in waterways are damaging wildlife across the nation and around the globe, research shows. Notably, male fish are being feminized, creating egg yolk proteins, a process usually restricted to females. Pharmaceuticals also are affecting sentinel species at the foundation of the pyramid of life — such as earth worms in the wild and zooplankton in the laboratory, studies show.
For several decades, federal environmental officials and nonprofit watchdog environmental groups have focused on regulated contaminants — pesticides, lead, PCBs — which are present in higher concentrations and clearly pose a health risk.
However, some experts say medications may pose a unique danger because, unlike most pollutants, they were crafted to act on the human body.
"These are chemicals that are designed to have very specific effects at very low concentrations. That's what pharmaceuticals do. So when they get out to the environment, it should not be a shock to people that they have effects," says zoologist John Sumpter at Brunel University in London, who has studied trace hormones, heart medicine and other drugs.A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood... more