Wednesday, October 27, 2010

Vital Drug Shortages- Who is to blame??

I find this news topic intriguing on a number of levels. First, why wouldn't the FDA slap a 'negligent attitude' type lawsuit against Big Pharma? Because that's exactly what they are, negligent. Second, can anyone else read between the lines here? We're being exterminated, one sick population segment at a time. I smell something in the air.... could it be.. maybe? .... a newly formed underground black market for these types of 'discontinued' or 'unavailable drugs.' Either way, the company gets it's money.

When vital drugs run out, patients pay the price

150 medications in short supply so far this year; deaths, injuries have followed

By JoNel Aleccia
Health writer
updated 10/27/2010 8:24:19 AM ET

Cancer patient Bob Dierker had just finished eight of 12 chemotherapy sessions when technicians broke the news.

Next time, they said, he'd get no leucovorin, the generic medication long used to battle his type of aggressive Stage 3 colorectal cancer. The drug was in short supply across the nation and he'd have to go without.

“It was like getting shot in the stomach,” said Dierker, 64, a lawyer from Fairfax, Va. “My odds just dropped dramatically because I can’t get this drug.”

Exactly how Dierker’s chances of beating the cancer will be affected is unclear, said his oncologist, Dr. Alexander Spira. Leucovorin has been used to boost the effectiveness of cancer drugs for decades, so no one knows how badly patients will fare without it. But Dierker is not alone.

Across the United States, life-saving or medically necessary drugs are running low — or running out — endangering care and increasing the odds of medication mistakes for a broad swath of patients.

Health officials say drug shortages pose a growing public health crisis, fueled in large part by financial motives of drugmakers who’ve watched low-cost generics erode their profits.

Numerous drugmakers contacted by either refused to comment on the shortages or confirmed only that they exist. None would discuss financial considerations.

Unprecedented numbers

“It’s disaster management, daily,” said Erin Fox, manager of the Drug Information Service at the University of Utah Health Care, who has tracked drug shortages for a decade. “The numbers are unprecedented.”

In 2005, Fox recorded 74 drug shortages in the U.S. By 2009, the number had jumped to 166. As of Sept. 10 this year, Fox had logged 150 new shortages — in addition to 30 drug shortages still unresolved and more being reported every week.

Worse, the drugs that are in short supply are often the ones needed most. This year has seen shortages of common drugs used for basic treatments: morphine for pain relief, propofol for sedation, Bactrim injections for infections.

Sterile injectables, including the pre-filled epinephrine syringes used in emergencies for heart attacks and allergic reactions, have been particularly hard to get.

“Our usual, everyday workhorse drugs are no longer available,” said Fox. “It’s just the unavailability of everything that we need every day.”

About 40 percent of the shortages are caused by manufacturing problems, including safety issues, said Valerie Jensen, associate director of the Food and Drug Administration's drug shortage program. Nearly 20 percent are caused when firms simply stop making drugs and another 20 percent are due to production delays. The rest are chalked up to raw material shortages, increased demand, site issues and problems with parts such as syringes or vials.

But underlying them all is the profitability problem, said Jensen.

“Normally, it’s a business decision. That does lead to shortages,” said Jensen. "These are just not usually money-makers."

FDA can't require drug production

Despite the concerns of doctors and pharmacists — and the distress of patients — no one can force the drugmakers to address the problem.

The FDA has no authority to compel drugmakers to continue producing a certain drug, or to require them to make a drug that’s in short supply, Jensen confirmed. And companies aren’t required to inform the agency about impending shortages unless the drugs don't have an alternative. Even then, there are no sanctions if they don’t.

When firms do tell FDA about a problem, the agency can’t publicly divulge proprietary information, Jensen said. Shortages on the FDA’s website are often chalked up to mysterious “manufacturing delays,” or frequently, no reason at all.

That has created a system in which pharmacists, doctors and patients may not know that a shortage exists until a drug is needed — and even then they don’t know how long it will last.

“There has been a lot of 11th hour scrambling,” said Dr. Richard L. Schilsky, a professor of medicine and chief of hematology/oncology at the University of Chicago. “We literally don’t know from week to week who’s going to be able to be treated.”

The problem has reached such a peak that four leading groups representing cancer doctors, anesthesiologists, pharmacists and safety advocates have convened an invitation-only meeting in Bethesda, Md., on Nov. 5. They’re asking drugmakers and supply chain representatives to join health experts and observers from the FDA to hammer out solutions.

“I’m going to give these folks the benefit of the doubt and assume they don’t know the impact at the patient care level,” said Bona Benjamin, director of medication-use quality improvement at the American Society of Health System Pharmacists.

But a nationwide survey of 1,800 health care workers conducted this summer by the Institute for Safe Medication Practices left little doubt about the impact on patients.

Two deaths blamed on morphine shortage

“It’s really a mess out there,” said Michael Cohen, director of ISMP, a nonprofit group that aims to reduce medical errors. “It is making us compromise the way we do things normally.”

More than half of the respondents to ISMP said that in the past year they had “always” or “frequently” encountered shortages of a list of common drugs.

One in three reported that the shortages caused medication errors that could have harmed patients and one in four said the mistakes reached patients. One in five said patients were actually harmed.

“We had two deaths where there was a morphine shortage,” Cohen said, explaining that a much more potent replacement drug, hydromorphone, was given at the level of the original, overdosing the patients.

Another patient woke up mid-way through surgery because medical crews trying to conserve the sedative propofol had given too little medication for the patient’s weight.

Such critical mistakes are bound to happen when shortages of so many drugs start to add up, said Thomas Burnakis, clinical coordinator of pharmacy services at Baptist Medical Center in Jacksonville, Fla.

“If I am the best centerfielder in the world, you can hit me a pop fly and I’ll catch it. You can hit me two or even three and I’ll catch them,” he said. “If you start hitting me 15, I’m going to start dropping them.”

It’s not just the mainstream drugs that are the problem. Shortages of niche drugs or those used for rare conditions have occurred, too.

In January, sufferers of a potentially blinding condition called birdshot retinochoroidopathy uveitis learned that Zenapax, the best drug for keeping symptoms at bay, had been discontinued by drugmaker Roche.

“I cannot tell you the panic I felt,” said Lynn Shaw, a 60-year-old nurse from Franklin, Mass., who was diagnosed with the disease 2 ½ years ago. “I was positive I was going to lose my vision. I thought, ‘Oh, my god, I’m going to go blind because of these jerks.'”

Chris Vancheri, a spokesman for Roche, said the company decided to stop making the drug, which is normally used in kidney transplant patients, because there were alternative treatments available. The problem, Shaw and other patients said, is that alternative drugs are either less effective or pose unacceptable side effects such as life-threatening high blood pressure and liver damage.

Drug companies won't talk

Shaw believes that Roche, like many manufacturers, stopped production when generics undercut the brand name price. Vancheri would not comment on the profitability of Zenapax.

Nor would representatives for Teva Pharmaceuticals and Bedford Laboratories, the makers of leucovorin, discuss the reasons for the shortage of the generic drug that has left Bob Dierker, the Virginia lawyer, with depleted cancer treatments.

Bedford representatives did not return repeated calls and e-mails from Teva representative Denise Bradley would only confirm what patients have known for months, that the drugmaker halted production at its Irvine, Calif., plant in April.

"I do not have an estimated date of when we will resume manufacturing at this time," Bradley wrote in an e-mail.

Representatives for the drug manufacturers’ trade group, PhRMA, declined to discuss the largest-ever drug shortage in the nation, referring questions to individual manufacturers.

But Dierker thinks he knows what’s behind the recent shortage of generic leucovorin, the second since 2008. In some regions, a 50-milligram dose of generic leucovorin costs 98 cents; a newer brand-name alternative called Fusilev costs $184.08. But many insurance companies, including Dierker's, won't pay for it.

“It’s money, pure and simple,” said Dierker, a new grandfather who fears he won’t see 6-month-old Rhett grow up.

He’d like to do something about the shortage: organize a class action lawsuit, get a colleague to pursue a criminal case. But for now, he’s just angry.

“To have some faceless, nameless coward running a pharmaceutical lab decide he wants a bigger BMW and isn’t going to make your drug — I feel helpless,” Dierker said. “That’s the really frustrating thing, not to be able to do anything about it.”

Saturday, October 2, 2010

Guatemala's Secret STD Experiments

Just released YESTERDAY, this article makes me asks a pretty obvious question: who shuffled this information into the wrong box? Or was it the wrong box? Still trust the Department of Health? Don't. They obviously only want guinea pigs for their Live Action studies.

The Tuskegee Experiment was called "arguably the most infamous biomedical research study in U.S. history." Well, here's some news- how about chemtrails? Great Britain's "Health Department" refuses to answer questions about the obvious chemical trails in the sky criss crossing the aerial view of certain locales. The US government denies it as well even though there are hundreds of videos released every day on YouTube SHOWING the difference between a contrail(normal condensation trail) and a chemtrail. Look up and the evidence is right there in your face.

This Guatemalan experiment may have ended in 1948 after two years but the Tuskegee experiment went unchecked for forty!!! Aerial biochemical experiments upon the civilians of our world have been going on for at least a hundred years.

By Brett Michael Dykes
Fri Oct 1, 1:04 pm ET

U.S. scientific researchers infected hundreds of Guatemalan mental patients with sexually transmitted diseases from 1946 to 1948 -- a practice that only came recently to light thanks to the work of an academic researcher. On Friday, Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius issued a formal apology to the Central American nation, and to Guatemalan residents of the United States.

"Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health," said Clinton and Sebelius in a joint statement. "We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices."

The discovery of the long-ago experiments stems from another, far better known episode of federal tampering with test subjects to study sexually transmitted diseases: the long-running "Tuskegee experiment," studying 399 poor black men from Macon County, Ala., who had been diagnosed with syphilis but never informed of their condition. Federal scientists simply told the men they had "bad blood" and researchers compiled a four-decades-long study monitoring "untreated syphilis in the male Negro." Researchers never treated the illness over its usually fatal course, even after the simple remedy of penicillin was shown to be an effective syphilis treatment; participants received only free meals and medical exams, together with federal funding of their funeral expenses after they died. The study began in 1932, continuing right through to 1972, when it was exposed in media reports.

One of the better-known experts on the Tuskegee scandal is Susan Reverby, a professor of women's and gender studies at Wellesley College who has published two books on the subject. As she was researching her most recent book, Reverby learned of the Guatemalan project, in which researchers from the U.S. Public Health Service conducted experiments on 696 male and female patients housed at Guatemala's National Mental Health Hospital. The scientists injected the patients with gonorrhea and syphilis -- and even encouraged many of them to pass the disease on to others.

"It was done in conjunction with the Guatemalan government," Reverby told The Upshot in a phone interview Friday morning. "They had permission from the Guatemalan government."

Reverby explained that she learned of the Guatemala study purely by accident.

"I was in the archives of the University of Pittsburgh looking at the papers of the surgeon general at the time," Reverby said. "And the papers there were also the papers of a man named John Cutler, who had also been involved in the Tuskegee study. When I opened the boxes of the Cutler papers, there was nothing in it about Tuskegee, but there was everything about this Guatemala study."

Reverby -- who was instrumental in getting former President Bill Clinton to offer an apology for the Tuskegee experiment in 1997 -- told us that she informed Dr. David Sencer, the former head of the Centers for Disease Control; Sencer then passed the discovery up the chain of command in the U.S. government.

"As with many of these things, it was just pure serendipity," Reverby said. "I was the right person in the right place at the right time."