The entire pharmaceutical industry needs to be changed. The way Big Pharma tests drugs, the way it makes drugs and the way it markets drugs all are more about profits than health. The FDA is supposed to protect us. Guess again. If the FDA didn’t learn hard enough lessons from the heparin debacle, maybe more and more investigations like this one about Cephalon, will suddenly shake the foundations of the relationship between the regulator and who it is supposed to regulate.
Doctors getting paid to tout drugs is nothing new, but some inside light was shed on the issue recently by the pharmaceutical maker Cephalon, as chronicled in The Philadelphia Daily News Friday.
http://www.philly.com/dailynews/local/84770832.html
In a settlement Cephalon had to pay $425 million in 2008 to settle a case where it illegally marketed three drugs. As part of that settlement, it had to disclose how much it had forked over to physicians to tout its medications.
On its Web site Cephalon, based in Frazer, Pa., said that it paid 936 health-care professionals, mainly doctors, more than $9.1 million last year for consulting and speaking fees. Those payments ranged from $63 to $149,900.
Cephalon had been charged with getting doctors to promote drugs for uses that don’t have Food and Drug Administration approval. That includes Actiq, a cancer pain treatment promoted to treat migraines; Gabitril, an epilepsy drug promoted for anxiety and pain; and Provigil, a medication for sleep disorders that was promoted to treat adult attention deficit disorder, depression and multiple sclerosis.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
Heparin Contamination – Flawed Processes to Determine Purity of the Drug
In our previous blog, we discussed the four essential problems with the manufacture of Heparin API at the SPL found during the FDA’s inspection of Changzhou SPL plant in China, which was the supplier of the contaminated Heparin to Baxter.
On April 29, 2008, the House Subcommittee on Oversight and Investigations initiated hearings: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
There were four majors areas of problems with production at Changzhou SPL highlighted in the testimony of Regina T. Brown, Consumer Safety Officer who did the inspection for the FDA. The first area was that inadequate procedures were being followed to determine what was in the Heparin API. Ms. Brown was questioned by U.S. Representative, Jan Schakowsky/: from Illinois, as follows:
The problem with this test is that it is not just a crude test. It is only an inclusion test. It tells SPL only that there is Heparin in the raw material, not that other impurities are not in the product.
Our next blog will discuss Regina Brown’s testimony with respect to non-sterile equipment that was used to make this drug.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
On April 29, 2008, the House Subcommittee on Oversight and Investigations initiated hearings: The Heparin Disaster: Chinese Counterfeits and American Failures
For more, click here: http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.042908.Heparin.shtml
There were four majors areas of problems with production at Changzhou SPL highlighted in the testimony of Regina T. Brown, Consumer Safety Officer who did the inspection for the FDA. The first area was that inadequate procedures were being followed to determine what was in the Heparin API. Ms. Brown was questioned by U.S. Representative, Jan Schakowsky/: from Illinois, as follows:
Q of Rep. Schakowsky: Isn’t it true that SPL’s processing steps provided no assurance that they were capable of removing impurities:
Answer of Brown: YES.
Q: Now can you tell us why understanding the origin, quality and purity of these materials are essential for meeting Good Manufacturing Practices, particularly when you are making a biologic, such as Heparin?
A: In particular for Heparin, the Certificate of Analysis that came with the crude material into Changzhou SPL was the only source identifying it as crude heparin from a porcine source, from pigs.
Q: And why is that important that that was the only document?
A: Changzhou SPL had just begun PCR testing, which verifies the pig origin of the crude heparin in June or July of 07. So it was a relatively new test that they were doing. Prior to that, they hadn’t done it at all in China.
Q: Didn’t you find that the test methods performed by Changzhou SPL not been verified to assure suitability under actual conditions of use, is that what you are saying that it was unverified?
A: Yes, unverified. The tests that they ran were USP Compendial methods and we ask firms to verify that methods are suitable for use with their particular product.
Q: So what does it mean when the FDA says Changzhou SPL tests methods had not been verified to assure suitability under actual conditions of use, and why is this important?
A: One of the tests they ran was a protein test, that was a turbidity test, they put required solution in a in a big test tube, then added there substance to it and if turbidity showed up, the crude heparin did not have protein in it and if it did show up, it did have heparin in it and the crude heparin didn’t have heparin in it.. if it did show up, their was protein there. I think it was the opposite. If it got turbid there was protein in it.
A: “It is kind of a crude test, the first steps of the purification process, for heparin, involved getting rid of protein, so when they tried to do a process validation, and they use this turbidity test, in the process validation too, they never showed that it was repeatable and it may not have been suitable for use as an in product test or a even as a finished product test.”
The problem with this test is that it is not just a crude test. It is only an inclusion test. It tells SPL only that there is Heparin in the raw material, not that other impurities are not in the product.
Our next blog will discuss Regina Brown’s testimony with respect to non-sterile equipment that was used to make this drug.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
INSIDE WASHINGTON: Is the FDA a broken agency?
Date: 3/3/2009
EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers
WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.
Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.
Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.
“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.
“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”
Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.
“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”
Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.
The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.
As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.
Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.
The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.
This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.
Last winter, heparin from China contaminated by a mysterious ingredient prompted an international recall. The blood thinner, used to treat people during heart surgery and kidney dialysis, was triggering life-threatening allergic reactions.
Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.
This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.
More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.
Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.
Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.
Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.
The pharmaceutical plant in China that made the heparin was never inspected by the FDA, partly because the agency confused its name with a similar name belonging to another factory. It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.
Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.
The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.
In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.
FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.
“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.
Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.
The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.
“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”
___
Baker reported from Raleigh, N.C.
___
On the Net:
FDA Science Board report — http://tinyurl.com/yvnk28
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney
EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers
WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.
Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.
Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.
“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.
“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”
Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.
“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”
Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.
The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.
As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.
Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.
The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.
This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.
Last winter, heparin from China contaminated by a mysterious ingredient prompted an international recall. The blood thinner, used to treat people during heart surgery and kidney dialysis, was triggering life-threatening allergic reactions.
Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.
This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.
More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.
Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.
Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.
Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.
The pharmaceutical plant in China that made the heparin was never inspected by the FDA, partly because the agency confused its name with a similar name belonging to another factory. It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.
Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.
The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.
In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.
FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.
“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.
Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.
The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.
“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”
___
Baker reported from Raleigh, N.C.
___
On the Net:
FDA Science Board report — http://tinyurl.com/yvnk28
Copyright 2009 The Associated Press.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
http://waiting.com :: http://vestibulardisorder.com :: http://youtube.com/profile?user=braininjuryattorney