Post by unlawflcombatnt on Mar 29, 2009 15:14:39 GMT -6
According to this New York Times article, most of America's pharmaceuticals are produced overseas, especially in China and India. Safety regulations are far more lax overseas, putting American consumers at tremendous risk from simply taking doctor-prescribed medications purchased at local pharmacies.
Worse still, many of these foreign-produced drugs are labelled as being produced in the US, simply because the foreign-produced drugs are put into tablet or capsule form in the United States. And the government allows for this secrecy, under the guise of "protecting proprietary information," or other such nonsense.
Anyone taking doctor-prescribed medication needs to have its efficacy verified wherever possible--such as checking choleterol levels if taking a statin to ensure that the drug is actually lowering cholesterol. Drugs taken for COPD or asthma, such as albuterol, Spiriva, & salmuterol, should be tested for efficacy by repeating pulmonary function tests, spirometry, and/or peak flow tests.
Unless you can actually locate the manufacturer and verify the production site, all antidepressants should be suspect. There is really no way to determine whether they work or not.
If you're taking birth control pills, you should check estradiol levels and perhaps LH and FSH levels. Ethinyl estradiol, which is the typical estrogenic component in birth control pills, will not show up in the blood when checking estradiol levels. If the BCP is working, estradiol levels should be suppressed, as should LH and FSH.
Clearly anti-hypertensives can be checked for efficacy by simply measuring blood pressure.
Checking efficacy is not always possible, however, such as with anti-osteoporosis medications.
from the New York Times
January 20, 2009
Drug Making’s Move Abroad Stirs Concerns
By GARDINER HARRIS
"In 2004, when Bristol-Myers Squibb said it would close its factory in East Syracuse, N.Y. — the last plant in the United States to manufacture the key ingredients for crucial antibiotics like penicillin — few people worried about the consequences for national security.
“The focus at the time was primarily on job losses in Syracuse,” said Rebecca Goldsmith, a company spokeswoman.
But now experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States.
“The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism,” said Senator Sherrod Brown, Democrat of Ohio, who has held hearings on the issue.
Decades ago, most pills consumed in the United States were made here. But like other manufacturing operations, drug plants have been moving to Asia because labor, construction, regulatory and environmental costs are lower there.
The critical ingredients for most antibiotics are now made almost exclusively in China and India. The same is true for dozens of other crucial medicines, including the popular allergy medicine prednisone; metformin, for diabetes; and amlodipine, for high blood pressure.
Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the Food and Drug Administration in 2007, only 13% were in the United States. 43% were in China, and 39% were in India.
Some of these medicines are lifesaving, and health care in the United States depends on them. Half of all Americans take a prescription medicine every day.
Penicillin, a crucial building block for 2 classes of antibiotics, tells the story of the shifting pharmaceutical marketplace. Industrial-scale production of penicillin was developed by an American military research group in World War II, and nearly every major drug manufacturer once made it in plants scattered throughout the country.
But beginning in the 1980s, the Chinese government invested huge sums in penicillin fermenters, “disrupting prices around the globe and forcing most Western producers from the market,” said Enrico Polastro, a Belgian drug industry consultant who is an expert in antibiotics.
Part of the reason these plants went overseas is that the F.D.A. inspects domestic plants far more often than foreign ones, making production more expensive in the United States.
“U.S. companies are more regulated and are under more scrutiny than foreign producers, particularly those from emerging countries. And that’s just totally backwards,” said Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association. “We need a level playing field.”
The Bush administration spent more than $50 billion after the 2001 anthrax attacks to protect the country from bioterrorism attacks and flu pandemics; some of that money went to increase domestic manufacturing capacity for flu vaccines.
Even so, officials have said that during a pandemic the United States would not be able to rely on vaccines manufactured largely in Europe because of possible border closures and supply shortages. And the situation is similar with antibiotics like penicillin; researchers have found that during the 1918 flu pandemic, most victims died of bacterial infections, not viral ones.
The Centers for Disease Control and Prevention has a stockpile of medicines with enough antibiotics to treat 40 million people. If more are needed, however, the nation lacks the plants to produce them. A penicillin fermenter would take two years to build from scratch, Mr. Polastro said.
Dr. Yusuf K. Hamied, chairman of Cipla, one of the world’s most important suppliers of pharmaceutical ingredients, says his company and others have grown increasingly dependent on Chinese suppliers. “If tomorrow China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse,” he said.
Since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. The F.D.A. has a public listing of drug suppliers, called drug master files. But the listing is neither up to date nor entirely reliable, because drug makers are not required to disclose supplier information.
One federal database lists nearly 3,000 overseas drug plants that export to the United States; the other lists 6,800 plants. Nobody knows which is right.
Drug labels often claim that the pills are manufactured in the United States, but the listed plants are often the sites where foreign-made drug powders are pounded into pills and packaged.
“Pharmaceutical companies do not like to reveal where their sources are,” for fear that competitors will steal their suppliers, Mr. Polastro said.
China’s position as the pre-eminent supplier of medicines is a result of government policy, said Guy Villax, the chief executive of Hovione, a maker of crucial drug ingredients with plants in Portugal and China.
The regional government in Shanghai has promised to pay local drug makers about $15,000 for any drug approval they garner from the F.D.A. and about $5,000 for any approval from European regulators, according to a document Mr. Villax provided....
Uhmmm. Isn't this almost the definition of an illegal subsidy???
The world’s growing dependence on Chinese drug manufacturers became apparent in the heparin scare. A year ago, Baxter International and APP Pharmaceuticals split the domestic market for heparin, an anticlotting drug needed for surgery and dialysis.
When federal drug regulators discovered that Baxter’s product had been contaminated by Chinese suppliers, the F.D.A. banned Baxter’s product and turned almost exclusively to the one from APP. But APP also got its product from China.
So for now, like it or not, China has the upper hand. As Mr. Polastro put it, “If China ever got very upset with President Obama, it could be a big problem.”
________________
The foreign importation of most "American" drugs exposes the lie about "unsafe" Canadian drug reimportation. There is nothing safe about American pharmaceuticals in the 1st place. Most are made overseas. Most "re-imported" drugs from Canada are the same foreign-produced drugs that are sold to Americans as "American" drugs.
And here's another insane policy, which seems almost unbelievable. Neither a US citizen, nor even a physician like myself, can import a drug from a foreign country. Though I'm a physician entrusted with prescribing these very same medications to patients, I can't actually buy them from a foreign producer to save patients money. (or for any other reason.) But I can buy it and prescribe it if I get it through a US manufacturer, after a 100-fold markup.
In contrast to US citizens and physicians, a US pharmaceutical company CAN purchase the same drug from a foreign manufacturer. Only drug manufacturers themselves can purchase drugs from other countries. (I know this for a fact, because I've spoken directly with US Customs and asked them this very question.)
So an (alleged) US manufacturer can import tainted Heparin from China, while claiming it is US produced, and then charge an exorbitant US-level price and possibly poison the US public. And then if lethal toxicity and American deaths come to light, they can claim it wasn't their fault, by revealing that their alleged American-made drug actually came from China.
As a physician, I can order pharmaceuticals--but only from US manufacturers. In contrast, I can not order them from abroad, because it cuts into the profits of Pharmaceutical Industry gangsters, who are selling the same imported drug at 100x the purchase price, all the while maintaining it's an American-made drug.
Worse still, many of these foreign-produced drugs are labelled as being produced in the US, simply because the foreign-produced drugs are put into tablet or capsule form in the United States. And the government allows for this secrecy, under the guise of "protecting proprietary information," or other such nonsense.
Anyone taking doctor-prescribed medication needs to have its efficacy verified wherever possible--such as checking choleterol levels if taking a statin to ensure that the drug is actually lowering cholesterol. Drugs taken for COPD or asthma, such as albuterol, Spiriva, & salmuterol, should be tested for efficacy by repeating pulmonary function tests, spirometry, and/or peak flow tests.
Unless you can actually locate the manufacturer and verify the production site, all antidepressants should be suspect. There is really no way to determine whether they work or not.
If you're taking birth control pills, you should check estradiol levels and perhaps LH and FSH levels. Ethinyl estradiol, which is the typical estrogenic component in birth control pills, will not show up in the blood when checking estradiol levels. If the BCP is working, estradiol levels should be suppressed, as should LH and FSH.
Clearly anti-hypertensives can be checked for efficacy by simply measuring blood pressure.
Checking efficacy is not always possible, however, such as with anti-osteoporosis medications.
from the New York Times
January 20, 2009
Drug Making’s Move Abroad Stirs Concerns
By GARDINER HARRIS
"In 2004, when Bristol-Myers Squibb said it would close its factory in East Syracuse, N.Y. — the last plant in the United States to manufacture the key ingredients for crucial antibiotics like penicillin — few people worried about the consequences for national security.
“The focus at the time was primarily on job losses in Syracuse,” said Rebecca Goldsmith, a company spokeswoman.
But now experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States.
“The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism,” said Senator Sherrod Brown, Democrat of Ohio, who has held hearings on the issue.
Decades ago, most pills consumed in the United States were made here. But like other manufacturing operations, drug plants have been moving to Asia because labor, construction, regulatory and environmental costs are lower there.
The critical ingredients for most antibiotics are now made almost exclusively in China and India. The same is true for dozens of other crucial medicines, including the popular allergy medicine prednisone; metformin, for diabetes; and amlodipine, for high blood pressure.
Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the Food and Drug Administration in 2007, only 13% were in the United States. 43% were in China, and 39% were in India.
Some of these medicines are lifesaving, and health care in the United States depends on them. Half of all Americans take a prescription medicine every day.
Penicillin, a crucial building block for 2 classes of antibiotics, tells the story of the shifting pharmaceutical marketplace. Industrial-scale production of penicillin was developed by an American military research group in World War II, and nearly every major drug manufacturer once made it in plants scattered throughout the country.
But beginning in the 1980s, the Chinese government invested huge sums in penicillin fermenters, “disrupting prices around the globe and forcing most Western producers from the market,” said Enrico Polastro, a Belgian drug industry consultant who is an expert in antibiotics.
Part of the reason these plants went overseas is that the F.D.A. inspects domestic plants far more often than foreign ones, making production more expensive in the United States.
“U.S. companies are more regulated and are under more scrutiny than foreign producers, particularly those from emerging countries. And that’s just totally backwards,” said Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association. “We need a level playing field.”
The Bush administration spent more than $50 billion after the 2001 anthrax attacks to protect the country from bioterrorism attacks and flu pandemics; some of that money went to increase domestic manufacturing capacity for flu vaccines.
Even so, officials have said that during a pandemic the United States would not be able to rely on vaccines manufactured largely in Europe because of possible border closures and supply shortages. And the situation is similar with antibiotics like penicillin; researchers have found that during the 1918 flu pandemic, most victims died of bacterial infections, not viral ones.
The Centers for Disease Control and Prevention has a stockpile of medicines with enough antibiotics to treat 40 million people. If more are needed, however, the nation lacks the plants to produce them. A penicillin fermenter would take two years to build from scratch, Mr. Polastro said.
Dr. Yusuf K. Hamied, chairman of Cipla, one of the world’s most important suppliers of pharmaceutical ingredients, says his company and others have grown increasingly dependent on Chinese suppliers. “If tomorrow China stopped supplying pharmaceutical ingredients, the worldwide pharmaceutical industry would collapse,” he said.
Since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. The F.D.A. has a public listing of drug suppliers, called drug master files. But the listing is neither up to date nor entirely reliable, because drug makers are not required to disclose supplier information.
One federal database lists nearly 3,000 overseas drug plants that export to the United States; the other lists 6,800 plants. Nobody knows which is right.
Drug labels often claim that the pills are manufactured in the United States, but the listed plants are often the sites where foreign-made drug powders are pounded into pills and packaged.
“Pharmaceutical companies do not like to reveal where their sources are,” for fear that competitors will steal their suppliers, Mr. Polastro said.
China’s position as the pre-eminent supplier of medicines is a result of government policy, said Guy Villax, the chief executive of Hovione, a maker of crucial drug ingredients with plants in Portugal and China.
The regional government in Shanghai has promised to pay local drug makers about $15,000 for any drug approval they garner from the F.D.A. and about $5,000 for any approval from European regulators, according to a document Mr. Villax provided....
Uhmmm. Isn't this almost the definition of an illegal subsidy???
The world’s growing dependence on Chinese drug manufacturers became apparent in the heparin scare. A year ago, Baxter International and APP Pharmaceuticals split the domestic market for heparin, an anticlotting drug needed for surgery and dialysis.
When federal drug regulators discovered that Baxter’s product had been contaminated by Chinese suppliers, the F.D.A. banned Baxter’s product and turned almost exclusively to the one from APP. But APP also got its product from China.
So for now, like it or not, China has the upper hand. As Mr. Polastro put it, “If China ever got very upset with President Obama, it could be a big problem.”
________________
The foreign importation of most "American" drugs exposes the lie about "unsafe" Canadian drug reimportation. There is nothing safe about American pharmaceuticals in the 1st place. Most are made overseas. Most "re-imported" drugs from Canada are the same foreign-produced drugs that are sold to Americans as "American" drugs.
And here's another insane policy, which seems almost unbelievable. Neither a US citizen, nor even a physician like myself, can import a drug from a foreign country. Though I'm a physician entrusted with prescribing these very same medications to patients, I can't actually buy them from a foreign producer to save patients money. (or for any other reason.) But I can buy it and prescribe it if I get it through a US manufacturer, after a 100-fold markup.
In contrast to US citizens and physicians, a US pharmaceutical company CAN purchase the same drug from a foreign manufacturer. Only drug manufacturers themselves can purchase drugs from other countries. (I know this for a fact, because I've spoken directly with US Customs and asked them this very question.)
So an (alleged) US manufacturer can import tainted Heparin from China, while claiming it is US produced, and then charge an exorbitant US-level price and possibly poison the US public. And then if lethal toxicity and American deaths come to light, they can claim it wasn't their fault, by revealing that their alleged American-made drug actually came from China.
As a physician, I can order pharmaceuticals--but only from US manufacturers. In contrast, I can not order them from abroad, because it cuts into the profits of Pharmaceutical Industry gangsters, who are selling the same imported drug at 100x the purchase price, all the while maintaining it's an American-made drug.