Counterfeit Drugs
http://thedianerehmshow.org/shows/2012-02-16/counterfeit-drugs
The FDA is investigating a fake supply of the anti-cancer drug Avastin that made its way into U.S. doctors' offices and medical clinics. The agency does not believe anyone was harmed by the counterfeit product. And it sought to reassure the American public about the safety of the medicines we take. But the fake-Avastin case follows similar ones involving the cholesterol drug Lipitor, a popular weight-loss pill and Viagra. And it has heightened concern that counterfeit medicine is a growing problem in the U.S. An estimated 80 percent of the active ingredients in U.S. medicines comes from overseas, making regulation more difficult. Diane and her guests talk about keeping the U.S. drug supply safe.
Guests
Ilisa Bernstein
acting director, FDA Center for Drug Evaluation and Research, Office of Compliance.
Gardiner Harris
science reporter for The New York Times and author of the mystery novel "Hazard."
Frank Palumbo
executive director of the University of Maryland School of Pharmacy Center on Drugs and Public Policy.
Heather Bresch
CEO, Mylan.
William Hubbard
former associate commissioner for the Food and Drug Administration.
.
Comments
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How can the FDA be so sure no one was affected? What is the effective rate of success for treatment when using the genuine drug? This drug is very expensive—yet the high cost that patients pay does nothing to offset the susceptibility of forgeries. Are the distributors supplying the doctors to blame? What authority does the FDA have over international suppliers?
If you don't understand that all output of drug manufacturing, of each drug, and the maintenance of the equipment, and status of the overseeing staff is monitored all over the world, looking for an opportunity to mine the abandoned products in the US, I d on't think you know what 'intelligence' is? Safari's into Africa, to check out minerals, water, etc., in the 60's? Sub-rosa presence in non-USA supporting countries, always with an eye for how to exploit? What do you think Kissinger was so interested in around the world? He was the slime-cat, negotiating with 'police power' for access to raw materials and exploitable labor by US companies. And on and on. .......Monkey see, Monkey do, that's what private, unregulated business is all about! It ain't your business, you undeserving poor! Oh, just carry on with your sweet smelling selfs. The smell of someone's success. Smoke that Cohiba, unregulated, in private venues, oh, you , blessed ones.
How can you even trust the FDA on a corporate level, (I am not speaking of the ability to analyze drug samples), but isn't this the same drug being touted as a treatment for Alzheimers. Couldn't this counterfeit' have been placed out there to achieve this very result, the attention, and then the glorious FDA, could do what it did with colchichine to allow a new profit stream for some 'special concern' with lab bobbers, and university departments, but really its all a revenue stream for some gated community.
How much of the concern about drugs entering the US has do do with the Federal Law that prohibits price negotiations by the Federal Government? It is often much cheaper to buy US manufactured drugs outside the US than in the US.
Brian
Apparently 19 medical practices knowingly purchased the counterfeit Avastin from a non-authorized distributor. Don't they also bear responsibility for subsequent adverse patient events?
See: http://www.drugchannels.net/2012/02/greedy-physicians-invite-fake-avasti...
I can tell the difference between the generic and the brand name drug that I take daily. The generic does not work as well. I always try to get generic drugs but with my current situation, I am having second thoughts.
I see a lot of press about the FBI and local law enforcement seizing counterfeit purses, clothing and DVDs but I rarely hear anything about counterfeit drugs. A counterfeit purse or DVD never killed anyone. Don't we have our national priorities backwards?
With all of the money involved in drug manufacturing etc coupled with americas need to continue to make nice nice friends with China etc why are we the people still sitting still and doing nothing vs paying attn to what politicians are NOT doing? This is called cronyism?
..There perhaps needs to be a more strigent uprising with the people in the US and money must be taken out of the picture This is all about money votes and myth..I have been a nurse for more than forty one yrs and when I became ill i went to Cuba. Ms Rehms i have never had another problem.I am ashamed of this country and the way it penalizes the sick esp the elderly and the chidren while we sit back and play nice nice with countries with their own issues?
I also learned about natural healing herbs Perhaps as a people americans would do better by eating less exercising more and trusting their gut>
What happens if a major over seas supplier either due to politics or natural disaster can no longer supply critical medicines?
Do we have a strategic reserve of antibiotics or other critical classes?
It seems like a fool hardy business model for companies to do business with any vendor that refuses inspections. The "our hands are tied" excuse is very thin.
If big pharma importers took their business elsewhere the resistance to inspection would evaporate.
Thank You
I do not understand why anyone is surprised at the current problems with the drug supply. The past decade has been filled with examples of corporate indifferance to the health and welfare of the American people and rife with examples of those companies putting a bit more profit ahead of all else. The same seems to be true with for-profit health-care entities, including hospitals, medical product manufacturers, and drug manufacturers. The health-care industry was safer when it consisted primarily of non-profit entities. Unlike fancy cars and electronics, health-care should not be a luxury, yet it is becoming one in America of all places. The industry itself must put more emphasis on reverting to its core values. I for one would choose to buy a stock that grew more slowly if I could be assured that the company in which I invested focused on safety and responsible governance, part of which is keeping tight controls on compensation. When a company's chief executives stand to lose an obscene amount of money if they stand on admirable principals, why are we all so shocked if the executives choose money over principal? Our "free market" capitalism unfortunately rewards the morally bereft and punishes or laughs at the ethically admirable. How many deaths will it take to turn this fundamental flaw around?
LongFeather,
What is your overarching hatred of profit. I agree that conterfeit drugs are a problem, but across all of your comments in the past you seem to despise the ability of people or companies\corporations making money. Would you suggest that we all just hand over all profits to the unemployeed and under employed? That should assure every one quits their jobs, and the companies go under. Then we have no money changing hands and the economy crumbles. Profit is good, it is the incentive to work hard and should be applauded, reasonably taxed, and we should all do our best to acheive it.
I heard one of your guests state that the FDA is underfunded, and another guest say he worked with the Clinton administration to try to get better funding for the FDA. I did not hear anyone explain why Congress is not adequately funding the FDA. Have "Big Pharma" lobbyists been paying off... I mean... lobbying Congressmen to weaken the FDA and/or regulations?
Longfeather:
You have as much to learn about the life science/pharma industry as you do about the structure of the English language. Your incoherent ramblings relative to the FDA make zero sense - none. The FDA is regarded by industry as being a major obstacle to commercialization, not some sort of corrupt collaborative partner. Regarding the clinical indications for the use of Avastin, it is an anti-angiogenic VEGF inhibitor. No one on earth has ever proposed the use of Avastin for the treatment of Alzheimer's. If you do not believe me, follow this link to PubMed http://www.ncbi.nlm.nih.gov/pubmed/ the National Institute of Health and the National Library of Medicine's on line repository for all scientific and clinical publications.
Making a profit is fine-making a killing at the expense of others is ridiculous. Yes, there will always be the haves and have-nots but gouging people of every cent you can just to turn a profit? I don't believe in handouts, I believe hard work is important, but it seems to me these drug companies are taking advantage of those of us who are working hard or who have worked hard to not only pay for the "will-nots" but to also pay for the drug companies themselves. But, in all honesty why should we be surprised. That money to pay those lobbyist has got to come from somewhere right?
In listening to the show on the radio one thing I never really heard addressed is how can the consumer know. One gentleman did state we can't know. Once I got home, I checked the medicines in my cabinet which are mostly OTC meds. Only 2 of those state where they are made-not who distributes them but actually where they are made-Benadryl in Canada and my Dollar General cough drops in the USA. Since the government can't seem to do anything (or won't) why not at the very least give the consumer the option of choice by making it mandatory to state WHERE it is made, not just where it is distributed from? That will not fix safety issues which should be addressed, but at least we the consumer will know where it came from and have a choice in some of our purchase options.
It would also make counterfeit drugs easier to trace for law enforcement, but good luck getting most of congress to side with the consumer/patient.
I do believe this is the main reason that the US does not allow travel to Cuba, although they have the putative cover of paying 'reverence' to the former landlords of Cuba. No, it is to the advantage of The American Medical Establishment, the whole FDA/University lab system, and the naming of buildings, and the social openings, that is behind the preventing of opening Cuba to Americans lame, ill, dispossessed, uninsured. Imagine the pilgramages to Cuba and their standing in the world. We can't have this! We must 'reverence' the establishment. They will require a level of proof, that requires fancy equipment, grants and aids and fund raising, when all over the rest of the world, observation, anecdote, is the standard. Proof was the standard of the Pope who insisted the sun circled the earth. It is how you like your proof that is the problem with American medicine. The same proof is required by the Pat Robertson, Tea Party, Gaited community and their minions?
I do apologize, StLouis, if I misspelled, or fumbled, in my rush to get some element of my knowledge of the FDA rules and regulations and their 'restrictions' out. The situation with colchichine is obscenity. Maybe I misheard about an existing cancer drug, only yesterday, being effective in mice who were bred to have high levels of what tangles in the human brain, and causes Alzhimers in humans. I thought they said Avastin, but maybe it was another drug beginning with an A. And I do not apologize by the damage to my brainstem, and brain that has affected my fine motor control, and my reaction to the light on the screen, and struggling with my vagus nerve. I am uninsured, and was rushing to get food at the Church, as this is my assigned day. I didn't want to wait another month so I could proof, and check out for a citation. I do apologize, but with limitations, for the offense I have caused you.
I do apologize, StLouis, if I misspelled, or fumbled, in my rush to get some element of my knowledge of the FDA rules and regulations and their 'restrictions' out. The situation with colchichine is an obscenity. Maybe I misheard about an existing cancer drug, only yesterday, or last Friday, being effective in mice who were bred to have high levels of what tangles in the human brain, and causes Alzhemers in humans. I thought they said Angiostatin, but maybe it was another drug beginning with an 'A.' And I do not apologize by the damage to my brainstem, and brain that has affected my fine motor control, and my reaction to the light on the screen, and struggling with my vagus nerve. I am uninsured, and was rushing to get food at the Church, as this is my assigned day. one hour opening. I didn't want to wait another month so I could have proof, and check out for a citation. I do apologize, but with limitations, for the offense I have caused you.
A wonderful discussion. ... please let the young lady know that Disincentivised is not a word. Using it took away from her otherwise excellent and intelligent remarks.
Why would anyone object to anyone reaping the rewards of their labor, ingenuity, industriousness? No, I object to the 'privatised' behind closed doors, unregulated, access to the back room, taking care of friends and family, that everyone who has been around it, been in the backrooms, seated behind the braggers on planes, here and overseas, the observant, curious class, knows. You are not dealing with a tea bagger, here. I am a Native American/Frenchwoman, out of Chicago. But here in the South, you have a billy goat gruff approach to anything, roads, schools, medicine, any human would need. And they do it very prettily, and must be seen, and they do have their 'reasons' that 'such as myself 'couldn't possibly understand' I have smelt many smells in the quagmire. And I do most definitely identify with our armed forces with PTSD and brain injury, and what they have to put up with on the 'dignified, southern ways,' They are enjoying their profits, but, hey, lets take the private party off the streets. People get hurt while they are attending to their lifestyle needs, on the phone, dropping in and expecting concierge service, in the midst of the Navy Seals, Joint Forces, Special Forces, and Coast Guard. Our loved ones are at risk in the City of Mermaids.
Your first responders at home deal with the aftermath of the lifestyle drivers. Their sport cars fade away, as we pick up the pieces. Party on, I say. But on private property, please.
ok