In future posts I will detail more about the history of the FDA and its makeup, but I want to comment on the recent illuminating editorials published in this week’s NEJM.
Let me say first that I am not a Communist and I am not a believer that government can fix all of society’s ills. I like freedom in general and am not a fan of too much government interference.
Except in areas where an industry cannot police itself. For instance, it’s pretty clear after Enron and all of the post dating options scandals that Wall Street cannot police itself. Obviously they need MORE regulation, NOT less.
Well, when it comes to the drug approval process, I guess you could say it’s an argument between freedom to have access to drugs, and restriction in the name of public safety. It was an environment of lawlessness depicted in books like Upton Sinclair’s “The Jungle” that led to President Theodore Roosevelt signing the Wiley Act in 1906, which created the agency that eventually became known as the FDA. The need to prevent interstate adulteration of foods and drugs was rampant. The industry needed POLICING!
Fast forward to 1992, and things are a lot better. But the FDA is understaffed. Their budget is not large enough. Congress can only appropriate 125 million dollars for their “Drug Regulation and Safety” division, not nearly enough resources to adequately study all the new drug applications. Also, AIDS activists are demonstrating in Washington because they want access to new, potentially life-saving medicines, and the understaffed, under funded FDA is taking too long to approve these drugs. Whatever can be done to resolve this crisis.
Well, our 102nd Congress had an idea (majority of Senate were Democrats, by the way). They passed the Prescription Drug User Fee Act, or PDUFA. (I like to call it “P-douche-A). Thanks to this bit of legislation, the pharmaceutical industry would now be PAYING THE SALARIES OF FDA EMPLOYEES!! Let’s repeat that: the very industry that the FDA would be policing, was PAYING THEIR SALARIES! If anyone thinks this is a good idea, after this whole Ketek debacle, then I must be on the wrong planet. The act has a lifespan of five years and we’re currently on PDUFA III. But here’s what is key: even though we now know the FDA is in a sorry state in light of these troubling reports, Congress is going to do… NOTHING! In fact, according to the editorial, it looks like reapproval is a done deal once the act expires on September 30th. They love the idea of all that free money from the “user fees” (read: Pharma grift). But guess what? That money isn’t free.
I’ll talk more about PDUFA in future posts.
Monday, April 30, 2007
Friday, April 27, 2007
MORE FDA NONSENSE
As a follow up to my original post about the FDA approval of Ketek, I did myself a favor and listened to the 16 minute interview Dr. David Ross gave to Rachel Gotbaum on the NEJM website. My goodness, this man deserves a medal of freedom way more than Wolfowitz and Tenet.
I plan to talk more about the FDA in future posts (its becoming my personal mission), but I just want to highlight some of the things Ross said in this interview.
Apparently, the fraud that occurred with Sanofi Aventis’ safety study (you know, the one where the top enroller is in a federal prison, and the second top enroller…is ALSO going to prison)… the company KNEW ABOUT IT and DIDN’T TELL ANYONE!!! What the f&%$!!! Is anyone going to jail for this? When confronted, they basically said “We’re sorry, and we promise we won’t do it anymore.” And the FDA claims in their letter to the Journal they only had “preliminary” evidence that fraud occurred at the approval committees. But, GUESS WHAT??? Dr. Ross says that that’s a bunch of BULLS%^&$!!! They knew the whole time!
In January of this year, the FDA wisely withdrew the indications of AECB and acute sinusitis from the Ketek label because “the risks outweigh the benefits”. Thank goodness they realized it after three long years. BUT WAIT…Dr. Ross told them exactly that…IN 2003!!!!! When he presented his opinion, he was told by his manager to “soften” up his report.
Why would his manager ask such a thing, the interviewer posits. And that’s when Dr. Ross issues my favorite phrase of the interview. He says that as of 10 years ago, the FDA’s mission has changed, and now there is… are you ready?... a “culture of approval”! Yes, that’s what we need at the nation’s safety-in-drugs watchdog.. a culture of approval.
The interview is a tour-de-force. I was speechless. He never mentions von Eschenbech, or any top person at the FDA by name because he is obviously too much of a gentleman or statesman. But one cannot deny that based on this report, the FDA are:
1)liars
2)greedy
3)lazy
4)EVIL!
Why do I say “evil”? Well, I don’t know what else to call approving a shoddy drug that led to 4 people dying of liver failure and dozens of others getting liver toxicity NEEDLESSLY!! This wasn’t like they made a medical mistake. They KNOWINGLY approved a drug based on flawed safety data made by a company who covered up the fraud.
As Neil Rogers would say “UN-believable!”
I plan to talk more about the FDA in future posts (its becoming my personal mission), but I just want to highlight some of the things Ross said in this interview.
Apparently, the fraud that occurred with Sanofi Aventis’ safety study (you know, the one where the top enroller is in a federal prison, and the second top enroller…is ALSO going to prison)… the company KNEW ABOUT IT and DIDN’T TELL ANYONE!!! What the f&%$!!! Is anyone going to jail for this? When confronted, they basically said “We’re sorry, and we promise we won’t do it anymore.” And the FDA claims in their letter to the Journal they only had “preliminary” evidence that fraud occurred at the approval committees. But, GUESS WHAT??? Dr. Ross says that that’s a bunch of BULLS%^&$!!! They knew the whole time!
In January of this year, the FDA wisely withdrew the indications of AECB and acute sinusitis from the Ketek label because “the risks outweigh the benefits”. Thank goodness they realized it after three long years. BUT WAIT…Dr. Ross told them exactly that…IN 2003!!!!! When he presented his opinion, he was told by his manager to “soften” up his report.
Why would his manager ask such a thing, the interviewer posits. And that’s when Dr. Ross issues my favorite phrase of the interview. He says that as of 10 years ago, the FDA’s mission has changed, and now there is… are you ready?... a “culture of approval”! Yes, that’s what we need at the nation’s safety-in-drugs watchdog.. a culture of approval.
The interview is a tour-de-force. I was speechless. He never mentions von Eschenbech, or any top person at the FDA by name because he is obviously too much of a gentleman or statesman. But one cannot deny that based on this report, the FDA are:
1)liars
2)greedy
3)lazy
4)EVIL!
Why do I say “evil”? Well, I don’t know what else to call approving a shoddy drug that led to 4 people dying of liver failure and dozens of others getting liver toxicity NEEDLESSLY!! This wasn’t like they made a medical mistake. They KNOWINGLY approved a drug based on flawed safety data made by a company who covered up the fraud.
As Neil Rogers would say “UN-believable!”
Thursday, April 26, 2007
ASK YOUR DOCTOR ABOUT....
When I was a little kid, I saw an episode of 20/20 where they did an expose on doctors who had defaulted on their student loans. (I think it was John Stossel). And they followed some doctors to their front door and asked why they were such deadbeats! Now, I grant you, defaulting on a student loan isn’t a stand up thing to do. But let’s put this in perspective: According to the Health and Human Services website (click here), approximately 150 million dollars in HEAL loans (now discontinued) is still owed by professionals, and guess how much of that is from allopathic doctors…19 million! So 90% of these defaulted HEAL loans is owed from non-physicians. The New York Times doesn't highlight this, as the title of this article from 1981 clearly indictaes who their beef is with. “Those deadbeat doctors” they scolded.
I mention this, not to talk about the student loans racket (we can take that up another day), but to give you an idea about how doctors are generally portrayed in the media, and how the media can make it more difficult for doctors to practice medicine. A recent article appeared in the Archives of Internal Medicine examining the effects of aspirin on mortality in women, and looked specifically at the effects on cardiovascular disease and cancer. I can’t link to the article, but the conclusion was that there was a 43% reduction in the risk of mortality from cardiovascular disease with the use of aspirin! That’s great! The Associated Press started their press release thusly:
Aspirin in low to moderate doses may lower the risk of death in women, particularly those who are older and prone to heart disease, a 24-year study of nearly 80,000 women suggests
Fantastic! Oh, but wait, this result disagrees directly with FIVE other good studies that said there is NO benefit for women from aspirin for cardiovascular disease. What gives? The AP doesn’t really specify. They do say this:
However, experts cautioned that the results are not definitive and that women should not take aspirin as a health preventive without talking to their doctor.
Nice! They manage to weasel out of it by putting it on the doctor to sort out the confusion. Thank you, o’ glorious AP! I guess they didn’t want to enter into a boring discussion about why observational studies aren’t so good, and how superior, placebo-controlled trials like the Woman’s Health Study are often more conservative in their findings, but also more reliable. No, why bother. Let’s just let a patient read this item, then he can scratch his head, and inundate his doctor with a bunch of conflicting advice. Or, maybe the patient will just throw up his hands and say “Gee, the doctors can’t even agree with themselves. So screw it. They probably don’t even know what they’re doing.”
Why did the Associated Press even write this piece? It doesn’t change the current thinking that aspirin does not prevent primary coronary disease in women and this information only confuses patients. The reason is the AP has to write articles for junk newspapers so we all have something to read on the subway.
This is just one example of studies published in the mainstream press, with no responsibility taken by the media for the disinformation that can spread. Some might argue that a well-informed patient is a better off one. That may be true. But with limited expertise, this knowledge can hamper patient care, as illustrated above. Also, the public doesn’t realize that one study alone proves nothing! Because the mainstream media don’t want to mention this uninteresting fact!
Please, a plea from me to the media: STOP making things worse!!! Leave the conclusions and the education of patients to scientists and doctors.
I mention this, not to talk about the student loans racket (we can take that up another day), but to give you an idea about how doctors are generally portrayed in the media, and how the media can make it more difficult for doctors to practice medicine. A recent article appeared in the Archives of Internal Medicine examining the effects of aspirin on mortality in women, and looked specifically at the effects on cardiovascular disease and cancer. I can’t link to the article, but the conclusion was that there was a 43% reduction in the risk of mortality from cardiovascular disease with the use of aspirin! That’s great! The Associated Press started their press release thusly:
Aspirin in low to moderate doses may lower the risk of death in women, particularly those who are older and prone to heart disease, a 24-year study of nearly 80,000 women suggests
Fantastic! Oh, but wait, this result disagrees directly with FIVE other good studies that said there is NO benefit for women from aspirin for cardiovascular disease. What gives? The AP doesn’t really specify. They do say this:
However, experts cautioned that the results are not definitive and that women should not take aspirin as a health preventive without talking to their doctor.
Nice! They manage to weasel out of it by putting it on the doctor to sort out the confusion. Thank you, o’ glorious AP! I guess they didn’t want to enter into a boring discussion about why observational studies aren’t so good, and how superior, placebo-controlled trials like the Woman’s Health Study are often more conservative in their findings, but also more reliable. No, why bother. Let’s just let a patient read this item, then he can scratch his head, and inundate his doctor with a bunch of conflicting advice. Or, maybe the patient will just throw up his hands and say “Gee, the doctors can’t even agree with themselves. So screw it. They probably don’t even know what they’re doing.”
Why did the Associated Press even write this piece? It doesn’t change the current thinking that aspirin does not prevent primary coronary disease in women and this information only confuses patients. The reason is the AP has to write articles for junk newspapers so we all have something to read on the subway.
This is just one example of studies published in the mainstream press, with no responsibility taken by the media for the disinformation that can spread. Some might argue that a well-informed patient is a better off one. That may be true. But with limited expertise, this knowledge can hamper patient care, as illustrated above. Also, the public doesn’t realize that one study alone proves nothing! Because the mainstream media don’t want to mention this uninteresting fact!
Please, a plea from me to the media: STOP making things worse!!! Leave the conclusions and the education of patients to scientists and doctors.
Wednesday, April 25, 2007
FOCUS!
Just thought I’d share a recent bizarre experience.
I was invited by a company called Schlesinger Associates to participate in some kind of focus group or something, for which they would pay me 175 bucks (pre tax). In retrospect, it wasn’t enough, but anyway, I went to the address sometime in the afternoon. It was being held at an advertising firm in midtown, near the Manhattan Mall. I was led through a labyrinth of cubicles and was thanking GOD I don’t work in one of those.
I was placed in a medium sized boardroom by an unattractive young woman. It was just me and her, so I got nervous. Then I was told we were being filmed and there people in the NEXT ROOM watching me and my responses. Can you say “interrogation”?
Ostensibly, I knew the topic was vaccines, but because I’m not in an office setting (yet), I’ve never met the vaccine reps of any company. So I get questions like this:
“When you think of Merck vaccines, what animal do you think of and why?”
Huh?
I had no idea what to say. I mean NONE! So I think I just said “leopard”. Leopard?? HAH!
Then she asked what animal do I think of when I think of Sanofi Aventis vaccines.
Oh jeez. I think I said “Owl”. They are very wise, aren’t they???
Then I was shown three plasterboards full of pictures that appear to have been taken in the 70’s, and asked which three pictures reminded me the most of the vaccine division of Merck. I don’t know about you, but I usually do NOT think of ANYTHING when I think of a vaccine maker.
I spent about thirty minutes making up a bunch of crap, was asked to fill out some paperwork, was handed an envelope filled with cash, and I booked it OUT of there.
So this is one of the places the $9 billion spent by the pharmaceutical companies per year on advertising goes: paying advertising firms to ask doctors what kind of animal Merck reminds them of. Ridiculous.
Tomorrow I’ll speak about how the media hurts doctors and practicing medicine.
I was invited by a company called Schlesinger Associates to participate in some kind of focus group or something, for which they would pay me 175 bucks (pre tax). In retrospect, it wasn’t enough, but anyway, I went to the address sometime in the afternoon. It was being held at an advertising firm in midtown, near the Manhattan Mall. I was led through a labyrinth of cubicles and was thanking GOD I don’t work in one of those.
I was placed in a medium sized boardroom by an unattractive young woman. It was just me and her, so I got nervous. Then I was told we were being filmed and there people in the NEXT ROOM watching me and my responses. Can you say “interrogation”?
Ostensibly, I knew the topic was vaccines, but because I’m not in an office setting (yet), I’ve never met the vaccine reps of any company. So I get questions like this:
“When you think of Merck vaccines, what animal do you think of and why?”
Huh?
I had no idea what to say. I mean NONE! So I think I just said “leopard”. Leopard?? HAH!
Then she asked what animal do I think of when I think of Sanofi Aventis vaccines.
Oh jeez. I think I said “Owl”. They are very wise, aren’t they???
Then I was shown three plasterboards full of pictures that appear to have been taken in the 70’s, and asked which three pictures reminded me the most of the vaccine division of Merck. I don’t know about you, but I usually do NOT think of ANYTHING when I think of a vaccine maker.
I spent about thirty minutes making up a bunch of crap, was asked to fill out some paperwork, was handed an envelope filled with cash, and I booked it OUT of there.
So this is one of the places the $9 billion spent by the pharmaceutical companies per year on advertising goes: paying advertising firms to ask doctors what kind of animal Merck reminds them of. Ridiculous.
Tomorrow I’ll speak about how the media hurts doctors and practicing medicine.
Tuesday, April 24, 2007
Acu-PUNK-ture
While the Journal of the American Medical Association has lost tons of credibility over the last few years, it is still cited and sought-after by many doctors looking to get published, is quoted in the news, and is widely read. So it is very anger-inducing to see them pander to the lowest rung of society…those who believe in homeopathy/quackery.
Their “Clinical Crossroads” section in this weeks’ issue is especially ulcer-inciting. The mere title alone gives me dyspepsia “A 60 year old woman Considering Acupuncture for knee pain”. If the article was simply two lines that said “Acupuncture is bogus and a waste of money. No doctor should recommend it” I might have enjoyed the article and even applauded the authors of JAMA.
However, instead I find the following disturbing comments. I’ll just list two of my “favorites”.First, and I cannot explain what possible reason they could have for doing this, they actually have the patient describe their scenario. (In this case, an active 60-ish female with knee pain).And I’m not just talking about describing their symptoms. She tells a classroom of eager medical students the following blather:
“I think there is a placebo effect and I think its curious. But that doesn’t
bother me. That doesn’t mean it doesn’t work. I think the process of our
brains is so interesting, and I don’t get it at all. But I’m okay with
that. If somebody told me it was just a “placebo effect” – fine.”
I see. She doesn’t understand the “brain process”, but she finds it so interesting. Why are we quoting this genius who hasn’t practiced medicine one day in her life and apparently is so stupid, even though she accepts it could all be a placebo effect, she’s STILL willing to pay for something she KNOWS is bogus? (I didn’t include the previous paragraph, where she complains about how much the sessions cost, and that you have to have a lot of them to achieve success… gee, doesn’t that sound an awful lot like a SCAM???) I can’t believe the editors printed this crap. And listen to Dr. Brian Berman pander to this class of rejects. Here’s a brilliant quote:
" To deal with the pain, Mrs. A emphasized that she felt it
important for physicians to take a holistic approach, with
emphasis on the mind-body interconnection. I agree with her. "
I added the boldface for emphasis. This jackass just sold out every allopathic doctor who stands against quackery. He probably sells growth hormone and does that cartilage removal procedure that was discredited years ago. (click here). These people should burn in hell.
Their “Clinical Crossroads” section in this weeks’ issue is especially ulcer-inciting. The mere title alone gives me dyspepsia “A 60 year old woman Considering Acupuncture for knee pain”. If the article was simply two lines that said “Acupuncture is bogus and a waste of money. No doctor should recommend it” I might have enjoyed the article and even applauded the authors of JAMA.
However, instead I find the following disturbing comments. I’ll just list two of my “favorites”.First, and I cannot explain what possible reason they could have for doing this, they actually have the patient describe their scenario. (In this case, an active 60-ish female with knee pain).And I’m not just talking about describing their symptoms. She tells a classroom of eager medical students the following blather:
“I think there is a placebo effect and I think its curious. But that doesn’t
bother me. That doesn’t mean it doesn’t work. I think the process of our
brains is so interesting, and I don’t get it at all. But I’m okay with
that. If somebody told me it was just a “placebo effect” – fine.”
I see. She doesn’t understand the “brain process”, but she finds it so interesting. Why are we quoting this genius who hasn’t practiced medicine one day in her life and apparently is so stupid, even though she accepts it could all be a placebo effect, she’s STILL willing to pay for something she KNOWS is bogus? (I didn’t include the previous paragraph, where she complains about how much the sessions cost, and that you have to have a lot of them to achieve success… gee, doesn’t that sound an awful lot like a SCAM???) I can’t believe the editors printed this crap. And listen to Dr. Brian Berman pander to this class of rejects. Here’s a brilliant quote:
" To deal with the pain, Mrs. A emphasized that she felt it
important for physicians to take a holistic approach, with
emphasis on the mind-body interconnection. I agree with her. "
I added the boldface for emphasis. This jackass just sold out every allopathic doctor who stands against quackery. He probably sells growth hormone and does that cartilage removal procedure that was discredited years ago. (click here). These people should burn in hell.
Monday, April 23, 2007
THE FDA IS SICK AND NEEDS HELP BADLY
This is my first post to a blog. Hopefully I can vent here and no one will really care, right? I mean, no fact checking, no angry reprisals, just an unhealthy explosion of rage. I don't know where to begin, so I'll begin in the middle.
For anyone who didn’t know that our government and the FDA have become corrupt and rotten just needs to read the excellent editorial in this weeks’ New England Journal of Medicine by Dr. David B Ross. Just click here.
Essentially, that great American Dr. Andrew von Eschenbech (you remember him, he’s the same douchebag who blocked Barr pharmaceuticals approval of Plan B contraception for women, check here) allowed Ketek, the bogus unnecessary antibiotic on the market in August 2004 (do we really need another drug to treat sinusitis and URI’s that don’t need treatment anyway) , which was a freaking bonanza for Sanofi Aventis. (stock went from mid 30’s in 2004 to above 45 by 2006). Even after July 2006 rolled around and the FDA was aware of 35 cases of liver toxicity and four deaths, as well as a front page expose by the New York Times (click here), this subhuman group of losers didn’t remove the drug from the market. Even after they realized that Sanofi’s so-called “post marketing” safety analysis consisted of physicians committing fraud (one of them is doing 5 years in a federal prison for this because she just MADE UP patients for her income) they continued to cite this study when safety concerns were raised. They finally were forced to stop citing this so-called "study" when that magical phrase was floated…”Congressional Oversight Committee”.
Von Eschenbech and the whole lot of them need to go away, FAR away. But god forbid the Bush-meister or anyone in our current pathetic over bloated government does anything to protect its citizens. Anyone who saw “The Constant Gardener” better wake up and realize that its not just African kids getting TB who are being used as lab rats, its US!
For anyone who didn’t know that our government and the FDA have become corrupt and rotten just needs to read the excellent editorial in this weeks’ New England Journal of Medicine by Dr. David B Ross. Just click here.
Essentially, that great American Dr. Andrew von Eschenbech (you remember him, he’s the same douchebag who blocked Barr pharmaceuticals approval of Plan B contraception for women, check here) allowed Ketek, the bogus unnecessary antibiotic on the market in August 2004 (do we really need another drug to treat sinusitis and URI’s that don’t need treatment anyway) , which was a freaking bonanza for Sanofi Aventis. (stock went from mid 30’s in 2004 to above 45 by 2006). Even after July 2006 rolled around and the FDA was aware of 35 cases of liver toxicity and four deaths, as well as a front page expose by the New York Times (click here), this subhuman group of losers didn’t remove the drug from the market. Even after they realized that Sanofi’s so-called “post marketing” safety analysis consisted of physicians committing fraud (one of them is doing 5 years in a federal prison for this because she just MADE UP patients for her income) they continued to cite this study when safety concerns were raised. They finally were forced to stop citing this so-called "study" when that magical phrase was floated…”Congressional Oversight Committee”.
Von Eschenbech and the whole lot of them need to go away, FAR away. But god forbid the Bush-meister or anyone in our current pathetic over bloated government does anything to protect its citizens. Anyone who saw “The Constant Gardener” better wake up and realize that its not just African kids getting TB who are being used as lab rats, its US!
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