OCTOBER 23, 2008
Vytorin Sales Continue to Tank, and With Good Reason
This has been an interesting week, and an interesting year, for that matter.
The cholesterol lowering drug Vytorin is back in the news because the good folks at
Scherlings-Got-Plowed
wrote about how Vytorin sales continue to tank.
Also the stop smoking drug Chantix
got up there with tainted Chinese heparin as causing the bulk of recently reported
adverse events and deaths (See my prior post
"Time To Die! (Oops) I Mean Time to Quit!"). Seems like country music singers
trying to give up the tobacco leaf now have to add driving their cars off of the road
to their fears of blowing away their neighbors in a Chantix induced psychosis.
As I wrote previously in "Zetia, Schmetia"
(Oh I love titles! me and William), Schering-Plough
(ed?) came out with full
page articles in the New York Times as well as faxes sent on behalf of their pals at the American Heart Association
(thanks for the million dollars a year, S-P and friends)
which came
sliding through the fax machines of cardiology departments and offices across the land (including ours), urging one and all to continue taking their
cholesterol lowering drug Vytorin (which combines Zetia (ezetimibe) with the statin Zocor (simvastatin)), in spite
of the fact that the recent ENHANCE trial showed that Vytorin did not prevent the development of atherosclerotic plaque better
than Zocor alone. If anything Vytorin was worse for plaque than Zocor alone. (I sing the ads in my head to the tune of
the song by Journey "Don’t stop believing, hang on to that feeling").
And in spite of the fact that Vytorin reduces
cholesterol to lower levels than Zocor, it isn’t better at preventing heart attacks and strokes.
Scientists have known for years that LDL cholesterol reduction isn’t the only game in town when it comes
to preventing heart attacks. Statins probably prevent heart attacks in other ways besides lowering cholesterol,
and decreasing your cholesterol level doesn’t necessarily prevent a heart attack. But the cholesterol numbers
game is great for marketing, especially when you can sell a drug like Vytorin to patients who didn’t get their
cholesterol down with a statin alone. And when Vytorin costs over two dollars a pill and simvastatin costs
less than a dollar. But what is most disturbing about this morality play is that the manufacturers,
Merck and Schering-Plough, delayed publicizing the study results for almost two years. That was worth a
couple of billion dollars of sales that they wouldn’t have gotten if doctors and patients knew how useless
Vytorin was compared to the much cheaper generic statins.
Back then the New York Times wrote an article that raised this issue and asked, is lowering cholesterol really
the key to heart attack prevention? The article was written as if no one had ever considered the question before.
I don’t think it was a coincidence that the day before I sent them my editorial entitled
"Delays and Suppression of Clinical Trial Results" (which they didn’t publish and which I published my
self on my own web site), in which I pointed out that
it was only last year that Pfizer’s new drug, Torcetrapib (now tanked), which lowers "bad" LDL cholesterol and raises
"good" HDL cholesterol, was shown to actually increase the risk of fatal heart attacks, and that for years scientists
in the cardiology field have known that cholesterol lowering is not the only mechanism by which statin drugs
work to prevent heart attacks. They act on inflammatory pathways and by other means that are not fully understood.
I got an incredulous response from one of the editors from the NY Times to the effect of "how could you say
that a drug that lowers your cholesterol isn’t good for you?" I could post the email exchange here but
I think it is lame to post emails and memos on your website. I am just making the point so that
you can beware of medical shills
and you can’t believe everything you read in the papers, especially the health news section,
and that maybe we should
learn about the process by which doctors shape their prescribing behaviors and not be like a bunch of
lemings and run off the cliff with our key opinion leaders (KOLs).
Why has the news about cholesterol been slow to disseminate to the public? Since half of Americans over age 35 have an LDL cholesterol
that is in the elevated range, and since these drugs definitely lower LDL cholesterol, it is easier to sell them
on that basis. In fact, Zetia got approved solely on the basis of its ability to get LDL levels down. The FDA didn’t
require the manufacturer to prove that it did what we want it to do, that is prevent heart attacks. And before we
get too excited about generic simvastatin, consider how many people with multiple risk factors need to be treated
for five years to save one from a heart attack. About 250. That means a risk of heart attack reduction of about 0.2%.
And with the risk of muscle pain that doesn’t go away right away. Put that
stuff in your own damn drinking water.
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Dan Abshear wrote on Oct 23, 2008
Published on www.brainblogger.com:
A Failed Attempt to Improve Misperceived Greatness: The ENHANCE Trial
While it seems that pharmaceutical company sponsors of clinical trials usually end up with results that clearly favor their meds studied in their trial, there are rare exceptions, and Merck and Schering proved that with their disappointing ENHANCE Trial, which many have heard about through the media not long ago. The drugs studied were Vytorin, which was compared with Zocor
Vytorin is a combination med for high cholesterol and contains Merck’s Zocor, which is now generic, and Schering’s Zetia, which works differently than Zocor, which is one of many statin drugs. Both Vytorin and Zetia are co-promoted by Merck and Schering. So, several years ago, an outcomes study was initiated to prove superiority of Vytorin over Zocor. The trial was named the ENHANCE trial, and possibly this trial was initiated because Zocor is generic now, and not a priority from a profit paradigm of its creator.
After several years passed, a disappointment arrived for the sponsors of this trial, which was first brought to the attention of Schering in March of 2007, yet the results existed since the spring of 2006, I believe upon information and belief.
The disappointment is that Vytorin lacked anticipated benefit or superiority over Zocor. Since about 1 million scripts were written for both Vytorin and Zetia every week in 2007, combined with what I believe was about 5 billion in revenue for these two drugs that year, this was a problem for the drug makers, meaning a fear of shareholder reaction. Perhaps for Schering in particular, it was more of a calamity, since over half of their profits and earnings were from these two drugs with Schering, I understand.
Being the responsible corporations both companies are, of course, alterations occurred after such events were discovered that fractured numerous rules and regulations with clinical trials, possibly in illegal and unethical tactics.
The trial sponsors delayed the release of the trial results for secrecy reasons, it has been speculated. Results from the trial existed, yet were not disclosed at the time of their discovery. After several months of possessing these trial results that were only known to the manufacturers, they created or implemented some atrocious tactics to improve the trial’s unimpressive results following the original results of this ENHANCE study. At the end of 2007, the companies changed the primary endpoint of the trial, which is what the results were measured upon during the entire course of the trial. Sort of like sorting cards to make a good hand not dealt to you. Anyway, since their deliberate concealment of these trial results was clearly wrong, to respond to those who asked where the results were actually as they had been anticipated for quite some time, and while such trial manipulation was occurring and results were being kept secret, Schering stated that continued data analysis from the trial results ws
the etiology for the delay.
With clinical trials, case report forms are used to record data from the trials, and are created in a manner where further analysis is not normally necessary, as such forms are quite clear and often not subject to interpretation as implied by the trial sponsors, one could conclude. So at the end of 2007, both Merck and Schering got the attention of relevant government officials who contacted both companies regarding this ENHANCE trial due to such suspicions on the facts known and presented, and an investigation began into the activities of both companies regarding this trial at that point.
This became a catalyst for the ENHANCE trial results to be finally released at the beginning of 2008, which caught the attention of major media organizations, as expected. In the spring of 2008, a very large cardiology meeting was held, where the audience was told, I understand, to stick with statins due to this trial’s lack of outcomes for Vytorin, when the ENHANCE trial was discussed at this meeting. Furthermore, it has been said that a cardiologist at this meeting also suggested that a moratorium should occur with the utilization of Vytorin by prescribers, since statins are much less expensive, and are highly regarded, as they have been available for a couple of decades, starting with Mevacor in the 1980s. Of course and as expected, Merck and Schering were not pleased, nor were they surprised at the review of Vytorin at this particular meeting. The following month after this cardiology meeting, Schering’s earnings dropped by 48 percent, as I recall. Also during much of this year,
Schering in partiular blamed the media for amplifying the situation regarding the ENHANCE trial.
Now, these cholesterol drugs promoted by Merck and Schering, Zetia and Vytorin, were aggressively marketed in a number of ways, including investing I believe about 200million dollars in 2007 for DTC ads for these products. To add to this, and soon after both meds were launched, reps from both companies made inferences to doctors about outcomes regarding plaque accumulation and how Vytorin was superior in that area, which, of course, this ENHANCE trial proved it is in fact not the case whatsoever. It did not matter, apparently, to both Merck and Schering that such claims were is entirely void of proof, which is not unique to any pharma rep, in my opinion. No remorse or regret from the makers of these drug makers, either, which did not shock many. Yet what is known now is that these companies, as stated by other researchers, performed junk science with their deliberate manipulation of this ENHANCE trial using such tactics. Also, last year, Zetia and Vytorin had about 20 percent of the cholesterol lowering market. It does not seem that there will be an increase of this percentage because of this scandal. Possibly if they presented the truth, the future of these meds might be better than what is anticipated presently.
Worst of all regarding this ENHANCE trial scandal is the harm caused to both doctors and patients. The ENHANCE trial concerned and confused both of these participants in the health care system. Furthermore, it’s likely they were devastated by being so clearly misled by the marketing of both Merck and Schering regarding the false benefits of Vytorin they were led to believe by the companies that promoted them- the health care providers in particular.
This whole situation is another example of the progressively frequent discovery of corruption of the scientific method by placing profits over the well-being of patients, which harms the well being of patients. In addition, most were shocked by Merck behaving in such a way in particular because of what use to be their excellent reputation as an ethical pharmaceutical company. And this alone shows the progression and infiltration of such damaging ethical atrophy that desperately needs to be stopped and corrected for the sake of others- for everyone.
Don’t just say something. Have something to say- to the right people, with conviction and with others who share your views.
“Try not to become a man of success, but rather try to become a man of value.” --- Albert Einstein
Dan Abshear
Author’s note: What you have read is based upon information and belief. Thank you
OCTOBER 22, 2008
In Vitro Fertilization and Cancer, by Jennifer Schneider, MD
[invited blogpost for "Before You Take That Pill, Read This" blog]
Hi, Doug,
My daughter, Jessica Grace Wing, died of metastatic colon cancer at age 31, some 7 years
after undergoing 3 cycles of egg donation to infertile couples. She had no family history of colon
cancer, and genetic tests showed she had no genetic risk. To produce multiple eggs for egg donation,
egg donors undergo ovarian stimulation by a series of injections of various female hormones. Infertile
women given a similar regimen to produce eggs for their own use have a slight long-term risk of developing
certain cancers. Egg donors have never been studied to find out what their risks are. Certain short-term
complications are common, but nothing is known about any possible long-term risks. Egg donors are treated
as vendors, not as patients. It is time that egg donors be followed carefully, as are other organ donors,
and that their long-term health risks are evaluated. Until then, potential egg donors cannot really
sign an informed consent form, because their risks are simply not know. A national egg donor registry is the first step.
Last year I did a Congressional briefing summarizing the whole issue. I wrote up what I said. You can find it
here.
And here is a story that appeared last March.
Also, for your information, here
is an article that is about to appear in the journal Fertility and Sterility.
Jennifer Schneider, MD
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Doug Bremner wrote on Oct 22, 2008
Thanks, Jennifer, for sharing that important information. As a parent I have great empathy for what you
have gone through, and as a doctor I think a registry is required.
OCTOBER 21, 2008
What Me Worry? The FDA Will Protect Me from Toxic Drugs (NOT!)
Tomorrow’s issue of JAMA has the results of an interesting
study by T.J. Giezen et al that examined 174 prescription medications (136 in the US,
the rest in Europe, and 67 approved in both places), as well as some letters on preemption
and an editorial that discusses these related topics. In the study of Giezen et al, 24% of the drugs had a
regulatory action after approval by the FDA or a European regulatory agency,
including 19 black box warnings, and 47 dear doctor letters. The probability of having
regulatory action in the ten years after approval was 29%. Drugs that were the first of their
kind ("first in class") had a four fold higher risk of safety regulatory action
than drugs that came on the market later.
Would you play Russian roulette with a four chamber gun and a single bullet in the
gun? I wouldn’t. That is why the looming probability that preemption
of tort litigation, which translates into English
as citizens giving up their right to have a day in court for toxicity or death related to FDA prescription
drugs, will become the law of the land, is particularly chilling. You see, the study by Giezen et al showed that one in four drugs
are found to have a dangerous side effects, like cancer, or impairment of the immune system
that can lead to life threatening infections after they have been on the market and approved
by the FDA that wasn’t known about before they were approved by the FDA.
It just isn’t possible to know all of the possible side effects of medications with the small numbers
of subjects that are included in studies leading up to the FDA approval process. The FDA itself admits that.
Which gets me to another topic that I have been harping about lately,
preemption, and
the case of Levine v Wyeth, which would take away the rights of citizens to have their day in
court for damage caused to them by FDA approved prescription drugs.
(See
"No Redemption for Preemption" and
"Some of Us Doctors Actually Care About Our Patients".
In a pair of letters,
Piwinski and Fitpatrick initially assert that the case of Riegel v Medtronic Inc., in which the Supreme Court
ruled that for medical devices that approval by the FDA preempted state law and eliminated the rights
of citizens to have a day in court, was a good thing, that we shouldn’t have juries and the right to trial
[causing Jefferson and Madison to toss in their graves, surely]
and that [in that particular case] the problem
was not that Medtronic made a lousy angioplasty device that exploded in the coronary artery
of the injured party, but that the guy had led a life of licence or had a star crossed
destiny that led to his demise.
Gostin replied that juries do not evaluate medical devices, they listen to medical experts,
and that we shouldn’t be ready to toss the constition just yet.
In an
editorial on these letters and the study of Giezen et al,
DeAngelis and Fontanaros cite the Institute of Medicine and FDA blue ribbon commission reports that noted
that the FDA was woefully inadequate to protect us from toxic side effects, and was putting Americans at risk.
They said that post approval the drugs are used in populations that are less carefully selected than participants
in clinical trials. [translation: the clinical trials pick squeaky clean participants that are least
likely to have a bad reaction, viz Chantix for stop smoking trial excluded patients with mental disorders,
who make up one fourth of the population and are twice as likely to smoke.
They then cut loose the drug on the population and were surprised when people started freaking out on the drug].
See
"Time To Die! (Oops) I Mean Time to Quit!"
DeAngelis and Fontanaros later write:
Tortlaw serves in effect as a way to close regulatory gaps
in the FDA premarketing approval process and to provide a
mechanism for postmarketing surveillance. Moreover, litigation
has been a rich source of information about how drug and device
manufacturing companies behave, such as with off-label promotion,
guest and ghost authorship, and reporting of safety findings.
Without the information revealed by the public release
of documents in tort liability actions, many of these behaviors
would remain unknown, some drug manufacturers judgments
about safety issues would be hidden from view, review, or oversight,
and the FDA would not be able to uncover them either.
In other words, law suits are the only way to keep the bastards honest.
Catherine DeAngelis is probably still pissed off about the
CLASS study of Celebrex that was published in JAMA when she was the editor, in which the authors
withheld data from the second six months of the study during which time Celebrex
patients were shown to have an increase in heart attacks.
That, my friends, is fraudulent.
But it isn’t clear that it would get snagged if preemption became the law of the land.
They further state that:
...drug manufacturers
have the authority and responsibility to modify labeling
when hazards manifest and may do so without
securing prior approval from the FDA...
The human body is in a constant state of change and the effects of some drugs
will manifest only after exposure over time. Furthermore, some
serious adverse drug effects are quite uncommon and require
use of the drug in large numbers of patients to become evident.
The safety of drugs in a clinical trial, the study type used for FDA
approval, is based on specific participant types, numbers, and
design that cannot ensure the true safety of a drug. In addition,
manipulation of study results by the drug manufacturers (who
almost always sponsor studies used for decisions about drug
approval) can obscure the true safety profile of a drug...
Therefore, unless and until the FDA drug approval process
and the postmarketing surveillance system improve significantly,
patients must have a means to seek recourse through
tort litigation against product manufacturers. Anything less
may well preempt the well-being and safety of the public.
In other words, the argument that the FDA alone decides what is a risky side effect, and that drug makers
can’t do anything without FDA approval, is poppycock.
I couldn’t agree more.
Pay attention guys. This isn’t just some bozo talking. This is from someone who has served
as the editor of JAMA, one of the leading journals in the medical field.
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Tom Lamb wrote a page to educated the public on his website
Here.
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OCTOBER 20, 2008
Some of Us Doctors Actually CARE About Our Patients!
The drug maker Wyeth has issued a
press release
on the topic of
preemption, as related to the case before the Supreme Court of Levine v. Wyeth.
Simply put, preemption strips away the rights of consumers to have redress in court
if they have a toxic or fatal side effect from an FDA approved prescription medication.
The
good people of Michigan have been struggling with this law for a decade,
and now the drug companies are trying to push it through to become the law of the land.
Here is their press release.
The public health is better served by having a single expert regulatory body making decisions
about risks, benefits, and warnings - rather than an ad hoc system that could produce hundreds of
conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile
or interpret. Such a system would undermine the careful balance struck by the FDA when making approval
decisions. If Wyeth prevails here, it will only reinforce the principle
that doctors are entitled to rely on FDA-approved professional labeling.
Ha ha ha ha ha ha ha!
These are just a FEW of the reasons I think this argument is ludicrous.
How can you say that their viewpoints are carefully balanced, when they are
guided by advisory panels of physician "key opinion leaders" that are usually on their
payrolls as consultants, speakers, and/or advisory board members? And the
fact that this advice is skewed can be shown by numerous examples, e.g.
the fact that "expert guidelines" recommend the use of statins for the
prevention of heart disease in women, when the evidence in the literature
clearly shows that there is no benefit, only the risk of harm in the
way of side effects? Preemption would effectively yank the protection that Americans get
from the judicial branch of government and leave the executive
and legislative branches in charge of protecting them. And what
do they know about drug safety? Since the FDA’s leadership is politically appointed,
this would put the responsibility for guarding Americans in the hands
of a small group of politicians who frequently benefit from donations from
pharmaceutical companies. Witness how Dan Troy went from representing
pharma to a job as chief counsel at the FDA, where he filed friends of the court
briefs on behalf of FDA on the side of pharmaceutical companies whose
medications had caused serious injury or death, on the rationale that since
the FDA had approved the medications that they had a stake in the outcome.
After this little jaunt he then tripped back to a cushy job in pharma.
Or here is another example. George Bush thought was so concerned
about protecting us from dangerous prescription medications, that he
appointed a veterinarian, Lester Crawford, to run our nation’s drug regulatory body, the
FDA. I’m not sure if I feel comfortable having an expert on cows
deciding which drugs end up in my medicine cabinet. Thankfully,
Lester was so stupid that he didn’t disclose or divest of the stocks he owned
in the pharmaceutical industry, and precipitously had to resign.
Lately we have had to watch senators shouting at the FDA to tell
him how much money they needed to keep America safe from Chinese
milk or pet food or the latest drug disaster. The Director couldn’t
tell him, or more likely wouldn’t, since his marching orders were to
keep the budget small.
With the
Prescription Drug User Fee Act" (PDUFA) resulting in pharmaceutical companies paying
more and more of the budget of the FDA, with PDUFA mandating that less goes to drug surveillance
(watching drugs already FDA approved),
the FDA is essentially working for them, so
sure pharma thinks it will be a good idea to have a "single regulatory body",
especially if it is working for them. And
outside reviews of the FDA
have said they are putting Americans at risk through their shoddy
regulation of prescription medications.
Another argument against preemption is that taking the issue out of
the courts removes a potential way to uncover fraud and deception
in the management of data related to clinical trials, something
that has come up not just once, but repeatedly, through the
discovery process of ongoing trials.
And what is the argument about the law being "impossible to interpret."
I have a suggestion for you, if a prescription medication is found to
have an adverse outcome, warn doctors and the public, and if is too
dangerous, take it off the market. That is what you are paying your
doctors and scientists to do, analyze your data and evaluate
risk/benefit ratios.
How about
...reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.
Let me translate that one for you:
Physicians, support this proposed ruling, because then you
won’t have to worry about covering your asses for prescription medication disasters.
I’ve got a thought for you, Wyeth. Maybe some of us physicians actually CARE about whether we are doing
harm or good for our pateints.
Whadya think about that?
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OCTOBER 20, 2008
The Prevention of Ignorance
A guest post, by Dan Abshear
Historically, information sources provided to American citizens were limited due to the few methods available to the public, such as radio, TV, or news print. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with arguably great elation, there is the internet, which can be rather beneficial for the average citizen.
Soon after the advent of the internet well over a decade ago, web logs were created, that are now termed ‘blogs’. At that time the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved into addressing topics that often were not often addressed in mainstream media, as they crossed previously existing political and social lines. In addition, blogs provide immediate contributions by others, the readers of the posts of the blog authors, instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers or magazines.
The authors of blogs vary as far as their backgrounds and intent of what they choose to address on their blogs exactly, just as with other media forms. Some are employed by the very media sources that existed before them. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that bloggers like to write, they may not be quality writers, yet several are in fact journalists, as well as doctors and lawyers, for example. But to write is to think, which I believe is a good quality one should have.
Yet presently, blogs have become quite a driving force for those with objectives and issues often opposed by others, and therefore have become a serious threat to others. These others may be politicians, our government, or corporations- all of which have been known to monitor the content of certain blogs of concern to them for their potential to negatively affect their image or their activities previously undisclosed. This is why blogs, on occasion, have become a media medium for whistleblowers, which will be addressed further in a moment.
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow in addition to the comments of its readers the posting of authentic internal or confidential documents that typically are not created to be viewed by the public, yet are acquired by certain bloggers. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter published by pharmaceutical company AstraZeneca on his blog site, and this newsletter was given to him by AstraZeneca’s employees who called themselves the ‘AZ Group of Seven’- with the intent of this group being to bring to the attention of others the illegal activity of off-label promotion of one of AZ’s cancer drugs promoted by their employer. Yet this particular concern by AZ seven, by surprise, is not what caught the attention of so many who viewed the posted newsletter by Dr. Rost and was read with great interest by others. It was instead a comment included in this newsletter that was stated by former regional AZ manager Mike Zubalagga, who was being interviewed by a district manager in this newsletter. Mr. Zubalagga, who in this newsletter posted on Dr Rost’s blog site, referred to doctors’ offices as ‘buckets of money’, which caught the attention of several readers. This and other statements by this man were in fact published in this newsletter clearly not reviewed before its publication. . Again, the statement and the newsletter created by AZ was indeed authentic and further validated due to the content being in the written word, which added credibility.
Mr. Zubalagga was fired the next day due to this ‘buckets of money’ comment due to the effect it had on the image of his employer. His manager resigned soon afterwards from AZ.
Blogs, one can safely conclude, reveal secrets.
And there have been other whistleblower cases on various blogs in addition to this one described a moment ago, which illustrates the power of blogs as being a very powerful and threatening media medium of valid information disclosure that others cannot prevent from occurring.
This, in my opinion, is true freedom of information- largely free of embellishments or selective omissions. It’s a step towards communication utopia, perhaps, yet a force that has the ability to both harm and protect many others.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made, as with other media sources. Of course, documents that are authentic is an example of a good validation source. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs, which may be a type of Socratic learning.
Like other written statements, some on such internet sites are composed with respect of the written word. Others are not. It’s the freedom that may be most appealing of this new medium which has the ability to convert citizens into journalists who want to contribute to an issue of their concern they share with the blogger often with great conviction and accuracy.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information disclosed on blogs could potentially be adverse to our well-being.
Ignorance is bliss, but knowledge is power.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear
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OCTOBER 17, 2008
DON’T PANIC!! KEEP TAKING YOUR VYTORIN! (I MEAN ASPIRIN)!
A study in the British Medical Journal published today
showed that aspirin confers no benefit in the prevention of heart attack or stroke, and may increase the risk of bleeding,
in patients with diabetes (who are considered at "hi-risk" for these problems)
The prevention of progression of arterial disease and diabetes (POPADAD) trial involved 1276 adults over age 40
with diabetes from 16 hospitals in Scotland. Primary outcome was heart attack or stroke
(fatal or non fatal) or amputation because of ischemia. Patients were treated with four variations of combinations of aspirin,
antioxidant pills, or placebo.
The antioxidant capsule contained alpha-tocopherol 200 mg, ascorbic acid 100 mg, pyridoxine hydrochloride 25 mg,
zinc sulphate 10 mg, nicotinamide 10 mg, lecithin 9.4 mg, and sodium selenite 0.8 mg.
There were no differences in the primary end point between those treated with aspirin plus antioxidant (58) (18%),
aspirin plus placebo 59 (18%), placebo plus antioxidant (59) (18%), or placebo plus placebo (58) (18%), p value=0.92.
People who took antioxidants actually had higher mortality, about 23%, compared to those who didn’t at about 16%.
More people who took aspirin (57) had gastrointestinal bleeding than those who did not (45), difference that was not
statistically significant.
The dismal results of this study did not stop a doctor from saying
"Don’t panic and don’t stop taking your aspirin!".
Kind of reminds me of the doc who said
"Don’t stop taking your..." You’ve got it. But we know who he was working for.
POPADAD... I wonder who came up with the name of that one anyway. Did you know that they make up the names
of the trials, and then try and come up with words that make sense to fit into the initials? But POPADAD is a good one.
It’s even better than VIGOR or ENHANCE. Kind of like
"who’s your daddy?" Maybe... the vitamin manufacturer?
Anyhoo, POPADAD’s results are yet more news that antioxidant vitamins are not helpful and actually increase
the risk of mortality as I have written about before.
I have also warned people that
the risk of bleeding outweighs the benefit of heart attack prevention for people without heart disease
who take a daily aspirin.
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Dan Abshear wrote on Friday Oct 17, 2008
Willow Bark Benefits
An Oldie, But A Goodie
Almost on a daily basis, one may read about a new medication being developed or approved for the benefit of patients. At times, these announcements may praise the innovation and novelty of such new drugs that are available to all in need of it.
But it’s possible the one super drug is not new and really is a super drug. In fact, it’s one of the oldest medications available, and that would be aspirin- the first non-steroidal anti-inflammatory drug (NSAID).
Noted as ASA by doctors typically, aspirin effects have been noted for thousands of years, as the active ingredient comes from the bark of a White Willow tree, and long ago, patients with pain or a fever would chew on this bark for relief. Yet due to the harshness of the natural chemical of this bark, Bayer decided to synthesize it to make it more friendly to the user.
Fast forward to over a hundred years ago and Bayer pharmaceuticals (pronounced ‘Beier’), which is the same company that brought us heroin and mustard gas, as well as methadone. The company originated in Germany, but presently has its U.S. headquarters in New York. Felix Hoffman, seeking to develop an agent for his father’s rheumatism, was involved in the development of what is known now as aspirin. And it was a difficult task to develop this drug, as it was toxic to the stomach due to the nature of the active ingredient again obtained from the bark of the white willow tree. Dr. Hoffman and others at Bayer developed a drug that proved to be tolerable to patients while keeping the active ingredient in tact through a method of delivery developed by Dr. Hoffman’s team at Bayer. After launching the medication, aspirin was priced at about 50 cents an ounce, as at the time it was only available in power form. Soon before 1920, aspirin developed the tablet form of the drug and was then available by prescription. Regardless, aspirin was responsible for one third of sales for Bayer during this time, due to its popularity due to the effects of this medication in need of relief.
While all drugs have side effects, aspirin is one of very few drugs that provides great efficacy and indications, with limited side effects. In fact, some of aspirin’s additional uses have been recently discovered. This may be why the New York Times called aspirin a wonder drug in the 1960s. In the 1970s, the mechanism of aspirin was isolated, which is the blockage of prostaglandins.
With Aspirin and its potential life-extending benefits:
Aspirin has been associated with decreased risk of asthma and prostate cancer in the elderly. Also, aspirin has been linked with lowering the risk of breast cancer and colon cancer as well. Aspirin is a blood thinner, and has been associated with decreasing the risk of heart attacks and strokes in certain patient populations, as the drug prevents clots. This was first suggested in the 1940s and the FDA suggested that it be the drug of choice for those who experienced a heart attack over a decade ago. Aspirin intake is beneficial for those after coronary bypass procedures. A topical formulation of aspirin was developed recently for those experiencing Herpes pain. The drug has been proven beneficial for those experiencing migraine pains. Aspirin at low doses is taken by many as a preventive drug to decrease cardiovascular incidents that may occur.
Aspirin has been the best selling painkiller absent of the past addictive qualities of opiate meds since the 1950s. It is also the most studied drug- with over 3000 scientific papers published worldwide. Also, over 15 billion tablets of aspirin are sold annually, which amounts to about 80 million aspirin tablets consumed daily by others. This amounts to over 16,000 tons of aspirin consumed during this time, or about 70,000 metric tons of aspirin a year. Over a decade ago, a study was performed and concluded that twice as many people would choose aspirin over a computer, given the two choices, because of the benefits of the drug.
Side effects would include GI bleeding if taken in large amounts, along with an association of Reye’s syndrome in children, yet both are relatively rare. Yet all things considered, clearly the benefits of aspirin outweigh any risks of the drug.
Lately, there have been issues with other NSAIDs, such as Cox II inhibitors, without full recollection or knowledge that aspirin is in fact the world’s most widely used drug, and for good reasons.
At times, something newer is not always better.
“There is no genius without a touch of madness.” --- Vaslav Nijinsky
Dan Abshear
originally posted on Medical News Today .com
OCTOBER 16, 2008
Before You Take That Pill, Read This Letter from Vexed Former Pharma Exec
Still reading your book. The HTN chapter now. Way to go discussing the ALLHAT trial. I was selling
an ARB when the results were released, and was glad actually what the results were from that trial, which
was funded by the NIH (I was a pharma critic even then). Sampling generics would solve many issues with
the cost of prescribing, but that would be beneficial for the patient, so, of course, that will not happen.
ALLHAT was never actualized because of both intentional lack of media attention, journals and other forms,
as well as copious amounts of branded HTN med samples left often with all who prescribe, as the prescriber
ignores deliberately the reality of appropriate treatment.
Samples are the number one influencer of your prescribing habits. I’d have 20 cases of Cozaar in my
possession when that study came out to dispense aggressively. That amounts to tens of thousands of pills
of Cozaar. I’d increase market share of Cozaar without ever knowing or meeting a doctor who would reflect
this growth by leaving samples only. UPS in a suit, my friend.
Kickbacks are in second place. It’s unfortunate. I’d spend close to 100 grand a year directly to doctors
very creatively, and similar to money laundering. And was coerced to do this for no reason other than
speculated reciprocity, and this act which would metamorphasize in various ways, yet was always tacit and secretive.
My writing is atonement, in a way. Mea Culpa remains intrinsically, however, within me.
Finally, I belong to some advocacy groups such as www.npalliance.org, www.communitycatalyst.org,
and others. Some are for doctors only. Might want to check such sites out, as you would benefit their
missions, I believe.
Thanks for reading this long note from a vexed ex pharma exec.
Postscript: There are also some interesting comments from marketing execs writing on this topic
anonymously on pharmalot.com here.
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Doug Bremner wrote on October 17, 2008
Note: Diuretic medications [the "old"] medications were shown to be safer than the "new" angiotension converting enzyme (ACE) inhibitors and
calcium channel blockers in the
ALLHAT study.
ALLHAT (2002): Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). Journal of the American Medical Association 288:2981-2997.
ALLHAT. JAMA 2002;288(23):2981-2997. *lisinopril (Prinivil)-angiotensin converting enzyme inhibitor or ACEI; >chlorthalidone (Hygroton)-diuretic, p<0.05; **
lisinopril and amlodipine (Norvasc) – Calcium channel blocker, or CACB >chlorthalidone, p<.05); doxazasin (alpha receptor blocker) stopped early (CHF)
OCTOBER 15, 2008
A Reader Notes That Evidence for Harm from Saturated Fats is not that Great
David Diamond wrote on Thursday Oct 16, 2008
hi Doug
I just read your book - before you take that pill - absolutely fantastic work - beautifully written Imagine that, an MD warning people about taking drugs as commonly prescribed as statins and antidepressants, and recommending exercise and diet - you’re quite a rebel!
the only criticism I’d like to offer is that your concern about saturated fat/meat is based on poorly conducted and biased research of the last 40 years - the fear of saturated fat is completely unsupported by rigorous research.
the literature of the opposing view is extensive, which indicates that the poor health (e.g., obesity) in westernized societies can be traced almost entirely to excess calories derived from refined sugar and hydrogenated fats, not from meat I could send you some info if you’re interested.
David Diamond: Thanks for the note, David. Yes it would be nice if you could forward some of this literature and I could
post it here. I admit I did not research the primary data for the saturated fats story. That is almost a topic for another story.
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OCTOBER 15, 2008
More Bullshit Healthcare Proposals From Our So-Called Future Leaders
I am watching the Obama-McCain debate on TV right now and I thought I should offer some
’’medical perspective’.
First of all, my disclosures are that I hope that Obama wins.
Ha ha ha ha ha ha ha ha ha!
Ok, so said.
Obama said he wanted a univeral digital healthcare registry system.
Well that is not possible, honey! with all the conflicting insurance programs where there
is no possibility of sharing information, there is no possibility that there could be a
common digital sharing system. The only possibility would be a national healthcare system.
And given the inherent American aversion to nationalization, that will never happen.
In spite of the fact that a national health care system is CLEARLY in the interests
of American PATIENTS.
McCain has this bullshit plan where he is going to eliminate the tax break
employers get for paying for half of your insurance, and he is going to
give you instead $5,000 per year to pay for health insurance. He is going to
use the private market to improve our broken system.
Well if that isn’t the stupidest idea I have ever heard. You
are going to take a system that is already broken, and give
it more power? I think it has been clearly shown that this is
going to INCREASE the number of uninsured, not decrease it.
My friend, sit down and shut up.
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Steve Rhodes wrote on Thursday Oct 16, 2008
You’re right that Obama’s stated plans are far from perfect… but I think (as apparently you) obviously far better than Republican alternatives.
Steve Rhodes
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OCTOBER 14, 2008
WE COME IN PEAS
I wanted to let everyone know that today is a special day.
It was announced several months ago that on today, October 14, 2008,
an 800 mile long
space craft will appear above the United States and hover there for two to three days.
There are a number of videos circulating on Youtube about the event.
Apparently, they are coming in such a large ship so that the mainstream media and government
won’t be able to cover up their appearance. Because if you show up in an 800 mile long
spaceship-- that’s kind of hard to keep secret, don’t you think?
They are apparently coming in peace in order to demonstrate to us that they exist, but are
using such a large ship so that there will be no way for the government or the media to conceal their
appearance. Many new age people (see below) feel that the arrival of the aliens will
coincide with a higher level of consciousness which includes peace with others and a respect of the
earth, including preserving the environment.
Our family, largely spurred by our daughter Sabina, has been trying to improve our footprint
on the earth. We collect water in buckets while waiting for the water to get hot in the shower
(we have a drought in Atlanta, GA), we put our vegetable refuse in a composte pile, and we
recycle. In the future we will try and use solar and other similar types of power.
We also get our vegetables from local community supported agriculture (CSA) group,
which means we pay a local network of Georgia farmers to drop off whatever vegetables they
have grown that week where we pick it up. We eat whatever is growing in Georgia that
week to avoid the carbon footprint of buying vegetables from Argentia or whereever.
Another one of my daughter’s ideas.
Which brings me to my next point.
We come in peas.
An old friend of my mother’s who was moved by a
memorial service we had for my mom last week
who
died in 1966
wrote to inform me that our service indeed signified spiritual healing and he implied that it was a sign
of better things to come.
I think my mom would like my daughter Sabina.
You see, many people with so-called New Age beliefs think that
we are moving toward a better time in our society when people will be able to abandon war and conflict and live together in
harmony.
I could live with that!
I’d even be willing to give up my Veterans Administration and Department of Defense research grants
on posttraumatic stress disorder (PTSD) related to Iraq combat for that!
Many thought the better time would happen in 1987, when there would be a so-called cosmic convergence. A lot of
people "converged" on places like Stonehenge and Sedona, Arizona, where there are special vortexes and other
things that permit connections with other dimensions.
As seen by President Bush’s invasion of Iraq, they were not completely successful.
New Age believers also look to the Mayan calendar which combines
calenders of 260 and 365 days into a cycle of so called Haabs, that represent a cyclical turning of time.
The Mayan calendar will end on December 12, 2012, following which the universe will presumably sucked away
like something being dragged into a cosmic toilet.
Many New Age believers look to various events as signifying the arrival of the new age.
The psychic Dr. Ralph Duby apparently "channeled" some information from a cosmic source regarding
the passing of my mother back in 1966.
But I’m not going to tell you what it was.
Ha ha ha ha ha!
I am glad to learn, however, that the ceremony for her is ushering in a better age when we may perhaps
be able to better live with people from other galaxies.
After all, our son does meet criteria for an Indigo Child.
And when he was a child we called him a "chip from outer space".
Coincidence? Space child? Who knows.
However, the Youtube sources say that the spaceship will arrive in Alabama. We have some sources
on our "Drug Safety and Health News Blog" network (you know who you are girls)
so I am sending out an urgent appeal.
When the spaceship appears, since the government will likely jam all sources of communication,
will you get on your ponies and ride over to Georgia and give us the warning?
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Ken wrote on Tue, 14 Oct 2008,
URL : www.lionbiocon.com;
Comment : Perhaps there is a grain of truth beneath all the fluff. Somethings going down my friend, and its not just a speed bump to be followed by business as usual.
Read the update here!
OCTOBER 14, 2008
DISCLOSURES... and paxil, paroxetine, seroxat, etc etc
My disclosures are on my web sites (click the link called "disclosures"), and interested readers can
follow the links to see the topics of my research, which include the effects of paroxetine
...
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OCTOBER 10, 2008
An Open Letter to Senator Charles Grassley (R-Iowa) From a Professor of Psychiatry at Emory University
This week the Chairman of my department at Emory, Charles Nemeroff, M.D., Ph.D., got caught up in a
a broo-ha-ha
about unreported earnings from outside activities related to giving lectures that were supported by the pharmaceutical industry.
This led to his resignation pending the result of an inquiry into the allegations raised by Senator Charles Grassley.
Mind you, I am not here to justify Dr. Nemeroff’s bad behavior. To not disclose the payment of more than $10,000 a year
from a drug company that makes a drug you are also studying with an NIH funded grant is clearly a violation of NIH policy
(although not a violation of the law).
Nevertheless, I have some questions for the Senator.
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OCTOBER 10, 2008
Response to University Diaries
I was attending a
memorial for my mother who died in 1966 this Saturday which
was a little fraught with conflict since my father remarried and the
"old mom" wasn’t always the most popular topic of conversation, when...
...the chairman of my department
imploded.
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Here is the Emory press release for my ’Pill’ book that was never... released (sniff, sniff)
The Missing Press Release
DRAFT COPY
EMORY Health Sciences News
http://www.whsc.emory.edu
XXX, 2008
Medications Put to the Test in New Book by Emory Researcher and Author
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SEPTEMBER 30, 2008
The Ups and Downs of the Dow Jones Industrial Average, Interpreted from a Personal Perspective (Literally)
We’ve known for some time that noone can predict the stock market, and that the efforts of stock pickers routinely
come out worse than chance. Now we are learning that noone has a clue about what to do about the current financial
meltdown, or where the Dow Jones Industrial Average (DJIA) will go in the future.
So I thought I would try a new approach. Why not interpret the stock market from the point of view of my personal life?
Yes, me. Doug Bremner. I mean why not? Maybe the events of my life and those of my family have an influence on the stock market
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SEPTEMBER 28, 2008
Health News You Won’t Read About in the New York Times
Here’s a forgotten chapter from pharmaceutical history. The acne drug, Accutane, manufactured by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005 the iPLEDGE program has required that patients, doctors, and pharmacists register and that patients prove they are on birth control before they can be prescribed this potentially dangerous drug.
But it wasn’t always that way.
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SEPTEMBER 9, 2008
Out-FOXed Again!
Last night I got a chance to watch the rest of the
Mike and Juliet Show
entitled "M&J Investigates" Accutane on TiVo. I am glad they put "investigates" in quotes because
the shoddy shuffling out of bogus MDs and random opinions hardly qualifies as "journalism".
Well things only got worse after the commercial break.
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SEPTEMBER 5, 2008
NO REDEMPTION FOR PREEMPTION
While Americans sit mesmerized by Sarah Palin clapping into the microphone and rambling on about
Greek Columns while her daughter wipes down her youngest child’s hair with her own spit, they are
utterly unaware of yet another attempt by the government to steal even more of their civil
rights and liberties. As if the “Patriot” Act wasn’t enough, the war mongerers now want to take away
your civil rights in the form of redress in the event that you or your family are damaged by dangerous
prescription drugs.
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July 17, 2008.
Blogmersion, Part 2: McProfessor.com
Now that I got on the psychiatry roll it’s hard to stop. After all I went into psychiatry because I was
really interested in philosophy and writing but they told me I couldn’t make a living that way. But what
about Socrates? Didn’t he live off of donations?
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July 16, 2008.
Blogmersion, Part 1: YouTube & Me
Salim Hamdan was a driver for Osama Bin Ladin who recently went on trial for terrorist activities. He seemed to have no interest
in the trial proceedings, being only interested in being moved from cell block 4 (where he was kept in isolation)
to cell block 5 (where he was with other detainees).
"What do I have a lawyer for if you can’t help me?" (i.e. get me back into cell block 5) he asked his lawyers, rhetorically.
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July 15, 2008.
More Bad News About Osteoporosis Drugs
Well it’s back from summer vacation and reviewing what happened while I was away
and today there was an article
in the New York Times about the potential for increased risk of fracture with bisphosphonate drugs like Fosamax
used for the treatment of osteoporosis.
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June 11, 2008.
Time To Die! (Oops! I Mean Time To Quit!)
I was sitting in my car dealership today waiting to get service on my car and working
on my laptop while the television was droning on in front of me. I mean this is one of the rare
times when I watch TV without the benefit of Tivo to pause the commercials or otherwise avoid them.
And it was like one prescription medication ad after another!
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June 2, 2008.
Mommy, Can I Have a Yummy Blue Pill?
Pharmaceutical companies are great about turning out prescription medications with hip designer
colors like deep blue, lavender, brightly colored red, and let’s not forget ’the purple pill’
(Nexium, for those of you without a TV). Those lovely colors make us say ’Yummy!’ and
increase our desire to wolf them down as fast as possible.
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