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Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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July 26, 2005

Merck on Trial

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Posted by Derek

I haven't been talking about the Merck-Vioxx trial, but people are asking me how I think the it's is going. Unfortunately, I have no idea. And, I'd think that most of the people commenting on it in the press have no idea, either, when you get right down to it. All I know about the testimony is what I read in the media, and I'm not willing to accept that data as good enough to use.

The daily reports coming out of Texas are probably about as misleading as a round-by-round commentary of a boxing match. Anyone reporting this story is looking for exciting news, a big quote, a damaging revelation or slip-up. That's what will get the most play, and if there wasn't anything in those categories on a given day, the next best thing will do. A trial is a natural fit for the narrative instincts of most reporters, and that's what the readers expect to see, too.

The similarities to the reporting of an electoral campaign or confirmation hearing should be kept in mind, and a political scandal is the perfect example of the form. Punch! Counterpunch! Attack from the right! Feint from the left! A steady delivery of reasonably sized news chunks keeps the story moving along, the viewers tuned in, and the readers buying papers. Never ignore narrative bias; you're soaking in it.

But, unlike a boxing match, we don't know who's ahead on points so far in the Merck trial. The jury will be influenced by the facts presented to them, but also how they were presented and by whom. All of this will be layered on top of what they already know and the opinions that they already have. I don't presume to know what's going through their minds, because even if I were sitting there in the courtroom with them, I'd surely have a different perspective on the whole matter. If I had to guess, I'd say that Merck has a reasonable chance of getting out of this one. But I'm not putting any money down on that opinion. Merck's got enough on the table for everyone.

Well, fine, you say - but who should win? Grudgingly, I have to admit that I don't know the answer to that one, either. The details of the death in this case aren't all out yet, and I'm not a pathologist. And the details of Merck's internal knowledge and subsequent marketing decisions aren't all out yet, either. I think that their problem was believing what they wanted to believe (a tendency never to be underestimated), but it could end up looking worse (or better) than that.

However, it does seem clear that COX-2 inhibitors have caused, or at least contributed to, some deaths. Balancing those against the benefits they may have had for a much larger group of people is a very difficult calculation, but it's one that you'd have to make before coming to a final judgment on the whole class. The FDA has, of course, decided to leave the drugs on the market, so you know where they finally came down.

But the overmarketing of the drugs (by everyone, not just Merck) is, in the end, how we got into this situation. If COX-2 inhibitors had been prescribed mostly to people who had demonstrated an intolerance to the existing drugs, I doubt if any excess deaths would have been noticeable even had they occurred. (But if that had been the expected market, how many companies would have entered the field at all?)

Things have come to the point where many companies have made the decision not to get involved in huge marketing battles over blockbuster drugs. They're trying to put together a business out of more specialized drugs in less competitive areas, or where there's less direct-to-consumer marketing (which is quite expensive.) The pendulum, perhaps, is swinging back.

Comments (16) + TrackBacks (0) | Category: Cardiovascular Disease


1. Don Butler on July 27, 2005 8:49 AM writes...

Dear Sir: The right portion of your comments are covered by the advertisements on the right of my screen when I try to read youe blog.

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2. David Rindge on July 27, 2005 3:24 PM writes...

Vioxx is a disaster of unprecedented proportions. According to David Graham who was the associate director of FDA's Office of Drug Safety, Vioxx caused between 89,000 and 139,000 heart attacks and strokes, and 30-40% of those died. This means Vioxx (by itself) may have killed nearly 56,000 people, a number greater than all American casualties in Vietnam.

Even if the body count were only a fraction of this estimate, I believe that the numbers are far too great to be swept under the rug.


Testimony of David J. Graham, MD, MPH, November 18, 2004
Mr. Chairman and members of the Committee,

Introduction. Good morning. My name is David Graham, and I am pleased to come before you today to speak about Vioxx, heart attacks and the FDA. By way of introduction, I graduated from the Johns Hopkins University School of Medicine, and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. After this, I completed a three-year fellowship in pharmacoepidemiology and a Masters in Public Health at Johns Hopkins, with a concentration in epidemiology and biostatistics. Over my 20 year career in the field, all of it at FDA, I have served in a variety of capacities. I am currently the Associate Director for Science and Medicine in FDA’s Office of Drug Safety.

During my career, I believe I have made a real difference for the cause of patient safety. My research and efforts within FDA led to the withdrawal from the US market of Omniflox, an antibiotic that caused hemolytic anemia; Rezulin, a diabetes drug that caused acute liver failure; Fen-Phen and Redux, weight loss drugs that caused heart valve injury; and PPA (phenylpropanolamine), an over-the-counter decongestant and weight loss product that caused hemorrhagic stroke in young women. My research also led to the withdrawal from outpatient use of Trovan, an antibiotic that caused acute liver failure and death. I also contributed to the team effort that led to the withdrawal of Lotronex, a drug for irritable bowel syndrome that causes ischemic colitis; Baycol, a cholesterol-lowering drug that caused severe muscle injury, kidney failure and death; Seldane, an antihistamine that caused heart arrhythmias and death; and Propulsid, a drug for night-time heartburn that caused heart arrythmias and death. I have done extensive work concerning the issue of pregnancy exposure to Accutane, a drug that is used to treat acne but can cause birth defects in some children who are exposed in-utero if their mothers take the drug during the first trimester. During my career, I have recommended the market withdrawal of 12 drugs. Only 2 of these remain on the market today-Accutane and Arava, a drug for the treatment of rheumatoid arthritis that I and a co-worker believe causes an unacceptably high risk of acute liver failure and death.

Vioxx and heart attacks. Let me begin by describing what we found in our study, what others have found, and what this means for the American people. Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx. The labeling at approval said nothing about heart attack risks. In November 2000, another Merck clinical trial named VIGOR found a 5-fold increase in heart attack risk with high-dose Vioxx. The company said the drug was safe and that the comparison drug naproxen, was protective. In 2002, a large epidemiologic study reported a 2-fold increase in heart attack risk with high-dose Vioxx and another study reported that naproxen did not affect heart attack risk. About 18 months after the VIGOR results were published, FDA made a labeling change about heart attack risk with high-dose Vioxx, but did not place this in the “Warnings” section. Also, it did not ban the high-dose formulation and its use. I believe such a ban should have been implemented. Of note, FDA’s label change had absolutely no effect on how often high-dose Vioxx was prescribed, so what good did it achieve?

In March of 2004, another epidemiologic study reported that both high-dose and low-dose Vioxx increased the risk of heart attacks compared to Vioxx’s leading competitor, Celebrex. Our study, first reported in late August of this year found that Vioxx increased the risk of heart attack and sudden death by 3.7 fold for high-dose and 1.5 fold for low-dose, compared to Celebrex. A study report describing this work was put on the FDA website on election day. Among many things, this report estimated that nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx. I emphasize to the Committee that this is an extremely conservative estimate. FDA always claims that randomized clinical trials provide the best data. If you apply the risk-levels seen in the 2 Merck trials, VIGOR and APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died. For the survivors, their lives were changed forever. It’s important to note that this range does not depend at all on the data from our Kaiser-FDA study. Indeed, Dr. Eric Topol at the Cleveland Clinic recently estimated up to 160,000 cases of heart attacks and strokes due to Vioxx, in an article published in the New England Journal of Medicine. This article lays out clearly the public health significance of what we’re talking about today.

So, how many people is 100,000? The attached Tables 1 and 2 show the estimated percentage of the population in your home State and in selected cities from your State that would have been affected had all 100,000 excess cases of heart attack and sudden cardiac death due to Vioxx occurred only in your State or city. This is to help you understand how many lives we’re talking about. We’re not just talking numbers. For example, if we were talking about Florida or Pennsylvania, 1% of the entire State population would have been affected. For Iowa, it would be 5%, for Maine, 10% and for Wyoming, 27%. If we look at selected cities, I’m sorry to say, Senator Grassley, but 67% of the citizens of Des Moines would be affected, and what’s worse, the entire population of every other city in the State of Iowa.

But there is another way to put this range of excess cases into perspective. Imagine that instead of a serious side-effect of a widely used prescription drug, we were talking about jetliners. Please ignore the obvious difference in fatality rates between a heart attack and a plane crash, and focus on the larger analogy I’m trying to draw. If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2-4 aircraft every week, week in and week out, for the past 5 years. If you were confronted by this situation, what would be your reaction, what would you want to know and what would you do about it?

Brief history of drug disasters in the US. Another way to fully comprehend the enormity of the Vioxx debacle is to look briefly at recent US and FDA history. The attached figure shows a graph depicting 3 historical time-points of importance to the development of drug safety in the US. In 1938, Congress enacted the Food, Drug and Cosmetic Act, basically creating the FDA, in response to an unfortunate incident in which about 100 children were killed by elixir of sulfanilamide, a medication that was formulated using anti-freeze. This Act required that animal toxicity testing be performed and safety information be submitted to FDA prior to approval of a drug. In 1962, Congress enacted the Kefauver-Harris Amendments to the FD&C Act, in response to the thalidomide disaster in Europe. Oversees, between 1957 and 1961, an estimated 5,000 to 10,000 children were born with thalidomide-related birth defects. These Amendments increased the requirements for toxicity testing and safety information pre-approval, and added the requirement that “substantial evidence” of efficacy be submitted. Today, in 2004, you, we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could have, should have been largely or completely avoided. But it wasn’t, and over 100,000 Americans have paid dearly for this failure. In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust. I believe there are at least 3 broad categories of systemic problems that contributed to the Vioxx catastrophe and to a long line of other drug safety failures in the past 10 years. Briefly, these categories are 1) organizational/structural, 2) cultural, and 3) scientific. I will describe these in greater detail in a few moments.

My Vioxx experience at FDA. To begin, after publication of the VIGOR study in November 2000, I became concerned about the potential public health risk that might exist with Vioxx. VIGOR suggested that the risk of heart attack was increased 5-fold in patients who used the high-dose strength of this drug. Why was the Vioxx safety question important? 1) Vioxx would undoubtedly be used by millions of patients. That’s a very large number to expose to a serious drug risk. 2) heart attack is a fairly common event, and 3) given the above, even a relatively small increase in heart attack risk due to Vioxx could mean that tens of thousands of Americans might be seriously harmed or killed by use of this drug. If these three factors were present, I knew that we would have all the ingredients necessary to guarantee a national disaster. The first two factors were established realities. It came down to the third factor, that is, what was the level of risk with Vioxx at low- and high-dose.

To get answers to this urgent issue, I worked with Kaiser Permanente in California to perform a large epidemiologic study. This study was carefully done and took nearly 3 years to complete. In early August of this year, we completed our main analyses and assembled a poster presentation describing some of our more important findings. We had planned to present these data at the International Conference on Pharmacoepidemiology, in Bordeaux, France. We concluded that high-dose Vioxx significantly increased the risk of heart attacks and sudden death and that the high doses of the drug should not be prescribed or used by patients. This conclusion triggered an explosive response from the Office of New Drugs, which approved Vioxx in the first place and was responsible for regulating it post-marketing. The response from senior management in my Office, the Office of Drug Safety, was equally stressful. I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting, and also noted that Merck needed to know our study results.

An email from the Director for the entire Office of New Drugs, was revealing. He suggested that since FDA was “not contemplating” a warning against the use of high-dose Vioxx, my conclusions should be changed. CDER and the Office of New Drugs have repeatedly expressed the view that ODS should not reach any conclusions or make any recommendations that would contradict what the Office of New Drugs wants to do or is doing. Even more revealing, a mere 6 weeks before Merck pulled Vioxx from the market, CDER, OND and ODS management did not believe there was an outstanding safety concern with Vioxx. At the same time, 2-4 jumbo jetliners were dropping from the sky every week and no one else at FDA was concerned.

There were 2 other revelatory milestones. In mid-August, despite our study results showing an increased risk of heart attack with Vioxx, and despite the results of other studies published in the literature, FDA announced it had approved Vioxx for use in children with rheumatoid arthritis. Also, on September 22, at a meeting attended by the director of the reviewing office that approved Vioxx, the director and deputy director of the reviewing division within that office and senior managers from the Office of Drug Safety, no one thought there was a Vioxx safety issue to be dealt with. At this meeting, the reviewing office director asked why had I even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done. At this meeting a senior manager from ODS labeled our Vioxx study “a scientific rumor.” Eight days later, Merck pulled Vioxx from the market, and jetliners stopped dropping from the sky.

Finally, we wrote a manuscript for publication in a peer-reviewed medical journal. Senior managers in the Office of Drug Safety have not granted clearance for its publication, even though it was accepted for publication in a very prestigious journal after rigorous peer review by that journal. Until it is cleared, our data and conclusions will not see the light of day in the scientific forum they deserve and have earned, and serious students of drug safety and drug regulation will be denied the opportunity to consider and openly debate the issues we raise in that paper.

Past experiences. My experience with Vioxx is typical of how CDER responds to serious drug safety issues in general. This is similar to what Dr. Mosholder went through earlier this year when he reached his conclusion that most SSRIs should not be used by children. I could bore you with a long list of prominent and not-so-prominent safety issues where CDER and its Office of New Drugs proved to be extremely resistant to full and open disclosure of safety information, especially when it called into question an existing regulatory position. In these situations, the new drug reviewing division that approved the drug in the first place and that regards it as its own child, typically proves to be the single greatest obstacle to effectively dealing with serious drug safety issues. The second greatest obstacle is often the senior management within the Office of Drug Safety, who either actively or tacitly go along with what the Office of New Drugs wants. Examples are numerous so I’ll mention just a few.

With Lotronex, even though there was strong evidence in the pre-approval clinical trials of a problem with ischemic colitis, OND approved it. When cases of severe constipation and ischemic colitis began pouring into FDA’s MedWatch program, the reaction was one of denial. When CDER decided to bring Lotronex back on the market, ODS safety reviewers were instructed to help make this happen. Later, when CDER held an advisory committee meeting to get support for bringing Lotronex back on the market, the presentation on ways to manage its reintroduction was carefully shaped and controlled by OND. When it came to presenting the range of possible options for how Lotronex could be made available, the list of options was censored by OND. The day before the advisory meeting, I was told by the ODS reviewer who gave this presentation that the director of the reviewing office within OND that approved Lotronex in the first place came to her office and removed material from her talk. An OND manager was “managing” an ODS employee. When informed of this, ODS senior management ignored it. I guess they knew who was calling the shots.

Rezulin was a drug used to treat diabetes. It also caused acute liver failure, which was usually fatal unless a liver transplant was performed. The pre-approval clinical trials showed strong evidence of liver toxicity. The drug was withdrawn from the market in the United Kingdom in December 1997. With CDER and the Office of New Drugs, withdrawal didn’t occur until March 2000. Between these dates, CDER relied on risk management strategies that were utterly ineffective and it persisted in relying on these strategies long after the evidence was clear that they didn’t work. The continued marketing of Rezulin probably led to thousands of Americans being severely injured or killed by the drug. And note, there were many other safer diabetes drugs available. During this time, I understand that Rezulin’s manufacturer continued to make about $2 million per day in sales.

The big picture. The problem you are confronting today is immense in scope. Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.

It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken. Now, I’m sure you have read the recent proposal to have the Institute of Medicine perform a review of CDER and its drug safety program and make recommendations for fixing things up. Don’t expect anything meaningful or effective from this exercise. Over the history of CDER’s drug safety program, a number of similar reviews have been done. In the late 1970’s, I believe that a blue ribbon panel recommended that there be an entirely separate drug safety operation in FDA with full regulatory authority. It wasn’t implemented. During the 1980’s and early 1990’s, CDER organized its own “program reviews” of drug safety. The basic premise underlying each of these reviews was that the “problem” was with the drug safety group; it didn’t fit into the Center. So, the charge given to the review panel members was always framed as “figure out what’s wrong with drug safety, and tell us what to do to get it to fit in.” There was and is an implicit expectation that the status quo will remain unaltered.

The organizational structure within CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is “safe and effective.” When a serious safety issue arises post-marketing, their immediate reaction is almost always one of denial, rejection and heat. They approved the drug so there can’t possibly be anything wrong with it. The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest. At the same time, the Office of Drug Safety has no regulatory power and must first convince the new drug reviewing division that a problem exists before anything beneficial to the public can be done. Often, the new drug reviewing division is the single greatest obstacle to effectively protecting the public against drug safety risks. A close second in my opinion, is an ODS management that sees its mission as pleasing the Office of New Drugs.

The corporate culture within CDER is also a barrier to effectively protecting the American people from unnecessary harm due to prescription and OTC drugs. The culture is dominated by a world-view that believes only randomized clinical trials provide useful and actionable information and that post-marketing safety is an afterthought. This culture also views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards and disrespects drug safety.

Finally, the scientific standards CDER applies to drug safety guarantee that unsafe and deadly drugs will remain on the US market. When an OND reviewing division reviews a drug to decide whether to approve it, great reliance is placed on statistical tests. Usually, a drug is only approved if there is a 95% or greater probability that the drug actually works. From a safety perspective, this is also a very protective standard because it protects patients against drugs that don’t work. The real problem is how CDER applies statistics to post-marketing safety. We see from the structural and cultural problems in CDER, that everything revolves around OND and the drug approval process.

When it comes to safety, the OND paradigm of 95% certainty prevails. Under this paradigm, a drug is safe until you can show with 95% or greater certainty that it is not safe. This is an incredibly high, almost insurmountable barrier to overcome. It’s the equivalent of “beyond a shadow of a doubt.” And here’s an added kicker. In order to demonstrate a safety problem with 95% certainty, extremely large studies are often needed. And guess what. Those large studies can’t be done.

There are 2 analogies I want to leave you with to illustrate the unreasonableness of CDER’s standard of evidence as applied to safety, both pre- and post-approval. If the weather-man says there is an 80% chance of rain, most people would bring an umbrella. Using CDER’s standard, you wouldn’t bring an umbrella until there was a 95% or greater chance of rain. The second analogy is more graphic, but I think it brings home the point more clearly. Imagine for a moment that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug and the bullets represent a serious safety problem. Using CDER’s standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let’s remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.

Consumers Union Offices: Communications Office, New York - Washington Office
West Coast Office - Southwest Office - Consumer Policy Institute

Permalink to Comment

3. Derek Lowe on July 27, 2005 3:39 PM writes...

I appreciate your trying to highlight Graham's testimony. But it's not particularly good form to dump the entire thing into a single comment. Relevant excerpts and a link would do the job just fine, and increase the chance of getting your point across.

I take it that you are the David Rindge who appears around the Web as a laser acupuncturist?

Permalink to Comment

4. Derek Lowe on July 27, 2005 10:54 PM writes...

Hmm - that site is written from the point of view of a trial lawyer, so it's interesting but hardly an unbiased source. Of course, neither am I - perhaps people should average our two viewpoints. . .

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5. Richard on July 28, 2005 2:36 AM writes...

I've always understood that the cardiovascular risk associated with Cox-2 inhibitors is because the old non-specific inhibitors (which greatly reduce cardiovascular morbidity/mortality) are contraindicated.

With that in mind I've always thought it was more an issue of inappropriate prescribing (and yes marketing does contribute to that) than the actual drug.

Permalink to Comment

6. Ursula on July 28, 2005 7:31 AM writes...

I think that the first vioxx case to go against MERCK should have been the best documented and one with cause of death, cardiac arrest.

We have such a case and it would make all of the rest of the cases either necessary or futile if ours had been presented first.

A good point though is that MERCK has vowed to fight every case on a case by case basis. Eventually ours will come up. We have waited three years and will wait as long as it takes for our turn.

All we can say to MERK for now is watch out California. Can you hear us now!

Permalink to Comment

7. John Di Saia on July 28, 2005 4:23 PM writes...

Any drug has side effects. When you choose to take a drug you are accepting that basic fact. There is never a guarantee that a drug will do you more good than bad.

The only thing that this latest episode of legal piracy demonstrates is that our current legal system will see to it that we as consumers will have fewer options for dealing with pain and other problems.

I personally know of a number of patients that really have had no relief from their joint pain since Vioxx was taken from their grasp. If told that they would have an increased risk of heart attack, most of them would accept this and take the Vioxx.

What ever happened to personal choice and personal responsibility in America?

Permalink to Comment

8. WBurke on July 30, 2005 10:23 PM writes...

But now for a serious note:

If the auto industry operated like Big Pharma: fifteen things you might notice

1. Your average car would cost $4.5 million, representing a 30,000% markup over cost, which is typical for prescription drugs. Automakers would justify this price by saying they needed the money to fund research and development, but in reality, most of their research would be funded by taxpayer dollars through government grants and university research centers.

2. That exact same car could be purchased in Mexico or Canada for under $5,000.

3. Automakers would lobby Congress to outlaw or regulate alternative forms of transportation such as bicycles and airplanes, forcing Americans to rely exclusively on cars. Explanation: the drug industry works hard to discredit alternative medicine, herbs and nutritional supplements, hoping to force consumers to rely on drugs alone.

4. Cars with no safety systems (no seatbelts, no airbags, no crumple zones) would be declared perfectly safe by federal regulators. Car companies, rather than address this lack of safety features, would focus on publicizing the dangers of riding bicycles. Explanation: the FDA currently approves deadly drugs as "safe." Meanwhile, drug companies ignore the dangers of their own drugs and, instead, try to get people to believe that herbs or vitamins are dangerous.

5. The manufacturers of those cars with no safety systems would grow tired of being sued by customers who were injured in their cars, and they would lobby Congress to pass "legal reform" that would immunize all car companies against class action lawsuits. Explanation: drug companies are currently trying to get Congress to pass laws that would make it illegal for consumers to sue for damages. This would shield them from the financial consequences of their dangerous products that kill hundreds of thousands each year.

6. All auto imports would be banned, forcing consumers to buy only U.S. manufactured cars. And if you bought a Toyota and drove it to the U.S., you might be arrested or searched. Explanation: the FDA works hard to maintain a U.S. monopoly on all prescription drug sales. The agency once famously conducted a "drug raid" search of a bus load of senior citizens returning from Canada who had purchased nothing more than prescription medications.

7. Car companies would heavily publicize the release of new car models each year, but in reality, the new models would essentially be "me-too" cars with no real improvements over those made in the 1970's. Explanation: most prescription drugs, even though they are touted as "breakthrough" drugs, are little more than me-too drugs that do nothing different than older, off-patent drugs.

8. Car crash dummy tests that produced fatalities and other disturbing data would be censored by the auto industry, never to see the light of day. Any safety scientist who produced such results would be blackballed from ever conducting crash tests again. Explanation: drug companies routinely bury clinical study results that show the dangers of their drugs. They specifically design studies in a way that exaggerates benefits and minimizes risks. Researchers who don't "play ball" and help distort these drug trial results are blackballed and will never find work in the industry again.

9. Car dealers would be visited by hoards of automobile sales reps promising bribes, first-class vacations, free food and free cars as long as those car dealers would push the right products onto consumers. Explanation: drug companies spend billions each year on handouts to physicians, including outright bribes, fully-paid vacations to exotic resorts (disguised as "Continuing Medical Education" programs), free drug samples, and a never-ending supply of free lunches and other food items.

10. Driver's education programs would be cancelled nationwide. Instead of teaching people how to avoid accidents or repair damaged cars, automakers would encourage people to keep buying new cars. Explanation: organized medicine doesn't teach healthy safety or disease prevention. Instead, the entire system is designed around waiting for people to get sick, then treating them with expensive drugs, surgeries and other medical procedures. The system actually encourages chronic illness by neglecting to teach prevention.

11. Companies would make up new reasons why you need more automobiles, hoping to convince you to buy a dozen or more. They might say you need one car to make you feel happy, another for basic transportation, a third to match the color of your house, and so on. Explanation: drug companies frequently invent new, fictitious diseases, and then try to sell you drugs to treat those made-up afflictions. Examples include ADHD, FSD (female sexual dysfunction), General Anxiety Disorder, and other made-up diseases that have no purpose other than selling drugs. Essentially, Big Pharma wants to define everyone as diseased in some way, and then convince people they need a lifetime of prescription drugs to "manage" those diseases. From the moment you're born, the drug companies say, you're already diseased.

12. Car advertising would show happy, healthy people driving down country highways with the wind blowing through their hair. But once you get the car, you find out it breaks all the time, it doesn't perform as promised, and after a couple of years, it won't even start anymore. Explanation: prescription drugs are advertised with images of happy, healthy, youthful, energetic people. But the reality is that once you start taking prescription drugs, the health of your entire body and nervous system (brain included) starts to go downhill. People who take lots of prescription drugs are nearly always extremely unhealthy, with obvious disease physiology and muddled cognitive function.

13. Cars would be hyped to buyers with fancy, full-color brochures touting all the benefits of the vehicle. But federally-mandated warnings about car safety problems would be printed in 6-point type on a tiny label hidden under the driver's seat. Explanation: drug companies are required by the FDA to print safety warnings on certain product labels and advertisements, but these warnings are almost always presented in an impossible-to-read format and are, therefore, routinely ignored by doctors and patients alike.

14. Driving certain cars would have unexpected side effects. Driving one car, for example, would make you extremely aggressive and violent... perhaps even suicidal. Driving another car might make all your muscles hurt. And a third car might make you feel an instant loss of sexual drive. Explanation: prescription drugs always have unintended side effects. Antidepressant drugs cause violent behavior and suicides. Statin drugs can cause severe muscle pain (rhabdomyolysis) and loss of cognitive function. They also block the production of cholesterol, the precursor to sex hormones.

... and finally ...

15. Cars would be sold to you with high-priced features like a sunroof, air conditioning, 6-CD changer, navigation system and other items, but upon delivery, you would find none of the features you paid for. The car would be completely different from the one you thought you bought. Explanation: drugs are sold to patients with hyped-up promises of multiple health benefits. But once people start taking the drugs, they find the benefits were exaggerated. In other words, the drug they end up taking is nothing like the drug they thought they purchased -- the drug advertised with all the features and benefits on TV.

Courtesy of the Health Ranger:

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9. daen on July 30, 2005 10:51 PM writes...

Metaphors plus "explanations" for the hard-of-thinking, how nice. What gets my goat is that these false experts (fauxperts?) spout this tedious drivel without any real references and then make sales on the back of it. The "Health Ranger" advises sensible eating habits and regular exercise (which is fair enough), and, oh, by the way, you can buy his "health system" for $69. So no conflict of interest or hypocrisy there, then.

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10. WBurke on August 1, 2005 7:43 AM writes...

What a bunch of drivel daen - your options consumer are as follows:

Go to your doctor - PAY $75 to say hello, how are you? They run some tests on you - PAY $100 to find out you have mildly elevated cholesterol (NO RISK FACTOR) - PAY $120/month for statin drug which is known to cause cancer and damage liver. At days end you've spent $295 and face a monthly bill of $120 plus the cost of "simple tests" to see if your liver is being ruined by the statin, which by the way does NOTHING TO SUPPORT HEALTH!

Or you could heed the FREE advice of a HEALING PRACTITIONER (medical doctors RARELY HEAL ANYTHING, they simply diagnose and drug you to BANKRUPTCY or DEATH!) begin eating a healthy diet, adhere to some physical activities at scheduled intervals, support your bodies need for nutrients which no diet in the world can provide with any assurance (notice to consumer - I pay only $70/month for high potency multi, patented cardiovascular support, digestive support, antioxidant cocktail, natural cholesterol support (last reading 185 Tot., 64 Trigly., 54 HDL - PERFECT!) and it is GUARANTEED 100% for 60 days should you decide you simply want your money back, GO FOR IT!

So let's see $295 + $120/month (or more if you have to be tested for liver problems) and potentially cancer to deal with OR $70/month with ENERGY and ENDURANCE to spare, Vitality and exceptional health? (They can even bypass the extras and just get the multi for $20/month and try it out for 90 days RISK FREE to see if they have more energy, renewed endurance and an overall better sense of well-being. What drug offers that promise? NOT ONE!!!) HMMMMMMMM!

You drug pushers are really sick people - and I don't mean just unhealthy - I mean demented!

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11. Tom Bartlett on August 2, 2005 8:36 AM writes...

Merck knew about the edema BEFORE putting the drug on the market. So did the FDA. The issue came up in the public FDA hearings (in 2000, if memory serves?). The FDA approved Vioxx, regardless. I fail to see how any reasonable person could believe Merck should be liable, given that they pulled the drug after a preponderance of evidence mounted against its risk versus benefit in the broader population. I guess we just live in a litigious society.

I hope Celebrex and other "coxibs" don't suffer permanent loss of sales because of guilt by association. My own mother, a Celebrex user, tells me that, at 80 and arthritic, it lets her walk without pain.

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12. tgibbs on August 6, 2005 11:31 PM writes...

If the auto industry operated like Big Pharma: fifteen things you might notice

16. The vast majority of attempts to develop a new model car would be miserable failures. Often the new automobile design would not run at all, or randomly burst into flames, killing all passengers. Frequently, this would not be discovered until the cars were ready to roll off the assembly line, and production would have to be discontinued at a huge loss to the manufacturer. Most of the time, there would be no way to correct the problem, and the entire design would have to be scrapped. Occasionally, serious problems would be discovered after large numbers were sold, and the manufacturer would face potentially ruinous lawsuits.

If Big Pharma operated like the auto industry, on the other hand:

Most customers would understand that they were purchasing a product whose use carried a substantial risk of serious injury or death. Annual fatality rates of tens of thousands per year would be widely considered acceptable in view of the substantial benefit provided by the product.

Aren't metaphors fun?

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13. daen on August 7, 2005 6:50 PM writes...

"last reading 185 Tot., 64 Trigly., 54 HDL - PERFECT"

Good for you. You would have gotten there with healthy eating and exercise anyway, so drop the $70 of pointless and meaningless

"potency multi, patented cardiovascular support, digestive support, antioxidant cocktail, natural cholesterol support"
and buy more vegetables, white fish, some 70% dark chocolate and red wine every month instead.

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14. WBurke on August 7, 2005 9:44 PM writes...

Hey Einstein (daen) - how much Vitamin C in a tomato? carrot? 4 oz. of spinach?

You can't determine it when you buy it, you don't know it when you eat it so the whole "get it from a healthy diet" is BS - IT CANNOT BE DONE! With any consistency you CANNOT ALWAYS get what your body needs from diet alone, you can try and in doing so you'll likely eat a lot healthier, but you cannot meet the needs of the average body everyday in todays high stress, fast-paced, fast-food environment.

The whole "eat more veggies" mantra you like to push is fruitless, pardon the pun.

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15. daen on August 8, 2005 4:27 AM writes...

how much Vitamin C in a tomato? carrot? 4 oz. of spinach?
Specious argument. By making your own vegetable juice you can get all the vitamin C you need.

The whole "eat more veggies" mantra you like to push is fruitless.

Nonsense and poppycock. It's common sense. Even your chum Mercola promotes high-vegetable diets. You're on your own on this one, chum.

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16. WBurke on August 8, 2005 9:16 AM writes...

You've got to be kidding me! You don't know, can't tell me how much Vitamin C is in specific veggies but hey if you just make your own vegetable juice you'll get all you need? What a bunch of hogwash, dude you're slipping.

I mean there was a time when you posted moderately plausible responses but this one is completely devoid of any sense at all.

As for the mantra - I am far from being on my own, you named Mercola as the only one who promotes high-vegetable diets, you are ignoring the fact that he encourages supplements to cover voids in diets, you are also not going to find that the many others who supplement will support your drug industry position that "diet is enough."

When you can look at a plate of food and tell me, with a high degree of accuracy, that your vitamin, mineral and amino acid needs as well as digestive aids are covered in the content of your plate for breakfast, lunch and dinner - then you can begin to have a point. But unfortunately at that point you may not even know what your needs are because they change from day to day based on the stress and environmental attacks on your body that change from one day to the next. There used to be a time when many doctors would err on the side of caution - but you drug pushing quacks have so distorted their minds with your relentless adverts and "continuing education courses" that they rarely do err on the side of caution. Thus you have nearly 1 million deaths per year attributable to Medicine.

The RDI for vitamin C is what 60mg? Linus Pauling, 2-time Nobel Prize winner and Vitamin C researcher took 14 grams, that's 14,000mg per day and lived to the ripe old age of 94 while your average doctor dies at the age of 57. Who in their right mind would be dumb enough to believe your average doctor when it comes to longevity issues?

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