Sunday, April 10, 2005

Respect

I read this piece on another blog and thought it was worth sharing.

When a word is worth $1,000 (each)

ArethaIt's been quite a week for disrespect. And it's only Thursday.

Half of my incidents have been business-to-business situations. The other half occurred in places where I was just a consumer.

Looking back, I'm really sort of amazed by two things: First, how visceral the feeling is when I feel as though I've been disrespected, and second, how easy it would be to avoid.

Let me be clear about a definition here: disrespect is in the eye of the beholder. It occurs when someone feels slighted, or demeaned, or undervalued or lied to. There is no absolute measurement, and, because it's relative, people will surely disagree about whether or not it has occurred at all.

Doesn't matter. If you feel disrespected, then you were.

#1. Just spent two hours at the doctor's office. An entire hour was spent in a little room, waiting. No updates, no apologies, nothing. Even after the doctor finally arrived, for him it was as though the long long wait didn't even happen. Then, when I nicely asked to talk to the office manager on my way out, she took a phone call instead.

#2. I spent nine months negotiating a deal with a company where I've had a long and fruitful relationship. This project was going very, very slowly, and not because I was slowing it down. I'd been patient and flexible and was working it through the system. Two days ago, I got an email. It said, in its entirety, "Unfortunately, this is getting way too complex and not worth the effort for either of us. I know that we keep trying to make this work (for months now!) but it's not working for either side. So, I think we should let this go and part friends."

There have been four others, just like this. I realized what they all had in common:

All the other person had to do was use a one or two sentences and the whole thing would have been fine. Almost all the instances of disrespect didn't have to do with the substance of the transaction, it was the style of it. If the person had accepted some responsibility and acknowledged how I might feel, the outcome wasn't really a big deal.

"I'm really sorry you had to wait. Mr. Wilson's eardrum exploded and we're doing everything we can to help him."

"I know you worked long and hard to make this deal work, but we just can't figure it out. I'm so sorry we wasted your time."

It's really simple: most of the time, most of your customers will cut you slack if you just acknowledge that the outcome isn't the one they (think they) deserve.

People have a hard time with this. If someone feels as though they're treating you technically correctly, they don't want to apologize. They don't want to acknowledge the feelings of the other side. This is awfully short-sighted. These are words that are worth thousands and thousands of dollars in lost sales and word of mouth.

"You must feel terrible about what happened. I know I do. If there were any way I could figure out how to make this better for you, I'd do it." When isn't that a true statement when you're dealing with an unhappy customer?

by Seth Godin, April 7, 2005

Saturday, April 09, 2005

What Are Those Sales Reps Thinking?

Last week was an international cardiology meeting called ISHLT. It's mostly focused on heart and lung transplantation, but still is a prime opportunity for Scios/Johnson and Johnson to talk about nesiritide. As you recall, we recently published data that, together with a recent study by Dr. Steve Gottlieb of the University of Maryland, proves that the perception that nesiritide is good for the kidneys is simply untrue. In fact, the most comprehensive analysis (ours in the medical journal Circulation) says it is bad for kidney function.

So what were the reps saying about it? Well I wasn't there to hear it, but I was told by more than one person that they were dismissing the study. "It's only 5 studies..." and "It's just a meta-analysis..." were two statements heard. Amazing. How can someone take this view with a straight face? Here they have no data that says the drug is good for the kidneys, and two studies say it isn't, and they are asking the doctors visiting their booth to ignore the data?

Wow.

In time, those reps and the company as a whole, will not be able to ignore all the signals that say that nesiritide seems likely to be associated with risk.

Maybe then, they will act responsibly, and do what they should have done since 2001; study the drugs safety and efficacy in an appropriately powered study.

Friday, April 01, 2005

Here Is My Goal

Drugs sold for the treatment of disease should be proven safe. While nothing is guarenteed in life, and no drug, vitamin etc. could ever be proven perfectly safe, studies can be performed that rule out any realistic possibility of risk.

Johnson and Johnson should be as responsible as every company and prove that nesiritide (Natrecor tm) is safe. They have not yet made the commitment to do so, instead talking about studies that are ongoing. Truth is, none of their ongoing studies will be able to prove the drug is safe. They know it, but are working hard to convince people otherwise.

A respected colleague provided very useful perspective for me today. Commending the work on nesiritide, he pointed out that this will start to change people's views, and then, momentum will lead to the studies being performed to determine whether there is risk with nesiritide.

I hope he is right.

Wednesday, March 30, 2005

Will J&J Do the Right Study?

By this question, I am really asking whether Scios/JandJ truly want to know whether the drug is safe. At this point, I don't consider this an issue for the FDA. Let's ask the CEO, do you want to know? Do you really want to know?

Maybe I should ask this way...

You do want to know with a high degree of confidence that your drug doesn't hurt people, don't you?

If the answer is yes, as it should be, it's simple. Put aside $20-40 million right now, today. Declare to your customers that you want to show everyone that you care, that you want to prove the safety of the drug beyond doubt. It may seem like a lot of money, but even if such a move slows sales by $200 million a year, and it takes two years to find the answer, it still is less than $250 million a year for two years for a company with $40 billion sales per year. That is like you or me spending a few thousand to make sure that people won't be hurt by the drug (i.e., killed).

If the supporters of JandJ are right, this investment will yield incredible increase in sales. The amazing thing is that Scios/JandJ knew about these data raising concerns about safety by 2001. We'd know whether it was safe or not by now if they had done the right thing then.

Talk about this with doctors, patients and anyone else who is interested. Maybe that will convince them to do the study now, and do it quickly, instead of just starting slowly and letting it drag on for 4 or 5 years, getting the answer as the patent expires!

Wednesday, March 23, 2005

Interesting Spin by J and J

Amazing to watch "damage control" in action. In response to the publication of our study in Circulation, Scios/J&J have enlisted the help of some of the smartest people in the field (I hope). Their responses focus on the fact that we included data from doses higher than are the recommended starting doses. This is true.

We included all the data that they used to get the drug approved by the FDA. I re-read the transcript of their public meetings from 1999 and 2001. I can't find one point where a representative of Scios asked the FDA to ignore any of these studies. Scios used all the studies to support their view that the drug was safe and effective.

So now they don't want some of these studies to be included in this independent safety analysis.

The company can't have it both ways. If you want to use all the data to get your drug approved (as you should), then you can't back away from most of your data for convenience, as they are doing now.

Bottom line: the drug probably has significant risk, and until they complete an appropriate mortality trial, nesiritide should not be used until a combination of diuretics and nitroglycerin prove inadequate.

Tuesday, March 22, 2005

Will Doctors Pay Attention?

Hopefully, at least a few will. For over 2 years, I have heard consistent comments from my peers finding fault with my view that nesiritide (Natrecor tm) could be dangerous. Now there is a publication in the pre-eminent cardiology journal, Circulation, based on our work. (you can read the report in the NY Times, Detroit News or at Forbes.com) Of course, it really is not something for which I deserve the bulk of the credit. So I want to thank those who allowed this observation to be made.

First, thanks to Scios/J&J. They did the studies that identified the risk of worsening kidney function, the harbinger of marked increased risk. Without them, I could not even have asked the question of whether the brief improvement in symptoms that nesiritide produces are worth the possibility that risk of death may be increased so markedly in the subsequent weeks and months. This is not "tongue-in-cheek" stuff. They did the initial studies very carefully. It's just that for some reason they did not do the appropriate follow-up studies.

Second, the investigators and patients, without whom the studies could not have been done.

Third, the FDA, for making so much information available for anyone with any curiosity to find. We all find things to do to fill our time, that's easy. But spending an extra hour or two looking up the information about a medicine on the FDA website does not seem to be all than much for a patient to expect a doctor to do. (Why not offer your doctor to pay cash and collect the insurance payment yourself for the next three visits in return for your doctor looking up all the relevant information about the medicines you are taking?)

Finally, there are several of my peers who have been supportive of my efforts. The guidance and encouragement have been invaluable. You know who you are.

Now, we need to get the definitive studies started. If we do that now, perhaps we'll know how, when and in whom to use nesiritide by 2007 or 2008.

Monday, March 21, 2005

Danger Appears Associated with Nesiritide

Today at 4pm, the results of an important study will be posted on the website of the medical journal Circulation, the official journal of the American Heart Association.

This study shows a troubling association between the use of nesiritide (NatrecorTM) and worsening kidney function. It is well recognized in the medical community that worsening kidney function typically means there is a higher risk of death subsequently. I can't prove that is the case for nesiritide, especially since the manufacturer of this medicine has refused to let me ask any questions based on their data. (I asked several tims in the past.) But they have known about this possibility since 1999, it seems to me, and certainly since 2001. In late 2003, they acknowledged it in a press release.

Perhaps the publication of this manuscript will provide some momentum to force the company to acknowleged that this risk is important to people getting the medicine and even fund an appropriate trial to prove its significance (or perhaps prove that the association we report is a statistical fluke). None of their on-going studies address this concern, though they assert they do.

By 4pm today, just follow this link to see the manuscript, and hopefully become part of the concern that forces the right thing to be done. Understand, I do not believe this drug should be pulled from the market. It can have potent effects when a person is critically ill with no other option. But it's safety is not equivalent to the old drugs, including nitroglycerin, milrinone or simply diuretics. Those should be used first.

Read the paper from Circulation, the official journal of the American Heart Association before using nesiritide for the treatment of acutely decompensated heart failure.

Sunday, March 13, 2005

Am I Naive?

I suppose I am. After all, perhaps I should expect people to be angry with me.

A fortune 500 company is selling a medicine that is touted by many of my peers as a breakthrough medicine. While it does not generate enough money to affect the bottom line, and therefore, any problems with the drug are unlikely to affect the stock value, there are many people whose livelihood relates to the use of this medicine. If information is revealed that casts doubt on the safety of a medicine, sales are likely to be affected in a way that could impact many people working for this big pharmaceutical company. Many doctors may feel obligated to publically acknowledge that their strong endorsement for the past 2-3 years may have been premature.

So when I started my investigation of this medicine, my goal was pretty simple: get a clinical trial performed to determine whether the data that suggested the possibility of risk was right or wrong. Merely because there was no proof of danger does not mean a drug is safe if no one ever looks to see if there is danger. We should be smart enough to realize that.

Yet several events are starting to make me a bit nervous about the events that could soon unfold. First, I was told (though it is hearsay) that part of a company sponsored teleconference within the past year or so included a discussion focused on defining my goals. Here is evidence I was definitely naive. I figured they would take me at my word, that I wanted to prod them into doing a definitive study. (They say they are doing a study that will answer the question of safety, but in fact, the current study evaluates the effect of the drug in a group of patients that are different than the ones that appear to be at risk.) More recently, a colleague told me that an employee of the company stated very clearly that there were ramifications to what was being done, that is, things that would happen as a result of the studies we are publishing this Spring.

It's hard to imagine that I could do much to stop a company of this size with these resources. So I suppose I'll need to continue with my naive view and hope that an ethical pharmaceutical company will follow the data, not merely consider the business of health as a business that relates to their own financial health.

Friday, March 11, 2005

Getting Ready

In the next week or two, a scientific paper will be published on line (and in print soon after) in a leading cardiology journal. This journal is the preeminent cardiology journal, and I am very proud that it's the journal where the results of my work with talented colleagues over the last 2.5 years will be published. The journal is so impressed by the importance of this research that there will be an editorial about it.

Now I am not permitted to say where this article will be published or reveal the contents, but if you were to look back over the entries in this blog since November, you will probably be able to guess. The research indicates that a drug that is commonly used appears likely to have some risk; risk previously not appreciated and risk that is quite relevant.

Last week at the American College of Cardiology meeting, a colleague told me that the manufacturer of this medicine is preparing a statement/press release in response to this paper. I'm not sure what it may say, but I am confident that if I focus the discussions on the data, all will work out smoothly.

I'm ready for anything. After all, what could a multibillion dollar company possibly do to me that would be damaging? Especially when they have projected this medicine to reach one billion dollars in annual sales?

The data will be the story. That's where the focus must remain.

Sunday, February 20, 2005

Is Nesiritide Safe? A Prestigious Journal Wants That Question Asked

I have written about a concern that nesiritide (Natrecor TM) may not be a safe medicine. When asked, I will certainly acknowledge the benefits of the drug. These include improving symptoms and lower the pressure in the heart very quickly (both good things if you have bad heart failure). But these advantages don't exist much longer than 3-6 hours. By 24 hours of treatment, the medicine is not different than the established options.

The reason that I expressed my concern initially (early 2002) was that it seemed to me that there could be a risk associated with use of nesiritide. I spoke at a national meeting in the spring of 2003 to present data that suggested this risk to me and was given the "freeze." The data from our analysis suggesting risk associated with nesiritide leaked to the Wall Street Journal in advance of the publication, but perhaps because I did not speak with the reporter, the lay press paid little further attention (according to the policy of the meeting where I was scheduled to present the data, I was not permitted to discuss the results in advance).

Discussion amongst my peers, focusing on the scientific and medical implications, was also fairly absent. I was told (this is hearsay, I have no proof it happened) that Scios (manufacturer of nesiritide) devoted a significant part of a teleconference with key cardiology opinion leaders to try to figure out what my agenda was. It was as simple then as it is now, drugs used in clinical medicine should undergo rigorous safety analyses in formal studies wheneven feasible.

Besides that "discussion," I was treated more as a pariah than did the analyses lead to meaningful discussions about how to learn whether there was a risk associated with nesiritide. For the most part, a huge database was analyzed (ADHERE registry) to see if there were any associations of concern. This kind of analysis is even less meaningful than the pooled analyses I have performed with my colleagues.

I gave apresentation at another national meeting (fall 2004), and was greeted by both outright attacks and quiet encouragement. Finally, more practicing physicians are realizing how important it is to look cautiously at the rationale for using nesiritide, hopefully as a first step towards carefully considering the rationale for any test or treatment. Ideally, doctors will go even one step further, and look at the data.

This is what the cardiology journal Circulation has done. This spring, they will be publishing our analysis that shows an association between nesiritide use and worsening kidney function. As a colleague said to me recently abou this association, "that is not good."

My goal; to continue to push for rationale, data-driven medical care.

Thursday, February 17, 2005

Perception of Safety

If I haven't made it clear enough, my attitude as a practicing cardiologist is pretty simple. If a treatment improves quality of life enough, it is worth considering even if, on average, it shortens life. I would apply this to the COX-2 inhibitors (Vioxx, Celebrex, Bextra) by using them for pain relief when other medicines don't work, IF a patient told me that it was worth the risk for them. That's a personal decision, based on my ability to explain the risks. Since there are now several studies that provide an estimate of risk, the discussion can be focused on risks compared to benefits.

Sometimes, I see other doctors have attitudes that are very different, and that's okay. But I am amazed by some of the attitudes displayed, which may apply to the use of drugs such as these.

Let's take the example of a medicine discussed in the medical journals but which is not currently approved for use. It's called ximelagatran and in theory, would replace the use of the blood thinner coumadin (warfarin). I like the idea of replacing coumadin. Most people are upset when they learn that their medicine is also a popular rat poison (rats eat it and bleed to death - rather brutal). I was on the FDA panel that reviewed the application for ximelagatran and I voted to reject it. Why? Aside from the fact that it seemed possible that it was far inferior in effectiveness relative to coumadin, meaning people would still have some risk of bleeding with this new blood thinner but not be as protected from the risk of strokes and heart attacks, it also may increase the risk, paradoxically, of having a heart attack. Then there's the possibility suggested by the data that it can cause liver failure. That's a big deal, as you can imagine.

So here's the amazing part. Some of the data was published in medical journals and in response, almost 2/3 of cardiologists surveyed (see lower left corner of the landing page of http://www.theheart.org) believe the drug should be approved.

Here's an example of the FDA doing the right thing, acting to protect the public, then publishing on their website several hundred pages of information from the company's application and the FDA analysis, yet doctors are unaware, uninformed and misguided in wanting access to a drug that appears likely to be dangerous and possibly less effective than the standard, coumadin.

Amazing that somehow, somewhere, there isn't a better way to disseminate information to patients and physicians.

Wednesday, February 16, 2005

Safety Issues Exist Beyond Vioxx and Celebrex

Check out the article on Forbes.com about our work on the relative risks of nesiritide, a medicine for the treatment of heart failure marketed by Scios/J&J. It is pretty impressive that somehow J&J has escaped the attention that this drug should be receiving. Although it is nowhere near the magical level of $1 billion in sales, nesiritide is used for about 10% of the one million heart failure hospitalizations annually.

I know why nesiritide was approved by the FDA; the drug does improve symptoms more quickly than other medicines that were already available. What I don't understand is why Medicare agreed to pay for it to be used in an unapproved setting, doctors' offices, when there was a lack of safety and effectiveness data in this setting.

Perhaps this press will help open people's eyes and minds. Merely because there is no evidence of danger associated with a medicine does not mean a medicine is safe, when, as is the case for nesiritide, no one has bothered to look.

Saturday, February 12, 2005

Vioxx, Celebrex or Neither?

The debate has been raging for a while now. But it's no longer whether Vioxx, Celebrex or any other COX-2 inhibitior is safe or dangerous. The debate is focused on whether Merck did the right thing, and therefore, whether Pfizer is doing what's right.

Here's the recap. Vioxx is shown to increase risk of heart attacks, strokes and bad stuff like that, even in people who don't seem to be at risk. Merck, aware of the liability associated with such a discovery, pulls the drug from the market. While Pfizer initially said the there was no evidence at all for any such risk associated with Celebrex, with more data available, they seem to be admitting that there is some risk after all, althought not as much as with Vioxx. Lost by some is that another medicine of this type, Bextra, also made by Pfizer, probably does increase risks as much as Vioxx.

Nonetheless, Pfizer took a different approach. They chose not to remove the drug from the market, even though their sales will drop dramatically and they will face some serious liability when court cases start to move ahead.

I "know" who did the right thing. And it isn't Merck.

Thousands of people suffer from horrible pain, some so affected that they can't get out of their house, can't sleep, can't sit. For these people affected by arthritis and chronic pain syndromes, COX-2 inhibitors represent their only chance to feel better and have the ability to function at a level that gets close to normal. For such people, the data from all of these studies allows a decision to be made about the relative risks and benefits of taking Vioxx, Celebrex or Bextra. For many, it's an easy decision. They'd rather feel less pain and enjoy a bit of life (by taking the medicines) even if it means that they may live a year or two less.

Why did Merck do what they did? To be able to project more accurately their quarterly earnings. And Pfizer? While I am sure that they are thinking similarly, I interpret their commitment to continue to sell Celebrex as an indication that they are committed to help people with pain, even at the risk of feeling some significant financial pain themselves.

Wednesday, January 05, 2005

Lots of Doctors Are Volunteering

I've never worked in a major disaster. Sure my hospitals have always had disaster drills. But I was never in one. The closest I got was 9-11. I was at a medical conference in Washington and spent the day on I-95 driving home to New York. Passing by the WTC from across the Hudson River was a powerful sight. By the time I got home and called my hospital, it was clear that there weren't a lot of casualties being brought into the ER.

So maybe I'm not the ideal candidate, but after talking it over with my family, I started to look around for organizations that would allow me to volunteer in South Asia. Yes my specialty is heart disease, but I can triage the sick and care for those with minor and serious infections.

I contacted many organizations, including Doctors of the World, both here in the US and in Spain. The Spanish affiliate has already sent a small team into Sri Lanka. I learned that they want experienced doctors for the time being. I understood.

The important news was when I heard from two different organizations that both were overwhelmed with qualified doctors volunteering to go - so many that they didn't really want any information from me.

I'd like to go because I can help. But if I don't, perhaps this disaster should be a reminder to me that I can help more people here at home too. Maybe that's one thing we should all consider.

Tuesday, December 21, 2004

Statins, ACE Inhibitors and Beta-Blockers Are Safe

With all the news about the risks of heart attacks with various pain medications, including Vioxx, Celebrex, Bextra and now Naproxen, one has to wonder which is the next disaster to be announced.

In my book, I aggressively recommend the use of three types of prescription medications, Statins, ACE inhibitors and beta-blockers with great conviction.

I can do this because several medicines within these groups have been formally tested in long-term trials to determine their effects on heart attacks, strokes and premature deaths. The studies are conclusive, these medicines save lives.

The pain medicines were approved based on their ability to reduce pain; only now do we know what their effect is on heart attacks because no study had been performed previously.

Within the classes of medicines I recommend to those at risk of heart attacks, some are proven to reduce risk while others are proven to change a blood pressure reading or cholesterol level. The recent news with these pain medicines teaches an important lesson; you don't know the effects of a drug on long-term risks unless you do a study to find out.

This is why my recommendations in the book are product specific. Some medicines are proven safe, others seem that way. Don't take a chance, ask your doctor for the ones proven to reduce risk of heart attacks, strokes and premature deaths.

Sunday, December 19, 2004

Celebrex: As Bad As Vioxx?

This question is the one I expect to hear in my office tomorrow. It's not that I write prescriptions for Celebrex any more than I did for Vioxx, but many of my patients have been treated with one of them. At first glance it seems to be an easy situation to deal with; stop the Celebrex.

In fact, it is far more complex.

Here's why. Many people have terrible pain. Mine isn't so bad, so I stopped taking Vioxx. But if pain is really bad and limits someone's ability to function, it becomes complex. Is the risk worth it? That is the key question and the question that the FDA seems most interested in helping doctors answer.

I say this because I have heard employess of the FDA say publically that a drug that improves quality of life but increases the risk of death may still be a reasonable drug to permit onto the market.
The information to quantify the benefits and risks is necessary and we are starting now to understand the risks of Celebrex or Vioxx.

I don't believe that Celebrex should be withdrawn from the market, but I do think it should become a niche drug, perhaps one that has a specific safety program associated with it. A patient could be given standard literature stating the risks and benefits prior to signing a consent form.

On the other hand, I suppose the lawyers wouldn't like that suggestion; it would prevent them from suing.



Friday, November 26, 2004

Glad Ron Artest Wasn’t There

In earlier posts, I discussed my concerns about the medicine nesiritide (Natrecor), used to treat heart failure. Although used commonly in practice, there is little data to prove its safety.

This week, theheart.org, the leading cardiology website (theheart.org) covered the presentation I made at the annual meeting of the American Heart Association in New Orleans.

The first comment during the question and answer period accused me of being dangerous. I find that incredible. Here’s why. What we did was look through the literature to review the studies that led to nesiritide’s use. None of them are studies designed to prove whether it is safe or not; they address the effect on pressures in the heart or shortness of breath when first starting the medicine. So we downloaded the FDA files on nesiritide and looked to see if they reported the effects on kidney function. Off all the parameters typically measured in clinical trials, changes in kidney function are one of the more powerful predictors of risk. If your kidney function worsens, even transiently, you are more likely to die in the hospital or within 1 to 6 months afterwards.

We performed a careful and standard statistical analysis and found that nesiritide increases the likelihood of worsening kidney function by about 50%. That means that instead of 15% of people affected, 22% were, putting them at higher risk of dying within the next few months.

The article on theheart.org cites the concerns raised by the audience, each of which we share. But it misses the point. Here is a drug used widely that may put people at risk – yet no one seems keen to do the study to ask the questions that need to be answered. Is it safe? (Sorry if the use of that phrasing gives “Marathon Man” fans heading to the dentist cause for concern.)

What kind of self-respecting doctor or researcher would stand by idly while nesiritide use is exploding through the medical community, instead of demanding a study? And where is Johnson and Johnson? They should be particularly concerned given the environment in this post-Vioxx, post-Baycol era.

I am excited at the prospect of publishing these data in a respected peer-reviewed journal. That will get the conversation going and hopefully result in the study being funded to determine the safety of nesiritide.

Until then, I am not concerned about being in conflict with a conglomerate like J&J. Unless Ron Artest is a major shareholder.

Tuesday, November 16, 2004

New York Times Article

Today's Science section of the New York Times has an essay focused on an important question: should you seek treatment after suffering from a disabling and possibly deadly health problem or should you proactively seek safe and scientific ways to prevent the problem in the first place? I'm not sure a NY Times essay is a place where the intricacies of such an issue can be sufficiently discussed, but it is nice to see the issue placed into the press for people to consider.

The underlying issues may seem to focus on whether you would want to take medicines to treat high blood pressure, cholesterol abnormalities and/or diabetes, but it is much more than that. Sure I am a part of the traditional medical community, using prescription drugs prior to nutritional supplements. Why not, the drugs are studied so I know the safety and effectiveness while dietary supplements are marketed based on logic and assumptions. Countless times studies have proven that logic and physiologic assumptions such as these are in fact in opposition to data when scientific studies are finally performed. So my fault is not that I believe in pharmaceutical therapy, it is that I follow data.

With that said, I consider the comparison between my views and those of Dr. Gilbert Welch. Dr. Welch is funded by grants that appear geared to prove that we are over medicalized; that diagnostic tests are overdone. He's right. In cardiovascular medicine, tests are aften used to substitute for clinical judgement, and I think this happens too much. But the article allows the reader to conclude that testing is overdone in all of medicine, according to Dr. Welch, and I don't believe that would be his point at all. Any good epidemiologist knows that diagnostic testing is invaluable for specific groups of people but not necessarily for everyone.

In my book, I make the case that treatment is ideal for many American adults, but not everyone. It just so happens that when you live in a country where 90% of people over the age of 50 have or will have high blood pressure, we have a lot of people who can benefit from blood pressure treatment. Look around. With most American overweight, it's obvious that lifestyle changes are not going to be enough. It is the same thing for high cholesterol and diabetes.

What my book also says about how to work with your doctor to get ideal care may be more important than anything I say about blood pressure, cholesterol or diabetes, more important than the risks I describe for suffering a heart attack or stroke. We need to be self-advocates, because the health care system will not look out for any of us as individuals. It is concerned with cost effectivness for society and not the risk benefit ratio for any of us as people who may be at risk.

I would be interested to hear your thoughts on the article. It is available at:

http://nytimes.com/2004/11/16/health/16essa.html

Thursday, November 11, 2004

Jumping on the Bandwagon

A year and a half ago, I presented a research study at an annual cardiology meeting. Few of my colleagues wanted to have anything to do with it. They seemed to shy away from the presentation and didn't want to talk about it. It was very frustrating to present data that strongly raised the possibility that a drug given to about 10,000 people a year (and increasing numbers) may double their risk of death within the following month. Sure it made people feel better, but the effects lasted for 3-6 hours and then the drug was no better than the old-fashioned treatment.

When I presented a follow-up research study this week at the American Heart Association, it was a very different scene. People (other cardiologists) were congratulating me on our "bravery" to stand up to Johnson & Johnson and tell the Giant that their drug may be dangerous - challenging them to start a new study to prove whether or not this is so.

In reality, I was merely following whtat the data said was truth.

So while most of the people at the meeting probably preferred to use denial mechanisms and pretend that their beliefs should be followed before the data, at least some were jumping on the wagon.

In the end, one can only hope that the truth will be sought and the risk, if any, be quantified.


Saturday, October 30, 2004

I'm Throwing Away My Vioxx!

I get pain in my knees and ankle pretty frequently; I used Vioxx occassionally when it was bad. Little did I know that was bad too, as Vioxx increases the risk of heart attacks. I really should have been smarter. The FDA had warned doctors that a 50 mg dose could be dangerous but they didn't know for sure about a 25 mg dose. Merck kept selling the 25 mg dose, and I took it a few times.

Now we know better. Vioxx is dangerous. Celebrex probably won't be as bad because it is not as strong as Vioxx, but Bextra probably will be dangerous too. We need some new approaches to pain management, perhaps increased frequency of stretching and exercising?

I'm starting to find the pain in my joints reassuring as I climb stairs. It reminds me that I am not taking a dangerous drug anymore.