“The Evidence Gap”: Pharma impedes patient access to better treatment

A lot of effort and study is going into improving healthcare and untangling its cost structure. So methinks it’s nearly criminal when someone blocks adoption of a treatment that’s better, especially when it’s also less expensive.

Case in point, from yesterday’s NY Times: The Evidence Gap: The Minimal Impact of a Big Hypertension Study

The surprising news made headlines in December 2002. Generic pills for high blood pressure, which had been in use since the 1950s and cost only pennies a day, worked better than newer drugs that were up to 20 times as expensive.

The findings, from one of the biggest clinical trials ever organized by the federal government, promised to save the nation billions of dollars in treating the tens of millions of Americans with hypertension.

Six years later, though, the use of [diuretics] is far smaller than some of the trial’s organizers had hoped.

What?? I use diuretics, prescribed by my e-patient doc, Danny Sands. Doesn’t every BP patient? They reduce water content in the body, lowering blood pressure. Why isn’t every BP patient doing this?

… pharmaceutical companies responded by heavily marketing their own expensive hypertension drugs and, in some cases, paying speakers to publicly interpret the Allhat results in ways that made their products look better.

“The pharmaceutical industry ganged up and attacked, discredited the findings,” Dr. Furberg said. He eventually resigned in frustration as chairman of the study’s steering committee, the expert group that continues to oversee analysis of data from the trial. One member of that committee received more than $200,000 from Pfizer, largely in speaking fees, the year after the Allhat results were released.

This is disgusting.

Obstruction of justice is a crime; why not obstruction of healthcare?

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10 Responses to ““The Evidence Gap”: Pharma impedes patient access to better treatment”

  1. Ted Eytan says:

    Dave – your post is very interesting to me because I think hypertension is a great area in which to “react by innovating.”

    Pre-Health2.0, I don’t think we would see patients writing about a preference for diuretics and and beta-blockers based on the data. The students can become the teachers…

    I just posted some theoretical workflows that a doctor/patient could use to manage blood pressure outside of the doctor’s office on my blog.

    I think it’s possible if we give patients even more information and control over the management of their condition, lots of people win. Having only 33-38% of 72 million people on the correct therapy for high blood pressure is an opportunity for all parts of the health system, including pharmaceutical manufacturers, if we figure this out!

  2. Ted Eytan says:

    Sorry, I didn’t put the right code in the link above. The workflows are here.

  3. Dan Hoch says:

    Dave, Ted, and all,

    This will be an interesting comment for me to write, since I’m usually the one doing the provoking about ties to Pharma, and conflict of interest. I guess this post will show that I’m just plain contrary, because I’m hoping to balance your reaction to the NYTimes perspective.

    First, let me add fuel to the fire. You missed, or at least didn’t comment on, additional media outrage over the ties of “opinion leaders” to big Pharma. There was also an Times piece further crucifying one of my Harvard colleagues for his ties to Pharma (http://www.nytimes.com/2008/06/08/us/08conflict.html) , and the NPR show On The Media also did an number on Fred Goodwin (podcast at http://www.onthemedia.org/transcripts/2008/11/28/01) . Apparently, he collected a small fortune in speaking fees from multiple Pharma sources all the while touting medical therapies on his show “the Infinite Mind”

    First, let’s be clear that ties to Pharma are exceptionally common, and the people blasted by the media and Rep. Charles Grassley are not exceptions to the rule, they are the rule. Pharma wants to have the best and brightest weigh in on their products, and they pay well, so most clinical scientists who have active research efforts have had some dealings with Pharma. Does this mean that any amount of money is corrupting? After all, the only thing anyone is yelling about is that the money is “undeclared”. Would we feel that much better if we always knew how much our experts were getting paid by Pharma? At what payola level would we begin to suspect the wisdom of their words, $1000/year, $100,000/year? One of the people interviewed for the On the Media show was Gary Schwitzer of Healthnewsreview.org in Minnesota who maintains a list of “experts” who can discuss medical treatments for the media and who do not have links to Pharma. A great start for journalists looking for experts, but given the size of the list, and the vast array of topics that need to be covered, his admirable effort is only a drop in the bucket (the list can be found at http://healthnewsreview.org/independentexperts.php ).

    A second point that is never mentioned by the critics is, what’s the “evidence” that Pharma money really impacts prescribing habits and opinion. This is, after all, the era of evidence based discussion. I’ve ranted about the influence of Pharma as much as anyone, but my principle argument is “they wouldn’t spend 14 billion a year if it weren’t effective”. Given the importance of this issue, you’d think we’d have more data than that! It’s out there, and I would love to see the discussion center on this, not the outrage.

    Finally, here’s a bit of hyperbole on the topic of expertise in general. Why is it that we continue to believe in elitist this concept of expertise anyway? In this era of smart mobs and wise crowds, the old cliché’ that “all of us is smarter then any one of us” clearly holds true. Why not let the “opinion leaders” spout off all they want while we take responsibility for our own action as patients? Our own founding “thought leader”, Tom Ferguson, questioned everything his doctors did to the very end. He always assumed that an individual’s recommendation was just that, an individual recommendation. The sooner weeditorial evolve as a species beyond a sheep-like approach to expertise and “leadership” the sooner we will claim a truly democratic system in both healthcare and civil society.

  4. Ted Eytan says:

    Dan,

    Good points all around. I would humbly add that physicians in society are more than part of the crowd, and our profession has cultivated a following by patients who want to be healed by someone. It’s similar to what a colleague once said to me, “Ted, always be aware that you words sometimes carry a lot more weight then you think or want them to.” Like the rest of us, you are working to diminish unrealistic expertise placed on a group of people that may not have it (and you are doing a fine, job, thank you!).

    I also want to suggest that “because everyone else is doing it” is a hard thing for a community to hear, regardless of the issue – everything from job outsourcing to conflicts of interest, because those who aren’t empowered don’t have the option to do it, just accept the consequences.

    In response to Shannon Brownlee’s call for a list of professionals that do not have ties, I added this statement to my blog’s “About” page:

    ‘Conflict of Interest: I do not have any financial interest or ties to, and have not received any honoraria from, pharmaceutical or device manufacturers. ‘

    Shannon requested a lookback period of 5 years. Why don’t we start with everyone here and anyone who would join a Society of Participatory Medicine, and then it won’t be an exception anymore.

    I do not of course mean to imply that pharmaceutical manufacturers should not conduct business in the interest of their customers, who are at some level our customers too. We just have to make sure we are always helping each other improve by asking good questions.

    With respect,

    Ted

  5. Ted Eytan says:

    One more thing – and I know this is a solution in search of a problem – I have been really interested in using zeemaps.com to to create location/region aware lists, as a trial.

    Perhaps we could collaborate with e-patients.net to host a registry of health care professionals and patients who are free of pharmaceutical/device maker financial ties, sorted by location, to be used as a ready resource for journalists or people seeking content expertise in the Web2 world?

    -Ted

  6. Dan Hoch says:

    The zeemaps idea is a great one. It would compliment the kinds of inventories that folks like Schwitzer are creating.

    But I still don’t know who has conflicts and who does not. I know people who have spoken for drug companies that I still think are absolutely objective and others who have no ties to Pharma but are so narcissistic that I wouldn’t trust them to order wine at dinner. Maybe what we need is some kind of “objective test of objectivity”.

  7. Ted Eytan says:

    So, e-patients, interested in collaborating on a conflict of interest zeemap?

    Dan, as you point out, I would not hold this up as a measure of trust or competence – the magic of Web2.0 and Google juice can help with that. What this would help with is differentiating between two equally compelling points of view (i.e. other things being equal). One offered by a person with device/drug financial ties may be of less interest relative to one that is offered by a person without conflicts.

    Based on activities like this one under way at University of Pennsylvania, I think enough people believe that this distinction is useful that it’s worth knowing about,

    Ted

  8. Ted Eytan says:

    Allright, Zeemaps is up, you can get to it here:

    http://cli.gs/noties

  9. Dan says:

    Cardiovascular disease, I surmise, is very concerning to both patients and their care givers, if this disease is expected, or in fact does exist. Furthermore, this disease is likely a cause of distress as well as confusion for many who seek the best treatment options for such diseases. As a result, there are increasingly many pharmacological options available to delay if not prevent such diseases, and these drugs work in different ways for the same cardiovascular diseases that are acquired often. Many health care providers are understandably unclear as to which treatment option would be most beneficial for their cardiac patient.
    One increasingly progressing cardiovascular disorder is hypertension, or high blood pressure, as it affects possibly over 70 million Americans- many of which are not either treated or have their hypertension controlled as it needs to be to prevent future cardiovascular events caused by prolonged hypertension in such individuals. Such events include an increased risk for strokes, heart attacks, and kidney failure, among other damage that can be caused in the unmanaged hypertensive patient. While hypertension is evaluated according to different stages of severity, most hypertensive patients have what is called primary, or essential hypertension, and often require medicinal treatment to control their high blood pressure.
    Additional reassurance for health care providers was made available regarding which pharmacological therapy for hypertension should be chosen by them due to the results of the ALLHAT trial. This trial lasted 4 years and was published in the Journal of the American Medical Association in 2002. Also, the trial was conceptualized and implemented by the National Institute of Health during the 1990s. This trial was the largest study to date addressing, among other variables, those patients in the study with hypertension, and the study examined which class of medications were most effective for these types of patients placed on these different classes of medications for their hypertension treatment that were to be studied
    in the ALLHAT trial. In addition, the ALLHAT trial included over 40,000 subjects who were over the age of 55 and were evaluated in over 600 clinics during the course of this trial. Nearly half of the patients in this trial had metabolic syndrome, which is a syndrome where one is obese, has dyslipidemia, and glycemic issues as well. While Pfizer financially contributed a small portion to support this trial, ALLHAT was overall funded by the National Institutes of Health at a cost of around 130 million dollars, which again was for the purpose to determine the best medicinal treatment for the patients that were studied in this trial according to the trial’s study plan to compare the effectiveness of the different classes of medications in this trial, which had not been done to this degree in the past.
    Because the NIH developed and funded this study, the ALLHAT trial, as a result, was largely if not completely void of bias and commercial interference compared with those trials that are sponsored by the manufacturers of drugs studied in other trials often. Because of the ideal design and methodology in which this trial was performed, most concur the results of this trial are quite accurate and valid that demonstrated the effectiveness of each class of medications in the ALLHAT trial.
    ALLHAT provided data that allowed a true comparative analysis of these various classes of drugs for hypertension, which included calcium channel blockers, ACE inhibitors, Alpha Blockers, Beta Blockers, and diuretics. The researchers examined the action of these classes of medications on the subjects who possessed various cardiovascular disease states- with a focus on the ability of each one of these different classes of drugs on the disease of hypertension the patients in the study had during the trial. As the trial was completed with data collected and analyzed after a 4 year period, the ALLHAT trial concluded that one particular class of medications involved in this study proved to be the most advantageous for the subjects as it relates to safety, efficacy and cost for those who require treatment for their cardiovascular disease state, as well as the prevention or the delay of progression of additional cardiovascular disease states studied and examined. Amazingly, this one drug class in this study is in fact nearly as old as the subjects involved in the trial.
    ALLHAT results specifically and clearly concluded that thiazide diuretics are, overall, the preferred choice of initial medicinal therapy for hypertensive patients, as this class of drugs overall proved to be equivalent if not superior in many ways compared with the other classes of drugs in the study. Diuretics offered great protection against cardiovascular disease and controlled hypertensive patients as they needed to be, and proved that diuretics should be the first line drug of choice in such patients. The diuretics also decreased the risk of heart failure and stroke, as well, compared with the other classes of drugs in this trial, and this class of drugs has existed since the 1950s. Thiazide diuretics were in fact superior in these risk factors in this comparative effectiveness protocol, and just as effective as the other classes of drugs it was compared to in this trial with preventing myocardial infarctions. Thiazide diuretics in fact have been studied in such disease states associated with cardiovascular disease for over 40 years, and thiazide diuretics are long acting for the benefit of the patients who take them for hypertension. Over half of all patients respond to this class of drugs as monotherapy. The effect of diuretics is most noticeable on the systolic level of blood pressure than the diastolic level.
    This class of medications, diuretics, have been available in the United States for well over 50 years, and presently costs about 25 dollars a year, instead of a few dollars a day for many if not most branded medications for CV conditions that were examined in the ALLHAT trial. So this finding, of course, concludes that diuretics not only provide equivalent if not superior benefits for cardiovascular disease patients, but also provides cost savings as well as illustrated in this trial. The ALLHAT trial was rare and unique in that it compared diuretics to these other classes of medications directly, which is not done frequently with clinical trials involving branded pharmaceuticals, as they usually do comparative studies with simply placebos most of the time, so their efficacy comes into question as a result of previous studies.
    Yet, even though this trial was potentially beneficial for so many who are involved with prescribing medications such as diruetics reasonably and necessary for their hypertensive patients, the acknowledgement of diuretics as being superior and preferred as initial medicinal therapy never really materialized or was fully recognized following the release of the results of the ALLHAT trial by the medical community, and this diuretic still is not utilized as often as it should be, according to others. There was hope that there would be an increase in the prescribing of diuretics based on the results of this trial for those patients who are determined to have the disease states in the ALLHAT trial. Even after the researchers of the ALLHAT trial implemented what was called an ALLHAT dissemination plan from the years 2003 to 2006 at a cost of close to 4 million dollars to educate health care providers about the ALLHAT results, and the significance of the findings, the acknowledgement of the benefits of diuretics continue to be unrecognized by health care providers who select other classes of drugs to treat their hypertensive patients, as they still do today. The other classes aside from diuretics do in fact have benefits with cardiovascular patients, with compelling indications in particular. Yet the etiology for the prescribing habits regarding diuretics and why this class of medications is not chosen as often as they should be is largely unknown
    Others have speculated why this issue with diuretics in the ALLHAT trial never caught the attention to change the prescribing habits of health care providers, overall.
    For example, and of no great surprise, these results of the ALLHAT study appeared to be of notable concern to those pharmaceutical companies who promote the other classes of medications in the ALLHAT trial that are more expensive than a thiazide diuretic. Reportedly, these companies who market these other classes of drugs increased their promotional spending in order to blunt the potential effects this trial may have on the usage of their cardiovascular medications that again belong to the classes that were involved in the ALLHAT trial soon after the results from this trial were published. Sampling of their branded medications to health care providers increased noticeably as well from those pharmaceutical companies that had branded medications for cardiovascular disease states. Thiazide diuretics, while clearly the apex for the prevention and management of hypertension and other cardiovascular disease states, do not engage in this promotional behavior that appears to be more of a powerful force than evidence-based medicine, as with the case of this diuretic and the benefits of this class of drugs that has been discussed..
    Furthermore, drugs combining two medications from different classes of medications for hypertension and other cardiovascular disease states are increasingly preferred by many health care providers for understandable reasons presently- depending on the severity of the cardiovascular disease states that may exist, along with the risk of developing these cardiovascular conditions. It has been said that nearly 70 percent of hypertensive patients alone require more than one medication to adequately have their hypertension controlled. It is not unusual, for example, for a branded pharmaceutical company to combine their medication for hypertension with a diuretic for those patients that may have a stage of hypertension that requires simply more than just one drug for reduction of their high blood pressure. On the other hand, some cardiovascular combination medications are absent of a diuretic. Yet diuretics remain the first line choice of treatment based on the results of the ALLHAT trial, regardless, and should be included in any combination drug chosen for the treatment of most cardiovascular disease patients with hypertension that requires more than one drug for control of their high blood pressure, according to others.
    More convincing is that the JNC-7, a report that concludes which medication is best for the prevention and treatment of high blood pressure as well as other cardiovascular conditions, concurs with the results of the ALLHAT trial, and as a result, the JNC states in their report that diuretics are preferred for first-step hypertension therapy, and acknowledge that this class of medications is presently under-utilized. The Report is rather thorough, and is developed by the American Heart Association. The report is also recognized and respected by health care providers who treat cardiovascular disease.
    I’m comfortable as a layperson in suggesting that the cardiovascular experts should and in fact be obligated to continue to make others aware of the results of the ALLHAT trial, and convince other health care providers that diuretics should be the preferred choice of medicinal therapy for the medical conditions illustrated and treated in the ALLHAT trial. In particular, thiazide diuretics are most beneficial for those hypertensive patients that are African American, the elderly, obese patients, those with heart failure, post-MI patients, diabetics, and those at risk for a stroke. And it should be noted that this type of diuretic depletes potassium from the patient taking this drug, so caution should be utilized regarding this issue, as well as the patient who is prescribed a diuretic should be informed of additional possible side effects associated with a thiazide diuretic, although they are infrequent, such as potassium loss.
    Along with the cost savings that could amount to billions of dollars saved annually, diuretic medicinal therapy would ensure both health care provider and patients that they are receiving the proven and ideal treatment which will control their hypertension, and delay the progression and prevent additional cardiovascular events with this particular drug.
    Unfortunately, it appears what may be one of the most authentic trials conducted has been and continues to be largely disregarded or not recalled by those who treat hypertension- possibly due to the forces of others whose objectives are of a different nature besides the restoration of the health of others as it relates to the diseases addressed in the ALLHAT trial. So again, it appears in this situation that promotion has been a more powerful force than what science has provided.

    Dan Abshear

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