Maggie Mahar and Niko Karvounis
Last week the New York Times published a story about one of the biggest medical trials ever organized by the federal government, a study that showed that the newest, most expensive drugs used to treat high blood pressure (a.k.a. hypertension) work no better than inexpensive diuretics—water pills that flush excess fluid and salt from the body. Moreover, the research revealed that the pricier drugs increase the risk of heart failure and stroke.
The trial was completed in 2002. Why is the story running now? Because six years later, the findings still have had little impact on what doctors prescribe for patients suffering from hypertension.
Allhat –which stands for the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial—demonstrated that when, it comes to preventing heart attacks, the diuretics—which have been used since the 1950s and cost only pennies a day—is just as effective as newer calcium channel blockers and ACE inhibitors that cost up to 20 times as much.
And the diuretic is safer. Patients receiving Pfizer’s calcium channel blocker (Norvasc) had a 38 percent greater chance of heart failure than those on the diuretic. And those receiving AstraZeneca’s ACE inhibitor were exposed to a 15 percent higher risk of strokes and a 19 percent higher risk of heart failure.
Meanwhile, NYT reporter Andrew Pollack noted, the diuretics cost only about $25 a year, compared with $250 for an ACE inhibitor and $500 for a calcium channel blocker.
In a rational world, the results “should have more than doubled” use of the less expensive drugs, says Dr. Curt D. Furberg, a public health sciences professor at Wake Forest University and the former head of the Allhat steering committee.
But that didn’t happen. Instead the share of hypertension patients receiving a diuretic rose only slightly: from 30 to 35 percent before the results were announced, to roughly 40 percent a year later. Since then, diuretic sales have leveled off, and the Times reports, and “use of newer hypertension drugs has grown faster than the use of diuretics.”
Big Pharma Pushes Back
Why did the 42,000 patient, six-year, $100 million clinical trial have such a small impact? Furberg blames the drug industry.
Consider how Pfizer reacted when Cardura, a fourth drug that went head-to-head with diuretics in the Allhat trials, failed the test. Over the course of the study, Furberg & Co. discovered that “patients taking Cardura faced serious risks: they were almost twice as likely as those receiving the diuretic to require hospitalization for heart failure.” Alarmed that putting patients on Cardura would mean putting them in danger, the Allhat team stopped testing Cardura in 2000, shortly before the study formally ended.
Cardura’s manufacturer, Pfizer, was quick to move when it heard the bad buzz surrounding its product. “Rather than warn doctors that Cardura might not be suited for hypertension,” says the Times¸ “Pfizer circulated a memo to its sales representatives suggesting scripted responses they could use to reassure doctors that Cardura was safe…” The company also mobilized its sales staff to downplay Allhat’s findings: “[I]n an e-mail message unearthed in…court documents, a Pfizer sales executive boasted to colleagues that company employees had diverted some European doctors attending an American cardiology conference from hearing a presentation on the Allhat results and Cardura. ‘The good news,’ the message said, ‘is that they were quite brilliant in sending their key physicians to sightsee rather than hear Curt Furberg slam Pfizer once again!’”
But Furberg did knock Cardura again in a 2004 article in which he accused the company of treating the trial results “as a marketing problem rather than a public health issue.” He noted that the company never submitted the Allhat results to the FDA, nor did it make an effort to inform doctors and patients of the risks associated with Cardura.
Meanwhile, Pfizer touted its other entry in the blood-pressure medication bake-off, Norvasc, the calcium channel blocker. By 2002 Norvasc was the best-selling hypertension treatment in the world, with sales of $3.8 billion, and Pfizer’s second-biggest drug behind the cholesterol medication Lipitor.
The company beat the drum for Norvasc. In a news release after the Allhat results were announced, it claimed that Norvasc was found to be “comparable to the diuretic in treating fatal coronary heart disease, heart attacks and stroke.” And, the Times reports, “in a medical journal advertisement, it proclaimed ‘ALL HATs off’ to its drug.
Neither the news release nor the ad included the 38 percent greater risk of heart failure with Norvasc that Allhat exposed.
Pfizer CEO Hank McKinnell was emphatic in his support for the drug “Contrary to what you might have read in the press,” Mr. McKinnell said, “Allhat is extremely positive for Norvasc. It will be our job to explain that to the medical community.”
And Pfizer did just that. By 2006 sales had hit $4.9 billion—up from $3.8 billion in 2002. That year, Mayoclinic.com advised patients: “A large group of medical experts known as the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends that most people should try thiazide diuretics as the first choice to treat high blood pressure and heart problems related to high blood pressure. But Big Pharma’s money talked louder.
Meanwhile, critics emerged—as they always will—to question the design of the Allhat trial. And a smaller, less definitive Australian study declared an ACE inhibitor superior to a diuretic. This all muddied the waters.
But the hundreds of millions that drug-makers spent promoting their more expensive products made the difference. No one was making a huge profit on diuretics, so no one was spreading money around to market them.
What the Allhat Story Means for Health Care Reform
If you are a health care reformer, you might find this story discouraging. Certainly, when the American Prospect’s Ezra Klein reported on it, he sounded glum: “Folks looking to things like comparative effectiveness review to save the health care system should take the story seriously. Evidence is only effective if physicians use it. And right now, they have no real reason to use it.
“Even in a system this expensive,” Klein noted, “there's no internal incentives to aggressively cut costs. Maybe it's time there were.”
Klein then suggests that doctors should be paid “by capitation—if they got a fixed amount of money per patient, and they kept whatever they didn't use…it’s hard to imagine that they wouldn’t’ have been more interested in the study’s results.
It’s not clear how capitated payment would motivate doctors to prescribe a cheaper, equally effective drug since it’s the patient (or his insurer), not the doctor, who pays for the more expensive drug. Though one could argue that if doctors were paid a lump sum to keep patients well, they would avoid a riskier product.
But on the main point, Klein is right. Data alone won’t cut it. Someone with clout is going to have to turn comparative effectiveness research into health care policy.
Here we come to the good news: the U.S. is now poised to give evidence-based medicine the institutional backing that the Allhat research lacked. That is why the Times ran the story last week. Three years ago, there was no hope that research like this would translate into policies that motivate doctors to practice evidence-based medicine, and so little reason to lament how little effect the Allhat research had. Now there is.
Legislation Already In Congress
Both President-elect Obama’s health care plan and the proposal for reform outlined by Senator Finance chairman Max Baucus paper call for a public Comparative-Effectiveness Institute. Former Senate Majority Leader Tom Daschle, who will be the next Secretary of the Dept. of Health and Human Services, and the point man on the transition team’s working group on healthcare, has talked about the need for such research to set guidelines for federal medical programs.
Moreover, last summer, Baucus and Senate Budget Committee chair Kent Conrad in August introduced a bill (S 3408) to create a comparative effectiveness institute, which would function as a not-for-profit private entity, not a federal agency. This would insulate it, at least to some degree, from Congress and the lobbyists who woo our legislators.
At the time, Congressional Budget Office Director Peter Orszag estimated that the U.S. could save up to $700 billion annually in health spending by identifying treatments that do not produce the best medical outcomes. Orszag’s support is key: since then, President-elect Obama has appointed him director of the Office of Management and Budget (OMB). Widely respected, Orszag is likely to become a powerful figure in the new administration.
Baucus has explained that the Health Care Comparative Effectiveness Research Institute would be "responsible for setting national priorities" for head-to-head trials and would contract with
the NIH, the Agency for Healthcare Research and Quality and private entities to provide peer-reviewed research studies that "answer the most pressing questions about what works in health care.”
According to the Kaiser Daily Health Policy Report, the Institute’s budget would be small to start—just $5 million in fiscal year 2009—but would climb quickly to $300 million in FY 2013. It would be funded by the federal treasury, Medicare and private insurers. Both Karen Ignagni, president of America’s Health Insurance Plans (AHIP), and BlueCross and BlueShield Association President Scott Serota announced support for the plan. (As well they should—the institute could save them billions of dollars by exposing ineffective treatments.)
But here’s the tantalizing part of the proposal. According to Kaiser “The Institute would be governed by a public-private Board of Governors. The 21 members of the Board would include the secretary of HHS and the directors of AHRQ and NIH. The Board's other 18 members, to be appointed by the Comptroller General, would include representatives from three of the following entities: private payers; pharmaceutical, device and technology companies; patients and health care consumers; physicians; and agencies administering public health programs.”
As HealthBeat observed at the time, “[There appear to be five entities and] it seems that the 18 board members will be drawn from three of them.” Who will be left out? To HealthBeat, the answer seems obvious: pharmaceutical, device and technology companies should not have a seat at the table. Their financial self-interest (which would lead them to favor the most expensive products) creates an immediate conflict of interest. They should be consulted; but they should not have a vote.
We’ll see what happens. No doubt, the bill will change many times as it wends its way through Congress. But the president-elect, Orszag, Daschle and Baucus all recognize that we must wring the waste out of our health care system.
Research is Available
Skeptics suggest that even if the new administration creates a Comparative Effectiveness Institute, it will be a long time before it generates enough research to make a difference. But this just isn’t true. The Institute does not have to re-invent the wheel.
We already have comparative studies like the Allhat trial plus work done by the U.S. Agency for Healthcare Research and Quality. Many studies have been done in Europe, where governments regularly use such research to make coverage decisions. As the Times reported recently, “Membership in an international group of drug and device assessment agencies has grown to 45 from 8 in 1992.”
In addition, the Veterans’ Administration, Kaiser Permanente and the Mayo Clinic all have electronic databases showing how patients fitting a particular profile have reacted to various treatments. This observational data can be very useful.
Moreover, as Osrzag’ Congressional Budget Office pointed out in December of 2007, we’ve already seen comparative effectiveness studies on a wide range of treatments, pitting angioplasties against drug regimens for heart patients, gauging the effectiveness of surgery for patients with emphysema, testing statins, and weighing mammograms against the combination therapy of mammograms and MRIs for breast cancer. Yet for all this research, our health care system remains bloated, inefficient and wasteful. In other words, Allhat isn’t the first time that good research has failed to change the game.
Part of this is because a for-profit health care industry opposes any efforts to reduce waste. One man’s risky and over-priced treatment is another man’s income stream. But the other problem is that our health care system doesn’t have a mechanism to do anything with good research except to let people talk about it informally
TCF’s Working Group on Medicare Reform
The Century Foundation’s Working Group on Medicare Reform already has discussed how Medicare might integrate the Institute’s comparative effectiveness research into its coverage decisions. The Group recognizes that Medicare would be reluctant to simply refuse to cover a popular, widely used treatment—even if there were evidence that it was riskier as well as more expensive than an equally effective alternative. Politically, that is probably a non-starter.
Nor is it likely that Medicare will refuse to cover treatments on cost alone. This would mean putting a price on what a year of life is worth when deciding whether to cover a drug that would give a cancer patient an extra year. The TCF Working Group recognizes that most Americans are not ready to see decisions made on “cost-effectiveness” alone.
But there is plenty of long-hanging fruit in the form of treatments that are less effective—and riskier—than less expensive alternatives. As we’ve discussed in an earlier post, too often we often use advanced medical technologies on a broad swath of patients when only a few, who fit a very specific profile, actually benefit from it.
The TCF Working Group believes that next year, Congress may well authorize Medicare to negotiate for discounts on drugs for Medicare patients, and if so, it seems certain that Medicare would take comparative risk and effectiveness into account when deciding how much it is willing to pay.
President-elect Obama made it clear that he believes that “drug negotiation is the right thing to do and the smart thing to do” in 2007, when the Senate failed to pass the Medicare Prescription Drug Price Negotiation Act. At the time, Obama observed that the Senate had failed “ to consider a bill that would have placed the needs of seniors ahead of the profits of the health industry…Over the last decade the cost of drugs has quintupled, now totaling almost $200 billion. In 2005, the drug companies' profit was 16 percent of their revenues, compared to only 6 percent for all Fortune 500 firms…
“The growth in the cost of drugs has slowed in recent years, in part because of greater use of generic drugs. But given the price tag, and the financial challenges of our health care system, we can—and must—take additional steps to curb how much we are spending on drugs.
“When you look at the prices the Federal Government has negotiated for our veterans and military men and women, it is clear that the government can—and should—use its leverage to lower prices for our seniors as well.” In 2009, as Medicare searches for ways to cut costs, a new president may well find the votes to pass the legislation.
Meanwhile, virtually everyone agrees that Medicare needs to adjust the fees that it pays doctors, raising reimbursements for primary care doctors, geriatricians, palliative care physicians and others who practice “cognitive medicine”—listening to and talking to patients. In a recession, Medicare will have to do this in what the Medicare Payment Advisory Commission (MedPac) calls a “budget-neutral way.” In o
ther words, while hiking fees for doctors at the bottom of the income ladder, Medicare should trim fees for certain very expensive services when they are used too broadly, exposing patients to risk with little, if any, benefit.
Today, the fees Medicare pays physicians are determined by how much the service costs the physician in terms of time, mental effort judgment, technical skill, physical effort and stress. But nowhere does “benefit to the patient” figure into the equation. If Medicare took comparative effectiveness findings into account, private insurers, who already follow Medicare’s fee schedule, would be almost certain to follow suit.
Finally, as Medicare looks at the research, the Working Group believes that it would make sense to raise co-pays for tests and treatments that offer little benefit to certain patients. For example, as noted in a recent HealthBeat post, when it comes the mammograms, medical evidence has convinced the American College of Physicians that the dangers of unnecessary biopsies far outweighs the likelihood of saving a life for average risk women over the age of 74. (Similarly, the U.S. Preventive Services Task Force does not recommend mammography screening for women over 69). Older Medicare patients who still wanted the mammograms could have them, but they would have to pay more out-of-pocket. More importantly, news stories explaining why patients over 74 are being asked to pay more might well alert patients to the risks.
Why a Comparative Effectiveness Institute Would Make a Difference
Just how much difference will an “Institute” make? Again, the Allhat story is informative. The Allhat research disappeared because the U.S. has no institution that advertises comparative-effectiveness research and integrates it into the decision-making process.
As the Times notes, in order to try to spread the word about Allhat findings, “the federal Heart, Lung and Blood Institute had to recruit Allhat investigators, provide them with training and then sent them to proselytize fellow physicians. In all, 147 investigators gave nearly 1,700 talks and reached more than 18,000 doctors and other health care providers.”
In other words, the Allhat team had to convince doctors around the nation, one by one, that the results of its study should change the way that they prescribe blood pressure medication. Unfortunately, this effort was “a coffee-and-doughnuts operation compared with the sumptuous dinners that pharmaceutical companies used to market to doctors.” And it took the organizers a full three years to get the outreach up and running.
This is a profoundly inefficient way to try to promote change. You first need to transform a clinical trial into an advocacy operation, secure funding for outreach, coordinate nationwide networks of doctors, schedule countless meetings, and then work to win over doctors,. Worst of all, by the time such an endeavor gets off the ground, it may already be too late.
By the time your physician missionaries are equipped to spread the word, medicine may have already moved on. Earlier this year, for example, the Economist pointed out that one “comparative trial in the early 1990s laboriously compared balloon angioplasty and bypass surgery over the course of many years; but the widespread adoption of innovative heart stents in the meantime made the results of the study almost meaningless.” When it comes to assessing the effectiveness of a treatment, time is of the essence—because the health care industry will always try to keep one step ahead of objective evidence.
But what if we had a Federal Comparative-Effectiveness Research Institute? Its recommendations could make headlines—especially if it was influencing Medicare fees and co-pays. This would be bound to have an impact on how both patients and physicians perceive treatments. No physician has the time to keep up with, review and compare all of the research in his specialty. An unbiased Institute with a good website would serve as a clearing-house for information.
Patients versus Lobbyists
Of course lobbyists representing Big Pharma, device- makers and even some health care providers will fight legislation creating a Comparative Effectiveness Institute tooth and nail.
But that is why stories like the one that the Times just ran on Allhat are important. Today the mainstream press is making the public more and more aware that many health care treatments are not only over-priced but hazardous to our health. And an informed public is becoming wary.
Americans may love new medical technologies—but they do not enjoy being gouged, and they do not like being turned into unwitting guinea pigs. They understand that overpriced treatments are driving insurance premiums skyward. Articles like the Allhat story, the Business Week cover story, “Do Cholesterol Drugs Do Any Good," or this piece in the New York Times–warning that angioplasty is not effective unless performed within three days after a heart attack—are drawing attention.
Indeed, some physicians are seeing the change in their practice. A couple of months ago, when Maggie saw a new primary care physician, she noted that her cholesterol is a little high and suggested Maggie start taking Lipitor, a cholesterol-lowering “stain”.
When Maggie began to explain her objections, the doctor pursed her lips and shook her head. “You know, these days I have a lot of patients like you say they won’t take statins.”
Maggie started to reply, ready to give the doctor a 20-minutes riff on ‘the cholesterol con’: “That’s because the research shows that for someone who hasn’t had a heart attack …”
But the physician cut her off. “I am not interested in continuing my medical education,” she said crisply. Great. Medical science stopped evolving the day she graduated. Clearly, a bad patient/doctor match. (Maggie’s new PCP suggested that she eat fewer eggs.)
But, given the medical evidence, the fact so many patients are questioning statins is a good sign. Lobbyists beware. Word is getting out.
This has been discussed all over for the last several days. While it probably is the case that doctors are pushed by drug companies into prescribing more expensive drugs that are marginally better (even worse), the particular example of the ALLHAT trial is a crummy one. For one thing, the ACE-Is are just about as cheap as the thiazide diuretics. Target, Walmart, and Rite-Aid are currently selling a selection of 20 or more generic antihypertensives for $4 for #30 or $10 for #90.
Also, the JNC VII (JNC VIII isn’t due out until 2010) says that diuretics are the first line choice for non-diabetics and people without heart failure or chronic kidney disease. In other words, according to the JNC VII, diuretics are the first line choice for probably no more than half the population. On top of that, there are always going to be some people who don’t tolerate any given drug. Suddenly the 40%+ use doesn’t look so bad.
The intent of your article is to point out that advertising influences provider behavior. That’s not a counter-intuitive finding, but you need to find some better data to support your claim here.
J Bean–
Thanks for your comment.
You write: “For one thing, the ACE-Is are just about as cheap as the thiazide diuretics. Target, Walmart, and Rite-Aid are currently selling a selection of 20 or more generic antihypertensives for $4 for #30 or $10 for #90. ”
Yes, I know that. (If you read the Times story, it makes this clear.) This is because since 2002, these drugs have gone off patent. (The Pfizer drug went off patent in 2007.When Pfizer stopped pouring money into marketing it, sales dropped.)
But the point is that, back in 2002, when these drugs were so expensive, practice patterns should have changed.
If there had been a Comparative Effectiveness Insitute that was getting the word out–and giving Medicare the information it needs to adjust fees and co-pays and drug prices based on benefit to the patient– the allhat study would have been integrated into practice patterns.
I don’t know where you get figures suggesting that half of the pepole in this country suffering from hypertension are diabetics or suffer from heart failure or chronic kidney failure . . .
This is an example, I’m afraid, of the “disease-mongering” that makes everyone feel that they are sick, and need the newest, most expensive medications.
Also, people suffering from heart failure should not be taking drugs that increase the chances of heart failure . . .
Finally, we have lots of reserach proving that drug advertising influences provider behavior.
That wasn’t the point of this post. The point was that a) we do have a surprising amoung of comparative effectiveness research–but doctors ignore it b) if we want it to be used we’ll need financial incentives in the form of lower fees and higher co-pays for less effective tests, procedures and drugs that steer doctor and patients to more effective treatments.
Beating the dead horses in harness, the National Institute of Nursing Research is a key stakeholder in that nurses are charged with providing care which is both medically indicated and is targeted to meet or exceed identified optimal patient outcomes. Nurses should be seated at any federal oversight table, and nursing practice should – and is – reflective of evidence-based best practices. The ALLHAT study should be guiding nursing practice that questions physician prescriptions which do not include the recommended diuretic(s) as integral bases of therapy.
This is one example of how nurses should be able to effectively advocate for patients. In hospital settings, nurses participate and often lead clinical performance improvement and regulatory/accreditation compliance initiatives.
You might look at the Institute for Healthcare Improvement website to see some exemplars of organizations that are moving forward around this particular problem.
But as Ms. Mahar discovered, in individual practice settings, some physicians and nurse practitioners are schmucks – anyone who feels as though they are “fully educated” is fully full of unexpelled intestinal contents. Anecdotally, I believe they are in the minority.
“The Group recognizes that Medicare would be reluctant to simply refuse to cover a popular, widely used treatment—even if there were evidence that it was riskier as well as more expensive than an equally effective alternative. Politically, that is probably a non-starter.
Nor is it likely that Medicare will refuse to cover treatments on cost alone. This would mean putting a price on what a year of life is worth when deciding whether to cover a drug that would give a cancer patient an extra year. The TCF Working Group recognizes that most Americans are not ready to see decisions made on “cost-effectiveness” alone.”
I think the most effective way to change physician practice patterns is to simply stop paying for drugs, devices and procedures that are not cost-effective. I don’t think Americans can have it both ways. If the British and, to a lesser extent, people in Western Europe, Canada, and Japan accept limited drug formularies and are willing to, in effect, put a price on a year of life in deciding whether or not to cover hugely expensive specialty drugs and we are not, we should stop complaining about our much higher costs. Drug price negotiation is all well and good, but I question how much can be saved by that approach alone. Specialty drugs account for 25% of drug spending now and rising. Often, older therapies are almost as good but far cheaper. If people want these expensive and cost ineffective products and procedures, they should pay for them out of pocket.
The incidence of smoking declined sharply in the U.S. after tobacco taxes were raised significantly. Before that, all the public service announcements and exhortations to stop smoking had comparatively little effect. People in Western Europe and Japan drive smaller, much more fuel efficient cars because gasoline prices are much higher than here, most of which is attributable to very high gas taxes. To require auto manufacturers to build cars to some legislated fuel efficiency standard when gas prices are very low may be politically expedient but it’s not very effective.
Back to medical care, doctors are unlikely to significantly change their practice patterns as a result of cajoling or posting comparative effectiveness research on a website. On the other hand, if they hear from patients that the drug they prescribed is not covered by Medicare or private insurers or the patient must pay much more of the cost out of pocket, docs would presumably be responsive to patients trying to mitigate their out of pocket exposure.
President Obama’s Chief of Staff, Rahm Emanuel said (paraphrasing) we don’t want to waste a good crisis. In these incredibly challenging economic times, all sorts of things might now be possible that were politically untenable previously. Especially in light of what Peter Orzag has been saying about the unsustainable rise in healthcare costs being the key threat to the federal government’s long term fiscal health, now is the time to more aggressively attack medical cost growth, especially if we want to try to extend insurance coverage to the 47 million currently uninsured as well.
Captopril (an ACE-I) has been a generic drug since before I finished residency in 2000 and lisinopril became available as a generic within the next year or so although possibly not long before the ALLHAT trial was completed. Atenolol and propranolol(beta blockers) and nifedipine and diltiazem (CCBs) were certainly available as generics lo those many years ago too.
I’m just guessing at the percentage of hypertensives who are diabetic. DM incidence is about 1:4 in caucasians and 1:3 in African-Americans, Hispanics, and southeast Asians so that’s a lower limit on the percentage of diabetic hypertensives. Hypertension affects about 1:4. DM is a metabolic process that is often (usually!) associated with hypertension, gout, and hypertriglyceridemia. Looking at my patient list for today, I’ve seen 5 people with both and 3 people with hypertension alone and one person with hypertension and insulin resistance. One of the hypertensive-onlys and two of the diabetics have a significant level of chronic kidney disease.
My point is that we do have a large amount of comparative effectiveness research (although Shannon Brownlee disagrees) and much of it is contradictory and hard to interpret. Also, it’s unrealistic to expect that there would be an instantaneous change in practice when new data becomes available. There is certainly lots of effectiveness data about statins, but as you have pointed out, that doesn’t tell the whole story.
In the case of hypertension, you can’t just look at a single trial. ALLHAT is a good trial, but still doesn’t address the nearly infinite variety of configurations in which my patients appear. Call me a bad doctor, but I’m still going by the JNC VII recommendations rather than the lefty blogs’ study du jour of physician malfeasance.
Unfortunately, there is a lot of effectiveness data out there. A big, huge, mushy pile of contradictory, hard to access, hard to evaluate data that comes at us in a huge, roiling tsunami of recommendations. Walk a few miles in my shoes.
BTW Kaiser published a big study this year about DM. Their data seemed to indicate that diabetics did best when treated with an ACE/ARB, aspirin, and a statin and never mind the blood sugar.
I feel like I live in a different world. Formularies? Are you kidding me? Each insurance plan has a different formulary with different tiers and copays with in the formularies. I spend all day long trying to sort out which medication is covered for which patient (one of the many things that could be done nicely by an EMR … but isn’t.)
Alot of wasted words for a simple cure. If you want doctors to follow practice guidelines and evidence based medicine, make them immune from lawsuits if they follow them. Done. Next issue please.
The easiest example to implement is midway through your post. If a female is over 69 and latter gets breast cancer, she can’t sue the physician for not ordering a mammogram. You will get your desired result in one swoop. No excess testing and extreme motivation on the physician side to follow guidelines.
What Jenga said. The doctor that tried to get you to take a statin knows that you can’t sue her if you have a heart attack as long as she told you to take a statin.
Over at Balloon Juice, Michael D is upset that his dad is being treated according to guidelines in Canada and not getting the surgery that he wants.
http://www.balloon-juice.com/?p=14300
jenga said:
“Alot of wasted words for a simple cure. If you want doctors to follow practice guidelines and evidence based medicine, make them immune from lawsuits if they follow them. Done. Next issue please.”
———-
This sounds good and simple, but on reflection, I think it requires a lot more potential reform-system information. I believe that most of us now think that guidelines kick in after a correct diagnosis (dx) is somehow made, and these guidelines involve the appropriate treatments (tx) for that dx. An inappropriate dx will still open the provider to suits and all that defensive medicine uncertainty they face now on BOTH the dx and tx sides. Therefore, the mechanisms setting up the guidelines will likely have incentives for overtesting to get the DX correct. That could still cause a lot of costs and ?? waste in the system, but it just may be unavoidable if we value a truly correct dx to begin with. System related comments?
Annie– I definitely agree: nurses should be at the table that reviews comparative effectiveness information and sets best practice guidelines.
I am going to try to focus more on the role nurses can play in healthcare reform. And I’m going to make sure that our Working Group on Medicare REform addresses that issue.
For example, we are going to be talking about the need for more palliative care teams, and geriatric teams.
In both cases, it’s a team approach to medicine. A palliative care team is made up of a specially trained doctor, palliative care nurse and social worker.
Geriatricians also work in teams with nurses.
And Primary Care docs need to work more closely with RNs.
Barry–
A federal court recently ruled that Medicare Cannot Refuse to Cover or Pay Less for a Treatment because it is less effective. According to the court “the market decides” what are fair prices and what drugs doctors and patients want.
CMS said it may appeal, but if this goes to the Surpeme Court, the Court is likely to rule against Medicare.
As I explained on an earlier post, if Medicare tries to make decisions based on COST-effectiveness, people in Washington say that the whole idea of comparing effectiveness will be thrown out the window. (Conservatives have already written many editorials in places like the WSJ arguing that once the government begins comparing effectiveness it will be trying to “save money” (as if that’s a bad thing) and Americans will be denied the care they need.
This is why the Working Group is careful to say that at this time, we should focous on risks and benefits when comparing two products–not cost. That’s the only way to meet the “government is rationing care we need” argument.
It’s going to take a long time to educate the American public to understand that many of the new wonderful high-tech treatments out there will hurt some patients more than they help them–and that just because a doctor they like recommends something does not mean that the benefits outweigh the risks.
So the best we can do, for now, is to look at comparative-effectiveness, without looking at cost.
The UK is the only country that makes deicisions strictly based on costs.
On the tobacco tax-Since the late 1990s-higher taxes have helped cut smoking, but the sea change came long before that. In the 1970s, smoking became socially unacceptable among well-educated upper-middle-class and middle-class people.
Suddenly, there were no longer ash trays at parties–people who wanted to smoke went outside.
By the late 1970s, you almost never saw a student smoking in college classrooms (at least where I taught– a fairly radical campus. This probably didn’t happen until the 1980s at more conservative universities.)
The peer pressure not to smoke was intense. An entire generation of 20-somethings, 30-somethings and 40-somethings gave up smoking at that point.
(By 1975, the Chilton study showed that 82% of non-smokers and 77% of former smokers felt smoking should be restricted in public places.)
And a generation of college students never started. (See “From Norm to Vice: When Smooking Became Socially Unacceptable) http://64.233.169.132/search?q=cache:m_H413uYr0EJ:www.no-smoking.org/nov99/11-22-99-4.html+smoking+and+1970s+and+%22socially+unacceptable%22&hl=en&ct=clnk&cd=1&gl=us
None of this had to do with the cost. Cigarettes were still very affordable.
(By 1993,, smoking among adults had fallen to the lowest level in 50 years–to 25%–and cigarette taxes were very low just 24 cents a pack.)
At that point, less well-educated,low-income people continued smoking. And it has taken huge hikes in cigarette taxes to affect their habits
It wasn’t until the late 1990s and early 21st century that smoking among less well-educated teens began to decline, due to much steeper taxes.
J Bean– The fact that Captopril was available as an inexpensive generic in 2000 isn’t really the point.
What’s signficant is that Pfizer’s expensive drug became the best-selling medication for hyper-tension DESPITE EVIDENCE OF SERIOUS RISKS when compared to less expensive, equally effective drugs.
Physicians simply ignored the comparative effectveness research.
Part of this is because Pfizer spent a great deal of money to market its product, part of it is because U.S. doctors just don’t pay that much attention to guidelines.
Solo practioners and those in small practices in particular, tend to do things their own way, based on what they learned in med school, habit or influence from industry.
In the UK NICE (which reviews compmarative effectiveness reserach) has achieved something like 88% compliance among doctors. (One wouldn’t expect 100% complicance because there are always individual casees where the doctor should deviate from guidelines.)
But according to hate Insitute of Medidince we don’t have anything close to that kind of compliance here. Even when it comes to things where there is a strong consensus–like giving the aspirin to the heart-attack victim–it doesn’t happen.
So financial incentives– in the form of lower fees for less effective services, higher fees for more effetive services, and co-pays that steer patients toward more effective services are, I think, needed.
This will also generate publicity and spread the news as to what the latest research shows.
You write: “Unfortunately, there is a lot of effectiveness data out there. A big, huge, mushy pile of contradictory, hard to access, hard to evaluate data that comes at us in a huge, roiling tsunami of recommendations. Walk a few miles in my shoes”
Exactly right. This is why we need an official clearing house of unbiased researchers sorting through the studies–separating those where researchers had a financial interest.. . etc
Are they ever going to find the perfect “true” study? No. And over time, guidelines will constantly have to be revised.
But other countires have unbiased clearing-houses for evidence (whether registries or a NICE) and we need something similar.
Right now, those with a financial stake control the information.
If it takes a “lefty blog” to see this–so be it. (Though I’m far from alone. See Dr. Roy Poses Health Care Renewal, Merrill Goozners GoozNews, and CBO director Peter Orszag’s blog. (Most people don’t think of Orszag as a Lefty.)
This is something that CMS, the AMA and other health provider groups should have insisted on long ago.
J.B. —
You point out that insurance companies have “formularies”–but I think you realize that the Mayo Clnic’s formularly, the VA’s formulary and the formulary that Medicare needs are very different.
Most for-profit insurers create a formulaty based on negotiations with drug-makers. If you’ll give me drug A at a certain price, I’ll include Drug B and C that you also make in my formulary–and exclude the drugs your rivals make that compete with B and C (even though the rivals’ durgs may be safer, more effective and cheaper.)
IN other words, most for-profit insurers make up a formulary based on price and “deals” they make with drug-mnakers.
Mayo, the VA, etc. look at benefits and risks first–not prices– and pick the most effective, least risky drug. (In the long run this is also the best choice for them financially since they are not paid fee-for-service, their goal is keep the patient well–or get him well as soon as possible.)
jegna– and J Bean –
Malpractice awards and settlements have been climbing much faster in the UK and Canada than in the US.
Yet doctors in those countires practice far more conservative medicine–and are much more likely to follow guidelines. (In some countires, people spend more days in the hospital but a Lot Less Happens to them while they are there. Fewer tests and high-tech treatments. Also fewer errors and infections.)
This comparison to other countries undermines the argument that fear of malpractice is the major factor behind overtreatment–or that doctors do or don’t follow guidelines based on fear of malpractice.
We have three decades of widely accepted Dartmouth research showing that overtreatment is directly linked to excess capacity–more hospital beds and specialists– with no improvment in outcomes,
We also know that multi-specialty clinics that use comparative effectiveness reserach (like Mayo and Geisinger) have better outcomes at a much lower price (patients spend less time in the hospital, see fewer doctors while there, fewer readmissions, etc.)
It’s impossible to quanify how much an effect fear of malpractice has (usually there are 4 or 5 reasons behind any medical decision) but the comparison to other countires where malpractice suits are on the rise is telling. One would think doctors there would be just as tempted to over-treat to cover their ass–but all the research shows that they don’t. Fewer angioplasties, fewer statins, fewer mammograms and MRIs for breast cancer, no PSA testing in most countries, etc. etc.
NG– Getting the diagnosis right is often the trickiest part of medicine.
At very efficient hospitals, talented doctors get the diagnosis right soon after the patients enters the hospital. At less efficient hospitals, the patient is passed from one specialist to another until finally directed to the specialist who can make the diagnosis.
One thing we have learned is that Too Much Testing stands in the way of good diagnosis. Doctors rely too heavily on the tests–assuming they must be right.
Too often, the doctor makes the wrong diagnosis becuase he ordered the Wrong Test. If he actually listened to the patient, asked questions and perofrmed a hands-on physical exam he would have arrived at the right diagnosis and ordered the right test to confrim.
Many medical schools are now teaching students the importance of old-fashioned hands-on diagnosis–and the danger of ordering multiple tests and relying on them for the diagnosis.
If Medicare starts paying significantly less for diagnostic testing(which it is likely to do) this will help. Though it will require a huge battle with companies like GE, that make the equipment.
You say: What’s signficant is that Pfizer’s expensive drug became the best-selling medication for hyper-tension DESPITE EVIDENCE OF SERIOUS RISKS when compared to less expensive, equally effective drugs.
Your explanation of this article doesn’t clarify any of the confusing points in the article. You note that Norvasc became (at some point) the best selling anti-hypertensive, presumably in dollar sales, not in unit dose sales. However, there are over 120 BP meds on the market; some branded and some generic, so that saying that one has “the best” total dollar sales doesn’t tell me much. If you look at the graph that accompanies the article, the prescription rate for CCBs decreases with time. In fact all CCBs together currently seem to be used about half as frequently as thiazide diuretics. The original article seems to be a kind of sensational piece that says that doctors ignore data, but the only numerical data in the article seems to contradict this point.
The EVIDENCE OF SERIOUS RISKS seems to be a little shaky, too. The article states that one of the secondary end points, congestive heart failure, was 38% more common in the Norvasc arm. The relative incidence rate doesn’t give me enough information to judge whether this is a rare or a common complication. Is there any subgroup analysis that shows that this is a new onset complication or worsening of a previous condition? How does the rather goofy choice of secondary agents affect this data? For instance, is the increase in CHF seen only the group that received Norvasc and Reserpine? The original article also waves away the fact that the diuretic arm saw in increase in diabetes. Was this a big effect or a small effect? We aren’t told, we don’t even get a relative rate (perhaps because it doesn’t fit into the author’s hypothesis?)
You say: Physicians simply ignored the comparative effectiveness research.
Again, not according to the included graph; diuretic use starts at a high level and goes up, CCB use starts at a lower level and goes down. Also, you seem to be confusing a study with a guideline. Other studies show a lot of positive effects from ACE-Is. The JNC VII guideline trys to take all of the studies into account. If you want to convince me that physicians ignore effectiveness research, show me a study that looks at deviation not from a single study, but deviation from a well circulated guideline. In this case you haven’t even shown me any data that shows that there is generalized lack of acceptance of the ALLHAT results, just opinion. Even if you could show me numerical data that shows a lack of acceptance of ALLHAT, perhaps there could be another explanation. Could ALLHAT be an outlier that contradicts many other studies? Could there have been a problem with its design? I don’t know. The original author and you have an hypothesis that physicians ignore comparative effectiveness research, but as far as I can tell, this is just a gut level feeling on your part. You certainly haven’t presented any data in support of that hypothesis.
You say: You point out that insurance companies have “formularies”–but I think you realize that the Mayo Clnic’s formularly, the VA’s formulary and the formulary that Medicare needs are very different.
I doubt it. I suspect that you see an enormous overlap between the Mayo clinic, the VA and Secure Horizons’ (e.g.) formulary. Like a lot of physicians, I trained at the VA. I didn’t notice any particularly huge change between the VA and the commercial plans when I went into practice. Again, with my old engineering hat on, I tend to be wary about arguing about the meaning of “very different”, “little different”, “a lot”, “a little”, and what have you. I’m sure that if you grab the Mayo’s formulary and compare it to SCAN’s you’ll find some differences which may or may not be significant. There are many drugs that are nearly equivalent within any class.
Believe it or not a lot of people who work for insurance companies (or big Pharma!) actually aren’t 100% evil. I happen to believe that a single-payer plan would be a far more efficient way to deliver medical care, but that doesn’t mean that I believe that Bill McGuire, as over-paid as he may have been, was the front man for Cthulhu.
I apologize for saying that this was only discussed on lefty blogs. As an aging lefty, I only read my team’s blogs.
J Bean–
I’m sorry it has taken
me so long to reply.
I actually did write a reply but then lost it.
I’ve very glad to hear that you are an aging lefty. Or, put it this way, I’m sorry that you’re aging, but if you’re “Lefty, that comes with the territory.
On the difference between how Mayo or the VA or Kaiser creates a formulary, and how a for-profit insurer creates a formulary, this is something I know about.
I was senior writer/editor at Barron’s from thh late 1980s through the late 1990s (preaching to the unconverted). And during that time I wrote about the health insurance industry, managed care, ec.
The for-profit industry did not “manage care” in
the way that Dr. Paul Ellwood (a very good man) had envisioned. Rather than judging treaments based on effectiveness, insuers judged them on price.
Insurers would agree to include a drug in its formulary if the drug-maker would give it a good discount on certain other drugs. And the insurer would agree not to cover durgs competing with those drugs.
. Whether those rival drugs were more effective did not enter into the discussion.
This is not how Mayo, the Va or Kaiser operate. They all stopped covering Vioxx long before it was pulled from the market because it was risky.
Private insurers continued to cover
Vioxx–they didn’t care if it was risky, not their problem–they knew that patients and patients’ employers wanted Vioxx in the formulary.
Cutting it out of the formulary would mean losing market share.
This is what for-profit insurers must worry about.
Their first obligation (by law) is to their shareholderes,not their customers.
I’ll take a closer look at the AllHat study and try to answer some of your other questions.
“A federal court recently ruled that Medicare Cannot Refuse to Cover or Pay Less for a Treatment because it is less effective. According to the court “the market decides” what are fair prices and what drugs doctors and patients want.”
Maggie,
I’m afraid I don’t understand. If it’s perfectly fine for the VA or Kaiser or Mayo to put one drug on its formulary because it’s cost-effective and exclude another because it isn’t, why can’t Medicare do the same, not just with drugs but with all medical treatments?
Barry–
This is the one downside to public-sector health care (i.e. Medicare).
A federal court cannot tell Kaiser or Mayo what to do. But since Congress runs Medicare, a court can tell Medicare what it can do.
In this case, instead of paying for an expensive drug that contains two active ingredients, Medicare wanted to pay for the two ingredients which are available separately at a lower cost. ( If the patient wanted the more expensive drug, fine, but Medicare’s reimbursement was going to be the lower amount–the cost of the two separate drugs.) The courts said Medicare couldnt’ do it.
The 1965 Medicare law says that Medicare has to pay 106 percent of the “average sales price” of a drug in the open market. The company argued that the law is saying that the “market should decide the cost of drugs” and that Medicare can’t try to pay less.
Of course, we know that when it comes to drugs that patients need, the market doesn’t work to lower costs the way it does in other sectors, but
the court ignored that fact.
Here’s the whole story:(from the NYT):
Court Blocks White House Push on Medicare Expenses
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By ROBERT PEAR
Published: November 3, 2008
WASHINGTON — A federal court has blocked the Bush administration’s effort to save money on Medicare by paying for only the least expensive treatments for particular conditions.
Congress sets Medicare payment rates and never intended to give officials broad discretion to alter them, the court said in an important test case on Oct. 16.
The case, just now being scutinized by Medicare officials and consumer advocates, involved drugs used to treat chronic obstructive pulmonary disease.
Judge Henry H. Kennedy Jr. of Federal District Court here said the policy of paying for only “the least costly alternative” was not permitted under the Medicare law.
The administration’s position would give the health and human services secretary “enormous discretion” to determine the amount paid for every item and service covered by Medicare, without reference to the detailed formulas set by Congress, Judge Kennedy said. “This flies in the face of the detailed statutory provisions,” he added.
Over the years, Medicare officials have often tried to adopt regulations that allow them to consider cost in deciding whether the program should cover various goods and services. Health care providers, manufacturers and some patients’ advocates have resisted these efforts, saying that coverage decisions should be made based on clinical effectiveness and not cost.
“We are disappointed with the ruling and continue to believe that our policy is supported by the statute,” Peter L. Ashkenaz, a spokesman for the federal Centers for Medicare and Medicaid Services, said Monday. “We are still considering our options and next steps.”
Federal health officials said the decision would make it more difficult to rein in Medicare costs.
Judge Kennedy found that Medicare and some of its contractors had unlawfully limited payments for DuoNeb, an inhalation drug taken through a nebulizer, which turns the medicine into a fine mist.
The drug, made by Dey, a unit of Mylan Inc., makes breathing easier by opening up the bronchial tubes. A single dose provides a combination of two commonly prescribed bronchodilators, albuterol and ipratropium.
Congress set forth the touchstone for Medicare coverage in a 1965 law that created the program. The law generally prohibits payment for items and services that are “not reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.”
If an item is covered, the payment rate is specified in other parts of the law.
The Bush administration argued that Medicare officials had the right to decide whether the expense incurred for a given item, not just the item itself, was “reasonable and necessary.”
Judge Kennedy said this argument “does not make sense” because Congress went to great lengths to establish payment rates.
Similar disputes have come up over other treatments.
Another pharmaceutical company, Sepracor, has for years challenged the government’s authority to use the “least costly alternative” as a basis for setting reimbursement rates for Xopenex, prescribed for asthma and chronic obstructive pulmonary disease.
In a friend-of-the-court brief, Sepracor said that Congress had set the payment rate at 106 percent of the average sales price. “Congress consciously chose to entrust the amount of reimbursement to the market, not to a government agency or its contractors,” the company said in its brief.
Court Blocks White House Push on Medicare Expenses
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By ROBERT PEAR
Published: November 3, 2008
WASHINGTON — A federal court has blocked the Bush administration’s effort to save money on Medicare by paying for only the least expensive treatments for particular conditions.
Congress sets Medicare payment rates and never intended to give officials broad discretion to alter them, the court said in an important test case on Oct. 16.
The case, just now being scutinized by Medicare officials and consumer advocates, involved drugs used to treat chronic obstructive pulmonary disease.
Judge Henry H. Kennedy Jr. of Federal District Court here said the policy of paying for only “the least costly alternative” was not permitted under the Medicare law.
The administration’s position would give the health and human services secretary “enormous discretion” to determine the amount paid for every item and service covered by Medicare, without reference to the detailed formulas set by Congress, Judge Kennedy said. “This flies in the face of the detailed statutory provisions,” he added.
Over the years, Medicare officials have often tried to adopt regulations that allow them to consider cost in deciding whether the program should cover various goods and services. Health care providers, manufacturers and some patients’ advocates have resisted these efforts, saying that coverage decisions should be made based on clinical effectiveness and not cost.
“We are disappointed with the ruling and continue to believe that our policy is supported by the statute,” Peter L. Ashkenaz, a spokesman for the federal Centers for Medicare and Medicaid Services, said Monday. “We are still considering our options and next steps.”
Federal health officials said the decision would make it more difficult to rein in Medicare costs.
Judge Kennedy found that Medicare and some of its contractors had unlawfully limited payments for DuoNeb, an inhalation drug taken through a nebulizer, which turns the medicine into a fine mist.
The drug, made by Dey, a unit of Mylan Inc., makes breathing easier by opening up the bronchial tubes. A single dose provides a combination of two commonly prescribed bronchodilators, albuterol and ipratropium.
Congress set forth the touchstone for Medicare coverage in a 1965 law that created the program. The law generally prohibits payment for items and services that are “not reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.”
If an item is covered, the payment rate is specified in other parts of the law.
The Bush administration argued that Medicare officials had the right to decide whether the expense incurred for a given item, not just the item itself, was “reasonable and necessary.”
Judge Kennedy said this argument “does not make sense” because Congress went to great lengths to establish payment rates.
Similar disputes have come up over other treatments.
Another pharmaceutical company, Sepracor, has for years challenged the government’s authority to use the “least costly alternative” as a basis for setting reimbursement rates for Xopenex, prescribed for asthma and chronic obstructive pulmonary disease.
In a friend-of-the-court brief, Sepracor said that Congress had set the payment rate at 106 percent of the average sales price. “Congress consciously chose to entrust the amount of reimbursement to the market, not to a government agency or its contractors,” the company said in its brief.
I can easily make arguments for avoiding me-too, more-costly drugs. I’ve also worked on expert decision support systems for hypertension therapy, and, I’m afraid, the choice is not nearly as binary or cost-based as seems to be the predominant view.
Yes, one can make an argument for picking from 4 major families for the first drug in treating hypertension. I do see that there was grudging concession that maybe the same rules don’t apply in diabetics (or people at risk for diabetes, hm?). Usually, a thorough history and some lab testing will narrow the first choice to 2 of the 4. Pick the cheapest.
More often than not, the starting dose won’t be enough, and this is expected. You bring it up. There may be side effects, at which you change to another first drug.
In a great many patients, two drugs will be safer and more effective than maximizing the dose of the first. It may be reasonable to try an alternate first drug before going to a combination, but much of the time, it will be a combination. Again, there are a whole set of non-obvious choices in the second drug.
Any chance the patient is asthmatic or at risk for it? Forget beta-blockers. Pregnant? Forget ACE inhibitors. At risk for kidney disease? Good choice for ACE. History of migraine? CCB or beta-blocker may help.
Notice that I’m not dealing with hypertension as the only thing wrong with the patient. In the real world, patients have multiple chronic conditions, and sometimes the choice of drugs is what seems best for the comorbid set of conditions, not hypertension alone.
I’m no fan of Big Pharma, but there seems to be a lot of oversimplifying and searching for eeEeevil here.
Howard–
Agreed that a NYT story doesn’t have the space to explore the complexities of blood presure treatments.
But, in medical circles (ie. among doctors), the AllHat study–and the lack of reponse–has stirred real concern.This strikes me as worth reporting.
If and when I have time, I’ll delve into the AllHat
study. I’m not an MD, but I can read medical research and tease out the details.
In the meantime, I’d urge you to get hold of a copy of Worried Sick by Nortin Hadler.
There is a long chapter on heart disease and treatments that you would find interesting, and I’d be interested in your response. (Though you should read the preface and opening chapter first. That puts what he says about how we approach heart disease in context.)
And this really isn’t about finding EEEvelll. It is about the fact that because we spend too much on over-priced, no more effective, sometimes risky treatments, we cannot afford, as a society, to provide treatments that we Know are effective to everyone–including poor children.
That, at least, is why I am in this game.
. If I just wanted to track down “bad guys” I would have stuck to financial journalism. (Like shooting fish in a barrel. Think Eliot Spitzer. I wrote about him in Bull!- before the good people of NY elected him governor. I couldn’t understand why. The man is not appealling in any way. He was clearly a sleaze back then: put it this way–his public life matched his private life. )
just some more data adding fuel to the “it ain’t as simple as it may seem” fire. re: diuretics, allhat, BP, etc.
via dr. RW’s blog.
http://doctorrw.blogspot.com/2008/12/lotrel-outdoes-lotensinhctz-in.html
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 involved to be studiedin the ALLHAT trial. In addition, the ALLHAT trial included over 40,000 subjects over the age of 55 who 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, and this class of drugs have been studied in such areas associated with cardiovascular disease for over 40 years.
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.
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, or those with chronic kidney disease, others have concluded. 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.
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
Maggie,
Respectfully, I have no particular interest in reading “Worried Sick”. I will spend my time in studying the approach to heart disease with both the scientific literature — not the marketing — about cardiology, and continue participating in very frank discussions among medical practitioners and medical scientists. I will continue to examine the approaches to hypertension therapy based on the quite substantial, and growing, understanding of the physiological mechanisms of essential hypertension.
For the record, when I first was diagnosed with hypertension, we indeed started with thiazides — two different ones. Even with supplemental potassium plus a potassium-sparing diuretic, I could not maintain a safe potassium level.
I wish I could take a thiazide. They took off about 30 pounds I didn’t need. Other drugs I take for hypertension and diabetes have added 30-50 pounds, even with a non-thiazide loop diuretic. Thiazides are absolutely appropriate as first choice for some, but not all, patients. They also may prove unsafe, as in my case, or simply not effective. Hypertension therapy is never going to be a one-size-fits-all approach, but I hear you seeming to really, really, want it to be.
Next, we switched to beta-blockers, but couldn’t find one that didn’t leave me overwhelmingly sedated.
At that point, we went to a CCB, which worked well for a while. Knowing some of my genetics, no one expected that any single drug was a long-term answer.
Were each of the steps along the way reasonable? Yes. When it came time to add a second drug, given two classes had unacceptable side effects, an ACE inhibitor was the only reasonable and then-available addition; the other classes, even some fairly cheap ones like reserpine, were far more dangerous.
Eventually, we did have to go to one of the drugs for resistant hypertension, a direct vasodilator, and yes, I need to take some drugs to help with its side effects. Like it or not, my hypertension, combined with prevention of recurrence of angina and suppression of some side effects, takes a seven-drug combination to achieve an optimal BP and absence of angina.
Before assuming that thiazides are always the best first choice, do look into some the not-fully-conclusive studies that indicate they may increase the risk of pre-diabetes becoming frank diabetes, which is another major public health problem.
I believe that eventually, first and second drug selection for hypertension will be on the basis of genetic testing, both for the predisposition to the type of hypertension in the presence of comorbidities and comborbidy risk factors.
Dan- and Howard–
Thanks for hte comments.
Howard–
No, I don’t want treatment for hyper-tension (or anything) to be one-size-fits-all.
But I tend to look at things from a public health perspective, and from that perspective it seems very likely that more people could be taking less expensive and potentialy less hazardous drugs to treat their hypertension.
What works for particular individuals is another question–which is why we need “guidelines” (not rules) for best practice so that doctors can deviate from the guidelines as needed for particular patients.
It may be that when it comes to certain complicated conditions they’ll need to deviate 40% of the time. We still need guidelines and we need to get the information out there about the simples, safest, most effective treatments what will work for large numbers of people.
As a country, we are over-medicated and over-treated. There is no question about that. And we over-use the most advanced medical technologies.
Too bad you’re not interested in Hadler’s book. He is a highly-respected physician;Dr.
Jerome Groopman wrote one of the blurbs for his book.
Dan–
Thanks for your long, informative comment.
I agree that the fact that the trial was so large–and overseen by NIH is important. And people need to know about the trial, and its findings.
No trial is perfect, but this one was done very well. Certainly, future trials may discover that some of its conclusions were wrong–or partially wrong, or don’t apply to Group Z.
There are few final answers in medicine.
But clearly, in this case, promotion set out to bury science, and succeeded to a degree that is distressing.