Tag Archives: prescriptions

How Well Does A Drug Work? Look Beyond The Fine Print

July 25, 2014 4:35 PM ET
 
 
Traditional warning labels on medicine boxes tend to be long on confusing language, critics say, but short on helpful numbers.

Traditional warning labels on medicine boxes tend to be long on confusing language, critics say, but short on helpful numbers.

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“Anybody who has ever seen a drug advertisement or talked over the pros and cons of a medicine with a doctor can be forgiven for being confused.

Sorting out the risks and benefits of taking a medicine can be complicated even for professionals.

This 2007 ad for the sleeping pill Lunesta stresses insomnia relief — not the relative usefulness of the drug.This 2007 ad for the sleeping pill Lunesta stresses insomnia relief — not the relative usefulness of the drug.

Lunesta

This spring, the Institute of Medicine convened a workshop with the Food and Drug Administration. The topic: How best to communicate to doctors and patients the uncertainty in the assessment of benefits and risks of pharmaceuticals.

The FDA not only approves drugs, it also approves the prescribing instructions that come along with them. For some drugs, the wad of paper filled with fine print about the risks and benefits of using the drug is accompanied by a medication guide that is supposed to summarize the main points.

During one question-and-answer session, Dr. Robert Temple of the FDA’s Center for Drug Evaluation and Research, acknowledged that those guides are full of information. “But it’s remarkably nonquantitative for the most part,” he said. “And I think we should try to think about whether there are quantitative ways of presenting that stuff.”

He then referred to Drs. Steven Woloshin and Lisa Schwartz, two of his fellow panelists, who have said it’s possible to pull that off.

The husband-and-wife team from Dartmouth are on a decade-long mission. They have been pushing the FDA to get useful and readable quantitative data about drugs to doctors and their patients.

Schwartz and Woloshin have designed a format they call a drug facts box. It shows the gist of what they say is buried in all the fine print: How does the drug compare to a placebo?

Drs. Lisa Schwartz and Steven Woloshin designed this "fact box" as a prototype to show how package inserts for medicines could be more helpful.

Drs. Lisa Schwartz and Steven Woloshin designed this “fact box” as a prototype to show how package inserts for medicines could be more helpful.

Courtesy of Dr. Steven Woloshin

That’s in contrast to what usually happens, Schwartz says. “The prescribing info is written by industry, and then negotiated with FDA, and then FDA ultimately approves it. And we have documented examples where important info — like how well the drug works — is not in the label.”

This drives Schwartz and Woloshin crazy.

Better Than A Sugar Pill

So, here’s their experiment: They showed people ads for two competing heartburn drugs, one plainly more effective than the other.

They also showed people two of their drug facts boxes, one for each of those two heartburn drugs, showing how each drug fared against a placebo (a sugar pill) in testing.

“When the people are presented with the standard information they see — like a drug ad — about 30 percent of people chose the better drug,” Woloshin says. “But when we showed them information in the drug facts box form, 68 percent of people were able to choose the objectively better drug. So that’s a really dramatic improvement. It just shows you that if you show people information in a way that’s understandable, they can use it, and it can improve their decision.”

Using FDA data, Woloshin and Schwartz developed a drug facts box for the sleep aid Lunesta.

Two columns compare people with insomnia who took Lunesta and people with insomnia who, unknowingly, took a sugar pill.

The results? Those who used Lunesta took 30 minutes to fall asleep. Those who got a sugar pill took 45 minutes — a difference of 15 minutes. Those who took Lunesta stayed asleep 37 minutes longer than those who took a sugar pill.

Woloshin and Schwartz say some people might consider those benefits worth taking the drug, and some might not.

“That’s the whole point of the drugs facts box,” Woloshin says, “to let people look at the evidence and come to their own judgments. But you can’t make those judgments without the facts.

He and Schwartz believe passionately in the numeracy of patients. They say we can handle numbers, like percents. It’s just that too often we’re given incomplete or misleading information.

How Good A Deal Is That Sale?

For example, a claim that some drug reduces the likelihood of a particular disease by 50 percent can be misleading.

Woloshin explains why. “If you heard about a sale, and it said 50 percent off, would you travel a great distance to go to the sale? Well, you might if it was on things that are really expensive, like a flat-screen TV or something,” he says. “But what if the thing that was on sale was gum, and you save only a couple of cents? So when you hear 50 percent reduction, you have to ask 50 percent of what?”

The doctors’ dream is to get those drug facts boxes into health systems and electronic medical records, so that doctors and patients can study the information and decide what’s best before the drug is prescribed.

“What we hope is that the box will encourage people to take drugs that are effective and that work, and discourage people from taking drugs that don’t work or are just harmful,” Woloshin says. “And also that just having this information in front of people will stimulate better drug research, because drug companies realize people are paying attention and looking at these numbers — and then we’d have a better quality of drug trials.”

Woloshin and Schwartz say medical information should be as quantitative as other information. And we digest quantitative data all the time.

“If you were reporting on an election, you wouldn’t say Obama won by a little,” he says. “You’d give the numbers. If you were reporting sports scores, you wouldn’t say the Celtics, won, hopefully won, by a bit. You’d give the score.”

Why should health care be different?

He and Schwartz are convinced that we can understand risk described by numbers, provided the numbers are clearly and honestly presented.

They have been lobbying the FDA to develop drug facts boxes, but say that seems unlikely. So they started their own company to do it — Informulary. It’s funded by the Robert Wood Johnson Foundation, which also supports NPR.

This is the final part of an All Things Considered series on Risk and Reason.”

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Why Do Other Rich Nations Spend So Much Less on Healthcare?

Why Do Other Rich Nations Spend So Much Less on Healthcare?

 JUL 23 2014, 9:57 AM ET

“Despite the news last week that America’s healthcare spending will not be rising at the sky-high rate that was once predicted, the fact remains that the U.S. far outspends its peer nations when it comes to healthcare costs per capita. This year the United States will spend almost 18 percent of the gross domestic product (GDP) on healthcare—six percentage points more than the Netherlands, the next highest spender. Because the U.S. GDP in 2014 will be approximately 17 trillion dollars, those six percentage points over the Netherlands amount to one trillion dollars in additional spending. The burden to the average household through lost wages, insurance premiums, taxes, out-of-pocket care, and other costs will be more than $8,000.

Why does the United States spend so much more? The biggest reason is that U.S. healthcare delivers a more expensive mix of services. For example, a much larger proportion of physician visits in the U.S. are to specialists who get higher fees and usually order more high-tech diagnostic and therapeutic procedures than primary care physicians.

Compared with the average OECD country, the U.S. delivers (population adjusted) almost three times as many mammograms, two-and-a-half times the number of MRI scans, and 31 percent more C-sections. Also, the U.S. has more stand-by equipment, for example, 1.66 MRI machines per 6,000 annual scans vs. 1.06 machines. The extra machines provide easier access for Americans, but add to cost. Similarly, occupancy rates in U.S. acute care hospitals are much lower than in OECD countries, reducing the likelihood of delays in admissions, but building that extra capacity adds to cost. Aggressive treatment of very sick elderly also makes the mix expensive. In the U.S. many elderly patients are treated in intensive care units (ICUs), but in other countries they would receive only palliative care. More amenities such as privacy and space in hospitals and more attractive clinics also add to U.S. costs.

While the U.S. mix of services is disproportionately tilted toward more expensive interventions, the other OECD countries emphasize a “plain vanilla” mix. Compared with the U.S., the average OECD country has 30 percent more physician visits and more than 30 percent more hospital days per capita.

One reason for the more expensive mix in the U.S. is it produces more income for drug manufacturers, specialist physicians, and others who have considerable influence on policy. Second, some patients prefer the more expensive mix, just as some prefer to shop at Whole Foods rather than Walmart. Third, some workers mistakenly believe that employers pay for their healthcare and that more expensive means better care. Health economists believe that the premiums for employer-sponsored insurance come out of potential wages. Similarly, the extra money the government spends for health could be used for education, infrastructure, the environment, and other public investment, but these alternatives are not readily apparent or agreed upon. Does the more expensive mix result in better health outcomes? There are no definitive studies to answer this question. Superficially, it appears that the systems in the other countries are more effective because their life expectancy is higher. But their advantage may be attributable to non-medical factors such as significantly lower poverty rates.

A second important reason for higher healthcare spending in the U.S. is higher prices for inputs such as drugs and the services of specialist physicians. The prices of branded prescription drugs in the U.S. are, on average, about double those in other countries. The fees of specialist physicians are typically two to three times as high as in other countries. The lower prices and fees abroad are achieved by negotiation and controls by governments who typically pay for about 75 percent of all medical care. Government in the U.S. pays about 50 percent, which would still confer considerable bargaining power, but the government is kept from exerting it by legislation and a Congress sensitive to interest-group lobbying.

The third and last important reason for higher spending in the U.S. is high administrative costs of insurance. This includes private insurance which covers more than half the insured population. Each year scores of insurance companies must estimate appropriate premiums for plans they wish to sell to several million employers plus 20 to 30 million individuals. In addition, hospitals, clinics, and individual physicians incur substantial costs in billing for each test, visit, and procedure regardless of whether they are covered by private or public insurance or self-pay. Many of our peer countries have lower administrative costs through more coordination, standardization, and in some countries a single national system or several regional healthcare-insurance systems, even when the provision of care is primarily a private-sector responsibility.

The complexity of private-sector insurance is not in the public interest. Each company offers many plans that differ in coverage, deductibles, co-pays, premiums, and other features that make it difficult for buyers to compare the prices of different policies. For most goods and services, wider choice for consumers is assumed to contribute to well-being. In the case of health insurance, however, the fact that the customer knows more than the insurance company about his or her likely use of care results in adverse selection. If the company sets a premium based on average utilization, the company will lose money on the high users and will lose as customers those who expect to use less than the average. It is not efficient or fair to allow a family to choose a plan with generous maternity benefits when they are planning to have a baby and then switch to a plan with no maternity benefits when they are not.

If we turn the question around and ask why healthcare costs so much less in other high-income countries, the answer nearly always points to a larger, stronger role for government. Governments usually eliminate much of the high administrative costs of insurance, obtain lower prices for inputs, and influence the mix of healthcare outputs by arranging for large supplies of primary-care physicians and hospital beds while keeping tight control on the number of specialist physicians and expensive technology. In the United States, the political system creates many “choke points” for diverse interest groups to block or modify government’s role in these areas.

For those who would like to limit government control, there is an alternative route to more efficient healthcare through “managed competition,” proposed by Alain Enthoven, a Stanford University Business School Professor, more than 25 years ago. It is based on integrated group practice, which brings the insurance function, physicians, hospital, drugs, and other elements of care into a single organization that takes responsibility for the health of a defined population for an annual risk-adjusted per capita payment. Examples include the Group Health Cooperative of Puget Sound in Seattle and the Kaiser Permanente organizations in California.

Such organizations deliver high-quality care at lower costs, and some employers offer such a plan as one option, but most don’t. And even those employers that do offer a low-cost integrated group practice as an option typically pay the same percentage subsidy of premium regardless of whether the employee chooses an expensive plan or the low-cost plan. For managed competition to be most effective, employees should be required to pay the marginal excess of a high-cost plan over the low-cost plan. For one large employer who did follow this approach, 71 percent of the hourly paid men chose the low-cost integrated group practice while 63 percent of the salaried men chose one of the more expensive plans.(This statistic comes from a study in progress by Enthoven and myself.)

With regard to healthcare, the United States is at a crossroads. Whether the Affordable Care Act will significantly control costs is uncertain; its main thrust is to reduce the number of uninsured. The alternatives seem to be a larger role for government or a larger role for managed competition in the private sector. Even if the latter route is pursued, government is the only logical choice if the country wants to have universal coverage. There are two necessary and sufficient conditions to cover everyone for health insurance: Subsidies for the poor and the sick and compulsory participation by everyone. Only government can create those conditions.”

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100,000 Americans Die Each Year from Prescription Drugs, While Pharma Companies Get Rich

“The study estimating that 100,000 Americans die each year from their prescriptions looked only at deaths from known side effects.”

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May 30, 2014 · 8:36 pm

The Average Heroin Addict Is Not Who You Think It Is

“…90% of heroin users are white men and women…the current median age for men and women now is around 23 years old. Three-quarters of these current users were first introduced to heroin by way of prescription opiates like Oxycontin. That means that expensive prescription drugs are serving as a gateway drug for young millennials living in suburbia trying to find an inexpensive but dangerous alternative: heroin…”

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May 30, 2014 · 8:31 pm