Tuesday, April 26, 2016

This is a TEST

Jeff Stahler

Compare the obscene amount of money plowed into our democratic political process and BIG PHARMA plowing money into 
TV ads to get people to buy new and expensive drugs.  Look closely - not much difference in corruption and sleaze.   
Be very wary on ads that say -TELL YOUR DOCTOR, or ASK YOUR DOCTOR:
CreditJeffrey Henson Scales/The New York Times, photographs from Getty Images

DRUG companies are eager to tell you about their newest medicines. Turn on your TV or go online and there's a new drug — with a hefty price tag — for whatever ails you, from antidepressants to painkillers to remedies forerectile dysfunction.

The pharmaceutical industry spends lavishly to get your attention: In 2014, drug makers poured $4.5 billion into so-called direct-to-consumer advertising, a 30 percent increase over two years. Drug makers claim they are educating the public with their ads, providing information that will help you make better choices about your medical care.

So in the spirit of education, let's consider a recent online ad for Latuda, a new antipsychotic medication. A young woman rides a bike off into the sunas we are told that Latuda has been shown to be effective for many people with bipolar depression, followed by that staccato recitation of potential side effects that most viewers tune out.

What Are You Paying For?

Here's what a helpful prescription drug label could look like, with facts that are now out of reach.

Pricing mysteries exposed

Missing: harms

Also missing: trials

These are question marks because, although many clinical trial results are published, they are difficult to find and compare. Rules should mandate that all studies are accessible.

Note the same high cost for a four-fold range of Latuda doses. Often the lowest dose is just as effective; some low-dose consumers realize they can save money by ordering the higher-dose units and splitting them into pieces.


The ideal label would have statistics on how many people have serious side effects. Data are not included for these drugs because they may take years to emerge, if ever. Other drugs have well-known side effects.

Sources: Truven Health Analytics (costs); published studies

Graphics by Bill Marsh/The New York Times

Fair enough. But the ad omits something that most consumers would like to know: There are many older and cheaper treatments that are just as effective. In fact, Latuda is one of 10 "second generation" antipsychotic medications, many available in generic forms, that essentially work the same way.

Of course, the goal of drug companies is not to educate, but to sell products.

We could ban the ads, as almost every other country does, and which I'd strongly support. But such a campaign in the United States would face fierce legislative and legal challenges. Instead, let's help the drug companies make their ads truly educational.

What I propose is a universal scorecard for all new drugs, to be overseen by the Food and Drug Administration, with information on how their cost and effectiveness measure up against similar medications. This could be a simple graphic that would fill the screen at the end of every video ad and be highly visible in every print ad. It should become a routine part of discussions with doctors whenever medications are prescribed, and should be provided by pharmacies alongside basic drug safety information.

Think of the scorecard as the batting average for a baseball player. If you want to know how good a player is, you don't just want to know how many home runs he hit, but how many hits per at bat he had. The batting average combines success and failure in one measure.

Different Prices for the Same Benefit

Sources: Truven Health Analytics (costs); published studies

Likewise, drug companies should have to reveal how many total clinical trials were conducted for each drug and how many of these trials were positive and how many were negative. If a new drug does better than a placebo in just two out of six clinical trials, you are going to think very differently about its efficacy than you would about that of another drug that beats a placebo in all six trials.

Drug companies might legitimately complain that there are many reasons a drug might fail to outperform a placebo besides ineffectiveness: quirks in the design of a trial; patients who were not typical of those with the disease; a dosage that was too low. But then the company should be happy to explain this to the public, since the goal is education, right?

Even savvy consumers cannot easily obtain this information because of the "file drawer effect": Positive clinical trials are much more likely to be published than negative trials. And while drug companies now have to register their clinical trials in a federal database, they often don't publish the results in a timely fashion, and it's unrealistic to expect the public to hunt for this kind of data; it should be as clear as the blue sky in those idyllic drug ads.

The drug scorecard should also include something called the "number needed to treat," or N.N.T. This is the number of patients that need to be treated for one to benefit, compared with a control in a clinical trial. For example, for a drug with a number needed to treat of six, six patients would have to be treated before one would benefit. The lower the number, the more effective the treatment. This is a clear measure that consumers could use to understand the efficacy of drugs that are invariably pitched as the next panacea.

New, and Expensive

Because this drug is new, there are no data yet for its effect on health or mortality.

Sources: Truven Health Analytics (costs); published studies

But even this isn't enough. What consumers and their doctors really want to know is not just whether a new drug is better than a placebo, which is generally the standard for approval by the Food and Drug Administration. (Typically, a drug has to beat a control, usually a placebo, in two randomized clinical trials.) We want to know whether the new drug is better than a comparable, older drug.

Drug companies have little incentive to make these comparisons. Why? Because a vast majority of "new" drugs are really not new at all; instead, they are minor tweaks and modifications of older drugs, and therefore unlikely to substantially outperform them.

For example, there are seven statins on the market that all lower cholesterolby the same mechanism, and eight antidepressants (selective serotonin reuptake inhibitors) that essentially work the same way.

Comparing the effectiveness of different treatments is one of the goals of the Affordable Care Act, through a nonprofit it created called the Patient-Centered Outcomes Research Institute. But comparative effectiveness research has yet to really take off.

When it does, the data it compiles should be added to the universal scorecard. For too long, we've allowed drug companies to tell us only their positive results. Now we're ready to hear the whole story.

Richard A. Friedman is a professor of clinical psychiatry and the director of the psychopharmacology clinic at the Weill Cornell Medical College, and a contributing opinion writer.


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