Study Finds That New Drugs Don't Look So Good Now that All Clinical Trials Must Be Registered

The FDA has traditionally required drug manufacturers to show that their products are more effective than a placebo, and that they don't do harm. But that is a low bar to jump. What patients and medical professionals really need to know is whether a new drug is better than the ones currently in use. Comparative effectiveness research is designed to answer this, and more specific questions.  Does a new drug have fewer side effects, work in different care settings, work better for certain groups of patients, or in some other way prove its mettle?

This month Mark Olfson and Steven C. Marcus published a study in Health Affairs using the statistical tools of effectiveness research to take a new look at old drug studies, those reported in major medical journals from 1966 to 2010. A random sample of studies found that over time the effect size of new drugs has decreased.  The newer the drug, the less effective it tends to be. We are getting diminishing returns for our health care buck.

The authors discussed several reasons this could be happening. New drugs are still coming to market, but  there have been relatively few new drug classes. This is especially true of antibiotics. A second issue is that with the requirement in the U.S. since 2007 that all clinical trials be registered, there is no longer the opportunity to select only the strongest studies for publication. This would imply that the effectiveness of our medications was being statistically pumped up before the ClinicalTrials.gov registry was formed. A third possibility is that drug manufacturers have preferred to bring variations of already popular drugs to market rather than investing the time and money to develop new ones. In order to get the new version to pass FDA review they may resort to increasing the number of participants in the trial. Even a very small effect size can look statistically significant against a placebo with a large enough sample size.  Sample sizes have indeed increased over the study period, making it a real possibility that drugs offering only a small tweak from standard treatments can pass review.

As the authors note, $100 billion is spent in the U.S. on biomedical research every year, and most of that is going into clinical trials. The diminishing rate of returns that this money has had in terms of clinical effectiveness makes it imperative that we shine light on this process. We need to guard against having clinical trials being used as marketing tools, and put the focus back on the reduction of human harm and suffering.

Read the Study: Decline in Placebo-Controlled Trial Results Suggests New Directions For Comparative Effectiveness Research
By Mark Olfson and Steven C. Marcus

The Affordable Care Act's Surprisingly Low Premiums

As implementation of the Affordable Care Act ramps, up two unexpected developments have been in the news. Some health plans look to be offered at a cost well below that predicted. This is good news and bad news.

The good news is that California's Insurance Exchange, called Covered California, has released its prices. It will be offering plans for 2014 at an unexpectedly low cost. This is because the Exchanges, which were designed to create a competitive marketplace for health insurance are actually functioning like a competitive marketplace. Consumers can choose between four levels of plan: bronze, silver, gold or platinum. The more  the plan costs up front, the lower the out-of pocket expenses will be. All the insurance companies offering bronze plans have to include the same types of services for those plans. All the silver plans have to be comparable to each other, and so on. Now that plans can actually be rated in a simple and transparent way, there is an incentive for insurers to bid low and compete against each other to gain market share.

Covered California is offering low rates despite expectations that premiums under Obamacare were going to rise. A widely reported study by the Milliman Company predicted that while older Americans aged 40-59 should see lowered costs, younger males would see their cost go up. A 28-year-old man making $50,000 a year, for example, had been expected to pay as much as $450 a month for a silver plan. The actual cost in California is going to be around $250 a month. This is comparable in cost to high-deductible plans on the private insurance market right now which offer much-less comprehensive benefits.  All plans purchased through Insurance Exchanges must cover at least 60% of the patient's costs, including co-pays and deductibles. California residents who buy through Covered California are going to get a good deal.

The same can't be said for all low-wage workers at large companies. Christopher Weaver and Anna Wilde Matthews at the Wall Street Journal recently reported that some companies with large numbers of service workers have been worried about the cost of the ACA's requirement to offer those employees health benefits. They are said to be in talks with insurance companies to craft new plans that will be very cheap, in the order of $40 a month, but will offer extremely limited coverage. Hospital stays, surgery and prenatal care will be excluded.

These firms are hoping to find a loop-hole in the law that allows them to offer low-benefit plans (termed mini-meds or "skinny plans" in insurance industry lingo).  Since most large firms offering insurance to their employees actually offer good plans in order to retain workers (think Google), big companies have been allowed to choose their own plans. The Department of Health and Human Services didn't anticipate that offering skinny plans  might be the way that some companies would try to lower premium costs.  It is unlikely that they will be allowed to, but watch this space for further developments.