Idea #315 for December 30th, 2009: Passing Muster or Stricter Device Approval Guidelines At The FDA

The FDA has announced plans to implement a more strict process for the approval of medical devices. This decision comes after several journal articles brought to light flaws in the current approval process. For instance, an article in JAMA showed that the approvals of a number of cardiovascular devices in the last decade were based on a single study. Also, only about half of the outcomes in the studies were compared to control groups. Rigor has certainly been lacking in these FDA approvals. It might be a case of too little, too late, but at least the FDA has admitted to the problem and will make an effort to address it.

Read more about this story here.

Idea #250 for October 26th, 2009: Rapid Deceit or The FDA and Accelerated Drug Approvals

The FDA has a policy in place for accelerated approval of certain drugs — that is, for potentially life-saving drugs, there is a rapid approval process and then follow-up studies to ensure the drugs are working effectively. The point of the alternate process, which has been around since the early ’90s, is to make sure that drugs that may save many lives are not caught-up in an extended approval process while people die waiting for the drug. But now the GAO reports that in many cases, the FDA does not enforce the follow-up studies that are meant to prove the drugs’ effectiveness.

To wit, out of the 144 drug studies requested by the FDA, only two-thirds have been produced drug manufacturers. Fifteen of those studies have been pending for more than five years. Many of the drugs involved are intended to treat AIDS and cancer. Of course, drug companies would love to delay these studies because if the drugs are found to be ineffective, they would be pulled from the market. Under the current setup, they can continue to make money off unproven drugs — with no repercussions from the FDA.

As we’ve seen before, the FDA is lacking teeth in its enforcement of this particular aspect of the approval process. There needs to be firm rules on when studies should be completed and consequences for allowing the status to linger as “pending” for too many years. We can’t allow drug companies to buy themselves time while patients may be spending their money on drugs that don’t work — or worse, drugs that do more harm than good.

Read more about this story in the Wall St Journal and New York Times.

 

Idea #249 for October 25th, 2009: A Small Habit or Occasional Smokers Deserve More Attention

Much effort has been made in recent years to curb smoking in this country. Studies and statistics in this area often define people as smokers or non-smokers. But there is another group that sometimes gets lost in the mix: occasional smokers. People in this group might smoke on a non-daily basis or just in social situations, but are involved in an unhealthy habit nonetheless.

Occasional smokers have increased in number coinciding with the rise of smoking bans in restaurants and workplaces, probably because some former full-time smokers have had to cut back to the point of smoking only on occasion. They tend to be younger than other smokers, with many in their twenties. They often do not label themselves smokers and feel that the health risks associated with daily smokers do not necessarily apply to them. Studies have shown that occasional smokers are at a higher risk of cardiovascular disease and other problems, though.

The main point is that this group is often overlooked in medical research on smokers because they don’t solidly fit in any group. And they are sometimes overlooked by providers trying to screen for smokers, because they may not label themselves as such. If occasional smokers are included in more smoking studies, we will be able to devise smoking cessation programs to meet the needs of this particular group in the future.

Read more about the issue in the LA Times.

Idea #174 for August 11th, 2009: Comparing Apples and Apples or Comparative Effectiveness Data on Drug Labels

The labeling on drug packages has become an issue in recent months. Now an essay in the New England Journal of Medicine is promoting the idea of including comparative effectiveness data on drug labels. Pharmaceutical companies generally test new drugs against placebos when assessing their efficacy. While a new drug may perform significantly better than a placebo, they are often not tested against other similar drugs on the market. It’s beneficial for drug companies not to mention that information when marketing a drug, but consumers would be in a better position if they were aware of a drug’s effectiveness compared to similar products.

When consumers see advertising for a new drug, they generally assume that it is more effective than existing drugs at treating the same condition. However, most new drugs do not offer vast improvements in effectiveness over previous drugs. Drug companies would likely fight any action by the FDA to require a change in labeling that includes comparative effectiveness because consumers would not pay for a costlier drug that is no more effective than what is already on the market. In the end, the FDA should make decisions that will inform and protect the consumer, and comparative effectiveness labeling certainly makes sense as a means of better informing the public on the drugs they buy.

See more about this in the LA Times and the NEJM.