Monday, October 24, 2011

Industry Funded Studies

One of the advantages of being a blogger is the comments, feedback and communications I receive from readers.  Though not all of it is positive, many of these interactions with people from across the globe that I do not know has been quite enjoyable for me personally.

One email I received from a reader had to do with industry funded studies.  This is not an uncommon concern, and one that frequently shows up on this blog and others.  The email encapsulates many people's concerns with industry funded studies.

Dear Dr. Mintz,

I am staring at my computer unable to formulate the words to express my opinion on a very important subject. I do not want to come across as rude, condemning or complaining, yet I am compelled to share with the medical community my honest patient perspective.

I view the medical profession as one of the most respected on earth. But it isn't perfect. As a patient I become very discouraged when I see a medical professional look towards industry funded drug studies to make medical decisions.

Now for the painfully honest part. When I see a Doctor subscribe to "results" from an industry funded drug study, my image of that physician goes to pot in a heartbeat. "How can he/she be so gullible" and "Incompetent" are thoughts that pass through my mind. I quickly lose trust in that physician's ability to make smart decisions in my health care, and the doctor loses my business.

On on the contrary, I asked a physician what he thought about industry funded drug studies, he answered "I ignore them." This doctor won me over in three words.

Obviously it takes excellent academic ability to become a physician, but I look for more than that. I look for wisdom and integrity when choosing a physician.

There is no question that industry studies are biased by nature.  The drug company is beholden to its stockholders to increase sales.  Therefore, they have a fiduciary obligation to make sure that their research puts their products in the best light.  This is not unlike any product in the US where a manufacturer does research stating that people prefer it or it works better than a competitor.  Unlike these products, medications are heavily regulated in the United States.  Thus, for a medication to get approval or to make any claims, all studies, including ones funded by the industry have to go through the FDA.

Here's the real problem:

Almost all research done on medications is funded by the industry. I would love it if instead of relying on industry sponsored studies, I could rely on non-biased information.  However, when it comes to medications, these studies are few and far between.  In 2005, the industry spent close to $40 billion dollars on research.  Compare this to the entire NIH budget that same year of less than $30 billion.  Also, understand that the NIH spends very little money on actual drug studies.  They focus more on finding a cure to cancer, not whether expensive medicine X is just as good as the older generic medication. 

When I want to know whether to buy product X vs. product Y, I can go to an independent source such as Consumer Reports, which does their own, independent research.  There is really no such independent source for drug information.  In fact, prescription drugs is one of the only areas that Consumer Reports does not do their own research.  All their recommendations on which medicine is "right for you" come from drug company sponsored studies.
If we ignored all industry funded studies, we be ignoring most of the data.  In addition, since these studies are heavily regulated, we would be ignoring mainly good, helpful data, even if biased.  The simple alternative is to fund the NIH or similar organization equally to the drug companies in order to do independent research.  Of course this would likely require significant government spending, which is likely a non-starter.

The good news is that independent comparisons of treatment, called comparative effective research, are starting to be done, and (whether you like health care reform or not), there is funding for this research in the Affordable Care Act.  Unfortunately, this funding is not nearly enough to compete with the drug companies.  Thus, unless you are willing to pay considerably more in taxes or drop some needed services, physicians and patients still need to rely on industry funded research. Many studies from the industry are actually quite good and useful, though, because of inherent bias, should always be looked at with a skeptical eye.

Sunday, October 9, 2011

PSA: To Screen or Not to Screen

There has been much confusion/concern/media attention since the recent announcement (see the NY Times article US Panel Says No to Prostate Screening for Healthy Men) that PSA tesing was no longer recommended by the US Preventative Services Task Force. (Here's the full version of their draft recommendation.) There are many responses out there (Tara Parker Pope's Answering Questions about the PSA test is a good one), but I believe there is still more to say on the issue.

Before answering the question regarding whether we should follow the USPSTF's new recommendation, please consider...

1. The USPSTF is the same group that says
-Women shouldn't get mammograms before 50
- Recommends against teaching self-breast examination
-States that screening for testicular cancer is harmful
-Only recommends screening for diabetes in patients with high blood pressure
-Recommends against screening for depression for most primary care doctors

(I am not stating that I necessarily disagree with these recommendations.  However, it is important to understand where USPSTF is coming from when considering their PSA recommendation). 

2. Prostate cancer is still a leading cancer killer for men in the US. 
From NY Times:

One in six men in the United States will eventually be found to have prostate cancer, making it the second most common form of cancer in men after skin cancer. An estimated 32,050 men died of prostate cancer last year and 217,730 men received the diagnosis. 

The new recommendations come from findings of two large studies.  One in the US that showed no benefit in saving lives, and one in Europe that showed only some benefit.  The US study have some major limitations, including that many of the men in the placebo/no-screening group actually got screened, so I will focus on the European study.

The European Randomized Study of Screening for Prostate Cancer looked at close to 200,000 men between 50-74 for about 9 years. Not surprisingly they found almost double the rate of prostate cancer in the screened group compared to the non-screened group (8.2% vs. 4.8%).  More importantly, they reduced the rate of death by about 20%. Unfortunately, most of the men treated for prostate cancer did not benefit.  They found that for every 1410 screened, there were 48 additional cases of prostate cancer found, that if treated would only prevent one death from prostate cancer. In other words, if you are treated for prostate cancer, there's only about 1/50 chance it will save your life. Now, if the treatment were without side effects, then besides costs, there would be no reason not to screen.  (My friend Dr. Stewart Segal in his post PSA Confusion suggests covert rationing is one motivation behind the USPSTF's recommendation).  The problem is that there are side effects with treatment, and not inconsequential ones. There is about a 20-30% chance of impotence, incontinence or both. 

However, there seems to be two things not discussed in any of the reports:
1. Though the writers of the guideline seem to give value/risk of the harms of treatment, they do not address the potential benefits of the piece of mind from a negative screen.  In the European study, over 90% of men had a negative screening over the course of almost a decade.  In other words, the vast majority of men screened had the piece of mind knowing that probably didn't have to worry about prostate cancer. (There is also additional evidence that men 65 and older with a very low PSA  will likely never get prostate cancer, and screening should be stopped). 
2. Just because you are diagnosed with prostate cancer, doesn't mean you need to treat it.  Given the complications as a result of prostate cancer treatment, and the fact that prostate cancer tends to progress slowly, especially after the first year, watchful waiting is a reasonable approach. If in fact, if the cancer remains stable, treatment can be deferred potentially indefinitely.  However, without the diagnosis, watchful waiting can not occur. 

Bottom Line:  There is no right answer for everyone.  Patients, in consultation with their doctor, need to make a decision that's right for them.  If you are a healthy person, with no cancer risks, worry about side effects and complications of medical treatment,  and realize that there's a 98% chance that screening for prostate cancer will not save your life, you should not get a PSA test or prostate exam.  However, if you are someone that is very fearful of cancer, would have substantial piece of mind if you were one of the 90% of men that tested negative, and if you did get diagnosed with prostate cancer are willing risk treatment knowing there is only a 1/50 chance it will save your life, but about a 20-30% chance you will get side effects from treatment, then you should get tested.