Three important FDA stories broke today that deserve your attention: the FDA crackdown on the genetic testing organization 23andMe, the loosening of restrictions on the diabetes drug Avandia, and the lack of a warning about potential ineffectiveness of the morning-after contraceptive Plan B for overweight women.
23and Me
If you believe the FDA, a little knowledge is a dangerous thing. The feds are cracking down on the genetic-testing company that sells a $99 home “spit kit.” Consumers swab the inside of their mouth, collect DNA material and send it off to be analyzed by the company 23andMe.
The test reveals genetic traits that may predispose people to certain diseases such as breast cancer, Alzheimer’s, diabetes or Parkinson’s. The analysis also assesses a patient’s susceptibility to medication. For example, it might reveal whether someone appears to be more vulnerable to bleeding from the anticoagulant warfarin (Coumadin).
The FDA is taking the stance that the 23andMe genetic test is a “medical device” that could put “consumers at risk of receiving inaccurate information that could result in delayed or inappropriate medical care.” The agency has expressed the fear that a patient might “undergo prophylactic surgery,” such as a radical mastectomy, based on information received from 23andMe.
We certainly side with the FDA that the testing process must be proven to be accurate. Where we disagree, though, is about the dangers of informing patients about possible risks. Any breast surgeon who would perform a radical mastectomy based on a test from 23andMe would be making an enormous mistake and opening herself to possible malpractice litigation or censorship by her medical board. Responsible doctors would hopefully follow up such a test result with other genetic testing and then thoughtful counseling before ever contemplating “prophylactic surgery.”
The same should hold true for any procedure a patient might consider after getting results from a genetic test. The 23andMe test should serve only as a first step in opening a dialog with well-informed health professionals. Someone worried about Parkinson’s or Alzheimer’s disease should discuss his fears with a knowledgeable neurologist before contemplating an MRI or any other follow-up tests. Let’s face it. Most of us know a little something about our family background. If Grandpa, Uncle Charlie and Mom all developed diabetes or dementia, we don’t need a genetic test to know there might be an increased personal risk.
The FDA seems quite fearful that with 23andMe data, patients might self-diagnose and then do something inappropriate. We only wish the FDA would be more consistent about its concerns. FDA-sanctioned prescription drug commercials encourage consumers to self-diagnose and then ask for a prescription. We’ve all seen the TV ads for antidepressant medications, arthritis drugs and now testosterone replacement therapy. Patients are told about symptoms of “low T” so that can they can self-diagnose and then ask their doctor if testosterone might be right for them.
Whether the home genetic test kit is a medical device or not is a question that could end up in court. In the meantime, we urge people to use common sense in evaluating their risks of developing any disease. And if the FDA is going to crack down on 23andMe, we only wish it would also crack down on all those annoying drug commercials we see on the evening news. We are just as worried about inappropriate diagnoses and treatments prompted by those ads as we are about genetic testing information.
FDA Eases Avandia Restrictions
It wasn’t that long ago that the FDA was cracking down on the diabetes drug Avandia. An expert panel for the agency determined in 2007 that the drug was linked to heart attacks. A safety expert for the FDA, David Graham, recommended that Avandia be removed from the market because of an increased risk of heart attacks, strokes, heart failure and “all-cause mortality” in older people.
As a result of the controversy, the agency increased warnings on the label and dramatically restricted the prescribing of Avandia. Now, in a fascinating about-face, the FDA has eased those restrictions. As a result of a re-analysis of the “RECORD trial,” the FDA says there is no increased risk of heart attack, stroke or cardiovascular death caused by Avandia. The most stringent prescribing restrictions are now lifted.
Should we all breathe a sigh of relief that a once-popular diabetes drug is being resurrected? Steve Nissen, MD, is chairman of cardiovascular medicine at the Cleveland Clinic. It was his research that initially brought attention to the potential dangers of Avandia. In response to the FDA’s actions he told MedPage Today, “The reasoning around the lifting of these restrictions is faulty. It makes no regulatory sense to reanalyze a previously unblinded clinical trial that was poorly designed in the first place.” In this interview Dr. Nissen pointed out that there were serious flaws in the RECORD trial: “Everybody knew which patients got Avandia and which got the comparator. Once that happened, the integrity of the trial was destroyed and it can never be resurrected.”
Some things to consider about Avandia (rosiglitazone):
AVANDIA (ROSIGLITAZONE) SIDE EFFECTS
- Headache
- Lung infections
- Fluid retention, edema, swelling in hands and feet, weight gain
- Shortness of breath
- Congestive heart failure
- Chest pain, angina, heart attack
- Liver damage
- Fractures
- Macular edema
- Severe skin reactions (require immediate medical attention!)
- Severe allergic reactions (require immediate medical attention!)
We cannot understand the FDA’s reversal on Avandia. To learn more about the controversy, you may want to read our blog of several months ago, “FDA Flip Flop on Avandia Misses the Point!” In this overview you will learn about the back story. The one thing that the FDA has seemingly ignored is that Avandia does NOT lower the risk of heart attacks, strokes and premature death. Isn’t that the whole point of taking a diabetes drug? So, even if the drug doesn’t cause these rather serious complications (and that may still be up for debate), the fact that Avandia doesn’t prevent these problems makes us disappointed in the FDA’s U-turn.
Plan B and Unwanted Pregnancies
Here’s something the FDA needs to act upon ASAP! Two weeks ago European drug regulators notified the manufacturer of a morning-after-pill contraceptive (Norlevo) that weight matters when it comes to drug effectiveness. Women who weigh more than 165 pounds appear to get less contraceptive protection. Those over 176 pounds may not get any benefit at all.
Although we have no doubt that there are many women in Europe who are overweight, the problem is especially acute in the United States. The same ingredient (levonorgestrel) found in Norlevo is in Plan B One-Step sold in the U.S. Other brands include Next Choice One Dose and My Way.
The FDA says it is reviewing the data and will determine whether there needs to be a labeling change for emergency contraceptives. Sometimes the FDA acts with impressive speed. Other times it can seemingly take forever for the agency to analyze, review and otherwise assess a problem. We think women should take this new information into account if they consider emergency contraception.
But this opens a can of worms about lots of other medications. If levonorgestrel is less effective if you are overweight, what about dozens of other drugs? Given that roughly one third of our children between the ages of 2 and 19 are overweight and that two-thirds of U.S. adults are overweight or obese, one wonders whether there are many people who are not being dosed correctly.
Does the FDA even take weight into account when approving drug doses? As far as we can tell, there are very few medicines that come with dosing recommendations that take weight into consideration. A 250-pound lumberjack may be given the same dose as a 98-pound grandmother. Perhaps this will serve as a wake up call for the FDA to start thinking more carefully about the kind of tests it requires of drug manufacturers, especially when determining the right dose for each patient.
We would love your thoughts on the three stories above. What is your opinion about the FDA’s stance on 23andMe, Avandia and Plan B? Share your insights in the comments section below.
