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. 

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  1. PRC
    Reply

    I did genetic testing through 23andme and found the information helpful. It showed I had a 45% risk of blood clots in my legs. I have not personally had this problem yet, but both my mother and brother have, so I know there is some genetic thing going on. I mentioned it to my doctor and she suggested I take a baby aspirin a couple of times a week.
    23and me also found a second cousin. Turns out our grandparents were siblings, I had no knowledge of him or his family. I think that’s interesting!

  2. KB
    Reply

    “A 250-pound lumberjack may be given the same dose as a 98-pound grandmother”. This is NO different than 9 Gin soaked raisins a day for arthritis. ONLY nine, not ten, not eight, with NO explanations about body size difference.

  3. gypsy_moon
    Reply

    I am REALLY disgusted with the FDA going after 23andMe. There is absolutely NO credible reason for it whatsoever, other than some Big Pharma company with their own test paying them to do it. I’ve always suspected that the FDA is in the pay of Big Pharma anyway, otherwise some drugs would never get approved at all while others would have been approved long since.

  4. Noah V
    Reply

    No mb, just plain “moronic.”

  5. john
    Reply

    Can anyone offer any credible reason for the FDA to pursue 23andMe? Would any reputable surgeon perform surgery based on this information alone? Is this information any more or less credible than the fact that Aunt Minnie died of breast surgery? While foreign drugs proliferate, untested, into our markets, the FDA chooses to shut down 23andMe? This is more of the government interfering unasked and unwanted into our private lives, while unable to perform it’s true responsibilities.

  6. tutorjb1JB
    Reply

    For the FDA to take a stance against people using 23andME to obtain initial genetic predictors is INSANE and in my opinion makes the FDA unworthy of being a U.S. health agency. If they continue issuing such ridiculous opinions, they should consider doing so from a third-world country. 23andMe is the only place I’ve heard about to get genetic predictors that’s simple and sounds like it wouldn’t cost a fortune.
    Could that be behind the FDA’s gripe? My opinion of the FDA’s judgement has just taken a nose-dive. I have no information (so no opinion) on the diabetes drug, but the makers of Plan-B, all Depts. of Social Services and guidance counselors and school and any other health Depts should issue Major Warnings about the ineffectiveness of Plan-B. I guess it’s back to trying to find safe abortions for a lot of people.
    Thank you Peoples Pharmacy and NPR,
    tutorJB1

  7. Roger Schultz
    Reply

    The FDA has to be ran by BIG Pharma. New drugs are getting to the market faster than ever before. That can only mean less and less testing which is evident with the frequent television ads for law firms asking “did you take this drug and experience these side effects”? The most recent drug, Risperdal, has side effects causing male breast enlargement and lactating. How could a drug like this get on the market if not for Pharma’s control over the FDA. I’ve resigned myself to the fact that if it’s approved by the FDA then I better do plenty of my own research.

  8. ch
    Reply

    23andme was the best thing I had done in a long time. It confirmed what I already knew and made me more cognizant of what I should do to avoid consequences of some of the diseases I had inherited. Our entire family took the test, and my husband came out above average for colon and esophageal cancer which he had before the test. Our 41 year-old-son was above average for colon cancer, had a colonoscopy because of his dad’s history, and he had two or three polyps removed. If he had not seen the test results, he may have put off having the colonoscopy.
    The FDA should put its efforts into some of the meds it approves and then patients find that the meds are removed from the market after the FDA approves the meds.

  9. Noah V
    Reply

    I think it is important to note that the FDA, as well as other “regulatory” bureaucracies, hasn’t been ‘infiltrated’ or taken over by industry touts. This is the way they were set up to begin with. Yes, to provide high standards, but standards that only the wealth of the contemporary BIG companies in the field could meet. Drug testing, for instance, is very time and labor and cost consuming. Can any of you afford to do it out of your kitchen or garage?
    These ‘commissions’ consist of “experts” whose expertise derives from their membership in the industry, whether as employees or beholden “(in)dependent researchers” who are supported by industry grants. The government supports this because these industries provide money for political campaigns and because the government itself has no expertise in anything. It is just a bunch of guys with delusions of grandeur.
    So these regulatory commissions are created by government, using industry personnel to police themselves. What should we, ultimately, expect?

  10. SL
    Reply

    While I generally agree with your comments on 23andMe, I do think this company and those who offer similar services should be required to prove that their results are accurate. I don’t worry about people who receive false positives for a serious condition. Rational people should get second opinions before doing something radical. I worry more about people who get a clean bill of health, but have serious undetected (or unreported) problems. As a genealogy enthusiast, I also wonder about the accuracy of the 23andMe genealogy information.

  11. mb
    Reply

    The saga of avandia-thousands-no millions of type 2 diabetics were prescribed avandia- The makers of avandia were earning BIG BUCKS! Then after more intensive studies many patients taking this drug had heart attacks! Bingo! The FDAd etermined that the original clinical; trials were flawed! So it was taken off the market and patients were advised by their physicians to cease and desist taking avandia- so now (someone out there is pushing this!) they are putting avandia back on the pharmacy shelves and saying it is a safe drug! is this an oxymoron?

  12. JS
    Reply

    Amazing that we’re only just hearing that women over 175 pounds may not get adequate effects from Plan B. The majority of women I know are well over 150 pounds, and the average American women is a size 14!!!! So….do they take a double dose now?

  13. Cynthia M.
    Reply

    I am one of the few people that was adopted & know little to nothing about my family medical history. While I will probably try 23andme, that does not necessarily equate to prophylactic surgeries. 23andme should be available to people & used as a tool only for sound medical decision making.

  14. JBG
    Reply

    The medical cartel reasserts itself. Not the first time; not the last. One wonders how long it will be before they bring the hammer down on Theranos.
    Joe and Terry — Do you have a program scheduled about Theranos?

  15. Noah V.
    Reply

    I see these stories as further examples of rampant corruption in the FDA but not limited to the FDA. We see a plethora of similar rulings from other regulatory bureaucracies in our government as regulations are relieved so companies can garner greater profits and all they need to do is to support the current set of politicians in office.
    As Nero watched Rome burn somebody was making a killing on torches.

  16. nb
    Reply

    Doctors should be more proactive and learn about the side affects of the drugs they are giving their patients and what drugs their patients are taking. Plus the FDA shouldn’t be looked to as the only information on such. I have written before that my husband died this year. In 2010 he was healthier than most 75 year olds and won the medal in his age group in a 5K because he was the only one in that category and the oldest entrant. He did have a history of stroke and had a pace maker, then other things began to happen. Each “Specialist” had a new drug to take care of anything that cropped up. Gradually his health deteriorated.
    I am not blaming the doctors for his death. However, if the doctors had been more aware of the side affects of the medications he was taking, the last three years didn’t need to be so troublesome. After his death I checked all of the side affects of every medication he was taking and the side affects all overlapped with each medication. I should have done this earlier.

  17. SPB
    Reply

    Is there an effective avenue for expression of our views on these matters that can have any actual influence on outcomes?
    PEOPLE’S PHARMACY RESPONSE:
    Our experience with the FDA would suggest that there is seemingly little interest in what the public has to say. Perhaps your Congressman would be the place to voice your concerns.

  18. CAK
    Reply

    How long is the FDA going to get away with being in bed with Big Pharma while pretending to be protecting you and me. They punched a big hole in the credibility they had with me when a few years ago I read in the Wall Street Journal that although tuna had one of the highest mercury content of any fish, the FDA was classifying it as moderate in mercury content TO PROTECT THE MARKET SHARE!

  19. Svea S.
    Reply

    Correction: 23andme uses saliva not scrapings from the inside of the cheek. Just had it done this past summer.

  20. emma k.
    Reply

    Wow I just sent my spit sample in to 23andme. My primary reason was ancester confirmation, but I also would like a preliminary tool to be used as a first step in diagnoses/predispositions.
    While 23andme has not handled prior queries from FDA well, I also agree that this like so much else smacks of big pharma’s fine Italian hand. BTW, a geneticist here in Seattle said on a local radio show that he had his spit analyzed by 23andme and found it helpful.

  21. Carla
    Reply

    I rely on the People’s Pharmacy for common sense, informed, well-sourced, unbiased reporting on matters essential to the health of my loved ones and myself. Please never stop providing this vital information to the public. On that theme, I hope you are mentoring young people to follow in your footsteps.
    Tragically, it appears that like virtually every other regulatory agency in this country, the FDA has been captured by those it is charged with regulating. This is the predictable outcome of a for-profit medical industrial complex that is by definition corrupt.

  22. xhert
    Reply

    I totally agree csoehl about the drug companies. And most people have the sense not to rush into any unnecessary medical procedures without consulting doctors. I wouldn’t be surprised if big pharma doesn’t want any preventative measures available to the public, I resent being controlled in this manner!

  23. csoehl
    Reply

    Well, this was predictable. The FDA is pursuing 23andMe on behalf of Big Pharma to stop people from having vital health information related to drug sensitivities.
    I already knew that statins were harmful to me. I already knew that I had a problem with common anesthesia medications. I already knew about my family history of a blood disorder. 23andMe confirmed these things and allowed me to share with my physician who can now, without being criticized by my insurance company, provide proper care for me by not prescribing drugs that have negative effects.
    The drug companies have been able to avoid doing the kind of drug testing that they should be doing based on genetic phenotypes. They don’t want to spend the money and claim that the small percentages of people that have serious side effects from their drugs are anomalies. Suppose that 100% of the people negatively affected belong to one of the phenotypes that should not be given the drugs? Follow the money on this one.

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