Drug Safety Jitters

How safe are the medicines we’re all taking?  Who’s to know?  As good Americans, we tend to put our faith in the system and assume that the authorities have it covered.  After all, they’d get sued or something if this stuff wasn’t safe, wouldn’t they?

A few recent headlines have shaken my blind faith in drug safety:Pill_question

* A front page feature in the San Francisco Chronicle last week about online pharmacies selling imported medicines for cheap.  And I don’t mean ordering some no-label stuff from some cloaked online vendor listing no physical location.  This story’s about a 31-year-old entrepreneur out of SF who now fills 1,000 medicine orders a month through his site, ProgressiveRx. He started the site when his brother and aunt lost their jobs and health insurance, and a friend was diagnosed with Lou Gehrig’s disease.  The best of intentions…

But "the practice of importing (FDA) unapproved drugs from other countries is technically illegal" so he’s had to use a number of legal loopholes, including purchasing his goods from Asia’s largest health care provider, since he can’t buy directly from Indian drug manufacturers.  The article notes that while this web provider takes great pains to ensure product quality, "as much as 20 percent of the medicines sold in India is fake," and cites the Organization for Economic Cooperation and Development stating that 75 percent of the world’s bogus drugs originate in India.

I’m not pointing fingers here, but just pointing out that in our quest for more affordable medicines, we’re running a high risk of buying — and taking — a bunch of veritable snake oil.  Not good.

* Possibly more disturbing is Scott Strumello’s frustrated criticism of the ADA for their "deafening silence" on a recent call for input on guiding diabetes treatments.  First off, he calls attention to a new FDA report about that agency’s internal problems and resulting inability to properly review the safety of food and medicines in this country.  It looked it up.

Major findings No.s 1-3:

1) The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.

2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability

3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate

OMG!

As of this month, however, the FDA is taking steps to remedy itself with a "multi-year hiring scheme" and "wide sweeping plans to improve" its efforts.

OK, helpful.  But in the meantime, Scott points out that the ADA has also failed to fulfill its mission by refraining from reacting or submitting any statements when the FDA recently solicited public comments on the Agency’s Draft Guidance for Diabetes Treatments.   

"How can an organization whose 501(C)3 status claims that its mission statement is ‘to prevent and cure diabetes and to improve the lives of all people affected by diabetes’ have remained silent on this issue?" he asks.

My question is: If the FDA is bottoming out and the ADA isn’t speaking out, who’s looking out for our safety as all these new medicines hit market?!

* Finally, there’s the issue of drug interactions.  How does your Aunt Bessie know if her heart medication is incompatible with her various inhalers or that blood thinner she’s taking?

According to this ABC News story, a new study shows that more than half of all insured Americans are taking prescription medicines regularly for chronic health problems. "Some of them are on 10 to 15 different medications. They could be going to different types of doctors, a lot of drug therapy," says Los Angeles Pharmacist Harold Capeloto.

Naturally, a number of new Health 2.0 websites have popped up to fill this market niche.  Among them are DoubleCheckMD.com; the brand new site eHealthMe.com for both generic and brand name drugs; and a user-ratings site called HealthGrades.com.

I have two worries about this:

1) the people who need this information most are probably the least likely to find and use slick new Health 2.0 websites (think Aunt Bessie).

and

2) This doesn’t account for so-called "off-label" use of drugs, meaning when doctors are encouraged to prescribe meds for additional conditions the drug wasn’t really meant for. 

For example, when my carpal tunnel was at its worst, the orthopedist suggested I try Nuerontin, which I looked up and was horrified to find was developed for the treatment of epilepsy. Later it turned out that Nuerontin was a classic off-label use drug scandal.

So what I’m saying is, you could easily end up experiencing some nasty side effects or drug interactions from a medicine you had no business taking in the first place.

                ***            ***            ***

This is a rather depressing post for a Monday, sorry.  But having looked into this, I just had to share; I’m feeling all jittery about this topic now.  Oooh, maybe it’s one or more of those prescription drugs I’m taking (Detrol, Diflucan, Zyrtec, Levoxyl, or Oxytrol, anyone?)

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13 Responses

  1. Elissa
    Elissa May 19, 2008 at 6:57 am | | Reply

    Interesting article from Slate arguing the other side of the off-label drug issue:
    http://www.slate.com/id/2180245/

  2. Kevin
    Kevin May 19, 2008 at 7:02 am | | Reply

    Thank you for pointing out the gap between H2.0 and Aunt Bessie.

  3. tmana
    tmana May 19, 2008 at 7:55 am | | Reply

    Dr. Mary Ruwart has been warning us about the FDA for years… they are completely controlled by politics and big pharma, take too long to approve safe drugs, approve non-safe drugs… and everyone gets scared to death the second there is a one-in-a-million chance of a serious interaction when without the drug there would be a fifty to one hundred percent chance of death, serious loss of quality of life, etc.

  4. Dave
    Dave May 19, 2008 at 8:21 am | | Reply

    Hello, you mentioned that you have Carpal Tunnel syndrome. Have tried going to a physical therapist? I mean a good one that will look at you overall posture? My wife is a PT and has mentioned that Carpal Tunnel is usually caused be bad posture or body alignment issues. Just thought you may want to look at that avenue instead of taking drugs. God know we diabetics already take plenty and one less is that much better.

    Dave

  5. Rian
    Rian May 19, 2008 at 8:27 am | | Reply

    Last week on Bill Moyers Journal, Mr. Moyers conducted a very interesting interview with journalist and author Melody Petersen about her new book “Our Daily Meds” investigating the pharmaceutical industry which she reports to be broken and warped by marketing. Link [ http://tinyurl.com/6o5ez5 ]

  6. Jo
    Jo May 19, 2008 at 11:29 am | | Reply

    First we need to remember that the news organizations that report on the FDA, ADA and pharmaceutical industry have their own agenda – and its not the health of this country. Its to make you afraid so you’ll go for one of the government run, funded and controlled options (ie: socialism).

    Second – I don’t take one medication before I’ve researched it thoroughly, especially to see if it will mess with my other medications.

    Thirdly – doctors over medicate. Its called “under the table bonus” or kick back from the drug companies.

    Fourthly — thanks for the post. We all must take charge and not rely on the doctor or drug companies to look out for ourselves.

    I made an appointment with the foot doctor today and the last thing she told me was to bring a list of all prescribed medications for the doctor to review. If more people took the time to write down what they take and what for, it would help out the various doctors we have to go to all the time. And that includes Aunt Bess.

  7. Mandy
    Mandy May 19, 2008 at 11:53 am | | Reply

    One of the scary things about the FDA is the circular problem of it’s staff. The FDA is too low in employees to effectively do the job, so they hire. The new hire learns how the internal system works, but then leaves for a better paying job at a drug company. Now the new drug company uses the knowledge and connections of the old FDA employee to facilitate quick approval of their new drug, and the FDA stays understaffed. Definitely a problem.

  8. Lauren
    Lauren May 19, 2008 at 10:44 pm | | Reply

    I disagree that doctors purposely overmedicate in return for kickbacks and drug company swag. That would be highly unethical. Plus, drug companies peering into patient files would violate HIPAA ten million times over.

    There’s tons of evidence for the efficacy of acupuncture and physical therapy and I agree that those avenues should be explored independently of, or in conjunction with, prescription meds.

  9. Susannah Fox
    Susannah Fox May 20, 2008 at 1:17 pm | | Reply

    Just to add fuel to your fire, check out what Joe & Terry Graedon were able to do at The People’s Pharmacy site when they began getting reports about a generic drug that wasn’t working right:

    http://www.e-patients.net/archives/2008/04/epatients_unite.html

    (The Wall Street Journal article is even more indepth: http://online.wsj.com/article/SB120882069010332969.html?mod=2_1566_leftbox)

  10. Stephen Rees
    Stephen Rees May 20, 2008 at 5:48 pm | | Reply

    I am Canadian. I am here to tell you that India is not the only source for cheap prescription meds. And none of ours are bogus. I am not a drug sales person or a spammer.

    We also have policy here (BC) that if there is a cheaper generic alternative to a brand name drug you are entitled to it, no matter what is on the prescription.

    Some people are lucky to have drug plans, and our governments do pay for some meds for the permanently disabled or the aged. But the rest of us are on our own, but not at the mercy of big pharma – yet.

  11. camille johnson
    camille johnson May 26, 2008 at 1:55 pm | | Reply

    re: “all these new medicines” and the cost trend (up, up, and away…)
    Can somebody please tell me why insulin has NEVER had a generic? Also why test strips and plain ol’ monitors have NEVER gone generic? Yes, I know Walgreens, etc., now have their own brand name versions but that’s not the same as “generic”. There just is no legitimate excuse, it seems to me.

  12. Krish
    Krish July 31, 2008 at 4:17 am |

    Krish…

    Just wanted to drop a note to let you know what a great site you have. It is a great resource and a great place to drop by….

  13. diabetes treatment
    diabetes treatment October 30, 2008 at 11:55 am | | Reply

    I know of certain individuals who had serious psychiatric problems as a result of a certain drug. It produced memory loss and extreme nausea. One wonders whether they do any safety trials on these things

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