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Wednesday, January 23, 2013

An Attempt to Exhume the "Ethical Drug Industry"

When was the last time you heard "ethical" and "drug industry" in the same sentence? These days, you are more likely to see "unethical" linked closely with the drug industry that during the time of its birth during the Civil War in the U.S. used "ethical" to distinguish its products from quack medicines. Here's a piece of drug industry history from "The Evolution of Pharmaceuticals in the United States," which I found by Google search:

"Frederick Stearns was [an] important industry pioneer. He started a manufacturing facility in Detroit in 1855 and it was an important supplier of medicines during the Civil War. Stearns also became a reactionary against the medical quackery that was rampant at that time, so he put his products into popular-sized packages bearing full directions for their use plus a plain statement of the names and quantities of the ingredients in the package. He thus pioneered the phrase 'ethical specialty' for his products, and that was the origin of the phrase 'ethical pharmaceuticals' that survives to the present day. (Frederick Stearns and Company was acquired by Sterling Drug in 1944.)"

I am not sure when this bit of history was written, but as I said, in the "present day" we no longer hear the phrase "ethical pharmaceuticals." We all know why. The industry has been found guilty of unethical and even unlawful practices that include hiding clinical trial data (see "GSK's Coverup of Avandia's Heart Risk Data: Is This How the Entire Industry Views Its Responsibility to Patients?") and illegally marketing drugs. In recent years, the industry has paid huge fines and instituted corporate integrity agreements to settle DOJ cases (see, for example, "Transparency Vs. Translucency in Reporting Physician Payments").  The industry's low esteem among the general public is a direct result of this bad behavior and not, as some industry defenders claim, due to skewed media reports and anti-industry books like "Bad Pharma" (see here).

So it was with great interest that I read about a new effort to improve the drug industry's reputation: the establishment by a bioethicist of an accreditation rating system (read all about it on Pharmalot: "Good Housekeeping Seal For Pharma?"). "Jennifer Miller, a fellow at the Edmund J Safra Center for Ethics at Harvard University and president of Bioethics International, a non-profit that advises educational programs on ethical issues on medicine and healthcare, is trying to develop the industry equivalent of a Good Housekeeping Seal of Approval," reports Pharmalot.

"The standards [for the rating system] have been compiled and developed by a council that I put together," said Miller. "It includes input from two former FDA commissioners – Mark McClellan and Andrew von Eschnebach, and some executives in the pharmaceutical industry, patient advocates, physicians."

Her choice of former FDA commissioners leads me to believe Miller's system is "fixed" so that no pharma company would get a bad grade. As one Pharmalot commenter pointed out "The credibility of this plan will depend on who the judges are. The fact that the 'committee' already includes an FDA Commissioner who himself resigned because of ethical trouble makes one wonder."

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative. If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright (see here)! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace. That would not be how the general public would want an "ethical" drug industry to operate.

Meanwhile, Mark McClellan was allegedly involved in the decision to bar Barr's Plan B OTC conversion. McClellan resigned after a very short term. According to a story in the NY Times, the FDA deleted or threw out all of McClellan's e-mail and written correspondence on the subject (see "Plan B FDAgate").

Is it any wonder that no pharma company will touch Miller's proposed plan with a 10-foot pole and become a "pilot" case?

3 comments:

  1. As someone as has been nagatively affected by a medicine, I can tell you the unethical portion of things might be to make more $ but it affects human lives and families.

    I went into a clinic for simple armpit pain, which started after a rough day of exercising but did not go away for a few weeks. So I went in they did a few x-rays said things were fine. She pointed out she saw something in the chest xray and that it could be "pnemonia" I personally had no symtoms but she recommended I start on Levaquin for 10 days just to be safe. So I did just that. I went about my days.

    3 days into taking the mdicine i started getting weakness in my arm, and then on day 5 (5th pill) my legs started burning. I stopped the med after I read the side effects (which were all the way down on 9th row) that if you get burning you need to stop the med.

    Next day everything chekcs out fine says I'll be fine in a few days. The probelms never stopped. My leg muscles few days later became tight, found rotator cuff tendinitis. Sharp pain all over my body, and some burning.

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  2. This continued on for nearly 4 to 6 months. It became very difficult to walk, my knees were swelling up, swelling in my tendons. Went to doc after doc to which all said they have no clue what's going on. NEver heard of any side effects w/ levaquin even after I pointed out the label and they said it only happens to 0.1% sO i can't be that 0.1%.

    I went from a normal 26 year old healthy person, to someone who had trouble just walking to the bathroom some mornings or getting out of bed.

    It didn't take long for me to google Levaquin side effects, only to find many websites and thousands of people complaining of crippling sid effects from taking the drug.

    It's now been 20 months and my ligaments in my feet are loose, I have tenditinis in my posterior tibialis, knee cap is loose, weak muscles which need serious Phys Therapy, dry eyes, floaters in my vision, ringing in my ear.

    For nearly 6 months or so just 1 day to the next new things were going on. And I found mealry 1 doc who had heard of it. And only a few who had any clue about levaquin tendinitis and ruptures.

    It's ruined my life. I live with it from the time I get up to the time I go to bed. I've spoken to 100's of people now who have similiar stories. Even though some of the side effects are on the labels nearly no doc has any clue what to do or even realize it's there. How can this be?

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  3. After speaking with my pharmacist he did some research himself and was astounded to see the complaints and news articles written on Forbes, NYTimes, PBS, and many other smaller websites. He said he's had about 10 people come in, the past 2 years he had been working at this small pharmacy with complain about things after taking levaquin or cipro but never this much. He said few that had serious side effects were lucky and they were good to go a few months later or required some surgery but are back to normal.

    Then I see that people have been to JNJ shareholder meetings who are now disabled after taking this drug. While it might be rare and my story is rare. HOW CAN DOCTORS NOT BE INFORMED?

    I've had doctors tell me, they use Levaquin for just about everything. It's their goto drug. Never had any side effects.

    Is it that doctors are largely ignorning side effects when patients come in like myself? Is it that JNJ has downlplayed side effects? Or had false clinical trials as i'ts been suggested?

    The drug is clearly very useful and does work. But why are they hiding the side effects and letting all these people suffer? It's not just a handful, but it's 1000's.

    I feel certain companies have a lot of work to do before they will be considered "ethical". They make products that help us, but then they have so much power when they slip a few bad things through they just say well we are doing good. So what we didn't recall it on time or we decided to make a few extra buck. Which happens to be the case in JNJ Hip replacement product's case that email's show the company thought it would hurt their sales if they just told the "truth". Instead they just let grandma and grandpa suffer and let insurance companies pay out insane fees for new surgeries, and drowing many patients with some expensive bills.

    This is what happens when companies down play situations or don't take care of things. People like me will suffer, and there's no reason this should of ever happened to me, all it took was FDA nad JNJ to do their part and inform doctors of proper use and devistation side effects it may have.

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