Wednesday, September 25, 2013

CORPORATE PERFIDY


      Warfarin was developed in 1948 as a pesticide. It functioned as a blood thinner. Pests like rats that consumed food to which warfarin was added died from internal bleeding. In the course of time, it became an object of interest as a means of preventing thrombosis in many physical disorders such as development of clotting following a joint replacement. Conclusions about its efficacy were firmed up in the early 1950’s and approved for treatment of humans in 1954. It has been used successfully ever since.
      Drawbacks are danger of bleeding and interaction with certain foods like leafy vegetables and some medications. The protime, INR, has to be monitored and kept within limits. Visits to clinics to have INR checked are a nuisance and could be every few days until stability is reached. Time between checks may be extended as the patient reaches a plateau in living pattern and food ingestion. Over time, safe usage of warfarin, or coumadin by another name, has lost any mystery and has become routine. Other than the possibility of bleeding, there are no known side effects that result in physical impairment. An advantage, insofar as the patient is concerned, is the low cost. Of course, pharmaceutical firms cannot be expected to support this medication and will naturally spend research money to come up with money makers that do the same job as warfarin.
      Hence the appearance of anticoagulants like Plavix, which, by astute marketing, its developers have captured a fair share of the market. Besides the risk of bleeding, which is not significantly different from controlled warfarin dosage, these compounds have other side effects, some of which are physically debilitating. One such effect, claimed to be rare, which I happen to be familiar with, is an onset of sudden numbness down the left side of the body after just a few days of  taking the medication. Bristol-Myers, which makes Plavix, doesn’t make much of it, though they do list it as a side effect, and cautions that one should immediately report to their doctor in the event that it occurs. Paradoxically, doctors seem to know nothing about it. My own experience draws from consulting a dozen local neurologists and cardiologists about the affliction, and none were helpful. At the very least one or two could have lifted the phone and called Bristol-Myers and said: “Hey, I’ve got a guy here whose left side has gone numb from taking Plavix. Can you tell me something about it?” My own attempts to contact the company went unanswered. Meantime, for anyone who suffers from this side effect, it isn’t going to go away so long it is reinforced every day. And it may never go away if permanent damage has been sustained. Patient complaints on the internet indicate that the problem is more common than is publicized.
      Meantime, the pharmaceutical firms, happily selling expensive Plavix pills, and aware that warfarin is still widely used, look for other ways to ease that medication out of the market with products like Plavix but with different names.
      One can imagine a scene, high up on the top floor of the Pistol-Fires Pharmaceutical headquarters building in the mahogany lined conference room. (Of course, the names and titles are imaginary too.
      On this particular morning Zachary Taylor Bremerton III, vice-president of marketing, has an idea while shaving before traveling to work in the chauffeured company car. Perks are good for administrators of his status. Upon arriving at work, he calls a meeting of his marketing underlings and product experts for a brain storming session.
      “It’s like this,” he says, addressing the gathering of bright young women and men and a scattering of middle-agers: “We’re doing pretty well with Slavix, but haven’t yet scratched the potential.... not so long as warfarin is the preferred medication. And you know full well, cheap as it is, we can’t make a nickel on it. So...........,” he looks about the room, “any ideas?” For a while it is quiet. Then, hesitantly, one idea after another idea is floated. It is Bremerton’s habit to dispose of ideas he doesn’t like with a wrinkle of his nose.
       Finally, up and coming, street smart, Summa Cum Laude, Phi Beta Kappa, MBA graduate of Wharton School of Business Joe Paskudnik speaks up. “Well,” he says, “there’s Cataxiban.” 
   “What about Cataxiban?” 
    “It’s been there sitting on the shelf for a year. We spent a lot of money developing it with Scyther. Trouble is, it’s too much like Slavix. But that might be a minor disadvantage. Advantage is that not many know about it, though all the approvals are in order. We take over the whole warfarin market. No small steps. A major push. What we need to do is give warfarin a bad rap, then move in.”
     “Great idea.” Bremerton sounds skeptical, but this one sounds far out enough to give it a little attention.
      "Go on."
      “Warfarin’s got  disadvantages. INR has to be checked every so often. Patients don’t like having to run into the clinic every few days.... a pain in the butt for clinics. Also the bleeding problem, we can make a lot out of that......high risk."
      No one suggests that self-testing for INR could soon become routine.
      “Any similar risk with Cataxiban?”
      “Well..... yes. They are very close. Warfarin is a shade worse.”
     
Poor Joe’s closest encounter with truth. Really too close to call. He plunges on.                                "We mount up a major campaign. Make warfarin look bad and at the same time tout the advantages of Cataxiban. Less risk of stroke. Papers, television, the internet.....anywhere people will stop, look and listen. Prescribe two pills a day at.. say nine dollars a pill. That’s a lot better... for us... than thirty cents a day for warfarin.“
      Bremerton looks about the room. He sees approving smiles, heads nodding, shining eyes. His fingers mesh and unmesh. “Paskudnik, You’re going to go far,” he said. “That’s all folks.” The group files out.
      Bremerton speaks to his secretary via the intercom. “Maria, get me Vice-President Jim Disher at Scyther headquarters.” He gets up and starts to pace the room. “This is gonna be big,” he mutters.
      Admittedly, the above didn’t happen exactly as portrayed. But something like it did. A short time ago an article appeared in the New York Times reporting that Bristol-Myers and Phizer had obtained FDA approval for a new drug, Apixaban, also under the generic name Eliquis, that is proclaimed to be safer than warfarin from the standpoint of bleeding risk. Comparison reports (New England Journal of Medicine, Aug 29) don’t confirm that there is much difference, if any. But in recent weeks we have seen a blow-out advertising campaign..... full-page ads in newspapers,.....long television commercials, countless internet ads trumpeting superiority over warfarin and warnings about potential strokes with that medication. Enough to scare the innocent witless.
      Quite the same as the appearance of Tono Bungay in H.G. Wells’ novel of the same title,
wherein, as George Ponderevo, he helped his uncle Sidney Ewart launch an elixir called Tono Bungay, on which he built an enormous fortune.
      Amusing, if it were not so serious, is the litany of side effects, which are similar to Plavix. Some are not noted.....MAY CAUSE SUDDEN NUMBNESS DOWN THE LEFT SIDE OF BODY. But the warning does appear elsewhere.
      Gullible as anyone, I signed up for the pill. Nine dollars each.. If anything, the medication has exacerbated the numbness problem.
     Articles of complaint aren’t too interesting if a concluding comment is not offered that recommends improvement in a situation.
      My observation is that one step further must be taken. FDA approval should not be the gate opener for launching a new medication on the public. There is too much at stake.
      My recommendation is that the AMA should establish a review board comprised of pro- fessionals over the age of sixty who have been around the block. They would study every FDA approval and deliver a message to the medical community and the public regarding its merits against their experience and whether a replacement should even be considered in light of that experience. Board members would be salaried and would be selected out of a slate that has no prior connection with pharmaceutical companies on any level other than normal exposure to sales for learning purposes.

Sunday, September 22, 2013

BUYER BEWARE




    When purchasing packaged foods, whether for human consumption or for pets, ALWAYS
check the package to see where it came from. If the label says Made in USA, it is usually a safe buy. If the package is labelled “Distributed by.....” one should immediately become skeptical, as the product is probably imported. Ask the cashier or store manager regarding it’s origin if you regard yourself a careful buyer.  I thought my pet food a bargain.....until paying my vet $300 to diagnose and treat one sick puppy.

Monday, September 2, 2013

MEDICATED MEDICINE - A MODERN HORROR STORY



    The annals of medicine will eventually, almost certainly, record instances where medical treatment went awry, with appropriate caveats admitting to the possibility that profits rather than good medicine were the driving force.
    In the latter half of the twentieth century a rather clever invention was taken into common practice as a method of keeping arteries open that were subject to clogging and closure, causing heart attack. The idea was to create a tubular wire mesh device which in its collapsed form could be emplaced in the blood vessel and then expanded so blood could flow unimpeded through that area. It worked remarkably well. A stent installed in one of my arteries sixteen years ago is still open.
    It happened then, that someone came up with the clever idea that if the wires in the stent were to be coated with a special medicine, then the stents could be relied upon to stay unclogged far into the future. The hitch was that in the first year things were a bit iffy. Unless the patients were treated with a blood thinner, the liklihood of the medicated stents to clog up during the first year was higher than for non-medicated stents. This is quite a bizarre concept: medication to make medication work. A parallel in the real world would be a need for an additive in motor oil to prevent the bearings from seizing. Why would common sense doctors accept that fix, something not too different from a computer software patch, but possibly far more risky?
    Six months ago I had two medicated stents installed following a mild heart attack.
    Coumadin is a reliable blood thinner. Pharmaceutical firms don’t like it because they can’t make a nickel on it. Coumadin is cheap. It is a bit of a nuisance for doctors as the patient has to come in frequently for a short check to be certain that the concentration of coumadin is in a safe and effective zone. Not much money there either. But Plavix, a new drug to save the stents is a wonder drug. It does the job and at the same time makes a pile of money at nine or ten dollars a pill. A prescription might call for two pills a day.
    But it would be too much to expect no other downsides. Plavix has several undesirable side effects. I happen to be the victim of one of the worst of them: may cause sudden numbness down the left side of the body. It doesn’t subside, probably because it is reinforced every day. It is interesting that the warning is accompanied by the advice: See your doctor immediately. As it happens, doctors don’t have a clue and don’t respond, not even to the extent of calling the pharmaceutical company that produces Plavix- Bristol-Meyers.  Not surprisingly, the company did not respond to my inquiry.
    Since Plavix is so profitable, it is not surprising also that other similar medications would soon make an appearance. An alternate to Plavix was suggested to me. The problem was it carried identical warning about the possibility of onset of sudden numbness down on the body’s left side.
    The mischief continues. Not many months ago another blood thinner appeared on the market, purportedly safer than coumadin on the basis that bleeding risks are lower.  It is called Apixaban; its generic name is Equilis. My cardiologist approved a switch to Equilis from Plavix, with the idea that the numbness might be abated. Unfortunately the new medicine carries the same warning about sudden numbness.  After a month there was no relief, and no relief from a $20.00 a day prescription charge. At times it seemed that the numbness was worsened.
    There comes a time when the patient has to take charge. Too often doctors are not using common sense. Too often they won’t lift the phone to talk with another or with a pharmaceuticasl firm. How much pressure they are under to live and let live with the pharmaceutical firms is  subject to conjecture.    
            To sum up: this patient has had it. The next step is hard negotiation to switch medication to coumadin. Failing that, a search for a new cardiologist.