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Supreme Court nixes hemophiliacs class-action lawsuit

Question:

  The National Hemophilia Foundation has my sympathies, but unless   they are Libertarians, they don’t have a clue as to what happened to If you read some of the literature on all this, I think you will find that the National Hemophilia Foundation was part of this tragedy…. Unless someone from the top exerts strong leadership, legal and competitive concerns may inhibit effective action by agencies tasked with primary responsibility.  In the beginning days of the AIDS-epidemic, there was no leadership.  

Response:

      The Right Lesson To Learn From Thalidomide            (c) 1992  Steven B. Harris, M.D.    The Food and Drug Administration was originally (early in this century) charged with establishing the purity and safety of foods and drugs.  As such, it was tolerable, and even did a certain amount of good in acting as policeman against certain types of actions which we all agree constitute "fraud" (i.e., putting horsemeat in the hamburger, or putting sugar instead of antibiotic in the "antibiotic" pills, etc.)    But then, and the late 1950’s and early 60’s, something horrible happened, both to the citizen and to the State.  In Europe, a drug called thalidomide was marketed as a tranquilizer. In America, the FDA official in charge of the American "new drug application" for thalidomide (submitted Nov., 1960) was a woman physician (Francis Kelsey, M.D.) whose physician/pharmacist husband did not like the way routine pharmacologic tests had been done on thalidomide.  Dr. Kelsey was also concerned about some medical reports in late 1960 that thalidomide might cause neuropathy (nerve damage) in some of its users.  Neither of these concerns was fatal for the thalidomide application, but together they were enough to hold up the FDA’s approval of thalidomide for a year, pending more pharmacology tests.  Since neither problem had anything to do with birth defects, it was only by the sheerest chance that the red-tape in these matters caused introduction of thalidomide to be delayed in the U.S. until it began to be suggested in late 1961 that thalidomide was a dangerous drug for pregnant women.  In the end, the association between thalidomide and birth defects was discovered in Europe, not America — and certainly was not discovered by the FDA.  Despite this, on August 7, 1962 a grateful President John F. Kennedy awarded the Distinguished Federal Civil Service Award to Dr. Kelsey, who by this time was beginning to make (in retrospect) statements about how she had been concerned with the reproductive safety of thalidomide all along.     However much we all like heroic tales and medals, there is actually very little in the record to bear out the official heroic version of the thalidomide story.  Upon careful examination it appears that no reproductive tests ANYWHERE were done at all on thalidomide before 1961, nor indeed did the FDA ask for any.  In fact, it appears that even had any pre-marketing reproductive tests of thalidomide in rats been done, they would have *still* shown negative results, for thalidomide (as we learned later) does not even cause birth defects in rats.  We now know that it would have taken a much more exhaustive set of animal tests to catch thalidomide than was routinely used anywhere in 1961.  An honest reading of the facts thus forces the conclusion that (questions of luck aside) Dr. Kelsey’s medal was awarded basically for being a delay-causing bureaucrat and thereby allowing Europeans to serve as first-class "guinea pigs" for Americans, in a case where many lab animals would not have done an adequate job.      Yet Dr. Kelsey’s medal was soon to become an excuse for much self-congratulation, regarding FDA policy.  Not much thought was given to what the consequences of a de-facto U.S. marketing delay policy might be, if applied to all new drugs across-the-board.   Indeed, a simple delay law preventing drugs from being approved in America until a certain time after they had been introduced in Europe could be passed, and enforced for much less money than we pay for an FDA– but THEN we’d have to face questions of the actual costs of "deliberate drug introduction delay" head on, instead of hiding from them, as we do now.    But exactly this was the other fallout from thalidomide besides Kelsey’s medal.  In 1962 the thalidomide disaster gave unexpected new life to several stalled bills on capitol hill which proposed to give the FDA power over not only safety, but also the _efficacy_ of new drugs.  There was a some irony in this, since the thalidomide disaster itself was of course an issue of safety, and had nothing at all to do with efficacy (the bills were themselves introduced before anyone had heard of thalidomide).  Unfortunately, however, the fine distinction was lost on congress, which only knew that the FDA seemed to be proving a good thing and should therefore be made bigger.  In 1962 the so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act were passed into law, giving the FDA new broad powers, and thus the bloated and mutated regulatory agency that we know today was born.  Thalidomide, as it turned out, had proved to be a monster-producing drug in more ways than one.    Today, thirty years later, the cost of developing and marketing a new drug in the United States has risen to an average of about a quarter of a billion dollars PER DRUG.  To make a long story short, a large part of this money is regulatory cost.  Not surprisingly, the huge sums spent in drug development are reflected in the price which the consumer pays when he/she picks up any prescription for a newer drug.  The reader who wishes to directly assess the regulatory cost of the FDA is invited to shop for pharmaceuticals in Mexico, where (except for packaging) the identical pharmaceutical product made by the identical company (example: Retin A creme) can sometimes be had for as little as 1/5th the U.S. price.    The FDA is responsible for high regulatory costs in money; the regulatory cost in lives is more difficult to assess, but is probably significant.  The high cost of drugs has led not a few impoverished patients to stop taking what the doctor ordered, sometimes with expensive or even tragic results.  Even worse, the newest drugs now, as a rule, are available in Europe for years before being available in the U.S., and in the interim many U.S. patients almost certainly die for lack of treatment.  One estimate, for instance, puts the number of people who died of cardiac arrhythmias as the direct result of the historical FDA’s multi-year lag-time in evaluating "beta-blocker drugs," in the hundreds of thousands– a number which, if correct, makes up for thalidomide many times over.      It is important to understand that this situation arises via one of the significant shortcomings of democracy.  In every political decision, there are effects seen, and effects unseen.   Politically, the FDA comes under severe pressure for passing a drug which is later shown to be unsafe, but (in an unbalanced way) comes in for much less political pressure as regards the equally dangerous failure to swiftly pass a drug which proves to be efficacious.  This lack of balance results from the fact that patients who die as the result of a drug-reaction are seen to die because of the drug, but patients who die as the result of lack of a drug (especially one which the local docs are not familiar with) are seen to die of the *disease*.   Even if the local doctor understands the FDA’s role in preventing the patient from being properly treated, "Stenosis of the Government" is not a medical diagnosis, and cannot be written on a Death Certificate.    It is also important to understand that this situation arises because of a certain laziness of the citizenry in understanding that the decision of whether to take a specific drug for a specific purpose, is only partly a scientific one.  The reason for this is that, even in the rare case where the probabilistic risks and the benefits of "taking the drug vs. not taking it" have been fully defined by science, the *balancing* of these risks and benefits is still an ethical and moral decision, and one which varies wildly from person to person, due to circumstance and personal preference.  Trying to make such decisions by central command for people makes as much sense in medicine as it does in economics, and is as doomed to failure.    To put it succinctly, the decision to try a new and possibly dangerous treatment may well and properly be influenced by how much pain the prospective treatment-taker is in, and even upon how soon he or she can expect to die if nothing is done.   Unfortunately, however, these factors do not directly enter into decisions made in Washington, basically because Washington is not in pain, and Washington is not dying.  If you are the patient with a serious problem, therefore, you may expect that having a decision about your treatment made for you in Washington is less likely to be satisfactory, if for no other reason simply due to the fact that they do not know you or your problems in Washington, and even if they did know you, still could not care about your problems nearly so much as you and your family do.  Empathy is a function of proximity; all physicians know this.  It is an elementary principle of medicine that nearly any displacement of medical decision-making away from patient and physician is bound to result in needless suffering.  Thus, the FDA as it functions today is basically engaged in an evil enterprise which cannot help but cause suffering.  To be sure, the people who run the FDA may not be evil people (though perhaps some are) but unfortunately, this does not change the facts about the FDA’s generally negative impact upon the country.    The FDA, it must be remembered, is in the game for the political power, not for the benefit of the citizenry.  This is a fact which comes across in many issues, large and small:    In large health issues, the FDA is known to bow to political pressure if it is massive enough (i.e., the AIDS lobby), but there are very few common fatal diseases in which those struck by the disease are characteristically young and full of energy (which can be used for lobbying) for many years before they succumb. The FDA as an institution is thus free to remain firmly entrenched to retard development of treatments for hundreds of equally deadly diseases which have smaller or … read more »

Response:

(Paul Vess) writes:

he US hemophilia population totals approximately 25,000. Over 85% of the U.S. hemophilia community born before 1982 are HIV-positive.

   No, it’s actually about 50%.  Total number infected: between 9 and 10 thousand.   If the average life span holds true from infection until death, within the next 2 years the vast majority of HIV infected US hemophiliacs will be dead.  

   Not even close.  Even for the infected hemophiliacs, the 50% mortality occurs at about 15 years.  Thus, we’ll have half of 10,000 people dead by 15 years after the time somewhere between median infection peak (1982) and end of the infection (1985).  That will occur in something like 1998.  Right now, something like 3300 hemophiliacs have died of AIDS in the US.        I believe the public is the US hemophilia community’s best hope if the hemophilia population is to have any justice.  Our elected officials respond to money and votes.  I challenge every caring individual to write your politicians and ask why individuals and companies who have profited from the sale of HIV contaminated products to the hemophilia community have not been held accountable.  Thousands of United States hemophiliacs have already died from AIDS, and the remaining HIV-positive hemophiliacs face the same terrible fate unless a cure is found in the very near future.  

   True enough.      I am extremely saddened by the willingness of many members of our society who will do whatever it takes to save the Spotted Owl, a beached whale, or any of a number of endangered species, but nothing is said, or little done, on behalf of humans who have been needlessly infected by HIV for the sake of profits.  The US hemophilia community is indeed an endangered species, with thousands subject to an early death.  The trust that was placed in the FDA to police companies to make sure that harmful products never reach the public, and the trust placed in companies to only produce products safe when used as directed, was severely abused.

   Well, what if it was?  That’s what happens when you let other people make your decissions for you.  If you were smart you’d be trying to dismantle the whole damned FDA, not sue to the most powerful government agency on in the country when it does ONE THING you decide you don’t like.  The FDA recently made the US Army discard millions of units of frozen blood, because they weren’t collected properly.  The army are the folks with the nuclear weapons and tanks, remember?  And the 300 billion dollar budget.  You think you’re going to do better?  ROFL.    Not until every single segment of this society harmed by the FDA takes them on in coordinated fashion, will you see any change at all. The National Hemophilia Foundation has my sympathies, but unless they are Libertarians, they don’t have a clue as to what happened to them, why it happened to them, or what to do about it.    I’ll append an article on the FDA you may be interested in.  It’s the tip of the iceberg.                                             Steve Harris, M.D.

Response:

Greetings,         Besides the O.J. Simpson saga, the following news confirms once again that America is a land where those who have enough money can escape justice.  The initial attempt to have the hemophiliacs lawsuit (below) certified as a class-action suit was denied, with the judge stating that such a lawsuit could "bankrupt" the industry.  That ruling was appealed to the Supreme Court only to be turned down again. The likely-hood of Dow-Corning going bankrupt did not prevent the judgement granting compensation to women who had been damaged by defendants products.           The US hemophilia population totals approximately 25,000. Over 85% of the U.S. hemophilia community born before 1982 are HIV-positive.  If the average life span holds true from infection until death, within the next 2 years the vast majority of HIV infected US hemophiliacs will be dead.           I believe the public is the US hemophilia community’s best hope if the hemophilia population is to have any justice.  Our elected officials respond to money and votes.  I challenge every caring individual to write your politicians and ask why individuals and companies who have profited from the sale of HIV contaminated products to the hemophilia community have not been held accountable.  Thousands of United States hemophiliacs have already died from AIDS, and the remaining HIV-positive hemophiliacs face the same terrible fate unless a cure is found in the very near future.           I am extremely saddened by the willingness of many members of our society who will do whatever it takes to save the Spotted Owl, a beached whale, or any of a number of endangered species, but nothing is said, or little done, on behalf of humans who have been needlessly infected by HIV for the sake of profits.  The US hemophilia community is indeed an endangered species, with thousands subject to an early death.  The trust that was placed in the FDA to police companies to make sure that harmful products never reach the public, and the trust placed in companies to only produce products safe when used as directed, was severely abused.  The "good ‘ol boy" network of individuals who became rich as the result of people’s suffering and need for their products continues unabated.  According to information in the book, "And the Band Played On," by Randy Shultz, and even minutes and memos from the National Hemophilia Foundation itself, the hemophilia community was told "not to change your treatment regimen at this time" after the Federal Drug Administration and the NHF had been warned by the Centers for Disease Control in 1982.     Court nixes class-action suit by HIV-positive hemophiliacs         -The Salisbury Post/Tuesday, Oct.3, 1995 Chicago (AP) – At 49, Jonathan Wadleigh has dealt with hemophilia since birth, the AIDS virus since 1984 and the courts since 1993.         He and thousands of other hemophiliacs say they contracted the virus from blood-clotting medicines and should be able to join in a mass lawsuit against drug companies.         On Monday, the Supreme Court dealt the group a setback when it refused to allow the class-action lawsuit against four companies in suburban Chicago, Pittsburgh, Los Angeles, and near Philadelphia.  The lawsuit was filed in Chicago in 1993.         "It’s a terrible injustice," said Wadleigh, whose brother died of AIDS in 1985.  Wadleigh, of Brookline, Mass., has AIDS.         Without comment, the court rejected the hemophiliacs’ bid to reinstate a judge’s order that would have let them sue as a class representing thousands of hemophiliacs.         "We’re going to continue fighting in the courts," said Wadleigh, a former computer executive who co-founded the Committee of 10,000, an organization of hemophiliacs.         Wadleigh expects more people will now file individual lawsuits.         Another HIV-positive plaintiff, free-lance journalist Corey Dubin of Santa Barbara, Calif., said class-action lawsuits could also be filed in state courts.         Wadleigh and other HIV-positive hemophiliacs were in Washington lobbying for federal legislation when they learned of the ruling.         The legislation being sought would have the government pay the HIV-positive hemophiliacs or their heirs $125,000 each.  In return, Wadleigh said, they would agree not to sue the Food and Drug Administration.         Jill Carter, a spokeswoman for Deerfield, Ill., based Baxter Healthcare Corp., one of the companies sued by the hemophiliacs, said the company is not at fault.         "The tragedy here is that the virus was out here and nobody knew it" at the time, Carter said.         The 1993 lawsuit named three other companies that also use blood plasma to make blood-clotting medicines for hemophiliacs: Rhone-Poulenc Rorer, Inc., based near Philadelphia; Miles, Inc., of Pittsburgh; and Alpha Therapeutic Corp., of Los Angeles.         Representatives for these companies did not return telephone calls Monday. Nationline: AIDS Lawsuit" USA Today (10/06/95) P. 3A;  Leavitt, Paul;  Rivera, Patricia V.; Goodwin, M. David; et al.      Collegeville, Pa.-based Armour Pharmaceutical Co. has agreed to an out-of-court settlement with three of six Canadian hemophiliacs who claim they were infected with HIV from tainted blood products, according to the Philadelphia Inquirer.  Each of the three plaintiffs will receive $1.55 million.  Documents presented as evidence at a government hearing in Toronto reveal that Armour continued to sell its blood-clotting product Factorate until 1987, even though it knew 10 years ago that its heat-treating process did not destroy HIV.  Related Stories: Wall Street Journal (10/06) P. B7; Washington Post (10/06) P. A2; New York Times (10/06) P. A17 *Paul Vess  Rockwell, North Carolina  USA **HEMOfact Mailing List** *Hemophilia Resources BBS  1-704-279-3555 **14,400/Set modem 8/N/1 More hemophilia LINKS & INFO:http://www.geopages.com/WallStreet/1450/ *****Original proponent for the alt.support.hemophilia newsgroup*****

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