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Saturday, May 10, 2008
Contaminated Heparin Still In Use
Posted by: Hugh Hewitt at 12:41 AM
This is incredible:



The Food and Drug Administration stepped up its heparin alerts to hundreds of hospitals, medical societies and pharmaceutical organizations on Friday after learning that some medical facilities still had the contaminated blood thinner among their supplies....

"Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in [California] since the recall announcement," the notice read. "Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used," it said.

A spokeswoman for the FDA said that California authorities had sent a letter out on May 2 about gaps in the recall response.

"They checked and found more than a handful of hospitals had not removed all contaminated heparin," said Karen Riley of the FDA. "We found it on crash carts, catheter labs, and even on one hospital pharmacist's shelf," she added. The additional alert should spur hospital surgery, cardiac and dialysis centers, which use a lot of heparin, to recheck for any contaminated heparin lots."






Thursday, May 08, 2008
The Return Of The Nanny State: "New Rules on Drug Ads Sought"
Posted by: Hugh Hewitt at 8:36 AM
The WSJ.com (subscription required) reports on the move by Democrats in Congress to regulate those prescription drug ads you see on television.

They may be annoying, especially in the recitation of side-effects, but this is what the Congress is worrying about?

Key graphs:

A subcommittee led by Michigan Democrat Bart Stupak has scheduled a hearing for Thursday with an agenda titled "Direct to Consumer Advertising: Marketing, Education or Deception?" Mr. Stupak says he wants to lay the groundwork for future legislation to tighten controls on drug marketing, including giving the Food and Drug Administration the right to force changes in TV drug ads before they are broadcast....

Committee members plan to question officials of Pfizer Inc. about ads for its cholesterol drug, Lipitor, which featured Robert Jarvik, the inventor of the artificial heart. Mr. Jarvik isn't a practicing doctor, but he "appears to be giving medical advice," according to the committee, which suggested that the ads are misleading. Pfizer and the joint venture between Merck and Schering-Plough have defended their ads as accurate.

"He appears to be giving medical advice"?

The Democrats think you are idiots.






Wednesday, April 30, 2008
The Heparin Death Toll Is Up To 81
Posted by: Hugh Hewitt at 10:30 AM
I hope the victims who survived and the families of those who died retain plaintiffs' lawyers experienced in suing foreign firms protected by governments hostile to American tort actions.

Baxter is an easy target, but getting past the PRC's defenses will be tough.  My pal Joseph Timothy Cook is a retired plaintiff's lawyer who was part of the team that pursued justice for the families of KAL007.  That case took years of aggressive litigation backed by diplomacy to conclude . Another trial lawyer friend suspects Baxter is setting up a defense that will push victims into endless struggles with the PRC. 

The U.S. government will have to push China hard for cooperation in the investigation and court proceedings.  The response to date has not been encouraging, and there are certainly still patients out there who received the contaminated drug but have not been informed.  The effort to publicize the problem and alert the patient population has been minimal, and the coverage absurdly low given the scale of the deaths and other illnesses.




Tuesday, April 29, 2008
Health Care Conference Call with McCain Campaign
Posted by: Matt Lewis at 1:00 PM
I just participated in a conference call on John McCain's health care policy with Senior policy advisor Doug Holtz-Eakin and former Hewlett-Packard CEO Carly Fiorina.

Both were very impressive surrogates for Sen. McCain.

McCain also deserves credit for continuing to provide bloggers with the same access mainstream reporters are granted.  For example, I asked a question, as did Capt. Ed of Hot Air.  Other questions came from MSM reporters such as Dana Bash of CNN -- as well as reporters from the New York Times and other venues. 

The primary message was to shift from an employer-based system to an individual-based system, and that allowing people to buy health insurance from anywhere in the U.S., will create competition that will improve choices and drive down costs.  They also stressed wellness and early prevention, as well as the use of technology and electronic systems to improve health care.  

Holtz-Eagan noted the "Safeway" model where employees were given free medical care for prevention, and costs were actually driven down.  When asked how prevention and wellness would be encouraged, Fiorina seemed to prefer models based on "incentives, not mandates."

I asked two questions.  My first question dealt with the difficulty conservatives face when trying to "sell" free market solutions versus liberals who promise government giveaways.  Fiorina noted that "choice and competition drive costs down," and that transparancy also drives costs down.  Holtz-Eagan noted that McCain is "the best retail politician on the planet" and that this would help him present his plan to the American people.

My follow-up involved McCain's support of drug reimportation, which would allow consumers to purchase drugs from Canada.  This, of course, is a controversial plan which is opposed currently by the Bush Administration for both safety and philosophical reasons.  When asked about it, Holtz-Eagan said it was consistent with McCain because he is a "free-trader."

Check out what other bloggers are saying ...

  • Ed Morrissey
  • The American Mind
  • Jason Linkins
  • Philip Klein
  • Megan McCardle
  • Lonely Libertarian
  • Jennifer Rubin
  • Little Miss Attila





  • Thursday, April 10, 2008
    The Heparin Toll
    Posted by: Hugh Hewitt at 5:11 AM
    The New York Times summarizes the recent developments, but neglects to note the recent move to recall medical devices that may be contaminated by the bad heparin produced in China.

    The last caller to yesterday's show recounted his friend's two adverse reactions to recent dialysis treatments, both of which involved heparin.  Of course he couldn't say that those reactions were the result of contaminated heparin still on shelves in the U.S., but if in fact some of the contaminated supply or tainted devices are still in use, it will be in part because the FDA's alert system is flawed and in part because MSM for whatever reason failed to follow this story with the vigor that usually accompanies a mass tort. 




    Saturday, March 29, 2008
    Another Heparin Recall
    Posted by: Hugh Hewitt at 8:56 AM
    From the Boston Globe:

    Diversified healthcare products company Covidien Ltd. issued a voluntary recall of its prefilled syringes containing heparin because some might contain a contaminant. Mansfield-based Covidien said its supplier, Wisconsin-based Scientific Protein Laboratories, said two lots of Heparin Sodium USP active pharmaceutical ingredient it received might contain a heparin-like contaminant. Covidien said it is recalling the product as a precaution; no adverse events have been reported. Last week, Scientific Protein said an ingredient it provided contained oversulfated chondroitin sulfate, a chemical that does not occur naturally.

    This remains the strangest health story in many years because it is so under-reported.  The Houston Chronicle uses the same but more of AP story as the Globe, but includes the standard and usually only details about the consequences of the Heparin that was adulterated in China:



    Contaminated heparin from a different manufacturer has been associated with 19 deaths and hundreds of allergic reactions....

    Typical symptoms of the allergic reaction to heparin include low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.

    The questions I have yet to see answered in a newspaper account (or anywhere for that matter):

    Where and when did the 19 fatalities occur?

    During what time frame did the "hundreds" of allergic reactions occur?

    Are there possible long-term consequences from use of the adulterated heparin which patients have to be vigilant about?

    Have all patients who received potentially contaminated heparin been informed?

    Why are there still possibly-contaminated Heparin products on the market?

    Either the 19 deaths and "hundreds" of allergic reaction numbers are inflated or conjecture, or this story has been terribly handled by MSM.

    Pointers?  hugh@hughhewitt.com







    Wednesday, March 26, 2008
    Nothing "Unnatural" in the Health-Wealth Connection
    Posted by: Michael Medved at 11:50 PM
    PBS has committed four hours of broadcast time in the next month to a project called “Unnatural Causes: Is Inequality Making Us Sick?” The series looks at official statistics showing that the richest 20% of Americans have a life expectancy  4 years longer than the poorest Americans. Both Senator Obama and Senator Clinton have spoken out on these disparities and introduced legislation requiring that they be reduced. Actually, the biggest reasons for wealthier people living longer lives reflect healthier habits: less smoking, better diet, more regular exercise, less divorce, fewer sexually transmitted diseases, and so forth. Educated and privileged people also get more and better information about protecting their own health, as well as more access to preventive care. The “inequalities” in life expectancy don’t indicate some profound injustice – in fact, it would be unjust and illogical if people who had created more wealth were unable to use those resources to secure better health outcomes. Alarmists who overreact to the new figures also ignore the old sociological principle that “correlation does not equal causation.” In other words, more money may contribute to good health, but it’s also undoubtedly true that good health helps produce more money: people with serious illnesses or chronic conditions will always find it more difficult to compete in a free market economy. In the final analysis, it’s actually the same set of habits and attitudes – deferred gratification, focusing on long-term goals, self-discipline, avoiding destructive addictions – that contribute to both long life and financial success. Meanwhile, rather than wringing our hands at the fact the people who’ve succeeded in life enjoy better health than those who’ve faced frustration and tragedy, we ought to congratulate ourselves on the improvement in life expectancy for every American at every income level. In the last twenty years, it’s true that the life spans of the richest group went up most sharply (3.4 years) but even among the poorest Americans there was a notable rise – from 73 years to 74.7 years. Despite the concerns of PBS and the Democratic presidential candidates, there’s nothing unnatural about a connection between wealth and health.






    Wednesday, March 19, 2008
    The Heparin Autopsy
    Posted by: Hugh Hewitt at 5:12 PM
    The hunt for the killer ingrediant in the bad batches of heparin is detailed by the New York Times.  Incredibly, the article does not discuss any potential medium- or long-range health hazards to patients who received the contaminated drug or where those patients might have been treated.

    At what point will the FDA issue an alert ot patients who may have received the adulterated drug with guidance on how to proceed?  A caller to Monday's show suggested a role for the CDC which may be appropriate, but a first step would be some news on how many patients received the rotten drug, and where it was distributed.  The FDA's general silence on this subject is inexplicable.

    Key graphs:



    Scientists who have examined batches of the contaminated heparin distributed by Baxter International in the United States said in interviews that they suspected that the heparin-like molecule was intentionally mixed into the drug.

    “A child could tell you it’s counterfeiting,” said Dr. Jawed Fareed, a professor of pathology and pharmacology at Loyola University Chicago, who has been studying batches of heparin since the problems with the drug were discovered.

    Dr. Fareed said he was conducting his own investigation because he was concerned that the quality problems with heparin were far more widespread than acknowledged.

    “Of seven or eight batches I have, six are contaminated,” said Dr. Fareed. “And these were used by doctors at Loyola University Medical Center.”

    One American chemist, who asked not to be identified because he had signed a confidentiality agreement, said he and the F.D.A. had looked at chondroitin sulfate, a substance derived from animal cartilage, as a possible contaminant because of its structural similarities with heparin. “It is something that is a little bit different,” said the chemist, “like a distant family relative you don’t recognize.”

    He added, “Once we have the exact fingerprint, we will try to figure out how it got into the product.” ...

    The F.D.A. has said it has the world’s top heparin chemists working on the contaminant at two F.D.A. laboratories, three American universities and several European academic institutions. There are more than a dozen scientists working to identify the contaminant, or contaminants, an F.D.A. spokeswoman said....

    Baxter has recalled virtually all of its heparin products in the United States and since that recall there have been no new deaths, the F.D.A. said last week....

    Dr. Fareed said it was too early to say whether the contaminant is causing the adverse reactions. A variety of reactions have been observed, including abdominal pain, hypotension, burning sensation, vomiting, diarrhea, rising temperature and anaphylaxis, he said, “but one cannot link all of these to one substance.”






    Monday, March 10, 2008
    The Heparin Recall
    Posted by: Hugh Hewitt at 7:18 PM
    Per my pledge on air, here is the FDA notice.

    Here is the most recent Baxter press release.

    UPDATE: Another e-mail:

    Hugh,
     
    Interesting listening to people call in and wondering how much China is involved with US medications.  I know someone very well working in the generic over the counter medication industry. 
     
    The US imports massive amounts of ingredients which go into MOST over the counter medications.  Over the counter for just about everything you would get at Wal-Mart, Costco, Walgreens etc.  All for colds, flu, allergies, and on and on.  The all have ingredients all mixed in China.   US companies can not make over the counter medications in the country today without China. 
     
    We as a nation we would be shocked as to what is in our medications which are made in China.   Again, not made in china, but imported ingredients all from China. 
     
    John
    Venice, CA

    Given the furious reaction among callers/e-mailers to the idea that medicines --not toys or dog food,, but medicine-- is outsourced to China, watch this story very carefully.  The plaintiffs' bar may finally be about to tackle a problem that really does need fixing --imposing quality control on off-shore pharma manufacturing.

    I have to think every American pharma company is ordering snap inspections of all its off-shore manufacturing in the aftermath of this story.





    Friday, October 19, 2007
    An Audacious Goal
    Posted by: Bill Gates at 1:27 PM
    This week in Seattle, an extraordinary group of people ˆ scientists, policymakers, and advocates ˆ came together for three days to discuss what can be done to stop malaria. Melinda and I issued a challenge to those attending the meeting. We asked them to begin charting a course to eradicate malaria ˆ not just to control or reduce it, but to work toward a time when no one on earth is infected with malaria, and no mosquitoes carry the disease.

    Today, malaria kills more than one million people every year, most of them children in Africa. That‚s the equivalent of losing every student in the New York City public school system in one year.

    We know that eradicating malaria is an audacious goal. But advances in science and medicine, new political commitments, and the dedication of people like you have given the world an historic opportunity to conquer malaria. It won‚t be easy and it won‚t happen quickly, but I‚m optimistic that we can make this disease history.

    At the forum in Seattle, Melinda and I called on the U.S. presidential candidates to commit to expand the President‚s Malaria Initiative, a great program started by President Bush. I hope you will join us in asking all of the candidates to make this pledge and keep the fight against malaria on the national agenda.

    I am confident that together, we can produce the energy, compassion, and commitment needed to win the fight against malaria.

    -Bill Gates

    *** To view a webcast of the Seattle malaria forum, visit www.kaisernetwork.org/healthcast/malariaforum2007. For more information about how you can help fight malaria, visit ONE.org.





    Tuesday, October 16, 2007
    S-CHIP poster family with Olbermann
    Posted by: Jonathan Garthwaite at 7:57 AM
    The S-CHIP poster-family that was exposed as a private-school-attending-three-car-owning-better-than-middle class family was on Olbermann's show to defend themselves.  (video)




    Friday, September 21, 2007
    Fred On HillaryCare
    Posted by: Patrick Ruffini at 10:28 AM
    Fred has exactly the right response to HillaryCare. Mark this for the general election.






    Tuesday, September 04, 2007
    Edwards: Doctor Visits Mandatory Under His Health Care Plan
    Posted by: Matt Lewis at 9:41 AM

    (Socialism on the march...)


    If John Edwards is elected President of the U.S., he will mandate that you and I go to the doctor.  From the AP:

    TIPTON, Iowa — Democratic presidential hopeful John Edwards said on Sunday that his universal health care proposal would require that Americans go to the doctor for preventive care.

    "It requires that everybody be covered. It requires that everybody get preventive care," he told a crowd sitting in lawn chairs in front of the Cedar County Courthouse. "If you are going to be in the system, you can't choose not to go to the doctor for 20 years. You have to go in and be checked and make sure that you are OK."

    He noted, for example, that women would be required to have regular mammograms in an effort to find and treat "the first trace of problem." Edwards and his wife, Elizabeth, announced earlier this year that her breast cancer had returned and spread.


    Of course, I would encourage folks to go to the doctor.  But the operative word here is require.  This is truly, truly distubring to anyone who loves freedom.  Talk about a nanny state!



    Tags: Edwards



    Tuesday, August 28, 2007
    Illegals Skew Healthcare Stats
    Posted by: Matt Lewis at 4:33 PM

    The  LA Times has once again proven the old adage about lies, damn lies, and statistics.  In a story today, they open with this:

    The number of Americans without health insurance rose last year from 44.8 million, or 15.3% of the population, to 47 million, or 15.8%, the Census Bureau reported today.
    ... But there’s only one problem.  Upon closer inspecting the Census report, what the LA Times call “Americans” the U.S. Census (page 29) refers to (more accurately) as “People.” 

    You see, when you subtract the 10 million, or so, folks referred to in the U.S. Census as, “Not a Citizen,” you are left with just 37 million – not 47 million as The Times suggests.)

    What is more, of the 37 million actual U.S. citizens without healthcare, 17.7 million earn more than $50,000 a year -- and could certainly afford insurance if they wanted it.

    But the LA Times story was really about how the number of Americans without health insurance has increased this year.  Looking again at the U.S. Census (again, page 29), you it is clear that almost 40 percent of the increase is due to non-citizens. 





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