Tainted Steroid Injections And Public Health
http://thedianerehmshow.org/shows/2012-10-10/tainted-steroid-injections-and-public-health
12 people have died and 121 in 10 states are sick with a rare form of fungal meningitis. The outbreak has been linked to tainted steroid injections used to treat back and neck pain. In all about 13,000 people in 23 states may have been exposed, and for many it’s now a waiting game to see if symptoms develop. An investigation is underway into how and why these contaminated medications were produced and distributed. Please join us to discuss drug manufacturing and public health
Guests
Denise Grady
reporter, New York Times
David Miller
executive vice president, International Academy of Compounding Pharmacists
Dr. Michael Carome
deputy director, health research group Public Citizen
Dr. John Dombrowski
medical director, Washington Pain Center
Jeffrey Gibbs
attorney in private practice, Hyman, Phelps and McNamara
Comments
Please familiarize yourself with our Code of Conduct and Terms of Use before posting your comments.
With the desire of so many to deregulate just about everything, this is a foretaste of what can happen when regulation is, shall we say, slack.
Just another example of not learning the lessons of the past.
Yes! In an atmosphere of government deregulation, how can we ask the government to do more? We need more investigators for health, medicine, drugs, borders, bridges, professionals, oil wells, coal mines, etc. etc. Pretty hard to hold the government responsible when there are hiring freezes and again, a desire to make government smaller.
With my health insurance I am strongly encouraged to use a out of state pharmacy for regular medications. I refuse to do this. I have written the FDA and the State of Florida due to my concerns with the medication being mailed and there is no temperature control. None have contacted me back. The medications are sent by the postal services or UPS. In Florida temperatures in a mail box and mail truck can exceed 100 degrees. How come these pharmacies do not have to control the recommended temperature ranges as recommended by the drug companies. Could this be how the drug got the virus in it??
As an ER physician I have seen several of the people who have recieved a shot of the possibly tained steroids. Understand that most people who have been exposed are NOT going to get sick, but they must be tested, say the experts, even if they have no symtpoms. But one aspect that makes the situation even more unfortunate is that the test that must be done to diagnose the patient -- a spinal tap -- will often, itself, often cause a headache days afterwards. (A so-called post-spinal heacache). Thus, this poor person, first worried that they are going to get a fungal infection of their brain, gets a negative test: hurrah. But days later is feeling worse due to the trest itself! And, further, for some reason, many anesthesiologists who under "normal" conditions would do a treatment to help intracable post-spinal headaches (called a "blood patch") are (in my area) refusing to do tis procedure on these patients. They say its dangerous in this particular setting.
My sports medicine physician decided to use topical pain meds/muscle relaxants in a cream format, rather than as oral medications. Only a compounding pharmacy can make this product! Mzy daughter also needed meds that were made by a compounding pharmacy.
I do think that these "pharmacies" should be regulated at a federal level and I'm shocked that no one did a physical inspection of the vials prior to use on a patient.
Can we expect more of these types of events in the case of a Romney presidency? At various points in the current campaigns, both Romney and Ryan have championed reducing or eliminating funding for public health and safety agencies and for reducing federal regulations. This is a very serious issue that I would like to hear the candidates address honestly.
Diane this all could be avoided if compounding pharmacies would adhere to USP 797 guidelines, these are followed by all hospitals regulated by JCAHO,
I heard, the other day, that this pharmacy should have been producing this product on a per prescription basis. If that is so, how could they get away with creating such vast quantity of this medication for shipment to other states?
One of your guests just mentioned that the compounding pharmacy is regulated by interstate commerce and was or should be a federal responsibility. Isn't that the problem we've been trying to address since the Reagan days? You've got nanny government getting in the way of business and taking away the freedom of these physicians and patients to choose these unregulated compounds.
The public keeps demanding we reduce taxes, which means the government keeps cutting budgets of regulatory agencies like FDA. If we do not give agencies the resources they need to do their job, it is OUR fault when there are safety problems. The public has to pay for services we need!
Is there any way for a consumer to check on their compounding pharmacy to see if any disciplinary action has been taken against it?
I use a generic medication for epilepsy. The newer forms are slightly different and priced out of my range to purchase, as I have no insurance and live under the poverty line. Your show has raised concerns about whether this drug might be made in a compounding pharmacy.
I am a nurse anesthetist and with the recent drug shortages where I work we have been turning to compound pharmacies to fill shortages of common drugs. Drugs like fentanyl and versed, used for almost every surgery, have been on national shortage and our hospital has turned to smaller, local compounding pharmacies to fill our need. We are now getting propofol from Europe. Drug shortages have had a major impact on our usual supply systems for taking care of our patients.
Another reason for compounding pharmacies are: 1) they can adjust the strength of meds where as large manufacturers only give a few choices.
And, 2) if you have certain food allergies (i.e. corn, maybe others) they can create meds without these componets. When I started Progesterone it was with peanut oil. I went to a cream without any of my allergies.
You had a prominent representative of the compounders on the show, but no one from FDA. Why?
In the opinion of this board, if a drug is available from a commercial manufacturer, but a compounder can make a copy and sell it for less, should this be allowed?
@KCA: If these newer mess were available from a compounder that simply copied it and sold it for less, would use use them?
I would also love to know how a customer can check to see if their compounding pharmacy has had disciplinary action against them. Many women use compounding pharmacies for bio-identical hormones and it would be a slap in the face of women's rights if those pharmacies were legislated out of existence. The public should not be beholden to greedy pharmaceutical companies nor should compounding pharmacies be allowed to follow the foot steps of those companies.
It's of interest to note that this oversight by the Massachusetts DPH occurred under Deval Patrick's watch. Combined with the recent scandal in the State Crime Lab (which has jeopardized thousands of convictions and undermined the legitimacy of Criminal Justice processes and outcomes) and the upcoming trial of the ex-head of the Probation Department, even those who talk a good game about regulation, such as Patrick, have clearly failed, multiple times, to deliver. This goes to the gap between rhetoric and reality, in a state that is predisposed to apply lots of regulation.
There are a couple of very old sayings that I think are relevant:
"The best things in life are free."
"You get what you pay for."
You can believe whichever you wish. Which would you choose?
If you believe that safe drugs are free, you would of course choose the first old saying. But in the real world, they are not free.
Maybe the truth is that nothing in life is free??? That a price of some sort must be paid???
Compounding pharmacies are the only way to get bio-identical hormones, which are the only safe hormones for women to take. Remember, pharmacies all started out as compounding their own medications.
It is also the way cancer patients or others that can't swallow can get their medication. Large pharmaceutical companies are into mass production and not into meeting people's needs that are other than those of the masses.
This is not a problem with compounding pharmacies. It is a problem with not following up on a company that was not abiding by the regulations. Compounding pharmacies fill a vital need and should not be considered a lesser alternative. I pray we don't over react with this unfortunate incident. That would be throwing the baby out with the bathwater.
And what makes you think taking any medicine is without risk?
Gail
Wichita KS
Thanks for the mention of bio-identical hormones, which I am concerned is trying to be discredited by the pharmaceutical companies and their influence over the FDA. My life depends on being able to get them.
Gail
Your medication being a generic is made in HUGE doses by a pharmaceutical company. Compounding pharmacies delve with much smaller individual doses. This is a company that was obviously breaking the rules and not relevant to your meds if they are generic.
Gail
Gcrafish on October 10, 2012 @ 12:39 pm wrote: “I pray we don't over react with this unfortunate incident. That would be throwing the baby out with the bathwater. And what makes you think taking any medicine is without risk?”
I don’t hear anyone suggesting compounding pharmacies be put out of business, so don’t worry about the “baby”. The problem here is clearly a failure of proper government oversight, proving that enforcing regulations is as important as making them.
And yes, all of Medicine involves risk, whether taking drugs or just visiting your doctor. But risk can be managed (and reduced). We don’t allow just anyone to put “M.D.” after their names. They have to go through a lengthy and arduous education, then equally hard on-the-job training (internships and residencies). We require they prove their knowledge by passing licensing tests. All of this is to lower the risk that your “doctor” is just a quack, instead of someone who knows what they’re doing.
I see no reason to make every trip to the pharmacy a case of “Russian roulette”. We can’t entirely eliminate risk, but we can lower the odds in our favor.
PART ONE
Returning to the issue of mindless ideology.
Remember this event the next time you hear politicians, or pundits, scream that “healthcare” or “health insurance” isn’t “in the Constitution” as an argument against national laws regulating either. Whatever your views on “Obamacare” there are good and bad arguments to be made both for and against it, but this particular argument is ridiculous, both as a matter of constitutional law and public policy.
The Constitution gives Congress the power to regulate commerce “among the several States”. (Art. 1, Sec. 8, Paragraph 3.) There is absolutely no question but that the manufacture and sale of this drug in Massachusetts, for use in Texas and other States, falls within that general power. Thus Congress has the power to regulate it, just as it has the power to regulate both the health care and health insurance industries (which also operate “among the several States”). This case demonstrates a proper use of that power.
It also demonstrates the need for such power, and for its use. Devotees of the mindless form of Laissez-Faire Capitalism (for example: the fans of the lunatic Ayn Rand - such as Paul Ryan), love to pretend that the “pure, perfect, sacred, and holy” free market can solve all our problems, and that government only “gets in the way”. Tell that to the people suffering and dying from this tainted drug. Tell that to their grieving relatives and friends. This is an example of what happens when the government fails to “get in the way”!
TO BE CONTINUED
PART TWO
And no, this isn’t an argument for every government regulation. Some (like the Pure Food and Drug Act, etc.) are both wise and necessary. Others (like New York City’s attempt to regulate the size of soft drinks served at fast food outlets) are neither. (Simply informing people of the calorie content, etc., should be enough.) The trick is being able to distinguish one from the other. Mindless ideologues (whether of the left or right) can’t.
An enormously disappointing show. All through the show it was asserted that FDA has the authority to act, but refuses to do so. NOWHERE was it mentioned that the IACP has fought the FDA tooth and nail - in fact, all the way to the US Supreme Court - to keep the FDA out of their businesses.
"Missy wrote:
With my health insurance I am strongly encouraged to use a out of state pharmacy for regular medications. I refuse to do this. I have written the FDA and the State of Florida due to my concerns with the medication being mailed and there is no temperature control. None have contacted me back. The medications are sent by the postal services or UPS. In Florida temperatures in a mail box and mail truck can exceed 100 degrees. How come these pharmacies do not have to control the recommended temperature ranges as recommended by the drug companies. Could this be how the drug got the virus in it??
October 10, 2012 - 10:37 am"
Mold blooms can arise from only one or two spores, but only if there is some medium to nourish them.
I wonder what was in the medication that allowed the mold to flourish.
Of course the obvious solution in today's system would be to put in a possibly harmful fungicide!!
I wonder if the success of the Republican Tort Reform Blitz and Deregulation has anything to do with the incredibly high-handed attitudes and arrogance of today's manufacturers.
They are not afraid of the Law, the Government, the People, the Media, the Courts, nothing!!
Monte Haun mchaun@hotmail.com
I often wonder how the we can forget the lessons from our past, such as The Jungle, and keep doing the same dance over and over...I can only pray that this unavoidable show of idiocy can not only force a quality control crackdown on "pharmaceutical medications" and also start attacking the "homeopathic", "natural" and "vitamin" industry which FDA is currently not required to evaluate for ANY form of safety before hitting store shelves for human consumptions .
For perspective:
12,000 die annually from unnecessary surgery
7,000 die annually from medication errors in hospitals
20,000 die annually from other errors in hospitals
80,000 die from infections in hospitals, and
106,000 die from non-error, negative side effects of drugs ea. year
1,742 individual drug recalls in 2009 (up from ~ 400/year)
Source: Journal of the American Medical Association.
The author was Dr. Barbara Starfield of the Johns Hopkins School of Hygiene and Public Health. Dr. Starfield's research documented how a staggering 225,000 Americans die from iatrogenic causes, i.e. their death is caused by a physician's, nurses, or pharmacists activity, manner, or therapy.
Lastly, this is a tragic, tragic, tragic outcome for the patients and families involved. We should remember that very, very, very few negative outcomes are a result of compounding. This (the NECC case) was NOT compounding but manufacturing.