Ruwart: FDA doesn’t need more bureaucrats
From the Mary Ruwart for President Committee:
The Food and Drug Administration’s proposal to hire 1,300 more employees is a cure worse than the disease, said Dr. Mary Ruwart, Libertarian candidate for president.
“As a research scientist for 19 years, I know government regulation is the primary reason healthcare costs are so high in the first place,” Dr. Ruwart said. “They add at least 80 percent to the costs of new, life-saving drugs.”
Dr. Ruwart worked for the Upjohn Company in Michigan from 1976 to 1995 developing new therapies for a variety of disease, including AIDS. She now lives in the Austin area and devotes her time to writing and providing consulting services to nutraceutical and pharmaceutical companies.
In announcing the hiring program, FDA Commissioner John Dyer direly warned, “Each month there is a delay in bringing critical staff on board impairs the agencies ability to fulfill its mission.”
“Just the opposite is true.” Dr. Ruwart contends. “As the FDA has grown larger, and its regulations more detailed, the cost and time needed to approve a new drug have increased dramatically. It now takes 15 years to get a new drug approved. It cost nearly $1 billion (capitalized) to bring the average new drug to market.”
“In the meantime, people die. Since 1962, almost 5 million people have died who could have been helped by a drug in development,” she asserted. “And that is just the tip of the iceberg.”
For example, the FDA’s tardy approval of propranolol, the first beta blocker for heart disease, needlessly killed an estimated 30,000 Americans during the three years it was available in Europe, but not the U.S.. “The FDA probably killed more people, by delaying this single drug, than it saved during its entire existence. Licensing laws are a cure worse than the disease.”
“If a loved one were dying, we’d never snatch lifesaving drugs from their grasp,” Dr. Ruwart said. “Yet we unwittingly do just that with FDA consumer protection regulations.”
On behalf of terminally ill cancer patients, the Abigail Alliance recently sued the FDA on the grounds that dying individuals have a Constitutional right to buy experimental medicines before FDA approval. When the courts ruled against the Abigail Alliance, the case was sent to the Supreme Court, which refused to hear it. Consequently, dying Americans have no Constitutional right to the medications that might save them. Bureaucrats in the FDA hold our lives in their hands.
Consequently, cancer and AIDS victims often turn to black market chemists, who do a brisk business selling new, but unapproved, drugs to dying patients.
Before the FDA became so pervasive, the American Medical Association and Consumers Research tested new drugs themselves and gave good ones their “Seal of Approval.”
“Certification by professional pharmaceutical organizations, or even the FDA itself, would be the more compassionate approach and won’t t make criminals of people fighting for their lives,” Dr. Ruwart proposed.
These organizations could certify drugs with ratings like “untested,” “safe in animal testing,” or “effective in humans.” “With the help of trusted medical professionals, consumers could make an informed choice that took into account their personal situation,” Dr. Ruwart explained.
Actually, the FDA does no drug testing at all, but simply mandates that drug companies do it, and even charges them for the approval process Dr. Ruwart said third-party testing by multiple certifying organizations would be much more objective. “Greedy corporations intent on defrauding consumers wouldn’t be able to falsify data, as they are sometimes accused of doing today,” she said. “Medications without any certification data at all would likely be shunned by both physicians and patients, effectively putting bogus companies out of business. Underwriters’ Laboratories perform the same function for electrical appliances and have an admirable safety record.”
“Draconian licensing and regulation schemes have increased the cost, reduced the availability, and damaged the quality of health care in America,” Dr. Ruwart concluded. “We’re literally protecting ourselves to death. It’s time to unleash the power of the market and usher in an era of access to quality—-and affordable—-health care for all.”
May 2nd, 2008 at 3:54 pm
Mary Ruwart is one hot GILF. Yowzaa!
May 2nd, 2008 at 5:00 pm
Jolly good press release Ms. Ruwart! Bravo—now that’s more like it. More like this and less like the other (which should, by the way, be removed from your web site ASAP). Good night.
May 2nd, 2008 at 6:52 pm
Time for a hard hitting question for Mary—
What’s your take on alternative medicine? For the scope of this question I am referring not to salvia or MMJ or other Schedule 1. I am instead referring to herbs, homeopathy, reiki, acupuncture, etc. A number of Party members are involved at some level with alternative medicine. I myself practice Reiki, which technically makes me an illegal medical device according to that little treatise on alternative medicine the FDA issued last year. (long story but true)
On the one hand, you favor deregulating the medical marketplace, which I tend to facor. One of the problems facing the alternatives industry is that protocols and remedies that are quite safe (Reiki is a great example since its energy cannot harm) are supposed to go through the trials, which obviously cannot happen. You can’t patent Artemisin the way you can, say, Adria (a chemo drug).
On the other hand, you are after all in the pharmaceutical industry….
What’s your take? What would be the role of alternatives in your view of a Libertarian world AND in the current system (if you were elected or became head of the FDA)
May 2nd, 2008 at 9:04 pm
Where does the FDA stand on Brazilian ass implants?
May 2nd, 2008 at 11:30 pm
What? No smear attempt?
May 3rd, 2008 at 1:39 am
If I could only abolish one federal department, it would be a hard choice, but I’d probably go with abolishing the FDA. After all, it kills so many absolutely innocent people.
May 3rd, 2008 at 2:29 am
Lidia, Dr. Ruwart is much beloved in the alternative medicine arena for her strong advocacy. She has made support for Ron Paul’s Health Freedom Protection Act part of her health care plank for the campaign. Her writings in the area are extensive and she has been featured in alternative medicine magazines. Her support in the alternative health care practitioner community was cited in support of her application to be FDA Commissioner. She has addressed in several places FDA censorship of health claims on alternative health care treatments. She has noted that the FDA interfering with the advertising of folic acid probably caused about 3 times as many birth defects as the infamous thalidomide incident. Here’s a good overall piece she wrote for ISIL: http://www.isil.org/resources/lit/death-regulation.html
She also did a study of the FDA called DEADLY SECRETS that provided straightforward evidence that the FDA killed 4, 700,000 people from 1962-1999 simply with the approval time delays on drugs that were eventually approved as lifesavers, while generously preventing, at most, around 70,000 deadly reactions. Those are pretty lousy odds.
Somebody quipped that the leading cause of death in this country is the FDA, and I am inclined not to think of it as a quip.
May 3rd, 2008 at 3:01 am
Excellent PR. She demonstrates her strength to the LP by making a quality PR, e.g. not a reaction to what this or that main party politician has said and not anything in the line as she is going to be interviewed by a Fox tv station only speaking about herself. (hint hint).
She needs more than these. Hopefully ther media will follow it up and schedule quality interviews with her, as they should.
May 3rd, 2008 at 4:36 am
Ah good. Perfect, actually.
It’s truly an insane world when a human being, because they’ve been attuned to Reiki energy, is considered a “medical device” by the FDA (and we are, honest) and because we haven’t gone through our “safety trials” we’re “unsafe”. Mind, we’re talking about an energy therapy that simply cannot harm. It’s benign. So the FDA war on Alternatives is a very personal thing indeed, especially since the Reiki attunement is permanent. There is no way I could “remove” the illegal aspect of myself in order to “come into compliance”.
Although, I am trying to picture the reaction of my kith-friend and Texian, who is even more rabidly against allopathic medicine than I am. Mary, you’ve got a bit of an uphill road to travel there. I do think there’s a lot of alternative folks out there who will have difficulty with your credentials when they learn you worked for U*J***. It’s not quite the cussword that M**** is, but it’s up there. I’d definitely consider working with Dr. Paul to win over Mercola—do that, and your road will be smoother.
May 3rd, 2008 at 12:55 pm
I could use some healing ass.
May 3rd, 2008 at 1:23 pm
Yank, this ain’t “Sexual Healing” this is a political forum. Your trolling has become tiresome.
Slight follow-up question to last night
Are there any alternative medicines that Ruwart would not trust? Or is she completely willing to let the market decide on all modalities? Second, are there any allopathic protocols (vaccines come immediately to mind) that Ruwart would still consider mandatory?Third, does she support food choice as well (permittting sale of raw dairy, etc)? I know RP won over a lot in the crunchy community for his legislation concerning raw milk (to fill people in here, there are some people who say that pasteurization of milk causes a lot of trouble and that milk fever (brucellosis) is preventable. On the latter point I absolutely agree… technology has advanced and you can now get snap tests for all the pathogens cows can carry. A farmer can, with regular testing, ensure his cows are healthy and have the lab results to back him up.. This technology did not exist when pasteurization became required. It may have been realistic then but it isn’t now)
May 3rd, 2008 at 2:37 pm
On this I certainly don’t necessarily speak for Ms. Ruwart, but as we are both members of the Life Extension Foundation, where the emphasis is on alternative and mainstream health measures, I believe that good research which isn’t tainted by the FDA bureaucracy, is a step is a major step in the right direction.
I highly doubt that she would recommend untried and potentially dangerous therapies, but certainly she understands that these choices are best left to individuals, especially those who run out of options if they are in a likely terminal state.
May 3rd, 2008 at 2:37 pm
On this I certainly don’t necessarily speak for Ms. Ruwart, but as we are both members of the Life Extension Foundation, where the emphasis is on alternative and mainstream health measures, I believe that good research which isn’t tainted by the FDA bureaucracy, is a major step in the right direction.
I highly doubt that she would recommend untried and potentially dangerous therapies, but certainly she understands that these choices are best left to individuals, especially those who run out of options if they are in a likely terminal state.
May 3rd, 2008 at 6:07 pm
WOW —MORE brilliant policy analysis from the genius Mary Ruwart. Maybe what she really means is, if we all just BELIEVE that our food is good, it will BECOME so. Or if we all just self-medicate our inner healer will find the right medical combination. Just like every other radical: long-winded on principle and absolutely no feasible recommendations for how to pick things. i’m really impressed that this woman is so popular in the party.
May 3rd, 2008 at 6:50 pm
John Stossel had a great anecdote about the FDA in his book “Give Me A Break” (which is a good read, by the way, especially for those new to the freedom movement).
He described a press conference at which an FDA official announced that the agency had approved a new drug that would save 14,000 lives that year. Stossel noted that the drug had been in the agency’s pipeline for a long time, and pointed out the relevant question that none of the assembled reporters bothered to ask the FDA spokesperson, because, he said, they weren’t used to thinking that way:
If this drug will save 14,000 lives this year, then didn’t you kill 14,000 people last year by not approving it a year ago?
Mary Ruwart is right, and it is definitely past time to abolish the FDA. “Democratic Republican,” I’m sure your intentions are good, but it is elitist and condescending to ordinary people to insist that the federal government should treat adults like children and tell them what they can and can’t put into their own bodies.
May 3rd, 2008 at 8:39 pm
Starchild: I never said the FDA is good or even functional. Sure, let people do whatever they want (if they are consenting adults). I’m just saying Mary doesn’t really have a coherently thought out plan about how a privately-oriented scheme would work.
May 3rd, 2008 at 10:48 pm
To borrow and rephrase a “Democratic Republican” phrase,
You are a libertarian lightweight, and are “long-winded” on policy prescriptions and “short-winded” on fundamentals.
“Mary doesn’t really have a coherently thought out plan about how a privately-oriented scheme would work.”
Anybody who thinks they KNOW how the market will play out is delusional, other than that the market process will honor the choices that people want to make much better.
May 4th, 2008 at 12:59 pm
This sort of talk is rubbish. Look at all the poisoned and tainted seafood pouring into the US from China. You want to feed that to your kids or yourself? With out many many more FDA inspectors we are foing to see more and more people killed from poison and tainted products from under-regulated China. How is each individual supposed to “take repsonsibility” (a favorite libertarian capitalist rubric) for testing the safety of all the food being imported? Let people die off and the markets will sort it out?! LOL. Wacky.
May 4th, 2008 at 7:42 pm
To those who support the existence of the FDA, I encourage you to read “How the FDA Killed My Dad” by Jim Babka.
FDA regulation is so insane, it wouldn’t even approve aspirin today, if aspirin weren’t already available. The FDA also engages in censorship.
The ISIL has put out this brocure on how destructive the FDA is, and this brocure on how government involvement in healthcare has caused costs to skyrocket.
On pages 82 through 91 of his new book The Revolution: A Manifesto, Dr. Ron Paul also gives a focus on our dire need to deregulate healthcare in America.
Finally, I encourage you to watch this ABC news special by John Stossel.
Those who wish to keep around—or even increase—the deadly government regulations in our healthcare system are, simply put, extremists. The FDA is certainly a despicable enemy to those who care about people’s health and well-being.
May 4th, 2008 at 7:43 pm
Respectfully yours,
Alex Peak
May 24th, 2008 at 8:44 am
Libertarian is the only party that makes sense. It’s not about natural versus pharmaceutical. It’s about freedom. If the playing field is level, if all the information is available, then the people can decide.