The FDA Is On The Side of the Microbes

Posted by on August 11, 2010 12 comments

This should be the golden era of antimicrobial medicine. Molecular biology has over the last two decades created new diagnostic tools like real-time PCR which can isolate and amplify minute quantities of bacterial DNA to identify individual species. Today’s researchers can design antimicrobial drugs that specifically target proteins, RNA, and DNA of individual pathogens.

Existing antibiotics obtained from fungi and plants often interfere with human biology, creating side effects that limit doses. Tomorrow’s antibiotics should defeat pathogens with minimal side effects, by acting only against molecules specific to bacteria, fungi, viruses, and protozoa.

This blog believes that nearly all diseases have an infectious origin. Infections outrun the immune system due to dietary and nutritional inadequacies. Diet, nutrition, and new antimicrobials should enable nearly all diseases to be defeated.

We are on the cusp of enabling nearly everyone to live to age 100 in good health. All we need is a renewed focus on antimicrobial research, and better diets.

Yet nothing is happening.

Via frequent commenter erp comes an excellent story that explains why (Trine Tsouderos, “Arsenal of antibiotics not being restocked: Dispute over rules for approving new drugs stalls production even as concern rises over deadly resistant bacteria,” Chicago Tribune, August 6, 2010):

Drug companies are abandoning the antibacterial business, citing high development costs, low return on investment and, increasingly, a nearly decade-long stalemate with the Food and Drug Administration over how to bring new antibiotics to market.

Soon, doctors fear, we could be defenseless against bacteria that can resist all existing antibiotics, which would mean more victims like Simon, dead from a staph infection that drugs used to conquer easily.

Dr. Brad Spellberg, an expert on antibiotic resistance, called the situation “catastrophic.”

At the core of the problem is a regulatory impasse over whether drug companies seeking FDA approval for antibiotics should be required to run much more stringent clinical trials.

The FDA says yes, citing advances in the science of clinical trial design and a series of humiliations involving trials for drugs the agency had approved, including the antibiotic Ketek….

But the pharmaceutical industry and some infectious-disease doctors say the proposed rules will make it so difficult and expensive to gain approval for new antibiotics that the few remaining companies will abandon the field altogether….

At times the debate has been so heated that the acting chairman of an FDA committee opened a 2009 meeting by warning that he didn’t want to read the next day about police “having to arrest scientists for breaking shop windows and turning over cars.”…

For years, new antibiotics often were approved based on clinical trials that didn’t have to show the new drug was better than an old one. Instead it had to fall within an acceptable margin of efficacy, which meant it could test somewhat worse and still be considered a success.

Just how much worse is OK with the FDA lies at the heart of the debate. The FDA wants the margins for these “non-inferiority trials” to be scientifically justified, and that may result in margins much tighter than before.

Whatever legal considerations may lie behind the FDA’s position, from a medical point of view its planned rules are ridiculous. To be clinically valuable, new antibiotics don’t need to be better than existing ones, just different.  Against most diseases, combinations of antibiotics are the best therapy.  Striking at a bacterium by several independent mechanisms is highly effective at impairing its activity and helping the immune system defeat it.

The fact that bacteria evolve resistance makes the need for a steady stream of new antibiotics even more critical.

Adding to the problem is that it is not feasible to organize clinical trials large enough to evaluate efficacy:

But showing one antibiotic is superior to another is hard because many antibiotics work so well, Spellberg said….

Placebo trials, in which the drug is tested against a look-alike but useless pill or injection, are also unrealistic, according to some experts. It’s nearly impossible to persuade patients with a painful sinus infection to enroll in a study with a 50 percent chance of getting a sugar pill and not a drug, they said….

Some are suggesting that for community-acquired pneumonia, antibiotics trials might require as many as 10,000 patients at a cost of about $50,000 a patient, or $500 million.

The solution is simple. Antimicrobials should be evaluated for safety only. Doctors can work out efficacy quickly through clinical experience.

Dr. David Shlaes, who worked in pharmaceutical antibiotic development for decades and is now a consultant to the industry, said it is absurd to be, in effect, questioning if antibiotics work.

“This is like asking how do I know parachutes work?… Those of us in infectious disease, we are all scratching our heads wondering: What the hell they are talking about?” said Shlaes, whose book, “Antibiotics: The Perfect Storm,” will be published this fall. “It is like proving gravity all over again.”

Soon after reading this story I learned that our next door neighbor, a 62-year-old man in seemingly fine health, died over the weekend from an MRSA infection he contracted while in the hospital for a surgical procedure. The antibiotics that might have saved him were never developed, due to clinical trial requirements that are about to become even more onerous.

“Nobody can run those trials,” said Shlaes. “[FDA administrators] live in a different world. Their world is numbers and logic. It is not patients and life.”

Dr. Shlaes is exactly right. The bureaucrats are not concerned about patients and life. They are concerned about drugs embarrassing them, as Vioxx did.

Without effective antibiotics, the whole medical system falls apart, experts say.

Yes. But when it does, how many will realize that the FDA, and the politicians who wrote their governing legislation, are to blame?

Love’s Labors Lost

Posted by on August 10, 2010 14 comments

One of my favorite writers is Elizabeth Scalia, “The Anchoress,” now a blogger for First Things. She has long suffered from a condition diagnosed as lupus, an autoimmune disease, but now after many years has been discovered to have Lyme disease. Lyme is a treatable infectious condition. Elizabeth writes:

A too-long-undiagnosed bout with Lyme Disease has left me challenged with arthritis and some neurological damage. The arthritis has its uses: I can predict rain, and the pain gives me something to offer up in prayer, or as penance.

Not so the neurological issues. At the peak of my illness I was unable to figure out how to do the dishes; my organizational skills have never fully recovered, and verbally I sometimes wander into strange lands, referring to cereal as cookies, or to hats as helmets.

Regular readers of this blog will know that I am not surprised that an “autoimmune” disease has turned out to be an infectious disease. Autoimmunity (where it genuinely exists – chronic infections are often misdiagnosed as autoimmune conditions even where no autoimmunity is present) seems to be mainly a side effect of chronic infections – collateral damage in a guerilla war with pathogens that conceal themselves behind human “cellular shields.”

Antibodies against the thyroid and gut engendered by gluten disappear within six months after cessation of wheat eating. [1, 2] I suspect that most autoantibodies engendered by pathogens will disappear on similar time scales once the underlying infection is cured.

I have previously written of my conviction that Alzheimer’s is an infectious disease. This conviction that grew out of my own experience: I had a 17-year chronic illness characterized by increasingly severe and embarrassing memory loss. At its worst I could not remember a friend with whom I had shared a small office for a year, and could not write (because I could not remember the previous paragraph when starting a new one, nor recall illustrative examples). The whole illness was cured by diet and antibiotics, and my memory is back to normal. I suspect that nearly all cases of Alzheimer’s can be cured by the same methods (the most important of which can be found here).

Elizabeth writes of the effect these diseases can have on a marriage:

CBS News correspondent Barry Petersen recently filed a report on the early-onset Alzheimer’s that began affecting his wife, Jan Chorlton, at the age of forty. It is an undeniably moving story; after introducing the viewer to images of the beautiful and lively Chorlton, the report shows us Petersen’s sixty-year old, still-beautiful wife, now living in what appears to be a top-notch assisted-living facility. She is unable to sustain simple conversation or to recognize her husband. Chorlton talks of a man she will always love, while Petersen openly weeps. When he asks his wife if she can name that man, she giggles, “Mr. Happy.”

Medical experts are introduced and they declare that there is no treatment for Alzheimer’s Disease, and no way to prevent it. In the near-future, we are told, sixteen million Americans will be diagnosed with Alzheimer’s Disease.

Petersen reveals that he is now in a relationship with a widow; they live together, and they both love Jan in what one of them calls “this very peculiar new American family.” The piece closes challenging anyone to gainsay them, who has not walked in their shoes.

But, was it not precisely for such situations that marriage vows were designed? “For better, for worse, for richer, for poorer, in sickness and in health, together or apart.” Love, which is limitless, is supposed to be strong enough – even if we do not think we are – to survive these challenges.

One of the saddest aspects of chronic illness is the damage it can do to marriages. A perusal of chronic disease message boards, like the one I followed at cpnhelp.org, can easily turn up tales of disease sufferers abandoned by their spouses.

It terrifies me to consider where I would be had I not had the persistent support of a loving wife. It is hard to believe I could have recovered without her.

Our motive for writing The Perfect Health Diet is to help people regain and maintain good health – to create healthy centenarians. But perhaps one side effect will be to save a few marriages – to encourage “Mr Happy” to be “Mr Persistent-In-Love.”

Caring for a chronically ill spouse is a labor of love. The laborer deserves his wage, and love deserves its reward. If there is one bit of advice that is more important than any other, in marriage and in disease, it is this: Don’t give up! Don’t ever give up!

References

[1] Berti I et al. Usefulness of screening program for celiac disease in autoimmune thyroiditis. Dig Dis Sci. 2000 Feb;45(2):403-6. http://pmid.us/10711459.

[2] Mainardi E et al. Thyroid-related autoantibodies and celiac disease: a role for a gluten-free diet? J Clin Gastroenterol. 2002 Sep;35(3):245-8. http://pmid.us/12192201.

On Vacation

Posted by on August 4, 2010 4 comments

The Perfect Health Diet blog is vacationing in Acadia National Park, and will return Tuesday August 10.

Thanks But No Thanks

Posted by on August 4, 2010 2 comments

“Humanity Needs to Start Farming Bugs for Food, Says United Nations Policy Paper”:

The raising of livestock consumes two-thirds of the planet’s farmland, and is a major source of greenhouse gases. Meanwhile, tons of edible, sustainable protein swarms all around us, free for the taking. In a new policy paper being considered by the UN’s Food and Agriculture Organization (FAO), Belgian entomologist Arnold van Huis makes the sensible recommendation that the western world eat more insects.

Farming edible insects like mealworms and crickets would produce far less greenhouse gas — 10 times less methane and 100 times less nitrous oxide — than the large mammals we currently farm. Insects are metabolically much more efficient, which makes them far cheaper to feed and raise; and, since they’re so biologically different from humans, they are less subject to contagious disease scares like mad cow. They are high in protein and calcium, and, with over 1,000 edible species, offer plenty of delicious variety.

Protein is 15% of energy in a healthy diet. What about the other 85%?

True, a few mealworms might make an apple more nutritious. But modern diets are deficient in saturated and monounsaturated fat, not protein.

Is inexpensive protein so dear, or an unchanged climate so sweet, as to be purchased at the price of fatty foods and health? I know not what insects the UN may eat. But as for me, give me steak, or give me fasting!