U.S. panel wants to scrutinize FDA safety actions

I read the below article and can't decide which amongthe following are more accurate.

* The FDA is trying to get the word out that they don't have enough clout to stop big drug companies from forcing approvals for their products.
* The reviews and recommendations are part of a normal, ongoing process but makes for good copy.
* Some reviewers of FDA processes are skeptical that any recommendations are ever taken seriously by the FDA which is failing to protect the consumer.
* Manufacturers of recently FDA-recalled drugs are attempting to pass blame onto the FDA for allowing their own unsafe drugs on the market in the first place.

But, that's why this is a great article, we can support any of these as the overriding conclusion.

dras

REUTERS 5/19/05 U.S. panel wants to scrutinize FDA safety actions By Lisa Richwine Members of a U.S. advisory panel told the Food andDrug Administration on Thursday they want to review how the agency handled drug recalls and serious safetyissues. The panel voted unanimously in favor of having the agency provide it with details on its actions leading up to drug withdrawal so that the advisers could help identify areas for improvement.

"I think it would be really helpful to have a transparent look back at where we think things could have been better," said panel member Arthur Levin, director of the Center for Medical Consumers. "It's always good to learn from mistakes. The FDA's drug-safety monitoring has come under scrutiny following the recent emergence of serious side effects of some medicines and the recalls of Merck & Co. Inc.'s Vioxx and Pfizer Inc.'s Bextra painkillers. The FDA will consider the panel's suggestion, saidAnne Trontell, deputy director of the agency's Office of Drug Safety. But she stressed that officials already were actively looking at ways to improve safety surveillance."It's already an area of active interest," she said. For example, the FDA has asked the Institute of Medicine to review its post-approval reviews of drug safety, she said. The agency also set up a board to evaluate emerging safety issues.The focus of the panel that met Thursday is to advisethe FDA on drug safety and management of risks from medicines. The panel is one of several committees of outside experts that provide non-binding recommendations to the FDA. Some panel members suggested the FDA needed more power to compel drug companies to complete studies after approval so regulators can learn about potential problems sooner. Now, the agency can only request the studies in most cases.Dr. Curt Furberg, a panelist and an epidemiologist at Wake Forest University, said was unsure if the FDAwould take the panel's advice."The feeling is our advice will go into a black boxand we don't know what will happen next. We should find a mechanism so that we can be involved in next step," he said.Vioxx was pulled from the market in September 2004 after a study linked the drug to elevated risks of heart attacks and strokes when taken for at least 18 months. Some critics said the FDA should have taken earlier signals of a problem more seriously. The FDA asked Pfizer to withdraw Bextra last month, saying the drug was too risky because it can cause rare but serious skin reactions and also has potential heart risk.

hypochlorhydria only exists in alt med

"hypochlorhydria," a term used almost exclusively by alt-med and the supplement industry, is also implicated in osteoporosis and other deficiencies due to alleged subsequent poor absorption. I've even seen blood tests for "intracellular mineral deficiency" advocated to diagnose it.

However, I think you'll find scientific evidence only associated with GI conditions. I found one interesting exception: Eastell R, Vieira NE, Yergey AL, Wahner HW,Silverstein MN, Kumar R, Riggs BL. Pernicious anaemia as a risk factor for osteoporosis. Clin Sci (Lond).1992 Jun;82(6):681-5. PMID: 1320549

"...gastric acid is not required for the absorption of dietary calcium. Thus, the loss of cancellous bone must be caused by some mechanism yet to be identified."

Lactation Nazis

http://www.timesonline.co.uk/article/0,,8123-1599898,00.html

About a decade ago when my son was born, it seemed every area hospital had a staff nurse lactation specialist. We knew them as lactation nazis. They heaped on fear and guilt to new mothers who did not intend to breast feed, and advocated pumping when personal contact was not possible.

My wife was valiant. Despite several calls and visits to the lactation specialist and hour-long feedings, it was only after a ruptured breast abscess did she succumb to formula and a bottle. My own mother reared 7 children in the 60's and 70's. None were breast-fed. According to the lactation na--er--specialist, I might blame any pychosocial problems I could have on this fact.

Perhaps formula companies back then had convinced us breast feeding was not in vogue.

myofascial pain syndrome: the next fibromyalgia

Here be it known that "myofascial pain syndrome" may very well be replacing chronic fatigue syndrome as the in-vogue malady of idiopathic distress/pain sufferers.

- It is a (arguably) mostly subjective diagnosis
- One can subjectively use palpation in the diagnosis.
- One can use EMG, surface EMG, thermography, electrical stimulation, manipulation, and a host ofother popular things to infer diagnosis or treatmentof MPS.
- It's popularly said to be amenable to all kinds of manipulation.
- MPS has been an accepted and treated malady foryears.
- And there are eligible Medicare/Insurance billing codes for injections into body tissue for (MPS) pain that will likely elude any suspicion of illegitimate practice.

Thanks to increased use of an already well-established diagnosis, a whole host of chiropractic manipulations, massage and cranial-sacral therapy, physical therapy, and the use of loads of electrical gadgets can be rationalized. MPS injection therapy could be getting acupuncture and prolotherapy legitimized into mainstream medicine all at once, thanks to a series of billing codes for injections that all third-party-payors will accept and pay for, sometimes on a weekly basis, likely without scrutiny.

The only antagonists to the trend could be neurologists, physiatrists, office-practice anesthesiologists, and a few orthopods who have typically held exclusive (mainstream medicine) rights to trigger point/ligament/tendon injections andtreatment of MPS.

It also should not take payors too long to start trying to bump the MPS treatment trends, but with an established diagnosis and accepted treatment paths for abusive clinicians to hide behind, they will be limited in what they can do.

Beyond my own opioning and soap-boxing, I doubt any PT will be overly critical of the PT services for it. For your own social perspective related to the above, try googling "myofascial pain syndrome" and follow that up with "trigger point injection," "prolotherapy," "CPT 20550," "CPT 20552," and maybe a few other unique terms, or follow a few links discovered in the process.

-dras

Check out this Yahoo Finance article on the 25 top jobs for 2005 at http://biz.yahoo.com/special/bestjobs05.html
......

Let's not forget that this report is NOT based on the potential for success of any person entering one of these fields. The fact that these occupations are great for "job growth, salary potential, education level, and room for innovation" says nothing about the market for these jobs.

Of Chiropractic, the report says: "Health insurance companies are also beginning to recognize the benefits, which bodes well for the practice's respect and reputation."

I don't think there is any support for that statement. I propose that insurance companies are caving into popular demand for coverage and have learned ways to structure, manage, and market a chiropractic benefit that allows them to do so.

-dras

Amazing acupuncture study

A few of comments about the acupuncture study below:

First, Cochran reviews published no less than 5 acupuncture or acupuncture related reviews two weeks ago. Since none of these have hit lay press we can suspect what the conclusions were. (Boringly inconclusive.) This study used PET "brain scans" to measure outcomes. Not much is known about imaging pain on PET scans. Newer imaging agents and ways to use PET (and MRI) are revolutionizing imaging in healthcare. That older first-generation MRI and PET machines are now working their way into tertiary clinics and practices helps to revolutionize imaging use as well - but that's another HF topic. Despite new cool ways to image brain physiology (maybe a primary point for doing the study), not enough has been observed to make the article's inferred associations about acupuncture's impact on the perception of pain in the brain. A PET scan can probably demonstrate that the "area of the brain associated with the production of natural opiates" were activated with trick, as well as real needle placement. And this is the most practical conclusion of the study in terms of better understanding of conjectured efficacy of acupuncture. That "another region of the brain, the insular, was excited" only by real treatment could really mean anything. But because this was observed during an acupuncture study, it's easy to speculate an affirmative association.

I have an idea, let's see if Tylenol stimulates the insular region. How about a loud noise, a nagging anxiety, or the violation of personal space by a stranger? What happens to this area on imaging when different kinds of pain are present, or administered? If we can determine this area can be associated with pain relief, how can we affect it consciously or therapeutically? How about after these questions are answered, we go back and review it in the context of acupuncture?


dras

Story from BBC NEWS:>http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/4493011.stm>
Acupuncture 'more than a placebo'> Scientists say they have proof that acupuncture> works in its own right.> > Sceptics have said that any benefits gained from> acupuncture are merely> down to a person's expectation that the treatment> will work.> > But researchers at University College London and> Southampton University> say they have separated out this placebo effect.> > Their findings, based on a series of experiments and> brain scan results,> are published in the journal NeuroImage.> > Dummy treatment> > The researchers used positron emission tomography> (PET) scans to see> what was happening in the brains of people having> acupuncture treatment> for arthritis pain.> > The great bulk of trials to date do not provide> convincing evidence of> pain relief over placebo [dummy pill]> Professor Henry McQuay, University of Oxford> > Each of the 14 volunteers underwent each of three> interventions in a> random order.> > In one intervention, patients were touched with> blunt needles but were> aware that the needle would not pierce the skin and> that it did not have> any therapeutic value.> > Another intervention involved treatment with> specially developed "trick"> needles that give the impression that the skin was> being penetrated even> though the needles never actually pierced the skin.> > The needles worked like stage daggers, with the tip> disappearing into> the body of the needle when pressure is applied.> This was designed to> make the patients believed that the treatment was> real.> > The third intervention was real acupuncture.> > Brain activity> > When the researchers analysed the patients' PET scan> results they found> marked differences between the three interventions.> > Only the brain areas associated with the sensation> of touch were> activated when the volunteers were touched with the> blunt needles.> > During the trick needle treatment, an area of the> brain associated with> the production of natural opiates - substances that> act in a> non-specific way to relieve pain - were activated.> > This same area was activated with the real> acupuncture but, in addition,> another region of the brain, the insular, was> excited by the treatment.> > This was a pathway known to be associated with> acupuncture treatment and> thought to be involved in pain modulation.> > Sarah Williams of the British Acupuncture Council> said: "This is very> positive news for acupuncture and this latest> research is an exciting> illustration of what acupuncturists have known for a> long time - that> acupuncture works and its effectiveness goes beyond> the placebo effect."> > Professor Henry McQuay, professor of pain relief at> the University of> Oxford and member of the Bandolier group that looks> at the evidence> behind different medical treatments, said: "The> great bulk of the> randomised controlled trials to date do not provide> convincing evidence> of pain relief over placebo.> > "Some people do report that acupuncture makes them> feel better.> > "But it is extremely difficult, technically, to> study acupuncture and> tease out the placebo effect.">