FDA attempts to shield drug makers from liability

New rules to be adopted by the Food and Drug Administration are set to redefine labelling requirements for pharmaceutical drugs. The new rules will go into effect on June 30. At the last minute, language was inserted into the new rule to attempt to limit liability of drug companies for the harm their faulty products might cause patients -- eliminating a patient's standing to bring lawsuits.

One might argue that the FDA has no legal authority to make such sweeping rules, and that may be the case. At the very least, this should leave no doubt in anyone's mind who the FDA is representing, and it is not the general public. Probably the agency should be renamed the Bureau of Pharmaceutical Industry Shelter and Sales. You can work an appropriate acronym yourself.

Here's what the June 8 issue of the New England Journal of Medicine had to say about the FDA's latest move:

"The most troubling aspect of the FDA's
new plan, however, has nothing to do with
providing information to prescribers. In
an unusual move after the end of a five-year
period of comments on the initial rule, the
agency used the passage of the new labeling
regulations to quietly add a new section to
its preamble that will make it extremely difficult
for anyone to bring legal action against a drug
manufacturer for harm caused by one of its
products. For years, the pharmaceutical industry
had sought to pass legislation that would prohibit
litigation over adverse effects as long as the
medication was approved by the FDA; Congress
has consistently rejected this idea. But after
the comment period for the new labeling regulation
had closed, language was added to the final rule
stating that any FDA-approved label, 'whether
it be in the old or new format, preempts . . .
decisions of a court of law for purposes of product
liability litigation.'

"Beginning at the end of this month, the new
regulations would preempt nearly all action by
patients in state courts against drug manufacturers
for unanticipated injuries resulting from the use of
their products. This immunity would apply even
if a company failed to warn prescribers or patients
adequately about a known risk, unless a patient
could prove that the company intentionally
committed fraud — a very hard test to meet.
Several members of the House and Senate have
vigorously objected to this provision, as well as to
the fact that there was no opportunity to debate it
before the regulations were made final; court
challenges are likely.

"Ironically, this low-profile aspect of the new
rules could have an effect on the health care system
that is much more profound than the small-scale
improvements of the new labeling rules themselves.
'It will make it impossible to file liability claims,' said
a former FDA general counsel who is now in private
practice."

As a conservative, I don't like judges legislating from the bench. I especially do not like career bureaucrats legislating by fiat from inside the executive branch -- that is equally unconstitutional.

Let your voice be heard in Washington. You have only about seven days of freedom left to file a lawsuit for damage a negligent drug company has caused. [LINK]

Drug mixups kill 40,000+ every year

"In November 1999, the Institutes of Medicine released a report that focused public attention on widespread medical errors. Quite often, these errors are drug related and are fairly mild and resolve. Unfortunately, some adverse reactions are severe. Researchers had found that each year some 44,000 Americans die as a result of such errors. "

"Although not every possible mishap is within your control, there are plenty of ways to help keep yourself safe from harm — both in and out of the hospital..."

For a list of precautions you can take to minimize the chance of this kind of tragedy, see this page:

intellihealth.com

Actually, there are studies estimating the death from improperly administered pharmaceuticals at much higher levels than 44,000 annually. In perspective, this makes the number of deaths in the Iraq war seem puny by comparison. Why is so little attention given to these casualties of a health care system that is making these deadly (and largely preventable) mistakes at an astounding rate?

Also, consider this: If 44,000 Americans are killed outright by drug errors every year, probably an even greater number were permanently injured.

arthritis pain relief from magnets

Most people probably find it odd, but I have used magnets for pain relief for many years. I use permanent magnets, mainly ceramic magnets that are flat, with the north pole on one face and the south pole on the opposite face. A double blind study of permanent magnets and their effect on bursitis pain was done several years ago. Apparently there is little interest in studying this type of magnet, but I find them effective.

The medical establshment has been more diligent in exploring the effects of pulsed or alternating magnetic fields -- electromagnets that are switched on and off at different frequencies. In this type of device, the magnetic field is delivered in pulses. A friend of mine whose child had a non-healing leg fracture told me that there is extensive literature on pulsed magnetic fields for bone healing. This began several decades ago when it was discovered that a small electrical current could stimulate bone growth and healing around a fracture. Since an electrical current produces a magnetic field, it was only natural to start testing magnets as well.

A recent study probed the effect of pulsed magnetic fields on fibromyalgia and rheumatoid arthritis pain. This double-blind placebo-controlled study found statistically significant lower levels of pain in those exposed to a low frequency pulsed magnetic field for thirty minutes, compared to patients who received a sham treatment. [Pain Res Manag. 2006 Summer;11(2):85-90]

The effects of magnetic fields on biology are real. I can't vouch for all of the products being sold in the alternative health field. Many of them may be ineffective. The concept, however, is sound. I haven't tried any of the products that create a pulsed field. Permanent magnets give me benefits, and they avoid the added complication of electronics, wires, etc.

Gary Null has written a book about magnetic healing, and he also sells some very odd and very expensive products on his website (a magnetic sports bra?!), none of which I have read, or used, or endorse. There is an old article on Gary Null's site that serves as an excellent introduction to the use of magnets for health, and it may be all you need to know to begin using magnets for pain relief, allergy relief, and other purposes.

http://garynull.com/node/11537

My only caveat would be to suggest finding an industrial source for the magnets, instead of paying the hugely inflated prices charged by companies selling them on the internet as health products. The magnets I use are 4" x 6" x ½" and have a field strength of 4000-5000 Gauss at the surface. They can be stacked for extra power -- which means the field can penetrate deeper into your tissues.