The Wombat’s Blog

How the FDA Operates0

Here is a short article how the FDA operates, what it can and cannot do, and how we may be legally introducing drugs into the sytem that may come back to bite us later on. There seems quite a bit of risk here that the FDA, as currently practicing, may not be able to mitigate.
(Original found here.)

EVER SINCE Ernst Chain and Howard Florey isolated penicillin in 1939, inaugurating the era of antibiotics, harmful microbes have steadily developed resistance to even the most robust bacteria killers. The more often a particular antibiotic is administered, the more likely that bacteria will adapt. So, along with the continual development of new antibiotics, the best way to preserve the efficacy of medications that treat dangerous infections is to use them as sparingly as possible. That’s why your doctor might not prescribe a course of amoxycillin for your sniffles.

But The Post’s Rick Weiss reported last week that the Food and Drug Administration might do the exact opposite. The FDA is considering approval of cefquinome, a powerful antibiotic, to treat a common bovine infection. Never mind that there are already 12 medications on the market to treat the illness, bovine respiratory disease, or that it would be more effective to simply house cows in more sanitary conditions. FDA officials are not supposed to discriminate against drugs because their purposes might overlap with others. Nor can they tell farmers how to raise their livestock.

What the FDA can do, however, is alter its self-imposed rules that prevent the agency from fully considering the public health risks of approving this antibiotic for use in animals. The FDA’s current rules say that the agency can deny approval if giving the medication to livestock would threaten the efficacy of a major antibiotic in the treatment of food-borne illnesses in humans.

But overusing cefquinome might undermine a similar antibiotic for humans, cefepime, that is an essential medication for treating many infections that are not classified as food-borne but are nevertheless very dangerous. James E. Leggett Jr., an infectious-disease specialist whom the FDA brought in to advise on the cefquinome issue, points out that risk analyses compiled according to FDA guidelines do not consider whether giving cefquinome to cows would encourage resistance to it and other valuable antibiotics in some of the bacteria that live in — and are excreted from — the bovine gut, such as E. coli.

Instead of ignoring these risks, the FDA should adopt the more sensible standard that the World Health Organization recommends, which would allow the FDA to reject drugs that might undermine an antibiotic important in fighting “serious human disease,” food-borne or not. With a fuller picture of how dangerous widespread use of cefquinome in cows might be, the FDA can make a better decision.

Posted: politics, health

If It’s Good for Rabbits …0

Another example of medical study results being thrown out the window.  In our local paper we couldn’t tell who conducted the study. Now this one is a little weird though because there are no references whatsoever on checking back on this study. It also left out the critical bit that carrots may still be good for you, or at least eating the 5 servings of vegetables are.

I wonder if all of this undermines medical science somehow, because you’re never quite sure.

But way, I found a second article showing how the FDA, that approved drugs, operates. Coming up.

(Original found here.)

Beta Carotene Pills May Not Save Vision
By CARLA K. JOHNSON
Associated Press Writer

CHICAGO (AP) - Carrots, rich in beta carotene, long have been thought to sharpen eyesight, but a new study suggests that beta carotene pills are powerless against a common type of vision loss among older people. Age-related macular degeneration is the leading cause of blindness in people 65 and older. The condition blurs the center of the field of vision, making it difficult to read, drive, thread a needle and even recognize faces. It affects more than 10 million Americans and there is no cure.

An earlier large study had shown that beta carotene _ when taken with certain vitamins and zinc _ could slow or prevent vision loss in people with age-related macular degeneration. Commercial formulations of the eye-protecting combination vitamins are sold over the counter.

But the new study found no benefit for beta carotene supplements alone against the disease.

That may be a comfort for smokers with signs of macular degeneration. Smoking is a risk factor for the condition, but beta carotene has been shown in other research to raise the risk of lung cancer in smokers. So eye doctors have advised smokers concerned about macular degeneration to find a vitamin regimen without beta carotene.

“This study at least suggests that beta carotene might not be an important component of that (vitamin) formulation,” said Dr. Stuart Fine of the University of Pennsylvania’s Scheie Eye Institute, who was not involved in the new study.

The finding is based on data from more than 21,000 male doctors who were followed for an average of 12 years. The doctors were randomly assigned to take either 50 milligrams of beta carotene every other day or a dummy pill. The doctors didn’t know whether the pills they took contained beta carotene.

Roughly the same number of doctors in both groups developed the eye condition, suggesting beta carotene didn’t help or hurt. After 12 years, there were 162 cases of macular disease in the beta carotene group and 170 cases in the group taking the dummy pills. The difference in the numbers was not statistically significant, meaning it could have occurred by chance.

Study co-author Dr. William Christen at Harvard-affiliated Brigham and Women’s Hospital in Boston said it’s possible that beta carotene might be helpful only in combination with the other vitamins and zinc, but he said that’s unlikely.

Christen said it’s unclear whether the latest findings would apply to women since the experiment only involved men; he said he’d like to see a similar study among women. The research, appearing in the March issue of the Archives of Ophthalmology, also says nothing about carrots and eyesight.

“Currently the best advice might be something you’ve heard before: Eat five or more servings of fruits and vegetables a day because it’s the combination of nutrients that seems to be the important factor,” Christen said.

The study was funded by grants from the National Institutes of Health. Some of the researchers reported receiving past funding from pharmaceutical and nutritional supplement makers.

On the Net:
Archives of Ophthalmology:
http://archopht.ama-assn.org

Posted: health

Quality of Life - State Proposal to Let Go0

Another bunch of tangled noodles to make sense of. There’s apparently a problem with a state law on “Death with Dignity”. The disabled are worried about being asked to be killed through “reduced protections.” And the law may lead to infant euthanasia (I’m assuming that’s a new term for “abortion”?).

I don’t know what the legislature was about, but given that the bill is now held because of a medical professional means it can’t be completely unreasonable. The writer implies that the state shouldn’t require doctors to act against their Hippocratic Oath (see wikipedia here), but then has no problem for an Ohana and their personal physician to take end of life decisions without legal sanction. So it’s better for a family to end the life of a loved one, than the state saying that they can do so without repercussions?
The word “dignity” seems to be a particular sore spot, as if there can be no dignity in any legal “killing.”

Yet

the state should never put itself in the position of sanctioning killing other than for the purpose of protecting society

This is icky. It’s ok to kill the bad guys, it’s not ok to assist the good guys. I thought the Hippocratic Oath said something about doing no harm (and that it also is against doctors assisting in executions). Sometimes when people get to the end of their life, you may be doing harm by not letting them go and helping them to go. People with terminal cancers are usually not “kept alive at all costs.” The decision is how to help them and increase their “quality of life.”

“Quality of life” is not the same as “alive.”
(Original found here.)

UPDATE: a day later another person wrote in regarding this article. He comes from a different perspective and sounds rather angry at the original views expressed. Of course more valid points. Sometimes you feel that it is time for new language to view all this. The Republican Administration is great at coming up with slogan, or new terms for things we already call something (like “Insurgents,” or “War on Terror,” or “Unlawful Combatants”). Let’s apply that same and rename something known. We have Conservatives and Liberals. But they’re conserving and liberating what - the Status Quo? OK - so how about “old fashioned” and “modern?” (or “stubborn” and “impatient” if that sounds better).

Anyways, the followup letter was pissed, though heartfelt.

Death with Dignity
Protect Marriage and the Terminally Ill
Saturday, March 10, 2007 9:49 AM HST

The person who recently wrote a letter castigating Hawaii’s Legislature for not passing a “death with dignity” bill was evidently not present in the Health Committee hearing where public testimony regarding this subject occurred.

I was, and I can tell you the testimony against this very deceptive legislation was overwhelmingly against it. There were no arguments given that were more powerful than those from the community of the disabled, all of whom understood (as well as the U.S. Supreme Court) that this type of law can push us further down the “slippery slope” of reduced protections for the most vulnerable in society.

There is nothing “humanitarian” or “dignifying” about giving legal sanction to health care providers to begin functioning contrary to their Hippocratic oaths. When the state tries to define which people have more or less dignity based upon their physical condition in a given near death experience, it perverts its role in society to treat everyone as equal under the law, and it will ultimately fail. This is the “fruit” of such actions in Belgium and Holland and at a minimum, we can learn from their story. Indeed, these same countries are now slowly embracing the concept of infant euthanasia and it started with embracing the conceptual paradigm of “death with dignity”.

This bill never came before the Legislature as a result of any groundswell of public opinion, nor the breakdown of traditions that safeguard individuals prerogatives of deciding among their ohana and with their personal physician what end of life decisions to take without the force of legal sanction. The state should never put itself in the position of sanctioning killing other than for the purpose of protecting society.

Bob Dylan sang a song with a line “when we practice to deceive, oh, what a tangled web we weave.” This legislation, while perhaps well intended, would have created a tangled web of deception. Let us never participate in this deception under the guise of helping our neighbors and family members to die more peacefully, or with “greater dignity”.

Our local state representative, Josh Green, and his committee by a vote of 5 to 2, chose the wisest course of action and held the bill.

A far more serious issue at present (and one which hundreds of thousands of people did speak their mind on) is the Legislature seeking to overturn the results of the state wide referendum in 1998 that protected the institution of marriage by a majority vote of 69 percent.

House bill 908, entitled “Civil Unions” and described as “extending the same rights and responsibilities of spouses to partners in a civil union” would make a mockery of the 1998 vote.

It simply results in marriage being called by another name. If it looks like a duck and quacks like a duck, it is a duck.

Husbands and wives take care for your children and let your legislators know your thoughts.

MS, Kailua-Kona

here is the follow up, found here.

Same sex unions
Conservative doublespeak
Saturday, March 17, 2007 9:47 AM HST

In his letter to the editor published on March 10, Mark Spengler, in his argument for protection of the terminally ill wrote, in arguing for the defeat of the bill, the state “perverts its role in society to treat everyone as equal under the law.”

Yet in the second part of his letter, he goes on to argue against “extending the same rights and responsibilities of spouses to partners in a civil union.” As so many in the conservative fight against any kind of legal recognition of civil unions, Mr. Spengler argues for the state to treat conservative issues “as equal under the law,” all while talking out of the other side of his mouth and demanding that civil unions not be recognized.

For someone who is so concerned about protecting marriage, perhaps their attention would be better focused on Las Vegas wedding chapels and the two-day marriages of the Britney Spears of the world. Furthermore, I would think that the conservatives of this country, if so concerned with holding marriage up as the proper adult relationship between two committed, loving people, they would be clamoring for co-habiting gays and lesbians to marry instead of “shacking up.”

Instead, conservatives seemingly have to have someone to feel superior to. Think about it: Gays and lesbians remain the last group of people that it is still socially acceptable, and legal, to discriminate against in most of the nation.

Yes, even toothless residents of trailer park ghettos can sit in their smoke-filled homes waiting for their next government handout, but they can still feel superior to even the most successful homosexual in their town, because they have the legal recognition of their relationship, whatever that may be.

Are conservative marriages on such shaky ground that if the gay couple in your neighborhood had equal recognition under the law, your marriage would lose its sanctity? Would you end up in divorce court? Would the thought of gays having the same rights as you regarding hospital visitation, inheritance, taxes, and all the rest cause you to question your own sexuality? Is your grasp on heterosexuality so weak that you are concerned that you would join my “team” if, God forbid, we had the same tax deduction, or my partner could be covered by my medical insurance?

Conservatives of America, you should know that gays are not clamoring to burst into their local Baptist, Pentecostal, or Catholic church during Sunday services and demand to be married. This may come as a shock to you, but in many cities, we have our own churches. But even in small towns like Kona, where there is not a gay church, being humans, we are not generally inclined to barge in on a body of Jesus’ followers — where we likely would be viewed with disdain, be unwelcome, and in some locales we would be at risk for physical harm –in a church or just outside of it.

“What would Jesus do?” The Jesus I know is about love, and I don’t believe He would look favorably on people who treat others as inferior humans.

Happily there are denominations where generally, all are welcome, so if your church is not among them you can relax: don’t look for me in your house of bigotry and homophobia, I won’t be there.

I will admit that HB 908, as written, had a flaw. I do not think any 16-year-old should be allowed to “marry” — anybody. But I am not the least bit interested in a 16-year-old, but I remain interested in my 41-year-old partner.

And he thanks you Mr. Spengler, and all the taxpayers of this country, as Medicare has paid for two expensive hip replacement surgeries in the last two years.

I’m sure that Blue Cross thanks America’s conservatives too, since they do not have to recognize a legal relationship with my partner, they didn’t have to insure him or pay for his expensive surgeries.

I hope you think of that when you write your next big check to the IRS.

B.L., Kailua-Kona

Posted: local, health, legal

The Medical Community wants Tort Reform0

Good article from a medical professional on the need for tort reform and the impact lawsuits have of the profession. There have to be better ways to have doctors “behave” than threatening them with financial ruin. The same goes for all professionals, especially those in charge of systems that can have life threatening side effects.
As far as unexpected side effects go

it is very clear that a medical center desperate for another orthopedic surgeon accepted a doctor with a demonstrably troubled background

That’s what happens. Go after the good guys, get more bad guys instead. The medical field is a business that needs to keep operating. If you race to the bottom - by kicking all the good guys out - you’ll end up in trouble. We’re still racing down. People are leaving the islands because they see it happening. What’s driving all this. There was an article in the paper today on private funds waiting to jump in and support a new Kona Hospital. And still it is not happening.
(Original found here.)

Public support needed for tort reform
John Bellatti, MD
Friday, March 9, 2007 9:06 AM HST

On March 1 at the Judiciary Committee hearing I, along with many other physicians and medical students and the state insurance commissioner, gave testimony urging passage of HB220 to allow consideration by the full House of Representatives. This bill would have placed a cap of $500,000 on “non economic damages” awarded to a plaintiff in a medical malpractice suit. It in no way limited the right or the ability of a person to sue a doctor.

This bill has been called a “tort reform” bill. Other states have experienced good results in regards to medical care availability as a result of tort reform. Following tort reform in 2003, the people of Texas have available to them 153 MORE orthopedic surgeons, 152 MORE ob/gyn, 33 MORE neurosurgeons. For an explicit description of the recent Texas experience, try Google “Texas liability miracle” and click the top link.

HB220 was initially sponsored by Kona Rep. Josh Green, who chairs the Health Committee, and it passed in that committee. It also passed Consumer Protection Committee (Robert Herkes, chairman) just a week before (13 yes, 0 no, 2 absent).

The newspaper accounts of the March 1 hearing stated that “Emotions carried the day.” The opposite was true. The results of the hearing were obviously predetermined. There was nothing emotional about this, just a cruel, hard dollar- value decision. The Democratic majority leader, Kirk Caldwell, was present watching over his brood to make sure they did nothing to upset the plaintiff’s attorneys. The Judiciary chairman, Tommy Waters, did his biding.

Rep. Cindy Evans who had earlier proposed a bill with identical language, and who had on Feb. 14 voted FOR the same HB220 in the Consumer Protection Hearing suddenly voted against the bill. Hilo’s Rep. Clift Tsuji changed his vote the same way. Apparently the doctor shortage for their constituents on the Big Island was trumped by some other considerations. The votes were: PASS Reps. Green, McKelvey, Souki, Marumoto, Pine. HOLD (Kill) Reps. Waters, Oshiro, Caldwell, Evans, Ito, Luke, Sonson, Tsuji, Yamane and Yamashita. Not present were Reps. Morita and Theilen. This prevented the bill from being debated by all the representatives in full view. The gallery of the Capitol holds a lot more citizens than the hearing rooms. Apparently the Democratic leaders do not want the Democrats’ electorate to understand the issues.

Many of us the hearing re were a captive audience while the malpractice attorneys, absent real arguments, provided emotional cover for their position. A staged reappearance of their clients occurred. Each of these represented real tragedies which occurred during the treatment of patients in Hawaii. For most of the cases no one would argue against compensating the patient, or survivors. Yet residual unhappiness and resentment in these clients was evident in spite of the multimillion dollar awards and the multi-million dollar fees to their attorneys. Compassion for these patients and their loved ones was sincerely felt by all of us — especially the doctors and medical students present. We have dedicated our lives, through education, training, and continuing practice to assisting in the midst of all sorts of tragedies.

What was most amazing to me was that, despite the presence of so many attorneys on the Judiciary Committee itself, there was no interest in showing any relevance of these cases to the matter at hand — HB220. No evidence whatsoever was brought to show that the existence of HB220 by itself would have prevented these lawsuits or have significantly limited the awards to the injured persons.

What also was lacking was a recognition that two or more of the cases could just as easily have been taken as justifications for the bill. In one case, the monetary award was $12 million for future medical and other care. Then there was an additional award for $4 million for loss of income and pain and suffering. This part of the award never made it to the plaintiff.

The attorney took $4 million in attorneys fees; no pain and suffering for him. The attorneys hinted that they would not be willing to represent these deserving clients if the awards were reduced. Unless the attorneys are threatening to strike, there are plenty others in the phone book who would. In a second case, it is very clear that a medical center desperate for another orthopedic surgeon accepted a doctor with a demonstrably troubled background.

This is exactly the situation that we (physicians, HMA and many concerned citizens) are seeking to avoid. HB220 is one important step in bringing more and better quality medical care to Hawaii. We all want less errors and less real malpractice. This will only come with a revitalized and expanding medical community. The current crisis trend will bring a different solution — no doctors — no malpractice.

The people of Hawaii are losing again. Last year a tort reform bill got no hearing at all in the House Judiciary Committee. This year Rep. Caldwell had to use his “leadership” to corral the bill. But the doctor shortage crisis is real and worsening by the week. Yesterday two more fine long-time Kona general practitioners announced they are leaving — 6,000 patients to find new doctors.

One physician is going to Texas (see above), the other to the Canadian Air Force. There is one last chance this session. SB813 is soon to be heard in the House committees for Health and then Consumer Protection. Passage there will lead back to another Judiciary consideration. Citizens could save this bill from being killed also. Submit testimony and SHOW UP. E-mail your representatives and senators.

Follow the newspaper and the Internet for announcements. Bring a water bottle for any hearings. They may last long to allow the attorneys their full show-time. Get up and speak your 3 to 5 minutes on how the doctor shortage affects you and will affect you. Mention how much you think an attorney should be able to take from his client’s pain and suffering. A recent article mentioned that there were many causes of the doctor exodus, not just liability issues.

Well, yes, there are. But does that mean that any multi-factorial problem is immediately insoluble in Hawaii? If an attorney drives over a box of nails and has three flat tires, must he junk the car because he can’t figure out which tire is to blame most for the rough ride? The health of our communities is too important to allow the status quo to continue. But no change will occur if the people affected in Hawaii do not voice their concerns, and where appropriate, their outrage (visit Evans and Tsuji).

It appears most legislators are hoping you’re not noticing. Please, remind them that you are.

John Bellatti is an orthopedic surgeon practing in Kona.

Posted: local, health

Do Or Don’t Eat Your Antioxidants0

Here are two health related articles talking about nutritional deficiencies. The first article talks about a study involving almost 200,000 people and how they’re determining whether eating vitamins and antioxidants helps or hastens death. The second article generously advises us, once again, on what we’re missing and what we need to keep eating to get our recommended intake. At least they’re not suggesting to eat vitamins, but suggest ways to increase our intake by shifting our diet.

But still, how do you make decisions here? Do you or don’t you have to get your minimum recommendable intake?

Consumers can’t know for sure what, if anything, sizable doses of antioxidants might do to their health.

(Original found here and here)

First, the warning article:

Don’t Take Your Vitamins?
Antioxidants might be dangerous.
Wednesday, March 7, 2007; Page A16

IN LAST WEEK’S issue of the Journal of the American Medical Association, a new study on antioxidant supplements, pills that magazine covers in the 1990s trumpeted as potential miracle drugs for their putative cancer-fighting power, concludes that they do not help users live longer and might even increase the risk of death. It’s a reminder that you can’t rely just on bottle labels to make smart choices about which pills to take.

A team of scientists performed an exhaustive review of the research on antioxidants, considering 68 trials conducted since 1990 that included more than a quarter-million subjects. After removing studies with a high risk of statistical bias, leaving 47 studies including 180,938 participants, the team found that taking beta carotene, Vitamin A and Vitamin E actually increased the likelihood of death by 5 percent. Vitamin C and selenium did not have any significant effect on mortality. Though fronts for the vitamin industry have tried to pick away at the findings, the data nevertheless generally support the work of a National Institutes of Health conference on multivitamin supplements — pills packed with antioxidants and other nutrients — held last May. Then, doctors and researchers concluded that antioxidants appear to have no beneficial health effects except in the cases of a few users with certain conditions, and that they might actually pose a risk to some populations, especially to those individuals who regularly ingest too much of a particular antioxidant supplement.

The next step in the research is determining which antioxidants assist in the treatment of which diseases and which supplements are harmful to which types of patients. Most American adults probably won’t see any effect, positive or negative, from taking a daily multivitamin, and participants at the NIH conference did not recommend discontinuing their use. But until reliable data appear to answer those questions, health experts say, consumers can’t know for sure what, if anything, sizable doses of antioxidants might do to their health.

Meanwhile, Americans buy about $23 billion worth of dietary supplements every year, and about half of American adults take some kind of supplement. The evidence analyzed last week should lead them to question whether the pills are worth the cost.

and then the “Business as Usual” article

Lost in the land of plenty
Overfed Americans still fall short on many important nutrients
By Janet Helm, a Chicago dietitian and nutrition consultant.
Special to the Tribune
February 28, 2007

Talk about nutrition tends to focus on America’s widening waistlines. No doubt, we’re a nation that’s overfed. But we’re also undernourished.

Government surveys show that we continue to suffer from nutritional shortfalls–a fact that’s often overlooked because we’re obviously eating enough calories.

The seven most neglected nutrients are calcium, potassium, fiber, magnesium and vitamins A, C and E.

Filling these nutrient gaps is not as tough as it may seem. Sure, a multivitamin could remedy part of the problem, but you would be missing out on some of the natural compounds in food that can’t be captured in a pill. Plus, supplements are meant to be just that–supplemental to the diet. Pills are not intended to be substitutes for real food.

Here’s why you need these nutrients and how you can easily get more.

What you’re missing

Nutrient: Calcium
People not getting enough: 70 percent
Why you need it: Promotes bone health, helps muscles contract, may help maintain normal blood pressure
Your daily goal*: 1,000 mg
And how to reach it: Drink a skim latte made with 8 ounces of milk and … Eat a cup of yogurt as a mid-afternoon snack and …
Grate 1 1/2 ounces of cheese on your salad or pasta at dinner

Nutrient: Potassium
People not getting enough: 97 percent
Why you need it: Regulates body fluids, helps maintain normal blood pressure, needed for muscle contractions
Your daily goal*: 4,700 mg
And how to reach it: Include 1 cup of orange juice and 1/2 cantaloupe at breakfast and …
Stir 1 cup of white beans and 1/4 cup of tomato paste into a soup and …
Eat a banana in the afternoon and …
Eat 5 ounces of pork tenderloin and a baked potato at dinner

Nutrient: Fiber
People not getting enough: 96 percent
Why you need it: Helps maintain healthy cholesterol levels, promotes regularity, can help reduce hunger
Your daily goal*: Men: 38 g, Women: 25 g
And how to reach it: Eat 1 1/2 cups of oatmeal topped with 1/4 cup raspberries for breakfast and …
Make a sandwich with whole-grain bread and eat a pear with your lunch and …
Snack on 1/4 cup dried figs and …
Eat 1 cup of steamed broccoli and 1 cup of whole-wheat pasta at dinner

Nutrient: Magnesium
People not getting enough: 56 percent
Why you need it: Supports bone and heart health, signals muscles to relax and contract
Your daily goal*: Men: 420 mg, Women: 320 mg
And how to reach it: Eat 1 ounce of whole-grain cereal and 1/2 cup milk for breakfast and …
Include 1 cup of sauteed spinach and 1 cup of brown rice with your dinner and …
Snack on 1 ounce of Brazil nuts

Nutrient: Vitamin A
People not getting enough: 44 percent
Why you need it: Promotes healthy skin, eyesight and immune function
Your daily goal*: Men: 900 mcg, Women: 700 mcg
And how to reach it: Add 1 cup of sliced carrots to your stir-fry or …
Bake a medium-sized sweet potato as a side with dinner

Nutrient: Vitamin C
People not getting enough: 31 percent
Why you need it: Promotes a healthy immune system, helps wounds heal, works as an antioxidant to inhibit damage to body cells
Your daily goal*: Men: 90 mg, Women: 75 mg
And how to reach it: Slice a small red pepper on your salad or …
Eat 1 cup of strawberries for dessert

Nutrient: Vitamin E
People not getting enough: 93 percent
Why you need it: Acts as an antioxidant that may help lower risk of heart disease and cancer, helps bolster the immune system
Your daily goal*: 15 mg
And how to reach it: Top a salad with half of an avocado and a dressing made with 1 tablespoon safflower oil and …
Snack on 1 ounce of almonds or sunflower seeds
*Recommended daily intakes for adults, ages 19-50

Source: What We Eat in America, U.S. Department of Agriculture, 2005. www.ars.usda.gov/foodsurvey.

Other missing nutrients
All women of childbearing age need to keep an eye on folic acid, a vital nutrient that helps reduce the risk of certain birth defects. Orange juice, dark leafy greens and fortified grains are top sources of folic acid.
Older adults often lack vitamin D, which partners with calcium to keep bones strong. Milk is a top source; some yogurts and juices also are fortified with vitamin D.

Janet Helm is a Chicago dietitian and nutrition consultant. 

Posted: health

How to Fix the Doctor Shortage Crisis0

Sometimes you get smarter people to contribute information to the local paper. Here is a doctor’s perspective on how to address the current “Medical Provider” crisis.

(Original found here.)

How To Fix The Doctor Shortage Crisis In Hawaii
By John Bellatti M.D.
Tuesday, January 23, 2007 8:25 AM HST

Rumors of my retirement are much exaggerated. I am an orthopedic surgeon in my 20th year of practice here in Kona. I read the Jan. 17 article on the M.D. shortage with great interest, including “don’t fracture a bone in Kona because there’s not an orthopedic surgeon.” Later that day, during my second surgery, fixing a broken hip, it occurred to me that perhaps the statement was correct. Perhaps I really did retire, and I’m just having one of those “work dreams.” So I pinched myself. No, I didn’t wake up from this bad dream.

We have an all-out crisis in medical care — a sinking ship. “No new patients” policies are commonplace at existing physician’s offices and more practicing physicians are contemplating jumping into the lifeboats. This problem is not going to turn around in the next six months. But what we do matters.

Realistically, if you are contemplating bringing a family member closer or moving to Kona, reconsider: There will not be adequate medical care available. Most of the readers of WHT do not want to join the emigration to the mainland. There is much hand wringing. Some ask the governor, HMSA, or the Legislature to “do something.”

The success of the U.S. has not come from its governments, nor its large corporations, but from its people, acting in their own interests, and with community spirit. The people of West Hawaii can take this problem into their own hands. Some may not agree with what I am about to say. Great, investigate, cogitate, and communicate. Twenty-five years ago, hospitals, clinics, and medical schools fell all over themselves, tearing down “hospital,” “medical center,” “medical doctor” signs. The term “health care” replaced “medical care.” When you have a heart attack or fracture a bone, you need medical care which is shrinking in Kona.

In order to convince physicians to stay and more physicians to move here, the reason for departures must be faced. The top reason every physician who has left or limited practice has done so, as personally told to me, is “HMSA.” Reimbursement rates are low for the services that physicians supply. Hassle factor is high for the services and prescriptions that physician recommends. When the extremely well paid HMSA executive responds to this letter, just ask yourself — do I believe him or my own eyes?

We need an independent investigation and audit of HMSA just like the one done for the Bishop Estate 10 years ago. For 2005, HMSA had a cash flow of $1.7 billion and a reserve fund of $700 million (see http://www.hmsa.com/about/annualreport/2005/fin_stmt.asp ). This is not subject to any oversight. Remember the old Bishop Estate trustees? Before the Bronster investigation, the papers carried statements that there was nothing to find, that this was a waste of money and time. After the investigation, the discussion of time turned from “waste of time” to jail time.

HMSA continually points to the fact that most physicians “participate” as a sign that most physicians are happy enough with their fee schedule. You’d participate too if someone had a full-nelson on your income. There is a check box on the insurance claim form where the patient can request that the insurance payment be sent to the physician instead of the patient. HMSA simply ignores this. “Non-participation,” for those physicians who tried it (I did once) means too commonly that patients use the check to pay for rent and buy gas, beer and cigarettes and other necessities, before considering paying for the medical services already received. HMSA uses human nature to enforce its protection racket on physicians.

Physicians who might be considering relocating to Hawaii hear of this, and realize they will not be able to set their own fee schedule. It’s HMSA way or bankruptcy — or don’t move here. One urologist did move here without realizing this reality. He left after three months.

This strong-arm practice would be ended very easily if Insurance Commissioner Jeffrey Schmidt could simply issue a regulation that all companies providing medical insurance must honor a request to send the reimbursement directly to the physician. But when it comes to things like this, HMSA says it is not an insurance company. It will take a Legislative statute to bring about change. This is harder because it means the populace (you) must rain down demands on the Legislature to fix. That’s the only way it will happen. Whether or not you are an HMSA member, this problem is seriously affecting you.

A third absolute requirement to attract physicians is to enact medical tort reform — a dollar limit on medical malpractice claims for non-economic damages. This would end the medical malpractice lottery where a very few attorneys can seek huge awards, of which they get one-third (plus expenses). Only a few attorneys in our state participate in the lottery. The rest are in the same boat with us when we or our families need medical care that is not available here.

There is a growing number of states where tort reform has been enacted. Malpractice insurance becomes less expensive; doctors move in. Presumably some of the affected attorneys moved out to greener pastures, like Hawaii. Again, only a concerted effort by the large number of citizens who consider that they might need a doctor for more than flu shots will force our attorney-dominated Legislature to act. This issue pits the medical plaintiff’s attorneys (small number) against the entire population of the state. In the past five years have you benefited from the current non-reformed system? Did you get to deposit the big check? Or, have you or a family member been negatively affected by the current system — long wait in the ER, trouble finding a doctor to be “your doctor,” deliver a baby, or fix a fracture?

Tort reform does not impede anyone’s ability to sue a doctor for malpractice; it just means your attorney may give you better advice on what is realistic to expect. The alternative is no doctor - no malpractice. In an ethical legislature, tort reform would already have come to a vote at least once. Sylvia Luke, malpractice attorney and chairperson of the Judiciary Committee, not only failed to recuse herself from decisions on a tort reform bill, she absolutely blocked discussion of this bill in committee. Don’t let them dodge the issue again. Rain down e-mails, faxes, letters and phone calls. We need medical tort reform now. It will benefit most of us.

I have outlined two key elements of the medical doctor shortage in Kona and in the state: HMSA’s death-grip on the reimbursement levels for physicians and continuation of the medical malpractice lottery for a few attorneys.

I have pointed out three key elements to attack and win.

1. HMSA must have a Bishop Estate-like investigation and public audit.
2. HMSA (and other payers) must be made to accept the request of their members to make payments directly to physicians.
3. The Legislature must pass a meaningful medical tort reform bill.

Any reader may feel ineffectual in writing a letter. If 1,000 Kona residents write one letter a week, and send it out to 10 people (legislators, senators, governor, HMSA execs, state bar association, insurance commissioner), then modify it and do it again next week, 50 weeks times 10 recipients times 1,000 citizens is 500,000 calls for action. Residents from the other islands would join in because you copy your e-mail to your friends, who do the same. Try 10,000 letter writers with 10 copies sent. One hundred thousand letters a week. This is attainable.

We don’t need another emergency summit with politicians, bands, and grinds, to hear more blah-blah-blah. We need the personal, earnest, broad-based, consistent, tenacious efforts of our many concerned citizens to pummel our elected officials into putting our interests first.

The Legislature and governor must step up to the plate and do just these three things to represent their constituencies. We do not elect leaders, we are the leaders. Let’s remind our representatives. The next election is a long way off. This problem can’t wait.

Please, make this problem your problem. The time to act is now.

Bellatti is a Kona orthopedic surgeon. 

Posted: local, health

Medical Missteps or Paths Forward0

It must be the season of medical experimentation. I just wrote an article (here) on medical side effects. Here is another followup pointing in the same direction.

Article 1) is a little pessimistic and talks about the fact that the medicine people take for chronic heartburn being prevents calcium intake and thus leads to weaker bones. Oops. And clinical trials did not consider that a possibility?

Article 2) is more optimistic and mentions that children may be able to overcome food allergies through training.

Not the easiest field to worry about:

(Originals found here and here.)

Popular heartburn drugs linked to hip fractures
By CARLA K. JOHNSON
Associated Press

CHICAGO - Taking such popular heartburn drugs as Nexium, Prevacid or Prilosec for a year or more can raise the risk of a broken hip markedly in people over 50, a large study in Britain found.

The study raises questions about the safety of some of the most widely used and heavily promoted prescription drugs on the market, taken by millions of people.

Researchers speculated that when the drugs reduce acid in the stomach, they also make it more difficult for the body to absorb bone-building calcium. This can lead to weaker bones and fractures.

Hip fractures in the elderly often lead to life-threatening complications. As a result, doctors should make sure patients have good reason to stay on heartburn drugs long term, said study co-author Dr. Yu-Xiao Yang of the University of Pennsylvania School of Medicine.

“The general perception is they are relatively harmless,” Yang said. “They often are used without a clear or justified indication for the treatment.”

Some people find relief from heartburn with over-the-counter antacids such as Tums, Rolaids and Maalox. But for others, those medicines do not work well. Moreover, heartburn can be more than a source of discomfort. People with chronic heartburn can develop painful ulcers in the esophagus, and in rare cases, some can end up with damage that can lead to esophageal cancer.

Dr. Sandra Dial of McGill University in Montreal, who was not involved in the study but has done similar research, said patients should discuss the risks and benefits with their doctors and taper off their use of these medicines if they can.

Nexium, Prevacid and Prilosec are members of a class of drugs known as proton pump inhibitors. The study found a similar but smaller risk of hip fractures for another class of acid-fighting drugs called H2 blockers. Those drugs include Tagamet and Pepcid.

The study, published in Wednesday’s Journal of the American Medical Association, looked at medical records of more than 145,000 patients in England, where a large electronic database of records is available for research. The average age of the patients was 77.

The patients who used proton pump inhibitors for more than a year had a 44 percent higher risk of hip fracture than nonusers. The longer the patients took the drugs, the higher their risk.

The biggest risk was seen in people who took high doses of the drugs for more than a year. That group had a 2 1/2 times greater risk of hip fractures than nonusers.

Yang said that for every 1,262 elderly patients treated with the drugs for more than a year, there would be one additional hip fracture a year attributable to the drugs. For every 336 elderly patients treated for more than a year with high doses, there would be one extra hip fracture a year attributable to the drugs.

our paper left out this portion

Dr. Doug Levine of AstraZeneca PLC, which makes Nexium and Prilosec, said the study does not prove that proton pump inhibitors cause hip fractures. It merely suggests a potential association, he said. Doctors need to monitor their patients for proper dosage and watch how long they take the drugs, Levine said.

Julia Ellwanger, a spokeswoman for TAP Pharmaceutical Products Inc., which markets Prevacid, said proton pump inhibitors’ safety has been well-established by rigorous studies, and the new study does not prove or disprove a connection to hip fractures.

Dr. Alan Buchman of Northwestern University, who was not involved in the research, said the study should not change medical practice, since doctors already should be monitoring the bone density of elderly people taking the drugs and recommending calcium-rich diets to all patients.

“Most people are not taking enough calcium to start with,” he said. He also wondered if a similar result would have been found in a sunny climate, because vitamin D from sunshine helps with calcium absorption.

Also, Buchman said it not known whether the acid-fighting drugs prevent esophageal cancer. He said the risk of esophageal cancer has been exaggerated in the marketing of these drugs.

“I think the risk has been overplayed and scared the community,” Buchman said.

Heartburn medicines are heavily advertised in “Ask your doctor about …” commercials in this country, particularly during the evening news.

Nexium is the third-biggest selling drug in the world, behind the cholesterol medicine Lipitor and blood thinner Plavix, with global sales totaling $5.7 billion last year, according to IMS Health, which tracks drug sales.

Yang and his co-authors disclosed in the paper that they have worked as consultants and received speaking fees from companies making acid-fighting drugs. The study was funded by the National Institutes of Health and the American Gastroenterological Association/GlaxoSmithKline Glaxo Institute for Digestive Health.

Men in the study had a higher drug-associated risk of hip fracture than women, possibly because women may be more aware of osteoporosis and may get more calcium in their diets, Yang said. He plans more research on whether calcium-rich diets or calcium supplements can prevent the problem.

and second article at:

Study: Overcoming allergies possible
By LAURAN NEERGAARD
AP Medical Writer
Mon Dec 25, 6:02 PM ET

Elizabeth White’s first encounter with peanuts - a nibble of a peanut butter cracker at age 14 months - left the toddler gasping for breath. Within minutes, her airways were swelling shut.

A mere fifth of a peanut was enough to trigger an allergic reaction.

So it was with trepidation that her parents enrolled Elizabeth, at 4 1/2, in a groundbreaking experiment: Could eating tiny amounts of the very foods that endanger them eventually train children’s bodies to overcome severe food allergies?

It just may work, suggest preliminary results from a handful of youngsters allergic to peanuts or eggs - and who, after two years of treatment, seem protected enough that an accidental bite of the forbidden foods is no longer a huge threat.

“We’re so lucky,” says Carrie White, Elizabeth’s mother.

Now 7, Elizabeth can safely tolerate the equivalent of seven peanuts. For the first time, the Raleigh, N.C., girl is allowed to go on playdates and to birthday parties without her parents first teaching the chaperones to use an EpiPen, a shot of epinephrine that can reverse a life-threatening reaction.

“Our whole worry level is really gone.”

Don’t try this experiment on your own, warns lead researcher Dr. A. Wesley Burks of Duke University Medical Center. Children in the study are closely monitored for the real risk of life-threatening reactions.

But if the work pans out - and larger studies are beginning - it would be a major advance in the quest to at least reduce severe food allergies that trigger 30,000 emergency-room visits and kill 150 people a year.

“I really think in five years there’s going to be a treatment available for kids with food allergy,” says Burks.

Millions of Americans suffer some degree of food allergy, including 1.5 million with peanut allergy, considered the most dangerous type. Even a whiff of the legume is enough to trigger a reaction in some patients.

Moreover, food allergies appear to be on the rise. Peanut allergy in particular is thought to have doubled among young children over the past decade, prompting schools to set up peanut-free cafeteria zones or ban peanut-containing products.

There’s no way to avoid a reaction other than avoiding the food, something the new research aims to change.

Allergies to pollen and other environmental triggers often are treated with shots called immunotherapy. A series of injections containing small amounts of the allergen builds up patients’ tolerance, reducing or even eliminating symptoms in many people.

Shots proved too dangerous for food allergy. So Burks and colleagues at Duke and the University of Arkansas developed an oral immunotherapy.

Here’s how it worked: First, youngsters spent a day at the Duke hospital swallowing minuscule but increasing doses of either an egg powder or a defatted peanut flour, depending on their allergy. They started at 1/3,000th of a peanut or about 1/1,000th of an egg, increasing the amount until the child broke out in hives or had some other reaction.

Then the children were sent home with a daily dose just under that reactive amount. Every two weeks, the kids returned for a small dose increase until they reached the equivalent of a tenth of an egg or one peanut - a maintenance dose that they swallowed daily.

After two years, four of the seven youngsters in the egg pilot study could eat two scrambled eggs with no problem, and two more ate about as much before symptoms began, researchers report in the January edition of the Journal of Allergy and Clinical Immunology.

In the peanut pilot study, yet to be published, six of the children challenged so far could tolerate 15 peanuts, Burks says; Elizabeth’s limit was seven.

“We thought it would make some difference. We’re surprised about the amount of difference it made,” says Burks. “From one peanut to 15 peanuts is basically a huge difference.”

But will it last? These youngsters still take their daily maintenance dose, which Elizabeth’s mother nicknamed “peanut medicine” so as not to confuse a child taught to avoid peanut products. No one knows if the protection will last if they stop that daily dose, notes Dr. Marshall Plaut of the National Institutes of Health, which has a Food Allergy Research Consortium that’s closely tracking Burks’ work.

The next step: Burks’ team is beginning larger studies that randomly assign youngsters to take either dummy powders or the egg- or peanut-containing ones, seeking better evidence for the treatment.

He’s also giving patients like Elizabeth larger doses, to try to increase their resistance to the allergens. Blood tests signal promise: People who tolerate higher doses in turn have lower blood levels of a compound called immunoglobulin-E that’s key to immune cells’ overreaction to allergens.

“Inducing tolerance is an attractive approach,” says NIH’s Plaut. But, “you don’t go into this kind of a study lightly” because of the risks.

“It’s not something we’re ready for everybody to do yet,” stressed Burks.

EDITOR’S NOTE - Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Posted: health

The Powerlessness of the Market - Health Services0

So here is an article of the state government being asked to help fix the medical situation on our island, where doctor’s are leaving, but nobody new is coming.

Now what happened to the market where magically over time the forces of capitalism will raise the whole boat? Even if you had money, you couldn’t get services, which is why my neighbor is running back to the mainland, after building his retirement home.

So the fix is … ta daaaa … government control. Wait, wait, wait that goes against everything we’re constantly being preached.

The best thing you can do for yourself is to be a turtle and just to not get sick. Don’t do anything you could break something. Don’t do anything risky. Don’t overdo anything. Just float along.

But just try.

(Original found here.)

Legislature called on to fix doctor shortage on the Big Island
by Nancy Cook Lauer
Stephens Capitol Bureau
Wednesday, December 27, 2006 8:27 AM HST

HONOLULU — Expect Hawaii’s doctor shortage to get a lot of attention in the state Legislature next year.

A task force lawmakers created to study the “physician on-call crisis” is recommending a professional analysis of the myriad reasons hospitals can’t retain on-call doctors for emergency rooms. But Gov. Linda Lingle, a Republican, says making it harder to sue doctors is an important first step.

“Medical malpractice insurance reform is going to be a huge issue this upcoming legislative session,” Lingle told reporters last week. “We can’t go on the way we are; hospitals will close because they can’t keep up with the expenses because of the increase in medical malpractice insurance doctors are not going to stay in the market because they cannot afford it any more because of the cost of insurance.”

Lingle said she hadn’t settled on what kind of reform is best — her legislative priorities are due to the Democrat-controlled Legislature on Jan. 22 — but she’s been reaching out to the insurance industry, plaintiff’s attorneys and physicians.

“And then after thinking it through, we’ll come up with what we feel is the right approach to medical malpractice reform,” Lingle said.

But Rep. Josh Green, himself an emergency room physician and chairman of the House Health Committee, thinks the focus should be broader than just medical malpractice insurance. Green, D-Kona, Keauhou, Honokohau, says adequate pay for doctors would go a long way toward resolving the on-call crisis.

“You can’t ask them to do that job and not pay them,” Green said. “The primary reason is there is a shortage of docs overall, so every doc has a bigger load.”

Green himself has been on call for 144 separate 24-hour shifts over the past year, in addition to his work in the Legislature. One month, he was on call for the entire month because there was no other doctor available to cover, he said.

Being on call means the doctor must be within a 15-minute drive of the hospital. In Kailua-Kona and other rural hospitals, that means staying at the hospital itself, Green said. Some doctors are paid a stipend for being on call; other doctors get paid only if they are actually called in.

The seriousness of the crisis and the shortage of doctors — especially specialists — on the Big Island was illustrated vividly last April when a Keauhou resident wrote a letter to the editor of West Hawaii Today praising Kona Community Hospital for finding an orthopedic physician for his wife after she was told she would have to wait almost a week to have her broken leg set because no doctors had openings until then.

The Physician On-Call Crisis Task Force, in its report to the Legislature, cites insufficient government reimbursements, high malpractice insurance and a shortage of specialists — especially on the neighbor islands — as the primary problems. Doctors working in emergency rooms think they are more likely to get sued because of the nature of the emergency and not knowing the patients’ medical history.

Government reimbursements through Medicaid and Medicare are running 15 percent to 25 percent lower than private-sector charges, the task force found. Total call-related costs for the 2005 fiscal year ran to $30.9 million, according to the Healthcare Association of Hawaii. The bulk of that — $22.9 million — was the cost of physicians, with only $8 million going to facilities.

But other factors play a role as well, the task force concluded.

Doctors in Hawaii tend to be older, and they may have moved to the state because of a lifestyle preference to relax more. Being on call is disruptive to that. Younger doctors who have borrowed heavily for their education, on the other hand, are more often attracted to states that pay better — and have a lower cost of living.

Insurance Commissioner J.P. Schmidt, chairman of the task force, said the task force did what it could, but he wants the Legislature to pay for a more in-depth study.

“To really get to the heart of it, we felt we needed a professional study,” Schmidt said. “The medical malpractice issue continually comes up, but it’s a problem with multiple facets.”

Certainly, medical malpractice insurance reform will play a role.

The Hawaii Health Systems Corporation will likely ask the Legislature to provide immunity to physicians performing Good Samaritan activities, said Vice President for Public Affairs Miles Takaaze. He said HHSC is also looking at call compensation for physicians as well as more on-call contracts.

The state House is considering some immunity for certain types of physicians in certain situations, said House Majority Leader Kirk Caldwell, D-Manoa, Manoa Valley.

Green said the House Health Committee has already taken some steps to earmark money from tobacco funds for a trauma special fund, which will provide for physicians as well as trauma care facilities. The fund, created last year, will start providing about $15 million a year for trauma care after two years, he said.

“If there is no other way to get the on-call care we need without the state paying for it, then I’ll have the state pay for it until we get a better solution,” Green vowed.

Posted: local, health

Medical Side Effects0

Medicine tries to improve lives for people. Many times that works, sometimes it doesn’t. And sometimes you need to come up with the next big thing to take medical technology forward. Three recent, seemingly unrelated, bits of news on suicides, antidepressants, circumcision, HIV, breast cancer, and hormones.

(Originals found here and here and here.)

FDA may expand antidepressant warning
By ANDREW BRIDGES
WASHINGTON

Antidepressants increase the risk of suicidal behavior for people up to age 24, the government said Wednesday. It plans new warning labels and says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at a meeting of outside advisers on the issue. The changes also would include a recommendation for careful monitoring, especially when patients are beginning treatment.

Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them.

In emotional testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for the new warnings.

Suzanne Gonzalez, shouting and in tears, goaded the panel to action, telling the experts that her 40-year-old husband who had been taking Paxil shot himself.

“I wake up every morning thinking, ‘Oh my God, he’s dead. He is freaking dead.’ Do you wake up and think, ‘How many people are going to die today because I am doing nothing?’” Gonzalez asked.

Still, mental health experts worry that additional warnings could curtail use of the drugs and ultimately do more harm than good.

Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients.

“We can do more good by providing more treatment for depressed children and adults,” Mann said.

The FDA proposed the changes after completing a review that found use of the drugs may increase the risk of suicidal thoughts and behavior among young adults 18 to 24, as well as among younger patients.

Psychiatrists testified Wednesday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 — and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, said Dr. Thomas Laughren, director of the FDA’s division of psychiatry products.

Expanding the “black box” or other warnings on the drugs could dissuade patients from seeking or starting treatment, mental health experts said. They warned that people with untreated depression — about half of those who suffer from the disease — face an estimated 15 percent greater likelihood of death by suicide.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of “Prozac Backlash,” said expanding the warnings wouldn’t scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated though small and short-term risk for suicidal thoughts and behavior among adults 18 to 24, the FDA said in documents released ahead of Wednesday’s meeting of its psychopharmacologic drugs advisory committee.

The FDA’s analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.

In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults and added that to the drug’s label.

“Anytime suicide is involved it is a tragic outcome. It is one of the things that keeps us motivated to search for better treatments because depression can be a fatal illness,” GlaxoSmithKline spokeswoman Mary Anne Rhyne said.

On the Net:
FDA on the use of antidepressants in children, adolescents and adults:
http://www.fda.gov/cder/drug/antidepressants/default.htm

and

Circumcision Shown to Slow Spread of HIV in Africa
By Craig Timberg
Washington Post Foreign Service
Thursday, December 14, 2006; A01

JOHANNESBURG, Dec. 13 — Two major studies released Wednesday confirmed that circumcision can dramatically slow the spread of HIV among African men, suggesting that widely offering the procedure could prevent millions of deaths in countries most seriously affected by AIDS, researchers said.

The studies, in Kenya and Uganda, found that circumcised men are about 50 percent less likely to contract HIV than those who are not, a result that echoed similar research last year from South Africa. In all three studies, the results were so persuasive that researchers stopped their experiments several months early and offered circumcisions to all of the subjects, deeming it unethical to withhold a procedure that might prevent an often-fatal disease.

The results appeared to dispel lingering doubt that circumcision protects men from AIDS. But it only sharpened questions about whether it is possible to offer the procedure widely enough to slow an epidemic that kills millions of people each year, mostly poor Africans with scant access to safe, modern medical facilities.

“People are dying,” said Bertran Auvert, a French researcher who led last year’s study in South Africa. “We must do it. It’s an ethical obligation. I’m not saying we need to circumcise people, but we must be making it accessible, affordable and widely available.”

Circumcision, which removes the foreskin from a man’s penis, eliminates the cells most vulnerable to HIV infection, researchers say. A circumcised penis also develops thicker skin that’s resistant to infection. A separate study underway in Uganda is attempting to determine whether, as some researchers believe, a circumcised man also is less likely to transmit the virus to his sexual partners.

Jews and Muslims routinely circumcise their sons, but the procedure has remained controversial in some areas of the world, with critics saying it diminishes sexual sensation while providing no meaningful medical benefits.

Most African tribes historically performed ritual circumcisions as adolescent boys became men, but the practice has been declining as the continent has Westernized and traditional practices have been abandoned. Studies have long shown that areas with the highest HIV rates — South Africa, Botswana, Swaziland, Zimbabwe and others — have low circumcision rates. And in West Africa, where circumcision remains common, HIV rates are far lower.

Researchers announcing Wednesday’s results in a conference call from the National Institutes of Health in Bethesda cautioned that circumcision should be used only as part of a broad prevention strategy, and they emphasized that its effect is limited.

In each study, thousands of men were recruited and half were circumcised. Both groups were counseled, urged to use condoms and routinely tested for HIV. The study found no significant difference in the sexual behavior between the two groups, yet they contracted HIV at sharply different rates.

In Rakai, Uganda, among 4,996 men, 22 of those who were circumcised and 43 of those who weren’t contracted HIV, a difference of 48 percent. In Kisumu, Kenya, among 2,784 men, 22 of those who were circumcised and 47 of those who weren’t contracted HIV, for a difference of 53 percent.

The protection was less than reported by the South African study, which estimated that circumcised men lowered their risk by about 60 percent, but higher than that provided by most potential vaccines under development.

But if the procedure was offered widely in countries with high rates of HIV, it might prevent “many tens of thousands, maybe hundreds of thousands, maybe even millions of infections over time,” said Kevin De Cock, director of HIV/AIDS for the World Health Organization, speaking on the conference call.

A study reported in the July issue of PloS Medicine, an open-access journal published online by the nonprofit Public Library of Science, estimated that over 20 years male circumcision could prevent more than 5 million new infections and 3 million deaths in sub-Saharan Africa.

“This could be a very historic thing for HIV prevention, especially in Africa,” said Daniel Halperin, a Harvard University AIDS prevention researcher and longtime advocate of expanding access to circumcision. He spoke from Harare, Zimbabwe, where he was traveling.

Perhaps the most serious obstacle to offering circumcisions is the widespread shortage of facilities and trained medical personnel. Surveys in several countries show high interest in circumcision, but even the $20 or $30 cost of the procedure is a hindrance for many.

Only a significant investment from major outside donors could build capacity quickly, researchers say.

Several United Nations agencies and the World Bank issued a joint statement on Wednesday noting “with considerable interest” the study results but stopping far short of committing new resources. A statement from President Bush’s $15 billion anti-AIDS program said it will support offering circumcisions in some cases, but only after international guidelines have been developed.

The announcement of the study results nonetheless culminated a remarkable shift in attitudes about the usefulness of circumcision as an AIDS-fighting tool. Only a few years ago, advocates were widely disregarded as prevention efforts focused heavily on distributing condoms and encouraging abstinence among youth. Even last year’s South African study was regarded warily by some experts and governments.

The South African government moved to sharply restrict the procedure this year because of concerns about the safety of traditional, ritual circumcisions. And the U.S. government, saying the usefulness of circumcision needed more study, suspended funding in October for a small pilot program in Swaziland that offered subsidized circumcisions in a country where about one-third of adults have HIV.

The tone was different on Wednesday. “This is not iffy data. This is serious data,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, in the conference call with reporters.

and then

Breast Cancer Rates Drop Dramatically
By MARILYNN MARCHIONE
The Associated Press
Thursday, December 14, 2006; 5:35 PM

SAN ANTONIO — U.S. breast cancer rates plunged an unprecedented 7 percent in 2003, the year after millions of women stopped taking menopause hormones when a study showed the pills raise the risk of tumors.

The startling new analysis, reported Thursday at the San Antonio Breast Cancer Symposium, does not prove a link between hormone therapy and breast cancer, but strongly suggests it, many experts said.

“When I saw it, I couldn’t believe it,” statistician Donald Berry of the University of Texas M.D. Anderson Cancer Center in Houston said of the drop.

Cancers take years to form, so going off hormones would not instantly prevent new tumors. But tumors that had been developing might stop growing, shrink or disappear so they were no longer detected by mammograms, doctors theorized.

Cases dropped most among women 50 and older _ the age group taking hormones. The decline was biggest for tumors whose growth is fueled by estrogen _ the type most affected by hormone use.

The drop was seen in every single cancer registry that reports information to the federal government, and no big change occurred with any other major type of cancer. These are strong signs that the breast cancer decline is no statistical fluke or error.

“It’s a big deal … amazing, really,” said another of the researchers, Dr. Rowan Chlebowski of Harbor-UCLA Medical Center in Los Angeles. “It’s better than a cure” because these are cases that never occurred, he said.

About 200,000 cases of breast cancer had been expected that year; the drop means that about 14,000 fewer women actually were diagnosed with the disease.

A separate study by the American Cancer Society, currently in press with a medical journal, also documents the drop. Lead author Ahmedin Jemal attributes two-thirds of it to a decline in hormone use and the rest to mammography use leveling off, resulting in fewer tumors being detected.

“We are really trying to look at the big picture,” he said. “You cannot rule out the effect of screening.”

Breast cancer is the most common major cancer in American women and the second leading cause of cancer deaths in women. About 213,000 new cases are expected to occur in the United States this year and more than 1 million worldwide.

Incidence in the United States rose almost 2 percent per year from 1990 to 1998, then began to slightly decrease, said Dr. Peter Ravdin, the M.D. Anderson doctor who led the new analysis and presented results at the Texas cancer meeting.

In July 2002, the federal Women’s Health Initiative study was stopped after more breast cancers and heart problems occurred among women taking estrogen-progestin pills.

That led to new warning labels on the drugs and doctor groups urging women to use the lowest dose for the shortest time possible for hot flashes and other menopause symptoms.

Within a year, about half of women who had been taking hormones stopped. Prescriptions had been steady at around 22 million each quarter, but plummeted to 12.7 million in the last quarter of 2003, according to IMS Health, which tracks drug sales.

Breast cancer rates declined, too. In 2002, there were roughly 134 cases per 100,000 women _ a 2.5 percent drop from about 137 the previous year. In 2003, there were only 124 cases per 100,000 women _ about a 7 percent drop over 2002. That is the most significant decline in the breast cancer rate since records have been kept beginning in the 1970s.

(Rates are used rather than raw numbers because they give a better picture of the situation as the population shifts and ages.)

Researchers saw an even stronger trend when they looked month-to-month. Cases dropped 6 percent in the first half of 2003 and 9 percent in the second half.

Estrogen-sensitive tumors declined twice as much as tumors that are not fueled by estrogen. The decline in incidence among women ages 50-69 was three times that of other age groups.

The numbers come from the National Cancer Institute’s surveillance database, which uses cancer registries around the country to project national incidence and death rates.

When the 2003 numbers were first released a few months ago, they were grouped with 2001 and 2002 and portrayed as a leveling off of breast cancer after decades of steady rise. The big single-year drop was not pointed out.

“You don’t want to overinterpret one point” without knowing whether it is a trend, said Kathy Cronin, a National Cancer Institute statistician who worked on the new analysis.

“The major health organizations have been cautious because of not wanting to call attention to something of this much interest to everyone prematurely,” said Dr. Michael Thun of the cancer society.

Ravdin disagreed.

“It doesn’t have to be a trend to be real,” he said. “Such a rapid effect is most consistent with the idea that cancers that were already there … were actually being stopped in their growth to the point where they would not be detected.”

It is not known whether these tumors will regress and never become a problem or just take longer to show up, he said.

However, doctors already know that withdrawing hormones causes tumors to shrink. If a woman with estrogen-sensitive breast cancer has her ovaries removed, “her tumor will stop growing immediately,” Ravdin said.

Dr. JoAnn Manson, a women’s health expert at Harvard-affiliated Brigham and Women’s Hospital in Boston who has a new book out on hormones and menopause, thinks the big drop in breast cancer cases could be due to hormones, “especially a reduction in long duration of use.”

“It’s also possible that a trend toward lower doses of hormones has played a role,” she said.

She and other doctors are continuing to study women in the big federal study who had been on hormones and then quit.

Federal statistics for 2004 are expected in April. Information from one large registry, California’s, published recently in the Journal of Clinical Oncology, hints that the trend is continuing.

On the Net:
San Antonio Breast Cancer meeting: http://www.sabcs.org
Hormone study: http://www.nhlbi.nih.gov/whi/index.html
Government’s cancer report:
http://www.cancer.gov/newscenter/pressreleases/ReportNation2005release
American Cancer Society: http://www.cancer.org
National Cancer Institute: http://www.cancer.gov

Posted: health

Designing Perfection in Babies0

Good and bad is often hard to separate. Genetics hold the promise of perfect babies. But what’s perfect to me may not be perfect to you. So if disabled parents want to turn a non-disabled baby into a baby just like them to better raise them, what’s wrong with that?

Everything! you say. But really, how is their decision so different from yours? Because their decision does not make things better for the child? But why wouldn’t it? Because the baby has no say in the matter? But it doesn’t have one in your decision either.

It’s somewhat presumptious for somelike non-disabled (and really that’s just a label we slap on something) to know what’s better for somebody disabled. If you enable DNA selection for one set, you might have to enable it for all sets, even if that’s reprehensible to you. You could choose to not be selfish, and just leave the entire genie in the box.

(Original found here.)

Playing with DNA
Some ponder designer’ babies
By Lindsey Tanner - AP Medical Writer

CHICAGO - The power to create “perfect” designer babies looms over the world of prenatal testing.

But what if doctors started doing the opposite?

Creating made-to-order babies with genetic defects would seem to be an ethical minefield, but to some parents with disabilities - say, deafness or dwarfism - it just means making babies like them.

And a recent survey of U.S. clinics that offer embryo screening suggests it’s already happening.

Three percent, or 4 clinics surveyed, said they have provided the costly, complicated procedure to help families create children with a disability.

Some doctors have denounced the practice, others question whether it’s true. Blogs are abuzz with the news, with armchair critics saying the phenomenon, if real, is taking the concept of designer babies way too far.

“Old fear: designer babies. New fear: deformer babies,” the online magazine Slate wrote, calling it “the deliberate crippling of children.”

But the survey also has led to a debate about the definition of “normal” and inspires a glimpse into deaf and dwarf cultures where many people do not consider themselves disabled.

Cara Reynolds of Collingswood, N.J., who considered embryo screening but now plans to adopt a dwarf baby, is outraged by the criticism.

“You cannot tell me that I cannot have a child who’s going to look like me,” Reynolds said. “It’s just unbelievably presumptuous and they’re playing God.”

Embryo screening, formally called preimplantation genetic diagnosis, is done with in vitro fertilization, when eggs and sperm are mixed in a lab dish and then implanted into the womb. In PGD, before implantation, a cell from a days-old embryo is removed to allow doctors to examine it for genetic defects.

The entire procedure can cost more than $15,000 per try.

The survey asked 415 clinics to participate, 190 responded and 137 said they have provided embryo screening. The most common reason was to detect and discard embryos with abnormalities involving a missing or extra chromosome, which can result in miscarriage or severe and usually fatal birth defects.

The survey is being published in an upcoming print edition of the medical journal Fertility and Sterility. It appeared in the online edition in September. Clinics were asked many questions about PGD, including whether they’d provided it to families “seeking to select an embryo for the presence of a disability.”

“We asked the question because this is an issue that has been raised primarily by bioethicists as something that could happen,” said Susannah Baruch of Johns Hopkins University’s Genetics and Public Policy Center.

“It’s sparking a lot of conversations,” she said. “These are difficult issues for everybody.”

While it’s technologically possible, whether any deaf or dwarf babies have been born as a result of PGD is uncertain. The survey didn’t ask. Participating clinics were promised anonymity, and seven major PGD programs contacted by The Associated Press all said they had never been asked to use the procedure for that purpose.

PGD pioneer Dr. Mark Hughes, who runs a Detroit laboratory that does the screening for many fertility programs nationwide, said he hadn’t heard of the technology being used to select an abnormal embryo until the survey.

“It’s total nonsense,” Hughes said. “It couldn’t possibly be 3 percent of the clinics” doing PGD for this purpose “because we work with them all.”

He said he wouldn’t do the procedure if asked.

“To create a child with a disability because a parent wanted such a thing … where would you draw the line?” Hughes wondered.

“It’s just unethical and inappropriate, because the purpose of medicine is to diagnose and treat and hopefully cure disease,” he said.

For the same reasons, Yury Verlinsky, another PGD pioneer and director of Chicago’s Reproductive Genetics Institute, said he also would shun those requests.

Dr. Jeffrey Steinberg, whose Fertility Institutes clinics in Los Angeles, Las Vegas and Guadalajara, Mexico, screen embryos for sex selection, said he’d likely consult ethicists if he were ever asked to help couples select a deaf or dwarf baby.

“Clearly it crosses some bounds,” he said.

He’d get a provocative response from University of Minnesota bioethicist Jeffrey Kahn.

“It’s an ethically challenging question and certainly it will trouble people, but I think there are good, thoughtful reasons why people who are deaf or … dwarves could say, ‘I want a child like me,”‘ Kahn said.

The traits are, for some, an important part of their cultural identity.

“If people in a shared culture all have the common clinical defect, then it’s maybe not a defect in the traditional sense,” Kahn said.

More challenging would be if normal-sized parents said they wanted a dwarf child, and yet, he added, “Why is that different from dwarf parents saying, ‘We want only an average-size child?”‘

Dr. Jamie Grifo of New York University, a past president of the Society for Assisted Reproductive Technology, has done embryo screening for more than a decade and said if it is being used to choose defective embryos, it certainly isn’t common. Cost is one thing. But IVF alone requires weeks of injections with ovary-stimulating drugs and surgery, and couples generally have a less than 50-50 chance of a baby with each IVF-PGD cycle, Grifo said.

Grifo said he wouldn’t oppose embryo screening to select a baby with a genetic defect if the parents have been informed of the pros and cons, risks and benefits.

“In our society, people are so quick to have knee-jerk reactions to something that’s none of their business,” he said.

Despite some teasing and childhood surgery to fix dwarfism-related bone deformities, Reynolds said she considers herself “very lucky. I have a wonderful husband and a beautiful life.”

Their newborn daughter died last year from a devastating dwarfism-related disease called homozygous achondroplasia. Dwarf couples have a 25 percent chance of having babies afflicted with the lethal condition, the same odds of having “normal” children, but a 50 percent chance of having dwarf children.

When the couple consulted a specialist earlier this year about embryo screening to avoid a similar tragedy, they discussed implanting dwarf or non-dwarf embryos.

“A healthy dwarf embryo is a healthy embryo. It’s a kid who’s going to go to school, go to college and make friends,” Reynolds said she told the specialist, and he wasn’t opposed to the idea. But she decided against the procedure because her insurance didn’t cover it and her age - 39 - limited chances for success.

Karen Krogstad, a 25-year-old partly deaf student in Bozeman, Mont., said she understands why parents “would go to great lengths to make sure their child will be deaf.”

She and her deaf friends “see ourselves as fully functional human beings who can’t hear. People who wear glasses, are they disabled? No, but if you have hearing aids, to assist with hearing, you are labeled as disabled.”

Krogstad said she wants children someday and would be happy with a deaf or non-deaf child. But she said she wouldn’t use embryo screening to have a deaf child “because I think it is wrong to choose the perfect baby.”

Posted: health