October 17, 2006

New Diabetes Drug

This might be of interest to my fellow diabetics.

Diabetics gained a new way of controlling their blood sugar levels Tuesday with federal approval of a novel pill for Type 2 diabetes, which affects about 20 million Americans.

The Food and Drug Administration said it approved Januvia, which enhances the body's own ability to lower blood sugar levels, after clinical trials showing the new pill works just as well as older diabetes drugs, but with fewer side effects like weight gain. The drug is made by Merck and Co. Inc.

* * *

Januvia, also known as sitagliptin phosphate, works with a one-two punch: It increases levels of a hormone that triggers the pancreas to produce more insulin to process blood sugar while simultaneously signaling the liver to quit making glucose. The pill does that by blocking production of an enzyme, called DPP-4, that normally inactivates that hormone.

Unfortunately, this drug may be out of reach for many Americans -- rather than the current $15.00 to $30.00 a month cost for the most common generic diabetes drugs, this one will cost nearly $150.00. Whether and when insurance companies will cover the medication and at what price level is unknown at this time.

Novartis is expecting approval of a similar medication by year's end.

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October 15, 2006

***AN IMPORTANT WARNING FOR DIABETICS (Bumped To Top For The Weekend)***

IF YOU USE A ONETOUCH METER FOR GLUCOSE MONITORING, YOU MUST READ THE INFORMATION BELOW. YOUR HEALTH MAY DEPEND UPON IT!

The government warned diabetics to watch for counterfeit versions of test strips used to monitor blood sugar levels. The strips, for use in glucose monitors made by a Johnson & Johnson company, were distributed nationwide, the Food and Drug Administration said. The strips are for use with various models of LifeScan Inc.Â’s OneTouch brand of blood glucose monitors. LifeScan is part Johnson & Johnson. Diabetics who bought the strips should stop using them, replace them and call a doctor, the F.D.A. said. The counterfeits are: OneTouch Basic/Profile, lot numbers 272894A, 2619932 and 2606340. The 50-count packages are labeled in English and French; and OneTouch Ultra, lot number 2691191. The 50-count packages are labeled in English, Greek and Portuguese.

I'd like to commend the New York Times for putting this story on its front page with the health news. While I wish it were higher up on the page, it is the only place I have seen this news about this important issue involving the sort of meter I currently use (no, I don't have the fake strips).

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August 23, 2006

Hope For Hurwitz – And Chronic Pain Patients

I’ve mentioned more than once that my dear wife suffers from a cluster of chronic neurological conditions which are degenerative and result in chronic pain. We have been fortunate that her doctors take her seriously and are willing to prescribe therapeutic dosages of appropriate pain medications.

Unfortunately, state and federal regulators have been going after doctors in the pain management field for prescribing such medications at therapeutic levels, second-guessing the medical judgments of physicians. One recent conviction really had me disturbed – but it has now been overturned on appeal.

A federal appeals court threw out the conviction of William E. Hurwitz yesterday, granting the prominent former Northern Virginia pain-management doctor a new trial because jurors were not allowed to consider whether he prescribed drugs in good faith.

The decision again galvanized the national debate that the Hurwitz case had come to symbolize: whether fully licensed doctors prescribing legal medication to patients in chronic pain should be subject to prosecution if their patients abuse or sell the drugs. Patient advocate groups strongly supported Hurwitz and expressed concern that his conviction would have a chilling effect on pain doctors.

The Richmond-based U.S. Court of Appeals for the 4th Circuit acknowledged that prosecutors presented "powerful" evidence at Hurwitz's trial that was "strongly indicative of a doctor acting outside the bounds of accepted medical practice." Hurwitz was convicted in December 2004 of running a drug conspiracy from his McLean office, causing the death of one patient and seriously injuring two others.

But a three-judge panel concluded that U.S. District Judge Leonard D. Wexler improperly told jurors that they could not consider whether Hurwitz acted in "good faith" when he prescribed large amounts of OxyContin and other painkillers -- in one instance, 1,600 pills a day.

"We cannot say that no reasonable juror could have concluded that Hurwitz's conduct fell within an objectively-defined good-faith standard," the judges wrote, adding that Hurwitz presented evidence that he ran a legitimate medical practice and believed that his prescriptions were "medically proper."

Patient and medical advocates hailed the decision. "It's about time that courts start to realize that these are doctors, not drug dealers," said Kathryn Serkes, a spokeswoman for the Arizona-based Association of American Physicians and Surgeons.

While my wife is not – quite – on as much medication as this doctor was prescribing, her dosages are increasing as her symptoms worsen. I would hate to think that her medical team would ever have to face a choice between giving her enough medication or staying out of jail.

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Hope For Hurwitz – And Chronic Pain Patients

IÂ’ve mentioned more than once that my dear wife suffers from a cluster of chronic neurological conditions which are degenerative and result in chronic pain. We have been fortunate that her doctors take her seriously and are willing to prescribe therapeutic dosages of appropriate pain medications.

Unfortunately, state and federal regulators have been going after doctors in the pain management field for prescribing such medications at therapeutic levels, second-guessing the medical judgments of physicians. One recent conviction really had me disturbed – but it has now been overturned on appeal.

A federal appeals court threw out the conviction of William E. Hurwitz yesterday, granting the prominent former Northern Virginia pain-management doctor a new trial because jurors were not allowed to consider whether he prescribed drugs in good faith.

The decision again galvanized the national debate that the Hurwitz case had come to symbolize: whether fully licensed doctors prescribing legal medication to patients in chronic pain should be subject to prosecution if their patients abuse or sell the drugs. Patient advocate groups strongly supported Hurwitz and expressed concern that his conviction would have a chilling effect on pain doctors.

The Richmond-based U.S. Court of Appeals for the 4th Circuit acknowledged that prosecutors presented "powerful" evidence at Hurwitz's trial that was "strongly indicative of a doctor acting outside the bounds of accepted medical practice." Hurwitz was convicted in December 2004 of running a drug conspiracy from his McLean office, causing the death of one patient and seriously injuring two others.

But a three-judge panel concluded that U.S. District Judge Leonard D. Wexler improperly told jurors that they could not consider whether Hurwitz acted in "good faith" when he prescribed large amounts of OxyContin and other painkillers -- in one instance, 1,600 pills a day.

"We cannot say that no reasonable juror could have concluded that Hurwitz's conduct fell within an objectively-defined good-faith standard," the judges wrote, adding that Hurwitz presented evidence that he ran a legitimate medical practice and believed that his prescriptions were "medically proper."

Patient and medical advocates hailed the decision. "It's about time that courts start to realize that these are doctors, not drug dealers," said Kathryn Serkes, a spokeswoman for the Arizona-based Association of American Physicians and Surgeons.

While my wife is not – quite – on as much medication as this doctor was prescribing, her dosages are increasing as her symptoms worsen. I would hate to think that her medical team would ever have to face a choice between giving her enough medication or staying out of jail.

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June 27, 2006

Talk To Your Doctor

If you take beta blockers for blood pressure, it is important that you raise this issue on your nect visit. I know I will.

Two million Britons are to be taken off blood pressure drugs after studies showed they increase the risk of strokes, heart attacks and diabetes.

From today, beta blockers will no longer routinely be prescribed for high blood pressure.

The dramatic change in guidance follows evidence that the drugs taken daily by millions of Britons are only half as effective at stopping strokes than a host of newer pills.

Beta blockers such as atenolol also raise the risk of stroke and of developing diabetes, compared with other blood pressure tablets.

I'm on one of the medications mentioned later in the article. I'm not happy about the findings about the family of drugs.

Studies have shown that beta blockers are only half as effective at stopping strokes as other blood pressure treatments.

Last year, a study of 20,000 patients showed that treatment with beta blockers cut the risk of stroke by 20 per cent, compared to no treatment at all.

In contrast, the newer treatments prevent 40 per cent of strokes and 15 per cent more heart attacks.

Patients on beta blockers are also up to 30 per cent more likely to develop diabetes.

Beta blockers such as atenolol, bisoprolol and metoprolol also have worse side effects, including fatigue, loss of libido and impotence.

Professor Bryan Williams, who helped draw up the new guidelines, said: 'For the majority of patients, we no longer recommend beta blockers as a first line option for treatment.

Now the question that I'm curious about is financial -- given the benefits of covering the newer, better medications, will insurance companies move these drugs to a lower co-pay tier so as to lower their overall costs of treating patients, saving both them and patients money in the long run.

'They are less effective at controlling blood pressure, less effective at preventing events (strokes and heart problems) and they are more likely than other treatments to increase the risk of developing diabetes.

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June 15, 2006

Stem Cell Solution

Many of us have grave moral concerns about the methods used to harvest fetal stem cells for medical research. The creation of human life in order to snuff it out for purposes of scientific research is both ghoulish and morally repugnant in our eyes. And yet many of us also believe the research itself is of vital importance -- in my case out of a heartfelt desire to see my wife's illness arrested and reversed. Folks like me cling to the hope that research on adult stem cells will produce treatments and cures -- and agonize over the moral questions raised by fetal stem cell research.

And so it is with great joy and hope that I post this information.

Stem cell scientists in the United Kingdom are reporting today a gene discovery that suggests a way to take adult cells back to an embryonic state -- a discovery that could help treat diseases without relying on controversial human embryonic stem cells or cloning.

The ultimate goal would be to use a patient's own cells as the starting material for a new kind of regenerative medicine. But scientists insisted that they will need to use embryonic cells for the foreseeable future to perfect the new techniques.

A team led by Austin Smith at the University of Edinburgh's Institute for Stem Cell Research published the latest results online in the journal Nature. The study used mouse cells to investigate the critical role of one gene in the process by which a stem cell, when fused to a more specialized adult stem cell found in the brain, reprograms the brain cell into a primitive state.

Reprogramming adult cells to give them this core trait of an embryonic stem cell could dramatically reshape both the science and politics of the stem cell field, which is fraught with controversy because the embryonic stem cells require the destruction of human embryos.

For example, reprogramming could make it possible to generate from a patient's skin cells customized cells of other types that had been destroyed by spinal cord injury or diseases such as Parkinson's or diabetes. Self-renewing lines of human cells also might be used to study how genetic diseases come about and how treatments could affect the disease process.

Smith said in an interview that reprogramming could take at least another year of experimental work to be well understood. Yet it no longer seems the deep mystery it was before the latest studies, which reveal the role of a gene known as "nanog."

Smith called nanog "the key gene in the process."

"We thought this was something that would take us a very long time to work out, but now this changes from being a black box to something we can work to understand," he said.

May this research be fruitful and produce results that avoid the moral concerns that current methods raise.

UPDATE: Tammy Bruce writes on this topic here.

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June 14, 2006

But They Claim To Be For Free Markets

The AMA is at it again – and your doctor may be looking to pick your pocket, or have the government do it.

Millions of upper-income Americans refuse to buy health insurance because they're young and healthy and figure they don't need it.

But now the American Medical Association wants to force them to buy coverage.

At its annual meeting in Chicago on Tuesday, the nation's largest doctors' group called for mandatory health insurance for anyone who makes more than five times the poverty level. That works out to $49,000 for an individual and $100,000 for a family of four.

No one would go to jail for refusing to buy coverage. The AMA instead suggested using the tax code to force compliance. There would be incentives such as tax credits for people who buy insurance and higher taxes for those who don't.

Of the 46 million uninsured Americans, about 5 million, or 11 percent, make more than five times the poverty level. The AMA said these people burden the health care system when they incur catastrophic medical bills they can't afford to pay. The cost gets passed on to those who largely pay for the health care system: taxpayers, employers and the insured.

"Society should not be penalized by the potential costly medical treatments of those uninsured who can afford to purchase health insurance coverage," an AMA report said.

Now I think it is stupid not to have health insurance. I cannot imagine doing without, but I understand that others may decide differently. That is a case of the free market at work. And we all know that mandatory health insurance will push prices higher, as companies have less incentive to compete for business.

On the other hand, the AMA doesnÂ’t want to take any action here.

Delegates defeated a resolution calling for price controls on prescription drugs.

Supporters of the resolution said drug companies make "excessive profits" and pay millions of dollars in salaries and perks to executives. Price controls would make drugs more affordable, they said.

But opponents said price controls would violate the AMA's long-standing support of free-market competition.

After all, that might cut the freebies that doctors get from those drug companies. That must be the free market they are concerned about.

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June 08, 2006

A Proper Decision

I applaud the approval of the vaccine – would that we could find more vaccines against cancers of various types.

The first vaccine to protect against most cervical cancer won federal approval Thursday.

The vaccine Gardasil, approved for use in girls and women ages 9 to 26, prevents infection by four strains of the human papillomavirus, or HPV, Merck & Co. Inc. said. The virus is the most prevalent sexually transmitted disease.

Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases.

Merck is expected to market Gardasil as a cancer, rather than an STD, vaccine. It remains unclear how widespread will be the use of the three-shot series, in part because of its estimated cost of $300 to $500. Conservative opposition to making the vaccine mandatory for school attendance may also curb its adoption.

The target age for receiving Gardasil is low because the vaccine works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine may not protect people already infected and may increase their risk of the kind of lesions that can lead to cervical cancer, the FDA has said.

The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if a vaccine is to become a standard of care.

It is this last part that concerns me. Some argue for making the vaccine mandatory for students as a condition of being allowed to receive an education . This is not a vaccine that stops a disease readily communicable like whooping cough, polio, or smallpox. We do not require a flu shot, despite the fact that influenza runs rampant in the bacterial and viral incubator that is a school classroom. To require a shot for what is, in the end, a SEXUALLY TRANSMITTED DISEASE intrudes upon the right of parents to make medical decisions for their children and to determine their upbringing in regard to sexual morality.

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May 22, 2006

An Unacceptable Mandate

Let’s be clear about this – I support the marketing of Merck’s new vaccine, Gardasil. If I had a daughter, I would have her vaccinated as a precaution against cervical cancer. But I draw the line at the notion of making a vaccination against a disease that is 100% sexually transmitted mandatory for admission to public schools.

The drugmaker's efforts to educate Christian groups while touting the vaccine's top selling point -- prevention of cervical cancer -- helped win them over.

But Merck may ultimately find itself at loggerheads with those same groups as it seeks to make the vaccine mandatory for school admission, a step considered key for widespread acceptance and one that many of the groups oppose.

The vaccine, known as Gardasil, with an estimated $2 billion U.S. market potential, targets four types of sexually transmitted human papilloma virus, or HPV, which is believed to cause more than 70 percent of cervical cancer cases and 90 percent of genital warts.

"We don't think it should be made mandatory for school attendance," said Peter Sprigg, vice president of policy at the Family Research Council, who attended the Food and Drug Administration (FDA) advisory panel meeting on Thursday.

That view is shared by evangelical Christian group Focus on the Family.
"We support the widespread availability of the vaccine, but we do oppose the mandatory vaccination for entry to public school," said Linda Klepacki, an analyst for sexual health for the group.

For Gardasil to be widely adopted, Merck must first win FDA approval. Then, it must garner widespread backing from the Advisory Committee on Immunization Practices -- a group that advises the U.S. Centers for Disease Control and Prevention on immunization standards. Both Merck and analysts deem widespread backing likely.

States would then consider whether it should be included in the list of vaccinations required for school admission.

And I do draw the line there. Cervical cancer and genital warts are not transmitted via casual contact. No child is going to catch the human papilloma virus just by sitting in the same classroom with and breathing the same air as a child who has the virus – or even either of the resulting conditions. There is simply no way to make the sort of public health argument that exists for requiring other childhood vaccines as a condition for being allowed into school – unless you want to argue that there is rampant sex taking place in the hallways and classrooms of America, and that this vaccination is the means of preventing the uncontrolled spread of the conditions in question. But if that argument is to be made, then there is a much bigger issue surrounding public education that needs be addressed much more quickly.

Frankly, requiring Gardasil would be no different than requiring Norplant of all female students. After all, the means of transmission for the condition to be prevented is identical, and the “exposure” to the risk of transmission is identically likely to happen outside of school as the means of transmission of genital warts and cervical cancer. Pregnancy, like the human papilloma virus, isn’t being transmitted through the air, in the drinking water, or via toilet seats. The very concept of state-mandated birth control shocks the conscience – why doesn’t state-mandated STD-preventatives cause the same outrage?

I teach high school. I know there are many health needs that go unaddressed among my students. We try to take care of some of them through school breakfast and lunch programs, through school-based health clinics (which are not, contrary to some claims, all about birth control and abortion), and through various health screenings. But we donÂ’t mandate a good breakfast, force-feed kids a healthy lunch, or require anything but the most minimal medical care or diagnostic testing. We donÂ’t even require a flu shot, despite the fact that a classroom is a swirling, seething culture of viruses and bacteria during certain times of the yearThat isnÂ’t our mission. Neither is this, and the advocates of mandatory Gardasil are just setting up one more big-government nanny-state intrusion into family decision-making on child-rearing issues.

And by the way, don’t forget that making the vaccine mandatory will also give Merck $2 billion in mandatory profits every year for the foreseeable future. So is this really about public health – or private profits?

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April 19, 2006

Bureaucratic Bumbling And Peculiar Priorities

Which is more important, medically speaking – aggressive cancer treatment, or tattoo removal? If you are Great Britain’s National Heath Service, the answer is obvious – the tattoo work.

A former sailor who has had a sex-change is to have her tattoos removed on the NHS because she feels "unladylike", it has been revealed.
NHS bosses who agreed the procedure have been criticised for wasting taxpayers' money, as thousands of nurses and doctors lose their jobs in cuts.

Tanya Bainbridge, 57, who was born Brian, wants the tattoos removed so she can wear sleeveless dresses and tops in summer. The procedure reportedly costs £2,500.

Miss Bainbridge, who has nine children - from whom she is now estranged - by three different women, had a £20,000 sex-change operation on the NHS in 2001 at Charing Cross Hospital in London.

Her local primary health care trust will pay for her to visit the hospital again for laser treatment to remove the tattoos.

Miss Bainbridge lives with her boyfriend, Mark, in Middleton, Greater Manchester. They are both unemployed.

Now a faded blue, the tattoos show a ship and a swallow which includes the names of some of her children. She had them done when she served in the Merchant Navy from 1964 to 1976.

Yes, we must help sexually confused ex-sailors with amputated genitalia get themselves into sun dresses. What could possibly be more important?

Certainly not this lady.

Mother-of-three Claire McDonnell, 33, has been refused "wonder drug" Herceptin by Wokingham Primary Care Trust to treat her aggressive form of breast cancer because of its cost.

Mrs McDonnell, from Reading in Berkshire, said the cost of removing Miss Bainbridge's tattoos, £2,500, was the same amount as the initial treatment of Herceptin. She added: "That money could pay for my breast cancer treatment."

Well, come on, how can this woman be so insensitive? ItÂ’s not like she is going to die and leave her children motherless without that medication.

Oh, wait – she will die without that treatment.

I guess NHS just feels there are some sacrifices that must be made in the name of fashion -- and it doesnÂ’t matter how many lives it costs.

Anyone need more reason to object to nationalizing healtcare in the manner advocated by Senator Clinton?

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April 18, 2006

Overcoming Obstacles To Generic Medications

My Darling Democrat takes a lot of medications, due to some serious health issues. We are fortunate to have reasonably decent insurance, but there are still some medications that end up costing us as much as $30, or even $50, each every month because they are brand name drugs -- and other medications that are not a consideration for the same reason. If moreedications were generics, we would be talking about a cost of under $75. Now I understand that the higher-priced drugs are under patent, and the need to recoup development costs. Still, I expect a quick release of a generic after the patent goes off.
That isn't always happening.

The brand-name drug industry is aggressively working to keep blockbuster drugs widely used by the elderly from being sold in cheaper generic versions when their patents expire, the organization that represents pharmacy benefit managers said yesterday.

With an unprecedented number of top-selling drugs scheduled to go off patent within five years, the organization said, branded drug companies are constructing roadblocks to potential savings of $23 billion to seniors and the Medicare system.

"There's an agenda to prevent generics from getting to the market as soon as they could," said Mark Merritt, president of the Pharmaceutical Care Management Association, which conducted the study. The association represents companies that administer prescription drug plans for employers and government programs.

"If they succeed," Merritt said, brand-name drug companies "could reduce the savings significantly."

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, disputed the charge and pointed to the high rate of generic drug usage in the United States as proof that branded companies are not keeping generics off the market. More than 53percent of prescriptions are filled with generic drugs.

"It would be more useful for the Pharmaceutical Care Association to collaborate with physicians and others in the health-care system to help achieve the highest quality of care for patients, and this includes use of new medicines which play a critical role in saving lives and reducing overall health costs," Johnson said.

What would be the cost differential for government if 14 commonly prescribed drugs within 4 years of patent expiration were to go generic immediately upon the expiration? Well, $13 billion just for Medicate -- and that doesn't include Medicaid, VA, and military expenditures. Nor does that take into account the savings to insurance companies (and, by extension, patients) if that happened. As i indicated, we are talking about a cost reduction in my household of some 60-70%. And i won't raise the issue of better outcomes for patients if the medications become more accessible financially.

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April 17, 2006

Good News On Breast Cancer?

Ever since Grandma battled breast cancer some thirty years ago, I have had an interest in this disease. It now appears there is another breakthrough in the prevention of breat cancer -- and it is from a drug that many women take to treat another common medical condition.

A drug used to prevent bones from thinning also offers millions of older women a powerful way to protect themselves against breast cancer, a large government-sponsored study has found.

The study of nearly 20,000 postmenopausal women found that raloxifene reduces their chance of developing breast cancer as effectively as tamoxifen, the only drug previously shown to reduce the risk, but is less likely to cause serious side effects such as uterine cancer and blood clots.

The findings indicate that raloxifene, sold under the brand name Evista, is a safer alternative for the estimated 9 million postmenopausal U.S. women at increased risk for breast cancer, experts said.

"This is good news for women," said Leslie Ford of the National Cancer Institute, which sponsored the $88 million study and released the preliminary findings early because of their public health implications. "Women now have a new option."

Because an estimated 500,000 women use raloxifene to reduce the risk of osteoporosis, many will be more comfortable using it for breast cancer protection, several experts predicted.

I hope that this treatment becomes common very quickly. Too many women I know have had to deal with this form of cancer in their lifetimes, and I would be happy to never hear them used in the present tense again.

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