National “DNA warehouse” bill passes

April 11th, 2008

Passing the House of Representatives on a voice vote, S. 1858 has been sent to President Bush for signature. The Newborn Genetic Screening bill was passed by the Senate last December. The bill violates the U.S. Constitution and the Nuremberg Code, writes Twila Brase, president of the Citizen’s Council on Health Care (CCHC). “The DNA taken at birth from every citizen is essentially owned by the government, and every citizen becomes a potential subject of government-sponsored genetic research,” she states. “It does not require consent and there are no requirements to inform parents about the warehousing of their child’s DNA for the purpose of genetic research. Already, in Minnesota, the state health department reports that 42,210 children of the 780,000 whose DNA is housed in the Minnesota ‘DNA warehouse’ have been subjected to genetic research without their parents’ knowledge or consent.”

The federal government lacks the Constitutional authority as well as the competence to develop a newborn screening program, states Rep. Ron Paul, M.D. (R-TX). He states that all hospitals will probably scrap their own newborn testing program and adopt the federal model, whatever its flaws, to avoid the loss of federal funding.

“Drafters of the legislation made no effort to ensure that these newborn screening programs do not violate the privacy rights of parents and children,” Dr. Paul noted.

Ms. Brase has called on President Bush to veto the bill.

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Insurers under investigation for fraudulent reimbursement rates

April 9th, 2008

New York Attorney General Andrew Cuoma has issued subpoenas to Aetna, Cigna, UnitedHealth, WellPoint, and other insurers in a broadening investigation of possible fraud in setting insurance reimbursements that cost consumers hundreds of millions of dollars. Insurers charge a higher premium to consumers, promising to cover 80% of reasonable and customary rate for out-of-network services. In setting the rates, however, they allegedly used rigged data from Ingenix, Inc. Called an “independent” research firm, Ingenix is actually a wholly owned subsidiary of UnitedHealth Group (Michael Gormley, AP 3/7/08).

“United’s secret black box is the foundation for virtually all insurance payments in New York,” writes Robert Goldberg, D.O., president of the Medical Society of the State of New York. “The lack of external oversight and audit, and Ingenix’s demonstrated indifference to fixing known defects in the database, justifies the Attorney General’s concern” (MSSNY’s News of New York, March 2008).

For an office visit costing $200, United might, for example, claim that the typical rate was only $77. The insurer would reimburse only $62 (80% of $77), leaving the consumer to pay the $138 balance.

“Had it not been for the complaints of non-participating physicians and their patients, this never would have come to light,” writes Lawrence Huntoon, M.D., Ph.D., New York neurologist and editor-in-chief of the Journal of American Physicians and Surgeons. “The conflicts of interest uncovered are astounding.”

The New York Health Plan Association blames the doctors for grossly inflating out-of-network charges (Vanessa Fuhrmans and Theo Francis, Wall Street Journal 2/14/08).

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French judges investigate vaccine manufacturer for manslaughter

March 19th, 2008

In what was called a “thunderclap in the vaccine industry,” French authorities have opened a formal investigation concerning a hepatitis B vaccination campaign by GlaxoSmithKline and Sanofi Pasteur in the 1990s. It is alleged that the companies failed to fully disclose neurologic side effects. Another investigation opened by Judge Marie-Odile Bertella-Geffroy concerns the death (“manslaughter”) of a 28-year-old woman from multiple sclerosis, allegedly connected to the vaccine (Le Figaro 1/31/08).

From 1994 to 1998, almost two-thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was temporarily suspended because of concerns about side effects.

Some 30 plaintiffs, including the families of five patients who died after the vaccination, have launched civil actions (Reuters 1/1/08).

A British case-controlled analysis showed an odds ratio of 3.1 (95% CI 1.5-6.3) for first symptoms of multiple sclerosis in recipients of recombinant hepatitis B vaccine compared to controls. Two previous French studies had shown a RR of about 1.5. Other studies showed a nonsignificant increase or null findings, especially when date of diagnosis rather than date of first symptoms was used (Neurology 2004;63:838-842).

According to attorney Clifford Miller, “British doctors administering hepatitis B vaccine to infants could face criminal prosecution if fully informed consent is not obtained. Civil prosecution for damages is possible over 21 years later if the injured survive as adults” (UK Press Association Newswire/Romeike, September 2005).

The hepatitis B vaccine has been considered “one of the safest vaccines ever produced” (Neurology, op. cit.). On the other hand, French medical expert Marc Girard has said that “for a preventive measure, hepatitis B is remarkable for the frequency, variety and severity of complications from its use” (Romeike, op.cit.)

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Registry for egg donors proposed after young woman dies of colon cancer

March 15th, 2008

After her daughter died at age 31 of colon carcinoma, Dr. Jennifer Schneider of Tucson wondered whether three cycles of egg donation might have been related. She is asking Congress to create a registry of egg donors. Research on the long-term effects of egg donation are not now possible because many donations are anonymous, and there is little, if any, follow-up care.Most prospective donors “don’t know the difference between being told ‘We don’t know of any significant long-term risks’ and ‘There are no significant long-term risks,’” Dr. Schneider said.

High doses of hormones are taken prior to the donation. Jessica Grace Wing had started donating eggs at age 25. She was diagnosed with advanced colon carcinoma at age 29. Her mother recently read a 1998 article in the British journal Human Reproduction, which reported a case of a woman who had donated her eggs, then died of colon cancer (Tucson Citizen 3/5/08).

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Vaccine compensation fund to pay award to autistic girl; broad implications feared

March 10th, 2008

Although an attorney representing the federal government said that it “has not conceded that vaccines cause autism,” Associated Press headlines read that “officials concede vaccines’ link to illness like autism” (AP 3/6/08). Petitioner Hannah Joling, now 9 years old, received 5 vaccines at once in 2000. According to a document that AP obtained from the U.S. Department of Health and Human Services, this aggravated an underlying mitochondrial disorder, causing metabolic dysfunction manifesting as worsened brain function with features of autistic spectrum disorder.

The document drew no conclusions as to the role of thimerosal. The government has previously denied any link at all between vaccine components and autism.

A Portuguese study suggested that 7% of autistic children might have a mitochondrial disorder, compared to 0.02% in the whole population.

Stories are conflicting about the time of onset of Hannah’s symptoms. Some state that she had suggestive symptoms at age 3 months; others that she was developing normally until the vaccines were given at 19 months. Her father Jon Poling, M.D., Ph.D., a neurologist, and mother, who is a lawyer and nurse, contend that the vaccines were also responsible for their daughter’s mitochondrial disorder (Kent Heckenlively, Age of Autism 3/5/08).

The family has filed a request with the court to unseal the documents on the case. A spokesman for the U.S. Department of Justice, which represents the government in all cases, refused to grant interviews or to explain to the Atlanta Journal-Constitution why it isn’t releasing the records (Alison Young, Atlanta Journal-Constitution 3/6/08).

The 5,000 families seeking compensation for autism or other developmental disorders they blame on vaccines are encouraged by the decision, the first of its type. However, each case needs to be proved on its own merits, and the decision is so narrowly worded that it may not be a helpful precedent.

Whatever the cause, the number of children receiving Supplemental Social Security Income (SSI) for disability has more than tripled in 20 years. In 1960, only 1.8% of U.S. children or adolescents were said by their parents to have a limitation of activity due to a health condition of more than 3 months’ duration; this rate had increased to more than 7% by 2004. Conditions include obesity, asthma (which has doubled since the 1980s), and attention-deficit/hyperactivity disorder (ADHD, affecting some 6% of schoolchildren).

Potential causative factors, according to JAMA, include maternal smoking (although its prevalence has decreased), poverty (which is stable), and “fast foods.” The only suggested role for the large increase in the number of vaccines is that less or less normal stimulation of the immune system, owing to less exposure to viral infections in early childhood, could cause greater susceptibility to allergens (JM Perrin, et al., JAMA 6/27/07).

There is also a significant increase in both type 1 and type 2 diabetes mellitus in children, at least partly attributed to obesity (RB Lipton, JAMA 6/26/07). Some wonder whether this too could have a link to vaccines. Hemophilus immunization has been associated with autoantibodies to islet cells. A Danish study recently showed an attributable risk of 2.3/100 (2.3%) of type 1 diabetes from hemophilus immunization in siblings of insulin-dependent diabetic children (JB Classen, Open Ped Med J 2/25/08).

Establishing the role of vaccines in any chronic, disabling condition could open floodgates of demand for compensation. And this single case of compensation for autism is making public health officials and pediatricians worry that parents will skip vaccinations.

A CDC panel voted unanimously to recommend influenza vaccine annually for all school-age children (WorldNetDaily 2/28/08). New Jersey officials have told parents that their babies can’t attend day care without their flu shot. Most influenza vaccine contains thimerosal.

Two other vaccine-court cases testing the alleged connection between thimerosal and autism go to trial in May.

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Economic shocks straight ahead?

March 6th, 2008

As former Comptroller General David Walker told 60 Minutes, the unfunded liabilities of entitlement programs, especially Medicare, are so huge that even shutting down the Pentagon would not help significantly. He states that leaving this huge debt to the next generation is morally wrong. He does not, however, address the question of who will continue to lend us the money that subsequent generations will have to repay. Apparently, it has been assumed that the funds would be forthcoming.

If the U.S. loses its triple-A credit rating—which is the anchor of the world financial system—severe global consequences would follow. This could occur within a decade (Francesco Guerrera et al., Financial Times 1/11/08).

The subprime mortgage crisis has exposed much deeper concerns. As more borrowers defaulted, banks and other institutional investors began discovering that they owned huge quantities of a new security, collateralized debt obligations or CDOs, which many financial writers don’t even understand. CDOs quickly became the most important influence on home values in America, writes Stephen Mihm (“The Black Box Economy,” Boston Globe 1/27/08).

Mortgage-driven securities are “but the tip of a much larger iceberg,” Mihm observes. Quoting Bill Gross, manager of the world’s largest bond mutual fund, he writes: “Our modern shadow banking system craftily dodges the reserve requirements of traditional institutions and promotes a chain letter, pyramid scheme of leverage, based in many cases on no reserve cushion whatsoever.”

We could see “failing banks, busted brokerages, toppled corporate giants, bankrupt cities, states in default, foreign creditors cashing out of U.S. securities,” warns Gerald Celente, director of the Trends Research Institute in Rhinebeck, N.Y. He predicts that the dollar will bottom out at 10 cents on the euro, perhaps by 2010, and notes that even some Third-World vendors are refusing payment in greenbacks. Formerly invited onto television and cable networks, Celente is now shunned, and USA Today did not cover the Trends Report for the first time in decades, writes Christopher Ketchum (“Trends for Downsizing the U.S.: the Bright Side of the Panic of ’08,” Pacific Free Press 1/31/08).

Arthur Robinson notes an immediate problem: 30% of U.S. energy is now produced abroad, costing $400 billion per year. “Either the government gets off the backs of our energy industries—especially our hydrocarbon and nuclear energy industries, or else the citizens of the United States will become the bankrupt inhabitants of a low-technology country” (Access to Energy, November 2007). Oil and gas that we now import will be purchased by “countries who are able to pay with goods and services and real money, rather than unpayable debt and fiat money.”

Of all the presidential candidates, only Ron Paul has acknowledged the seriousness of the impending economic crisis. The stimulus package will not do the job, he says. “Unfortunately, too many in Washington still believe that we can spend our way into prosperity. This will not work and never has.” Business and jobs go overseas when “taxes bleed away profits and burdensome regulation hamstrings operations,” Paul writes (Ron Paul’s Texas Straight Talk 1/27/08).

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NHS updates: Patients starve; not allowed to pay for extra care

February 27th, 2008

Recent news from the UK:

1. Statistics obtained by Conservatives show that the number of patients released from British National Health Service (NHS) hospitals with malnutrition has doubled in the decade since Labour came to power, increasing from 74,431 in 1997 to 139,127. While most of the patients had nutritional deficiencies on admission, the nutritional condition of at least 8,500 actually worsened during their hospital stay. Last year, health minister Ivan Lewis admitted that patients were being starved on the wards, with some elderly patients given little more than a scoop of mashed potatoes for lunch. Often, elderly patients are given non-pureed food that they cannot chew or swallow. Food trays may be placed out of reach and simply taken away when patients are too weak to get to them (Telegraph 1/1/08).

2. To meet government targets, which require emergency department patients to be treated within 4 hours, thousands of patients are kept in ambulances outside the department for hours. Last year, more than 43,000 patients waited for more than an hour before being allowed into the emergency room.

Ambulances that are being used as “mobile waiting rooms” are unavailable to take fresh calls.

The Labour government brought in the 4-hour standard in an effort to end the scandal of patients waiting in casualty for days (Daily Mail 2/20/08).

3. British patients are being denied certain operations because of lack of worthiness, based on smoking, obesity, heavy drinking, or age. Officials are urging patients to turn to “self care” instead of physician visits.

“The threat to cut benefits to the old and the unhealthy in Britain is a clear confirmation that health care can never be free…. The threat also shows that health care can’t be truly universal, at least not for the long term, because it becomes too costly to maintain as such” (“Health Freezes Over,” Investor’s Business Daily 1/29/08).

4. One way to relieve strains on the system is to allow patients to pay privately for portions of their care—while still receiving “basic” care from the NHS. For example, patient Debbie Hirst, who has metastatic breast cancer, was attempting to raise $120,000 to pay for Avastin, a drug widely used in the U.S. and Europe but not available to NHS patients, at least not until the cancer is so widespread that treatment may be hopeless.

Such arrangements have tacitly been allowed before, but in this case the doctor delivered the news that he was getting his wrists slapped by the higher-ups. If the patient paid for Avastin, she’d have to pay for all of her treatment—far more than she could afford.

Patients “hopscotch” all the time, say paying for a timely private consultation or MRI, then getting their surgery from the NHS.

But “[t]hat way lies the end of the founding principles of the NHS,” said health secretary Alan Johnson to Parliament.

The rules for private copayments are contradictory and confusing. The idea of the NHS may be to assure that rich and poor get equal treatment, but the system is riddled with inequities. Drug availability, waiting lists, and per capita spending for cancer care vary wildly from region to region.

As Mrs. Hirst explained: I’m a person who left school at 15 and I’ve worked all my life and I’ve paid into the system, and I’m not going to live long enough to get my old-age pension from this government” (Sarah Lyall, New York Times 2/21/08).

Could that be the main point?

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Patients and doctors reject protocol medicine

February 23rd, 2008

While pressure mounts to get doctors to follow “best practices,” getting patients to follow them will be even more difficult. A 2007 Harris Interactive poll found that 43% of Americans say they are concerned about overly aggressive treatment. And 44% have ignored a doctor’s advice or sought a second opinion because they felt a doctor’s treatment was unnecessary or too aggressive. More than a quarter left a prescription unfilled because they thought it was not needed, and 13% failed to get a recommended diagnostic test. Among respondents who chose not to follow a doctor’s advice, 89% said that nothing negative happened as a result (Wall St J 3/15/07).

More than 35% of Americans report using some form of alternative medicine, according to a survey conducted by Thomson Medstat (www.Thomson.com 2/17/07). Nearly half (49.9%) of all households with incomes greater than $100,000/yr, and 49.6% of those with postgraduate degrees used alternative medicine. Utilization dropped to 18% among those without a high school diploma.

Herbal supplements and massage/chiropractic care were the most common modalities used, followed by mind/body practices, energy therapies, and naturopathy. About two-thirds of respondents said that their regular physicians were aware of their use of these practices.

Almost half of the physicians surveyed at three U.S. medical schools admit to prescribing placebos, defined as remedies they expected to have no physical effect, but only 4% told the patients that the prescription was a placebo. This included antibiotics for colds and ibuprofen, as well as vitamins and herbal supplements. Doctors may give a prescription to “boost patient morale,” although the practice is widely unacknowledged (Tom Randall, Bloomberg News 1/4/08).

Some medical boards are issuing guidelines about the use of “alternative,” “complementary,” or “integrative” medicine. Believing that this signals a significant change, the Pima County (Arizona) Medical Society has resumed meetings of a committee on such practices, which were suspended out of fear that physicians could be considered guilty of unprofessional conduct if they listened to physicians explaining their use of nonstandard treatments and did not report them to the medical board.

The definition of “alternative” is treacherous, as it includes practices that may be based on Western scientific concepts but are not generally “made available.” Moreover, it is possible that medical boards could employ a double standard in evaluating evidence for efficacy and safety of practices deemed “alternative,” cautioned AAPS Executive Director Jane Orient, M.D.

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Study touches off cholesterol debate

February 12th, 2008

Merck and Schering-Plough are running full page ads, as in the Wall Street Journal, in an attempt to control the damage from a study questioning the benefits of ezetimibe (Zetia) or Vytorin (ezetimibe/simvastatin). “All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN,” states the advertisement. But it also notes that “ZETIA [a drug that limits cholesterol absorption] has not been shown to prevent heart disease or heart attacks.”

Two years after the “Enhance” study ended, results have not been published in a medical journal, but will be presented at a cardiology conference in March. Findings were issued in a press release, after Congress had pressured the companies to disclose the outcome. The delay is related to complexity, not to the negative nature of the findings, spokesmen said (Alex Berenson, New York Times 1/15/08).

The combination drug was shown to lower LDL cholesterol more than either ezetimibe or simvastatin (Zocor) alone; however, arterial plaque formation was not reduced. Actually, plaques grew twice as fast in patients on Vytorin, but the difference was not statistically significant (Tara Parker-Pope, New York Times 1/22/08).

The results were called “shocking” by Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic. But at least “it didn’t show any harm,” stated Dr. Paul D. Thompson, director of cardiology at Hartford Hospital.

About 5 million patients are taking Zetia or Vytorin worldwide, and the $5 billion in sales are important contributors to the drug companies’ profits.

At the same time, CBS News and Business Week are discussing whether statins and cholesterol are over-hyped (CBSNews.com 1/17/08).

Business Week points out that the touted 36% reduction in heart-attack risk is a relative number. The absolute risk is reduced by 1%, from 3 in 100 to 2 in 100. And while benefits are overstated, risks are understated. BW states that side effects occur in 10% to 15%, not the mere 2% to 3% claimed by statin-drug advocates.

Some assert that the benefits of statin drugs result from their vitamin D-like actions, and that vitamin D supplements provide the benefit without the risks (Bill Sardi, LewRockwell.com). A meta-analysis of randomized trials of patients receiving vitamin D supplementation showed a 0.93 relative risk for all-cause mortality (Philippe Autier and Sara Gandini, Arch Intern Med 2007;167:1730-1737). The mechanism may be prevention of arterial calcification.

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REAL ID, electronic tracking spark civil liberties concerns

February 5th, 2008

Children are getting their fingerprints scanned every day at school—to make the lunch line move faster. It’s more efficient than debit cards, ID cards, or cash. State Senator Karen Johnson of Arizona is trying to do something about this, as well as other measures that enable intrusive government monitoring of citizens in the name of efficiency or safety (Andrea Natekar, East Valley Tribune 1/8/08). Soon, all Americans might have to prove their identity constantly, with a REAL ID card—to board an airplane, to enter a federal building, or even to prove employment eligibility, open a bank account, or buy a cold remedy.

Concerns are mounting as May 2008 approaches, the deadline set for state compliance in the REAL ID Act of 2005. The program has been delayed because 29 states passed or introduced laws refusing to comply, citing enormous costs and a bureaucratic nightmare, but a showdown is approaching.

The rules would require all current identification holders under the age of 50 to reapply with certified birth and marriage certificates. States would also have to interlink their Department of Motor Vehicles (DMV) data bases.

Proposed regulations issued by the Department of Homeland Security (DHS) last March brought an astounding 21,000 public comments. Final regulations issued 9 months later address only 11 percent of the problems that were identified, according to an analysis by the American Civil Liberties Union. The analysis was based on a list of 56 problems noted by privacy activists, domestic violence victims, conservatives, religious leaders, and DMV administrators.

Montana governor Brian Schweitzer has declared independence from federal identification rules and called on 17 other states to join him in facing down the federal government. After May 11, citizens presenting a Montana driver’s license will have to undergo a pat-down search and have their carry-on bag hand-screened before boarding an airplane.

States have until May 11 to request extensions out to 2014 for compliance, but they must promise to start work on necessary changes. These are expected to cost billions, with only a pittance in federal funding to help offset the cost. Schweitzer pledges that he will not ask for an extension. In a letter to other states, he says that “if we stand together either DHS will blink or Congress will have to act to avoid havoc at our nation’s airports and federal courthouses.”

DHS spokeswoman Laura Keehner says DHS has no intention of blinking, not even if Georgia also fails to apply for an extension, resulting in massive delays at the nation’s busiest airport. She thinks citizens will turn their wrath on their state government, not Washington (Privacy Digest 1/18/08).

Computer errors and identity theft are already causing frightening snafus involving the DMV and DHS. Schoolteacher Debbie Williams Arthur was called a convicted felon and a fugitive when she tried to get her vehicle decals online. Her identification had been connected, through DHS, with that of a Debra K. Williams, who apparently is a fugitive. Had Arthur been stopped for a traffic violation, she could have been arrested.

After much stress, she eventually got her identity back. Lacey Putney, her representative in the Virginia House of Delegates, told her of a glitch in the Virginia computer system: One in 30 Virginians are either keyed in incorrectly, or there is some flaw in the system.

The former student who accompanied Arthur to the DMV to get a duplicate license, hers having been stolen, was misidentified as a 40-year-old male Hispanic when her Social Security number was entered (OurValley.org 1/15/08).

Not having the proper ID could also result in loss of benefits. When Don Lorenz was prematurely declared dead by the Social Security Administration, he had to take his birth certificate, driver’s license, and Social Security card to the Social Security Office to prove that he was still alive. He also had to get his supplemental policy reinstated. Someone had apparently mis-entered the SSN of a deceased individual (Sun Cities Independent 8/22-28/2001).

A mother who wants to opt out of the fingerprint scanning for school lunches fears that hackers could get into the program. When her child grows up older and tries to buy a house, what if his identity has been stolen by someone who has had a foreclosure? (Natekar, op. cit.).

While the controversial radio frequency identification technology (RFID) microchip isn’t required by REAL ID at this time, it could come later. Combined with pervasive and top-secret high-tech surveillance being employed by government even now, it has chilling Orwellian potential (Freedom’s Phoenix 1/18/08).

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