Archive for the ‘informed consent’ Category

Poling case intensifies debate; vaccine-autism link worth investigating, says former NIH director

Saturday, May 24th, 2008

The U.S. vaccine court recently conceded that the brain damage suffered by Hannah Poling, who has a coexisting mitochondrial disorder, stemmed from her exposure to five vaccines. “I would not be too quick to dismiss Hannah as an anomaly,” writes Bernadine Healy, M.D., former director of the National Institutes of Health and a member of the President’s Council of Advisors on Science and Technology.

“Families are not alone in searching for a trigger that might explain why autism and autism spectrum disorders have skyrocketed,” she writes; “now they reportedly afflict about 1 in 150 kids” (US News & World Report 4/10/08).

In a May 12 interview with CBS News, Healy said that public health officials have been too quick to dismiss the hypothesis that vaccines may be linked to the autism epidemic.

She told CBS that public health officials have intentionally avoided researching whether certain subsets of children are especially susceptible to vaccine side effects, to avoid scaring the public.

“I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.”

CBS said that government officials would not respond to Healy directly, but reiterated that vaccines are safe.

Paul Offit, M.D., co-inventor of the rotavirus vaccine RotaTeq, writes that the Vaccine Injury Compensation Program (VICP) “seems to have turned its back on science.” Instead of a preponderance of evidence, it now simply requires that an expert propose a plausible mechanism for vaccine injury. In the wake of the Hannah Poling case, he writes, “the VICP should more rigorously define the criteria by which it determines that a vaccine has caused harm. Otherwise, the message that the program inadvertently sends to the public will further erode confidence in vaccines….” (N Engl J Med 2008;358:2089-2091).

On Mar 6, CDC Director Julie Geberding claimed that Hannah’s case was a virtually one-of-a-kind case with little if any relevance to the other 4,900 autism cases currently pending before vaccine court. Then, on Mar 11, there was the “conference call heard ’round the world,” set up by the CDC’s Clinical Immunization Safety Assessment (CISA) Network. Some researchers said that mitochondrial dysfunction may be much more common that the previously stated 1-in-4,000 estimate (David Kirby, Huffington Post 5/15/08). Some speculate the genetic mutation could affect as many as 1 in 50 Americans.

Another case nearly identical to Hannah’s, involving a boy from New York, has recently been withdrawn as a test case for thimerosal. Only one theory of causation can be heard at a time, and it will be hard to deny the boy compensation on the basis that has just been found appropriate in Hannah’s case.

Hundreds of cases could follow this precedent. Some estimates of mitochondrial dysfunction in autistic children range as high as 20% to 30%, and in regressive autism, up to half the children may show signs of it, writes David Kirby (Spectrum Magazine 4/24/08). According to an abstract presented at the Apr 13 meeting of the American Academy of Neurology, 65% of 37 children with autistic spectrum disorders had oxidative phosphorylation (mitochondrial) defects, writes British attorney Clifford Miller.

During April, designated Autism Awareness Month, one expert denied not only a vaccine-autism link but the existence of an autism epidemic. Dr. Bennett L. Leventhal of the University of Illinois at Chicago said that the incidence of autism—the number of new cases over a certain time period—has remained constant since about 1943. Only prevalence, or number of counted cases, has changed, he claims (Courier News 4/11/08).

Clifford Miller challenges Leventhal to produce evidence backing up his assertion—and to locate all the aging autistic adults that the claim implies must exist.

The British Department of Health has hired a psychiatrist to track down the alleged 500,000 adult autistics in the UK and their alleged 500,000 full-time caregivers. The claims are obviously nonsense, Miller writes. According to the UK’s Office of National Statistics, the total number of adults caring for another adult who required full-time care for any reason was 326,000 in 2001.

Healy is the best-known “mainstream” American physician to speak out in opposition to the academicians and officials who either deny the existence of a pandemic or any chance of a link to vaccines. She asks why, over the past decade, the government hasn’t compared the autism/ADD rate of unvaccinated children with that of vaccinated children. And why do some in government treat vaccines as an all-or-nothing proposition? Either everybody gets vaccinated at the same time with the same vaccines, or nobody will get vaccinated and long-gone deadly diseases will re-emerge. “Personalized medicine” is done in virtually all areas of medicine today—except with vaccines, notes Sharyl Attkisson, an investigative correspondent for CBS News.

There are groups of unvaccinated children. In addition to the Amish, there are thousands of children cared for by Homefirst Health Services in metropolitan Chicago. As far as physicians are aware, there are no cases of autism in an unvaccinated child—and only one case of severe asthma, writes Dan Olmsted (UPI 12/7/07).

Hillary Clinton, Barack Obama, and John McCain all say they support research into the link between vaccines and autism (David Kirby, Huffington Post 4/22/08).

 Additional information:

National “DNA warehouse” bill passes

Friday, 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.

Additional information:

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

Saturday, 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).

Additional information:

Study touches off cholesterol debate

Tuesday, 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.

Additional information:

Oral contraceptives increase breast cancer risk, study shows

Saturday, December 29th, 2007

According to a meta-analysis published in the Mayo Clinic Proceedings¸ but virtually ignored in the mainstream press, use of oral contraceptives increases risk of premenopausal breast cancer, writes Dennis Byrne (Chicago Tribune 12/3/07).

The greatest increase in risk, 52%, was in parous women who used oral contraceptives for four or more years before their first full-term pregnancy (Kahlenborn C, et al.Mayo Clinic Proc 2006;81:1290-1302, 2006).

Byrne notes that stories about other breast cancer risks were plentiful, including one about sleeping with a night light on. The National Institute of Cancer doesn’t mention the study on its web site, nor does the American Cancer Society. The latter concedes only that “it is still not clear what part” the pill plays in breast cancer.

Curiously, those who protest about government and big business failing to “do enough” to protect consumers are silent about this particular risk, Byrne writes.

“Here, I also should clarify some things to all the folks who are itching to hit the ‘post comment’ button. Kahlenborn is pro-life, but what has that to do with his research? As for me, I am not opposed to contraception, oral or otherwise. I am not plotting to get the pill banned. I am not writing this column for hidden religious reasons. I’m not saying the Kahlenborn study is the last word…. I’m writing about it because people have the right to know about the existence of health information, even if it is contradictory to the given wisdom.”

Additional information: