Another Flu Vaccine Casualty, where was informed consent

It is very disturbing to me as a long-time health care professional as I listen to local friends and read and listen to news report about flu and swine flu vaccines.

So many necessary questions are just not being asked. And required information is being withheld from those who are choosing to get theses jabs.

In a recent case of a severe adverse reaction to just the "seasonal" flu vaccine, the young woman who thought she was doing a good thing found out otherwise. Her comment is however very telling -

"I would've much rather won the lottery and bought that ticket instead of gotten the flu shot if I knew that risk existed," she said.

Desiree Jennings, now dealing with serious neurological injury made this point, "...if I knew that risk existed."

My question is why the person at Safeway who was administering the flu jabs failed to offer required risk/benefit data to Jennings as is required by law under FDA and CDC guidelines.

This basic guideline, a cornerstone of medical care, is known as "Informed Consent".

Flu shot suspected in Redskins cheerleading hopeful's neurological condition

More on Vaccine Issues

This following document is a very important evaluation of the latest AAP and CDC spin on vaccines.

There are risks to health involving vaccines. It is a known fact for many years. Unfortunately you may not be receiving the information you need to meet the informed consent standard.

A few issues ago our opt-in newsletter, herbalYODA Says! focused on informed consent issues.

Press Release
For Immediate Release:Feb 6, 2009
Response to Dr. Ari Brown and the Immunization Action Coalition

Informed consent is a crucial element of the foundation upon which ethical medical practice rests. Providing patients, parents, or guardians with an honest assessment of the risks and benefits of any medical procedure requires the physician to be, to the best of his or her ability, “informed.”

Read Full Document: Response to Dr. Ari Brown and the Immunization Action Coalition

The full response was produced by Thoughtful House Center for Children in response to one written by Dr. Ari Brown titled “Clear Answers and Smart Advice About Your Baby’s Shots,” which attempts to deal with the vaccine-autism controversy. Brown is an official spokesman for the American Academy of Pediatrics. Her document [1], is endorsed and published by the Immunization Action Coalition (IAC), a US organization funded by the Centers for Disease Control (CDC) and the vaccine manufacturers. In short, it is the public relations arm of those who are legally and ethically responsible for vaccine safety. Given this background, one might reasonably expect a comprehensive, well researched, and persuasive overview. Since the topic of vaccination is so important and because we have major concerns about the accuracy of much of what this document says, we are providing a point-by-point response.

We are most grateful to the Editor and staff of Medical Veritas for their expert assistance in the review and editing of this document. The article will appear in Medical Veritas 2009;6:1907-1924.

Andrew J Wakefield, MB, BS, FRCS, FRCPath

Laxative Colonoscopy Prep Products and Kidney Damage

Laxatives are one of the most commonly overused products sold to consumers, over-the-counter (OTC). These same products, and others available by prescription only, have caused serious side effects associated with kidney damage (nephropathy) and dehydration.

The products are particularly risky for the elderly and people with existing heart, kidney and some gastrointestinal problems.

Since colon cancer prevention and screening are important health concerns, consumers are encouraged to be educated about using these products.

Osmolar Phosphate Laxatives: Keeping Water in its Place

Osmolarity is a fancy word that refers to a basic rule of physics and biology and it is about how fluids - in this case it’s water – move in and out of cells based on the presence of electrolytes, most often sodium and potassium. Phosphorus and calcium are two other electrolytes that are important health and often work together.

Your body depends on a delicate balance of trace elements and enzyme reactions to keep humming like a top. When this balance is altered you run the risk of dehydration and problems with the way your kidneys work.

Simply put, when you ingest a large amount of sodium containing foods or liquids, the kidneys work to flush the excess sodium out of the body. It does this by removing fluid from inside the cells, from your tissues and organs and moves it through the kidneys or the gastrointestinal tract. This may lead to excessive urination and diarrhea. In the process you lose not only the water but your electrolyte balance is altered.

Phosphorus and calcium reactions with dehydration may lead to the formation of crystals or “stones” and reduction of kidney function.

Laxatives often become the culprit in these cases, especially for the elderly, those with heart failure, people with kidney problems, and people using prescription or over-the-counter (OTC) medication affecting kidney function (diuretics for example).

Oral Sulfur Phosphates as Preps for Screening for Colorectal Cancer

Currently colorectal cancer is the third most common cancer and it is the second leading cause of cancer related deaths, therefore screening and early detection have become an important public health issue.

Thorough bowel cleansing is an important part of preparation for this screening and it is crucial to find a product that is safe and easy use. The difficulty in getting more people to seek the screening may be increased because of concerns with the products.

One very popular laxative has been Fleet’s Phospho-Soda. The C.B. Fleet Co. of Lynchburg, VA recently, in a voluntary action, withdrew its oral, over-the-counter Fleet Phospho-Soda bowel cleansing solutions after FDA regulators warned of potential harm to the kidneys when the Phospho-Soda is used as a bowel cleanser.

While the FDA has not required a recall, Fleet also removed the EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy.

Information found urges anyone using Phospho-soda to review current FDA product information pages. They also state that it is important to follow your doctor’s guidelines and drink at least nine 8-ounce glasses of water daily to prevent dehydration.

The FDA is now moving to have these laxative products relabeled to include warnings and make them available only by prescription.

Other prescription products, Visicol and OsmoPrep, will add the new FDA required warning regarding potential kidney damage to their oral sodium phosphate products.

The concern at the FDA is that oral sodium phosphate products have been connected with kidney function problems such as acute phosphate nephropathy that can cause permanent damage and lifelong dialysis or death. In acute phosphate nephropathy, calcium-phosphate crystals deposit in the renal tubules inside each kidney.

When used as directed or at lower levels, the FDA stated there is no evidence that the OTC laxatives lead to kidney problems. The agency, however, started issuing alerts in 2006. Other data show that product lawsuits for oral sodium phosphate laxatives, including lawsuits where OSP product users developed acute phosphate nephropathy began appearing in 2003.

While Phospho-soda has been the bowel prep product used and recommended by physicians for decades, Fleet is not asking doctors to not recommend the Phospho-soda products.

Gastroenterologists and proctologists have recommended Fleet’s Phospho-soda products for years, especially in patient preparation for screening colonoscopy (a colon cancer screening examination). In a clinical trial the product achieved the highest patient acceptance scores, and cleansing was generally rated as excellent.
However, Fleet Phospho-soda should not be used in patients with congenital megacolon, bowel obstructions, ascites, congestive heart failure or kidney disease.
When problems do not exist, physicians believe the product is good because it is effective, easily tolerated by patients and affordable.

Generally most patients do not like bowel prep products. Some doctors, like Mark Wax MD, suggest the need for “virtual bowel prep”. He adds that “until that becomes an option, patients will have to undergo conventional preparation and that requires making informed decisions about available options.” Wax is associated with a company that offers virtual colonoscopy.

The company states that virtual colon screening is a minimally invasive, safe and more comfortable procedure. Recent studies have shown it to be comparable to conventional colonoscopy for finding polyps larger than one centimeter. The risk of cancer in smaller polyps is almost negligible. With virtual colonoscopy, 100% of the colon surface can be seen. It is estimated that physicians only see 70%-80% of the colon surface with conventional colonoscopy.

Should you have medical questions about using these products, contact your health care provider.

This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Bernstein Liebhard, LLP, who sponsors the consumer advocate website, www.ConsumerInjuryLawyers.com

Patient Consent Update Needed Now

The following two paragraphs come from the January 2008 issue of my newsletter, herbalYODA Says!

"herbalYODA Says! Volume 5, Number 1 – January 2008

The Importance of Informed Consent

Informed consent, according to the University of Washington's School of Medicine, "is the process by which a fully informed patient can participate in choices about his/her health care. It originates from the legal and ethical right the patient has to direct what happens to (their) body and from the ethical duty of the physician to involve the patient in (their) health care."

Informed consent is the cornerstone of ethical conduct in health care. Written consent does not take the place of a patient fully understanding a proposed drug or treatment. Rarely does a person who may have language or illiteracy concerns receive the clarification necessary to understand what it being prescribed or proposed as treatment. (more...)"

I am a staunch supporter of and educator about informed consent. This doctrine is required for any and all medications, treatments, surgeries or tests ordered for you by your health care provider.

The pure reason I am such a stickler is that year after year I find that very little of this process is going on, at least at a level a patient would understand.

The blank stares I get when I ask people about drugs that have been prescribed are telling enough.

The problem, as I see it, is that this is an all too common practice, and a practice that ultimately gets everyone in trouble.

For the very reason that is stated in the title, this article addresses the critical issue, education. I have to agree that is is well past time that not only consent forms, but the consent process come back into vogue.

Patient Consent Forms Should Educate Not Intimidate, Experts Urge
ScienceDaily (Dec. 24, 2008) — It’s time patient consent forms came back full circle to a tool for patient education, rather than the waiver of liability they have become, experts urge.

The original purpose of the consent forms was for a surgeon or doctor to inform the patient of common or serious risks associated with the procedure to be performed. However, the way current consent forms are written – as formal, legal documents – plants a litigious relationship in both the patient’s and the surgeon’s mind even before treatment has begun.

Lawrence Brenner is an attorney on the faculty of the Department of Orthopedics at Yale University. He and his colleagues propose a set of five recommendations to return consent forms to their intended purpose – that of allowing patients to meaningfully take part in the decision-making process. Their suggestions have been published online in Springer’s journal, Clinical Orthopaedics and Related Research.

As surgeons have become increasingly concerned about potential litigation, the informed consent process has lost its educational value. The focus is now on obtaining ‘preoperative release’, rather than an exchange of information to help patients make important decisions about their healthcare choices. In reality, the majority of patients find it a challenge to understand the complicated legal jargon used on the forms.

Research also suggests that proper informed consent has a direct impact on the quality of patients’ recovery after surgery. Indeed, patients have more realistic expectations and are better prepared psychologically to cope with the outcome of the operation when they have had an open discussion with their physician about what to expect during and after surgery.

In order to return informed consent forms to a tool for patient education rather than a form written by lawyers to absolve surgeons from liability, the authors make five recommendations. First, the informed consent form should never be viewed as a substitute for educating the patient; it is merely evidence that an appropriate discussion has taken place. Second, the forms should be designed to be understandable. Third, surgeons should not be afraid to communicate uncertainty in order to have a truly open discussion with their patients. Fourth, patients need to be active participants in the dialogue about the potential risks of the procedure. Finally, a note by the surgeon in the patients’ medical notes, that states that a discussion has taken place, is likely to be much more effective than a lengthy signed, but incomprehensible, form.

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Journal reference:

Brenner et al. Beyond Informed Consent: Educating the Patient. Clinical Orthopaedics and Related Research, 2008; DOI: 10.1007/s11999-008-0642-4

Springer (2008, December 24). Patient Consent Forms Should Educate Not Intimidate, Experts Urge.

ScienceDaily: http://www.sciencedaily.com? /releases/2008/12/081217124158.htm

Doctors: Disclose Off-label Prescribing To Patients

There exists a culture today in mainstream medicine, and sadly in the hybrid called naturopathic medicine, to treat patients like objects. Failing to explain medications or treatments is one of the missing links and a basic but forgotten ethic of health care practice.

There are just too many people who have not understanding of why they are given a drug for a symptom or what the drug or treatment might do or the adverse effects.

Arrogance fails to heal: Here take this drug, maybe it will make you sicker or kill you, but we're not telling.

Roulette anyone?

ScienceDaily (Nov. 11, 2008) — Doctors should be required to disclose when they are prescribing drugs off-label, argues a new article in this week's PLoS Medicine. Michael Wilkes and Margaret Johns from the University of California Davis argue that the ethics related to informed consent and shared decision-making provide an imperative for doctors to inform patients about the risks of a medical treatment when their use has not been approved by regulators.

Off-label prescriptions are those that do not comply with the use approved by the Food and Drug Administration (FDA) for the drug. While off-label prescribing is legal and accounts for roughly half of all prescriptions currently written in the US, it is often not supported by sound scientific evidence. Worse, say the authors, off-label prescribing can put patients at risk and drive up healthcare costs.

The public often assumes that all common uses of prescription drugs have been approved by the FDA, say the authors. But current law does not prevent doctors from prescribing a drug to any patient for any use whether it was approved for this use or not.

And while off-label prescribing is common and sometimes necessary (as in the area of paediatrics where many drugs have not been tested on children), Wilkes and Johns argue that off-label prescribing can also pose potentially serious risks. By definition no governmental body has conducted a review of the effectiveness or safety of the drug for the off-label use, they say. As a result, an off-label prescription may be ineffective or detrimental, and could be more costly than existing drugs.

Wilkes and Johns argue that the strict requirement that doctors obtain informed consent from patients before enrolling in a research study means they should obtain the same consent when a drug is being prescribed off-label as each such prescription is just like a mini research study. The contemporary expectation for shared decision-making between doctors and patients also supports full disclosure about off-label prescribing, leaving the option open for patients to opt for a drug which has received FDA approval for the condition in question.

"From an ethical perspective," say Wilkes and Johns, "[what is required is] open, honest discussions where doctors tell their patients that the use of the drug will be off-label and thus not approved for this indication, explain the risks, potential benefits, and alternatives, and then ask patients for their permission to proceed."

A recent PLoS Medicine paper (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050210) described techniques by which drug companies covertly promote off-label use. Adriane Fugh-Berman (Georgetown University Medical Center, Washington DC) and Douglas Melnick (a preventive medicine physician working in North Hollywood, California) discussed the use of "decoy indications" and drug representatives to engage in illegal pharmaceutical marketing. Pharmaceutical marketing, they say, has "distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown."

"Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies," say Fugh-Berman and Melnick.
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http://www.sciencedaily.com/releases/2008/11/081110223328.htm

Journal reference: Wilkes M, Johns M. Informed consent and shared decision-making: A requirement to disclose to patients off-label prescriptions. PLoS Med, 5(11): e223

Public Library of Science (2008, November 11). Doctors Should Disclose Off-label Prescribing To Their Patients, Experts Argue. ScienceDaily. Retrieved November 12, 2008, from http://www.sciencedaily.com? /releases/2008/11/081110223328.htm