I haven’t seen the new Michael Moore movie Sicko, but plan to at some point, due to the content. Yes, I lived what he’s talking about for 15 years as a nurse. I noticed today and yesterday that there are news stories filtering in complaining about the content of the movie; he doesn’t give “fair time” to the industry, he’s romanticizing the health systems in other countries and not mentioning their flaws; and that some of his data isn’t correct. Well that may be, but Michael Moore’s movies are not meant to be balanced wimpy reviews of a topic. His point is to demonstrate what is wrong with American healthcare, and I think he only scratches the surface, quite frankly.

This article appeared in June, in the SF Gate, but it can hardly be considered outdated. This is an experience that Americans every day have to deal, and what is sadder, is that the person highlighted is a nurse. A healthcare professional. And she can’t get the healthcare she needs. How wrong is that?

From SF Gate:

For Cynthia Campbell, a San Francisco nurse battling two forms of advanced cancer, every day is a race against time. But no single day looms larger than July 20.

That’s the day her health insurance policy runs out.

“I did everything I was supposed to do about insurance — never let it lapse, never had a gap. Yet here I am with stage IV cancer with surgery that needs to be done and my insurance is running out,” said Campbell, 53, whose hair is just beginning to grow back after a break in chemotherapy.

Campbell’s coverage nightmare is notable for what she does have rather than what she doesn’t, and that’s health insurance. But her coverage is what’s known as a short-term or temporary policy — a type of low-cost insurance that has grown in popularity in recent years. Many customers are people who have lost their job-based group benefits and can’t afford to buy long-term individual coverage.

Short term policies usually provide coverage for up to a year, and not are designed to take the place of “real” health insurance. They’re meant for people in transition, like Campbell, who purchased the short-term policy through Blue Cross of California in March 2006 while she was working as a contract registered nurse at UCSF Medical Center.

But such policies are difficult to renew or extend if customers file claims. Patients such as Campbell who develop serious medical conditions while on short-term policies can find it almost impossible to obtain other coverage once the insurance expires.

Campbell used her policy once, for a minor infection and then Blue Cross refused to renew it. She then purchased another short-term policy, this time through Blue Shield of California, and paid in advance for an entire year. But just a few days later, she was diagnosed with 2 forms of soft tissue cancers, which basically made her uninsurable.

Her Blue Shield policy has paid for the cost of her cancer treatment, but they will not renew it after it expires. Campbell can’t find anyone else who will insure her.

Campbell has worked as a nurse for 31 years, saving other people’s lives. She’s not eligible for early Medicare benefits, and she and her husband earn too much to qualify for state Medi-Cal. While California does have program for people who have serious health conditions and are unable to obtain coverage, it only covers up to $75,000 a year, which is barely enough to even scratch the surface for the care that Campbell needs.

“I have a cancer that can go from zero to death in less than three months,” Campbell said. “With the kind of cancer they’ve diagnosed me with, an 18-month wait or a 12-month wait is too long.”

Despite her condition, Campbell said, she has applied for three nursing jobs and has interviewed for one. She did not get the job.

“At a time when other cancer patients are resting, I’m out there trying to find a job so I can get on someone’s group insurance,” she said.

On Thursday, Campbell received word that she may be hired as a staff member by state Sen. Sheila Kuehl. That would allow her to receive group coverage until she is eligible for Medicare.

Kuehl, D-Santa Monica, is the author of a bill that calls for universal coverage under a single-payer system that eliminates the need for insurance companies. Kuehl’s office did not confirm the job offer on Thursday.

Campbell and her husband are scheduled to testify Tuesday before a state Assembly health committee meeting in support of Kuehl’s legislation.

Allen Campbell, who worked as a pilot carrying out aid missions in Africa, said he plans to stage protests on the steps of the state Capitol and in front of insurers’ offices. He spent decades working to help people in war-torn regions, he said, but has never felt so helpless.

“I cannot save my own wife,” he said.

So even if SICKO romanticized healthcare systems in other countries, it remains a fact that the U.S. is the only industrialized nation that does not offer some type of universal coverage to all of its citizens. There are millions of people like Campbell who fall right into the cracks. People criticize systems like in Canada, where you may have to wait for treatment. Well, what good is accessibility if you can’t pay for it?

This story is so sad, that this hard working woman may die because she can’t afford to pay for treatment. And that her husband (who is currently disabled and on Medicare), spent a lifetime helping those in need, yet can do nothing for his own wife.

The irony is of having a nurse, working her butt off taking care of patients, and yet who is dying of a disease that she can’t afford to treat.

One of the most bizarre trends in healthcare has been to repackage jobs with fancy new names. As though calling it something else is going to change the duties of the job, eliminate the negatives, and make the person feel more important.

These were jobs that were advertised at a fancy medical center in California. There were 126 vacancies for nurse, which fortunately, are still called nurses. The pay offered was quite good, so there must be more to the story. I have worked at this particular hospital through the registry, and it was a pretty miserable place to work-although granted, that was 20 years ago.

Anyway, there were a number of vacancies for “Administrative Care Partner.” Now that sounds like a mouthful, and what does it mean, exactly? Does someone ever really show up looking for a job, and say, “I’m looking for a job as an administrative care partner. Any openings?”

Having no idea what it was, I looked at the description.

Provide clerical support to the Administrative Nurse of the designated unit. Transcribe Doctor’s orders; verify, record, post and file information materials via manual and/or automated systems; evaluate and report data pertinent to the functioning of the patient care unit; interpret and apply medical terminology; coordinate intra-departmental communications; foster public relations; participate in meetings and continuing education.

In other words, they are looking for a secretary or unit clerk. Pray tell, what is wrong with the word “secretary?” Or “clerk?” Are they politically incorrect? Do they denote a person of a lowly status? No wonder they have opening for those jobs, because no one knows what they are.

Here’s the next gem: a clinical care partner. Now that sounds like something from school, you know, when you pair up with another kid in chemistry lab. Again, another baffling moment on the job board. Can you imagine putting that on a resume? Objective: clinical care partner

Clinical care partner
Under direct supervision of nurse manager, the incumbent will perform the following patient care responsibilities and safety measures: assist patient with admission procedure; assist patients during transfer procedure; assist patients with discharge procedure; provide for patients’ personal hygiene; assist with patients’ excretory needs; assist patients with meals and nourishment; and assist in providing for patient safety and comfort measures.

In other words, this is a nurse’s aide or assistant. Are those bad words now? Do they imply someone of low intelligence? Does newspeak now turn this into a fancy new position? I mean, a nurse’s aide helps patients use the bedpan. But a clinical care partner “assists with patients’ excretory needs.” Wow, I’m blown away.

These are the stats that rarely make it to the mainstream media, because, well, they’re so boring. And they imply that there is really something wrong in healthcare. It is like, so much more politically correct to scream about the nursing shortage being caused by old geezer nurses who are reaching retirement age, and the “need” to mass produce new ones. You know, if only we can get those scholarships in place, that’ll bring in new blood and keep it on the job for the next 40 years.

This data is from 2002, so it’s going on five years old. However, I can only imagine that the numbers have gotten higher than what is written here, considering that working conditions are progressively getting worse and not better.

From the University of Pennsylvania:

In one of the most far-reaching studies of the current state of nursing, a University of Pennsylvania researcher has discovered that newly minted nurses are leaving the profession at far faster rates than their predecessors, suggesting that the current shortage of nurses may reach crisis proportions sooner than anticipated.

One additional surprising finding is that beginning male nurses are leaving the profession at twice the rate of women. The research, which analyzes data from the National Sample Survey of Registered Nurses collected by the Division of Nursing in the U.S. Department of Health and Human Services in 1992, 1996 and 2000, is reported today in the influential health care policy journal Health Affairs.

“The study indicates that new nurses begin their careers with higher levels of job satisfaction, but the workplace itself seems to be convincing growing numbers to leave the bedside earlier in their careers for other professions,” said Julie Sochalski, Ph.D., RN, associate professor at the University of Pennsylvania School of Nursing. “We know the nation is facing a shortfall of nurses. If new RNs are leaving the profession after only a few years, the shortage is likely to reach crisis proportions sooner rather than later.”

As baby boomers age, thus increasing demands on the health care system, the median age of nurses is rising toward retirement. The U.S. Department of Labor predicts a shortfall of 331,000 nurses by 2008, leading to national recruitment efforts. However, Dr. Sochalski found that nearly 136,000 nurses are working in other professions, suggesting policy makers should turn their attention to nurse retention as well as the current emphasis on recruitment.

Specifically, the research found that:

o in the most recent nurse survey, 7.5 percent of new male nurses dropped out of nursing within four years of graduating from nursing school, compared to 4 percent of women;

o the dropout rate for both male and female new graduates is accelerating, rising from 2 percent of men in 1992 to 7.5 percent in 2000; and 2.7 percent of women in 1992 to 4.1 percent in 2000;

o among new nurses, 75 percent of women reported being satisfied with their jobs compared to only 67 percent of men; among more established nurses 69 percent of women and 60 percent of men were satisfied.

“One might predict that this new cohort of nurses may be destined to see their satisfaction levels sag over time, which, depending on the market conditions, may influence decisions to continue in their position or to leave nursing entirely,” Dr. Sochalski reports in Health Affairs. “The accelerating rate of loss in the supply of nurses, at a time of substantially increasing demand, underscores the need to determine the reasons for the exodus. And while men may not yet comprise a sizable number of the total who are leaving, the growth in their retreat from nursing is nonetheless concerning.”

There are an estimated 500,000 nurses who are no longer working in nursing. Sochalski only mentions the ones who are working full time in other professions (about 136,000–that number has gone up). Almost 20% of all registered nurses no longer work in nursing, and while some are retired, many are back in school, some have opened businesses, or are working part time in other jobs. But the fact that 136,000 are working full time in jobs completely removed from nursing is an eye opener. Do you think that the “poor image” of nurses in the media has driven these people out of nursing? Or that if the shortage of nursing instructors can be remedied, all of these nurses will come running back to hospital jobs?

In Nurse.com, there is an interesting article about former auto workers are being aggressively recruited to become nurses in a new life. Even to the point of being given “priority” over other applicants to a BSN program.

In an effort to address the persistent nursing shortage, several Detroit-area health systems launched accelerated and second-degree programs specifically targeted at a growing pool of displaced auto workers.

Oakland University School of Nursing (OUSN) in Rochester, Mich., has enrolled about 70 students in the accelerated BSN program in partnership with Henry Ford Health System and about 130 students in the second-degree program. The Ford Motor Company is offering several reimbursement packages that cover tuition costs for two- and four-year college degree programs, a living-expense stipend as well as healthcare coverage; for auto workers who opted to accept the voluntary buyout program.

I think it’s great that Ford is offering some alternatives for workers who have been “displaced” and is willing to help them retrain for a new profession. But should these workers get priority, for example, over other applicants to the nursing programs? Applicants who may even be more qualified? I don’t know anything about the school offering the BSN, but if it is a state institution, then chances are, there is a waiting list of people trying to get into nursing programs.

But what I find funny about this article is the correlation between recruiting former auto workers (think assembly line, especially since Henry Ford was the founder of the concept), and the “assembly line mass production” of nurses that the experts and talking heads think is needed to solve the nursing shortage. You know, the nursing shortage is simply a shortage of warm bodies, and if we can mass produce enough, then the shortage will disappear. Oh, and as an added benefit, if enough nurses are produced, that will depress wages and erase all of the gains that nurses have made in working conditions. Great news for everyone.

But getting back to this article….

It does say that some of the potential nursing students said that they had always been interested in health care but never pursued it. But what about the bulk of them? The problem with all of these “nurse reach-out” scenarios is that they basically say that anyone can be a nurse. Whether you’re a laid off auto worker, an accountant who’s been fired for embezzling funds, a housewife who thinks it would be fun to work in a real “General Hospital,” a retired police officer looking for a second career, a squeamish type who can’t bear the thought of touching body fluids…” nursing can be for you. The ads that are curently running are ludicrous and insulting to the intelligence, in giving a very distorted version of what nursing is and isn’t.

While I don’t believe that we should return to that nonsense about nursing being a calling, and that nurses are angels, and yadda yadda, still–the profession is not for everyone and should not be sugar coated with cream on top when trying to pull people in. The result is that attrition rates in school are high, and judging from nursing feedback, some of the new nurses who are entering the profession really show little to no interest in patients. They are not interested in bedside care, and are just looking to get in their one year of clinical experience before moving on.

What I find most interesting about this article, is the person they highlighted, Kenneth Kidd, also has no plans to stick around bedside care.

Kidd says after he completes his BSN, he plans to continue his studies to become a physician assistant or nurse anesthetist. “We’re an example of what can happen if you follow your dreams,” he says.

While PAs and CRNAs are needed, there is a great deal of competition for those programs, and no shortage of applicants. The real need for nurses is in bedside care, and also as faculty. But Mr. Kidd, who is entering this program in an effort to solve the shortage, has no plans to do bedside nursing–at least, for any longer than it will take to get accepted into PA or CRNA school. It does seem rather strange, to focus on an applicant who has expressed no real interest in working in the hospital doing patient care, which I would assume would be their emphasis–that this program was designed to fill vacancy slots in hospitals.

But perhaps, maybe they couldn’t find any other applicants to this program who are interested in working on a med/surg floor, taking care of 10 sick patients, and taking the usual crap that’s dished out.

I am not a recruiter for LA Children’s Hospital, nor have I had any contact with the place in about 20 years. That is just a disclaimer for what I am about to post here.

I did work there a great deal through the registry, during the 1980s. It was a really nice place to work and staffing was superb. I mean, like really superb. I have no idea what Children’s is like now, how their nurse:patient ratios go, whether they fired all of their secretaries, or if they routinely give nurses subscriptions to National Geographic in lieu of pay raises. Really, I don’t know much about the place other than what I’ve seen advertised.

I am simply reporting on an ad that I received via Nursing Spectrum, and thought I’d pass it along. If you live in LA and want to work with kids, or would like to live in LA and work with kids, then this sounds like a great deal.

Generous incentives for Experienced Nurses (BSN preferred) include:
• $10,000 sign on bonus
• $1500 monthly housing allowance (for up to 6 months for moves over 250 miles)
• $5000 relocation package (for moves over 250 miles)

www.childrenshospitalla.org/nursing or call 323-361-8578

They are having a Virtual Open House on Thursday, August 23rd, 3-7pm (Pacific Standard Time)
Log on to: http://www.nurse.com/chat

The downside is that it is almost prohibitively expensive to live in LA, at least, to live in a place where you don’t have to worry about bullets flying into your window at night. The $10,000 bonus is not going to go very far in saving for a mortgage, and to be quite honest, the real estate is priced out of proportion and not worth it. When the bubble breaks, many people are going to be stuck with tiny condos that they signed over their soul for, and they will be unable to even break even trying to sell them. Foreclosures are already mushrooming out of control….well anyway, that’s the downside.

The upside is that LA is a fun place to live and work, and I would move back today if I could afford a nice house in a nice area. This sounds like a great deal from Childrens, so I just thought I’d pass it along, for those readers who don’t receive Nursing Spectrum in their mailbox.

Oh, you didn’t know? That Nesquik, the chocolate powder you add to milk, is really good for you. Builds strong bones and bodies, and never mind all the sugar and other ingredients which you need an organic chemistry textbook to decipher. If TV says it’s so, then it’s so.

Apparently, the milk industry is getting desperate because it sounds like they are moving to the point where they can get sued for false advertising. Chocolate milk healthy for kids? Uh, unless you want a roly-poly who is going to grow into a fat teen and an obese adult.

Milk is going to make your hair healthier? Uh, would they like to elaborate on that? Eating Yoplait is going to make you lose weight?

This is a press release from the Physicians Committee for Responsible Medicine. Yes, I know, they have an agenda, but their agenda isn’t fueled by the food industry, the oil industry, the dairly industry, the meat industry, or any other major players. Their agenda is good nutrition, preventive medicine, and they are in favor of vegetarian and vegan diets. Not much money in the vegan industry.

Nesquik Commercial Voted Most Deceptive Ad in Online “Badvertisements” Poll

Voters Weigh In on Dairy Commercials’ Faulty Health and Beauty Claims

WASHINGTON— Got deception? Voters say that a Nesquik television ad that tries to sell moms on the supposed health benefits of chocolate milk certainly does. An online poll sponsored by the Physicians Committee for Responsible Medicine (PCRM) asked web visitors to choose between the Nesquik commercial and two other ads that target female consumers: a Yoplait spot claiming that women can “Burn More Fat, Lose More Weight” by eating yogurt and a Got Milk? commercial in Spanish asserting that milk maintains stronger and healthier hair while featuring “Amazon goddesses” using their hair as lassos, self-defense tools, and jumping ropes.

All three commercials use misleading health and beauty claims to sell dairy products to women. The ads dupe women by making claims that are not supported by scientific evidence. Voters in the web poll selected the Nesquik ad as the worst, giving it 37 percent of the vote. The Yoplait and Got Milk? spots received 36 percent and 27 percent of the vote, respectively.

The Nesquik commercial juxtaposes the image of a mom dressing her kids in helmets and knee pads with the message that half of today’s kids aren’t being protected on the inside by getting enough calcium. The narrator claims that the sugar-laden, chocolate beverage will help kids’ bodies by “building strong bones, one glass at a time.”

“Nesquik and other dairy products contribute to the excessive calories, saturated fat, cholesterol, and sugar that kids consume today,” said Susan Levin M.S., R.D. “Parents who want to strengthen their kids’ bones and protect them from obesity should provide kids with green leafy vegetables, sweet potatoes, and beans.”

A 2005 review published in Pediatrics showed that milk consumption does not improve bone integrity in children. Similarly, the Harvard Nurses’ Health Study, which followed more than 72,000 women for 18 years, showed no protective effect of increased milk consumption on fracture risk. Studies show that a diet rich in legumes, whole grains, fruits, and vegetables is one of the best ways to promote strong bones and overall health.

A tidbit in medical history; on August 14, 1767, the King’s College Medical School in New York awarded the first MD degree in the U.S. Well, I guess it wasn’t the United States just yet–still just an extension of the motherland Great Britain.

So what mysterious school is this, as we no longer have any medical school’s with that name. Well, right after the Revolutionary War, in 1784, the name was changed its name to Columbia University. I guess they didn’t want any connection of old King George. Columbia has a nice “new world” sound to it, and that very same medical school is in operation today–albeit a bit more modernized than in 1767.

I have received several comments on my Aug 10 post about the recent court decision to deny terminally ill patients the right to potentially effective treatment–on the grounds that they are “experimental.” You know, the drug might turn out to cause impotence in male patients 20 years after taking it, so that is a major concern for a dying patient.

I have decided that this is a subject worth more than a passing mention, and will be revisiting it regularly. Who knows, I should start a whole new blog on it. That is something worth considering.

Please go and read the comments that people have posted. They are well thought out, poignant, and filled with very intriguing information. Especially about Provenge. It seems that the article I took the information from said that Provenge extended life 4.5 months. As a commenter posted, some patients have now survived 15 months longer than they should have. A drug that adds over a year of life of a dying patient should not be ignored or dismissed. But there may be some sinister underlying reasons.

This is a comment I received, and I think the information is worth reading. It is so typical of the FDA, and may explain the heart of the Provenge controversy. It is also frightening, to see just how much conflict of interest the FDA is steeped in.

Roxanne,

I am writing to you in response to your article, Dying? Tough Luck, dated August 10th, 2007. Dr. Howard Scher, as an employee of the FDA, has been granted a level of public trust and the stewardship of such a position demands the highest levels of ethical and moral conduct. Voting on and participating in an FDA advisory meeting in order to determine which drugs receive FDA marketing approval in which you play a decisive role in and in which you have a financial interest in (or counter interest in), is contrary to unbiased public concern and counter to the fiduciary duty Dr. Scher accepted as a special government employee and FDA panel advisor. Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant’s own sibling participating on a jury resulting in a hung jury decision. Knowing of Dr. Scher’s close professional relationship to ProQuest Investments, how is the public to believe that the FDA made the correct decision? Surely you can see the travesty of his participation in this matter. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests.

The fact that Dr. Howard Scher sits on an advisory board to ProQuest Investments and has been granted an ownership position in ProQuest Investments, a $1 billion venture capital fund which has a major financial ownership stake in Novacea, a direct competitor to Provenge, and is allowed to participate in and vote on marketing approval of Provenge is unacceptable ethically. Furthermore, Dr. Scher’s apparent over the top crusade to deny this choice to terminally ill patients for what appears to be financial gain is immoral in light of the lack of treatment options available to terminally ill androgen-independent prostate cancer (AIPC) patients and when considering the undeniable survival benefit demonstrated in combination with Taxotere, the only FDA approved treatment for AIPC.

The survival data shows that the patients that received Provenge had longer median survival (4.5 months) than that reported for Taxotere therapy, without having to endure 7 months of infusion therapy and coping with the poisonous toxic side effects related to Taxotere infusion. In support of its efficacy, a direct correlation between Provenge induction of immune response and survival benefit was also demonstrated in these patients. Most impressively, the data analysis also shows that when Provenge treated patients were subsequently treated with Taxotere, their median survival almost doubled (from 20 months to 35 months). This is compelling survival data further supporting the efficacy of Provenge for hormone refractory prostate cancer. In comparison, Taxotere increases median survival by only 2-3 months. This increase in survival is so dramatic and remarkable, it could not have been due to a random chance. This clearly shows that Provenge is effective at extending overall survival from AIPC beyond any reasonable doubt. This is amazing data.

Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. Both Dr. Howard Scher and Dr. Maha Hussain, each of whom voted in the minority and are very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from Provenge may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report by Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute).

A request for a Conflict of Interest Waiver was requested by Dr. William Freas, Director of Scientific Advisors and Consultants for CBER, on February 5, 2007. The request was concurred by Vince Tolino, Director of Ethics and Integrity, on February 26, 2007. On March 8, 2007, Dr. Howard Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon’s FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. I don’t understand how the need for Dr. Howard Scher’s individual services could outweigh the above demonstrated conflict of interest created by the financial interest attributable to Dr. Scher. I can’t imagine an individual participant with more financial conflicts of interests sitting on the FDA advisory panel for Provenge. It is my fear that Dr. Scher’s financial interests have come before the best interests of terminal AIPC patients.

There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.

Provenge should be approved now! Cancer patients and advocates will be holding an FDA rally September 18th raise awareness of the current situation and elicit change at the FDA. You can find out more at: http://www.arighttolive.com Please come support cancer patients September 18th. Every voice counts.

If you’re dying of some dread disease, and all of your options spent, and you weren’t lucky enough to qualify for a clinical trial–well, tough luck. Even if an experimental drug may help you, our court system and FDA has decided that you are better off dead than to dare use an unapproved drug.

This does go back to the militancy which developed early in the AIDS epidemic, when patients mobilized and demanded drugs be made available sooner. They didn’t have time to wait until the next century, until the FDA got around to giving potential life saving/prolonging drugs approved. But now it seems, we are back to square 1.

Granted, I think that in many cases, the FDA is far too lax in what is approved and what pharm companies are allowed to claim about their products. For starters, the FDA is a joke when it comes to post-marketing surveillance, although that is beginning to change. But what we have to realize is that most drugs approved these days are mostly for non-life threatening conditions. Some are mere remakes of older drugs, with a few new bells and whistles, and are really not essential in the grand scheme of things.

What I am now referring to are drugs for potentially lethal diseases, made available to dying patients who have run out of options and whose physicians feel that they may help this patient. These are experimental drugs, which are in clinical trials. The patient is willing to pay for them out of pocket, and is willing to take any risks (although, when you are soon to be dead, the word “risk” takes on a whole new meaning). But yet, a court decided today that a patient has no right to these drugs.

From the OC Register:

The U.S. Court of Appeals for the District of Columbia Circuit apparently believes that bureaucracies can and do have power so absolute that they trump the traditional right of free people to control their own bodies and try to protect their own lives. If that’s not the case, it’s difficult to see how the court arrived at the 8-2 decision in Abigail Alliance v. Eschenbach, which denies terminal patients and their doctors access to medications that have passed safety tests required by the Food and Drug Administration, but not the full battery of tests to prove efficacy.

The best course would be for the FDA to loosen up its restrictions on access to partially tested drugs, which lead to “thousands of people dying because of the FDA’s bureaucratic know-it-all attitudes,” as Paul Kamenar of the Washington Legal Foundation, which was co-plaintiff in the case, put it to us.

The next-best course (because it would take longer) would be for the U.S. Supreme Court to reverse this misguided ruling. Mr. Kamenar assured us that an appeal will be filed before the end of the month.

It’s one thing to deny a patient the use of an experimental acne drug, but a cancer patient? One dying of AIDS? One dying of a severe bacterial infection? Come on, let’s get real. This is about the cruelest and most devastating thing that the FDA has ever done. And apparently, the judges who ruled in favor of the FDA seem to think that they are invincible, and will never be a dying patient themselves, without options. Then again, when you are rich and well connected, having a connection to unapproved drugs isn’t a problem. It’s just the peons who will suffer.

“The FDA’s policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects,” Judge Thomas Griffith wrote in Tuesday’s majority opinion.

Does he really think that a person who is dying wants to be “protected” by the FDA, or by him for that matter? Do they care about the potential side effects? And the unknown therapeutic effects–gee, if it doesn’t work, they’ll just die, same as before. This paternalistic and arrogant attitude is mind boggling. Someone ought to lock this person in a room with a hundred dying patients, and then let him explain to them how his decision is “helping” them.

The FDA’s comments about this are priceless, but then, they always are. They never miss an opportunity to show their supreme stupidity, or how out of touch with reality they are. But I guess that it is their right to hold the power of life and death over defenseless patients. People should live and die by their word, it seems.

FDA spokeswoman Julie Zawisza said the agency was pleased with the appeals court ruling.

The decision “upholds the constitutionality of FDA’s role in facilitating appropriate treatment access to investigational therapies,” Zawisza said. It also protects the public by requiring that drugs be proven safe and effective before they are sold, she added.

Again, this protection bit. Did anyone explain to this chicklit that we are not talking about a treatment for nail fungus, but for diseases like cancer? That the word “protection” has little meaning to someone who is peering into their grave and doesn’t want to jump in like a good little patient.

On the bright side was the dissent by Judge Judith Rogers. “Denying a terminally ill patient her only chance to survive without even a strict showing of government necessity [for denying access to the drugs]presupposes a dangerous brand of paternalism.”

Right on sister, I couldn’t have said it better myself.

So where are out healthcare professionals? This is a volatile issue, but I haven’t seem much feedback on this coming from doctors and nurses. But some of them also seem to have this idea that a dying patient should be kept from their options.

From BusinessWeek:

Even cancer specialists, who often seek compassionate use programs for their patients, aren’t keen on expanded access. “I understand emotionally why patients would want this right, but the issues surrounding experimental drugs are very complex, and I think this could potentially backfire,” says leading oncologist Dr. George Demetri of the Dana-Farber Cancer Institute in Boston. “Patients really need to know the relative benefit of a drug versus the relative risk, and expanded access could prevent them from gaining that insight.”

Well gee, Dr. Demetri, then why not sit down and explain the relative risk of a drug to the patient. You know, spend some time with the patient, and go through it. Give them the lowdown. Expanded access is not going to prevent that from happening. The only thing that will prevent that is if doctors like yourself don’t take the time to confer with your patients.

Activist patients, however, are disinclined to wait for such data when it comes to diseases for which treatments are few to nonexistent. Prostate cancer patient advocates in particular are up in arms these days over the FDA’s controversial refusal in May to approve Dendreon’s (DNDN) Provenge without further clinical trials, which could take a year or more to complete. Provenge is a novel cancer vaccine meant to prime the body’s immune system to attack tumors, and if approved would have been the first new treatment in more than 20 years for advanced, stage-4 prostate cancer, which is almost always fatal. Some 30,000 men die each year in the U.S. from prostate cancer.

In a trial, Provenge failed to stop the disease from progressing, but when it dug into the data it found that patients on the drug lived an average of 4.5 months longer than those on standard treatment. Despite the uneven results, an FDA advisory panel voted 13-4 in March to recommend the drug for approval, and the FDA usually follows such recommendations. So when the agency withheld approval on May 9, a firestorm erupted. Prostate cancer activists (and disgruntled Dendreon investors) have lobbied Congress, held demonstrations, and met with the FDA’s Commissioner, Dr. Andrew von Eschenbach.

So now you have to wonder, why did the FDA withhold approval? It’s not like they’ve never approved a drug that was shown to be sketchy, or lacked solid safety data, or was shown to have minimal efficacy. They have also approved drugs that their advisory board turned down. So what’s up with Provenge? It’s not like people are just going to take it for the hell of it. The opportunity to live another 4 or 5 months is a real blessing to someone with a terminal illness. Is the FDA just trying to show how truly corrupt and cruel it can be?

It feels like I went from summer to winter, going from NY back to Seattle. In a matter of hours, I went from wearing the skimpiest of summer tops and mopping sweat off my face, to long sleeves and a sweater and socks. Amazing, and it’s not long I traveled to the Southern Hemisphere or the North Pole. I don’t really enjoy high heat and humidity, but I was also surprised that I was able to tolerate it better than expected.

Anyway, more later. The only friend I have who’s still working as a nurse told me this simply horrific story about hospital politics, nursing antics and apathy (including their refusal to “get involved” and stick together), and how unions can work against you or prove themselves useless.

Well here I am in beautiful NY. Exciting, hectic and sizzling–as in the temperature. It is 90 degrees outside and about 90% humidity. August in NYC–not the best time to visit.

I’m at a meeting right now, in a nice air conditioned room, so I’ll try to pop back later and blog something.