Naked Medicine

By Dan Abshear

Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.

Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men who have prostate cancer in the United States. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA (Prostate Specific Antigen) blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.

Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as Taxotere (Sanofi Aventis, docetaxel). The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.

Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as urologists and oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.

Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!

Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.

Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.

The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.

“Facts do not cease to exist because they are ignored.” — Aldous Huxley

Doctors can now fax Senator Chuck Grassley at 202-228-2131 to report on drug companies that the doctors perceive to “push too far” and are being “bullied” by drug companies. Doctors can remain anonymous and send information by mail or fax. This effort came at the heels of the Avandia investigation earlier this year, where manufacturer GlaxoSmithKline was accused of pressuring Avandia critic John Buse to change his story about Avandia risks. The company said it wanted Buse to correct factual errors Buse made about the drug, while Buse said the company used intimidation tactics.

I wonder if Grassley knows what floodgate he’s opening up by creating a service that allows anonymous tips on what is very much a subjective behavior (i.e. what one perceives to be intimidation or bullying or “hardball tactics”), and whether the senator is actually equipped to conduct investigations into every complaint filed. Source: WSJ Blog.

A Consumer Reports video of the Requip DTC ad (another drug used to treat RLS, manufactured by GlaxoSmithKline) has been published.

Let me first state that I’ve seen the Requip ad in question many times when I watch TV, and each time I have the same negative reaction to the ad. This means I have some negative personal bias against the ad itself and the way the company is marketing this to consumers en masse. That said, I decided not to go to the drug company’s “defense video”, which may predispose me to additional bias, and I present my analysis of the anti-ad video by Consumer Reports.

A young woman is seen in the ad to go through the drug company’s ads line by line. She comments on the statements made by the drug company ad. She doesn’t really “analyze” the statements as much as comment – and there’s a big difference between an unbiased analysis and editorial/opinion/commentary (example, “Ooh! Sounds Serious” and “Sounds like the side effects are worse than the condition!” and lots of sentences beginning with exclamations like “Ahh!”).

Given that she doesn’t suffer from RLS, her commentary is biased and nothing more than an opinion. I’d like to hear from a member of that 3% population who DOES suffer from RLS and hear whether he or she agrees that the side effects are worse than the condition.

She does mention selectively the 2 people whose compulsive gambling caused them to lose over $100K each as a result of the side effect of Requip. $100K is a lot of money, no question about it. But 2 people – that’s a small “sample size” and in the medical community and the lines of “evidence based medicine” would constitute “case reports” – the weakest type of “evidence” and would be considered anecdotal more than actual evidence. Other types of side effects like nausea and headache probably had more reports, but $100K is more sensational. It seems like the Consumer Reports anti-ad video is using some of the techniques that they’re criticizing the drug company for doing – sensationalizing what is actually a very small percentage of occurrence.

Does the Consumer Report ad make valid points? Sure. Is the anti-ad “ad” video a spin? Yes. A gloating male voice comes at the end to say “This ad is sponsored by – NO ONE!” as a vehicle to suggest that everything it claims in the its video must be unbiased and therefore, credible. However, the video itself contains very little evidence, lots of editorial claims, and does not address symptoms of the actual condition of RLS so that consumers can be “better educated” if Consumer Reports does not believe the GSK’s Requip ad is doing a good job.

This reminds me a bit of smear campaigning that politicians use against each other. What I’d like to see is a curbing of anti-anything from activist groups. For once, I’d like to see someone spend the dollars coming up with the better solution to educating consumers credibly and objectively and setting a positive example for others to follow.

Source: John Mack who has been following the restless leg syndrome (RLS) “phenomenon”.

This past week’s Sunday “Post Secrets” had a postcard that said, “I don’t care what you said, I still think RLS IS BULLSHIT” sent on a postcard made from a Mirapex (prescription drug for restless leg syndrome or RLS) ad. This generated a flurry of comments in the Post Secret discussion forum, where people talked about experiencing RLS or witnessing a loved one who suffers from RLS.

Hence is the dilemma for direct to consumer advertising by drug companies.

On the one hand, there is a grain of truth in the ethics of drug companies to mass market to consumers a condition that affects a very small percentage of the population. One wonders why a drug company would choose huge media outlets like magazines and television to talk about a drug for a condition a very small percentage of the population suffers from. Would this create false diagnoses? Foster hypochondrias in those who do not actually suffer from the condition, but have become suggestive to think they do based on what little they know about the condition in a 30 second TV commercial?

On the other hand, those who do suffer from the rare condition can feel a sense of relief that they were not alone or “crazy”, that the condition is indeed a medical one requiring medical intervention, and that there is medical help. Even if drug companies try to educate doctors on a rare condition, doctors may not always have time to do a detailed workup and uncover the condition unless the patient proactively offers this information.

As cynical as I am of DTC advertising by drug companies, I still choose having the information out there than not having the information available at all.

Shirley Loewe had one of the most aggressive form of breast cancer (inflammatory breast cancer). Her tumor was already 4 inches wide when she was diagnosed in 2003.

Adding insult to cancer, Shirley was repeatedly denied care because she was either “not poor enough” to qualify on Medicaid in Texas because she made $15,000 a year, or “not sick enough” to receive treatment otherwise.

Texas had an obscure law that allowed women diagnosed in federally-funded cancer detection clinics to cover women with cancer by Medicaid even if they did not otherwise meet eligibility – only Shirley did not go to a federally-funded cancer detection clinic because she had no clue about this obscure law.

Since then, Texas amended the law to lift this restriction, but it was too late for Shirley – she died in June 2007.

Source: A Breast Cancer Death, Tangled in Bureaucracy.