Naked Medicine

Let's Face It: Medicine is Business

Category: Drug Companies

Teva Canadian MS Community: No Win for the Company

Teva is closing its community forum from its Canadian multiple sclerosis education website because of Canadian healthcare regulations around dissemination of information relating to prescription drugs.

You’ll read the explanation if you visit the Teva MS website, but keep reading for the crux of the situation:

I have to agree with Teva’s decision because it becomes a no-win for Teva. If Teva were to hire someone to conform to regulations and actively monitor the site, the patients could claim that Teva would allow only favorable comments when it may in …fact be a perception issue. Teva could be allowing only approved/indicated usage discussions posted, rather than removing unfavorable comments to Teva.

On the other hand, Teva stands to be liable for any damages claimed by patients who said they tried something because of what they had in a Teva-hosted discussion forum even if it was not sanctioned by Teva and even if Teva could have disclaimers abound. If I were a company I would not allow a truly “free” discussion forum, other than one that deals specifically with the approved indication of its drug, and even then would question the utility of this over an actual conversation with a licensed healthcare provider.

I see this as a case of controlling information not for restricting its availability but for the sake of responsibility of how that information is used. Drug information can be used out of context and inadvertently harm patients.

On the other hand, non-profit patient advocacy sites will host these discussion forums, and they appear to legally be able to do so. It would be interesting to see how these associations deal with legal situations that could potentially arise from patients being injured or harmed by information shared on the site that may not be accurate or even safe for others. This is a delicate balance of sharing information to help while keeping that Hippocratic “do not harm” oath in mind. Even if the intention is good, injury can occur because of misuse (and that misuse does not have to be intentional, either, it could be accidental).

But the reality is, drug companies are more likely to get sued than non-profits!

First heard from: Nat Bourre

Advil PM v. Tylenol PM Ad is Misleading

This has been bugging me for a long time, but recently I saw another one of these “advil PM versus tylenol PM” commercials, so I am going to finally write about it!

First of all, the commercial is basically a “why Advil PM is so much better” ad. It talks about how the person taking tylenol PM isn’t getting as good of a sleep as the person taking advil PM, and it shows the person on tylenol tossing and turning while the advil taker snoozing peacefully.


What’s wrong with this picture? Several:

1. They are different drugs. Advil is ibuprofen, an NSAID. Tylenol is acetaminophen, which works on pain by a different pathway. Both work for pain, and both have their advantages and disadvantages as pain killers.

2. But is Advil focusing on this fact – PAIN? NO! Advil is now talking about sleep! All right then, let’s look at the ingredients for sleep. It is basically the same ingredient as Benadryl. The exact same ingredient in both. But I thought I was watching a commercial for a pain killer drug. And instead of focusing on the key indication (pain), the Advil ad focuses on the side indication (sleep).

3. Fine. So why does Tylenol’s sleep aid work less better than Advil’s sleep aid even when both offer THE SAME SLEEP AID? Simple answer: Advil puts more Benadryl (38 mg) in its combo med. OK more accurately, “the active ingredient in Benadryl”.

So it’s not because Tylenol’s sleep drug is less effective, it’s not because Tylenol PM uses an inferior or less effective sleep drug than Advil.

It’s because Tylenol has less (25 mg) of the same sleep drug as Advil.

[On a personal note, Benadryl’s regular dosage is 25 mg, which already makes me feel completely drowsy and dried up. I don’t need an extra 13 mg of antihistamine to make me sleepier!]

This commercial annoys me because it exemplifies what is wrong with many commercials on TV relating to meds. They dupe consumers by playing with words and making apples-to-oranges comparisons, instead of true head-to-head comparisons.

Come on, Pfizer (maker of Advil), you can spend millions of bucks on a better commercial!

Which Side Are You Really On, Jane Chin?!

I received what is probably the most passionate email from a reader of this blog that I’ve ever gotten since creating NakedMedicine.com in 2006. The email concludes with this:

I can’t figure out what your agenda is Ms Chin. Are siding with the poor hard working physicians who are fighting a losing battle with their idiot patient’s lifestyles? Are you siding with the tirelessly industrious pharmaceutical scientists who are selflessly dedicating their efforts to cure our ills? Are you siding with the poor neglected suffering individuals who are bravely pushing onward in their lives, struggling with disease, possible disease, possible pandemics, or just plain plainness requiring cosmetic medicine? Doctors, business, persons, for whom are you advocating?

I was shocked by the email, because this reader “hit the nail on the head”! He can’t figure out what my agenda is, because my agenda is in NONE of those sides he described. In other words, if I were guilty of picking “a side”, it wasn’t part of the “usual suspects”.

Here’s my very long response to my reader, to whom I’m grateful, because he took the time and effort to share with me this question that obviously is frustrating him.

******

You wrote what you felt, and I don’t fault you for that. I can sense a real feeling of frustration from you, and I don’t blame you for feeling frustrated about the healthcare system that seems to be broken in many ways.

I want to address specific points you brought up – first one being ‘cures’. I genuinely don’t think that the drug industry is prevented from, or are resistant to, discovering cures for diseases. It’s not about ‘cure’ versus ‘not the cure’ that is the problem. It is often the economy of scale that is the problem, and a very understandable one when you consider that the drug industry is – and has to run like a business – in order to remain in business. I have no doubt that the drug industry would love to find a cure – because they can charge for the price of a ‘cure’ and be justified in charging such a price.

The problem on the one hand is that many times we simply cannot find ONE underlying factor of a disease, especially the chronic diseases like diabetes and heart disease (in fact, many diabetics die of a heart attack and don’t live long enough to die of diabetes complications, especially those consuming a western diet). It is not like a bacterial infection where we can pinpoint ONE origin of the disease and target that specifically, the way we can target an infecting bacteria with an antibiotic and ‘cure’ the patient.

The other problem is about the number of people with a certain disease. For example, there may be fewer companies willing to research rare diseases that may be ‘repaired’ let alone ‘cured’, simply because the companies need to get the money somehow to do all the experiments and clinical trials necessary to jump through regulatory hurdles to even get the drug approved. When i was a graduate student, doing what are pretty simple experiments (and not even in people – i worked off the petri dishes), i was often using reagents that cost my employer thousands of dollars to purchase from reagent companies. Each of my experiments has to cost at least a thousand bucks, and many of my experiments failed and produced no result.

These prices are nothing compared to the amount of money it costs to run a clinical trial at the scale required by the FDA. Now the drug companies have to pay for the drugs, the cost of mountains of paperwork needed to get the clinical trials started, the doctors who do the clinical trials (and some doctors get really snobby and brag to each other about how much $ they can muscle out of drug companies “per patient” to enroll in the drug companies’ trials), not to mention the “overhead” that the academic institutions charge the drug companies because their doctors work there (and these overhead costs can mean more than 50% of the total study budget).

And then most of the drugs end up not passing the FDA’s requirements and fail to get approved. So if you’re running a company, you will tend to want to go into areas where you will likely have more customers – heart disease for example – just so you stand a better chance of keeping your company operating should it succeed in getting a drug treating that disease approved. This is also why the government has to create incentives for companies that are willing to go into rare or “orphan” diseases – for example, Gaucher’s disease is a rare lysosomal storage disease affecting maybe 1 in 40,000 people. A drug company that competes in this market will be happy selling 1 prescription every 3 months.

I honestly do not view drug companies as entities that profit from the suffering of others, because of the logic of this assumption: If drug companies are creating diseases in people in order to make drugs for the very diseases they created, then that to me qualifies for the statement. However, drug companies happen to offer the tools to treat the disease, not unlike device companies making scalpels and surgical tools to allow doctors to cut us open should our illnesses demand it. It seems illogical to me to accuse device companies for profiting from people having tumors that require scalpels to operate and excise the tumors – unless we’re also implying that the scalpel companies are putting tumors in people that only their brand of scalpel can remove.

Additionally, I have observed that for the most part, people in our society today tend to prefer that we “have a pill to treat XYZ”, so that they do not have to do the hard work required to get their own health back on track. And then you add to the fire media agencies that charge pharma companies millions of dollars to come up with brainless gimmicky advertisements, and it is no wonder why many people feel like the drug companies are “profiteers of suffering.” Some years ago, there was a government funded study that shows that rigorous diet and exercise will help reduce diabetes risk at a very real level – in fact – the study patients who had diet and exercise regimen did as well in reducing their diabetes symptoms as study patients who took an anti-diabetic drug.

But why hasn’t the government or the doctors (not the drug companies – their responsibility is in making drugs) done anything about this amazing result? Because the of costs involved to the clinics in order to make “diet and exercise” possible in patients at a therapeutic level. Clinics would need to hire case workers and nurses whose job is to counsel and support and follow each and every single patient who opts for this “natural and effective” treatment. OK then, how about asking patients themselves to do this? Seriously, if you are a patient at risk for diabetes (i.e. risk factors are there, but patient is still “pre-diabetic” and not yet requiring drugs to control their blood sugars), you have everything you need at your disposal to go for the natural and effective (and less expensive than prescription drugs) cure! why aren’t patients doing this? because willpower and discipline are key – and you’re going to need both for a lifetime to prolong the onset of disease.

I can share this true experience – my husband had prediabetic blood work results some years ago when I urged him to see an endocrinologist, because his side of the family also suffers from diabetes. the endocrinologist told him that because he was so young (not yet 40 at the time), she preferred that he try the old fashioned diet and exercise, and see if he could get the risk factors down, before she put him on a drug. He happens to have a level of willpower and discipline that even I don’t have – and he altered his lifestyle dramatically – and it was enormously difficult. 6 weeks later he went back and the endocrinologist was so impressed with his results that she told him that most of his blood work results were approaching normal numbers. But she also told us that not every patient she sees can make this happen – and often she is forced to give the patient drugs to make sure that the patient doesn’t end up with uncontrolled diabetes symptoms (resulting in all sorts of nasty things including death).

I see drugs as exactly what you said you wished to see – repairs and cures. However, the reality is, few are truly cures because of the complexities of most diseases, and repairs don’t always “fix” things without creating new problems (called side effects) EXACTLY because of the complexities of most diseases.

The doctors’ hands are tied not by pharma companies, but by insurance companies as well as their own malpractice lawsuit concerns. Your average primary care doctor has to track how many patients he sees everyday because he needs to make sure he breaks even. That’s not the drug companies doing, but the insurance companies that capitate how much doctors are paid for doing what. So you also have a system that don’t reward doctors for spending more time with patients – in fact – you’re making it very bad business for the doctor to spend too much time because then he’ll lose money that day – and this does not do well to cultivate trust with patients who then need to heed the doctors’ advice about doing the hard things they need to do to steer their health status back on track.

I hope my email begins to help you understand where I am coming from – perhaps I can’t take any sides because I don’t think there are any sides that I can reasonably take without acknowledging that there are other entities that also need to be held accountable. the healthcare ‘system” is truly a “system” and a staggering, complex one at that. the best I can do is to help the consumers – people like you and me – to think for ourselves about what is being “sold” to us whether it’s from the drug companies, insurance companies, the government, the doctors, even patient groups. If I am guilty of siding with anything, it will be on the side of “critical thinking” about the system of healthcare with all of its players.

Best wishes,
Jane Chin

Pharma Offering Lifestyle Drugs – Power will Shift to Patient Customers

You’ve probably seen it coming – smelled hints of it on TV – pharmaceutical companies are getting into what we call “lifestyle drugs”; products that focus on “enhancing” your life rather than “extending” it.

Yes, there is a big difference, and you may think that “extending” life pays big, “enhancing” life may pay even BIGGER. (just ask the Botox people.)

It’s only a matter of time before pharmaceutical companies shift their focus from “therapeutic intervention” to “lifestyle / recreation” because they now deal with a ready-and-willing customer base who are willing to pay.

This also creates a more dramatic shift: one of bargaining power from the physicians to the patients. Eventually, pharma’s customers will become the patients more directly than before, with doctors becoming more of a “broker” – the people who writes the drugs but apart from that having no real power. Doctors are already complaining about patients leaving them if they don’t do what they’re told by the patients – “if you don’t write me this drug, I’ll go to someone else who will!”

There’s a bit of theatrical irony if this happens, because doctors will get a taste of what pharma sales reps have dealt with for years: being punted to the position of a measly “order taker” or “human sample dropper”. How about doctors eventually becoming “order takers” and “human Rx writers”?

Pharma Industry’s Job is NOT Disease Prevention. THAT’S YOUR JOB.

I’ve heard the argument, so have you.

“Those evil pharma companies aren’t interested in prevention! They want people to get sick and stay sick because that’s how they make their money! On the drugs!”

Recently I had railed against the pharma companies that are capitalizing on increasing trends of people using certain prescription drugs as “lifestyle drugs” – not to mention appearing on the Wall Street Journal this past Friday to rail against pharma companies that abuse the role of medical science liaisons, so I have my own pet peeves and criticisms with pharma. What irks me is when a criticism about any industry is not based on a fundamental flaw in that industry, but is simply born of politicking sensationalizing this-is-how-I-get-more-readers/viewers tactic.

Most of these people have taken a basic science class at some point in their lives and learned about a phenomenon called “entropy”. How things in a system tend to go toward disorder, and to halt this “natural” occurrence from occurring, you have to add in a great deal of energy, and even that won’t ultimately stop the inevitable.

Kind of like the idea of life and death, which is relevant to the assessment of this dimension of our hostility towards the pharmaceutical industry.

Obviously, pharma companies want you to stay alive, preferably as long as possible. This is not so they can capitalize on you dying (a dead person is no longer a customer)! The pharmaceutical industry is a business that capitalizes on your DESIRE to PROLONG YOUR LIFE AND MINIMIZE PHYSICAL PAIN AND SUFFERING. If you aren’t interested in prolonging life and minimizing physical pain and suffering, the pharma industry ain’t gonna benefit from YOU since you’re not a customer to begin with!

Let’s say you are sick from complications of heart disease.

Pharma companies that are in the heart disease business is not responsible for PREVENTING YOU from getting heart disease. YOU ARE RESPONSIBLE for making sure you do what you’re supposed to do to reduce your risk of getting heart disease, unless somehow you have signed the claim to your physical existence over to another person who is legally responsible for your physical survival and health.

Your family doctor may have a responsibility to educate you on mitigating the risks of getting heart disease, so those who want to rant about prevention may want to point their antennae to the medical profession, but ultimately YOU are STILL RESPONSIBLE for the behaviors and actions YOU TAKE that lead to the result of heart disease or no-heart disease. Your doctors can be the best doctors they can be and even give you a diet and exercise regimen that will lower your cholesterol, reduce your blood pressure, and take down your diabetes risk factors a few notches – but if you DON’T DO WHAT YOU’RE SUPPOSED TO, then you will end up with the health consequences. Actually, this is EXACTLY what happens in many obesity and heart disease cases today. Doctors themselves will admit that many of their patients won’t heed their advice, and most will lack the discipline required to stick with a rigorous healthy lifestyle to make a lifesaving change.

Are we saying that it’s the pharma industry’s job to PREVENT us from assuming behaviors that will put our health at risk? If there’s a pill for stopping us from risky behaviors, and pharma makes it commercially available, then we’ll simply turn around and say “now pharma wants to control our thoughts and actions!” (I think we already have those kind of pills, and there are activists and lawyers jumping on that bandwagon.)

Seriously, if you take care of your body, do everything healthy like you’re inundated by all media outlets to do (don’t drink, don’t smoke, don’t go out in the sun without wearing sunscreen, eat more fruits and vegetables, exercise at least 30 minutes a day, etc…), then you’re probably not going to need all those pharmaceuticals until the inevitable process of aging occurs, where your cells can’t care less what you’ve done because they’re all getting old and breaking down as a natural part of the decline of “life” in your physical human existence.

Female Sexual Dysfunction: Pharma’s Next Lifestyle Market

I’m posting this from one of Steve Woodruff’s blog posts that I shared via my Facebook profile, which turned into a full blown debate between me, Dmitriy Kruglyak, and Yvette – one of my FB friends.

Jane Chin
I’m pro-pharma, but I’m NOT happy w/ female sexual dysfunction disease mongering I expect to see from pharmacos! http://ow.ly/4xQH

Dmitriy Kruglyak at 8:18am April 30
Where do you draw the line between “disease mongering” and “disease awareness”?

Jane Chin at 8:21am April 30
When the ‘awareness” generated makes patients who otherwise are not candidates for the drug pressure docs to write the Rx.

Dmitriy Kruglyak at 8:23am April 30
Ah, but who gets to decide “who are the candidates” and what qualifies as “pressure”? Especially if we are talking DTC, rather than Rx. Are there hard and fast rules?

Jane Chin at 8:25am April 30
that’s why I don’t think DTC is responsible for niche diseases. Pressure=if you don’t write it, I’ll go to another doctor who will.

Dmitriy Kruglyak at 8:27am April 30
Hmmm, seems to me “if you don’t write it, I’ll go to another doctor who will” can come from any kind of patient empowerment, not just driven by Rx advertising.

Jane Chin at 8:28am April 30
Yes it can, but true patient empowerment IS NOT “take this pill, fix your problem” when the problem is not always solved by “a” pill.

Dmitriy Kruglyak at 8:47am April 30
Patients just want to do what they want to do. People have, are and will always look for quick fixes. That’s human nature.

Jane Chin at 8:51am April 30
I know this is human nature, and one capitalized by advertising. But where health and human life are concerned, the ethical standards should be higher.

Dmitriy Kruglyak at 8:53am April 30
Seems to me advertising is simply fulfilling demand

Jane Chin at 9:02am April 30
No, advertising is meant to CREATE demand. Even better when advertising increases the market from perception-based v. needs-based demand. (more…)

How to See Through Pharma Ad BS?

Like all marketing campaigns, the aim of any pharma advertisement is to get you to think that you need a certain product or a service. I understand that all pharma companies will say that they want to educate patients on the condition first and foremost, but I guarantee that when pharma companies are forking over multimillion dollar checks to ad agencies, they’re looking for more product sales as a return on investment (ROI).

This is not a “bad” thing – this is business. Let’s say you’re an inventor and you created a program that would improve the amount of sassing teenagers give to their parents. Would you pay an agency half of your annual paycheck so that parents can be educated about the prevalence of sassing by teenagers? NO! You want parents to buy your program so you can make back at least the money you spent on the ad, plus more so you can pay your mortgage and keep your family fed!

Well, pharma’s like that. I know for some it is incredible to believe, but pharma companies are not alive in themselves, as if there is a force called “the pharma company” making decisions. Pharma companies are made up of hundreds of thousands of people who have to feed themselves and their families and put a roof over their heads. (Many of them are parents and most of them probably wish that you did invent a program that improves teen sassing of parents.)

So the key is not to spend your energy hating companies and talking trash about how misleading some commercials are or how annoying you find that a computer graphic bee is selling you asthma medication or how a group of red-towel clad women looking like they think they’re better than you want to sell you a hormone replacement drug.

As consumers, the key is to see through BS!

And the best way to see through any “BS” – whether it is from pharma or any other industry – is to know the difference between:

– what you NEED

– what you WANT

– what you are led to THINK you NEED

This last item – what you are led to think you need – is the crux of how ads work. Ads lead you think you need something, and usually tap into our animal instincts, or tap into our more “evolved” desires like convenience.

Example:

– buy this car and you’ll attract sexy partners (taps into animal instinct)

– take this pill (taps into convenience in some cases where diet, exercise, life style change is much harder)

Therefore, a question consumers can ask themselves whenever they are confronted with an agent of influence is,

“Is this what I REALLY need? Or is this what I want? Or is this what I am tempted to think I need?”

You can apply these questions to 99% of the junk ads you see on television these days, aside from pharma ads.

We Already Have Been Personalizing Medicine

By Jane Chin, Ph.D.

Let’s take the trend of “personalized medicine” to start. Yes, gene-based and protein-based medicines sound alluring. We talk about targeted therapies like they’re silver bullets against deadly diseases, when we still don’t know of the long term effects of many small molecule and biologics as medicines.

All that talk about personalized medicine and how wonderful it would be if we were to have drugs tailored for us? We’ve been doing that for years!

Yet pharma has been providing a level of “personalized” medicine for years, which has created its reputation as a greedy industry with “mediocre” innovation as perceived by its critics.

Critics ask why we need yet another statin? Do we really need to have that many antidepressants in the SSRI class? How many more erectile dysfunction product ads can we endure? Should we blackbox all the glitazone drugs?

We can apply the “personalized” medicine argument to these so called “me-too” drugs reviled by academics and consumer watch dogs. We do need that many statins, because a patient may tolerate atorvastatin better than rosuvastatin. Someone’s life may be saved by paroxetine even when their depression symptoms didn’t respond well to sertraline.

But all this comes at a cost, because of the fundamental reality that personalized medicine requires segmentation of patient types to the point where what used to be ‘blockbuster marketing” is becoming “specific patient population/niche marketing”.

Truthfully, pharma marketers don’t like that. The return on investment isn’t as impressive. Investors on wall street are more impressed by blockbuster numbers than special patient populations. Executives don’t get as big of a bonus at the end of the year. Ad agencies don’t get as many multi-million dollar contracts for celebrity ads or computer graphic-generated creatures talking about allergies.

So the first shift requires pharma companies to begin training their marketers and sales teams to view patients as patient groups with specific tolerances and response profiles rather than a faceless generic group from which blockbusters are created.

This shift in marketing thinking, however, is going to take a while.

Most Doctors Don’t Recommend Their Own Profession

Dan Abshear

Lately in the media, others have said and expressed concern about the apparent shortage of primary care doctors, most notably. Typically, the main reason stated for this shortage is lack of pay of this particular specialty compared with others chosen by potential physicians.

Yet considering the additional attention of shortages of students in some medical schools, one may ask the question as to whether or not people want to be any type of doctor in the first place in the United States. About one third of their lives are spent achieving the requirements of this profession. Reasons for not choosing to enter this profession are several and valid.

There is the issue of long hours- with primary care in particular because of the apparent lack of doctors of this specialty. Such doctors may be over-worked without an expected pay reflecting the work they do. Furthermore, those doctors employed by health care systems are required to see a certain number of patients a day, and receive a monetary bonus if this expectation is exceeded. It seems that most doctors are members of such health care systems. So burnout certainly may occur. And I consider such a requirement mandated by health care systems demeaning to this profession, and leaves the doctor without the control that the doctor is entitled to due to their training and experience.

However, the recent increases in hospitalists, who are those doctors that are usually Internal Medicine doctors who specialize in patients presently under hospital care, and they have lessened the load for all doctor specialties for the work they do that the admitting doctors would have to do without their presence. This in itself makes a doctor possibly more effective and efficient in their practice outside of the medical institution.

All doctors, I presume, face a high degree of emotional and physical stress associated with their profession, as stated in the previous paragraph, for example. And this is not to mention the incredible stress associated with patient care in the first place, with some patient cases causing more stress than others

Doctors, due to the changes that have occurred recently in the U.S. health care system, not only have the issue of money to deal with, but also a loss of autonomy regarding patient care combined with loss of respect that may be due in large part to others dictating on how they practice medicine. Ironically and often, these others are not as qualified as the doctor in the first place. This is complicated by the perception that the public, with some who view doctors as having the easy life with their pay and profession, which does not seem to be the case presently.

There are also reasons of malpractice insurance, which is why doctors choose to join health care systems, it is believed, to pick up the tab for this necessity, along with eliminating the concerns of running a practice in a private manner, which historically has been the case, as their offices are owned by the health care system as well.

Up to 90 percent of malpractice cases against a doctor are baseless and without merit, so they are unsuccessful for the plaintiff, yet this still affects the rate the doctor has to pay for malpractice insurance. I understand that simply filing a lawsuit against a doctor, as frivolous as it may be, still increases the malpractice premium of that doctor. This is combined with the amount the doctor has to spend to defend themselves in such cases, which approaches about 100,000 dollars over the course of about 4 years for such cases. A tort reform in Texas in 2004 resulted in annual malpractice premiums reduced by about a third of what they were. Soon afterwards, claims against doctors remarkably dropped by about 50 percent. Some specialties of doctors pay more premiums for malpractice than others. For example, OB/GYN doctors have been known to pay around 300 thousand dollars a year for this insurance. Certain types of surgeons experience a similar high rate of malpractice premiums.

Also, about a third of the U.S. is insured by Medicare, which progressively has lowered what they will reimburse a doctor for regarding the care they give a patient they treat. This fact is recognized by other insurance companies who will eventually follow the recommendations of Medicare, usually, regarding the reimbursement issue, so it seems. This will lead to a doctor having to see even more patients in order to make it financially with their profession, as this has resulted in the overall income of a doctor experiencing a decline of about 10 percent over the last decade.

Furthermore, doctors normally have to pay off the debt acquired from attending medical school, which averages well over 100,000 dollars today after their training. About 20 years ago, that debt was only about a fifth of what it is today. Paying this debt off is typically about 2 thousand dollars a month that doctors on average have to pay in order to eliminate this debt in a timely fashion. There are some who believe that doctors in the U.S. are over-paid. This may be true, but they are not absent of financial concerns as with any other profession.

Most doctors do not recommend their profession to others for such reasons stated in this article, and perhaps others not mentioned. This is somewhat understandable, yet extremely unfortunate for the health of the public in the future, especially. There have been cases where doctors do in fact change careers, and get into vocational fields such as medical communications or corporate medical companies. Also, expert witnessing is another consideration for those who choose to leave their profession. Finally, other choices considered include consulting and research. The training of doctors fortunately leaves them with options not involved directly with the flaws of medical care, but this is bad for us as citizens, overall.

No all doctors are saints. Like others, some are greedy and corrupt, which complicates others in this profession. Personally, I believe that the intentions of most physicians are bona fide. Yet in time, due to the nature of the current health care system, doctors frequently become cynical and apathetic, and this may be considered a significant concern to the well-being of those in need of restoration of their health.

Not long ago, the medical profession that has been discussed had honor and an element of nobility. Such traits are not as visible anymore, which saddens many intimate with the profession needed by many.

“In nothing do me more nearly approach the Gods then in giving health to men.” — Cicero

Disclosure: The author was formerly an employee of the pharmaceutical industry (sales) and is currently seeking employment in the same industry.

Provenge and FDA’s Etiology For Not Approving

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

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