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Category: Politics in Medicine

Why Consumers aren’t Buying “High Cost-of-Developing Drugs” Argument

The Economist recently published an article on the government of India denying Novartis the patent for its cancer drug, Glivec (in the U.S. marketed as Gleevec).

In reading the reader comments, it is obvious that a sense of fairness violation was perceived by readers who felt that the government was correct in denying Novartis this patent, given that the readers perceived the company should have “made back its R&D losses” in developing this drug and beyond.
Image by Chris Holder
Pharma companies cite R&D development costs as well as the pitiful yield in its success rate in developing novel drugs as the reason why drugs cost so much. Thus patent is given as a way for companies to recover overall losses in this risk-intensive business as well as remain sustainable over the long term.

Yet companies are also known to go for patent extension strategies that do not represent truly novel contribution to market, by creating slightly different forms – or formulations of the drug – and then gaining patent on that slightly different form. Then companies use their sales and marketing arms to then keep patients on the “newer” (in patients’ mind, “better”?) version of the drug instead of the cheaper generic.

Those who argue for patent protection speaks about the risk and astronomical costs in bringing a drug to market. This is true, especially during human clinical trials, which consumers are rarely given the full picture of just how much “each patient” in a clinical trial actually costs the company to run the complete trial, especially when there is tremendous overhead in setting up these trials across different clinical settings within the country.

But consumers also perceive the unfairness of the pricing and when it comes to healthcare and medicine, emotions run high and it is common to conclude that pharma companies are greedy and being unfair given that they should have had already recuperated on their fixed costs and now they are using strategies to boost their bottom-line when they aren’t really investing in that drug (but they have to keep investing in their pipelines of drugs, many of which will fail, rendering huge losses to the companies).

Drug companies try, and its advocacy arm (PhRMA in the u.s.) tries, but the approach and message don’t seem effective. These messages are often very abstract and statistics-driven, which do not lend well to personalization. Statistics aren’t stories the average consumer can relate to.

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.

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 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…)

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

Bullied by Pharma Co? Fax Senator Grassley

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.

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