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SKEPTOID BLOG:

Here Is Where Big Pharma Pulls My Funding

by Stephen Propatier

August 28, 2013

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Donate I often and vociferously advocate science based medicine. I attack poor reporting and media fails related to medicine and medical science. Many critics of my posts accuse me of being "blind" or some form of gullible advocate for "Big Pharma", Big Food", or some other form of corporate nonsense. I get the impression that they think I am a disinformation agent or just extremely gullible. Everyone has biases and I am no different. I know that I am overly critical and sometimes I think that I am too cynical about new research. Pretty much the opposite of gullible. There is an underlying theme to alternative-phile critique. I am trained in science based medicine therefore I unable to see the failings of "Western Medicine". Not really true I know medicine has problems. Science based medicine is not perfect it is simply the best we have.

Medical Science is a tool. Like any other tool it has abuses. I have criticisms of medicine. Some are objective and some are not. Social values, resource allocation and implementation are big trouble spots in my opinion. I rarely write posts about medical science because there is just so much to address. I tend to stick with the most egregious topics or personally nit-picky issues. I also follow the blog Science Based Medicine and I try not to retread their topics. I am consistently infuriated by the grey area of medicine. Namely what is effective and what is useful. It sounds counter intuitive but they are not always the same thing. In my opinion the alternative medicine industry plays off of people's poor science knowledge and critical thinking skills. What may not be as clear is that the medical industry has taken to using the same principals to try to subvert the science. I am about cash my last "Big Pharma Check" after targeting a resounding fail of the pharmaceutical industry. Namely direct marketing to you, the consumer.

I will keep my discussion of direct marketing of pharmaceuticals and medical devices in the United States market. I am not familiar enough with other countries that allow direct medical advertising. To my knowledge New Zealand is the only other one that allows it. There are two categories that pharmaceutical companies directly market. The consumer and the prescriber. The latter was direct marketing to physicians, nurse practitioners, physician assistants, basically anybody who could legally carry what's called a DEA number. Over time the medical profession, and the medical regulatory commissions have realized the folly of allowing this. There was extensive research showing this abnormally affected prescribing habits of providers and was cost ineffective. There has been subsequent litigation and legal restrictions placed upon pharmaceutical and medical device companies. This has greatly restricted directly marketing to prescribers. Despite the regulation related to prescribers, directly marketing to the consumer has continued unabated.

Mostly this advertising has continued under the banner of patient information. There is the catch. There is upside to direct marketing. People will speak to their doctor about a problem and they may begin a necessary discussion. In a perfect world this is always good. The problem with direct marketing is that the manufacturers draw the best possible picture for a drug or medical device. The patient walks into the doctor's office expecting to receive that medicine/device and perceives the prescriber as a barrier to receiving it. This puts the provider in a position of having to talk the person off the ledge literally. Often having to teach them all the knowledge they need to know understand why this medication may not be the best or most cost-effective option for them. This automatically put us in the position of being the adversary with our patient.

Television especially is very effective marketing. The same effective marketing tools that cause people to go out and pursue useless and problematic alternative therapies also works for proven beneficial therapies. Unfortunately the newest most expensive treatment does not always mean the best treatment. Because of the money involved there has been little push back from political bodies to restrict direct marketing to consumers. It is an interesting irony in the United States that direct marketing of hard liquor on television was restricted in the 1970's. Yet today I can have a one-hour infomercial about the benefits of OxyContin on television.

So what does this have to do with science-based medicine? Does this mean that the medication is useless or does not deliver the promised benefit? Actually, that is a very complicated question. Simply put medications have to prove safety and efficacy to the FDA. They are purposefully not cost comparative studies. For example the super marketed "Nexium" was often compared to other PPI drugs in advertisements. In actuality the drug was never comparatively studied. They took the data from like studies and compared the data findings. They used this to present Nexium as better than the others. That is the old shell game. They were not comparative studies and never meant to be used in that way. Yet for two years the drug "the purple pill" was one everyone wanted. Time showed Nexium was no better than any other PPI. Yet billions were spent on it.

That is the problem with the initial FDA trials. They often paint what I would call the rosiest picture of effectiveness and safety for medication. Over time what you'll see often is a flattening of the benefit curve and in increase of the risk curve. This is simply due to the structural problems of minimizing variables in the FDA trials. You do not want extremely sick and elderly people as your primary candidates for research. They have too many variables to properly control for all factors. Once the medication has been widely prescribed across the US population FDA reporting systems will often show the true nature of the problems with the medication/device. There is a risk to benefit balance. In medications that preserve and save life the higher risk curve makes trying it worthwhile. In medications/devices that improve quality of life I recommend a much more cautious approach.

That is not the case in direct marketing. In direct pharmaceutical and medical device marketing the push is for the newest, hottest device and medication. This is simply because that is where the greatest investment is. There is a ticking timer from the time the device or medication is first approved. Once that timer goes off their exclusive rights to the drug or device have disappeared. For that reason. When a drug is newly approved it is most heavily marketed. It also gives them the greatest freedom to market directly. The most money is spent. In the United States, there is a clear correlation between money spent on advertising and prescribing. Despite the best intentions of medical professionals patient pressure does work, and it is often simpler to write the prescription than to argue with patient.

An excellent example of this is the recent push on television for testosterone medications. There is little scientific evidence that low testosterone is a problem as men age. There are certain medical conditions for which low testosterone is a problem. That is not what the television advertising has been geared for. The television advertising gives you the impression that testosterone is a fountain of youth for an aging male."Feeling like a shadow of your former self?"," Lost your appetite for romance?", The problem could be"low T". This medication has become so popular that the American Urological Association has come out and added testosterone therapy to a list of overused and potentially dangerous medical treatments. Despite that recommendation drugmakers have spent lavishly on commercials. 14.3 million in 2011, 107.3 million in 2012. Mostly focused on two drugs and AndroGel, and Axiron.

I watched the advertisement on TV, and I become incensed at the 5 second legal ramble describes the highlights of some of the most significant risks. Always with the disclosure that you should check with your doctor before starting all medications. Like you can self prescribe anyways. Companies advertise this way because it works. It is not good science. It is good business. In 2010 they spent about 2 million on advertising for testosterone. They sold about 1 billion dollars worth of testosterone medications. In 2012 they spent greater than 100 million. They sold $2.3 billion of testosterone medication.

I can only draw one conclusion from this radical change in prescribing. Either there has been a 100% increase in Hypogonadism, or pharmaceutical companies are taking advantage of the fact that men's testosterone levels drop as they age. The FDA has only allowed prescription of these treatments if a male testosterone level has fallen to a certain level. It is only in cases of significant hypogonadism that the treatment is warranted.

Even if you do have the condition. The treatment has significant problems. Breast enlargement, reduced fertility, heart attacks, worsening acceleration of prostate cancer, women and children can be accidentally exposed to the topical hormone and can develop male characteristics.

This treatment has the same significant problems we ran into with female hormone replacement therapy. There are several essential science questions that have not been completely answered in this condition. Is it normal or even beneficial for our bodies testosterone level to decline as we age? Are we putting undue stress on the parts of our body that are affected by hormones, resulting in higher risk for life-threatening injury such as heart attack? Are we running our hundred thousand mile engine on high-octane gasoline, resulting in more breakdowns colloquially speaking? Personally I like not turning into a blithering idiot everytime I talk to a pretty woman, like I did when I was a testosterone revved kid. Secondly, there are many causes for lowered sex drive as we age. Poor sleep, no exercise, high stress, feelings about your partner can all sap your sexual energy. Diabetes, hypertension, pituitary tumors, and some drugs can lower your testosterone level. Removing those treatments or changing your activity is a much safer treatment option than slapping some testosterone into your armpit.

This is just one very expensive example of how direct marketing distorts the purpose of science, evokes simple solutions to complex questions, and costs us untold billions. Both in primary cost and secondary side effects. Does this sound familiar to you? Skeptics, it should, it is the same problems that arises from alternative therapies.

If you're concerned about your condition, speak to your physician about it. Don't go looking for a specific treatment. Asked their advice, ask them what works, and most importantly asked them what the risks are. Secondly, we are all paying for healthcare directly and indirectly. Even if you are only paying the co-pays you should always ask how much does this cost compared to other treatments. If you don't no one will. It's good science, it's good economics, and it's good medicine.

If this means I've given up my executive washroom key to the Big Pharma bathroom so be it.

Please be forgiving of the typos's for personal reasons I had to use voice recognition and little editing.

References:

http://www.bcmj.org/articles/testosterone-deficiency-practical-guidelines-diagnosis-and-treatment

http://www.hindawi.com/journals/ije/2012/625434/

http://www.who.int/bulletin/volumes/87/8/09-040809/en/

Guay et al., Clomiphene increases free testosterone levels in men with both secondary
hypogonadism and erectile dysfunction: who does and how does not benefit? Int J Impot
Res , June 2003;15(3):156-65.
Rhoden EL, Morgentaler A. Risks of testosterone-replacement therapy and
recommendations for monitoring. New England Journal of Medicine 350 (2004):482-92.
Steiner and Pound, Phase IIA clinical trial to test the efficacy and Safety of Toremifene in
men with high-grade prostatic intraepithelial neoplasia (PIN). Clinical Prostate Cancer,
June 2003, 24-31.

by Stephen Propatier

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