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Industry Bias in Biomedical Science

wisdom — Sat, 26 May 2012 21:10:25 +0000

An interesting article written by Christopher T. Robertson titled “The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment,” appears in the American Journal of Law and Medicine (vol. 37, pages 358-387, 2011).

The article discuses how the medical industry spends billions of dollars to create innovative products but also spends nearly as much to change the behavior patterns of those interested to make sure the products are purchased.

The author states

“As a veteran of the industry writes, ‘ in the pharmaeeutieal industry, there are two ways to market an approved drug for a new use: the ‘indication’ route—performing studies necessary for regulatory approval—or the ‘publication’ strategy, whieh stimulates off-label prescribing by using research ‘to disseminate the information as widely as possible through the world’s medical literature.’ “

A mention is made of a candid document by Pfizer which states

“What is the purpose of publications? The answer: the ‘purpose of data is to support, directly or indirectly, the marketing of our product.’ Or in short: “Purpose of Publications: The Bottom Line.’ “

The author mentions a quote by a judge

“The pervasive commercial bias found in today’s research laboratories means studies are often lacking in essential objectivity, with the potential for misinformation, skewed results, or cover-ups.”

The author later says

“Thus, as the industry succeeds in warping biomedical science to represent industry interests rather than physiological reality, it degrades the practice of medicine, harms patient welfare, and raids tbe treasuries of state and national governments.”

The author then goes in to discuss three current regulatory mechanisms 1) litigation, 2) peer review, 3) mandatory disclosure and then discusses why these mechanisms fail to solve the problem of corruption of industry on biomedical science.

The author then attempts to discuss the root cause of biased science by stating that the company chooses the investigator it wishes to support and may even ghost-write the article.

The author goes on to mention double-blind studies and how they are the gold standard:

“A double-blind study is one in which the human subjects are unaware of whether they are receiving a placebo or the studied intervention, and where the clinicians actually assessing the outcomes are also unaware of which subjects are in the “control” and the “treatment” conditions.”

The author states that even double-blind studies can cause biased studies and states that companies should be blinded to selection of investigators and not be allowed to handpick investigators who are likely to run favorable studies. Hence the author suggests some sort of intermediary between companies and investigators and mentions the NIH as possibly filling this role.

The author is wise enough at this point to mention that even the intermediary might become interested in helping out the companies for money and mentions scandals by the NIH in the early 2000s. The author then goes on to discuss some way sin which the money-blind can be implemented without violating the first ammendment.

The author states in conclusion

“There can be little doubt that biomedical science drives a significant portion of the practice of medicine and the billions of dollars of spent on healthcare in America each year. Thus the integrity of biomedical science would seem to be foundational to a well-functioning healthcare system. It is critical that biomedical science be objective, and tbat it appear objective, so that pbysicians and regulators can confidently rely upon it.”

“Money-blinding is thus a promising partial solution, even if it would not completely extirpate industry’s role in setting the agenda for biomedical science.”

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Scientific Integrity and the Commercial Speech Doctrine for Industry

wisdom — Sat, 19 May 2012 20:28:37 +0000

An interesting article by Joanna K. Sax titled “Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications,” appeared in the American Journal of Law and Medicine in 2011 (vol. 37, pages 203-224).

The article opens up by discussion how the economic reality of survival and profits may distort a company’s decision making process regarding full disclose on a particular drug. Dow Corning, which manufactured implants, withheld important data from long-term animal models which demonstrated adverse effects from breast implants and failed to conduct long-term studies. It was necessary for litigation in order to expose Dow’s failure to conduct the necessary studies. It was found that even though Dow denied liability they had evidence which demonstrated they had knowledge of the harmful effects of the breast implants and suppressed these findings.

The author later mentions how the tobacco industry used propaganda in the 1960s and 1970s to refute evidence of the harmful effects of second-hand smoke by flooding the scientific literature with studies which concluded that passive smoking was not harmful.

A discussion is made of a potential regulation called the Truth in Marketing (TIM) Act which would expand the Food and Drug Administration’s (FDA) role to penalize pharmaceutical companies for false or misleading direct-to-consumer advertising and allow them to regulate scientific journals.

The article then goes into a discussion of misleading industry publications which tend to have a bias in that they tend to report positive results of clinical trials. The author does point out though that this bias is not as extreme in publications by academic laboratories which receive public funding.

The author also points out how a variety of problems come about from the failure to report negative results. One issue is the widespread dissemination of these results which can be picked up by media reporters who are writing a story. A second issue is that the scientists may be lead on a dead-end chase of exploring the biochemical pathways of the drug even though the new drug is not better than the standard treatment already in place. A third issue is that misleading publications can influence policy decisions which can stifle scientific progress and erode the public’s trust in scientists.

The author mentions the Lanham Act which is designed to prohibit false advertising which states

“….in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in civil action by any person who believes that he or she is or is likely to be damaged by such act.”

One issue mentioned with the Lanham Act is that a publication in a medical or scientific journal may not meet the definition of commercial advertising or promotion.

The author states

“ At present, no regulations exist that fully combat the problem of the dissemination of misleading or biased industry publications. The government has a substantial interest in protecting the health and welfare of its citizens. In addition, scientific integrity is called into question if the failure to report negative results from clinical trials is used to move science in the wrong direction.”

The author then goes into a discussion of a trial registry to ensure that information is publicly available. The author then mentions the Bad Ad Program by the FDA. A discussion is then made of the commercial speech doctrine applied to misleading or biased industry publications.

The author ends by concluding

“Policymakers can learn from publicized stories over the past few decades — such as the tobacco industry tactics and breast implant eases—to draft regulations to ensure that the scientific and medieal communities, policymakers, and the publie have accurate information in order to make the best healthcare decisions. In this way, scientific integrity—which beneflts the public—can be protected and continue to provide improved healthcare services to the public.”

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Dental Cleanings May Reduce Stroke and Heart Attack Risk

wisdom — Sat, 12 May 2012 07:22:14 +0000

A study in Taiwan looked at those who have had professional tooth scraping and cleaning performed and found that they had reduced risks of stroke and heart attack.

The study showed that more frequent scraping/cleaning was associated with more reduced risk compared to never having teeth cleaned/scraped or occasionally having it performed.

The study looked at over 100,000 people and found that if either a dentist or dental hygienist scraped and cleaned teeth those people in that group had a 24% lower risk of a heart attack and a 13% lower risk of a stroke when compared to those who never had a dental cleaning performed. The people in the study were followed for an average of 7 years.

The study was conducted using data from the Taiwan National Health insurance data base. One of the researchers was Emily (Zu-Yin) Chen, M.D., cardiology fellow at the Veterans General Hospital in Taipei, Taiwan, who stated

“Protection from heart disease and stroke was more pronounced in participants who got tooth scaling at least once a year.”

She went on to further address how tooth scaling appears to reduce inflammation-causing bacterial growth which can potentially lead to stroke or heart disease.

As discussed over at the risks of keeping wisdom teeth page located at http://www.teethremoval.com/risks_of_keeping_wisdom_teeth.html, it is important to see a dentist typically at least once or twice a year in addition to brushing at least twice a day and flossing at least once a day.

If you care about your long term health you should make it a priority to focus on your oral health and make sure you regularly take care of your oral health and visit your dentist.

The source of this study is over at the American Heart Association in an article titled “Professional dental cleanings may reduce risk of heart attack, stroke,” written on November 13, 2011, and located at http://newsroom.heart.org/pr/aha/professional-dental-cleanings-217760.aspx.

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Cluster Headache Features and Therapeutic Options

wisdom — Sat, 05 May 2012 07:20:56 +0000

A review article titled “Cluster Headache: Clinical Features and Therapeutic Options” written by Charly Gaul, Hans-Christoph Diener, and Oliver M. Muller published in Deutsches Ärzteblatt International (vol. 108, issue 33, pages 543-549, 2011) provides an interesting look on new options for those with a chronic refractory cluster headache.

The article discusses how 120,000 people in Germany are affected by cluster headache. The attacks are in the periorbital area on one side and last 90 minutes on average. The attacks often posses a circadian and seasonal rhythm. The author lists the diagnostic criteria for cluster headache as from the International Classification of Headache Disorders (ICHD-II).

First line drugs for treatment include verapamil and cortisione or lithium and topirmate. In addition, short term relief can be obtained by local anesthetics and steroids along the course of the greater occipital nerve.

I have taken verapamil as discussed over at http://www.teethremoval.com/ndph.html and also had lidocaine injected into my occipital nerve as discussed over at http://www.teethremoval.com/occipital_nerve_block.html as treatment strategies after suffering from a 24/7 headache 2 days after having all 4 healthy wisdom teeth removed. I did not have a positive experience with the occipital nerve block which just led to more lasting pain and problems.

Another treatment strategy is inhaling oxygen which I also have experience with. The author also suggests administering lidocaine solution into the nostril which I also have experience with as well.

In those cluster headaches that are refractory to treatment which is defined as a cluster headache that over 24 months has significant impairment’s to the patient’s quality of life and socioeconomic status there is no uniform treatment strategy. Guidelines recommend verapmil of greater than 400 mg, lithium carbonate of greater than 800 mg, topiramate of greater than 100 mg, indomethacin of greater than 150 mg to exclude hemicrania continua, methysergide of greater than 8 mg, and corticosteroids such as prednisolone of greater than 100 mg.

I also did take indomethacin and prednisolone in the earlier stages of my treatment.

The author goes on to discuss newer invasive procedures that are available for severely impacted patients with chronic cluster headaches that are refractory to treatment which includes deep brain stimulation in the hypothalamus (DBS) and bilateral occipital nerve stimulation (ONS).

The author states

“Ablative procedures such as rhizotomy of the root exit zone of the trigeminal nerve or destructive procedures to the Gasserion ganglion have been abandoned because of severe irreversible side effects (anesthesia dolorosa). Stereotactic radiosurgical interventions (gamma knife) have proved effective in a small case series, albeit at the cost of persistent hyposensitization.”

Other possibilities mentioned include spinal cord stimulation (SCS), vagus nerve stimulation (VNS), and stimulation of the sphenopalatine ganglion (SPG) but limited evidence is available for these methods.

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Headaches after Traumatic Brain Injury Highest in Adolescents and Girls

wisdom — Sun, 29 Apr 2012 06:02:12 +0000

A recent study has been conducted by the Seattle Children’s Research Institute and appeared in Pediatrics, vol 129, number 1, January 2012, pages 1 to 9, titled Headache After Pediatric Traumatic Brain Injury: A Cohort Study, wirtten by Heidi K. Blume and et al.

The article discusses how in the adult population 18% to 33% of those who suffer from traumatic brain injury suffer from headaches 1 year after the injury.

In the child population most of the investigations conducted have been small, retrospective, lacked a control, or involved only short term follow up. Chronic headaches with children are associated with interference in social function, parental productivity, and poor quality of life.

The study randomly selected 1507 patients with TBI and 495 controls with arm injury (AI) for the study. However, some patients were not reachable, others were inegligible, and others refused. This left 512 patients with TBI and 137 with AIs for the study. Headache was reported by 43% of children with mild TBI and 37% of children with moderate/severe TBI, and 26% of the patients in the control group.

The authors noted that the frequency of serious headache appeared to be increased after mild TBI and in teenagers.

Twelve months after injury headache was reported for 41% children with mild TBI, 34% with moderate/severe TBI, and 34% of the patients in the control group.

Girls with mild TBI were found to have a higher prevalence of serious headache after 12 months than controls.

The study found that adolescents and girls had the highest frequency of headaches three months after injury.

The authors state

“The prevalence of migraine is associated with age and gender and is roughly equivalent in boys and girls until puberty when migraine prevalence begins to increase with age in girls, but not boys, reaching adult levels in late adolescence when migraine is much more common in girls than boys. We found a similar pattern of headache after mild TBI.”

Hence the authors speculate that the pathophysiology of posttraumatic headaches after mild TBI share similarities with the pathophysiology of migraine.

The authors did not label the headaches in this study according the the International Classification of Headache Disorders II criteria. I reference this criteia when discussing new daily persistent headache (NDPH) over at http://www.teethremoval.com/ndph.html and also in my limited amount of headaches listed in the headache guide over at http://www.teethremoval.com/headache.html.

In the conclusion of this study the authors state

“This study provides evidence that the response to and recovery from TBI is different in children, adolescents, and adults, and there are likely to be differences in symptoms of and recovery from TBI between boys and girls. Although only a fraction of children and adolescents with TBI develop chronic headaches related to their injury, because thousands of children sustain TBI each year, our findings indicate that many children and adolescents suffer from TBI associated headaches each year.”

Hence the results of this study may have implications for parents as girls and teenagers were found to be at the most increased risk for a headache after a mild TBI which could of course comes from a sports related injury. In some of the cases the headache may only last for a few weeks or months and most will recover after some time.

Dr. Heidi K. Blume has a list of SMART tips to help manage headaches in children and adolescents.

This stands for Sleep, Meals, Activity, Relation, and Trigger avoidance. Additional details can be found in the press release by Seattle Children’s Research Institute which is titled “Study Finds Headaches after Traumatic Brain Injury Highest in Adolescents and Girls” and written on December 5, 2011, and located over at http://www.seattlechildrens.org/Press-Releases/2011/Study-Finds-Headaches-after-Traumatic-Brain-Injury-Highest-in-Adolescents-and-Girls/

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