In this month’s Save Our Bones Bulletin we cover three new developments relating to Big Pharma. First, we look at a new plant-derived compound that could potentially become the next osteoporosis drug. Next, we take you to Australia, where Big Pharma’s tactics to increase the number of prescriptions have been uncovered.
And finally, we bring you the latest chapter on the ongoing saga of lawsuits levied against Merck over a failure to disclose the life-altering side effects of their osteoporosis drug Fosamax.
Squash Root Derivative May Be Next Osteoporosis Drug
The biomedical research company Viromed has published new research about a substance derived from squash roots called dehydrodiconiferyl alcohol (DHCA). The study found that DHCA effectively regulates bone formation in postmenopausal women.1
This naturally occurring lignan compound, when isolated from the squash plant, binds to estrogen receptors and is a potent anti-inflammatory and antioxidant. Viromed tested the impact of synthetic DHCA and found that its estrogenic effects regulated osteoblast and osteoclast synthesis, making it a potential new osteoporosis drug.
“The company’s studies have shown that DHCA acts on estrogen receptor signaling pathways. Also, by regulating the activity of various signaling factors such as AMPK, NF-kB, and MAPK, involved in osteoporosis progression, the treatment promoted differentiation in osteoblasts, a type of bone cell that promotes bone growth, as well as suppressing osteoclasts, a type of bone cell that breaks down bone tissue.
Since osteoporosis is a state where the equilibrium between the process of osteoblasts and osteoclasts becomes unbalanced, the company believes that these dual effects of DHCA will allow the substance to become an ideal for treatment for osteoporosis.
“The Viromed Natural Products Headquarters is discovering various kinds of bioactivities in plants,” said Son Mi-won, head of research at Viromed. “The results were obtained from experiments that chemically synthesized a component found in squash roots.”
This is significant as the company can develop DHCA into a natural (semi) synthetic drug, such as aspirin, Son added.”2
There is no such thing as a “natural synthetic” drug. It’s either natural or synthetic, and for this company to get a patent, they will have to add at least one synthetic chemical to the naturally occurring compound DHCA.
This is a core problem with how the pharmaceutical industry works. They compromise promising discoveries in the interest of turning a profit. Keep an eye out for more studies on DHCA and Viromed’s new synthetic drug.
A biomedical company has isolated dehydrodiconiferyl alcohol (DHCA, a compound found in the roots of squash, that promotes osteoblast differentiation and suppresses osteoclasts, regulating bone remodeling. They intend to create a synthetic patentable osteoporosis drug by adding chemicals to this natural compound.
Big Pharma Encourages Overtreatment Through Doctor Education Events
New research from the University of Sydney Charles Perkins Centre for Evidence, Policy and Influence has exposed a form of corruption aimed to ensure that doctors prescribe drugs.
The study found that pharmaceutical companies are spending large sums of money treating doctors to lavish dinners at trendy restaurants. At these dinners, Big Pharma representatives tell doctors about the drugs they want them to prescribe. They describe this as an “educational event.”
“One of the report's authors, University of Sydney senior lecturer Barbara Mintzes, said attendance at these educational events could potentially lead to overtreatment, or lead doctors to prescribe less effective drugs.
“Our concern is that the information that doctors are getting at those sponsored events is not necessarily going to be leading to the best quality treatment,” she said.
The research, by the university's Charles Perkins Centre for Evidence, Policy and Influence, looked at events for health workers for the three conditions: depression, osteoporosis and overactive bladder.
That's because these conditions are all, “highlighted in medical literature as potentially subject to overdiagnosis and overtreatment.”3
The research found that it was most often general practitioners who attended the dinners and that more than 100,000 Australian medical professionals attended some 3,000 events between 2012 and 2015.
Big Pharma companies are just as sneaky in the United States as they are in Australia. No matter where you live, drugs are not a safe or effective means of treating osteoporosis, even if your doctor has been convinced to claim otherwise.
A report has revealed that Big Pharma companies have been inviting doctors to expensive private dinners where they are lectured on reasons to prescribe the drugs they manufacture. Researchers argue that this leads to over-prescribing and to the prescription of less effective, unnecessary drugs.
Merck Eyes SCOTUS Victory In Fosamax Case
Pharmaceutical giant Merck has been dealing with a string of lawsuits over the damage and suffering caused by Fosamax (alendronate), a top-selling osteoporosis drug that is still in use and approved by the FDA, despite the ongoing devastation it has wrought on unsuspecting patients seeking to diminish bone loss.
These lawsuits generally argue the lack of an adequate warning on Fosamax’s labeling about the terrible, life-changing side-effects it can cause, such as Osteonecrosis of the Jaw (ONJ) and spontaneous femoral fractures. The current case being brought against them has turned in favor of Merck as the US Solicitor General has issued a statement urging the Supreme Court to take up the case.
The question at hand is whether Merck can be held responsible for a failure to adequately warn its customers because the pharmaceutical giant submitted new warning text for Fosamax's label to the FDA, and the FDA didn’t allow them to add the additional warning. Merck has argued preemption, meaning that they were preempted in their attempt to provide adequate warning.
“More than 500 patients who took Fosamax suffered femoral fractures before the FDA added a warning of that risk to its label in 2011.
Merck previously argued that preemption should apply because it had attempted to update the label earlier, only to be defeated by the FDA because of wording. But the patients contended that the “stress fracture” term used in Merck’s request did not describe the injuries they experienced. “[Merck] proposed a warning only about a different risk,” therefore, the FDA never rejected a warning of “the risk at issue,” the attorney representing the patients previously said.
In his brief—and in a victory for Merck—the Solicitor General said the FDA’s rejection of the label change was “clear evidence” supporting preemption. “[B]ecause FDA’s decision here prevented [Merck] from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting [Merck’s defense].”4
At the end of the day, the facts are still the same. Merck knew that their drug could cause atypical fractures and they failed to warn the public of that danger. That won’t be changed whether or not the Supreme Court hears this case or on the court’s decision based on legal technicalities.
A drug-free approach to increasing bone density and lowering fracture risk doesn’t have any side effects… unless you count improved health and a better life.
The US Solicitor General has sided with Merck in the current lawsuit brought by Fosamax users who suffered femoral fractures. The Supreme Court will decide whether to hear the case in which Merck has argued that the FDA prevented warning patients about the dangerous side effects of Fosamax.
Stay Tuned For More Updates
Every month there are new developments in the world of bone health. We’ll be following these stories to keep you up-to-date on the latest science and news related to building stronger bones and staying healthy.
Keep learning and keep questioning!
1 Lee W. “Dehydrodiconiferyl alcohol promotes BMP-2-induced osteoblastogenesis through its agonistic effects on estrogen receptor.” Biochem Biophys Res Commun. Jan 15, 2018. 495(3):2242-2248. Web. https://www.ncbi.nlm.nih.gov/pubmed/29253565
2 Lee Han-soo. “Substance derived from squash effective in treating osteoporosis.” Korea Biomedical Review. June 8, 2018. Web. http://www.koreabiomed.com/news/articleView.html?idxno=3463
3 Sophie Scott. “Study of big pharma's education events for doctors raises concerns about overtreatment.” Australian Broadcasting Corporation. Feb 13, 2018. Web. http://www.abc.net.au/news/2018-02-14/study-of-big-pharma-education-events-for-doctors-overtreatment/9442964
4 Angus Liu. “In a win for Merck—and, just maybe, for pharma—Solicitor General urges SCOTUS to hear Fosamax case.” Fierce Pharma. May 24, 2018. Web. https://www.fiercepharma.com/pharma/a-temporary-win-for-merck-solicitor-general-urges-supreme-court-to-consider-fosamax-case