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Doctor defends ‘80 clinical studies’ showing ivermectin ‘89% effective’ at preventing COVID

‘People are trying to scare us from taking ivermectin. It’s one of the safest drugs in the world.’

Life Site News | April 29, 2021

A doctor from the Philippines strongly defended the use of ivermectin for preventing and treating COVID-19, pointing to “80 clinical studies” which support his arguments, and alluding to “bias” and conflicts of interest, which have led medical bodies to be reluctant about promoting the drug.

Appearing on Philippine television channel ABS–CBN, Dr. Benigno Agbayani answered a range of questions about the efficacy and safety of the drug, as well as the peculiar reticence to recommend it for treating COVID-19.

Agbayani, the president of Concerned Doctors and Citizens of the Philippines, revealed that since last year, he had spent over five hours a day studying scientific literature on all things pertaining to COVID-19, including the non-effectiveness of lockdowns. “I think I’ve read more than anyone on COVID-19,” he stated.

However, Agbayani did not spend long defending his medical credentials, but instead advocated the use of ivermectin by referring to the wealth of scientific studies with which he was by now very familiar. He already prescribed ivermectin to over 300 of his own patients, but despite the success he has experienced so far, Agbayani stated that he looks “at the success rate of studies, rather than my personal experience, because that’s where I base my recommendations.”

“As much as anecdotal [pieces of evidence] are good, and we have many, I really prefer that we stick to the science,” he said. “People are trying to scare us from taking ivermectin. It’s one of the safest drugs in the world.”

Mentioning a study from September 2020, Agbayani stated that ivermectin had been shown to actually block “the receptor sites of the virus onto our cells, therefore blocking it from ever getting to the cell.”

“You have over 26, as of today, randomized control trials showing effectiveness, even as high as 89% for prevention, and as high as 80% for treatment. So I think regardless of what the other groups are doing, you have so much science behind it, I do not see why we have to be so concerned.”

Some studies mentioned ivermectin in conjunction with accompanying treatments, but Agbayani noted that even with this, it was possible to prove the effectiveness of ivermectin on its own. Pointing to the evidence found by Dr. Tess Lawrie, Agbayani explained that the drugs accompanying ivermectin in the studies were there, “but not all the time,” and that they “have already been proven not to work, so if you have two drugs given with ivermectin, and one drug doesn’t work, then you have to conclude that it must be ivermectin,” which produces the result.

He alluded to the peculiar antagonism which has been levied against ivermectin, noting how scepticism regarding studies promoting ivermectin is not mirrored with other drugs: “[T]he same thing can be said of every drug that we tried. Even people who are taking remdesevir, they also try other drugs, and yet you don’t question that.”

Continuing, he noted that “most” of the drugs accompanying ivermectin in the trials were “not even anti-virus [drugs], most of them are supportive of your immune systems.”

“There are 80 clinical studies [about the use of ivermectin]. If the 80 clinical studies show positive response, and maybe about 2% only showing no response to ivermectin, in clinical studies, of the doses that we give, I think that should be enough proof that it works.”

Drawing once more on the scientific data, Agbayani promoted ivermectin both as a prophylactic, and as a treatment once infected with COVID-19. Conclusions drawn from “at least 12 clinical studies,” of which 3 were randomized, controlled trials, revealed “an 89% rate of preventing COVID-19.”

Global Reluctance Regarding Ivermectin

Yet despite this, medical bodies have been consistently reluctant to promote the use of ivermectin, with Big Tech even weighing in and deleting videos which defended the drug. Thanks to the efforts of the Front Line Covid-19 Critical Care Alliance (FLCCC), the U.S. National Institutes of Health (NIH) upgraded their recommendation for the “miraculous” drug ivermectin, making it an option for use in treating COVID-19 within the United States, but only since January.

Agbayani suggested two reasons for the global reticence regarding the drug. Dealing first with the NIH, he suggested that “the NIH, the U.S. I mean, just needs to update their data. I think the last time they gave an update was February. They said it could be useful, it may not be useful.”

But he also mentioned that there was some deliberate avoidance at properly promoting ivermectin, commenting on how the World Health Organization’s March 3 recommendation of the drug did not include preventative use, but “only mentioned treatment and for severe cases. For severe cases and early treatment.”

“They did not include prophylaxis, because I think they’re afraid to recommend it, that’s why they did not make a comment,” he continued. “If you look at the way they studied it, they did include so many other studies … there seems to be a bias in those recommendations and we feel that they do not want to look at certain studies preferentially, and this was observed even before this recent announcement.”

“There is some kind of bias going on that we’d like to question. This is the time in our history when we should look at conflicts of interest.”

Such a conflict of interest could exist in the vaccine company Merck, Agbayani added, in answer to why the company even issued a statement advising against the use of ivermectin for COVID, despite having developed it some 30 years prior. This was an “excellent example of conflict of interest,” stated Agbayani.

“Merck is coming out with a new drug for the early treatment of COVID-19. How can Merck make money out of ivermectin, if the patents already expired in 1996, so even if it tries that, I don’t think they’ll make money at all, when so many other companies are making ivermectin. So they have to put their mouth on their research expenses on their new drug.”

Despite Merck joining other vaccine companies in pushing out speedily developed new drugs, ivermectin was still being side-lined, although it has been “used for 25 years,” said Agbayani. Even taking a dose, “ten times” the NIH daily recommended amount, would “have no [side] effect.”

“Compare that to other drugs that we are now using that are fairly new, where you are getting so many reports of side effects. So it’s really amazing that people still say it’s an unsafe drug when it’s been used for 25 years, over 3.7 billion doses have been given.”

Dr. Agbayani is by no means alone in his promotion of ivermectin for treating and preventing COVID-19.

Back in December, intensive care specialist Dr. Pierre Kory, a founding member of the FLCCC, delivered an impassioned address to the Senate Homeland Security Committee, defending the “miraculous effectiveness of ivermectin,” and stating that it “basically obliterates transmission of this virus.”

“It literally destroys the virus in most people within 48 hours,” agreed fellow panelist Dr. Jean-Jacques Rajter, whose peer-reviewed study found 60% fewer deaths among patients given the drug.

In fact, the efficacy of ivermectin with regard to COVID-19 was already hinted at in April 2020, when researchers in Australia pointed to a dramatic effect the drug had on the virus. “We showed that a single dose of Ivermectin could kill COVID-19 in a petri dish within 48 hours, indicating potent antiviral activity,” stated Dr. David Jans, a professor of biochemistry and molecular biology at Monash University in Melbourne.

Even after just 24 hours, “there was a really significant reduction” in the virus, added Dr. Kylie Wagstaff, a senior research fellow in biochemistry and molecular biology at Monash University.

May 1, 2021 Posted by | Corruption, Science and Pseudo-Science, Timeless or most popular | , , | 2 Comments

COVID-19: RDIF Points to Absence of Long-Term Studies on Vaccines Based on Monkey Adenoviral Vectors

By Aleksandra Serebriakova – Sputnik – 09.09.2020

The third round of trials for the AstraZeneca anti-COVID-19 drug is now on pause over “potentially unexplained illness” in a participant in the UK. On 11 August, Russia registered its own Sputnik V anti-coronavirus vaccine, which is said to have been developed in a different way.

The Russian Direct Investment Fund (RDIF) the investor which has funded the development of Russia’s Sputnik V anti-coronavirus vaccine, could not comment on the halt of AstraZeneca trials, it said in a statement.

However, RDIF pointed out that the fund’s CEO Kirill Dmitriev had previously discussed the differences between the human adenoviral vector-based platform used in Russia’s Sputnik V vaccine and those used by some of their international colleagues, that rely on “novel unproven technologies such as monkey adenoviral vectors or mRNA”.

“The safety of the human adenoviral vector used in Sputnik V has been proven over decades in over 250 clinical studies, as human adenovirus has been shown to be the safest vaccine delivery mechanism and the most ‘organic for humans’, as human adenovirus has coexisted with humans for over 100,000 years,” RFID said.

Meanwhile, “mRNA and monkey adenoviral vector-based platforms have not been studied over a long period of time,” RDIF CEO Dmitriev pointed out this Tuesday.

Commenting on the so-called “pledge of safety” earlier voiced by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi in relation to the development of the first COVID-19 vaccines, Dmitriev stressed that this plea was “insufficient” as it did not “discuss the lack of long-term studies on the carcinogenic effects and impact on fertility of newly-developed vaccine technologies”.

“Since some of the companies developing these vaccines have taken the ‘pledge of safety’, we would like to stress that public health and safety requires not only short-term evidence of a lack of serious adverse effects, but also the safety and efficacy proved by the results of long-term studies,” Dmitriev added.

AstraZeneca COVID-19 Vaccine Trials on Pause

It was revealed this week that the third round of trials for the AstraZeneca anti-COVID-19 vaccine has been halted due to a “potentially unexplained illness” which had developed in a participant in the United Kingdom, without further specifications about the nature of possible side effects. The vaccine in question was developed in partnership with Oxford University and has reportedly involved around 30,000 participants in the UK, US, Brazil and South Africa. AstraZeneca described the pause as “routine” so as to allow for a “standard review process” of “safety data”.

Russia’s First Anti-Coronavirus Vaccine

On 11 August, Russia registered the world’s first vaccine against COVID-19, called Sputnik V, which was developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the RDIF after several rounds of clinical trials. On Monday, the vaccine was made available to the public.

According to RDIF, Russia has now received requests for 1 billion doses of the vaccine; at least 20 countries, including the UAE, Saudi Arabia, Indonesia, Philippines, Mexico, Brazil and India, have expressed an interest in obtaining Sputnik V.

September 9, 2020 Posted by | Aletho News | , , , , , , , , , | Leave a comment

Big Pharma Still Tries to Push Dangerous Drug Class

By Martha Rosenberg | CounterPunch | February 16, 2018

Bisphosphonate bone drugs are among the most harmful and misrepresented drug classes still on the market. But that has not stopped Pharma-funded medical associations like the American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance from periodically wringing their hands over low sales. [1]

This week the New York Times repeats the industry lament. “Currently, many people at risk of a fracture — and often their doctors — are failing to properly weigh the benefits of treating fragile bones against the very rare but widely publicized hazards of bone-preserving drugs, experts say,” it writes. Hip fractures among women 65 and older on Medicare are rising says the piece and Medicare reimbursements for bone density tests are falling. “Doctors who did them in private offices could no longer afford to [do them] which limited patient access and diagnosis and treatment of serious bone loss,” says a doctor quoted in the article which sounds like a Pharma plea for tax-payer funding.

But here is the back story.

The first bisphosphonate bone drug approved for osteoporosis, Merck’s Fosamax, received only a six month review before FDA approval. When its esophageal side effects were revealed, the FDA tried to unapprove it but Merck got the FDA to settle for a warning label that told patients to sit upright for an hour after taking the drug. Six months after Fosamax was approved, there were 1,213 reports of adverse effects including 32 patients hospitalized for esophageal harm. One woman who took Fosamax but remained upright for only thirty minutes was admitted to the hospital with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine (NEJM).

Soon bisphosphonates (which include Boniva, Actonel and Zometa) were shown to weaken not strengthen bones by suppressing the body’s bone-remodeling action. Yes bone loss is stopped but since the bone is not renewed, it becomes brittle, ossified and prone to fracture. More than a decade ago, articles in the NEJM, the Annals of Internal Medicine, the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopaedic Trauma and Injury warned of the paradoxical drug results. One-half of doctors at a 2010 American Academy of Orthopaedic Surgeons annual meeting presentation said they’d personally seen patients with bisphosphonate-compromised bone. “There is actually bone death occurring,” said Phuli Cohan, MD on CBS about a woman who’d been on Fosamax for years.

By 2003, dentists and oral surgeons found that after simple office dental work, the jawbone tissue of patients taking bisphosphonates would sometimes not heal but become necrotic and die. They had received no warnings though Merck knew about the jawbone effects from animal studies since 1977.

“Up to this point, this rare clinical scenario was seen only at our centers in patients who had received radiation therapy and accounted for 1 or 2 cases per year,” said the authors of an article titled “Osteonecrosis of the Jaws Associated with the Use of Bisphosphonates: A Review of 63 Cases,” published in the Journal of Oral and Maxillofacial Surgery.

Despite reports of ulcerative esophagitis, bone degradation, fractures and jawbone death Merck aggressively promoted Fosamax. It hired researcher Jeremy Allen to plant bone scan machines in medical offices across the country to drive sales and to push through the Bone Mass Measurement Act which made bone scans Medicare reimbursable paid by you and me. Hopefully that is changing.

Blaming hip fractures on not enough people taking bisphosphonates is not a new tactic for Pharma. It blamed increasing suicides on not enough people taking antidepressants (even when as much as a fourth of the population takes antidepressants). Get ready for Pharma to blame obesity on not enough people taking prescription obesity drugs. The ruse is even more dishonest because many popular drugs people are taking like GERD medications really do thin bones. First do no harm.

Notes.

[1] According to the British Medical Journal, the National Osteoporosis Foundation is funded by Bayer Healthcare, Lane Laboratories, Mission Pharmacal, Novartis, Pharmavite, Pfizer, Roche, Warner Chilcott and Eli Lilly. The American Society for Bone and Mineral Research is funded by Pfizer and Eli Lilly. The National Bone Health Alliance is a public- private partnership that is an offshoot of the National Osteoporosis Foundation.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

February 16, 2018 Posted by | Deception, Science and Pseudo-Science | , , , , | Leave a comment

TPP: Big Pharma’s Big Deal

By Joyce Nelson | CounterPunch | October 7, 2015

We still don’t know all the details of the Trans-Pacific Partnership (TPP) trade deal tentatively agreed to on Oct. 5 by negotiators from 12 Pacific Rim countries, but already critics are slamming it for many reasons, including its generous concessions to the pharmaceutical industry.

Doctors Without Borders claims the TPP will “go down in history as the worst trade agreement for access to medicines in developing countries.” [1] That’s because the TPP will extend patent protection for brand-name drugs, thereby preventing similar generic drugs (which are far less costly) from entering the market. This will drive up the prices.

Judit Rius Sanjuan, legal policy adviser for Doctors Without Borders, told vox.com that TPP creates patent-related obligations in countries that never had them before. People in “Peru, Vietnam, Malaysia, and Mexico” will be especially affected, she said. “They’ll face higher prices for longer periods of time.” [2]

Ruth Lopert, a professor at George Washington University, told Bloomberg News that provisions in the TPP agreement will affect health-care budgets and drug access in all signatory countries, but especially the poorest. “She said as many as 40,000 people in Vietnam, the poorest country in the agreement, could stop getting drugs to fight HIV because of provisions that will boost the price of [pharmaceutical] therapy.” [3]

Other countries like Canada will also be hit with higher costs. The Council of Canadians says that if the TPP is ratified, “[p]harmaceutical patents will be extended, delaying the release of more affordable generic drugs and adding $2 billion to our annual public health care bill.” [4] In the U.S., many people already cannot afford to pay for the expensive medicines that could save their lives, and they try to access generics available elsewhere.

Extending patent rights for life-saving drugs is an obvious gift to Big Pharma. Conor J. Lynch at opendemocracy.net has called it “a clear corporate handout that would greatly affect international access and most definitely cause preventable deaths. The clear objective here is to increase industry profits, plain and simple. This is not surprising, that’s what private industry does, but there is a serious moral dilemma here.” [5] That moral dilemma is made even more apparent by recent findings.

Tax Cheats

In an ironic coincidence, the TPP agreement was reached on the same day that a damning report on corporate tax-avoidance – Offshore Shell Games 2015 – was released by Citizens for Tax Justice and the US Public-Interest Research Group Education Fund. The report reveals the extent to which top U.S. companies use tax havens like Bermuda, Luxembourg, Cayman Islands, and the Netherlands to set up “tax haven subsidiaries” that are usually little more than a post-office box.

Of the top 30 Fortune 500 companies with the most money held in offshore tax-havens, nine are pharmaceutical companies: Pfizer ($74 billion held offshore), Merck ($60 billion), Johnson & Johnson ($53.4 billion), Proctor & Gamble ($45 billion), Amgen ($29.3 billion), Eli Lilly ($25.7 billion), Bristol Myers Squibb ($24 billion), AbbeVie Inc. ($23 billion), and Abbott Laboratories ($23 billion). [6]

Concerning Pfizer, the world’s largest drug maker (declared profits of $22 billion in 2013), the report states: “The company made more than 41 percent of its sales in the U.S. between 2008 and 2014, but managed to report no federal taxable income for seven years in a row. This is because Pfizer uses accounting techniques to shift the location of its taxable profits offshore. For example, the company can transfer patents for its drugs to a subsidiary in a low- or no-tax country. Then when the U.S. branch of Pfizer sells the drug in the U.S., it ‘pays’ its own offshore subsidiary high licensing fees that turn domestic profits into on-the-books losses and shifts profit overseas.”

Overall, the study found that the 500 largest U.S. companies hold more than US$2.1 trillion in accumulated profits offshore. “For many companies, increasing profits held offshore does not mean building factories abroad, selling more products to foreign customers, or doing any additional real business activity in other countries,” but simply establishing a PO box.

Some companies use the money supposedly “trapped” offshore as “implied collateral” in order to borrow funds at negligible rates for investing in U.S. assets, paying dividends to shareholders, or repurchasing stock.

Of course, as the report makes clear, “Congress, by failing to take action to end this tax avoidance, forces ordinary Americans to make up the difference. Every dollar in taxes that corporations avoid by using tax havens must be balanced by higher taxes on individuals, cuts to public investments and public services, or increased federal debt.”

The report finds that, through a variety of tax-avoidance measures, an estimated US$620 billion in U.S. taxes is collectively owed by the 500 largest companies with headquarters in the U.S.

Corporate Coup

Now the TransPacific Partnership – which is being called “NAFTA on steroids” – would award Big Pharma and other multinationals even more corporate “rights” in more countries, including the controversial investor-state dispute settlement (ISDS) mechanism by which they can sue signatory governments for regulatory changes that affect their profits.

As the Canadian website rabble.ca notes: “The Canadian government is currently being sued through NAFTA by Eli Lilly, an American pharmaceutical company, for invalidating the firm’s patent extensions on two mental health drugs. A Canadian Federal Court decided in 2010 that the patent extensions had not delivered the promised benefits and the drugs should therefore be opened up to generic competition. Generic drugs significantly reduce the cost for end users, but Eli Lilly cried foul and launched an ISDS claim against the government, demanding US$500 million in compensation for lost profits. The case is still in progress, but regardless of the outcome we can expect the TPP to lead to similar ISDS disputes. Powerful multinational pharmaceutical companies will use any available means to cling to over-priced drug monopolies. Greater intellectual property protections in the TPP will give these companies an even stronger quasi-legal basis to sue governments and crowd out generic [drug] competition.” [7]

The final text of the TransPacific Partnership agreement won’t be available for at least a month, likely weeks after the Canadian federal election on October 19. The details will undoubtedly reveal more generous concessions to the multinationals. It will be up to the elected legislators in all twelve countries to approve or reject the TPP. In Canada, NDP leader Tom Mulcair has pledged to scrap the deal if elected as Prime Minister, explaining that the Stephen Harper government had no mandate to sign it during an election campaign when it is merely a “caretaker” government.

The U.S. website zerohedge.com calls the Trans-Pacific Partnership “a Trojan horse” and “a coup by multinational corporations who want global subservience to their agenda.” In no uncertain terms, it adds: “Buyer beware. Citizens beware.” [8]

Footnotes/Links:

[1] http://www.theaustralian.com.au/business/latest/tranpacific-partnership-deal-reached/story-e6frg90f-1227558154056

[2] Julia Belluz, “How the Trans-Pacific Partnership could drive up the cost of medicine worldwide,” Vox, October 5, 2015.
http://www.vox.com/2015/10/5/9454511/tpp-cost-medicine

[3] “Pacific Deal Rewrites Rules on Trade in Autos, Patented Drugs,” Bloomberg News, October 5, 2015.
http://www.bloomberg.com/news/articles/2015-10-05/pacific-deal-rewrites-rules-on-trade-in-autos-patented

[4] Council of Canadians, “Tell party leaders: Reject the TPP,” October 6, 2015.

[5] Conor J. Lynch, “Trans-Pacific Partnership’s Big Pharma giveaway,” Open Democracy, February 14, 2015.
http://www.opendemocracy.net/conor-j-lynch/transpacific-partnership%E2/80%/99s-big-pharma-giveaway

[6] http://ctj.org/ctjreports/2015/10/orrshore_shell_games_2015.php//executive

[7] Hadrian Mertins-Kirkwood, “Trans-Pacific Partnership a big win for corporate interests,” Rabble.ca, October 6, 2015.

[8] Tyler Durden, “Trans-Pacific Partnership Deal Struck As ‘Corporate Secrecy’ Wins Again,” Zero Hedge, October 5, 2015.
http://www.zerohedge.com

October 7, 2015 Posted by | Corruption, Economics | , , , , | Leave a comment

After First Drug Injures Patients Shameless Drug Company Pursues Follow-up Drug

By Martha Rosenberg | Dissident Voice | October 22nd, 2012

The year 1999 was a good one for the drug company Merck. In its 64 page annual report, it predicted that the arthritis medicine Vioxx (“Our Biggest, Fastest, and Best Launch Ever!”) would also prevent Alzheimer’s disease and colon cancer. It announced it was seeking approval to market the asthma drug Singulair to two-year-olds. And it forecast that 40 million women would take its new osteoporosis drug, Fosamax, as Merck continued to “help educate both doctors and patients” about the bone disease.

It turned out Merck spoke too soon. Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long-term users; Singulair now carries FDA warnings about “neuropsychiatric events” and Fosamax is suspected of doubling the risk of esophageal cancer, causing bone fractures instead of preventing them and causing heart problems, intractable pain and jawbone death. Oops!

There’s plenty of ka-ching in selling “strong bones” products for the same reason there was plenty of ka-ching in selling “hormone replacement” products: one-half the population is female, and no one wants to look old. Of course, “avoiding hot flashes” really means “still looking hot” in hormone marketing terminology, and “avoiding fractures” really means “still looking hot” in bone product marketing lingo. That’s why attractive women like Meredith Vieira from the Today show and former Charlie’s Angel Cheryl Ladd and actress Sally Field push bone drugs, just as model Lauren Hutton pushed hormone replacement therapy.

To cash in on Fosamax, the first in the bisphosphonate bone drug class, Merck decided to market the dangers of osteoporosis “far beyond ailing old ladies.” It hired researcher Jeremy Allen to whip up fears of “osteopenia,” the risk of osteoporosis, as a health epidemic to sell bone drugs and planted bone scan machines in medical offices across the country, says National Public Radio. Allen created the faux “Bone Measurement Institute” which also maneuvered Medicare reimbursement for the scans. By 1999, there were 10,000 bone scan machines in medical offices, said the Associated Press, when there had been only 750 before Fosamax.

Like its trouble-laden drug Vioxx, Merck’s Fosamax flew out of the FDA. It received only a six month review before its 1995 FDA approval. (The government also helped its promotion with the HHS secretary herself, Donna Shalala, participating in a 1998 rally kicking off free bone density screenings to be offered in 100 cities.)

But the wheels soon came flying off the bone drug. Patients experienced esophageal “irritation”  and the warning to stay upright for one full hour after taking Fosamax, eating or drinking nothing was added after approval. One woman who took Fosamax but remained upright for only 30 minutes, not 60, had to be admitted to the Mayo Clinic with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine.

Next, dentists and oral surgeons discovered after simple tooth extractions and other in-office dental work, the jawbone tissue of patients on bisphosphonates would sometimes not heal but become necrotic and die — a condition called osteonecrosis of the jaw(ONJ), The necrotic condition did not take long to manifest “even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients” — wrote a dental journal, but it somehow slipped through Fosamax’s two, three-year clinical trials on which its FDA approval was based. Doctors, dentists, and pharmacists were enraged at what looked like deliberate obfuscation by Merck.

And there were second, third and fourth opinions about Fosamax! According to an FDA epidemiologist writing in New England Journal of Medicine in 2009 there were 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and 27 incidences of cancer in Europe and Japan and six deaths.

Next reports in medical journals linked bisphosphonates to the risk of developing atrial fibrillation, or a chronically irregular heartbeat and to severe bone, joint or muscle pain. “In the most serious cases, the pain was so severe that patients could not continue their normal activities,” wrote the FDA in a press release. “Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.” Clearly, the FDA was trying hard to avoid the word irreversible.

Finally, in a development that suggests tremendous medical ineptitude if not duplicity, bisphosphonates were found to sometimes cause the very fractures they were supposed to prevent. The thigh bones of patients on bisphosphonates have “simply snapped while they were walking or standing,” after “weeks or months of unexplained aching,” reported the New York Times in an article called “Drugs to Build Bones May Weaken Them.”

It should be embarrassing to the medical establishment that a prominent drug company and the FDA “discovered” severe side effects after years of patient use and that bone scans are still merchandised though they are of no value to 90 percent of women, according to the New England Journal of Medicine. It should be further embarrassing that Merck was allowed to make $3 billion a year off a drug that many say would not have been approved had clinical trials lasted longer. Its patent expired in 2008.

Now Merck is about to launch a new drug for osteoporosis called odanacatib which has already intrigued the money men on Wall Street. “Odanacatib may be a viable alternative for patients who need continued therapy and who want benefits beyond what they received from bisphosphonates,” a senior Merck research executive told Reuters without a hint of irony.

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

October 22, 2012 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , , , , , | Leave a comment

Chinese Melamine and American Vioxx: A Comparison

By Ron Unz | The American Conservative | April 18, 2012

In contrasting China and America, pundits often cite our free and independent media as one of our greatest strengths, together with the tremendous importance which our society places upon individual American lives. For us, a single wrongful death can sometimes provoke weeks of massive media coverage and galvanize the nation into corrective action, while life remains cheap in China, a far poorer land of over a billion people, ruled by a ruthless Communist Party eager to bury its mistakes. But an examination of two of the greatest public-health scandals of the last few years casts serious doubt on this widespread belief.

First, consider the details of the Chinese infant formula scandal of 2008. Unscrupulous businessmen had discovered they could save money by greatly diluting their milk products, then adding a plastic chemical compound called melamine to raise the apparent protein content back to normal levels. Nearly 300,000 babies throughout China had suffered urinary problems, with many hundreds requiring lengthy hospitalization for kidney stones. Six died. A wave of popular outrage swept past the controlled media roadblocks and initial government excuses, and soon put enormous pressure on Chinese officials to take forceful action against the wrongdoers.

China’s leaders may not be democratically elected, but they pay close attention to strong popular sentiment. Once pressed, they quickly launched a national police investigation which led to a series of arrests and uncovered evidence that this widespread system of food adulteration had been protected by bribe-taking government officials. Long prison sentences were freely handed out and a couple of the guiltiest culprits were eventually tried and executed for their role, measures that gradually assuaged popular anger. Indeed, the former head of the Chinese FDA had been executed for corruption in late 2007 under similar circumstances.

Throughout these events, American media coverage was extensive, with numerous front-page stories in our leading newspapers. Journalists discovered that similar methods of dangerous chemical adulteration had been used to produce Chinese pet food for export, and many family dogs in America had suffered or died as a result. With heavy coverage on talk radio and cable news shows, phrases such as “Chinese baby formula” or “Chinese pet food” became angry slurs, and there was talk of banning whole categories of imports from a country whose product safety standards were obviously so far below those found in Western societies. The legitimate concerns of ordinary Americans were fanned by local media coverage that sometimes bordered on the hysterical.

However, the American media reaction had been quite different during an earlier health scandal much closer to home.

In September 2004, Merck, one of America’s largest pharmaceutical companies, suddenly announced that it was voluntarily recalling Vioxx, its popular anti-pain medication widely used to treat arthritis-related ailments. This abrupt recall came just days after Merck discovered that a top medical journal was about to publish a massive study by an FDA investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market.

Within weeks of the recall, journalists discovered that Merck had found strong evidence of the potentially fatal side-effects of this drug even before its initial 1999 introduction, but had ignored these worrisome indicators and avoided additional testing, while suppressing the concerns of its own scientists. Boosted by a television advertising budget averaging a hundred million dollars per year, Vioxx soon became one of Merck’s most lucrative products, generating over $2 billion in yearly revenue. Merck had also secretly ghostwritten dozens of the published research studies emphasizing the beneficial aspects of the drug and encouraging doctors to widely prescribe it, thus transforming science into marketing support. Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.

Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War. In fact, the media coverage often seemed considerably less than that later accorded to the Chinese infant food scandal, which had caused just a handful of deaths on the other side of the world.

The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.

A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck’s stock price eventually reached new heights in 2008 and today is just 15 percent below where it stood just before the disaster.

Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. The year after the scandal unfolded, Merck’s long-time CEO resigned and was replaced by one of his top lieutenants, but he retained the $50 million in financial compensation he had received over the previous five years, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future. American media conglomerates quietly mourned their loss of heavy Vioxx advertising, but continued selling the same airtime to Merck and its rivals for the marketing of other, replacement drugs, while their investigative arms soon focused on the horrors of tainted Chinese infant food and the endemic corruption of Chinese society.

This story of serious corporate malfeasance largely forgiven and forgotten by government and media is depressing enough, but it leaves out a crucial factual detail that seems to have almost totally escaped public notice. The year after Vioxx had been pulled from the market, the New York Times and other major media outlets published a minor news item, generally buried near the bottom of their back pages, which noted that American death rates had suddenly undergone a striking and completely unexpected decline.

The headline of the short article that ran in the April 19, 2005 edition of USA Today was typical: “USA Records Largest Drop in Annual Deaths in at Least 60 Years.” During that one year, American deaths had fallen by 50,000 despite the growth in both the size and the age of the nation’s population. Government health experts were quoted as being greatly “surprised” and “scratching [their] heads” over this strange anomaly, which was led by a sharp drop in fatal heart attacks.

On April 24, 2005, the New York Times ran another of its long stories about the continuing Vioxx controversy, disclosing that Merck officials had knowingly concealed evidence that their drug greatly increased the risk of heart-related fatalities. But the Times journalist made no mention of the seemingly inexplicable drop in national mortality rates that had occurred once the drug was taken off the market, although the news had been reported in his own paper just a few days earlier.

A cursory examination of the most recent 15 years worth of national mortality data provided on the Centers for Disease Control and Prevention website offers some intriguing clues to this mystery. We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn. Vioxx was almost entirely marketed to the elderly, and these substantial changes in national death-rate were completely concentrated within the 65-plus population. The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates.

The impact of these shifts was not small. After a decade of remaining roughly constant, the overall American death rate began a substantial decline in 2004, soon falling by approximately 5 percent, despite the continued aging of the population. This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.

Patterns of cause and effect cannot easily be proven. But if we hypothesize a direct connection between the recall of a class of very popular drugs proven to cause fatal heart attacks and other deadly illnesses with an immediate drop in the national rate of fatal heart attacks and other deadly illnesses, then the statistical implications are quite serious. Perhaps 500,000 or more premature American deaths may have resulted from Vioxx, a figure substantially larger than the 3,468 deaths of named individuals acknowledged by Merck during the settlement of its lawsuit. And almost no one among our political or media elites seems to know or care about this possibility. A recent Wall Street Journal column even called for relaxing FDA restrictions aimed at avoiding “rare adverse events,” which had been imposed after the discovery of “unanticipated side effects of high-profile drugs like Vioxx.”

There are obvious mitigating differences between these two national responses. The Chinese victims were children, and their sufferings from kidney stones and other ailments were directly linked to the harmful compounds that they had ingested. By contrast, the American victims were almost all elderly, and there was no means of determining whether a particular heart attack had been caused by Vioxx or other factors; the evidence implicating the drug was purely statistical, across millions of patients. Furthermore, since most of the victims were anyway nearing the end of their lives, the result was more an acceleration of the inevitable rather than cutting short an entire young life, and sudden fatal heart attacks are hardly the most unpleasant forms of death.

But against these important factors we must consider the raw numbers involved. American journalists seemed to focus more attention on a half-dozen fatalities in China than they did on the premature deaths of as many as 500,000 of their fellow American citizens.

The inescapable conclusion is that in today’s world and in the opinion of our own media, American lives are quite cheap, unlike those in China.

April 20, 2012 Posted by | Corruption, Deception, Timeless or most popular | , , , , , | 3 Comments