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Thursday, July 9, 2015

How Conflicts of Interest Have Corrupted the Centers for Disease Control and Prevention (CDC)

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Conflicts of interest have become more the rule than the occasional exception. Even the trusted US Centers for Disease Control and Prevention (CDC) receives heavy funding from industry.
How this conflict of interest may have affected the organization’s decisions is the topic of an article1 in the British Medical Journal (BMJ), penned by the journal’s associate editor, Jeanne Lenzer, who notes:
“The Centers for Disease Control and Prevention (CDC) includes the following disclaimer with its recommendations:
“CDC, our planners, and our content experts wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products… CDC does not accept commercial support.”
The CDC’s image as an independent watchdog over the public health has given it enormous prestige, and its recommendations are occasionally enforced by law.
Despite the agency’s disclaimer, the CDC does receive millions of dollars in industry gifts and funding, both directly and indirectly, and several recent CDC actions and recommendations have raised questions about the science it cites, the clinical guidelines it promotes, and the money it is taking.”

Is the CDC Protecting the Private Good Rather Than the Public?

When confronted about the discrepancy between the CDC’s public disclaimer and the reality that corporate funding is flowing into the organization, Tom Frieden, director of the CDC, responded, saying:
“Public-private partnerships allow CDC to do more, faster. The agency’s core values of accountability, respect, and integrity guide the way CDC spends the funds entrusted to it.
When possible conflicts of interests arise, we take a hard, close look to ensure that proper policies and guidelines are followed before accepting outside donations.”
In other words, the CDC believes, and “assures” you, it has the moral backbone to do the right thing, despite the fact that studies have revealed moral fiber tends to significantly deteriorate as soon as a funding source with an agenda starts doling out money.
Moreover, a 2009 investigation by the Office of the Inspector General concluded the CDC has “a systemic lack of oversight of the ethics program,” noting 97 percent of disclosure forms filed by the organization’s advisors were incomplete, and 13 percent of advisors didn’t file one.

Did Industry ‘Buy’ CDC Recommendation for Expanded Hepatitis C Screening?

External funding to the CDC in the form of industry “gifts” was authorized in 1983—nearly 40 years after the organization’s inception in 1946. After the passing of legislation in 1992 that encouraged relationships between the CDC and industry, the non-profit CDC Foundation was formed in 1995.
Last year, this Foundation received $12 million from private corporations, and the CDC itself received another $16 million in funding earmarked for special projects from companies, manufacturers, and various philanthropists.
“For example, in 2012, Genentech earmarked $600 000 in donations to the CDC Foundation for CDC’s efforts to promote expanded testing and treatment of viral hepatitis. Genentech and its parent company, Roche, manufacture test kits and treatments for hepatitis C,” Lenzer writes.
Since 2010, when the CDC and the CDC Foundation formed the Viral Hepatitis Action Coalition, manufacturers of hepatitis C tests and treatments have donated more than $26 million to the coalition.
In addition to Genentech, donors include: Abbott Laboratories, AbbVie, Gilead, Janssen, Merck, OraSure Technologies, Quest Diagnostics, and Siemens.
Two years later, in 2012, the CDC issued guidelines recommending expanded screening for hepatitis C for everyone born between 1945 and 1965, saying newer antiviral drugs can effectively halt disease progression.
However, “the science behind cohort screening has been challenged and is said to be ‘the subject of major debate.’ The scientific debate along with the price tags of the newer drugs (over $84 000 per treatment course for the new drug sofosbuvir), raise questions about CDC’s industry funding,” Lenzer writes.

CDC Recommendations Increasingly Skewed

The CDC and the CDC Foundation also received monies from Roche for the creation of the CDC’s “Take 3” flu campaign, again raising questions about the influence of funding on its drug recommendations.
Genentech, the manufacturer of the controversial and dangerous influenza drug Tamiflu, is a member of the Roche Group.
Step 3 in the CDC’s flu campaign advises you to “take antiviral medicine if your doctor prescribes it.” In an article titled, “Why CDC Recommends Influenza Antiviral Drugs,” the agency cites a number of studies supporting its recommendation, including a recent meta-analysis published in The Lancet.2
The problem with that, Lenzer points out, is that the CDC describes this study as “independent,” when in fact it was sponsored by Roche. Moreover, all of the four authors have financial ties to Roche, Genentech (both of which sell Tamiflu), or Gilead (which holds the patent).
In addition to that, the CDC did not include last year’s systematic review3 of 83 trials conducted by the Cochrane Collaboration, which is the “gold standard” for independent research analysis.
Was this analysis ignored because it concluded Tamiflu alleviates symptoms of the flu by less than 17 hours, has limited effect on your risk of pneumonia, no effect on adult hospital admissions, and causes nausea, vomiting, headaches, renal problems and psychiatric syndromes?
According to the Cochrane group: “The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir [brand name Tamiflu] for treatment, prophylaxis, or stockpiling.”
Another issue is this: CDC director Tom Frieden has stated that taking Tamiflu might save your life, yet the US Food and Drug Administration (FDA) has warned Roche it cannot claim the drug reduces pneumonia or deaths as they’ve never produced any evidence for that claim.
But who needs scientific evidence when the CDC is making off-label claims for you? “Shannon Brownlee, senior vice president of the Lown Institute and former journalist covering the CDC, told

The BMJ
, “This looks like classic stealth marketing, in which industry puts their message in the mouths of a trusted third party, such as an academic or a professional organization,” Lenzer writes.

FDA:  The Poster Child for Industry Bias

The Food and Drug Administration (FDA) has also become notorious for its conflicts of interest and close ties to various industries, and there are many examples of this.
Last year, emails and letters between the FDA and Pfizer suggest the drug giant was given an inappropriate  amount of leverage to decide when and how to tell the public about the hazards associated with its veterinary drug roxarsone.4,5
FDA researchers found low levels of inorganic arsenic in the livers of chicken who consumed the drug. Correspondence between Heidi Chen, then attorney in Pfizer’s animal health division, and William Flynn, the FDA’s deputy director for science policy at the Center for Veterinary Medicine, reveal the agency allowed Pfizer to edit the wording of a press release about the roxarsone data, and more.

Government Must Act to Protect Scientific Integrity

Getting back to the CDC, it was created and has been relied upon as anindependent agency without industry ties that might muddy the water in terms of the health and safety recommendations it issues. Now, it’s become apparent that not even the CDC can be counted on for unbiased science-based advice. So what, if anything, can be done to rectify the situation?
Considering the fact that CDC funding from industry was approved by the government, the answer, as noted by Jerome R Hoffman,6 methodologist and emeritus professor of medicine at UCLA, is to “get the government to reject this devil’s bargain, by changing the rules so this can no longer happen.” It’s simply unreasonable to believe that any organization will ignore its cash cows, and it’s equally naïve to believe that industry will continue donating money if the agency decides to do anything that even hints at cutting into industry profits.
For example, the NRA promptly withdrew its CDC funding when the agency began investigating gun violence.7 In summary, conflicts of interest endanger lives. People’s well-being become secondary to the corporate bottom line, and no organization or corporation is immune to the effects of conflicts of interest—not even the CDC. Even well-respected research universities like the University of Minnesota have fallen prey, relaxing research ethics to the point that research subjects die.8

Head of CDC Now Head of Merck Vaccines

The infamous revolving door between the government and the drug industry is another factor that has done an awful lot to destroy scientific integrity and government accountability. One classic example is Dr. Julie Gerberding, who headed up the CDC—which among other things is charged with overseeing vaccines—from 2002 to 2009 before becoming the president ofMerck’s vaccine division, a position she currently holds today.
The influence her former high-level ties to the CDC wields is enormous, considering the fact that Merck makes 14 of the 17 pediatric vaccines recommended by the CDC, and 9 of the 10 recommended for adults. And while vaccine safety advocates are trying to rein in the number of vaccines given to babies, safety concerns keep falling on deaf ears. The vaccine industry is booming, and it’s become quite clear that profit potential is the driving factor behind it. It is this type of reprehensible and inexcusable behavior that makes it an enormous challenge to change this seriously flawed paradigm.

Half of Published Research Likely to Be Completely False, Warns Editor-in-Chief of Major Medical Journal

Just as the CDC insists it has the ability to maintain its integrity awash in industry cash, corporations insist they have the integrity to stay on solid scientific ground when researching its own products. But, just as studies show the source of funding alters scientific conclusions, so research reveals that industry-funded research is riddled with flaws, shortcomings, and outright fraud. As reported by the Progressive Review:9,10
“… Dr. Richard Horton, the current editor-in-chief of the Lancet…recently published a statement11 declaring that a lot of published research is in fact unreliable at best, if not completely false. ‘The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness…’
Dr. Marcia Angell…makes her view of the subject quite plain: ‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine’” [Emphasis mine]

Omission of Data Often Protects Corporate Profits

Omission of data is another common tactic employed to skew the scientific consensus, and this is just as dangerous as publishing complete fabrications. For example, according to Dr. Lucija Tomljenovic,12,13 a post-doctoral fellow at the University of British Columbia (UBC) where she works in neurosciences and the Department of Medicine, many vaccine manufacturers and health authorities are actually well aware of dangers associated with vaccines, but have chosen to withhold this information from the public. She writes, in part:
“Deliberately concealing information from the parents for the sole purpose of getting them to comply with an ‘official’ vaccination schedule could thus be considered as a form of ethical violation or misconduct. Official documents obtained from the UK Department of Health (DH) and
the Joint Committee on Vaccination and Immunization (JCVI) reveal that the British health authorities have been engaging in such practice for the last 30 years, apparently for the sole purpose of protecting the national vaccination program.”
Many industry-funded studies with negative findings simply never see the light of day, as suggested by a recent NEJMreview14 looking at compliance rates with results reporting at ClinicalTrials.gov. The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov, but only 13.4 percent of trials reported summary results within 12 months of completing the trial, and 45 percent of industry-funded trials were not required to report results. For comparison, only six percent of trials funded by the National Institutes of Health (NIH) and nine percent of studies funded by other government or academic institutions were excluded from result reporting.

Doctors Also Share the Blame…

Bias is another major problem that has increasingly sullied the scientific community, and no one is immune—not even doctors, especially not when they’re receiving large sums of money from a drug company. According to “the most comprehensive accounting so far of the financial ties that some critics say have compromised medical care,” published last year, American doctors and teaching hospitals received a whopping $3.5 billion from drug and medical-device companies in the last five months of 2013 alone.15
A recent article16 in NEJM titled “Understanding Bias — The Case for Careful Study,” offers a discourse on bias, at the core of which you find financial conflicts of interest. But there are also a number of other hidden, largely subconscious conflicts within any given individual that can color his or her decision-making, such as how easy one treatment is versus another—one might require hours of work, while the other would allow the doctor some well-needed sleep.
Either way, conflicts of interest do have an impact on the patient, and when the motive is selfish—be it to gain more money or sleep—that impact is likely to be detrimental. As noted in the NEJM article:
“Some 94 percent of physicians have relationships with industry, though these interactions most often involve activities such as receiving drug samples or food in the workplace… Physicians who attend symposia funded by pharmaceutical companies subsequently prescribe the featured drugs at a higher rate… Are any of these interactions, or efforts to curtail them, beneficial or harmful to patients? It depends on how you define harm. Consider pharmaceutical ‘gifting,’ a practice that smacks of bribery — which may be sufficient reason to prohibit it. But does it actually hurt patients? According to one influential commentary, it does…”

Doctors Urged to Stop Overtreating Patients

Yet another BMJ article17 urges doctors to stop overmedicating and overtreating patients, warning they’re doing more harm than good. As reported by BBC News18:
“Launching the Choosing Wisely campaign, experts are calling on medical organizations to identify five procedures each that should not be offered routinely or in some cases not at all. These might include: Pills for mild depression; Too many routine and unnecessary blood tests; Medicines for mildly raised blood pressure… [E]xperts say individuals should be encouraged to check whether procedures are definitely right for them. For example, patients are advised to ask: Do I really need this test or procedure?; Are there simpler options?; What happens if I do nothing?”
Overmedicating and overtreating is one result of excessive industry influence, although it’s certainly not the sole reason. From my perspective, it seems clear that more drugs, tests, and surgeries do not equate to better health. On the contrary, it raises the risks of side effects that may be as bad or worse than the original problem. It also raises the risk of fatal medical errors—a fate that befalls 440,000 Americans each year! As reported by Forbes19 in 2013:
“These people are not dying from the illnesses that caused them to seek hospital care in the first place. They are dying from mishaps that hospitals could have prevented. What do these errors look like? The sponge left inside the surgical patient, prompting weeks of mysterious, agonizing abdominal pain before the infection overcomes bodily functions. The medication injected into a baby’s IV at a dose calculated for a 200 pound man. The excruciating infection from contaminated equipment used at the bedside. Sadly, over a thousand people a day are dying from these kinds of mistakes.”

Most Astonishing Health Disaster of the 20th Century

Drug Ads May Lose Fine Print Details About Side Effects

Have you ever asked your doctor if a certain drug was right for you—as instructed by virtually every drug ad you see on TV? Clearly, this ploy works, or the drug industry wouldn’t spend $4.53 billion a year on direct-to-consumer (DTC) advertising.20 In the midst of all the faux science backing up recommendations to use drugs of all kinds, the Food and Drug Administration (FDA) is considering simplifying DTC print ads by making the manufacturers summarize potential side effects in layman’s terms—and omitting certain drug details altogether. Cutting the laundry list of side effects from radio and TV ads is also under consideration, ostensibly to improve your understanding of the drug’s risks.
According to Forbes:21
“‘In general, FDA believes that exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks,’ the FDA says in its draft guidance on the proposed changes to print ads.The agency cites research showing that people can only process a limited amount of information offered in DTC drug ads. Furthermore, the FDA found, virtually no one reads even half of the fine print in drug ads, and of those who do, 55 percent say it’s hard to understand. The agency also cites several studies showing that when drug risks are described in laymen’s terms instead of medical jargon comprehension skyrockets.”
It’s difficult to discern whether a change like this might actually change how consumers “hear” or “see” the benefit versus risk potential of any given drug. In my view, the most reasonable approach would be to dramatically reduce or ban DTC drug ads altogether, as they do absolutely nothing to improve public health.  On the contrary, luring people into thinking they might benefit from a drug is a recipe for disaster, as it reinforces the fallacy that there’s a magic pill for every ill, when in fact most ailments can be effectively prevented or addressed with inexpensive lifestyle changes that have no detrimental side effects whatsoever.
History is replete with examples of drugs causing far more harm than good. Vioxx is one classic example. It killed about 60,000 people before being withdrawn from the market. Most recently, Takeda Pharmaceutical has agreed to pay $2.4 billion to settle some 9,000 lawsuits from patients who developed bladder cancer from the drug22–a side effect the company concealed, according to plaintiff attorneys. Despite such risks, Actos is still sold in the US and other countries.
Hopefully, you will resolve to take control of your health and avoid becoming a statistic of a conflict-of-interest-driven system that places greater value on share holders than patients. Addressing your diet is an obvious place to start, along with a regular exercise program.

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