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The world cannot rely solely on free markets to deliver medicines needed by billions of people in poor countries, so governments should commit to a legally binding convention to coordinate and fund research and development. That's the conclusion of a major United Nations report. The high-level panel was set up last year by UN Secretary-General Ban Ki-moon to find solutions to the "policy incoherence" between the rights of inventors, international human rights law, trade rules and public health needs. The final report ... calls for a de-linkage of R&D costs and drug prices — at least in areas where the system is failing, such as tropical diseases and the hunt for new antibiotics against "superbug" resistant bacteria. The report attacks the "implicit threats" it says are sometimes used by Western governments and companies to stop poorer countries from exercising their right to over-ride drug patents under World Trade Organization rules. That may not go down well in Washington, given the United States' long-standing defence of the international intellectual property system, which has governed world trade for more than two decades. The panel also calls for greater transparency on the true cost of developing a new drug, citing estimates of anything between $150 million US and $4 billion US per medicine. And it wants disclosure on the real prices paid by insurers and governments for drugs, after discounts. The UN panel consisted of representatives from government, academia, health activism and industry.
Note: Big Pharma has long lobbied for protection of its rights to huge profits from new medicines and kept secret its costs for R&D by refusing to separate these costs from marketing costs. For lots more, read a profoundly revealing essay by the former head of one of the most prestigious medical journals in the world. For more along these lines, see concise summaries of deeply revealing news articles on Big Pharma corruption and income inequality.
Major drug companies took hefty price increases in the U.S., in some cases more than doubling listed charges, for widely used medications over the past five years, a Reuters analysis of proprietary data found. Prices for four of the nation's top 10 drugs increased more than 100 percent since 2011, Reuters found. Six others went up more than 50 percent. Together, the price increases on drugs for arthritis, high cholesterol, asthma and other common problems added billions in costs for consumers, employers and government health programs. Extraordinary price hikes by two small companies, Turing Pharmaceuticals and Valeant Pharmaceuticals International Inc ... drew new attention to drug costs. Turing expected to book $200 million by raising the price of Daraprim, an antiparasitic used for a rare infection, by 5,000 percent, according to company documents released by Congressional investigators. Routine price increases by bigger players may draw less attention, but they add up. Sales for the top 10 drugs went up 44 percent to $54 billion in 2014, from 2011, even though prescriptions for the medications dropped 22 percent, according to IMS Health data. Even after discounts, pharmacy benefit managers told Reuters they pay annual price increases on top medications of up to 10 percent. By comparison, the U.S. consumer price index rose an average of 2 percent annually over the last five years.
Note: For more along these lines, see concise summaries of deeply revealing big Pharma profiteering news articles from reliable major media sources.
The U.S. Department of Justice has reached a settlement in the largest health care fraud case in U.S. history. The ruling, which included accusations of false advertising, forced the once widely respected British drugmaker, GlaxoSmithKline ... to pay a record-shattering $3 billion to various plaintiffs and the Department of Justice. Despite this $3 billion settlement, advertising fraud is on the rise in the United States. Expert public relations teams are called in to spin stories and confuse consumers. It is clear there is not enough being done to prevent, stop or resolve matters of false advertising in this country. The effect of the GlaxoSmithKline case has yet to be fully seen. If GlaxoSmithKline is [creative and deceptive] then we might see it roll out ads that skew the $3 billion loss in its favor - blatantly distorting the ruling as an endorsement of its products. At this point, even as regulators secure record-breaking settlements, the American people are losing, and the corporate spin teams are winning, the fight. Record settlements mean little if the deception continues. While winning lawsuits is a first step, what really matters is changing corporate behavior.
Note: For lots more from reliable sources on corporate corruption, click here.
Propelled by an increase in prescription narcotic overdoses, drug deaths now outnumber traffic fatalities in the United States, a Times analysis of government data has found. Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to preliminary data from the U.S. Centers for Disease Control and Prevention. While most major causes of preventable death are declining, drugs are an exception. The death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety. Public health experts have used the comparison to draw attention to the nation's growing prescription drug problem, which they characterize as an epidemic. This is the first time that drugs have accounted for more fatalities than traffic accidents since the government started tracking drug-induced deaths in 1979. Fueling the surge in deaths are prescription pain and anxiety drugs that are potent, highly addictive and especially dangerous when combined with one another or with other drugs or alcohol. Such drugs now cause more deaths than heroin and cocaine combined.
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Last year, Stanford banned its physicians from giving paid promotional talks for pharmaceutical companies. One thing it didn't do was make sure its faculty followed that rule. A ProPublica investigation ["Dollars for Docs"] found that more than a dozen of the school's doctors were paid speakers in apparent violation of Stanford policy - two of them were paid six figures since last year. Conflict-of-interest policies have become increasingly important as academic medical centers worry that promotional talks undermine the credibility not only of the physicians giving them, but also of the institutions they represent. Yet when it comes to enforcing the policies, universities have allowed permissive interpretations and relied on the honor system. That approach isn't working. Many physicians are in apparent violation, and ignorance or confusion about the rules is widespread. As a result, some faculty physicians stay on the industry lecture circuit, where they can net tens of thousands of dollars in additional income. Critics of the practice say delivering talks for drug companies is incompatible with teaching future generations of physicians. That's because drug firms typically pick the topic of the lecture, train the speakers and require them to use company-provided presentation slides.
Note: "Dollars for Docs" is an ongoing investigation into the influence of drug company marketing payments on medical providers. To search for a doctor in the database, click here.
Many drug trials involve a placebo, a sham drug whose results are compared with the results of the real medication. A placebo is supposed to contain a harmless substance, such as sugar or vegetable oil, which has no significant effect on the body. In [a new] study, researchers delved into 176 studies published in reputable medical journals ... from January 2008 to December 2009 to see if placebo contents were disclosed and if so, what they were. The study authors argue that placebo ingredients may not always be as inconsequential as some may think. They write: "For instance, olive oil and corn oil have been used as the placebo in trials of cholesterol-lowering drugs. This may lead to an understatement of drug benefit: The monounsaturated and polyunsaturated fatty acids of these 'placebos,' and their antioxidant and anti-inflammatory effects, can reduce lipid levels and heart disease." Certain placebos, they add, may skew results in favor of the active drug. The researchers referenced a trial for a drug used to treat anorexia linked with cancer in which a lactose placebo was used. Since lactose intolerance is common among cancer patients, the fact that some suffered stomach problems from the placebo may have made the actual drug look more beneficial. "Perfect placebo is not the aim," they write, "rather, we seek to ensure that its composition is disclosed."
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Johnson & Johnson CEO William Weldon delivered both a mea culpa and clear admission to [the Committee on Oversight and Government Reform] that his company let the public down through numerous recent drug recalls. He also admitted that the company secretly bought up defective drugs without informing regulators and consumers of its actions. The committee has been investigating circumstances that have led to more than half a dozen recalls this year of non-prescription cold and pain drugs such as Tylenol, Benadryl and Motrin made by Johnson & Johnson's McNeil Consumer Healthcare unit. Weldon's [pledge] to never let this happen again was met with some skepticism. [Committee Chairman Edolphus Towns (D-NY)] said [the] testimony indicates some very serious problems in "the way Johnson & Johnson viewed its responsibility to the public and its day-to-day relationship with the FDA." There is often a thin line between "working cooperatively" and having a "cozy relationship," he said. "The documents we have seen in this case indicate this line may have been crossed early and often."
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Nearly two years ago, a study known as the JUPITER [Justification for the Use of Statins in Primary Prevention] trial hinted at a new era in the use of statins -- one in which the cholesterol-busting drugs could be used to stave off heart-related death in many more people than just those with high cholesterol. Now, however, researchers behind a new review that takes a second look at the findings of the landmark study say that these results are flawed -- and that they do not support the benefits initially reported. Not only did this second look turn up no evidence of the "striking decrease in coronary heart disease complications" reported by investigators behind JUPITER, but it has also called into question drug companies' involvement in such trials, according to an article in the June 28 issue of Archives of Internal Medicine. Moreover, Dr. Michel de Lorgeril of Joseph Fourier University and the National Center of Scientific Research in Grenoble, France, and coauthors argue that major discrepancies exists between the significant reductions in nonfatal stroke and heart attacks reported in the JUPITER trial and what has been found in other research. "The JUPITER data set appears biased," Lorgeril and coauthors wrote in conclusion. De Lorgeril and coauthors point out that nine of 14 authors of the JUPITER article have financial relationships with AstraZeneca, which sponsored the trial.
Note: There is intriguing evidence that much of the fear around cholesterol was fabricated to sell drugs. For more on this, see the article by one of the most respected doctors on the Internet at this link.
A former Pfizer scientist is suing the pharmaceuticals giant after alleging she contracted an artificial, HIV-like, virus created by a colleague. In her lawsuit, Becky McClain claims Pfizer unlawfully dismissed her while she suffered bouts of paralysis brought on by the man-made virus. Pfizer denies these accusations, and says McClain simply didn't come to work, and only linked her problems to engineered-disease exposure after she was fired. According to McClain, researchers in her lab genetically engineered an artificial lentivirus, a class of viruses that also includes HIV. McClain believes that she became infected by the virus due to faulty safety measures, resulting in complete body paralysis as often as 12 times every month. Most likely, we will never know if it is Pfizer's virus that caused McClain's health problems. The court case will focus mostly on safety procedures in the laboratory, not on what exactly from the lab caused the illness. Also, Pfizer refuses to release the genome of the suspected virus, preventing both identification of the disease, as well as the development of a possible cure.
Note: Isn't it interesting that Pfizer is involved in creating HIV-like viruses? How long has this been going on?
[Anne Underwood:] President Obama hopes to increase the number of Americans with insurance and to rein in costs. Do you believe any of the plans under consideration by Congress will accomplish those goals? [Dr. Marcia Angell:] They won’t, and that’s the essential problem. If you keep health care in the hands of for-profit companies, you can do one or the other — increase coverage by putting more money into the system, or control costs by decreasing coverage. But you cannot do both unless you change the basic structure of the system. Q. Segments of the health care industry — pharmaceutical companies, for instance — are promising to cut costs. A. It’s not going to happen. These are investor-owned companies. Their fiduciary responsibility is to maximize profits. If they behaved like charities, heads would roll in the executive suites. Q. But what about market mechanisms for reducing costs? Wouldn’t the public option, for instance, provide competition for the insurance companies? A. Theoretically it would, but I doubt the public plan will pass. Industry is lobbying against it, and the president has not said this is a “must.” Even if it does pass, I’m afraid the private insurance industry will use their clout in Congress — and they have enormous clout in Congress — to hobble the public option and use it as a dumping ground for the sickest while they cream off the young and healthy for themselves. Q. How? Won’t insurance companies have to cover all applicants regardless of health status? A. It’s hard to regulate an enormous industry without setting up a bureaucracy to oversee it. That’s very expensive and creates a whole new set of problems.
Note: Dr. Marcia Angell is a senior lecturer in social medicine at Harvard Medical School and former editor of The New England Journal of Medicine. A longtime critic of the pharmaceutical industry, she has called for an end to market-driven delivery of health care in the United States. To read a two-page summary of her critique of market-driven health care, click here.
Almost 30 key lawmakers helping draft landmark health-care legislation have financial holdings in the industry, totaling nearly $11 million worth of personal investments in a sector that could be dramatically reshaped by this summer's debate. The list of members who have personal investments in the corporations that will be affected by the legislation -- which President Obama has called this year's highest domestic priority -- includes Congress's most powerful leaders and a bipartisan collection of lawmakers in key committee posts. Their total health-care holdings could be worth $27 million, because congressional financial disclosure forms released yesterday require reporting of only broad ranges of holdings rather than precise values of assets. Senate Majority Leader Harry M. Reid (D-Nev.), for instance, has at least $50,000 invested in a health-care index, and Sen. Judd Gregg (R-N.H.), a senior member of the health committee, has between $254,000 and $560,000 worth of stock holdings in major health-care companies, including Bristol-Myers Squibb and Merck. The family of Rep. Jane Harman (D-Calif.), a senior member of the House Energy and Commerce Committee drafting that chamber's legislation, held at least $3.2 million in more than 20 health-care companies at the end of last year. "If someone is going to be substantially enriched by the consequences of the vote, particularly if it represents a meaningful amount of their net worth, then there is a problem," said Harlan Krumholz, a professor of medicine at Yale University.
Note: For more powerful information on major corruption in health care reform, click here. For lots more on government corruption from reliable, verfiiable sources, click here.
What are the pills in your medicine cabinet, and how do you know they're best for you? When drug companies seek approval to market new medicines, they must show the U.S. Food and Drug Administration the results of all the tests they've run on volunteer patients - at first on only a few, then on dozens, and finally on hundreds or sometimes thousands. After winning approval, the companies typically sponsor reports of those tests in medical journal publications, which many doctors often rely on to determine whether to prescribe new drugs for their patients. Now a skeptical team of medical investigators at UCSF has accused the major drug companies of bias by distorting the results of their trials in those publications, making it hard for doctors to judge for themselves the pros and cons of prescribing the new drugs. As a result, the researchers say, patients may sometimes be taking medicines they don't need - or with unwanted side effects - that their doctors have prescribed on the basis of inadequate information. The UCSF team, led by Lisa A. Bero of the medical center's Institute for Health Policy Studies, probed the details of 164 drug trials involving as many as 1,500 patients over a two-year period and then examined reports on those trials that were published in medical journals, as well as those that remained unpublished. "We found really important information from the official trial reports that were either not published at all or that stressed mostly the positive results of trials in the published versions," said Kristin Rising, a physician at the institute who did the major investigation.
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It seemed an ideal marriage, a scientific partnership that would attack mental illness from all sides. Psychiatrists would bring ... their expertise and clinical experience, drug makers would provide their products and the money to run rigorous studies, and patients would get better medications, faster. But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors’ arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field’s premier professional organization, give an accounting of its financing. "I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said. In 2006 ... the drug industry accounted for about 30 percent of the association’s $62.5 million in financing. One of the doctors named by Mr. Grassley is the association’s president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company raised the senator’s concern. Commercial arrangements are rampant throughout medicine. In the past two decades, drug and device makers have paid tens of thousands of doctors and researchers of all specialties. Worried that this money could taint doctors’ research plans or clinical judgment, government agencies, medical journals and universities have been forced to look more closely at deal details.
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Bristol-Myers Squibb Co. and a former subsidiary have agreed to pay more than $515 million to settle federal and state investigations into their drug marketing and pricing practices. The civil settlement ... resolves a broad array of allegations against Bristol-Myers Squibb, dating from 1994 through 2005. Among them was a charge that the ... company illegally promoted the sale of Abilify, an anti-psychotic drug, for pediatric use and to treat dementia-related psychoses. Neither use is approved by the U.S. [FDA]. Although physicians are permitted to prescribe drugs for off-label uses, drug companies are prohibited from marketing them for uses that have not been approved by the FDA. U.S. Attorney Michael Sullivan said when pharmaceutical companies market drugs for unapproved uses, there is a potential risk that patients could be harmed, because the drugs have not been tested as rigorously as they are during the FDA approval process. The government also alleged the company paid illegal inducements in the form of consulting fees and trips to luxury resorts to influence doctors and other health care providers to buy and prescribe the company's drugs. The company's former generic drug subsidiary, Apothecon Inc., also was accused of giving illegal enticements to induce retail pharmacy and wholesale customers to buy its products. Bristol-Myers Squibb misreported its best price for the anti-depression drug Serzone, violating a law that requires drug companies to report their lowest price to Medicaid, prosecutors said. The company was selling Serzone to a larger commercial purchaser at a lower price, prosecutors said. Bristol-Myers Squibb and Apothecon also inflated prices for an assortment of oncology and generic drugs knowing that federal health care programs established reimbursement rates based on those prices, Sullivan said.
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The revelation that the diabetes drug Avandia can potentially cause heart disease is the latest in a string of pharmaceutical disappointments. Vioxx was pulled from the market in 2004 because it doubled the risks for heart attacks and strokes. Eli Lilly recently paid $750 million to settle lawsuits alleging that Zyprexa causes diabetes. Many have criticized the Food and Drug Administration as being too lax about monitoring drug safety. While those criticisms have merit, there is another culprit: the transformation of continuing medical education into an enterprise for drug marketing. The chore of teaching doctors how to practice medicine has been handed to the pharmaceutical industry. As a result, dangerous side effects are rarely on the curriculum. Most states require that doctors obtain a minimum number of credit hours of continuing medical education each year to maintain their medical licenses. Not so long ago, most of these courses were produced and paid for by universities and medical associations. But this has changed drastically over the past decade. Drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care. For example, GlaxoSmithKline footed the bill for dozens of educational courses intended to emphasize the benefits of Avandia over other drugs.
Note: For a concise, reliable overview of medical corruption, click here.
By Dr. Michael Wilkes. When is a disease really a disease? Young doctors in training work hard, and so do lots of other people. When people work 24 hours in a row ... the body feels tired. Is this fatigue an abnormal physiologic state requiring medication and treatment, or is it a normal part of belonging to the human race? If abnormal, then doctors and pharmaceutical companies argue that the fatigue requires treatment. If it is normal -- despite a movement to label it as an illness -- then post-work fatigue belongs to the growing phenomenon of disease-mongering. "Disease-mongering" ... is the process of trying to convince healthy people that they are sick, or people with minor problems that they have extremely worrisome symptoms. This is all in an attempt to sell treatments. Countless examples of disease-mongering are driven by the pharmaceutical industry's drive to sell drugs. Conditions such as female sexual dysfunction syndrome, premenstrual dysphoric disorder, toenail fungus, baldness and social anxiety disorder (a.k.a. shyness) are a few places where the medical community has stepped in, thereby turning normal or mild conditions into diseases for which medication is the treatment. Most pharmaceutical companies devote huge amounts of money to prevent, control and cure diseases. When their profits don't match corporate expectations, they invent "new" diseases to be cured by existing drugs. What happens to real diseases when [the media] are filled with information promoting disease mongering? Government funding for public health campaigns pales by comparison with the billions spent by pharmaceutical companies on disease mongering intended to increase the markets for their products.
Note: For more reliable information about major corruption in the pharmaceutical industry, click here.
The ties between doctors and drug manufacturers are close indeed. Most physicians (94 percent) reported some type of relationship with the pharmaceutical industry ... according to [a] study, published in the April 26 issue of the New England Journal of Medicine. Most of these relationships involved receiving food in the workplace (83 percent) or receiving drug samples (78 percent). More than one-third of the respondents (35 percent) were reimbursed for costs associated with professional meetings or continuing medical education, while more than one-quarter (28 percent) were paid for consulting, delivering lectures or enrolling patients in clinical trials. Over the past two decades, physician-industry relationships have attracted increasing scrutiny. One review found that, on average, physicians meet with industry representatives four times a month, and medical residents accept six gifts annually from industry representatives. "We know that these relationships have benefits and risks, and we know that they benefit the companies that are involved, and we know from our data that they benefit doctors," said study author Eric G. Campbell, an assistant professor of health care policy at the Institute for Health Policy at Harvard Medical School. "The real question is to what extent do these relationships benefit patients, and the answer is, we don't know." Campbell said that he found it hard to believe that free football tickets for a doctor would trickle down to benefit patients.
Note: For an excellent article by one of the foremost doctors in the nation on how the pharmaceutical industry has corrupted politics and damaged our health, click here.
The most widely prescribed sleeping pills can cause strange behavior like driving and eating while asleep, the Food and Drug Administration said yesterday, announcing that strong new warnings will be placed on the labels of 13 drugs. Use of those medications and other similar drugs has soared by more than 60 percent since 2000, fueled by television, print and other advertising. Last year, makers of sleeping pills spent more than $600 million on advertising aimed at consumers. Sales in the United States of Ambien and Lunesta alone last year exceeded $3 billion. Last year ... some users of the most widely prescribed drug, Ambien, started complaining online and to their doctors about unusual reactions ranging from fairly benign sleepwalking episodes to hallucinations, violent outbursts, nocturnal binge eating and — most troubling of all — driving while asleep. Sleep-drivers reported frightening episodes in which they recalled going to bed, but woke up to find they had been arrested roadside in their underwear or nightclothes. The agency also received reports of people making phone calls, purchasing items over the Internet, or having sex under the influence of sleep medication. In each case the consumers had no recollection of the events, which they said had occurred after they took their pills and headed for bed. "Hopefully this will make doctors think twice before blindly giving patients a prescription," said Dr. Mahowald. He also criticized marketing of the products. "I personally think the extent of advertising has just been unconscionable," he said.
Note: A reliable insider told us of a harrowing story where his company and the FDA made a secret agreement not to report numerous deaths resulting from one test drug so that it would pass and bring major profits. For lots more reliable, verifiable information on major corruption in the drug companies affecting your health, click here.
Gov. Rick Perry on Thursday angrily defended his relationship with Merck & Co. and his executive order requiring that schoolgirls receive the drugmaker's vaccine against the sexually transmitted cervical-cancer virus. The Associated Press reported Wednesday that Perry's chief of staff had met with key aides about the vaccine on Oct. 16, the same day Merck's political action committee donated $5,000 to the governor's campaign. In issuing the order, the governor made Texas the first state to require the vaccine Gardasil for all schoolgirls. But many lawmakers have complained about his bypassing the Legislature altogether. The executive order has inflamed conservatives, who said it contradicts Texas' abstinence-only sexual education policies and intrudes into families' lives. Critics have previously questioned Perry's ties to Merck. Mike Toomey, Perry's former chief of staff, now lobbies for the drug company. And the governor accepted a total of $6,000 from Merck during his re-election campaign. Merck has waged a behind-the-scenes lobbying campaign to get state legislatures to require girls to get the three-dose vaccine to enroll in school. But on Tuesday the pharmaceutical company announced it was suspending the effort because of pressure from parents and medical groups. The Kentucky House on Thurday passed a bill that would require the vaccination for middle school girls unless their parents sign a form opposing it. Virginia lawmakers have also passed legislation requiring the vaccine, but the governor has not decided if he will sign it.
Note: The drug company lobby is the most powerful in the U.S., as reported by the former editor-in-chief of one of the most respected medical journals in the U.S. Click here for more.
Several government doctors say drug maker Eli Lilly & Co. subtly orchestrated medical guidelines for treatment of an often lethal blood infection, hoping to boost sales of a drug whose value is being debated. “This company is trying to insinuate its drug into many aspects of patient care that industry really shouldn’t be involved in,” said Dr. Naomi O’Grady, a critical care specialist at the National Institutes of Health. Three of her NIH colleagues claim in Thursday’s New England Journal of Medicine that Lilly worked through medical societies to influence standards for treating the blood infection, sepsis. Ultimately, Xigris was incorporated into the guidelines. Both the guidelines committee and a larger information campaign on sepsis were heavily funded by [Lilly]. Dr. Phil Dellinger, who helped lead the guidelines committee, said...“We’ve been catching grief because we’ve been taking a lot of Lilly money — and we’re appreciative of Lilly giving it.” The U.S. Food and Drug Administration approved Xigris in 2001, despite an evenly split vote by its advisory committee. The lead author of Thursday’s journal article, Dr. Peter Q. Eichacker, voted against approval. Some critics are unhappy that the drug, which works only for the sickest patients, was approved on the basis of a single experiment. Academic officials acknowledged in the published guidelines that Lilly gave more than 90 percent of $861,000 in grants for the campaign and medical recommendations. O’Grady, of NIH, said a panel of disease experts that she headed refused to endorse the sepsis guidelines largely because Lilly “convened the whole panel.”
Note: For lots more on how the powerful pharmaceutical industry endangers our lives, click here.
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