Transparency International’s Pharmaceuticals & Healthcare Programme has launched a set of new principles focused on strengthening ethical standards across the pharmaceutical sector in Latin America, promoting integrity and ethical business practices. “Business Principles for Promoting Integrity in the Pharmaceutical Sector in Latin America” calls on pharma companies to implement these Principles to help reduce the risk of corruption, which holds back effective healthcare, for example by denying millions of people to fair access to necessary, and often life-saving medicines. The Pharma Integrity Principles for Latin America aim to promote integrity in the pharmaceutical sector and guide companies in eliminating bribery and related conflicts of interest; demonstrating that the pharma industry is able to do business with integrity; making a positive contribution to improving business standards of integrity, transparency and accountability; and development, or strengthening of a practical and effective internal anti-corruption or integrity programs.
High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. This study investigated the environmental presence of active pharmaceutical ingredients and their association with MDR bacteria in Hyderabad, South India, a major production area for the global bulk drug market.
Water samples were collected from the direct environment of bulk drug manufacturing facilities. Samples were analyzed for 25 anti-infective pharmaceuticals. All environmental specimens from 28 different sampling sites were contaminated with antimicrobials.
High concentrations of moxifloxacin, voriconazole, and fluconazole as well as increased concentrations of eight other antibiotics were found in sewers. Corresponding analyses revealed an extensive presence of enterobacteria. Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.
Citation: Lübbert, C., Baars, C., Dayakar, A. et al. Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens Infection (2017). Published online on April 26,2017.
The Food and Drug Administration’s approach to consumer protection faces a potential turning point when a Senate committee takes up President Trump’s nomination of Scott Gottlieb to head the agency, writes POGO, the nonprofit Project on Government Oversight. Trump has called for slashing FDA restraints on pharmaceuticals, and with Gottlieb’s appointment he would entrust the task to a doctor and former FDA official who has been immersed in the pharmaceutical industry. One of The FDA’s main missions is making sure that prescription medicines sold to the public are safe and effective. The FDA gets much of its funding through so-called “user fees” paid by pharmaceutical and medical device companies, and the money comes with strings attached, giving industry extraordinary leverage over its federal overseer. In Gottlieb, Trump has chosen a potential FDA commissioner whose financial disclosures list line after line of payments from drug and biotech companies.
The Pharmaceutical Research and Manufacturers of America has begun running television ads in New York criticizing Gov. Andrew Cuomo’s proposed new state controls over drug prices, reports the Wall Street Journal. Airing in several upstate counties, the ads describe Cuomo’s proposal and similar legislation put forth by the New York State Assembly’s Democratic majority as a tax from “New York City politicians” that would raise out-of-pocket costs and weaken health care quality. “Tell your legislators to reject the tax on prescription drugs,” a narrator states in the ads. The ads are said to be partly intended to pressure Republicans, who run the state Senate, to keep the measure out of the budget. Cuomo’s office disputed that his plan would increase out-of-pocket costs or weaken the quality of care. His plan seeks to cap drug prices through a series of state measures. He proposed creating a price ceiling for drugs that are reimbursed under Medicaid, imposing a surcharge on companies that exceed state price recommendations, and tightening regulations on intermediary brokers who negotiate drug prices for insurance plans
As it readies for battle with President Donald Trump over drug prices, writes Pacific Standard, the pharmaceutical industry is deploying economists and health-care experts from the nation’s top universities. In scholarly articles, blogs, and conferences, they lend their prestige to the lobbying blitz, without always disclosing their corporate ties. Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs. That isn’t an easy sell, because the price of the treatments ranges from $40,000 to $94,000 — or, because the treatments take three months, as much as $1,000 per day.
Big Pharma is striking back at Gov. Cuomo’s proposal to control the price of prescription drugs, reports the New York Daily News. The Pharmaceutical Research and Manufacturers of America is set to launch a new campaign on Wednesday calling on state lawmakers to reject Cuomo’s plan, saying it will do nothing to improve patient access to needed prescription drugs while threatening research and development and New York jobs. The “Prescribe Real Solutions” campaign will include online ads, a new website and a series of events across the state urging New Yorkers to contact their legislators, those close to the effort say. State of Politics, meanwhile reports that Gov. Cuomo’s top health officials told state lawmakers that price control regulations will withstand legal challenges.
President Trump met with leaders of some of the world’s biggest pharmaceutical companies Tuesday and emphasized the need to lower “astronomical” drug prices, decrease regulations and bring more drug manufacturing into the United States, reports The Washington Post. Trump offered no specific policies, but mentioned increasing competition and “bidding wars” as a way to bring down prices. In the past, he has lashed out at the pharmaceutical industry for “getting away with murder” and threatened to use the government’s bargaining power to force down drug prices for programs like Medicare.
Public Citizen Response
In a response to this proposal, Michael Carome, Director of Public Citizen’s Health Research Group wrote:
President Donald Trump’s preposterous promise to pharmaceutical company CEOs to slash U.S. Food and Drug Administration (FDA) regulations by 75 to 80 percent would, if fulfilled, fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements, and dangerous tobacco products, among other things. The end result would be countless preventable deaths, injuries and illnesses across the U.S. Trump’s horrifying proposal reflects utter ignorance about the FDA’s essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people.
OxyContin is a dying business in America. With the nation in the grip of an opioid epidemic that has claimed more than 200,000 lives, the U.S. medical establishment is turning away from painkillers. Top health officials are discouraging primary care doctors from prescribing them for chronic pain, saying there is no proof they work long-term and substantial evidence they put patients at risk. Prescriptions for OxyContin have fallen nearly 40% since 2010, meaning billions in lost revenue for its Connecticut manufacturer, Purdue Pharma. So the company’s owners, the Sackler family, are pursuing a new strategy: Put the painkiller that set off the U .S. opioid crisis into medicine cabinets around the world. This report is the third in a three part series in which the Los Angeles Times explores the role of OxyContin in the nation’s opioid epidemic. In another post, the journalists who reported the story describe their investigatory methods.
Congresswoman Rosa DeLauro has urged Labor, Health and Human Services Appropriations Subcommittee Chairman Tom Cole to revoke his hold on the Department of Health and Human Services (HHS) Report: Prescription Drugs: Innovation, Spending, and Patient Access. “By blocking the American people from seeing the HHS Drug Price report, Chairman Cole is denying the public critical information on spiraling drug spending in Medicare, Medicaid, and other federal health programs.” The full report is available here. The report found that almost 10% of U.S. Adults aged 18-64 reported not taking drugs as prescribed because of the high costs.
“Patient advocacy” groups have a unique power on Capitol Hill, writes David Dayen in The Intercept. They claim to represent the true voice of constituents, untainted by special interest bias. Politicians and the Food and Drug Administration use their endorsements as reflective of genuine public support. But a new study shows that nearly all of these patient advocacy groups are captured by the drug industry. David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards. The study is particularly notable now because Congress is poised to pass the 21st Century Cures Act, which trades temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process. Over 1,400 lobbyists have been working on this bill, which would be a major financial boon to the drug and medical device industries.