July, 25 2012, 03:45pm EDT
Doctors, Researchers and Health Officials Call on FDA to Change Labels on Opioid Painkillers to Deter Misprescribing
Drug Companies Should Not Be Permitted to Advertise Long-Term Opioids for Non-Cancer Pain, Experts Say
WASHINGTON
Labels on opioid pain medications should be revised to prevent overprescribing, a broad coalition of doctors, researchers and public health officials said in a petition filed today with the U.S. Food and Drug Administration (FDA). If the requested changes were adopted, drug companies would not be able to claim that the pain medications are safe and effective for long-term use by non-cancer patients.
According to the petition, opioid labels are overly broad because they fail to limit opioid use to severe pain, to include a time frame for use and to specify a maximum dose. Presently, the label on opioid analgesics simply states that they're approved for "moderate to severe pain."
The petition, available at https://www.citizen.org/documents/2048.pdf, is signed by 37 prominent experts, including leaders in the fields of pain medicine, addiction and primary care; health commissioners; researchers; and program directors at public interest groups.
The requested changes relate specifically to when opioids are used for non-cancer pain. The petition calls for striking the term "moderate," adding a suggested maximum dose equivalent to 100 milligrams of morphine and adding a suggested duration of use. The petition's co-signers believe that preventing drug companies' aggressive promotion of these medications for moderate pain will help curtail overprescribing. According to the Centers for Disease Control and Prevention, excessive prescribing of opioid analgesics is fueling an epidemic of addiction and overdose deaths.
Drugmakers prefer a non-specific FDA-approved label because it allows them to encourage use of opioids for an indefinite period of time and for a wide range of common problems. The proposed label changes would have serious implications for drugmakers because federal law prohibits "off-label" advertising. Drugmakers wouldn't be able to promote opioids for continuous long-term use by people who don't have cancer.
The coalition of experts who signed the petition believes that the label must be changed to reflect existing medical evidence. The long-term effectiveness and safety of opioid analgesics has not been established by scientific studies, and recent research calls into question the safety and effectiveness of these drugs when used long-term, particularly at higher dosage levels.
The FDA typically approves conditions that a drug can be used to treat on the basis of clinical trials that are 12 weeks in length. In the case of opioid analgesics, Dr. Edward Covington, director of the Neurological Center for Pain at the Cleveland Clinic, believes that short-term studies like this are inadequate. According to Dr. Covington, "It's clear that the short-term effects, on the basis for which they are approved and marketed, do not mirror their effects in long-term use. In the absence of long-term studies demonstrating safety and effectiveness, we need limits on what drug companies can claim about opioids." Covington also believes that suggested dose limits must be added to the label "given the lack of experimental support for using high doses."
Although the proposed label changes would limit the way drug companies promote opioid analgesics, doctors would continue to be able to make prescribing decisions based on their clinical judgment, assessment of patient needs and response to treatment. "Off-label" prescribing is considered appropriate, even though "off-label" advertising is prohibited. According to Dr. Jane Ballantyne, a pain specialist at the University of Washington in Seattle and a co-signer of the petition, "A form of constraint that controls overuse while preserving opioids for patients in need can only be a positive step towards more rational and safer prescribing."
Dr. Lewis Nelson, an emergency physician and medical toxicologist at NYU Langone Medical Center, explained that "It's time to close the loophole on opioid labels," which he says amounts to "a mechanism that allows drug companies to promote opioids for unproven uses." Physicians are wrong to assume that "on-label" indications are evidence-based with regard to safety and efficacy.
Over the past 15 years, Purdue Pharma, maker of OxyContin, and other opioid manufacturers have sponsored a campaign to encourage wide-scale, long-term prescribing of opioids for common chronic conditions like fibromyalgia and low back pain. Previously, doctors had been reluctant to use opioids long-term because they were worried about causing addiction. But company-sponsored education misled doctors to believe that addiction was rare and that withholding opioids was cruel.
"Over-prescribing of opioids is harming many chronic pain patients," Covington said. "The label change is a way for the FDA to let the medical community know that risks may outweigh benefits when used long-term." He continued, "The issue is tricky, because a subset of chronic pain patients benefit from chronic opioids, usually in low to moderate doses, and it is important that access is not restricted for those who show lasting benefit. The label change we're requesting balances the need to preserve access for these patients with the need to reduce overprescribing."
Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people - not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.
(202) 588-1000LATEST NEWS
Congressional Progressives to Fed: Cut Rates to 'End This Squeeze' on Workers
Lawmakers warned Federal Reserve Chair Jerome Powell that keeping interest rates high "needlessly worsens housing market imbalances" and "could threaten" workers' jobs and wages.
Mar 18, 2024
Progressive lawmakers in the House and Senate urged the Federal Reserve on Monday to begin slashing interest rates in the near future, warning that the increasingly tight monetary conditions the central bank has imposed over the past two years risk imperiling strong post-pandemic job and
wage growth.
In a
letter to Fed Chair Jerome Powell, Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.) joined 19 House Democrats in calling for a "prompt timeline for future rate reductions," noting that the central bank has hiked rates 11 times since March 2022 and that inflation has nearly fallen "into line with the Federal Reserve's target."
"Today's excessively contractionary monetary policy needlessly worsens housing market imbalances and the unaffordability of home ownership, creates risks for banking stability, and could threaten the achievements of strong employment and wage growth and its attendant reductions in economic and racial inequalities," reads the letter, which was sent a day ahead of the Federal Open Market Committee's (FOMC) March 19-20 meeting.
If the Fed waits too long to begin cutting rates, the lawmakers cautioned, overly restrictive monetary policy could "reduce employment and real wage growth."
"We worry that higher unemployment and a harmful economic slowdown could result from a lagged effect of the prior 11 interest rate hikes since March 2022," the lawmakers added. "We believe it is critical for the FOMC to present the public with a clear and rapid timetable for reducing interest rates, ideally beginning at the May FOMC meeting in order to ensure a strong labor market and full employment for working Americans."
The Federal Reserve has raised interest rates 11 times in the last 2 years, keeping working people from being able to get a raise, a mortgage, or car.
Today, @SenSanders, @SenWarren, and House progressives call on the Fed to finally lower interest rates.https://t.co/VvFNPwZ8lS
— Progressive Caucus (@USProgressives) March 18, 2024
Since the Fed started raising interest rates for the first time since 2018 just over two years ago, progressive lawmakers, advocates, and economists have been arguing that jacking up borrowing was not the solution to inflation fueled in large part by pandemic-related supply chain disruptions and corporate price gouging. According to one recent study by the Groundwork Collaborative, corporate profiteering drove more than half of inflation between April and September 2023.
Last month, following a strong jobs report, Groundwork's Bilal Baydoun called for rate cuts, arguing that "the data is very clear that we never had to sacrifice jobs for lower prices."
"High interest rates will only slow our clean energy transition and put families in more debt," said Baydoun. "Chair Powell must change his tune and cut rates in March."
But the Fed is not expected to announce rate cuts following the two-day FOMC meeting that begins on Tuesday. The Associated Pressreported Monday that "Powell and his fellow Fed officials are expected to play it safe when they meet his week, keeping their rate unchanged for a fifth straight time and signaling that they still need further evidence that inflation is returning sustainably to their 2% target."
The Consumer Price Index (CPI) report released last week showed that overall inflation was 3.2% year-over-year—a slight uptick from January's reading but far below the 9.1% peak in 2022.
Hiring, meanwhile, has remained strong even as Powell has explicitly targeted the jobs market and workers' wages. Employers added 275,000 jobs last month, according to the U.S. Labor Department, and unemployment stayed low at 3.9%.
Rep. Pramila Jayapal (D-Wash.), chair of the Congressional Progressive Caucus, said in a statement Monday that "the American economy recovered from Covid because congressional Democrats and President Biden partnered to invest in workers over corporations and created paths to economic security for people who had been locked out before."
"Unnecessarily high rates put all that at risk," Jayapal added. "They will only punish everyday Americans: exacerbating the housing crisis, hindering the deployment of clean energy, and throwing the future of the Biden recovery into uncertainty, while threatening the wages and jobs that our communities depend on. It's past time for the Fed to end this squeeze on working- and middle-class families."
Keep ReadingShow Less
Greenpeace Says Ban Deep-Sea Mining, Not Our Right to Protest Against It
"How can Greenpeace's activists paddling on kayaks be a threat to the environment, but the plundering of the oceans be a solution to the climate catastrophe?"
Mar 18, 2024
As the International Seabed Authority kicked off its annual summit in Jamaica on Monday to discuss rules for extracting minerals from the ocean floor, Greenpeace—which could be expelled from the United Nations body over a demonstration targeting a mining company—is urging the ISA to "stop deep-sea mining, not protests."
Representatives of 167 nations are gathering in Kingston to draft the regulatory framework for deep-sea mining, which ISA member states agreed to work out by July 2025. Although there are no current commercial deep seabed mining operations, the ISA has issued exploration licenses to state-owned companies and agencies in China, France, Germany, India, Japan, Russia, and South Korea, and to private corporations including U.K. Seabed Resources, a subsidiary of U.S. military-industrial complex giant Lockheed Martin.
The Metals Company, a Canadian startup looking to make a big splash in deep-sea mining, has been targeted by Greenpeace "kayaktivists," who last November boarded a ship belonging to subsidiary Nauru Ocean Resources Inc. in the Pacific Ocean and occupied the vessel's stern crane to draw attention to the potential harm that mineral extraction would cause to one of the world's last untouched ecosystems.
That peaceful protest could cost Greenpeace its ISA observer status, as members will consider whether to punish the environmental group during this week's conference. ISA Secretary-General Michael Lodge claimed that Greenpeace's kayak protest posed a "serious threat" to company personnel and "the marine environment."
However, last November a Dutch court rejected The Metals Company's request for an injunction against the protesters, finding it "understandable" that Greenpeace took direct action in the face of "possibly very serious consequences" of the company's mining plans.
Greenpeace plans to hold a side event at the ISA conference on Monday focusing on the right to protest.
"If Michael Lodge had put as much effort into properly scrutinizing deep-sea mining companies and ensuring transparent negotiations as he has chasing dissent, a pristine ecosystem would have a fair chance to remain undisturbed," said Greenpeace International Deep-Sea Mining campaign lead Louisa Casson. "How can Greenpeace's activists paddling on kayaks be a threat to the environment, but the plundering of the oceans be a solution to the climate catastrophe?"
This year's ISA conference comes as two dozen nations are calling for a moratorium on deep-sea mining and campaigners are urging the United States to ratify the U.N. Convention on the Law of the Sea, under which the ISA was established.
"Over the past year, it's been outstanding to see the growing call for a moratorium from countries in the Pacific, Europe, and Latin America," said Casson. "Responsible nations at the ISA are listening to the mounting science that shows deep-sea mining would cause irreversible damage to the oceans... The momentum is on the side of a moratorium."
There is also pushback. Last week, more than 350 former military and political leaders in the United States including former Secretary of State Hillary Clinton published a letter urging the U.S. Senate to sign and ratify the Law of the Sea in a bid to boost deep-sea mining amid rising international competition for minerals.
"Almost everyone agrees that the United States should ratify the Law of the Sea—it's a no-brainer and has been since the treaty was adopted over 40 years ago. This might be the only thing that Greenpeace and Big Oil agree with each other on," said Arlo Hemphill, who heads the Oceans Are Life campaign at Greenpeace USA.
"Now, deep-sea mining corporation The Metals Company has jumped on the bandwagon, hoping it will increase their chances of making it big after several costly failed ventures," Hemphill added. "With two dozen countries already on the record opposing the launch of deep-sea mining any time soon, there is little possibility it will be permitted."
However, earlier this year Norway became the first country to green-light deep-sea mining, a decision one environmental campaigner warned will have "severe impacts on ocean wildlife."
Keep ReadingShow Less
'Positive Step,' Says Sanders After AstraZeneca Agrees to Cap Inhalers at $35
"Americans who have asthma and COPD should not be forced to pay, in many cases, 10 to 70 times more for the same exact inhalers as patients in Europe and other parts of the world."
Mar 18, 2024
AstraZeneca announced Monday that it will cap out-of-pocket costs at $35 per month for U.S. inhaled respiratory medicines—becoming the second pharmaceutical giant to make that move since U.S. Sen. Bernie Sanders launched a probe in January.
The policy change—which will benefit patients with asthma and chronic obstructive pulmonary disease (COPD), including those who are uninsured and underinsured—is set to start in June, like the Boehringer Ingelheim decision announced earlier this month.
While welcoming the development, Sanders (I-Vt.) noted that it comes after the Senate Committee on Health, Education, Labor, and Pensions (HELP) that he chairs began investigating "the outrageously high cost of inhalers that 25 million Americans with asthma and 16 million Americans with COPD rely on to breathe."
"If AstraZeneca and Boehringer Ingelheim can cap the cost of inhalers at $35 in the United States, these other companies can do the same."
"In my view, Americans who have asthma and COPD should not be forced to pay, in many cases, 10 to 70 times more for the same exact inhalers as patients in Europe and other parts of the world," declared Sanders. "Since we launched that investigation, I have had conversations with all of the CEOs of the major manufacturers of these products."
The senator said that he is "very pleased" with AstraZeneca's announcement, adding that "this is a very positive step which will help save Americans thousands of dollars a year on the inhalers they need to breathe."
The panel's probe—supported by Sens. Tammy Baldwin (D-Wis.), Ben Ray Luján (D-N.M.), and Ed Markey (D-Mass.)—also targets GlaxoSmithKline (GSK) and Teva. Sanders called on the pair to "take similar action," arguing that "if AstraZeneca and Boehringer Ingelheim can cap the cost of inhalers at $35 in the United States, these other companies can do the same."
Sanders pledged that his committee "will continue to do everything we can do to make sure that Americans no longer pay, by far, the highest prices in the world for prescription drugs."
In AstraZeneca's announcement, CEO Pascal Soriot called for federal action, saying that "we remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone. It is critical that Congress bring together key stakeholders to help reform the healthcare system so patients can afford the medicines they need, not just today, but for the future."
AstraZeneca highlighted that the cap will apply to medicines including Airsupra, Bevespi Aerosphere, Breztri Aerosphere, and Symbicort—which cost up to $645—and that the company "substantially reduced the list price" of Symbicort at the beginning of the year.
The Federal Trade Commission (FTC) in November disputed more than 100 patents held by pharmaceutical companies that make asthma inhalers, EpiPens, and other products listed in a Food and Drug Administration database, including Symbicort.
Acknowledging AstraZeneca's cap decision, FTC Chair Lina Khan said on social media Monday, "I urge the other firms whose patents FTC challenged—including GSK and Teva—to withdraw their improperly listed patents and drop costs for Americans."
Keep ReadingShow Less
Most Popular