President Donald J. Trump’s first State of the Union speech since taking office has drawn little comment from the medical community, despite his vows to lower drug prices and take on the opioid epidemic.
He did not take the opportunity to address any other science- or health-related topics, including questions over budget issues at the National Institutes of Health, or the ongoing effort to allow states to impose work requirements for Medicaid recipients.
At press time, few organizations had issued any statements on the address, and several contacted by Medscape Medical News for comment had not responded.
On drug prices, Trump said reducing the cost for Americans would be a top priority for his administration this year. “And prices will come down substantially. Watch.”
This is not brand new. In January 2017, when he was still president-elect, Trump vowed to go after drug prices. John J. Leppard, senior editor and healthcare analyst of Washington Analysis, said he doesn’t see the president being able to follow through on his promise.
The government might require some givebacks from pharmacy benefit managers (PBMs), he said in a note to clients, but “We are skeptical that this will result in the sweeping actions that would substantially inhibit the pricing discretion of manufacturers and business practices of supply chain members to bring down prices for consumers to the extent implied by the president last night.”
Leppard said PBMs, not drug makers, will likely feel the brunt of any Trump administration pushback. “We do not expect to see a direct assault on the pricing practices of manufacturers,” he said.
Michael Munger, MD, president of the American Academy of Family Physicians, said in a statement that the organization “welcomes the Administration’s continued attention to high drug prices.” AAFP wants to see some movement, said Dr Munger. “We urge the administration to move beyond rhetoric and take action that ensures patients can afford the medications their physicians prescribe,” he said.
Funding Still Needed for Opioid Programs
The president said that his administration would tackle the opioid epidemic by increasing law enforcement efforts and making sure more treatment was available. But he did not urge Congress to take action — despite having issued two public health emergency declarations — and did not offer up any funding or call on lawmakers to provide appropriations to address the epidemic.
Mike Fraser, PhD, executive director of the Association of State and Territorial Health Organizations (ASTHO), told Medscape Medical News that ASTHO was gratified that the opioid epidemic had been mentioned in the speech. But more emphasis on prevention is needed, he said. Treatment is important, “but you can’t treat your way out of an Ebola epidemic,” said Dr Fraser, adding that the same was true for the opioid epidemic. More needs to be done to understand the drivers of substance use and addiction, he said.
It is irrelevant who asks for — or provides — the funding, said Dr Fraser. The most important issue is to allocate money for the epidemic, he said. “Someone needs to act soon,” he said, adding, “We’ve got programs we know that work that need to be scaled up. We need new dollars to do that.”
A joint statement from the Infectious Diseases Society of America and the HIV Medicine Association also stressed the need for increased funding.
“Mention of America’s opioid crisis during the State of the Union address last night must be followed by increased funding and evidence-based policies that go beyond law enforcement if we are to end this epidemic and prevent the co-occurring epidemics of HIV and hepatitis C,” they said.
After the speech, new Health and Human Services Secretary Alex Azar said Trump “deserves tremendous credit for his leadership in addressing the opioid crisis that’s hitting communities all across America.” Azar cited several administration accomplishments, including declaring the public health emergency, handing out $800 million in grants, approving new Medicaid waivers for two states to expand access to substance abuse treatment, proposing a streamlined process for more such approvals, and clarifying privacy regulations to inform hospitals and doctors that they can share information with patients’ families during crisis situations, such as opioid overdoses.
The administration also delinked patient scores of hospital pain management from Medicare reimbursement, said Azar.
On the morning of the State of the Union speech, Attorney General Jeff Sessions went to the US Attorney’s Office in Louisville, Kentucky, to launch a new Drug Enforcement Administration (DEA) effort against healthcare providers who are illegally prescribing or selling opioids. “I am announcing today that, over the next 45 days, DEA will surge Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs,” he said.
The agency will analyze information in the 80 million transaction reports it receives each year from drug manufacturers and distributors to determine outliers “and put them into targeting packages,” said Sessions.
The move is not unexpected, as the Department of Justice announced in August 2017 that it was creating an Opioid Fraud and Abuse Detection Unit to focus on opioid-related healthcare fraud.
Congress will begin holding another series of hearings on the opioids crisis, beginning with a February 26 meeting of the House Energy and Commerce Committee.
Right to Try Controversy
Trump called on Congress to enact a federal right-to-try law to give Americans the ability to access experimental therapies that have not been approved by the US Food and Drug Administration (FDA). Both Trump and Vice President Mike Pence have made such legislation a priority.
The Goldwater Institute, a Phoenix, Arizona–based conservative think tank, supports right-to-try laws, says that 38 states have passed such legislation. The Senate passed a right-to-try bill in August 2017, but the House has not taken up the legislation.
Those opposed to such laws say that they aren’t likely to offer the same protections to patients as those afforded in clinical trials. And, under the proposal making its way through Congress, drug companies would be able to charge patients for therapy.
In a recent opinion piece in JAMA Internal Medicine, two New York University researchers said the Senate proposal lets patients access investigational drugs that have completed phase 1 studies, grants companies and physicians broad immunity from liability, and “largely blinds the FDA to safety or efficacy data from these therapeutic attempts.”
A federal law “would upend the agency’s expanded access program, which has worked successfully for decades to provide patients who are seriously ill and without therapeutic options access to investigational drugs and still assure the safety and efficacy of new drugs before these products gain marketing approval,” said Alison Bateman-House, PhD, and Christopher T. Robertson, PhD, in the article.
They said that a review of a decade’s worth of requests to the FDA expanded-access program in the Center for Drug Evaluation and Research found that 99% of the 1000 or so applications submitted each year are approved and are done so within days or hours.
The American Society of Clinical Oncology said in April 2017 that it has many concerns about right-to-try laws on the books, including that they don’t protect patients as well as clinical trials do and may interfere with the FDA’s efforts to improve its compassionate- and expanded-use protocols.
After the Trump speech, the Men’s Health Network said that it supported the option to access developmental drugs that have not gotten FDA approval but have shown some life-saving potential. “The right to access should include protections for patients, health care providers and institutions while enhancing and supporting the scientific and regulatory process in such a way as to contribute to marketing approval for these important treatments,” said Sal G. Giorgianni, PharmD, Men’s Health Network senior science advisor, in a statement emailed to Medscape Medical News.
For more news, join us on Facebook and Twitter
Tidak ada komentar:
Posting Komentar