Dr. Leslie Hendeles began lobbying the Food and Drug Administration to reject decongestants in cold medicine when Bill Clinton was a new president with curly red hair.
By the time opponents of the drug were united, Dr. Handeles, who was 80 years old and had whitened his hair, gave an overview of the ingredient over 50 years and served as an expert testifying before government agency advisers. He was in court.
His argument culminated in a unanimous vote by the advisory committee on Tuesday to conclude that decongestants commonly used in cold and flu treatments are ineffective.
Prompted by this news, consumers learned that phenylephrine, a decongestant, is listed in more than 250 of over 250 congestion medicines, including DayQuil, Sudafed, Tylenol, and some versions of Theraflu. I opened the box. And this decision caused some confusion. Experts say the ingredient is still effective in a nasal spray, but not when taken orally in tablet or liquid form.
The drug is considered safe, so there is no need to throw away products containing other effective ingredients, experts say.
Nothing will change immediately. FDA officials should scrutinize the committee’s decision, solicit public comment, and urge drug manufacturers to adjust or replace ingredients rather than face a decision that strips so many consumer staples from store shelves. It is likely to give you time to do something. Other delays may occur if a company challenges a lawsuit in court. And some experts, especially Dr. Scott Gottlieb, Former FDA Commissioner, has long argued that phenylephrine is somewhat effective. Some advocates of the drug may seek to oppose any measures that completely eliminate decongestants.
But how phenylephrine has remained on the market for so long, despite decades of research and doubts, is due to old drug standards dating back to legislation signed by President Kennedy, and routine drug standards in the 1990s. It’s a complicated story involving the proliferation of stimulant drug laboratories using cold medicine and a pandemic. .
Like other federal agencies, the FDA can move glacially, hampered by outdated rules and muddy regulatory procedures.
“There’s no question that over-the-counter drug regulations have been broken for years,” says Dr. Joshua Sharfstein, a former agency official and associate dean at the Johns Hopkins Bloomberg School of Public Health. He said recent developments show that “government agencies are now finally taking off the handcuffs.”
Some would argue that the process of dissecting phenylephrine (a drug used to dilate the eyes and soothe hemorrhoids) took approximately 60 years. During the Kennedy years, new laws were enacted that required the FDA to evaluate the effectiveness of drugs in addition to existing safety standards.
It wasn’t until 1976 that the FDA began reviewing over-the-counter cold medicines like phenylephrine as drugs.
But by the early 1990s, the nasal decongestant still hadn’t received full approval, and the long delay had caught the attention of Dr. Hendeles and a group of pharmacy professors at the University of Florida.
These will be the only constants in phenylephrine’s 30-year history, putting pressure on the FDA to do something.
Dr. Handeres published his first critique of the drug in 1993, saying the agency was overseeing two common nasal decongestants that were effective and a third, phenylephrine, that was ineffective. It pointed out. This drug was intended to constrict blood vessels and relieve nasal congestion. But he wrote that it had been destroyed in his stomach. medical journal. This means that most of the drug did not reach the bloodstream, much less the nose.
The 2000s saw a proliferation of seemingly unrelated issues. Illegal methamphetamine laboratories were exploding in the rural West Coast, as well as illegal drug abuse.
The meth cook’s ingredient of choice was pseudoephedrine, one of the most common nasal decongestants on the market at the time, and could be found in pharmacies.
At that time, it was one of only two nasal decongestants available for congestion relief. A third were removed in 2000 after a study found a link to stroke.
The meth crisis began the passage of state and federal laws restricting the sale of products containing pseudoephedrine, requiring consumers to show identification to purchase from behind a pharmacy counter or in a locked cabinet. I had to sign the ledger.
Concerned about declining sales, companies whose drugs include the popular stimulant additive turned to the last FDA-approved option, phenylephrine.
Dr. Handeres said he was disappointed when he saw the ingredients in the medicines on pharmacy shelves, knowing that patients were complaining that the alternatives were simply ineffective.
He worked with colleague Dr. Randall Hutton to comb through the data used to get the drug first approved in the 1970s.
Dr. Hutton unearthed memos to the FDA from the 1960s and 1970s that had not been peer-reviewed.He and his colleagues ran the data on the latest analysis software And the medicine is It was no different from a placebo.
As the research progressed, Dr. Hendeles tried to contact the FDA, where he had previously served as a visiting scientist. He wasn’t breaking through, he said. So he sought help from the office of California activist U.S. Rep. Henry Waxman.
Waxman fired off four letters citing the professors’ findings and calling on institutions to take action. “The FDA has a duty to provide Americans with the information they need so they don’t waste their hard-earned money on drugs that don’t work.” he wrote in a letter In 2006.
of FDA responded In the same year, it restated the findings of the 1976 decision. The letter suggests that if a consumer does not obtain symptom relief from phenylephrine, “consumers have the option not to purchase phenylephrine.”
The letter said Dr. Hendeles was free to petition the authorities.
And he did. Dr. Hendeles requested a review of the drug’s dosage and testing of its use in children. This led to an FDA public advisory hearing in 2007. So the Consumer Health Care Products Association, an industry group representing over-the-counter drug makers, insisted the drug was effective.
Dr. Hendeles recalled what he considered to be the definitive testimony. Representatives of Schering-Plough, the maker of Claritin-D, which contains the then-restricted nasal decongestant pseudoephedrine, told advisors that they had studied its rival, phenylephrine, but found it to be ineffective. Told. The company’s newspaper ads touted its “bold move” to maintain Claritin D’s “potent formulation,” according to Waxman’s letter.
Still, the advisory committee voted 11-1 that “the evidence supports” that phenylephrine “may be effective,” and called for more research.
Eight years have passed.
So Dr. Hendeles and his colleagues jumped on a study published by Merck & Co., which had acquired Schering-Plough. The company tested the drug at the approved dose and at a dose four times higher and found it still did not reduce symptoms.Merck Funding was also provided Research on sustained release formulations.
But that stubborn head complaint – traffic jams – didn’t go away.
(In 2014, Merck sells Claritin DI will report it to Bayer as it still contains pseudoephedrine. )
Florida pharmacists have petitioned authorities to ban the use of the latest research as ammunition. But their efforts were hampered by what many former agency officials described as a struggling over-the-counter division. There were 31 staff members. Members of 2018.
Dr Peter Lurie, who served as the agency’s deputy director until 2017, said staff had to follow “an arcane process in which they were handcuffed to the authorities and provided insufficient resources to resolve the backlog”. He said it didn’t happen.
The Florida team encountered another hurdle over the years.
After this week’s vote, Posted by Xformerly known as Twitter, and Dr. Gottlieb, who served as director of the agency from 2017 to early 2019, called the commission’s decision “unfortunate.” He recalled that phenylephrine was “considered to be weakly active when we looked at this question around 2005/06”. Currently, there may not be a good, cheap, and accessible option for consumers to receive gradual relief. ”
In an interview Friday, Dr. Gottlieb said he believes more research is needed on this ingredient. “I think it’s too early to say it’s not effective,” he said.
Interest in nasal decongestants has reignited after the pandemic law expanded agency staffing and overhauled the FDA’s over-the-counter drug procedures to better align with prescription drug division decisions. .
Shortly thereafter, the FDA team tackled a long-standing problem with nasal decongestants and produced painstaking research. 89 page review Phenylephrine, which the advisory committee considered as the basis for its decision. (The agency’s report corroborated Dr. Hendeles and his colleagues’ findings, but also pointed out obvious biases in some of the data from the 1970s that led to the drug’s initial acceptance.)
“It was a lot of fun to read,” Dr. Hendeles said.
Testifying on a panel earlier this week, Dr. Handeles talked about a 1971 study that used a modified scuba mask to measure nasal congestion. This was the first time that phenylephrine was found to be a failure.
Other groups, including Public Citizen, the American College of Clinical Pharmacy, and the National Center for Health Research, also asked the commission not to use the ingredient. Industry groups argued that the ingredient is effective and that low blood levels do not negate its effectiveness. Kenvue, a Johnson & Johnson spinoff, said in a statement that products containing phenylephrine are only a small part of its business, and that it also sells cold products that do not contain phenylephrine.
Dr. Hendeles was thrilled when the agency’s advisers voted 16-0. “There was nothing more exciting and exhilarating than voting,” he said.
Lawyers representing people who bought cold and flu medicines containing phenylephrine have already announced a lawsuit against the drug companies, alleging that the drug companies knew the nasal decongestants would not work.
For now, the products are on store shelves. “We feel that what we have been working on for a long time has been vindicated,” Dr. Hutton said. “But we’re not done yet.”
