Lilly rolls out insulin discount program
http://www.drugstorenews.com/article/lilly-rolls-out-insulin-discount-program?
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http://www.drugstorenews.com/article/lilly-rolls-out-insulin-discount-program?
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http://www.medscape.com/viewarticle/872510
Editor’s Note: Arthur Caplan, PhD, interviewed Timothy Quill, MD, as part of the Medscape video series Both Sides Now. Only a portion of Dr Quill’s interview could be included in the video because of time constraints. Here, we are posting the interview in its entirety. In the coming weeks, we will post interviews with other speakers in that video.
Arthur L. Caplan, PhD: It’s my great pleasure to have as a guest on this difficult topic one of the leading voices—for many decades—in physician-assisted dying, Dr Tim Quill. He is a professor at the University of Rochester School of Medicine. He is also the director of the Center for Ethics, Humanities and Palliative Care, and he is board certified in palliative care. It is a pleasure to welcome you to the program. I can’t think of a better voice to listen to about some of the complexities of these issues. Thanks for coming.
Timothy E. Quill, MD: Glad to be here. Thanks for having me.
Dr Caplan: Let’s have you do a little cleaning up of the landscape. What is the difference between physician-assisted dying and physician-assisted suicide? Both terms are around. How do you differentiate those in your mind?
Dr Quill: Many times, the two terms are conflated. Those who believe that this should be a legal option prefer to use the language “physician-assisted dying” rather than “physician-assisted suicide.” Why is that? Well, suicide equates the act with mental illness and with people who have other choices. An important fact is that other languages have more than one word for suicide. There can be rational suicide. There can be heroic suicide, the warrior jumping on a bomb. And there might be suicide for mental illness. The opponents of physician-assisted death would like it to be called “physician-assisted suicide” because they want to equate it in some sense with mental illness.
Dr Caplan: When you say mental illness, do you mean depression?
Dr Quill: Depression, psychosis, an act that makes no sense and could be prevented by good medical care. People who are advocates see it as a possible rational approach when suffering is very hard and there aren’t a lot of other good options. We know that it can be rational because we’ve met people who are in that circumstance who have asked for our help.
Dr Caplan: Do you think there’s a subtle difference in terms of the role of the doctor in physician-assisted dying? People are going to die. For physician-assisted suicide, maybe they’re not terminally ill.
Dr Quill: I suppose it could be the lack or the potential absence of terminal illness. Physicians are also regularly involved in helping people to die. I work in palliative care in hospice. You can take a frame on that to say that we’re at least in part helping people to die better. That’s what we do. So, you want to be sure that you know what we’re talking about as well. There is some issue of clarity that could be an argument in this debate in terms of language.
Dr Caplan: Your field has evolved a lot over the past couple of decades. I think it would be fair to say that you’ve been a pioneer in palliative care as well. We’ve certainly seen palliative care spread out into American healthcare. Not that it’s where it should be everywhere, but it’s certainly available starting earlier for many people. Some physicians are going to say, “Why do we even have this discussion about assistance in dying if we have palliative care?” Continue Reading
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The Wall Street Journal on June 13, 2015, published an Op-Ed piece written by prominent Boston criminal defense and civil rights attorney Harvey Silverglate commenting on the recent acquittal of Dr. Joseph Zolot and Nurse Practitioner Lisa Pliner on multiple counts of alleged violations of federal conspiracy and drug distribution laws.
Dr. Zolot was represented by Todd & Weld attorneys Howard M. Cooper, Benjamin J. Wish, and Hillary A. Lehmann and was acquitted after a 26-day trial.
In the WSJ opinion article, attorney Silverglate questions the legitmacy of federal drug prosecutors using drug laws to prosecute pain physicians where there is little, if any, guidance given to physicians about the line between legitimate medical treatment and improper prescribing.
“This prosecution,” Silverglate writes, ” shows why drug warriors need either to clarify the currently indecipherable line between treating pain and unlawfully feeding drug addicts’ habits, or get out of the business of policing and terrorizing physicians. Unfortunately, the government uses legal ambiguity for tactical advantage and will not readily clarify the lines it expects doctors to follow at their peril.”
Dr. Zolot was a Needham, Mass.-based pain medicine physician whose office was raided by the government in May 2007, after which he was indicted on multiple counts of unlawfully prescribing opioids such as OxyContin, Fentanyl and Methadone to patients. Nurse Pliner was accused of participating in the drug dealing operation. A first trial resulted in a hung jury, after which U.S. Attorney Carmen Ortiz decided to retry the case.
Following his acquittal, Dr. Zolot publicly expressed his hope that the verdict would help doctors feel less intimidated by the federal government in treating patients who are in chronic pain with available pain medications.
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http://www.healthcarefinancenews.com/news/pharmacy-benefit-managers-facing-crackdown-drug-pricing
The financial future of pharmacy benefit managers is uncertain as payers, legislators and regulators focus on rising drug prices, according to Moody’s Investors Service.
The rising price of drugs such as Mylan’s EpiPen has resulted in a firestorm of scrutiny from legislators and PBM customers.
Humira and Enbrel, popular anti inflammatories that represent a significant portion of the drug spend, saw double digit increases, even after rebates, between 2014 and 2015, Moody’s said.
Because of the growing public attention, manufacturers are expected to moderate drug price increases over the coming year, a factor confirmed by large drug distributors and some drug manufacturers.
However, specialty drugs will account for a larger portion of the nation’s drug spend, due in part to innovation and higher pricing.
[Also: Healthcare spending, driven by prescription drug costs, outpaces economy]
The current PBM model could be altered or undermined by changes proposed by employers, customer groups and legislation that is aimed at drug companies, or even a slowing of brand drug price inflation, Moody’s said.
Earnings guidance is down because branded drug inflation will moderate between 7-9 percent, from around 10 percent.
Pharmacy benefit managers feeling the heat include Express Scripts, CVS Health and Optum RX, which is part of UnitedHealth Group.
Both Express Scripts and CVS Caremark will continue to exclude certain drugs from their formularies to help clients cut drug spending, Moody’s said.
The number of drugs on the PBM formulary exclusion lists for both CVS health and Express Scripts has risen from 76 and 48 respectively, in 2014, to 154 and 85 for 2017.
The problem is, Moody’s says, that with limited transparency on actual pricing and discounts and rebates, it’s not easy to determine if PBMs are making formulary decisions that are best for their clients or for themselves.
PBMs have disclosed little about the profits gained from placing certain drugs on their formularies, Moody’s said.
PBMs have said they pass on the lion’s share of the rebates they receive to their clients.
“We estimate that Express Scripts keeps about 15 percent of the rebates,” Moody’s said.
But none disclose this information.
A Health Transformation Alliance has highlighted employer concerns regarding rising drug costs. The coalition of more than 20 high-profile employers focuses on making the healthcare benefit market most cost-effective by changing how PMBs purchase and pay for prescription drugs.
They will do this by renegotiating contracts with PBMs, Moody’s said. Branded drug price inflation will slow, but the impact on PBMs depends on contract terms.
The coalition has yet to release firm proposals, but are considering fee for service payment models, in which the PBM client would pay for the cost of the drug, plus an agreed upon fee.
Legislative proposals include allowing the federal government to negotiate drug prices for seniors covered under Medicare Part D, and modifying the reimbursement structure for dual-eligible patients.
In January 2015, a bipartisan bill introduced in the House would help pharmacies receive appropriate levels of reimbursement from PBMs. Independent pharmacies had argued they were losing money because they were being reimbursed by PBMs for less than it cost them to buy the drugs.
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baddrug.news/news/invokana-lawsuits-coordinated-mdl/
The U.S. Judicial Panel on Multidistrict Litigation granted a coordinated docket for more than 100 lawsuits alleging the diabetes drug Invokana caused significant injuries. Cases are currently being transferred and coordinated in a multidistrict litigation in the U.S. District Court for the District of New Jersey.
All of these Invokana lawsuits have similar allegations against manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J). Plaintiffs allege the drug led to chronic kidney disease caused by a condition called ketoacidosis.
Ketoacidosis is a buildup in the blood of proteins called ketones. This condition can cause patients to suffer from a diabetic coma, require extended hospitalization, and can even cause death.
This past summer, the U.S. Food and Drug Administration (FDA) issued a safety warning for patients and doctors about Invokana and similar drugs. Between 2013 and 2015, the FDA received 101 reports of kidney injuries associated with Invokana use. This prompted the FDA to heighten its warnings regarding Invokana to include the risk of potentially life-threatening side effects like ketoacidosis and other kidney injuries.
Kidney injuries are not the only debilitating side effects reportedly caused by Invokana. Several months ago, the European Medicines Agency (EMA) warned doctors to discontinue use of Invokana in certain patients because the drug had an increased risk of amputations. An ongoing study found patients taking Invokana were twice as likely to require foot amputations than patients taking a placebo.
The newly created multidistrict litigation (MDL) will help Invokana patients from across the country get to a quicker resolution. Now that the MDL has been formed, more Invokana lawsuits will likely be filed. Janssen and J&J face a large number of lawsuits over more than one of their prescription medications, including Risperdal, so the companies might consider resolving Invokana lawsuits before the litigation grows to large numbers.
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http://wvpublic.org/post/state-board-request-reports-painkiller-orders
West Virginia’s Board of Pharmacy plans to ask prescription drug wholesalers to report pharmacies that place suspiciously large orders of painkillers or other controlled substances.
The board plans to forward those reports to the state Attorney General’s Office, which last week sued a pharmacy in Boone County, alleging it provided too many highly addictive painkillers over more than a decade.
The distributors McKesson Corp. and Cardinal Health now notify the state of such questionable orders.
The Charleston Gazette-Mail (http://bit.ly/2hAI2Wi) reports the pharmacy board has agreed to send letters asking other wholesalers.
The board’s rules require they report suspicious prescription drug orders, but the regulations don’t spell out the criteria.
Distributors already submit reports on suspicious drug orders to the U.S. Drug Enforcement Administration.
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Tell all contacts from your list not to accept a video called the “Dance of the Pope”. It is a virus that formats your mobile. Beware it is very dangerous. They announced it today on the radio. Fwd this msg to as many as you can!
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http://www.insightcrime.org/news-briefs/dea-lays-out-new-dynamic-regional-heroin-trafficking
A top DEA official has sounded the alarm over how heroin traffickers in Mexico have massively increased poppy cultivation and expanded their distribution networks into the east coast of the United States as they look to cash in on the growing number of US heroin users.
In Congressional testimony (pdf) on October 8 regarding drug abuse, Acting Deputy Administrator of the Drug Enforcement Administration (DEA) Jack Riley said the DEA had documented a 50 percent increase in the cultivation of poppy (the plant used to make heroin) in Mexico, primarily in the state of Guerrero and the Mexican “Golden Triangle” of Durango, Sinaloa, and Chihuahua.
Mexican criminal organizations such as the Sinaloa Cartel have also been expanding territorially in US markets and developing more sophisticated production techniques, Riley asserted.
Traditionally, Riley said, the US heroin market has been divided by the Mississippi River: markets west of the river used Mexican black tar and brown powder heroin, while the most lucrative markets, the large east coast urban centers, were dominated by higher quality Colombian-produced white powder heroin. However, Mexican drug traffickers are now also competing for the lucrative East Coast market, introducing Mexican brown/black tar heroin but also seeking to produce their own version of the more refined white powder variety.
The preferred trafficking routes for these networks is the Southwest US-Mexico border, where heroin seizures doubled between 2009 and 2013 from 846 to 2,196 kilograms, according to Riley
The Mexican traffickers are supplying a rapidly increasing number of US heroin users, which more than doubled between 2007 and 2014, from 373,000 to 914,000, according to Riley. Today, he said, heroin is higher in purity, less expensive, and often easier to obtain than prescription opioids — such as the painkillers oxycodone and hydrocodone. .
There are numerous market forces that explain the changing dynamic in regional heroin production, trafficking and distribution.
One of most important is the rapidly rising demand as a result of the growing number of US users. As Riley elaborates on in his testimony, rising US heroin use is closely linked to abuse of prescription painkillers, the most commonly used illegal drug in the United States after marijuana. Many users start off on pills but turn to heroin because it is cheaper, more easily available or because it has a stronger effect.
Exploiting this growing market may also be making up for shortfalls in revenues elsewhere for Mexican traffickers. In recent years, US cocaine consumption has decreased and the legalization of marijuana in several US states has opened that market to increased competition, and the cartels may see heroin as a profitable replacement for these shrinking markets.
These new conditions appear to have led to Mexican traffickers developing a strategy based on three pillars; ramping up production, expanding into new markets, and innovating production techniques to better compete with the superior product of their Colombian rivals.
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https://youtu.be/dm6xexu_wJY?t=3m32s
TAMPA — A former Drug Enforcement Administration agent was sentenced Tuesday to a year and a day in prison, having pleaded guilty to charges stemming from his demanding cash from an imprisoned drug trafficker’s brother.
Samuel Murad, 62, once a respected federal agent, apologized in court for his role in a scheme that centered on efforts to secure an early release for Joe Pegg, whom Murad helped send to prison in the 1990s.
“I have no excuse for my behavior,” Murad said. “I’ve hurt my family. I’ve hurt my friends—
“You’ve also hurt the DEA,” U.S. District Judge Susan Bucklew interjected. “You made law enforcement look bad.”
The scheme that ensnared Murad — and another former DEA agent who has already been sentenced — began in 2009 when Pegg’s lawyer hired Murad to assist in getting Pegg a reduced sentence, according to the U.S. Attorney’s Office.
More than a decade earlier, Murad had led an investigation into Pegg, the leader of a massive marijuana import operation.
Federal rules prohibited Murad from doing anything on Pegg’s behalf. He was advised as much in a written ethics opinion from a DEA attorney.
But the opinion noted that Murad was not restricted from providing “behind the scenes” advice to Pegg and his family.
Murad, who was retired, contacted DEA Agent Robert Quinn and asked him to handle, on the DEA side, the effort to reduce Pegg’s sentence.
Pegg, who is still in prison, is accused in a separate case of paying his former cellmate to act as a confidential source for the DEA so that he could receive a reduced sentence. The agency later made arrests based on the information the cellmate provided.
Murad wanted to get paid, too, for his efforts to spring Pegg from prison early, according to federal authorities. In June 2012, he sent Pegg’s brother, Buck Pegg, an email demanding $700,000.
“If we can’t come (to) some kind of understanding,” he wrote, “then you guys get to keep your money and (he) stays in jail because good luck getting him out without my testimony.”
Buck Pegg and Murad later met in the parking lot of a Cracker Barrel restaurant in Gainesville, prosecutors said. There, Buck Pegg gave Murad a shopping bag with $223,000. Murad also took the $800 Pegg had in his wallet.
When the FBI began investigating the matter, Murad told Quinn not to talk to them. Quinn later admitted he lied to FBI agents about his knowledge of the scheme. He was sentenced to probation earlier this year.
In court Tuesday morning, Jerome Froelich, a lawyer for Buck Pegg, argued that his client was a victim in the case and was therefore entitled to restitution. He asserted that what Murad had done was extortion.
But prosecutors pointed out that they never charged Murad with extortion. He pleaded guilty only to tax evasion and witness tampering. Therefore, they argued, Buck Pegg was not entitled to restitution.
Judge Bucklew agreed, but also said that the matter “smells bad” and “doesn’t feel right.”
Murad’s defense featured a cameo appearance by former U.S. Attorney Robert O’Neill, who recalled a 2009 lunch meeting with the retired agent where the topic of Joe Pegg came up.
At the time, O’Neill was an assistant U.S. attorney.
Murad told O’Neill he was going to do some work for Pegg — meaning, help in Pegg’s efforts to get a reduced sentence.
“I said, ‘Sam, you can’t do that,'” O’Neill recalled.
O’Neill said he advised Murad to read the applicable federal laws and seek permission from the DEA first. About a month later, Murad called O’Neill and told him the agency had given him permission.
“It was pretty shocking,” O’Neill said.
Kehoe asked for a sentence of probation and community control. But Bucklew said Murad, a former law enforcement officer, was held to a higher standard.
“You knew better,” she said.
Along with prison, Bucklew ordered Murad to pay a $10,000 fine and $65,341 in restitution to the Internal Revenue Service.
Contact Dan Sullivan at dsullivan@tampabay.com or (813) 226-3386. Follow @TimesDan.
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On Dec. 7, the New York Times ran an inspiring, dangerous story about Celine Ryan, a 50-year-old whose advanced colon cancer was successfully treated with experimental immunotherapy. Inspiring, because researchers repeatedly rejected Ryan’s requests to participate in a clinical trial, but her heroic refusal to accept their verdict led to her eventual admission—and remission. Dangerous, because although the article emphasizes that success in one patient proves very little, Ryan’s story served as powerful anecdotal reinforcement of a widespread and mistaken view that groundbreaking cures are stuck in trial stages, and that patients need to take it upon themselves to fight bureaucratic gatekeepers for access. This type of narrative undermines the necessity of the Food and Drug Administration, whose scientific standards are crucial to keeping medical costs down, preventing health crises, and ensuring objective evaluations of new drugs.
The consequences of buying into this mistaken picture are illustrated perfectly by the recently approved 21st Century Cures Act, an enormous piece of health care legislation that includes everything from increased funding for the National Institutes of Health to programs that will fight opioid addiction. Packaged with these uncontroversial goodies, however, is a provision that asks the FDA to relax evidentiary standards for drug approval by granting weight to “real-world evidence” and “patient-experience data.” Supporters argue that the provision will allow patients quicker access to cures. If passed, it could also incentivize competitive development of new drugs by lowering their cost to market—the current gold-standard for evidence of efficacy is randomized placebo-controlled trials, which are time-consuming and expensive. Health policy experts, on the other hand, are rightfully nervous about the unintended results of laxer standards: A market flooded with potentially unsafe drugs that are no more effective than placebo.
From the perspective of a cancer sufferer who has just read Ryan’s story—gutsy individual triumphs over hidebound bureaucracy—it’s hard to take calls for caution seriously. How many others have suffered and died, the logic goes, because they didn’t stand up to the system? Patient advocacy groups—often funded by industry—routinely take this position, criticizing the FDA for excessive conservatism that forecloses on Americans’ right to decide what constitutes a promising treatment and whether or not to take it. (As one Wall Street Journal op-ed put it in 2002: “FDA to Patients: Drop Dead.”) The push for less stringent FDA standards makes willing but unlikely bedfellows of pharmaceutical companies and everyday people, united against the perceived inefficiency of callous government elites who prefer exercising power to saving lives.
But this picture of the FDA couldn’t be further from the truth. In reality, regulations are in place to protect everyday people against the interests of pharmaceutical companies and our own impatience for new medicine. Left unregulated, the market for medicine can generate catastrophic results. Just ask Louise Medus, one of thousands of severely deformed “thalidomide babies” born in the late 1950s and early ’60s. (Medus, who is British, was born with limb deformities.) Thalidomide, developed to treat morning sickness, was made available in 49 countries for two years—despite early evidence that the drug might cause rare birth defects including phocomelia, the underdevelopment or absence of limbs. “I can’t imagine what my dad thought or felt when a grim-faced doctor led him to a delivery room an hour after my birth,” Medus told the Guardian. “All I know is that he almost fainted with shock when I was fully revealed and blurted out: ‘Surely you’re not going to allow a child in this state to live.’ ”
Unlike many other countries, the United States managed to avoid the thalidomide crisis, thanks to a heroic FDA regulator named Frances Oldham Kelsey. Despite intense pressure from the drug’s manufacturer, Oldham demanded further testing, pointing to inconclusive results about thalidomide’s efficacy in humans and initial evidence that the drug caused nervous system side effects. Six applications for approval were denied, and the subsequent birth of countless deformed babies like Medus vindicated the wisdom of Kelsey’s tenacity. For her efforts, she received the President’s Award for Distinguished Federal Civilian Service from John F. Kennedy in 1962. That same year Congress unanimously passed the landmark Kefauver Harris Amendment, which raised the evidentiary bar for new drug approval.
“It’s well-known scandals and crises like thalidomide that led to the FDA having the power it has today,” says Rachel Sachs, a law professor at Washington University who specializes in health law, innovation, and patient access. “Perhaps the existence of the FDA is a slight barrier to innovation. But in my view, it’s far more important to prevent unsafe, ineffective drugs from coming to market.”
Even if eroded standards don’t lead to a devastating public health crisis, it’s almost certain that they’ll lead to a massive increase in costly drugs that don’t actually work. As Sachs pointed out to me, ineffective drugs are already a problem. Under enormous pressure from patient advocacy groups and biotech companies, the FDA recently approved Exondys 51, a drug for a rare disease called Duchene’s muscular dystrophy, despite only limited evidence of efficacy and the sky-high cost of $300,000 per year. The manufacturer of Addyi, aka “pink Viagra,” secured approval for a drug that many experts believe to be not only ineffective but also dangerous. And a recent report suggests that more than a dozen cancer drugs with prices of more than $100,000 per year remain on the market without good evidence they work, approved on the basis of shoddy evidence. If anything, we should be strengthening the FDA’s regulatory oversight. Instead, we are weakening it at our own peril.
The reduced evidence standard proposed by the 21st Century Cares Act is a bad solution aimed at the wrong problem. Evidence is not collected or paid for by the FDA. (It’s paid for by the drug companies.) Reducing the standards simply means that the FDA will not have the necessary evidence it needs to ensure efficacy. “FDA approval is not what shows that a drug works; clinical data do that,” Derek Rowe, an expert on pharmaceutical development, wrote in response to the 21st Century Cures Act. “You can instruct everyone to collect less data, but then you will approve—and ask people and their insurance companies to pay for—more things that don’t actually work.”
So are we destined for rocketing insurance costs and another thalidomide? It’s still hard to gauge the potential consequences of the provision. According to Patti Zettler, a professor at Georgia State who served as associate chief counsel for the FDA, the provision’s vague wording gives the FDA a significant amount of interpretive authority. “There’s room for them to minimize the impact of the law and construe it narrowly,” she told me. Staff members of the FDA seem inclined to that approach, and recently offered a conservative interpretation of the new evidentiary standards in the New England Journal of Medicine.
Unfortunately, President-elect Trump seems to be on the bad side of the law.* His selection for head of the FDA might embrace the act, and open it to a free-for-all. Silicon Valley venture capitalist Jim O’Neill, rumored to be one of Trump’s picks for FDA commissioner, made an extreme case against FDA regulation of drug efficacy in a 2014 speech. “Let’s prove efficacy after they’ve been legalized,” he suggested, an absurd statement that reflects O’Neill’s frightening lack of scientific or medical qualifications. (For one thing, safety and efficacy are not separable factors in drug approval; side effects that are acceptable in effective cancer medication, say, would be unacceptable in headache medicine.) Trump is also rumored to be considering venture capitalist Scott Gottlieb, who, as a former deputy commissioner at the FDA, would be a more traditional choice.
Even without an FDA head who is abjectly anti-evidence, the bill’s passage paired with increased leniency toward pharmaceutical companies could be devastating. Imagine if a drug were developed with a focus on addressing a condition with a specific end point, for example, the ability to concentrate. Without randomized controlled trials, the data on these drugs is virtually guaranteed to be infected by bias, especially if it comes from the company that developed them. Autism would be an ideal condition, since autism research is plagued by difficulties distinguishing real treatment effects from placebo—exactly the kind of problem that high-quality trials are designed to address.
Next, pharma companies could sponsor patient advocacy groups’ campaigns for approval, using testimony from mothers whose children participated in experimental, low-quality trials with miraculous results. Trump tweets something about how the FDA needs to get its act in gear so autistic children don’t suffer. So, they do, and a potentially unsafe, ineffective, and highly profitable medication is approved. Rinse and repeat.
This will be the model for medication approval driven by outrage and desperation, rather than evidence and reason. It is tragic that some people end up waiting for effective treatment, and it is inspiring when patients like Ryan take matters into their own hands and end up beating the odds. I cannot imagine anything more painful than watching a loved one suffer or die, only to find out that speedier approval might have saved them. But allowing such stories to inform our medical decisions is not kind; it is potentially dangerous. This is precisely the kind of mistake that randomized controlled trials are meant to guard against in medicine. Let’s not make the same mistake with public policy.
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