611 W. Union Street
Benson, AZ 85602
(520) 586-0800

Health Choice Integrated Care crisis Line
1-877-756-4090

AzCH Nurse Assist Line
1-866-495-6735

NAZCARE Warm Line
1-888-404-5530



SEABHS
611 W. Union Street
Benson, AZ 85602
(520) 586-0800

AzCH Nurse Assist Line
1-866-495-6735

NAZCARE Warm Line
1-888-404-5530


powered by centersite dot net

Getting Started
Here are some forms to get started. These can be printed and brought with you so that you can pre-fill out some known info ahead of time. More...


Health Policy & Advocacy
Resources
Basic InformationMore InformationLatest News
The Damage of Vaccine MisinformationCan Online Reviews Help Health Inspectors Keep Tabs on Restaurants?AHA News: Can Social Media Be Good for Your Health?Flame Retardants, Pesticides Remain Threat to U.S. Health: StudySimple Tweak to Hospital Computer Program Cuts Opioid PrescriptionsJust 2% of Patients Who Need It Get Anti-Opioid Drug NaloxoneAre Doctors Discarding 'Injured' Kidneys That Might Be Used for Transplant?Probiotics: Don't Buy the Online HypeNew Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?Would Tighter Swimming Rules at Public Beaches, Lakes and Rivers Save Lives?Seniors Still Wary of Online Reviews When Picking DoctorsMany Drugstores Misinform on Disposal of Unused MedsAHA News: Get Started on the Path to Better Health in the New YearAHA News: Bystander CPR Less Common in Hispanic NeighborhoodsPrepared Bystanders Save Lives When Cardiac Arrest StrikesVaccinations Rose After California Curbed ExemptionsSpecial 'Invisible' Dye Could Serve as Skin's Vaccination RecordGrowing Obesity Rates May Contribute to Climate ChangeHealth Tip: Do's and Don'ts While Waiting for an AmbulanceFDA to Allow States to Import Prescription Drugs From Other CountriesWhere Pot Is Legal, People Are Likely to Believe Its BenefitsFewer Americans Have a Primary Care Doctor NowHospital-Level Care in Your Home? It Could Be the FutureSleepy Nurses Could Put Patients at RiskTighter Alcohol Laws Might Help Curb CancerMany Young Adults Misusing Medical Marijuana, Study SuggestsAnother Possible Effect of Climate Change: More Preemie Babies1 in 18 U.S. Teens Carries a Gun to School: StudyU.S. Poison Centers Field More Calls About Psychoactive Substances: StudyDoctors' Group Calls for Ban on Most Vaping ProductsAs Disease Outbreaks Tied to 'Anti-Vaxxers' Rise, States Take ActionAHA News: Millions Who Never Smoked Cigarettes Are Using Other Tobacco ProductsMost Docs Don't Know Hair Care Is a Barrier to Exercise for Black WomenHealth Tip: Do's and Don'ts for Calling 911Climate Change Will Hurt Kids Most, Report WarnsYou Won't Get Sued If You Do CPR, Review SuggestsRacial Bias Seen in Heart TransplantsTrump Administration Wants to Raise Age to Buy E-Cigs to 21Juul Stops Sales of Mint-Flavored E-CigarettesDo You Take Biotin Supplements? They Could Affect Your Medical TestsClimate Change a 'Threat to Human Well-Being,' Scientists SayAnti-Vaxxers Find Ways Around States' 'Personal Exemption' BansMedia Reports on Celeb Suicides Could Trigger CopycatsStill Way Too Much Smoking in Movies Aimed at KidsConsumers' Orders Changed Slightly After Calorie Counts Added to MenusReport Finds Americans' Health Is FlaggingAfter Mass Shootings, Docs Even Less Likely to Mention Gun SafetyBan on Sale of Sugary Drinks Trimmed Employees' WaistlinesAre You Accessing All Your Medical Records Online?New Database Shows 'Rare' Diseases Are Not So Rare Worldwide
Questions and AnswersLinksBook Reviews
Related Topics

Health Insurance
Healthcare

New Drugs Getting FDA's Blessing Faster, but Is That a Good Thing?

HealthDay News
by By Dennis Thompson
HealthDay Reporter
Updated: Jan 14th 2020

new article illustration

TUESDAY, Jan. 14, 2020 (HealthDay News) -- New drugs are being approved by the U.S. Food and Drug Administration for patients based on less and less solid evidence, thanks to incentive programs that have been created to promote drug development, a new study shows.

Researchers report that more than 8 out of 10 new drugs in 2018 benefitted from at least one special program that streamlines the approval process.

The result is that patients are being prescribed pricey new medications that have not been tested as rigorously, said lead researcher Jonathan Darrow, an assistant professor at Harvard Medical School.

"The evidence standards have changed, but it's not clear that physicians, let alone patients, understand either the basic FDA approval standard or that requirements have become increasingly flexible over the past 40 years," Darrow said.

The share of new drugs supported by two strong clinical trials, rather than just one, decreased from 81% to 53% between the 1990s and the 2010s, researchers found.

The time that the FDA spent reviewing each new drug dropped during the same period, from 2.8 years in the late 1980s to about 7.6 months in 2018, Darrow added.

This might be good news if highly effective new drugs were reaching the market quicker, but other research has found that the large majority of newly approved drugs offer modest benefits over existing therapies, he said.

"In many cases, you can get almost all of the benefit of the new drugs by taking older drugs," such as generics, Darrow said.

The programs also haven't really improved the number of new drugs approved each year, either.

"Even with that flexibility, there has been no strong upward trend in the number of drug approvals, which on average has remained about 30 new drugs approved per year since the 1980s," Darrow said.

The average annual number of new drug approvals was 34 from 1990-1999, decreasing to 25 from 2000-2009 and then increasing to 41 from 2010-2018, researchers found.

In a statement, the FDA said that the new study "covers a very wide range of issues," and "we are concerned that the researchers do not adequately consider the marked changes in the types of drugs and the patient populations targeted by development programs that FDA now reviews, compared to those from just 10 or 20 years ago, nor the type, quality, and extent of data FDA routinely receives now compared to decades ago."

The agency added that it believes that a failure to take those "marked changes" into account "can result in inaccurate conclusions."

HealthDay also reached out to PhRMA, a trade group representing the pharmaceutical industry, but did not receive comment.

Since the 1980s, various programs have been enacted by U.S. Congress or developed by the FDA to promote the creation of drugs for rare diseases or accelerate approval of promising medications that could benefit multitudes, researchers said in background notes.

"In 2018, more than 80% of new drugs benefitted from at least one special program," Darrow said.

These programs have weakened the review process by requiring the FDA to accept more flexible evidence, he said.

For example, evidence of a drug's effect on cholesterol levels or tumor size can be used to get it approved, rather than evidence that the drug helped people live longer or feel better or avoid emergencies such a heart attacks, Darrow said.

But there's been no benefit from these programs in terms of how long it takes a company to create a new drug, he said.

"We found there was a relatively stable period between when clinical trials began and when drugs were approved. We did not see a steep decline in the clinical development period," Darrow said.

Disturbingly, the FDA has also become more financially reliant on money from pharmaceutical companies, researchers found.

The amount of the FDA budget that comes from the pharmaceutical industry has increased from about $300 million in the 1990s to just over $4 billion in the 2010s, researchers found. These fees are used to accelerate review times, researchers said.

The FDA has tried to offset the accelerated approval process by requiring companies to track drug effectiveness and safety after it's reached the market, Darrow noted.

"But in the meantime, the agency is allowing doctors and patients to use the drug while the additional information is being collected," Darrow said. "Once drugs are available, they are available to all patients due to off-label prescribing, and those patients may not realize those drugs were approved on the basis of limited evidence or that more evidence is still being collected."

The findings were published Jan. 14 in the Journal of the American Medical Association.

These accelerated review programs have driven up health care costs needlessly, said Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health in Baltimore.

The new study provides "an opportunity to pause for a minute and say, 'Can we get the benefit that's intended at perhaps a lower cost, and focus the incentive on products that are going to make the most difference?'" said Sharfstein, who wasn't part of the research.

For example, the Orphan Drug Act was intended to promote the development of drugs for very rare diseases, but "a lot of these incentives have benefitted companies that are selling drugs for many, many patients," Sharfstein said.

"I think that it's very important for FDA to study which incentives, under what circumstances, really lead to medications that make a huge difference for patients, and propose more efficient ways to apply those incentives," Sharfstein noted.

More information

The U.S. Food and Drug Administration has more about the drug development and review process.