Pharmaguy's Insights Into Drug Industry News
181.4K views | +6 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Rescooped by Pharma Guy from Pharma & Medical Devices
Scoop.it!

Judging the Benefits and Harms of Drugs: More Transparency Needed

Only trustworthy evidence will earn the public’s trust

How should society judge the safety and efficacy of drugs? This was the question posed by England’s chief medical officer, Sally Davies, in February 2015. Citing controversies about oseltamivir (Tamiflu) and statins, as well as growing disquiet about overmedication by doctors and conflicts of interest among researchers, she feared an erosion of public trust and asked the Academy of Medical Sciences to undertake a review. In June that same year, editorialists in The BMJ called on the academy to recommend “simple practical improvements that would address legitimate concerns.” The academy has now published its report. Does it deliver?

From the outset of the review, the academy confirmed that there is a problem. Its survey found that only one in three members of the public trusts the results of research. It also found that more than four fifths of general practitioners and two thirds of British adults disbelieved the results of trials funded by the drug industry.

In response to this finding, which the chair of the report, John Tooke, called “startling,” the academy has produced a wide ranging report that says many of the right things. But the overall result is disappointing. In their 2015 editorial, Heneghan and Goldacre warned against focusing on gaining the public’s trust through false assurances. They proposed instead improving the evidence base through changes in the funding, conduct, and dissemination of research. The academy report includes welcome calls for researchers to involve patients and be more transparent.


Via Richard Meyer
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Nonprofit Working To Block Drug Imports Has Ties To Pharma Lobby

Nonprofit Working To Block Drug Imports Has Ties To Pharma Lobby | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerful lobbying group that includes Eli Lilly, Pfizer and Bayer.

 

The nonprofit, called the Partnership for Safe Medicines, has recently emerged as a leading voice against Senate bills that would allow drugs to be imported from Canada.

 

Both the lobbying group and the nonprofit partnership have gone to great lengths to show that drugmakers are not driving what they describe as a grass-roots effort to fight imports, including an expensive advertising blitz and an event last week that featured high-profile former FBI officials and a former Food and Drug Administration commissioner.

 

However, a Kaiser Health News analysis of groups involved in the partnership shows more than one-third have received PhRMA funding or are local chapters of groups that have received PhRMA funding, according to PhRMA tax disclosures from 2013 to 2015.

 

Forty-seven of the organizations listed in the ads appear to be advocacy organizations that received no money from PhRMA in those years.

 

A PhRMA senior vice president, Scott LaGanga, previously led the Partnership for Safe Medicines for 10 years. At PhRMA, LaGanga was responsible for the lobbying group's alliances with patient advocacy groups, and he was simultaneously listed as the executive director of the Partnership for Safe Medicines on each of that group's annual tax filings since 2007, the earliest year for which they are available from ProPublica's Nonprofit Explorer.

 

LaGanga wrote a 2011 article about the partnership's origins. Published in the Journal of Commercial Biotechnology, it described "public-private partnerships in addressing counterfeit medicines." His PhRMA job was not disclosed in the article.

 

From 2010 to 2014, the organization hosted a conference called the Partnership for Safe Medicines Interchange. In a video from a 2013 event, LaGanga thanks pharmaceutical companies, most of them PhRMA members, for sponsoring the event.

 

In February, LaGanga moved to a senior role at PhRMA and stepped down as executive director of the Partnership for Safe Medicines, just as the group's campaign to stop import legislation was revving up.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers

Direct-to-Consumer Advertising (DTCA) Is Effective In Increasing Inappropriate Prescribing, Say Researchers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If you needed more evidence as to why drugmakers continue to plunge billions of dollars into direct-to-consumer advertising, look no further than a recent study published in JAMA. In it, researchers found that broadcast DTC ads for drugs treating low testosterone were linked with “substantial overall increases” in patients being tested and treated for the same condition.

 

Researchers at the University of North Carolina at Chapel Hill investigated this potential link in 75 areas across the U.S. They found that out of 17 million commercially insured men, one million were tested and just over 283,000 began treatment between 2009 and 2013.

 

“Although the average increase in testosterone rates associated with a single ad exposure was less than 1%, advertisements were widespread and and frequent during the study period, direct-to-consumer advertising was associated with substantial overall increases in testosterone testing and initiation,” the study's' authors wrote.

 

[Note: The authors also wrote:

 

“While other studies have demonstrated associations between DTCA and increasing medication use, this study demonstrates increases in potentially inappropriate use and increasing initiation during a time when most testosterone use was of questionable value for age-related testosterone decreases without strong evidence of benefit. Characterizing the role of DTCA in promoting testosterone initiation among a large segment of middle-aged and older men for nonspecific symptoms and age-related declines in testosterone levels is relevant to ongoing policy debates regarding DTCA. This study complements many others that suggest the contribution that DTCA may make in the early adoption of recently approved treatments whose risk-benefit profile may be quite unclear.”

 

Consider the implications if drug marketers were allowed to promote off-label uses to consumers. In those cases the risk-benefit profile is certainly unclear or unverified by the FDA.]

 

Further Reading:

 

Podcast:

The Marketing of Low T.” Adriane Fugh-Berman, MD, Associate Professor at Georgetown University Medical Center and Director of PharmedOut discusses how the marketing of Androgel uses ghostwriting, celebrities, symptom quizzes, and numbers to convince men and physicians that "low testosterone" is a medical condition that should be treated.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Many Americans Mistakenly Believe #Pharma Rx Drugs Are Safe

Many Americans Mistakenly Believe #Pharma Rx Drugs Are Safe | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Many Americans appear to be misusing their prescription drugs in ways that put their health at risk, notably combining dangerous combinations of medicines, according to a report released this week.

 

The rate at which drugs were misused was 54 percent last year, according to the new analysis of more than 3.1 million de-identified laboratory test results. This was down from 63 percent in 2011, although the findings were quite similar to what was found in 2013 and 2014, according to Quest Diagnostics, the laboratory testing company, which conducted the analysis.

 

The analysis combed through test results for inconsistencies, such as a patients taking medicines with other drugs for which they don’t have prescriptions, or if they were skipping doses.

 

Of the tests indicating misuse, about 45 percent showed evidence that patients mixed medicines, which the lab company interpreted as a sign that a “sizable” number of patients might be using dangerous drug combinations.

 

Notably, this finding was much higher than in previous years — there was evidence that drugs were inappropriately mixed in 32 percent of the 2011 lab tests and 35 percent of the 2014 tests. Quest said the most recent results are significant because combinations of certain drugs — notably, opioids, and sedatives — can cause dangerous interactions, such as severe respiratory depression, coma, and death.

 

“The discovery that a growing percentage of people are combining drugs without their physician’s knowledge is deeply troubling, given the dangers,” said F. Leland McClure III, Quest’s medical affairs director, in a statement. “Perhaps patients do not understand that mixing even small doses of certain drugs is hazardous, or they mistakenly believe prescription medications are somehow safe.”

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability

How Gilead Manipulates HIV Drug Patents at the Expense of Patient Safety & Affordability | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Gilead Sciences won a victory last week when a federal court judge tossed a lawsuit in which an AIDS activist group accused the drug maker of manipulating the patent system in order to thwart competition for its HIV medicines.

 

At issue was tenofovir, or TDF, which until recently had been a cornerstone of the widely used combination HIV treatments sold by the company. The patent on the TDF compound expires in December 2017, and Gilead is replacing it with a modified version known as TAF. But the patent on TAF doesn’t expire until May 2022, providing another five valuable years without generic competition.

 

TAF is also more potent and causes fewer side effects, notably bone damage and kidney toxicity. AHF argued Gilead knew of the safety benefits dating back to 2001, but the company delayed testing TAF in humans until 2011. In doing so, AHF charged Gilead purposely waited to seek regulatory approval for drugs containing TAF until shortly before its older TDF-based products lost patent protection.

 

This maneuvering meant that Gilead would be able to forestall patent challenges on its TAF-based drugs for a few years, but meanwhile, HIV patients faced side effects unnecessarily. Moreover, AHF maintained that since TAF is simply a modified form of TDF, the drug maker does not deserve patent protection and sought to have the TAF patents invalidated.

 

But in a ruling last Wednesday, Judge William Alsup of the US District Court in San Francisco shot down the arguments made by the nonprofit, which buys medicines for the 46 health centers it operates in the United States. “Gilead’s patents gave it a monopoly over both TDF and TAF. It had no obligation to introduce the improved product at an earlier date,” he wrote.

           

The decision, by the way, came less than a week after Gilead raised prices on two older HIV medications — Complera and Stribild — that contain TDF and face patent expiration. In fact, it was the second time in six months the company boosted list prices — which do not reflect rebates offered payers — a break from its usual strategy of increasing prices annually.

 

At the same time, Gilead left intact prices for two much newer versions of these drugs — Odefsey and Genvoya — which contain TAF. And these newer medicines are now priced higher than the older treatments. AIDS activists criticized the company for raising payer and patient costs.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping"

Researchers Call for FDA Transparency To Avoid Black Box Warning "Flip-Flopping" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels.

 

For example, the researchers point to two recent cases where drugmakers petitioned FDA to lift a black box warning from one of their products.

 

In one case, Pfizer unsuccessfully petitioned FDA to lift a boxed warning for severe psychiatric events, including suicidality, from its smoking cessation drug Chantix. Five years after FDA recommended a boxed warning on the label for Chantix, Pfizer asked the agency to remove the warning based on data from five short-term observational studies.

 

However, after convening a joint meeting of its Psychopharmacology Drugs and Risk Management Advisory Committees, FDA opted to maintain the black box warning for the drug.

 

In another case, GlaxoSmithKline (GSK) managed to persuade FDA to remove the black box warning for its blockbuster diabetes drug, Avandia, using an independent analysis of data from a large randomized open-label controlled trial.

 

In both cases, the researchers say FDA's decision to impose a black box warning was based on less evidence than was necessary to support the removal of a warning. This is necessary, they argue, as FDA must act quickly to protect patients when safety issues emerge.

 

However, when it comes to removing a warning, the researchers argue that FDA should require more substantial evidence than it used to impose the warning in the first place.

 

"To avoid frequent flip-flopping, we believe it is ethically justified for the FDA to require a greater burden of proof, or a greater level of certainty provided by the evidence at hand, to justify removal of a boxed warning than it did to impose one," they write.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

A System That Identifies Needed Drug Safety Label Changes Before the FDA Does!

A System That Identifies Needed Drug Safety Label Changes Before the FDA Does! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A study from Advera Health Analytics, Inc., A Pharmacovigilance Signaling System based on FDA Regulatory Action and Post-Marketing Adverse Event Reports, was published this week in Drug Safety. The study details a method to accurately predict future labeling changes the Food and Drug Administration (FDA) will make to prescription drugs. 

Prescription drug labels contain safety warnings and information about potential adverse drug events that patients may encounter.  The data contained in the labels are initially based on evidence gathered in clinical trials that are performed before the drug is approved for sale.  Once the drug is approved and made available for sale, FDA monitors reports of new serious adverse events in the real world submitted to its FDA Adverse Event Reporting System (FAERS).  If previously unreported serious adverse events occur frequently, FDA may change the drug’s label to add more warnings to reflect these new adverse events.  In the most serious cases, FDA may even remove the drug from the market.

Predicting FDA’s future labeling changes is a key element to improving patient safety and reducing the billions of dollars in avoidable costs caused by adverse drug events.  Many healthcare practitioners rely on FDA labeling changes to supplement their prescribing decisions. FDA, however, can often take years to make labeling changes after new adverse events emerge.  Accelerating that timeline and being able to provide healthcare decision makers with advance notice of future potential labeling changes based on emerging trends in adverse events reporting is a crucial tool to fight unnecessary safety risk.

Today’s published study highlights Advera Health Analytics’ predictive algorithm called RxSignal.  RxSignal is the only tool on the market that alerts users to emerging and/or previously unidentified side effect threats that may prompt a future FDA regulatory action.  RxSignal takes the millions of potential adverse event concerns in Advera Health’s curated FAERS data and isolates those that FDA is most likely to take action on based on a number of factors.  As a result, RxSignal is shown in today’s study to accurately predict 73% of future FDA labeling changes.
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

J&J and Drug Safety: States Preempt FDA on Protecting Consumers

J&J and Drug Safety: States Preempt FDA on Protecting Consumers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Johnson & Johnson now faces having to pay $140 million after the Supreme Court declined to hear the firm's appeal of verdict involving Children's Motrin. 


At issue was whether Johnson & Johnson should have upgraded its product labeling to reflect the risk that a patient may develop toxic epidermal necrolysis, which can lead to a rare disease called Stevens-Johnson syndrome.


However, Johnson & Johnson sought to convince the Supreme Court that federal law preempted the state court verdict.


In response to a citizen’s petition seeking upgraded labeling, the Food and Drug Administration had agreed that an increased warning about skin reactions — such as rashes and blisters — was warranted. But the agency did not agree to add the names of the skin diseases, which are unfamiliar to most consumers.


Consequently, the company maintained it would have violated federal law if the Motrin labeling was updated with the sort of specific language the family believed should have been used.


the Supreme Court acknowledged that a state court lawsuit could be preempted if there was “clear evidence” showing the FDA would not have approved a change in labeling. Such a situation would otherwise create a conflict between the state and federal labeling requirements. But ever since, the pharmaceutical industry has argued that “clear evidence” was never properly defined.


In this case, Johnson & Johnson argued the hurdle for clear evidence had been met, even though a Massachusetts appeals court disagreed. The company maintained that the less specific labeling for Children’s Motrin, which is intended for consumers, reflected FDA thinking and, therefore, was true to both the letter and intent of the law, according to its filing with the Supreme Court.


Pharma Guy's insight:

Meanwhile, the GAO has said that FDA's drug safety tracking problems "restricted the agency's ability to perform systematic oversight of postmarket drug safety"; http://sco.lt/898BUn 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Only Old Drugs That Don't Need Safety Tests Get Studied & Win Monopoly Status from FDA

Only Old Drugs That Don't Need Safety Tests Get Studied & Win Monopoly Status from FDA | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Colchicine, a gout remedy so old that the ancient Greeks knew about its effects, used to cost about 25 cents per pill in the U.S. Then in 2010 its price suddenly jumped 2,000 percent.


That’s just one of the side effects of a U.S. Food and Drug Administration plan to encourage testing of medicines that have been around longer than the modern FDA itself, and so have never gotten formal approval.  Companies that do the tests are rewarded with licenses that can temporarily give them monopoly pricing power as most rivals are eased or kicked off the market. The result has been a surge in the cost of drugs used in treatments from anesthesia to heart surgery and eye operations.


It can bring big paydays for the producers. URL Pharma, the small Philadelphia drugmaker granted rights over colchicine, was bought for $800 million by Takeda Pharmaceutical Co. in 2012. Asia’s biggest drugmaker has since brought in $1.2 billion in revenue from the branded drug, Colcrys, which went on the market at a wholesale price of almost $6 a pill. Takeda says testing for FDA approval made the drug safer.


But patients and hospitals are feeling the pinch, and politicians have begun to notice. Hillary Clinton’s recent promise to address the issue sent pharmaceutical stocks plunging. Critics say the FDA plan lets entrepreneurs make windfall profits on drugs where there was never much concern about safety or efficacy.


In many cases, the program “almost had the opposite effect as intended,” said Joseph Biskupiak, a professor at the University of Utah College of Pharmacy. “The only drugs that got studied are the ones that don’t have a problem.”


The FDA’s rationale is that some drugs have never been measured against modern safety standards. The program “has been a success” that has removed dangerous drugs from the market, said Michael Levy, deputy director in the compliance office of the FDA’s drug evaluation unit.


The agency acknowledges that approving branded versions of old generic drugs may make them more expensive when a sole manufacturer remains to make a medication, but says that’s outside its remit. “FDA does not regulate according to economic factors, nor do we have control over drug pricing,” spokesman Christopher Kelly said.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Addyi + Alcohol = 1 Death So Far. FDA Not Concerned.

Addyi + Alcohol = 1 Death So Far. FDA Not Concerned. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

During clinical studies of the female libido drug flibanserin, a 54-year-old woman taking the drug died of "acute alcohol intoxication" and a senior regulator at the FDA concluded that "it is not possible to exclude a role of flibanserin in this patient's death." It was possible, though, for the agency to approve the drug, which will soon be marketed by Valeant as Addyi, after acquiring the drug in a $1 billion buyout.


That interaction between the drug and alcohol was a major concern at the FDA, as regulators balanced the risks posed by a drug that they knew had only a modest impact on improving the number of sexually satisfying events in the average month of women who suffered from a chronic absence of such experiences. Looking at the broad data available for the review, the overall improvement in satisfaction scores hovered around 10% compared to placebo, noted Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products at the FDA, in a memo dated August 18.


As Bloomberg first reported today, the memo covers an internal discussion at the FDA over the controversial drug, including a hesitation on one reviewer's part to approve a female sexual dysfunction drug with a known interaction risk with alcohol, when most of the subjects recruited for the safety trial were men.


Joffe, though, concluded that a slate of postmarketing studies along with a program requiring prescribing doctors and pharmacists to consistently warn women to avoid alcohol while taking the daily drug was sufficient to warrant an approval for the first such drug to hit the market.


There's also little doubt, though, that a large number of women in the target population for this drug will continue to drink.


"According to the Centers for Disease Control and Prevention (CDC), among non-pregnant women 18-44 years of age in the United States (2006-2010), approximately 50% reported drinking alcohol within 30 days of taking the self-reported survey and approximately 15% reported binge drinking (four or more drinks on one occasion) at least one time during that same timeframe," writes Joffe.


more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Can We Rely on FDA for Post-Marketing Safety Surveillance?

Can We Rely on FDA for Post-Marketing Safety Surveillance? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to an analysis by BioMedTracker that was commissioned by Forbes Magazine, 89% of drugs that were submitted for approval to FDA were given the green light this year. That means FDA has only rejected three uses for new chemical entities. This on the back of an 88% approval rate in 2014.


This is an astonishing approval rate, especially when considering that in 2008 only half of the drugs submitted to FDA were approved. Of course, there are a lot of explanations for why this is occurring. Matthew Herper, staff writer for Forbes that covered the analysis, provides nine such explanations in a follow up article to his original post about the analysis. From his explanations the reason we found the most striking, was his last: In the current political environment, the agency is approving drugs it shouldn’t.


If this is an accurate portrayal of what is occurring, then we are entering into a new era, where post-approval drug safety surveillance will be more important than ever. Warning sirens should be going off throughout every managed care organization, integrated delivery network and payer globally (Hereafter referred to as managed care organizations or MCO) who bear the brunt of the financial risk. They are being forced into a position in which they will not only need to conduct initial comparative effectiveness research to determine formulary placement and utilization, but also need to invest in, and establish significant in-house post-marketing safety surveillance to avoid, and preempt costly adverse events.


This kind of rampant approval rate, in combination with the lack of FDA resources and funding, means there is no possible way the agency itself can be relied on by MCOs for comprehensive post-marketing safety surveillance and reviews. By the time FDA identifies an issue, and the manufacturer and FDA negotiate the label change or other safety action, millions of dollars in adverse event related downstream medical costs have already been accrued by the MCO, not to mention the significant patient harm that could be avoided.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions!

FDA Warns of Increased Chance of Heart Attack or Stroke Caused by NSAIDs - No Exceptions! | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.


Prescription NSAID labels will be revised to reflect the following information:


  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.


Pharma Guy's insight:


In a 2007 COX-2 Health Advisory, FDA said: "FDA has concluded that the benefits of Celebrex outweigh the potential risks in properly selected and informed patients." I don't see FDA mentioning that in this safety alert.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Not Seeing a Link Between Zyprexa Relprevv & Deaths of 2 Schizophrenia Patients

FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary), FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.


BACKGROUND: Treatment with Zyprexa Relprevv may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for Zyprexa Relprevv carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013.


RECOMMENDATION: Patients should read the Medication Guide that comes with the Zyprexa Relprevv prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving Zyprexa Relprevv or their caregivers should immediately report symptoms of PDSS to a health care professional.

Pharma Guy's insight:


Interesting and suspicious that "much of the drug level increase could have occurred after death." How does that happen?

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Safety Events Common for Pharmaceuticals and Biologics after FDA Approval

Safety Events Common for Pharmaceuticals and Biologics after FDA Approval | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Among more than 200 new pharmaceuticals and biologics approved by the U.S. Food and Drug Administration from 2001 through 2010, nearly a third were affected by a postmarket safety event such as issuance of a boxed warning or safety communication, according to a study published by JAMA.

 

The majority of pivotal trials that form the basis for FDA approval for therapeutics (pharmaceuticals and biologics) enroll fewer than 1,000 patients with follow-up of six months or less, which may make it challenging to identify uncommon or long-term serious safety risks. These risks may only become evident when new therapeutics are used in much larger patient populations and for longer durations in the postmarket period. Postmarket safety events can change how these therapeutics are used in clinical practice and inform patient and clinician decision making.

 

Joseph S. Ross, M.D., M.H.S., of the Yale University School of Medicine, New Haven, Conn., and colleagues examined safety events (a composite of withdrawals due to safety concerns, FDA issuance of incremental boxed warnings added in the postmarket period, and FDA issuance of safety communications) for all novel therapeutics approved by the FDA between January 2001 and December 2010 (followed-up through February 2017).

 

During this time period, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new postmarket safety events (3 withdrawals, 61 boxed warnings, and 59 safety communications) during a median follow-up period of 11.7 years, affecting 32 percent of the novel therapeutics. The median time from approval to first postmarket safety event was 4.2 years, and the proportion of novel therapeutics affected by a postmarket safety event at 10 years was 31 percent. Postmarket safety events were significantly more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near-regulatory deadline approval. Events were significantly less frequent among those with regulatory review times less than 200 days.

 

The authors write that these findings should be interpreted cautiously but can be used to inform ongoing surveillance efforts.

 

“The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle,” the researchers write.

 

Further Reading:

 

  • “Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe a New Drug for 1st 7 Years After FDA Approval”; http://sco.lt/5ndDMX
more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Johnson & Johnson Innovation Launches QuickFire Challenge to Improve Safe Use of Drugs

Johnson & Johnson Innovation Launches QuickFire Challenge to Improve Safe Use of Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Challenge awards up to $200,000 to novel solutions that advance safety by informing patients and consumers, simulating surgical procedures or ensuring proper storage and use of prescription, over-the-counter and cosmetic products

 

NEW BRUNSWICK, N.J., March 29, 2017 - Johnson & Johnson Innovation LLC today announced the launch of the newest QuickFire Challenge: Advancing the Safe Use of Healthcare Products. The challenge seeks to identify entrepreneurs, academics, scientists, engineers or startup companies who are advancing potentially game-changing, early stage, innovative solutions to advance safety in healthcare products that help inform patients and consumers, simulate surgical procedures, and ensure proper storage and use of prescription, over-the-counter and cosmetic products.

 

"Dedicated to scientific excellence, bioethics and values-based decision-making, the Johnson & Johnson Office of the Chief Medical Officer has a history of collaborating externally to create innovative solutions for patients and consumers," said Joanne Waldstreicher, M.D., Chief Medical Officer, Johnson & Johnson.  "Through our collaboration with Johnson & Johnson Innovation on this challenge, we hope to identify scientifically sound, breakthrough ideas that will advance both the safe use and a greater understanding of the safety of healthcare products to positively impact outcomes."

 

This initiative represents the Johnson & Johnson Family of Companies' ongoing commitment to patient and consumer safety and independent safety assessments. It is open globally to applicants with solutions across the pharmaceuticals, medical devices and consumer products sectors. QuickFire Challenge winners will receive research grants totaling up to USD 200,000, entrance to a Johnson & Johnson Innovation – JLABS facility and / or mentoring from Johnson & Johnson Innovation.

 

Prescription medication errors cause at least one death every day and injure approximately 1.3 million people each year.1 Moreover, with increased dissemination and sharing of health information via social media and online, there is a greater need than ever before for bioethical, transparent and evidence-based information sources that help patients and consumers make more informed healthcare decisions. To help make this possible, the challenge aims to improve safety in healthcare through improving the provision of balanced and factual information – and development of solutions – to ensure safety across the spectrum of medical devices, pharmaceutical and consumer products.

 

QuickFire Challenge entries that reflect the overall mission of improving the safety of and safe use of healthcare products will be evaluated by a juried panel comprising senior scientific and medical research staff as well as medical safety experts within Johnson & Johnson who have expertise across pharmaceuticals, medical device and consumer sectors. Participants can enter innovative ideas, methods or technologies that will help improve safety and healthcare outcomes for patients and consumers.

 

The QuickFire Challenge innovation focus areas are:

 

  • Empowering patients and consumers to make more informed healthcare decisions by providing better information and education about the safety of healthcare products (pharmaceuticals, medical devices and consumer products).

This challenge focus area seeks ways to maximize consumer and patient education and understanding of healthcare products and their safety and efficacy, including medical devices, pharmaceuticals and consumer products. The objective is to empower patients, consumers and healthcare providers to make more informed decisions and obtain maximum benefit from product use through greater understanding of safety data and by ensuring more effective communication and enhancing education.

 

  • Improving training and development for surgeons by identifying new models that simulate the operating room environment.

This focus area seeks new and robust models and methods to evaluate medical devices used by surgeons in a simulated environment representative of operating room procedures, with the goal of helping the surgeon understand how to safely and effectively use a medical device and understand variability in device and performance/outcome. Entries should focus on soft tissue models that anatomically represent organ-specific anatomic features and biological properties, such as tissue injury, bleeding and clotting responses.

 

  • Empowering patients and consumers to more safely administer and handle healthcare products.

The third focus area seeks ways to address the challenge of prescription medication errors. Entries should identify patient- and consumer-focused devices, solutions or platforms that will prevent errors and solutions to promote safe storage and administration or extend the shelf life of prescription, over-the-counter or cosmetic products.

 

"Entrants can submit ideas in one of three focus areas that are critical for ensuring that we make the safest possible products on behalf of patients and consumers," said Melinda Richter, Head of Johnson & Johnson Innovation, JLABS. "In addition to funding, Advancing the Safe Use of Healthcare Products QuickFire Challenge winners will be awarded JLABS support that includes infrastructure, services, educational programs and networks in global hotspots."

 

Information about entering the challenge and entry guidelines can be found online at jlabs.tv/safetyquickfirechallenge. Participants must indicate whether they have a team in place that can bring their idea to life. Entries must be submitted by May 24, 2017. Winning entries will be evaluated and winners in each category selected in fall 2017.

 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

558 Pharma Funded Post-Marketing Drug Studies and Not a Single Adverse Event Reported – Sounds Too Good to be True

Studies drug companies fund after medicines go on sale may be too small to detect rare side effects, a recent German study suggests.

 

Even if these so-called post-marketing studies do uncover previously undetected adverse events, physicians conducting the trials are often required to keep results confidential, limiting the potential for regulators or patients to learn about safety issues, according to the study in The BMJ.

 

When drugs are approved based on tests in only a few thousand patients, very little is known about long-term safety or the potential for rare side effects to occur when tens of thousands of people take the medicines, said lead study author Dr. Angela Spelsberg, medical director of the Comprehensive Cancer Center in Aachen, Germany.

 

"The fact that many physicians are obliged by contracts to handle adverse drug reactions as confidential business information rather than reporting them is very disturbing," Spelsberg added by email. "In light of the indispensable role of general practitioners and clinicians in detecting, diagnosing and publicly reporting adverse drug reactions, this means a very big threat to public safety."

 

For the study, Spelsberg and colleagues made freedom of information requests to three regulatory authorities responsible for registering post-marketing studies in Germany and obtained data on 558 studies.

 

Not one adverse event report could be identified from any of the 558 post-marketing studies.

 

Still, the study offers fresh insight into several potential shortcomings of post-marketing drug studies, said Dr. Barbara Mintzes of the University of Sydney in Australia.

 

"When a drug first comes to market it has been tested on average in 2,000 to 3,000 people, too few people to uncover most rare serious harmful drug effects," Mintzes, who wasn't involved in the study, said by email. "Often, patients at greatest risk of harm like the frail elderly or people with several serious health conditions are excluded from the trials, so post-marketing safety studies are very important."

 

[What’s even worse is the fact it takes many years to complete these studies (see here) while the drug is on the market.]

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

AMA Chastises Lawyers for Alarming Drug Ads 

AMA Chastises Lawyers for Alarming Drug Ads  | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At its annual meeting last month, the American Medical Association adopted a policy to advocate for a requirement that attorney commercials that may cause patients to stop using necessary medications to include “appropriate” and “conspicuous” warnings.

The AMA, the largest association of physicians, contends late-night television is “rampant” with attorney ads that seek plaintiffs regarding complications from new medications.

“Potential complications are spoken about in an alarming way, and often it is the first time the public learns about those potential complications and side effects,” the association said in a statement following its meeting, held in Chicago this year.

“These ads describe only the lethal side effects and not the benefits of the medications that many patients have experienced — but this is not explained to the viewers.”

In an effort to better protect the public’s health, the AMA has adopted a policy to push for ads that include warnings that patients should not discontinue medications without seeking the advice of their physician.

“The onslaught of attorney ads has the potential to frighten patients and place fear between them and their doctor,” Russell W. H. Kridel, M.D., and AMA board member, said in a statement. “By emphasizing side effects while ignoring the benefits or the fact that the medication is FDA (Food and Drug Administration)-approved, these ads jeopardize patient care.

“For many patients, stopping a prescribed medication is far more dangerous, and we need to be looking out for them.”

Pharma Guy's insight:

Hmmm... "often it is the first time the public learns about those potential complications and side effects..." Seems to me that these ads should be praised rather than condemned! Why don't the doctors pro-actively warn their patients of potential side effects in the first place! The fact that they often don't do that is reason for the fear between patient and physician.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe a New Drug for 1st 7 Years After FDA Approval

Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe a New Drug for 1st 7 Years After FDA Approval | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At a 2013 Selling Sickness conference in Washington, DC. Sydney Wolfe, MD (Public Citizen), gave a rousing keynote presentation and declared war on the medical-pharma-industrial complex.

One of the main "weapons" Wolfe proposed to help win the war against what he sees as the dangers of FDA-approved drugs is his "Seven-year Rule for Safer Prescribing - No prescribing or imbibing any new drug, except true breakthrough drugs, for the first 7 years after approval." Here's the rule described in Australian Prescriber:


"You should wait at least seven years from the date of release to take any new drug unless it is one of those rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labelling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release."


Listen to this auto snippet of Wolfe's presentation that includes the 7-year Rule and other "solutions.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels

FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Taxotere: A Chemo Drug Bringing More Suffering to Women’s Lives

Taxotere is an unnecessary chemo drug that is adding even more suffering to women’s lives. America’s Lawyer, Mike Papantonio, and attorney Ben Gordon discuss this.

Pharma Guy's insight:

"[These women] look like Ben Franklin!" I guess the lawyer being interviewed is representing patients harmed by taxotere in lawsuits. For more on this issue, read "sanofi aventis Feels the Social Media Pain"; http://bit.ly/SASMpain 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks!

GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

FDA has supported efforts to shorten development and streamline the agency’s review of drug applications through expedited pathways. However, we found problems with the agency’s efforts to oversee and track potential safety issues and postmarket studies once those drugs are on the market. While internal control standards for the federal government specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes, FDA’s data on postmarket safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult. 


FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight. Tracked safety issues are potential safety issues that FDA determines are significant and that it tracks using an internal database. Internal control standards for federal agencies specify that information should be recorded in a form and within a time frame that enables staff to carry out their responsibilities and that relevant, reliable, and timely information should be available for external reporting purposes. However, evaluations conducted by CDER of data in its database revealed problems with the completeness, timeliness, and accuracy of the data. These problems, as well as problems with the way data are recorded that impair their accessibility, have prevented FDA from publishing statutorily required reports on certain potential safety issues and postmarket studies in a timely manner, and have restricted the agency's ability to perform systematic oversight of postmarket drug safety. Although FDA has taken some steps to address the problems with its data, the agency lacks plans that comprehensively outline its efforts and establish related goals and time frames. Additionally, FDA does not have plans to use these data to inform its oversight of its expedited programs, such as determining if drugs that used an expedited program were subsequently associated with tracked safety issues at rates or of types that differed from drugs that used FDA's standard process.

Pharma Guy's insight:

I reported on this problem back in 2013:


Many drug approvals were fast-tracked on the promise that pharma companies would meet study deadlines and supply the FDA with data about any adverse events discovered via observational postmarketing studies after market approval.

So, how well has the FDA held pharma companies feet to the fire regarding postmarketing commitments under FDAAA jurisdiction?

Not very well at all, according a Research Letter published in the July 10, 2013, issue of JAMA. The authors of the study found that NONE (zero) of the 865 studies under FDAAA jurisdiction from 2008 through 2011 have been completed. Of the 387 studies mandated in 2011, 271 (70%) have not even begun.


For more on that, read "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY 

more...
Pharma Guy's curator insight, March 28, 2016 2:41 PM

I reported on this problem back in 2013:

 

Many drug approvals were fast-tracked on the promise that pharma companies would meet study deadlines and supply the FDA with data about any adverse events discovered via observational postmarketing studies after market approval.

So, how well has the FDA held pharma companies feet to the fire regarding postmarketing commitments under FDAAA jurisdiction?

Not very well at all, according a Research Letter published in the July 10, 2013, issue of JAMA. The authors of the study found that NONE (zero) of the 865 studies under FDAAA jurisdiction from 2008 through 2011 have been completed. Of the 387 studies mandated in 2011, 271 (70%) have not even begun.

 

For more on that, read "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY 

Scooped by Pharma Guy
Scoop.it!

FDA's "Breakthrough Drug" Designation May Lead to Unwarranted Consumer Confidence

FDA's "Breakthrough Drug" Designation May Lead to Unwarranted Consumer Confidence | Pharmaguy's Insights Into Drug Industry News | Scoop.it
What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows.


The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence in new drug claims.


As the researchers on the new study describe it, the FDA Safety and Innovation Act, passed in 2012, allows the FDA to give breakthrough designation to any drug treating a serious or life-threatening condition that "may demonstrate a substantial improvement over existing therapies" for one clinical endpoint, or outcome, in preliminary evidence.


“These clinical endpoints can be surrogate outcomes and don't have to be a direct outcome of the disease,” said coauthor Tamar Krishnamurti, a research scientist at Carnegie Mellon University in Pittsburgh.

“For example, cholesterol can be a surrogate outcome for measuring the effectiveness of a drug to treat heart disease,” she told Reuters Health by email.

e

Many people with heart disease have high cholesterol levels, but not all people with heart disease do - and many people with high cholesterol levels have no heart disease at all, she said.

Pharma Guy's insight:

Meanwhile, two drug safety experts have accused the FDA of speeding approval of new drugs for stroke prevention, cancer and multiple sclerosis without proper safety analysis. This doesn't seem very "patient-centric." For more on that, read FDA Caught Speeding. Puts Public Safety at Risk.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Are Online Consumer Drug Reviews More Trustworthy Than Scientific Studies?

Are Online Consumer Drug Reviews More Trustworthy Than Scientific Studies? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A small number (3-4%) of Internet users have shared their experiences with drugs online, which extrapolates to millions of drug experiences. The large size and broad accessibility of this database has an advantage over controlled clinical trials that recruit a finite number of patients. This is counterbalanced by the fact that Internet users represent a diverse population, in contrast to controlled clinical trials, which consist of homogeneous patients who meet strict trial inclusion criteria. Nevertheless, our study characterizes the use of Web-based reviews for comparing performances of drugs. In conclusion, we have shown that consumer reviews can be used as an orthogonal source to reveal insights on drug performance.


We discovered that (1) drugs with FDA black box warnings or used off-label were rated poorly in Web-based reviews, (2) drugs with addictive properties were rated higher than their counterparts in Web-based reviews, and (3) second-line or alternative drugs were rated higher. In addition, Web-based ratings indicated drug delivery problems.

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

OpEd: FDA's Antiquated Drug Safety Program is "Obscene"

OpEd: FDA's Antiquated Drug Safety Program is "Obscene" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

There was quite a bit of news coverage recently about a study published in JAMA Internal Medicine that documented delays in the disclosure of serious adverse events to FDA (read "Pharma Delays Reporting Adverse Events to FDA").


But that's not the real problem. Not by a long shot.


The first real problem is the much more extensive delay FDA has in releasing these data to the public. Currently, the most recent publicly available FAERS data includes case reports received by FDA through December 31, 2014. That means that critical, potentially life-saving, data is currently 7 months out of date. And we're not talking about 10% of the data being late. We're talking about 100% of the data being late. While pharmaceutical companies have a requirement to report adverse event cases to FDA in a timely manner, FDA has no such obligation to release those data to the public in a timely manner.


Some could argue that the delay in public data release is critical so that FDA can examine the case reports, perform analysis and issue relevant warnings and label changes. And in fact that does happen from time to time. But not nearly the way it should.


Which leads to the second real problem. An analysis of our safety signaling system shows that it takes on average a full 5 years for FDA to issue a label change after a safety signal is detected from FAERS. We know this because we track active safety signals from FAERS data and record the delays in FDA labeling changes. Why does the issue of label changes matter? Specifically because of the reasons Dr. Redberg cites -- patients and physicians need to understand the real world risks. And in the current healthcare system they simply won't know until FDA issues a label change.


So, is the fact that pharmaceutical companies fail to report 10% of serious and unexpected adverse events within the 15-day window a problem? Sure. But it's a little problem.



more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Amgen's R&D Chief More Concerned About "Labeling" Than Patient Safety... Ugh!

Amgen's R&D Chief More Concerned About "Labeling" Than Patient Safety... Ugh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A month ago, Amgen and AstraZeneca were confidently rolling up data from three highly touted late-stage studies on the psoriasis drug brodalumab for a new drug application that was widely viewed as a shoo-in at the FDA. But late Friday evening, as the industry was heading out for a long Memorial Day weekend, Amgen abruptly said it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.


"During our preparation process for regulatory submissions, we came to believe that labeling requirements likely would limit the appropriate patient population for brodalumab," said Amgen R&D chief Sean Harper in a statement. AstraZeneca, which paid $50 million and shouldered the lion's share of the R&D costs to partner with Amgen three years ago, was left holding the damaged goods as it said separately that R&D execs would now think through what the future could hold for the drug.

Pharma Guy's insight:


Nice way to express your concern for patient safety, Sean! I suppose if Amgen did not have to mention suicidal thoughts that you'd be OK with it. Ugh!

more...
No comment yet.