Hot Topics: Pharmaceuticals

Blog Posts (43)

May 8, 2018

Speaking to the Media about Antimicrobial Resistance: A Deeper Description of How I Wear Many Hats as a Bioethicist

by Craig Klugman, Ph.D.

Last week, I was interviewed by an academic news serviceabout antimicrobial resistance (AMR) after a study reported that giving antibiotics to children in selected African towns led to a decreased mortality rate.  …

January 9, 2018

Blindness Cure Is Out of Sight

by Craig Klugman, Ph.D.

The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…

August 9, 2017

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017.…

June 20, 2017

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

by Craig Klugman, Ph.D.

Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies.…

May 1, 2017

Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’ in the health care industry has created legal, ethical, and public policy issues because patients are not able to get access to their prescribed medications based on the expense.  Specialty drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap alternatives.[1] Although there is debate about how much finances should influence medical decision making, it is a conversation that can not be ignored when patients can not get access to treatment based on ability to pay. There should be increased access to these drugs but how to increase access is up for debate.

One posed solution has been the creation of biosimilar which are the generic version of a specialty drug. A biological medication is different from a traditional drug in molecular make up.[2]  “A biologic drug is ‘a substance that is made from a living organism or its products[,]’”[3]  while a traditional prescription drug is made up of simple molecules.[4]  This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary.[5]  This also means making a generic form, known as a biosimilar, is more expensive and harder to make.[6] Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.”[7] There also are patent infringement concerns when making biosimilar.

 

From ethics perspective, one of the key aspects of justice is ensuring equal access to healthcare or at least fairly allocating available resources. For biosimilar drugs, it truly depends on what insurance company, what insurance plan, and what pharmacy benefit manager the patient has as to whether the patient will even have a chance to get these drugs. One could argue that it is hard to say we have a fair allocation system when it dependent on what backroom deals pharmaceutical companies have with insurance companies. On the other side, fairness includes ensuring that pharmaceutical companies are properly compensated for their time, energies, and resources used to develop these drugs. Yes, they are cheaper than brand name biologics but they are still expensive and arguably unaffordable. Competition has been the suggested method for decreasing prices to ensure better access. However, patents exclusivity and the Food and Drug Administration approval process make competition slow.

 

On April 27, 2017, The United States Supreme Court heard a case that addresses exactly this issue of access. The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up.[8] Amgen, a California pharmaceutical company who makes the name brand version Neupogen, had challenged the early release. The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. The case revolves around a provision in the Affordable Care Act which aimed at creating an expedited path for approval of biosimilar drugs. The goal was to increase access of new innovations to the public as well as increase competition to decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost 15 percent less than Neupogen, which is a decrease in cost but not a substantial in cost. Part of the issue is health insurance companies expect biosimilar drugs to work like generic medications and they do not. Biosimilars themselves are still innovation and companies charge for the research and development that goes into innovations. The final decision is due to come in June and this case could determine whether justice will be respected in regards to how quickly consumers can get access to biosimilars.

 



[1] Joseph J. Hylak-Reinholtz & Jay R. Naftzger, Is it Time to Shed a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April 26, 2008) http://healthcareorganizationalethics.blogspot.com/2008/04/how-us-rations-specialty-drugs.html.

[2] Michael Callam, Who Can Afford it?: The Patient Protection and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of Prescription Biologic Drugs, 27 J.L. & Health 99, 103 (2014).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] Andrew Chung, U.S. Top Court Grapples Over Making Copycat Biologics Available Sooner, Reuters (Apr. 26, 2017), http://mobile.reuters.com/article/idUSKBN17S2BF.

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 28, 2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 28, 2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 28, 2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 28, 2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

February 3, 2017

A Solution In Search of A Problem: Streamlining the FDA

by Craig Klugman, Ph.D.

A professional association for regulatory affairs posted an article on Wednesday reporting Trump’s comments “calling for a massive overhaul of US Food and Drug Administration (FDA) regulations.” Trump issued an executive that called for reducing the number of federal regulations (for each new one created, two must be retired).…

View More Blog Entries

Published Articles (4)

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials Lisa McManus & Jill A. Fisher

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

Undisclosed conflicts of interest among biomedical textbook authors Brian J. Piper, Drew A. Lambert, Ryan C. Keefe, Phoebe U. Smukler, Nicolas A. Selemon & Zachary R. Duperry

American Journal of Bioethics: Volume 18 Issue 4 - Apr 2018

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility Nancy S. Jecker, Aaron G. Wightman, Abby R. Rosenberg & Douglas S. Diekema

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

News (124)

May 25, 2018 9:00 am

FDA just approved the first drug to prevent migraines. Here’s the story of its discovery—and its limitations (Science)

Worldwide, migraines strike roughly 12% of people at least once per year, with women roughly three times as likely as men to have an attack. The Migraine Research Foundation estimates that U.S. employees take 113 million sick days per year because of migraines, creating an annual loss of $13 billion. The toll underscores how little current treatments—not just drugs, but nerve-numbing injections, behavioral therapies, and special diets—can help many people. On the horizon, however, is a new class of drugs that many scientists believe can stop migraines at their root.

May 23, 2018 9:00 am

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition (Washington Post)

On Thursday, the F.D.A. took a new tack and began posting a list of makers of brand-name drugs that have been the target of complaints, to persuade them to “end the shenanigans,” in the commissioner’s words. Dr. Gottlieb calls it transparency, but this approach is better known among ethicists as naming and shaming.

May 16, 2018 9:00 am

Is your pharmacist under a 'gag rule' about drug prices? (CNN)

Independent pharmacist Ira Katz has been serving the eclectic community of Little Five Points in Atlanta for 37 years. But it wasn’t until Georgia passed a law last year banning “gag rules” that Katz could legally tell his patients they might save big bucks on their prescriptions if they paid cash or used a lower-priced generic. The gag rule was a clause in his contract with one of the pharmaceutical benefit managers, also known as PBMs, that manage most of our nation’s prescription drug programs.

May 15, 2018 9:00 am

Why Hemophilia Patients Could Pay $1.5 Million For Gene Therapy (Investor's Daily)

BioMarin Pharmaceuticals (BMRN), Spark Therapeutics (ONCE) and UniQure(QURE) are racing to be the first to market with a gene therapy that treats hemophilia — a prospect that could offer revenue north of $1.5 million per patient, an analyst said Monday.

April 18, 2018 9:00 am

Drug companies get tax windfall, but they're not reducing prescription prices (USA Today)

Drug prices are a top pocketbook issue for Americans. President Trump understood that and campaigned on promises to bring down the cost of prescriptions. You’d think the massive tax cut he signed into law in December would be the perfect opportunity for drug companies to take some of their windfall and bring down those prices. But a new analysis shows that so far, you’d be wrong.

April 17, 2018 9:00 am

Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny (The New York Times)

Trump administration officials, seeking ways to lower drug costs, are targeting pharmaceutical companies that refuse to provide samples of their products to generic drug companies, making it impossible to create inexpensive generic copies of a brand-name medicine.

March 14, 2018 9:00 am

For all their risks, opioids had no pain-relieving advantage in a yearlong clinical trial (The LA Times)

For years, doctors turned to opioid painkillers as a first-line treatment for chronic back pain and aches in the joints. Even as the dangers of addiction and overdoses became more clear, the drugs’ pain-relieving benefits were still thought to justify their risks. Now researchers have hard data that challenges this view.

March 13, 2018 9:00 am

Ask Your Doctor. Until Then, Here’s a Word From Our Sitcom. (The New York Times)

 It’s true that only the United States and New Zealand allow direct advertising of prescription drugs to consumers, while Brazil allows some advertising of nonprescription, over-the-counter medications.

February 21, 2018 9:00 am

Find drugs that delay many diseases of old age (Nature)

A class of drugs called geroprotectors might be able to delay the onset of concurrent age-related diseases (multimorbidity) and boost resilience. In various animal models, these drugs can ward off problems of the heart, muscles, immune system and more.

February 14, 2018 9:00 am

How drug company money turned patient groups into 'cheerleaders for opioids' (USA Today)

The five biggest opioid manufacturers shelled out more than $10 million to patient advocacy groups, professional medical societies and affiliated individuals — who then “echoed and amplified” messages that encouraged use of those highly addictive drugs and set the stage for the current opioid epidemic.

View More News Items