Tag: drug industry

Bioethics News

Guess Who’s Tracking Your Prescription Drugs?

August 3, 2017

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As drug overdose deaths continue their record climb, Missouri last month became the 50th state to launch a prescription drug monitoring program, or PDMP. These state-run databases, which track prescriptions of certain potentially addictive or dangerous medications, are widely regarded as an essential tool to stem the opioid epidemic. Missouri Gov. Eric Greitens last month announced he was creating one in what had been the lone holdout state; legislative efforts to establish a program there had repeatedly failed because of lawmakers’ concerns about privacy.

Their concerns were not unfounded.

Federal courts in Utah and Oregon recently ruled that the Drug Enforcement Administration, in its effort to investigate suspected drug abusers or pill mills, can access information in those states’ PDMPs without a warrant, even over the states’ objections. And last month in California, the state supreme court ruled that the state medical board could view hundreds of patients’ prescription drug records in the course of its investigation of a physician accused of misconduct. “Physicians and patients have no reasonable expectation of privacy in the highly regulated prescription drug industry,” District Judge David Nuffer wrote in the Utah case.

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

A Drug Quintupled in Price.

Now, drug industry players are feuding over the windfall. Amid public concern over spiking drug prices, a powerful middleman is suing a tiny drugmaker over unpaid rebates and fees. The maker calls the suit baseless; analysts say the suit offers a window into an opaque world

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Financial Ties Between Researchers and Drug Industry Linked to Positive Trial Results

January 18, 2017

(Medical Xpress) – Financial ties between researchers and companies that make the drugs they are studying are independently associated with positive trial results, suggesting bias in the evidence base, concludes a study published by The BMJ today. Relationships with industry are common among investigators of randomised clinical trials (RCTs) – raising concerns about the effect that financial ties may have on the evidence base. But studies investigating these relationships have been conflicting. So a team of US based researchers set out to investigate the association between financial ties of principal investigators and study outcomes in a random sample of 195 drug trials published in 2013.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Rare Diseases Are Becoming Too Common. Sound Impossible? Here’s Why It’s Not

It is hard to make money treating rare diseases. There simply aren’t enough customers to generate many profits. That’s why the U.S. government passed the Orphan Drug Act in 1983, a law which created a series of incentives to encourage drug companies to develop treatments for rare or “orphan” diseases – conditions affecting less than 200,000 people in the U.S. Thanks to longer patent protection, tax reductions, and fee waivers, the orphan drug industry has become quite profitable.

Are rare orphan diseases now becoming too common?

In the 1980s, the pharmaceutical industry received orphan drug status for about 3 or 4 products per year, with most of these drugs being either the first treatments available for the diseases in question or major improvements over prior treatments. From 1983 through 2010, the pharmaceutical industry never received approval for more than 10 orphan drugs in a given year.

To read the rest of this article, please visit Forbes.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Report: EpiPen Execs Are Second-Best Paid in the Industry

September 15, 2016

(Managed Care Magazine) – Mylan Pharmaceuticals––currently the target of public and congressional ire over its hefty price increases for the EpiPen––had the second-highest executive compensation among all U.S. drug and biotech firms during the past five years, according to a Wall Street Journal analysis. The big paydays are unusual in view of the company’s small size in the U.S. drug industry, where it is No. 11 by revenue, the article notes.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully

On Monday, the Massachusetts Joint Committee on Health Care Financing held a hearing on Senate bill 1048, which would require pharmaceutical companies to report to the state a range of information on their research & development costs, marketing and advertising costs, and prices charged to a number of different purchasers.  The hearing, recapped by the Boston Globe and Gloucester Times (among others), went as expected, with industry executives opposing the bill and health insurers, consumer advocates, and others testifying in support.

Massachusetts is not the only state considering a transparency bill.  At least ten other states, including California, North Carolina, Oregon, and Virginia have all drafted bills that would advance similar goals.  These bills do differ in their details.  As just one example, each state would require disclosure from a different set of drugs and companies.  Massachusetts would only require disclosure of costs and pricing for the top twenty selling drugs in the state (where the list is based around a set of criteria including but not limited to cost), California, Oregon, and Virginia would require disclosure for any drug whose wholesale cost is $10,000 or more per year (in California, this includes over 900 drugs), and North Carolina’s bill is framed around classes of drugs, rather than prices.

It is no accident that these bills have been developed in the wake of Martin Shkreli, Valeant Pharmaceuticals, and other drug pricing scandals.  Patients and policymakers are seizing this moment to take action against the drug industry. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

An F.D.A. Commissioner With Ties to the Pharmaceutical Industry? Heaven Forbid?

On September 16, 2015, President Obama nominated the internationally known Duke University cardiologist-researcher Robert M. Califf, MD, to be Commissioner of Food and Drugs. He will replace Margaret Hamburg, MD, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as Deputy Commissioner at the F.D.A. since February. The Senate must confirm the commissioner.

Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.

However, he also has many strong ties to the pharmaceutical and medical device industries. One article called him the ultimate drug industry insider.

It may seem logical to be suspicious of having a F.D.A. Commissioner who understands clinical drug research inside and out. After all, Dr. Califf learned much by working with drug and device manufacturers over the years, directing a clinical research trials center with an annual $200 million budget and with 65% of that amount coming from big pharma.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Drug Price Hikes and the Misguided Profit Imperative

by Craig Klugman, Ph.D.

Headlines this past week were abuzz with news that Daraprim—a drug that has fought parasitic infections such as toxoplasmosis for 62 years—saw its price hiked by 5500%, nearly overnight. For decades Daraprim has been a front line drug available for $13.50 a table. When Turing Pharmaceuticals bought the company that makes the drug last month, the new owners raised the price to $750 per pill. Often used by HIV patients, the per year cost would be $634,500. As if that was not enough, the drug’s previous owners entered into an exclusivity arrangement with Walgreens, making Walgreen’s specialty pharmacies the sole place where the drug was available.

Cycloserine is a drug that fights multi drug resistant tuberculosis. When it’s owners sold the patent to Rodelis Therapeutics, the new company raised the price to $10,800 per package ($360 per capsule) from its previous $500 ($16.60 per tablet).

Valeant Pharmaceuticals bought the rights to two heart medications: Isuprel and Nitropress. They raised the price of Isuprel by 525% to $1,346.62 and of Nitropress by 212% to $805.61.

AARP reports that brand name drugs have increased in price an average of 12.9%. And for generic drugs, they report that price savings have slowed and 27 percent of generics saw increases of up to 1,000% over the last few years. Increases this much cannot be absorbed by insurance companies which are raising prices on premiums, deductibles, and co-pays for drug benefits. Drugs that used to cost $4 a month are suddenly costing $100 per month for consumers.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Guest Post: Real change in food systems needs real ethics

Written By Paul B. Thompson

W.K. Kellogg Professor of Agricultural, Food and Community Ethics at Michigan State University

This blog is a cross-posting from the OUPblog.

Please see the original post here: http://blog.oup.com/2015/06/food-systems-need-real-ethics/

In May, we celebrated the third annual workshop on food justice at Michigan State University. Few of the people who come to these student-organized events doubt that they are part of a social movement. And yet it is not clear to me that the “social movement” framing is the best way to understand food justice, or indeed many of the issues in the food system that have been raised by Mark Bittman or journalists such as Eric Schlosser, Michael Pollan, or Barry Estabrook.

Social movements attain what clarity of purpose they have because they have a morally compelling cause. The labor movement, the women’s movement, and the civil rights movement had factions and divisions over strategy, tactics, or the value of subsidiary goals. But each was united by faith in the underlying justice of a unifying cause, however vaguely stated. There are a lot of things wrong with our contemporary food system, but that is about the only thing on which people enrolled in today’s food movement agree.

I would submit that the whole idea of a food movement came out of academia. First dozens and later hundreds of sociologists, anthropologists, and geographers have studied discontent and protest over food issues under aegis of social movement theory since the 1960s. Their work on the food system originated as studies on bona fide social movements: the labor movement (Caesar Chavez), the women’s movement (globally, most farmers are women), and the civil rights movement (slavery, sharecropping and the racialization of migrant agricultural labor).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

“Reasonable Profits” For Pharmaceutical Manufacturers?

With
the recent success of the blockbuster drug Sovaldi© (Gilead Sciences, Inc.), the
manufacturer’s stock price has quintupled in the last four years.
This supports the views of some that pharmaceutical prices in America should be
subject to greater government scrutiny and controls like other industrialized
countries.

High
profits within the pharmaceutical industry are nothing new. “Historically
[before the recent recession], the drug industry in America has been the
top
performing
[sector] in terms of return on revenues (average 18.6%) and return
on assets (average 17.7%) compared to 4.9% and 3.9% respectively for median
companies in the Fortune 500 industries.” 

The
extremely high costs of drug research and development (R&D) are often cited
as the principal rationale for allowing an above average return and minimizing
government price controls.
However, studies have shown that “[as t]o the question of whether
pharmaceutical drugs costs are justified by R&D, the answer is no.
Pharmaceutical firms do indeed invest money in R&D, as do other production
and service firms, but this investment does not account for their large ongoing
profit, which ranges from 2.5 to 37 times the non-pharmaceutical industry
average over time.”

Such
begs the question: How high are profits that are too high? Or perhaps, what is
a reasonable rate of return for drug companies? Or, if the Congress were to
intervene because profits are excessive,
what options might be available
without unreasonably regulating an already heavily regulated industry?

As
a compromise, perhaps it would be prudent to tax pharmaceutical industry “excessive
profits” at a higher rate? Excessive profits taxes or excise taxes have been
used in the United States during wartime to minimize the risk of
war-profiteering or war-related windfall profits.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.