Ethical concerns with online direct-to-consumer pharmaceutical companies

Curtis H, Milner J
Journal of Medical Ethics 
2020;46:168-171.

Abstract

In recent years, online direct-to-consumer pharmaceutical companies have been created as an alternative method for individuals to get prescription medications. While these companies have noble aims to provide easier, more cost-effective access to medication, the fact that these companies both issue prescriptions (via entirely online medical reviews that can have no direct contact between physician and patient) as well as distribute and ship medications creates multiple ethical concerns. This paper aims to explore two in particular. First, this model creates conflicts of interest for the physicians hired by these companies to write prescriptions. Second, the lack of direct contact from physicians may be harmful to prospective patients. After analysing these issues, this paper argues that there ought to be further consideration for regulation and oversight for these companies.

The info is here.

Israel Approves Compassionate Use of MDMA to Treat PTSD

Ido Efrati
www.haaretz.com
Originally posted February 10, 2019

MDMA, popularly known as ecstasy, is a drug more commonly associated with raves and nightclubs than a therapist’s office.

Emerging research has shown promising results in using this “party drug” to treat patients suffering from post-traumatic stress disorder, and Israel’s Health Ministry has just approved the use of MDMA to treat dozens of patients.

MDMA is classified in Israel as a “dangerous drug”, recreational use is illegal, and therapeutic use of MDMA has yet to be formally approved and is still in clinical trials.

However, this treatment is deemed as “compassionate use,” which allows drugs that are still in development to be made available to patients outside of a clinical trial due to the lack of effective alternatives.

The info is here.

Hospitals are fed up with drug companies, so they’re starting their own

Carolyn Johnson
The Washington Post
Originally posted September 6, 2018

A group of major American hospitals, battered by price spikes on old drugs and long-lasting shortages of critical medicines, has launched a mission-driven, not-for-profit generic drug company, Civica Rx, to take some control over the drug supply.

Backed by seven large health systems and three philanthropic groups, the new venture will be led by an industry insider who refuses to draw a salary. The company will focus initially on establishing price transparency and stable supplies for 14 generic drugs used in hospitals, without pressure from shareholders to issue dividends or push a stock price higher.

“We’re trying to do the right thing — create a first-of-its-kind societal asset with one mission: to make sure essential generic medicines are affordable and available to everyone,” said Dan Liljenquist, chair of Civica Rx and chief strategy officer at Intermountain Healthcare in Utah.

The consortium, which includes health systems such as the Mayo Clinic and HCA Healthcare, collectively represents about 500 hospitals. Liljenquist said that the initial governing members have already committed $100 million to the effort. The business model will ultimately rely on the long-term contracts that member health care organizations agree to — a commitment to buy a fixed portion of their drug volume from Civica.

The info is here.

Novartis links bonuses to ethics in bid to rebuild reputation

John Miller
Reuters
Originally posted September 17, 2018

Swiss drugmaker Novartis (NOVN.S) has revealed its employees only get a bonus if they meet or exceed expectations for ethical behavior as it seeks to address past shortcomings that have damaged its reputation.

Chief Executive Vas Narasimhan has made strengthening the Swiss drugmaker’s ethics culture a priority after costly bribery scandals or legal settlements in South Korea, China and the United States.

Employees now receive a 1, 2 or a 3 score on their values and behavior. Receiving a 2, which Novartis said denotes meeting expectations, or a 3, for “role model” behavior, would make them eligible for a bonus of up to 35 percent of their total compensation.

Novartis said it began the scoring system in 2016 but details have not been widely reported. Company officials outlined the system on Monday on a call about its ethics efforts with analysts and journalists.

The info is here.

Pharma exec had 'moral requirement' to raise price 400%

Wayne Drash
CNN.com
Originally published September 12, 2018

 A pharmaceutical company executive defended his company's recent 400% drug price increase, telling the Financial Times that his company had a "moral requirement to sell the product at the highest price." The head of the US Food and Drug Administration blasted the executive in a response on Twitter.

Nirmal Mulye, founder and president of Nostrum Pharmaceuticals, commented in a story Tuesday about the decision to raise the price of an antibiotic mixture called nitrofurantoin from about $500 per bottle to more than $2,300. The drug is listed by the World Health Organization as an "essential" medicine for lower urinary tract infections.

"I think it is a moral requirement to make money when you can," Mulye told the Financial Times, "to sell the product for the highest price."

The info is here.

Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals

Charles Ornstein and Katie Thomas
The New York Times
Originally published September 8, 2018

One of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet.

The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations, has had a stake in start-ups testing cancer therapies, and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.

According to an analysis by The New York Times and ProPublica, Dr. Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group’s journal, Cancer Discovery. At the same time, he has been one of the journal’s two editors in chief.

The info is here.

The So-Called Right to Try Law Gives Patients False Hope

Claudia Wallis
Scientific American
Originally posted in the September 2018 issue

There's no question about it: the new law sounds just great. President Donald Trump, who knows a thing or two about marketing, gushed about its name when he signed the “Right to Try” bill into law on May 30. He was surrounded by patients with incurable diseases, including a second grader with Duchenne muscular dystrophy, who got up from his small wheelchair to hug the president. The law aims to give such patients easier access to experimental drugs by bypassing the Food and Drug Administration.

The crowd-pleasing name and concept are why 40 states had already passed similar laws, although they were largely symbolic until the federal government got onboard. The laws vary but generally say that dying patients may seek from drugmakers any medicine that has passed a phase I trial—a minimal test of safety. “We're going to be saving tremendous numbers of lives,” Trump said. “The current FDA approval process can take many, many years. For countless patients, time is not what they have.”

But the new law won't do what the president claims. Instead it gives false hope to the most vulnerable patients. “This is a right to ask, not a right to try,” says Alison Bateman-House, a medical ethicist at New York University and an expert on the compassionate use of experimental drugs.

The info is here.

Japanese doctor who exposed a drug too good to be true calls for morality and reforms

Tomoko Otake
Japan Times
Originally posted November 15, 2017

Here is an excerpt:

Kuwajima says the Diovan case is a sobering reminder that large-scale clinical trials published in top medical journals should not be blindly trusted, as they can be exploited by drugmakers rushing to sell their products before their patents run out.

“I worked at a research hospital and had opportunities to try new or premarket drugs on patients, so I knew from early on that Diovan and the same class of drugs called ARB wouldn’t work, especially for elderly patients,” Kuwajima recalled in a recent interview at Tokyo Metropolitan Geriatric Hospital, where he has retired from full-time practice but still sees patients two days a week. “I had a strong sense of crisis that hordes of elderly people — whose ranks were growing as the population grayed — would be prescribed a drug that didn’t work.”

Kuwajima said he immediately found the Diovan research suspicious because the results were just too good to be true. This was before Novartis admitted that it had paid five professors conducting studies at their universities a total of ¥1.1 billion in “research grants,” and even had Shirahashi, a Novartis employee purporting to be a university lecturer, help with statistical analyses for the papers.

The article is here.

Rigorous Study Finds Antidepressants Worsen Long-Term Outcomes

Peter Simons
madinamerica.com
Originally posted

Here is an excerpt:

These results add to a body of research that indicates that antidepressants worsen long-term outcomes. In an article published in 1994, the psychiatrist Giovanni Fava wrote that “Psychotropic drugs actually worsen, at least in some cases, the progression of the illness which they are supposed to treat.” In a 2003 article, he wrote: “A statistical trend suggested that the longer the drug treatment, the higher the likelihood of relapse.”

Previous research has also found that antidepressants are no more effective than placebo for mild-to-moderate depression, and other studies have questioned whether such medications are effective even for severe depression. Concerns have also been raised about the health risks of taking antidepressants—such as a recent study which found that taking antidepressants increases one’s risk of death by 33% (see MIA report).

In fact, studies have demonstrated that as many as 85% of people recover spontaneously from depression. In a recent example, researchers found that only 35% of people who experienced depression had a second episode within 15 years. That means that 65% of people who have a bout of depression are likely never to experience it again.

Critics of previous findings have argued that it is not fair to compare those receiving antidepressants with those who do not. They argue that initial depression severity confounds the results—those with more severe symptoms may be more likely to be treated with antidepressants. Thus, according to some researchers, even if antidepressants worked as well as psychotherapy or receiving no treatment, those treated with antidepressants would still show worse outcomes—because they had more severe symptoms in the first place.

The article is here.

The target article is here.

Moral Hard-Wiring and Moral Enhancement

Introduction

In a series of papers (Persson & Savulescu 2008; 2010; 2011a; 2012a; 2013; 2014a) and book (Persson & Savulescu 2012b), we have argued that there is an urgent need to pursue research into the possibility of moral enhancement by biomedical means – e.g. by pharmaceuticals, non-invasive brain stimulation, genetic modification or other means directly modifying biology. The present time brings existential threats which human moral psychology, with its cognitive and moral limitations and biases, is unfit to address.  Exponentially increasing, widely accessible technological advance and rapid globalisation create threats of intentional misuse (e.g. biological or nuclear terrorism) and global collective action problems, such as the economic inequality between developed and developing countries and anthropogenic climate change, which human psychology is not set up to address. We have hypothesized that these limitations are the result of the evolutionary function of morality being to maximize the fitness of small cooperative groups competing for resources. Because these limitations of human moral psychology pose significant obstacles to coping with the current moral mega-problems, we argued that biomedical modification of human moral psychology may be necessary.  We have not argued that biomedical moral enhancement would be a single “magic
bullet” but rather that it could play a role in a comprehensive approach which also features cultural and social measures.

The paper is here.

Drug company faked cancer patients to sell drug

Aaron M. Kessler
CNN.com
Originally published September 6, 2017

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

To boost sales, the company allegedly took patients who didn't have cancer and made it look like they did.

The drug maker used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.

The new report by McCaskill's office released Wednesday includes allegations about just how far the company went to push prescriptions of its sprayable form of fentanyl, Subsys.

Because of the high cost associated with Subsys, most insurers wouldn't pay for it unless it was approved in advance. That process, likely familiar to anyone who's taken an expensive medication, is called "prior-authorization."

The article is here.

Financial ties between researchers and drug industry linked to positive trial results

British Medical Journal
Press Release
Originally released January 17, 2017

Here is an excerpt:

More than half (58%) of principal investigators had financial ties to the drug industry - including travel expenses, honorariums, payment for advisory work, or stock ownership.

The results show that trials authored by principal investigators with financial ties to drug manufacturers were more likely than other trials to report favourable results.

Even after accounting for factors that may have affected the results, such as funding source and sample size, financial ties were still significantly associated with positive study outcomes.

The authors point to possible mechanisms linking industry funding, financial ties, and trial results such as bias by selective outcome reporting, lack of publication, and inappropriate analyses.

The pressor is here.

Ethicists unpack the argument for why doping should be kept out of sports

Olivia Goldhill
Quartz
Originally published August 21, 2016

Here is an excerpt:

Bioethicist Thomas Murray, who was chair of Ethical Issues Review Panel for the World Anti-Doping Agency for many years, says that doping “short-circuits the connection between talent, dedication, and performance in sport. It takes control and responsibility away from the athlete and gives it to the chemist or gene therapist or whoever’s manipulating the athlete’s body and physiology.”

Allowing doping would likely lead to a pharmaceutical race, with ever more effective drugs changing athletes’ ability. And even if athletes were able to take drugs safely under the supervision of doctors, Murray points out that still-growing teenagers mimicking their idols would face far greater risks.

Some sporting competitions might decide to allow certain drugs, he says, but to allow doping in the Olympics would make it impossible to compete without the help of pharmaceuticals.

The article is here.

Secrets and lies: Faked data and lack of transparency plague global drug manufacturing

By Kelly Crowe
CBC News 
Originally posted: June 10, 2016

Here is an excerpt:

In another case, when the FDA responded to complaints from U.S. manufacturers about impurities in raw ingredients from a Chinese company and asked to see the data, inspectors discovered it had been deleted and the audit trail disabled.

Two companies on Health Canada's watch list have been caught falsifying the source of their active pharmaceutical ingredient. Both claimed to have made the raw material, but actually purchased it from somewhere else.

There's tragic proof that data integrity matters. In 2008, 19 people in the U.S. died and hundreds more were sickened by a contaminated blood thinner made from a raw material the FDA believes had been tampered with at its source in China.

The article is here.

Off-label Promotions: Pharma Wants More Freedom to Pitch Durgs

By Ed Silverman
Stat News
Originally published February 29, 2016

Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.

This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.

Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.

The article is here.

Document Claims Drug Makers Deceived a Top Medical Journal

By Katie Thomas
The New York Times
Originally published March 1, 2016

It is a startling accusation, buried in a footnote in a legal briefing filed recently in federal court: Did two major pharmaceutical companies, in an effort to protect their blockbuster drug, mislead editors at one of the world’s most prestigious medical journals?

Lawyers for patients suing Johnson & Johnson and Bayer over the safety of the anticlotting drug Xarelto say the answer is yes, claiming that a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University left out critical laboratory data. They claim the companies were complicit by staying silent, helping deceive the editors while the companies were in the midst of providing the very same data to regulators in the United States and Europe.

Duke and Johnson & Johnson contend that they worked independently of each other. Bayer declined to comment. And top editors at The New England Journal of Medicine said they did not know that separate laboratory data existed until a reporter contacted them last week, but they dismissed its relevance and said they stood by the article’s analysis.

The article is here.

French drug trial leaves one brain dead and five critically ill

By Angelique Chrisafis
The Guardian
Originally published January 15, 2916

Here is an excerpt:

Touraine said the study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

Bial said it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries, adding that the clinical trial had been approved by French regulators.

The story is here.

The Problem with Drug Monopolies: Ethics and Money

How the Government Could Punish That Hedge Fund Bro Who Wanted to Raise a Drug’s Price 5,000 Percent

By Jordan Weissmann

Slate.com

Originally published September 22, 2015

Here is an excerpt:

Assuming his conscience doesn't send Daraprim's price all the way back to $13.50 a tablet, Shkreli will be able to get away with his price gouging for a simple reason: Even though the drug's patents are long-expired, nobody else makes it. Thus, he has an effective monopoly over a life-saving treatment that lacks an alternative. One could argue that this speaks to the fundamental flaws of American oversight of the pharmaceutical industry. While the rest of the developed world uses price controls to keep medication affordable, the U.S. allows drug companies to charge whatever they please, with the hope that once their patents expire, competition from generics will drive down costs. To some slight extent, that's worked—about 8 out of every 10 prescriptions filled in this country are for generic drugs. But as production has become concentrated in the hands of fewer and fewer manufacturers, the prices of some generics have rapidly risen in recent years. And the costs of some specialty medications, like Daraprim, have skyrocketed.

The entire article is here.

What the FDA’s approval of “pink Viagra” tells us about the problems with drug regulation

by Julia Belluz
The Vox
Originally published on September 18, 2015

Here is an excerpt:

The episode raised hard questions about the changes wrought by the patient movement and other reforms that have followed. There were excellent reasons for the FDA to bring HIV-positive patients into its deliberations in the 1980s — they provided a crucial perspective that the agency's in-house scientists and officials lacked. But these days, some critics argue that those listening sessions have been hijacked by drug companies. As I found in my reporting, the patients who had lobbied the FDA to approve pink Viagra were often sponsored by the drug's manufacturer.

"The role of pharma in patient groups in the contemporary era is entirely fraught," says Yale Law School's Gregg Gonsalves, who was once one of those HIV activists in the 1980s. "[Drug companies] learned from the early days of the AIDS epidemic that the patient community could be useful allies, and they've poured money into patient groups here in the US and around the world."

So is the FDA approving drugs too easily? Has the push for speed and efficiency now undermined the agency's ability to protect public health? To find out, I took a closer look at the approval of "pink Viagra," which offers a vivid illustration of just how much the FDA has transformed over time — and why those changes worry many experts.

The entire article is here.

The Best-Selling, Billion-Dollar Pills Tested on Homeless People

How the destitute and the mentally ill are being used as human lab rats

by Carl Elliott
Matter
Originally posted on July 27, 2014

Here are two excerpts:

If you’re looking for poor people who have been paid to test experimental drugs, Philadelphia is a good place to start. The city is home to five medical schools, and pharmaceutical and drug-testing companies line a corridor that stretches northeast into New Jersey. It also has one of the most visible homeless populations in the country. In Philly, homeless people seem to be everywhere: sleeping in Love Park, slumped on benches in Suburban Station, or gathered along the Benjamin Franklin Parkway, waiting for the free meals that a local church gives out on Saturdays.

(cut)

Not long ago, such offers would have been considered unethical. Paying any volunteer was seen as problematic, even more so if the subjects were poor, uninsured, and compromised by illness. Payment, it was argued, might tempt vulnerable subjects to risk their health. As trials have moved into the private sector, this ethical calculus has changed. First came a hike in the sums that volunteers could be paid: Many clinical trial sites now offer over $6,000 for an inpatient drug study. Eligibility requirements have changed, too. For years, trial sites paid only healthy volunteers, mainly to test new drugs for safety. These days people with asthma, diabetes, kidney disease, liver disease, and other conditions can be paid take part in trials.

The entire article is here.