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FDA May Soon Be Replaced by Judicial Off-Label Activism

FDA May Soon Be Replaced by Judicial Off-Label Activism | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a deal that could change the way some companies market their drugs, the Food and Drug Administration has agreed to allow a pharmaceutical company to promote a drug for a use that the agency has not approved, the company said on Tuesday.

 

The agency on Tuesday downplayed the implications of the deal. In a statement, it said that the settlement applied only to the Amarin case and that its position on whether companies have a constitutional right to provide truthful information about off-label uses had not changed.

 

Under the settlement, Amarin would have to submit proposed marketing materials to the agency, which could then object if it felt the information was untrue or misleading. If the two parties could not agree, a federal judge would sort it out.

 

Leaving such decisions to a judge, not the F.D.A., concerned Dr. Joshua M. Sharfstein, a former principal deputy commissioner at the F.D.A. who is now an associate dean at the Johns Hopkins Bloomberg School of Public Health.

 

“The courts are at the precipice of taking over a fundamental F.D.A. function of calling balls and strikes in the drug market about what’s truthful and not misleading,” Dr. Sharfstein said.

 

Alan Bennett, a lawyer who represents the Medical Information Working Group, a coalition of drug and device companies that want the F.D.A. to expand their ability to talk about their products, said he agreed that the F.D.A., not the judiciary, was best able to evaluate information about drugs.

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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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You May Soon Be Able To Take A Drug To Prevent Depression

You May Soon Be Able To Take A Drug To Prevent Depression | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Right now, someone with depression has only two clinical options: antidepressants (that often don’t work particularly well) and therapy. But there soon may be a third possibility: a vaccine that could prevent depression rather than attempting to treat it after the disease occurs.

 

Neuroscientist Rebecca Brachman is working on the development of a drug that increases resilience to stress–and because exposure to stress can trigger depression, the drug could help prevent the disease. Before someone enters a high-stress situation, they could take a dose of the drug.

 

“Imagine a scenario where we know someone is predictively at high risk for exposure to extreme stress,” Brachman, cofounder of the startup Paravax, said at TED 2017 (Brachman is a TED Fellow). “Say, a Red Cross volunteer going into an earthquake zone. In addition to the typhoid vaccine, we could give her an injection of a resilience enhancer before she leaves, so when she is held at gunpoint by looters or worse, she will be protected against developing depression or PTSD. It won’t prevent her from experiencing the stress, but it allows her to recover from it. That’s what’s revolutionary here. By increasing resiliency, we can dramatically reduce her susceptibility to depression and PTSD.”

 

While in a doctoral program at Columbia University, working with neurobiologist Christine Denny, Brachman studied the effects of giving mice an injection of ketamine, the drug known as special-K. When the mice were later put through a series of stressful situations, they were less depressed, less afraid, and more social than a control group. That effect lasted at least a month, long after the drug had left a mouse’s system.

 

Through her startup, Brachman is working on developing a related drug that could be used as a “resilience enhancer” to protect against depression.

 

“Preventative interventions, especially if they give a long lasting protection, have a much higher likelihood of making it to underserved communities,” she says. “That’s why when people go into Africa they bring vaccines. It’s easier to get governments to invest, and it’s easier to administer if it only needs to be done once.”

 

It’s possible that the drug, or a variation of it, could also be potentially be used to prevent addiction, OCD, bipolar disorder, or a variety of other mental illnesses.

 

“It’s a whole new field–preventative psychopharmacology,” Brachman says.

Pharma Guy's insight:

Yikes! I can't believe this! This woman wants to unleash a Special-K knockoff drug on us and she actually believes it can prevent addiction!!!!

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The Who's Who of "Health Care" (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets

The Who's Who of "Health Care" (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drug companies dug deep into their lobbying piggy banks in President Trump's first quarter, but they weren't the only health care companies or trade groups that increased their budgets in Washington. Here's a list of the top 25 spenders and how much they budgeted for health care lobbying, based on an Axios review of the Senate lobbying database.

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Health Benefits of Marijuana Infographic

Health Benefits of Marijuana Infographic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Also, Big Pharma won't like this:

 

People with Medicaid coverage who live in states with medical marijuana laws are less likely to take medications commonly prescribed to treat conditions like nausea, pain, and depression, according to a new study.

 

The research, published last week in Health Affairs, looked at nine conditions and found reductions in prescriptions of medications used to treat depression (13%), nausea (17%), psychosis (12%), seizure disorders (12%), and pain (11%). There was no statistically significant difference for drugs used to treat anxiety, glaucoma, sleep disorders, and spasticity.

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Top #pharma R&D Spenders in 2016 & R&D Share of Income

Top #pharma R&D Spenders in 2016 & R&D Share of Income | Pharmaguy's Insights Into Drug Industry News | Scoop.it

You usually don’t see much annual fluctuation in the overall R&D budgets of the top 15 companies. The trend over the last few years has been to keep the lid on spending, particularly among the giants in Big Pharma. Companies didn’t cut much overall, but there was plenty of realignment going on as the industry refocused pipelines and continued a migration to the big hubs.

 

This past year, though, it was clear that a few companies wanted to turn up the heat in drug development, and this kind of fuel costs real money for companies that traditionally focus heavily on late-stage blockbuster drug research.

 

The top five in the business saw their collective spending jump by more than $5 billion, from 2015 to 2016, based on the annual numbers filed largely — though not entirely — with the SEC and gathered by Endpoints News. Two of those companies, Roche and the new number 2, a hard charging Merck, accounted for the lion’s share of the increase. (To be sure, some onetime non-R&D spending, such as Merck’s patent settlement with Bristol-Myers on Keytruda, figured in. But so did bread and butter spending.)

 

Gilead also saw a significant increase in research costs, with Eli Lilly — now off course following two bad setbacks for solanezumab and baricitinib — and the ever aggressive Celgene joining the action as they pressed the accelerator on new drug programs.

 

Curiously, the added spending coincided with a bad drop in new drug approvals in 2016. But they don’t correlate, and we’ve already seen that turnaround under way as regulators get busy with a brand new year — and soon a brand new FDA commissioner.

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"Go Boldly" Rings Hollow as Biotech & #Pharma are No-Shows at Historic March for Science 

"Go Boldly" Rings Hollow as Biotech & #Pharma are No-Shows at Historic March for Science  | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The rallies and marches Saturday — with hundreds of thousands of people attending events around the world — served as a turning point for scientists, when many of them left the sterility of their labs and entered the muck that is politics.

 

The overwhelming sentiment was that science is under attack, and they could no longer afford to try to float above it all (listen to John Pharmaguy Mack's speech at the Doylestown, PA march). Scientists had to engage and take their demands to political leaders and policymakers, so they stood for hours on a sodden National Mall here and then marched through puddles to Capitol Hill.

 

All of that amounted to a message of resistance — the need for enduring defiance in the face of what participants see as an anti-science administration. There was little sense, at least from the speakers, that they see grounds for compromise or cooperation with the administration. To them, science is on the ropes, and they needed to fight back.

 

The no-shows: biotech and pharma

 

Biotech and pharma companies have been tiptoeing around the Trump administration, worried about proposals to regulate drug prices. But companies that are now marketing their “bold” work in scientific discovery and developing new treatments largely lacked an official presence at the marches. There was some action in the Boston area, and Google spinoff Verily Life Sciences donated some funding to the San Francisco march. It’s also likely that many company scientists were marching as private citizens and not flagging their corporate affiliations. Still, their absence felt all the more notable when one speaker in Washington started attacking pharma companies for drug prices, portraying them as enemies of the broader scientific community.

 

At the rallies and marches, there was general advice given: call your representatives, don’t forget to get involved on the local level, maybe even run for office yourself. But can that spirit endure? Or will scientists simply float back into the daily grind of their labs?

 

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Bayer's New Grants4Apps DealMaker for Mature Companies

Bayer's New Grants4Apps DealMaker for Mature Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Calling all mature teams, startups and companies that have a solution ready to go! Our new Dealmaker is all about quality face time between you and our experts for one full day.

 

  • Close a potential project deal with Bayer
  • Attend the One-day matchmaking event
  • Pitch your startup and discuss possible projects

 

If there is a match, we will invite you to Berlin to pitch your solution, discuss collaboration options and close a deal. Travel expenses are on us! Find out, if there is a mutual interest to start a bigger journey together!

 

We have put together specific challenges in which we are especially interested in solving with you! Applicants are asked to address one or multiple of these challenges below. However, we are also open for other solutions that help healthcare providers or patients, as well as products dedicated to preventing or diagnosing diseases or improving pharmaceutical processes.

 

Challenges:

 

  • Artificial Intelligence
  • Data Analysis
  • IT
  • Clinical Trials
  • Nephrology
  • Women’s Health
  • Pulmonology
  • Ophthalmology

 

By the way – in case you are not aware – we are also running an Accelerator program. If this is also of interest for you, you have the option to apply.

 

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John Pharmaguy Mack at March for Science in Doylestown PA

John Pharmaguy Mack at March for Science in Doylestown PA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

My name is John Mack and I live in Newtown.

 

On Twitter I am known as PharmaGuy – that’s P-H-A-R-M-A, plus “Guy!” I PUBLISH a newsletter for the pharmaceutical industry. And I have a graduate degree in Biochemistry.

 

Every day we benefit from medicines and vaccines created by scientists who work in pharmaceutical and government-funded research laboratories.

 

We need to discover new drugs faster and defend efforts that make those drugs cheaper and more accessible to everyone.

 

In doing so, however, we also need to defend the scientific methods the drug industry uses to prove that medicines WORK.

 

A big part of that process is the Food and Drug Administration, which ensures that drugs are proven safe and effective through rigorous clinical trials.

 

Today the Food and Drug Administration and other science-based agencies like the National Institutes of Health and the Environmental Protection Agency are under attack by the current administration,

 

WHICH intends to increase SPENDING on the military and decrease SPENDING on these and other science-based agencies that help improve our lives.

 

We should not have to sacrifice science for security.

 

DEFUNDING science impacts us on a local level whether the issue is the quality of our air and water, fracking, opioid drug abuse, or the heroin epidemic.

 

We need leaders who believe in data and scientific evidence to help solve these problems.

 

More scientists must get involved in politics today just as Benjamin Franklin did during the American Revolutionary War.

 

There is a war being fought today – a war against science.

 

We must defend science in THIS war.

 

Marching together is a good first step.

 

But we must follow up by electing pro-science leaders and ensure that they rely on evidence, not beliefs, when making decisions about our health, our environment, and our general well-being.

 

Thank you for listening and may Science be with you!

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Theranos Deceived Investors and Offers Them Shares Not to Sue! Can You Believe the Gall???

Theranos Deceived Investors and Offers Them Shares Not to Sue! Can You Believe the Gall??? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Theranos allegedly misled company directors about its laboratory-testing practices, used a shell company to "secretly" buy commercial-lab equipment, and improperly created rosy financial projections for investors, according to newly unsealed court filings in a suit by one of its investors.

 

The Silicon Valley company--which once promised to revolutionize the blood-testing industry using tiny samples from finger pricks--also allegedly ran "fake 'demonstrations tests' for prospective investors and business partners" using commercial devices while pretending to showcase its own technology, according to the filings.

 

Theranos said the documents reflected a "one-sided filing by one party to litigation" and that it disagrees with much of what a hedge fund suing Theranos alleges in its complaint.

 

Meanwhile, the company plans to offer investors shares in the company in exchange for them not filing lawsuits against the embattled blood-testing company. LOL!

 

Further Reading:

  • “Not Only Investors, Patients Also Were Hurt by Criminal Theranos. Lock HER Up!”; http://sco.lt/8V3Qif
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Synthroid, aka levothyroxine, Often Prescribed for Mild Hypothyroidism, Has Absolutely No Effect on Symptoms

Synthroid, aka levothyroxine, Often Prescribed for Mild Hypothyroidism, Has Absolutely No Effect on Symptoms | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“During the past four weeks, have you been tired? Been exhausted? Had difficulty getting motivated to do anything at all?”

 

These questions — which a substantial chunk of the population probably could answer in the affirmative — appeared on a questionnaire used in a major European study published recently in The New England Journal of Medicine.

 

The authors were researching the effectiveness of a drug that is widely, if controversially, used to treat older adults with subclinical hypothyroidism, better known as a slightly underactive thyroid.

 

So many Americans take that medication — levothyroxine (brand name Synthroid) — that it topped the list of prescription drugs dispensed in the United States in 2015, according to the research firm QuintilesIMS Institute.

 

With 121 million prescriptions annually, levothyroxine outpaced statins, blood pressure meds — and everything else. A Johns Hopkins survey published last year found that more than 15 percent of older Americans were taking it.

 

So you’d think these study results would come as shocking news: The European team reported that in older people with mild hypothyroidism, the drug had no significant effect on symptoms. At all.

 

Yet once patients begin thyroid replacement, they rarely end it, even if they feel as draggy or achy as ever. “Here’s a golden opportunity for many patients to simplify their medication regimens,” Dr. Alexander said.

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Astellas Scientist Shows How to Light Ice on Fire!

Astellas Scientist Shows How to Light Ice on Fire! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Astellas YouTube channel showcases several of its scientists as part of the company's Science WoRx (get it? ie, "Rx" for prescription) project, which is a local mentoring program and online resource network for science teachers.

I think this is an interesting program because it shows us some of the real people who work in the pharmaceutical industry and how they got there.

 

P.S. Astellas says "We understand that the future of innovation lies in our children and that a child’s interest in science is sparked in the classroom," says Astellas. "We also recognize that America’s science teachers are key in igniting this spark and that it’s their commitment that compels a child’s desire to pursue their interest further. In fact, many of our own employees attribute their passion for science to dedicated science educators like you."
 

It's too bad that state governments currently under Republican rule like Wisconsin and Pennsylvania are drastically cutting funds to education and undermining the teachers that Astellas and other pharmaceutical companies depend upon to get future scientists on their payrolls. I think the drug industry needs to step forward FINANCIALLY to fill some of the void being created by draconian budget cuts. That's my opinion at least.

 

See the video here.

 

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Drug Overdose Mortality by State

Drug Overdose Mortality by State | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[From STAT Morning Rounds:] Determined to rein in the opioid epidemic, CDC director Dr. Anne Schuchat is introducing a new campaign to raise awareness about prescription drug abuse in America. The ads feature the stories of patients and families impacted by prescription drug overdoses. “A lot of times, [opioids] are prescribed without the patient asking or recognizing the harm,” Schuchat tells STAT. Health officials are trying to encourage patients to talk to their doctors from the get-go when they’re prescribed opioids. “We want the public to be comfortable asking questions. And we don't want it to be too late by the time that you're hooked,” Schuchat says. The videos will be initially be released in four states hit hard by prescription drug overdoses: West Virginia, Rhode Island, Oregon, and Ohio.

 

The agency also updated its data this week on the rate of prescription drug overdose deaths in recent years. Take a look at the shift above —the darker the color, the higher the rate of prescription drug overdose deaths — and find the full data here.

Pharma Guy's insight:

I am ashamed to say that my state - Pennsylvania - ranks number 6 in deaths dues to drug overdoses!

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Science Needs Your Cells (and Bodies at #marchforscience)

Science Needs Your Cells (and Bodies at #marchforscience) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s often portrayed as a story of exploitation. In the early 1950s, Henrietta Lacks, a poor, young African-American woman, learned she had terminal cancer. Cells collected from a biopsy of her cancer were cultured without her knowledge or permission to develop a cell line, called HeLa. Over the ensuing decades, research using HeLa cells led to scores of medical advances, saving lives — and making a lot of money for a lot of people, though not for Ms. Lacks’s family.

 

Now enter Oprah. She’s the star of HBO’s new movie “The Immortal Life of Henrietta Lacks,” based on Rebecca Skloot’s best-selling book and making its premiere Saturday night.

 

All of this has gotten people talking about the previously obscure world of research with discarded biospecimens, the parts left over after we undergo surgeries, biopsies and blood tests. Some are calling to change the rules, to require consent from patients before biospecimens are studied or to pay patients if specimens lead to medical advancements down the line.

 

Rather than demanding consent and payment, we should promote biospecimen research, shore up privacy protections and push for universal health care to ensure that the benefits of the research are available to all.

 

It’s not every day that scientists get Oprah’s help drawing attention to their work. Let’s not squander the opportunity.

Pharma Guy's insight:

I hope Oprah will be attending the March for Science, which will also draw attention to the work of scientists!

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March for Science Signage - Proof that Scientists are Nerds. Not That There's Anything Wrong with That!

March for Science Signage - Proof that Scientists are Nerds. Not That There's Anything Wrong with That! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The March for Science is expected to make history with hundreds of thousands of people attending rallies across the US and around the world on Saturday in support of science. In attendance will be not just scientists and doctors but also educators, kids, environmentalists, and others.

Of course, one of the best parts of any march is the signs — and the early evidence is that this march will definitely deliver on that front.

So, as a preview of what’s to come Saturday, we’ve rounded up the most clever signs marchers are making, and what our readers say the march means to them.

 

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Elijah Smith's curator insight, April 23, 10:52 PM
On sunday may 23rd the global march for science took place. Many of marches all across the world were filled with people to promote science. The rally was also politically charged. Many of the marchers were asking for laws to be backed by science. Also many of the marchers were opposed to Trumps denial of climate change.

Overall I think that this march was a great idea. Not only did it get people together for things they believe in, but it was to make a positive change all across the globe. The march spread awareness to keep the earth clean and also to show politicians that they should support science based policies.
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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.

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Pfizer & Wholesaler Say "Drug Addicted" Arkansas Lied to Get Drugs for Executions!

Pfizer and drug wholesaling giant McKesson, along with drugmakers Fresenius Kabi and West-Ward, have all weighed in to stop Arkansas from using their drugs in its effort to perform seven executions in short order before the drugs expire at the end of the month, exhausting the state’s only remaining, or available, supply.

McKesson was able to get a state judge in Arkansas to issue a temporary restraining order on Friday, Reuters reported. It told the judge the state has refused its demand that it return the drug, vecuronium bromide, after McKesson learned it intended to use it for executions in violation of its sales agreement.

The drug was manufactured by Pfizer, which has said it has made clear to its wholesaler and to states that still do executions that the drug, and about 15 others, are not to be sold or used for executions.

“Pfizer has twice requested that Arkansas return any Hospira or Pfizer manufactured restricted product in their possession. In addition, we considered other means by which to secure the return of the product, up to and including legal action,” Pfizer said in its statement, adding that McKesson has violated its contract with Pfizer by selling the drug to the department of corrections.

McKesson, in its defense, said in a statement that Arkansas had essentially lied to it when it bought the drug, claiming it was going to be used “for medical purposes.”

Meanwhile, Fresenius Kabi USA and Hikma’s West-Ward Pharmaceuticals have also weighed in, the New York Times reports, saying they have asked a judge to prevent the state from using their drugs, potassium chloride and midazolam, in the executions. They also claim the state got the drugs in violation of their policies against use of their drugs for executions.

Drugmakers, under pressure from groups that oppose capital punishment, began about four years ago to write contracts that restricted any of their drugs from being sold for use in drug cocktails for executions. As shortages of drugs began to impede executions, states took a variety of steps to get their hands on sufficient supplies to keep up their death penalty schedules. Sometimes legal delays would result in drugs expiring before they were used, sending states to scavenge for new supplies. Some went to compounders for drugs, and others looked to manufacturers in other countries. The FDA has also gotten involved by raising questions about states, like Texas, buying some of the drugs from manufacturers overseas.

Pharma Guy's insight:

Arkansas is addicted to drugs that kill and just like every addict it will do anything - including lying - to get hold of them!

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March for Science Gains Corporate Sponsors

March for Science Gains Corporate Sponsors | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The revolution will be on-brand, it seems. In addition to the academic and nonprofit partners of the March for Science, the event has recently been backed by a number of companies eager to align with its pro-environment, pro-science message. These partners — including biotech companies, a salon chain, and a local soap producer — are providing fundraising help and brand endorsement for the event, which in its meteoric rise has struggled with internal divisions and a series of public gaffes.

 

Companies that have joined in to help fundraise for local marches include a brewery in Chicago and a soapmaker near Boston. Some companies, like Cambridge, Mass.-based drug development firm Warp Drive Bio, have formally sponsored their local satellite marches. (The satellite events don’t receive funding from the organizers hosting the march in Washington.)

 

More expected corporate supporters — biotech and life sciences companies — have also gotten on board. Alnylam and its CEO, John Maraganore, have come out in support of the march, as has Jeff Albers, Blueprint Medicine’s CEO, and Sobi North America president Rami Levin. All of the companies cited science’s role in helping patient populations affected by diseases for which they produce pharmaceuticals as reasons why they were supporting the march.

 

The event aligns with activism that, in many cases, the companies are already engaging in. Executives from all three companies were among the 166 biotech leaders who signed an open letter criticizing Trump’s immigration order published on a Nature Biotechnology blog in February. Blueprint continues to participate in the #ActualLivingScientist campaign on Twitter, intended to raise public awareness about scientists after a survey showed most Americans could not name a single living scientist.

 

For both companies and activists, corporate endorsements can be a fraught endeavor — risking, on the one hand, diluting a movement’s message, and on the other, politicizing a brand.

 

March organizers have put together a pledge for participants that highlights the event’s intended peaceful nature and refrains from using specific partisan labels. However, recent social media posts indicate that the march may still be grappling with getting its political tone right. The main march’s Twitter account deleted tweets last week, in response to the recent strike in Afghanistan, that referred to the role of science in developing bombs. Organizers apologized for the posts’ partisan nature.

 

However, the risk to brands endorsing the march is still very low, said David Hessekiel, president of social marketing organization Engage for Good.

 

“I think that there is a tremendous body of companies whose existence is based upon science, technology, engineering, and mathematics,” Hessekiel said. “And so, within that world and within their customer base, I don’t think there’s going to be a huge controversy about them saying that science is core to their business.”

 

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Dilbert's Solution to High Drug Prices

Dilbert's Solution to High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Pharma Guy's insight:

Why not create brandname drugs as well?

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Pharma Urged to Support March for Science

Pharma Urged to Support March for Science | Pharmaguy's Insights Into Drug Industry News | Scoop.it

As scientists across the globe prepare to flood the streets to speak up for research, organizers for the March for Science have expressed their disappointment at the lack of support from the pharmaceutical industry.

 

The main march is in Washington DC on April 22 but more than 500 associated demonstrations are planned across the world. Organizers hope the events will be “the first step of a global movement to defend the vital role science plays in our health, safety, economies and governments.”

 

Huge numbers are expected and yet the pharmaceutical industry has been conspicuous by its absence in the build-up. In the UK, Sophie Morgan, organizer of the Bristol March for Science, told The Pharma Letter that, while everybody is giving their time and skills for free, there are essential safety, first aid and technology costs to raise and response from the industry itself has been poor.

 

She said that “due to the short time frame we have had for organizing the march, we have had to take the initiative to approach companies and groups. However, when we have tried to contact pharma and other large STEM (science, technology, engineering and mathematics) companies we rarely get further than the front desk and struggle to get responses to emails.”

 

Ms Morgan went on to say that “in the current climate there is a lot of insecurity regarding the future of science and scientific careers, so whilst we’ve engaged with a broad spectrum of the community, we’ve found young people, early in their now uncertain science careers, have really connected with the march ethos.” She added that “beside the obvious recruitment opportunities for pharma, it is the chance to get behind a new generation, and perhaps new more outspoken era, of scientists and say ‘we support you’.”

 

Ms Morgan concluded by making a final plea to the pharmaceutical industry: “With more than 500 marches taking place across the globe, this is an event that could be quite literally the biggest in the entire history of science. Shouldn’t an industry based entirely on science be part of it?”

 

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Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation

Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health care nonprofits backed by the pharmaceutical industry have inundated Democratic Sen. Yvanna Cancela’s inbox over the last couple of days as discussions on a major piece of legislation she sponsored continue behind the scenes.

 

Since Friday, seven groups have sent similar letters addressed generally to Nevada state senators asking them to oppose a polarizing pharmaceutical bill, SB265. All of the groups have taken money from either PhRMA, the trade association representing pharmaceutical companies in the United States and the driving force behind the opposition to the bill, or directly from pharmaceutical companies themselves.

 

Four of the seven organizations received grant funding directly from PhRMA in recent years including:

 

  • RetireSafe, a nationwide senior advocacy organization, received a $25,000 grant in 2014
  • The Epilepsy Foundation received a $25,000 grant in 2014
  • Caregivers Voices United’s affiliate Caregivers Action Network, a family caregiver organization, received $315,000 from PhRMA as a general contribution and funding to help with an event in 2014
  • National Council of Asian Pacific Islander Physicians received two $10,000 grants in 2013 and 2014

 

Many of the organizations also took money from pharmaceutical companies in 2016, including Pfizer and Sanofi, both which have registered lobbyists this session. The local nonprofit Lupus of Nevada, Inc. has also been encouraging people on Facebook to contact their legislators about the bill and provides them with a form letter, of which Cancela says she has received many copies.

 

The legislation, which Cancela introduced in February, would put price controls on diabetes medication, require pharmaceutical sales representatives to be licensed and annually report their activities and mandate disclosure of any pharmaceutical-related contributions by nonprofits in the healthcare sector.

 

The letters, which in some portions use nearly identical language, argue that SB265 could threaten access to medications by causing stockpiling in response to the required 90-day notice ahead of certain price increases, will help pharmacy benefit managers (PBMs) and insurance companies instead of patients and require nonprofits to disclose certain information about contributions they receive from pharmaceutical companies that is already publicly available — similar arguments proffered by the pharmaceutical industry in opposition to the bill.

 

Further Reading:

  • “Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists”; http://sco.lt/6wBAp7 
  • “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh 
  • “The Yin Yang of Patient Advocate Groups and the Pharma Industry”; http://sco.lt/6400R7 
  • “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh 
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Many Americans Resort to Crowdfunding to Help Pay for Expensive Medications

Many Americans Resort to Crowdfunding to Help Pay for Expensive Medications | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lonnie Cucinitti gets choked up when he thinks about all the people in his life who chipped in when he needed money for his four prescriptions.

 

The 76-year-old Texan launched a GoFundMe page in January with the hopes of collecting enough money to cover his 90-day prescriptions. He shared the fundraiser on his Facebook page, and he started receiving small donations, a few from people he didn't know.

 

Cucinitti is one of many people who have turned to crowdfunding to cover routine medical expenses. While crowdfunding is mainly used for emergency medical costs, many still turn to sites like GoFundMe for costly prescriptions, including insulin, a life-saving diabetes medication that's seen its list prices increase an average of 300% over the last decade.

 

A search for "prescription" on GoFundMe bought up roughly 13,600 results of past and current funding pages. For insulin — both for insulin pumps and the medication itself — there were almost 6,000 results. GoFundMe did not respond to requests for comment on the topic.

 

A March article in the Journal of American Medical Association took a look at crowdfunding for medical expenses. The authors noted that there's little regulation about how funding from crowdfunding sites is reported, so there's not much data about how frequently people use it to pay for medical expenses. The authors called research based on this data "long overdue."

 

"The rise of medical crowdfunding carries the promise of more efficiently matching potential donors with unmet needs in ways that may increase overall giving, mirroring emerging technologies in other industries such as ride-hailing and retail services that aim to more efficiently match supply and demand," the authors wrote.

 

At the same time, there are ethical and legal questions that may come up, especially if people are raising money for experimental treatments. The article also brought up concerns about how doctors should interact with the sites if their patients are using them.

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Pfizer’s Prevnar 13 DTC Not Effective with “Baby Boomers” Who Are Doing All They Can to Avoid Its Side Effects

Pfizer’s Prevnar 13 DTC Not Effective with “Baby Boomers” Who Are Doing All They Can to Avoid Its Side Effects | Pharmaguy's Insights Into Drug Industry News | Scoop.it

When Pfizer was gearing up to launch Prevnar 13 in adults age 50 and over, it faced a few unique challenges.

 

[Guess first two.]

 

And third? The adults Pfizer was targeting—baby boomers—felt “invincible,” she said. “To them, age is a mindset, not a number. I think many of the adults in our cohort felt like they’re doing everything possible to stay healthy ... they’re not going to get pneumonia ... that’s for older adults.”

 

So instead of trying to convince them otherwise, the pharma giant “leaned into that” mindset. “We knew in order to break through to this audience, we needed to empower them and not scare them,” Christa Albeck, senior product manager at Pfizer Vaccines, explained.

 

The result was “One Step,” a spot that featured healthy adults getting one Prevnar shot between doing a single yoga pose and eating a single blueberry. It emphasized “the notion of one and done” to people who were “otherwise primarily healthy,” Post said. In terms of staying healthy, for Pfizer’s target consumers, “Prevnar 13 was an option that was relatively simple compared with the other things they were doing,” Albeck added.

 

In the meantime, though, sales of the blockbuster shot are suffering against its previous numbers. In last year's fourth quarter, Prevnar fell significantly short of Wall Street estimates; its $1.41 billion haul came in 25% below 2015's $1.86 billion tally (read “Vaccine Business is Very, Very Good for #Pharma, Especially Pfizer!”; http://sco.lt/7kY77p).

 

In 2015, the vaccine enjoyed a “high initial capture rate of the eligible population," Pfizer said in a statement in January, leaving less “catch-up opportunity” for 2016 and beyond.

 

[Meanwhile, Gilead has another strategy to deal with those "pesky" baby boomers. Interestingly, Gilead pictures them lunging around the forest like lazy sloths rather than  exercising in gyms and yoga classes! Read: “Gilead’s New Hep C TV Campaign Urges Baby Boomers to Get Off Their Butts & Get Tested” http://sco.lt/9KSHIn]

 

Pharma Guy's insight:

Pfizer's TV DTC ad spending for Prevnar13  was #2 among the top advertised drugs in 2015: $101.7 million. See http://sco.lt/8KZEAb 

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The War Against Science Hurts All of Us

The War Against Science Hurts All of Us | Pharmaguy's Insights Into Drug Industry News | Scoop.it

My guest opinion published in the Bucks County Courier Times.

Pharma Guy's insight:

I will be speaking at the March for Science in Doylestown. Hope to see you there.

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Despite Years of "Educational" DTC Ads, 82% of Americans Unaware of Dangers of High Cholesterol

Despite Years of "Educational" DTC Ads, 82% of Americans Unaware of Dangers of High Cholesterol | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People who have high cholesterol may understand they need to manage their condition, but many aren’t sure how to do that, nor do they feel confident they can, according to a new survey from the American Heart Association.

 

The survey was conducted as part of Check.Change.Control.Cholesterol™, the association’s new initiative to help people better understand and manage their overall risk for cardiovascular disease, especially as it relates to cholesterol. Participants included nearly 800 people from across the country with either a history of cardiovascular disease (e.g. heart attack, stroke) or at least one major cardiovascular disease risk factor, (e.g. high blood pressure, high cholesterol or diabetes).

 

High cholesterol is a known risk factor for heart disease and stroke, causing about 2.6 million deaths each year. Yet, nearly half (47 percent) of survey respondents with a known history of or at least one risk factor for heart disease or stroke, had not had their cholesterol checked within the past year. Respondents with high cholesterol reported more recent testing, although 21 percent of them had not had their cholesterol checked in the past year.

 

Among other survey findings:

 

  • Most people with high cholesterol said they understood the importance of managing their cholesterol, being confused, discouraged and uncertain about their ability to do so.
  •  82 percent of all respondents identified a link between cholesterol and risk for heart disease and stroke.
  • Overall, people with a history of cardiovascular had lower perceptions of their real medical risk of cardiovascular disease.
  • Patients with a history of cardiovascular disease are at high risk for having another cardiovascular disease event, but among these patients, only 29 percent recognized they were high risk for another cardiovascular disease event.
  • Primary care providers were the healthcare professionals who participants talked about cholesterol with most often, and were more likely the ones to first diagnose high cholesterol.
  • The most common treatment recommendation given by healthcare providers were medication (79 percent), exercise (78 percent) and diet modifications (70 percent).
  • Patients with high cholesterol felt they were least informed about what should be their target body weight, the differences between the types of cholesterol (LDL vs HDL) and goals for cholesterol management.
Pharma Guy's insight:

OK, I understand you can't blame this all on the failure of direct-to-consumer advertising, but the industry's claim that such ads help educate people seems to take a big hit based on this American Heart Association survey.

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Traditional vs. Programmatic Media Buying [Infographic]

Traditional vs. Programmatic Media Buying [Infographic] | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Over the past few years, marketers have been hearing more about "programmatic media buys." So just what is programmatic buying, and should marketers trust the technology?

An infographic by Choozle lays out the differences between traditional and programmatic ad buying.

It outlines the strengths and weakness of both strategies on the basis of pricing, reporting, optimization, and efficiency.

With programmatic media buying, the buy happens via software in an automated manner, which allows for efficiencies such as one consolidated dashboard, faster turnarounds, and real-time optimization, the infographic explains.

 

Further Reading:

Pharma Guy's insight:

In this 4.5-minute audio snippet, R.J. Lewis, President and CEO of eHealthcare Solutions, talks about programmatic ad buying aka the 'Auction-based' model. He also explains how fraud in the system can be handled with technology. http://sco.lt/5sxc9p

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#Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists

#Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry is teaming up with advocacy groups that are training and even paying for patients who need their medicines to promote their causes in Washington.

 

National polls identify high drug prices as Americans’ No. 1 health care complaint (read, for example, “Kaiser Health Tracking Poll: Americans Weigh In on How to Keep Drug Costs Down”; http://sco.lt/5EGuMT),  and President Trump has declared that pharmaceutical companies are “getting away with murder”; http://sco.lt/6W2Ly5 

 

But these behind-the-scenes partnerships between the pharmaceutical industry and advocacy groups may work against reducing the price of high-price drugs. Critics say vulnerable patients are being manipulated and the goals promoted are skewed by the pharma benefactors who want faster government approval for new products and to get insurers or government programs to pay for them, whatever the price tag.

 

Dr. Ezekiel Emanuel, a bioethicist who has studied the issue, said he questions whether patient advocacy groups truly are “white knights defending the good fight.” He said research suggests that the conflicts of interest that occur when drug companies train and finance patient groups are “pretty rampant.” Emanuel co-authored a March study that found 83 percent of the 104 largest patient advocacy groups take money from the drug, medical device, and biotech industries (read "83% of Patient-Advocacy Organizations Receive Substantial Financial Support from the Drug Industry But Few Disclose How Much"). Smaller organizations are even more likely to be disproportionately dependent on industry funding for their operating budgets, he said.

 

The patient-lobbying conference, organized by the EveryLife Foundation for Rare Diseases, underlines how the financial interests of manufacturers and the medical needs of patients are intertwined.

 

More than 300 patients and advocates attended, and nearly all took part in a subsequent “Lobby Day” to visit congressional staff and lawmakers. They permitted a reporter from Kaiser Health News to observe and also join in a reception showcasing art by some of the patients.

 

Many patients were visibly sick or terminally ill. When deployed to pay visits to politicians, they add a human face to lobbying efforts around proposed legislation that affects pharma. Legislation like the Cures Act might increase spending on drug development or grease the pathway of drugs to market and with fewer regulations.

Before going to Capitol Hill, the patients and their families underwent a day of training, learning how to tell their stories. If at a loss for what to talk about, they were provided talking points on what EveryLife staffers called potential “asks.”

 

The group’s president, Dr. Emil Kakkis, is a drug industry executive. He said the foundation doesn’t “tell patients what to do on the Hill. They are given options.”

 

During one session called “Tricks of the Trade: Preparing for a Successful Meeting,” Soapbox Consulting chief executive Christopher Kush walked the audience through logistics for the next day.

 

The attendees were given a mobile app, which shows each advocate’s prearranged meeting list. Checking a map, Kush looked at the audience and said: “If you see a little dot where you live, you may have a new member of Congress—or a green check on your state, that means you have a new senator.”

 

Emanuel said he believes that patient advocacy groups should openly state their potential conflicts while participating in regulatory meetings. In addition, Emanuel said, drug and device manufacturers should annually report how much they pay patient advocacy groups just as they do with physicians and teaching hospitals.

 

Further Reading:

  • “PhRMA Deploys Scientists & Patients as Lobbyists on Capitol Hill”; http://sco.lt/5xer57
  • “How a #pharma Funded ‘Grassroots’ Patient Advocacy Campaign Changed FDA's Approval Process”; http://sco.lt/4tqlbF
  • “Pharma Lines Up Patient Groups to Fight for PDUFA Boondoggle”; http://sco.lt/6o27VZ
  • “The Ying Yang of Patient Advocate Groups and the Pharma Industry”; http://sco.lt/7q2g8f
  • “Transparency is Good in Theory, But Not in Practice”; http://sco.lt/6qCqTR
  • “#Pharma to Patient Advocacy Groups Questioning High Drug Prices: ‘Why Are You Doing This to Us?’"; http://sco.lt/4sOB7J
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
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Pharmaguy™ (@pharmaguy) is a "constructive critic" of the pharmaceutical industry. He is not shy about giving his opinion, which is respected by many insiders who share some of his views but who are unable to voice them on their own. See pharmaguy.com