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Federal Pain Panel That Bashed Anti-Oxycontin Over Rx Plan, Rife with Links to #pharma

Federal Pain Panel That Bashed Anti-Oxycontin Over Rx Plan, Rife with Links to #pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly a third of the members on a government panel that made headlines by calling an effort to curb overprescribing of OxyContin and other painkillers "horrible," have drug-industry ties.

The Interagency Pain Research Coordinating Committee is a government advisory panel of federal scientists, outside academics and patient representatives. Of the 18 committee members at a recent meeting to discuss government handling of pain issues, at least five had financial connections to painkiller manufacturers.

One, a pain specialist from Duke University, has received thousands of dollars in payments from drugmakers, including OxyContin-maker Purdue Pharma and Teva Pharmaceuticals, which sells generic painkillers. Another, a patient advocate, holds a nonprofit position created by a $1.5 million donation by Purdue.

The revelation comes after the committee last month bashed a federal plan to recommend doctors scale back on prescribing painkillers for chronic pain. The guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to highly-addictive opioid drugs, including Percocet and Vicodin.

At the time, various committee members called the proposal "ridiculous," ''horrible," and "shortsighted." A week later, the CDC said it would seek more public input on its guidelines — which were largely written behind closed doors.

The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving. Financial payments from drugmakers have been shown to shape doctors' medical decisions and researchers' conclusions. Concerns about that influence led the federal government to begin posting drug-industry payments to doctors in 2014.

Industry critics say the panelists should have disclosed their financial ties publicly at the meeting on Dec. 3, and in some cases, recused themselves from the discussion.

Pharma Guy's insight:

You might also be interested in reading this: "OxyContin Been Very Very Good to Sackler Family, Owners of Purdue #pharma"; http://sco.lt/6ke7BR 

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Pharmaguy's Insights Into Drug Industry News
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The Original Scientific Preprint Revolutionaries Were Quashed by the Medical Journal Industry

The Original Scientific Preprint Revolutionaries Were Quashed by the Medical Journal Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The movement to make biology papers freely available before they have been peer-reviewed, let alone published in a reputable journal, finally succeeded in 2013, when bioRxiv (pronounced bio-archive) was launched by Cold Spring Harbor Laboratory. But 50 years before, the National Institutes of Health tried something similar: distributing unpublished scientific papers, or preprints, to a handpicked group of leading researchers.

 

The effort was intended to speed the dissemination of potentially important advances, but it was met with such hostility from some eminent biologists and journals — one called the papers “shoddy merchandise” — that it was shut down after just six years, a historian reported recently in PLOS Biology:

 

ABSTRACT

In 1961, the National Institutes of Health (NIH) began to circulate biological preprints in a forgotten experiment called the Information Exchange Groups (IEGs). This system eventually attracted over 3,600 participants and saw the production of over 2,500 different documents, but by 1967, it was effectively shut down following the refusal of journals to accept articles that had been circulated as preprints.

 

“It’s fascinating to see that the same things happened 50 years ago,” said bioRxiv co-founder Richard Sever, who had never heard of the earlier preprint effort (which, of course, used snail mail). “The business concerns of the journals, the scientists who warned about the terrible things that would happen if information that wasn’t peer-reviewed got out — that was very much what we experienced with bioRxiv.”

 

The long-forgotten NIH effort began in 1961, when an official named Errett Albritton, then 70, dreamed up “Information Exchange Groups.” They initially consisted of “leading investigators” in a narrowly defined field, such as “computer simulation of biological systems,” found Matthew Cobb, a scientist and historian at the University of Manchester, who stumbled on dusty documents about it in the archives of Cold Spring Harbor Lab.

 

Researchers sent in drafts of their soon-to-be-published (they hoped) papers, and the NIH made copies and mailed them to members of the relevant specialty group. The idea, as one supporter wrote, was to allow scientists “to be fully informed in record time of all important developments in the field.”

 

Not everyone saw it that way. Francis Crick, co-discoverer of the double helix structure of DNA, told Albritton in a 1961 letter that “there is far too much careless and rapid communication already in every area of this field of study,” referring to genetics. “The idea of increasing it even in this semi-public manner fills me with horror.”

 

Further Reading:

  • “Medical Journals Serve as Big Pharma Drug-Marketing Platform: Study by COI ‘Enabler’”; http://sco.lt/538ZHt
  • “The Privatization of Peer Review: #BigPharma Would Benefit”; http://sco.lt/5LItc1
Pharma Guy's insight:

Does bypassing medical journal peer review fill you with "horror?" I think some pharma marketers may like the idea. But not the FDA, I hope!

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Trump Is Turning U.S. Health Agencies Into a “Pharma Swamp”

Trump Is Turning U.S. Health Agencies Into a “Pharma Swamp” | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump has vilified the pharmaceutical industry and made bold promises to lower prescription drug prices. But when it comes to staffing the health care agencies empowered to oversee those efforts, he has turned regularly to the pharmaceutical industry.

 

His Food and Drug Administration chief, Scott Gottlieb, was a longtime industry investor and adviser to major players like GlaxoSmithKline and Bristol-Myers Squibb. A senior adviser at the Health and Human Services Department, Keagan Lenihan, joined the administration after running the lobby shop for the drug and distribution giant McKesson. Tim Clark, the White House liaison for political personnel at HHS, was still lobbying for pharma company Eisai earlier this year. And Trump has a former Gilead lobbyist, Joe Grogan, reviewing health care regulations at the Office of Management and Budget. The chief of staff at HHS, Lance Leggitt, lobbied for a whole host of drug clients, even last year.

 

This week the president named Alex Azar, who spent more than a decade at the pharmaceutical giant Eli Lilly, as his health secretary nominee.

 

It’s a lengthy list that highlights just how reliant Trump is on the industry he has promised time and again to rein in. And his picks stand out when compared with those of previous administrations. In a STAT review of the public biographies of more than five dozen top health officials and advisers across the Obama, Bush and Clinton administrations, only a handful of individuals appear to have joined the administration directly from the private sector.

 

“The trends in pharmaceuticals kind of run in parallel to the trends in the financial sector and Wall Street — you have an industry that Trump ran against pretty aggressively, with pretty strident language in 2016, and he is now seeing those industries as essentially farm clubs. He’s going to bring them up to the major leagues of his administration,” said Jeff Hauser, who runs the Revolving Door Project at the Center for Economic and Policy Research. “It’s unusually stark and unapologetic.”

 

Further Reading:

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Should We Stop Suggesting Physicians are "Bought" by Pharma Gifts?

Should We Stop Suggesting Physicians  are "Bought" by Pharma Gifts? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Every few months, another study is released with the same general theme: Gifts from pharmaceutical companies compel docs to prescribe more costly drugs.

 

Last June, it was JAMA Internal Medicine suggesting that a single meal swayed doctors’ prescribing habits. Now, a review of Washington, D.C.-based physicians is again painting the entire profession in a bad light.

 

In a study published in the journal PLOS One, 2,873 Medicare Part D prescribers in the nation’s capital were analyzed based on their prescribing habits. The study found that 39% of the docs received gifts from pharmaceutical representatives in 2013—ranging from meals to ownership interest in products.

 

These physicians wrote 2.3 more prescriptions per patient claim, prescribed $450 more in medications per claim and prescribed 7.8% more branded drugs compared with those who did not receive a gift. The study also cited internal medicine and family medicine as two of the specialties most associated with significantly increased average cost of prescription claims.

 

[BTW, these were not physicians. Read “Nurse Practitioners and Physician Assistants are Also Swayed by Gifts from Pharma”; http://sco.lt/7ZWafp]

 

… to simply claim that “gift equals increased prescriptions” is not only disingenuous, it’s offensive to all doctors throughout the U.S. (not only those based in D.C.) And it is just unnecessary information to share with patients without explaining more of the details of these exchanges, which is simply not available in every case.

 

Physicians will do what is best for their patients. It’s time that studies like this start putting some facts behind their inflammatory research.

Pharma Guy's insight:

I think research results go beyond "suggesting" - there's proof! You know, based on data. Similar to how pharma is able to "suggest" that drugs work :)

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Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit

Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The U.S. Food and Drug Administration (FDA) should ban the sale of a certain hypertension medication because it can cause life-threatening health risks, Public Citizen said today.

 

Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits, the organization warned.

 

Public Citizen is petitioning the FDA to stop the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.

 

The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.

 

The petition noted that with millions of prescriptions for olmesartan-containing medications filled each year, immediately banning the drug is essential to prevent avoidable serious harm to thousands of patients.

 

In 2012, researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. By 2013, the FDA had concluded that olmesartan “can cause” sprue-like enteropathy and issued a safety warning about the medication. However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling.

 

Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication. The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.

 

In addition, many other medications exist that are equally effective for treating hypertension and do not pose these risks to patients. In short, the petitioners say, olmesartan “has unique serious risks but no unique benefit.”

 

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

Pharma Guy's insight:

Interesting that this comes when new hypertension AHA guidelines may mean millions more Rx's for such drugs.

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Which Opioid Addiction Treatment Reigns Supreme? Vivitrol or Suboxone?

Which Opioid Addiction Treatment Reigns Supreme? Vivitrol or Suboxone? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
 

A long-awaited study has found that two of the main medications for treating opioid addiction are similarly effective, a finding likely to intensify the hard-fought competition between drugmakers seeking to dominate the rapidly expanding opioid treatment market.

 

The study, funded by the federal government, compared Vivitrol, which comes in a monthly shot and blocks the effects of opioids, and Suboxone, which is taken daily in strips that dissolve on the tongue and contains a relatively mild opioid that helps minimize withdrawal symptoms and cravings.

 

Researchers found that 52 percent of those who started on Vivitrol relapsed during the 24-week study, compared with 56 percent of those who started on Suboxone.

 

But the study, conducted with 570 adults addicted mostly to heroin, also found a substantial hurdle for Vivitrol. Because the medication can be started only after a person is completely detoxed from opioids — a process that can take over a week — more than a quarter of the study participants assigned to Vivitrol dropped out before being able to take their first dose. Suboxone can be started shortly after withdrawal symptoms begin, and only six percent of those assigned to take that drug dropped out before taking an initial dose.

 

Drug manufacturers have been competing fiercely to develop and market medications to treat opioid addictions, which have propelled a steep increase in the number of drug deaths in the United States. Last year, 64,000 Americans died from drug overdoses, up 22 percent from the previous year.

 

There is significant money at stake. Under a law passed by Congress in 2016, the Trump administration is sending $1 billion to states to deal with the epidemic over the next two years, with directions to prioritize so-called medication assisted treatment. Mr. Trump’s opioid commission recently implored Congress to swiftly appropriate more money.

 

Suboxone, made by Indivior, is the older, cheaper, and much more widely studied and used of the two medications. The manufacturer of Vivitrol, Alkermes, has tried to catch up by marketing its drug as a cleaner alternative, emphasizing that Vivitrol is the only federally approved addiction medication that does not contain an opioid.

 

Vivitrol is also the most expensive addiction medication, with Medicaid paying about $500 per shot, according to Alkermes, and private insurers paying $1,000. Suboxone tends to cost a third to half as much.

 

Further Reading:

  • “Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction!”; http://sco.lt/4u7u6L
Pharma Guy's insight:

Don't you just love it when a company that helped create the current opioid addiction crisis may profit from its treatment?

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Trump Nominates a Pharma Fox to Run the HHS Henhouse

Trump Nominates a Pharma Fox to Run the HHS Henhouse | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump's pick for health secretary previously served as a high-ranking executive at a pharmaceutical company that repeatedly raised the prices of its drugs, doubling the U.S. list price of its top-selling insulin over the five years he served as a company president.

 

Trump endorsed Alex Azar, a previous deputy secretary of Health and Human Services under President George W. Bush and pharmaceuticals executive at diabetes pharmaceuticals giant Eli Lilly, as “a star for better health care and lower drug prices” on Twitter.

 

Supporters said that Azar's understanding of the complicated dynamics behind pharmaceuticals pricing would give him an advantage in figuring out how to make drugs more affordable. Critics, however, noted that Azar's tenure at Lilly coincided with massive list price increases on insulin and made him particularly ill-suited to lower drug prices.

 

While Azar led Eli Lilly's largest affiliate, Lilly USA, the U.S. list price of Humalog insulin more than doubled, from $123 per vial in Jan. 2012 to $255 per vial when he left the company in early 2017, according to data from Truven Health Analytics. Lilly, along with other insulin makers, was hit by a class-action lawsuit alleging overpricing of insulin earlier this year.

 

“Alex had a successful career at Lilly, and we wish him the best in his future work,” Lilly spokesman Greg Kueterman said in an email.

 

Azar joined Lilly in 2007 as a senior vice president of global corporate affairs and communications. He rose to become president of the company's largest affiliate, Lilly USA, in 2012. Kueterman said his responsibilities included direction over the sales and marketing operations of the entire U.S. commercial business, including diabetes.

 

“This is the terrible record on price that we saw; now we’re talking about putting him in charge of the people's health agency — what reason do we have to expect any difference?” said Peter Maybarduk, director of the Access to Medicines Program at Public Citizen, a watchdog group. “It's a pharma fox to run the HHS henhouse.”

 

Further Reading:

  • “If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse”; http://sco.lt/67pLZR
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"Abuse-Deterrent" Drugs Are Not the "Holy Grail" Pharma, i.e., Purdue, Claims It to Be

"Abuse-Deterrent" Drugs Are Not the "Holy Grail" Pharma, i.e., Purdue, Claims It to Be | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry was listed as one of the “Contributors to the Current Crisis” in the final report of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis. The report cites decades of aggressive marketing and industry-sponsored physician “conferences” aimed at expanding opioid use by minimizing the dangers of addiction. Lawsuits by state attorneys general, counties and local jurisdictions allege that the industry fostered the epidemic by overpromoting its products, while raking in billions as Americans became addicted and overdosed. “To this day,” the commission says, “the opioid pharmaceutical industry influences the nation’s response to the crisis.”

 

It sure does. In its response to an epidemic that now kills 50,000 Americans a year, the Trump administration wants to spend tens of millions of dollars in part to help the industry responsible sell ostensibly nonaddictive pain medications and “abuse deterrent” opioids that are as addictive as the original opioids.

 

Purdue executives call abuse-deterrent opioids, along with highly effective non-opioid pain products, the “holy grail” for the pharmaceutical industry.

 

“Abuse-deterrent is a marketing term used to mislead,” says Dr. Adriane Fugh-Berman, a pharmacology and physiology professor at Georgetown University who directs PharmedOut, a group that monitors pharmaceutical industry marketing efforts. “At least half of prescribers think that abuse-deterrent means less addictive.” It does not; abuse-deterrent pills are simply harder to crush or alter for injection or snorting. “It doesn’t prevent you from swallowing them, which is the most common way of abusing opioids,” Dr. Fugh-Berman said.

 

The N.I.H. began its public-private initiative this summer with a series of closed-door meetings with pharmaceutical companies and academics. An N.I.H. spokeswoman, Renate Myles, said the research would include work on non-pharmacological approaches, but “we need to develop new nonaddictive medications for pain. These medications can only be brought to market with the active participation of the pharmaceutical industry.”

 

Purdue participated in the N.I.H. initiative. In June, in response to a call for public comments, J. David Haddox, the company’s vice president for policy, sent a letter to the commission outlining Purdue’s proposed “policy options,” including recommending that the F.D.A. “convert” the opioid market to predominately abuse-deterrent formulations.

 

The commission’s report includes important recommendations like expanding Medicaid coverage for inpatient treatment; expanding treatment with buprenorphine, methadone and other medications, including some still being developed; establishing a national curriculum and standards for opioid prescribers; and expanding an alternative system of drug courts that encourage treatment. Those should be the immediate priorities, not channeling money for more meds to drug companies, from the pockets of Americans whose pain was the industry’s gain.

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johnmacknewtown's curator insight, November 11, 9:04 AM
Pharmaceutical companies that produce and market opioids need to step up with funding for solutions to the opioid addiction crisis they "contributed to". I have some ideas regarding local programs that can benefit from such funding.
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Big Pharma's Effective Tax Rate is Lower Than Yours!

Big Pharma's Effective Tax Rate is Lower Than Yours! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Pharma has had a rocky relationship with President Trump since inauguration, but the two agree on at least one thing: Corporate taxes are too high.

 

And yet the nation’s biggest drug makers aren’t paying anywhere near the top corporate tax rate Trump, and congressional Republicans, hope to slash.

 

Over the past three years, the 10 largest U.S. drug companies paid an average tax rate of about 20 percent. That’s well below the top rate, which is 35 percent. And it falls short of the 26 percent rate paid the average American worker over the same period, according to OECD data.

 

Furthermore, Big Pharma’s 20 percent tab likely overstates what drug makers are paying the U.S.

 

Further Reading:

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Why Flu Vaccines Are Not as Effective as They Should Be

Why Flu Vaccines Are Not as Effective as They Should Be | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People grumble a lot about the shortcomings of the flu vaccine, which some years offers less protection than expected. (Warning: This year may be one of them.) What they may not know is that the source of at least some of the problems is a common item found in all grocery stores and many fridges.

 

The egg.

 

The overwhelming majority of flu vaccines are made from viruses grown in eggs. This production process is inexpensive and time-tested; flu vaccines have been made this way as long as flu vaccines have been made.

 

But the process is not ideal — and it leads to issues that can undermine the vaccine’s effectiveness. Increasingly, experts are questioning whether the pros of egg production are worth putting up with the cons.

 

“We need to do a lot to improve existing vaccines. And getting away from eggs would be very valuable,” said Dr. Kanta Subbarao, director of the World Health Organization’s influenza collaborating center in Australia.

 

Further Reading:

  • “Academic Research Goes Where No Pharma was Willing to Go: Develops a Universal Flu Vaccine”; http://sco.lt/5kHIOn
  • “Your Next Flu Vaccination May Not Be as Effective as You Think”; http://sco.lt/9CKgl7 
  • “Flu Shot Doesn't Work as Well as #pharma Clinical Data Suggests”; http://sco.lt/4pRtTd 
  • "Everything You Wanted to Know About Vaccine Marketing, PR, Earned Media, Lobbying, and 'Anti-Vaxxers'"; http://bit.ly/29H0UOL 
  • “Pharma Needs to Step Up & Help Develop a Universal Flu Vaccine"; http://bit.ly/PMBalbum012913 
  • “Adults Only Really Catch the Flu About Twice a Decade, Study Suggests: Another Good Reason Not to Get Flu Vaccine”; http://sco.lt/7yRU9J 
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EpiPen Failures on the Rise Just Like Its Price

EpiPen Failures on the Rise Just Like Its Price | Pharmaguy's Insights Into Drug Industry News | Scoop.it

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Failure of EpiPens to deploy correctly have been cited in seven deaths this year through mid-September, according to reports by patients and physicians made to the U.S. Food and Drug Administration and obtained by Bloomberg News. The FDA received a total of 228 reports of EpiPen or EpiPen Jr. failures during the same time period, according to documents made available as a result of a Freedom of Information Act request. In addition to the deaths, 35 people were hospitalized, according to the reports.

 

Until now, the medical device has been the subject of controversy for a different reason. EpiPen is sold by Mylan NV, a drugmaker legally based in the Netherlands but run from Pennsylvania, that was under fire last year for significantly raising the price of the allergy shot, from about $50 for a single pen to more than $600 for a two-pack. Congress held hearings, government agencies began inquiries, and rival Sanofi sued. The Paris-based competitor claimed Mylan sought “to preserve the monopoly position of their $1 billion crown jewel” by engaging in anti-competitive conduct. Mylan has denied any wrongdoing.

 

EpiPen and EpiPen Jr. failures, meanwhile, resulted in a recall of some units in March by the company that makes the device for Mylan, Pfizer Inc.’s Meridian Medical Technologies. Mylan, which sells the drug-device combo using Meridian’s “pens,” called the defect “extremely rare” (read “A Pfizer Company that Makes EpiPen Devices Failed to Investigate Patient Deaths Says FDA”; http://sco.lt/8L7r8b).

 

Reports submitted by users to the FDA, however, show broadening accounts of malfunctions dating as far back as 2014.

 

More About EpiPen:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Pharma's CEO's Are Beholding to Wall Street, Not Patients

Pharma's CEO's Are Beholding to Wall Street, Not Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Now I [Rich Meyer, author of World of DTC Marketing blog] get that most pharma CEO’s earn a lot of money and cozy up to Wall Street but what about the rank and file under them? Do these people tell themselves the PhRMA lie about the “value” their drugs bring to society in order to cash their paychecks with a clear conscience?

 

With new cancer drugs commonly priced at $100,000 a year or more hundreds of thousands of cancer patients are delaying care, cutting their pills in half or skipping drug treatment entirely, a Kaiser Health News examination shows.

 

One-quarter of all cancer patients chose not to fill a prescription due to cost , according to a 2013 study in The Oncologist. And about 20 percent filled only part of a prescription or took less than the prescribed amount. Given that more than 1.6 million Americans are likely to be diagnosed with cancer this year, that suggests 168,000 to 405,000 ration their own prescription use.

 

It would be so easy for pharma CEO’s to hold a joint press event and inform the public that “under no circumstances should anyone enter financial consequences because of our drugs” but that would of course make the Street very unhappy.

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"The Night Of" Creator is Sanofi/Regeneron Spokesperson for Atopic Dermatitis Awareness Campaign

"The Night Of" Creator is Sanofi/Regeneron Spokesperson for Atopic Dermatitis Awareness Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

TV writer Peter Moffat has an intimate knowledge of severe atopic dermatitis; he’s lived with it for 50 years. Moffat even wrote the condition into his hit BBC series “Criminal Justice,” which became the hit HBO miniseries “The Night Of.” Both shows feature a lawyer named Stone with noticeable atopic dermatitis on his always-sandaled feet.

 

Now, Moffat has teamed up with Regeneron, Sanofi and the National Eczema Association on an atopic dermatitis disease awareness effort called “Understand AD: A Day in the Life.” The featured “day in the life” short film is one that Moffat wrote, directed and narrated to bring the reality of eczema and atopic dermatitis into clearer view. It follows a young woman with atopic dermatitis and shows how everyday items like a sink, bleach, lotion and even a hairbrush play into her life in ways they don’t for people without the skin condition.

 

“What was great about ‘The Night Of,’ among many things, was the response of the community at large to the story of (John Turturro’s character John Stone’s) disease, which probably for the first time in American television was laid out in all its proper, full story.

 

Sanofi and Regeneron market the treatment Dupixent, approved in March as the first drug to inhibit the IL-4 and IL-13 immune system pathways, and the first new treatment in years for atopic dermatitis.

Pharma Guy's insight:

Analysts expect the drug to reach peak sales of $4 billion. Whaaa! How much does this drug cost per treatment?

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America's Opioid Epidemic: From Evidence to Impact

America's Opioid Epidemic: From Evidence to Impact | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On October 30, 2017, the Clinton Health Matters Initiative and the Johns Hopkins Bloomberg School of Public Health will co-host a forum focused on elevating high-impact solutions to the nation’s opioid epidemic. Speakers, panelists, and thought leaders representing diverse stakeholders affected by the crisis will consider critical components needed to reduce the injury and death rates nationwide. Evidence-based recommendations that reflect the most current science will be the focus, and translating that evidence to action will be the goal. Speakers & Panelists 


• Ellen J. MacKenzie, PhD ’79, MSc ’75, Dean, Johns Hopkins Bloomberg School of Public Health 

• Elijah Cummings, U.S. Congressman, Maryland’s 7th District 

• President Bill Clinton, Founder and Board Chair, Clinton Foundation; 42nd President of the United States 

• G. Caleb Alexander, MD, MS, Co-Director, Johns Hopkins Center for Drug Safety and Effectiveness 

• Michael Botticelli, MEd, Executive Director, Grayken Center for Addiction at Boston Medical Center; Distinguished Policy Scholar, Johns Hopkins Bloomberg School of Public Health, Department of Health Policy and Management; Former Director of National Drug Control Policy 

• Carol Forster, MD, Physician Director, Pharmacy & Therapeutics/Medication Safety, Mid-Atlantic Permanente Medical Group 

• Tom Geddes, CEO, Plank Industries 

• Andrea Gielen, ScD, Director, Johns Hopkins Center for Injury Research and Policy 

• Jim Hood, CEO, Facing Addiction 

• Erica Poellot, Project Director, Shaping Sanctuary, Senior Community Minister, Judson Memorial Church, Director of Faith and Community Partnerships, Harm Reduction Coalition 

• Tom Synan, Chief of Police, Newtown, Ohio 

• Randi Weingarten, President, American Federation of Teachers 

• Leana Wen, MD, MSc, FAAEM, Baltimore City Health Commissioner


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Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales

Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales | Pharmaguy's Insights Into Drug Industry News | Scoop.it

You can't make this stuff up!

According to Huffington Post, "Pharmaceutical sales representatives selling an opioid-based drug 50 times more powerful than heroin filmed a company-made rap video in which they danced with a giant bottle of their deadly fentanyl spray, a federal grand jury alleged in an indictment unsealed this week (for more about that, read "Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!").

"The grand jury alleged that 'prominent' sales reps at Insys Therapeutics Inc. appeared in a 2015 music video that used a song by rapper A$AP Rocky, which was played at the company’s national sales meeting that year...Court documents didn’t say which A$AP Rocky song was used in the video, but the indictment documents strongly suggested it could be the 2012 song “Fuckin’ Problems."

Pharma Guy's insight:

The video ended with the company’s vice president of sales removing the Fentanyl Spray costume, revealing his identity. The vice president of sales, Alec Burlakoff, was previously indicted back in December. Burlakoff has been accused of trying to boost drug sales by controversial means before.

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Trump Has Not Grasped What’s Needed to Combat Opioid Crisis, Says NYT. Channels Nancy Reagan.

Trump Has Not Grasped What’s Needed to Combat Opioid Crisis, Says NYT. Channels Nancy Reagan. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In what was billed as a major speech on Thursday, Mr. Trump demonstrated that he has not grasped what’s needed to combat the opioid problem and, more important, the ways in which his own policies impede recovery for millions of Americans.

 

He declared the opioid epidemic a national public health emergency, which sounds urgent but doesn’t free any significant new money to fight it. In doing so, he ignored the plea of his own opioids commission to declare a full-on national emergency, which would immediately free billions of dollars for emergency response, addiction treatment and efforts to stop the flow of illegal opioids into the country — a comprehensive approach that is so far missing.

 

Combine this with his repeated attempts to gut health care for poor and middle-class Americans, and the president has offered few tangible solutions for a scourge that now kills about 50,000 Americans a year.

 

Mr. Trump said he would address the flow of deadly, illegal synthetic opioids into this country during his coming trip to China, and repeated old promises to stop drug trafficking from Mexico by building the wall.

 

[I predicted that Trump would bring up the issue of Mexico and the wall. Read “Thoughts on Trump Declaring Opioid Epidemic a National Emergency”; http://bit.ly/2ibl4CH]

 

He said the administration would produce “really big, really great advertising” aimed at young people because, “If we can teach young people not to take drugs, it’s really, really easy not to take them.” This is sloganeering reminiscent of the ineffective, Reagan-era “Just Say No” programs, when the ravages of drug abuse in black and Hispanic communities were treated with harsh punishment, rather than the empathy and care that is being called for today.

 

[I predicted that Trump would revive the old “Just Say No” approach. Read “Thoughts on Trump Declaring Opioid Epidemic a National Emergency”; http://bit.ly/2ibl4CH]

 

At least Mr. Trump said on Thursday that the administration planned to roll back a rule preventing Medicaid funding from being used for treatment in large inpatient addiction facilities, a recommendation made by the opioids commission in late July.

But it is still not clear who will lead the response to the epidemic, since Mr. Trump has yet to appoint a number of officials who could do so. He was forced to withdraw his nominee to head the Office of National Drug Control Policy, Representative Tom Marino, Republican of Pennsylvania, after news emerged that Mr. Marino had helped drug wholesalers make it harder for the Drug Enforcement Administration to crack down on black-market opioid distribution. Tom Price, Mr. Trump’s former health and human services secretary, lost his job because of his use of private jets.

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Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!

Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The founder of Insys Therapeutics Inc. was arrested Thursday and charged with allegedly bribing doctors to improperly prescribe Insys drugs containing the powerful opiate Fentanyl — the biggest arrest in a nationwide crackdown that’s already netted two convictions in Mobile.

 

John N. Kapoor, 74, was arrested in his home state of Arizona Thursday and charged with RICO conspiracy as well as other felonies including conspiracy to commit mail and wire fraud and conspiracy to violate the Anti-Kickback Law. To date, Kapoor is the most prominent pharmaceutical executive to be charged in any drug conspiracy.

 

John Kapoor, billionaire founder of pharmaceutical company Insys Therapeutics, was arrested and charged with leading a drug conspiracy on Oct. 26, 2017. (insysrx.com)

Kapoor, the former Executive Chairman of the Board and CEO of Insys, founded the company in the late 1990s.

He resigned after six former Insys executive board members were indicted in December 2016, though he has remained an active boardmember and majority owner of the company.

 

The month after those indictments, the Department of Justice turned its attention to Mobile, where Dr. John Patrick Couch and Dr. Xiulu Ruan — owners and operators of Physicians Pain Specialists of Alabama — were being tried on many of the same charges Kapoor himself now faces.

 

After a seven-week trial, Ruan and Couch became the first medical professionals in U.S. history to be convicted on federal RICO charges that were originally intended to combat organized crime. They were each sentenced to at least 20 years in federal prison, and the federal government has since seized millions of dollars in cash, cars and property from both.

 

What ties the two local pain docs to Kapoor are the drugs that his company produced and marketed, most notably the fentanyl-based product Subsys. Intended and FDA approved to treat “breakthrough pain in Cancer patients,” Ruan and Couch were accused of prescribing the drug to non-cancer patients without a legitimate medical purpose.

 

Further Reading:

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Trump’s National Health Emergency Falls Short. The Missing Piece? Naloxone

Trump’s National Health Emergency Falls Short. The Missing Piece? Naloxone | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Trump administration’s designation of the opioid crisis as a public health emergency on Thursday paves the way for officials to increase access to inpatient addiction treatment, redirect some federal resources, and launch a major public education campaign [but read “Does Trump's Opioid Crisis National Health Emergency Offer Anything That Hasn't Already Been Implemented?”; http://sco.lt/9B0muX].

 

But the announcement included nothing about access to naloxone, the overdose-reversal drug that first responders across the country have credited with saving innumerable lives.

 

“I think this was a missed opportunity,” said Regina LaBelle, the chief of staff for the Office of National Drug Control Policy under former president Barack Obama. “They could have purchased naloxone and distributed it to hard-hit areas, to local governments as well as to community groups.”

 

Another policy expert in Capitol Hill circles indicated the administration could also put out a bid document for drug manufacturers for naloxone and addiction treatment drugs. After negotiating a new and deeper price discount, the federal government could allow state and local governments access to the drug at the cheaper price point — an action the administration has not yet taken.

 

While LaBelle and other drug policy authorities celebrated the administration’s push to expand treatment capacity and allow telemedicine-based access to medication-assisted treatment, many said President Trump’s announcement had fallen short of recommendations from a commission he created in March to address the opioid crisis.

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Does Trump's Opioid Crisis National Health Emergency Offer Anything That Hasn't Already Been Implemented?

Does Trump's Opioid Crisis National Health Emergency Offer Anything That Hasn't Already Been Implemented? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Prescriber training

 

Trump said he would require prescribers who work for the federal government to “receive, finally, special training” for prescribing opioids. It’s not clear what sort of education campaign Trump is envisioning, but the Obama administration in 2015 also announced a training program in opioid prescribing for prescribers who worked for the federal government.

 

[In the beginning of October, 2017, the FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses for doctors, nurses and pharmacists. For more on that, read “FDA Requiring Makers of Fast-Acting Opioids to Pay for Physician Training”; http://sco.lt/5rVhVR] 

 

Pain treatment

 

Federal health officials are going to launch a task force to come up with best practices for treating pain, Trump announced. This speaks to something that is often lost when discussing the opioid epidemic: There are still lots of patients who need pain medication, and there are some concerns that because of new prescribing limits and the fear of feeding addiction, they are not able to get access to them.

 

Whatever best practices the task force comes up with will likely be scrutinized by advocates both for pain patients who worry about not being able to get medication they feel they need and those who support stronger prescribing limits. (At the event, Trump highlighted CVS Caremark’s recent announcement that it was imposing prescription limits for first-time opioid prescriptions.)

 

[Meanwhile, “Is There a Role for Medical Cannabis in Combating the Opioid Epidemic?”; http://bit.ly/CannabisRole]

 

‘Bad actors’

 

Trump said the federal government will “pretty soon” start suing “bad actors,” including people and companies that are “hurting our people.” He offered no specific details, but dozens of cities, counties, and states have filed lawsuits against drug makers and drug distributors for their alleged roles in seeding the opioid crisis.

 

[Read “Attacking the Root of the Opioid Crisis - Pharmaceutical Companies”; http://bit.ly/2tEHoNT and “Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic; http://sco.lt/6fpClt ]

 

Public education

 

Trump said “it’s really, really easy” not to use drugs if you never start — and suggested public education would be an important strategy for the government.

 

["Just Say No!"déjà vu all over again?]

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An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course!

An “Army” of Allergan Sales Reps is Being Recruited to Storm OB-GYNs Across the U.S. DTC Ads Too, Of Course! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

From where Allergan’s sitting, forthcoming uterine fibroid treatment Esmya could become a flagship product. But the company knows that getting it there won’t be easy—or cheap.

 

For one, there’s going to be “a lot of education required” to make Esmya successful, company commercial chief Bill Meury said in an interview. Currently, there are no FDA-approved treatments for uterine fibroids, and Allergan’s research suggests that many women living with the condition aren’t aware of treatment options.

 

“They’re employing various coping strategies, or just normalizing symptoms,” Meury said.

 

Allergan, though, is up for the task. The product is going to get “a great deal of investment,” starting with backing from a women’s health field force of roughly 300 representatives—an army Meury said is one of, if not the, largest in the industry. They’ll call on 20,000 OB-GYNs nationwide, and that’s where Allergan things its “excellent relationships” with OB-GYNs around the country will come into play.

 

“They know us and we know them,” thanks to oral contraceptive Lo Loestrin and estrogen replacement product Estrace, Meury said. “Esmya will fit right into that group.”

 

The company is also plotting a branded DTC campaign that will put Esmya “front and center,” Meury said, and that effort will include TV, print and social media components.

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Nurse Practitioners and Physician Assistants are Also Swayed by Gifts from Pharma

Nurse Practitioners and Physician Assistants are Also Swayed by Gifts from Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Doctors, nurse practitioners, and physicians who were given meals, fees, grants, and other goodies by drug makers were much more likely to prescribe a larger number of medicines for each patient than health care providers who did not receive such payments, according to a new study. And often, the prescriptions were written for more-expensive, brand-name drugs.

 

The study examined $3.9 million in gifts and payments made to more than 1,100 Medicare Part D prescribers in Washington, D.C., in 2013, and found those health care providers prescribed 2.3 more claims per patient than providers who did not receive anything from drug companies. What’s more, the prescriptions cost $50 more per claim, and this trend was seen among six specialties in particular.

 

Indeed, several other studies have explored the extent to which financial ties between drug makers and doctors influence prescribing. But this latest study, which was published in PLOS One, is the first to examine prescribing trends among physician assistants and nurse practitioners in response to industry largesse, as well as all prescriptions written for Medicare recipients during a specific place and time.

 

Fugh-Berman noted nurse practitioners and physician assistants play an increasingly important role in health care because they are writing more prescriptions than ever before. The study noted this number has more than doubled over the past five years. And in 2015, these health care providers wrote 676 million, or 15.4 percent, of the 4.4 billion prescriptions in the U.S. It is worth noting that drug makers are required to report payments made to physicians, but not nurse practitioners or physician assistants, to the federal OpenPayments database.

 

Among nurse practitioners, gifts and payments were associated with a significant increase in the average cost of Medicare Part D claims — $180 versus $86. Among physician assistants, there was also a significant increase in the average cost of such claims — $213 versus $63. And gifts to physician assistants were also associated with a significantly higher portion of branded drugs – 30 percent versus 17 percent.

 

Further Reading:

  • “Senate Bill Would Bring Sunshine to #Pharma Payments to Nurses & Physician Assistants”; http://sco.lt/6Y8WDh
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Celgene "Gets Away with Murder!" Raises Prices Again and Again.

Celgene "Gets Away with Murder!" Raises Prices Again and Again. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Judging by the latest pricing data, Robert Hugin is still getting away with murder.

 

Last January, the Celgene (CELG) chief executive sat alongside President Trump at a widely covered White House meeting to discuss pharmaceutical issues. The gathering was held shortly after Trump claimed drug makers are “getting away with murder” over their prices. And four months earlier, Allergan (AGN) chief executive Brent Saunders challenged other companies to hold their annual price hikes to single digits.

 

So what does Hugin do? He keeps raising prices.

 

Last week, Celgene raised the price of its best-selling Revlimid cancer treatment by 9 percent, the third time this year the biotech has taken a price hike, according to Cowen analyst Eric Schmidt.

 

In July, Celgene boosted the price by 1.75 percent after an 8 percent increase in January. The latest price hike brings the average price for Revlimid up by 14.1 percent this year compared with last year, which is well above the price increases of 11.4 percent last year and 9.4 percent two years ago, Schmidt noted.

 

But wait, there’s more.

 

Further Reading:

  • “Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion”; http://sco.lt/5kJeZV
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Is There a Role for Medical Cannabis in Combating the Opioid Epidemic?

Is There a Role for Medical Cannabis in Combating the Opioid Epidemic? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The current opioid epidemic is forcing many physicians to reevaluate their use of prescription opioids for pain control and to consider alternative pain management strategies. There is an emerging body of evidence that suggest that medical cannabis (smoked, vaporized or ingested) can effectively manage and control chronic non-cancer pain, reduce opioid consumption and help to lower opioid overdose deaths.

While cannabis is not approved as a treatment for pain in the US, there is a growing body of evidence from states where medical cannabis is legal that cannabis reduces opioid consumption in chronic pain patients. Several studies in the US and around the world showed that opioid use dropped by as much as 50% among chronic pain patients when they were given access to cannabis.

 

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Pharma Guy's insight:

Guest post by Cliff Mintz who writes for Cannabis Science Blog.

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314 Action Endorses John Mack (aka @PharmaGuy) for Local Office

314 Action Endorses John Mack (aka @PharmaGuy) for Local Office | Pharmaguy's Insights Into Drug Industry News | Scoop.it

314 Action, a nonprofit 501(c)4 that was founded by members of the STEM community, grassroots supporters and political activists who believe in science, has endorsed these scientists and other STEM leaders who will fight to protect science and stand up to climate deniers.

 

John Mack (Newtown, PA Township Supervisor)

Martin Miller (West Norriton, PA Commissioner)

Herbert Riede (Meadville, PA City Council)

Christina VandePol (Chester County, PA Coroner)

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Dear HHS: Forget About Childhood Obesity, Diabetes, Heart Disease, etc., Says Trump in Memo

By now you may have seen the media coverage of the extraordinary, secret memo leaked from the Trump White House.

 

Incredibly, this memo criticizes Trump’s former Secretary of Health and Human Services for recognizing the importance of childhood obesity. And it describes childhood obesity as “Not a priority of this administration.”

 

The memo claims childhood obesity was a priority of the high-flying Secretary “for inexplicable reasons” and that the initiative “should probably be reversed.”

 

Are you kidding me?

 

Have they seen last week’s study from HHS suggesting that childhood obesity hasn’t leveled off, but may still be increasing? Perhaps they are the only people in the country who haven’t heard that childhood obesity has tripled in the last two decades and leads to diabetes, heart attacks, and cancer—major contributors to our nation’s sky-high health care costs.

 

It gets worse.

 

The memo suggests that the Centers for Disease Control and Prevention actually “shift money away from chronic disease!”

 

Is it possible they are unaware that “chronic diseases” means diabetes, heart disease, and cancer, and that they are responsible for seven out of every 10 deaths and more than 75 percent of the nation’s $2 trillion medical care costs?

 

Please help us push back against the ignorance and short-sightedness coming out of this White House. Childhood obesity has tripled in the last two decades and leads to diabetes, heart attacks, and cancer — major contributors to our nation’s sky-high health care costs. This execrable memo needs a muscular response. Can the Center for Science in the Public Interest count on you to help?

 

Please give today. We’ll be your voice as we take on this latest Trump outrage.

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Very Few Patient Groups Don’t Take Pharma Money

Very Few Patient Groups Don’t Take Pharma Money | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most patient and consumer advocacy groups receive funds from the pharmaceutical industry, according to a new study released by the group PharmedOut.

 

Only a handful out of 7,685 health advocacy groups in the U.S. are completely independent of pharmaceutical industry money, according to a list the group released Oct. 13. PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates health-care professionals about pharmaceutical marketing practices.

 

And industry funding of patient groups, including websites and informational materials, is often not apparent to the average consumer, which could mislead consumers into believing they’re getting unbiased health advice.

 

“Industry funding is often not disclosed on websites or informational materials or is hidden,” PharmedOut Director Adriane Fugh-Berman told me in an Oct. 16 phone call. Funding and sponsorship is often very subtle and difficult to identify, she said.

 

In addition, she said, industry sponsorship can affect the stands patient and consumer groups are willing to take, she said.

 

Groups that accept industry funding are affected by that money, regardless of whether they think they are, she said.

 

"Look at the stands taken and not taken,” she said. “For example, where is the anger and outrage about drug costs?”

 

Fugh-Berman is an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center.

 

Further Reading:

  • “Pharma 'Patient Centricity' Aids & Abets the Opioid Epidemic”; http://sco.lt/5RJse1

  •  “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh

  • “Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation”; http://sco.lt/6QlP9N
  • “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh
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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