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"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic

"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Former Mississippi Attorney General Mike Moore, who famously led a campaign to punish tobacco companies for lying about the dangers of smoking, has set his sights on the pharmaceutical industry, according to Bloomberg Businessweek.

 

Moore, a University of Mississippi alumnus who served as the state’s attorney general from 1998 to 2004, was the first state AG to file a lawsuit against Big Tobacco and won the largest corporate settlement in history—$246 billion for 50 states, with the money earmarked to fund smoking cessation and prevention programs.

 

Since exiting the political sphere, Moore has continued to practice law with two partners in the Mike Moore Law Firm, headquartered in Flowood. But the national opioid epidemic has brought him back into the media spotlight.

 

 

When his nephew nearly died of an overdose of fentanyl—a powerful synthetic analog to the opium poppy and the drug that killed Prince—Moore decided the legal strategy that had proven so successful against the tobacco industry could also work against pharmaceutical companies. In the case of Big Tobacco, a coalition of state attorneys general, led by Moore, bombarded companies like Phillip Morris and RJ Reynolds with individual, costly lawsuits, forcing them into negotiating a single—and massive—settlement rather than fighting each suit separately.

 

Bloomberg Businessweek hailed Mississippi AG Mike Moore as the “Opioid Avenger.”

 

According to Bloomberg Businessweek, Moore and his legal team have assembled another coalition, including 10 states and dozens of counties and cities, to file suits against pharmaceutical companies like Purdue Pharma, Endo and Johnson & Johnson’s Jannsen Pharmaceuticals. All totaled, 40 states are looking into the viability of launching their own suits

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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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Misinfo About Health Topics is Widespread. NIH is Here to Help: 9 Qs To Help You Make Sense of Health Research

Misinfo About Health Topics is Widespread. NIH is Here to Help: 9 Qs To Help You Make Sense of Health Research | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Almost every day, new findings on medical research are published, some of which may include complementary health approaches.

Research studies about medical treatments and practices published in scientific journals are often the sources of news stories and can be important tools in helping you manage your health.

But finding scientific journal articles, understanding the studies they describe, and interpreting the results can be challenging.

One way to make it easier to understand information you find in a scientific journal is to share the information with your health care providers and get their opinions. Once you understand the basics and terminology of scientific research, you have one more tool to help you make better, informed decisions about your health.
 
Here are 9 questions that can help you make sense of a scientific research article.

Pharma Guy's insight:

Misinformation about health topics is widespread. The need for stronger science literacy efforts is especially clear in the complementary and integrative health space, where many approaches are readily available in the marketplace and are often selected for self-care. Recognition of science literacy gaps and identifying opportunities to fill them, led the National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health, to conduct a series of conversations with in-house experts across NIH and well as external stakeholders in the field.

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Healthcare Distribution Alliance Defends Law Weakening DEA. A Law It Helped Finance.

Healthcare Distribution Alliance Defends Law Weakening DEA. A Law It Helped Finance. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A major trade association for pharmaceutical distributors defended a law that weakened the Drug Enforcement Administration (DEA), while ignoring key facts about how the now-stripped power once let the agency suspend distributors that shipped alarming numbers of opioid pills.

 

The pharmaceutical industry – including the Healthcare Distribution Alliance – spent millions lobbying for the Ensuring Patient Access and Effective Drug Enforcement Act, which made it nearly impossible for the DEA to suspend drug distributors if their opioid-based painkiller shipments reached suspicious volumes, The Washington Post and 60 Minutes jointly reported (read “How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids”; http://sco.lt/6j9dAn).

 

The alliance called the DEA’s suspensions a “hit-and-miss approach” that jeopardized legitimate patients’ access to opioid-based painkillers.

 

The alliance has also argued that, prior to the new law, the DEA didn’t set clear guidance on how large pill shipments would be considered suspicious, and that the agency didn’t communicate well enough with distributors.

 

But the Healthcare Distribution Alliance ignored examples in the WaPo/60 Minutes report where the DEA suspended distributors that were shipping especially large numbers of pills.

 

In one instance, 11 million painkillers were shipped to a West Virginia county with a population of 25,000, according to the WaPo/60 Minutes investigation. In another, some Walgreens pharmacies in Florida sold more than one million opioid pills a year – nearly 14 times the number sold by a typical pharmacy.

 

The trade association also said the primary source for the WaPo/60 Minutes investigation was a former DEA official who consults trial lawyers suing the pharmaceutical industry. But the article included interviews with other several other sources and quotes from a significant number of documents.

 

The DEA’s aggressiveness with suspensions was already hampered before the law passed, according to the WaPo/60 Minutes investigation. Officials were forced to present more evidence before suspending distributors and the agency’s management became more willing to cooperate with the pharmaceutical industry.

 

Meanwhile, dozens of DEA officials left the agency and took jobs with drug companies over the past few years, according to the investigation.

 

Additionally, the Healthcare Distribution Alliance spent $3.5 million on lobbying in support of the legislation between 2014 and 2016, WaPo/60 Minutes found, which the association didn’t address in its statement.

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@Richmeyer Says Pharma Not to Blame for Opioid Epidemic

@Richmeyer Says Pharma Not to Blame for Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to the Atlantic “opioid abuse is rampant in states like Ohio, where paramedics are increasingly spending time responding to overdoses and where coroners’ offices are running out of room to store bodies. In 2012, there were 793 million doses of opioids prescribed in the state, enough to supply every man, woman, and child, with 68 pills each”. But is pharma really to blame?

 

Who is responsible for the opioid epidemic? Some attorneys general and advocates are now asking, in court, whether the pharmaceutical companies who marketed the drugs and downplayed their addictive nature can be held legally responsible for—and made to pay for the consequences of—the crisis.

 

Individual plaintiffs who have sued pharmaceutical companies over how opioids have been marketed have rarely been successful, according to Richard Ausness, a professor at the University of Kentucky College of Law. Courts have made clear that they believe that individual victims are largely responsible for their addiction. People who die of overdoses are often using the pills not as they were prescribed, but are obtaining the pills on the black market. They are disregarding doctors’ prescriptions and taking more than is safe. “It is difficult to persuade courts that FDA-approved prescription drugs are defective and that their warnings are inadequate,” Ausness said.

 

Now you can say what you want about drug company marketing and I agree they bear some responsibility, but does anyone really believe that a reputable doctor is going to believe any drug company marketing that opioids are not additive?

 

Finally, it’s no coincidence that high opioid addiction has a strong correlation with economically depressed areas of the country.   As the number of pills begins to decline heavy opioid users are going to turn to more dangerous street drugs like heroin. Let’s put the blame where it belongs.

 

Further Reading:

Pharma Guy's insight:

I have a lot of problems with Rich's position. First, he thinks doctors don't believe what pharma sales reps tell them. Maybe not now after they have read in the news how pharma sales reps lied & told them opioids are not addictive. But the over prescribing of opioids has been going on for many years and still continues. Second, he claims that when less opioids are prescribed, heavy opioid users are going to turn to heroin. Does he mean patients who get previously got legitimate opioid prescriptions? Or patients who illegally obtained these prescriptions from "pill mills?" Third, he does not specific where to put the blame but hints that low income/poverty may have something to do with it. Hmmm... now that the crisis has spread to middle income families in EVERY socioeconomic bracket, it's difficult to blame it on problems associated with low income. 

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Pharma “Patient Centricity” Aids & Abets the Opioid Epidemic

Pharma “Patient Centricity” Aids & Abets the Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The machinations of Washington are complex, but it’s hard to overstate the influence — often behind the scenes — of lobbyists. For years, the opioid industry has been funding nonprofit organizations that promote patient access to their drugs. These medical organizations pushed for Congress to approve Marino’s Ensuring Patient Access and Effective Drug Enforcement Act, which serves the interests of major drug distributors and retailers.

 

On Jan. 26, 2015, a number of organizations nominally interested in ensuring legitimate access to pain medication wrote to Marino, Rep. Peter Welch, D-Vt., Rep. Marsha Blackburn, R-Tenn., and Judy Chu, D-Calif., praising their fight for the now controversial legislation. They argued that the country needs need a balanced approach to the opioid abuse crisis that ensures access for pain patients while stopping drug abusers. Among the groups were the Alliance for Patient Access, which describes itself as “a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care” and the American Academy of Pain Management (since renamed the Academy of Integrative Pain Management), which describes itself as an organization advancing “integrative pain care approaches” defined by the National Institute of Health.

 

As of June 2017, the Alliance for Patient Access’ list of associate members and financial supporters contains over two dozen pharmaceutical companies, including Pfizer and Purdue Pharma. The latter’s marketing practices have been blamed for fueling the opioid epidemic.

 

“Federal agencies, law enforcement, pharmaceutical industry participants and prescribers each play a role in working diligently to prevent drug abuse and diversion,” they wrote. “However, it is also imperative that legitimate patients are able to obtain their prescriptions without disruption.”

 

Andrew Kolodny, the co-director of opioid policy research at Brandeis University, said this argument — that legitimate pain medication patients should not pay the price for the fight against drug abuse — is how the opioid lobby has framed (and continues to frame) the issue of prescription abuse from the beginning.

 

“These pain organizations make the case for the opioid lobby. But if you scratch the surface, you’ll find that the pain organizations that signed the letter are receiving money from the opioid lobby,” Kolodny told Yahoo News.

 

Kolodny said the opioid lobby often uses “phony front groups” to support its efforts in blocking any reduction in prescribing — and uses them very effectively.

 

An explosive investigation by the Washington Post and “60 Minutes” released Sunday revealed that Marino had accepted large donations from the pharmaceutical industry while pressing for the legislation that they favored (read “How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids”; http://sco.lt/6j9dAn).

 

The next day, Missouri Sen. Claire McCaskill, the top-ranking Democrat on the Homeland Security and Governmental Affairs Committee, announced that she would introduce legislation to repeal the law.

 

Further Reading:

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If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse

If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If Alex Azar Is Confirmed as HHS Secretary, Big Pharma’s Coup of Health Care Sphere Will Be Virtually Complete

Statement of Robert Weissman, President, Public Citizen

Note: Media reports indicate that President Donald Trump is likely to nominate Alex Azar, who served for five years as president of Lilly USA, LLC, the largest affiliate of global biopharmaceutical leader Eli Lilly and Company, to be the next U.S. Secretary of Health and Human Services.

Just days after denouncing “out-of-control” drug prices, President Donald Trump appears set to show he doesn’t mean it by naming a former pharmaceutical company executive to run the U.S. Department of Health and Human Services. If Alex Azar is nominated and his nomination confirmed, then Big Pharma’s coup d’etat in the health care sphere will be virtually complete.

In his public statements, Alex Azar has made clear that he is opposed to measures to restrain drug company profiteering and limit improper marketing and favors weaker drug safety approval standards.

Americans understand, passionately, that drug company price gouging leads to rationing of care. It is unethical and must end. Even President Trump says so. But it is highly unlikely that a pharmaceutical company executive who has made passionate arguments against price restraints is going to advance real reform. Much more likely is that he serves as the instrument by which Big Pharma aims to defend its monopolies and unaffordable prices.

The swamp only gets worse. Tom Price supported Big Pharma in the U.S. Congress. Now apparently Trump has decided to cut out the middleman, and let a pharmaceutical executive literally run the health department.

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Patients with Chronic Pain Will Help Medical Marijuana To Become Major Part Of Pharma Industry

Patients with Chronic Pain Will Help Medical Marijuana To Become Major Part Of Pharma Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to a research report by New Frontier Data, medical marijuana sales are forecast to grow to $5.3 billion in 2017, accounting for 67 percent of total cannabis sales. Medical sales in currently legal states are forecast to grow to $13.2 billion by 2025, at which point medical sales will account for 55 percent of all sales. In comparison, adult-use sales in 2017 are forecast to reach $2.6 billion, rising to $10.9 billion by 2025.

 

Medical cannabis products are known to be beneficial for such conditions as chronic pain, post-traumatic stress disorder (PTSD), sleep disorders, anxiety, nerve pain and others. “Looking at these numbers, it would appear that medical cannabis would be a drop in the bucket when it comes to impacting the total pharmaceutical industry. However, when you start to break down the numbers by specific sectors of the industry, like chronic pain or symptoms associated with chemotherapy, which are very lucrative markets for pharmaceutical companies, you will certainly see cannabis have a major impact,” said Aguirre De Carcer, CEO of New Frontier Data.

 

The research points out that the United States constitutes 35 percent of the global pharmaceutical market, the largest market in the world, and a major driver of the US economy, and it is estimated that cannabis and related products can replace $4.4 billion to $4.9 billion per year of current spending on existing treatments.

 

Further Reading:

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LIVE NOW! Addiction in America: A Nation Responds (Maybe) 


LIVE NOW: The Washington Post brings together lawmakers, industry leaders and journalists to discuss how the nation is responding to America’s opioid epidemic. The program also features an inside look at a joint Washington Post-CBS "60 Minutes" investigation on the drug industry and the U.S. Drug Enforcement Administration

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Wounded US Vets & Families of US Soldiers Killed in Iraq Sue Drug Companies Over Bribes

Wounded US Vets & Families of US Soldiers Killed in Iraq Sue Drug Companies Over Bribes | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Several US veterans and relatives of soldiers killed or wounded in Iraq sued five pharmaceutical and medical equipment makers on Tuesday, accusing them in effect of funding an Iraqi terrorist militia that killed hundreds of American soldiers following the 2003 US-led invasion.

 

The civil lawsuit, filed in federal court in Washington, accuses the multinationals of routinely bribing Iraqi Ministry of Health officials to win drug contracts when the office was controlled by the virulently anti-American Jaysh al-Mahdi, or Mahdi Army. 

 

Named in the suit are the parent companies and subsidiaries of AstraZeneca, General Electric, Johnson & Johnson, Pfizer and Roche Holding. 

 

“Defendants’ corrupt transactions aided and abetted Jaysh al-Mahdi’s terrorist operations against Americans in Iraq,” the lawsuit alleges. 

 

The lawsuit includes 27 pages of itemised deaths and injuries that US military personnel suffered in Mahdi Army attacks from 2005 to 2009 as well as claims of suffering by their relatives. Led by Muqtada al-Sadr, the radical cleric, the Shia militia was backed by Hizbollah, the Iranian-backed Lebanese terror outfit. 

 

“My hope is that we can get justice for my brother’s death and for so many others who didn’t have to die in Iraq,” said Ami Neiberger-Miller, a plaintiff. 

 

Corporate bribery helped fund the Mahdi Army’s acquisition of weapons, training and logistical support, the lawsuit claims. The health ministry and the terror group were so intertwined that US officials labelled the militia the “pill army” — a nod to Mr Sadr’s habit of paying young troops with drugs they could resell rather than cash, the suit alleges.

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Why Do We Need Drug Rebates, Anyway? Good Question Senator!

Why Do We Need Drug Rebates, Anyway? Good Question Senator! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

resSen. Lamar Alexander has a question: why do we have drug rebates, anyway?

 

“Why do we need rebates?” the Tennessee Republican asked a panel of pharmaceutical industry representatives at a Senate committee hearing. The Health, Education, Labor, and Pensions committee met Tuesday morning for the second of three hearings on drug pricing, and heard testimony from five interest groups representing companies that play different roles in getting medicines to patients.

 

Rebates are payments made by drug manufacturers to “pharmacy benefit managers,” middlemen that negotiate drug prices on behalf of companies, unions, and government agencies. PBMs come up with lists of drugs that receive preferred coverage from insurers and also arrange rebates from drug makers in exchange for favorable insurance coverage.

 

Sometimes the payments that drug manufacturers make to PBMs are passed on to insurers, and sometimes insurers pass on to patients the savings from those rebates. But the amount of those payments are kept secret.

 

Sound complicated and opaque? Alexander seems to thinks so too.

 

“Why don’t we just get rid of rebates and let you negotiate directly with manufactures, take that $100 billion a year, and just reduce the list price?”

 

Alexander turned to the drug manufacturers at the hearing, represented by Lori Reilly, executive vice president for policy, research, and membership at the trade group Pharmaceutical Research and Manufacturers of America.

 

“Would you like to eliminate rebates?” Alexander asked.

 

Find the response here…

 

Further Reading:

  • “Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?”; http://bit.ly/1T68qmn
  •  “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Trump to Mitch McConnell: "Even you" Get Away with Murder - Accepting Oodles of $ from Pharma

Trump to Mitch McConnell: "Even you" Get Away with Murder - Accepting Oodles of $ from Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump on Monday addressed a well-established tenet of life in Washington: The pharmaceutical industry has loads of money and doesn’t hesitate to spend it on Congress.

 

“They contribute massive amounts of money to political people,” Trump said during an impromptu news conference, turning to Senate Majority Leader Mitch McConnell, who was standing to his side. “I don’t know, Mitch, maybe even to you.”

 

McConnell let out a short laugh.

 

Trump was not wrong. In his last race in 2014, McConnell raked in $550,923 from the pharmaceutical and health products industries — more than any other individual lawmaker received that year, according to the Center for Responsive Politics, which analyzes political spending data from the Federal Election Commission.

 

Through a separate leadership political action committee, McConnell brought in another $244,000 from the sector, the database shows. Those figures represent contributions from both individuals employed by the industry and companies’ political action committees. And he’s on track to raise even more this year: in the current cycle, he’s already raised some $654,173 from the sector, all per the same Center for Responsive Politics data.

 

Trump’s comments came after he once again claimed that the pharmaceutical industry is “getting away with murder” with high drug prices.

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Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics

Allergan’s Tribal Warfare to Save Multi-Billion $ Blockbuster Restasis from Death by Generics | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In an unprecedented move, leading global pharmaceutical company Allergan appears to have handed its Orange Book-listed US patents covering its blockbuster dry eye drug Restasis to the Native American St. Regis Mohawk Tribe in Northern New York.  

The Tribe has granted exclusive licenses in the patents back to Allergan.  The deal will provide the Tribe, which has a population of around 13,000, with $13.75 million up-front and annual royalties of up to $15 million, (crucially, in this case) provided the patents remain valid.

Allergan may have made the move in an attempt to evade challenges from competitors at the Patent Trial and Appeal Board (PTAB) – an administrative court created in 2011 that can cancel patents – in a somewhat controversial, post-issuance review process called "inter partes review" (IPR).

IPRs against the Allergan patents were launched on behalf of generics companies Mylan, Teva, and Akorn Pharmaceuticals. They were expected to reach a result this December. 

Although the deal creates what may seem like a significant yearly dent in Allergan’s accounts, annual sales of Restasis stand at approximately $1.5 billion – second only to Allergan’s biggest-selling, wrinkle treatment product, Botox – and are expected to increase.  With the patents covering Restasis not due to expire until 2024, this multi-million dollar outlay in exchange for extra protection could turn out to be a shrewd piece of business by Allergan’s decision makers.

IPRs were authorised by the 2011 America Invents Act and have arguably revolutionised the way and regularity in which patents are challenged in the USA.  While invalidating a patent via litigation in federal court typically costs millions of dollars, invalidating a patent through the IPR process costs the challenger the relative bargain of a few hundred thousand dollars.  This is similar to the European post-grant opposition process.

The Tribe is, in theory, able to file a motion to dismiss the ongoing IPRs against the granted Restasis patents on account of its “sovereign immunity” status. 

IPRs were designed to improve the US patent system, and quickly and efficiently settle patent validity disputes on novelty and obviousness.  Statistics have shown that fewer IPR petitions are brought against biotech and pharma patents, and there is a lower rate of invalidation of these compared to all technical fields combined, but Allergan have seemingly gone on the defensive early doors. 

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How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids

How Congress Allied with Drug Company Lobbyists to Derail the DEA’s War on Opioids | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.

 

By then, the opioid war had claimed 200,000 lives, more than three times the number of U.S. military deaths in the Vietnam War. Overdose deaths continue to rise. There is no end in sight.

 

A handful of members of Congress, allied with the nation’s major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law, undermining efforts to stanch the flow of pain pills, according to an investigation by The Washington Post and “60 Minutes.” The DEA had opposed the effort for years.

 

The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.

 

The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar. Marino spent years trying to move the law through Congress. It passed after Sen. Orrin G. Hatch (R-Utah) negotiated a final version with the DEA.

 

As Rep. Tom Marino’s Pennsylvania district was reeling from the opioid crisis, he sponsored a bill that, current and former Drug Enforcement Administration officials say, undermined the DEA's efforts to stop the flow of pain pills. 

 

For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales.

 

The new law makes it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies, according to internal agency and Justice Department documents and an independent assessment by the DEA’s chief administrative law judge in a soon-to-be-published law review article. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.

 

Political action committees representing the industry contributed at least $1.5 million to the 23 lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $106 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.

 

“The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.”

 

Further Reading:

Pharma Guy's insight:

No wonder that Pennsylvania Underestimates Death Due to Opioids by More Than Half!: http://sco.lt/93iR3h 

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Ad Revenue Drops Sharply in 1st Half of 2017 for Medical Journals - Except Oncology!

Ad Revenue Drops Sharply in 1st Half of 2017 for Medical Journals - Except Oncology! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Journal ad revenue in the first half of 2017 was down nearly 17% against the year-ago period, but it shouldn't come as a surprise. Two possible reasons: First, established brands with money to spend will continue to spread it across channels, but smaller ones' dollars have shifted to other media. And second, a younger generation of planners aren't as sold on print as their predecessors. Perhaps the most pressing question is whether this is a blip on the radar or the beginning of the end.

See the top 5 journals ranked by revenue, the top 25 advertised brands, and the top 25 advertised categories here.

 

Further Reading:

“Reports of the Demise of Medical Journal Ads Have Been Greatly Exaggerated”; http://sco.lt/6kNvRx

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“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing

“F*** Silver Linings and Pink Ribbons”: A Cancer Patient’s Critique of Cancer Healthcare Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Lori Wallace is dying of breast cancer. As Wallace's cancer has progressed over the past seven years, she has become more critical of what she sees as excessive positivity in health care marketing. It's everywhere: TV ads, radio commercials, billboards. The advertisements feature happy, healed patients and tell stories of miraculous recoveries. The messages are optimistic, about people beating steep odds. Wallace says the ads spread false hope, and for a patient like her, they are a slap in the face.

 

A couple of decades ago, hospitals and clinics did not advertise much to customers. Now, they are spending more and more each year on marketing, according to university professors who study advertising, and are keeping track.

 

Wallace pulls up an ad on her computer from UCSF Benioff Children's Hospital, in San Francisco. An announcer intones, "Amid a thousand maybes and a million nos, we believe in the profound and unstoppable power of yes."

 

There is a similar kind of optimism at the heart of a lot of the ad campaigns by health care providers — with slogans like "Thrive" and "Smile Out." Wallace says the subtext of the ads is that people like her — who get sick and will die — maybe just aren't being positive enough.

 

Karuna Jaggar is executive director of Breast Cancer Action. She says health care providers are following in the footsteps of other companies.

 

"It's the basics of marketing," Jaggar says. "In order to sell products or services, you have to sell hope."

 

She says health care advertisers are adopting the kind of optimistic messaging that really began in force with the pink ribbons and rosy depictions of breast cancer.

 

The hospital ads Wallace is objecting to tug at emotions, just like other advertising that is trying to win over consumers. With increasing health care costs and choices, patients are shopping around for care. Tim Calkins is a professor of marketing at Northwestern University. These days, he says, hospitals have to sell themselves.

 

Hospitals are spending more than ever on advertising, he says, and, as with other products, that advertising is filled with lots of promises. He says you don't see the same promises in the pharmaceutical industry. Their ads are regulated by the Food and Drug Administration, which is why they have to list all those side effects and show scientific backing for their claims.

 

"Hospitals aren't held to any of those [FDA] standards at all," Calkins says. "So a hospital can go out and say, 'This is where miracles happen. And here's Joe. Joe was about to die. And now Joe is going to live forever.' "

 

Lori Wallace is not going to live forever. Before cancer, she says, she would have been attracted to the messages of hope. But now, she says, she needs realism — acceptance of both the world's beauty and its harshness. She wrote an essay about that for the women in her breast cancer support group.

 

The essay is titled "F*** Silver Linings and Pink Ribbons." Wallace reads me the whole piece from start to finish. We are sitting at her kitchen table. Her son is nearby with his pet snake.

 

Toward the middle of the essay, Wallace writes, "My ovaries are gone, and without them my skin is aging at hyperspeed. I have hot flashes and cold flashes. My bones ache. My libido is shot and my vagina is a desert."

 

"That's what I wrote," Wallace says. "That's what I wrote. Brutal honesty."

 

Further Reading:

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Only Half of New Cancer Therapies Help Patients Live Longer

Only Half of New Cancer Therapies Help Patients Live Longer | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Only about half of the cancer drugs approved by the European Medicines Agency in the last few years were later shown to help patients live longer or improved their lives, a new study says.

 

Scientists in Britain and Latvia analyzed reports from the European regulator on cancer approvals from 2009 to 2013. Many of the approvals were based only on initial measures that suggested the drug might improve health, like tumor shrinkage.

 

During that time, the EMA green-lighted 48 drugs for 68 different uses. Of those, the researchers determined that 35 approvals significantly improved patient survival or their quality of life, while data for 33 uses were “uncertain.”

 

Many regulators, including the U.S. Food and Drug Administration, often OK drugs based on initial surrogate measures because it can take many years before solid data about the drugs’ effectiveness exists. In the study, 39 of the 68 approvals relied on surrogate measures.

 

“We were quite surprised about the high proportion of drugs entering the market without evidence,” said Huseyin Naci, of the London School of Economics and Political Science, one of the study’s authors.

 

Further Reading:

“Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”; http://sco.lt/8UsdHd

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"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic

"Opioid Avenger" Fights Big Pharma - 40 States May Join In Fight Against Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Former Mississippi Attorney General Mike Moore, who famously led a campaign to punish tobacco companies for lying about the dangers of smoking, has set his sights on the pharmaceutical industry, according to Bloomberg Businessweek.

 

Moore, a University of Mississippi alumnus who served as the state’s attorney general from 1998 to 2004, was the first state AG to file a lawsuit against Big Tobacco and won the largest corporate settlement in history—$246 billion for 50 states, with the money earmarked to fund smoking cessation and prevention programs.

 

Since exiting the political sphere, Moore has continued to practice law with two partners in the Mike Moore Law Firm, headquartered in Flowood. But the national opioid epidemic has brought him back into the media spotlight.

 

 

When his nephew nearly died of an overdose of fentanyl—a powerful synthetic analog to the opium poppy and the drug that killed Prince—Moore decided the legal strategy that had proven so successful against the tobacco industry could also work against pharmaceutical companies. In the case of Big Tobacco, a coalition of state attorneys general, led by Moore, bombarded companies like Phillip Morris and RJ Reynolds with individual, costly lawsuits, forcing them into negotiating a single—and massive—settlement rather than fighting each suit separately.

 

Bloomberg Businessweek hailed Mississippi AG Mike Moore as the “Opioid Avenger.”

 

According to Bloomberg Businessweek, Moore and his legal team have assembled another coalition, including 10 states and dozens of counties and cities, to file suits against pharmaceutical companies like Purdue Pharma, Endo and Johnson & Johnson’s Jannsen Pharmaceuticals. All totaled, 40 states are looking into the viability of launching their own suits

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California Delivers Blow to Pharma: Requires Drug Price Transparency

California Delivers Blow to Pharma: Requires Drug Price Transparency | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a blow to the pharmaceutical industry, California Gov. Jerry Brown on Monday signed a bill into law that requires drug makers to explain and justify price hikes, making this the latest state to actively address the high cost of medicines.

 

The bill, which was vociferously fought by the pharmaceutical industry, is set to become one of the more comprehensive state efforts to address pricing transparency.

 

For instance, drug makers have to provide 60-day notice to insurers and government health plans before increasing list prices of any medicine that costs more than $40 by at least 16 percent in a two-year period. And health plans have to provide detailed information about prescription drug costs and the portion of premiums attributed to this expense. (Here is a fact sheet on the bill.)

 

“Californians have a right to know why their medical costs are out of control. This measure is a step in bringing transparency, truth, exposure to a very important part of our lives – that is, the cost of prescription drugs,” said Brown at a ceremony where he signed the bill into law, which goes into effect on Jan. 1 (you can watch the ceremony here).

 

“It’s a monumental achievement for the entire nation,” state Sen. Ed Hernandez said last month after the state legislature sent the bill to Brown. The legislation “will set national health care policy, having impact for consumers and providers in other states.”

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Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media

Merck Will Try Belsomra Ads Without Mascots and Focus on Digital Media | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Belsomra's furry word creatures have officially retired. Merck & Co.'s "sleep" cat and "wake" dog in the insomnia drug's first wave of TV ads are giving way to a new empathy-oriented campaign that builds on sleepless patients' personal frustrations.

 

In a new TV ad begun last week, a woman turns off her television, shuts the curtains, dims the lights and turns off her phone before lying down to sleep. But one by one, the devices turn themselves back on to keep her awake.

 

“The original ad served its purpose. We were a very late entrant to the market, and at the time, the team felt we needed to break through,” said Doug Black, U.S. marketing leader for insomnia at Merck. “What we’ve learned since then as we’ve listened to our consumers, is that to reach a broader audience, we needed to find a more empathetic message.”

 

The original ad did “tremendously well” in launching the brand, he said, but the time had come for a change to the more empathetic and customer-focused message.

 

Another change is the emphasis on mechanism of action (MOA). In the furry creature words ad, there was a dedicated push to explain the market-differentiating MOA for Belsomra versus that of competitors already on the market. Now, Merck is backing off MOA as a focal point, although the marketing does still mention its differences.

 

Black explained the change to focus on efficacy “because ultimately, for a broader audience, efficacy is the main driver. … If the product doesn’t work the way you want it to, it doesn’t matter what the MOA is.”

 

The TV ad will run selectively, he noted, with the bulk of Belsomra’s ongoing effort in digital. Thanks to the earlier campaign and market experience since the drug's launch in 2015, the brand team has learned how to craft and optimize its digital media mix to reach potential patients all along their journeys, Black said.

 

Further Reading:

 

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Women of Color in Pharma Marks Official Launch with First Annual Conference

Women of Color in Pharma Marks Official Launch with First Annual Conference | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Women of Color in Pharma (WOCIP) today announced that its official launch will take place at the WOCIP first annual conference, scheduled for Sunday, November 5 and Monday, November 6, 2017 in Princeton, N.J. WOCIP is a professional society focused on fostering the growth and development of Black and Latina women in the pharmaceutical industry. WOCIP enables the cultivation of a sustainable pipeline of Black and Latina women leaders who, together, can harness the power of their diverse expertise, bringing a competitive advantage to industry.

"WOCIP's vision is to enable the transformation of the pharmaceutical professional landscape with women of color," said co-founder Charlotte Jones-Burton, M.D., M.S. "Our mission is to empower women of color in pharma to excel in their personal and professional development and to transform their pathway within the pharmaceutical industry."

Speakers at the first annual conference include representatives from pharmaceutical companies and contract research organizations. Wanda Bryant Hope, Chief Diversity Officer for Johnson & Johnson, will deliver the keynote address. Other speakers include Michelle Amador of Covance, Marisa Co of Bristol-Myers Squibb, Cristina Santos of Sanofi, and Celeste Warren of Merck. The conference is co-sponsored by Bristol-Myers Squibb and Novo Nordisk, with generous support from Covance.

"The conference theme is 'Get Inspired. Be Empowered,'" said co-founder Patricia Cornet, M.A. "We welcome colleagues in the pharmaceutical industry who are interested in engaging in professional development, networking and discussing key areas that are shaping the pharmaceutical landscape for WOCIP to join us."  

The Conference opens with a welcome reception on Sunday, November 5 at 6 p.m. at the Hyatt Regency in Princeton, N.J. The full-day conference is Monday, November 6 at 8 a.m. at the Novo Nordisk Inc. training facility in Princeton, N.J. To register, visit the WOCIP website http://wocip.org/conferences/

About Women of Color in Pharma (WOCIP)

Women of Color in Pharma (WOCIP) is a 501(c) (6) non-profit corporation whose purpose is to promote the development and advancement of women of color who are employed in the pharmaceutical industry. Founded in March 2015 by Charlotte Jones-Burton, M.D., M.S. and Patricia Cornet, M.A., WOCIP has an informal network of approximately 500 members and is supported by member dues and corporate sponsors. For more information, please visit http://wocip.org/.

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Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines

Botox - the Duct Tape/Swiss Army Knife of Drugs - Approved for Forehead Lines | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan’s Botox, which the company has called a “pipeline in a drug,” has delivered again.

On Tuesday, the FDA approved the blockbuster product to temporarily improve the appearance of certain forehead lines in adults. The green light marked the med’s third cosmetic indication—it also bears go-aheads to treat crow’s feet and glabellar lines—and makes it the only neurotoxin that can boast approvals in three separate facial treatment areas.

The approval presents another opportunity for Allergan in an aesthetics market that company CEO Brent Saunders has called the best market in the world.

“It's high-quality, it's cash-pay, it's global,” he said on this summer’s second-quarter earnings call. “We are just at the initial stages of market development in the U.S. and almost every market in the world. So we have very high conviction around the sustainability,” he added.

 

Further Reading:

  • “Allergan CEO Brent Saunders is Not Just a Botox Fan, He's Also a Botox User!”: http://sco.lt/4jUjmD
  • Botox, the Swiss Army Knife of Drugs, Featured on Cover of Time Magazine”; http://sco.lt/56XOfB
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Whoops! STATnews Forced to Retract Op-Ed Ghostwritten by Industry-Funded Alliance for Patient Access

Whoops! STATnews Forced to Retract Op-Ed Ghostwritten by Industry-Funded Alliance for Patient Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In an era of widespread calls for action to tame skyrocketing prescription drug costs, one organization consistently opposes measures to rein them in: the Alliance for Patient Access (AfPA).

 

The AfPA claims it’s trying to ensure patients have access to FDA-approved therapies. However, its track record shows it pushes platforms that help drug companies’ bottom lines. HealthNewsReview.org frequently writes about how patient advocacy groups are co-opted by drug industry funding, but the AfPA is something different, observers say: a front group established solely to do the bidding of industry.

 

To advance its agenda, the AfPA often uses politicians and the news media, and rarely are its deep pharmaceutical connections called out.

 

Recently, for example, STAT ran a ghostwritten op-ed piece from an AfPA board member that extolled a $24,000-a-year drug to treat psychosis related to Parkinson’s disease. The op-ed was retracted after HealthNewsReview.org discovered and reported that it was ghostwritten.

 

Asked about STAT’s participation with the AfPA and other industry partnerships, Executive Editor Rick Berke told HealthNewsReview.org Managing Editor Kevin Lomangino: “Every partnership we enter into, we think about the optics and appearances. We’re comfortable with the decisions we’ve made. They may not be up to your standards but they’re up to our standards.”

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He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent

He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent | Pharmaguy's Insights Into Drug Industry News | Scoop.it

His face is everywhere: in TV commercials during late-night comedy shows, in the pages of Wired and Politico, on a billboard at the airport near Washington, D.C.

 

Brian Kursonis, who was diagnosed last year with early-onset Alzheimer’s at age 55, is a star of the drug industry’s “Go Boldly” campaign — a sophisticated PR push, costing tens of millions a year, to highlight pharma’s commitment to develop cures for dreaded diseases.

 

The ads might improve pharma’s battered reputation. But behind the soft lighting and inspiring music, the patient who’s helping anchor the campaign says his life is falling apart.

 

He is living alone, after a nine-year relationship broke up as his memory deteriorated. He had to give away his beloved dogs. He loves fly-fishing, but forgets how.

 

And he is fast running out of money.

 

Kursonis hopes he can find a way to earn a living as an advocate, but if money doesn’t come in soon, he won’t be able to make the December rent on his spartan apartment in a suburb outside Charlotte, N.C. He fears he will soon be homeless, his best option the men’s shelter in downtown Charlotte.

 

Kursonis’s story highlights the complicated, often heartbreaking realities that compound the challenges of living with a disease like Alzheimer’s.

 

In the “Go Boldly” ads — which were funded by the drug industry lobbying group PhRMA — he’s paired with a scientist who promises to bring an Alzheimer’s drug to patients in her lifetime. Even if she succeeds, a long shot in a field that has been marked by failure after failure, Kursonis knows it will likely be too late to help him and millions of other patients in the grip of the degenerative disease.

 

Now, he’s begun speaking candidly about his challenges — both on his blog and in interviews with STAT — in hopes of raising awareness and building a new career as a patient advocate.

 

“I want people to know, if I disappear, that at least I tried,” Kursonis said.

 

Further Reading:

Pharma Guy's insight:

The only option is for him to become a paid Alzheimer's patient advocate. Good luck with that! There will be many more patients vying for that opportunity.

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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