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The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts

The $70 Million Breast Job: That's What J&J Must Pay to Male Teen Who Took Risperdal and Developed Large Breasts | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a blow to Johnson & Johnson, the company was ordered last Friday to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug.

In reaching its decision, the jury found that J&J failed to properly warn Risperdal could cause gynecomastia, which is the abnormal development of large mammary glands in males. Moreover, the jury also determined that the company “intentionally falsified, destroyed, or concealed records” that Risperdal could cause boys to develop breasts.

Last week’s verdict, which only included compensatory damages, dwarfs the $2.5 million that was awarded last year to an Alabama man, who sued J&J after he developed size 46 DD breasts. The latest case was brought by Andrew Yount, who was born in 1998, and was given Risperdal in 2003 to treat a psychiatric problem, according to one of his attorneys.

Pharma Guy's insight:

Speaking of films, Two "Unbroke Girls" & George Clooney Aim to Give J&J Its Comeuppance in New Film “America’s Most Admired Lawbreaker”; http://sco.lt/7Gz2q9 The film should depict "How Gorsky Drove 46% - 66% of Risperdal Sales for Off-Label Use"; http://sco.lt/7gkFl3 

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Why cancer patients don't have enough information to make decisions about their treatments

Why cancer patients don't have enough information to make decisions about their treatments | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At a time when expensive new cancer treatments are proliferating rapidly, patients have more therapy choices than ever before. Yet they are largely kept in the dark because their doctors either can’t or won’t communicate clearly. Many patients compound the problem by avoiding news they don’t want to hear.


Via Richard Meyer
Pharma Guy's insight:

Doctors also may not have enough information about oncology drugs: http://sco.lt/95IUzZ

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STAT forecast: Opioids could kill nearly 500,000 in U.S. in next decade

STAT forecast: Opioids could kill nearly 500,000 in U.S. in next decade | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Opioids could kill nearly half a million people across America over the next decade as the crisis of addiction and overdose accelerates.

Deaths from opioids have been rising sharply for years, and drug overdoses already kill more Americans under age 50 than anything else. STAT asked leading public health experts at 10 universities to forecast the arc of the epidemic over the next decade. The consensus: It will get worse before it gets better.

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Purdue Lawyers Up: Says Public "Has No Right Whatsoever" to See "Secret' Documents About Oxycontin Marketing

Purdue Lawyers Up: Says Public "Has No Right Whatsoever" to See "Secret' Documents About Oxycontin Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A state appeals court Monday heard arguments over whether secret records regarding the marketing of the powerful prescription opioid OxyContin should be released to the public.

A three-judge panel of the Kentucky Court of Appeals is considering a request from OxyContin maker Purdue Pharma to overturn a lower court ruling ordering the release of the documents — the result of a motion filed by STAT. The records include a deposition of Dr. Richard Sackler, a former president of Purdue and a member of the family that owns the privately held Connecticut company.

 

Lawyers for Purdue and STAT made their arguments during a 30-minute hearing, interrupted occasionally by questions from presiding Judge Glenn Acree. At the end, he said the panel would try to issue a ruling within 30 to 45 days.

 

Much of the hearing focused on a key question: Did Pikeville Circuit Court Judge Steven D. Combs, who ruled last year that the records should be unsealed, have discretion to release documents that the two parties to the case — Purdue and the state of Kentucky — had agreed to keep secret.
 

The records were filed as part of a lawsuit brought by the state against Purdue alleging that the marketing of OxyContin helped create a wave of addiction and related crime. That case was settled in December 2015, with Purdue making a $24 million payment to the state.

 

Jon Fleischaker, a Louisville lawyer representing STAT, said trial courts in Kentucky have great discretion to open their files. “This is more than a private dispute resolution,” he argued, noting that the public has a right to know what went into the settlement between the state and the drug company. “How did the court behave? How did the attorney general behave? Was it settled for too little or too much? You’re dealing with public offices and public trust in the system.”

 

His comment came in response to a question from Acree about the extent to which a trial judge is obligated to honor an agreement between lawyers that documents will be kept secret.

 

Purdue’s lawyer, Daniel Danford of Lexington, Ky., said there was no common right of law “to pry into affairs of individual litigants.” He added that “merely filing a document does not make it public.” The key, he said, was whether it’s a “judicial document” — one that the court relied on in making its rulings in the case. Most of the documents were filed in court by the Kentucky attorney general to support motions made before the suit was settled, and Purdue has argued that none of those motions were ruled on by the trial court.

 

“The public has no right of access to them whatsoever,” Danford said.

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Stop Picking on Docs That Receive Free Lunch from Pharma. The Real Problem is Members of Congress Accepting Gifts!

In a recent Washington Post op-ed, Dr. Nicole Van Gronigen made the case that Big Pharma successfully influences physician prescribing behavior via marketing. Specifically, drug reps do with with free lunches provided by the pharmaceutical reps, or educational dinners at nice restaurants. She reported a JAMA study correlating industry-sponsored meals with increased promotion of branded medication to Medicare patients.

 

It's no surprise that marketing works. If it didn't, Big Pharma would not spend $24 billion per year on it -- more than they spend on research and development. And perhaps, as Dr. Van Gronigen suggests, restricting pharma reps' access to physicians may yield cost savings in healthcare. But is it really that simple?

 

In my retina practice, if I prescribe an expensive eye drop made by the pharma company that brought Chick-fil-A lunch for my office staff the previous week, I will get usually a call from the pharmacy telling me my patient cannot afford the expensive drop, requesting a cheaper alternative. Problem solved.

 

In my retina practice, if I prescribe an expensive eye drop made by the pharma company that brought Chick-fil-A lunch for my office staff the previous week, I will get usually a call from the pharmacy telling me my patient cannot afford the expensive drop, requesting a cheaper alternative. Problem solved.

 

The real question is, why are physicians the only ones under scrutiny for payments received from industry? Over $3 billion per year is spent lobbying Congress and federal agencies to influence laws and government contracts, potentially costing taxpayers hundreds of billions of dollars. They influence members of Congress not with a few slices of pizza for lunch, but with all-expense paid African safaris for lawmakers and their families.

 

Physician morale continues to decline due to changing payment and delivery models. Going after doctors who accept a free lunch or occasional restaurant dinner, along with a chance to interact with colleagues and hopefully learn something, may be an easy way to save a few dollars. But that's a red herring when it comes to the cost of care. There are already more powerful cost saving mechanisms in place that don't involve beating down members of an already demoralized profession.

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Astellas UK Slapped on Wrist by ABPI for "Lamentable Lack of Concern for Patient Safety"

Astellas UK Slapped on Wrist by ABPI for "Lamentable Lack of Concern for Patient Safety" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Astellas’ U.K. unit was already suspended from the Association of the British Pharmaceutical Industry thanks to what the trade group last year called “serious breaches” of its code of practice. And now, that suspension has been extended.

The organization has tacked another 12 months onto Astellas’ penalty, it said Friday, citing cases that “have shown wholly inadequate oversight and control at both Astellas UK and Astellas Pharma Europe and a 'lamentable lack of concern for patient safety.'” And the re-suspension very nearly became an expulsion, it noted.

The extra 12 months come in response to three new cases that Astellas voluntarily served up over the course of audits this April and last September. One case “highlighted a lack of oversight and training of agency nurses who delivered patient support programs, including failing to update them with product changes,” the ABPI said. Two others focused on “failures to update and provide complete prescribing information for a number of medicines.”

All three of these instances raised “very serious concerns around patient safety,” the ABPI said, adding that Astellas UK’s “failure to understand the scale of the problem was concerning.”

As for Astellas, it said Friday that "we deeply regret our failings, and in light of this we have reinforced our focus on patient safety. We are committed to providing the highest standards of care for everyone who relies on our medicines and services."

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Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage

Patient Advocates Should Have Fought For Affordable Duchenne Drug as More Insurers Deny Coverage | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The story of Exondys 51 raises complex and emotionally charged questions about what happens when the F.D.A. approves an expensive drug based on a lower bar of proof. In practice, health insurers have taken over as gatekeeper in determining who will get the drug.

 

Disputes like the one over the Duchenne drug are likely to become more commonplace in the coming months. A federal law, passed last year, directs the agency to remove barriers to approving drugs and medical devices, and its new commissioner, Dr. Scott Gottlieb, has called on the F.D.A. to be more lenient, especially when it comes to rare pediatric diseases.

 

While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases.

 

The agency’s approval of Exondys 51, though, prompted a rebellion among some insurers, who are refusing to play along and saying they are concerned about the cumulative impact of such breathtakingly expensive drugs on health care costs. Anthem, one of the nation’s largest insurers, calls Exondys 51 “investigational” because the F.D.A. reserved the right to withdraw it from the market if future clinical trials fail to show it works.

 

Another insurer, Premera Blue Cross, went so far as to tie coverage to an invasive procedure — a muscle biopsy — but then rescinded the requirement.

 

“I’m reading a lot of denial letters,” said Christine McSherry, who until recently served as executive director of the Jett Foundation, an advocacy group that guides families through the insurance appeal process. Her insurer, Blue Cross Blue Shield of Massachusetts, is covering the drug for her son, Jett, through next April. “It’s very disheartening to have worked that hard, and to have sacrificed that much, and to now have to battle the insurance companies.”

 

The drug’s high cost is driving the resistance. While the drug manufacturer, Sarepta, has said Exondys 51 costs about $300,000 a year per child, the price, based on a child’s weight, can be much higher. For the dozen boys in the main clinical trial, the average list price would be more than double Sarepta’s quote — $750,000 each, according to an analysis by the drug benefit firm Prime Therapeutics.

 

“I think a lot of the advocates in this space maybe thought that getting a drug on the market was the goal of their advocacy,” said Dr. Aaron S. Kesselheim, an associate professor of medicine at Harvard University who voted against the drug’s approval as part of an F.D.A. advisory committee. “The goal of the advocacy should have been getting a product on the market, and making sure that it’s available at a reasonable cost.”

 

Further Reading:

  • “2nd Largest Health Insurer – Anthem – Won’t Pay for FDA-Approved Duchenne Drug”; http://sco.lt/6hlYP3
  • “FDA’s Approval of Exondys 51 for DMD Was Primarily Based on Money, Not Efficacy”; http://sco.lt/62xNoH
Pharma Guy's insight:

This article also points out that this may be a trend for expensive drugs that are approved for rare diseases: "While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases."

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Trump Is Letting Pharma Continue to "Get Away With Murder!"

Trump Is Letting Pharma Continue to "Get Away With Murder!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the early days of his administration, President Trump did not hesitate to bash the drug industry. But a draft of an executive order on drug prices appears to give the pharmaceutical industry much of what it has asked for — and no guarantee that costs to consumers will drop.

 

The draft, which The New York Times obtained on Tuesday, is light on specifics but clear on philosophy: Easing regulatory hurdles for the drug industry is the best way to get prices down.

 

The proposals identify some issues that have stoked public outrage — such as the high out-of-pocket costs for medicines — but it largely leaves the drug industry unscathed. In fact, the four-page document contains several proposals that have long been championed by the industry, including strengthening drugmakers’ monopoly power overseas and scaling back a federal program that requires pharmaceutical companies to give discounts to hospitals and clinics that serve low-income patients.

 

Mr. Trump has often excoriated the drug industry for high prices, seizing on an issue that stirs the anger of Republicans and Democrats alike. He has accused the industry of “getting away with murder,”[http://sco.lt/6W2Ly5] and said that he wanted to allow the federal government to negotiate directly with drug companies over the price of drugs covered by Medicare (but read “Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?”; http://sco.lt/8CcWbB).

 

But the proposed order does little to specifically call out the drug industry and instead focuses on rolling back regulations, a favorite target of the administration across many federal agencies.

 

“I do believe that the president wants to do something to lower drug prices for people, but this is a far cry from what he said on the campaign trail,” said David Mitchell, the founder of Patients for Affordable Drugs, a nonprofit that does not take money from the industry. “I don’t see anything there that addresses the drug companies getting away with murder, and it appears that is because Pharma has captured the process.”

 

Several of the proposals appear to reflect that industry influence. For example, the document directs the United States trade representative to conduct a study of price differences between the United States and other countries, and to review trade agreements that may need to be revised “to promote greater intellectual property protection and competition in the global market” (read I”an Read, CEO of Pfizer, aka the ‘Donald Trump of Pharma,’ Bashes Global ‘Freeloading’ Off U.S.”; http://sco.lt/7TRiDZ).

 

The draft order targets a program, 340B, that requires the drug industry to give discounts to hospitals and clinics that serve large numbers of low-income patients. The industry has complained that the program is being abused, while hospitals say they would have to cut services without it.

 

“That’s one that sticks out as a bit of a head scratcher,” said Dr. Joshua M. Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health who was a top F.D.A. official under President Barack Obama. “This is the executive order to lower drug prices — why would you put in a provision that would raise drug prices?”

 

In recent weeks, the industry has shown signs it believes it is getting a fairer shake.

 

In May, Joseph Jimenez, the chief executive of Novartis, told investors that he believed the administration would offer a solution that “will preserve the business model of how we innovate and discover and develop and launch in the U.S., as opposed to some of the bigger and more draconian elements that were discussed earlier,” according to Bloomberg.

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Only 2% of Health Journalists Think Pharma PR & Communications Are Trustworthy

Only 2% of Health Journalists Think Pharma PR & Communications Are Trustworthy | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Healthcare communications is "on life support", with almost nine in 10 journalists unhappy with the information they receive.

 

New research out today reveals a huge gulf between the information provided by drug companies and what journalists actually need to create their content.

 

The survey, conducted by digital communications platform ISEBOX, reveals that 85 per cent of health journalists view healthcare communications as either "out of shape" or "on life support".

 

Half (50 per cent) admit they never visit the newsrooms of drug companies, with almost a quarter (22 per cent) calling them "unsatisfactory" and two thirds (64 per cent) saying there is "room for improvement" when it comes to the information provided.

 

85% of health journalists not satisfied with Pharma & Healthcare Comms

Only 2% find pharmaceutical and healthcare information trustworthy

36% feel government agencies acting on behalf of consumer best interest

Pharma Guy's insight:

But they often reprint what's in press releases verbatim. Just sayin'

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More Cannes Lions Health Gobbly Gook: Social Centricity

More Cannes Lions Health Gobbly Gook: Social Centricity | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s time to move past patient centricity to social centricity. That was the message from inVentiv Health and GSW at Cannes Lions Health, where they presented the idea of a more holistic perspective.

What is social centricity? Not social media, as one might think at a marketing conference, but rather the entirety of a patient's social life and influences—things like family, friends, community, habits, cultural norms and workplace environment. The agency recently published a white paper with the findings, “Advancing Beyond Patient Centricity.”

“It started with the observation that the patient-centric approach that pharmaceutical companies, pharma advertising agencies and communications agencies in general are taking is not really moving the needle,” said Susan Perlbachs, executive director of inVentiv agency GSW. “Everyone thought patient-centric would win the day. If we focused on patients, the outcomes would be better and healthcare would be better. But it’s just not working.”

So Kathleen Starr, behavioral scientist at inVentiv, and her team InVentiv’s began what became a two-year enthnography study in which they followed 30 families from Boston; Portland, Oregon; Kansas City and Shreveport, Lousiana, and looked at the entire ecosystem and wide-ranging spheres of influence on patients.

“We’ve gotten really good about prompting initial behavior change. We can get people to do something the first time, maybe the second time—talk to your doctor, go to the pharmacy pick up your script, right? But what we haven’t figured out is what is the secret sauce for long-term behavior change?” she said.

“Studying those families for two years and seeing how their real life intersects with all the efforts they made to manage their conditions was really enlightening," she went on. "What we saw is that we aren’t going to make a dent in long-term behavior change until we start thinking about the social influences and use creativity to create a social context in which people can actually engage in healthcare.”

At Lions Health, the two presented insights from the study and then launched into an interactive session that included dozens of real-world examples where patients' behaviors were influenced by some kind of societal change.

 

Further Reading:

Pharma Guy's insight:

C'mon! Enough already! Do I need to add this to my Pharma Buzzword Glossary or will it just fade away if we ignore it?

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Cannes Lion Health Sends Message to Pharma Marketers, Again: Your Ad Creativity Stinks!

Cannes Lion Health Sends Message to Pharma Marketers, Again: Your Ad Creativity Stinks! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For the second time in its four-year history, the pharma jury at the Cannes Lions Health International Festival of Creativity did not award a Grand Prix (read “Pharma Advertising is So Bad It Has No Big Winner at Cannes Lions Health 2014”).

 

“We want to send a clear and strong message what a pharma entry and what a pharma winner looks like,” June Laffey, creative director at McCann Health in Australia and Southeast Asia, and this year's Lions Health pharma jury president, said. “We only awarded what was the best work in the pharma industry.”

 

The only U.S. work to win a Gold Lion was a campaign developed by Polaris, a non-profit that fights human trafficking, and Interpublic Group's Area 23, called the Anti-Trafficking Exam and Otoscope. It won for its use of technology.

 

Several drugmakers won Bronze Lions: Boehringer Ingelheim, with McCann Health and Craft Worldwide, for a Pradaxa campaign; Merck, with Matter Unlimited, The Whitelist Collective, and Marina Maher Communications, for a Merck for Mothers campaign; and Roche, with Langland, for a clinical trial campaign.

 

In the first year of Lions Health, the pharma jury declined to award a Grand Prix. AstraZeneca later won, in 2015, for its unbranded campaign for Take It From a Fish and last Philips took home the Grand Prix for its Breathless Choir campaign.

 

Further Reading:

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Communications Experts Urge Pharma Industry to Do More to Take on Opioid Crisis

Communications experts are calling on drugmakers to come together in a leadership role to take on the country’s opioid crisis head on, going well beyond compliance with Food and Drug Administration warnings about the addiction risks posed by prescription painkillers.

PRWeek contacted more than a dozen major drugmakers with opioid products. They either declined to comment or did not respond to interview requests. However, a number of experts speaking on a not-for-attribution basis say the opioid epidemic has reached a crisis point in part because pharmaceutical companies have failed to pool their resources in a concerted, community-focused effort.

Kelly Dencker, EVP and healthcare director at Coyne Public Relations, says the misuse of and addiction to opioids has been an epidemic for years, but has passed a tipping point as it has scourged communities across the country. Someone in the U.S. dies from an overdose of a prescription painkiller such as OxyContin or Vicodin every 19 minutes, according to the Centers for Disease Control and Prevention.

"There has been this hometown hit. You can’t pick up a local newspaper, turn on the local news, go on social media, or talk to people in communities where there hasn’t been a death of someone in their 20s or 30s because of an overdose," he says.

Dencker adds that pharmaceutical companies must step up their drug education and treatment initiatives, and publicly demonstrate they are doing so.  

"The best pharma can do is to cooperate with authorities and show that they are applying money to education for doctors," he explains. "They also have to show that they support programs that educate people about opioid use, and, most importantly, support programs that help people who have developed a dependency. That is one of the greatest challenges, to identify and treat a dependency before something tragic happens."

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There’s No Magical Savings in Showing Prices to Doctors

There’s No Magical Savings in Showing Prices to Doctors | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Physicians are often unaware of the cost of a test, drug or scan that they order for their patients. If they were better informed, would they make different choices?

 

Evidence shows that while this idea might make sense in theory, it doesn’t seem to bear out in practice.

 

A recent study published in JAMA Internal Medicine involved almost 100,000 patients, more than 140,000 hospital admissions and a random distribution of laboratory tests. During the electronic ordering process, half the tests were presented to doctors alongside fees. While the cost to the patient might vary, these Medicare-allowable fees were what was reimbursed to the hospital for the test or tests being considered. The other half of the tests were presented without such data.

 

The researchers suspected that in the group seeing the prices, there would be a decrease in the number of tests ordered each day per patient, and that spending on these tests would go down. This didn’t happen. Over the course of a year, there were no meaningful or consistent changes in ordering by the doctors; revealing the prices didn’t change what they did much at all.

 

While focusing solely on physicians, or on patients, might not work well, trying to work on both simultaneously might (read “Can You Put a Price Tag on Consumer Drug Ads? AMA Thinks It's Possible.”; http://sco.lt/82xivx).

 

Finally, trying to make physicians focus strictly on cost may be off base as well. Some care, even more expensive care, is worth it. What we really should attend to is value — the quality and impact relative to the cost. It is certainly harder to determine value than price, but that metric might make more of a difference to physicians, and to their patients.

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Heads Up! Migraine Drug Ads Soon May Give Millions Headaches!

Heads Up! Migraine Drug Ads Soon May Give Millions Headaches! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Four major pharmaceutical companies are in a race to be the first to offer a drug that may rapidly reduce—and even prevent—migraines to the more than 38 million Americans affected by the debilitating illness each year.

Alder Biopharmaceuticals, Eli Lilly, Amgen and Teva Pharmaceutical have all developed migraine drugs which have completed or are currently undergoing Phase 3 clinical trials using a compound called calcitonin gene-related peptide (or CGRP) that contains antibodies that attack the protein in the brain that causes the severe headaches.

“All four anti-CGRP trials currently underway by the separate companies are positive, showing very promising efficacy for patients and good safety profiles so far. In terms of timing, Amgen’s drug is currently on track to be the first available to patients,” Carl Cincinnato, director of Quantified Health and The Migraine World Summit, told FOX Business.

According to the Migraine Research Foundation, the illness is the 3rd most prevalent—and the 6th most disabling—in the world and affects 12% of the U.S. population, including children. Women and children are impacted the most at 18% and 10%, respectively, while men make up just 6% of the population.

Pharma Guy's insight:

First, If all 4 of these biological drugs hit the market at the same time, there is sure to be a barrage of DTC ads competing to gain market share.

 

Second, these drugs are sure to be super expensive!

 

Third, if only 6% of men suffer from Migraines vs. 18% of women, why did this news report show the image of a man suffering from Migraine - I'm sure the image was picked up from a PR packet supplied by one of the four companies mentioned.

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Can You Put a Price Tag on Consumer Drug Ads? AMA Thinks It's Possible.

Can You Put a Price Tag on Consumer Drug Ads? AMA Thinks It's Possible. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Seeking to restrain drug prices, the American Medical Association passed a resolution that would require drug makers to disclose pricing in ads that are aimed at consumers.

 

The proposal, which was approved by AMA delegates at their annual meeting in Chicago, came in response to concerns over rising drug costs and an unsuccessful bid by the medical organization to convince Congress to ban so-called direct-to-consumer advertising altogether (read “AMA Calls for a Ban on Direct-to-Consumer Drug Ads”; http://sco.lt/4iRfrF).

 

The resolution, which must still clear some review hurdles at the AMA, is designed to improve transparency, according to the Massachusetts Medical Society, one of six organizations in New England that jointly proposed the idea (see Resolution 236). [UPDATE: The AMA wants drug makers to disclose the suggested manufacturer’s retail price, but does not offer a definition, and there are myriad prices, of course, that can vary].

 

Ultimately, the medical organization hopes to persuade the Federal Trade Commission, the Federal Communications Commission, and the Food and Drug Administration to formalize the pricing disclosure. But one opponent predicted the effort will go nowhere for several reasons.

 

“I don’t expect anything to happen,” said John Kamp, who heads the Coalition for Healthcare Communication, a trade group for medical publishers and advertising agencies. “This is a Republican administration and all three of those agencies are unlikely to be very interested.” [LOL! I once thought that passing a law to ban DTC drug ads was about as likely as trump being elected president: http://sco.lt/7NoUtd So, you never know!]

 

Further Reading:

Pharma Guy's insight:

LOL! I once thought that passing a law to ban DTC drug ads was about as likely as trump being elected president. So, you never know!

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Sage's Postpartum Depression Awareness Campaign "Infantilizes"Women Say Critics

Sage's Postpartum Depression Awareness Campaign "Infantilizes"Women Say Critics | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sage Therapeutics, a biotech developing an experimental treatment for postpartum depression, this week trumpeted strong results from a clinical trial, which cheered investors and pushed up its stock price. But outside the lab, the company’s aggressive efforts to raise awareness of postpartum depression have proved divisive.

 

The campaign’s message: “When it comes to postpartum depression, silence sucks.” It features close-up photos of distressed, tearful women who can’t speak — because they have pacifiers stuck in their mouths.

 

The images have been plastered on bus stops, buses, conference booths, and on a dedicated website. The ads don’t specifically mention Sage’s drug, which still needs further testing before the company can bring it to the Food and Drug Administration for possible approval. Instead, they urge women to talk “openly and honestly” about postpartum depression. An estimated 600,000 women in the U.S. alone experience symptoms, which range from insomnia and irritability to difficulty bonding with their baby.

 

“I like it. Informative and somewhat reassuring,” said Meg Arthur, a 34-year-old mother of three who’s a member of a Facebook support group for postpartum depression. But critics say the choice to picture women sucking on pacifiers “infantilizes” mothers and their illness.

 

“Even if they had just used the pacifier alone, that would have been better than having women experiencing rage, pain, and sadness with baby pacifiers in their mouths,” said Mara Acel-Green, a psychotherapist in Watertown, Mass. who specializes in counseling women with postpartum depression.

 

Green and other clinicians also said they see the campaign as a missed opportunity to prod doctors to be more proactive in asking women about their symptoms.

 

“‘Silence Sucks’ places the onus on women [to speak up],” she said. “I think providers are silent. It’s not the women. Nobody is asking them.”

 

Dr. Steve Kane, the chief medical officer at Sage, said he hoped the campaign would encourage conversation. “During an episode of postpartum depression, feelings of guilt, shame or fear can be significant barriers that prevent women from speaking up about their symptoms,” he said.

 

Dr. Anna Glezer, a California psychiatrist who treats patients with postpartum depression, said such campaigns are helpful — whatever viewers may think about the pacifiers — in raising awareness.

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2017 Medical Sales Salaries Climbed to $95,791 in 2017, Compared to $88,038 in 2016

2017 Medical Sales Salaries Climbed to $95,791 in 2017, Compared to $88,038 in 2016 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

2017 marks the seventh year MedReps has conducted an annual medical sales rep salary report. According to the most recent research in 2017, the average medical sales rep total compensation is $147,424, with an average base of $95,791, and an average bonus of $53,405.

 

Medical sales reps know their income potential varies for several reasons. The 2017 Medical Sales Salary Report examines the following key factors that impact salaries:

 

  • Product
  • Market
  • Job title
  • Company type and size
  • Age
  • Experience
  • Gender
  • Ethnicity/race
  • Travel
  • Location

 

As medical sales reps continue their adventurous climb throughout their career, they tend to reap the rewards both financially and in terms of job satisfaction.

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The "Safety Argument" Against Making It Legal to Import Rx Drugs is a "Cop Out"

The "Safety Argument" Against Making It Legal to Import Rx Drugs is a "Cop Out" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Consider this: Sixty percent of Americans say lower drug costs should be a top priority, and a whopping 72 percent support the idea of importing medicines from Canada, according to a recent Kaiser Family Foundation poll. In fact, 8 percent of adults surveyed reported that they or someone in their household have already bought prescription drugs from outside the U.S.

 

Meanwhile, the cost of 20 widely used drugs is three times cheaper in Canadian than in New York pharmacies, according to PharmacyChecker.com, a website that vets overseas pharmacies and compares prices. And as drug makers regularly hike prices — sometimes to sky-high levels — or set steep price tags for the newest treatments, more American pocketbooks are pinched than ever before.

 

“The problem is getting worse,” said Rep. Peter Welch, a Vermont Democrat who last week unsuccessfully attempted to stick an importation amendment onto a regulatory bill.

 

Yet from the time nearly two decades ago when seniors made headlines by taking buses to Canada to stock up, the pharmaceutical industry has stymied every attempt to allow Americans to import medicines (read, for example, “PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada”). Drug makers have succeeded by exploiting fears over safety concerns. They’ve also lavished political contributions on members of Congress.

 

Can importing drugs bring down prescription prices for Americans? Yes and no

The latest example of pharma pushing back against importation came in the form of a report released this month by former FBI director Louis Freeh, who was once a Bristol-Myers Squibb board member and now runs a consulting firm. His sobering conclusion: Importation would increase the threat of counterfeit medicines into the U.S.

 

“The burden of enforcement will fall on American authorities and the resources for this are really minimal,” said Freeh, whose firm was commissioned by the Partnership for Safe Medicines, a nonprofit with ties to the pharmaceutical industry. “… I think safety would go right off the boards.”

 

His prediction comes shortly after four former Food and Drug Administration commissioners chimed in with their own dire warnings. In an open letter to Congress, they wrote that importation is “a complex and risky” idea that would harm consumers and compromise the existing safety system.

 

To be sure, there is reason to be cautious.

 

Counterfeit medicines have entered the U.S. supply chain before. In one widely publicized episode several years ago, a Canadian company supplied doctors with fake copies of the Avastin breast cancer treatment. And in 2003, a crime ring successfully peddled phony Lipitor pills to wholesalers, some of whom looked the other way.

 

But this doesn’t mean that importation is impossible.

 

“We should be able to address the safety issue,” said Dr. Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School who has studied the topic. “To not have the conversation and instead say there’s no way to import medicines safely is a cop-out.”

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Sun, Sand and Drugs. Yes, It's Fort Lauderdale. No, It's Not Flakka

Sun, Sand and Drugs. Yes, It's Fort Lauderdale. No, It's Not Flakka | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry was once an elusive market with its facilities confined to traditional powerhouse cities such as Boston and San Francisco. But today’s Pharma companies have diversified significantly as pockets of corporate offices, manufacturers and R&D facilities are being found in seemingly surprising places.

 

Greater Fort Lauderdale, typically known for its sandy beaches and palm trees has spent the past few years quietly assembling one of the most dynamic pharmaceutical clusters in the country. The region currently holds 1,500 biotech institutions that employ more than 26,000 people and generate $4 billion in revenue each year.

 

Considered a gateway to Latin America, Broward County also has continued to expand its ties to businesses overseas. In April 2016, Ecolab Inc., announced plans to create its Latin America regional headquarters in Miramar, just south of Fort Lauderdale.

 

Pharmaceutical executives’ time is precious; their company’s capital even more so. When scouting out potential new locations, it is important to consider how the surrounding area will impact the businesses’ bottom line.

 

Outlined here are a few reasons why Greater Fort Lauderdale has evolved past its reputation of being a magnate for retirees and spring breakers and become a hotspot for pharmaceutical research and development, manufacturing and office space.

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In a Blow to PhRMA, Only 9% of People in U.S. Rank Pharma as the Most Innovative Industry

In a Blow to PhRMA, Only 9% of People in U.S. Rank Pharma as the Most Innovative Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Only 17% of consumers polled in the 2017 Klick Health Consumer Survey on Healthcare Innovation currently perceive health-related industries as being the most innovative, out of 18 industries examined. Specifically, pharmaceuticals & biotech, health & wellness, and hospital sectors lagged considerably in perceived innovation behind consumer electronics, telecommunications, and media & entertainment.

However, respondents ranked health & wellness first in terms of the industry that should be the most innovative, quickly followed by pharmaceuticals & biotech, and hospitals in the top five industries. These results suggest a desire by consumers for innovation in healthcare, even though they do not believe that healthcare-related industries are particularly innovative today.
Pharma Guy's insight:

On the bright side, Pharma does rank #4 in a list of 19 industries, most of which no one considers most innovative.

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Opioid Crisis Complicates GOP’s Health-Law Push

Opioid Crisis Complicates GOP’s Health-Law Push | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The nation’s worsening opioid crisis has become another sticking point in Republican plans to dismantle major portions of the Affordable Care Act, with key GOP senators hesitating to support a bill that could threaten addiction treatment for millions of people.

Several provisions of the ACA, also known as Obamacare, allowed millions of Americans seeking substance-abuse treatment to gain coverage, including through an expansion of the Medicaid health program for the poor. But the House bill repealing the ACA, passed in early May, would roll back that Medicaid expansion beginning in 2020 and allow insurance companies to charge some people with drug addictions higher premiums or deny them substance-abuse coverage.

Concerns about those provisions cut into Republican support for the replacement measure in the House. Of the 20 Republicans who voted against the House bill, 16 represent states that saw significant increases in drug-overdose death rates in recent years.

Two of those lawmakers hail from Ohio, which, through the state’s ACA expansion, has enrolled more than 500,000 new Medicaid recipients who have behavioral-health needs, including those with drug addiction and different mental-health disorders.

Now, the same concerns are emerging as a factor as the Senate takes up the House bill and ponders how to change it.

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Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its Marketing Principles. Why Not?

In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance the PhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.

Despite the thundering unanimity of the PhRMA Board, several current board members are NOT signatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!

Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guidelines. In addition, Alkermes, which sells Zohydro, a powerful opioid (see here), is not a signatory to PhRMA's Code on Interactions with Healthcare Professionals

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Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction!

Alkermes - Maker of Powerful Opioid Zohydro - Lobbies Hard for Its Expensive Treatment for Addiction! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The [reminder ads] have been popping up on billboards, buses and subways and in glossy magazines, with portraits of attractive men and women and a simple question in bold letters: What is Vivitrol?

 

Five years ago, Vivitrol was a treatment for opioid addiction that was struggling to find a market. Now, its sales and profile are rising fast, thanks to its manufacturers’ shrewd use of political connections, and despite scant science to prove the drug’s efficacy.

 

Last month, the health and human services secretary, Tom Price, praised it as the future of opioid addiction treatment after visiting the company’s plant in Ohio. He set off a furor among substance abuse specialists by criticizing its less expensive and more widely used and rigorously studied competitors, buprenorphine and methadone, as medications that “simply substitute” for illicit drugs.

 

It was the kind of plug that Vivitrol’s maker, Alkermes (the producer of a powerful new opioid called Zohydro), has spent years coaxing, with a deft lobbying strategy that has targeted lawmakers and law enforcement officials. The company has spent millions of dollars on contributions to officials struggling to stem the epidemic of opioid abuse. It has also provided thousands of free doses to encourage the use of Vivitrol in jails and prisons, which have by default become major detox centers.

 

The company’s strategy highlights the profit opportunities that drug companies and investors see in an opioid epidemic that killed 91 Americans every day in 2015 and is growing worse. But some of its marketing tactics, and Mr. Price’s comments, ignore widely accepted science, as nearly 700 experts in the field wrote the health secretary in a letter.

 

Not a single study has been completed comparing Vivitrol with its less expensive competitors. Some studies have shown high dropout rates, or found that many participants returned to opioid use while taking Vivitrol or after going off it. In one study that the company used to secure the Food and Drug Administration’s approval of Vivitrol for opioid addiction treatment, conducted with 250 patients in Russia, nearly half of those who got Vivitrol failed to stay abstinent over a six-month period, although they stayed abstinent and in treatment longer than those who got a placebo.

 

Further Reading:

 

Pharma Guy's insight:

Note the ad in the photo – it’s a “reminder ad,” which is forbidden by PhRMA for its members. Unfortunately, only reminder ads on TV are forbidden and only "signatories" of PhRMA's DTC Guidelines abide by the rules. Alkermes is a member of PhRMA and Richard Pops, Chairman and CEO of Alkermes, is on the board of directors of PhRMA! but Alkermes is NOT a signatory!

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Enough Blame to Go Around for Opioid Epidemic

Enough Blame to Go Around for Opioid Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A Long Island doctor is using a novel defense against federal prosecutors accusing him of overprescribing opioid painkillers: He’s blaming the drug manufacturers.

 

In a motion pending in the Eastern District, Dr. Michael Belfiore argued that the multiple counts against him of illegally distributing oxycodone should be dropped, and that the “true culprits in the creation of the opioid epidemic, to wit: Big Pharma” should be held responsible.

 

“With all due respect to the government, its overly simplistic ‘knee jerk’ presentment to the grand jury totally ignored these compelling factors and wrongfully placed the blame on Dr. Belfiore,” Belfiore said in the motion.

 

The argument may be easier to make and sell in light of the growing wave of plaintiffs lawyers joining state and local governments in filing lawsuits against big pharmaceutical companies blaming them for the prescription opioid addiction epidemic and trying to recover taxpayer funds spent dealing with it. On Wednesday, the plaintiffs firm of Simmons Hanly Conroy filed separate lawsuits against pharmaceutical manufacturers and physicians on behalf of Dutchess, Seneca and Sullivan Counties following pending actions on behalf of Suffolk, Broome, Erie and Orange Counties.Although the pharmaceutical companies are not defendants in the Belfiore case, it is arguably the most creative lawsuit to accuse them of inundating the country with painkillers by deceiving doctors and the public about their safety, thereby playing a significant role in the nationwide epidemic.

 

In addition to going after Big Pharma through his defense in his federal criminal case, Belfiore has moved to intervene in the state civil case brought by Suffolk County, arguing that his complaint is “nearly identical” to the plaintiff-county’s.

 

“Dr. Belfiore, like many other doctors and their patients, is a victim of an opioid epidemic created by Purdue and other Big Pharma companies, which encouraged the aggressive prescribing of opioids for chronic pain,” the motion in Belfiore’s criminal case said.

 

Belfiore allegedly prescribed nearly 3,700 pain pills to three separate patients from September 2011 to August 2013, ranging from 248 to 2,910 pills per patient.

 

Further Reading:

  1. “NIH Summarizes the Statistics of the Current Opioid Crisis Caused by Prescriptions”; http://sco.lt/75Vzu5
  2. “Purdue #Pharma Doesn't Want Court to Unseal Oxycontin Marketing Documents. What's It Hiding?”: http://sco.lt/6wb24f 
  3. “OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It”: http://sco.lt/8RfD5F 
  4. “The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic”: http://sco.lt/6RajLd
  5. “DUIPs (Docs Under the Influence of #Pharma) Prescribe Opioids - Sales Reps Arrested”; http://sco.lt/7grUor
  6. “Former FDA Commish Kessler Slams Docs, #FDA for Opioid Epidemic”; http://sco.lt/6AGBgf 
  7. “Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways”; http://sco.lt/7uZNGT 
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Euros for Docs in Germany Reports Payments by Pharma: It's Voluntary, So...

Euros for Docs in Germany Reports Payments by Pharma: It's Voluntary, So... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the U.S., the Open Payments database lays out pharma's payments to doctors for all to see. In Germany, where disclosure isn't mandated as it is in the U.S., a nonprofit is trying transparency based on the honor system.

 

German doctors will be able to voluntarily disclose contributions from pharma in a database compiled by the nonprofit journalism organization Correctiv, according to Germany’s DW. About 71,000 doctors in the country received €575 million in cash or in-kind contributions from the drug industry last year, a Correctiv investigation found in December.

 

That's far less than the $7.52 billion that drug and device makers funneled to doctors and healthcare providers in the U.S. in 2015, the most recent data available, but slightly more than the £345 million that changed hands in the U.K. (read “Sun Rises on UK Pharma Payments to HCPs”; http://sco.lt/5MQJqD) Making those payments public at the doctor-by-doctor level is important, advocates say, because studies show financial relationships between drugmakers and doctors can affect physicians' prescribing habits.

 

Unlike in the U.S., German or European law doesn’t require docs to disclose industry contributions. Correctiv and Spiegel Online found that only 29% of doctors in the country were willing to have their pharma payment info published as of the December report. Correctiv is now making that voluntarily reported data public.

 

Further Reading:

  • “Surprise! #Pharma $ to Docs Continue Virtually Unabated Despite Sunshine Law”; http://sco.lt/6wERKj
Pharma Guy's insight:

...essentially useless!

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New Opdivo DTC Ad Asks: “Who Wouldn’t Want [a 50-50 Chance] to Live Longer [2.8 Months on Average]?”

New Opdivo DTC Ad Asks: “Who Wouldn’t Want [a 50-50 Chance] to Live Longer [2.8 Months on Average]?” | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“We updated the commercial to highlight potential life events that may be possible for some patients who receive treatment with Opdivo, and include new information about the number of patients that have been prescribed Opdivo, which patients find meaningful,” a Bristol-Myers Squibb spokeswoman said in an email.

 

The ad does note that Opdivo has demonstrated longer life versus chemotherapy and adds that 40,000 patients have been prescribed Opdivo. The new Opdivo ad has only spent a little over $1 million on national TV media since it began airing in the last week of May, according to data from real-time TV ad tracker iSpot.tv. Similar creative will also run in print and digital ads, the spokeswoman said.

 

This is the third national TV ad for Opdivo, which began its mainstream bid on the airwaves in the fall of 2015. The ad campaign has attracted some criticism, however, most notably last summer after a New York Times op-ed, and then two oncologists writing in the Journal of the American Medical Association, disputed the value of the DTC cancer advertising (read “Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”).

 

Further Reading:

Pharma Guy's insight:

Read the fine print!

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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