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Keytruda Ads Promise a Lot That's Not on the Label

Keytruda Ads Promise a Lot That's Not on the Label | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recently, during some research, I had the opportunity to talk with a leading Oncologist in the Pittsburg area. I specifically wanted to hear his thoughts on the cancer DTC ads that were airing on TV and he was not happy. “The ads are promising too much . I have patients who are demanding certain treatments even though they don’t meet the criteria for treatment”. He specifically pointed to the Keytruda ad in a magazine (see image).

 

“Now I’m the one who has to explain to a patient that this treatment may not be for them and even if it is I have to try and set realistic expectations” he continued. I asked him if the ads were “too aggressive” to which he replied “absolutely”.

 

“Look, we would love to be able to tell patients that this treatment is going to allow them to live a lot longer, but that’s not what the product label says based on the company’s own clinical data. These ads have to set realistic expectations , but even before that idea they have to be a lot clearer on the criteria to be a candidate for treatment”.

 

John Mack, the Pharmaguy, has been critical of these ads as well (read, for example, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH), but my feeling has been of they give patients hope then maybe they are OK. That may be the wrong and it could lead to unrealistic expectations and anger for what patients feel are misleading ads.

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Pharmaguy curates and provides insights into selected drug industry news and issues.
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Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen!

Mylan Achieved an ROI of 2.7 by Overcharging Medicaid for EpiPen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan will pay $465 million to settle claims that it overcharged states for its signature EpiPen, according to a Thursday Department of Justice press release. The company also signed an agreement with the federal government to enter into a review of its Medicaid pricing practices.

 

For years, Mylan classified EpiPen in a way that forced Medicaid to overpay for the product, according to the Centers for Medicare and Medicaid Services. The company may have overcharged taxpayers as much as $1.27 billion over 10 years, the Department of Health and Human Services’s watchdog organization said in May.

 

Lawmakers slammed the federal agencies on Thursday for letting Mylan get off the hook too easily with the settlement. Sen. Richard Blumenthal (D-Conn.) called it “completely insufficient,” and Sen. Chuck Grassley (R-Iowa) cast is as “disappointing” in statements. Mylan, meanwhile, called the settlement, “the right course of action,” and said that the product has been reclassified under Medicaid as of April 1.

 

[“Mylan ripped off the government big time,” said Public Citizen, “and the U.S. Department of Justice is letting the company get away with it. Mylan misclassified EpiPen in such a way as to provide less generous discounts to Medicaid purchasers than the law requires.

 

Today’s shameful settlement is for barely a third of the amount of the rip-off, and it fails to include an admission of guilt – an appalling omission for a decade-long scheme that enabled Mylan to fatten its bottom line by more than a billion.]

 

Further Reading:

  • “Letters to "Pharma Sis" to Cut EpiPen Price to Improve Goodwill Will Fall on a Tin Ear”; http://sco.lt/8mfk5x
  • “Mylan CEO Bresch, aka "Pharma Sis," Defends Price Gouging, Tax Evasion as Job Savers”; http://sco.lt/7uKmLB
  • “FDA is Cause of Mylan's Monopolistic Pricing of EpiPen, Says WSJ. Allergist Has Cure.”; http://sco.lt/7F88nJ
  • “Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen”; http://sco.lt/8NWO0H
  • “Sarah Jessica Parker to Stop Shilling for Mylan Because of EpiPen Pricing: What Did She Expect?”; http://sco.lt/7oM4HZ
  • “Awash in Criticism, Mylan Has Decreased its Fearmongering Awareness Advertising”; http://sco.lt/6WeuSv
  • “Mylan, EpiPen Price Gouger, Ranks No. 2 in U.S. #Pharma Exec Pay!”; http://sco.lt/6lVvf7
  • “Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!”; http://sco.lt/6Sl0ld
  • “Mylan CEO's Mom Used Position with Education Group to Boost EpiPen Sales Nationwide”; http://sco.lt/8tL3kP
  • “Yes, Mylan DID "Misclassify" EpiPen as a Generic, Says Medicaid”; http://sco.lt/5aJWEb
  • “Mylan "Gamed the System" and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj
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Is There an “Unconscious” Bias in Hiring Women for Top Positions in BioPharma?

Is There an “Unconscious” Bias in Hiring Women for Top Positions in BioPharma? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

There’s no better time for women to advance their career in biotech, recruiter Robin Toft said. But many just aren’t asserting themselves as they could.

 

Toft, who runs San Diego-based life sciences recruitment agency The Toft Group, said there’s “a universal awareness” that companies with diverse boards perform better, and that mixed management teams are more effective. Companies are actively looking for women to fill top roles. But women just need to step up to the plate, she said.

 

“I personally don’t see a boys’ club in biotech,” Toft said — adding that the she doesn’t think this is conscious.

 

“It’s my personal experience with biotech that if a woman who shows up who is competent and confident, she will get every consideration,” she said. Women are not intentionally discriminated against: “It’s absolutely my experience that women are in demand,” she said.

 

But even so, isn’t there often unconscious bias in hiring women?

 

Employers need to understand that unconscious bias exists, Toft said — and they often hire in their own likeness. So the easiest way to bypass this phenomenon is to consciously advance some women to executive roles, and then allow them to play a role in hiring — so they will hire in their own likeness, Toft said.

 

Further Reading:

Pharma Guy's insight:

According to women surveyed (see chart), "Unconscious bias in my workplace" is the #2 factor holding them back.

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Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’

Merck CEO Frazier Quits Trump Advisory Council in ‘Stand Against Intolerance and Extremism’ | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The head of U.S. drugmaker Merck & Co. has resigned from a manufacturing advisory council to the Trump administration in an apparent protest of the president’s failure to condemn in stronger terms the white supremacists who marched and waged violence in Charlottesville, Va., over the weekend.

 

Merck issued a statement Monday morning on Twitter from Chairman and Chief Executive Kenneth Frazier, saying, “America’s leaders must honor our fundamental values by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal.”

 

”As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism,” Mr. Frazier said in the statement.

 

Almost an hour later, Mr. Trump posted on Twitter: “Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!”

 

Trump joins other online wackos who have bad-mouthed Frazier. For more on that, see “Merck CEO Ken Frazier's Inspirational Facebook Message Gets No Respect from Followers”; http://sco.lt/7gUdZh

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United States Opioid Crisis is a Warning to the World: Pharma Partly to Blame

United States Opioid Crisis is a Warning to the World: Pharma Partly to Blame | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Writing recently in The Lancet, Stanford’s Keith Humphreys, PhD, shines a spotlight on the expanding globalization of the opioid epidemic. He urges leaders in other nations to learn from the United States’ mistakes and take immediate action to prevent an international crisis

 

Humphreys cites sobering statistics showing more than 530,000 Americans died from drug overdoses between 2001 and 2015. “The USA was an ideal environment for opioid prescribing to explode and thereby produce an epidemic of overdose and addiction,” he writes, describing the cultural, legal and industry-based forces that fueled the crisis.

 

Of particular relevance to other nations is the role that some opioid drug manufacturers have played in the spread of opioid use, he said. In the piece, Humphreys discusses how opioid drug manufacturers — responding to physicians’ concerns about the poor management of chronic pain — began marketing their products as effective, low-risk medications in the 1990s.

 

Humphreys calls out particular pharmaceutical companies including Purdue Pharma and Mundipharma International for engaging in deceptive practices such as understating the addiction risk of their opioid products. With the U.S. taking steps to curtail the issue of excessive opioid use, drug manufacturers like Mundipharma are likely to continue efforts to further expand sales internationally, Humphreys writes.

 

Further Reading:

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Trump Declares "OK, Maybe [the opioid crisis] Is an Emergency!"

Trump Declares "OK, Maybe [the opioid crisis] Is an Emergency!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Just two days after a top White House official said the United States has the resources it to address the opioid problem without declaring a state of emergency, President Donald Trump now says the deadly opioid epidemic is indeed a national emergency.

 

Trump said he is drafting documents to make the official declaration, which will provide states and federal agencies with more resources and power to combat the epidemic.

 

"The opioid crisis is an emergency, and I am saying, officially, right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump told reporters at his Trump National Golf Club in Bedminster, New Jersey.

 

Two days ago, Trump rejected calls from a White House commission to declare the crisis a national emergency. Instead, Tom Price, secretary of the Department of Health and Human Services, said that the government is already doing work on the recommendations made by the commission without declaring it a national emergency (see “Trump and Health Secretary Price Reject Call for National Emergency to Deal with Opioid Epidemic”; http://sco.lt/5oRPOb).

 

In a statement released yesterday, the White House said that "building upon the recommendations in the interim report from the President's Commission on Combating Drug Addiction and the Opioid Crisis, President Donald J. Trump has instructed his Administration to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic."

 

A White House commission, chaired by New Jersey Gov. Chris Christie, issued a report last week in which its top recommendation was for the president to issue an emergency declaration. It will be up to Trump to issue the details of such a declaration and spell out what resources will be made available.

 

It wasn’t clear what had caused the president’s abrupt reversal, but some Democrats had criticized him for not taking the step and said despite campaign promises he was doing little to address the crisis.

 

In a statement yesterday, Christie thanked the president for accepting the commission recommendation.

Pharma Guy's insight:

I think Trump saw my "We will win this by doing nothing." meme and tweet: http://sco.lt/5oRPOb 

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Trump and Health Secretary Price Reject Call for National Emergency to Deal with Opioid Epidemic. So Sad!

Trump and Health Secretary Price Reject Call for National Emergency to Deal with Opioid Epidemic. So Sad! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Trump administration on Tuesday stopped short of declaring the opioid epidemic a national emergency, rejecting an urgent recommendation from a White House panel on tackling the crisis.

 

“We believe at this point that the resources we need or the focus that we need to bring to bear to the opioid crisis, at this point, can be addressed without the declaration of an emergency,” Health and Human Services Secretary Tom Price said at a press conference in Bedminster, N.J., after a meeting with President Trump and other White House officials.

 

He added that the option, like the rest of the policies suggested in the commission’s report, was still “on the table.”

 

The Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey Gov. Chris Christie, called an emergency declaration it’s “first and most urgent” recommendation, in an interim version of a long-awaited report last week that included a number of policy proposals for addressing the crisis.

 

“Declare a national emergency under either the Public Health Service Act or the Stafford Act,” the five-member panel wrote to the president, adding that the option is “direct and completely within your control.”

 

“We’re going to have a tremendous team of experts and people that want to beat this horrible situation that has happened in our country — and we will. We will win. We have no alternative,” Trump said in brief remarks before Tuesday’s meeting.

 

While experts say stemming the flow of drugs is part of any solution, many, including top administration officials, have said that law enforcement alone cannot end an addiction crisis. That points to the need to expand treatment for people who are already addicted to opioids, experts say.

 

Further Reading:

 

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Pennsylvania Underestimates Death Due to Opioids by More Than Half!

Pennsylvania Underestimates Death Due to Opioids by More Than Half! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

An important barrier to formulating effective policies to address the rapid rise in U.S. fatal overdoses is that the specific drugs involved are frequently not identified on death certificates.

Current death certificate data are problematic for understanding the drug poisoning epidemic, with a particular issue being the frequency with which no specific drug is identified. This results in an underestimate of the involvement of specific drugs in fatal overdoses (but not in the overall number of drug fatalities), which is sometimes substantial. For instance, mortality rates calculated using imputed data on specific drugs where such information was lacking on death certificates suggest that in 2014 opioid and heroin involved death rates were understated by more than half in Pennsylvania (8.5 vs 17.8 per 100,000 for opioids and 3.9 vs. 8.1 per 100,000 for heroin).

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Allergan's Promotion of New Rosacea Drug: Is It False or Misleading Advertising?

Allergan's Promotion of New Rosacea Drug: Is It False or Misleading Advertising? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Allergan told investors it plans to increase its promotional efforts for its new rosacea drug, Rhofade, now that it has secured access on CVS Health's formulary. Rhofade is a treatment for erythema, or redness of the face, a common symptom of rosacea.

 

The FDA in January approved the drug, which works by constricting blood vessels in the face. Persistent facial redness is often treated with laser therapy. Rhofade, however, is a topical cream.

 

The company began advertising on Facebook last week and will ramp up other aspects of its consumer-advertising program, Bill Meury, Allergan's chief commercial officer, told investors during an earnings call on Thursday.

 

Allergan CEO Brent Saunders further discussed the company's promotional strategy, saying, “as you get formulary coverage, that gives you the ability to advertise more broadly. I liken it back to my consumer days: You don't run a lot of advertising until your product is on the shelf, and that's akin to having formulary coverage. So the team's really focused on access, and they're doing a great job. And as that continues to build, you'll see us continue to ramp up promotion.”

 

Allergan kicked off marketing efforts for Rhofade in May with Less Red More You, an awareness campaign featuring singer and actress Kristin Chenoweth, who suffers from rosacea. Allergan has frequently leaned on celebrities to market its dermatology, women's health, and aesthetics portfolios. In the past two years, the company developed partnerships with actors Lea Michele, Kate Bosworth, and reality-TV personality Khloé Kardashian. Michele worked with Allergan for its women's health campaign, Actually She Can, while Kardashian kicked off the Live Chin Up campaign for Kybella, a chin-fat injection. Bosworth helped promote acne treatment, Aczone.

 

Further Reading:

  • “Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?”; http://sco.lt/5CPdfl
Pharma Guy's insight:

Allergan again resorts to side-by-side "before and after” images to prove that this product works. This is the same technique the company used  to promote Kybella for double chin syndrome.

 

In that case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image (see "Further Reading" link). The ad, however, claimed they were “unretouched photos.”

 

Despite some anonymous commentator to my blog post claiming he/she “worked on this campaign and I saw first hand that not one photo in the treatment area was retouched,” I don’t buy it.

 

But I will point out that the photos in this ad for Rhofade are definitely not retouched versions of the same photo. The ad, however, says “Illustration only.” Which means this is not a real case study of a real person’s response to the drug.

 

Perhaps that commentator learned from my blog to be more careful about its before-and-after imagery.

 

Whatever! Allergan is again practicing misleading and/or false advertising, IMHO!

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The "No Generics for You!" Trend - Et Tu EpiPen?

The "No Generics for You!" Trend - Et Tu EpiPen? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Something strange happened when Alice Bers went to the pharmacy earlier this year to fill her son’s EpiPen prescription: The doctor had prescribed the generic, but it would have cost her more out-of-pocket than the branded version.

 

So the pharmacy asked her son’s doctor for a prescription for the brand-name EpiPen, and her health plan got a bill for $438.53, or $227.52 more than the generic would have cost it. Many EpiPen customers, from a range of different health plans, have wound up getting the more expensive brand.

 

“I couldn’t believe how crazy our system is that it cost us less to get the brand name, while of course it cost our insurer more,” Ms. Bers said.

 

The high cost of EpiPens was a red-hot controversy and target of congressional hearings last year, prompting the device’s maker, Mylan, to introduce a lower-priced generic version of the emergency allergy treatment, and rivals to bring their own products to market.

 

But more than seven months after the introduction of the generic, the more expensive brand-name EpiPen still accounts for more than one-quarter of the market, according to Bernstein Research, even though a brand-name drug’s sales usually shrink after low-cost competition arrives.

 

One reason, according to multiple people familiar with the drug industry, is that a middleman can profit from the sale of pricier medicines, such as EpiPen. In the murky world of the U.S. drug-supply chain, higher prices can mean a bigger piece of the pie for middlemen such as pharmacy-benefit managers. There is no way to know exactly how much, however, because the amount a PBM makes is laid out in confidential contracts.

 

“The complexity in the system and lack of the right information available to buyers at the right time costs the country billions of dollars, unnecessarily,” said Michael Rea, chief of executive of Rx Savings Solutions, which sells software to help patients and their employers choose the least-expensive medicines.

 

When Ms. Bers picked up an EpiPen two-pack in March, several companies beyond the drugmaker Mylan were involved in filling the prescription. These middlemen warehoused, shipped and handed over the drug. Overseeing it all was a pharmacy-benefit manager, or PBM.

 

Each was paid for their involvement. For a typical brand-name drug listing for $300, middlemen generally receive more than $37 in gross profit, according to Adam Fein, president of Pembroke Consulting, which advises drug companies on the drug-distribution chain. A PBM gets the biggest share, $18.

 

Further Reading:

 

More About EpiPen:

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

Keytruda Ads Promise a Lot That's Not on the Label | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recently, during some research, I had the opportunity to talk with a leading Oncologist in the Pittsburg area. I specifically wanted to hear his thoughts on the cancer DTC ads that were airing on TV and he was not happy. “The ads are promising too much . I have patients who are demanding certain treatments even though they don’t meet the criteria for treatment”. He specifically pointed to the Keytruda ad in a magazine (see image).

 

“Now I’m the one who has to explain to a patient that this treatment may not be for them and even if it is I have to try and set realistic expectations” he continued. I asked him if the ads were “too aggressive” to which he replied “absolutely”.

 

“Look, we would love to be able to tell patients that this treatment is going to allow them to live a lot longer, but that’s not what the product label says based on the company’s own clinical data. These ads have to set realistic expectations , but even before that idea they have to be a lot clearer on the criteria to be a candidate for treatment”.

 

John Mack, the Pharmaguy, has been critical of these ads as well (read, for example, “Merck’s New Keytruda DTC Ad is a ‘TRU Story’ Told by a Fake Patient (Actor)”; http://sco.lt/6nURcH), but my feeling has been of they give patients hope then maybe they are OK. That may be the wrong and it could lead to unrealistic expectations and anger for what patients feel are misleading ads.

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"No Generics for You!" No Biosimilars Either, Say Insurers!

"No Generics for You!" No Biosimilars Either, Say Insurers! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Consumers have grown accustomed to being told by insurers — and middlemen known as pharmacy benefit managers — that they must give up their brand-name drugs in favor of cheaper generics. But some are finding the opposite is true, as pharmaceutical companies squeeze the last profits from products that are facing cheaper generic competition.

Out of public view, corporations are cutting deals that give consumers little choice but to buy brand-name drugs — and sometimes pay more at the pharmacy counter than they would for generics.

The practice is not easy to track, and has been going on sporadically for years. But several clues suggest it is becoming more common.

In recent months, some insurers and benefit managers have insisted that patients forgo generics and buy brand-name drugs such as the cholesterol treatment Zetia, the stroke-prevention drug Aggrenox and the pain-relieving gel Voltaren, along with about a dozen others, according to memos and prescription drug claims that pharmacies shared with ProPublica and The New York Times. At the same time, consumers are sounding off on social media.

Now it appears the practice is spreading to biosimilars, the competitors for expensive, complex biologic drugs that are beginning to arrive on the market.

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'Pharma bro' Martin Shkreli found guilty of 3 of 8 charges, including securities fraud

'Pharma bro' Martin Shkreli found guilty of 3 of 8 charges, including securities fraud | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A federal jury Friday found notorious "Pharma bro" Martin Shkreliguilty of three counts of securities fraud — but acquitted him of five other criminal counts related to hedge funds investors and a drug company he founded.

 

The split verdict in Shkreli's trial came at about 2:37 p.m. on the fifth day of jury deliberations, after a more-than-month-long trial in Brooklyn, New York, federal court.

 

At that trial, prosecutors claimed Shkreli had defrauded multiple investors in his two hedge funds out of millions of dollars, only to repay them with stock and cash that he looted from a the biotech company he created, Retrophin.

 

While the seven-woman, five-man jury clearly accepted some of the prosecution's evidence, it rejected other parts of their argument.

 

The mixed decision perplexed many in the courtroom, including the 34-year-old Shkreli, who first drew widespread public scorn in 2015 for raising the price of a lifesaving drug by more than 5,000 percent.

 

He looked over quizzically at one of this lawyers, Marc Agnifilo, each of the three times that Judge Kiyo Matsumoto interrupted a set of "not guilty" announcements she was reading off of the jury's verdict sheet with a "guilty" one.

 

A juror who was quoted anonymously by the New York Times, said "In some of the counts at least we couldn't find that he intentionally stole from them and the reasoning was to hurt them."

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@PhRMA Employs a "Dark Money" Shell Game to Oppose OH Drug Price Relief Act

@PhRMA Employs a "Dark Money" Shell Game to Oppose OH Drug Price Relief Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The skirmish in Ohio over a ballot measure for lowering drug prices took a twist as a consumer advocate filed a complaint with state authorities alleging the pharmaceutical industry is illegally masking “dark money” from individual drug makers that oppose the initiative.

 

Known as the Ohio Drug Price Relief Act, the ballot measure would require state agencies to pay no more for medicines than the Department of Veterans Affairs. The agency currently gets a 24 percent federally mandated discount off average manufacturer prices. Supporters say the measure would save state residents $400 million annually.

 

In her complaint, Tracy Jones, a former executive director of the AIDS Taskforce of Greater Cleveland, charges that a limited liability company established by the pharmaceutical industry trade group failed to comply with state campaign finance disclosure laws, such as not providing a list of donors.

 

About $15.8 million was donated in recent weeks by the Ohioans against the Deceptive Rx Ballot Issue LLC, to a political action committee with the same name, and which was created at the same time as the LLC. In effect, the LLC is allegedly functioning as a political action committee and, therefore, is obligated to disclose contributors, according to the complaint filed on Wednesday with the Ohio Elections Commission.

 

The LLC was registered last May with state officials and the form was signed by Scott LaGanga, a senior vice president in charge of state advocacy at the Pharmaceutical Research & Manufacturers of America, the industry trade group. Another form lists the LLC as a wholly owned subsidiary of PhRMA.

 

One campaign financing expert had this to say:

 

“Circumventing disclosure of individual donors is certainly nothing new. But it’s somewhat difficult to understand why a trade group that represents the pharmaceutical industry thinks that hiding company names will achieve anything,” Edwin Bender, executive director, National Institute on Money in State Politics, a non-profit, told us. “Everyone knows who they represent.

 

“It appears they’re forming a shell company to move money around so they’re not held accountable, but corporations aren’t people — they don’t have feeling, morals, or civic courage. They’re protecting bottom lines. But in the age of the Internet, it’s an old strategy that’s getting a little tired. It’s also bad policy.”

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Unused Prescription Opioids After Surgery Are Reservoir for Illegal Use

Unused Prescription Opioids After Surgery Are Reservoir for Illegal Use | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Key Points

Question  How commonly are prescription opioid analgesics unused among adult patients after a surgical procedure?

Findings  In this review of 6 studies involving 810 unique patients who underwent orthopedic, thoracic, obstetric, and general surgical procedures, 67% to 92% of patients reported unused opioids. Rates of safe storage and/or disposal of unused prescription opioids were low.

Meaning  Unused opioids prescribed for patients after surgery are an important reservoir of opioids available for nonmedical use and could cause injuries or even deaths.

 

Abstract

Importance  Prescription opioid analgesics play an important role in the treatment of postoperative pain; however, unused opioids may be diverted for nonmedical use and contribute to opioid-related injuries and deaths.

Objective  To quantify how commonly postoperative prescription opioids are unused, why they remain unused, and what practices are followed regarding their storage and disposal.

Evidence Review  MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials were searched from database inception to October 18, 2016, for studies describing opioid oversupply for adults after a surgical procedure. The primary outcome—opioid oversupply—was defined as the number of patients with either filled but unused opioid prescriptions or unfilled opioid prescriptions. Two reviewers independently screened studies for inclusion, extracted data, and assessed the study quality.

Findings  Six eligible studies reported on a total of 810 unique patients (range, 30-250 patients) who underwent 7 different types of surgical procedures. Across the 6 studies, 67% to 92% of patients reported unused opioids. Of all the opioid tablets obtained by surgical patients, 42% to 71% went unused. Most patients stopped or used no opioids owing to adequate pain control, and 16% to 29% of patients reported opioid-induced adverse effects. In 2 studies examining storage safety, 73% to 77% of patients reported that their prescription opioids were not stored in locked containers. All studies reported low rates of anticipated or actual disposal, but no study reported US Food and Drug Administration–recommended disposal methods in more than 9% of patients.

Conclusions and Relevance  Postoperative prescription opioids often go unused, unlocked, and undisposed, suggesting an important reservoir of opioids contributing to nonmedical use of these products, which could cause injuries or even deaths.

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Should we tax opioid makers and use the money to pay for treatment?

Should we tax opioid makers and use the money to pay for treatment? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Once again, a bill has been introduced that would require companies to pay a tax on the amount of opioids they make or import, and the funds would be used by the federal government to establish abuse prevention and treatment centers.

 

The latest bid is from Rep. Michelle Lujan Grisham (D-N.M.), who first introduced such a bill last December, and follows similar moves by Sen. Joe Manchin (D-W. Va.), whose most recent bill arrived in March. Their initial efforts went nowhere and it is unclear if these latest attempts will fare any better.

 

Nonetheless, the idea is provocative, and comes as a growing number of city, county, and state governments sue drug makers to recover money spent on pills and treatment.

 

The tax is estimated to raise about $2 billion, which one expert says would be a good start. Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University, estimates $6 billion is needed to “clean up the mess” made by drug makers and to ensure adequate treatment.

 

“Given the profits made from selling these products, despite the known risks, having the companies cover a portion of the harm is sensible,” added Dr. Lewis Nelson, who chairs the Department of Emergency Medicine at Rutgers New Jersey Medical School.

 

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Doctors Say Most Pharma Sales Details Are "Stale" 

Doctors Say Most Pharma Sales Details Are "Stale"  | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite the pharma sales force making great strides towards “digitizing the field” with tablets and other technologies – a new study from DRG Digital’s Manhattan Research finds that the content reps are showing in details is often old news. Physicians who see sales reps say that over half of the time (51%), the reps show them information they have already seen through their own research or in previous meetings.

 

The ePharma Physician® study of 1,814 U.S. practicing physicians across 25 specialties found several key missed opportunities in the field.

 

Details are not evolving in step with physicians’ reliance on digital for info:

  • The “stale detail” phenomenon is even more prominent among certain specialties. For example, medical oncologists who see reps say that 68% of the time, their reps show them info they’ve already seen, and dermatologists say the same of 62% of details.
  • Today’s physicians are now adept at finding clinical info online, as they need it – and reps that focus too much time on basic product and promotional info risk boring them with info they already knew. 74% of physicians use search engines weekly or more, and 52% use pharma digital resources regularly, with product-related info being the most accessed website resource.
  • Reps must evolve their details to stay relevant and provide utility to docs, and showing non-promotional resources on tablets can help. 63% of physicians agreed that in-person meetings with sales reps are more valuable when resources not related to the product are shown.
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Senator expands opioid probe to more drug makers, wholesalers

Senator expands opioid probe to more drug makers, wholesalers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Top Senate Democrat is expanding a probe into the opioid crisis by asking four more drug makers, as well as the nation’s largest pharmaceutical distributors, for a raft of information.

In a series of letters, U.S. Sen. Claire McCaskill (D-Mo.) wants the companies to explain the steps they have taken to mitigate the opioid epidemic, particularly monitoring suspicious orders and preventing the diversion of the prescription painkillers. The letters were sent to Teva Pharmaceuticals, Allergan, Endo International, and Mallinckrodt, along with Cardinal Health, McKesson, and AmerisourceBergen.

“We’ve seen numerous reports that potentially hundreds of millions of opioid pills wound up on the black market, fueling a nationwide epidemic,” McCaskill said in a statement.

 

We need a better understanding of how committed these companies are to preventing this type of drug diversion or whether they are turning a blind eye.

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Pharma Scientists Mad About Mad Scientists Portrayed in Hollywood Movies

Pharma Scientists Mad About Mad Scientists Portrayed in Hollywood Movies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“Big Pharma is a perfect movie villain because it’s combining the mad scientist of science fiction with the big banks, the big-money villains of dramas and thrillers,” said Miranda Banks, an associate professor of cinema studies at Emerson College.

 

And the drug industry, witting or not, isn’t helping its cause with all those TV drug ads.

 

“Think about what the American public sees,” said Jeanine Basinger, a movie historian and professor of film studies at Wesleyan University. “Let’s say you’re watching TV and on comes an ad for Vicatacapoo. ‘It’ll make you well! It’s wonderful! And let me just mention the side effects: You will turn into a kangaroo, your ears will fall off, and you won’t be able to have sex.’”

 

Each 30-second spot serves as a reminder of an age-old theme: Miracle cures are rarely what they seem. “It goes back to the very beginning,” Basinger said. “It’s Adam and Eve — ‘you ate the apple,’ which is a form of ‘you took the pill.’”

 

And thus a replicable cinematic formula: Combine a noble scientific endeavor gone awry with a virulent strain of capitalism and you get — spoiler from 1968 — the downfall of human society.

 

Actual scientists are not always amused.

 

“I think it’s a huge chasm,” said John Maraganore, CEO of Alnylam Pharmaceuticals and chairman of BIO, the biotech sector’s largest trade group. “We’re an industry where our scientists come to work every day not worried about making money but about new inventions, new discoveries, and cures for patients.”

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Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs

Celgene to Pay $280 Million to Settle Fraud Suit Over Illegal Marketing of Cancer Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.

 

Under the terms of the settlement, which resulted from a lawsuit filed by a whistle-blower — a former sales representative at Celgene — the company will pay $259.3 million to the United States and $20.7 million to 28 states and the District of Columbia.

 

The Celgene settlement is the latest in a string of multimillion-dollar fines that pharmaceutical companies have paid to settle charges that they inappropriately marketed certain drugs in recent years, but this case is one of the largest settlements to involve a cancer drug, said Reuben A. Guttman, who represented the whistle-blower, Beverly Brown.

 

Cancer drugs are seen as more difficult to pursue in so-called off-label marketing cases in part because oncologists often prescribe drugs for unapproved uses in an effort to combat a deadly and still mysterious disease.

 

“The company got the idea that it could be fast and loose with what it was saying about its drug because it was selling to cancer patients who might be in need,” Mr. Guttman said. “At the end of the day, what this is about is that even when you’re on life’s edge,” he added, a company “can’t break the law by off-label marketing a drug.”

 

Brian Gill, a spokesman for Celgene, which is based in New Jersey, said in a statement on Tuesday that the company denied any wrongdoing and said it was “settling to avoid the uncertainty, distraction, and expense of protracted litigation.”

 

For background, read:

  • “A Pharma Marketing "Bait-and-Switch" Scheme: Sales Reps Disguised as Medical Science Liaisons”; http://bit.ly/Mxr9I3
  • “Thalidomide Offsprings Yield Blockbuster Profits for Celgene Aided by Off-Label Promotion”; http://sco.lt/5kJeZV

Pharma Guy's insight:

The CEO of Celgene looks like Bruce Willis! :) But he's no "good guy"!

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Multi-Channel Learning Best for Teaching Oncologists How to Use New-Fangled Precision Meds

Multi-Channel Learning Best for Teaching Oncologists How to Use New-Fangled Precision Meds | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Background: Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies.

 

Objective: This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning.

 

Methods: In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment.

 

Results: A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02).

 

Conclusions: Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content.

 

Further Reading:

  • “Why cancer patients don't have enough information to make decisions about their treatments”; http://sco.lt/8rrlZZ
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Cleveland Clinic Cardiologist Nissen Likens Anti-Statin “Internet Cult” to Anti-Vaxxers

Cleveland Clinic Cardiologist Nissen Likens Anti-Statin “Internet Cult” to Anti-Vaxxers | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers studied over 28,000 patients in Massachusetts and found three in 10 stopped taking statins after experiencing side effects, which were presumed to be due to the drugs. Some 8.5% of them had a cardiovascular event, such as a heart attack or stroke, within four years -- versus 7.6% of those who continued taking statins.

 

"That's a very significant number," said Cleveland Clinic cardiologist Dr. Steven Nissen, who was not involved in the study but penned an accompanying editorial in the same journal.

 

One expert questioned whether his findings had much to do with statins at all.

"We don't know what (else) was different about the groups," said Dr. Rita Redberg, a professor of medicine at University of California, San Francisco. Redberg was not involved in Turchin's research. "People that take medicines and are adherent do better than people that don't."

 

For example, those who take medications consistently might also eat better or exercise more, Redberg added. So a "small difference" between the groups "isn't that revealing," she said.

 

Nissen said that statins have developed a "bad reputation with the public," largely due to websites that peddle scary and unscientific claims about statins.

 

"We have a large number of people in the public that have been convinced by this internet cult that statins are bad for you," said Nissen, who compared the trend to discussions surrounding vaccines and climate change. "How did we get into this kind of a mess?"

 

These claims, Nissen said, could actually increase reported side effects. The more patients are aware -- and perhaps fearful -- of statins and their side effects, the more likely they are to report those side effects. This phenomenon is known as the "nocebo effect," the opposite of the placebo effect.

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AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ!

AbbVie Must Pay $150 Million for Misleading AndroGel Marketing, But Not to DOJ! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a split decision, a federal jury in Chicago ordered AbbVie to pay $150 million in punitive damages for fraudulently misrepresenting the risks of its AndroGel testosterone replacement drug. But at the same time, the jury decided the drug maker was not liable for a heart attack that the plaintiff, Jesse Mitchell, suffered after taking the medication.

 

The trial was the first in an estimated 6,000 lawsuits that the drug maker faces over its controversial marketing, which warned that low testosterone can interfere with sex drive, moods, and energy levels. However, the increased usage was accompanied by dueling medical studies — and subsequent debate — over the extent to which AndroGel and other such drugs could increase cardiovascular risks.

 

AndroGel was approved by regulators to treat hypogonadism, a condition in which the body does not produce enough testosterone and is supposed to be prescribed due to illness or injury. However, the consumer marketing campaign, which was dubbed “Low T,” also suggested that AndroGel could be used to treat typical signs of aging, such as low energy, low sex drive, and moodiness.

 

Moreover, the lawsuits also allege that AbbVie either hid or downplayed the risk of heart attacks. Two years ago, after sustained scrutiny, the Food and Drug Administration required drug makers to add information on their product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments.

 

In the case decided on Monday, Jesse Mitchell, a 54-year-old laundry manager from Fairview, Ore., alleged AbbVie misled him and his doctor about the possibility that AndroGel could cause blood clots, which can lead to fatal heart attacks. Mitchell suffered a heart attack in 2012 after taking AndroGel for four years, according to court documents.

 

However, the jury did not find that AbbVie was negligent and so did not award anything to Mitchell for his heart attack. As a result, he was not awarded any compensatory damages; the $150 million award is only for punitive damages. An AbbVie spokeswoman wrote us that “the jury found that Androgel did not cause any damage. We expect the punitive damage award will not stand.”

 

Further Reading:

  • “Insurers ‘Duped’ by Deceptive Low-T #Pharma Marketing”; http://sco.lt/5iII89
  • “Too Many Healthy Men Receive ‘Low-T’ Treatment & Are at Risk for Major Adverse Cardiovascular Events”; http://sco.lt/7UBZq5
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Republicans Becoming More Aggressive in Soliciting Funds from Pharma Ahead of Mid-term Elections

Republicans Becoming More Aggressive in Soliciting Funds from Pharma Ahead of Mid-term Elections | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[8 of the top 10 recipients of pharma $ in the first half of 2017 are Republicans.]

 

For pharma companies, “now would be the time to give out the money, ahead of a piece of legislation that may come down the road,” said Kent Cooper, a former Federal Election Commission official who has tracked political money for decades. “You want to get your name out there and make a connection with these members’ legislative assistants — so you are known to them and you can get in their door.”

 

Evidence has grown that pharma companies helped fuel the nation’s addiction and overdose crisis with sales of powerful painkillers, prompting calls for an overhaul. Drug developers are also preparing for renewal of the Prescription Drug User Fee Act, which generates revenue to pay for government review and approval of drugs.

 

At the same time, drug companies anticipated Republican efforts to repeal and replace the Affordable Care Act, which finances billions in drug sales. That process has stalled in the Senate. All of this gives drugmakers the most powerful incentives in years to cultivate policymakers, analysts say.

 

Tense politics may also be prompting members of Congress to be energetic about soliciting donations.

 

“My sense is that Republicans are nervous in the House — especially given the long-term record of the presidential party losing seats in the midterm,” said David Magleby, a political scientist at Brigham Young University who studies campaign finance. “I would be surprised if Republican incumbents across the board aren’t more aggressive in raising money in the first and second quarters.”

 

Kaiser Health News analyzed first-quarter campaign finance reports for members of Congress. We included contributions made both directly and through joint fundraising committees to candidate campaign committees by political action committees (PACs) that are associated with pharmaceutical companies, pharmacy benefit managers and trade groups. These reports are subject to change as candidates file amendments and issue refunds. We did not include contributions made by individuals.

 

Further Reading:

  • “Opioid Drug Maker Mallinckrodt Spends Big Lobbying Lawmakers About Opioids”; http://sco.lt/6lxyqX
  • “The Who's Who of ‘Health Care’ (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets”; http://sco.lt/8oWq4f
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Why Does Pharma Love Cancer? It's Where the Money Is. Duh!

Why Does Pharma Love Cancer? It's Where the Money Is. Duh! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It’s not going to come as a surprise to anyone who’s been paying attention to drug R&D trends that cancer is the number 1 disease in terms of new drug development projects. But it is amazing to see exactly how much oncology dominates the industry as never before.

 

At a time the first CAR-T looks to be on the threshold of a pioneering approval and the first wave of PD-(L)1 drugs are spurring hundreds of combination studies, cancer accounted for 8,651 of the total number of pipeline projects counted by the Analysis Group, crunching the numbers in a new report commissioned by PhRMA. That’s more than a third of the 24,389 preclinical through Phase III programs tracked by EvaluatePharma, which provided the database for this review.

 

That’s also more than the next 5 disease fields combined, starting with number 2, neurology — a field that includes Parkinson’s and Alzheimer’s. Psychiatry, once a major focus for pharma R&D, didn’t even make the top 10, with 468 projects.

 

Moving downstream, cancer studies are overwhelmingly in the lead. Singling out Phase I projects, cancer accounted for 1,757 out of a total of 3,723 initiatives, close to half. In Phase II it’s the focus of 1,920 of 4,424 projects. Only in late-stage studies does cancer start to lose its overwhelming dominance, falling to 329 of 1,257 projects.

 

Further Reading:

  • “Cancer Experts Say Majority of New Cancer Drugs are Ineffective & May Cause More Harm Than Good”; http://sco.lt/8UsdHd
  • “Ads for “Breakthrough” Cancer Drugs Are “An Ocean of Hype,” Say Oncologists”; http://sco.lt/5NIzOD
  • “New Cancer Drugs Have Limited Efficacy Extending Survival by Only 3.5 Months on Average”; http://sco.lt/5ySRYf
  • “Breakthrough Cancer Therapy DTC: Boldly Emphasizing the Positive”; http://bit.ly/pmn150402h
  • “Widespread Hype Gives False Hope To Many Cancer Patients”; http://bit.ly/2oEtZmx
  • “Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data;” http://sco.lt/5OtIdl
  • “Immunotherapy Drugs: A Chance to Live Longer or Die from Myriad Side Effects”; http://sco.lt/5Qsymn
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Harvard Opioid Study Calls for Crackdown on Big Pharma

Harvard Opioid Study Calls for Crackdown on Big Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Weak patenting standards and ineffectual policing” have helped turn the pharmaceutical industry into a key driver of the opioid epidemic, according to a study published in the Harvard Law & Policy Review.

 

The study, entitled “The Opioid Epidemic: Fixing a Broken Pharmaceutical Market,” argues that the failure to effectively regulate fraudulent marketing and anti-competitive practices by Big Pharma have contributed to the “over-utilization of costly and often harmful” branded prescription drugs.

 

At the same time, it has hindered access to low-cost generics, say the three authors of the study, Ameet Sarpatwari, Dr. Michael S. Sinha and Dr. Aaron S. Kesselheim—all professors at Harvard Medical School with appointments to the Brigham and Women’s Hospital.

 

“To boost profits, pharmaceutical companies have often engaged in false or misleading marketing,” the authors charge. “Over the past twenty-five years, the industry has paid $35.7 billion to settle claims of illegal marketing, including making false or misleading claims or failing to disclose known risks.”

 

A fundamental cause of the epidemic was—and continues to be—an over-prescription of opioids, the study says. From 2000 to 2010, the number of prescriptions for oral opioid analgesics rose 104%.

 

The authors call on the federal government to take a more “proactive” role in challenging pharmaceutical patents, and recommend that Congress authorize the Food and Drug Administration to “impose user fees that would fund comparative cost-effectiveness research and dissemination.”

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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