Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks

Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Novo Nordisk will pay $58.65 million to the Justice Department to resolve allegations that it instructed some of its sales representatives to share information with physicians that downplayed safety risks for Victoza, its type-2 diabetes medication.

 

The FDA approved Victoza in 2010, on the condition that the company implement a Risk Evaluation and Mitigation Strategy (REMS) to warn physicians about the potential risk of patients developing a rare cancer called medullary thyroid carcinoma. The drug now has a black-box warning.

 

The allegations against Novo include that managers instructed reps to “sandwich” the risk information between promotional messages in order to minimize that information. Reps also reportedly told doctors that the risk of cancer is only associated with mice and rats; that all diabetes drugs have boxed warnings and Victoza was no different; and that this type of cancer is “easy to treat” if a patient was diagnosed.

 

Because the reps gave doctors a misleading impression about the risks cited in the FDA-mandated REMS program, some physicians who prescribed Victoza were unaware of those risks, the Justice Department alleged. A government survey conducted in 2011 found that half of primary-care doctors were unaware of the cancer risks associated with Victoza.

 

In a statement, the drugmaker said it disagreed with the government's “legal conclusions” and denied wrongdoing. “We're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients,” Doug Langa, Novo Nordisk's president and EVP and head of North America operations, said in the statement.

 

Novo reported that Victoza – part of a class of drugs called GLP-1s, which includes Eli Lilly's Trulicity – brought in $3 billion in sales in 2016. In addition, the drugmaker has pursued new indications for the therapy. In 2015, a formulation of Victoza was approved as Saxenda, a treatment for weight loss. Earlier this year, the FDA approved Victoza as a treatment to lower the risk of cardiovascular events like heart attacks and strokes.

 

Novo spent $128 million on direct-to-consumer advertising for Victoza in 2016, according to Kantar Media.

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Saxenda for Weight Loss: A #pharma Ghost Writing Case Study

Saxenda for Weight Loss: A #pharma Ghost Writing Case Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Weight-loss medications have had a checkered history. But after a long drought in the diet drug market, several new ones have recently been introduced. Last April, drugmaker Novo Nordisk announced its entry, a daily injection called Saxenda, which contains a higher dose of the active ingredient in the company's diabetes drug Victoza.


It's too soon to say what the $1,000-per-month Saxenda will mean for long-term weight control.


But it provides a window into how the pharmaceutical industry is influencing the portrayal of its products in academic journals, a development that has some experts worried.


The same week Saxenda was announced, a top obesity research journal posted a preview of an article that made a strong case for weight-loss pharmaceuticals, specifically touting liraglutide, the scientific name for Saxenda.


At the end of the nine-page article, author Frank L. Greenway, a physician and researcher, disclosed that the drugmaker had paid a consultant to provide him with "writing assistance" on the manuscript. What's more, he wrote that the company, which has U.S. operations in Plainsboro, N.J., got to review the article before publication. In an interview, Greenway said he wrote the article at Novo Nordisk's suggestion.


Greenway, the review author, said Novo Nordisk proposed the idea for the article, to reinforce the idea that obesity is a medical condition.

"They said, 'Can you help write a review to support what is in the literature, to show there are reasons why this should be thought of as a chronic disease rather than bad habits?' " he said.


The writing assistance was provided by a consulting firm called AXON Communications, which has offices in London, Toronto, and New York, but Greenway said he held final responsibility for the content.


"It was sort of a cooperative effort," Greenway said. "I came up with things, and they came up with things."

Pharma Guy's insight:

Meanwhile, Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015, urging him “to stop the apparently violative off-labelpromotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs, including Victoza. Now we know why weight loss was mentioned in the ads. Read more about this here: http://bit.ly/1PaM0Ke 


Take my ghost writing survey: https://www.surveymonkey.com/r/2V5GR5X 

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Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians. Better Investment Than Paula Deen!

Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians. Better Investment Than Paula Deen! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Novo Nordisk paid more than $9 million to physicians for promotion of its diabetes drug Victoza in the last five months of 2013, topping the list of drugs that were responsible for the most physician payments during the first reporting period covered by the CMS Open Payments database.


The bulk of the drugs on the list are blood-thinners vying to replace Coumadin (warfarin), followed by antipsychotics and anti-inflammatory drugs.


Most are relatively new, having received FDA approval since 2010. The only older drug that made the list, Humira, was approved in 2002.

Following Victoza (liraglutide[rDNA origin] injection) at  $9.07 million; the rest of the list is as follows:


  • Bristol-Myers Squibb, $7.99 million for anticoagulant Eliquis (apixaban);
  • AstraZeneca, $7.71 million for the blood-thinner Brilinta (ticagrelor);
  • Johnson & Johnson, $7.16 million for its type 2 diabetes drug Invokana (canagliflozin);
  • Dainippon Sumitomo Pharma, $7.03 million for atypical antipsychotic Latuda (lurasidone) for schizophrenia;
  • Bayer, $6.93 million for blood-thinner Xarelto (rivaroxiban);
  • AbbVie, $5.58 million for anti-inflammatory Humira (adalimumab) for a number of autoimmune indications, including arthritis, Crohn’s disease and ankylosing spondylitis;
  • Forest, $5.31 million for Tudorza (aclidinium bromide inhalation powder) and $5.2 million for Daliresp (roflumilast), both for chronic obstructive pulmonary disease;
  • Otsuka, $5 million for Abilify Maintena (aripiprazole) for schizophrenia.
Pharma Guy's insight:


Impressive. But at least it probably had a much better ROI than the millions Novo paid Paul Deen et al to be a spokesperson. For more on that, read Paula Deen & Victoza: Brilliant or Dumb?

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Higher dose of Victoza helped patients drop weight

Higher dose of Victoza helped patients drop weight | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At the American Diabetes Association meeting in San Francisco, the drugmaker said its Phase-III SCALE trial showed that patients taking a once-daily injection of 3mg of liraglutide achieved average weight loss of 5.9% body weight, compared to 2.0% weight loss among those on placebo. Patients who took a lower Victoza dose of 1.8mg reached average weight loss of 4.6% of body weight. All enrolled patients were also put on a diet and exercise program.


Novo Nordisk submitted new drug applications to the FDA and EMA to support approval of liraglutide 3mg as a weight-loss treatment in December 2013.


Victoza saw $2.1 billion in US sales for 2013, a 31% increase from the year prior, according to IMS Health.

Pharma Guy's insight:


Public Citizen in a petition it filed in 2010 with the Food and Drug Administration (FDA) called on the agency to "immediately remove from the market the increasingly prescribed diabetes drug Victoza because it puts patients at higher risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure that outweigh any documented clinical benefits."

The Public Citizen press release states the case regarding pancreatitis:


"Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported. In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of taking Victoza."


At a Selling Sickness conference in Washington, DC, Wolfe gave a rousing keynote presentation in which he spoke about the "selling sickness" aspect of marketing Victoza in spite of its dangerous side effects: Listen to this Pharmaguy Audio Snippet.

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Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events

Novo Nordisk Thanks #FDA for Forcing It to Prove Victoza Can Decrease CV Events | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Researchers announced that Victoza, a diabetes drug sold by Danish drug giant Novo Nordisk , prevents heart attacks, strokes and cardiovascular deaths.

 

It is only the second diabetes drug ever to do so. The first, Jardiance, a pill sold by Eli Lilly and Boehringer Ingelheim , presented its positive results just last year. Researchers say that the new results could change the way that doctors treat diabetes, shifting the treatments doctors reach for after metformin, the tried-and-true first-line drug, which is generic.

 

“There’s a building momentum that maybe we do need to rethink the way diabetes is cared for in America,” says John Buse, the University of North Carolina, Chapel Hill researcher who led the study, which was funded by Novo Nordisk.

 

And doctors and Novo Nordisk itself give credit to the new diabetes data to a surprising source: Tougher regulations for diabetes drugs from the Food and Drug Administration, which many in industry had previously decried, saying it was keeping new drugs from the market and hurting patients.

 

“I can almost guarantee you that these trials would not have been done if it had not been for the FDA regulations,” says Buse, who has been a consultant to many companies for years. “Before the guidance I was constantly pushing on companies to do these trials.”

 

That fact – that companies and patients are likely to benefit from the FDA’s toughness – goes against one of the common narratives in the drug industry and among the FDA’s critics: that high regulations slow patients’ access. In some cases, its clear, they also create a bar for industry to leap over, and deliver billions of dollars in spoils to companies that actually manage to help patients, not just blood test results.

 

The Victoza result is exactly the kind of marketing claim that makes a drug company salivate: Novo Nordisk can now tell patients and their insurers that the alternative to its drug is an earlier death.

Pharma Guy's insight:

The research showed that 13% of patients on Victoza had a heart attack, stroke, or death, compared to 14.9% on placebo, a 13% decrease in risk. Reductions in cardiovascular death (22%) and death from any cause (15%) were also statistically significant.

 

Now, perhaps, Novo won't have to bribe so many physicians or promote the drug for weight loss. For more on that, read "Novo Nordisk’s Victoza Tops List of Drug Payments to Physicians"; http://sco.lt/9141vV "Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs"; http://sco.lt/84lZtR

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Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs

Public Citizen: Off-Label Uses Promoted in DTC Ads for Diabetes Drugs | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, sent FDA’s OPDP Director Tom Abrams a letter on March 31, 2015 urging him “to stop the apparently violative off-labelpromotional statements in the direct-to-consumer (DTC) advertisements of five prescription drugs approved for the treatment of Type 2 diabetes. The drugs are Farxiga (dapagliflozin), Jardiance (empagliflozin), Invokana (canagliflozin), Victoza (liraglutide) and Bydureon (extended-release eventide).”

Usually, pharmaceutical companies are accused of promoting drugs “off-label” to physicians, which is understandable because it is perfectly legal for physicians to prescribe drugs for so-called off-label use.

The FDA rarely cites off-label or “unapproved use” claims made in DTC ads. None of the letters issued by FDA in 2014 mentioned that violation. Historically (between 2004 and 2013), only 4% of violations cited in FDA letters was concerned with off-label/unapproved use promotion and no TV ad received such a letter (see here).

Public Citizen includes a Farxiga ad that “touts” weight loss and blood pressure reduction as potential benefits although the drug has not been approved for those indications (see the ad in the above figure; also included is a screen save from the TC ad).

“These five drugs have been approved solely to lower hemoglobin A1C levels in patients with Type 2 diabetes,” says Public Citizen, “but the advertisements presented in this letter clearly convey the false perception to patients and doctors that the drugs have been deemed safe and effective for weight loss and/or reducing blood pressure.”

Public Citizen wonders if the FDA approves on such off-label ads and asks a couple of interesting questions in light of the recent paucity of warning letters issued by the FDA (read “Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions”).


Read more here.

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Fat Chance? Novo Hopes to Sell Victoza as a Diet Drug

Fat Chance? Novo Hopes to Sell Victoza as a Diet Drug | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Can an injectable diabetes drug make a successful transition into a big-selling fat fighter?


That’s the bet Novo Nordisk NVO +0.27% is making as the drug maker goes before an FDA advisory panel tomorrow in hopes of winning a recommendation to sell its Victoza diabetes treatment to combat obesity.


The gambit comes amid increasing efforts by health officials to convince Americans to lose weight, although prescriptions for a pair of relatively new diet drugs – known as Belviq and Qsymia – have been flagging.  One key question for Novo Nordisk is whether enough people will be willing to stomach a daily injection instead of swallowing a pill.


This remains to be seen, but already analysts believe the Novo drug – which is marketed as Victoza for treating diabetes, but will be called Saxenda for the overweight – is likely to win a recommendation and later FDA approval. Why? For one, the trial data submitted to the FDA shows effectiveness – across all trials, 60% of patients achieved a 5% weight loss and 31% achieved a 10% weight loss (here are the Novo briefing documents).


There are safety risks, though.


[Indeed there are safety risks. Read  Victoza, Januvia, and Other Diabetes Drugs Under FDA Scrutiny

Pharma Guy's insight:


A Public Citizen press release states the case regarding side effects of Victoza:


"Even in the small numbers of patients in clinical trials, pancreatitis was increased 3.7-fold in patients getting Victoza over that seen in patients getting other diabetes drugs; additional cases of pancreatitis continue to be reported to the FDA in alarming numbers, considering how few adverse events are ever reported. In the first 17 months of Victoza being on the market, 200 patients were diagnosed with acute pancreatitis, according to Public Citizen’s review of the FDA’s adverse event database. Because only an estimated 10 percent of cases are reported, potentially as many as 2,000 patients or more have suffered a painful and serious outcome as a result of taking Victoza."

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