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.
Curated by Pharma Guy
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Report questions safety of the newest hepatitis C drugs

Report questions safety of the newest hepatitis C drugs | Pharmaguy's Insights Into Drug Industry News |

Over the past few years, billions of dollars have been spent on new hepatitis C medicines because they could eliminate the virus in 90 percent or more of patients. But a new report ( finds that hundreds of cases of liver failure were associated with the drugs, and the authors suggest that regulators may have been too quick to embrace the treatments as a panacea.


Specifically, 524 cases of liver failure were found, along with another 1,058 reports of severe liver injury, according to side effects reports that were filed with the US Food and Drug Administration and reviewed by the Institute for Safe Medicine Practices. The nonprofit group also noted 761 instances in which the reported side effect was a failure of the medicines to combat the virus. The report arrives just three months after the FDA issued a warning that the drugs could reactivate hepatitis B.


…The study authors maintain their findings should be seen as a warning about the “negative consequences” of the drugs. The medicines “should be ranked as a major medical advance, [but] the large number of cases of liver failure and death, as well as antiviral failure, show the need for further investigation of the serious adverse effects of this expensive new class of drugs.”


Indeed, the latest generation of hepatitis C treatments has been revolutionary, offering a desirable combination of high cure rates and manageable side effects. They include the Sovaldi and Harvoni treatments sold by Gilead Sciences. But the drugs come at a cost, literally. List prices range from $54,600 to $94,500, depending upon dosing and regimens, although these do not reflect rebates or discounts.


Spending per patient has ranged from $55,000 to $125,000 per patient, according to the ISMP report, citing data from QuintilesIMS, and about 250,000 patients were treated in 2015. The study authors noted that list-price spending for the drugs exceeded similar spending for antibiotics, and cholesterol and blood pressure drugs, each with patient populations measured in tens of millions.


“These new data raise more questions than they resolve about the adverse effects of direct-acting antiviral drugs…. The FDA and pharmaceutical companies were also overoptimistic in labeling as a ‘cure’ the results of a laboratory assay at 12 weeks indicating undetectable levels” of the virus.


“This is an example of the price we pay for faster drug approval with reduced clinical testing,” said Thomas Moore, a senior scientist at ISMP and one of the study authors. “Don’t we really want to know more than this about a new drug treatment on which we spent more than $10 billion to $20 billion in 2015 alone? We spent more than twice as much on these direct-acting antivirals for about 250,000 patients as the NIH did on all research into all infectious diseases in one year.”


Not everyone is convinced, however, that the report should alter medical practice.


More here…


Further Reading:

  • “What's Gilead & FDA Hiding? Advocacy Groups Sue to Access Hepatitis C Trial Data”;
Pharma Guy's insight:

I'm on record for wondering if, in the long run, the claims of enduring cure of Hepatitis C may be over optimistic. Now, in addition, there are serious side effects associated with these drugs.

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Spoofing #Pharma Ads, Dodge Campaign Puts "Side Effects" Front & Center

Spoofing #Pharma Ads, Dodge Campaign Puts "Side Effects" Front & Center | Pharmaguy's Insights Into Drug Industry News |

Dodge is launching a new ad campaign with the tagline "Domestic. Not Domesticated." 

The brand, which had been running a Wieden & Kennedy campaign hearkening back to founding brothers John and Horace Dodge, has shifted gears with a pair of new ads backed by the Metallica song "Fuel."

One spot called "Warning" portrays Dodge as a drug by mimicking pharmaceutical ads with a laundry list of over-the-top warnings like "Dodge may cause loss of inhibitions and in some cases bodily functions." The campaign also includes a long-form video that shows a robotic "hellcat" animal that transforms into the the Dodge Challenger SRT Hellcat muscle car.

Fiat Chrysler Automobiles in March ended a six-year relationship with agency Wieden & Kennedy, which led creative for the Dodge and Chrysler brands.

Omnicom Group's GSD&M of Austin, Texas, was named lead agency for Dodge in late May, while Chrysler is still in review. But FCA is using a variety of agencies on the new campaign, which is consistent with the automaker's practice of moving work around. GSD&M is credited with creating the new tagline. The "Warning" ad is by Argonaut of San Francisco. The Hellcat video is by Mind Over Eye, a creative content studio based in El Segundo, Calif.

The new tagline first appeared earlier this month in a print ad in ESPN The Magazine's "Body Issue." It marks the first overall tagline for Dodge in many years, according to the brand. Dodge had been using separate lines for different vehicles, such as "New Rules" and "Don't Touch My Dart" for recent Dodge Dart campaigns. The new tagline will be used across TV, print, digital ads as well as social media and event marketing.

Pharma Guy's insight:

Kind of reminds me of the old "Deep Dive" Celebrex ads as described here: 

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Everyone Loses When Doctors Trust Pills Over Patients. Implications for Adherence.

Everyone Loses When Doctors Trust Pills Over Patients. Implications for Adherence. | Pharmaguy's Insights Into Drug Industry News |

Treating pain is a notoriously tricky business. But it’s even harder if the medications on which we rely are inappropriately marketed. Last month, a Los Angeles Times investigation of Purdue Pharma asserted that for years, the company falsely elevated the efficacy of its twice-daily OxyContin, a powerful opioid pain reliever. The L.A. Times’ review of evidence—including three decades of court cases, investigations, patient and sales rep testimonies—provides good data that the drug's effect may not, as claimed by Purdue, last for 12 hours across the board (read “OxyContin's 12-hour Problem: Misrepresentation of Efficacy Leads to Addiction & Purdue Knew It”; ).


In other words, OxyContin may not be the magical drug that provides longer-lasting pain relief than all other oral opioids. Purdue has argued that the L.A. Times’ claims are not valid, and it remains to be seen whether there will be federal investigations into this claim as recommended by Massachusetts Sen. Edward Markey.


In the meantime, as a doctor who bought the hype about OxyContin’s twice-daily efficacy for decades, I’m frustrated. While my gut sense that someone was pulling the wool over my eyes was correct, I was casting blame in the wrong direction—toward my patients.

Pharma Guy's insight:

When drugs don't work as advertised - especially if they have side effects that are downplayed by sales reps - it impacts what the drug industry terms the "problem" of lack of adherence. Patients will stop taking drugs that don't work or have side effects and thus they will be labelled as non-adherent and seen as the problem that has to be solved by more advertising or by more adherence apps and programs, when in fact it is the drug that is the problem. That's why I say “Medication Adherence Won't Get Better Unless Pharma Marketers Accept Some Blame”;

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Side Effects of Major Statins Compared. Guess Which Company Has the Worst?

Statins have been linked with cardiovascular problems as well as amnesia and mental decline. But neurological side effects are not turning up as frequently in postmarketing safety data. And muscle-related side effects, which are also commonly linked to the drugs, show up more often in three Merck products than in the rest of the class.

That's the word from healthcare informatics company Advera Health Analytics. The firm sifted through FDA postmarketing safety reports, and compiled data on side effects for companies producing statin drugs. Advera's report found that Merck's ZocorMevacor and Vytorin were associated with more muscle-related side effects than other drugs in the class such as Pfizer's ($PFECaduet, AbbVie's ($ABBVSimcor and AstraZeneca's ($AZN) blockbuster Crestor.

For example, Zocor had 4275 reports of myalgia, 632 reports of myopathy, and 3552 cases of rhabdomyolysis, a condition commonly linked to statins that involves the breakdown of muscle tissue. In comparison, Caduet had 59 reports of myalgia, 5 reports of myopathy and 12 reports of rhabdomyolysis in postmarketing data. And AbbVie's Simcor was linked to 365 reports of myalgia.

Still, Merck is standing by its drugs, saying that reports submitted under the voluntary reporting system "often have incomplete medical and drug histories and unsubstantiated diagnoses," the company told FiercePharma in a statement.

Pharma Guy's insight:

One potential side effect to keep an eye on is Type 2 diabetes... Lipitor was linked to 7,061 reports of Type 2 diabetes mellitus in Advera's report, and Crestor was tied to 557 reports of the disease. Those numbers could come as bad news to AstraZeneca, which will face U.S. generics for Crestor in May 2016 and is already dealing with competition from off-patent Lipitor.

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Is Gardasil a "Flop" Because of Faulty Investigative Reporting or Because of Social Media?

Is Gardasil a "Flop" Because of Faulty Investigative Reporting or Because of Social Media? | Pharmaguy's Insights Into Drug Industry News |
The Toronto Star, Canada's highest-circulation daily newspaper, has built a reputation for excellent investigative reporting, including justly celebrated exposes of Toronto Mayor Rob Ford.

But now that reputation is in tatters, due to an evidence-free "investigation" of the health risks of the vaccine Gardasil, which immunizes against the dangerous human papillomavirus. The Star's Feb. 5 piece, ominously headlined "A wonder drug's dark side," exploited heart-wrenching family anecdotes of illness and death to undermine a vast library of scientific studies proving the vaccine to be safe.

Worse, the Star responded to an uproar over the article by scientific and medical experts by smearing and demeaning critics -- until the paper's publisher finally acknowledged publicly that the story was wrong: "We failed in this case. We let down. And it was in the management of the story at the top," he told a radio audience on Feb. 11. On Friday, the Star added a subheadline to the online version of the article, acknowledging the uproar and stating in part, "There is no scientific medical evidence of any 'dark side' of this vaccine."

Pharma Guy's insight:


Meanwhile, some think social media is to blame. Read the following excerpt from a comment to "Will Social Media Make it Harder for Pharma to "Hide" Drug Side Effects?", a Pharma Marketing Blog post:


"Why was Gardasil a flop? It flopped because girls told each other via social media that they felt like $#^& after getting the shot. Not only is uptake in general low but the percentage of girls who get one shot and don't finish the three dose series is astronomical. Social media is killing Gardasil. People won't put up with feeling terrible for some theoretical protection thirty years down the road against something that may never happen to them anyways. Parents won't watch children suffer for the same reason. When they thought their child's adverse reaction was the proverbial "one in a million", they put up with it. Once they began to network (and read the package inserts) and realized how common these adverse reactions really were, parents started saying no. More an more say no every year.

"Pharma can't put the genie back in the bottle. They once controlled the flow of information as the mainstream media wouldn't jeopardize their pharma advertising revenue with critical stories. Blogs, facebook, twitter, etc. have broken the gatekeepers stranglehold on information. It's already happened with vaccines, and it will also happen with traditional drugs. The only reason it hasn't fully happened yet is that the primary market (senior citizens) aren't as plugged into social media as younger consumers. That's changing and it won't be good for pharma."

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Former Lilly in Sweden Insider Talks Side Effects and Death

Former Lilly in Sweden Insider Talks Side Effects and Death | Pharmaguy's Insights Into Drug Industry News |

The former managing director of drug giant Eli Lilly and Company in Sweden continues to reveal the business practices of the pharmaceutical industry, scoring a major victory in announcing that his first book, Side Effects: Death. Confessions of a Pharma-Insider, will be turned into a full-length feature film.

John Virapen, who began his career with “Big Pharma” in 1968 as a salesman knocking on doctors’ doors, rose through the ranks to realize what he was pitching were not drugs, but death. Virapen was well aware early on that thousands had died or committed suicide by taking the drugs he was pushing. “I indirectly contributed to the death of . . . people, whose shadows now haunt me,” he explained in his book.

Dave Gahary had the opportunity to sit down with Mr. Virapen to discuss how he got into bed with Big Pharma, what motivated him to write this book, and what his long-term goals are, in this informative interview (15:36).

Pharma Guy's insight:

John Virapin was first interviewed by PharmaGuy back in 2007 on this Pharma Marketing Talk show: A Former Lilly Insider Blows the Whistle on Criminal Activity in Sweden

lorraine cleaver's curator insight, October 27, 2014 8:13 PM

This guy knows what we are up against. The continual polypharmacy that feeds profit yet keeps us ill. Chronic patients - the gift that keeps on giving.

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OMG! Drug Side Effects (Almost) Killed Granny! ER Study Shows

OMG! Drug Side Effects (Almost) Killed Granny! ER Study Shows | Pharmaguy's Insights Into Drug Industry News |

The study has a lot of interesting information, and here are some highlights:


Side effects from medication are causing more older Americans to visit emergency rooms and leading to more hospitalizations, according to an analysis of ER data from 2005-2006 and 2013-2014. And across all age groups, the drugs most often causing side effects that sent people to an ER were the same ones identified a decade ago —anticoagulants, antibiotics, diabetes agents, and opioid analgesics.


These were among the findings in a study that examined emergency department visits for adverse reactions to medicines in 2013 and 2014, compared with 2005 and 2006.


An estimated four ER visits for adverse drug events occurred per 1,000 individuals annually. The rate of ER visits among older adults, aged 65 years and older, was 9.7 visits per 1,000 individuals compared with 3.1 visits per 1,000 individuals for those younger than 65 years.


An estimated 35 percent of ER visits for adverse drug events occurred among adults aged 65 years or older in 2013 and 2014 compared with nearly 26 percent in 2005 and 2006.


Even after accounting for prescribing frequency, the authors found that the rate of ER visits for adverse drug events per prescription was previously significantly higher for anticoagulants and diabetes medicines than for most other drugs.


Prescribing more medicine than needed or taking excess dosages was the most common type of adverse drug event. Medication errors were documented in 1 of 10 ER visits for adverse drug events and an estimated 27 percent of visits hospitalization.


The proportion of ER visits due to side effects involving anticoagulants rose during the last decade along with increased use. From 2009 to 2014, oral anticoagulant use increased by approximately 38 percent, whereas the proportion of ER visits for anticoagulants increased by 57 percent.


Among children, aged 5 years and younger, antibiotics were most commonly implicated as well as among older children and adolescents, aged 6 to 19 years old. Among older adults — aged 65 and older — anticoagulants, diabetes drugs, and opioid analgesics were implicated in approximately 60 percent of ER visits for adverse drug events.


Among older children and adolescents, antipsychotics were the second most commonly implicated type of drug in ER visits for adverse drug events. This occurred, the authors noted, as antipsychotic prescribing increased sharply during the last two decades. “Up to 75 percent of antipsychotic use in children and adolescents is estimated to be for off-label indications and there is evidence of low adherence to recommendations for safety monitoring,” they wrote.


Compared with 2005 and 2006, the rates of ER visits increased among older adults — 5.2 visits per 1,000 individuals in 2005 and 2006 versus 9.7 visits per 1,000 individuals in 2013- 2014 — and among adults aged 50 years to 64 years — 2.5 visits per 1,000 individuals in 2005 and 2006 versus 4.3 visits per 1,000 individuals in 2013 and 2014. The rates for other age groups were similar for both periods.

Pharma Guy's insight:

From JAMA Editorial:

Preventing, identifying, and addressing ADEs from prescribed medications will require systematic rethinking and redesign of how medications are prescribed, monitored, and discontinued, particularly medications for chronic conditions. Clinicians across the continuum of care must be involved in this redesign. Patients with ADEs often seek care in the ED, but these visits are frequently isolated from the rest of the patient’s clinical care. The most effective interventions for preventing ADEs will require greater involvement and integration of pharmacists, meaningful implementation and use of medication reconciliation, and the inclusion of patients and their caregivers. Overcoming the insidious and pervasive diffusion of responsibility within the current health care system must be a key component in preventing, identifying, and addressing ADEs from prescribed medications.

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AMA Chastises Lawyers for Alarming Drug Ads 

AMA Chastises Lawyers for Alarming Drug Ads  | Pharmaguy's Insights Into Drug Industry News |

At its annual meeting last month, the American Medical Association adopted a policy to advocate for a requirement that attorney commercials that may cause patients to stop using necessary medications to include “appropriate” and “conspicuous” warnings.

The AMA, the largest association of physicians, contends late-night television is “rampant” with attorney ads that seek plaintiffs regarding complications from new medications.

“Potential complications are spoken about in an alarming way, and often it is the first time the public learns about those potential complications and side effects,” the association said in a statement following its meeting, held in Chicago this year.

“These ads describe only the lethal side effects and not the benefits of the medications that many patients have experienced — but this is not explained to the viewers.”

In an effort to better protect the public’s health, the AMA has adopted a policy to push for ads that include warnings that patients should not discontinue medications without seeking the advice of their physician.

“The onslaught of attorney ads has the potential to frighten patients and place fear between them and their doctor,” Russell W. H. Kridel, M.D., and AMA board member, said in a statement. “By emphasizing side effects while ignoring the benefits or the fact that the medication is FDA (Food and Drug Administration)-approved, these ads jeopardize patient care.

“For many patients, stopping a prescribed medication is far more dangerous, and we need to be looking out for them.”

Pharma Guy's insight:

Hmmm... "often it is the first time the public learns about those potential complications and side effects..." Seems to me that these ads should be praised rather than condemned! Why don't the doctors pro-actively warn their patients of potential side effects in the first place! The fact that they often don't do that is reason for the fear between patient and physician.

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#Pharma Only Has to Warn Your Doctor of Drug Side Effects, Say State Courts

The Arizona Supreme Court issued an opinion in favor of drug manufacturers, clarifying how prescription drug makers are expected to warn patients about potential side effects of their drugs.

The Arizona Supreme Court opinion overturned an Arizona Court of Appeals opinion and now is in line with the way other states expect drug manufacturers to warn patients of potential side effects.

"The Arizona Supreme Court has issued an opinion clarifying that a prescription drug manufacturer fulfills its duty to warn a consumer of the risks associated with a prescription drug when it provides a full, adequate warnings to the consumer's medical provider," said Lori Voepel, partner at Jones, Skelton & Huchuli law firm in Phoenix, which represented Medicis in the lawsuit.

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Statin Side Effects: More Than Half the Time Doctors Don't Take Patient Complaints Seriously

Statin Side Effects: More Than Half the Time Doctors Don't Take Patient Complaints Seriously | Pharmaguy's Insights Into Drug Industry News |
The science on statins and sexual function is inconclusive, but it does appear that taking a statin can affect a person’s sex life, in both positive and negative ways.

2008 report from the University of California, San Diego, tells a different story. Researchers looked at statin use and sexual function in 1,000 men and women, half of whom were given a statin and half of whom took a placebo. Over all, men on statins were about twice as likely as those taking placebos to report that their ability to achieve orgasm had become “somewhat worse” or “much worse.”

Dr. Beatrice Golomb, a professor at the University of California, San Diego, medical school, who helped conduct that study, says doctors don’t always take patients seriously when they talk about side effects, sexual or otherwise. In other research, Dr. Golomb found that when patients complained about the most commonly recognized side effects of statins, their doctors denied the possibility of a connection more than half the time.

Pharma Guy's insight:

So much for "patient empowerment" and "patient centricity!" 

What about diabetes as a side effect?

New York Times OpEd piece published by a well-known cardiologist who said Americans are being "over-dosed" with statins to treat high cholesterol (see "We're overdosing on cholesterol-lowering statins says Top(ol) cardiologist").

"It is only with the more potent statins -- Zocor (now known as simvastatin), Lipitor (atorvastatin) and Crestor (rosuvastatin) -- particularly at higher doses, that the risk of diabetes shows up," said Dr. Topol. "The cause and effect was unequivocal because the multiple large trials of the more potent statins had a consistent excess of diabetes."

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Breaking Up With My Meds: "Non-Adherence" Is Not Just Dumb Patients Who Don't Follow Directions

Breaking Up With My Meds: "Non-Adherence" Is Not Just Dumb Patients Who Don't Follow Directions | Pharmaguy's Insights Into Drug Industry News |
The drugs I take for anxiety, depression and insomnia have helped, but I’ve decided to quit.

In the fall of 2014 the author decided to quit the prescription medications she has been taking to treat her anxiety, depression and insomnia, and began the process of gradually reducing her dosages. In Going Off, a series of Anxiety posts in the coming weeks, she will chronicle the challenges she faces from both the drugs and the withdrawal in her pursuit of a drug-free life.

Antidepressants make me less depressed and benzodiazepines, with the help of trazodone, calm my anxiety and help me to sleep. Since March 2013, I’ve tried various combinations of drugs, searching for the perfect balance: a stable mood, low anxiety, freedom from insomnia, minimal side effects. But balance, too, is an urban legend. When I reduce, my anxiety and depression creep back in; when I increase, my side effects range from grim to unbearable. Even at my current low doses, my hair is falling out. My thinking is slowed, my creativity stymied. When I work, I feel as though boulders are strapped to my brain. I’m constantly thirsty. I’ve lost my taste for exercise, a mood-enhancer I’ve long relied on, and become more sedentary than I’ve ever been. Perhaps most disruptive of all, depression still lies, dead weight, on top of me — a few hours here, a few hours there — and medicated, I feel less motivation to wriggle out from under it.

I’m not free from anxiety, either, particularly anxiety over my medication. I worry about the long-term effects of these drugs, which are still relatively new to consumers. I worry about Big Pharma. My stomach clenches when I read about covered-up studies and the ugliest side effects of the very medications pharmaceutical companies hard-sell to psychiatrists, including to pediatric psychiatrists. I feel great discomfort with my doctor’s Celexa clock.

NEXT: Dealing with the side effects of my drugs.

Pharma Guy's insight:

So many pharma marketers think they can improve adherence by just educating consumers and developing mobile apps to remind patients to take their medications, as if "non-adherence" was just dumb patients who can't follow instructions!

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