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

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

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

 

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

 

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

 

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

 

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

 

Further Reading:

Pharma Guy's insight:

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

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Are TV Ads for Drug Lawsuits Bad for your Health?

[Faces of Lawsuit Abuse.org is a project of the U.S. Chamber Institute for Legal Reform.]

 

In 2015, trial lawyers spent 128 million dollars to air 365,000 ads hawking lawsuits against drugs and medical devices. But these ads can be harmful to the public health.

According to a recent report submitted to the Food and Drug Administration, at least 30 people suffered strokes, heart attacks and other serious medical problems because they stopped taking the blood thinning drug Xarelto after seeing a lawsuit commercial. And two people have died.

 

Further reading:

 

Hmmm... AMA (http://sco.lt/5RkA4X) says "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.

Pharma Guy's insight:

Note: I could not find the alleged "recent report" that claims 2 people died after seeing such an ad for Xarelto. 

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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 | Scoop.it

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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AMA Takes Aim at Pfizer et al for Hiking Prices of Opioid Overdose Treatment Just When It's Most Needed!

AMA Takes Aim at Pfizer et al for Hiking Prices of Opioid Overdose Treatment Just When It's Most Needed! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades.

The letters, which did not cite any official figures on price increases or make any specific demands of the manufacturers, cited two recent articles, one from Politico, noting a 17-fold increase in the price of one version of naloxone, and one from Healthline, which highlighted drug shortage issues at hospitals.

Daniel Raymond, policy director at the Harm Reduction Coalition, explained to Focus that he’s heard that a few of his coalition’s programs have run out of funds a few months into 2016 because of naloxone purchases.

Raymond explained that a number of manufacturers of the sterile injectable version of naloxone dropped out of the market, leaving Pfizer’s Hospira as the sole provider. Since then, Mylan has joined in the mix, he said, but, “You need at least three or four competing generics to lower prices.”

Pfizer told Focus in a statement: "As other manufacturers have exited the Naloxone market over the years, Hospira worked hard for more than three decades to maintain the availability of this important, medically necessary product as part of our commitment to patients and physicians. We are reviewing the letter that we received late Friday afternoon from Senators Collins and McCaskill and look forward to working with the Committee on this issue."

The price of the off-patent drug in the US, despite being first approved by FDA in 1971, has steadily increased, from $1 per dose about a decade ago to between $30 per dose and $45 per dose at CVS pharmacies in 14 states, though the formulations of the drug have changed and made it easier to administer.

But what’s different about naloxone, which still isn’t offered as an over-the-counter drug in the US, as opposed to other generic drugs that have been on the market for decades and remain cheap because of competition, is that even as different versions of naloxone become more available, the price of the drug continues to rise.

Pharma Guy's insight:

On June 15, 2017, AMA "took aim at the sudden increase in cost of naloxone, the life-saving drug used to reverse the effects of opioid overdose. Community groups, schools, first responders and local governments rely on naloxone to save lives every day but are finding it increasingly costly. The AMA will raise awareness of the troubling conduct of the three manufacturers of naloxone that enlisted assistance of physician, community groups, and elected officials to raise awareness and coverage of naloxone only to precipitously and inexplicably dramatically increase prices as soon as public policy changed to increase access. The AMA also will support legislative, regulatory, and national advocacy efforts to increase access to affordable naloxone." 

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Do #Pharma DTC Drug Ads Have Enough Value to Argue Against Banning Them?

Do #Pharma DTC Drug Ads Have Enough Value to Argue Against Banning Them? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The AMA's proposal to ban all drug ads is, at best, misguided, and, at worst, ignores the benefits of such ads to patients, a former pharma executive said.


According to a study on DTC marketing that was conducted by Eli Lilly, 25 percent of patients who were prompted to visit their doctor after seeing an ad were given a new diagnosis. Of those patients, 43 percent were a “high priority” diagnosis for a serious health condition, like diabetes or hypertension. That same study indicated that 53 percent of physicians felt that DTC ads lead to better discussions with patients because patients are better educated and informed.


In addition, a 2004 Food and Drug Administration survey of physicians and patients found that exposure to DTC ads spurred 27 percent of Americans to make an appointment with their doctor to talk about a condition they had not previously discussed. Another study found that the small print in a drug ad was strongly associated with patients contacting their health care providers.


But there is more.


Pharma Guy's insight:

Rich Meyer is the author of World of DTC Marketing Blog. Although Rich has skin the game, he cites many studies that tout the benefit of direct-to-Consumer (DTC) ads.


Proponents of DTC ads maintain that such ads are educational. What do you think? Take my Value of DTC Survey. You can see a summary of results afterward.

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Passing Law to Ban DTC Drug Ads About as Likely as Trump Being Elected President

Passing Law to Ban DTC Drug Ads About as Likely as Trump Being Elected President | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The AMA wants to ban prescription drug ads, but it should work with the pharmaceutical industry to limit them instead.


For a ban to go into effect, Congress would have to pass a new law. And given the slim chances for political change, the AMA might be better off reaching a compromise than setting up an antagonistic relationship with drug makers.


The organization argues that the ads largely feature the latest and priciest medicines that few can afford.


“Most of the ads are often for newer drugs that are getting more expensive,” said John Mack, a marketing consultant to drug makers (sic).


By pointing to high prices, the AMA is making a smart move. The accelerating cost of medicines has galvanized Americans. About three-quarters of the public believes that prices for brand-name drugs are too high, according to a poll conducted last month by STAT and the Harvard T.H. Chan School of Public Health.


Lawmakers have pushed bills to ban drug ads before, but a new effort is likely to be extremely contentious because of criticism that any limits on drug advertising would trample on the free speech rights of pharmaceutical companies.


“There could be a very serious challenge,” said Sonja West, an associate professor at the University of Georgia School of Law. Courts have ruled that “truthful information” about medicines has public value, West noted, “so it should not be regulated or banned unless there’s an important government interest.”


Pharma Guy's insight:

BTW, I am NOT a consultant to drug makers. In any case, you may be interested in this Pharma Marketing News article: "Anti-DTC Resurgence"; http://bit.ly/pmn140701h 

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Many Physicians Like Medical Journal Ads, Says Kantar Media, But Not DTC Ads, Says AMA

Many Physicians Like Medical Journal Ads, Says Kantar Media, But Not DTC Ads, Says AMA | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to Kantar Media's Sources & Interactions Study, September 2015: Medical/Surgical Edition, 43% of physicians feel that ads in print medical journals are a necessary compromise because they keep costs down. What is perhaps even more optimistic is that 48% said ads are a useful component in journals.


Only 7% that think ads interfere with their ability to read journal content, and even less (5%) prefer to read medical journals that do not carry any advertising even if it means paying more.  We’ve also discovered that 24% of those surveyed pay more attention to ads for new products.

 

Kantar Media’s Sources & Interactions studies power informed decisions on healthcare professional promotional mix strategy for marketers and agencies, and provide medical publishers and content providers with actionable data on where their offerings fit into healthcare professionals’ information inventory. 


The Medical/Surgical edition of the study, conducted every six months and based on input from more than 3,000 physicians across 22 specialties, documents how doctors prefer to learn and keep up to date on medical developments through media, meetings, sales rep interactions and more. Sources and Interactions provides critical insight into how to most effectively engage physicians and reach them with news, educational content and promotional messaging.  

Pharma Guy's insight:

Meanwhile, the American Medical Association wants to ban all DTC ads directed at consumers. For more on that, read "AMA Calls for Ban on Direct-to-Consumer Ads"; http://sco.lt/4iRfrF 


Drug print ads aimed at patients are usually upbeat showing the benefits of the pill. Print ads intended for physicians on the other hand are often dark and downright scary. Maybe that's why they like them :) For more on that read "Scary Pharma/Drug Ads in Medical Journals"; http://bit.ly/21g6evh 

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AMA Calls for a Ban on Direct-to-Consumer Drug Ads

AMA Calls for a Ban on Direct-to-Consumer Drug Ads | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The American Medical Association (AMA) is urging the federal government to ban drug ads that doctors warn are inflating the demand for costly treatments and driving up prices nationwide.


Hundreds of physicians voted in support of an advertising ban at the group’s annual meeting in Atlanta on Tuesday. Under the policy, drug companies in the U.S. would no longer be allowed to promote products directly to consumers, a type of marketing that is banned in all other countries except New Zealand.


Dr. Patrice Harris, the group’s newly elected board chairwoman, said in a statement that the advertising “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”


The AMA is wading into the drug-pricing debate at a time when the majority of voters now say they care more about drug prices than almost any other issue.


The group says it will also launch an advocacy campaign on drug affordability “by demanding choice and competition in the pharmaceutical industry and greater transparency.”


“If there is greater understanding of the factors that contribute to prescription drug pricing, including the research, development, manufacturing, marketing and advertising costs borne by pharmaceutical companies, then the marketplace can react appropriately,” the AMA wrote in a statement.

Pharma Guy's insight:

Wow! I had to go back to 2009 to get the graphic used in this post. That was the last time this issue was debated and I was quoted in the New York Times. Read more about that here: http://bit.ly/3u7JrX 


AMA board chair-elect Patrice Harris said physicians are concerned "about the negative impact of commercially-driven promotions and the role that marketing costs play in fueling escalating drug prices," in a news release; http://bit.ly/1OQCUHF 

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AMA Says Docs Need More Time to Review Sunshine Data

AMA Says Docs Need More Time to Review Sunshine Data | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The American Medical Association (AMA) is calling on the Centers for Medicare and Medicaid Services (CMS) to expand the timeframe for registering and using the Open Payments system to allow physicians adequate time to review and seek correction of inaccurate claims made by pharmaceutical companies, device manufacturers, and group purchasing organizations under the Sunshine Act. The call comes amidst continued poor functionality of the government website and poor communication to physicians and the public, which has led to widespread confusion among physicians and hindered education efforts about the program.


CMS reports that it has reopened the Open Payments database as of today, but indicates it will only allow physicians until September 8th to complete registration and seek correction of data.  Yet, the agency has not fixed the major problems that continue to mark the roll-out of this database including confusing and inaccurate information, lack of reliable functionality, and excessive time required to register and review reports.  This inadequate response will lead to inaccurate publication of data.  


While the AMA believes that transparency can strengthen our health care system and benefits both physicians and patients, if the government releases incorrect information to the public it can create misinterpretation and misrepresentation and inhibit the delivery of quality care to patients.


“In order for the Sunshine Act to be effective, physicians need enough time to review and correct any inaccurate data that may be reported,” said AMA President Robert M. Wah, MD. “The issues that resulted in the system being taken offline further underscore the need for more time than CMS proposes to ensure the system is actually ready and that physicians have adequate time to register, review, and seek correction of inaccurate data. The lack of faith physicians have in the system at this point in time, is making them wonder if taking time away from patients to go through the process is even worthwhile.”


CMS created widespread confusion by taking the Open Payments database offline without notice to physicians or physician organizations and without any indication of when the database would be available again. According to media reports, the Open Payments system was taken offline the evening of August 3rd due to significant technological problems. CMS inadequately communicated about website failures, not releasing a public statement about the system being offline until August 7th and not providing any indication of when the database would be available again, causing confusion among physicians.


Physicians were already given a short window to go through the cumbersome process of registering for the Open Payment System (which required a more than 360 page guidebook), reviewing information reported about them, and disputing any inaccurate data before publication in September. In order to get proper participation in the program to ensure all data reported is fair and accurate, AMA is asking CMS to significantly expand the timeframe for registration and data correction until March 31, 2015.


While the AMA supports the Sunshine Act, it cannot support the publication of inaccurate data. Wrong information, reduces patient trust which unnecessarily damages patient-physician relationships. Physicians deserve adequate amount of time to ensure the information being reported is accurate.

Pharma Guy's insight:


Meanwhile, Pharmalot reports:


Despite a disruptive tech glitch this past week, the U.S. Centers for Medicare and Medicaid Services is sticking with its Sept. 30 date for publishing detailed information about how much money drug and device makers pay physicians and teaching hospitals.

CMS announced today it would extend to Sept. 8 from Aug. 27 a review period for doctors and teaching hospitals to get an online preview the payment data before it goes public, in order to compensate for the 11 days the system was offline while CMS investigated a data mix-up.


But notably, CMS did not change the Sept. 30 date for the launch of a widely anticipated online searchable database, despite a recent request by some medical groups to delay the publication by six months so that doctors have more time to review and correct any inaccurate payment data.


[UPDATE: Meanwhile, more problems emerged. CMS is withholding about one-third of the data from the site. Why? The agency is "returning records to the manufacturers and group purchasing organizations because of intermingled data, and will include these records in the next reporting cycle," a spokesman tells us. This latest snag was reported byProPublica. CMS is due to report the next batch of payment data in June 2015]

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DTC Advertising “Not Helpful” in Making Sermo Doctors’s Jobs Easier

DTC Advertising “Not Helpful” in Making Sermo Doctors’s Jobs Easier | Pharmaguy's Insights Into Drug Industry News | Scoop.it

It's well documented that the American Medical Association isn't a huge fan of direct-to-consumer advertising for pharmaceuticals and devices (read “AMA Calls for a Ban on Direct-to-Consumer Drug Ads”; http://sco.lt/4iRfrF). Individual doctors, however, have been far less vocal about their feelings toward DTC. Do they believe that the ads help educate patients? Do they derive any benefits themselves, in terms of awareness or anything else, from the ads?

 

We had SERMO, a social network for physicians, ask them. In response to the question, “Do you believe DTC drug advertisements primarily (1) are helpful to doctor–patient communications and educate patients or (2) make doctor–patient communications more difficult and do not provide valuable educational content to patients,” 21% (353 doctors) said the former and 79% (1,343 doctors) said the latter.

 

We've synthesized their comments here, preceded by the physician's area of specialty.

Pharma Guy's insight:

But I bet it increases their take home pay!

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AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine

AMA & Many Other Physician Groups Lobby to Keep CME Payments Out of the Sunshine | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly 100 national and state medical societies from around the United States are backing a Senate bill (see “21st Century Cures: Hide CME Payments & Allow Off-Label Promotion”; http://sco.lt/62vgQr) that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education, or CME, sessions, medical journals, or textbooks. Among them are the American Medical Association and the American College of Cardiology.

 

The move is the latest push in a long-running effort to roll back requirements for reporting such payments to a federal database, which tracks financial relationships between companies and physicians. Known as OpenPayments, the database was launched in 2014 in response to concerns that financial ties between drug firms and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. A recent analysis found that payments can affect prescription rates.

 

But more than once over the past few years, the Centers for Medicare and Medicaid Services, which maintains the database, appeared to change its mind on reporting requirements for CME payments, in particular. These payments are made by manufacturers or group purchasing organizations to CME providers, which are either commercial firms or nonprofits that organize courses for physicians.

 

CME has been a particularly controversial issue, with accusations that drug and device companies not only fund the courses but they also tightly control the educational curriculum. Last year, industry support for CME totaled $693 million, a 2 percent rise, from the previous year, according to the latest report from the Accreditation Council for Continuing Medical Education, which regulates CME activities.

 

In late 2014, CMS ultimately decided that reporting CME payments would be required. As far as the agency is concerned, medical information — whether in the form of courses, journals, or textbooks — has value that physicians would otherwise have to pay for themselves. However, the CMS decision prompted a lobbying push by industry and medical societies to eliminate the reporting requirement.

 

The support from the medical societies for the bill, which is called the Protect Continuing Physician Education and Patient Care Act, is hardly surprising. In a letter to US Senator John Barrasso, a Wyoming Republican and a physician who introduced the bill, the medical groups argue, however, that Congress initially intended to create such exemptions and CMS may hurt medical practice.

 

“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by CMS that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent” CME, they wrote to Barrasso in a June 30 letter.

 

“When a company gives a grant to an accredited CME provider, it’s pretty hands off. They’re not supposed to suggest speakers or influence the curriculum, for instance,” said Thomas Sullivan, president of Rockpointe. “So if a company that supports commercial CE has no control (over the use of its grant dollars), I don’t see why that should be reported. Doctors don’t have the direct relationship with the company.”

 

“It’s a stretch to view free textbook and free medical education as being anything other than a benefit to physicians,” said Daniel Carlat, who runs a company that publishes CME newsletters for mental health practitioners. “These are not direct benefits to patients. The only way these would benefit patients is if a drug company gave free books or courses to patients themselves.”

Pharma Guy's insight:

For a closer look at CME funding data, read "For First Time in Seven Years, Pharma Support of CME Increases"; http://bit.ly/1Ctqf8D 

 

As you can see from the charts, most of the increase in CME funding comes from for-profit CME providers - those so-called "hands-off" 3rd parties. With regards to pharma grants to such groups, it's widely understood that pharma's hands remain "off" perhaps the first time, but if the pharma sponsor is not satisfied with the MECC's CME program, then there may not be a second round of funding via that "independent" CME provider.

 

A Pharma Marketing News survey asked respondents if CME activities that accept commercial support from pharmaceutical companies have more bias that activities that don't and what should be done to limit any potential bias. About one third of respondents said that pharma/device companies should cease funding CME courses provided directly by for-profit, third-party companies (eg, medical education and communication companies), but continue paying for courses offered by medical schools, teaching hospitals and medical societies. Another third disagreed and the rest weren't sure. For more, see http://www.surveys.pharma-mkting.com/PharmaCME.htm

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AMA May Propose Eliminating Drug Marketing Cost as Tax Writeoff

AMA May Propose Eliminating Drug Marketing Cost as Tax Writeoff | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The American Medical Association thinks it may have found a backdoor way to discourage pharmaceutical companies from mounting direct-to-consumer ad campaigns: eliminating their marketing costs as a federal tax deduction.

 

At today’s AMA annual meeting in Chicago, IL, delegates discussed a California delegation’s scheme to thwart DTC advertising: eliminate pharma’s ability write off the costs of these campaigns.

 

“We can’t prevent DTC ads undere the First Amendment, but we could eliminate companies’ ability to write off DTC advertising [expense] said a Massachusetts delegate in support of the resolution.

 

Those supporting the resolution expressed longstanding frustration with pharma’s DTC campaigns, charging that most are for “me-too” drugs that duplicate other products but usually have a higher price. The cost of marketing adds to healthcare costs, they note.

 

The AMA has already stated its blanket opposition to DTC advertising, saying it causes headaches for physicians who must constantly debate patients’ who are convinced a drug is right for them because they have seen it advertised (see here: http://sco.lt/4iRfrF).

 

Another issue to be tackled is whether, if such restrictions were enacted, they would apply to all health care advertising, including that of medical device makers, hospitals and healthcare systems, and even physicians themselves.

 

A delegate from Florida said “We appreciate the concerns and we don’t like DTC advertising either, but we oppose the resolution as a no-win situation that would have negative fallout for the AMA.”

Pharma Guy's insight:

69% of respondents to the Pharma Marketing News Future of DTC Survey said "yes" (39%) or "maybe, it depends" (30%) when asked if the DTC business tax deduction should be eliminated (see chart).

 

You can take this survey here and give you opinion about this and other issues that will have an imppact on the future of DTC. Afterward, you can view a summary of the latest, de-identified results.

 

Also read “Lobbyist Argues DTC Ad Tax Deduction is as American as Cheeseburgers”; http://sco.lt/6FPZzd and "Ad Industry Association Says Tax on DTC Ads Would Violate 1st Amendment"; http://sco.lt/8QdtJJ 

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The End of Pharma TV? Not Likely! But Consider a Partial Ban

The End of Pharma TV? Not Likely! But Consider a Partial Ban | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a recent 30 minute network “news” program, I counted 21 commercials/promos, half of which were for prescription drugs, most with computer-generated names that include Xs and Zs, aimed primarily at the AARP/Medicare generations, the largest consumers of these drugs (and the only ones who still consistently watch network evening news programs). Most popular magazines — yeah, there are still a diehard few who actually buy print media — contain multi-page ads for these drugs.

 

The ads, which mostly feature happy seniors leisurely riding in vintage autos or walking/biking/dining/boating/taking photos in bucolic, sun-dappled settings (except when playing lovey-dovey in adjacent bathtubs), with the injunction to “talk to your doctor to see if (fill in the name) is right for you,” have proliferated like amoeba since restrictions on drug ads were removed by the Food and Drug Administration in 1997 (the U.S. and New Zealand are the only two countries that now allow direct marketing of prescription drugs). Pharmaceutical company profits have soared as a result of the ad barrage.

 

In 2014, the companies spent $4.53 billion on ads for prescription drugs. But that pales in comparison to the $24 billion they spent in 2014 on campaigns aimed directly as physicians, many of whom get hundreds of thousands of dollars from the companies in “speaking fees,” meals, gifts, and other perks.

 

The American Medical Association, to its credit, has asked the federal government to ban these direct marketing ads. Citing “a growing concern” among physicians about the negative impact of these constant promotions directly to the pubic, it says, “A growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.”

 

Given that Big Pharma is, year-in year-out, the top spender on lobbying members of Congress, and that legal challenges would certainly follow any ban of the TV ads, the AMA request has about as much chance of passage as the proverbial snowball in Hades.

Pharma Guy's insight:

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.

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Giuseppe Fattori's curator insight, March 1, 2016 4:48 PM

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.

eMedToday's curator insight, March 1, 2016 10:33 PM

I once said that banning DTC advertising is about as likely as Donald Trump being elected president. You know where that's going! 

 

What I propose is an experiment. Let's eliminate TV broadcast DTC advertising of brandname drugs altogether for one year, but keep print and Internet-based DTC advertising. That is, no broadcast DTC for ANY drug, new or old.

Drug companies could pocket the money saved or spend it on print and Web promotions or on disease awareness TV ads, which are not a target of DTC critics in Congress and elsewhere.

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OMG! Dr. George Lundberg, Editor-at-Large for Medscape, Agrees DTC Ads Should be Banned!

OMG! Dr. George Lundberg, Editor-at-Large for Medscape, Agrees DTC Ads Should be Banned! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

"Oh my God," said Lundberg, "there it was, an unexpected bombshell."


Just like that, the American Medical Association (AMA) House of Delegates voted to ban direct-to-consumer (DTC) advertising of prescription products and some medical devices. The original resolution, brought by the Hospital Medical Staff section only to study DTC, suddenly snowballed into a resolution to ban it.


When politics reaches a tipping point, movement can be at lightning speed. The American public and its physicians are sick of egregious drug price gouging and ubiquitous, misleading DTC ads that drive drug use and costs way up. Our AMA actually did something that the great majority of American physicians can support. Hooray!


Will it have an effect?


Advertising of pharmaceutical products to the public unequivocally influences drug prescribing and use. Advertising of prescription drugs to physicians unequivocally influences drug prescribing and use.

Could the FDA itself prohibit DTC of prescription drugs? It could try, but Big Money from Big Pharma would raise holy hell with Congress and through the courts.


There is a major American right called freedom of speech and a relatively new factor called "freedom of commercial speech," also known as advertising. You know that the current US Supreme Court has ruled that corporations are people and that money may speak as people, so don't hold your breath.


This new AMA policy is only one step, but it is an important step, if the AMA executive hierarchy decides to put its lobbying clout behind its very popular new policy. This could be fun to watch.

Pharma Guy's insight:

Fun to watch, indeed! For more on that, read this Pharma Marketing News article:   "'Anti-DTC Resurgence"; http://bit.ly/pmn140701p

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NBER Study: DTC Ads Boost Rx Drug Adherence. More or Less Confirms AMA's Argument

NBER Study: DTC Ads Boost Rx Drug Adherence. More or Less Confirms AMA's Argument | Pharmaguy's Insights Into Drug Industry News | Scoop.it

While measurement in DTC advertising--in all advertising actually--is often difficult, NBER took a unique and targeted approach to assess as exactly as possible the effect of DTC ads. By using the introduction of Medicare Part D in isolated geographic areas and concentrating on 5 drugs for chronic conditions, researchers believe they were able to isolate and determine the specific effects of DTC on prescription drug use and adherence.


They found that a 10% increase in DTC ad viewing led to a 5.4% increase in the total number of prescriptions filled for the advertised drugs. That same 10% spike in viewing resulted in an increase in drug adherence by 1% to 2.5%, NBER reported.


"We find that drug utilization is highly responsive to advertising exposure," the study asserts. "Advertising increases the take-up of drug treatments and improves compliance for existing patients. Expanded take-up of prescription drugs accounts for about 70% of the total effect of advertising, while increased use among existing patients accounts for the remaining 30%."


The researchers also noted another "important component" to the increased use and compliance of drugs in general. That is, the increase and compliance wasn't just a switch from nonadvertised brands to the pushed one. Evidence showed the ads increased use and compliance of nonadvertised drug in the same therapeutic category in similar proportions, calling the effect "substantial positive spillover."




Pharma Guy's insight:

This more or less conforms what AMA said in its call for the ban on DTC advertising:  advertising “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate" (http://sco.lt/4iRfrF). 

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ANA v. AMA: Proposed Ban on Rx Drug Direct-to-Consumer Advertising is a Bad Idea

ANA v. AMA: Proposed Ban on Rx Drug Direct-to-Consumer Advertising is a Bad Idea | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a surprise vote on Tuesday at the Interim Meeting of the American Medical Association (AMA), the physician group adopted a policy aimed at banning direct-to-consumer (DTC) pharmaceutical advertising (see here). The group will now begin lobbying Congress for a ban on these ads.

Unfortunately, this is not a new idea, just a bad one. It would roll the clock back decades to the days when only doctors could be “trusted” to receive information about important health issues. Such an approach is wrong and misguided.

Prescription drug advertising is one of the most highly-regulated advertising categories.  

The FDA has very powerful tools to ensure that these ads are truthful and non-deceptive, as well as the power to impose civil penalties for any ads which cross the line. Congress rejected sweeping proposals to restrict DTC advertising in 2007 when they passed major legislation reforming the FDA. 

Banning DTC advertising also raises very serious First Amendment concerns. In the Western States case in 2003, a case which involved pharmaceutical advertising, the U.S. Supreme Court held that, “If the First Amendment means anything, it means regulating speech must be a last – not a first – resort.” Clearly the AMA proposal fails that test.

The AMA’s proposal comes several weeks after presidential candidate Hillary Clinton’s call to ban the tax deduction for DTC advertising. It is clear that we are seeing a major renewed focus on this important speech category.  
 
There is substantial data which demonstrates that DTC advertising plays a critical role in our nation’s health care system. One of the greatest health dangers in the United States is the under treatment of life threatening or debilitating diseases. Millions of Americans are unaware that they have high blood pressure, high cholesterol, clinical depression or diabetes. All of these diseases can be successfully treated with prescription drugs. Early treatment can be a matter of life or death, or the avoidance of serious disability. Clearly, these drugs help patients avoid strokes, heart attacks, kidney disease and combat mental illness and can thereby save enormous costs in hospitalization or constant treatment by physicians.

We believe that consumers should have more information about their health, not less. DTC advertising, under the FDA’s strict oversight, is providing extremely valuable information to millions of Americans about their health care. Banning these ads or denying the current tax deduction for them would be unwise and counterproductive.

Pharma Guy's insight:

ANA is the Association of National Advertisers. 


From MM&M (http://bit.ly/1X2CORM):

 

A Kaiser Health poll conducted in mid-October found that the majority of US adults said government action against drug pricing should be a top priority for the President and Congress. Respondents also said that drug companies spend too much money on marketing and drugmakers have considerable influence on the medicines that doctors choose to prescribe.


PhRMA spokesperson Tina Stow defended DTC advertising, citing FDA research from 2014 that found “that accurate information about disease and treatment options makes patients and doctors better partners.” She added that “beyond increasing patient awareness of disease (including undiagnosed conditions) and available treatments, DTC advertising has been found to increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines.”


Coalition for Healthcare Communication executive director John Kamp said that the AMA's decision is a “policy mistake” and that abolishing DTC “would violate the spirit and letter of the First Amendment right of companies to tell the truth about their products and services.”

 

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AMA Lobbies to Keep CME Payments to Docs Out of the Sunshine

AMA Lobbies to Keep CME Payments to Docs Out of the Sunshine | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A big stream of money from drug industry to doctors remains hidden, despite efforts to increase disclosure of industry influence. The American Medical Association, the biggest Washington lobby for doctors, wants to keep it that way.


Federal law allows pharmaceutical and medical device companies to funnel millions of dollars a year, without disclosure, to doctors who teach continuing education programs. The conduits for the money are independent companies that sponsor medical lectures for doctors. Since 2011, drug industry payments to these outside companies have risen 25 percent, to $311 million in 2014, according to a Boston Globe analysis.


Doctors who deliver the lectures typically receive between $2,000 and $3,000 per appearance.


The biggest lobbying organization for doctors is fighting in Congress to keep those payments out of public view, backing a bill to derail an Obama administration push for more transparency. The lobbying group, the American Medical Association, says disclosure would unfairly stigmatize doctors who are leaders in their fields and deliver lectures on breakthroughs in medicine.


But some physicians say payments to provide medical education have been transformed into a bigger channel to conceal drug company cash.


“To be blunt, this is just government-sanctioned money laundering,” said Dr. Paul Lichter, a University of Michigan ophthalmologist who heads the medical school’s conflict of interest committee. “Companies are making it appear charitable, but it’s clearly to influence physicians to prescribe expensive drugs and order expensive tests.”


Continuing education for doctors has long been underwritten by drug manufacturers who have a direct financial stake in medical decision-making. Industry subsidies help pay speaking stipends for top doctors in their specialties while also keeping costs low for rank-and-file doctors who attend the lectures to maintain professional certification.


Defenders of the system say medical education companies have already pledged, when they get accreditation, that their lectures and classes “were made free of the control of a commercial interest.”

Pharma Guy's insight:

For a closer look at CME funding data, read "For First Time in Seven Years, Pharma Support of CME Increases"; http://bit.ly/1Ctqf8D 


A 2004 Pharma Marketing News survey asked respondents if CME activities that accept commercial support from pharmaceutical companies have more bias that activities that don't and what should be done to limit any potential bias. About one third of respondents said that pharma/device companies should cease funding CME courses provided directly by for-profit, third-party companies (eg, medical education and communication companies), but continue paying for courses offered by medical schools, teaching hospitals and medical societies. Another third disagreed and the rest weren't sure. For more, see http://www.surveys.pharma-mkting.com/PharmaCME.htm 

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christopher cyril's curator insight, August 7, 2015 7:34 AM

For a closer look at CME funding data, read "For First Time in Seven Years, Pharma Support of CME Increases"; http://bit.ly/1Ctqf8D ;

 

A 2004 Pharma Marketing News survey asked respondents if CME activities that accept commercial support from pharmaceutical companies have more bias that activities that don't and what should be done to limit any potential bias. About one third of respondents said that pharma/device companies should cease funding CME courses provided directly by for-profit, third-party companies (eg, medical education and communication companies), but continue paying for courses offered by medical schools, teaching hospitals and medical societies. Another third disagreed and the rest weren't sure. For more, see http://www.surveys.pharma-mkting.com/PharmaCME.htm ;