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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Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation

Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health care nonprofits backed by the pharmaceutical industry have inundated Democratic Sen. Yvanna Cancela’s inbox over the last couple of days as discussions on a major piece of legislation she sponsored continue behind the scenes.

 

Since Friday, seven groups have sent similar letters addressed generally to Nevada state senators asking them to oppose a polarizing pharmaceutical bill, SB265. All of the groups have taken money from either PhRMA, the trade association representing pharmaceutical companies in the United States and the driving force behind the opposition to the bill, or directly from pharmaceutical companies themselves.

 

Four of the seven organizations received grant funding directly from PhRMA in recent years including:

 

  • RetireSafe, a nationwide senior advocacy organization, received a $25,000 grant in 2014
  • The Epilepsy Foundation received a $25,000 grant in 2014
  • Caregivers Voices United’s affiliate Caregivers Action Network, a family caregiver organization, received $315,000 from PhRMA as a general contribution and funding to help with an event in 2014
  • National Council of Asian Pacific Islander Physicians received two $10,000 grants in 2013 and 2014

 

Many of the organizations also took money from pharmaceutical companies in 2016, including Pfizer and Sanofi, both which have registered lobbyists this session. The local nonprofit Lupus of Nevada, Inc. has also been encouraging people on Facebook to contact their legislators about the bill and provides them with a form letter, of which Cancela says she has received many copies.

 

The legislation, which Cancela introduced in February, would put price controls on diabetes medication, require pharmaceutical sales representatives to be licensed and annually report their activities and mandate disclosure of any pharmaceutical-related contributions by nonprofits in the healthcare sector.

 

The letters, which in some portions use nearly identical language, argue that SB265 could threaten access to medications by causing stockpiling in response to the required 90-day notice ahead of certain price increases, will help pharmacy benefit managers (PBMs) and insurance companies instead of patients and require nonprofits to disclose certain information about contributions they receive from pharmaceutical companies that is already publicly available — similar arguments proffered by the pharmaceutical industry in opposition to the bill.

 

Further Reading:

  • “Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists”; http://sco.lt/6wBAp7 
  • “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh 
  • “The Yin Yang of Patient Advocate Groups and the Pharma Industry”; http://sco.lt/6400R7 
  • “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh 
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Overhyped Drug Ads Are Often “Pain Points” for Some Physicians

Overhyped Drug Ads Are Often “Pain Points” for Some Physicians | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The major “pain point” between healthcare professionals and drugmakers is trust, and pharmaceutical ads often get in the way of that trust, Dr. Joseph Habboushe, a physician at NYU Langone Medical Center, told attendees at ePharma.

 

“Us doctors, we get advertised to constantly, and it's not always the most straightforward way,” said Habboushe, who is also CEO of MDCalc, a medical score provider.

 

Oftentimes, drugmakers blur the lines between a drug's benefits and risks, quoting drug benefits in relative risks and actual risks in absolute value, making the benefits appear substantial and the risks less significant, noted Habboushe, while speaking Tuesday at the annual conference in New York City (read, for example, Opdivo TV Ads Educate Patients About the Positive, Not the Negative Trial Data; http://sco.lt/5OtIdl).

 

“Doctors start sensing this and at the end of the day, we don't fully trust our medical references,” said Habboushe. “We look for messaging from pharmaceutical companies not necessarily to help us treat our patients but to some extent to flag and discredit it.”

           

“What works for us is not just a flashy advertisement as much as, ‘Here's information that will help with the decision you're making now,” said Habboushe. “‘Or by the way, there's this new drug out there, and there are some other patients you might see tomorrow [who may be suitable for it.]''”

 

Transparency is key, agreed all speakers on the panel. The more drugmakers get comfortable with sharing negative as well as positive information, the more healthcare professionals will trust them and their messages, said Rohit Heryani, senior manager of multichannel marketing at Daiichi Sankyo.

 

Further Reading:

Pharma Guy's insight:

It’s appropriate that this discussion took place on the Intrepid aircraft carrier. It’s going to take more than a panel discussion to move the “aircraft carrier” issue of transparency in drug ads and promotions to physicians.

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83% of Patient-Advocacy Organizations Receive Substantial Financial Support from the Drug Industry But Few Disclose How Much

83% of Patient-Advocacy Organizations Receive Substantial Financial Support from the Drug Industry But Few Disclose How Much | Pharmaguy's Insights Into Drug Industry News | Scoop.it

This study shows that among 104 of the largest U.S.-based patient-advocacy organizations, at least 83% received financial support from drug, device, and biotechnology companies, and at least 39% have a current or former industry executive on the governing board.

 

Our results raise four points worth highlighting.

 

First, industry financial support of patient-advocacy organizations is widespread, with at least 83% of reviewed organizations receiving financial support from drug, device, and biotechnology companies. By comparison, a recent study showed that 41% of physicians across all specialties received industry payments in 2013–2014.19 Moreover, … we found that the support was often substantial, with at least 39% of the organizations that disclosed donation amounts receiving at least $1 million annually from industry.

 

Second, we found that ties between patient-advocacy organizations and industry are reflected in the governance structures of many organizations: at least 39% of patient-advocacy organizations have a current or former industry executive on the board, and at least 12% have a current or former industry executive in a leadership position on the board.

 

Third, current disclosure practices of patient-advocacy organizations are limited. Although we can conclude that industry support for such organizations is common, the full scope of this support and the severity of conflicts of interest remain difficult to determine given the disclosures of the organizations.

 

Fourth, we found little evidence of self-regulation of conflicts of interest among patient-advocacy organizations. Only 12% of such organizations have published policies in place for managing institutional conflicts of interest.

Pharma Guy's insight:

Further Reading:

  • “How Patient Advocates Make Money from Pharma with the Help of Agents Who Take a Cut”; http://sco.lt/7kUFBR
  • “Transparency is Good in Theory, But Not in Practice”; http://sco.lt/6qCqTR
  • “Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent?”; http://sco.lt/7kZg1J
  • “Survey: Should Pharma Hire Online ‘Patient Opinion Leaders’?”; http://sco.lt/9MVFYH
  • “Pharma-Patient Collaboration: Activist Survey is a ‘Wake Up Call’”; http://sco.lt/6m4iGH
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More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding

More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At a time when drug company lobbyists are widely vilified as icons of avarice, patient advocacy groups still wear the white hats.

 

But those organizations, which promote cures for every type of cancer and hundreds more diseases, have come under criticism lately for favoring their drug company funders in contests on Capitol Hill.

 

In one case, a diabetes group accepted money from food companies and played down the health risks from their high-sugar products; in another case, a mental health association, reliant on drug company dollars, opted to keep quiet about the soaring prices of its antidepressants. And many of the patient advocacy groups pushing for passage of the 21st Century Cures Act, which consumer groups argue rolls back patient protection, are funded in large part by pharmaceutical firms.

 

“The public should be concerned about this for many reasons,” said Jonathan H. Marks, director of the bioethics program at Pennsylvania State University. “One of the most important is that patient advocacy groups have credibility with policymakers — as corporate donors are well aware. Policymakers tend to assume that these organizations are acting in the interests of patients, or public health more broadly.”

 

But, said Marks, this is not always the case when the groups are reliant on drug or device industry donations — a point not often discussed when they lobby the Food and Drug Administration to speed new drugs to market, participate in National Institutes of Health panels, bring patients to testify before Congress, or advise patients on courses of treatment.

 

A study published Tuesday in JAMA Internal Medicine offers evidence of the ways in which patient advocacy organizations, or PAOs, rely on industry dollars.

 

The research, led by Susannah Rose of the Cleveland Clinic, shows that PAOs receive industry funding more often than previously believed. Some of the groups’ leaders, responding to a confidential survey, also acknowledged donor pressure to take policy positions that are best for the donors. Others said they doubted their own level of independence.

 

Rose, director of research in the Cleveland Clinic Office of Patient Experience, and her colleagues surveyed 439 patient advocacy organizations across the United States.

 

Of the 289 groups that responded, more than two-thirds reported receiving industry funding, with a median of $299,000. Twelve percent said they received over half their funding from industry. Almost 9 percent received $1 million or more. The pharmaceutical, medical device, and biotechnology sector accounted for a median of 45 percent of the donations. Only one quarter of the groups said they had policies on disclosing their financial relationships.

 

Further Reading:

  • Transparency is Good in Theory, But Not in Practice; http://sco.lt/6qCqTR
  • #Pharma to Patient Advocacy Groups Questioning High Drug Prices: "Why Are You Doing This to Us?"; http://sco.lt/4sOB7J
  • Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!; http://sco.lt/6Sl0ld
  • UK Patient Groups that Backed New Cancer Drug Received £ from #Pharma Firm; http://sco.lt/84W3En
  • Majority of Patients’ Groups Siding With Pharma Against Medicare Part B Pricing Reforms Receive Industry Funding; http://sco.lt/574i6D
  • #Pharma's "Patient Centricity" Pays Off: Patient Groups Mum on Drug Costs; http://sco.lt/8ydeuv
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Blog: Transparency is Good in Theory, But Not in Practice

I attended a Pharmaceutical Industry conference in the UK some time ago and, as usual whenever I attend these conferences in the UK, I meet some very interesting people and get a new perspective on important issues that usually are not discussed in the U.S.

Take ethics, for example. I touched upon that topic in my presentation ("The Sorry State of Pharma Mobile Apps and What to Do About It"; http://sco.lt/4n05wH). But the presentation by Nick Broughton (@NickBroughton) was 100% devoted to "implementing social media ethics" in the pharmaceutical industry.

One of the principles Broughton espoused was "the first obligation is to act morally, not just compliantly." Pharma's first obligation, said Broughton, is to "act well. There's no defense if you make a mistake, especially in social media. When the rules are not clear -- and often they're not -- you have to rely on moral principles to make decisions that you can justify."

One of the moral principles discussed by several presenters at the conference was "transparency," which is very important for the industry these days. Everyone at the conference, I'm sure, would agree with EFPIA (the European Federation of Pharmaceutical Industries and Associations):  "The pharmaceutical industry recognises that it has a responsibility to show leadership in advancing responsible transparency."

The problem, I soon learned, is that transparency is good in theory, but not in practice when it comes to revealing payments to patient bloggers who "contribute" content to pharma-owned sites.

 

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Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices

Pharma CEO Rips Insurance CEOs a New One! Exposes Salaries, Blames Them for High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The major contributor to soaring drug list prices is continual and progressive rebating demands by Big Insurance and the PBMs.

 

Without at all justifying Mylan (they need to account for their own actions), do you not find it noteworthy that they raised price on EpiPen by 31% in 2015 and also saw a 7% increase in prescriptions, yet net revenue from EpiPen actually DECLINED by 2%? That implies that Mylan did not keep a dime of the 31% increase and actually went backward in sales, which would have declined even more without the 7% increase in units sold.

 

Where did that money go? It went to rebates and fees to the PBMs, wholesalers, etc. We are stuck in a vicious, escalating circle of rising rebates, requiring drug innovators to take ever higher list prices, of which they only keep some fraction or even none. There is no transparency so everyone can know who is taking what part of the drug dollar (“Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency?”).

.

 

Written by: Ron Cohen- Ron Cohen, M.D., President and Chief Executive Officer, founded Acorda Therapeutics, Inc.

Pharma Guy's insight:

This is not the first time a pharma representative implied that  insurers have been throwing the pharma and biotech industry under the bus. For more on that, read “Former Washington Pol, Now CEO of BIO, Says Insurers Discriminate Against #Pharma”; http://sco.lt/7NhS53

 

Also read “Secretive Boards of HCPs Control Access to Rx Drugs. Should There Be More Transparency?”; http://sco.lt/65BMHp

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#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped

#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A closely watched effort in California to pass a bill that would require drug makers to explain their price hikes has been scuttled. The decision came after amendments were made during an assembly committee hearing last Friday that sources told us “effectively gutted” the legislation.

 

The bill would have required drug makers to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would also have had to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move.

 

“Unfortunately, recent amendments have made it more difficult for us to accomplish our fundamental goal,” said California state Senator Ed Hernandez, who pulled the bill after introducing the legislation and succeeding in getting the state Senate to approve the measure two months ago.

 

The legislation was one of more than a dozen such efforts by state legislatures around the country in response to rising medicine costs. Beyond sensational examples of drug prices rising by sky-high amounts, average prices for prescription drugs increased 10 percent last year, according to Truveris, a health care data company. And prices for brand-name medicines, specifically, jumped nearly 15 percent.

 

Related stories:

  • J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure; http://sco.lt/8itVIH
  • Big #Pharma Out Spends AIDs Advocates 10-to-1 to Defeat California Drug Price Ballot; http://sco.lt/8gcLGz
Pharma Guy's insight:
 

Pharma spokesmen resist [these calls] for transparency, claiming that the measure would dampen incentives for companies to develop lifesaving therapies. Their objection also sings the PhRMA's old tune that while drugs constitute only 10 to 12 percent of health care costs, they save the system money by keeping patients out of the hospital.

 

Other states that may still be in play: Massachusetts, New York, Pennsylvania, Texas, North Carolina, and Oregon [may still] have various bills pending to expose the way pharma company’s price their drugs. Read "Transparency Hits a Wall When It Comes to Drug Pricing"; http://sco.lt/7jfBo1 
 
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Pharma Marketing Blog: Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent?

Pharma Marketing Blog: Novartis Respects the Patient Perspective and Pays for It Too! But Is It Absolutely Transparent? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On Patientpower.eu, David Palacios, Head of Global Patient Relations, and Sanja Njegic, Head of Patient Advocacy & Relations in Europe at Novartis, explain how their company has moved from working with doctors and payers to working directly with patients. The interview was recorded at Eyeforpharma Barcelona 2016.

“We developed last year what we call the 'patient declaration,' which is a public statement about what patients can expect from us,” said Palacios. “It is an internal and external commitment. By having this document everybody in the company needs to work seriously to honor what we said in the patient declaration. That has triggered a lot of discussion internally.”

Some of that discussion must have been around "transparency" with regard to compensating patients -- especially patient bloggers and patient advocates -- for their opinion, much like pharma has traditionally paid physician Key Opinion Leaders (KOLs) for their opinions. Did that discussion result in any relevant disclosure in the "patient declaration?

 

Find out here.

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Pharma Guy's curator insight, July 23, 2016 9:40 AM

Back in 2013, the U.S. Justice Department  filed a civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers (read the details here).

DOJ claims that Novartis violated the Anti-Kickback Statute by paying doctors to speak about certain drugs, including its hypertension drugs Lotrel and Valturna and its diabetes drug Starlix, at events that were often little or nothing more than social occasions for the doctors. 


Many speaker programs were held in circumstances in which it would have been "virtually impossible for any presentation to be made, such as on fishing trips off the Florida coast," the suit claims.

"Other Novartis events were held at Hooters restaurants."

 

Read "Novartis Wines -- er, Beers -- and Dines Docs at Hooters!"; http://bit.ly/PMBalbum042713

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Pharma's New RockStars: Patients

Pharma's New RockStars: Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Any good research-based pharma company is built on the foundations of strong science and relationships with healthcare providers. As such, as we have seen significant interaction between these groups, with medical doctors either advising companies or taking on roles internally (noting that this should be in a transparent way).


If we now consider that as a model for the evolution of patient-centricity, I believe we are seeing the same transformation. The way in which social media democratised access to health information gave the patient a voice – and a new way for the pharma industry to listen to it. Next, proactive patients went a stage further, using social media to empower themselves as epatients, or Patient Opinion Leaders, sitting alongside more traditional medical Key Opinion Leaders. The industry started listening to them.

Pharma Guy's insight:

Pharma is not only "listening" to patients, they are "using" patients in drug ads and other kinds of promotion such as PhRMA's Hope campaign, which features a "rockstar" 5-yo with diabetes. For more on that, see http://sco.lt/76LFBp 

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The Real Lesson of the Shkreli Circus - Lack of Drug Pricing Transparency

The Real Lesson of the Shkreli Circus - Lack of Drug Pricing Transparency | Pharmaguy's Insights Into Drug Industry News | Scoop.it

For veteran Martin Shkreli-watchers, the fact that this week's congressional hearing on drug pricing only featured a few short minutes of the former Turing Pharmaceutical CEO's presence didn't make it any less of a gift. There was fifth-pleading, smirking, a case of mistaken SUV identity"unfortunate" tweeting and, inevitably, a livestream


But beyond the theatrics, the hearing highlighted what an opaque and broken mess drug pricing is in the United States. No one, not even the government, really knows what companies charge for drugs across a fragmented market. That creates dark corners where Shrkeli thrived, where Valeant Pharmaceuticals (whose CEO Howard Schiller was also grilled on Thursday) devised its now publicly disavowed price-hike-focused business model, and where many others have massively boosted prices more quietly.


It will take more transparency, not outrage, to fix that. However, Congress seemed more interested in a bit of righteous on-camera yelling -- and revealing some remarkable ignorance about the health care system -- than in root causes. 


Reliably, when asked about prices, pharma executives note that list prices don't reflect reality. It's the oldest of news for anyone who follows the industry, but apparently novel to Congress.


The lack of transparency in the market all but guarantees the sorts of abuses that necessitated the hearing in the first place. The fact that real prices are so opaque makes it difficult to measure cost in the system and to assess value. It lets drugmakers charge wildly varying prices as they negotiate with disparate groups that have imperfect information. It's hard for anybody to negotiate price effectively when they start with a fake number. It helps companies raise prices on old drugs, and gives everyone a ready-made excuse for six-figure prices

Pharma Guy's insight:

Also read: "House Committee Focuses on Drug Cost Transparency"; http://sco.lt/6Om1RZ 

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Federal Pain Panel That Bashed Anti-Oxycontin Over Rx Plan, Rife with Links to #pharma

Federal Pain Panel That Bashed Anti-Oxycontin Over Rx Plan, Rife with Links to #pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Nearly a third of the members on a government panel that made headlines by calling an effort to curb overprescribing of OxyContin and other painkillers "horrible," have drug-industry ties.

The Interagency Pain Research Coordinating Committee is a government advisory panel of federal scientists, outside academics and patient representatives. Of the 18 committee members at a recent meeting to discuss government handling of pain issues, at least five had financial connections to painkiller manufacturers.

One, a pain specialist from Duke University, has received thousands of dollars in payments from drugmakers, including OxyContin-maker Purdue Pharma and Teva Pharmaceuticals, which sells generic painkillers. Another, a patient advocate, holds a nonprofit position created by a $1.5 million donation by Purdue.

The revelation comes after the committee last month bashed a federal plan to recommend doctors scale back on prescribing painkillers for chronic pain. The guidelines by the Centers for Disease Control and Prevention are intended to curb deadly overdoses tied to highly-addictive opioid drugs, including Percocet and Vicodin.

At the time, various committee members called the proposal "ridiculous," ''horrible," and "shortsighted." A week later, the CDC said it would seek more public input on its guidelines — which were largely written behind closed doors.

The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving. Financial payments from drugmakers have been shown to shape doctors' medical decisions and researchers' conclusions. Concerns about that influence led the federal government to begin posting drug-industry payments to doctors in 2014.

Industry critics say the panelists should have disclosed their financial ties publicly at the meeting on Dec. 3, and in some cases, recused themselves from the discussion.

Pharma Guy's insight:

You might also be interested in reading this: "OxyContin Been Very Very Good to Sackler Family, Owners of Purdue #pharma"; http://sco.lt/6ke7BR 

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Here's a "New York Value" for You: Rational Drug Pricing!

Here's a "New York Value" for You: Rational Drug Pricing! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a provocative move, New York Governor Andrew Cuomo has become the latest entrant in the escalating war over rising drug prices with a budget provision that would effectively cap prices and require drug makers to provide a raft of information about their costs.

The proposal marks yet another high-profile attempt to force the pharmaceutical industry to respond to the intensifying clamor over the cost of medicines. The issue has made its way into the presidential campaign and, next week, another in a series of congressional hearings on the topic is scheduled.


Under the proposal, which must be approved by the state legislature, the state health department would “develop a list of critical prescription drugs for which there is a significant public interest in ensuring rational pricing.” The department would then assess the value of the drugs in order to set a “ceiling price” and could require a minimum rebate to the state Medicaid program.


As part of the process, the administration wants companies to provide data about development, manufacturing, and marketing costs for drugs on this list. The proposal would also require drug makers to submit information about the prices charged other purchasers in the state and outside the United States, any rebates offered customers, and profit margins, among other things.

Pharma Guy's insight:

Talk about drug pricing transparency!

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A Broken Covenant With Patients

A Broken Covenant With Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In 2007, federal law mandated that all pharmaceutical companies, universities and hospitals conducting clinical trials must disclose study results and adverse events on ClinicalTrials.gov, a website used by a large percentage of doctors and patients. Mr. Piller’s evidence proves that pharmaceutical companies have often failed to follow the law while prestigious medical research institutions have routinely flouted it. Malfeasance appears to be the rule, not the exception.

An example from the pharmaceutical industry: According to Mr. Piller, in my home state, Indiana, the nonprofit Hoosier Cancer Research Network, which runs trials for drug companies, terminated a study of Avastin in 2009 because it did not help but harmed patients with metastatic breast cancer. During the next two years, the trial’s investigators neither published their results in a journal nor posted them on ClinicalTrials.gov. It was not until 2011 that the F.D.A. revoked approval of Avastin for metastatic breast cancer because of its life-threatening risks. How many sick women were unnecessarily endangered between 2009 and 2011?

An example from the prestigious medical research institutions: According to Mr. Piller, Memorial Sloan Kettering Cancer Center broke the law on 100 percent of its studies—“reporting results late or not at all.” In two trials of the experimental drug ganetespib, it failed to report adverse consequences — heart and liver disorders, bowel and colon obstructions, death — affecting “volunteers” with breast and colorectal cancers.

The word “volunteers” reminds us that the often debilitated participants in clinical cancer trials decide on their own accord to put their lives on the line, usually with no resulting personal health benefit. It also brings to my mind the first anxious days of my participation in the Phase I trial that I began in August 2012.

My husband and I undertook the one-hour drive from Bloomington to the Indianapolis cancer center at the crack of dawn. Inside a hospital room from 8 a.m. until 11 p.m., I spent a long period of that time fasting. Because the experimental drug had never been used on human beings before, I was monitored every hour with all sorts of tests that were followed by various infusions to offset potential side effects. Totally exhausted upon release, my husband and I got lost finding our way to a bleak motel, paid for by the trial because we had to return to the hospital the next morning for more testing.

The stressful and demanding start of the trial forecast its evolution. To date, I have had approximately 20 CT scans for the trial—not one of which was good for me physically or psychologically, but all of which help researchers ascertain how the drug I take works. Yet the knowledge they gain from this study remains barren, if it does not circulate among other researchers, cancer doctors, and patients. I benefit from the study drug, but no one else will be aided unless at its conclusion the results of the trial are promptly reported not just in a medical journal but on the site provided for the dissemination of information required by law.

Pharma Guy's insight:

This story suggests to me another way that can be more "patient-centric" - Publish all clinical trial results. For other suggestions for pharma to be more patient-centric, see http://sco.lt/5e6HKb 

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The Yin Yang of Patient Advocate Groups and the Pharma Industry

The Yin Yang of Patient Advocate Groups and the Pharma Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The more visible, expanded role of patient advocates in shaping FDA regulatory and policy decisions for drug development has focused attention on the financial and operational links between biopharma companies and independent health organizations. FDA-industry user fee agreements in recent years have promoted “patient centricity” and strategies for giving the “patient voice” a more visible and articulate role in calculating the benefits as well as risks in drug testing and market approval (read, for example, “The New, Patient-Centric FDA: A Double-edged Sword”; http://sco.lt/5la6qn). Patient groups now are more involved in agency deliberations over development strategies for specific drug classes and in vetting approval pathways for new medicines.

 

Greater patient involvement in regulatory processes, though, has boosted scrutiny of drug company financial support for independent patient organizations, raising questions about whether the views expressed by such groups fully reflect broader public needs and values. During the debate last year on the 21st Century Cures legislation, consumer activists criticized “so-called patient advocacy groups” for supporting changes in standards to permit greater consideration of real-world evidence and biomarkers in product approval decisions.

 

[An example of a “so-called patient advocacy group” is or was the Restless Leg Foundation, which had many ties to GSK:

 

  • GSK is a Gold Corporate Sponsor of the RLS Foundation, which means GSK has given the foundation a good chunk of change;
  • at least one member of the Foundation's Medical Advisory Board has financial ties to a pharmaceutical company (GSK) with a treatment for RLS;
  • the PR activity of the organization seems to have picked up right when that company's drug (ReQuip) hit the market;
  • the first RLS Foundation Science Award went to Ronald L. Krall, MD, Senior VP of Worldwide Development at GSK;
  • Richard Allen, a member of the RLS Foundation's Medical Advisory Board, had the "pleasure" of "collaborating" with GSK to do studies supporting the data on the prevalence of RLS in the US and in Europe;
  • the color scheme of the RLS Foundation's Web site matches that of the Requip product site.

 

See http://bit.ly/RLS-GSK ]

 

These concerns have been heightened by analyses documenting industry financial support of patient organizations. A study published in the New England Journal of Medicine (NEJM) March 2, 2017 found that 83% of 104 large patient advocacy organizations receive financial support from drug, medical device and biotech companies, and that industry executives regularly serve on their governing boards (find the data here: http://sco.lt/7KCmkj). Similarly, a survey of patient advocacy executives published in JAMA in January 2017 reported that 67% of the groups acknowledge industry support (find the data here: http://sco.lt/6Ftgzh). Last year, the Project on Government Oversight (POGO) highlighted pharma funding of leading patient organizations such as the National Health Council, the Alliance for Aging Research and the National Organization for Rare Disorders (NORD), raising questions about their independence in backing the Cures legislation and FDA funding by user fees.

 

The authors of these studies speculate that industry funding raises conflicts of interest, particularly in the area of drug pricing, as patient advocates funded by pharma companies may be less vocal in seeking access to cheaper medicine (read, for example, #Pharma's "Patient Centricity" Pays Off: Patient Groups Mum on Drug Costs; http://sco.lt/8ydeuv).

 

Further Reading:

 

  • Transparency is Good in Theory, But Not in Practice; http://sco.lt/6qCqTR 
  • #Pharma to Patient Advocacy Groups Questioning High Drug Prices: "Why Are You Doing This to Us?"; http://sco.lt/4sOB7J 
  • Holy Sh*t! Is There No End to Mylan's Shenanigans? Paying Off Patient Groups to Lobby!; http://sco.lt/6Sl0ld 
  • UK Patient Groups that Backed New Cancer Drug Received £ from #Pharma Firm; http://sco.lt/84W3En 
  • Majority of Patients’ Groups Siding With Pharma Against Medicare Part B Pricing Reforms Receive Industry Funding; http://sco.lt/574i6D 
  • #Pharma's "Patient Centricity" Pays Off: Patient Groups Mum on Drug Costs; http://sco.lt/8ydeuv 
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Drug Companies Refuse Shareholder Request to be More Transparent About Drug Pricing

Drug Companies Refuse Shareholder Request to be More Transparent About Drug Pricing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Several major U.S. drug companies have squelched an investor campaign aimed at forcing companies to disclose more information about when and why they raise prices.

 

In October, a group of institutional investors, including many with ties to religious organizations, submitted shareholder proposals asking 11 U.S. drug companies, including Pfizer Inc. and Merck & Co., to issue reports listing average annual price increases for their top-selling drugs between 2010 and 2016, and to state the rationale for the increases. The investors asked the companies to include the proposals on proxy ballots that will be put to shareholder votes at annual meetings this spring.

 

But 10 of the companies plan to omit the drug-price transparency proposals from their proxy ballots, generally on the grounds that they would interfere with “ordinary business,” according to company documents filed with the Securities and Exchange Commission.

 

An SEC rule allows a company to omit a shareholder proposal from a proxy ballot if the proposal deals with the company’s ordinary day-to-day business operations, rather than a “significant social-policy issue.”

 

The SEC notified 10 companies that it won’t pursue any enforcement actions if the companies exclude the drug-price proposals, according to letters posted on the SEC’s website. The investor group withdrew the transparency proposal it had submitted to the 11th drug company, Regeneron Pharmaceuticals Inc., because the company said it hasn’t raised the prices of its drugs and shared information about its approach to drug pricing, according to a spokeswoman for the investor group.

 

[Interestingly, Regeneron Pharmaceuticals Inc. Chief Executive Officer Leonard Schleifer, recently called out Pfizer CEO Ian Read on its pricing policies. For more on that, read “Oh Snap! Regeneron CEO Says What to Pfizer CEO Ian Read???”; http://sco.lt/8ZED0T]

 

The investors, which own shares of the companies, are members of the New York-based Interfaith Center on Corporate Responsibility. Different members of the group sent the proposals to different drug companies.

 

Merck sent a letter to the SEC in January saying it planned to omit a price-transparency proposal submitted by several Catholic religious orders. Merck called the proposal “a clear attempt to exert influence on the pricing decisions made by the Merck management team. Such an attempt is perhaps the perfect example of ‘micromanaging’ the business affairs of Merck,” the letter said.

 

A Merck spokeswoman said the company recently released information about its price increases that allows people to understand its practices while protecting proprietary information negotiated with customers.

 

Pfizer said in a letter to the SEC in January that it should be permitted to exclude a transparency proposal submitted by Trinity Health, a Catholic hospital group, and other religious shareholders. Pfizer said it has already addressed the underlying concerns of the proposal by disclosing on its website and in SEC filings its rationale for pricing decisions. A Pfizer spokeswoman declined to comment beyond the letter.

 

“We’re really disappointed the companies did not allow their shareholders to express themselves on this issue,” said Donna Meyer, director of shareholder advocacy for Interfaith member Mercy Investment Services Inc. of St. Louis, which runs retirement funds for the Roman Catholic congregation Sisters of Mercy.

Pharma Guy's insight:

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How Patient Advocates Make Money from Pharma with the Help of Agents Who Take a Cut

How Patient Advocates Make Money from Pharma with the Help of Agents Who Take a Cut | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A health care company is hoping that it can connect some of the most influential and underutilized health experts—patients—with brands that are willing to pay for their knowledge and connections.

 

Leanna Mullen has Gaucher's disease, a rare genetic disorder that is associated with a variety of debilitating symptoms, from lung disease to arthritis. Mullen, a New Jersey-based television producer in her late twenties, has built up a vast network in the patient advocacy community and has used her media platform to raise awareness of her disease. Several months ago, she was contacted by a research firm called BrandTrust regarding a survey into the mental health of patients with Gaucher's. She was told that the information would be delivered to a pharmaceutical company, but she declined to disclose the company to me after signing a non-disclosure agreement.

 

If Mullen could recruit a diverse set of patients to participate in the research, she would be paid about 80% of a $10,000 fee. "I had the connections, and was able to recruit almost my entire demographic within two or three days," she says. Mullen was able to reach out directly to patients in closed Facebook groups and private forums, which would have been off-limits to recruiters. "Many people wanted to support research that will help make others' lives better," she says.

 

Mullen's name was initially floated to BrandTrust by a Boston, Mass.-based company called Wego Health, which has built up a vast database of patient influencers over the years. Wego's chief strategy officer, David Goldsmith, came up with the idea of connecting these patients directly with brands, after researching how other sectors, such as transportation and tourism, slowly adapt to new labor models as part of the "sharing economy" movement. He figured that health care was next.

 

With Goldsmith's new service, Wego Health Experts, brands can connect with patients for help with finding clinical trial participants, research and surveys, "awareness" campaigns, speaking engagements and so on. Goldsmith says some of these processes, such as clinical trial recruitment, used to take months and cost "tens of thousands of dollars," which typically went to third-parties rather than patients. But influencers like Mullen can often get the job done faster and for a fraction of the price, he adds. Wego makes money by taking a cut of the overall fee (in this case, the remaining $2,000 of the $10,000 offered via BrandTrust).

 

PROMISE AND PITFALLS

Compared to other industries, health care carries some unique opportunities, risks, and challenges. Nick Blum, general manager of Catalant, a company that connects big brands with freelance experts, stresses the need for full awareness of biases and agendas. "The key here will be transparency," he says. "Who has what relationship with whom, how does compensation flow, what incentives exist, and so on."

 

Mullen says she did not disclose in every discussion that she would be paid, as she figured that it would be obvious. "They're aware that there's usually some sort of headhunter," she says. Also, she figured that the risk would be low, as it was a survey rather than a clinical trial.

 

Bioethicists such as New York University's Arthur Caplan have some concerns about patients leveraging their influence on behalf of brands. He compares this approach to celebrities like Bob Dole and Barry Manilow appearing on television to tout pharmaceutical products they may never have used, ranging from Viagra to cholesterol medication. In the long run, he explains, there's always the risk that trust will be eroded.

 

Caplan suggests that guidelines should be formulated to clarify how patients should disclose conflicts of interest, if they're getting paid. That's particularly important if they're being asked to recruit for a potentially risky clinical study.

 

For her part, Mullen wouldn't agree to every project sent her way. She was willing to tap into her network for this project, as she could personally vouch for it having taken the study. And the money that she made helped her with expenses related to managing her disease. "For many of us, this could be an opportunity make others' lives better and become a part-time job," she says.

Pharma Guy's insight:

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TrialsTracker Reveals that Nearly Half of All Clinical Trials Go Unpublished

TrialsTracker Reveals that Nearly Half of All Clinical Trials Go Unpublished | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Around half of all trials run by pharma companies, universities and other major research sponsors remain unpublished, according to a tool built to promote greater trial transparency.

 

The TrialsTracker monitors ClinicalTrials.gov, the world's largest clinical trial register, for whether or not studies have been published two years after their stated end date.

 

Collecting data from January 2006 to November 2014, the tracker found that 45% of the 25,927 eligible trials had not had their results published.

 

The TrialsTracker was created by a team of academics at the University of Oxford that includes Dr Ben Goldacre, author of Bad Pharma and one of the founders of the AllTrials campaign for clinical trial transparency.

 

“Everyone has been talking about this problem for far too long. We hope that increasing accountability will help to drive change forward,” he said.

 

“The TrialsTracker helps to identify the individual universities and companies with the most overdue trials. If any institution is concerned that it is doing badly in our league tables, then there is one simple thing they can do: publish their trial results, using their trial registry number, so that this information can be accessed and read by doctors, researchers, and patients.”

Pharma Guy's insight:

You might also like to read:

 

"Ben Goldacre Says Pharma Industry Has Destroyed Its Own Reputation. Duh!"; http://sco.lt/6mneQj

 

“Scientific Community Get Poor Grades for Sharing and Reporting Results of Clinical Trials”; http://sco.lt/8p9yCH

 

“Results of Over 500 Clinical Trials Each Year Go Undisclosed to Public”; http://sco.lt/7eA89p

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PinUp: FDA Muzzles Journalists, Cancer Drug.com Sites Emphasize Positive, Prescribing Medical Mobile Apps, More...

PinUp: FDA Muzzles Journalists, Cancer Drug.com Sites Emphasize Positive, Prescribing Medical Mobile Apps, More... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Welcome to the September 27, 2016, issue of Pharma Industry News Update (aka PinUp). PinUp is published every Tuesday as part of your Pharma Marketing News subscription service. It features curated pharma industry news and views of topical interest from a variety of sources.

 

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Featured Event

West Coast Electronic Benefit Verification & Prior Authorization Summit

25 - 26 October 2016 | San Francisco, CA

http://bit.ly/MTG1355fl

 

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How the FDA Turns Journalist Watchdogs Into Lapdogs

  

Documents obtained by Scientific American through Freedom of Information Act requests now paint a disturbing picture of the tactics that are used to control the science press. For example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access - including ones from major outlets such as Fox News - and even deceives them with half-truths to handicap them in their pursuit of a story. 

 

More here... http://sco.lt/9AcuG1 

 

FDA isn't alone in manipulating the press. Read, for example, "Academics Exaggerate, Journalists Regurgitate"; http://sco.lt/8sNzPN  and "Bad Journalism Abets Bad Pharma: Philly Inquirer Editors Raked Over Coals"; http://sco.lt/7rkRZB 

 

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Just Like DTC Ads, Pharma Cancer Drug Websites Emphasize Benefits Over Risks

 

Researchers from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) and research firm RTI International say that websites for cancer-drugs are ten times more likely to include quantitative information about all the benefits of a drug versus all its risks.

 

More here... http://sco.lt/8soJrV 

 

Also read: "Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients"; http://sco.lt/8Imgdd  and " Breakthrough Cancer Therapy DTC Advertising Boldly Emphasizes the Positive"; http://sco.lt/80LqSX 

 

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Apple Hires YouTube @DocMikeEvans to Prescribe Health Apps!

 

Mike Evans, known on YouTube as "DocMikeEvans," has joined Apple to work on digital health care. Evans is best known for his videos where he narrates while an animated doctor gives health tips and advice.

 

"In future, I'll prescribe you an app. One of our whiteboards will drop in and explain what high blood pressure is. The phone will be Bluetoothed to the cap of your pills. I'll nudge you towards a low salt diet. All of these things will all happen in your phone. I see you two or three days a year. The phone sees you everyday."

 

 

More here... http://sco.lt/5urPMX 

 

You might also be interested in reading: "AMA CEO Calls Out Medical Apps as 'Digital Snake Oil'"; http://sco.lt/8zuIld  and "Most Doctors Not Yet Ready to Recommend Mobile Apps & Wearable to Patients"; http://sco.lt/8yujoX  and " Kevin Pho, MD, is not ready to prescribe mobile health apps. Why not?"; http://sco.lt/8oj9rV 

 

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Forget Mobile-Enabled Web - You Need an App for That + Video!

 

This year, US adults will spend 1 hour and 54 minutes a day using apps on their smartphones, 7 minutes more than last year. In contrast, they’ll only surf the mobile web on their phones for 19 minutes a day, a decline of 2 minutes from last year. In other words, apps will account for 86% of adults' nonvoice smartphone time this year, with the mobile web accounting for just 14%.

 

More here... http://sco.lt/7QzAbR 

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Pharma is Spending $ Millions to Shield & Protect High Drug Prices

Pharma is Spending $ Millions to Shield & Protect High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Despite Mylan’s offer Thursday of discount coupons for some EpiPen users, the only system at work here is a cash-fat industry routinely preying on sick people. It’s a system that the drug industry will do whatever’s necessary to protect.

 

Of roughly $250 million raised for and against 17 ballot measures coming before California voters in November, more than a quarter of that amount — about $70 million — has been contributed by deep-pocketed drug companies to defeat the state’s Drug Price Relief Act.

 

The Drug Price Relief Act would make prescription drugs more affordable for people in Medi-Cal and other state programs by requiring that California pay no more than what’s paid for the same drugs by the U.S. Department of Veterans Affairs. It would, in other words, protect state taxpayers from being ripped off.

 

Industry donations to crush the Drug Price Relief Act “will top $100 million by the election, I’m quite certain of it,” said Michael Weinstein, president of the AIDS Healthcare Foundation and a leading backer of the state measure, also known as Proposition 61. “They see this as the apocalypse for their business model.”

 

The drug industry already has succeeded in eviscerating Senate Bill 1010, legislation in Sacramento that would have required pharmaceutical companies to detail the costs of producing medicine and explain any price increases (read “#Pharma Lobbying Wins: California Drug Price Transparency Bill is Scrapped”; http://sco.lt/5uLjOb).

 

The Drug Price Relief Act wouldn’t force pharmaceutical companies out of business. It simply would provide a mechanism for state programs to pay something closer to fair prices for medication.

 

The fact that the drug industry is willing to spend as much as $100 million to keep that from happening tells you all you need to know.

Pharma Guy's insight:

The author of this opinion piece, David Lazarus, asked Kathy Fairbanks, a spokeswoman for the No on 61 Campaign, if she’d characterize sky-high drug prices as a problem for patients. No, she said, that’s not how she’d put it.

 

“It’s an issue, how about that?” Fairbanks allowed.

 

The No on Prop 61 -- Californians Against the Deceptive Rx Proposition is “a coalition of veterans, doctors, patient advocates, seniors, taxpayers, and members of Pharmaceutical Research and Manufacturers of America with major funding by Merck & Co, Inc., Pfizer, Inc. and other companies.” http://www.noprop61.com 

 

Related stories:

  • J&J is Largest Contributor to #Pharma Lobbying Group Opposing Drug Pricing Relief Ballot Measure; http://sco.lt/8itVIH
  • Big #Pharma Out Spends AIDs Advocates 10-to-1 to Defeat California Drug Price Ballot; http://sco.lt/8gcLGz
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Two Case Studies of Pharma Marketing Influence Over Science & Journal Publications

Two Case Studies of Pharma Marketing Influence Over Science & Journal Publications | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Inappropriate prescription and overconsumption of pharmaceuticals is one of the most pressing public health concerns in North America. Aggressive pharmaceutical promotion practices are widely recognized as a major contributing factor. Two recent medical journal articles provide further evidence of serious problems with the scientific record that has become an intrinsic part of pharmaceutical marketing.

 

Jon N. Jureidini, Jay D. Amsterdam, and Leemon B. McHenry’s paper in the International Journal of Risk and Safety in Medicine is a case study of how the pharmaceutical company Foster used a scientific publication to boost prescription of its blockbuster anti-depressant citalopram. A paper by Joanna Le Noury and colleagues in the British Medical Journal is the first publication produced as part of an innovative initiative by the scientific community aimed at correcting the scientific record on a host of pharmaceutical products. The study involves a reanalysis of the raw data of a Smithkline Beecham (now GSK)-sponsored published study on the efficacy of paroxetine and imipramine for the treatment of depression in adolescents.

 

That both publications deal with anti-depressants is not entirely surprising. They have been among the most prescribed—in fact overprescribed—drugs of the last decades. The vagueness of diagnostic criteria and the subjective nature of efficacy measurements in relation to most mental health conditions further facilitate data manipulation. Yet it should not lull us into thinking that the problems are restricted to psychiatric drugs. Both papers confirm … that industry control over the design, conduct, analysis, and reporting of clinical drug trials has turned many scientific publications into marketing tools. It has enabled the industry to selectively report positive results, hide negative results, manipulate statistical tools for favorable outcomes, and underplay problems.

 

Both papers reveal problems of scientific integrity in pharmaceutical industry-sponsored publications and raise serious questions about the collaboration of academic scientists. In light of what is being exposed in these and in many other related publications, it is remarkable how academic institutions remain silent about the alleged scientific misconduct by some of their researchers.

Pharma Guy's insight:

Also read “Researchers Demand APA Retract ‘Deviant’ Celexa Article That Promotes Rx for Kids”; http://sco.lt/8yaLKL

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Another Buzzword: "Influencer Marketing." Does It Pass the "Authenticity" Smell Test?

Another Buzzword: "Influencer Marketing." Does It Pass the "Authenticity" Smell Test? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

With it’s massive growth, proliferation on difficult-to-control social media platforms, and the oftentimes contradictory language from influencer marketers themselves, influencer marketing has become something of a wild west—something that, if influencers and marketers aren’t careful, could end up hurting the longterm prospects of the industry as a whole.

 

The practice is another form of native advertising, except it relies on social media influencers rather than in-house advertorial. Native advertising on publisher sites has come under fire for sometimes deceiving and confusing readers. Our 2015 study, showed that 48 percent of respondents felt deceived by native advertising.

 

So far, influencer marketing has escaped much of the same criticism.

 

In December, the FTC finally released an updated version of guidelines for native advertising, asking publishers to include a variation of “Ad,” “Advertisement,” “Paid Advertisement,” or “Sponsored Advertising Content” in the beginning of an article or video. Most framed the guidelines as an attempt to reign in native advertising on digital publications. (The FTC’s use of “native advertising” as an umbrella term for any sort of promotional material that’s not a traditional ad probably didn’t help.)

 

In a Digiday article, Todd Krizelman, co-founder and CEO of MediaRadar, an ad data firm, estimated that only 30 percent of publishers were in compliance with the rules and that 26 percent do not disclose at all.

 

But few considered the ramifications of the new guidelines on influencer marketing, which is subject to the same rules.

 

“They are looking for very explicit call-outs,” Krizelman said. “They want to see the words ‘This is an ad’ or ‘Paid advertisement.’ They do not want to see things like, ‘Presented by.’ Today, if Kim Kardashian is posting [an ad], she may just post it. No one would know if she was paid or not paid.”

 

“The FTC and other regulatory authorities are very concerned about influencer and native advertising,” said Andrew Lustigman, an attorney at Olshan Frome Wolosky who specializes in advertising and marketing. “Because the message is now coming from a third party, regulators want to make sure that consumers know that there is business relationship between the parties so that they can evaluate the message with that in mind.”

 

Unfortunately, this is anything but standard practice.

 

When you browse influencer marketing best practices, “trust” and “authenticity,” are two words that constantly appear. A February 2016 study by eMarketer suggested that influencer marketing has become more popular, in part, because of young people’s trust in social media stars, who they tend to see as more authentic than a brand or an advertisement.

 

“The key word that I’m coming back to in everything I talk about with influencers is authenticity,” said Todd Cameron, head of content and strategy at influencer marketing software company TapInfluence.

 

Trustworthy influencer marketing is only possible when social influencers disclose, boldly and proudly, that what they’re doing is a paid advertisement. If the brand or the influencer try to hide this fact, they risk undermining consumer trust for both parties.

 

Even if influencers and marketers continue to deceive consumers, there’s little doubt that more regulation—and better clarified regulation—from the FTC is coming.

Pharma Guy's insight:

I've docmented many cases where pharma uses celebrities to market its products. But when social media is involved, other influencers -- e.g., patient bloggers -- are also employed. For more on that read "Transparency is Good in Theory, But Not in Practice"; http://bit.ly/bloggertransparency 

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Another Buzzword: "Influencer Marketing." Does It Pass the "Authenticity" Smell Test?

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Obama Wants #Pharma to Open Its Books to Justify High Drug Prices

Obama Wants #Pharma to Open Its Books to Justify High Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Lawmakers are pressuring the drug industry to reveal how much it spends to develop, manufacture, and market new medicines.


For years, drug makers have argued that the rising prices of prescription medicines reflect, in part, the rising costs of discovery and development. Now, President Obama wants to peek behind the pharmaceutical curtain to see for himself.


Buried inside the White House budget proposal released last week is language (on page 62) that would require drug makers to publicly disclose various data, including research and development costs. The administration hopes to use the information as part of a plan to negotiate lower prices for the Medicare drug program, known as Part D.


In doing so, Obama joins a growing list of lawmakers seeking transparency in order to understand drug pricing.


Since the pharmaceutical industry conceded that data are available under the Sunshine Act, “they can hardly claim that these R&D bills aren’t fair political game,” said Scott Gottlieb, a former Food and Drug Administration official who is now a resident fellow at the American Enterprise Institute, a conservative think tank.


In effect, the call for cost transparency amounts to a “show me” moment for the pharmaceutical industry.


Drug makers can’t have it both ways. If costs really can be justified, then expenses should be disclosed. If not, then the industry will have to come up with another explanation for its approach to pricing — and that explanation will have to be transparent.


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Is #pharma at Risk from The Clinical Trial Transparency Movement?

Is #pharma at Risk from The Clinical Trial Transparency Movement? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Calls for transparency in the pharmaceutical industry have grown in recent years, focusing on issues including pricing, access to medicine and how companies report finances. While these calls for transparency have come from healthcare professionalsinvestors and regulatory bodies, the cause for clinical trial transparency has had a vocal leader in Ben Goldacre.


Based on trends in social media discussion over the last three months, alva has identified the following risks to the pharma sector where clinical trial transparency is concerned:


  1. AllTrials expansion in the US and beyond. Multiple tweets ask for AllTrials to “go global”, and recent articles in US news media signify that awareness of this issue is likely to grow
  2. Emotional campaigning linked to topics including veterinary care and prevention of patient harm. Members of the general public have shared posts using this emotional messaging to boost visibility among a patient audience
  3. Campaigns to “name and shame” universities not reporting clinical trial results as required. This poses a risk to individual pharmaceutical companies that are partnered with targeted institutions – and could augment criticism of individual firms


Though the issue of clinical trial transparency currently represents only a minor risk in relation to the general public, it is possible that increasing public awareness combined with Goldacre’s determination to “name and shame” will bring more individual companies – and their record on trial transparency – into the spotlight of public discussion.


Pharma Guy's insight:

You might also like to read: "Ben Goldacre Says Pharma Industry Has Destroyed Its Own Reputation. Duh!"; http://sco.lt/6mneQj 

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Canadian Medical Society Not So Transparent About #Pharma Payment Transparency

Canadian Medical Society Not So Transparent About #Pharma Payment Transparency | Pharmaguy's Insights Into Drug Industry News | Scoop.it

An effort to provide greater transparency in the relationships between physicians and the pharmaceutical industry has taken a controversial turn in Canada, where a leading medical society is being criticized for a new report on the topic.


The College of Family Physicians of Canada, which represents more than 35,000 doctors, earlier this month released a report featuring 21 recommendations that address conflicts of interest and continuing medical education, among other things.


The report emerges amid ongoing debate over the extent to which companies unduly influence medical research and practice. The CFPC, which itself does not accept industry funding, portrayed its effort as a forward-looking statement that will evolve in order to bolster trust and transparency among patients.


Yet the report was first begun five years ago and completed two years ago but was not released until some critics publicly raised a fuss. A CFPC spokeswoman wrote us that the report was never designed to be released publicly, but “in retrospect, we recognize that we should have posted the report to our web site …"

Pharma Guy's insight:

Ha! Ha! This is a great quote: "The report is embarrassing,” said Alan Cassels, a drug policy researcher at the University of Victoria. “Finding good quality — unbiased and useful — drug information is like finding a needle in a haystack. And pharma’s information just makes the haystack bigger.”

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House Committee Focuses on Drug Cost Transparency

House Committee Focuses on Drug Cost Transparency | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Washington House Health Care and Wellness Committee held a public hearing Tuesday on HB 2363, a bill looking at pharmaceutical costs and utilization transparency which is one component of the larger all payer claims database initiative.


The bill has strong support from both party whips and is sponsored by Committee Chair Rep. Eileen Cody (D), Minority Whip Rep. Paul Harris (R), Rep. June Robinson (D), Majority Whip Kevin Van De Wege (D), Rep. Laurie Jinkins (D), and Rep. Steve Tharinger (D).


The public hearing heated up during Rep. Cody’s questioning of lobbyist Jeff Gombowsky [27:35] who testified on behalf of the pharmaceutical trade association. Gombowsky argued that “disclosure requirements are further than any other states.”


Rep. Cody: Can you tell me what pharma feels we should be able to see in transparency?

 

Jeff Gombowsky [lobbyist]: Ah… good question.

 

[Laughter from the hearing]

 

Rep. Cody: Only wanting to know what you’re willing to share. […]

 

Rep. Tharinger: Isn’t it distorted to price your product based on the savings to the health system as opposed to your cost to create and deliver the product? […]


Rep. Cody: I’ve been a nurse forever. I work with multiple sclerosis patients. The first drugs came out in 1994. I keep track in a notebook and update it every few years. Each time a new drug comes out, the old drug’s price is raised to match it […] Do you understand why we’re having questions? Why don’t you come back to me with what pharma is willing to share with us for transparency?


Notably, the bill would require the publication of total profit margin of a particular drug and the percentage of total company profit derived from said drug, providing as comprehensive reporting of actual production costs versus cost borne by payers as the state has ever seen. It would also require the following:


The total amount spent by state and local government entities for the purchase of prescription drugs, including spending as a percentage of the total amount spent on medical care;


The 20 prescription drugs with the highest cost to state and local governments in terms of the total amount spent and the amount spent per prescription. The report must include a comparison of the costs of these drugs to the price paid by the US Department of Veterans Affairs and the 340B drug discount program; and


On an annual basis, trend data over time related to the amount spent on prescription drugs by Medicaid, Public Employees Benefits Board programs, and city and county governments, including generic, brand name, and specialty drugs. In addition, this information must compare the costs by manufacturer, provide profit margins for the previous three years, and identify the price of these prescription drugs in foreign countries.


In addition, manufacturers of drugs that cost $10,000 or more annually, or per one course of treatment, will have to issue reports detailing all costs associated with R&D, drug trials, studies, materials, manufacturing, administration, and marketing.

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