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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Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit

Public Citizen Calls Upon FDA to Ban Hypertension Drug That Has Unique Serious Risks But No Unique Benefit | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The U.S. Food and Drug Administration (FDA) should ban the sale of a certain hypertension medication because it can cause life-threatening health risks, Public Citizen said today.

 

Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits, the organization warned.

 

Public Citizen is petitioning the FDA to stop the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.

 

The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.

 

The petition noted that with millions of prescriptions for olmesartan-containing medications filled each year, immediately banning the drug is essential to prevent avoidable serious harm to thousands of patients.

 

In 2012, researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. By 2013, the FDA had concluded that olmesartan “can cause” sprue-like enteropathy and issued a safety warning about the medication. However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling.

 

Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication. The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.

 

In addition, many other medications exist that are equally effective for treating hypertension and do not pose these risks to patients. In short, the petitioners say, olmesartan “has unique serious risks but no unique benefit.”

 

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

Pharma Guy's insight:

Interesting that this comes when new hypertension AHA guidelines may mean millions more Rx's for such drugs.

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Pharma, Medical Device Industries Got an Early Christmas Present

Pharma, Medical Device Industries Got an Early Christmas Present | Pharmaguy's Insights Into Drug Industry News | Scoop.it

But Not Everything on Their List

Statement of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

Note: Today, the U.S. Senate passed the 21st Century Cures Act. Last Wednesday, the U.S. House of Representatives passed the measure. See Public Citizen’s work surrounding the legislation – highlighting the serious impacts the bill will have on patient safety.

It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act. This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.

However, because of the efforts of Public Citizen and allies, Big Pharma and medical device corporations did not receive all the goodies they put on their long wish list. Our pressure helped eliminate provisions that would have 1) opened a gaping hole in the Physician Payments Sunshine Act for educational gifts made by industry to physicians; 2) increased medication prices and cost taxpayers an estimated $12 billion over 10 years; 3) encouraged hospitals to overuse the newest antibiotics thereby contributing to the harmful spread of antibiotic resistance; and 4) allowed medical device manufacturers to make changes to high-risk medical devices without U.S. Food and Drug Administration oversight.

The bill passed today does less harm than the original bill that passed the House last summer, but Congress should not have had to jeopardize patient safety to increase medical research funding.

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Majority of Patients’ Groups Siding With Pharma Against Medicare Part B Pricing Reforms Receive Industry Funding

Of the 147 Patients’ Groups That Co-Signed Industry Opposition Letters to Congress and CMS, at Least Three in Four Get Funding From Big Pharma

The overwhelming majority of patients’ groups opposing a Medicare Part B proposal to reduce drug expenditures got funding from the pharmaceutical industry, according to a new Public Citizen report.

The report, “Patients’ Groups and Big Pharma,” examined industry funding for 147 patients’ groups publicly opposing the Medicare Part B proposal, documenting disclosures of funding and sponsorships from the drug and medical device industry to 110 of those groups (75 percent of the total).

The patients’ groups voiced their opposition to the Medicare Part B reforms by signing either a letter to congressional leadership (organized by the Community Oncology Alliance) or a letter to the Centers for Medicare and Medicaid Services (organized by the Partnership to Improve Patient Care). An additional 241 groups, mostly associated with doctors or the pharmaceutical industry – both of which have a financial incentive for opposing the reforms – also signed letters.

Because the report’s findings are based on voluntary disclosures that patients’ groups and pharmaceutical companies provide, they likely underrepresent the proportion of patients’ groups receiving pharmaceutical industry sponsorship. Total amounts of how much the groups receive from the industry are mostly unknown.

The Medicare Part B demonstration project, which Public Citizen supports along with numerous allied consumer and health groups, aims to remove incentives for needlessly prescribing high-priced medicines when equally effective and affordable alternatives are available.

These findings come on the heels of a recent Public Citizen report revealing that members of the U.S. House of Representatives who oppose the reform received 82 percent more in campaign contributions from pharma than members who are not opposed.

“While it is certainly not the case that every patient group that takes industry money is a Big Pharma puppet, the fact that three-quarters of the patients’ groups opposing these reforms receive industry money should make policymakers skeptical of these groups’ independence,” said Rick Claypool, a Public Citizen research director and author of the report.

Pharma Guy's insight:

I think 3/4 of all patient groups receive funding from pharma - even those groups that might be in favor of Medicare pricing reform. This analysis does not take that into account. :)

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1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge!

1 Person Correctly Ranked All Companies in The Pharma Criminal & Civil Penalty Challenge! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen released additional data on pharmaceutical industry criminal and civil settlements, stemming from its March report tallying all settlements with both federal and state governments from 1991 through 2015. The new data provide company-specific totals for the most recent 10-year period (2006-2015), which demonstrate that, for most companies, the vast majority of penalties were paid out in those 10 years since 2006. During the 10 years from 2006-2015, 21 companies entered into two or more settlements with the federal government.

The Challenge: Can you rank the Top 10 of those companies in terms of the amount paid over those 10 years? Click on "Read More" to see how well respondents did.

Forty-three brave souls took the challenge. Only one person was able to put all the companies in the correct order.

 

Click here for more...

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25 Years of Pharma Criminal and Civil Penalties: Off-Label Marketing Tops the List, But...

25 Years of Pharma Criminal and Civil Penalties: Off-Label Marketing Tops the List, But... | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to a Public Citizen report, stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs. The report – an update to a previous study released in 2012 with additional data through 2015 – catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015, which totaled $35.7 billion.

Of the 373 settlements over those 25 years, 140 were federal settlements totaling $31.9 billion, and 233 were state settlements totaling $3.8 billion. GlaxoSmithKline and Pfizer reached the most settlements and paid the most in financial penalties – $7.9 billion and $3.9 billion, respectively. From 1991 through 2015, 31 companies entered into repeat settlements with the federal government. The violation resulting in the most federal penalties was unlawful promotion, usually off-label marketing.

There is one surprising result. More...

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Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI

Wolfe Disapproves, but "Wolf" Approves FDA Decision re ADDYI | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group


The U.S. Food and Drug Administration’s (FDA’s) decision to approve flibanserin as a treatment for women with hypoactive sexual desire presents serious dangers to women, with little benefit, and recklessly disregards the worrisome risk information in the agency’s briefing package to the advisory committees that met on June 4 to review the drug.


It would not be surprising that after enough women have been seriously harmed by the “irreversible, or life threatening injuries” about which the FDA is concerned, flibanserin will have to be taken off the market. It is unconscionable that the FDA does not have the courage to prevent such damage from a drug with such a high ratio of risks to benefits.


The FDA’s analysis showed that women using the drug had an average of only half to one more “satisfying sexual encounter” every month compared to those using a placebo.


Meanwhile, the FDA’s list of serious risks includes abnormally low blood pressure and fainting. The agency noted that these could be experienced when flibanserin is taken alone or with alcohol, and that these side effects “can result in serious, irreversible, or life threatening injuries.”


The agency also noted that a study showed taking the drug with alcohol consumed over 10 minutes led to drowsiness, low blood pressure when standing up, and fainting. Although the study subjects were predominantly male (23 of 25 subjects), the FDA stated that “[t]he effect of the combination of flibanserin and ethanol may be more pronounced in females.”


The FDA noted the difficulty of preventing alcohol use in women using the drug, saying that limits on such prevention would exist even with the implementation of a type of risk management plan intended to ensure that the benefits of prescription drugs outweigh their risks.


Unfortunately, we haven’t heard the last of this drug. Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.

Pharma Guy's insight:

Wolfe et al have a good track record predicting which drugs will eventually be pulled from the market due stop safety issues. read, for example, "Sydney Wolfe's 7-Year Drug Rule/Itch: Don't Prescribe or Imbibe Any New Drug for First Seven Years After FDA Approval"; http://bit.ly/MQPrwR 

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Another Useless New Drug #FDA Will Probably Approve, Eventually

Another Useless New Drug #FDA Will Probably Approve, Eventually | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Treatment for Frequent Nighttime Urination Should Be Rejected, Public Citizen Tells FDA Advisory Committee

Agency Is Considering Nocdurna for the Third Time; It Provides Minimal Benefits, Carries the Risk of a Potentially Life-Threatening Condition

WASHINGTON, D.C. – The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee should reject Nocdurna – designed to prevent frequent nighttime urination – because it provides few meaningful benefits and can cause a potentially life-threatening condition, Public Citizen said in testimony today.

After being rejected twice by the FDA, Ferring Pharmaceuticals is back before the agency a third time seeking approval for Nocdurna (whose generic name is desmopression). It is supposed to treat nocturnal polyuria, a condition that causes adults to awaken two or more times each night to urinate. But Ferring hasn’t provided any new data to show why the FDA should approve it this time. Nocdurna can cause dangerously low blood sodium levels.

“Getting out of bed to use the bathroom may be annoying, but it’s not worth risking your life to avoid,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “We hope the FDA will once again recognize that the risks of this medication strongly outweigh the benefits, and flush this application away.”

Pharma Guy's insight:


The major concerning risk of Nocdurna is hyponatremia. Desmopressin, given its mechanism of action in blocking water excretion by the kidneys, has long been known to cause acute hyponatremia. Acute severe hyponatremia is a medical emergency because it can cause cerebral edema, which can result in loss of consciousness, seizure, coma, respiratory arrest, and death. In addition, FDA reviewers noted that mild chronic hyponatremia may be associated with neurocognitive impairment, gait disturbances and predisposition to falls, osteoporosis and fractures in elderly patients.


The majority of patients who would be candidates for Nocdurna under its proposed indication would already have one or more of the following factors predisposing to hyponatremia: advanced age, female gender, use of concomitant medications (e.g., thiazide and loop diuretics, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-depressants), and specific disease states (e.g., renal impairment, congestive heart failure, nephrotic syndrome). 


Not to mention that nighttime urination may be a sign of other serious medical conditions that should be treated first.

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Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance

Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen has told HHS secretary Sylvia Burwell that FDA should withdraw its recent draft guidance on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.


In an October 22 letter to Burwell, the group's founder and senior advisor, Sidney M. Wolfe wrote that  the guidance would allow pharmaceutical salespeople to “inform physicians of the purportedly lower risks by distributing peer-reviewed articles assessing a drug's risks and discussing with doctors the information about the ‘lower' risks, without the FDA reviewing the articles, analyzing the data, or approving distribution of that information.”


His letter also complained about FDA's decision to withhold over 1,700 public comments on the draft guidance, suggesting that it is trying to cover-up criticism of the proposal.


“Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency's Web site in the 58 days since the comment period closed,” Wolfe wrote, adding that on 10/15 it requested under the Freedom of Information Act the release of the comments.


Pharma Guy's insight:


Sidney Wolfe Cries Foul!

In a JAMA Internal Medicine viewpoint article pub- lished on August 15, 2014, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Re- search Group, argues that the draft guidance “suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products” and would “let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approv- ed labeling.”

Does Wolfe have a case? 


For more about that, read More FDA Guidance on Distribution of Reprints

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Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By

Health Canada Issues Warning About Possible Cardiovascular Problems Associated with Testosterone Products - FDA Sits Idly By | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.


Testosterone hormone replacement products are used in men who are experiencing medical conditions because their body cannot make enough testosterone. In Canada, there are 12 testosterone replacement products, including brand-name products: Androderm, Andriol, Delatestryl, Androgel, Axiron, Depo-Testosterone, Testim, and their equivalent generics.


Health Canada has recently completed a safety review on testosterone replacement products. This review found a growing body of evidence (from published scientific literature and case reports received by Health Canada and foreign regulators) for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products. 


Health Canada is working with manufacturers to update the Canadian product labels regarding this risk. The Department continues to collaborate with foreign regulators including the United States Food and Drug Administration and the European Medicines Agency regarding this safety concern. Health Canada will keep Canadians informed and take action, as appropriate, if any new safety information is identified.

Pharma Guy's insight:


At the exact same time that Health Canada issued its warning, FDA denied a petition by Public Citizen’s Health Research Group calling for a black-box warning about these same risks. FDA said it needs “further exploration of a possible safety signal” before issuing any warning about the risks of heart attacks and strokes. 

 

Sidney M Wolfe, MD, Founder and Senior Advisor, Public Citizen’s Health Research Group, issued a statement claiming that FDA's inaction vs. Canada Health's action on this health risk is an indication that the agency needs "new, more public health-oriented leadership" (read the statement here).


BTW, Public Citizen has a pretty good track record of identifying drug risks years in advance of those drugs being withdrawn for the market due to the risks it identified. Read more about that & listen to Wolfe's comments in this post:

Sydney Wolfe's 7-Year Drug Rule/Itch


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Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations

Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen, the Natural Resources Defense Council (NRDC) and the Communications Workers of America sued the Trump administration today to block an executive order signed by President Donald Trump on Jan. 30 that directs federal agencies to repeal two federal regulations for every new rule they issue.

The plaintiffs are asking the court to issue a declaration that the order cannot be lawfully implemented and bar the agencies from implementing the order.

The order requires new rules to have a net cost of $0 this fiscal year, without taking into account the value of the benefits of public protections.

The suit, filed in the U.S. District Court for the District of Columbia, names as defendants the president, the acting director of the Office of Management and Budget (OMB) and the current or acting secretaries and directors of more than a dozen executive departments and agencies. The complaint alleges that the agencies cannot lawfully comply with the president’s order because doing so would violate the statutes under which the agencies operate and the Administrative Procedure Act.

"No one thinking sensibly about how to set rules for health, safety, the environment and the economy would ever adopt the Trump Executive Order approach – unless their only goal was to confer enormous benefits on big business,” Public Citizen President Robert Weissman said. “If implemented, the order would result in lasting damage to our government’s ability to save lives, protect our environment, police Wall Street, keep consumers safe and fight discrimination. By irrationally directing agencies to consider costs but not benefits of new rules, it would fundamentally change our government’s role from one of protecting the public to protecting corporate profits.”

Pharma Guy's insight:

Further Reading: “FDA Regulation Cutting Will Impact Drug Approvals Too”; http://sco.lt/6XmjR3

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Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen

Mylan's Patient Assistance is a "Convoluted Scheme," Says Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan’s announcement of an expanded discount card system for EpiPens is a false solution that can be summed up as too little, too late.

If the company wants to calm public outrage over its contemptible and unconscionable price spikes for EpiPens, there’s only one course of action: actually lower the price.

Canadian online pharmacies offer EpiPens for a little over a $100 per pen. That would be an excessively high price, but at least within the bounds of reasonability.

Coupons, discount cards and patient assistance programs are a false solution for consumers hit with gigantic out-of-pocket costs. First, many consumers will not use the coupons or the programs. Second, many consumers with high deductibles or no insurance will still need to pay far too much for EpiPens – $300 for a set of two – a problem made worse by the facts that many families purchase multiple sets of EpiPens and that EpiPens must be replaced every year.

Equally as important, coupons and discount cards do virtually nothing to alleviate the rip-off of the health care system, for which all Americans pay as consumers and taxpayers. Because of the opacity in the pharmaceutical market, we don’t know what private and public insurers actually pay for EpiPens, but there’s no question that the price is higher than it would be if Mylan’s retail price were lower.

Mylan’s scheme is a convoluted effort to avoid plain talk about price. It is an excellent example of how corporations are gaming the health care system with elaborate show offers that allow them to continue to price gouge the rest of us.

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Public Citizen: Pharma Industry Abuse-Deterrent Opioid Subsidy Won't Curb Overdose Epidemic

A provision tucked into a U.S. House of Representatives bill to address opioid addiction is nothing but an expensive handout to the pharmaceutical industry that will do little to address the epidemic, Public Citizen said in a letter to Congress.

Lawmakers in the conference committee for the Comprehensive Addiction and Recovery Act are scheduled to meet on Wednesday, July 6, for the first time to discuss the bill.

The provision – Section 803 – would give manufacturers of so-called “abuse-deterrent” forms of opioids unnecessary financial incentives under the Medicaid program for their products.

“There is absolutely no need to provide additional incentives to manufacturers to develop new abuse-deterrent pain products. Manufacturers already are heavily promoting abuse-deterrent formulations as the future of opioid pain relief,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “Moreover, new abuse-deterrent products do not warrant expensive incentives because they have not yet been proven to substantially reduce the opioid abuse epidemic. If lawmakers are serious about fighting this public health crisis, they will oppose section 803.”

Read the letter.

Pharma Guy's insight:

Meanwhile, under pressure to stop the US epidemic of opioid abuse and related deaths, the Food and Drug Administration launched a plan to toughen warning labels, improve treatment of both addiction and pain, and expand the use of abuse-deterrent medications. For more on that, read "Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways"; http://sco.lt/9Mufmj 

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The Pharma Criminal & Civil Penalty Challenge!

Public Citizen released additional data on pharmaceutical industry criminal and civil settlements, stemming from its March report tallying all settlements with both federal and state governments from 1991 through 2015. The new data provide company-specific totals for the most recent 10-year period (2006-2015), which demonstrate that, for most companies, the vast majority of penalties were paid out in those 10 years since 2006. During the 10 years from 2006-2015, 21 companies entered into two or more settlements with the federal government.

The Challenge: Can you rank the Top 10 of those companies in terms of the amount paid over those 10 years? Try it here. Afterward, you'll see a chart of the actual data and see how good your ranking was.

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Fed Up! Demands that Senators Release Findings on Role of #Pharma in Opioid Addiction

Fed Up! Demands that Senators Release Findings on Role of #Pharma in Opioid Addiction | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a letter sent to the U.S. Senate Finance Committee, 36 physician groups, addiction agencies and consumer advocacy organizations, including Public Citizen, request public release of the results of a 2012 investigation by the committee into financial ties between producers of pain medications and organizations that aggressively promote the medications.

Pharma Guy's insight:

Good luck with that in an major election cycle!

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Dr Adam Smith's curator insight, September 24, 2015 3:00 AM

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The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic

The History of Purdue's Marketing of Oxycontin & Its Connection to the Opiate Epidemic | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Between physician databases, incentive-happy sales reps, and an aggressive blitz package of promotional ephemera, Purdue's multifaceted marketing campaign pushed OxyContin out of the niche offices of oncologists and pain specialists and into the primary care bazaar, where prescriptions for the drug could be handed out to millions upon millions of Americans. The most scathing irony is that what allowed OxyContin to reach so many households and communities was the claim that it wasn't dangerous.


Whatever the gray areas on OxyContin's many paths to perdition, the statistics on the first decade of this century bear out a staggering epidemic. From 1999 to 2010, the sale of prescription painkillers to pharmacies and doctors' offices quadrupled. In the exact same time span, the number of overdose deaths from prescription painkillers also quadrupled, rising to almost 17,000.


To call this a coincidence would be analogous to declaring no connection between loosening enforcement on drunk driving laws and observing a sudden increase in deaths caused by drunk driving. It goes almost without saying that these figures dovetail seamlessly with the release of OxyContin and Purdue's marketing timeline, which hit hardest in the early 2000s.

Pharma Guy's insight:


Meanwhile, FDA, in its quest to approve more and more drugs and despite no votes from its advisory committee, continues to approve powerful addictive painkillers such as Zohydro, "an opioid so powerful that a single dose could kill a child," according to Public Citizen, is the most recent.

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FDA Takes 3 Years to Issue Stronger Warnings on Nexium, Prevacid, etc. & Only After Being Sued by Public Citizen

FDA Takes 3 Years to Issue Stronger Warnings on Nexium, Prevacid, etc. & Only After Being Sued by Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Note: On Friday, Oct. 31, the U.S. Food and Drug Administration both accepted and rejected portions of Public Citizen’s 2011 petition for stronger warnings on certain common antacid medications. It acted in response to a lawsuit filed by Public Citizen against the agency for unreasonably delaying action on the petition.

It now has been more than three years since the U.S. Food and Drug Administration (FDA) received our urgent 2011 petition for stronger warnings and patient medication guides on all proton pump inhibitor (PPI) products (such as Nexium, Prevacid, Prilosec, Protonix and several over-the-counter versions). It also has been six months since we sued the agency in federal District Court for unreasonable delay in responding to our petition. The FDA finally responded to our petition last Friday.

In its response (PDF), the FDA agreed with and granted the following requests:


  • “In the labeling of all PPI products, addition of information regarding the risk of Clostridium difficile-associated diarrhea and the risk of drug-drug interactions between PPIs and mycophenolate mofetil [anti-transplant rejection drug] and methotrexate [for rheumatoid arthritis and other conditions];
  • In the labeling of certain PPI products (omeprazole [Prilosec] and esomeprazole [Nexium]), addition of information regarding the risk of drug-drug interactions with clopidogrel [Plavix];
  • In the labeling of certain prescription PPI products, addition of information regarding the risks of vitamin B 12 deficiency and acute interstitial nephritis and certain information regarding treatment length for gastroesophageal reflux disease (GERD); and
  • Issuance of Medication Guides for certain prescription PPI products regarding certain safety risks.”


The approved uses for prescription PPIs include treatment of gastroesophageal reflux disease (GERD), erosive and ulcerative esophagitis, peptic ulcer and H. pylori eradication, pathological hypersecretory conditions, and upper-gastrointestinal bleeding prophylaxis in critically ill patients and those taking nonsteroidal, anti-inflammatory medications. However, PPIs are often prescribed for conditions they aren’t approved to treat. Many studies have found that the majority of people on PPIs were not prescribed them for an approved use.

The FDA’s rejection of our request for black box warnings on all these medications was misguided. The agency stated that three very serious conditions – C. difficile diarrhea, osteoporotic fractures and hypomagnesemia (low magnesium in the blood) – were not serious enough or occurred too infrequently to warrant such warnings. The agency also denied our request that several other warnings be added.

Although we are disappointed in the rejection of certain requests, the portions of the petition granted by the agency are important and will make the products safer. At the same time, it is unconscionable that the agency took more than three years to respond. The evidence for all of the warnings now granted was available more than three years ago, but the agency unreasonably delayed, endangering millions of patients.

In 2013, 130 million prescriptions were filled in the U.S. for these grossly overused products, which have evidence of serious adverse reactions, as we documented in our petition (PDF). The FDA delay, in addition to being unreasonable by the standards of the Administrative Procedures Act governing petitions to the government, has posed needless, avoidable, serious dangers to millions of patients in this country.

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Is the FDA Trying to Cover Up Criticism of a Dangerous Proposal by Hiding Comments?

Proposed Guidance Would Let Pharmaceutical Industry Tell Doctors Medications Are Safer Than They Really Are

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should release all comments to the public that were submitted about a recent proposal to allow the pharmaceutical industry to circumvent labeling rules and tell doctors that its products have fewer risks than those described in FDA-approved labeling, Public Citizen said in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell today.

Public Citizen calls on the Secretary to order the FDA to withdraw the dangerous proposal.

Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency’s website in the 58 days since the comment period closed. Public Citizen, on Oct. 15, requested the FDA, under the Freedom of Information Act, to release the full text of all the comments.

The FDA says that it may redact or withhold comments if they contain proprietary information, inappropriate language or duplicate language (indicating they were generated by a mass email campaign). But this couldn’t account for all the missing submissions, Public Citizen maintains.

“The draft guidance ultimately lets the pharmaceutical industry tell doctors that medications are safer than they really are. If finalized as written, it will be very dangerous to public health and safety,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “It is likely that a large proportion of the 1,780 undisclosed comments are in objection to this reckless proposed FDA guidance. By not making these comments public, it looks as if the FDA is trying to cover up opposition to the inherent dangers of the proposal.”

In June, the FDA issued draft guidance that would allow pharmaceutical companies that believe that the FDA-approved labeling information overstates a medication’s risks to tell doctors that the risks are lower. Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency seeing the articles, reviewing the data or approving them – and discuss with doctors the information about the “lower” risks.

In an August article published in the Journal of the American Medical Association’s JAMA Internal Medicine, Wolfe wrote that to protect patients and the public health, when new information supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations. If the agency is convinced, the label can be changed.

Read Public Citizen’s letter to Burwell.

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Higher dose of Victoza helped patients drop weight

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

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


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


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

Pharma Guy's insight:


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

The Public Citizen press release states the case regarding pancreatitis:


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


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

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