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News

Last 50 News Postings

 (Click on title to be directed to posting, most recent listed first)

Pulmonary Disease Linked to Vaping
CEO Compensation-One Reason Healthcare Costs So Much
Doctor or Money Shortage in California?
FDA Commissioner Gottlieb Resigns
Physicians Generate an Average $2.4 Million a Year Per Hospital
Drug Prices Continue to Rise
New Center for Physician Rights
CMS Decreases Clinic Visit Payments to Hospital-Employed Physicians
   and Expands Decreases in Drug Payments 340B Cuts
Big Pharma Gives Millions to Congress
Gilbert Hospital and Florence Hospital at Anthem Closed
CMS’ Star Ratings Miscalculated
VA Announces Aggressive New Approach to Produce Rapid Improvements
   in VA Medical Centers
Healthcare Payments Under the Budget Deal: Mostly Good News
   for Physicians
Hospitals Plan to Start Their Own Generic Drug Company
Flu Season and Trehalose
MedPAC Votes to Scrap MIPS
CMS Announces New Payment Model
Varenicline (Chantix®) Associated with Increased Cardiovascular Events
Tax Cuts Could Threaten Physicians
Trump Nominates Former Pharmaceutical Executive as HHS Secretary
Arizona Averages Over 25 Opioid Overdoses Per Day
Maryvale Hospital to Close
California Enacts Drug Pricing Transparency Bill
Senate Health Bill Lacks 50 Votes Needed to Proceed
Medi-Cal Blamed for Poor Care in Lawsuit
Senate Republican Leadership Releases Revised ACA Repeal and Replace Bill
Mortality Rate Will Likely Increase Under Senate Healthcare Bill
University of Arizona-Phoenix Receives Full Accreditation
Limited Choice of Obamacare Insurers in Some Parts of the Southwest
Gottlieb, the FDA and Dumbing Down Medicine
Salary Surveys Report Declines in Pulmonologist, Allergist and Nurse 
   Incomes
CDC Releases Ventilator-Associated Events Criteria
Medicare Bundled Payment Initiative Did Not Reduce COPD Readmissions
Younger Smokers Continue to Smoke as Adults: Implications for Raising the
   Smoking Age to 21
Most Drug Overdose Deaths from Nonprescription Opioids
Lawsuits Allege Price Fixing by Generic Drug Makers
Knox Named Phoenix Associate Dean of Faculty Affairs
Rating the VA Hospitals
Garcia Resigns as Arizona University VP
Combination Influenza Therapy with Clarithromycin-Naproxen-Oseltamivir
   Superior to Oseltamivir Alone
VAP Rates Unchanged
ABIM Overhauling MOC
Substitution of Assistants for Nurses Increases Mortality, Decreases Quality
CMS Releases Data on Drug Spending
Trump Proposes Initial Healthcare Agenda
Election Results of Southwest Ballot Measures Affecting Healthcare
Southwest Ballot Measures Affecting Healthcare
ACGME Proposes Dropping the 16 Hour Resident Shift Limit

 

For an excel file with complete news listings click here.

A report from Heartwire described a letter written by Peter Wilmshurst to the AHA asking for full disclosure of conflicts of interest in the MIST trial. Wilmshurst was portrayed in SWJPCC on April 27, 2012 in our Profiles of Medical Courage series. We felt the report of the letter might be of interest to the readership of SWJPCC but there was no good section to pass along the Heartwire article. For this reason, a new Section entitled “News” has been started to report developments outside the usual medical journal purview or from other sources which might interest our readers. We encourage bringing news-worthy articles to our attention and would welcome submission of written reports of such articles.

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Entries in drug (4)

Tuesday
Oct102017

California Enacts Drug Pricing Transparency Bill

The Mercury News is reporting that California governor Jerry Brown signed a bill Monday making drug pricing more transparent (1). The legislation requires pharmaceutical companies to notify health insurers and government health plans at least 60 days before making price hikes and explain the reason for the increase. The pharmaceutical industry had lobbied hard against the measure, worried that it could become a national model and the first big step toward price controls. “The essence of this bill is pretty simple,” Brown told a room filled with supporters of Senate Bill 17. “Californians have a right to know why their medical costs are out of control, especially when the pharmaceutical profits are soaring. That’s the take-away message.”

“It is disappointing that Gov. Brown has decided to sign a bill that is based on misleading rhetoric instead of what’s in the best interest of patients,” said Priscilla VanderVeer, spokeswoman for the Washington, D.C.-based Pharmaceutical Research and Manufacturers of America. She added that there is “no evidence that SB 17 will lower drug costs for patients.”

The bill does not actually control drug prices, leading some critics to suggest it is toothless. However, the bill’s backers say that transparency in other health care sectors has been successful in reducing costs. Anthony Wright, executive director of Health Access California, agreed. He said the advance notice and information required under SB 17 “is invaluable” to large health care purchasers such as insurers, union trusts and employers, and would enable them to drive a better deal for consumers.

Brown also signed a related bill on Monday. Assembly Bill 265 will prohibit prescription drug manufacturers from offering discounts for name-brand drugs, if a less-expensive equivalent brand is available, preventing the use of higher-priced drugs when unnecessary.

Richard A. Robbins, MD

Editor, SWJPCC

References

  1. Seipel T. Gov. Brown signs drug pricing transparency bill. The Mercury News. October 8, 2017 (updated October 9). Available at: http://www.mercurynews.com/2017/10/08/gov-brown-to-sign-drug-price-transparency-bill/ (accessed 8/10/17).

Cite as: Robbins RA. California enacts drug pricing trasparency bill. Southwest J Pulm Crit Care. 2017;15(4):159. doi: https://doi.org/10.13175/swjpcc122-17 PDF 

Friday
Apr142017

Gottlieb, the FDA and Dumbing Down Medicine

Gottlieb, the FDA and Dumbing Down Medicine

In the last few weeks several events have occurred that might impact drug approval in the US. President Donald Trump's pick for FDA commissioner, Dr. Scott Gottlieb. Gottlieb, like many of Trump’s picks for administration healthcare positions, is a physician. He also has experience as deputy FDA commissioner from 2005-7.  However, his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed some who say his deep ties to the pharmaceutical industry will cause a conflict of interest (1). Others praised Gottlieb as the right man to lead the FDA.

As opposed to Trump, Gottlieb denied any connection between vaccines and autism (1,2). Dr. Gottlieb called the issue "one of the most exhaustively studied questions in medical history," before saying, "There is no plausible link between vaccines and autism. At some point, we have to accept 'no' for an answer." However, Gottlieb did not give a straight answer when asked to share his thoughts on drug importation. While President Donald Trump has supported increased drug importation and is reported to be working with Democratic lawmakers on drug importation legislation, Dr. Gottlieb had previously opposed the measure (1). When asked if he opposes importing cheaper drugs from foreign countries, he said, "I can tell you I have a lot of ideas that I want to work on right away on how I think we can get more product competition onto the market."

Gottlieb stated that the FDA could speed up approval of new drugs and devices (1). However, a letter to the editor published in the New England Journal of Medicine examined compared review times for new therapeutic agents that were approved by the FDA or the European Medicines Agency (EMA), the primary drug regulator in Europe, between 2011 and 2015 (3). The median total review time was 306 days (interquartile range, 239 to 371) at the FDA, as compared with 383 days (interquartile range, 327 to 446) at the EMA.

In welcome news to many physicians, Gottlieb voiced uneasiness over increasing regulation of physicians’ practices (1). “My concern that the agency was losing confidence in physicians and felt it need[ed] …to supplant their judgment for the judgment of doctors,” Gottlieb said. He had previously referred to the FDA’s action on Arcoxia, a pain killer that was rejected in April 2007 because of concern that it could increase the risk of heart attack and stroke with prolonged use despite being meant for short-term pain relief. Gottlieb stated the opioid epidemic would be his "highest and most immediate priority." He added that the epidemic is a "public health emergency on the order of Ebola and Zika" that requires dramatic action from the FDA. "[T]o address it now, the types of actions that we are going to need to take are going to be more dramatic, perhaps, than the types of actions we would have taken 10 years ago."

Gottlieb did not note that some have linked the present opioid crisis to meddling by bureaucrats, administrations and politicians as an unattended consequence of the pain scale, opioid prescribing guidelines and patient satisfaction ratings (4). Furthermore, he did not note that increasing prescribing authority has been given to non-physicians with less education and clinical experience, e.g., unsupervised nurse practitioners in the Department of Veterans Affairs (5). Whether these non-physician clinicians will use drugs any more or less appropriately than physicians is unclear.

Richard A. Robbins, MD

Editor, SWJPCC

References

  1. Dickson V. Gottlieb favors regulations that empower doctors while keeping FDA standards. Modern Healthcare. April 5, 2017. Available at: http://www.modernhealthcare.com/article/20170405/NEWS/170409965 (requires subscription, accessed 4/11/17).
  2. Dodgson L. Trump has suggested vaccines cause autism — an idea that couldn't be more wrong. Business Insider. January 24, 2017. Available at: http://www.businessinsider.com/trump-vaccines-autism-wrong-2017-1 (accessed 4/11/17).
  3. Downing NS, Zhang AD, Ross JS. Regulatory review of new therapeutic agents — FDA versus EMA, 2011–2015. N Engl J Med. 2017Apr 6;376:1386-7. [CrossRef] [PubMed]
  4. Robbins RA. Pain scales and the opioid crisis. Southwest J Pulm Crit Care. 2017;14(3):119-22. [CrossRef]
  5. Department of Veterans Affairs. VA grants full practice authority to advance practice registered nurses. December 14, 2016. Available at: https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2847 (accessed 4/11/17).

Cite as: Robbins RA. Gottlieb, the FDA and dumbing down medicine. Southwest J Pulm Crit Care. 2017;14(4):166-7. doi: https://doi.org/10.13175/swjpcc047-17 PDF 

Saturday
Dec172016

Lawsuits Allege Price Fixing by Generic Drug Makers

Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1). The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit.

The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of sharply rising drug prices led to Congressional hearings. "We believe that this is the tip of the iceberg," Connecticut Attorney General George Jepsen told Reuters in an interview. "Price fixing in the generic industry is widespread and pervasive, and it involves many other drugs and a number of other companies."

Both former Heritage CEO Jeffrey Glazer and former Heritage Vice President of Commercial Operations Jason Malek are expected to plead guilty. According to Reuters, it is typical for the Justice Department to file one lawsuit about an ongoing issue and use evidence from those defendants to build subsequent cases against others. Several companies have publicly disclosed receiving subpoenas from the Justice Department related to generic drug pricing including Mylan, Allergan, Lannett, Impax, Par, Sun and Mayne.

The drugs involved in the Justice Department lawsuit include two older drugs, doxycycline hyclate and glyburide. Doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014.

Richard A. Robbins, MD

Editor, SWJPCC

Reference

  1. Bartz D, Lynch SN. U.S. states sue Mylan, Teva, others for fixing drug prices. Reuters. December 16, 2016. Available at: http://www.reuters.com/article/us-usa-drugpricing-idUSKBN14420C (accessed 12/17/16).

Cite as: Robbins RA. Lawsuits allege price fixing by generic drug makers. Southwest J Pulm Crit Care. 2016;13(6):313. doi: https://doi.org/10.13175/swjpcc142-16 PDF 

Tuesday
Nov152016

CMS Releases Data on Drug Spending

Yesterday (11/14/16) the Centers for Medicare and Medicaid Services (CMS) released data on spending for drugs under Medicare and Medicaid (1,2). Medicare paid $137.4 billion on drugs covered by its prescription drug benefit in 2015. About $8.7 billion of that spending occurred on drugs that had "large" price hikes, defined as a more than 25 percent increase between 2014 and 2015. In 2015, Medicaid paid $57.3 billion about $5.1 billion of which was spent on drugs that had large price increases.

The Medicare spending database highlights 11 drugs that doubled in price. The Medicaid database identified 20 drugs that more than doubled in price with 9 of these being old, generic drugs. Medicare drugs were led by Glumetza, a Type 2 diabetes drug which saw its price soar 380 percent and hydroxychloroquine sulfate, a generic malaria drug, which went up 370 percent. Medicaid drugs were led by Ativan, an anti-anxiety medication approved in 1977, which increased by 1,264 percent in price between 2014 and 2015. Daraprim, a decades-old antiparasitic drug that helped spark political attention to the issue of high drug prices after former pharmaceutical executive Martin Shkreli hiked the price, leapt up in average cost by 874 percent.

However, drugs commonly used in respiratory diseases also increased in price. These were led by mitomycin, an anticancer drug sometimes used in lung cancer, an antidepressant also used as a smoking cessation aid (Table 1).

Table 1. Medicare Spending on Respiratory Drugs. (Open table in separate window)

The data on price on small prices rises can be deceiving when calculating total costs. For example, Advair Diskus, a bronchodilator, ranked in the top-five of Medicare expenditures, with $2.3 billion in spending in 2015. However, he utilization of the drug has actually declined a little over the last five years. Meanwhile, the total spending has not gone down, but increased. Fueled by relatively modest price increases, from $3.81 per unit in 2011 to $5.28 in 2015, the spending on the drug increased by more than half a billion dollars over that period.

Of particular concern is a rise in price of some generics, a class of drugs that are intended to decrease drug prices and spending. Drugs that were responsible for large amounts of overall spending tended to see smaller increases that gradually increased the government outlay. In one outlier, the price of the hepatitis C treatment, Harvoni, decreased slightly in 2015, even as it led overall spending.

The prices do not include the impact of rebates, which are prohibited by law from being released (3). Those discounts can be significant, and not knowing what they are means the numbers almost certainly overstate how much the government actually paid for these drugs. CMS disclosed that, on average, rebates for brand name drugs were 17.5 percent for medicines covered by Medicare's "part D" prescription drug benefit in 2014.

Richard A. Robbins, MD

Editor, SWJPCC

References

  1. CMS. 2015 Medicare drug spending dashboard. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/2015Medicare.html (accessed 11/15/16.
  2. CMS. 2015 Medicaid drug spending dashboard. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/2015Medicaid.html (accessed 11/15/16).
  3. Johnson CY. Drugs for hepatitis C and diabetes drove Medicare spending in 2015. Washington Post. November 14, 2016. Available at: https://www.washingtonpost.com/news/wonk/wp/2016/11/14/the-drugs-driving-up-medicare-spending/ (accessed 11/15/16).

Cite as: Robbins RA. CMS releases data on drug spending. Southwest J Pulm Crit Care. 2016;13(5):242-3. doi: https://doi.org/10.13175/swjpcc118-16 PDF