DOES WEATHER PLAY ANY ROLE IN PAIN PRODUCTION?

DOES WEATHER PLAY ANY ROLE IN PAIN PRODUCTION?

Perhaps the most common fantasy (old wives tale?) is the idea that changes in the weather, including temperature, humidity, air pressure, wind direction and precipitation, can bring on aches and pains, especially those related to joint (arthritis) and back pains. Although there is no biologic reason to believe such a theory, little research has been devoted to this subject in the past.

Now research from The George Institute for Global Health has revealed the weather plays no part in the symptoms associated with either back pain or osteoarthritis.

Professor Chris Maher, of The George Institute for Global Health, said: “The belief that pain and inclement weather are linked dates back to Roman times. But our research suggests this belief may be based on the fact that people recall events that confirm their preexisting views.

“Human beings are very susceptible so it’s easy to see why we might only take note of pain on the days when it’s cold and rainy outside, but discount the days when they have symptoms but the weather is mild and sunny.”

Almost 1000 people with lower back pain, and around 350 with knee osteoarthritis were recruited for the Australian–based studies. Weather data from the Australian Bureau of Meteorology were sourced for the duration of the study period. Researchers compared the weather at the time patients first noticed pain with weather conditions one week and one month before the onset of pain as a control measure.

Results showed no association between back pain and temperature, humidity, air pressure, wind direction or precipitation. However, higher temperatures did slightly increase the chances of lower back pain, but the amount of the increase was not clinically important.

The findings reinforce earlier research on back pain and inclement weather from The George Institute which received widespread criticism from the public on social media.

Professor Maher, who led the back pain study, added: “People were adamant that adverse weather conditions worsened their symptoms so we decided to go ahead with a new study based on data from new patients with both lower back pain and osteoarthritis. The results though were almost exactly the same – there is absolutely no link between pain and the weather in these conditions.”

Back pain affects up to a third of the world’s population at any one time, while almost 10 percent of men and 18 percent of women over the age of 60 have osteoarthritis.

Associate Professor Manuela Ferreira, who led the osteoarthritis research at The George Institute, said: “People who suffer from either of these conditions should not focus on the weather as it does not have an important influence on your symptoms and it is outside your control.”

A/Prof Ferreira, Senior Research Fellow at The George Institute and at the Institute of Bone and Joint Research, added: “What’s more important is to focus on things you can control in regards to managing pain and prevention.”

The back pain study was published in the journal Pain Medicine, and the study on osteoarthritis, in the journal Osteoarthritis and Cartilage.

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High Prices for Drugs With Generic Alternatives: The Case of Duexis and Others

 

    A recent article appeared in the AMA journal noted why certain drug prices, especially generics, are outrageously high. As I explained in a previous post, (http://www.mortontavel.com/2017/01/06/), some drug makers employ legal “scams” to achieve such astronomical results. Below we describe a more subtle means they achieve the same results of bilking the public.

To begin, approximately 13% of health care expenditures in the United States are for prescription drug spending, nearly $420 billion in 2015. High-priced pharmaceuticals, therapies that cost more than $600 per month, are projected to eclipse 50% of total drug spending by 2018. Price increases for these therapies have been persistent, with unit costs increasing 164% between 2008 and 2015.

Pharmacy benefit managers are third-party administrators that process and pay prescription drug claims and negotiate drug prices with manufacturers. These managers are ostensibly charged with the responsibility of mitigating cost increases through such means as controlling increased co-payment requirements for patients, and exclusion of some expensive medications from health plan formularies. Below we use the illustrative example of Duexis, a single-tablet, fixed-dose combination of the nonsteroidal anti-inflammatory (NSAID) ibuprofen and the common antacid, famotidine (PepcidR), marketed by Horizon Pharma (Dublin, Ireland). This is how the pharmaceutical companies have sought to circumvent such restrictions and maintain high prices for drugs with generic alternatives.

Duexis was approved by the US Food and Drug Administration (FDA) in 2011 to relieve symptoms of arthritis and to decrease the risk of developing peptic ulcers in patients at risk for such problems. After approval, Duexis was first marketed at an average wholesale price, used for pricing and reimbursement of prescription drugs, of $158.40 per month. The drug is a combination of 2 over-the-counter medications that are sold as generics and would cost approximately $16 per month if purchased separately at the same doses. Since 2012, Duexis has had 11 price increases. As of August 12, 2016, the monthly wholesale price was $2061, representing a 1131% aggregate increase. In 2015, nearly $200 million was spent on Duexis in the US, with estimated cumulative revenue over 5 years of more than $600 million since FDA approval.

To circumvent co-payment requirements imposed by pharmacy benefit managers on patients to reduce use of high-priced drugs, pharmaceutical companies frequently offer co-pay assistance, also known as drug coupons; coupons cover direct costs to patients but not the amounts that insurers pay the manufacturer. In 2015, pharmaceutical manufacturers spent more than $7 billion on co-pay assistance. Horizon reports that 98% of patients prescribed Duexis have co-payments of no more than $10. Thus, patient out-of-pocket costs for Duexis are less than for ibuprofen and famotidine purchased separately. Federal programs, such as Medicare, do not permit manufacturers to provide co-pay assistance, because such assistance is considered an illegal inducement to encourage use of the drugs. Pharmaceutical companies, however, can work around this federal policy by providing financial assistance to patients through “independent” charities. The Patient Access Network Foundation, a large co-pay charity, provides financial assistance to patients prescribed Duexis and others.

Pharmacy benefit managers can also limit use of high-priced drugs by excluding them from health insurance formularies. When 2 large pharmacy benefit managers, Express Scripts and Caremark, excluded Duexis in 2015, Horizon provided Duexis without charge to patients covered by plans using these benefit managers. This response ensured that patients who received Duexis at no cost and the physicians who prescribed it remained aware of the brand, while the company collected revenue from other payers that continued to reimburse the drug. Pharmaceutical companies also ensure that their expensive therapies remain on formularies by providing rebates to pharmacy benefit managers, calculated as a percentage of the dollar value of a dispensed drug. As the result of an increased rebate offer from Horizon, Caremark removed Duexis from its exclusion list for 2017. Pharmacy benefit managers may provide some of the rebate savings to their customers, but typically much of the rebate is kept by the benefit manager as additional revenue, clearly an ethical violation.

In 2015, Horizon’s CEO was among 5 industry leaders elected to the board of directors of the Pharmaceutical Research and Manufacturers of America. Such tactics have been used to increase sales for other expensive drugs with effective, lower-priced, generic alternatives. Examples include Horizon’s Vimovo (naproxen/esomeprazole), Novum’s Alcortin A (hydrocortisone/iodoquinol) topical gel, Valeant’s Zyclara (imiquimod) topical cream, Mallinckrodt’s Acthar gel (Corticotropin injection), and Insys Therapeutics’ Subsys (fentanyl) sublingual spray.

The US experience with Duexis illustrates the problem of self-serving interests in health care. Companies charge what the market will bear and use available strategies to circumvent price constraints. Insurance plans and pharmacy benefit managers generally avoid the negative publicity that accompanies restrictive drug formularies and pass along the associated increases in costs through higher premiums. Patients, noting that they have paid for health insurance coverage, request what they believe to be the best and most convenient therapies, regardless of the price or generic alternatives. Physicians, perceiving that they are acting in the best interests of the individual patient and seeking to avoid disagreements and insurance hassles, are often unwilling to advocate for clinically equivalent but less costly therapies.

REMEDY FOR THIS PROBLEM

There should be greater scrutiny of the medical value of expensive drugs, especially those with inexpensive generic alternatives. The states and the federal government should ban all third parties from being involved in prior authorization. This is the responsibility of the physician who prescribes the medication. Additionally, states should restrict the use of co-pay assistance programs, particularly since the majority of drug coupons are for brand-name medications for which lower-cost therapeutics are available. Finally, better federal regulation of “charitable” organizations that provide financial assistance to patients is needed. For example, contributions to such organizations from manufacturers should not be allowed for diseases treated by a single drug, because manufacturers can effectively ensure that donations will be spent only on co-pay assistance for their products. To preserve the long-term financial stability of the health care system, the use of medications that provide clearly established benefit to patients should be the first priority, although they have their own challenges. High-priced drugs with generic alternatives should be, as described above, carefully controlled by governmental action

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PHYSICIANS IN GOVERNMENT: USUALLY GOOD, BUT SOMETIMES NOT

    This is a summary of an article appearing in the New England Journal of Medicine (Jan 12, 2017)§ With regard to the department of health and human services (HHS), only two previous secretaries have been physicians. For the most part, all of us physicians work to defend not only our own patients, but society at large against dangers to health, and in the process, usually eschew venal and self serving goals. That is why most of us chose this respected profession of care-giving in the first place.

Let us begin by describing the good doctors: Otis Bowen, our former Indiana Governor, was Ronald Reagan’s second HHS secretary, and he engineered the first major expansion of Medicare, championed comparative effectiveness research and, together with Surgeon General C. Everett Koop, another exemplary physician, led the fight against HIV-AIDS. Louis Sullivan, HHS secretary under President George H.W. Bush, focused his attention on care for vulnerable populations, campaigned against tobacco use, led the development of federally sponsored clinical guidelines, and introduced President Bush’s health insurance plan, which incorporated income-related tax credits and a system of risk adjustment. All these aforementioned physicians, serving in GOP administrations, drew on a long tradition of physicians as advocates for the most vulnerable, were defenders of public health, and enthusiastic proponents of scientific approaches to clinical care.

Now comes the bad: In sharp contrast with these previous examples, Tom Price, Trump’s pick for secretary of HHS, shows a record that demonstrates less concern for the sick, the poor, and the health of the public, in favor of greater concern for the economic well-being of the rich and the care-givers themselves.

To exemplify this point, let’s enumerate his previous positions.

  1. Price has sponsored legislation opposing regulations on cigars and has voted against regulating tobacco as a drug, in reality, this product is actually far worse than most drugs!
  2. In 2007, during the presidency of George W. Bush, he was one of only 47 representatives to vote against the Domenici-Wellstone Mental Health Parity and Addiction Equity Act, which improved coverage for mental health in private insurance plans.
  3. He voted against funding for combating AIDS, malaria, and TB, and against expansion of the State Children’s Health Insurance Program, and in favor of allowing hospitals to turn away Medicaid and Medicare patients seeking nonemergency care if they could not afford copayments.
  4. He favors converting Medicare to a premium-support system.
  5. He opposed reauthorization of the Violence Against Women Act, and has voted against legislation prohibiting job discrimination against LGBT people and against enforcement of laws against anti-LGBT hate crimes.
  6. He favors amending the Constitution to outlaw same-sex marriage.
  7. He opposes stem-cell research and voted against expanding the NIH budget and against the recently enacted 21st Century Cures Act, showing particular animus toward the Cancer Moonshot. Would he continue this stance if he were afflicted with cancer himself?
  8. He is a leader of the repeal of the ACA (“Obamacare”) in favor of a regressive “plan” which, without going into details, will offer much greater subsidies relative to income for purchasers with high incomes and more meager subsidies for those with low incomes. In effect, Price’s replacement proposal would make it much more difficult for low-income Americans to afford health insurance, diverting federal tax dollars to people who can already afford it, and also substantially reducing protections for those with preexisting conditions. The end result would be a shaky market dominated by health plans that offer limited coverage and high cost-sharing.
  9. Strongly anti-abortion and advocating the defunding of Planned Parenthood, Price has accepted the validity of the fraudulently modified videotapes used against this organization—despite their many pro-health programs for the poor.

CONCLUSION

   The HHS Department oversees a broad set of health programs that touch about half of all Americans. Over five decades covering nine presidential tenures of both parties, secretaries have used these programs to protect the most vulnerable Americans. The proposed nomination of Tom Price to HHS highlights a sharp contrast between this tradition of compassionate leadership and the priorities of the incoming administration.

I am not at all proud of this “fellow” physician!

  • Glied SA and Frank RG, Care for the Vulnerable vas Cash for the Powerful—Trump’s Pick for HHS. N.Engl J. Med. 376;2. 2017: 103-105.
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Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Bilks Both Patients and the Entire Public

high-drug-prices

In May 2015, when Isla Weston was just two months old, doctors diagnosed her with a life-threatening parasitic infection known as toxoplasmosis. Immediate treatment was needed to cure this infection; otherwise, the parasite would attack vital cells in the little girl’s brain, potentially leaving her with lifelong deficits in cognition and function—or even causing death. Isla was prescribed Daraprim, the standard of care, which would cure the active infection within a year. To the shock and dismay of the infant’s family, and other Americans who relied on this vital medicine, the price of the 63-year-old drug that this child desperately needed had just spiked from $13.50 a tablet to $750 a tablet, an increase of more than 5,000 percent, in just one day. Shocked by the astronomical price, Shannon Weston, Isla’s mother, sought desperately to come up with the almost $360,000 necessary to treat her daughter for a year with a drug that she needed. This family’s struggle sadly represents the struggle of thousands of Americans in the face of soaring prescription drug costs. In this instance, Isla ultimately received treatment, not through affordable access to Daraprim, but through the genius and goodwill of her health care team at the University of North Carolina. Mrs. Heyman ultimately found affordable treatment by switching to an alternate drug, but in doing so, she endures lifestyle restrictions and uncertainties about future effectiveness of the drug actually used.

Nearly 60 percent of Americans, including roughly 90 percent of seniors, take prescription drugs to treat conditions ranging from cancer and diabetes to high blood pressure and depression. Staggering increases in the price of some prescription drugs threaten not only the economic stability of American households, but also the health of individuals who discover that drugs they need are unaffordable. This year alone, Americans are expected to spend more than $328 billion on prescription drugs. Of this amount, individuals will pay about $50 billion out of pocket. The federal government will pick up another $126 billion in payments through Medicare, Medicaid, the Department of Veterans Affairs, and other programs. These price increases affect all Americans, whether they take prescription drugs or not, as taxpayers shoulder a substantial portion of the cost of federal health care programs.

In November 2015, Chairman Susan Collins (R-Maine) and Ranking Member Claire McCaskill (D-Missouri) formed a bipartisan Senate Special Committee on Aging to investigate the abrupt and dramatic price increases in prescription drugs whose patents had expired long ago. The Committee’s investigation centered on Turing Pharmaceuticals, Retrophin, Inc., Valeant Pharmaceuticals International, Inc., and Rodelis Therapeutics—companies that acquired decades-old, off-patent affordable drugs and then raised the prices suddenly and astronomically.

For many decades, federal policy has sought to strike the right balance between maintaining the incentives needed to promote innovation and development of new drugs, and keeping medicines affordable for patients. This balance has been struck by allowing a period of patent protection for innovative drugs, and then opening the market to generic competition to help drive down prices. On average, generics cost 80 percent less than brand-name drugs. That balance never anticipated companies acquiring off-patent drugs, for which they contributed not a single research dollar, and then dramatically increasing their prices in the absence of generic competitors.

The congressional investigation uncovered a business model that these four companies used (with some variation) to raise prices of generics excessively, which enabled them to identify and acquire off-patent sole-source drugs over which they could exercise de facto monopoly pricing power and a means to protect the astronomical price increases. The business model consists of five central elements: 1) Sole-Source. The company acquired a sole-source drug, for which there was only one manufacturer, and therefore faces no immediate competition, thus maintaining monopoly power over its pricing. 2) Gold Standard. The company ensured the drug was considered the “gold standard”—the best drug available for the condition it treats, ensuring that physicians would continue to prescribe the drug, even if the price increased. 3) Small Market. The company selected a drug that served a small market, which was not attractive to competitors and which had dependent patient populations that were too small to organize effective opposition. 4) Closed Distribution. The company controlled access to the drug through a closed distribution system or specialty pharmacy where a drug could not be obtained through normal channels, or the company used another means to make it difficult for competitors to enter the market. 5) Lastly, the company engaged in price gouging, maximizing profits by jacking up prices as high as possible. All the drugs investigated had been off-patent for decades, and none of the four companies had invested a penny in research and development to create or to significantly improve the drugs. Further, the Committee found that the companies faced no meaningful increases in production or distribution costs.

This investigation has shed light on why such companies can impose egregious price increases on off-patent drugs they have acquired and what federal policies should be considered to counter this disturbing practice. During the course of the Committee’s investigation, other companies raised their prices sharply. In April 2016, a study found that the mean price of insulin, a lifeline therapy for the 29 million Americans with diabetes, increased from $4.34 per milliliter in 2002 to $12.92 per milliliter in 2013, a 200 percent increase. In July 2016, a flurry of news stories reported another staggering price spike: the price of Naloxone, the antidote to prescription painkiller overdoses, increased by 1,000 percent, amid an opioid public health crisis. And in August 2016, news broke of a 500 percent price spike in the epinephrine auto-injector, EpiPen, which is used to save lives during allergy emergencies.

Facilitating such nefarious practices, investors and representatives from the business community often control company boards and policies which install such measures and, in the process, likely consider them business as usual, without regard to public welfare.

WHAT CAN BE DONE

The Senate Special Committee is committed to improving access and affordability of prescription medications. They strongly support continued efforts to stop the bad actors who are acquiring drugs that have been off-patent for decades, and they are considering a few counter measures noted below:

           To expedite entry into the market by potential challengers, In March 2016, senators Collins and McCaskill introduced The Increasing Competition in Pharmaceuticals Act. This legislation would take steps to incentivize competition and provide solutions to regulatory uncertainty, small market size, and other factors that serve as inherent limitations to generic entry. The bill proposes setting a reduced timeframe for the FDA to expedite the review of generic drugs that are in short supply, requiring this agency to act to approve such drug applications within 150 days. They would also encourage generic competition by allowing the FDA more latitude in approving potential individual generic competitors.

They would allow highly targeted temporary drug importation of off-patent drugs to combat major price increases.

They will study methods to prevent the misuse of patient assistance programs and co-pay coupons. Some patient assistance programs can be used to steer patients toward higher priced drugs, resulting in higher expenditures for beneficiaries, federal health care programs, and commercial providers.

The Federal Trade Commission (FTC) should be strengthened to enforce action when it comes to drug company mergers, operations, and drug market dynamics. The FTC should be allowed greater use of its authority to conduct studies of the marketplace and to consider partnerships with academia and other federal agencies. The FTC needs more resources to allow it to more vigorously oversee the off-patent prescription drug market.

Transparency in drug prices should be improved. Releasing, for example, the true price of a drug, the Average Manufacturer Price, could empower patients and doctors, prevent surprise costs at the pharmacy or on health bills, and provide Americans with a refreshing dose of reality.

By pursuing such reprehensible methods to line their own pockets, these and other companies behaving in this way—while currently operating within the limits of the law—could be controlled. We applaud efforts by governmental departments to control them. Despite the current prevailing political sentiment against governmental intervention, the ultimate salvation of the masses will likely be provided by—you guessed it—Uncle Sam!

 

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