healthcare Archives - Page 2 of 4

What if Endometriosis Was a Men’s Health Issue?

Published on October 4, 2013

4360 views

As a health journalist and a co-founder of Endo Warriors, a support organization for women with endometriosis, I often get asked “what is endometriosis?”

Which is funny since it is estimated that 176 million women worldwide have endometriosis and yet no one knows about this global health issue.

Sometimes I say “it’s a secondary autoimmune disease where the lining of the uterus is found outside of the uterus and throughout the abdominal cavity — to varying degrees — causing chronic pain and infertility.

And other times I say “it sucks.”

Nancy Peterson of the ERC said “If 7 million men suffered unbearable pain with sex and exercise and were offered pregnancy, castration or hormones as treatment, Endo would be a national emergency to which we would transfer the defense budget to find a cure.” And, I don’t disagree.

If 7 million American men had unbearable pain every time they ejaculated, no one would ever suggest chopping off their balls. If they went to a health clinic that also offered pregnancy prevention services, we wouldn’t shut those clinics down. If 7 million American men were in pain every time they masturbated, urinated or tried to have sex we wouldn’t tell them “it’s all in their head” or “to take the pain like a man.” No, we would listen and try to find them a cure that didn’t include castration or drug-induced de-masculinization.

But that’s not the case.

Instead we have 7 million American women with chronic pain related to the tissue in their uterus and their menstrual cycle. 7 million American women who have pain before, during and after their menstrual cycle. 7 million American women who experience pain while exercising, having sex and going to the bathroom. So we offer them chemical-menopause and hysterectomies and when those don’t work we throw our hands up in the air and say “well, at least I tried.” Better luck in your next life, perhaps you’ll come back as a man.

The menstrual cycle is the butt of all jokes directed towards women. Bad day? Is it your period? Is Auntie Flo in town?

Seeing red? Are you on the rag?

No, actually I’m just mad that the idea of healthcare for women makes people want to cover their ears and run screaming.

Free birth control for women?

Great idea!

That is until some political pundit insinuates women should just learn to shut their legs.

Maybe instead we should learn to listen to the myriad of women on birth control for issues beyond planning pregnancies. Maybe women should just get easy access to low cost birth-control without having to recite their medical record.

October is health literacy month and when it comes to health literacy, Americans are kindergartners trying to eat the paste off their fingers.

We think Obamacare and the Affordable Care Act are two different things; getting outraged at the notion of Obamacare yet think the idea of ‘affordable’ healthcare is quite nice.

Access to low-cost health care for everyone? Let’s shutdown the government!

Rather, if we want the government out of our private healthcare, then how about they get out of our uteri as well?

Will the Sunshine Act Curb Pharma Payments to Doctors?

by Chandler Marrs, PhD

Published on February 12, 2013

2616 views

Just two weeks ago, as part of the Affordable Care Act, the Centers for Medicare and Medicade Services published its final rule on the reporting mandates for physician payments from pharmaceutical and medical device makers. Called the Physician Payment Sunshine Act, this law requires:

applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals (“covered recipients”).

Why Is This Important?

For too many physicians, the medications they choose to prescribe are influenced by these payments. A case control study at a university hospital found that physicians who requested a new drug be added to the formalary were 19X more likely to have received money or gifts from the drug company. According to the New England Journal of Medicine as of 2007 fully 94% of all physicians accepted gifts from pharma, although by 2009, only 84% of physicians accepted gifts from pharma.

In their Dollars for Docs series, Propublica not only detailed the trail of money from the pharmaceutical industry to physicians and the changes in prescribing practices that ensued, but also, found that over 250 of the physicians receiving these payments had been disciplined by their state’s medical boards with the public never the wiser.

Wouldn’t you want to know if your physician was receiving payments to ‘consult’ on a particular drug or medical device? What if that drug or device turned out to be dangerous like, Avandia or Vioxx or in the case of women’s health Yasmin, Yaz or Ocella or even the vaginal mesh implants? I would. And soon, you will be able to find this information, at least for those physicians that accept medicare or medicade. For the remaining physicians, we’ll have to rely on the stellar, investigative reporting of organizations like Propublica.

What Is the Physician Payment Sunshine Act?

The Physician Payment Sunshine Act mandates payments or ‘transfer of value’ to physicians be reported to the Secretary of Health and Human Services. Collection of this information is set to begin in August with full compliance and reporting expected in 2014.

The cool thing about this act, if it is implemented correctly, is that payment or transfer of value includes money for marketing activities, such as promotional or conference talks and consultation services. It also will include research grants and “charitable” contributions (which usually come with some promotional strings attached), funding to attend conferences, honoraria and royalties and license fees. The pharmaceutical and device companies making these payments will be required to list names, address, amount of payment, date of payment(s) and describe the service for the payment made for anything over $10. The database will be searchable so that patients can determine what monies their physicians received from pharma or device companies.

Where the Sunshine Act Fails

From the original to the final regulations, a work-around for paying physicians to speak at pharma sponsored continuing medical education (CME) events was added. According to the regulations, so long as the sponsoring company doesn’t pay the physician/speaker directly, those fees are acceptable and need not be listed publicly. Instead, the pharma company must pay a third party vendor to arrange and pay the speakers. CME conferences are where most physicians learn the latest drug therapy, device or medical technique. It is unlikely that speakers at these conferences will speak against the sponsor’s product. Funneling the payments through a third party vendor, who is also paid by the sponsor, is no more than a quick pass at laundering the fees.

What Do Physicians Think About the Sunshine Act?

The opinions are mixed, at least publicly. Some physicians are fully behind the new efforts in transparency and have begun their own campaigns to disentangle the marketing relationships between pharma and physicians. The National Physicians Alliance sponsors the Unbranded Doctor campaign:

The National Physicians Alliance’s Unbranded Doctor is unmasking the pharmaceutical industry’s bogus claim that its marketing efforts are just educational ventures for physicians. By signing up physicians to renounce gifts, lecture fees, and “education” from companies, the Alliance is championing objectivity, integrity, and professionalism.

—Jerome Kassirer, MD
former Editor-in-Chief, New England Journal of Medicine

Similarly, the British Medical Journal (BMJ) has positioned itself as a lead proponent of transparency and open data. On the other hand, CME released a survey of over 500 physicians asking if the new regulations to list publicly whether industry sponsored their attendance at CMEs would curtail their attendance. The result was a resounding – yes.

75% of physicians said the disclosure rules would affect their decision to attend at least somewhat.
47% of physicians said the disclosure rules would affect their decision to attend to a great extent.
46% of CME speakers said the disclosure rule would affect their decision to participate as a panelist or presenter to a great extent
25% percent said it would somewhat affect their participation

Will the Sunshine Act Curb Pharma Payments to Doctors?

Probably not. Unless and until full transparency about medical research, clinical trials and adverse events are made open and accessible to patients and physicians, medical marketing, fabricated data or omitted data, publication bias, and conflicts of interest will continue to pervade our healthcare system. Dangerous medications like the Yasmin suite of birth control pills and unsafe medical devices like J&J’s Gynecare Prolift will remain on the marketplace long after any reasonable person could vouch for their safety.

The Sunshine Act will, however, give patients one more tool to evaluate their physicians and give researchers, investigators and others a way to identify and publicize bad behavior. Who knows, maybe it will even save some money.

To find out if your physician receives money from the pharmaceutical industry go to Dollars for Docs.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter.

Photo by kike vega on Unsplash.

Photo by Hush Naidoo Jade Photography on Unsplash.

Going off on the off-label trail

by Lynda Chang

Published on December 19, 2012

2378 views

Did you know that your doctor can send you to the pharmacy with a prescription for an antidepressant, with the goal of helping you stop smoking? Hold on, wait a minute… what? While the average consumer may not be aware of it, off-label use is very common, with up to one-fifth of all drugs prescribed as such according to the April 3, 2008 New England Journal of Medicine. Some of the most common off-label drug uses include the areas of cardiac, anticonvulsants, obstetrics and cancer medicine. Off-label prescriptions occur most often with older, generic medicines that have revealed themselves over time to alleviate additional symptoms or conditions such as:

Anti-seizure drugs to treat migraines, depression, nerve pain
Antipsychotics to treat Alzheimer’s Disease, autism, dementia, Attention Deficit Hyperactivity Disorder (ADHD)
Antidepressants to treat chronic pain, ADHD, biopolar disorder
Antihistamines to treat colds, asthma, ear infection symptoms, as sleep aids

In women’s health, perhaps because many drugs are not designed specifically for women, off-label prescriptions are common. A study published in Archives of Internal Medicine revealed that women received more off-label drugs than men (11.8% vs 9.7%), and was attributed to women being more likely to be treated for problems such as anxiety, nocturnal leg pain, and insomnia, and off-label prescribing is common for these conditions.

Oral contraceptives are prescribed as the first line of treatment for a range of conditions beyond birth control and for which these medications were not approved. Currently, Bayer, the makers of the Yasmin line of birth control, is facing lawsuits for marketing these drugs for lifestyle purposes, PMS and other ailments for which there were no data and the drugs were not approved.

In obstetrics, terbutaline, indomethacin, nefidepine and magnesium sulfate are medications that have been used off-label for years to halt pre-term contractions. None has strong data supporting their efficacy or safety, and this stems from pregnant women being routinely excluded from studies. Thus, most drug treatment during pregnancy is off-label. According to a June 1993 article in Obstetrics and Gynecology, reasons for such off-label use during pregnancy include:

Prevention of repetitive abortion
Inhibition of premature labor
Reduction of fetal or neonatal infection
Reduction in development of pre-eclampsia and its complications
Ripening of the cervix or induction of labor

What’s the difference between FDA approved labels and non-approved off-labels?

One of the FDA’s primary roles is approving the labeling on a drug; approving what can and cannot be said about the medication. Once the FDA has approved that a drug works and is safe, it works closely with the drug manufacturer to create the drug label, which is a detailed report of specific information about the drug. The FDA-approved drug label is provided to all health professionals who prescribe or sell the drug, and gives information about the drug, its approved doses and instructions on appropriate administration to treat the medical condition(s) for which it was approved.

“Off-label” use is when the drug is used differently from what its label states. This can be when the drug is used for a different disease or medical condition, given in a different way (such as injected versus orally) or given in a different dose than in the approved label. Off-label use is also called “non-approved” or “unapproved” use of a drug, which is not regulated, but is legal in the U.S. and many other countries.

It is legal for doctors to prescribe drugs off-label, but it is not legal for drug companies to market the drug for off-label use. It is important to note that off-label marketing is very different from off-label use, and drug companies can be fined if they promote drugs for uses that have not been approved by the FDA. .

My doctor has prescribed a medication for me – what should I do?

As always it is our responsibility, as patients to do our homework when it comes to our health and wellness. Here are some tips before venturing off on the off-label trail:

Ask your doctor if what they have prescribed is for an approved use, and then verify that information with your pharmacist.
Go to the U.S. National Library of Medicine National Institutes of Health’s DailyMed site and search for the drug you are considering taking. Click on the “Indications & Usage” tab to see if your condition is listed.
If the drug is for off-label use, ask your doctor if there is existing scientific support for your specific condition.
Ask your doctor for the reason why they believe the drug will work better off-label than approved drugs.
Check that your health insurer covers payments for off-label use as some may require evidence of effectiveness or failure with conventional treatments. This is most often the case with expensive drugs.

Check your medicine cabinet now. Have you already gone off on the off-label trail without knowing it?

Over the Counter Birth Control Pills

by Chandler Marrs, PhD

Published on December 10, 2012

2956 views

Should birth control pills be available over the counter? In an unexpected and likely controversial position statement, the American College of Obstetrics and Gynecology (ACOG) announced its desire to see birth control pills sold over-the-counter (OTC). Stating that “oral contraceptives are very safe, and data show women can make these decisions for themselves.” Dr. Kavita Nanda who co-wrote ACOG’s paper, suggested that OTC birth control pills could reduce the rate unintended pregnancy significantly and save the nation $11 billion annually.

The bold move from prescription birth control pills to OTC is sure to remove barriers, provided the to-consumer pricing doesn’t skyrocket as is often the case when medications are sold OTC. Given the ongoing politicization of women’s reproductive health, returning the control of women’s health to women’s hands would be a laudable move and might even turn the volume down on current debates.

Imagine if birth control decisions were entirely personal and unhindered by political whims. Consider that greater access to birth control might be the key to reducing unintended or unwanted pregnancies. The availability of OTC birth control pills could be a very positive development for women’s health.

Are Oral Contraceptives Safe Enough to be OTC?

Unlike other over-the-counter medicines like ibuprofen that represent a single compound to be used for specific ailments – pain and inflammation – there are dozens of different birth control pills. Birth control pills are prescribed for an ever-increasing list of female ailments beyond simply preventing pregnancy. The question of whether birth control pills are safe must take into consideration the specific compound, dosage and woman. Some oral contraceptives have better safety profiles than others and some are quite dangerous (See Here).

Within the current market, determining which pill works best for which women, even in the doctor’s office, is a trial-and-error process. Much of the medication safety information is provided through the marketing channels of the product manufactures and–as has been reported here–those data are frequently biased and sometimes fraudulent. In that light, letting women self-select the appropriate birth control pill may be no worse than the current sub-optimal process.

Over-the-Counter Birth Control in Other Countries

In other countries where for-prescription regulations are not enforced, oral contraceptives and other medications may be purchased over the counter already. Numerous studies suggest women are capable of self-screening for the contraindications or risk factors associated oral contraceptives. This supports the argument that women can manage their own oral contraceptive use, at least for its intended purpose of preventing pregnancy. Whether women would continue to utilize oral contraceptives for the myriad of other conditions for which these pills are currently prescribed, remains unclear.

Though no data exists for oral contraceptive usage, ease of access to non-prescription medication shows a direct relationship to the use and abuse of prescription medications and mortality by overdose. That is, countries with strictly enforced prescription drug laws (the US, Canada) have higher prescription use rates and higher mortality from overdose with no concomitant decrease in morbidity or mortality by disease or really any overall improvement in health. These data suggest that as prescription requirements loosen, use of more potent medications decreases. In the case of oral contraceptives, it is possible that OTC access could reduce the current trend of utilizing oral contraceptives as the magic pill that treats all reproductive disorders. This could be good thing for women, but it may not be a good thing for industry.

The Economics of Birth Control

Social and political benefits aside, women’s reproductive health is a market. Unlike other markets affected negatively by the economic downturn, the birth control market appears untouched, even bolstered. Sales of oral contraceptives are expected to reach $17.2 billion worldwide within the next few years. As one of the most commonly (over)prescribed medications in women’s health, oral contraceptives are used as a first line of treatment for a range of conditions unrelated to birth control. One has to wonder why the organization that controls access to this medication in the US would want to lose such a lucrative cash cow.

For millions of healthy women, the annual exam to renew one’s birth control prescription is the only reason to visit a physician. For the millions of other women with endometriosis, PCOS, PMS, and a host of other common conditions, oral contraceptives remain the first and sometimes only line of treatment. Selling oral contraceptives OTC would effectively remove those business segments from the gynecologist’s bottom line. When combined with other market segment encroachments on the business of obstetrics and gynecology (midwifery for healthy birth and maternal-fetal medicine for complicated birth), from a purely economic and albeit cynical standpoint, it is perplexing that that this organization would give away the largest remaining revenue stream of its members.

The economic drivers from the pharmaceutical industry’s perspective are no less perplexing. If priced correctly, over the counter oral contraceptives could increase sales–especially to lower income women who were previously locked out of the market by lack of insurance or access to healthcare providers. However, OTC access might also reduce the growing percentage of ‘off-label’ uses. For an industry unaccustomed to R&D in this sector, (why develop specialized therapeutics for the array of women’s health conditions, when birth control pills can be prescribed for all), the move to OTC could have serious financial ramifications.

There must an economic upside for these organizations, but for the life of me, I cannot figure it out.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

Nevada Receives F in Women’s Health and Reproductive Rights

by Chandler Marrs, PhD

Published on December 4, 2012

1570 views

According to the Population Institute’s 2012 Report Card on Reproductive Health and Rights, Nevada, my current home state, received a failing grade. That’s right, the state that depends upon women for its thriving tourist industry does nothing to care for those women while they are here.

Nevada was only one of nine states receiving the F in women’s health.

The most striking statistic:Nevada spent only $44,000 on family planning clinics for low income women in 2010. That equals about $0.08 per woman. Way to go Nevada!

To learn how your state ranks: The Population Institute 2012 Report Card on Reproductive Health and Rights.

B Corporations: A Way Forward for Healthcare

by Chandler Marrs, PhD

Published on November 28, 2012

1968 views

The healthcare system is broken. Healthcare costs are skyrocketing and services are diminishing.The for Benefit Corporation or B Corporation could provide a solution, if the designation came with a beneficial tax structure.

What is a B Corporation?

B Corporations represent the intersection of social good and corporate benefit.

The B corporation is a recently defined class of corporation that must create societal benefit as well as shareholder profit. It combines the dedication to social purpose ascribed to by non-profits with the for-profit and growth potential of C corporations. Proponents of the B corporation argue that act of codifying the social good requirement within the corporate charter allows companies to maintain their for-benefit or social good programs, which are often less profitable and frequently disbanded by the boards of directors in favor of higher profits.

The B corporation is a recent invention. Since its conception in 2010, 11 states have enacted legislation to recognize the B corporation, while 16 states are considering the option. At this time, the B corporation receives no special tax consideration. Maybe it should.

How Might the B Corporation Solve the Healthcare Problem?

By putting health into the corporate charter of ‘healthcare’ companies.

The healthcare system is comprised of two major players, pharmaceuticals and insurers. On both sides, profits rule over of the social good of promoting, maintaining or managing health. As C corporations, their charters demand that they maximize profits for their shareholders. And maximize they do!

The pharmaceutical and medical device industries focus on blockbuster, one-size-fits-all drugs and devices ignoring the inherent variability of human biology and the need for more personalized approaches to medicine. Selling one pill or procedure to all indiscriminately is much more profitable than developing specialized medications for smaller populations or orphan diseases.The result is a never-ending cycle of bad drugs, adverse events and unsafe medical devices marketed heavily and often fraudulently. This cycle leads first to blockbuster profits, then to class action lawsuits and astronomical court awards and fines. The return on investment to shareholders is enormous, even with multi-billion dollar lawsuits.

The insurers, on the other hand, maximize profits increasing premiums while cutting services and denying procedures. Health has not been in the equation for these businesses for some time, although this may change with the new healthcare regulations.

Imagine if companies playing in the healthcare space could codify in their corporate charters a dual role of providing a societal good – health – along with the goal of shareholder profits. Imagine if the mission of providing ‘health’ came with tangible, measurable outcome objectives that were transparent and verifiable. Imagine if the ‘for-benefit’ designation came with a favorable tax structure.

The business climates created by B Corporations could change the healthcare industry in ways our laws don’t currently support. The for Benefit Corporation designation could be a key towards restoring greater fairness and efficacy in our healthcare system.

Put Treatment to the Test

by Elena Perez

Published on August 21, 2012

1764 views

Researchers found hormone replacement therapy caused breast cancer and heart disease; yet this form of preventative treatment was recommended to healthy women for more than ten years, up until testing proved that HRT caused more harm than good.

H. Gilbert Welch, a medical researcher from Dartmouth, recommends putting more money into testing the medical practices and treatment we push onto patients, so that Americans can benefit from healthcare that is tested to be effective.

Currently, only .03% of health care costs go towards researching our health care practices and treatment; Welch recommends increasing it to 1%. We spend so much money on healthcare nowadays that it only seems sensible to make sure our money is going towards medicine that works.

His entire opinion can be read in The New York Times.

Women Eligible for No-Cost Preventive Services

by Elena Perez

Published on August 8, 2012

1614 views

Women are 33% more likely to visit the doctor than men, yet studies have shown that health costs have deterred women from seeking medical attention, even when they are insured. As of August 1, 2012, under the new Affordable Care Act, women can take advantage of certain preventive services without having to pay out-of-pocket costs for new, non-grandfathered private health plans. Keep Reading

Hormones Matter

Where health, hormones, and a whole bunch of other stuff, make sense.

healthcare - Page 2

What if Endometriosis Was a Men’s Health Issue?

Will the Sunshine Act Curb Pharma Payments to Doctors?

Why Is This Important?

What Is the Physician Payment Sunshine Act?

Where the Sunshine Act Fails

What Do Physicians Think About the Sunshine Act?

Will the Sunshine Act Curb Pharma Payments to Doctors?

We Need Your Help

Going off on the off-label trail

Over the Counter Birth Control Pills

Are Oral Contraceptives Safe Enough to be OTC?

Over-the-Counter Birth Control in Other Countries

The Economics of Birth Control

Real Risk Study: Birth Control and Blood Clots

Nevada Receives F in Women’s Health and Reproductive Rights

Put Treatment to the Test

Women Eligible for No-Cost Preventive Services

healthcare - Page 2

Related posts:

You might be interested in

Why Is This Important?

What Is the Physician Payment Sunshine Act?

Where the Sunshine Act Fails

What Do Physicians Think About the Sunshine Act?

Will the Sunshine Act Curb Pharma Payments to Doctors?

We Need Your Help

Related posts:

You might be interested in

Related posts:

You might be interested in

Are Oral Contraceptives Safe Enough to be OTC?

Over-the-Counter Birth Control in Other Countries

The Economics of Birth Control

Real Risk Study: Birth Control and Blood Clots

Related posts:

You might be interested in

Related posts:

You might be interested in

What is a B Corporation?

How Might the B Corporation Solve the Healthcare Problem?

Related posts:

You might be interested in

Related posts:

You might be interested in

Related posts:

You might be interested in