FDA Approves Delays in Labeling Sunscreen Products

Under intense lobbying from the cosmetic and personal care industries, the Food and Drug Administration has wilted and granted sunscreen manufacturers an extra six months to clarify the efficacy of their products in terms of how they are labeled. Originally it was hoped that the new labeling would be in effect for the 2012 summer season with correct labeling required by June 17, 2012.  That has been pushed back to December 17, 2012.

It is widely known that sunscreens with an SPF of 15 or less do not provide total sun protection. The new labeling system was supposed to carry warnings so that consumers do not think they are getting more sun protection than they actually are.

Under the new regulations, manufacturers may no longer refer to their products as “sun block,” “waterproof,” “sweat proof,” or providing “ all day protection”.  If the product is SP15 or greater they may say that the product protects against sunburn, early signs of aging and skin cancer. Sunscreens that meet the FDA’s guidelines and protect against both ultraviolet A and B rays will be allowed to say they are “broad spectrum”.

The FDA claims the extra time was granted to allow testing of each product to determine if the product can justify its packaging claims. The delay was felt to be preferable to pulling products from the shelf in the summer sun exposure season.

Computerized Prescribing and Pain Medications

As part of the government initiative to modernize health information recording and exchange , doctors and health care providers are encouraged (with financial incentives) to prescribe medications using the computer.  This “e-RX” system allows you to send prescriptions to the patients’ designated pharmacy right from your computer screen with a few clicks and turns of your computer mouse controls. The only medications you are not permitted to prescribe are narcotics, controlled substances and pain medications with narcotic contents.

At the same time this initiative is occurring, there is a massive crackdown in the State of Florida on prescribing medications for pain. Sloppy legislation in Tallahassee by the State Legislature led to the opening and growth of “pill mills.”   Drug addicts and suppliers from all over the country routinely travelled to Florida to obtain massive quantities of prescription medications from these fraudulent facilities staffed by criminal physicians. The medications ended up on the streets causing numerous drug and alcohol related deaths around the country.

The “sloppy” Florida State Legislature then attempted to rectify the problem by passing new rules and regulations that closed the “pill mills” with the help of the police and drug enforcement authorities but has frightened the legitimate physician population into not being willing to prescribe for legitimate chronic pain. Their actions included updating physicians’ online profile with the state licensing agency to declare whether you write narcotic scripts for chronic pain or not.  If you reply “yes” you are apparently placed on a list of “chronic pain” prescribing doctors that the public can access as well as the criminal elements looking for doctors to write scripts for cash.

At the same time legislation now requires doctors to take specific courses to prescribe some of the newer pain delivery products necessitating the physician to leave their practice to train on the use of the new medications. The result is that legitimate neurologists and anesthesiologists are shying away from seeing chronic pain patients less than 65 years of age even if they have been referred and have legitimate needs for pain medications.

This brings me back to computerized prescription ordering. If you are trying to track narcotic prescriptions, why prevent the doctors from using the computer to prescribe controlled substances?   What is easier to track and trace, a computerized order or a hand written prescription?   It would seem that computerized record keeping through electronic order entry would be the preferred method of tracking narcotic prescriptions.

Deep Vein Thrombosis Prophylaxis, Safety and the Joint Commission on Accreditation of Hospitals

Over the last few years, great emphasis has been placed on preventing blood clots from forming in the legs and pelvis of all hospitalized patients. These blood clots can break off and travel to the lungs causing life-threatening breathing problems and fatal heart arrhythmias and sudden death. Preventing these “venous thromboembolic events” has been a priority of quality organizations like the Joint Commission on Accreditation of Hospitals which inspect hospitals and offer certification if the hospital meets their criteria.

The movement to prevent these clots and sudden death has become so strong that you cannot admit a patient to the hospital without addressing these issues. Physicians must either choose to give injections below the skin with the blood thinner heparin three times a day or the low molecular weight heparin twice a day. You are additionally asked to prescribe mechanical compression stockings to the legs to further reduce the risk.

If you choose not to institute these orders you must clearly write out and outline your objections and reasons for not taking these measures. Even if you document your reasons for not instituting these measures you’re assured of receiving a call from your hospital’s quality care organization.

This all becomes newsworthy because two recent studies called into question the practices. One study concluded that mechanical compression stockings added nothing to the use of blood thinners in preventing deep vein clots. The other study cited that for every 1000 patients treated with blood thinners to prevent pulmonary emboli; you prevented three non-fatal pulmonary emboli at the expense of causing nine bleeding events – four of which are major.  I suspect this data will be discussed in our medical journals and at scholarly meetings and a consensus opinion will be reached on how to proceed. Letters will be written to journals criticizing the methods of these studies and other letters will be written defending them and, ultimately, a common sense approach will be reached.

In the meantime, it would be far more interesting to look at the Joint Commission on Accreditation of Hospitals and determine how they got so powerful that they can mandate procedures which may not have any value and may do harm?  Who are they?  How do they generate income and how much goes to who and why?

It is a fact that in the state of Florida, private insurers like Blue Cross Blue Shield, Aetna, Humana, will not contract with a hospital or institution unless it receives certification from this organization.  A study should be done to see if these JCAHO inspections costing $7-8 million dollars every other year resulted in any reduction of in-hospital errors, iatrogenic illnesses, death rates and serious illness?

Insurers and employers who pick up the “lion’s share” of our health care costs are always asking for accountability and efficiency and want to pay for what works. It would be nice to know if their relationship with JCAHO has made the patient safer or healthier over the last 15 years.

The 20 Minute Rule

To meet Federal patient satisfaction goals, our hospital administration is requiring community based physicians to give patient admission orders before we have a chance to see the patient. Patients who self-refer themselves to the emergency department, are evaluated by the emergency room staff, and who are determined to require admission must be admitted by their community physician within 20 minutes of receiving a call from the ER staff advising the patient requires admission. In most cases, the community physicians have no idea the patient is actually at the ER until they receive that call.

It is bad medicine to issue patient orders on a patient you have not seen, taken a history from or performed an examination on. To complicate matters, the hospital does not require physicians to actually come in and see the patient for 12 hours after admission.   Think about it, diagnostic and care orders are being given routinely by doctors who have not examined the patient. The doctors then have the latitude to not show up for half a day to actually do an onsite evaluation.

One of the cardinal rules of medical training is you should do a thorough history and exam before constructing a theory of the causes of an illness and instituting diagnostic and therapeutic measures. The local hospital rule is a direct effort of the hospital to control all aspects of patient care for financial gain. They are buying up practices, revamping medical staff bylaws by manipulating the rules and, filling the decision making committees and legislative physician groups with salaried doctors they control.

Hospitals perceive community based physicians who are advocates for their patients as a threat to their financial planning.  The goal is to drive out the community based physicians because they act as a check and balance to the designs of the hospital system working as advocates of their patients. Do not believe for one moment that the goals and aspirations of patients in a community setting are aligned with the goals and aspirations of hospital administration.

I recommend that citizens look into the politics of their local hospital system.  If you do not, you may find that your doctor can no longer take care of you when you are sickest and in need of those professional services provided by someone who knows you well. You may find that you are transported from the ER to the floor quickly but you may not get to see a doctor for half a day.

How should this policy be altered to make sense?  Staff physicians should have 90 minutes to arrive at the ER and assume the care of their patients. In critical life threatening situations requiring immediate intervention, hospital ER staff should be providing stabilizing care until the patient’s care team arrives.

Requiring doctors to give orders on patients they have not seen is bad medicine. Giving those same doctors 12 hours to show up is irresponsible.

Generic Drugs- Small Government and Less Regulation Lead to Lack of a Safety Net in Production

Years ago under pressure from consumer groups, Congress dramatically reduced the time a drug manufacturer could retain a patent on a brand drug.  The patent was reduced from 21 years from release of the product after FDA approval to 7 years from the time development begins. The extremely short window of opportunity to research and develop new medications led to extraordinarily high prices for the new medications. The law met its intended result of encouraging the rise of copy cat less expensive generic drugs.

At the same time under the Reagan Administration, the Food and Drug Administration closed its research and evaluation labs for testing new pharmaceutical products before they can be released to the American public. Under the new laws, pharmaceutical manufacturers now can contract with outside labs to test their products and the reports are then submitted to the FDA for review and approval.  No longer did a drug company have to submit its actual product to the FDA for their independent testing and approval or denial.

The results of these two pieces of government de-regulation was the rise of generic pharmaceutical manufacturing plants in remote regions of China , India and Asia with the most reliable and technologically advanced plants in Israel. Generics needed to prove to the FDA that they possessed 85% of the bioavailability of the brand product in reports generated by contracted labs and sent to the FDA for the products approval.

For years I suggested to my patients that if they could afford the brand name they were best served paying the higher price to obtain a product they knew was produced locally with relatively high standards.  The NY Times on Saturday August 13, 2011 ran a front page article noting that over 80% of generic products are produced in “shadowy” foreign factories that have never ever been inspected.  Several years ago 81 individuals perished because Chinese manufacturers substituted cheaper and tainted products in the making of the anti coagulant heparin. Counterfeit packaging and products originating with the Russian mob proliferate throughout the world market and are difficult for experts to distinguish from the real thing.

It appears that the Obama administration has finally reached an agreement with the generic drug industry for the industry to pay for government inspection of their facilities every few years. The legislation may pass through Congress this fall.

My suggestion to my patients remains the same. If you can afford the brand product purchase it. Know where your pills come from. Demand that your Congressional elected official works to fund the FDA so it can reopen its research and evaluation lab and be the independent agent determining the safety and efficacy of the drugs we are prescribed. Consider extending the length of a patent on new products in exchange for lower pricing on brand name drugs. It’s time to stop allowing only market forces to be watching out for the safety of our medications. That’s like asking the fox to watch the hen house.

Medicare, if you only knew…

The following guest post was written by Aimee Seidman, M.D., FACP.  Dr. Seidman is an award winning internal medicine physician in Rockville, MD, a suburb of Washington, D.C.

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If I could have a penny for every dollar I saved Medicare, I’d be rich. As a concierge physician, my patients can expect advocacy that stretches from the office to the home, hospital, rehab facility, long term care setting, and to the hospice. When I work with a patient, they can expect me to intervene between the various subspecialty physicians or hospitalists involved in their care, spread out my arms in front of them as if ready to take a bullet for them, and defiantly yell “get your paws off my patient until we hear what the plan is”.

How often are x-rays, ultrasounds, MRI’s, cardiac caths, and yada, yada, yada done in patients with a shortened life expectancy, poor quality of life, or clear living will instructions? How often is patient autonomy ignored in the rush to ‘complete work-ups’? Why do we have to work everything up? We need to stop what we’re doing (and stop the cowboys who are shooting from the hip) and think about the patient’s status and whether or not the proposed intervention is appropriate.

The last time I asked one of my 80-101 year olds how aggressively they wanted their medical treatment to be, they said “no way…leave me the hell alone! When my time comes, it comes. Just make a nice party!“  I shudder to think of the feeding tubes inserted and other interventions done in clear violation of a living will, even if that living will is right there with the patient or family members present.

I believe we scare the daylights out of people by telling them all the horrible things that will happen if they don’t consent to treatment plans. But it’s all defensive medicine. “I’ve got to be able to document that I warned them about this horrible death so I don’t get sued”. I suspect non-intervention, comfort measures, and hospice care are rarely offered to families in a way they can hear it. ER doctors and hospital physicians are just doing their jobs-they want to ‘save lives’ (or at least keep them alive until the next shift) and the primary care doctor is never consulted.

What do people think we do, order mammograms all day? Those of us in concierge medicine who have close relationships with our patients know them and their families well enough to expedite decision-making in a way that is medically and ethically appropriate. The whole point of my concierge practice is to first, do no harm (remember that?), allow my late stage Alzheimers disease patient to have a dignified death, and not spend millions of dollars on unnecessary procedures.

Not only that (I’m almost done), if all primary care physicians and the health care community made a conscious effort to inquire about living wills, explain the subtleties, and respect the choices made, fewer people would use ambulances, go to the ER, stay in the hospital, etc.

The other piece to this is the education of families regarding end of life issues, preparation, ethics, and closure. As it is, families deal with guilt, sadness, confusion, and anger when called upon to make these tough decisions or to respect an established living will. Most of us have seen families reluctant to honor a living will because they can’t bear the thought of letting grandpa starve to death.

If consulted about these decisions ahead of time, much of the combat will not occur. So how much have I saved Medicare by avoiding all this unnecessary stuff? Tens of thousands of patients, times a fortune of money, equals a boatload of bucks.

So, do you want to know ways to fix health care?

1.      Tort reform so docs aren’t so paranoid and aren’t playing “cover-your-butt medicine”;

2.      Docs, shut up and listen to your patients;

3.      Stop insulting the community of doctors who want to practice medicine in a particular model labeling them elitist and focus on things that will work (and by the way, most of us have scholarship patients, indigent patients and perform community service);

4.      A national campaign to educate consumers about the importance of living wills and have discussions over details, including family members in the discussion;

5.      Make it clear to the medical community that honoring a patient’s autonomy in the form of an advance directive is their obligation under the law

6.      Do no harm.

Just listen to me and give me a penny for every dollar I save Medicare, then I’ll really be rich.

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Please note, the opinions expressed in this guest blog post are those of Dr. Aimee Seidman, founder of Rockville Concierge Doctors.

Who Says Concierge Practice Is Unjust For Patients And Doctors Alike?

Medscape Medical Ethics published an article in August 2011 written by Art Caplan, PhD., Professor of Bioethics and Philosophy at the University of Pennsylvania claiming that Concierge Practice Is Unjust For Patients And Doctors alike.  A PDF of the article is attached for your review.  Concierge Practice Unjust For Patients and Doctors Alike by Art Caplan, PhD.

I am in disagreement with Mr. Caplan’s article.  Below is my perspective.

Like the shots fired at Concord and Lexington in 1776, concierge medicine and direct pay practices are the initial shots fired by concerned primary care physicians in the revolution against health care systems which limit access to physicians and destroy the doctor / patient relationship. Concierge medicine arose as a result of government, private insurance, and employer intrusion into the health care field destroying primary care and a physician’s ability to spend the time required with patients to adequately and comprehensively prevent and treat disease.

The only thing that is unjust or unethical about concierge and direct pay practices is that they had to be formed to begin with. They formed after 30 years of:

  1. Primary care doctors lobbying unsuccessfully for adequate compensation for evaluation and management services and for protesting the widening gap between cognitive services and procedural specialty practices.
  2. Going through channels protesting the unfair bureaucratic and administrative burdens placed on primary care practices by Medicare, Medicaid and private insurers.
  3. Warning that the population is aging and their chronic health care problems are far more complex requiring more time with a physician rather than less.
  4. Primary care physicians leaving medical practice for early retirement or for paid jobs with pharmaceutical companies, medical device manufacturers and hospital administrations where hard work and achievement were rewarded without having to deal with system imposed overheads of up to 65 cents on the dollar.
  5. Legislators providing no relief from frivolous lawsuits which makes seeing complex patients in 5-10 minute sessions for “single problem directed visits” a legal liability.
  6. Medical students realizing that the time and financial commitment to the practice of primary care medicine didn’t cover the bills essentially directing them toward more lucrative procedure dominated specialties.

Physicians also left after salaried academic physicians, who never took risk and invested a cent of their own money in building a practice, pontificated and moralized in peer journals supported wholeheartedly by biased pharmaceutical company ads that generating passive income through shared labs and imaging centers was a kickback.

If we look at the data accumulating on care from concierge and direct pay practices, we find that despite a sicker patient population these practices generate fewer visits to emergency departments and fewer acute emergent hospitalizations saving the system money.  These practices provide coordinated care for their patients steering them through a complex and confusing health care system riddled with inappropriate advertising and claims and, get the patients to the best people to treat their problems.

Concierge physicians have more time to spend with their patients thus, achieving unheard of levels of retention and patient satisfaction while giving pro bono scholarships to patients who cannot afford their membership fees but were with them prior to their conversion to a retainer model.

After years of being on the conveyor belt of having to see more patients per day, every day, to stay abreast of system generated overhead cost increases and declining payment for services, concierge physicians now have time to teach students, volunteer at health fairs and screenings and participate in the stewardship of what remains of their profession.

If anything is unjust and unethical it is salaried academic non-physicians writing articles about morality and justice about issues they have no hands-on experience practicing. As a primary care physician for 32 years, I feel like a chameleon having to change colors and practice style every few years based on new rules imposed by private insurers, employers and government programs. At no time were these new rules designed to improve the patients’ access to care or total care.  In each case the new rules were designed to save money and do nothing else.

Concierge and direct pay medicine is the first volley in a revolution to take outstanding care of a smaller panel of older sicker patients on a long term basis.  Its proponents have worked hard for decades to change the system through channels. Failure of legislators, government bureaucrats, health insurers, employers and professional associations such as the AMA and the ACP to react and fix the inequities has generated these practices which cost less than a cup of Starbucks grand latte per day to be a patient of and provide comprehensive care and access.