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.

Strolling After Dinner Wards Off Peripheral Arterial Vascular Disease Risk

Healthy lifestyles with excellent food choices and regular physical activity have been encouraged as the secret to a long and healthy life for years.  The U.S Department of Health and Human Services has promoted and encouraged every adult to get up to 90 minutes of exercise per day to stay healthy.  This type of time commitment is difficult for many active working adults to achieve.

In an article published recently in the Journal of Vascular Surgery, Stanford researchers point out that you just might be able to protect yourself against peripheral arterial vascular disease with a much more modest evening stroll. They noted that “a lifetime of even light exercise not only protects the heart but also the legs, reducing the risk of peripheral arterial disease (PAD).”

According to John P. Cooke, M.D., PhD of Stanford University Medical Center, a sedentary lifestyle predicted a 46% higher risk of peripheral arterial disease compared with a lifetime of recreational activity of any intensity. The biggest gains in PAD protection came in people who went from virtually no physical activity to minimal activity. “Even light activity, such as strolling, is enough to protect against PAD.” According to Dr. Cooke “ Get up off the couch, go for a walk, and you will be less likely to have problems in the future.”

Cooke and his group at Stanford looked at 1,381 patients and noted that inactive patients were nearly twice as likely to have PAD as those who had active lives. While inactivity is a risk factor in developing PAD other controllable risk factors exist and should be modified. These would include tobacco use, elevated blood sugars and elevated triglyceride levels. Once individuals develop narrowing of the peripheral arteries producing pain on exertion called claudication, their activity becomes limited by the pain.

The message is clear.  Stop smoking and start walking – even if the walk is a slow relaxing stroll.

A Physician’s Call for Help – Rewarded by the Best Payment of All

My wife and I were sitting down to an uncharacteristically late dinner for us Friday at a local eatery when my cell phone rang. Caller ID identified it as Dr David Rosenberg, a family physician practicing concierge medicine about one hour north of my home in Jupiter, Florida.  We had not spoken in months and after some pleasantries and catching up he said, “Steve I just saw a story on the TV News that there is a back to school community fair in Pearl City in your community tomorrow morning and the doctor they had counted on to perform the required school exams for new students had cancelled due to a personal crisis.

Dr. Rosenberg wanted to know if I would join him for a few hours at the Wayne Barton Learning and Community Center and perform the physicals. He told me he had phoned fifty physicians and no one had yet agreed to come. He was prepared to do them himself.  I gave my wife that “duty calls” look and she nodded back approvingly and I told him it would be my pleasure. I agreed to meet him at 10 a.m. at the center.

Wayne Barton is a former City of Boca Raton police officer who is now a community leader and activist. He created a nonprofit agency and, with generous philanthropic support, has built an educational and community center for students from poor homes. He provides year-round learning and tutoring for students and has an annual “Back to School Jam” where new students receive the required school physical plus receive backpacks filled with school supplies that their working parents have great difficulty affording.

Mr. Barton greeted me at the entrance as I walked in and thanked me for coming on short notice. The regular physician who cancelled due to a family crisis has been volunteering for years and is my personal friend, mentor and is my patient. Trying to fill in for him is a tall order and made the experience even more special for me. Dr. Rosenberg, who organized this last minute physician participation, was there as well and with him were two other concierge physicians and a wonderfully warm physician’s assistant.

For the next several hours, with the help of a large dedicated volunteer staff, we saw numerous lovely children with their families. A mother and her high school age daughter and son, who had escaped the ravages of the earthquake in Haiti, were among the first.

A young woman and her two children who had escaped Communism and Castro’s Cuba nine months ago came through my station.  I saw a young man with lead poisoning requiring treatment and follow-up and another lad who wanted permission to play football despite the jaundice in his eyes tipping me off to his history of sickle cell anemia that he had conveniently left off his form.  I was able to stay for three of the four hours and I received the best payment of all – beautiful smiles, blessings from several and a thank you from all.

The degree of appreciation coupled with the level of need leads me to believe it’s time to discuss with Mr. Barton a regular free clinic at the center.

Once last thought, I couldn’t help but notice that the physicians who responded to the call for help were all practicing in a concierge medicine model.

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.

Hospital Administration: Spending Your Tax Payer Dollars / Shorting You on Benefits

Last summer my 86 year old father awoke in the middle of the evening with profuse rectal bleeding. He felt weak and dizzy and called 911. The paramedics transported him to the local emergency room at a hospital close to his home – about one hour south of my home.

I call my parents daily to check up on them and learned of the trip to the hospital during one of these calls.  Mom is 84 and wheelchair bound with multiple structural and cardiovascular issues. Dad is 86, a WWII decorated paratrooper with dementia and orthopedic issues that dwarf his other chronic problems. They have an aide for several hours a day that is the glue that holds their lives together in their own home.

No one was home when I called and of course my folks had their Jitterbug senior special cell phone turned off so they were unreachable.   I left several messages and finally about 8:00 p.m. my mom answered the phone, denied that the cell phone was turned off, denied that I had left any messages on her answering machine and told me that dad was in the ER at Memorial Hospital. Her description was quite vague as to what was going on but I did learn that their long-time physician was unavailable and the hospitalist service was caring for him.

I phoned the ER and spoke to a nurse who was nice enough to tell me that he was stable and they were holding him for observation. He had not yet required blood transfusions and they did not know the exact source of the bleeding but he was still in the emergency department and comfortable.  I drove down that evening and saw dad in the ER. The next evening, unable to find his doctor, I drove down as well and saw dad in his hospital room on the medical floor.  He was weak but in good spirits.  I left a note with his nurse to please ask his physician to call me at his convenience and left my office and cell phone numbers.

Two days later I received a phone call from his long-time physician, who had returned from visiting her family to explain what was going on. She said that his gastroenterologist had been in to see him and he was doing well. The next day after some “tests”, dad’s liquid diet was advanced to a soft diet.

At 5:00 p.m. I received a harried phone call from my mother. She told me that dad was being discharged immediately and that if they stayed longer Medicare would not pay for it and my folks would be totally responsible for the bill. Dad had been in bed for four days, had not walked the halls, had not showered or washed himself and had not yet had a bowel movement since admission.

As a board certified geriatrician I realize the importance of these benchmark pre-discharge steps being achieved BEFORE you send a patient home.  It was too late for dad who was out the door and home.   His aide was upset because she leaves at 7:00 p.m. and she felt dad was too weak to get out of bed and walk to the bathroom without falling. I hired a night nurse and put in a call to his doctor.  I demanded that he be evaluated for a stay in a rehab facility until he was able to ambulate or at least send in a physical therapist to help him regain his strength and ability to walk. A few days of bed rest completely de-conditions most senior citizens and the complications of falls, and their prevention, must be addressed to prevent a bad situation from becoming worse.

His physician told me that “he did not meet criteria for home health assistance or rehabilitation stay” because he had been in the hospital for less than three full days.  I was astonished. He had been in the hospital for five to six days by my count.  She told me his first two days in the hospital were not as an admitted inpatient but as an outpatient observation.   By discharging him at 5:00 p.m. he had missed being an inpatient and qualifying for benefits by several hours.

Outpatient observation status is a game hospital case managers and administrators play to bill more money. When a Medicare senior citizen is admitted as an inpatient the hospital receives a bundled total payment based on the diagnosis or DRG.  If the patient is kept in observational status the hospital is no longer limited to receiving a flat rate but can unbundle the charges and bill ala carte for each service rendered.

The Center for Medicare and Medicaid Services (CMS) in its 12/03/2009 bulletin on page 3 defines outpatient observation services as “the use of a bed and possible monitoring by nursing or other ancillary staff, which are reasonable and necessary to evaluate the patient’s condition for possible inpatient admission.”   The decision as to inpatient admission status or observational status is supposed to be made by the patient’s doctor.  The problem is that is as far as it goes. No one at the CMS level has actually delineated criteria for an inpatient or traditional admission or for outpatient observation.

At the hospital level, administration now places a document on each patient chart requiring the physician to defer that decision to the hospital employed case manager who is not a physician. Over the years, hospital administration has diminished the political power of the individual physicians and medical staff to be advocates for their patients by destroying the medical staff bylaws and infiltrating medical staff governing bodies with physicians loyal to, and employed entirely by, the hospital.

The result is a tremendous conflict of interest with no one watching out for the patient.  The hospital then controls the rules and regulations and can even bully staff members into relinquishing decisions on admission status to the hospital employees rather than the patient’s physician.  One of the reasons hospitalist medicine has become so popular is that hospital administrators love the idea of controlling the physician side of care, something that acted like a “check and balance” in favor of patient advocacy when physicians were independent.

I bring this up because at my community hospital, where I care for my patient’s administration, is now attempting to influence doctors to give up the decision-making on admission and cede it to their case managers as well. A note was sent to the entire staff instructing us to not admit patients who do not meet “interqual” criteria for admission but to let their case managers assign them to observational status.

When I inquired about what interqual criteria were, and where “interqual” criteria were listed in the CMS bulletins or Federal Register, I was told they did not exist there.  Once again the fox is watching the hen house.

In these times of deficit spending and economic crisis hospitals are using our tax dollars to bill ala carte at a higher level and limiting senior citizens right to qualify for necessary post-hospital rehabilitative care by making much of their hospital stay “ observational” as opposed to traditional inpatient status.

I wrote a letter to Memorial Hospital about my dad’s stay and asked to see their criteria for inpatient admission.  Just like my local hospital could not produce criteria, neither could Memorial Hospital. I wondered how a frail 86 year old, dizzy, bleeding rectally and on anti-platelet agents to prevent clotting did not meet criteria for hospital admission?  I received a phone call from the Chief Medical Officer at Memorial Hospital months later saying he had reviewed my dad’s case and he was comfortable with their decision-making.

The issue needs to be addressed by patients, family members, legislators and concerned physicians. Hospital administrations are bullying physicians into relinquishing their advocacy and decision making so that they can charge more using the observational status rather than the inpatient admission status. By using this technique the patient does not meet the three day minimum hospital stay to provide post hospital care and treatment paid for by Medicare and the patients supplemental insurance policies. Once the patient’s personal physician relinquishes decision-making power to the hospital employees, they have created a conflict of interest which, if left unaddressed, will raise health care costs and affect quality of the patient’s care.