Pumped Up about Promising new Parkinson’s Pump

parkinson-disease60Parkinson’s disease, as many of our readers know is a chronic, progressive neurological disease that causes sufferers to lose control of body movements, resulting in tremors, muscle stiffness, loss of balance and a host of other problems. Currently, there is no cure for Parkinson’s disease and treatment options are limited. Therapy is directed at treating the symptoms that are most bothersome and for this reason, there is no standard or “best” treatment for that applies to every patient.

Treatment approaches include medications and surgery (deep brain stimulation) as well as general lifestyle modifications (rest and exercise), physical, occupational and speech therapy.

levodopaAmong the drug-related therapies, levodopa is considered one of the most effective for relieving the symptoms of Parkinson’s disease. It helps reduce tremor, stiffness, and slowness and helps improve muscle control, balance, and walking. Levodopa does not slow the disease process, but it improves muscle movement and delays severe disability. So far, levodopa, which had been used to treat Parkinson’s since the 1970’s, has only been available in pill form.

But a new Cleveland Clinic study finds that using a pump to administer a gel form of levodopa directly into the small intestine is much more effective.

Neurologist Hubert Fernandez, MD, who led the study, says, “The levodopa pump decreased or improved what we call the ‘bad time’ in Parkinson’s patients by up to four hours per day.” The levodopa can control this ‘bad time’ — the tremors, muscle spasms and other movement disorders that makes it difficult for Parkinson’s patients to function on a daily basis.

parkinsons-gel-drug-pump-190x155This is an amazing finding,” says Fernandez. “We know of no other oral therapy that will improve the bad time in Parkinson’s by an average of four hours daily.”

The levodopa pump is external. It sits in a pouch under the patient’s shirt and provides a steady dose of the drug. The levodopa gel is administered directly into the small intestine, where most of the drug is absorbed. The constant dose makes the body’s movements more controlled and predictable, making it easier for people with the disease to plan and go about their day without worrying that the drug’s effects will wear off.

The biggest advantage of the levodopa is its efficacy,” Dr. Fernandez says. “We’re trying to deliver it on a continuous basis so the patients don’t need to take it every hour.” parkinsons gel pump

69-year-old Bob Van Housen has been living with Parkinson’s disease for over 12 years.  Prior to enrollment in the study he was having to take up to five levodopa pills every three hours to control his symptoms. Even then, his symptoms progressed to the point where it was hard to keep up.  “He was ‘off’ for at least seven hours,” said Van Housen’s wife, Carol. “Seven hours is a long time to not be able to function every day.”

The couple often had to cut their trips together short and limit their social outings outside of the house. Van Housen says that being part of the trial at Cleveland Clinic has been life-changing. “We can predict better how I’m going to feel and how I’m going to act and can plan trips and work around those times when I otherwise would have been problematic.”

The gel pump which is not yet available in the United States is currently under review by the Food and Drug Administration. Let’s hope it doesn’t hit any hurdles along the way, so others with Parkinson’s can avoid the roller-coaster of symptoms and enjoy the type of benefits that Bob has experienced.

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Pharma Under Fire for Fair Balance Failings

Unfair balanceUh oh! Seems like the Pharma industry is in trouble again.

Research published in the Journal of General Internal Medicine suggests that family physicians receive “little or no information” about adverse effects associated with medicines in the majority of drug promotions made by sales representatives.

In the study, 255 family doctors from urban practices in the US [Sacrameto], France [Tolouse] and Canada [Montreal and Vancouver] answered questionnaires following visits from sales representatives.  The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).

The findings showed that sales representatives did not provide any information about common or serious side effects, or identify the patients who should not be using the drug, in 59% of the promotions. In Canada, no potential side effects were mentioned for 66% of promoted products, according to the results.

yes no riskThe researchers also indicated that although 57% of the promoted drugs carried boxed warnings from the FDA or Health Canada, serious adverse events were only discussed in about 6% of the sales pitches.

Félicitations to the French reps who provided information on harm for 61% of the promotions, compared to only 34% in Canada and 39% in the US.

Despite this lack of “fair balance” overall, the doctors considered the quality of the scientific information to be good or excellent for 54% of the promotions and indicated that they would be willing to prescribe the drugs 64% of the time.

Laws in all three countries require sales representatives to provide information on harm as well as benefits,” says lead author Barbara Mintzes, Assistant Professor at the University of British Colombia. “But no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”

Despite widespread belief by physicians to the contrary, the information provided by pharmaceutical sales representatives has been shown to influence prescribing. Greater exposure to promotion is associated with higher prescribing volume and costs.  And while regulations in all three countries require sales representatives to provide information on the risks as well as the benefits of their drugs, there are differences.  It’s interesting, to correlate the above results with the fact that that France has the strictest information standards, whereas Canada relies on industry self-regulation.

However, across all three countries, the results of this study would appear to question if current approaches are adequate to protect patient health.

The Pharma Industry should take note.  Time to clean up your act before the Government and Regulatory Authorities do it for you.

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Ugly Shades of Gray

Ever thought you were paying too much for your meds?

A new report just released by the US House Committee on Oversight and Government Reform’s entitled  “Shining Light on the Gray Market” has examined the how’s and why’s of this.

The House staff investigation examined a group of companies that buy and sell prescription drugs used by hospitals and other health care providers. As SRxA’s Word on Health has previously reported, over the past several years there have been a growing number of supply shortages of prescription drugs. Operating outside of authorized distribution networks, “gray market” companies take advantage of these shortages to charge exorbitant prices for drugs used to treat cancer and other life-threatening conditions.

These companies’ questionable business practices put patients at risk and cost the US health care system hundreds of millions of dollars each year.

Here’s how it works. During drug shortages, hospitals find themselves unable to buy drugs from their normal trading partners – usually one of the three large national “primary” distributors, AmerisourceBergen, Cardinal Health, or McKesson.

At the same time, hospitals are deluged by sales solicitations from gray market companies offering to sell the same drugs for prices that are often hundreds of times higher than normal.  Not surprisingly, hospital pharmacists want to know why the hospitals can’t get these products but the ‘scalpers’ can.

The drug pedigree documents reviewed in the investigation show that some short-supply injectable drugs do not reach health care providers through the manufacturer-wholesaler distributor-dispenser chain.  Instead, these drugs leak into gray market distribution networks, in which a number of different companies – some doing business as pharmacies and some as distributors – buy and resell the drugs to each other before one of them finally sells the drugs to a hospital or other health care facility.

And this is not happening at nights, in dark alleys.  In 69% of the 300 drug distribution chains reviewed, prescription drugs leaked into the gray market through pharmacies. Instead of dispensing the drugs in accordance with their professional duties and state laws, these pharmacies re-sold the drugs to gray market wholesalers. Some pharmacies sold their entire inventories into the gray market. The wholesalers in turn sold the drugs, usually at significant markups, to other gray market companies.

As the drugs pass through these gray market distribution chains, they are significantly marked up, sometimes to prices that are hundreds of times higher than the prices that hospitals and other health care providers normally pay. The markups in these chains often bear no relation to the companies’ cost of purchasing, shipping, or storing the drugs. Instead, they reflect an intent to take advantage of the acute demand for short supply drugs.

In the example above, each company in the chain marked up the meds, even if they never took physical custody of them. The hospital that purchased the drug ended up paying $600 per vial for a drug that a pharmacy had purchased for $7 per vial.

Hospitals say they have no choice but to pay exorbitant prices for short-supply drugs because they need to take care of their patients.

Carmen Catizone, executive director of the National Association of Boards of Pharmacy has called for federal legislation to control pharmacies that are re-selling drugs on the gray market.

We need to take some steps to remove pharmacies’ ability to act as wholesalers, in the way that they are. The end point of these transactions should be to patients and not to wholesalers,” Catizone said.

While some of the pharmacies that are selling drugs on the gray market are not necessarily doing anything illegal, according to Catizone it is a moral and ethical issue. “There are provisions in state laws in which pharmacies can wholesale up to 5% of their product. The intent was that, if you have a situation where a pharmacy runs short on a product, they can buy it from another pharmacy or wholesaler for that patient. They are violating the intent of those laws, morally and ethically.”

Well said, Mr. Catizone, well said.

Prescription Abandonment

You get sick, you go to the doctor, he or she writes you a prescription for some pills, you take it to the pharmacy and then…   Logic would suggest that the next steps would be that you pick up the prescription, take the medicine and get better.

Well, not always.  According to a new study published in the Annals of Internal Medicine almost 2% of these prescriptions are never picked up.

Using databases from a large retail pharmacy chain and a pharmacy benefits manager, researchers examined factors associated with prescription abandonment over a 3-month period.

Unsurprisingly, drugs with high copayments are the most likely to go unclaimed.  Prescriptions with copayments of $40 to $50 and prescriptions costing more than $50 were 3.40 times and 4.68 times more likely, respectively, to be abandoned than prescriptions with no copayment.

In addition, electronic prescriptions were 1.6 times more likely than non-electronic prescriptions to be left behind, and new prescriptions were almost three times more likely to be abandoned than previously filled prescriptions.

Interestingly, young adults were more likely than older patients to abandon their prescriptions, while opiates and anti-platelet agents were the least likely to be left behind.

Although the accompanying editorial called the low rate of abandonment “reassuring,” they suggest that physicians “remain mindful that costs are an important barrier to adherence and should aim to prescribe or recommend less expensive alternatives whenever feasible.”

SRxA’s Advisors can help pharmaceutical companies increase medication compliance and implement programs to lower the consumer cost of prescription drugs. Contact us today for more information.

Putting an “i” in adherence!

Poor adherence to medications has been a bugaboo in the healthcare system for a long time. When sick patients don’t take their meds, they often get even sicker and end up in the hospital.  According to the New England Healthcare Institute, patients who don’t take their medicine when they’re supposed to cost the U.S. healthcare system a mind-boggling $290 billion per year.

This problem caught the attention of entrepreneurs from MIT and physicians affiliated with Harvard Medical School and has led to the creation of several innovative solutions. Among these is an electronic pill box called “Maya” that uses wireless technology and sensors to alert patients with chronic diseases when they don’t take their pills on time.

Another medication-reminder technology is GlowCaps.  These “intelligent” caps fit onto standard pill bottles and use light and sound to signal when it is time to take a pill. They also sense when the bottle is opened and wirelessly relay their status to a secure network. If the bottle is not opened after two hours, the user is automatically reminded with a telephone call.  Additionally, each week, a report summarizing progress is emailed to the user or care-giver. The caps can even call with refill reminders and connect the patient to their pharmacy as pills deplete.

Other solutions include iPhone apps such as MediMemory.

One company has even developed pills that deliver wireless signals after they are swallowed.

Even though such systems have shown to be effective, there’s still a question of who should pay for the technology. “The way that the economic models are currently set up,” says Joseph Kvedar, director of The Partners Healthcare Center for Connected Health , “it’s the patient’s responsibility to take their medication, and nobody will give them a cash subsidy to cover a program like this.”

Given that costs increase dramatically when patients don’t take their drugs, Word on Health suggests it’s about time insurers started paying attention to initiatives such as this.

In the meantime, SRxA’s Health Outcomes group are standing by to help pharmaceutical companies improve patient adherence to their drugs.  Contact SRxA for more information.

A Drug by any other name?

Your friendly SRxA Bloggers are keenly aware of the increasing scrutiny of all aspects of pharmaceutical marketing, but a recent criticism by a fellow blogger seems especially troubling to us.  Barry Silverstein of  On the Button claims that pharma companies are hiding disclosure about side-effects behind brand names that hint at their possible indications for use.

Why is he so rattled by drugs with clever and attractive sounding names? After all he works for a naming, strategy and branding company that in its own words “has a  knack for coming up with names that are provocative and human”.

What is so heinous about Flomax or ProAir?  Are they any worse than “Pooch Punch” – the name for a canine electrolyte drink (seriously?!?) dreamed up by Silverstein’s agency?

His objection to the names Cymbalta,  Lyrica, Chantix, Levitra and Spiriva  are beyond us.  His insinuation that the use of these names is nothing but a ruse to circumvent FDA regulations is even more puzzling.

As he himself points out, the pharmaceutical industry in already riddled with marketing land mines.

Please, Mr. Silverstein, let’s not add another.