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Posts Tagged ‘medications’

Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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Here is the latest press release from DrScore.com …

DrScore.com’s Four Friendly New Year’s Resolutions to Improve
Your Health and Patient Satisfaction

These resolutions for doctor visits are easy to keep!

WINSTON-SALEM, N.C. (December 28, 2010 ) — Eat five servings of fruits and vegetables daily, exercise longer, lose weight … it’s time to make those annual New Year’s Resolutions. This year, the patient satisfaction and online doctor rating website DrScore.com suggests a few resolutions to improve your health and patient satisfaction — and these resolutions are easy to keep!

 

“One way to improve your health is to have a better relationship with your physician or health care provider,” said patient satisfaction expert Steve Feldman, M.D., founder of DrScore. “We want patients to make resolutions to empower them so they can be better advocates for their own health and well-being.”

 

Resolution No. 1: Bring a list to doctors’ appointments. Having a written list of all your medications, your past illnesses, your current problems and your questions with you every appointment provides vital information the doctor needs and helps you remember the questions you need answered. “By listing your problems, concerns and questions, you will be better prepared for your visit with the doctor, and the visit will go much more smoothly,” said Dr. Feldman. “Don’t be afraid to ask any questions. Doctors appreciate patients who have organized their information and have done their research.”

 

Resolution No. 2: Speak up. If you are unsure about a situation, speak up and ask about it. “Doctors and medical office staff should be keeping you informed about what is going to happen during the office visit, what tests are being run, etc.,” Dr. Feldman said. “If you feel like you don’t understand something, are unsure about what is happening or are upset about how you are being treated, speak up and try to address the situation in a positive, non-threatening way.”

 

Resolution No. 3: Get written instructions. At the end of the visit, make sure you have written instructions on medications and treatment plans, and find out how and when you will get results from any tests. “The end of the visit is a critical time where the doctor writes prescriptions, gives you the best advice on how to take care of yourself or treat your illness, and talks about test follow-up,” Dr. Feldman said. “The details of medical care are common knowledge for the doctor, but it may be new information for you. Ask for your treatment plan in writing so you don’t forget anything.  Missed test results can also cause problems, so make sure you are proactive in finding out how the office will get the results to you.”

 

Resolution No. 4: Give your doctor feedback. Take the time to let your doctor know how the visit went either by telling him or her, communicating to the office staff, writing a letter or participating in an anonymous patient satisfaction survey at DrScore.com. “Don’t ever be afraid to give your doctor advice on how to be a better doctor,” said Dr. Feldman. “When you give your doctor feedback — whether it is positive or negative — you are giving them a gift. And then your doctor will know what New Year’s resolutions he or she needs to make to be a better doctor!”

For more information on patient satisfaction and improving your visit to the doctor, check out “Great Medical Care: The Handbook for Making Your Visit to the Doctor Better,”, written by Dr. Feldman. Or, visit the DrScore Blog, Thoughts on Patient Satisfaction.

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Apparently there are senators from both parties seeking to remove a ban on generic drug settlements from an upcoming appropriations bill. The proposal would stop brand-name drug makers from making deals with generic manufacturers to keep generics off the market.

I’m not sure why we would need such legislation. That kind of deal sounds like the kind of collusion that should be impermissible under competition/anti-trust law.

Here are some of my other blogs on generic drugs:

It’s unfair to keep generics off the market

Pay for delay in generic drugs isn’t good for the patient


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One of the great joys of medicine is seeing patients get better. One of the greatest frustrations is seeing patients not improve as expected with treatment.

One of the biggest problems in medicine — one that causes patients to suffer and that increases the cost of care — is that patients don’t take their medications as recommended.

A research group in Massachusetts studied how well patients with eczema take their medications and whether text messages could increase patients’ use of the medicine.  The researchers found that the text messages did increase patients’ use of the prescribed treatment.

People can improve the effectiveness of our health care system just by doing a better job taking their medications.  Hopefully, the new, inexpensive electronic technologies can help patients do that.

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The pharmaceutical company Merck sent me a letter describing Merck’s upcoming efforts to implement greater transparency in their business.  This will include public disclosure of payments to physicians who speak on behalf of Merck.

This, and similar programs started by other pharmaceutical companies, is most welcome.  I think it is only fair that patients know if their doctor is taking money from drug companies.  This way, patients will get to see if their doctor is considered a cutting edge expert whose advice is sought by companies and by other physicians. It also will give patients a sense if they should be at all concerned about whether their doctor’s decisions are influenced by company relationships.

This hot topic is the subject of another Getting Better Health Care radio program, in which I interview Dr. Guy Chisolm, Director of the Innovation Management and Conflict of Interest Program at the Cleveland Clinic.


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Investigators have found that pharmaceutical company sponsored drug studies are more likely to find positive results compared to government funded studies (Bourgeois FT, Murthy S, Mandl KD. Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Ann Intern Med. 2010 Aug 3;153:158-66.).

The authors couldn’t conclude whether this was good or bad. Does it mean that the drug companies inject an element of bias into their studies, or perhaps does it mean that they are more careful with their research dollars, using their funds to support studies they deem are highly likely to be successful?  Or does it mean they are doing follow up studies to expand the use of products that are known to be effective?  Are they funding studies of their drugs for conditions for which physicians have determined there seems to be efficacy?

The government studies show success much less commonly.  Is that bad?  Or does it mean government is taking on more risky studies in the hopes of finding new treatments for conditions for which there may not be good treatment?
This study does show that published drug studies by industry are more likely to show positive results, but I’m not sure we should make much of it.

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Sometimes, there is  not one right answer to the problems faced in medicine (or in any other field).  For example, we want drugs that have awesome efficacy.  We want drugs that are extremely safe.  We want drugs that are affordable.  It’s not likely we’ll get all three (or even two of the three) at once.

Providing the best information about prescription medications to patients is another conundrum.  As pointed out in a recent publication (Winterstein AG, Linden S, Lee AE, Fernandez EM, Kimberlin CL. Evaluation of consumer medication information dispensed in retail pharmacies. Arch Intern Med.  2010;170:1317-24), the law requires that most prescriptions be accompanied by useful written consumer medication information.

But what does “useful” mean exactly?  Putting together a “useful” handout that is readable and has the basic information is certainly going to help patients, but it is also presents a risky situation for the manufacturer.  Of course “useful” information includes material that is understandable and necessary to understand and correctly use the medication.  But should every side effect be included?  Where do you draw the line between side effects that are common and those that are too rare to include?  And if you do exclude any, how would patients feel if they developed a known rare side effect that was left out of the brochure?

National Public Radio quotes Joe Graedon — a pharmacologist, host of the People’s Pharmacy and an expert on practical drug information — as saying that there are only a few key things people really need to know about their drugs:

  • how to take the drug
  • the most common side effects
  • symptoms to watch out for and what to do if they happen

That’s sensible advice.  However, there are many of lawyers out there — you’ve seen their ads on TV.  With so many of them around, how will people justify excluding information for patients  about even the rarest of risks, and making the brochures so long and so technical that they are no longer considered “useful?”


Note: I have been a big fan of  Graedons’ Peoples Pharmacy program for years and have been a guest on the show a few times.  You should check it out here. It is a terrific medical resource.

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Our health care and patent system is designed to give pharmaceutical companies strong financial incentives to develop new drugs. The system is also set up for innovative products to go generic after a time. This makes those products inexpensive. There’s concern, though, that some companies may collude to keep generics off the market. This could happen if the innovator company pays generic manufacturers not to market a product.

There’s something that just doesn’t sound right about that. Congress is working on legislation to stop the practice, and the House has approved legislation to restrict the ability of companies to enter agreements that keep generic medicines off the market. (U.S. House Approves Restrictions on Brand-Name Drug Agreements,).

Innovator companies and generic manufacturers may have disagreements on when a drug should become available as a generic. These disagreements can lead to litigation. Ideally, the solution to those disagreements shouldn’t be deals that pay off generic companies to keep generic drugs off the market.  Deals like that don’t help patients.


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Representatives from pharmaceutical companies are continually visiting my office bringing new, ever more generous, “copayment assistance cards” designed to make drugs more accessible.  Insurers often require patients to pay a significant share of the cost for brand name medications. These patient costs can be very high. Pharmaceutical companies are helping patients have easier access to these medications by helping pay those co-payments.

But here’s the problem. The point of the copayment is to help steer patients to lower cost alternative treatments. These copayment assistance programs not only help patients get access to expensive drugs, they eliminate the incentive to choose more cost-effective medications. Without such incentives, pharmaceutical companies don’t have to compete on price.

While I love the idea of my patients having lower cost access to drugs, I am concerned that eliminating the incentive to choose cost effective treatments is going to hurt all patients in the long run through higher drug prices.  While insurance companies are paying for those drugs, the money insurance companies use doesn’t grow on trees, it comes from patients’ pockets. It should be clear to everyone that a copayment assistant card that helps the patient “get the medication for free” doesn’t do that at all; it just means that we’re all paying for it.

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