Posts Tagged ‘generic drugs’

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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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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While drug companies make the innovative products that help improve and save lives, these companies also get a bad rap. Pharmaceutical companies are responsible for modern-day medications that let doctors work miracles. Is there a downside, too?

To understand the industry perspective, I spoke with Lori Reilly, Vice President for Policy and Research at the Pharmaceutical Research and Manufacturers of America (PHRMA) on Getting Better Health Care.

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Campaign finance legislation failed to pass the Senate today.  Last year, U.S. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) introduced legislation to require drug companies to publicly report money they give to doctors over $100 every year.

This is a wonderful idea. Greater transparency helps everyone.  At DrScore, this is a focus of our beliefs about U.S. medicine. Doctors have nothing to fear and much to gain from transparency, whether we talk about patient satisfaction scores or pharmaceutical company support. The last thing we doctors need to do is to raise suspicions by fighting efforts to improve transparency.

In fact, physicians should lead the way in support of more transparency.  Not only should we be supporting the Grassley/Kohl measure, but  we should encourage Congress to expand the measure to include payments to politicians and their campaign funds.  Senator Grassley hit the nail on the head when he said, “The goal of our legislation is to lay it all out, make the information available for everyone to see, and let people make their own judgments about what the relationships mean or don’t mean.  If something’s wrong, then exposure will help to correct it.  Like Justice Brandeis said almost a century ago, ‘sunshine is the best disinfectant.’”

This applies to both physicians and politicians.  I hope we find that politicians are as ethical as physicians are.  If so, the public will be well served.

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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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The issues raised in the This American Life program on health care reform resonated with me as they are common issues in my practice. As a dermatologist, one of the most common problems my patients have is psoriasis, a red, scaly rash that can affect different parts of the skin. These spots on the skin are caused by inflammation; in other words, they are caused by an overactive immune system. When psoriasis is particularly severe, the inflammation causes internal problems. Psoriasis is associated with arthritis, heart disease and depression.

Psoriasis can help us better understand the costs in our health care system. A patient with relatively mild psoriasis (a few red, scaly spots on the elbows and knees) has several options for treatment, the first being a high-potency topical cortisone medication, which typically clears up the spots if the patient uses it regularly. The topical cortisone medicines are reasonably safe; however, with persistent long-term use, cortisone medicines can cause some thinning of the skin. 

  • The high potency topical corticosteroids have been around a long time. Generic versions are available in creams and ointments and can be purchased for only a few dollars a tube; however, they can be messy.
  • If patients prefer less mess, they can choose newer formulations of topical corticosteroids, including a spray or foam. These are easier to use but significantly more expensive, costing $100 to $200 per container.
  • Patients also have the option of a vitamin D cream or ointment. These drugs are considerably more expensive than generic topical cortisones, but have fewer long-term side effects. One company developed a combination cortisone/vitamin D ointment that contains both products. While this is a convenient way to get the benefit of both drugs at once, a large tube of the medication can cost $800 or more.

The newer options may perform better on a patient’s psoriasis than the first, but patients tend to choose the drug based on the type of insurance they have: 

  • If patients are uninsured, have no prescription benefit or have a high co-payment for medications, they will often choose one of the low cost, generic topical cortisone medications.
  • If patients have good prescription coverage as part of their insurance, they may choose a branded cortisone medication. I had one patient who had terrific drug coverage in their insurance plan. When offered the choice of a low-cost generic cortisone, the less messy/more costly high strength cortisone in the spray, and the highest cost combination cortisone/vitamin D medication, the patient said, “Doc, give me the spray and the combination drug. I’ll try them both and see which I like better. My insurance covers the cost of my medications.”

The cost of medical care doesn’t follow the rules of cost that apply to most consumer goods because the people who consume the medical care aren’t the ones directly paying for it. If well insured patients are given a choice between a $10 drug that may work reasonably well and a $10,000 drug that might work 10 percent better, the patient is quite likely to choose the $10,000 drug. That kind of thing doesn’t happen at a place like Best Buy. People won’t pay a 100 times higher price for a computer that offers just 10 percent more RAM or a camera that has 10 percent more pixels.

If people were paying for care out of their own pockets, they wouldn’t buy $50 aspirin pills in the hospital —they would pay for less expensive products that met their needs. They would search for the best deals on medical care. Providers of services would be forced to compete on price, and the price of health care services would drop, making care more affordable for everyone.

There are people who argue that medical care is inherently different from other services we purchase, that we need health insurance companies to make decisions for us and to pay for things that we can’t afford. Certainly the growth in the cost of health care is different from other goods, but much of the high cost is caused by health insurance, not solved by health insurance.

Yes, there are emergencies and complexities that make purchasing health care somewhat different from purchasing other products. But it isn’t completely different — there are non-health care emergencies and other incredibly complex products and services that we purchase regularly.

The difference is that when we buy those products with our money, our tendency to search out low prices and only pay for those things that are worth the price. 

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