Non-equivalent Generic ADHD Drug

For years, pharmacies have been substituting lower-cost generic alternatives for methylphenidate hydrochloride (Concerta; Janssen Pharmaceuticals). However, the FDA has announced that two of the three available Concerta generics (Mallinckrodt Pharmaceuticals and UCB/Kudco) could no longer be considered equivalent to the brand and, in most states, could not be automatically substituted by pharmacies for the brand-name product. (A third product, sold by Actavis, was found to be equivalent to the brand. Johnson & Johnson makes Concerta as well as the Actavis generic.)

The FDA did state that it considered the drugs to be safe; data shows that their effectiveness began to wear off much more quickly-after about 7 hours. The FDA has allowed the companies to continue selling their drugs but gave the drug makers 6 months to either prove the drugs were equivalent, or remove them from the market. Now, 7 months later, the deadline has passed and the drugs are still being sold (together the drugs have managed to hold on to about 30% of the market). The difficulty partly reflects the controversy around the ability of generic companies to reproduce extended-release drugs that require more technical expertise to manufacture.

Physicians have been asked to change their prescriptions to the less-expensive, non-equivalent products. "This has gone on for months," said Dr. Kraus, chief of child psychiatry at Rush University Medical Center. "The lack of action by the F.D.A.", he said, "has undermined his faith in generics. We're as much in the black as the patients are. And then we find this out, and it's really frightening."

Concerta's mechanism of drug release is that it absorbs fluid and pumps the active drug out of a laser-cut hole. Under FDA rules, generic companies do not need to use the same mechanisms to produce copies of long-acting drugs. The generic product must simply release the drug into the body at the same rate as the brand-name drug. Mallinckrodt and UCB/Kudco products use different techniques, which may account for the shorter effectiveness.

Since Actavis is now the only approved substitute for Concerta, it has raised its prices.

"It's very puzzling to me," said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who has become an advocate for improving the quality of generic drugs. "If the F.D.A. rules it's not the same, how can it be sold? I don't understand the rationale for that happening."

New York Times (06/17/15) Thomas, Katie

http://www.webmd.com/add-adhd/news/20141114/two-generic-versions-of-adhd-drug-not-as-effective-fda

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/11/mallinckrodt-sues-fda-after-agency-downgrades-therapeutic-equivalence-rating-for-generic-concerta.html

News

ADHD Patch May Cause Leukoderma
The methylphenidate patch Daytrana for ADHD may cause permanent skin-color loss, according to the FDA. "Postmarketing reports of acquired skin depigmentation or hypopigmentation of the skin, consistent with chemical leukoderma, have been associated with the use of the Daytrana patch," the FDA notes. Although not physically harmful, it is disfiguring; the areas of skin color loss have ranged up to 8 inches in diameter.
http://www.medscape.com/viewarticle/846964

Medical Marijuana Lacking Evidence in 10 Different Conditions
Reports in Science Now show that researchers reviewed studies testing the effectiveness of medical marijuana on 10 different conditions and concluded that "there's very little reliable evidence to support the drug's use." This is according to a review published in the Journal of the American Medical Association. The review did find "moderate-quality evidence" for the use of medical marijuana to treat "chronic neuropathic pain or cancer pain." It also found that "trials testing the pain-relieving effects of medical marijuana in people with fibromyalgia, HIV-associated sensory neuropathy, rheumatoid arthritis, multiple sclerosis and other conditions did not show that it worked." The review reported only "low-quality evidence" that medical marijuana could "relieve nausea and vomiting in patients undergoing chemotherapy, that it could stimulate appetite in people with HIV to help them gain weight, that it could help people with insomnia and other sleep disorders get more rest, and that it could reduce the severity of tics in people with Tourette syndrome," and there was no reliable evidence that medical marijuana was useful to treat depression, anxiety disorders, psychosis, or to reduce eye pressure for patients with glaucoma.

LA Times (6/24/15) Kaplan

http://www.latimes.com/science/sciencenow/la-sci-sn-medical-marijuana-review-20150623-story.html

http://mailview.bulletinhealthcare.com/mailview.aspx?m=2015062401ashp&r=3276068-8d43#S1

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Did You Know ...

�that:

1. "We the people�" is being changed in practice to "We the government�"?
2. "Slavery" is defined as "a person who has lost control of himself/herself and is dominated by something or someone"; "one who is submissive or subject to a specified person or influence"?

Tip of the Week

Slavery, in some form, has been around for millennia and has affected virtually every nationality, race, culture, people, and group at different times. What appears to be developing in the U.S. is that many are becoming "slaves to the government."

As an Irish Statesman once said, "The only thing necessary for the triumph of evil is for good men to do nothing."

Think and act!

Looking Back

If your peach,
Keeps out of reach,
Better practice,
What we preach!
     Burma Shave

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